Research in this area considers which newly developed technologies or services should be adopted into widespread clinical practice.

Current Projects

Kidney DAR

The ARCHITECT and Alinity urine NGAL assays, urine NephroCheck test, and urine and plasma BioPorto NGAL tests to help assess the risk of acute kidney injury for people who are being considered for admission to critical care (Diagnostic Assessment Review) 

As part of the NICE Diagnostic Assessment Review (DAR) process, the Aberdeen external assessment group (EAG) were commissioned to conduct a systematic review of diagnostic accuracy evidence and develop a decision analytic model to determine the cost-effectiveness of the candidate tests.

This assessment is ongoing and can be followed at: Tests to help assess risk of acute kidney injury for people being considered for critical care admission (ARCHITECT and Alinity i Urine NGAL assays, BioPorto NGAL test and NephroCheck test). In development [GID-DG10028].

HERU researchers involved in this research project: Elisabet Jacobsen, Dwayne Boyers and Graham Scotland

External collaborators: Brazzelli, M., Cummins, E. and Campbell, M. (Health Services Research Unit (HSRU), University of Aberdeen).

BSRBR-AS: British Society for Rheumatology Biologics Register in Ankylosing Spondylitis

The British Society for Rheumatology Biologics Register – Ankylosing Spondylitis (BSRBR-AS) was established to monitor the safety of biologic treatments for patients with AS and to determine how such treatments affect symptoms, function, co-morbidities and quality of life. The study is a prospective cohort enrolling two groups of patients meeting international criteria for AS and who are naïve to biologic therapy: those commencing biologic therapy (etanercept or adalimumab) and those who are not commencing biologic therapy.

HERU researchers involved in this research project: Paul McNamee

External collaborators: G Macfarlane, G Jones (Other Applied Health Sciences, University of Aberdeen); K Hyrich, K Watson, M Lunt, D Symmons (Arthritis Research UK Epidemiology Unit, University of Manchester); R Sturrock (Centre for Rheumatic Diseases, University of Glasgow); L Kay (Freeman Hospital, Newcastle) and A Neilson (University of Edinburgh)

 

CATHETER II Study

Randomised controlled trial comparing the clinical and cost-effectiveness of various washout policies versus no washout policy in preventing catheter associated complications in adults living with long-term catheters

Urinary catheters are soft tubes inserted into the bladder to drain urine to a collection bag or valve. Current best practice for LTC care includes educating patients on how to look after their catheter. Patients normally change their catheter bag every week while the catheter itself is changed by a nurse every 10-12 weeks. Despite this, complications such as blockages, urinary tract infections and urinary incontinence can occur with LTC use. Blockages are one of the most common complications, and can lead to urine retention, incontinence, severe pain, anxiety and the need for an emergency catheter change.

There are two broad strategies to deal with the prevention and management of catheter blockage: more frequent change of the catheter and/or the use of liquid washout solutions to flush the catheters. LTC washouts are widely used in clinical practice to prevent LTC blockage but there is limited evidence to recommend their widespread use or stoppage. In CATHETER II, participants with a LTC are being randomised to receive standard catheter care with or without weekly catheter washouts (citric acid or saline). The alternative policies will be compared on a range of outcome measures, including the number of catheter blockages; catheter-associated urinary tract infections; health-related quality of life; and costs incurred by patients and NHS.

HERU researchers involved in this research project: Graham Scotland and Mary Kilonzo

External collaborators: Abdel-Fattah, M., N'Dow, J., Murchie, P., MacLennan, S., Myint, P., Omar, I. (Institute of Applied Health Sciences, University of Aberdeen); MacLennan, G. (Health Services Research Unit (HSRU), University of Aberdeen).

Quality of life in older patients with CKD (BiCARB study)

Does oral sodium bicarbonate therapy improve function and quality of life in older patients with chronic kidney disease and low-grade acidosis? A randomised controlled trial

BICARBA randomised controlled trial is being undertaken to test whether bicarbonate treatment makes older people with advanced kidney disease healthier. 380 patients will receive either bicarbonate or dummy (placebo) tablets three times a day for two years.

We test muscle strength and bulk, walking and balance ability, quality of life, kidney, bone and blood vessel function at intervals over the two-year period. We record blood pressure and side effects, record falls, admissions to hospital and contact with GPs, and also test the cost of treatment against the cost of not treating.

International Standard Randomised Controlled Trial Number Register number ISRCTN09486651

HERU researchers involved in this research project: Paul McNamee and Huey Chong.

External collaborators: M Witham (University of Dundee), A Avenell (HSRU, University of Aberdeen) and R Soiza (School of Medicine, Medical Sciences and Nutrition, University of Aberdeen).

 

Enzalutamide with androgen deprivation therapy for treating metastatic hormone-sensitive prostate cancer (Single Technology Assessment)

As part of the NICE single technology appraisal process, the Aberdeen evidence review group (ERG) was commissioned to critically review the company’s submission related to the clinical and cost-effectiveness of Enzalutamide with androgen deprivation therapy for treating metastatic hormone-sensitive prostate cancer. The appraisal is ongoing and NICE are expected to publish guidance in 2020: Enzalutamide with androgen deprivation therapy for treating metastatic hormone-sensitive prostate cancer ID1605. In development [GID-TA10488].

HERU researchers involved in this research project: Graham Scotland and Daniel Kopasker

External collaborators: Ramsay, C., Brazzelli, M., Cummins, E. and Campbell, M. (Health Services Research Unit (HSRU), University of Aberdeen).

 

Follow-up study for PROSPECT (PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trial)

The lifetime risk of undergoing surgery for prolapse is nearly 10%. There are several different traditional surgical techniques, none of which have been properly evaluated. The initial study embedded two large RCTs investigating different surgical techniques for two distinct patient populations of women with vaginal prolapse (primary and secondary) within a comprehensive cohort of all patients.

The economic evaluation investigated the costs and cost-effectiveness of the interventions from the perspective of the NHS and for the women and their families. Information on the cost of the intervention and the use of primary and secondary NHS services by the women (including referral for specialist management) were collected, as were personal costs to the women (such as costs of travelling to appointments and work/social restrictions).

Trial participants were asked to complete the EQ–5D at baseline and at 6, 12 and 24 months after randomisation, and responses were used to compute QALYs. In a sensitivity analysis, QALYs were also estimated from the SF–12 completed at the same time points.

Since the long-term effects of the treatments are not known, participants are being followed up over an extended period of five years. These longer-term data will be used to update model based estimates of cost-effectiveness that were previously derived by extrapolation of the data observed to 24 months. 

