Unpacking the care-related quality of life effect of England's publicly funded adult social care. A panel data analysis.

Adult Social Care (ASC) is the publicly-funded long-term care program in England that provides support with activities of daily living to people experiencing mental and/or physical challenges. Existing evidence suggests that ASC expenditure improves service users' care-related quality of life (CRQoL). However, less is known about the channels through which this effect exists and the effect on outcomes other than CRQoL. We fill this gap by analyzing survey data on ASC service users who received long-term support from 2014/15 to 2019/20 using panel data instrumental variable methods. We find that the beneficial impact of ASC expenditure on the CRQoL of both new and existing users is mostly driven by users aged 18-64 without any learning disability and users with no learning disability aged 65 or older receiving community-based ASC. Moreover, control over daily life, occupation, and social participation are the CRQoL domains that are improved the most. We also find that ASC expenditure has a beneficial effect on several other outcomes beyond CRQoL for both new and existing users including user satisfaction and experience, the ability to carry out activities of daily living independently, whether their home is designed around needs, accessibility to local places, general health, and mental health through reduced anxiety and depression. Greater ASC expenditure, however, does not address the need for other forms of support such as unpaid informal and privately-funded care.

Achieving dynamic efficiency in pharmaceutical innovation: Identifying the optimal share of value and payments required.

It has been argued that cost-effectiveness analysis of branded pharmaceuticals only considers static efficiency, neglects dynamic effects and undermines incentives for socially valuable innovation. We present a framework for designing pharmaceutical pricing policy to achieve dynamic efficiency. We develop a coherent framework that identifies the long-term static and dynamic benefits and costs of offering manufacturers different levels of reward. The share of value that would maximise long-term population health depends on how the quantity and quality of innovation responds to payment. Using evidence of the response of innovation to payment, the optimal share of value of new pharmaceuticals to offer to manufacturers is roughly 20% (range: 6%-51%). Reanalysis of a sample of NICE technology appraisals suggests that, in most cases, the share of value offered to manufacturers and the price premium paid by the English NHS were too high. In the UK, application of optimal shares would offer considerable benefits under both a public health objective and a broader view of social welfare. We illustrate how an optimal share of value can be delivered through a range of payment mechanisms including indirect price regulation via the use of different approval norms by an HTA body.

How Uncertainty Matters Under Risk Neutrality.

It is typical in cost-effectiveness analysis to invoke a normative decision-making framework that assumes, as a starting point, that "a quality-adjusted life-year (QALY) is a QALY is a QALY." The implication of this assumption is that the decision maker is risk neutral and that expected values could be considered sufficiently informative for a given "approve or reject" decision. Nevertheless, it seems intuitive that less uncertainty should be desirable and this has led some to incorporate "real" risk aversion (RA) into cost-effectiveness analysis. We illustrate in this article that RA is not always necessary to justify choosing more over less certain options. We show that for a risk neutral decision maker, greater uncertainty can make the approval of technology less likely in the presence of (1) model nonlinearities, (2) nonlinear opportunity costs, and (3) irreversible costs. We call these cases of "apparent" RA. Incorporating explicit risk preferences into decision making can be challenging; nevertheless, as we show here, it is not necessary to justify caring about uncertainty in approval decisions.

The effect of hospital spending on waiting times.

Long waiting times have been a persistent policy issue in the United Kingdom that the COVID-19 pandemic has exacerbated. This study analyses the causal effect of hospital spending on waiting times in England using a first-differences panel approach and an instrumental variable strategy to deal with residual concerns for endogeneity. We use data from 2014 to 2019 on waiting times from general practitioner referral to treatment (RTT) measured at the level of local purchasers (known as Clinical Commissioning Groups). We find that increases in hospital spending by local purchasers of 1% reduce median RTT waiting time for patients whose pathway ends with a hospital admission (admitted pathway) by 0.6 days but the effect is not statistically significant at 5% level (only at the 10% level). We also find that higher hospital spending does not affect the RTT waiting time for patients whose pathway ends with a specialist consultation (non-admitted pathway). Nor does higher spending have a statistically significant effect on the volume of elective activity for either pathway. Our findings suggest that higher spending is no guarantee of higher volumes and lower waiting times, and that additional mechanisms need to be put in place to ensure that increased spending benefits elective patients.

Electron-induced dissociation dynamics studied using covariance-map imaging.

