The complexities of integrating evidence-based preventative health into England's NHS: lessons learnt from the case of PrEP.

BACKGROUND: The integration of preventative health services into England's National Health Service is one of the cornerstones of current health policy. This integration is primarily envisaged through the removal of legislation that blocks collaborations between NHS organisations, local government, and community groups. AIMS AND OBJECTIVES: This paper aims to illustrate why these actions are insufficient through the case study of the PrEP judicial review. METHODS: Through an interview study with 15 HIV experts (commissioners, activists, clinicians, and national health body representatives), we explore the means by which the HIV prevention agenda was actively blocked, when NHS England denied responsibility for funding the clinically effective HIV pre-exposure prophylaxis (PrEP) drug in 2016, a case that led to judicial review. We draw on Wu et al.'s (Policy Soc 34:165-171, 2016) conceptual framing of 'policy capacity' in undertaking this analysis. RESULTS: The analyses highlight three main barriers to collaborating around evidence-based preventative health which indicate three main competence/capability issues in regard to policy capacity: latent stigma of 'lifestyle conditions' (individual-analytical capacity); the invisibility of prevention in the fragmented health and social care landscape related to issues of evidence generation and sharing, and public mobilisation (organizational-operational capacity); and institutional politics and distrust (systemic-political capacity). DISCUSSION AND CONCLUSION: We suggest that the findings hold implications for other 'lifestyle' conditions that are tackled through interventions funded by multiple healthcare bodies. We extend the discussion beyond the 'policy capacity and capabilities' approach to connect with a wider range of insights from the policy sciences, aimed at considering the range of actions needed for limiting the potential of commissioners to 'pass the buck' in regard to evidence-based preventative health.

Correction to: Respiratory tract infection-related healthcare utilisation in children with Down's syndrome.

The original version of this article unfortunately contained an omission.

Respiratory tract infection-related healthcare utilisation in children with Down's syndrome.

PURPOSE: Children with Down's syndrome (DS) are prone to respiratory tract infections (RTIs) due to anatomical variation, immune system immaturity and comorbidities. However, evidence on RTI-related healthcare utilisation, especially in primary care, is incomplete. In this retrospective cohort study, we use routinely collected primary and secondary care data to quantify RTI-related healthcare utilisation in children with DS and matched controls without DS. METHODS: Retrospective cohort study of 992 children with DS and 4874 matched controls attending English general practices and hospitals as identified in Clinical disease research using LInked Bespoke studies and Electronic health Records (CALIBER) from 1997 to 2010. Poisson regression was used to calculate consultation, hospitalisation and prescription rates, and rate ratios. Wald test was used to compare risk of admission following consultation. The Wilcoxon rank-sum test was used to compare length of stay by RTI type and time-to-hospitalisation. RESULTS: RTI-related healthcare utilisation is significantly higher in children with DS than in controls in terms of GP consultations (adjusted RR 1.73; 95% CI 1.62-1.84), hospitalisations (adjusted RR 5.70; 95% CI 4.82-6.73), and antibiotic prescribing (adjusted RR 2.34; 95% CI 2.19-2.49). Two percent of children with DS presenting for an RTI-related GP consultation were subsequently admitted for an RTI-related hospitalisation, compared to 0.7% in controls. CONCLUSIONS: Children with DS have higher rates of GP consultations, hospitalisations and antibiotic prescribing compared to controls. This poses a significant burden on families. Further research is recommended to characterise healthcare behaviours and clinical decision-making, to optimise care for this at risk group.

Patient and public involvement in priority-setting decisions in England's Transforming NHS: An interview study with Clinical Commissioning Groups in South London sustainability transformation partnerships.