HERU researchers involved in this research project: Mary Kilonzo and Dwayne Boyers

External collaborators: C. Glazener, A. Grant, J. Norrie, G. MacLennan, A. McDonald, G. McPherson (Health Services Research Unit (HSRU), University of Aberdeen); A.R.B. Smith, (St. Mary’s Hospital Manchester); R.M. Freeman (Plymouth Hospital NHS Trust); C. Bain, K. Cooper (NHS Grampian); S. Hagan (Glasgow Caledonian University); I.B.G. Montgomery (Aberdeen).

LENS: Lowering Events in Non-proliferative retinopathy in Scotland

Diabetic retinopathy (DR) and diabetic maculopathy are common microvascular complications of diabetes mellitus. At an advanced (clinically significant) stage, these complications can lead to visual loss and blindness. While the risk of cardiovascular events in DM has been substantially reduced by various preventive strategies, there are few effective options to slow the progression of microvascular complications. However, sub-studies from two large cardiovascular trials have suggested that a drug called fenofibrate may be effective in slowing the progression of DR (measured as a composite tertiary outcome). Whilst suggestive of some benefit, these sub-studies do not provide definitive evidence.

The LENS study aims to provide better evidence by randomising 1,060 individuals, at moderate to high risk of progressing to clinically significant DR, to either fenofibrate or placebo for at least a median of four years. Participants will be followed up for progression to clinically significant DR, retinal laser therapy, vitrectomy or intra-vitreal injection of medication owing to DR, health-related quality of life, and health service resource use.

The economic evaluation will take the form of cost–utility analysis conducted alongside the trial, and modelling will be used to extrapolate longer-term cost-effectiveness if necessary.

More information on the trial is available at the NIHR project portfolio.

The trial is registered in the ISRCTN  Registry: ISRCTN15073006

HERU researchers involved in this research project: Graham Scotland

External collaborators: D Preiss, J Armitage (University of Oxford); J Olsen (NHS Grampian), J Logue, N Sattar, H Murray (University of Glasgow), G Leese and H Colhoun (University of Dundee)

Long term follow up for VUE - Vault or Uterine prolapse surgery Evaluation

Long term follow up for VUE - Vault or Uterine prolapse surgery Evaluation: Two parallel randomised controlled trials of surgical options for upper compartment (uterine or vault) pelvic organ prolapse

Gynaecologists have recognised for some time that both anatomical failure and recurrence of prolapse symptoms after surgery are common: one in three women who have a prolapse operation will go on to have another, though not necessarily in the same compartment.

More recently, it has also been recognised that surgery can be followed by a greater impairment of quality of life than from the original prolapse itself (for example the development of new-onset urinary incontinence after surgery or prolapse at a different site). Whilst anterior and posterior prolapse surgery is most common (90% of operations), around 43% of women also have a uterine (34%) or vault (9%) procedure at the same time. Indeed, this demonstrates that women who have a hysterectomy have around a 27% chance of needing a subsequent vault prolapse repair. 

This extended follow-up of women randomised to the VUE trial is being conducted to better inform lomg-term clinical and cost – effectiveness of the alternative surgical procedures. 

HERU researchers involved in this research project: Mary Kilonzo

External collaborators: C. Glazener, S. Breeman, G. McPherson, A. McDonald, J. Norrie, A. Elders (Health Services Research Unit (HSRU), University of Aberdeen); I.B.G. Montgomery (Aberdeen); S. Hagen (Glasgow Caledonian University); A.R.B. Smith (St. Mary’s Hospital Manchester); R.M. Freeman (Plymouth Hospital NHS Trust); C. Bain, K. Cooper (NHS Grampian).

Lorlatinib for previously treated ALK-positive advanced non-small-cell lung cancer (Single Technology Assessment)

As part of the NICE single technology appraisal process, the Aberdeen evidence review group (ERG) was invited to critically review the company’s submission related to the clinical and cost-effectiveness of Lorlatinib for previously treated ALK-positive advanced non-small-cell lung cancer. The appraisal is ongoing and NICE are expected to publish guidance in 2020: Lorlatinib for treating ALK-positive advanced non-small-cell lung cancer [ID1338] In development [GID-TA10317]

HERU researchers involved in this research project: Graham Scotland and Daniel Kopasker

External collaborators: Ramsay, C., Brazzelli, M., Cummins, E. and Campbell, M. (Health Services Research Unit (HSRU), University of Aberdeen).

 

MASTER: Male synthetic sling versus Artificial urinary Sphincter Trial for men with urodynamic stress incontinence after prostate surgery: Evaluation by Randomised trial

Around one in five men who undergo prostate surgery for cancer or benign disease need to use incontinence pads because of leakage of urine when they walk around, cough or do any physical exertion. This impacts upon quality of life, can lower self-esteem and productivity, and can damage personal relationships. At present the only effective surgical treatment is insertion of a plastic artificial urinary sphincter (AUS) device which involves a major operation to place an inflatable cuff around the urine pipe close to the bladder, and inflating it to prevent leakage. A new male sling has been developed which, when inserted under the urine pipe, supports the outlet of the bladder but doesn’t need a pump. It is less expensive for the NHS (around £6,000) and easier to insert, but some men may still need a subsequent operation to insert an AUS if they feel their incontinence has not improved enough. It is also uncertain whether there are other advantages or disadvantages compared to the AUS, and whether men will be as satisfied with the results.

The ISRCTN for the trial is ISRCTN49212975 and more details are available at the project website.

HERU researchers involved in this research project: Mary Kilonzo

External collaborators: P Abrams (North Bristol NHS Trust); M Drake (University of Bristol); C Glazener, J Norrie, C Ramsay, C Boachie, K McCormack, G McPherson, A McDonald (HSRU, University of Aberdeen); R Pickard (University of Newcastle upon Tyne) and N Cotterill (University of Bristol)

 

RAACENO: Reducing Asthma Attacks in Children using Exhaled Nitric Oxide as a biomarker to inform treatment strategy - a randomised controlled trial

Primary research question: Is a schedule of FeNO plus symptom treatment more efficacious in reducing asthma when compared to a symptom-only schedule? Secondary research questions: (1) Is a FeNO plus symptom treatment schedule more efficacious in improving asthma control and spirometry when compared to a symptom-only schedule? (2) Are there correlations between changes in repeated measurements of FeNO and sputum eosinophil count? (3) Is sputum eosinophilia associated with increased risk of asthma exacerbations but not asthma control over the following three months? (4) Is asthma treatment guided by symptoms plus FeNO more efficacious in reducing risk of asthma exacerbations where FeNO and sputum eosinophilia are concordant? (5) What are the relative costs, effects and cost-effectiveness of a FeNO plus symptom treatment schedule compared to a symptom-only schedule over 12 months? (6) Is FeNO plus symptom treatment acceptable to children and their parents? What are their and the research nurses’ perceptions?

