Cardiovascular-related conditions and risk factors in primary care for deprived communities before and during the COVID-19 pandemic: an observational study in Northern England.

OBJECTIVES: The North East of England, ranked as having the highest poverty levels and the lowest health outcomes, has the highest cardiovascular disease (CVD) premature mortality. This study aimed to compare CVD-related conditions and risk factors for deprived practice populations with other general practice (GP) populations in Northern England to England overall, before and during COVID-19 to identify changes in recorded CVD-related risk factors and conditions and evidence-based lipid prescribing behaviour. DESIGN: A population-based observational study of aggregated practice-level data obtained from publicly accessible data sets. SETTING: 34 practices that fall into the 15% most deprived practice populations in England were identified as the most deprived communities in the North East and North Cumbria (Deep End). PARTICIPANTS: Patients aged ≥16 registered with GP and diagnosed with any form of CVD. PRIMARY AND SECONDARY OUTCOME MEASURES: CVD-related conditions and risk factors, statin prescribing. RESULTS: Deep End (n=263 830) had a smaller, younger and more deprived population with lower levels of employment and full-time education and higher smoking prevalence. They had some higher recorded CVD-related conditions than England but lower than the non-Deep End. Atrial fibrillation (-0.9, -0.5), hypertension (-3.7, -1.3) and stroke and transient ischaemic attack rates (-0.5, -0.1) appeared to be lower in the Deep End than in the non-Deep End but the optimal statin prescribing rate was higher (3.1, 8.2) than in England. CONCLUSION: Recorded CVD-related risk factors and conditions remained comparable before and during COVID-19. These are higher in the Deep End than in England and similar or lower than the non-Deep End, with a higher optimal statin prescribing rate. However, it was not possible to control for age and sex. More work is needed to estimate the consequences of the pandemic on disadvantaged communities and to compare whether the findings are replicated in other areas of deprivation.

Tailoring lipid management interventions to reduce inequalities in cardiovascular disease risk management in primary care for deprived communities in Northern England: a mixed-methods intervention development protocol.

INTRODUCTION: Hyperlipidaemia contributes a significant proportion of modifiable cardiovascular disease (CVD) risk, which is a condition that disproportionally affects disadvantaged socioeconomic communities, with death rates in the most deprived areas being four times higher than those in the least deprived. With the national CVD Prevention programme being delivered to minimise risk factors, no evidence is available on what has been implemented in primary care for deprived populations. This study describes the protocol for the development of a tailored intervention aiming to optimise lipid management in primary care settings to help reduce inequalities in CVD risks and improve outcomes in deprived communities. METHODS AND ANALYSIS: A mixed-methods approach will be employed consisting of four work packages: (1) rapid review and logic model; (2) assessment and comparison of CVD risk management for deprived with non-deprived populations in Northern England to England overall; (3) interviews with health professionals; and (4) intervention development. A systematic search and narrative synthesis will be undertaken to identify evidence-based interventions and targeted outcomes in deprived areas. General practice-level data will be assessed to establish the profile of lipid management, compared with the regional and national levels. Health professionals involved in the organisation and delivery of routine lipid management to deprived populations will be interviewed to understand the implementation and delivery of current lipid management and associated challenges. The prototype intervention will be informed by the evidence generated from workpackages 1-3, which will be reviewed and assessed using the nominal group technique to reach consensus. Training and skills development materials will also be developed as needed. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Faculty of Medical Sciences Research Ethics Committee at Newcastle University, UK. Findings will be disseminated to the participating sites, participants, commissioners, and in peer-reviewed journals and academic conferences.

Health inequalities are worsening in the North East of England.