BACKGROUND: Patient and public involvement (PPI) in health-care commissioning decisions has always been a contentious issue. However, the current moves towards Sustainability and Transformation Partnerships (STPs) in England's NHS are viewed as posing the risk of reducing the impact of current structures for PPI. OBJECTIVE: To understand how different members in clinical commissioning groups (CCGs) understand PPI as currently functioning in their decision-making practices, and the implications of the STPs for it. DESIGN: Thematic analysis of 18 semi-structured interviews with CCG governing body voting members (e.g. clinicians and lay members), non-voting governing body members (e.g. Healthwatch representatives) and CCG staff with roles focussed on PPI, recruited from CCGs in South London STPs. RESULTS: There are contestations amongst CCG members regarding not only what PPI is, but also the role that it currently plays and could play in commissioning decision making in the context of STPs. Three main themes were identified: PPI is 'going out' into the community; PPI as a disruptive power; and PPI as co-production, a 'utopian dream'? CONCLUSIONS: Long-standing issues distinctive to PPI in NHS prioritization decisions are resurfacing with the moves towards STPs, particularly in relation to contradictions between the rhetoric of 'partnership' and reorganizations that foster more top-down control. The interviews reveal pervasive distrusts across a number of levels that are counterproductive to the collaborations upon which STPs rely. And it is argued that such distrust and contestations will continue until a formalized space for PPI in STP priority-setting is created.

Affordability and Non-Perfectionism in Moral Action.

One rationale policy-makers sometimes give for declining to fund a service or intervention is on the grounds that it would be 'unaffordable', which is to say, that the total cost of providing the service or intervention for all eligible recipients would exceed the budget limit. But does the mere fact that a service or intervention is unaffordable present a reason not to fund it? Thus far, the philosophical literature has remained largely silent on this issue. However, in this article, we consider this kind of thinking in depth. Albeit with certain important caveats, we argue that the use of affordability criteria in matters of public financing commits what Parfit might have called a 'mistake in moral mathematics'. First, it fails to abide by what we term a principle of 'non-perfectionism' in moral action: the mere fact that it is practically impossible for you to do all the good that you have reason to do does not present a reason not to do whatever good you can do. And second, when used as a means of arbitrating between which services to fund, affordability criteria can lead to a kind of 'numerical discrimination'. Various attendant issues around fairness and lotteries are also discussed.

Levers for addressing medical underuse and overuse: achieving high-value health care.

The preceding papers in this Series have outlined how underuse and overuse of health-care services occur within a complex system of health-care production, with a multiplicity of causes. Because poor care is ubiquitous and has considerable consequences for the health and wellbeing of billions of people around the world, remedying this problem is a morally and politically urgent task. Universal health coverage is a key step towards achieving the right care. Therefore, full consideration of potential levers of change must include an upstream perspective-ie, an understanding of the system-level factors that drive overuse and underuse, as well as the various incentives at work during a clinical encounter. One example of a system-level factor is the allocation of resources (eg, hospital beds and clinicians) to meet the needs of a local population to minimise underuse or overuse. Another example is priority setting using tools such as health technology assessment to guide the optimum diffusion of safe, effective, and cost-effective health-care services. In this Series paper we investigate a range of levers for eliminating medical underuse and overuse. Some levers could operate effectively (and be politically viable) across many different health and political systems (eg, increase patient activation with decision support) whereas other levers must be tailored to local contexts (eg, basing coverage decisions on a particular cost-effectiveness ratio). Ideally, policies must move beyond the purely incremental; that is, policies that merely tinker at the policy edges after underuse or overuse arises. In this regard, efforts to increase public awareness, mobilisation, and empowerment hold promise as universal methods to reset all other contexts and thereby enhance all other efforts to promote the right care.

Costs and Outcomes of Increasing Access to Bariatric Surgery: Cohort Study and Cost-Effectiveness Analysis Using Electronic Health Records.

OBJECTIVES: To estimate costs and outcomes of increasing access to bariatric surgery in obese adults and in population subgroups of age, sex, deprivation, comorbidity, and obesity category. METHODS: A cohort study was conducted using primary care electronic health records, with linked hospital utilization data, for 3,045 participants who underwent bariatric surgery and 247,537 participants who did not undergo bariatric surgery. Epidemiological analyses informed a probabilistic Markov model to compare bariatric surgery, including equal proportions with adjustable gastric banding, gastric bypass, and sleeve gastrectomy, with standard nonsurgical management of obesity. Outcomes were quality-adjusted life-years (QALYs) and net monetary benefits at a threshold of £30,000 per QALY. RESULTS: In a UK population of 250,000 adults, there may be 7,163 people with morbid obesity including 1,406 with diabetes. The immediate cost of 1,000 bariatric surgical procedures is £9.16 million, with incremental discounted lifetime health care costs of £15.26 million (95% confidence interval £15.18-£15.36 million). Patient-years with diabetes mellitus will decrease by 8,320 (range 8,123-8,502). Incremental QALYs will increase by 2,142 (range 2,032-2,256). The estimated cost per QALY gained is £7,129 (range £6,775-£7,506). Net monetary benefits will be £49.02 million (range £45.72-£52.41 million). Estimates are similar for subgroups of age, sex, and deprivation. Bariatric surgery remains cost-effective if the procedure is twice as costly, or if intervention effect declines over time. CONCLUSIONS: Diverse obese individuals may benefit from bariatric surgery at acceptable cost. Bariatric surgery is not cost-saving, but increased health care costs are exceeded by health benefits to obese individuals.