More information on the project is available on the RAACENO website.

HERU researchers involved in this research project: Paul McNamee, Graham Scotland

External collaborators: S Turner, H Morgan (HSRU, University of Aberdeen); S Fielding, D Price (Applied Health Sciences, University of Aberdeen); M Thomas (University of Southampton) and E Gaillard (University of Leicester)

 

SIMS Trial

SIMS Trial: Adjustable anchored single-incision mini-slings versus standard tension-free mid-urethral slings in the surgical management of female stress urinary incontinence: a pragmatic multicentre non-inferiority randomised controlled trial

Stress urinary incontinence (SUI) is the most common type of urinary incontinence (UI) in pre-menopausal women, accounting for almost 50% of cases. Surgical procedures for the management of female SUI have been continuously evolving over the last four decades with the ultimate aim of providing an effective and truly ambulatory surgical procedure. In the most common surgical procedure, tension-free, standard mid-urethral slings (SMUS), a synthetic mesh (tape) is placed under the urethra to add support by creating a sub-urethral hammock. An alternative procedure known as adjustable anchored single-incision mini-sling (SIMS) is designed to have advantages over tension-free SMUS in that it avoids the blind insertion trajectory into the pelvic cavity or the thigh muscles while maintaining the concept of the hammock support to the urethra. The aim of the current study is to conduct a health economic evaluation alongside a randomised controlled trial comparing these two interventions.

The SIMS Trial builds on earlier work in the SIMS pilot study

Project website for the SIMS Trial, at the Centre for Healthcare Randomised Trials.

The ISRCTN is ISRCTN93264234

HERU researchers involved in this research project: Mary Kilonzo

External collaborators: M Abdel-Fattah, J N'Dow (Other Applied Health Sciences, University of Aberdeen); R Assassa (Mid Yorkshire Hospitals NHS Trust); G MacLennan, K McCormack, J Norrie (HSRU, University of Aberdeen); J Wardle (Continence Foundation)

 

TYRX Absorbable Antibacterial Envelope for preventing infection from cardiac implantable electronic devices (Single Technology Assessment)

The Aberdeen Health Technology Group was commissioned by NICE as the Evidence Review Group (ERG) for this Single Technology Assessment (STA). The ERG reviewed all the clinical and economic evidence submitted by the company (Medtronic).

One randomised controlled trial (RCT) comparing the use of TYRX versus standard practice (no TYRX) formed the main source of clinical evidence (the WRAP-IT RCT). WRAP-IT was a prospective, single blind multicentre RCT involving nearly 7000 participants. The submitted cost-effectiveness evidence was based on decision tree informed by the WRAP-IT trial and other sources of evidence. The model recreated the possible care pathways (i.e. no infection, infection, partial/complete extraction with/without device replacement) out to 12 months post-surgery, and applied expected lifetime costs and QALYs, adapted from a previous NICE STA, as final pay-offs for survivors at 12 months.

The STA for TYRX Absorbable Antibacterial Envelope for preventing infection from cardiac implantable electronic devices is still ongoing and so the outcome of this project is not yet available. This assessment can be followed on the NICE website: TYRX Absorbable Antibacterial Envelope for preventing infection from cardiac implantable electronic devices [ID1440].

HERU researchers involved in this research project: Rodolfo Hernández and Graham Scotland

External collaborators: Ramsay, C., Brazzelli, M., Cummins, E. and Campbell, M. (Health Services Research Unit (HSRU), University of Aberdeen).

 

UK-REBOA: The UK Resuscitative Endovascular Balloon Occlusion of the Aorta

REBOA is currently used in a small number of trauma centres in the USA, France, Scandinavia, and Japan, and in a single centre in the UK. Whilst REBOA has shown early promise, recent observational studies have provided conflicting evidence as to its potential benefits. A robust evaluation of its feasibility, safety, efficacy and cost-effectiveness is urgently required.

The study will randomise a maximum of 120 patients from 10 large MTCs across the UK. The total sample size is constrained by the limited number of centres and the relative infrequency of trauma patients with life-threatening torso haemorrhage. Due to this constrained sample size we have adopted a Bayesian group-sequential trial design.

The study will include a full economic evaluation conducted alongside a Bayesian group-sequential randomised controlled trial. The primary economic outcome will be lifetime incremental cost per Quality Adjusted Life Year (QALY) gained, from a health care provider perspective and from a personal perspective (time to return to work or usual activities). Routine data will be collected where possible alongside the trial to estimate resource use with minimal patient burden. The 6 month follow up will include quality of life and return to normal activities questionnaires. A Markov decision analysis model will be used to extrapolate short term trial outcomes over a lifetime horizon. The project will also report data on shorter term (six month) costs to the NHS, mortality, EQ-5D-5L and extended Glasgow Outcome Score (GOS-E) at 6 month follow up. A value of information analysis will be included to assess the need for further research to address any remaining uncertainty in cost-effectiveness.

HERU researchers involved in this research project: Dwayne Boyers

UK REBOA Trial - Resuscitative endovascular balloon occlusion of the aorta for traumaExternal Collaborators:
rinicipal Investigators: Jansen, J. and Campbell, M. (University of Aberdeen)

More information about this project is available on the REBOA project website.

 

VUE: Vault or Uterine prolapse surgery Evaluation: two parallel randomised controlled trials of surgical options for upper compartment (uterine or vault) pelvic organ prolapsed

Gynaecologists have recognised for some time that both anatomical failure and recurrence of prolapse symptoms after surgery are common: one in three women who have a prolapse operation will go on to have another, though not necessarily in the same compartment.

More recently, it has also been recognised that surgery can be followed by a greater impairment of quality of life than from the original prolapse itself (for example the development of new-onset urinary incontinence after surgery, or prolapse at a different site). Whilst anterior and posterior prolapse surgery is most common (90% of operations), around 43% of women also have a uterine (34%) or vault (9%) procedure at the same time. Indeed, this demonstrates that women who have a hysterectomy have around a 27% chance of needing a subsequent vault prolapse repair.

These data are derived from the first 700 women recruited in PROSPECT, a large HTA-funded UK RCT of anterior or posterior prolapse surgery with or without the use of mesh (HTA No. 07/60/18). In VUE, the opportunity has arose to then switch from randomising between lower compartment surgery to trials involving different surgical options for upper compartment prolapse (uterine and vault).

