Do the comparative safety and effectiveness of these therapies differ among specific patient subgroups of interest? The final KQ seeks to evaluate the comparison of the available rate- and rhythm-control therapies discount aristocort 15mg without prescription. Does the comparative safety and effectiveness of these therapies differ among specific patient subgroups of interest? Analytic Framework Figure 2 depicts the analytic framework for this project discount 40mg aristocort. Analytic framework Abbreviations: AF=atrial fibrillation; CV=cardiovascular; KQ=Key Question This figure depicts the KQs within the context of the PICOTS described elsewhere in this document generic aristocort 10 mg with visa. The patient population of interest is adults with AF. Interventions of interest are procedural and nonpharmacological therapies for rate control (KQs 3 and 6), pharmacological therapies for rate control (KQs 1, 2, 3, and 6), pharmacological therapies for rhythm control (KQs 4, 5, and 6), electrical cardioversion (KQs 4, 5, and 6), and procedural and nonpharmacological therapies for rhythm control (KQs 5 and 6). Strict versus more lenient pharmacological therapies for rate control are considered in a separate question (KQ 2). Intermediate outcomes of interest are restoration of sinus rhythm, maintenance of sinus rhythm, recurrence of AF at 12 months, ventricular rate control, and development of cardiomyopathy. Final outcomes of interest are mortality (all-cause and cardiovascular), myocardial infarction, cardiovascular hospitalizations (including AF hospitalizations), heart failure symptoms, control of AF symptoms (e. Also of interest are the following adverse events associated with pharmacological treatment: hypotension, hypo/hyperthyroidism, arrhythmias, allergic reactions, hepatotoxicity, neurotoxicity, pulmonary toxicity, ophthalmological toxicity, and dermatological toxicity. Procedural complications of interest include pulmonary vein stenosis, left atrial esophageal fistula, phrenic nerve palsy, cardiac tamponade, and other complications (such as infection, bleeding, and thromboembolic events). For all six KQs, we will attempt to determine whether the comparative safety and effectiveness of the various therapies investigated differ among specific patient subgroups of interest. Patient characteristics to be assessed here include age, comorbidities, type of AF, previous pharmacological therapy failure, sex, enlarged left atrium, and high risk for stroke and bleeding events. The main sections in this chapter reflect the elements of the protocol established for the CER; certain methods map to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 23 (PRISMA) checklist. Topic Refinement and Review Protocol During the topic refinement stage, we solicited input from Key Informants representing medical professional societies/clinicians in the areas of general internal medicine, geriatrics, cardiology, electrophysiology, and primary care; patients; scientific experts; Federal agencies; and payers to help define the Key Questions (KQs). The KQs were then posted for public comment for 4 weeks from September 27 to October 25, 2011, and the comments received were considered in the development of the research protocol. We next convened a Technical Expert Panel (TEP) comprising clinical, content, and methodological experts to provide input to the draft protocol in defining populations, interventions, comparisons, and outcomes, and in 24 identifying particular studies or databases to search. Before involvement in the CER process, the Key Informants and members of the TEP were required to disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts. Any potential conflicts of interest were balanced or mitigated. Neither Key Informants nor members of the TEP performed analysis of any kind, nor did any of them contribute to the writing of this report. Literature Search Strategy Search Strategy ® ® To identify relevant published literature, we searched PubMed , Embase , and the Cochrane Database of Systematic Reviews (CDSR), limiting the search to studies published from January 1, 2000, to August 1, 2012. We believe that the evidence published from 2000 on represents the current standard of care for patients with atrial fibrillation (AF) and relevant comorbidities. In addition, a 2001 AHRQ report on the management of new onset AF summarized the evidence 25-27 prior to 2000. Where possible, we used existing validated search filters (such as the Clinical Queries Filters in PubMed). An experienced search librarian guided all searches. We supplemented the electronic searches with a manual 16,19,25-135 search of citations from a set of key primary and systematic review articles. We also considered studies identified through suggestions from external peer and public reviewers. Final updating of all database searches was performed during the review period. All citations were ® imported into an electronic database (EndNote X4; Thomson Reuters, Philadelphia, PA). We used several approaches to identify relevant grey literature including requests to drug and device manufacturers for scientific information packets and searches of study registries and conference abstracts for relevant articles from completed studies. Grey literature databases searched included ClinicalTrials. Search terms used for all of the above sources are provided in Appendix A. Inclusion and Exclusion Criteria The PICOTS (Populations, Interventions, Comparators, Outcomes, Timings, and Settings of interest) criteria used to screen articles for inclusion/exclusion at both the title-and-abstract and full-text screening stages are detailed in Table 1. Inclusion and exclusion criteria PICOTS Element Inclusion Criteria Exclusion Criteria Populations • Humans • Patients who have known • Adults (age ≥ 18 years of age) reversible causes of AF (including • Patients with AF (includes atrial flutter) but not limited to postoperative, o Paroxysmal AF (recurrent episodes that self- postmyocardial infarction, terminate in less than 7 days) hyperthyroidism) o Persistent AF (recurrent episodes that last more • All subjects are <18 years of age, than 7 days) or some subjects are under <18 o Permanent AF (an ongoing, long-term episode) years of age but results are not • Subgroups of potential interest include: broken down by age o Patients stratified by age (≤ 40, 41–64, 65–74, 75–84, 85+) o Patients with different types of AF (paroxysmal, persistent, permanent) o Patients with specific comorbidities (heart failure, coronary artery disease, kidney disease, hypertrophic cardiomyopathy, thyroid disease, pulmonary disease) o Patients for whom a prior rate- (KQ 3) or rhythm- control (KQ 5) pharmacological strategy was ineffective o Women o Patients with an enlarged left atrium o Patients at high risk for stroke and bleeding events (patients with diabetes, heart failure, and hypertension) 8 Table 1. Inclusion and exclusion criteria (continued) PICOTS Element Inclusion Criteria Exclusion Criteria Interventions • Pharmacological agents for rate control (KQ 1, KQ 2, • Studies comparing different KQ 3, KQ 6): imaging or mapping techniques o Beta blockers (e. Inclusion and exclusion criteria (continued) PICOTS Element Inclusion Criteria Exclusion Criteria Outcomes Study assesses a