The appraisal of public health interventions: an overview.

BACKGROUND: The approach currently used to appraise public health interventions is close to that of health technology appraisal for drugs. This approach is not appropriate for many public health interventions, however, when extremely small individual level benefits are delivered to extremely large populations. In many such situations, randomized controlled trials with sufficient size and power to determine individual level effects are impractical. Such interventions may be cost-effective, even in the absence of traditional evidence to demonstrate this. METHODS: We outline an alternative approach based on decision theory. We apply it to cases where prior beliefs are sufficiently strong and well grounded to allow decision-makers to assume the direction of change of the intervention's outcome, within the context of a transparent and deliberative decision-making process. Decision theory also assumes that decision-makers are risk neutral, implying that they should make decisions based on an intervention's mean cost-effectiveness, and should therefore disregard variance except when deciding to wait for more information. However, they must allow for biases. RESULTS: A framework is presented which has the potential to achieve large health gains at no additional cost. CONCLUSIONS: This analysis provides a rigorous theoretical framework for decision-makers in public health. The implied paradigm shift also applies to some clinically based areas.

Public healthcare resource allocation and the Rule of Rescue.

In healthcare, a tension sometimes arises between the injunction to do as much good as possible with scarce resources and the injunction to rescue identifiable individuals in immediate peril, regardless of cost (the "Rule of Rescue"). This tension can generate serious ethical and political difficulties for public policy makers faced with making explicit decisions about the public funding of controversial health technologies, such as costly new cancer drugs. In this paper we explore the appropriate role of the Rule of Rescue in public resource allocation decisions by health technology funding advisory bodies such as the National Institute for Health and Clinical Excellence. We consider practical approaches to operationalising the Rule of Rescue from Australia and the UK before examining the relevance of individual moral imperatives to public policy making. We conclude that that whilst public policy makers in a humane society should facilitate exceptional departures from a cost effectiveness norm in clinical decisions about identified individuals, it is not so obvious that they should, as a matter of national public policy, exempt any one group of unidentified individuals within society from the rules of opportunity cost at the expense of all others.

Vibration activity and mobility of structure-borne sound sources by a reception plate method.

This paper considers a practical structure-borne sound source characterization for mechanical installations, which are connected to plate-like structures. It describes a laboratory-based measurement procedure, which will yield single values of source strength in a form transferable to a prediction of the structure-borne sound power generated in the installed condition. It is confirmed that two source quantities are required, corresponding to the source activity and mobility. For the source activity, a high-mobility reception plate method is proposed which yields a single value in the form of the sum of the squared free velocities, over the contact points. A low-mobility reception plate method also is proposed which, in conjunction with the above, yields the source mobility in the form of the average magnitude of the effective mobility, again over the contact points. Experimental case studies are described and the applicability of the laboratory data for prediction and limitations of the approach are discussed.

Health equity monitoring for healthcare quality assurance.

Population-wide health equity monitoring remains isolated from mainstream healthcare quality assurance. As a result, healthcare organizations remain ill-informed about the health equity impacts of their decisions - despite becoming increasingly well-informed about quality of care for the average patient. We present a new and improved analytical approach to integrating health equity into mainstream healthcare quality assurance, illustrate how this approach has been applied in the English National Health Service, and discuss how it could be applied in other countries. We illustrate the approach using a key quality indicator that is widely used to assess how well healthcare is co-ordinated between primary, community and acute settings: emergency inpatient hospital admissions for ambulatory care sensitive chronic conditions ("potentially avoidable emergency admissions", for short). Whole-population data for 2015 on potentially avoidable emergency admissions in England were linked with neighborhood deprivation indices. Inequality within the populations served by 209 clinical commissioning groups (CCGs: care purchasing organizations with mean population 272,000) was compared against two benchmarks - national inequality and inequality within ten similar populations - using neighborhood-level models to simulate the gap in indirectly standardized admissions between most and least deprived neighborhoods. The modelled inequality gap for England was 927 potentially avoidable emergency admissions per 100,000 people, implying 263,894 excess hospitalizations associated with inequality. Against this national benchmark, 17% of CCGs had significantly worse-than-benchmark equity, and 23% significantly better. The corresponding figures were 11% and 12% respectively against the similar populations benchmark. Deprivation-related inequality in potentially avoidable emergency admissions varies substantially between English CCGs serving similar populations, beyond expected statistical variation. Administrative data on inequality in healthcare quality within similar populations served by different healthcare organizations can provide useful information for healthcare quality assurance.