VUE logoHERU researchers involved in this research project: Mary Kilonzo

External collaborators: C Glazener, S Breeman, G McPherson, A McDonald, J Norrie, A Elders (HSRU, University of Aberdeen); I.B.G. Montgomery, (University of Aberdeen); S Hagen (Glasgow Caledonian University); A.R.B. Smith (St. Mary’s Hospital Manchester); R.M Freeman (Plymouth Hospital NHS Trust); C Bain and K Cooper (NHS Grampian)

 

 

Recently Completed Projects

Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia (Single Technology Assessment for NICE)

ARCHIVED


Primary hypercholesterolaemia is a form of dyslipidaemia characterised by abnormalities of lipoprotein transport, associated with high concentrations of cholesterol in the blood. Mixed dyslipidaemia is defined as elevations in LDL cholesterol and triglyceride (TG) levels that are often accompanied by low levels of HDL cholesterol. People with hypercholesterolaemia and mixed dyslipidaemia are at increased risk of cardiovascular disease (CVD) due to the fact that long-term high concentrations of cholesterol are known to accelerate atherosclerosis, the build-up of fatty deposits in the arteries.

This project was carried out as part of the National Institute for Health and Care Excellence (NICE) Single Technology Appraisal Process. The company responsible for alirocumab (Sanofi Ltd) submitted an evidence review and an economic model assessing the cost-effectiveness of alircoumab, alone or in combination with statin +/- ezetimibe, against no treatment or statin alone or in combination with ezetimibe, for the treatment of primary hypercholesterolaemia and mixed dyslipidaemia. The Aberdeen HTA group were commissioned to act as the Evidence Review Group (ERG) for the project, and to provide an independent report reviewing the company’s evidence submission.

Outcome and Translation

Following consideration of the company submission and the ERG reports, the NICE appraisal committee recommended alirocumab as a treatment option for certain subgroups of people with heterozygous-familial and non-familial hypercholesterolaemia and dyslipidemia:

National Institute for Health and Care Excellence (2016) Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia, Technology Appraisal Guidance [TA393], London: NICE.  

 

STA: Brentuximab vedotin for relapsed or refractory systemic anaplastic large cell lymphoma (Single Technology Assessment for NICE)

As part of the NICE single technology appraisal process, the Aberdeen evidence review group (ERG) critically reviewed the company’s submission related to the clinical and cost-effectiveness of brentuximab vedotin for treating relapsed or refractory anaplastic large cell lymphoma (sALCL). In terms of clinical effectiveness, the company’s submission focussed on the findings from one single single arm open label, non-randomised, phase II study (SG035-0004) with 58 patients with relapsed or refractory sALCL after treatment failure with at least one other therapy and an Eastern Cooperative Oncology Group (ECOG) performance status less than 2.

The primary clinical outcome in the study was objective response rate. Secondary outcome data, namely progression free survival and overall survival were used to extrapolate the study’s findings and populate a partitioned survival economic model.

The committee’s preferred economic modelling assumptions resulted in a base case deterministic incremental cost-effectiveness ratio (ICER) of £18,324 per quality adjusted life year (QALY) gained. The preferred probabilistic ICER was £20,399 per QALY gained. The committee considered different assumptions surrounding extrapolation of PFS and OS data and noted the impact of alternative survival modelling methods on results. 

Outcome and translation

After consideration of all the evidence, NICE have issued the following recommendation in their Final Appraisal Determination for brentuximab vedotin:

“Brentuximab vedotin is recommended as an option for treating relapsed or refractory systemic anaplastic large cell lymphoma in adults, only if:

  • They have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and

  • The company provides brentuximab vedotin according to the commercial access agreement with NHS England.”

HERU researchers involved in this research project: Graham Scotland, Dwayne Boyers and Elisabet Jacobsen

 

CLASS: Comparison of LAser, Surgery and foam Sclerotherapy

Randomised controlled trial comparing foam sclerotherapy, alone or in combination with endovenous laser therapy, with conventional surgery as a treatment for varicose veins

A randomised controlled trial comparing foam sclerotherapy, alone or in combination with endovenous laser therapy, with conventional surgery as a treatment for varicose veins. The study involves participants from hospitals throughout the UK and in addition to clinical measures, NHS and patient costs were assessed, and QALYs were derived from responses to the EQ–5D and SF–36 at baseline, six weeks and six months. Given that the initial report was based on follow-up data to six months, results were extrapolated to a longer time horizon using an economic decision analytic model. 

Outcome and translation

The trial has now completed a period of extended follow-up to five years post randomisation. Results based on this extended follow-up are are now published, and suggest that laser has the highest probability of being cost-effective at thresholds commonly applied in the UK NHS. 

HERU researchers involved with this research project: Luke Vale, Graham Scotland, Emma Tassie and Maria Dimitrova

External Collaborators: J Brittenden, K Cassar, P Bachoo, J Norrie (School of Medicine, Medical Sciences and Nutrition, University of Aberdeen); MJ Gough, IAD Mavor, J Scott (University of Leeds); P McCollum (University of Hull); IC Chetter (Hull NHS Trust); J Burr, M Campbell and C Ramsay (HSRU, University of Aberdeen)

 

 

STA: Dupilumab for treating moderate to severe atopic dermatitis after topical treatments

As part of the NICE single technology appraisal process, the Aberdeen evidence review group (ERG) was invited to critically review the company’s submission related to the clinical and cost-effectiveness of Dupilumab for treating moderate to severe atopic dermatitis after topical treatments. 

Outcome and Translation

This appraisal is now complete. Based on the evidence submitted by the company, and the critique provided by the evidence review group, NICE developed recommendations on the use of Dupilumab for treating moderate to severe atopic dermatitis in adults: Dupilumab for treating moderate to severe atopic dermatitis after topical treatments [ID1048] 

HERU researchers invovled in this project: Rodolfo Hernández, Maria Dimitrova and Graham Scotland 

External collaborators:  Ramsay, C., Brazzelli, M; Cummins, E; Campbell, M. (Health Services Research Unit (HSRU), University of Aberdeen).

 

EAGLE: Effectiveness, in Angle closure Glaucoma, of Lens Extraction

The active group had early lens extraction, i.e. cataract surgery. The control group had standard care where laser treatment was used to open drainage but did not improve sight. The outcomes were changes in quality of life; visual field; intra-ocular pressure; angle closure; need for additional medications; need for further surgery (trabeculectomy). The costs of the treatment and subsequent management for both interventions were estimated and incremental cost per QALY gained calculated, based on the responses to the EQ–5D.

Approximately 23 specialist centres in the UK, 7 centres in East Asia (from Singapore, Malaysia, Hong Kong and Taiwan), and 1 in Australia participated in this trial.