patient-centered outcome of interest: Study does not include any outcomes • Intermediate outcomes: of interest o Restoration of sinus rhythm (conversion) o Maintenance of sinus rhythm o Recurrence of AF at 12 months o Ventricular rate control o Development of cardiomyopathy a • Final outcomes: o Mortality (all-cause, cardiovascular) o Myocardial infarction o Cardiovascular hospitalizations (including AF hospitalizations) o Heart failure symptoms o Control of AF symptoms (e. Abbreviations: AF=atrial fibrillation; AVN=atrioventricular node; CRT=cardiac resynchronization therapy; KQ=Key Question; ICD=implantable cardioverter defibrillator; PICOTS=Populations, Interventions, Comparators, Outcomes, Timing, Settings; RCTs=randomized controlled trials 10 Study Selection Using the prespecified inclusion and exclusion criteria described in Table 1, two investigators independently reviewed titles and abstracts for potential relevance to the KQs. Articles included by either reviewer underwent full-text screening. At the full-text review stage, paired researchers independently reviewed the articles and indicated a decision to “include” or “exclude” the article for data abstraction. When the two reviewers arrived at different decisions about whether to include or exclude an article, they reconciled the difference through review and discussion, or through a third-party arbitrator if needed. Full-text articles meeting our eligibility criteria were included for data abstraction. Relevant systematic review articles, meta-analyses, and methods articles were flagged for manual searching of references and cross-referencing against the library of citations identified through electronic database searching. For citations retrieved by searching the grey literature, the above-described procedures were modified such that a single screener initially reviewed all search results; final eligibility of citations for data abstraction was determined by duplicate screening review. All screening decisions were made and tracked in a Distiller SR database (Evidence Partners Inc. Data Extraction The research team created data abstraction forms and evidence table templates for abstracting data for each KQ. Based on clinical and methodological expertise, a pair of investigators was assigned to abstract data from each eligible article. One investigator abstracted the data, and the second reviewed the completed abstraction form alongside the original article to check for accuracy and completeness. To aid in both reproducibility and standardization of data collection, researchers received data abstraction instructions directly on each form created specifically for this project within the DistillerSR database. We designed the data abstraction forms to collect the data required to evaluate the specified eligibility criteria for inclusion in this review, as well as demographic and other data needed for determining outcomes (intermediate, final, and adverse events outcomes). We paid particular attention to describing the details of treatment (e. In addition, we described comparators carefully, as treatment standards may have changed during the period covered by this review. The safety outcomes were framed to help identify adverse events, including those from drug therapies (e. Data necessary for assessing quality and applicability, as described in the 22 Methods Guide, were abstracted. Before the data abstraction form templates were used, they were pilot-tested with a sample of included articles to ensure that all relevant data elements were captured and that there was consistency/reproducibility between abstractors. Forms were revised as necessary before full abstraction of all included articles. In these instances, we used the web-based software, EnGauge Digitizer (http://digitizer. Appendix B provides a detailed listing of the elements included in the data abstraction forms. We applied criteria for each study type derived from core elements described in the Methods Guide.

In fact generic 40 mg aristocort overnight delivery, there was an upgrade in that the central triage was to be staffed by a qualified psychotherapist cheap aristocort 15mg on-line. The new service was to be more holistic generic aristocort 10 mg without a prescription, more person centred and more widely cast to include well-being and sustainable living. The idea was to move away from an overt medicalised approach to mental health problems. Clinical leadership was present in this case in the form of a credible, knowledgeable and committed leader operating in the operational arena who was able to harness the power of his diverse network and, as a consequence of that, to win support from the CCG strategic level. Yet even with a credible leader and widespread support there were significant institutional challenges. Although the creative institutional work was seen to be efficient and effective, there was the legacy effect of the extant services to be taken into account. The CCG was working across a spectrum of services that they could influence through clinical commissioning. Even within mental health, other developments were taking place which the CCG saw as equally important. One of these focused on CAMHS, which was being extended beyond the normal age range to take in young adults up to the age of 25 years, whereas previously patients would transfer into adult mental health services at either 16 or 18 years of age, depending on their position in other services (social services or educational services). It demonstrates the difficulty faced by clinical commissioners trying to look after whole health economies within a transactional framework. It is a stark example of coexisting competing logics. Case D: system and multilevel redesign Case D illustrates many important aspects of the current reality of the leadership of multilevel service redesign attempts in the English NHS. The unit of analysis in this case was the area which became the new STP footprint. It comprised six CCGs, a county council, a city council and a collection of acute hospital trusts and community trusts. They are analysed as one unit here because these particular CCGs had made strenuous efforts to work together and indeed had been prompted to do so. They all operated within one large, mainly rural, county and had worked together in pairs, in triads and indeed across all six CCGs. Case D covers a population of approximately 1 million people. The health system in the region is in deficit and it is considered not sustainable without radical reform. The context is also one of major change to hospital services following the dissolution of one of its hospital trusts and there were difficulties in recruiting clinical staff in both primary and secondary care. The health economy so defined was identified as one of the 11 national challenged economies. There was a £140M deficit (2015/16), that is 7% of the funding available. It was forecast that if no change was made this would increase to £240M (11%) per annum over the next 5 years with an accumulated deficit of > £1B. The extent and severity of the challenges helps explain why these neighbouring CCGs were impelled to work together beyond the norm for CCGs nationally. The analysis that follows works through service redesign attempts at different levels and in different arenas starting with GP practices and moving up through localities, the CCG level and then the supra-CCG level. Practice level We investigated, in some depth, an example of very active service redesign activity originating within one general practice but extending into a multipractice initiative. Ironically, the context was one of general conservativism. For example, one interviewee observed: Practices see themselves as individual businesses just getting on with the job. In the main they just follow the traditional model which is, you know, well, just what general practice was 20 years ago. