Female Urgency, Trial of Urodynamics as Routine Evaluation (FUTURE study): a superiority randomised clinical trial to evaluate the effectiveness and cost-effectiveness of invasive urodynamic investigations in management of women with refractory overactive bladder symptoms

Abstract Background Overactive bladder (OAB) syndrome is a symptom complex affecting 12–14% of the UK adult female population. Symptoms include urinary urgency, with or without urgency incontinence, increased daytime urinary frequency and nocturia. OAB has a negative impact on women’s social, physical, and psychological wellbeing. Initial treatment includes lifestyle modifications, bladder retraining, pelvic floor exercises and pharmacological therapy. However, these measures are unsuccessful in 25–40% of women (refractory OAB). Before considering invasive treatments, such as Botulinum toxin injection or sacral neuromodulation, most guidelines recommend urodynamics to confirm diagnosis of detrusor overactivity (DO). However, urodynamics may fail to show evidence of DO in up to 45% of cases, hence the need to evaluate its effectiveness and cost-effectiveness. FUTURE (Female Urgency, Trial of Urodynamics as Routine Evaluation) aims to test the hypothesis that, in women with refractory OAB, urodynamics and comprehensive clinical assessment is associated with superior patient-reported outcomes following treatment and is more cost-effective, compared to comprehensive clinical assessment only. Methods FUTURE is a pragmatic, multi-centre, superiority randomised controlled trial. Women aged ≥ 18 years with refractory OAB or urgency predominant mixed urinary incontinence, and who have failed/not tolerated conservative and medical treatment, are considered for trial entry. We aim to recruit 1096 women from approximately 60 secondary/tertiary care hospitals across the UK. All consenting women will complete questionnaires at baseline, 3 months, 6 months and 15 months post-randomisation. The primary outcome is participant-reported success at 15 months post-randomisation measured using the Patient Global Impression of Improvement. The primary economic outcome is incremental cost per quality-adjusted life year gained at 15 months. The secondary outcomes include adverse events, impact on other urinary symptoms and health-related quality of life. Qualitative interviews with participants and clinicians and a health economic evaluation will also be conducted. The statistical analysis of the primary outcome will be by intention-to-treat. Results will be presented as estimates and 95% CIs. Discussion The FUTURE study will inform patients, clinicians and policy makers whether routine urodynamics improves treatment outcomes in women with refractory OAB and whether it is cost-effective. Trial registration ISRCTN63268739. Registered on 14 September 2017.

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Alternative tumour necrosis factor inhibitors (TNFi) or abatacept or rituximab following failure of initial TNFi in rheumatoid arthritis: the SWITCH RCT

Health Technology Assessment ◽

10.3310/hta22340 ◽

2018 ◽

Vol 22 (34) ◽

pp. 1-280 ◽

Cited By ~ 1

Author(s):

Sarah Brown ◽

Colin C Everett ◽

Kamran Naraghi ◽

Claire Davies ◽

Bryony Dawkins ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Cost Effectiveness ◽