Outcome and Translation

This international, multicentre trial determined the best way of treating angle closure glaucoma, one of the main causes of blindness. The results of the study are being disseminated in a series of peer reviewed papers, keynote presentations and a lay summary.

HERU researchers involved in this research project: Graham Scotland, Mehdi Javanbakht (HERU)

External collaborators: A Azaura-Blanco, C Ramsay, J Norrie (HSRU, University of Aberdeen); T Aung (Singapore National Eye Centre); J Burr (University of St. Andrews); P Foster (UCL); D Friedman (The Johns Hopkins Hospital); J Lai (United Christian Hospital); Da-Wen Lu (Tri-Services General Hospital); C Lui (Taipei Veterans General Hospital); W Nolan (Sandwell and West Birmingham Hospital); J See (National University Hospital) and D Wong (University of Hong Kong)

International Standard Randomised Controlled Trial Number Register (ISRCTN) 44464607.

The National Institute for Health Research (NIHR) have produced an NIHR Signal for this research project.

 

eTHoS: eiTher Haemmorrhoidectomy or Stapled haemmorrhoidopexy for haemmorrhoidal diseas

ARCHIVED


A pragmatic multi-centre randomised controlled trial comparing stapled haemorrhoidopexy to conventional excisional haemorrhoidectomy

Haemorrhoids are common in all age groups from mid-teens onwards. In England in 2006/2007, approximately 25,000 haemorrhoidal procedures were performed as hospital day-case or inpatient admissions, placing a significant burden on health service resources. Stapled haemorrhoidopexy (SH) offers a new alternative to traditional haemorrhoidectomy (TH).

There have been multiple randomised controlled trials (RCTs) comparing SH with TH and these have been analysed in two recent systematic reviews and an HTA monograph. SH appears to be associated with less pain in the immediate post-operative period, but a higher rate of recurrence in the longer term and need for further surgery. However, these findings are based on data from small trials, all with methodological flaws and providing limited data on utilities in the early post-operative period.

The eTHoS RCT is comparing SH with CH. The primary outcomes are:

  • (1) Health-related quality-of-life profile derived from the EQ–5D;
  • (2) Incremental cost per quality-adjusted life year (QALY) at two years.

Participants have now been followed up to two years. The results of the trial are currently being disseminated through peer reviewed publications and other activities. The trial results will guide NHS decision making on the optimal approach to the surgical management of haemorrhoids.

Outcome and translation

The trial results indicated that TH is both more clinically effective and less costly when compared with SH. It is more painful in the short term, but return to normal activity rates are equal. In addition to superior quality of life measures, haemorrhoid symptoms scores, continence and tenesmus rates and the need for further surgery were all lower in TH. TH is, therefore, a superior surgical treatment for the management of grades II to IV haemorrhoids when compared with SH. Given the current financial status of the NHS, commissioners of healthcare may consider being more prescriptive about procedures being offered for haemorrhoids.

HERU researchers involved in this research project: Mary Kilonzo

External collaborators: AJ Watson (NHS Highland); M Loudon (Aberdeen Royal Infirmary); L Vale (University of Newcastle); D Jayne (Leeds Teaching Hospitals NHS Trust); A Maw (Glan Clwyd Hospital); F Curran (Stepping Hill Hospital); S Brown (Northern General Hospital); J Cook, J Norrie (HSRU, University of Aberdeen); J Burr (University of St. Andrews) and B Buckley (National University of Ireland)

Further details on this project are available on the project page on the Health Services Research Unit website and on the eTHoS project site.

International Standard Randomised Controlled Trial Number Register: ISRCTN80061723

The National Institute for Health Research (NIHR) have produced an NIHR Signal for this research project.

 

STA: Eluxadoline for treating irritable bowel syndrome with diarrhoea

As part of the NICE single technology appraisal process, the Aberdeen evidence review group (ERG) critically reviewed the company’s submission related to the clinical and cost-effectiveness of Eluxadoline for treating irritable bowel syndrome with diarrhoea. In terms of clinical effectiveness, the company’s submission focused on evidence from 3 double-blind randomised controlled trials: IBS‑2001 (a phase 2 trial), IBS‑3001 and IBS‑3002 (both phase 3 trials). The economic evidence was based on a Markov decision model informed by the clinical evidence and structured around 16 health states defined by changes in IBS‑QoL (four categories) and pain from baseline (two categories), and treatment status (on and off-treatment). 

Outcome and Translation

Based on consideration of evidence submitted by Allergan and a review of these submissions submitted by the evidence review group, NICE recommended Eluxadoline as an option for treating irritable bowel syndrome with diarrhoea in adults meeting certain criteria. Details of the appraisal and the full guidance are available on the NICE website: https://www.nice.org.uk/guidance/ta471 

HERU researchers invovled in this project:  Graham Scotland

External collaborators:  Ramsay, C., Brazzelli, M; Cummins, E; Campbell, M. (Health Services Research Unit (HSRU), University of Aberdeen).

 

STA: Enzalutamide for treating non-metastatic hormone-relapsed prostate cancer (Single Technology Assessment)

As part of the NICE single technology appraisal process, the Aberdeen Evidence Review Group (ERG) was invited to critically review the company’s submission related to the clinical and cost-effectiveness Enzalutamide for treating non-metastatic hormone-relapsed prostate cancer.

Outcome and Translation

Following consideration of evidence submitted by the company, and a review of the submission submitted by the evidence review group, NICE decided not to recommend Enzalutamide for treating high-risk hormone-relapsed non-metastatic prostate cancer in adults. Details of the appraisal and the full guidance are available on the NICE website: Enzalutamide for hormone-relapsed non-metastatic prostate cancer. Technology appraisal guidance [TA580].

HERU researchers involved in this project: Huey Chong and Graham Scotland

External collaborators: C., Ramsay, M. Brazzelli, and M. Campbell (Health Services Research Unit, (HSRU), University of Aberdeen

 

Got-it-trial: A pragmatic, adaptive, sequential, placebo controlled randomised trial to determine the effectiveness of glycerine triturate for retained placenta

Retained placenta (RP) affects 2% of vaginal deliveries, which equates to nearly 11,000 women in the UK per annum, and is a major cause of post-partum haemorrhage with major obstetric haemorrhage itself affecting nearly 1 in 180 women and being the commonest cause of significant maternal morbidity.

It was hypothesised that sublingual glyceryl trinitrate (GTN) spray could reduce the need for manual removal of the placenta (MROP) following failure of the current approach to management (oxytocin and controlled cord traction). GTN was compared with placebo on outcomes measured over four interrelated domains – clinical, safety, patient-sided and economic.

The economic evaluation took the form of a cost–consequence analysis, relating differences in costs to the health service out to six weeks post-delivery with differences on the clinical, safety, and patient-sided outcomes.

