What interventions should we implement in England's mental health services? The mental health implementation network (MHIN) mixed-methods approach to rapid prioritisation.

Introduction: Setting mental health priorities helps researchers, policy makers, and service funders improve mental health services. In the context of a national mental health implementation programme in England, this study aims to identify implementable evidence-based interventions in key priority areas to improve mental health service delivery. Methods: A mixed-methods research design was used for a three step prioritisation approach involving systematic scoping reviews (additional manuscript under development), expert consultations and data triangulation. Groups with diverse expertise, including experts by experience, worked together to improve decision-making quality by promoting more inclusive and comprehensive discussions. A multi-criteria decision analysis (MCDA) model was used to combine participants' varied opinions, data and judgments about the data's relevance to the issues at hand during a decision conferencing workshop where the priorities were finalised. Results: The study identified mental health interventions in three mental health priority areas: mental health inequalities, child and adolescent mental health, comorbidities with a focus on integration of mental and physical health services and mental health and substance misuse problems. Key interventions in all the priority areas are outlined. The programme is putting some of these evidence-based interventions into action nationwide in each of these three priority mental health priority areas. Conclusion: We report an inclusive attempt to ensure that the list of mental health service priorities agrees with perceived needs on the ground and focuses on evidence-based interventions. Other fields of healthcare may also benefit from this methodological approach if they need to make rapid health-prioritisation decisions.

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.

Effect of antibiotics in preventing hospitalizations from respiratory tract infections in children with Down syndrome.

BACKGROUND: Children with Down syndrome (DS) are at high risk of respiratory tract infections (RTIs) due to anatomical variations, comorbidities, and immune system immaturity. Evidence on interventions to reduce this risk is incomplete. This study aims to quantify the effect of antibiotics prescribed for RTIs in primary care on the subsequent risk of RTI-related hospitalization for children with DS versus controls. METHODS: We conducted a retrospective cohort study of 992 children with DS and 4874 controls managed by UK National Health Service General Practitioners (GPs) and hospitals as identified in CALIBER (Clinical disease research using LInked Bespoke studies and Electronic health Records), 1997-2010. Univariate and multivariate logistic regression were undertaken. RESULTS: In children with DS, the prescription of antibiotics following an RTI-related GP consultation did not significantly reduce the risk of RTI-related hospitalization in the subsequent 28 days (risk with antibiotics, 1.8%; without, 2.5%; risk ratio, 0.699; 95% confidence interval, 0.471-1.036). Subgroup analyses showed a risk reduction only in infants with DS, after adjustment for covariates. There was no reduction in risk for controls, overall or across subgroups. CONCLUSIONS: In conclusion, while prescription of antibiotics following RTI-related GP consultations were effective for infants with DS in reducing subsequent RTI-related hospitalization, this was not the case for older children with DS. We would encourage further high-quality cohort and randomized controlled trials to interrogate this finding, and to examine the impact of antibiotics on other endpoints, including symptom duration.

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.

Creating sustainable health care systems.

PURPOSE: In order to create sustainable health systems, many countries are introducing ways to prioritise health services underpinned by a process of health technology assessment. While this approach requires technical judgements of clinical effectiveness and cost effectiveness, these are embedded in a wider set of social (societal) value judgements, including fairness, responsiveness to need, non-discrimination and obligations of accountability and transparency. Implementing controversial decisions faces legal, political and public challenge. To help generate acceptance for the need for health prioritisation and the resulting decisions, the purpose of this paper is to develop a novel way of encouraging key stakeholders, especially patients and the public, to become involved in the prioritisation process. DESIGN/METHODOLOGY/APPROACH: Through a multidisciplinary collaboration involving a series of international workshops, ethical and political theory (including accountability for reasonableness) have been applied to develop a practical way forward through the creation of a values framework. The authors have tested this framework in England and in New Zealand using a mixed-methods approach. FINDINGS: A social values framework that consists of content and process values has been developed and converted into an online decision-making audit tool. RESEARCH LIMITATIONS/IMPLICATIONS: The authors have developed an easy to use method to help stakeholders (including the public) to understand the need for prioritisation of health services and to encourage their involvement. It provides a pragmatic way of harmonising different perspectives aimed at maximising health experience. PRACTICAL IMPLICATIONS: All health care systems are facing increasing demands within finite resources. Although many countries are introducing ways to prioritise health services, the decisions often face legal, political, commercial and ethical challenge. The research will help health systems to respond to these challenges. SOCIAL IMPLICATIONS: This study helps in increasing public involvement in complex health challenges. ORIGINALITY/VALUE: No other groups have used this combination of approaches to address this issue.

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.

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.

Public participation in decision-making on the coverage of new antivirals for hepatitis C.

Purpose - New hepatitis C medicines such as sofosbuvir underline the need to balance considerations of innovation, clinical evidence, budget impact and equity in health priority-setting. The purpose of this paper is to examine the role of public participation in addressing these considerations. Design/methodology/approach - The paper employs a comparative case study approach. It explores the experience of four countries - Brazil, England, South Korea and the USA - in making coverage decisions about the antiviral sofosbuvir and involving the public and patients in these decision-making processes. Findings - Issues emerging from public participation ac tivities include the role of the universal right to health in Brazil, the balance between innovation and budget impact in England, the effect of unethical medical practices on public perception in South Korea and the legitimacy of priority-setting processes in the USA. Providing policymakers are receptive to these issues, public participation activities may be re-conceptualized as processes that illuminate policy problems relevant to a particular context, thereby promoting an agenda-setting role for the public. Originality/value - The paper offers an empirical analysis of public involvement in the case of sofosbuvir, where the relevant considerations that bear on priority-setting decisions have been particularly stark. The perspectives that emerge suggest that public participation contributes to raising attention to issues that need to be addressed by policymakers. Public participation activities can thus contribute to setting policy agendas, even if that is not their explicit purpose. However, the actualization of this contribution is contingent on the receptiveness of policymakers.