Recently, covariance analysis has found significant use in the field of chemical reaction dynamics. When coupled with data from product time-of-flight mass spectrometry and/or multi-mass velocity-map imaging, it allows us to uncover correlations between two or more ions formed from the same parent molecule. While the approach has parallels with coincidence measurements, covariance analysis allows experiments to be performed at much higher count rates than traditional coincidence methods. We report results from electron-molecule crossed-beam experiments, in which covariance analysis is used to elucidate the dissociation dynamics of multiply-charged ions formed by electron ionisation over the energy range from 50 to 300 eV. The approach is able to isolate signal contributions from multiply charged ions even against a very large 'background' of signal arising from dissociation of singly-charged parent ions. Covariance between the product time-of-flight spectra identifies pairs of fragments arising from the same parent ions, while covariances between the velocity-map images ('recoil-frame covariances') reveal the relative velocity distributions of the ion pairs. We show that recoil-frame covariance analysis can be used to distinguish between multiple plausible dissociation mechanisms, including multi-step processes, and that the approach becomes particularly powerful when investigating the fragmentation dynamics of larger molecules with a higher number of possible fragmentation pathways.

A Health Opportunity Cost Threshold for Cost-Effectiveness Analysis in the United States.

BACKGROUND: Cost-effectiveness analysis is an important tool for informing treatment coverage and pricing decisions, yet no consensus exists about what threshold for the incremental cost-effectiveness ratio (ICER) in dollars per quality-adjusted life-year (QALY) gained indicates whether treatments are likely to be cost-effective in the United States. OBJECTIVE: To estimate a U.S. cost-effectiveness threshold based on health opportunity costs. DESIGN: Simulation of short-term mortality and morbidity attributable to persons dropping health insurance due to increased health care expenditures passed though as premium increases. Model inputs came from demographic data and the literature; 95% uncertainty intervals (UIs) were constructed. SETTING: Population-based. PARTICIPANTS: Simulated cohort of 100 000 individuals from the U.S. population with direct-purchase private health insurance. MEASUREMENTS: Number of persons dropping insurance coverage, number of additional deaths, and QALYs lost from increased mortality and morbidity, all per increase of $10 000 000 (2019 U.S. dollars) in population treatment cost. RESULTS: Per $10 000 000 increase in health care expenditures, 1860 persons (95% UI, 1080 to 2840 persons) were simulated to become uninsured, causing 5 deaths (UI, 3 to 11 deaths), 81 QALYs (UI, 40 to 170 QALYs) lost due to death, and 15 QALYs (UI, 6 to 32 QALYs) lost due to illness; this implies a cost-effectiveness threshold of $104 000 per QALY (UI, $51 000 to $209 000 per QALY) in 2019 U.S. dollars. Given available evidence, there is about 14% probability that the threshold exceeds $150 000 per QALY and about 48% probability that it lies below $100 000 per QALY. LIMITATIONS: Estimates were sensitive to inputs, most notably the effects of losing insurance on mortality and of premium increases on becoming uninsured. Health opportunity costs may vary by population. Nonhealth opportunity costs were excluded. CONCLUSION: Given current evidence, treatments with ICERs above the range $100 000 to $150 000 per QALY are unlikely to be cost-effective in the United States. PRIMARY FUNDING SOURCE: None.

Does public long-term care expenditure improve care-related quality of life of service users in England?

Public long-term care (LTC) systems provide services to support people experiencing difficulties with their activities of daily living. This study investigates the marginal effect of changes in public LTC expenditure on care-related quality of life (CRQoL) of existing service users in England. The public LTC program for people aged 18 or older in England is called Adult Social Care (ASC) and it is provided and managed by local authorities. We collect data on the outcomes and characteristics of public ASC users, on public ASC expenditure, and on the characteristics of local authorities across England in 2017/18. We employ an instrumental variable approach using conditionally exogenous elements of the public funding system to estimate the effect of public ASC expenditure on user CRQoL. Our findings show that by increasing public ASC expenditure by £1000 per user, on average, local authorities increase user CRQoL by 0.0030. These results suggest that public ASC is effective in increasing users' quality of life but only to a relatively small extent. When combined with the other potential effects of LTC expenditure (e.g., on informal carers, mortality), this study can inform policy makers in the United Kingdom and internationally about whether social care provides good value for money.