Tumour Necrosis ◽

Cost Effective ◽

Health Technology ◽

Treatment Groups ◽

The Uk ◽

Necrosis Factor ◽

Post Randomisation

Background Rheumatoid arthritis (RA), the most common autoimmune disease in the UK, is a chronic systemic inflammatory arthritis that affects 0.8% of the UK population. Objectives To determine whether or not an alternative class of biologic disease-modifying antirheumatic drugs (bDMARDs) are comparable to rituximab in terms of efficacy and safety outcomes in patients with RA in whom initial tumour necrosis factor inhibitor (TNFi) bDMARD and methotrexate (MTX) therapy failed because of inefficacy. Design Multicentre, Phase III, open-label, parallel-group, three-arm, non-inferiority randomised controlled trial comparing the clinical and cost-effectiveness of alternative TNFi and abatacept with that of rituximab (and background MTX therapy). Eligible consenting patients were randomised in a 1 : 1 : 1 ratio using minimisation incorporating a random element. Minimisation factors were centre, disease duration, non-response category and seropositive/seronegative status. Setting UK outpatient rheumatology departments. Participants Patients aged ≥ 18 years who were diagnosed with RA and were receiving MTX, but had not responded to two or more conventional synthetic disease-modifying antirheumatic drug therapies and had shown an inadequate treatment response to a first TNFi. Interventions Alternative TNFi, abatacept or rituximab (and continued background MTX). Main outcome measures The primary outcome was absolute reduction in the Disease Activity Score of 28 joints (DAS28) at 24 weeks post randomisation. Secondary outcome measures over 48 weeks were additional measures of disease activity, quality of life, cost-effectiveness, radiographic measures, safety and toxicity. Limitations Owing to third-party contractual issues, commissioning challenges delaying centre set-up and thus slower than expected recruitment, the funders terminated the trial early. Results Between July 2012 and December 2014, 149 patients in 35 centres were registered, of whom 122 were randomised to treatment (alternative TNFi, n = 41; abatacept, n = 41; rituximab, n = 40). The numbers, as specified, were analysed in each group [in line with the intention-to-treat (ITT) principle]. Comparing alternative TNFi with rituximab, the difference in mean reduction in DAS28 at 24 weeks post randomisation was 0.3 [95% confidence interval (CI) –0.45 to 1.05] in the ITT patient population and –0.58 (95% CI –1.72 to 0.55) in the per protocol (PP) population. Corresponding results for the abatacept and rituximab comparison were 0.04 (95% CI –0.72 to 0.79) in the ITT population and –0.15 (95% CI –1.27 to 0.98) in the PP population. General improvement in the Health Assessment Questionnaire Disability Index, Rheumatoid Arthritis Quality of Life and the patients’ general health was apparent over time, with no notable differences between treatment groups. There was a marked initial improvement in the patients’ global assessment of pain and arthritis at 12 weeks across all three treatment groups. Switching to alternative TNFi may be cost-effective compared with rituximab [incremental cost-effectiveness ratio (ICER) £5332.02 per quality-adjusted life-year gained]; however, switching to abatacept compared with switching to alternative TNFi is unlikely to be cost-effective (ICER £253,967.96), but there was substantial uncertainty in the decisions. The value of information analysis indicated that further research would be highly valuable to the NHS. Ten serious adverse events in nine patients were reported; none were suspected unexpected serious adverse reactions. Two patients died and 10 experienced toxicity. Future work The results will add to the randomised evidence base and could be included in future meta-analyses. Conclusions How to manage first-line TNFi treatment failures remains unresolved. Had the trial recruited to target, more credible evidence on whether or not either of the interventions were non-inferior to rituximab may have been provided, although this remains speculative. Trial registration Current Controlled Trials ISRCTN89222125 and ClinicalTrials.gov NCT01295151. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 34. See the NIHR Journals Library website for further project information.

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Cost-effectiveness of a domestic violence and abuse training and support programme in primary care in the real world: updated modelling based on an MRC phase IV observational pragmatic implementation study

BMJ Open ◽

10.1136/bmjopen-2017-021256 ◽

2018 ◽

Vol 8 (8) ◽

pp. e021256 ◽

Cited By ~ 2

Author(s):

Estela Capelas Barbosa ◽

Talitha Irene Verhoef ◽

Steve Morris ◽

Francesca Solmi ◽

Medina Johnson ◽

...