BACKGROUND: The North of England, particularly the North East (NE), has worse health (e.g. 2 years lower life expectancy) and higher health inequalities compared to the rest of England. SOURCES OF DATA: We explore this over time drawing on publicly available data. AREAS OF AGREEMENT AND CONTROVERSY: Whilst overall health is improving, within-regional health inequalities are getting worse and the gap between the NE and other regions (particularly the South of England) is worsening. The gap in life expectancy is widening with substantial variation between deprived and affluent areas within the NE. Those living in the NE are more likely to have a shorter lifespan and to spend a larger proportion of their shorter lives in poor health, as well as being more likely to die prematurely from preventable diseases. GROWING POINTS: We highlight wide, and in some cases increasing, inequalities in health outcomes between the NE and the rest of England. This health disadvantage and the north-south health divide are recognized; despite this, the situation appears to be worsening over the time. AREAS TIMELY FOR DEVELOPING RESEARCH: Research to understand and reduce health inequalities is needed particularly in the NE of England where reductions could have enhanced the impact.

Doing transformational change in the English NHS in the context of "big bang" redisorganisation.

PURPOSE: The purpose of this paper is to examine a bold and ambitious scheme known as the North East transformation system (NETS). The principal aim of the NETS is the achievement of a step-change in the quality of health services delivered to people living in the North East region of England. The paper charts the origins of the NETS and its early journey before describing what happened to it when the UK coalition government published its proposals for unexpected major structural change in the NHS. This had a profound impact on the leadership and direction of the NETS and resulted in it taking a different direction from that intended. DESIGN/METHODOLOGY/APPROACH: The research design took the form of a mixed methods, longitudinal 3.5-year study aimed at exploring transformational change in terms of content, context, process and outcomes. The sample of study sites comprised 14 NHS trusts in the North East region chosen to provide geographical coverage of the area and to reflect the scale, scope and variety of the bodies that formed part of the NETS programme. The qualitative component of the research, which the paper draws upon, included 68 semi-structured interviews, observational studies and focus groups. Data analysis made use of both deductive and inductive frameworks. The deductive framework adopted was Pettigrew et al.'s "receptive contexts for change" and four of the eight factors stood out as especially important and form the basis of the paper. FINDINGS: The fate of the NETS was shaped and influenced by the eight factors comprising the Pettigrew et al. receptive contexts for change framework but four factors in particular stood out as being especially significant: environmental pressure, quality and coherence of policy, key people leading change, supportive organisational culture. Perhaps the most significant lesson from the NETS is that achieving whole systems change is particularly vulnerable to the vicissitudes of politics especially where that system, like the UK NHS, is itself subject to those very same pressures. Yet, despite having an enormous influence on health policy, the political context is frequently avoided in research or not regarded as instrumental in determining the outcomes in respect of transformational change. RESEARCH LIMITATIONS/IMPLICATIONS: The chief limitation is the credibility and authenticity of the interviews captured at particular points in time. These formed the datebase for subsequent analysis. The authors sought to guard against possible bias by supplementing interviews with observational studies and focus groups as well as running two dissemination events at which emerging findings from the study were subjected to independent external scrutiny and comment. These events provided a form of validation for the key study findings. PRACTICAL IMPLICATIONS: The research findings demonstrate the importance of context for the likely outcome and success of complex transformational change initiatives. These require time to become embedded and demonstrate results especially when focused on changing culture and behaviour. But, in practice, allowing sufficient time during which the organisation may remain sufficiently stable to allow the change intervention to run its course and become embedded and sustainable is highly problematic. The consequence is that bold and ambitious efforts like the NETS are not given the space and stability to prove themselves. Too often, politics and external environmental pressures intrude in ways that may prove dysfunctional and negative. SOCIAL IMPLICATIONS: Unless a different approach to transformational change and its leadership and management is adopted, then changing the NHS to enable it to appear more responsive to changing health care needs and expectations will remain a cause for concern. Ultimately the public will be the losers if the NHS remains insensitive to changing needs and expectations. The patient experience was at the centre of the NETS programme. ORIGINALITY/VALUE: The study is original insofar as no other has sought to evaluate the NETS independently and over a reasonable time period. The research design, based on a mixed-methods approach, is unusual in evaluations of this nature. The study's conclusions are not so original but their value lies in largely confirming and reinforcing the findings from other studies. It perhaps goes further in stressing the impact of politics on health policy and the negative consequences of constant organisational change on attempts to achieve deep change in the way the NHS is organised and led.

