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37 result(s) for "Wilson, Edward C.F"
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Transparency in Decision Modelling: What, Why, Who and How?
Transparency in decision modelling is an evolving concept. Recently, discussion has moved from reporting standards to open-source implementation of decision analytic models. However, in the debate about the supposed advantages and disadvantages of greater transparency, there is a lack of definition. The purpose of this article is not to present a case for or against transparency, but rather to provide a more nuanced understanding of what transparency means in the context of decision modelling and how it could be addressed. To this end, we review and summarise the discourse to date, drawing on our collective experience. We outline a taxonomy of the different manifestations of transparency, including reporting standards, reference models, collaboration, model registration, peer review and open-source modelling. Further, we map out the role and incentives for the various stakeholders, including industry, research organisations, publishers and decision makers. We outline the anticipated advantages and disadvantages of greater transparency with respect to each manifestation, as well as the perceived barriers and facilitators to greater transparency. These are considered with respect to the different stakeholders and with reference to issues including intellectual property, legality, standards, quality assurance, code integrity, health technology assessment processes, incentives, funding, software, access and deployment options, data protection and stakeholder engagement. For each manifestation of transparency, we discuss the ‘what’, ‘why’, ‘who’ and ‘how’. Specifically, their meaning, why the community might (or might not) wish to embrace them, whose engagement as stakeholders is required and how relevant objectives might be realised. We identify current initiatives aimed to improve transparency to exemplify efforts in current practice and for the future.
NICE’s early value assessment: an external assessment group’s commentary on the challenges and opportunities of NICE’s new life cycle approach to HealthTech
The National Institute for Health and Care Excellence (NICE) early value assessment (EVA) was launched in 2022 as a process to assess new technologies that have the potential to meet an unmet need or demand. The recommendations that result from the process are best viewed as a type of managed entry agreement – that is, time-limited and conditional on further evidence being generated. This commentary, from authors in PenTAG (an external assessment group involved in assessing medical technologies for NICE, based at the University of Exeter), explores the challenges that have arisen during 3 years of performing EVAs, offers some thoughts on EVA’s role in evidence generation, and their fit in NICE’s wider evidence landscape. The commentary identifies areas for potential improvement in terms of timelines, scoping and protocol development, searching, reviewing, and economic modeling. Many of the suggested changes are relatively minor tweaks to the process, or requests for clearer guidance or expectation management. We conclude that, with some changes to the EVA process and its accompanying guidance, the assessments could become more efficient. In summary, the EVA represents NICE’s life cycle approach in their HealthTech program, wherein evidence is collected along the life cycle to help monitor initial assumptions and recommendations made. The process is designed to continuously capture incremental innovation over the lifetime of a medical device. As such, EVAs reflect a small but important shift in how health technology assessment is practiced.
Cost Effectiveness of Imiquimod 5% Cream Compared with Methyl Aminolevulinate-Based Photodynamic Therapy in the Treatment of Non-Hyperkeratotic, Non-Hypertrophic Actinic (Solar) Keratoses A Decision Tree Model
Background : Actinic keratosis (AK) is caused by chronic exposure to UV radiation (sunlight). First-line treatments are cryosurgery, topical 5-fluorouracil (5-FU) and topical diclofenac. Where these are contraindicated or less appropriate, alternatives are imiquimod and photodynamic therapy (PDT). Objective : To compare the cost effectiveness of imiquimod and methyl aminolevulinate-based PDT (MAL-PDT) from the perspective of the UK NHS. Methods : A decision tree model was populated with data from a literature review and used to estimate costs and QALYs gained and incremental cost effectiveness over 1 year. The model simulated patients who were in secondary care, who had four to nine AK lesions, and for whom cryosurgery, 5-FU and diclofenac were contraindicated or considered less appropriate. Results : Over 1 year, imiquimod cost £174 less than MAL-PDT (year 2006 values) but resulted in 0.005 fewer QALYs gained. The incremental cost-effectiveness ratio (ICER) of MAL-PDT over imiquimod was d34 576. In the probabilistic sensitivity analysis, there was a 75% probability that imiquimod was cost effective compared with MAL-PDT at a threshold of £20 000 per QALY gained, falling to 73% at £30 000. Conclusions : Imiquimod may be the more cost-effective treatment at conventional cost-effectiveness thresholds. A direct head-to-head study of MALPDT versus imiquimod is required to reduce uncertainty.