Cured Today, Ill Tomorrow: A Method for Including Future Unrelated Medical Costs in Economic Evaluation in England and Wales.

OBJECTIVES: In many countries, future unrelated medical costs occurring during life-years gained are excluded from economic evaluation, and benefits of unrelated medical care are implicitly included, leading to life-extending interventions being disproportionately favored over quality of life-improving interventions. This article provides a standardized framework for the inclusion of future unrelated medical costs and demonstrates how this framework can be applied in England and Wales. METHODS: Data sources are combined to construct estimates of per-capita National Health Service spending by age, sex, and time to death, and a framework is developed for adjusting these estimates for costs of related diseases. Using survival curves from 3 empirical examples illustrates how our estimates for unrelated National Health Service spending can be used to include unrelated medical costs in cost-effectiveness analysis and the impact depending on age, life-years gained, and baseline costs of the target group. RESULTS: Our results show that including future unrelated medical costs is feasible and standardizable. Empirical examples show that this inclusion leads to an increase in the ICER of between 7% and 13%. CONCLUSIONS: This article contributes to the methodology debate over unrelated costs and how to systematically include them in economic evaluation. Results show that it is both important and possible to include future unrelated medical costs.

Incorporating Affordability Concerns Within Cost-Effectiveness Analysis for Health Technology Assessment.

BACKGROUND: Recent policy developments and journal articles have emphasized a divergence: when interventions are found to be cost-effective but unaffordable. This apparent paradox reflects a conventional practice of cost-effectiveness analysis that does not properly evaluate the opportunity costs of an intervention that imposes non-marginal costs on the healthcare system. OBJECTIVE: Taking the perspective of an exogenously resource constrained decision maker, this paper presents a framework by which concerns for affordability can be appropriately incorporated within cost-effectiveness analysis. METHODS: A net benefit framework is proposed where health opportunity costs are estimated for each simulation iteration within each time period. The framework is applied to a hypothetical case study based on the recent experience of the English NHS with new hepatitis C drugs. RESULTS: Under the proposed framework, but not under conventional cost-effectiveness analysis, estimates of health opportunity costs differ between scenarios involving different profiles of budget impact even when their net present value, or expected value, are the same. CONCLUSIONS: The framework presented here reflects the importance of the scale of budget impacts along with their uncertainty distribution and time profile. In doing so it resolves issues with the conduct of conventional cost-effectiveness analysis where affordability concerns are not explicitly incorporated.

Estimating the Marginal Productivity of the English National Health Service From 2003 to 2012.

OBJECTIVE: Estimates of the marginal productivity of the health sector are required for a wide range of resource allocation decisions. Founding these estimates on robust empirical analysis can inform these decisions and improve allocative efficiency. This article estimates the annual marginal productivity of the English NHS over a 10-year period (between 2003 and 2012). METHODS: Data on expenditure and mortality by program budget category are used in conjunction with socioeconomic and demographic variables from the censuses for 2001 and 2011. This article applies an econometric strategy that employs an established instrumental variable approach, which is then subjected to a number of sensitivity analyses. The results of the econometric analysis, along with additional data on the burden of disease, are used to generate an estimate of the marginal productivity for each of the study years. RESULTS: We find that an additional unit of health benefit has cost between £5000 and £15 000 per quality-adjusted life-year from 2003 to 2012. Over this period these estimates (all in current prices) have increased at a faster rate than NHS price inflation, suggesting an increase in real terms. CONCLUSIONS: These results are discussed in the context of the existing literature, and the potential policy implications for decisions about resource allocation are explored.

Implications of Nonmarginal Budgetary Impacts in Health Technology Assessment: A Conceptual Model.

OBJECTIVES: This paper introduces a framework with which to conceptualize the decision-making process in health technology assessment for new interventions with high budgetary impacts. In such circumstances, the use of a single threshold based on the marginal productivity of the healthcare system is inappropriate. The implications of this for potential partial implementation, horizontal equity, and pharmaceutical pricing are illustrated using this framework. RESULTS: Under the condition of perfect divisibility and given an objective of maximizing health, a large budgetary impact of a new treatment may imply that optimal implementation is partial rather than full, even at a given incremental cost-effectiveness ratio that would nevertheless mean the decision to accept the treatment in full would not lead to a net reduction in health. In a one-shot price-setting game, this seems to give rise to potential horizontal equity concerns. When the assumption of fixity of the incremental cost-effectiveness ratio (arising from the assumed exogeneity of the manufacturer's price) is relaxed, it can be shown that the threat of partial implementation may be sufficient to give rise to an incremental cost-effectiveness ratio at which cost the entire potential population is treated, maximizing health at an increased level, and with no contravention of the horizontal equity principle.