Leadership and transformational change in healthcare organisations: a qualitative analysis of the North East Transformation System.

The research project 'An Evaluation of Transformational Change in NHS North East' examines the progress and success of National Health Service (NHS) organisations in north east England in implementing and embedding the North East Transformation System (NETS), a region-wide programme to improve healthcare quality and safety, and to reduce waste, using a combination of Vision, Compact, and Lean-based Method. This paper concentrates on findings concerning the role of leadership in enabling tranformational change, based on semi-structured interviews with a mix of senior NHS managers and quality improvement staff in 14 study sites. Most interviewees felt that implementing the NETS requires committed, stable leadership, attention to team-building across disciplines and leadership development at many levels. We conclude that without senior leader commitment to continuous improvement over a long time scale and serious efforts to distribute leadership tasks to all levels, healthcare organisations are less likely to achieve positive changes in managerial-clinical relations, sustainable improvements to organisational culture and, ultimately, the region-wide step change in quality, safety and efficiency that the NETS was designed to deliver.

Improving patient-centered care for people with dementia in medical encounters: an educational intervention for old age psychiatrists.

BACKGROUND: Health care professionals are recommended to deliver patient-centered care in dementia; however, guidance and training on how to do this in practice is currently lacking. The aim of this study was to develop and evaluate pragmatically an educational intervention for old age psychiatrists to promote patient-centered care in their consultations with people with dementia and their carers. METHODS: We used a range of methods to (i) identify the theoretical components of patient-centered care (literature review) and (ii) observe actual practice (video recording of 53 consultations between old age psychiatrists and people with dementia and their family carers). We also interviewed participants from (ii) including 7 old age psychiatrists, 25 people with dementia and 44 carers. From this we developed a workshop for old age psychiatrists and piloted and evaluated it. Pre- and post-workshop questionnaires were completed; the latter included an assessment of planned and subsequent behavior change by participants. RESULTS: The educational workshop, attended by 41 old age psychiatrists, focused on how best to structure the consultation and the most effective communication skills to use in consultation with people with dementia. Three months after the workshop, 59% had made one or more changes to the structure of their consultations, 71% had used new communication skills and 56% had reflected further on their practice. CONCLUSIONS: We developed an educational intervention with both a theoretical and empirical basis. The workshops resulted in many changes to self-reported practice; whether this was noticeable to patients and carers requires further study.

Improving professional practice in the disclosure of a diagnosis of dementia: a modeling experiment to evaluate a theory-based intervention.

BACKGROUND: Among health professionals, there is wide variation in the practice of disclosing a diagnosis of dementia to patients. PURPOSE: The purpose of this study was to evaluate the effect of one theory-based and two pragmatic interventions on intention to perform three behaviors, namely (1) finding out what the patient already knows or suspects about their diagnosis; (2) using the actual words "dementia" or "Alzheimer's disease" when talking to the patient (i.e., the use of explicit terminology); (3) exploring what the diagnosis means to the patient. METHOD: Within an intervention-modeling process, members of old-age mental health teams in England were sent postal questionnaires measuring psychological variables. Respondents were randomized by team to one of four groups to receive: theory-based intervention; evidence-based communication; patient-based intervention; or no intervention (control). Interventions were delivered as pen-and-paper exercises at the start of a second postal questionnaire that remeasured the same psychological variables. The outcome measures were intention and scenario-based behavioral simulation. RESULTS: Responses were received from 644 of 1,103 (58%) individuals from 179 of 205 (87%) mental health teams. There were no significant differences in terms of intention or simulated behavior between the trial groups. The theory-based intervention significantly increased scores for attitudes to (p = 0.03) and perceived behavioral control (p = 0.001) for the behavior of "finding out what the patient already knows or suspects about their diagnosis." CONCLUSIONS: The intervention had a limited effect. This may be partly explained by clinical or methodological factors. The use of a systematic intervention modeling process allows clearer understanding of the next appropriate steps which should involve further evaluation of the interventions using an interactive delivery method in a less selected group of study participants.