Keyword(s):

Cost Effectiveness ◽

Health Service ◽

Cost Effective ◽

Uncertainty Interval ◽

The Uk ◽

The Cost ◽

Training And Support ◽

Domestic Violence And Abuse ◽

Service Perspective ◽

Health Service Perspective

ObjectivesTo evaluate the cost-effectiveness of the implementation of the Identification and Referral to Improve Safety (IRIS) programme using up-to-date real-world information on costs and effectiveness from routine clinical practice. A Markov model was constructed to estimate mean costs and quality-adjusted life-years (QALYs) of IRIS versus usual care per woman registered at a general practice from a societal and health service perspective with a 10-year time horizon.Design and settingCost–utility analysis in UK general practices, including data from six sites which have been running IRIS for at least 2 years across England.ParticipantsBased on the Markov model, which uses health states to represent possible outcomes of the intervention, we stipulated a hypothetical cohort of 10 000 women aged 16 years or older.InterventionsThe IRIS trial was a randomised controlled trial that tested the effectiveness of a primary care training and support intervention to improve the response to women experiencing domestic violence and abuse, and found it to be cost-effective. As a result, the IRIS programme has been implemented across the UK, generating data on costs and effectiveness outside a trial context.ResultsThe IRIS programme saved £14 per woman aged 16 years or older registered in general practice (95% uncertainty interval −£151 to £37) and produced QALY gains of 0.001 per woman (95% uncertainty interval −0.005 to 0.006). The incremental net monetary benefit was positive both from a societal and National Health Service perspective (£42 and £22, respectively) and the IRIS programme was cost-effective in 61% of simulations using real-life data when the cost-effectiveness threshold was £20 000 per QALY gained as advised by National Institute for Health and Care Excellence.ConclusionThe IRIS programme is likely to be cost-effective and cost-saving from a societal perspective in the UK and cost-effective from a health service perspective, although there is considerable uncertainty surrounding these results, reflected in the large uncertainty intervals.

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Cost-effectiveness of positive airway pressure modalities in obesity hypoventilation syndrome with severe obstructive sleep apnoea

Thorax ◽

10.1136/thoraxjnl-2019-213622 ◽

2020 ◽

Vol 75 (6) ◽

pp. 459-467 ◽

Cited By ~ 4

Author(s):

Juan F Masa ◽

Babak Mokhlesi ◽

Iván Benítez ◽

Francisco Javier Gómez de Terreros Caro ◽

M-Ángeles Sánchez-Quiroga ◽

...

Keyword(s):

Cost Effectiveness ◽

Primary Outcome ◽

Cost Effective ◽

Sleep Apnoea ◽

Obesity Hypoventilation Syndrome ◽

Obstructive Sleep ◽

The Mean ◽

Hypoventilation Syndrome ◽

Obesity Hypoventilation

BackgroundObesity hypoventilation syndrome (OHS) is treated with either non-invasive ventilation (NIV) or CPAP, but there are no long-term cost-effectiveness studies comparing the two treatment modalities.ObjectivesWe performed a large, multicentre, randomised, open-label controlled study to determine the comparative long-term cost and effectiveness of NIV versus CPAP in patients with OHS with severe obstructive sleep apnoea (OSA) using hospitalisation days as the primary outcome measure.MethodsHospital resource utilisation and within trial costs were evaluated against the difference in effectiveness based on the primary outcome (hospitalisation days/year, transformed and non-transformed in monetary term). Costs and effectiveness were estimated from a log-normal distribution using a Bayesian approach. A secondary analysis by adherence subgroups was performed.ResultsIn total, 363 patients were selected, 215 were randomised and 202 were available for the analysis. The median (IQR) follow-up was 3.01 (2.91–3.14) years for NIV group and 3.00 (2.92–3.17) years for CPAP. The mean (SD) Bayesian estimated hospital days was 2.13 (0.73) for CPAP and 1.89 (0.78) for NIV. The mean (SD) Bayesian estimated cost per patient/year in the NIV arm, excluding hospitalisation costs, was €2075.98 (91.6), which was higher than the cost in the CPAP arm of €1219.06 (52.3); mean difference €857.6 (105.5). CPAP was more cost-effective than NIV (99.5% probability) because longer hospital stay in the CPAP arm was compensated for by its lower costs. Similar findings were observed in the high and low adherence subgroups.ConclusionCPAP is more cost-effective than NIV; therefore, CPAP should be the preferred treatment for patients with OHS with severe OSA.Trial registration numberNCT01405976

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Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial)

Health Technology Assessment ◽

10.3310/hta21240 ◽

2017 ◽

Vol 21 (24) ◽

pp. 1-198 ◽

Cited By ~ 9

Author(s):

Sarah Cockayne ◽

Sara Rodgers ◽

Lorraine Green ◽

Caroline Fairhurst ◽

Joy Adamson ◽

...