Outcome and translation

The results that have now been published showed GTN to be ineffective for the management of retained placenta. There was no significant impact on health service costs. 

International Standard Randomised Controlled Trial Number Register: ISRCTN88609453

HERU researchers involved in this research project: Graham Scotland

External collaborators: F Denison, J Lawton (University of Edinburgh); J Norrie, G McPherson (HSRU, University of Aberdeen) and S Brook-Smith (NHS Lothian)

 

HEALTH: Hysterectomy or Endometrial AbLation Trial for Heavy menstrual bleeding

A multicentre randomised controlled trial comparing laparoscopic supra-cervical hysterectomy with second generation endometrial ablation trial for the treatment of heavy menstrual bleeding

One woman in five in the UK experiences HMB, which can have a major impact on her quality of life. It is the fourth most common reason for women to attend gynaecology outpatient clinics and accounts for 20% of all gynaecology outpatient referrals. The NICE guideline on HMB recommends EA as well as hysterectomy as options for women with HMB. However, up to a quarter of women who undergo EA require subsequent gynaecological surgery and despite the demonstrated clinical and cost-effectiveness of hysterectomy, concerns remain about its invasiveness and the risks of short- and long-term morbidity associated with the procedure.

Unlike conventional hysterectomy, the more recent approach of laparoscopic supra-cervical hysterectomy (LASH) is minimally invasive, quick, relatively easy to learn and associated with low morbidity, short hospital stay (under 24 hours) and rapid recovery time. HEALTH is a multicentre randomised controlled trial (RCT) comparing LASH with second-generation EA (the current first line surgical treatment for HMB).

The trial is registered at the ISRCTN Registry: ISRCTN49013893

HERU researchers involved in this research project: Graham Scotland

External collaborators: S Bhattacharya (Other Applied Health Sciences, University of Aberdeen) K Cooper (NHS Grampian); J Clark (Birmingham Women’s Hospital); J Hawe (Countess of Chester NHS Foundation Trust); K Phillips (Hull and East Yorkshire Hospitals NHS Trust); R Hawthorne (NHS Greater Glasgow and Clyde); J Norrie and J Cook (HSRU, University of Aberdeen)

 

Inotersen for treating hereditary transthyretin-related amyloidosis (NICE Highly Specialised Technologies)

To critically appraise the company submitted evidence to NICE’s Highly Specialised Technologies (HST) programme, regarding the clinical and cost-effectiveness of Inotersen (Tegsedi®, Ionis USA Ltd, London, UK) for treating Hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN)

As part of the NICE HST process, the Aberdeen evidence review group (ERG) were commissioned to critically review the company’s submission related to the clinical and cost-effectiveness of Inotersen for treating Hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN).

The clinical-effectiveness evidence focussed on a phase 3, double-blind, placebo-controlled, multi-centre RCT (NEURO-TTR) followed by an open label extension study in the same population. The study randomised 173 participants (2:1 to inotersen 300mg or placebo). The co-primary outcomes were change from baseline to week 66 in A) Modified neuropathy impairment score +7 composite score (mNIS+7) and B) Norfolk Quality of Life–Diabetic Neuropathy (Norfolk QoL-DN) questionnaire total score.

The economic evidence was based on a Markov cohort state transition model, with a lifetime horizon, from an NHS and PSS perspective. The model described the progression of disease according to Coutinho disease stages using transition probabilities based on the NEURO-TTR study.

Outcome and Translation

Based on consideration of evidence submitted by Tegsedi® and a review of the company submitted evidence by the evidence review group, NICE recommended Inotersen, within its marketing authorisation, as an option for treating stage 1 and stage 2 polyneuropathy in adults with hereditary transthyretin amyloidosis under the terms of a commercial arrangement.

Details of the appraisal and the full guidance are available on the NICE website: Inotersen for treating hereditary transthyretin amyloidosis. Highly specialised technologies guidance [HST9].

HERU researchers involved in this project: Dwayne Boyers and Graham Scotland 

External collaborators: C. Ramsay, M. Brazzelli, E. Cummins and M. Campbell (Health Services Research Unit (HSRU), University of Aberdeen)

 

Lanadelumab for preventing recurrent attacks of hereditary angioedema (Single Technology Assessment)

As part of the NICE single technology appraisal process, the Aberdeen evidence review group (ERG) critically reviewed the company’s submission related to the clinical and cost-effectiveness of Lanadelumab for preventing recurrent attacks of hereditary angioedema. 

Outcome and Translation

Based on consideration of evidence submitted by the company and the review of the submitted evidence by the Aberdeen evidence review group, NICE recommended Lanadelumab as an option for preventing recurrent attacks of hereditary angioedema in people aged 12 and older. Certain restrictions were applied to the recommendations, full details of which can be found on the NICE website: Lanadelumab for preventing recurrent attacks of hereditary angioedema. Technology appraisal guidance [TA606].

HERU researchers involved in this project: Elisabet Jacobsen and Graham Scotland 

External collaborators: C. Ramsay, M. Brazzelli, E. Cummins and M. Campbell (Health Services Research Unit (HSRU), University of Aberdeen)

 

Maintained physical activity and physiotherapy in the management of distal arm pain

The best approach to managing arm pain is unclear. Patients are often advised to rest and avoid purported harmful activities, and are commonly referred to physiotherapy. However, none of these strategies are evidence-based and there are reasons to suppose that rest may be inferior to remaining active. Well-conducted randomised trials are needed to resolve these uncertainties and to improve outcomes. This project addressed this need through the conduct of a multicentre randomised trial together with a cost–utility analysis. Project findings are currently being written up for publication.

Outcome and Translation

The results of the study will inform clinical practice over how best to manage distal arm pain.

This trial is registered on the ISRCTN Registry: ISRCTN79085082

HERU researchers involved in this research project: Paul McNamee and Aileen Neilson

External collaborators: G Jones, G Macfarlane (Other Applied Health Sciences, University of Aberdeen); K Palmer, D Coggon (University of Southampton); K Burton (University of Huddersfield); K Walker-Bone (Brighton and Sussex NHS Trust); S Lamb (University of Warwick); A McConnachie (University of Glasgow); C McCabe (University of Bath); N Shenker (Cambridge University Hospitals)

 

Multiple frequency bioimpedance devices

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Multiple frequency bio-impedance devices (BCM – Body Composition Monitor, BioScan 920-II, BioScan touch i8, InBody S10, and MultiScan 5000) for fluid management in people with chronic kidney disease having dialysis

Chronic kidney disease can lead to kidney failure and the need for waste products and excess fluid to be removed from the blood by a process called dialysis. In people having dialysis, it is important to monitor the amount of fluid being removed, as removing too much, or not enough, fluid, can cause other health problems during dialysis or between dialysis sessions. Assessing the fluid levels has traditionally been done by medical staff using their experience and clinical judgement but this can be unreliable.