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals 57 provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. As an individual practice over a number of years they have redesigned the way they work, redesigned their staffing structures, and redesigned the way that they do things. The emphasis on concerted action led to the formation of a GP federation. This initiative was launched by the National Association of Primary Care. This includes an integrated primary, secondary and social care workforce providing more personalised and better-co-ordinated care closer to home. The initiative is designed to pilot and test a different and expanded mode of primary care. It includes a new workforce profile, less dependent on GPs, with an expanded array of services supported by new and enhanced training and development for the wide array of roles. This initiative works to a model devised at national level but the detailed design and implementation is dependent on local initiative and activity by local leaders. Realising the concept and making it work is also dependent on a number of bodies, including educational and training bodies, such as Health Education England, working through community education provider networks. The new model is designed to galvanise primary care, community health and social care professionals to work in partnership with specialists so as to provide out-of-hospital care in a holistic way. It has similarities with the multispecialty community provider (MCP) model as described in the Five Year Forward View. Physician associates take postgraduate training under the supervision of a doctor, so as to equip the role holder with the skills to take medical histories, perform examinations, diagnose illnesses, analyse test results and develop management plans. The urgent care practitioners have a nursing or paramedic background. Accreditation and assurance is being arranged through existing Nursing and Midwifery Council and the Health and Care Professions Council regulatory bodies. Just one of the implementation leadership complexities includes the issue of indemnity. Steps were being taken to enable this to be covered by an existing provider who would also provide the necessary supervision. A further important element is an increased use of telemedicine and information technology allowing diagnostic tests without GP presence. As all of the above indicates, the redesign of primary care services in the GP practices that we studied required many complex interlocking aspects: reimagining the nature of primary care in relation to other services, such as community care, social care and secondary care; redesigning the workforce to match the new service profile; arranging the necessary training, supervisory and indemnity arrangements; and designing and operationalising the required technology support. Few GPs were in a position to take the lead on such an ambitious agenda. It required imagination, creativity, funding and persistence to even get such a package launched. It also required networking skills to bring on board not only fellow professionals, but also professionals from related but separate disciplines. In the case we studied, the GP leaders had also to negotiate with the CCG in order to gain some assurance of ongoing support and eventual ongoing funding for the new model of primary care. The CCG leaders had their own priorities and they were reluctant to devolve funding to 58 NIHR Journals Library www. This provided a stark example of clinical leaders needing to exercise unusual levels of capacity in managing ambiguity and uncertainty. Not all of those who were taking a leadership role in this venture displayed the same level of tenacity in the face of setbacks. Some were inclined to step back and revert to business as usual (that is to retreat to their normal clinical role) when faced with lack of support, but one or two were very different in that they showed persistence and determination to continue in the face of adversity. Locality level The locality level was the sublevel of the CCG where groups of practices came together to share experiences and to act as a communication channel with the CCG. It was a potential arena for the exercise of clinical leadership. So part of the [rationale] is to represent the local practices, with me as a sort of figurehead to feed things in, and represent the locality at CCG level. And indeed for me to represent CCGs in the bigger picture at locality and practice level.

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The British Hypertension Society guidelines define optimal blood pressure control in people with kidney disease as <130/80 mmHg and suggest reducing blood pressure to <125/75 mmHg in those with proteinuria ≥1 g/24 h buy cheap aristocort 15 mg. All post-hoc analyses of RCTs were downgraded to level two evidence discount 15 mg aristocort. A case series (N=860 purchase aristocort 10mg otc, follow-up 10 years) investigated the association of systolic blood pressures <133 mmHg and mortality in a cohort of men (mean age 68±10 years) with stages 3 to 5 CKD. Two post-hoc analyses of the Irbesartan in Diabetic Nephropathy Trial (IDNT) RCT (N=1590, median follow-up 2. Diastolic blood pressure was not significantly associated with all-cause mortality, cardiovascular mortality, or congestive heart failure. There was a significantly higher risk of cardiovascular mortality for people with an achieved SBP <120 mmHg compared with SBP >120 mmHg. People with an achieved SBP ≤120 mmHg had a significantly greater risk of congestive heart failure compared to people with an achieved SBP >120 mmHg. For people with baseline urinary protein excretion >3 g/day (N=32), there was a benefit of intense control (GFR decline 5. There was NS risk for the combined renal endpoint 104 9 Blood pressure control between people with achieved SBP 130–139 mmHg (N=401) compared to people with achieved SBP <130 mmHg (N=278). People with an achieved DBP <70 mmHg (N=365) had a significantly lower risk of reaching the combined renal endpoint compared with those with an achieved DBP of 90–99 mmHg (N=152). People with an achieved DBP of 90–99 mmHg (N=144) had a significantly higher risk of reaching ESRD or death compared to people with achieved DBP <70 mmHg (N=377). People with achieved SBP 140–159 mmHg (N=518) had a significantly higher risk of reaching ESRD or death compared with people with achieved SBP <130 mmHg (N=286). Achieved SBP 140–159 mmHg (N=518) was associated with a significantly higher risk of reaching ESRD compared with achieved SBP <130 mmHg (N=286). Achieved DBP of 90–99 mmHg (N=144) was associated with a significantly higher risk of reaching ESRD compared to achieved DBP <70 