Explaining the effects of an intervention designed to promote evidence-based diabetes care: a theory-based process evaluation of a pragmatic cluster randomised controlled trial.

BACKGROUND: The results of randomised controlled trials can be usefully illuminated by studies of the processes by which they achieve their effects. The Theory of Planned Behaviour (TPB) offers a framework for conducting such studies. This study used TPB to explore the observed effects in a pragmatic cluster randomised controlled trial of a structured recall and prompting intervention to increase evidence-based diabetes care that was conducted in three Primary Care Trusts in England. METHODS: All general practitioners and nurses in practices involved in the trial were sent a postal questionnaire at the end of the intervention period, based on the TPB (predictor variables: attitude; subjective norm; perceived behavioural control, or PBC). It focussed on three clinical behaviours recommended in diabetes care: measuring blood pressure; inspecting feet; and prescribing statins. Multivariate analyses of variance and multiple regression analyses were used to explore changes in cognitions and thereby better understand trial effects. RESULTS: Fifty-nine general medical practitioners and 53 practice nurses (intervention: n = 55, 41.98% of trial participants; control: n = 57, 38.26% of trial participants) completed the questionnaire. There were no differences between groups in mean scores for attitudes, subjective norms, PBC or intentions. Control group clinicians had 'normatively-driven' intentions (i.e., related to subjective norm scores), whereas intervention group clinicians had 'attitudinally-driven' intentions (i.e., related to attitude scores) for foot inspection and statin prescription. After controlling for effects of the three predictor variables, this group difference was significant for foot inspection behaviour (trial group x attitude interaction, beta = 0.72, p < 0.05; trial group x subjective norm interaction, beta = -0.65, p < 0.05). CONCLUSION: Attitudinally-driven intentions are proposed to be more consistently translated into action than normatively-driven intentions. This proposition was supported by the findings, thus offering an interpretation of the trial effects. This analytic approach demonstrates the potential of the TPB to explain trial effects in terms of different relationships between variables rather than differences in mean scores. This study illustrates the use of theory-based process evaluation to uncover processes underlying change in implementation trials.

Is untargeted educational outreach visiting delivered by pharmaceutical advisers effective in primary care? A pragmatic randomized controlled trial.

BACKGROUND: There is increasing evidence that clinical guidelines can lead to improvements in clinical care. However, they are not self-implementing. While educational outreach visits may improve prescribing behaviour, the effectiveness of routine delivery of these visits by existing pharmaceutical advisers is unknown. METHODS: Within a pragmatic randomized controlled trial, involving all general practices in two primary care trusts (PCTs), routine methods were used to distribute guidelines for the choice of antidepressants for the management of depression. Intervention practices were offered two visits (most accepted only one) by their PCT pharmaceutical adviser who had been trained in the techniques of outreach visiting. Intervention practices were visited regardless of whether they had prior problems with prescribing ('untargeted' visits). The intervention was evaluated using level three prescribing analysis and cost (PACT) data for antidepressant drugs for the six months during which the intervention was delivered and the subsequent twelve months. RESULTS: Across the 72 study practices there was no significant impact of the intervention on usage of any group of antidepressant drugs. CONCLUSION: The routine use of untargeted educational outreach visiting delivered by existing pharmaceutical advisers may not be a worthwhile strategy.

Difficulties implementing a mental health guideline: an exploratory investigation using psychological theory.