Public Reasoning and Health-Care Priority Setting: The Case of NICE.

Health systems that aim to secure universal patient access through a scheme of prepayments-whether through taxes, social insurance, or a combination of the two-need to make decisions on the scope of coverage that they guarantee: such tasks often falling to a priority-setting agency. This article analyzes the decision-making processes at one such agency in particular-the UK's National Institute for Health and Care Excellence (NICE)-and appraises their ethical justifiability. In particular, we consider the extent to which NICE's model can be justified on the basis of Rawls's conception of "reasonableness." This test shares certain features with the well-known Accountability for Reasonableness (AfR) model but also offers an alternative to it, being concerned with how far the values used by priority-setting agencies such as NICE meet substantive conditions of reasonableness irrespective of their procedural virtues. We find that while there are areas in which NICE's processes may be improved, NICE's overall approach to evaluating health technologies and setting priorities for health-care coverage is a reasonable one, making it an exemplar for other health-care systems facing similar coverage dilemmas. In so doing we offer both a framework for analysing the ethical justifiability of NICE's processes and one that might be used to evaluate others.

Setting standards and monitoring quality in the NHS 1999-2013: a classic case of goal conflict.

2013 saw the National Health Service (NHS) in England severely criticized for providing poor quality despite successive governments in the previous 15 years, establishing a range of new institutions to improve NHS quality. This study seeks to understand the contributions of political and organizational influences in enabling the NHS to deliver high-quality care through exploring the experiences of two of the major new organizations established to set standards and monitor NHS quality. We used a mixed method approach: first a cross-sectional, in-depth qualitative interview study and then the application of principal agent modeling (Waterman and Meier broader framework). Ten themes were identified as influencing the functioning of the NHS regulatory institutions: socio-political environment; governance and accountability; external relationships; clarity of purpose; organizational reputation; leadership and management; organizational stability; resources; organizational methods; and organizational performance. The organizations could be easily mapped onto the framework, and their transience between the different states could be monitored. We concluded that differing policy objectives for NHS quality monitoring resulted in central involvement and organizational change. This had a disruptive effect on the ability of the NHS to monitor quality. Constant professional leadership, both clinical and managerial, and basing decisions on best evidence, both technical and organizational, helped one institution to deliver on its remit, even within a changing political/policy environment. Application of the Waterman-Meier framework enabled an understanding and description of the dynamic relationship between central government and organizations in the NHS and may predict when tensions will arise in the future. © 2016 The Authors. The International Journal of Health Planning and Management Published by John Wiley & Sons Ltd.

The NICE alcohol misuse standard - evaluating its impact.

Purpose The purpose of this paper is to explore factors affecting implementing the National Institute for Health and Care Excellence (NICE) quality standard on alcohol misuse (QS11) and barriers and facilitators to its implementation. Design/methodology/approach Qualitative interview study analysed using directed and conventional content analyses. Participants were 38 individuals with experience of commissioning, delivering or using alcohol healthcare services in Southwark, Lambeth and Lewisham. Findings QS11 implementation ranged from no implementation to full implementation across the 13 statements. Implementation quality was also reported to vary widely across different settings. The analyses also uncovered numerous barriers and facilitators to implementing each statement. Overarching barriers to implementation included: inherent differences between specialist vs generalist settings; poor communication between healthcare settings; generic barriers to implementation; and poor governance structures and leadership. Research limitations/implications QS11 was created to summarise alcohol-related NICE guidance. The aim was to simplify guidance and enhance local implementation. However, in practice the standard requires complex actions by professionals. There was considerable variation in local alcohol commissioning models, which was associated with variation in implementation. These models warrant further evaluation to identify best practice. Originality/value Little evidence exists on the implementing quality standards, as distinct from clinical practice guidelines. The authors present direct evidence on quality standard implementation, identify implementation shortcomings and make recommendations for future research and practice.