A Practical Guide to Value of Information Analysis
Value of information analysis is a quantitative method to estimate the return on investment in proposed research projects. It can be used in a number of ways. Funders of research may find it useful to rank projects in terms of the expected return on investment from a variety of competing projects. Alternatively, trialists can use the principles to identify the efficient sample size of a proposed study as an alternative to traditional power calculations, and finally, a value of information analysis can be conducted alongside an economic evaluation as a quantitative adjunct to the ‘future research’ or ‘next steps’ section of a study write up. The purpose of this paper is to present a brief introduction to the methods, a step-by-step guide to calculation and a discussion of issues that arise in their application to healthcare decision making. Worked examples are provided in the accompanying online appendices as Microsoft Excel spreadsheets.
The People with Asperger syndrome and anxiety disorders (PAsSA) trial: a pilot multicentre, single-blind randomised trial of group cognitive–behavioural therapy
There is a growing interest in using cognitive-behavioural therapy (CBT) with people who have Asperger syndrome and comorbid mental health problems. To examine whether modified group CBT for clinically significant anxiety in an Asperger syndrome population is feasible and likely to be efficacious. Using a randomised assessor-blind trial, 52 individuals with Asperger syndrome were randomised into a treatment arm or a waiting-list control arm. After 24 weeks, those in the waiting-list control arm received treatment, while those initially randomised to treatment were followed up for 24 weeks. The conversion rate for this trial was high (1.6:1), while attrition was 13%. After 24 weeks, there was no significant difference between those randomised to the treatment arm compared with those randomised to the waiting-list control arm on the primary outcome measure, the Hamilton Rating Scale for Anxiety. Trials of psychological therapies with this population are feasible. Larger definitive trials are now needed. None. © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) licence.
Screening for breech presentation using universal late-pregnancy ultrasonography: A prospective cohort study and cost effectiveness analysis
Despite the relative ease with which breech presentation can be identified through ultrasound screening, the assessment of foetal presentation at term is often based on clinical examination only. Due to limitations in this approach, many women present in labour with an undiagnosed breech presentation, with increased risk of foetal morbidity and mortality. This study sought to determine the cost effectiveness of universal ultrasound scanning for breech presentation near term (36 weeks of gestational age [wkGA]) in nulliparous women. The Pregnancy Outcome Prediction (POP) study was a prospective cohort study between January 14, 2008 and July 31, 2012, including 3,879 nulliparous women who attended for a research screening ultrasound examination at 36 wkGA. Foetal presentation was assessed and compared for the groups with and without a clinically indicated ultrasound. Where breech presentation was detected, an external cephalic version (ECV) was routinely offered. If the ECV was unsuccessful or not performed, the women were offered either planned cesarean section at 39 weeks or attempted vaginal breech delivery. To compare the likelihood of different mode of deliveries and associated long-term health outcomes for universal ultrasound to current practice, a probabilistic economic simulation model was constructed. Parameter values were obtained from the POP study, and costs were mainly obtained from the English National Health Service (NHS). One hundred seventy-nine out of 3,879 women (4.6%) were diagnosed with breech presentation at 36 weeks. For most women (96), there had been no prior suspicion of noncephalic presentation. ECV was attempted for 84 (46.9%) women and was successful in 12 (success rate: 14.3%). Overall, 19 of the 179 women delivered vaginally (10.6%), 110 delivered by elective cesarean section (ELCS) (61.5%) and 50 delivered by emergency cesarean section (EMCS) (27.9%). There were no women with undiagnosed breech presentation in labour in the entire cohort. On average, 40 scans were needed per detection of a previously undiagnosed breech presentation. The economic analysis indicated that, compared to current practice, universal late-pregnancy ultrasound would identify around 14,826 otherwise undiagnosed breech presentations across England annually. It would also reduce EMCS and vaginal breech deliveries by 0.7 and 1.0 percentage points, respectively: around 4,196 and 6,061 deliveries across England annually. Universal ultrasound would also prevent 7.89 neonatal mortalities annually. The strategy would be cost effective if foetal presentation could be assessed for £19.80 or less per woman. Limitations to this study included that foetal presentation was revealed to all women and that the health economic analysis may be altered by parity. According to our estimates, universal late pregnancy ultrasound in nulliparous women (1) would virtually eliminate undiagnosed breech presentation, (2) would be expected to reduce foetal mortality in breech presentation, and (3) would be cost effective if foetal presentation could be assessed for less than £19.80 per woman.