BACKGROUND: Evaluations of interventions to improve implementation of guidelines have failed to produce a clear pattern of results favouring a particular method. While implementation depends on clinicians and managers changing a variety of behaviours, psychological theories of behaviour and behaviour change are seldom used to try to understand difficulties in implementation or to develop interventions to overcome them. OBJECTIVES: This study applied psychological theory to examine explanations for difficulties in implementation. It used a theoretical framework derived from an interdisciplinary consensus exercise to code interviews across 11 theoretical domains. The focus of the study was a National Institute for Health and Clinical Excellence's Schizophrenia guideline recommendation that family intervention should be offered to the families of people with schizophrenia. METHODS: Participants were recruited from community mental health teams from three United Kingdom National Health Service (NHS) Trusts; 20 members (social workers, nurses, team managers, psychologists, and psychiatrists) participated. Semi-structured interviews were audio-taped and transcribed. Interview questions were based on the theoretical domains and addressed respondents' knowledge, attitudes and opinions regarding the guideline. Two researchers independently coded the transcript segments from each interview that were related to each theoretical domain. A score of 1 indicated that the transcript segments relating to the domain did not appear to contain description of difficulties in implementation of the family therapy guidelines; similarly a score of 0.5 indicated possible difficulties and a score of 0 indicated definite difficulties. RESULTS: Coding respondents' answers to questions related to the three domains 'beliefs about consequences,' 'social/professional role and identity,' and 'motivation' produced the three highest total scores indicating that factors relating to these domains were unlikely to constitute difficulties in implementation. 'Environmental context and resources' was the lowest scoring domain, with 'Emotion' scoring the second lowest, suggesting that these were likely to be areas for considering intervention. The two main resources identified as problems were time and training. The emotions that appeared to potentially influence the offer of family therapy were self-doubt and fear. CONCLUSION: This exploratory study demonstrates an approach to developing a theoretical understanding of implementation difficulties.

A pragmatic cluster randomised controlled trial of a Diabetes REcall And Management system: the DREAM trial.

BACKGROUND: Following the introduction of a computerised diabetes register in part of the northeast of England, care initially improved but then plateaued. We therefore enhanced the existing diabetes register to address these problems. The aim of the trial was to evaluate the effectiveness and efficiency of an area wide 'extended,' computerised diabetes register incorporating a full structured recall and management system, including individualised patient management prompts to primary care clinicians based on locally-adapted, evidence-based guidelines. METHODS: The study design was a pragmatic, cluster randomised controlled trial, with the general practice as the unit of randomisation. Set in 58 general practices in three Primary Care Trusts in the northeast of England, the study outcomes were the clinical process and outcome variables held on the diabetes register, patient-reported outcomes, and service and patient costs. The effect of the intervention was estimated using generalised linear models with an appropriate error structure. To allow for the clustering of patients within practices, population averaged models were estimated using generalized estimating equations. RESULTS: Patients in intervention practices were more likely to have at least one diabetes appointment recorded (OR 2.00, 95% CI 1.02, 3.91), to have a recording of a foot check (OR 1.87, 95% CI 1.09, 3.21), have a recording of receiving dietary advice (OR 2.77, 95% CI 1.22, 6.29), and have a recording of blood pressure (BP) (OR 2.14, 95% CI 1.06, 4.36). There was no difference in mean HbA1c or BP levels, but the mean cholesterol level in patients from intervention practices was significantly lower (-0.15 mmol/l, 95% CI -0.25, -0.06). There were no differences in patient-reported outcomes or in patient-reported use of drugs, or uptake of health services. The average cost per patient was not significantly different between the intervention and control groups. Costs incurred in administering the system at the register and in general practice were in addition to these. CONCLUSION: This study has shown benefits from an area-wide, computerised diabetes register incorporating a full structured recall and individualised patient management system. However, these benefits were achieved at a cost. In future, these costs may fall as electronic data exchange becomes a reliable reality. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN) Register, ISRCTN32042030.

Costs and consequences of enhanced primary care for depression: systematic review of randomised economic evaluations.