mmHg (N=377). For people with urine protein excretion ≥1 g/day, there was NS risk for renal disease progression when SBP was 120–129 mmHg compared with SBP 110–119 mmHg. For people with urine protein excretion ≥1 g/day, there was a significantly increased risk for renal disease progression when SBP was 130–139 mmHg (RR 4. This was seen in people with baseline proteinuria >0. In a cohort of type 1 diabetic patients with nephropathy (N=301), more people with a lower follow-up MAP achieved remission. Stratified by MAP: MAP 93 mmHg (58% remission), MAP 99 mmHg (33% remission), MAP 103 mmHg (25% remission), MAP 107 mmHg (20% remission), MAP 113 mmHg (17% remission). In a cohort of type 1 diabetic patients with nephropathy (N=301), more people with a lower follow-up MAP achieved regression. Stratified by MAP: MAP 93 mmHg (42% regression), MAP 99 mmHg (32% regression), MAP 103 mmHg (11% regression), MAP 107 mmHg (20% regression), MAP 113 mmHg (17% regression). The adjusted odds ratio for regression associated with a 10 mmHg decline in MAP was 2. SBP >120 mmHg (IDNT*) continued 106 9 Blood pressure control Table 9. Intense MAP control – – creatinine clearance usual MAP control (MDRD) (GFR decline 5. SBP <130 mmHg (RENAAL*) ESRD or death NS risk intense vs. SBP <130 mmHg (RENAAL*) Doubling serum NS risk SBP <110 to NS risk SBP 120–129 – – creatinine or ESRD >160 mmHg (Jafar vs. DBP <65 mmHg (US vet) Cardiovascular – – – DBP not predictive mortality (IDNT*) Congestive heart – – – DBP not predictive failure (IDNT*) Myocardial infarction – – – ↑ Risk DBP <70 mmHg vs. DBP <70 mmHg (RENAAL*) ESRD or death – – – NS risk DBP 70–-89 mmHg vs. DBP <70 mmHg (RENAAL*) ESRD – – – NS risk DBP 70–89 mmHg vs. DBP <70 mmHg (RENAAL*) Doubling serum DBP not predictive DBP not predictive – – creatinine or ESRD (Jafar meta-analysis) (Jafar meta-analysis) *Post-hoc analysis. Evidence relating to lifestyle advice (such as salt restriction) in blood pressure control can be found in the NICE clinical guideline 34 on hypertension. The evidence presented suggests that there are optimal ranges, with increased risk of adverse outcomes both above and below the optimal range, for both systolic and diastolic blood pressure. In practice, when treatment is given to maintain the systolic blood pressure in the optimal range, this results in the diastolic blood pressure falling below its optimal range. Recommendations were therefore made for a systolic range and a diastolic threshold. In people with CKD without diabetes, there is some evidence to suggest lower blood pressure targets in those with a threshold level of proteinuria equivalent to an ACR of ≥70 mg/mmol, or PCR ≥100 mg/mmol (approximately equivalent to urinary protein excretion of ≥1 g/day). In order to be consistent with the available evidence on ACEI/ARB therapy a threshold level of proteinuria at which ACEI/ARBs should also be recommended for blood pressure control in people without diabetes was set at an ACR of ≥30mg/mmol, or PCR ≥50 mg/mmol (approximately equivalent to a urinary protein excretion of 0. R40 In people with diabetes and CKD or when the ACR is ≥70 mg/mmol, or PCR ≥100 mg/mmol (approximately equivalent to PCR ≥100 mg/mmol, or urinary protein excretion ≥1. Danger zones: systolic blood pressure 120 130 140 150 160 Increased risk of: Increased risk of: Increased risk of: • mortality • 2 x SCr or ESRD* • 2 x SCr, ESRD or death • CV mortality • ESRD or death • stroke • ESRD • congestive heart failure *When proteinuria >1 g/24 h Danger zones: diastolic blood pressure 60 70 80 90 100 Increased risk of: Increased risk of: • mortality • 2 x SCr, ESRD or death • myocardial infarction • ESRD or death • decline in GFR • ESRD Figure 9. Hypertension is extremely common in people with CKD and the mean number of antihypertensive agents prescribed is associated with the stage of CKD, increasing as GFR falls. The UK CKD guidelines15 recommend that ACEI/ARBs should be used as first line therapy only for people with diabetic kidney disease and for those with proteinuria (urine PCR >100 mg/mmol) and this was endorsed by the UK consensus conference. Although the evidence is less clear in non- diabetic kidney disease with lesser degrees of proteinuria the Quality and Outcomes Framework requires the use of ACEI/ARBs in people with stage 3–5 CKD hypertension and proteinuria. The CARI guidelines36 recommend that regimens including ACEI/ARBs are more effective in slowing progression of non-diabetic CKD, and that combination of ACEIs and ARBs slow progression more effectively than either single agent. They also conclude that ACEI/ARBs are more effective than beta-blockers and dihydropyridine calcium channel blockers, and that beta- blockers may be more effective than dihydropyridine calcium channel blockers. Most trials used non-ACEI or non-ARB antihypertensive agents in both arms to achieve blood pressure control and to ascertain if ACEI or ARBs provided renoprotective effects beyond blood pressure control. The sample sizes in these studies ranged from N=180 to 39485 and the duration of the trials ranged from 6 months to 6 years. The mean age of study participants was under sixty years of age, with the exception of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) study,118 in which the mean age was 67 or 70 in each treatment arm. The studies were also quite heterogeneous in terms of the population studied – diabetic nephropathy or nondiabetic CKD. A systematic review of ten RCTs241 comparing combination therapy ACEI + ARB versus monotherapy (ACEI or ARB) in adults with diabetic nephropathy was excluded because the quality of each included trial was not assessed; the primary outcome (proteinuria change) had significant heterogeneity and there was no heterogeneity analysis for sub-group analyses. Studies included in the meta-analysis were only 8–12 weeks long. There was wide variation in the dosage of ACEI and ARB, and few studies titrated to the maximum tolerated dose. Two more studies267,268 evaluated ACEI or ARB treatment based on meta-analysis of RCTs. Most papers evaluated the drugs in the context of diabetic nephropathy. Studies which are not UK-based may not be easily transferable to a UK setting. However, the UK studies reached similar conclusions to the North American and European studies. Another systematic review (49 RCT, N=6181, trial durations 1–12 months) assessed changes in proteinuria in people with renal disease of various causes randomised to ARBs versus placebo, calcium channel blockers, or ACE inhibitors. It also assessed combination therapy (ACEI + ARB) versus ACEI or ARB monotherapy. The Ramipril Efficacy in Nephropathy (REIN) RCT compared an ACE inhibitor (ramipril) with placebo in non-diabetic adults with CKD (N=352) stratified by baseline proteinuria: stratum one covered 1–2. A higher baseline urinary protein excretion rate was associated with a higher risk of reaching the combined endpoint in the placebo group, but not in the ramipril group. There was NS reduction in progression from micro- to macroalbuminuria for ACEI vs. There was NS difference in regression to normoalbuminuria for ACEI compared with ARB. Trials of ACE inhibitors were not separated from trials of ARBs, thus confounding factors such as differences in drug tolerability could not be separated.