In recent years, a type of technical device has been introduced to estimate a person’s fluid (hydration) status, and help determine the amount of fluid to remove during a dialysis session. These devices work by sending painless electrical currents through the body via electrodes attached to certain parts of it (e.g. hand and foot). Based on the impedance offered by the body to currents of different electrical frequency, an algorithm is used to compute a person’s body composition (i.e. lean tissue, fat tissue, intracellular and extracellular water). In turn, this data can be used to estimate the amount of fluid that should be removed during dialysis in order to achieve normal levels of hydration.

This modelling systematic review and modelling study assessed the clinical and cost-effectiveness of the using multiple frequency bio-impedance devices to guide fluid management decision in patients on dialysis. While the cost-effectiveness modelling suggested potential for such devices to prove cost-effective, the limited evidence on clinically relevant outcomes lead to a high degree of uncertainty in the findings.

Outcome and translation

Based on consideration of the report and consultation comments, the NICE diagnostics committee concluded that “there is currently not enough evidence to recommend the routine adoption of the BCM – Body Composition Monitor to guide fluid management in people with chronic kidney disease having dialysis in the NHS”. The committee recommended further research is to assess effects on clinical outcomes: https://www.nice.org.uk/guidance/dg29  

This review is registered with PROSPERO International prospective register of systematic reviews: PROSPERO 2016:CRD42016041785

HERU researchers involved in this research project: Graham Scotland and Elisabet Jacobsen

External collaborators: M. Brazzelli, M. Cruickshank (HSRU, University of Aberdeen), A. Marks (Other Applied Health Sciences, University of Aberdeen).

 

OPAL – Optimal PFMT for Adherence Long-term

OPAL – Optimal PFMT for Adherence Long-term: Multicentre randomised trial of the effectiveness and cost-effectiveness of basic versus intensive, biofeedback-assisted pelvic floor muscle training for female stress or mixed urinary incontinence

Based on previous research, current UK guidelines recommend that women with stress incontinence are offered at least three months of pelvic floor muscle exercises. These exercises are taught by a specialist physiotherapist or nurse. There is evidence that these exercises can work to strengthen the muscles and decrease leakage, but it is not clear how ‘intensively’ women have to exercise to get a good result that lasts, thus improving their quality of life and reducing the likelihood of surgery.

This research aims to find out whether the use of biofeedback can help to improve the results of the exercise training in both the short- and longer-term. We also want to find out how much urine leakage women in both groups have, how much this impacts on their lives, what other bladder problems they have, what other treatments they have had, how much exercise they did, how confident they were, and how much their muscles have strengthened. We also measure the costs of the treatments and any costs to the women and their families, and balance these costs against any benefits of the intensive treatment.

Outcome and Translation

Our aim is to establish if the addition of biofeedback to PFMT is more cost effective than PFMT alone.  The results will inform the decision makers on the cost effectiveness of the addition of biofeedback machines to  pelvic floor muscle training treatment  of women with urinary incontinence.

HERU researchers involved in this research project: Mary Kilonzo

External collaborators: S Hagen, D McClurg, J Booth (Glasgow Caledonian University); C Glazener, J Francis, J Norrie, A Elders, A McDonald, G McPherson, N Kolehmainen (HSRU, University of Aberdeen); A Wael (NHS Ayrshire and Arran); M Abdel-Fattah (Other Applied Health Sciences, University of Aberdeen); C Bugge (University of Stirling); B Buckley (Independent); S Dean (University of Exeter); H Smith (University of Otago, NZ); KL Guerrero (clinical expert) and LE Wilson (User)

International Standard Randomised Controlled Trial Number Register: ISRCTN57746448

 

STA: Padeliporfin for untreated localised prostate cancer

As part of the NICE single technology appraisal process, the Aberdeen evidence review group (ERG) was asked to critically review the company’s submission related to the clinical and cost-effectiveness of Padeliporfin for the treatment of untreated, unilateral, low-risk prostate cancer in adults.

Outcome and Translation

Based on consideration of evidence submitted by the company and the review submitted by the Aberdeen Evidence Review Group, NICE decided not to recommend Padeliporfin for this treatment indication. Details of the NICE appraisal committees’ consideration of the evidence can be found here: Padeliporfin for untreated localised prostate cancer. Technology appraisal guidance [TA546].

HERU researchers involved in this research project: Graham Scotland

External collaborators: Ramsay, C., Brazzelli, M; Campbell, M. (Health Services Research Unit (HSRU), University of Aberdeen).

 

PROSPECT

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PROSPECT:  Clinical and cost-effectiveness of surgical options for the management of anterior or posterior vaginal wall prolapse: pragmatic evaluation by multi-centre randomised controlled trial - PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trial

The lifetime risk of undergoing surgery for prolapse is nearly 10%. There are several different traditional surgical techniques, none of which have been properly evaluated. The study embedded two large RCTs investigating different surgical techniques for two distinct patient populations of women with vaginal prolapse (primary and secondary) within a comprehensive cohort of all patients.

The economic evaluation investigated the costs and cost-effectiveness of the interventions from the perspective of the NHS and for the women and their families. Information on the cost of the intervention and the use of primary and secondary NHS services by the women (including referral for specialist management) were collected, as were personal costs to the women (such as costs of travelling to appointments and work/social restrictions).

Trial participants were asked to complete the EQ–5D at baseline and at 6, 12 and 24 months after randomisation, and responses were used to compute QALYs. In a sensitivity analysis, QALYs were also estimated from the SF–12 completed at the same time points.

The difference in effectiveness was expressed in terms of the numbers of patients cured and improved. Incremental cost–utility ratios were computed comparing the interventions. An economic model that considers a longer time horizon was developed to provide additional information for policy makers. In the model, the findings of the trial were extrapolated to the patient’s lifetime.

Outcome and Translation

The study concluded that there is no clear superiority of the synthetic mesh, biological graft or mesh kit over standard repair in the first two years after surgery. Unless there is a significant decrease in the reoperation rates for failure in the medium or long term in the mesh or graft arms, compared to standard repair, it is unlikely that any type of mesh or graft is going to be cost-effective, given the excess cost over standard repair and the excess cost of treatment for the adverse effect of mesh exposure or extrusion. Long-term follow-up is now on-going.

The results of the PROSPECT Trial informed the 2017 Scottish Independent Review of the use, safety and efficacy of transvaginal mesh implants in the treatment of stress urinary incontinence and pelvic organ prolapse in women.