Information will be the key to successful implementation.

Making Fair Choices on the Path to Universal Health Coverage [UHC; World Health Organization (WHO), 2014] is to be welcomed because tackling the relationship between cost-effectiveness and fairness has been given too little attention in policy-making. The consensus that universal coverage is a good thing quickly disperses as the concept is translated into working national policies and local delivery processes. As Weale (2014) and Rumbold and Wilson (2014) point out, seeking practical solutions can lead to the re-exploration of previous givens and result in unexpected ethical and philosophical consequences. While the basic premise underlying the discussion on the ethics of resource concurs with the view that equity is always at odds with efficiency, this is not inevitable as the authors of the report point out in their analysis - a view more fully explored by Culyer (2006). The present report is a welcome attempt to reconcile, as countries progress to UHC, ethical norms with the reality of setting priorities, involving what to pay for and under what circumstances.

Prioritising patients for bariatric surgery: building public preferences from a discrete choice experiment into public policy.

OBJECTIVES: To derive priority weights for access to bariatric surgery for obese adults, from the perspective of the public. SETTING: Australian public hospital system. PARTICIPANTS: Adults (N=1994), reflecting the age and gender distribution of Queensland and South Australia. PRIMARY AND SECONDARY OUTCOME MEASURES: A discrete choice experiment in which respondents indicated which of two individuals with different characteristics should be prioritised for surgery in repeated hypothetical choices. Potential surgery recipients were described by seven key characteristics or attributes: body mass index (BMI), presence of comorbid conditions, age, family history, commitment to lifestyle change, time on the surgical wait list and chance of maintaining weight loss following surgery. A multinomial logit model was used to evaluate preferences and derive priority weights (primary analysis), with a latent class model used to explore respondent characteristics that were associated with variation in preference across the sample (see online supplementary analysis). RESULTS: A preference was observed to prioritise individuals who demonstrated a strong commitment to maintaining a healthy lifestyle as well as individuals categorised with very severe (BMI≥50 kg/m2) or (to a lesser extent) severe (BMI≥40 kg/m2) obesity, those who already have obesity-related comorbidity, with a family history of obesity, with a greater chance of maintaining weight loss or who had spent a longer time on the wait list. Lifestyle commitment was considered to be more than twice as important as any other criterion. There was little tendency to prioritise according to the age of the recipient. Respondent preferences were dependent on their BMI, previous experience with weight management surgery, current health state and education level. CONCLUSIONS: This study extends our understanding of the publics' preferences for priority setting to the context of bariatric surgery, and derives priority weights that could be used to assist bodies responsible for commissioning bariatric services.

Does accountability for reasonableness work? A protocol for a mixed methods study using an audit tool to evaluate the decision-making of clinical commissioning groups in England.

INTRODUCTION: Clinical commissioning groups (CCGs) in England are tasked with making difficult decisions on which healthcare services to provide against the background of limited budgets. The question is how to ensure that these decisions are fair and legitimate. Accounts of what constitutes fair and legitimate priority setting in healthcare include Daniels' and Sabin's accountability for reasonableness (A4R) and Clark's and Weale's framework for the identification of social values. This study combines these accounts and asks whether the decisions of those CCGs that adhere to elements of such accounts are perceived as fairer and more legitimate by key stakeholders. The study addresses the empirical gap arising from a lack of research on whether frameworks such as A4R hold what they promise. It aims to understand the criteria that feature in CCG decision-making. Finally, it examines the usefulness of a decision-making audit tool (DMAT) in identifying the process and content criteria that CCGs apply when making decisions. METHODS AND ANALYSIS: The adherence of a sample of CCGs to criteria emerging from theories of fair priority setting will be examined using the DMAT developed by PL. The results will be triangulated with data from semistructured interviews with key stakeholders in the CCG sample to ascertain whether there is a correlation between those CCGs that performed well in the DMAT exercise and those whose decisions are perceived positively by interviewees. Descriptive statistical methods will be used to analyse the DMAT data. A combination of quantitative and qualitative content analysis methods will be used to analyse the interview transcripts. ETHICS AND DISSEMINATION: Full ethics approval was received by the King's College London Biomedical Sciences, Dentistry, Medicine and Natural and Mathematical Sciences Research Ethics Subcommittee. The results of the study will be disseminated through publications in peer review journals.

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.

Social values and health priority setting in Australia: an analysis applied to the context of health technology assessment.

OBJECTIVE: To describe the role of social values in priority setting related to health technology assessment processes and decision-making in Australia. APPROACH: The processes and decision criteria of the Pharmaceutical and Medical Benefits Advisory Committees are described based on literature and policy sources, and analysed using a framework for identifying social values in priority-setting. FINDINGS: Transparency and accountability of processes are apparent. Participation balances inclusiveness and effectiveness of decision-making, but presents an opportunity to enhance priority setting processes. Clinical and cost-effectiveness are important content considerations. Social values related to justice/equity are considered, without quantification of criteria weights for equity relative to other factors. HTA processes support solidarity through subsidising approved technologies for all Australians, whilst retaining autonomy by permitting non-subsidised technologies to be accessed privately, leading to possible tension between the values of solidarity, autonomy and equity. CONCLUSIONS: Priority setting related to health technology subsidy incorporates a range of inter-related social values in the processes and content of decision-making. Participation in decision-making could arguably be improved if a patient and public engagement policy were to be formulated alongside more widespread changes across processes to assess social values using approaches such as the Citizens' Jury.

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).