Jane Maddison (Research Fellow) is an Applied Social Scientist working in health and care services research; co-led on data collection and data analysis; contributed to writing of the final report generic aristocort 10mg overnight delivery. Data sharing statement Requests for access to anonymised data should be made to the corresponding author buy aristocort 15mg line. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed discount 40 mg aristocort free shipping, the full report) may be included in professional journals 105 provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 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INTERMED – a clinical instrument for biopsychosocial assessment generic 40mg aristocort otc. Psychosomatics 2001;42:106–9) for use in hospital settings to identify complex patients at admission buy aristocort 4 mg lowest price, and is used for early integral case management purchase aristocort 15 mg with visa. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals xvii provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. It aims to increase the rate of health improvement in deprived communities by enhancing primary care services to deliver anticipatory care. In the Keep Well programme, individuals aged between 40 and 64 years living in areas of high deprivation are invited to attend a health check. The checks include screening for cardiovascular disease and its main risk factors, such as high blood pressure and cholesterol level, smoking and diet, as well as discussions around wider life circumstances, such as employment and literacy. Links worker An individual who provides support, sometimes in a general practice setting, to people who require help to improve their circumstances, health and well-being. This may be provided through supportive conversations and assistance to identify and access helpful connections and appropriate resources. The definition does not relate to any one condition, care group or age category. Examples of long-term conditions are diabetes mellitus, coronary heart disease, chronic obstructive pulmonary disease, arthritis and multiple sclerosis, among many others. Morbidity A way to describe how often a particular disease or condition occurs in a population, and commonly the impact of its presence in an individual. Multimorbidity The presence of two or more illnesses or conditions in a population or an individual. Normalisation process theory A sociological toolkit that can be used to understand the dynamics of implementing, embedding and integrating some new technology or complex intervention. It is mainly applied to understanding how new technologies or interventions are taken up or adopted in health-care settings by health-care professionals and/or patients. NVivo A software program that supports qualitative and mixed-methods research. It is designed to help organise, analyse and find insights in unstructured or qualitative data, such as interviews, open-ended survey responses, articles, social media and web content. Patient-centred care A term with many definitions, but which usually means care that puts patients at the centre and gives them the opportunity to make informed decisions about their care and treatment in partnership with their health and social care practitioners. Patient outcome measures Tools and measures that patients can complete that help to measure their experience of their illness. Quality and Outcomes Framework The annual reward and incentive programme detailing general practice achievement results. It rewards practices for the provision of high-quality care and helps standardise improvement in the delivery of primary medical services. It is a voluntary process for all surgeries in England and was introduced as part of the general practitioner contract in 2004. The indicators for the Quality and Outcomes Framework change annually, with new measures and indicators xviii NIHR Journals Library www. General practices in Scotland ceased to use the Quality and Outcomes Framework on 1 April 2016. Scottish Index of Multiple Deprivation A tool that provides a standardised way to describe the extent of deprivation in any one Scottish residential area, and which allows for the comparison of levels of deprivation between areas. Scottish Mental Health Research Network A network set up in 2009 and funded by the Chief Scientist Office in Scotland to provide support to improve the quality and quantity of research conducted in Scotland, including through increasing the number of people participating in mental health research, and to promote excellence in mental health clinical research in Scotland. Scottish Primary Care Research Network A network set up in 2002 and funded by the Chief Scientist Office in Scotland to co-ordinate national research activity in primary care in Scotland and to increase the amount of research relevant to patient care undertaken in a primary care setting. Service user Someone who uses health and social care services, or who is a potential user of health and social care services. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals xix provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals xxi provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. The broader mental well-being and social needs of patients are also important if they are to live well. The Patient Centred Assessment Method (PCAM) is a new tool to help PNs improve their ability to respond to the physical, mental and social needs of patients. This study explored the acceptability of the PCAM tool for use in primary care, and whether or not it would be feasible to run a full-scale trial to test its impact on nurses or patient outcomes. Methods The feasibility randomised controlled trial aimed to recruit eight general practitioner (GP) practices with 16 nurses and to train half of the nurses to use the PCAM tool. Results The study recruited only six practices and 10 nurses. Before any nurses were trained to use the PCAM, they collected data on 113 patients, of whom 71 (53%) completed follow-up questionnaires. Following this, only seven nurses stayed in the study and collected data on 77 patients, with 40 (52%) completing follow-up questionnaires. Patients were not always aware of its use, but most were happy to have their broader needs assessed by the nurse. Conclusions Use of the PCAM tool in primary care shows promise. It seems to be generally acceptable to PNs and patients. However, practice recruitment problems mean that it is not feasible to run a trial at this time in primary care in Scotland (and perhaps in the UK as a whole). This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals xxiii provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. This may be as a result of the limited experience and lack of confidence of primary care nurses who conducted most depression screening as