Keyword(s):

Cost Effectiveness ◽

Usual Care ◽

Incidence Rate ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Clinical Effectiveness ◽

Cost Effective ◽

Falls Prevention ◽

Randomised Controlled

BackgroundFalls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care.DesignA pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study.SettingNine NHS trusts in the UK and one site in Ireland.ParticipantsIn total, 1010 participants aged ≥ 65 years were randomised (intervention,n = 493; usual care,n = 517) via a secure, remote service. Blinding was not possible.InterventionsAll participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises.Main outcome measuresThe primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness.ResultsThe primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05;p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00;p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI –£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI –0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants.LimitationsOwing to the difficulty in calculating a sample size for a count outcome, the sample size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care.ConclusionsThe intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective.Future workFurther research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients.Trial registrationCurrent Controlled Trials ISRCTN68240461.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 24. See the NIHR Journals Library website for further project information.

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Evaluation of the cost-effectiveness of buprenorphine in treatment of chronic pain using competing EQ-5D weights

Scandinavian Journal of Pain ◽

10.1016/j.sjpain.2014.07.002 ◽

2015 ◽

Vol 6 (1) ◽

pp. 24-30 ◽

Cited By ~ 4

Author(s):

Hanna Norrlid ◽

Peter Dahm ◽

Gunnel Ragnarson Tennvall

Keyword(s):

Chronic Pain ◽

Cost Effectiveness ◽

Treatment Cost ◽

Cost Effective ◽

Elderly Persons ◽

Physician Visits ◽

Annual Treatment ◽

The Uk ◽

The Cost ◽

Annual Treatment Cost

AbstractBackground and aimsChronic pain is a life altering condition and common among elderly persons. The 7-day buprenorphine patch could be a suitable treatment for managing chronic pain of moderate severity in elderly patients in Sweden.The objective of this analysis was to investigate the cost-effectiveness of the 7-day buprenorphine patch, versus no treatment, in patients >50 years old who suffer from moderate pain in a health economic perspective. An additional aim was to evaluate how the cost-effectiveness is affected by the choice of EQ-5D weights.MethodsThe annual treatment cost and the potential gains in health-related quality of life (HRQoL) of buprenorphine, compared to no treatment, were evaluated. Original EQ-5D data were collected from four clinical reference studies at baseline and at the final visit. Treatment effects on HRQoL were then assessed using both UK and Swedish EQ-5D weights. Annual treatment costs were calculated based on costs of physician visits and pharmaceuticals.The optimal treatment dose was 10-15 μg/h and the analysis was hence performed on both a 10- and a 15 μg/h buprenorphine patch.ResultsThe analysis of buprenorphine treatment resulted in improved HRQoL in all reference studies, irrespective of choice of EQ-5D weight set. The change in quality adjusted life years (QALYs) varied with a gain of 0.042-0.118 using the UK weights and 0.020-0.051 with the Swedish weights. The average annual treatment cost was SEK14454 for the 10μg/h patch and SEK17 017 for the 15 μg/h patch, while cost for the no-treatment alternative was SEK 9 960. The base case incremental cost-effectiveness ratios (ICER) with the UK weights were SEK 40000-SEK 170000 and SEK 90000-SEK 350000 when applying the Swedish weights. The corresponding ICER-span in the sensitivity analysis was SEK 15 000-SEK 400 000 when applying the UK weights and SEK 30 000-SEK 840 000 with the Swedish weights (SEK 100 is about €11).ConclusionsThe results imply that the 7-day buprenorphine patch may be a cost-effective treatment of moderate chronic pain in patients over 50 years of age. The UK and the Swedish EQ-5D weights generated vastly different HRQoL estimates but buprenorphine remains cost-effective regardless choice of weight set.