Are brief interventions to increase physical activity cost-effective? A systematic review
ObjectiveTo determine whether brief interventions promoting physical activity are cost-effective in primary care or community settings.DesignSystematic review of economic evaluations.Methods and data sourcesWe searched MEDLINE, EMBASE, PsycINFO, CINAHL, EconLit, SPORTDiscus, PEDro, the Cochrane library, National Health Service Economic Evaluation Database and the Cost-Effectiveness Analysis Registry up to 20 August 2014. Web of Knowledge was used for cross-reference search. We included studies investigating the cost-effectiveness of brief interventions, as defined by National Institute for Health and Care Excellence, promoting physical activity in primary care or the community. Methodological quality was assessed using Drummond's checklist for economic evaluations. Data were extracted from individual studies fulfilling selection criteria using a standardised pro forma. Comparisons of cost-effectiveness and cost-utility ratios were made between studies.ResultsOf 1840 identified publications, 13 studies fulfilled the inclusion criteria describing 14 brief interventions. Studies varied widely in the methods used, such as the perspective of economic analysis, intervention effects and outcome measures. The incremental cost of moving an inactive person to an active state, estimated for eight studies, ranged from £96 to £986. The cost-utility was estimated in nine studies compared with usual care and varied from £57 to £14 002 per quality-adjusted life year; dominant to £6500 per disability-adjusted life year; and £15 873 per life years gained.ConclusionsBrief interventions promoting physical activity in primary care and the community are likely to be inexpensive compared with usual care. Given the commonly accepted thresholds, they appear to be cost-effective on the whole, although there is notable variation between studies.
Methodological Note: Reporting Deterministic versus Probabilistic Results of Markov, Partitioned Survival and Other Non-Linear Models
When making decisions under uncertainty, it is reasonable to choose the path that leads to the highest expected net benefit. Therefore, to inform decision making, decision-model-based health economic evaluations should always present expected outputs (i.e. the mean costs and outcomes associated with each course of action). In non-linear models such as Markov models, a single ‘run’ of the model with each input at its mean (a deterministic analysis) will not generate the expected value of the outputs. In a worst-case scenario, presenting deterministic analyses as the base case can lead to misleading recommendations. Therefore, the base-case analysis of a non-linear model should always be the means from a probabilistic analysis. In this paper, I explain why this is the case and provide recommendations for reporting economic evaluations based on Markov models, noting that the same principle applies to other non-linear structures such as partitioned survival models and individual sampling models. I also provide recommendations for conducting one-way sensitivity analyses of such models. Code illustrating the examples is provided in both Microsoft Excel and R, along with a video abstract and user guides in the electronic supplementary material. Video abstract DHf6dvh-_KsbyZjCZkB-ZU Supplementary file 6 (MP4 20900 kb)