Resolving the "Cost-Effective but Unaffordable" Paradox: Estimating the Health Opportunity Costs of Nonmarginal Budget Impacts.

Considering whether or not a proposed investment (an intervention, technology, or program of care) is affordable is really asking whether the benefits it offers are greater than its opportunity cost. To say that an investment is cost-effective but not affordable must mean that the (implicit or explicit) "threshold" used to judge cost-effectiveness does not reflect the scale and value of the opportunity costs. Existing empirical estimates of health opportunity costs are based on cross-sectional variation in expenditure and mortality outcomes by program budget categories (PBCs) and do not reflect the likely effect of nonmarginal budget impacts on health opportunity costs. The UK Department of Health regularly updates the needs-based target allocation of resources to local areas of the National Health Service (NHS), creating two subgroups of local areas (those under target allocation and those over). These data provide the opportunity to explore how the effects of changes in health care expenditure differ with available resources. We use 2008-2009 data to evaluate two econometric approaches to estimation and explore a range of criteria for accepting subgroup specific effects for differences in expenditure and outcome elasticities across the 23 PBCs. Our results indicate that health opportunity costs arising from an investment imposing net increases in expenditure are underestimated unless account is taken of likely nonmarginal effects. They also indicate the benefits (reduced health opportunity costs or increased value-based price of a technology) of being able to "smooth" these nonmarginal budget impacts by health care systems borrowing against future budgets or from manufacturers offering "mortgage" type arrangements.

The impact of NHS expenditure on health outcomes in England: Alternative approaches to identification in all-cause and disease specific models of mortality.

Several recent studies have estimated the responsiveness of mortality to English National Health Service spending. Although broadly similar, the studies differ in how they identify the outcome equation. One approach uses conventional socio-economic variables as instruments for endogenous health care expenditure, whereas the other exploits exogenous elements in the resource allocation formula for local budgets. The former approach has usually been applied to specific disease areas (e.g., for cancer and circulatory disease), whereas the other has only been applied to all-cause mortality. In this letter, we compare the two approaches by using them to estimate the direct all-cause elasticity as well as disease-specific elasticities. We also calculate the implied all-cause elasticity associated with the disease-specific results. We find that the "funding rule" approach to identification can be successfully replicated and applied to disease area models. This is important because disease area models reduce the danger of aggregation bias present in all-cause analysis, and they offer the opportunity to link estimated mortality effects to more complete measures of health outcome that reflect what is currently known about the survival and morbidity disease burden in different programmes.

Healthcare Cost Regressions: Going Beyond the Mean to Estimate the Full Distribution.

Understanding the data generating process behind healthcare costs remains a key empirical issue. Although much research to date has focused on the prediction of the conditional mean cost, this can potentially miss important features of the full distribution such as tail probabilities. We conduct a quasi-Monte Carlo experiment using the English National Health Service inpatient data to compare 14 approaches in modelling the distribution of healthcare costs: nine of which are parametric and have commonly been used to fit healthcare costs, and five others are designed specifically to construct a counterfactual distribution. Our results indicate that no one method is clearly dominant and that there is a trade-off between bias and precision of tail probability forecasts. We find that distributional methods demonstrate significant potential, particularly with larger sample sizes where the variability of predictions is reduced. Parametric distributions such as log-normal, generalised gamma and generalised beta of the second kind are found to estimate tail probabilities with high precision but with varying bias depending upon the cost threshold being considered.

The impact of different types of NHS expenditure on health: Marginal cost per QALY estimates for England for 2016/17.