When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework.

BACKGROUND: Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials. METHODS: An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials. RESULTS: A randomised trial can usefully be classified as 'health equity relevant' if it assesses the effects of an intervention on the health or its determinants of either individuals or a population who experience ill health due to disadvantage defined across one or more social determinants of health. Health equity-relevant randomised trials can either exclusively focus on a single population or collect data potentially useful for assessing differential effects of the intervention across multiple populations experiencing different levels or types of social disadvantage. Trials that are not classified as 'health equity relevant' may nevertheless provide information that is indirectly relevant to assessing equity impact, including information about individual level variation unrelated to social disadvantage and potentially useful in secondary modelling studies. CONCLUSION: The conceptual framework may be used to design and report randomised trials. The framework could also be used for other study designs to contribute to the evidence base for improved health equity.

Patient and hospital determinants of primary percutaneous coronary intervention in England, 2003-2013.

OBJECTIVE: Primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI) is insufficiently implemented in many countries. We investigated patient and hospital characteristics associated with PPCI utilisation. METHODS: Whole country registry data (MINAP, Myocardial Ischaemia National Audit Project) comprising PPCI-capable National Health Service trusts in England (84 hospital trusts; 92 350 hospitalisations; 90 489 patients), 2003-2013. Multilevel Poisson regression modelled the relationship between incidence rate ratios (IRR) of PPCI and patient and trust-level factors. RESULTS: Overall, standardised rates of PPCI increased from 0.01% to 86.3% (2003-2013). While, on average, there was a yearly increase in PPCI utilisation of 30% (adjusted IRR 1.30, 95% CI 1.23 to 1.36), it varied substantially between trusts. PPCI rates were lower for patients with previous myocardial infarction (0.95, 0.93 to 0.98), heart failure (0.86, 0.81 to 0.92), angina (0.96, 0.94 to 0.98), diabetes (0.97, 0.95 to 0.99), chronic renal failure (0.89, 0.85 to 0.90), cerebrovascular disease (0.96, 0.93 to 0.99), age >80 years (0.87, 0.85 to 0.90), and travel distances >30 km (0.95, 0.93 to 0.98). PPCI rates were higher for patients with previous percutaneous coronary intervention (1.09, 1.05 to 1.12) and among trusts with >5 interventional cardiologists (1.30, 1.25 to 1.34), more visiting interventional cardiologists (1-5: 1.31, 1.26 to 1.36; ≥6: 1.42, 1.35 to 1.49), and a 24 h, 7-days-a-week PPCI service (2.69, 2.58 to 2.81). Half of the unexplained variation in PPCI rates was due to between-trust differences. CONCLUSIONS: Following an 8 year implementation phase, PPCI utilisation rates stabilised at 85%. However, older and sicker patients were less likely to receive PPCI and there remained between-trust variation in PPCI rates not attributable to differences in staffing levels. Compliance with clinical pathways for STEMI is needed to ensure more equitable quality of care.

Incorporating psycho-social considerations into health valuation: an experimental study.

This study used multiple elicitation question modes and group discussions to value psycho-social considerations associated with public perceptions of health risks. Values for saving 100 statistical lives in six different policy contexts varied by +/- 50%, largely due to psycho-social considerations of choice and control. A "currency effect" was found: value of life differentials were smaller when questions were framed directly in the currency of lives saved rather than willingness to pay or public spending to save lives. Discussions reduced but did not eliminate inconsistencies, and slightly increased the relative valuations of health interventions involving less choice and control by those at risk.