Probability of an Obese Person Attaining Normal Body Weight: Cohort Study Using Electronic Health Records.

OBJECTIVES: We examined the probability of an obese person attaining normal body weight. METHODS: We drew a sample of individuals aged 20 years and older from the United Kingdom's Clinical Practice Research Datalink from 2004 to 2014. We analyzed data for 76,704 obese men and 99,791 obese women. We excluded participants who received bariatric surgery. We estimated the probability of attaining normal weight or 5% reduction in body weight. RESULTS: During a maximum of 9 years' follow-up, 1283 men and 2245 women attained normal body weight. In simple obesity (body mass index = 30.0-34.9 kg/m(2)), the annual probability of attaining normal weight was 1 in 210 for men and 1 in 124 for women, increasing to 1 in 1290 for men and 1 in 677 for women with morbid obesity (body mass index = 40.0-44.9 kg/m(2)). The annual probability of achieving a 5% weight reduction was 1 in 8 for men and 1 in 7 for women with morbid obesity. CONCLUSIONS: The probability of attaining normal weight or maintaining weight loss is low. Obesity treatment frameworks grounded in community-based weight management programs may be ineffective.

Evidence informed decision making: the use of "colloquial evidence" at nice.

OBJECTIVES: Colloquial evidence (CE) has been described as the informal evidence that helps provide context to other forms of evidence in guidance development. Despite challenges around quality, and the potential biases, the use of CE is becoming increasingly important in assessments where scientific literature is sparse and to also capture the experience of all stakeholders in discussions, including that of experts and patients. We aimed to ascertain how CE was being used at the National Institute for Health and Care Excellence (NICE). METHODS: Relevant data corresponding to the use of CE was extracted from all NICE technical and process manuals by two reviewers and quality assured and analyzed by a third reviewer. This was considered in light of the results of a focused literature review and a combined checklist for quality assessment was developed. RESULTS: At NICE, CE is utilised across all guidance producing programmes and at all stages of development. CE could range from information from experts and patient/carers, grey literature (including evidence from websites and policy reports) and testimony from stakeholders through consultation. Six tools for critical appraisal of CE were available from the literature and a combined best practice checklist has been proposed. CONCLUSIONS: As decisions often need to be made in areas where there is a lack of published scientific evidence, CE is employed. Therefore to ensure its appropriateness the development of a validated CE data quality check-list to assist decision makers is essential and further research in this area is a priority.

What drives junior doctors to use clinical practice guidelines? A national cross-sectional survey of foundation doctors in England & Wales.

BACKGROUND: Clinical practice guidelines (CPGs) aim to improve patient care, but their use remains variable. We explored attitudes that influence CPG use amongst newly qualified doctors. METHODS: A self-completed, anonymous questionnaire was sent to all Foundation Doctors in England and Wales between December 2012 and May 2013. We included questions designed to measure the 11 domains of the validated Theoretical Domains Framework (TDF). We correlated these responses to questions assessing current and future intention to use CPGs. RESULTS: A total of 13,138 doctors were invited of which 1693 [corrected] (13 %) responded. 1,035 (62.5 %) reported regular CPG use with 575 (34.4 %) applying CPGs 2-3 times per week. A significant minority of 606 (36.6 %) declared an inability to critically appraise evidence. Despite efforts to design a questionnaire that captured the domains of the TDF, the domain scales created had low internal reliability. Using previously published studies and input from an expert statistical group, an alternative model was sought using exploratory factor analysis. Five alternative domains were identified. These were judged to represent: "confidence", "familiarity", "commitment and duty", "time" and "perceived benefits". Using regression analyses, the first three were noted as consistent predictors of both current and future intentions to use CPGs in decreasing strength order. CONCLUSIONS: In this large survey of newly qualified doctors, "confidence", "familiarity" and "commitment and duty" were identified as domains that influence use of CPGs in frontline practice. Additionally, a significant minority were not confident in critically appraising evidence. Our findings suggest a number of approaches that may be taken to improve junior doctors' commitment to CPGs through processes that increase their confidence and familiarity in using CPGs. Despite limitations of a self-reported survey and potential non-response bias, these findings are from a large representative sample and a review of existing implementation strategies may be warranted based on these findings.