English data from 2003 to 2012 suggests that it costs the NHS £10,000 to generate an additional quality-adjusted life year (QALY).  This estimate relates to all NHS expenditure and no attempt was made to explore possible heterogeneity within this total.  Different types of expenditure - such as secondary care, primary care and specialized commissioning - may have different productivities and estimates of these may help policymakers decide where additional investment is most beneficial.  We use the two-stage least squares estimator and data for 2016 to explore the mortality response to three types of healthcare expenditure.  Three specifications are estimated for each type of expenditure: backward selection and regularized regression are used to identify parsimonious specifications, and a full specification with all covariates is also estimated.  The regression results are combined with information about survival and morbidity disease burden to calculate the marginal cost per QALY for each type of expenditure: the most conservative results suggest that this is about £8,000 for locally (CCG) commissioned services, while estimates for specialized commissioning and primary care are more uncertain.  When this heterogeneity is taken into account, the estimated marginal cost per QALY for all NHS expenditure increases slightly, from about £6,000 to £7,000.  Our results suggest that additional investment is likely to be most productive in primary care and in locally commissioned services.

Is extending eligibility for adult social care better than investing more in existing users in England? A cross-sectional evidence for multiple financial years.

OBJECTIVES: Publicly funded adult social care (ASC) in England aims to improve quality of life through the provision of services for individuals with care needs due to physical and/or mental impairment or illness. Access to these services, however, is often restricted to contain public expenditure. With a fast-growing care need, information on whether extending eligibility is good value for money becomes policy-relevant. PRIMARY AND SECONDARY OUTCOME MEASURES: This study investigates the effect of extending ASC eligibility on user care-related quality of life (CRQoL), a policy-relevant measure of quality of life. DESIGN: We use English cross-sectional survey data from 2017/2018 to 2019/2020 on users receiving publicly funded long-term support including domiciliary and other community-based social care, as well as residential and nursing care from local authorities responsible for ASC. We employ the two-stage least square method to estimate the impact of ASC expenditure on CRQoL at various levels of ASC expenditure in each financial year. This includes the CRQoL effect of increasing expenditure from zero to some level, which captures the effect of extending ASC eligibility to new users. RESULTS: We find that publicly funded ASC improves the CRQoL of both existing and newly eligible users, although the latter are likely to experience greater CRQoL gains. Moreover, from 2017/2018 to 2019/2020, spending as much as an average user for a newly eligible user costs between £54 224 and £77 778 per social care-quality-adjusted life year (SC-QALY) gained. These results are statistically significant at the 5% level. Compared with this finding, increasing expenditure for an existing user has always a higher cost per SC-QALY gained. CONCLUSIONS: Extending ASC eligibility to new users is likely to be more cost-effective compared with using the same resources to increase expenditure for existing users.

Informing a cost-effectiveness threshold for Saudi Arabia.

BACKGROUND: Saudi Arabia's Vision 2030 aims to reform health care across the Kingdom, with health technology assessment being adopted as one tool promising to improve the efficiency with which resources are used. An understanding of the opportunity costs of reimbursement decisions is key to fulfilling this promise and can be used to inform a cost-effectiveness threshold. This paper is the first to provide a range of estimates of this using existing evidence extrapolated to the context of Saudi Arabia. METHODS AND MATERIALS: We use four approaches to estimate the marginal cost per unit of health produced by the healthcare system; drawing from existing evidence provided by a cross-country analysis, two alternative estimates from the UK context, and based on extrapolating a UK estimate using evidence on the income elasticity of the value of health. Consequences of estimation error are explored. RESULTS: Based on the four approaches, we find a range of SAR 42,046 per QALY gained (48% of GDP per capita) to SAR 215,120 per QALY gained (246% of GDP per capita). Calculated potential central estimates from the average of estimated health gains based on each source gives a range of SAR 50,000-75,000. The results are in line with estimates from the emerging literature from across the world. CONCLUSION: A cost-effectiveness threshold reflecting health opportunity costs can aid decision-making. Applying a cost-effectiveness threshold based on the range SAR 50,000 to 75,000 per QALY gained would ensure that resource allocation decisions in healthcare can in be informed in a way that accounts for health opportunity costs. LIMITATIONS: A limitation is that it is not based on a within-country study for Saudi Arabia, which represents a promising line of future work.