part of routine annual reviews. The tick-box and medicalised nature of the QOF served only to limit these skills even further and contributed to little or no attention being paid in these assessments to the social problems that might contribute to poor physical and mental well-being. The Patient Centred Assessment Method (PCAM) has been developed to enable broad assessment of patient biopsychosocial needs in primary care, and to promote action based on the severity and urgency of needs. The PCAM is an adapted version of the Minnesota Complexity Assessment Method, which was derived from the INTERMED (a method to assess health service needs). The PCAM has previously been evaluated in anticipatory (Keep Well) health check clinics, which were initiated by the Scottish Government for early identification of LTCs, or risk of LTCs, in those aged 40–64 years and living in deprived communities in Scotland. However, the PCAM has neither been evaluated for use by primary care practice nurses (PNs) in regard to its potential value for addressing mental well-being in patients with LTCs nor been subject to clinical trial to determine its impact on nurse behaviour and patient outcomes. Research questions Is it feasible and acceptable to use the PCAM in primary care nurse-led annual reviews for people with LTCs? Is it feasible and acceptable to run a cluster randomised trial of the PCAM intervention in primary care? Aim This research aimed to assess the acceptability and implementation requirements of the PCAM for enhancing the care of patients with LTCs and comorbid mental and social care needs in primary care. It also aimed to assess the fidelity of its implementation/use among nurses (i. Methods Practitioner and patient focus groups were used to assess the views of primary care professionals and people with LTCs about the acceptability and implementation requirements of the PCAM, especially for nurse consultations for LTCs. The PCAM was then tested in a feasibility cluster randomised controlled trial (RCT), which aimed to recruit eight general practitioner (GP) practices and 16 PNs. Four practices (eight nurses) were to be allocated to deliver the PCAM intervention and four practices (eight nurses) would deliver care as usual (CAU).

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Adenosine acts preferentially on excitatory have been cloned and are coupled to Gq11 discount aristocort 15 mg otc. Receptor activa- versus inhibitory neurotransmitter release order aristocort 15 mg line, a finding suggest- tion results in stimulation of phospholipase C and IP3 acti- ing a degree of physiologic specificity in modulating brain vation and subsequent release of calcium from intracellular function cheap aristocort 40mg mastercard. Adenosine also directly modulates postsynaptic stores. The P2T receptor, present in platelets and preferen- neuronal excitability by activating A1 and A2A receptors re- tially sensitive to ADP, has been cloned, as the P2Y12 re- sulting in hyperpolarization of the postsynaptic membrane. Over the past 2 decades, many studies have provided The P2Y1 receptor is preferentially activated by adenine evidence of involvement of purines in the actions of various nucleotides, with 2MeSATP the most potent. UTP and CNS-active drugs including antipsychotics, antidepressants, UDP are inactive at this receptor. Suramin, PPADS, ciba- anxiolytics, and cognition enhancers. These studies have cron blue, A3P5PS, and MRS 2179 (Fig. The P2Y2 receptor drugs representative of these therapeutic classes were exam- is activated by both ATP and UTP; nucleotide diphosphates ined for their ability to modulate adenosine-mediated re- are inactive (1,52). Antagonists such as suramin are less sponses in the CNS, or, alternatively, they studied the effects efficacious at the P2Y receptor. UTP is the preferred ago- of various P1 ligands, both agonists or antagonists, on the 2 nist for the P2Y receptor, with ATP and the nucleotide effects of such prototypic CNS agents. Diphosphates are more active at the only single, somewhat high, concentrations of an isolated P2Y receptor than triphosphates, and this has led to the compound, or limited numbers of compounds, were used 6 classification of the P2Y receptor as a UDP-preferring re- to generalize to a complete class of psychotherapeutic agents, 6 ceptor. The P2Y receptor is unique among other P2Y often with no negative control data, thus limiting the value 11 receptors in that only ATP serves as an agonist for this of the data (58). For P2 receptors, the absence of ligands, agonists, and receptor (53). The P2Y12 and P2Y13 receptors are ADP- antagonists has limited the functional characterization of selective receptors. The delineation of a role for Diadenosine polyphosphates including Ap4A and Ap5A P2 receptors in CNS disorders has been postulated largely (Fig. Receptors for the For both P1 and P2 receptors, the use of mice either defi- diadenosine polyphosphates have not yet been cloned. A3-receptor agonists have biphasic effects on cell sur- tion (A1) and reduced exploratory activity, aggressiveness, vival. At nanomolar concentrations, they are neuroprotec- hypoalgesia, and high blood pressure (A2A) (59). P2 knock- tive and inhibit apoptosis, but at micromolar concentrations outs are associated with decreased male fertility (P2X1) (60), they are neurotoxic (31). A after middle cerebral artery occlusion in the rat (49), a find- preliminary report on a P2X7 knockout has appeared (64). Antisense to the P2X7 receptor or selec- tive receptor antagonists may represent a novel approach to PURINERGIC THERAPEUTICS the treatment of stroke. Three distinct classes of compound can modulate P1 and P2 receptor function: (a) conventional agonist, partial ago- Epilepsy nist and antagonist ligands; (b) allosteric modulators of re- ceptor function; and (c) modulators of the endogenous sys- Seizure activity is associated with rapid and marked increases tems that regulate the extracellular availability of ATP, in CNS adenosine concentrations in animals (68), as well adenosine, UTP, and their respective nucleotides. This last as in patients with epilepsy with spontaneous-onset seizures group includes the various ecto-ATPases that catalyze the (69). Seizure activity induced by a variety of chemical and degradation of nucleotides (5), ADA, AK, and the bidirec- electrical stimuli in animal models is reduced by adenosine tional member transporter systems that remove adenosine and related agonists (68) acting through A1receptors. From data on electrically kindled seizure models, adenosine agonists re- AK effects in brain tissue (22), it appears that modulation duce seizure severity and duration without significantly al- of endogenous adenosine levels by inhibition of AK is not tering seizure threshold. These anticonvulsant effects are a viable drug discovery