HERU researchers involved in this research project: Dwayne Boyers and Mary Kilonzo

External collaborators: C Glazener, A Grant, J Norrie, G MacLennan, A McDonald, G McPherson (HSRU, University of Aberdeen); ARB Smith (St. Mary’s Hospital Manchester); RM Freeman (Plymouth Hospital NHS Trust); C Bain, K Cooper (NHS Grampian); S Hagan (Glasgow Caledonian University) and IBG Montgomery (Aberdeen)

Further details are available on the PROSPECT study website.

 

Radium-223 dichloride for prostate cancer

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Radium-223 dichloride for treating hormone-relapsed prostate cancer with bone metastases (men who have not received docetaxel and for whom docetaxel is contraindicated or not suitable) (NICE re-consideration of current Cancer Drug Fund (CDF) technologies under the new proposed CDF criteria)

Advanced prostate cancer is often associated with bone metastases which cause significant morbidity and mortality. Radium‑223 dichloride (Xofigo, Bayer) is a radiopharmaceutical agent designed to deliver alpha radiation to bone metastases without affecting normal bone marrow.

This project was carried out to support NICE’s decision making process surrounding the re-consideration of current Cancer Drug Fund (CDF) technologies under the new proposed CDF criteria. Radium-223 was previously rejected by NICE for routine commissioning in men who had not previously received treatment with docetaxel. It was subsequently made available to these patients through the CDF in England. Following a decision to reform the old CDF, NICE began to reappraise all drugs already in the CDF in April 2016.

The company responsible for radium-223 (Bayer) submitted updated evidence for review and a revised economic model addressing the committee concerns from the previous appraisal. The Aberdeen HTA group were commissioned to act as the Evidence Review Group (ERG) for the appraisal, and to provide an independent report reviewing the company’s evidence submission. Following review of the revised modelling, the ERG established that the company’s revisions to the model were generally appropriate, and that these updates improved the cost-effectiveness estimates for radium-223.

Outcome and Translation

Following consideration of the company submission and the ERG reports, the NICE appraisal committee recommended radium-223 as an option for treating hormone-relapsed prostate cancer with symptomatic bone metastases (in men without prior docetaxel treatment), only if docetaxel is contraindicated or is not suitable for them: https://www.nice.org.uk/guidance/ta412.

National Institute for Health and Care Excellence (2016) Radium-223 dichloride for treating hormone-relapsed prostate cancer with bone metastases, Technology Appraisal Guidance (TA142), London: NICE.

HERU researchers involved in this research project: Graham Scotland and Rodolfo Hernández

External collaborators: C Robertson, C Fraser (Health Services Research Unit, University of Aberdeen); N Scott (Medical Statistics Team, University of Aberdeen)

 

Risankizumab for treating moderate-to-severe plaque psoriasis (Fast Track Appriasal)

As part of the NICE Technology Appraisal Process, the Aberdeen Evidence Review Group (ERG) was commissioned to critically review the company’s submission related to the clinical and cost-effectiveness of Risankizumab for treating moderate to severe plaque psoriasis.

Outcome and Translation

Based on consideration of the company’s evidence and the evidence review group report, the NICE committee recommended risankizumab as an option for treating plaque psoriasis in adults with severe disease. Details of the restrictions that apply can be found on the NICE website: Risankizumab for treating moderate to severe plaque psoriasis. Technology Appraisal Guidance [TA596].

HERU researchers involved in this research project: Rodolfo Hernández and Graham Scotland

External collaborators: Ramsay, C., Brazzelli, M., Cummins, E. and Campbell, M. (Health Services Research Unit (HSRU), University of Aberdeen).

 

SIMS Pilot Study long term - Follow up

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Long term follow up of the SIMS – PILOT study: Single Incision Mini-Slings versus standard mid-urethral slings in surgical management of female stress urinary incontinence

Stress urinary incontinence (SUI) is the most common type of urinary incontinence (UI) in pre-menopausal women, accounting for almost 50% of cases. Surgical procedures for the management of female SUI have been continuously evolving over the last four decades with the ultimate aim of providing an effective and truly ambulatory surgical procedure. However, evidence on the clinical and cost-effectiveness of new methods of surgery is lacking. Data are particularly scarce in relation to longer-term outcomes, such as resource implications, quality of life and failure rates of the respective treatments.

This project is an update of an earlier pilot study comparing single incision mini-slings (SIMS), performed under local anaesthetic with standard mid-urethral slings (SMUS) performed under general anaesthetic for the surgical treatment of SUI has already been conducted. An initial assessment of the one-year pilot data showed that there were no significant differences between randomised groups in terms of QoL or patient reported success rate. Analysis of the four-year follow-up data has been completed and papers are currently being written up for the project. 

Outcome and Translation

The purpose of the current study was to determine if initial cost-effectiveness results are maintained over longer term, four-year follow-up. Work from this project has already contributed to securing funding for a larger study to definitively determine the relative effectiveness, safety and cost-effectiveness of the respective interventions. This project therefore runs alongside the larger study of the SIMS intervention, which is currently on-going.

HERU researchers involved in this research project: Dwayne Boyers, Mary Kilonzo and Elisabet Jacobsen.

External collaborators: M Abdel Fattah and A Mostafa (Other Applied Health Sciences, University of Aberdeen).

STA: Teduglutide for treating short bowel syndrome

As part of the NICE single technology appraisal process, the Aberdeen evidence review group (ERG) critically reviewed the company’s submission related to the clinical and cost-effectiveness of Teduglutide for treating people aged 1 year and above with short bowel syndrome who are stable following a period of intestinal adaptation after surgery. In terms of clinical effectiveness in adults, the company’s submission focused on evidence from STEPS, a 24-week double-blind phase III randomised controlled trial comparing 24 weeks of treatment with teduglutide with placebo, and its extension studies STEPS2 and STEPS3.

The Paediatric case was supported by evidence from the TED-C13-003 phase III open-label study comparing teduglutide with standard care in children between 1 year and 17 years. The economic case was built around a Markov decision model structured around the number of days of parenteral support required per week, informed by the available clinical effectiveness evidence for the adult and paediatric populations. 

Outcome and Translation

The Aberdeen HTA group’s involvement in this project has been completed. NICE were unable to make a recommendation on teduglutide for short bowel syndrome as the company withdrew its evidence submission.

HERU researchers invovled in this project: Graham Scotland, Daniel Kopasker, Rodolfo Hernández

External collaborators:  Ramsay, C., Brazzelli, M; Cummins, E; Campbell, M. (Health Services Research Unit (HSRU), University of Aberdeen).