BACKGROUND: A number of enhancement strategies have been proposed to improve the quality and outcome of care for depression in primary care settings. Decision-makers are likely to need to know whether these interventions are cost-effective in routine primary care settings. METHOD: We conducted a systematic review of all full economic evaluations (cost-effectiveness and cost-utility analyses) accompanying randomised controlled trials of enhanced primary care for depression. Costs were standardised to UK pounds/US dollars and incremental cost-effectiveness ratios (ICERs) were visually summarised using a permutation matrix. RESULTS: We identified 11 full economic evaluations (4757 patients). A near-uniform finding was that the interventions based upon collaborative care/case management resulted in improved outcomes but were also associated with greater costs. When considering primary care depression treatment costs alone, ICER estimates ranged from 7 ($13, no confidence interval given) to 13 UK pounds ($24,95% CI -105 to 148) per additional depression-free day. Educational interventions alone were associated with increased cost and no clinical benefit. CONCLUSIONS: Improved outcomes through depression management programmes using a collaborative care/case management approach can be expected, but are associated with increased cost and will require investment.

A trial platform to develop a tailored theory-based intervention to improve professional practice in the disclosure of a diagnosis of dementia: study protocol [ISRCTN15871014].

BACKGROUND: For people with dementia, care should include an explanation of the diagnosis to individuals and their carers, and information about the likely prognosis and possible packages of care. However, this is neither routine nor inevitable, and there is wide variation in the practice of disclosure. The aim of this study is to develop a tailored theory-based intervention to promote appropriate disclosure of diagnosis of dementia. METHODS: There are three objectives. Objective 1 is to define and develop an appropriate model of disclosure; this will be addressed using a multidisciplinary consensus development process. Objective 2 is to identify factors that influence disclosure of diagnosis; a questionnaire based upon theoretical constructs from a range of behavioural theories will be developed and members of old age mental health teams will be surveyed. The analysis will identify those factors that best predict intention to disclose a diagnosis to a person with dementia. Objective 3 is to develop and pilot test a theory-based intervention to promote disclosure of diagnosis that targets attitudes, beliefs and actions most amenable to change. Objective 3 will use the results of Objectives 1&2 to design and pilot test an intervention to improve the process of and increase the proportion of individuals receiving a diagnosis of dementia, for members of old age mental health teams. This work will lead to a proposal for a randomised controlled trial of the intervention.

Research, audit and quality improvement.

PURPOSE: The purpose of this article is to clarify the distinction between research and audit, and propose appropriate regulatory arrangements for audit and related activities. DESIGN/METHODOLOGY/APPROACH: The methods used were literature reviews and conceptual analysis. FINDINGS: Research and audit overlap in various ways, but differ in terms of their purposes and the risks likely to be encountered and distinguished, along with a third related category of activities called quality improvement. PRACTICAL IMPLICATIONS: Appropriate regulatory arrangements are proposed for audit and quality improvement activities. Using these should ensure appropriate ethical standards and risk management, while avoiding the time-consuming over-regulation that occurs when projects are unnecessarily submitted to the ethical scrutiny appropriate for research projects. ORIGINALITY/VALUE: Gives suggestions and information that could be of great value in spreading service improvement.

Educational and organizational interventions to improve the management of depression in primary care: a systematic review.