approach. Adenosine antagonists including caffeine, the- hypoxia and focal ischemia, a finding providing additional ophylline, and BIIP 20 (Fig. Adenosine-receptor agonists such as CHA models by blocking the actions of endogenous adenosine. The clinic for their efficacy in cognitive disorders. Although pro- neuroprotective effects of adenosine are mediated by several vocative clinical data have been generated, neither com- P1 receptors: A1-receptor activation stabilizes neuronal pound showed sufficiently robust efficacy in larger AD trials Chapter 15: Purinergic Neurotransmission 201 to warrant continuation. However, aged patients with rheu- of the pars reticulata, which, turn, through a pars reticu- matoid arthritis who consume large quantities of antiinflam- lata–thalamic GABAergic pathway, inhibits the thalamic- matory agents such as indomethacin show an inverse corre- cortical glutaminergic pathway. Dysfunction of this path- lation for the incidence of AD, a finding highlighting the way may underlie the movement disorders seen in Hunting- pivotal role of inflammation in disease origin. A direct pathway originating in striatal agonists and AK inhibitors have marked antiinflammatory GABAergic–substance P–dynorphinergic neurons inhibits activity (67), inhibiting free radical production, and thus the internal segment of the pars reticulata to disinhibit the they may be effective in maintaining cell function in AD, ascending thalamic glutaminergic pathway and to activate in addition to modulating cytotoxic events. The balance between the direct (corti- Trophic factors in nervous tissue act to ensure neuronal cal activating) and indirect (cortical inhibiting) striatal do- viability and regeneration. Withdrawal of nerve growth fac- paminergic pathways provides a tonic regulation of normal tor, which exerts a tonic cell death–suppressing signal, leads motor activity. These studies indicate that striatal adenosine to neuronal death. Polypeptide growth factors linked to re- A2A receptors may play a pivotal role in neurologic disorders ceptor tyrosine kinases, such as fibroblast growth factors, involving basal ganglia dysfunction such as PD. The A2A epidermal growth factor, and platelet-derived growth factor, agonist, CGS 21680, given intrastriatally, attenuates the are increased with neural injury (70). ATP can act in combi- rotational behavior produced by dopamine agonists in uni- nation with various growth factors to stimulate astrocyte laterally lesioned rats. Mechanistically, radioligand-binding proliferation and to contribute to the process of reactive studies have shown an increased efficacy of CGS 21680 in astrogliosis, a hypertrophic-hyperplastic response typically reducing the binding affinity of supersensitive D2 receptors, associated with brain trauma, stroke and ischemia, seizures, a finding supporting the increased sensitivity of animals and various neurodegenerative disorders. In reactive astro- with supersensitive dopamine receptors to CGS 21680 gliosis, astrocytes undergo process elongation and express treatment. Repeated administration of the dopamine antag- glial fibrillary acidic protein, an astrocyte-specific intermedi- onist, haloperidol can up-regulate the density of both D2 ate filament protein with an increase in astroglial cellular and A2A receptors in rat striatum. ATP increases glial fibrillary acidic protein Adenosine A1 receptor activation can reduce the high- and activator protein-1 (AP-1) complex formation in astro- affinity state of striatal dopamine D1 receptors, the A1 re- cytes and mimics the effects of basic fibroblast growth factor ceptor agonist, and CPA blocking D1-receptor–mediated (70). Both ATP and guanosine triphosphate induce trophic locomotor activation in reserpinized mice (72). The nonse- factor (nerve growth factor, neurotrophin-3, fibroblast lective adenosine agonist, NECA, can attenuate the perioral growth factor) synthesis in astrocytes and neurons. The ef- dyskinesias induced by D1-receptor activation in rabbits. Nonetheless, these rectly modulates dopamine-receptor–mediated effects on studies have focused research on the hypoxanthine analogue, striatal GABA-enkephalinergic neurons and striatal neotrofin (AIT-082) (Fig. These adenosine trophin production and enhances working memory and re- agonist–mediated effects are independent of G-protein stores age-induced memory deficits in mice (71). This com- coupling and may involve an intramembrane modulatory pound has shown positive effects in early phase II trials for mechanism involving receptor heterooligimerization (26). The dynamic interactions between dopaminergic and In 1974, Fuxe showed that methylxanthines such as caf- purinergic systems in striatum suggest that dopaminergic feine could stimulate rotational behavior and could poten- dysfunction may be indirectly ameliorated by adenosine re- tiate the effects of dopamine agonists in rats with unilateral ceptor modulation. Selective adenosine A2A receptor antag- striatal lesions Conversely, adenosine agonists blocked the onists such as KF 17837 and KW 6002 (Fig. Anatomic links be- shown positive effects in 1-methyl-4-[henyl-1,2,3,6-tetra- tween central dopamine and adenosine systems are well es- hydropyridine–lesioned marmosets and cynomolgus mon- tablished; adenosine A2A receptors are highly localized in keys, well characterized animal models of PD, enhancing striatum, nucleus accumbens, and olfactory tubercle, brain the effects of L-dopa (73,74). KW-6002 has successfully regions that also have high densities of dopamine D1 and completed human phase I trials. In men who drank no coffee, the incidence to the globus pallidus that originates from striatal GABA- of PD was 10. Through GABAergic relays, this 10,000 person-years in men drinking at least 28 oz of coffee pathway interacts with a glutaminergic pathway from the per day (75). Dopamine–adenosine (ADO) interactions in the substantia nigra. An indirect path- way dopaminergic pathway arises from the striatal GABA-enkephalinergic dopaminergic neurons on which both dopamine D1 and adenosine A2A receptors are co-localized. Through a GABAergic interneuron originating in the external globus pallidus, the indirect pathway connects to a gluta- minergic pathway arising in the subthalamic nucleus. This, in turn, can activate the internal seg- ment of the pars reticulata and, through another GABA pathway, inhibit ascending glutaminegic neurons arising from the thalamus that innervate the cortex. The direct pathway arises from striatal GABA–substance P–dynorphinergic neurons that, through a GABAergic relay, inhibit the internal segment of the pars reticulata to disinhibit the ascending thalamic-cortical glutaminergic pathway. The balance between the direct (activating) and indirect (inhibitory) striatal dopami- nergic pathways can then tonically regulate normal motor activity.