Guidance on priority setting in health care (GPS-Health): the inclusion of equity criteria not captured by cost-effectiveness analysis.

This Guidance for Priority Setting in Health Care (GPS-Health), initiated by the World Health Organization, offers a comprehensive map of equity criteria that are relevant to health care priority setting and should be considered in addition to cost-effectiveness analysis. The guidance, in the form of a checklist, is especially targeted at decision makers who set priorities at national and sub-national levels, and those who interpret findings from cost-effectiveness analysis. It is also targeted at researchers conducting cost-effectiveness analysis to improve reporting of their results in the light of these other criteria. THE GUIDANCE WAS DEVELOP THROUGH A SERIES OF EXPERT CONSULTATION MEETINGS AND INVOLVED THREE STEPS: i) methods and normative concepts were identified through a systematic review; ii) the review findings were critically assessed in the expert consultation meetings which resulted in a draft checklist of normative criteria; iii) the checklist was validated though an extensive hearing process with input from a range of relevant stakeholders. The GPS-Health incorporates criteria related to the disease an intervention targets (severity of disease, capacity to benefit, and past health loss); characteristics of social groups an intervention targets (socioeconomic status, area of living, gender; race, ethnicity, religion and sexual orientation); and non-health consequences of an intervention (financial protection, economic productivity, and care for others).

Health technology reassessment: the art of the possible.

BACKGROUND: Health technology reassessment (HTR) is "a structured, evidence-based assessment of the clinical, social, ethical, and economic effects of a technology currently used in the healthcare system, to inform optimal use of that technology in comparison to its alternatives." The purpose of this study is to describe the key themes in the context of current HTR activities and propose a way forward for this newly emerging field. METHODS: Data were gathered from a workshop held as part of the 2012 Canadian Agency for Drugs and Technology in Health (CADTH) symposium. The workshop consisted of two panel presentations followed by discussion; data gathered, including presentations and rich audience discussion transcripts, were analyzed for key themes emerging in the field of HTR using constant comparative analysis. RESULTS: The language chosen to describe HTR will set the tone for engagement. The identification of champions at multiple levels and political will are essential. Key lessons from international experience are: disinvestment is difficult, focus on clinical areas not specific technologies, identify clear goals of the HTR agenda. Six key themes were identified to move the HTR agenda forward: emphasize integration over segregation, focus on development of HTR methods and processes, processes are context-specific but lessons must be shared, build capacity in synergistic interdisciplinary fields, develop meaningful stakeholder engagement, strengthen postimplementation monitoring and evaluation. CONCLUSIONS: To move this field forward, we must continue to build on international experiences with a focus on developing novel methodological approaches to generating, incorporating, and implementing evidence into policy and practice.

Legal and ethical implications of NICE guidance aimed at optimising organ transplantation after circulatory death.

Increasing the number of organ transplants is a priority for most governments. While potential new legislation for donor registration, such as the Welsh Government white paper on establishing an opt-out system for Welsh residents, is the focus of most ethical and legal scrutiny, there are also other approaches to increase the number of patients receiving organ transplants. The then National Institute for Health and Care Excellence (NICE) published guidance on this issue in 2011, but subsequent debate in this journal has suggested that the guidance was presumptuous and might encourage unethical practice. This paper addresses these concerns and concludes that the NICE guidance provides a legal, ethical and clinically relevant way forward in a complex and developing public health issue.

How reforms hamper priority-setting in health care: an interview study with local decision-makers in London.