Cost of schizophrenia to UK Society. An incidence-based cost-of-illness model for the first 5 years following diagnosis.

OBJECTIVE: This study estimated the cost to UK society of an annual cohort of newly diagnosed patients with schizophrenia over the first 5 years following diagnosis, using an incidence-based cost-of-illness framework. DESIGN AND SETTING: A discrete event model of the course of schizophrenia was constructed, based on a literature review and interviews among a panel of healthcare professionals (n = 7). Seven discrete disease states were defined within the model. Patients' movements between these disease states enabled 10 disease courses to be identified. In each disease state, the model estimated resource use and corresponding costs borne by the National Health Service (NHS), Local Authorities, the Home Office and society as a result of lost productivity. PATIENTS AND PARTICIPANTS: The model simulated patients' movements between disease states over the first 5 years following diagnosis. Since there are 7500 new cases of schizophrenia per year in the UK, the model was run for 7500 patient simulations. MAIN OUTCOME MEASURES AND RESULTS: The total discounted cost to society attributable to an annual cohort of newly-diagnosed patients with schizophrenia over the first 5 years following diagnosis was estimated at 862 million Pounds (range: 788 million Pounds to 926 million Pounds in sensitivity analysis). The discounted mean 5-year cost was estimated to be approximately 115,000 Pounds (range: 105,000 Pounds to 124,000 Pounds) per patient or approximately 23,000 Pounds (range: 21,000 Pounds to 25,000 Pounds) per patient per year. The NHS accounted for 38% of the total cost, Local Authorities for 12% and the Home Office for 1%. Indirect costs due to lost productivity accounted for 49%. Of the NHS costs, hospital admissions accounted for 69% and hospital visits (outpatient, day ward and day centre attendances) for a further 26%. Drugs (antipsychotics and adjunctive medications) accounted for 2%. CONCLUSIONS: NHS expenditure and lost productivity costs predominated, irrespective of disease course. This indicates that treatments that reduce hospitalisation and potentially enable patients to return to active employment could significantly reduce the societal burden of schizophrenia.

Cost analysis of palliative care for terminally ill cancer patients in the UK after switching from weak to strong opioids. Palliative Care Advisory Committee.

OBJECTIVE: We constructed a UK-based decision model of palliative care for terminally ill cancer patients who were switched from a weak to a strong opioid so that the expected direct healthcare costs in the UK could be estimated from the time a patient commenced a strong opioid until death. DESIGN: Decision analysis techniques were used to estimate the expected total direct healthcare cost per patient, stratified according to the first choice of strong opioid. The model was based on prescription data on 1975 terminally ill cancer patients who were on the Intercontinental Medical Statistics database, Mediplus (IMS Ltd, Middlesex, England). Resource-use data were obtained from published literature, a Delphi Panel and an advisory panel with expertise in palliative care. MAIN OUTCOME MEASURES AND RESULTS: The expected cost of managing terminally ill cancer patients after they switched from a weak to a strong opioid ranged from 2391 pounds sterling (Pounds) to 3701 Pounds at 1995/1996 prices, depending primarily on the patient's duration of survival. Sensitivity analyses showed that the cost could be as low as 1500 Pounds or as high as 6000 Pounds, depending on resource use (at 1995/1996 prices). The key cost drivers were: hospice care, hospitalisation, general practitioner (GP) consultations and specialist nurse visits. In contrast, neither the choice of opioid nor managing constipation impacted substantially on the expected cost. Approximately two-thirds of the expected total cost was incurred by the UK National Health Service (NHS), with the remainder incurred by voluntary and charitable sectors. Hospice care and hospitalisation collectively accounted for between 50 and 80% of the expected costs. Management of patients in the community by the primary healthcare team accounted for between 10 and 40% of the costs. The acquisition cost of opioids accounted for between 2 and 8% of the expected cost and discounting the cost of these drugs sold to hospitals did not impact substantially on the total expected costs. The use of other resources such as antiemetics, NSAIDS, antidepressants and gastrointestinal drugs accounted for up to 3% of the expected cost. CONCLUSION: The expected cost of palliative care in the UK healthcare setting ranged from approximately 2500 Pounds to 4000 Pounds (1500 Pounds to 6000 Pounds in the sensitivity analysis) depending on the length of survival after patients switch from weak to strong opioids. Since opioids account for only 2 to 8% of expected costs, factors other than economic issues, such as tolerability profile, patient preference and convenience of use, should form the basis of clinical decision-making between opioids with similar analgesic efficacy.