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A Cost-Effectiveness Analysis of Newborn Screening for Severe Combined Immunodeficiency in the UK

International Journal of Neonatal Screening ◽

10.3390/ijns5030028 ◽

2019 ◽

Vol 5 (3) ◽

pp. 28 ◽

Cited By ~ 2

Author(s):

Alice Bessey ◽

James Chilcott ◽

Joanna Leaviss ◽

Carmen de la Cruz ◽

Ruth Wong

Keyword(s):

Cost Effectiveness ◽

Severe Combined Immunodeficiency ◽

Cost Effective ◽

Sensitivity Analyses ◽

Combined Immunodeficiency ◽

Tree Model ◽

Life Years ◽

The Uk ◽

The Cost ◽

The Impact

Severe combined immunodeficiency (SCID) can be detected through newborn bloodspot screening. In the UK, the National Screening Committee (NSC) requires screening programmes to be cost-effective at standard UK thresholds. To assess the cost-effectiveness of SCID screening for the NSC, a decision-tree model with lifetable estimates of outcomes was built. Model structure and parameterisation were informed by systematic review and expert clinical judgment. A public service perspective was used and lifetime costs and quality-adjusted life years (QALYs) were discounted at 3.5%. Probabilistic, one-way sensitivity analyses and an exploratory disbenefit analysis for the identification of non-SCID patients were conducted. Screening for SCID was estimated to result in an incremental cost-effectiveness ratio (ICER) of £18,222 with a reduction in SCID mortality from 8.1 (5–12) to 1.7 (0.6–4.0) cases per year of screening. Results were sensitive to a number of parameters, including the cost of the screening test, the incidence of SCID and the disbenefit to the healthy at birth and false-positive cases. Screening for SCID is likely to be cost-effective at £20,000 per QALY, key uncertainties relate to the impact on false positives and the impact on the identification of children with non-SCID T Cell lymphopenia.

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The cost-effectiveness of pegaspargase versus native asparaginase for first-line treatment of acute lymphoblastic leukaemia: a UK-based cost-utility analysis

Health Economics Review ◽

10.1186/s13561-019-0257-3 ◽

2019 ◽

Vol 9 (1) ◽

Cited By ~ 2

Author(s):

Xingdi Hu ◽

Kingsley P. Wildman ◽

Subham Basu ◽

Peggy L. Lin ◽

Clare Rowntree ◽

...

Keyword(s):

Cost Effectiveness ◽

Cost Effective ◽

Line Treatment ◽

Newly Diagnosed ◽

First Line ◽

Link Type ◽

Search Trial ◽

Erwinia Asparaginase ◽

The Uk ◽

The Cost

Abstract Background L-asparaginase is a key component of treatment for patients with acute lymphoblastic leukaemia (ALL) in the UK. Commonly used forms of asparaginase are native E. coli-derived asparaginase (native asparaginase) and pegaspargase in first-line combination therapy, and native Erwinia chrysanthemi-derived asparaginase (Erwinia asparaginase) as second-line treatment. The objective of this study was to evaluate the cost-effectiveness of pegaspargase versus native asparaginase in first-line combination therapy for patients with newly diagnosed ALL. A combined decision tree and health-state transition Markov cost-effectiveness model was developed to assess the relative costs and health outcomes of pegaspargase versus native asparaginase in the UK setting. Results In base case analyses, first-line pegaspargase (followed by Erwinia asparaginase in cases of hypersensitivity) dominated first-line native asparaginase followed by Erwinia asparaginase; i.e. resulted in lower costs and more quality-adjusted life year gain. The favourable hypersensitivity rates and administration profile of pegaspargase led to lifetime cost savings of £4741 versus native asparaginase. Pegaspargase remained cost-effective versus all treatment strategies in all scenario analyses, including use of the 2500 IU/m2 dose, recommended for patients ≤21 years of age. Conclusions Pegaspargase, as part of multi-drug chemotherapy, is a cost-effective option for the treatment of newly diagnosed ALL. Based on this study, The National Institute for Health and Care Excellence Technology Appraisal Committee concluded that it could recommend pegaspargase as a cost-effective use of National Health Service resources in England & Wales for treating ALL in children, young people and adults with untreated, newly diagnosed disease. Trial registration UKALL 2011, EudraCT number 2010-020924-22; UKALL 2003, EudraCT number 2007-004013-34; UKALL14, EudraCT number 2009-012717-22.