The fair allocation of scarce resources for health remains a salient topic in health care systems. Approaches for setting priorities in an equitable manner include technical ones based on health economic analyses, and ethical ones based on procedural justice. Knowledge on real-world factors that influence prioritisation at a local level, however, remains sparse. This article contributes to the empirical literature on priority-setting at the meso level by exploring how health care planners make decisions on which services to fund and to prioritise, and to what extent they consider principles of fair priority-setting. It presents the findings of an interview study with commissioners and stakeholders in South London between 2017 and 2018. Interviewees considered principles of fair prioritisation such as transparency and accountability important for offering guidance. However, the data show that in practice the adherence to principles is hampered by the difficulty of conceptualising and operationalising principles on the one hand, and the political realities in relation to reform processes on the other. To address this challenge, we apply insights from the policy and political sciences and propose a set of considerations by which current frameworks of priority-setting might be adapted to better incorporate issues of context and politics.

Public health by organizational fix?

In August 2020 the UK government announced without warning the abolition of Public Health England (PHE), the principal UK agency for the promotion and protection of public health. We undertook a research programme seeking to understand the factors surrounding this decision. While the underlying issues are complex two competing interpretations have emerged: an 'official' explanation, which highlights the failure of PHE to scale up its testing capacity in the early weeks of the COVID-19 pandemic as the fundamental reason for closing it down and a 'sceptical' interpretation, which ascribes the decision to blame-avoidance behaviour on the part of leading government figures. This paper reviews crucial claims in these two competing explanations exploring the arguments for and against each proposition. It concludes that neither is adequate and that the inability adequately to address the problem of testing (which triggered the decision to close PHE) lies deeper in the absence of the norms of responsible government in UK politics and the state. However our findings do provide some guidance to the two new organizations established to replace PHE to maximize their impact on public health. We hope that this information will contribute to the independent national COVID inquiry.

Impact of information and deliberation on the consistency of preferences for prioritization in health care - evidence from discrete choice experiments undertaken alongside citizens' juries.

BACKGROUND: Public preferences are an important consideration for priority-setting. Critics suggest preferences of the public who are potentially naïve to the issue under consideration may lead to sub-optimal decisions. We assessed the impact of information and deliberation via a Citizens' Jury (CJ) or preference elicitation methods (Discrete Choice Experiment, DCE) on preferences for prioritizing access to bariatric surgery. METHODS: Preferences for seven prioritization criteria (e.g. obesity level, obesity-related comorbidities) were elicited from three groups who completed a DCE: (i) participants from two CJs (n = 28); (ii) controls who did not participate in the jury (n = 21); (iii) population sample (n = 1,994). Participants in the jury and control groups completed the DCE pre- and post-jury. DCE data were analyzed using multinomial logit models to derive "priority weights" for criteria for access to surgery. The rank order of criteria was compared across groups, time points and CJ recommendations. RESULTS: The extent to which the criteria were considered important were broadly consistent across groups and were similar to jury recommendations but with variation in the rank order. Preferences of jurors but not controls were more differentiated (that is, criteria were assigned a greater range of priority weights) after than before the jury. Juror preferences pre-jury were similar to that of the public but appeared to change during the course of the jury with greater priority given to a person with comorbidity. Conversely, controls appeared to give a lower priority to those with comorbidity and higher priority to treating very severe obesity after than before the jury. CONCLUSION: Being informed and undertaking deliberation had little impact on the criteria that were considered to be relevant for prioritizing access to bariatric surgery but may have a small impact on the relative importance of criteria. CJs may clarify underlying rationale but may not provide substantially different prioritization recommendations compared to a DCE.

Public preferences are an important consideration for priority-setting. However, some people worry that if the public doesn't know much about the issues, their opinions might not lead to the best decisions. To make these decisions, we used two different methods to get people's opinions: Deliberative methods and preference elicitation methods. Deliberative methods gather a small group of people and have them discuss an issue in detail, whereas preference elicitation methods seek opinions through surveying a large group of people.In this paper, we assessed the impact of information and deliberation via a deliberative method (Citizens' Jury, CJ) or a preference elicitation method (Discrete Choice Experiment, DCE) on preferences for prioritising access to bariatric surgery. We used data from two CJs and a DCE focussed on prioritising access to the surgery, to find out if the opinions of those in the CJs changed or stayed the same after they heard information from experts and discussed the topic.The results showed that the important criteria were rather similar across the groups, but the order of importance was a bit different. The people in CJs had more varied opinions after discussing it, while those who didn't discuss it had less varied opinions. The participants in CJs also prioritized those with other health problems more than they did at the beginning.This study helps us understand how different methods can be used to get the public's opinions on healthcare decisions.