Healthcare in Saudi Arabia is undergoing wide-ranging reform through Saudi Arabia's Vision 2030. One aim of these reforms is to ensure that money spent on healthcare generates the most improvement in population health possible. To do this requires understanding the trade-offs that exist: funding one pharmaceutical drug means that same money is not available to fund another pharmaceutical drug. This is relevant whether the new drug would be funded from within the existing budget for healthcare or from an expansion of it. If the drugs apply to the same patient population and have the same price, the question is simply, "which one generates more health?" In reality, we need to compare pharmaceutical drugs for different diseases, patient populations, and at a range of potential prices to understand whether the drug in question would generate more health per riyal spent than what is currently funded by the healthcare system. This paper provides the first estimates of the amount of health, measured in terms of quality adjusted life years (QALYs), generated by the Saudi Arabian healthcare system. We find that the healthcare system generates health at a rate of one QALY produced for every 50,000­75,000 riyals spent (58­86% of GDP per capita). Using the range we estimate to inform cost-effectiveness threshold can aid decision-making.

We need to talk about values: a proposed framework for the articulation of normative reasoning in health technology assessment.

It is acknowledged that health technology assessment (HTA) is an inherently value-based activity that makes use of normative reasoning alongside empirical evidence. But the language used to conceptualise and articulate HTA's normative aspects is demonstrably unnuanced, imprecise, and inconsistently employed, undermining transparency and preventing proper scrutiny of the rationales on which decisions are based. This paper - developed through a cross-disciplinary collaboration of 24 researchers with expertise in healthcare priority-setting - seeks to address this problem by offering a clear definition of key terms and distinguishing between the types of normative commitment invoked during HTA, thus providing a novel conceptual framework for the articulation of reasoning. Through application to a hypothetical case, it is illustrated how this framework can operate as a practical tool through which HTA practitioners and policymakers can enhance the transparency and coherence of their decision-making, while enabling others to hold them more easily to account. The framework is offered as a starting point for further discussion amongst those with a desire to enhance the legitimacy and fairness of HTA by facilitating practical public reasoning, in which decisions are made on behalf of the public, in public view, through a chain of reasoning that withstands ethical scrutiny.

Accounting for country- and time-specific values in the economic evaluation of health-related projects relevant to low- and middle-income countries.

Economic evaluation of health-related projects requires principles and methods to address the various trade-offs that need to be made between costs and benefits, across sectors and social objectives, and over time. Existing guidelines for economic evaluation in low- and middle-income countries embed implicit assumptions about expected changes in the marginal cost per unit of health produced by the healthcare sector, the consumption value of health and the appropriate discount rates for health and consumption. Separating these evaluation parameters out requires estimates for each country over time, which have hitherto been unavailable. We present a conceptual economic evaluation framework that aims to clarify the distinct roles of these different evaluation parameters in evaluating a health-related project. Estimates for each are obtained for each country and in each time period, based on available empirical evidence. Where existing estimates are not available, for future values of the marginal cost per unit of health produced by the healthcare sector, new estimates are obtained following a practical method for obtaining projected values. The framework is applied to a simple, hypothetical, illustrative example, and the results from our preferred approach are compared against those obtained from other approaches informed by the assumptions implicit within existing guidelines. This exposes the consequences of applying such assumptions, which are not supported by available evidence, in terms of potentially sub-optimal decisions. In general, we find that applying existing guidelines as done in conventional practice likely underestimates the value of health-related projects on account of not allowing for expected growth in the marginal cost per unit of health produced by the healthcare sector.

Economic Evaluation Evidence for Resource-Allocation Decision Making: Bridging the Gap for Local Decision Makers Using English Case Studies.

Best-practice economic evaluation methods for health-related decision making at a national level in England are well established, and as a first principle generally involve attempting to maximise the amount of health generated from the health system's budget. Such methods are applied in ways that are broadly transparent and accountable, often at arm's length from explicit political pressures. At local levels of decision making, however, decision making is arguably less likely to be applied according to established overarching principles, is less transparent and is more subject to political pressures. This may be owing to a multiplicity of reasons, for example, undesirability/inappropriateness of such methods, or a failure to make the methods clear to local decision makers. We outline principles for economic evaluations and break down these methods into their component parts, considering their relevance in the English local context. These include taxonomies of decision-making frameworks, budgets, costs, outcome, and characterisations of cost effectiveness. We also explore the role of broader factors, including the relevance of assuming a single fixed budget, pressures resulting from political and budgetary cycles and affordability. We consider the data requirements to inform such deliberations. By setting out principles for economic evaluation methods in a clear language aimed at local decision making, a potential role for such methods can be established, which to date has failed to emerge. While the extent to which these methods can and should be applied are a matter for continued debate, the establishment of such a mutual understanding may assist in the improvement of methods for such decision making and the outcomes resulting from their application.