Money or your life? The health-wealth trade-off in pharmaceutical regulation.

For decades the development of pharmaceuticals has been regulated by safety, efficacy and quality rules for product registration. In public health care systems, these three 'hurdles' are increasingly being supplemented by a fourth: the mandatory requirement to demonstrate economic efficiency in order to obtain reimbursement. This requirement challenges the wealth creation ethic of industry (money) with the population health ethic of public health and health economics (your life). Despite practical and methodological obstacles to the use of economic evidence in decisions, the logic of this development is evident: in order to maximise improvements in population health, scarce resources must be targeted towards developing and applying technologies that deliver the greatest health gains per unit cost. The impact of this policy change on industry practice and profits will be considerable, and companies that fail to demonstrate the economic efficiency of their products will stumble at the fourth hurdle.

Public views on health care rationing: a group discussion study.

This small-scale study develops a new methodology for investigating which ethical principles of health care rationing the public support after discussion and deliberation. In ten groups of about six people, members of the public are asked to discuss a hypothetical rationing choice, concerning four identified patients who are described in general terms but without detailed information. It is explained to respondents that the purpose of the exercise is to find out what general ethical principles they support. Discussions are chaired by an academic specialising in health policy, whose role is to encourage debate but not actively to participate. On the basis of an innovative qualitative data analysis, which translates what people say into ethical principles identified in the theoretical literature, the public appear to support three main rationing principles: (1) a broad 'rule of rescue' that gives priority to those in immediate need, (2) health maximisation and (3) equalisation of lifetime health. To our knowledge, this pluralistic viewpoint on rationing has never been developed into a coherent theoretical position, nor into a quantifiable model that health care managers can use for guidance.

A qualitative study of the extent to which health gain matters when choosing between groups of patients.

There is considerable debate about the appropriateness of allocating health care resources on the basis of the size of the health improvement that they generate. The aim of this study was to elicit the general public's views about the extent to which health gain matters vis-a-vis other considerations. A total of 60 respondents took part in group discussions designed to enable them to raise, discuss, and reflect upon, different arguments. The qualitative data showed that many responses were being generated by factors that were not directly included in the questions, and so it is difficult to meaningfully interpret the results of other studies which have asked similar questions but which have not looked at the reasons underlying the responses. However, a clear message did come through from the data; namely, that equality of access should prevail over the maximization of benefits. However, this was subject to the outcome constraint that treatments are sufficiently effective. An important question for future research, then is 'how effective do treatments have to be for the principle of equal access to apply?'

Avoiding the pitfalls of sponsored multicentre research in general practice.

Research in general practice is becoming increasingly popular, and most general practitioners will sooner or later have to decide whether to become involved with clinical trials sponsored by drug companies. This paper outlines the advantages and disadvantages of multicentre research--based on experience of running a research group since the early 1980s--to enable doctors to reach the appropriate decision and to avoid involvement in trials which are either unethical or ineffective.

Effect of discussion and deliberation on the public's views of priority setting in health care: focus group study.