CONTEXT: Depression is commonly encountered in primary care settings yet is often missed or suboptimally managed. A number of organizational and educational strategies to improve management of depression have been proposed. The clinical effectiveness and cost-effectiveness of these strategies have not yet been subjected to systematic review. OBJECTIVE: To systematically evaluate the effectiveness of organizational and educational interventions to improve the management of depression in primary care settings. DATA SOURCES: We searched electronic medical and psychological databases from inception to March 2003 (MEDLINE, PsycLIT, EMBASE, CINAHL, Cochrane Controlled Trials Register, United Kingdom National Health Service Economic Evaluations Database, Cochrane Depression Anxiety and Neurosis Group register, and Cochrane Effective Professional and Organisational Change Group specialist register); conducted correspondence with authors; and used reference lists. Search terms were related to depression, primary care, and all guidelines and organizational and educational interventions. STUDY SELECTION: We selected 36 studies, including 29 randomized controlled trials and nonrandomized controlled clinical trials, 5 controlled before-and-after studies, and 2 interrupted time-series studies. Outcomes relating to management and outcome of depression were sought. DATA EXTRACTION: Methodological details and outcomes were extracted and checked by 2 reviewers. Summary relative risks were, where possible, calculated from original data and attempts were made to correct for unit of analysis error. DATA SYNTHESIS: A narrative synthesis was conducted. Twenty-one studies with positive results were found. Strategies effective in improving patient outcome generally were those with complex interventions that incorporated clinician education, an enhanced role of the nurse (nurse case management), and a greater degree of integration between primary and secondary care (consultation-liaison). Telephone medication counseling delivered by practice nurses or trained counselors was also effective. Simple guideline implementation and educational strategies were generally ineffective. CONCLUSIONS: There is substantial potential to improve the management of depression in primary care. Commonly used guidelines and educational strategies are likely to be ineffective. The implementation of the findings from this research will require substantial investment in primary care services and a major shift in the organization and provision of care.

A randomised controlled trial of a patient based Diabetes Recall and Management System: the DREAM trial: a study protocol [ISRCTN32042030].

BACKGROUND: Whilst there is broad agreement on what constitutes high quality health care for people with diabetes, there is little consensus on the most efficient way of delivering it. Structured recall systems can improve the quality of care but the systems evaluated to date have been of limited sophistication and the evaluations have been carried out in small numbers of relatively unrepresentative settings. Hartlepool, Easington and Stockton currently operate a computerised diabetes register which has to date produced improvements in the quality of care but performance has now plateaued leaving substantial scope for further improvement. This study will evaluate the effectiveness and efficiency of an area wide 'extended' system incorporating a full structured recall and management system, actively involving patients and including clinical management prompts to primary care clinicians based on locally-adapted evidence based guidelines. METHODS: The study design is a two-armed cluster randomised controlled trial of 61 practices incorporating evaluations of the effectiveness of the system, its economic impact and its impact on patient wellbeing and functioning.

Improving the delivery and organisation of mental health services: beyond the conventional randomised controlled trial.

BACKGROUND: There is an ethical imperative to evaluate service and policy initiatives, such as those highlighted in the recent National Service Framework, just as there is to evaluate individual treatments. AIMS: To outline the best methods available for evaluating the delivery and organisation of mental health services. METHOD: We present a narrative methodological overview, using salient examples from mental health services research. RESULTS: Cluster randomised studies involve the random allocation of groups of clinicians, clinical teams or hospitals rather than individual patients, and produce the least biased evaluation of mental health policy, organisation or service delivery. Where randomisation is impossible or impractical (often when services or policies are already implemented), then quasi-experimental designs can be used. Such designs have both strengths and many potential flaws. CONCLUSIONS: The gold standard remains the randomised trial, but with due consideration to the unit of randomisation. Use of quasi-experimental designs can be justified in certain circumstances but should be attempted and interpreted with caution.

Public health in hospitals: the missing link in health improvement.

Traditionally, public health professionals have scorned hospitals as the antithesis of community health. Secondary care remains notably distant from public health practice and policy. Yet hospitals consume over 50 per cent of the health budget and over a quarter of the population have contact with hospital services every year. There is an important public health agenda in hospitals for promoting health and an environment that encourages community partnership and a healthy place to work and be. Public health skills have a key role in ensuring high-quality, safe and evidence-based health care. Epidemiological support for hospitals can promote a much-needed culture of monitoring and evaluation of health services. A public health approach to planning of secondary care services can encourage a more objective and strategic assessment of health needs and how these are best met. We argue that public health hospitals should not be an oxymoron, but an essential component of public health strategy. Different approaches to putting public health into hospitals are discussed.