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Cost-effectiveness of an insertable cardiac monitor in a high-risk population in the UK

Open Heart ◽

10.1136/openhrt-2019-001037 ◽

2019 ◽

Vol 6 (1) ◽

pp. e001037 ◽

Cited By ~ 1

Author(s):

Claudia I Rinciog ◽

Laura M Sawyer ◽

Alexander Diamantopoulos ◽

Mitchell S V Elkind ◽

Matthew Reynolds ◽

...

Keyword(s):

Cost Effectiveness ◽

High Risk ◽

Oral Anticoagulants ◽

Cost Effective ◽

Sensitivity Analyses ◽

High Risk Population ◽

Risk Population ◽

Life Years ◽

The Uk ◽

The Cost

ObjectiveTo evaluate the cost-effectiveness of insertable cardiac monitors (ICMs) compared with standard of care (SoC) for detecting atrial fibrillation (AF) in patients at high risk of stroke (CHADS2 >2), using a UK National Health Service (NHS) perspective.MethodsUsing patient characteristics and clinical data from the REVEAL AF trial, a Markov model assessed the cost-effectiveness of detecting AF with an ICM compared with SoC. Costs and benefits were extrapolated across modelled patient lifetime. Ischaemic and haemorrhagic strokes, intracranial and extracranial haemorrhages and minor bleeds were modelled. Diagnostic and device costs were included, plus costs of treating stroke and bleeding events and costs of oral anticoagulants (OACs). Costs and health outcomes, measured as quality-adjusted life years (QALYs), were discounted at 3.5% per annum. One-way deterministic and probabilistic sensitivity analyses (PSA) were undertaken.ResultsThe total per-patient cost for ICM was £13 360 versus £11 936 for SoC (namely, annual 24 hours Holter monitoring). ICMs generated a total of 6.50 QALYs versus 6.30 for SoC. The incremental cost-effectiveness ratio (ICER) was £7140/QALY gained, below the £20 000/QALY acceptability threshold. ICMs were cost-effective in 77.4% of PSA simulations. The number of ICMs needed to prevent one stroke was 21 and to cause a major bleed was 37. ICERs were sensitive to assumed proportions of patients initiating or discontinuing OAC after AF diagnosis, type of OAC used and how intense the traditional monitoring was assumed to be under SoC.ConclusionsThe use of ICMs to identify AF in a high-risk population is cost-effective for the UK NHS.

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OP60 Optimising Risk-Based Screening: The Case Of Diabetic Eye Disease

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462318001046 ◽

2018 ◽

Vol 34 (S1) ◽

pp. 21-21

Author(s):

Christopher Sampson ◽

Marilyn James ◽

David Whynes ◽

Antonio Eleuteri ◽

Simon Harding

Keyword(s):