OBJECTIVE: To investigate the extent to which people change their views about priority setting in health care as a result of discussion and deliberation. DESIGN: A random sample of patients from two urban general practices was invited to attend two focus group meetings, a fortnight apart. SETTING: North Yorkshire Health Authority. SUBJECTS: 60 randomly chosen patients meeting in 10 groups of five to seven people. MAIN OUTCOME MEASURES: Differences between people's views at the start of the first meeting and at the end of the second meeting, after they have had an opportunity for discussion and deliberation, measured by questionnaires at the start of the first meeting and the end of the second meeting. RESULTS: Respondents became more reticent about the role that their views should play in determining priorities and more sympathetic to the role that healthcare managers play. About a half of respondents initially wanted to give lower priority to smokers, heavy drinkers, and illegal drug users, but after discussion many no longer wished to discriminate against these people. CONCLUSION: The public's views about setting priorities in health care are systematically different when they have been given an opportunity to discuss the issues. If the considered opinions of the general public are required, surveys that do not allow respondents time or opportunity for reflection may be of doubtful value.

Anthelmintic efficacy against cyathostomins in horses in Southern England.

Cyathostomins are considered to be the most important group of helminths to affect equids due to their high prevalence, potential pathogenicity and ability to develop anthelmintic resistance. Their control relies almost exclusively on frequent anthelmintic use. Currently, fenbendazole (FBZ), pyrantel embonate (PYR), ivermectin (IVM) and moxidectin (MOX) are licensed for use in horses in the UK. With no new anthelmintics likely to be licensed in the near future, it is essential that investigations into the efficacy of current anthelmintics in different locations are performed to help inform control programmes. Here, efficacy of FBZ, PYR, IVM and MOX in horse populations in the South of England was investigated. Horses with a strongyle faecal egg count (FEC) of ≥50 eggs per gram (EPG) were enrolled onto a faecal egg count reduction test (FECRT) study. Efficacy was determined by calculating the percentage reduction in FEC between the group mean at Day 0 and 14 days post-treatment. Efficacy was indicated when a group arithmetic faecal egg count reduction (FECR) of ≥90% was recorded for FBZ and PYR, and ≥95% for IVM and MOX. Between March and December 2012, 404 FECRT were performed on 12 yards examining 101, 110, 93 and 100 equids for FBZ, PYR, IVM, and MOX, respectively. FBZ resistance was identified on all yards (mean FECR range 0-65.8%). On 10 of 12 yards, PYR efficacy was >90% (91.0-99.4%) and on two yards, PYR resistance was suspected (86.8-87.2%). IVM (96.4-100%) and MOX (99.9-100%) were >95% efficacious on all yards. As the prevalence of FBZ resistance was 100%, the future use of this anthelmintic for the control of strongyles should be questioned. PYR should be used strategically to reduce reliance on the macrocyclic lactone class products. Over-dispersion of FEC between horses was observed (average k=0.21) with 80% of the strongyle eggs counted measured in 15% of horses tested, strongly supporting the application of targeted helminth control programmes in this host species.

Comparison of injury severity between AIS 2005 and AIS 1990 in a large injury database.

The aim of this study is to investigate the differences in car occupant injury severity recorded in AIS 2005 compared to AIS 1990 and to outline the likely effects on future data analysis findings. Occupant injury data in the UK Cooperative Crash Injury Study Database (CCIS) were coded for the period February 2006 to November 2007 using both AIS 1990 and AIS 2005. Data for 1,994 occupants with over 6000 coded injuries were reviewed at the AIS and MAIS level of severities and body regions to determine changes between the two coding methodologies. Overall there was an apparent general trend for fewer injuries to be coded at the AIS 4+ severity and more injuries to be coded at the AIS 2 severity. When these injury trends were reviewed in more detail it was found that the body regions which contributed the most to these changes in severity were the head, thorax and extremities. This is one of the first studies to examine the implications for large databases when changing to an updated method for coding injuries.