Diabetic Retinopathy ◽

Cost Effectiveness ◽

Screening Program ◽

Cost Effective ◽

Eye Disease ◽

Risk Calculation ◽

Diabetic Eye Disease ◽

The Uk ◽

The Cost ◽

Level Of Risk

Introduction:There is growing evidence that many people attending annual screening for diabetic retinopathy in the United Kingdom (UK) are at low risk of developing the disease. This has led to new policy statements. However, the basis on which to establish a risk-based individualized variable-recall screening program has not yet been determined. We present a methodology for using information on an individual's risk factors to improve the allocation of resources within a screening program.Methods:We developed a patient-level state-transition model to evaluate the cost-effectiveness of risk-based screening for diabetic retinopathy in the UK. The model incorporated a recently developed risk calculation engine that predicts an individual's risk of disease onset, and allocated individuals to alternative screening recall periods according to this level of risk. Using the findings, we demonstrate a means of estimating: (i) a threshold level of risk, above which individuals should be invited to screening, and (ii) the optimum screening recall period for an individual, based on the expected cost-effectiveness of screening and treatment.Results:The cost-effectiveness analysis demonstrated that standardized screening (current practice) is the least cost-effective program. Individualized screening can improve outcomes at a reduced cost. We found it feasible – though computationally expensive – to incorporate a risk calculation engine into a decision model in Microsoft Excel. In an optimized screening program, the majority or patients would be invited to attend screening at least two years after a negative screening result.Conclusions:Individualized risk-based screening is likely to be cost-effective in the context of diabetic eye disease in the UK. It is expected that risk calculation engines will be developed in other disease areas in the future, and used to allocate screening and treatment at the individual level. It is important that researchers develop robust methods for combining risk calculation engines into decision analytic models and health technology assessment more broadly.

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Cost-effectiveness analysis of tranexamic acid for the treatment of traumatic brain injury, based on the results of the CRASH-3 randomised trial: a decision modelling approach

BMJ Global Health ◽

10.1136/bmjgh-2020-002716 ◽

2020 ◽

Vol 5 (9) ◽

pp. e002716

Author(s):

Jack Williams ◽

Ian Roberts ◽

Haleema Shakur-Still ◽

Fiona E Lecky ◽

Rizwana Chaudhri ◽

...

Keyword(s):

Cost Effectiveness ◽

Tranexamic Acid ◽

Randomised Trial ◽

Cost Effective ◽

Sensitivity Analyses ◽

Risk Of Death ◽

Life Years ◽

Markov Decision Model ◽

The Uk ◽

The Cost

IntroductionAn estimated 69 million traumatic brain injuries (TBI) occur each year worldwide, with most in low-income and middle-income countries. The CRASH-3 randomised trial found that intravenous administration of tranexamic acid within 3 hours of injury reduces head injury deaths in patients sustaining a mild or moderate TBI. We examined the cost-effectiveness of tranexamic acid treatment for TBI.MethodsA Markov decision model was developed to assess the cost-effectiveness of treatment with and without tranexamic acid, in addition to current practice. We modelled the decision in the UK and Pakistan from a health service perspective, over a lifetime time horizon. We used data from the CRASH-3 trial for the risk of death during the trial period (28 days) and patient quality of life, and data from the literature to estimate costs and long-term outcomes post-TBI. We present outcomes as quality-adjusted life years (QALYs) and 2018 costs in pounds for the UK, and US dollars for Pakistan. Incremental cost-effectiveness ratios (ICER) per QALY gained were estimated, and compared with country specific cost-effective thresholds. Deterministic and probabilistic sensitivity analyses were also performed.ResultsTranexamic acid was highly cost-effective for patients with mild TBI and intracranial bleeding or patients with moderate TBI, at £4288 per QALY in the UK, and US$24 per QALY in Pakistan. Tranexamic acid was 99% and 98% cost-effective at the cost-effectiveness thresholds for the UK and Pakistan, respectively, and remained cost-effective across all deterministic sensitivity analyses. Tranexamic acid was even more cost-effective with earlier treatment administration. The cost-effectiveness for those with severe TBI was uncertain.ConclusionEarly administration of tranexamic acid is highly cost-effective for patients with mild or moderate TBI in the UK and Pakistan, relative to the cost-effectiveness thresholds used. The estimated ICERs suggest treatment is likely to be cost-effective across all income settings globally.

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