The programme involved all of the relevant health and social care organisations in this part of London (three CCGs buy 4mg aristocort free shipping, one acute provider purchase aristocort 4 mg with mastercard, two mental health and community providers discount 15 mg aristocort, all general practices and three LAs) across the area served by the acute provider. The integrated care programme aims to ensure consistency and efficiency across physical health, mental health and social care. Interventions focus primarily on the top 20% of patients most at risk of hospital admission, a group responsible for approximately 80% of the activity and costs across health and social care in all three boroughs. The work targets the population in a phased approach, beginning with those at very high risk of hospital admission (the top 2% of people at highest risk), and working downwards to cover the full 20% over a 5-year period. The programme is supported by a programme management office. There are workstreams on contracting and reimbursement, informatics and information technology, and evaluation. The programme management office also supports the local implementation of integrated care within the three localities. Integrated care boards within each CCG are responsible for the operational design and commissioning of their local programmes. The three lead CCGs work in partnership, but also retain a high degree of autonomy within the wider programme. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals 65 provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. FINDINGS FROM THE CASE STUDIES mature of the partners, particularly in terms of the emphasis placed on clinical leadership. CCG informants reported that they felt constrained by the slower pace of change in the other two areas. Clinical leadership across different arenas The chairperson of the CCG, the lead for the GP network, the local medical committee representative and the named CCG integrated care lead were widely seen as each having a particularly important role in advocating for integrated care not only in strategic arenas, but also to their colleagues involved in delivering primary care. However, there was evidence of a disconnect between the clinical leadership and institutional work of advocating and resourcing integrated care in strategic arenas and the level of engagement of many of the front-line clinical staff with delivering the various aspects of the programme. There was one clinically led fundamental challenge to the integrated care programme, when a respected GP questioned the evidence base for focusing on unplanned hospital admissions. This can be seen as an instance of counter-implementation leadership, whereby a provider clinician actively opposes implementation of the new service model. The GP complained that if reducing unplanned admissions to hospital was a key rationale for the programme (which at a national level it is) then, on the basis of past evidence, the programme was probably doomed to failure. Instead, he felt that the CCG should be focusing on evidence-based, disease-focused interventions to manage the rising demand for hospital care, specifically by greater use of statins to reduce cholesterol and more effective management of atrial fibrillation. The GP arranged a meeting of key clinicians to discuss the issue and he gained some support from colleagues, although not enough to derail the wider integrated care programme. Case E2: urgent care The urgent care work in this case aimed to produce a single point of access for patients rather than the current array, which included a hospital A&E department, two walk-in centres, NHS 111 as an urgent telephone consultation and triage service, a GP out-of-hours service, a number of minor injuries centres and an urgent care centre. The ends or break clauses of the contracts for these commissioned services were aligned by the CCG in a way that enabled a system-level review of provision, its overlaps and its variation in per head/per visit cost. The plan was to use this to retender all urgent care services and achieve a more coherent and cost-effective result. This review involved a number of different partners, including the clinical leads of these services, A&E staff, the lead for extended GP hours (which is being funded nationally), and also a number of staff from the local CSU and a senior CCG manager responsible for urgent care. The review was carried out through a series of workshops facilitated by the CSU. In terms of Figure 24, the review can be seen as taking place in an operational commissioning arena, with commissioners and providers coming together to consider the future pattern of services. It remained in progress at the end of our fieldwork period. There were a number of important local contextual factors affecting this urgent care review. First, and the biggest issue for the CCG, was the rapid increase in the population and the potential impact of this increase on future demand for urgent care services. A second factor was the co-location in the local acute hospital of traditional A&E services alongside some of the newer community-led services. This arrangement carried the potential for novel ideas in the way services were provided. Third, the distribution of urgent care services across the CCG area was at the time asymmetrical, and the desire to distribute all kinds of urgent care services evenly across this geography created logistical, estates and financial challenges for the CCG. This initiative raised the profile of urgent care redesign led by GPs, many of whom had been arguing that general practice should be the first port of call for patients requiring urgent care services. Others complained of a lack of clarity about how differing costs between the various existing out-of-hours or urgent care providers would be rationalised and how the pressure on the local A&E service would be solved. As the review progressed there was a growing consensus that a single point of access using a telephone or online service was desirable, with patients triaged to the most appropriate service for their needs. Clearly, in this case, clinical leadership in the operational commissioning arena took the form of combining advocacy for more integrated and patient-centred services with arguing for the preservation of existing clinical services and the capabilities they had developed. The relatively early stage of service redesign in this case meant that there was no opportunity for us to study clinical leadership in operational delivery arenas – the initiative was not yet entering the stage of implementation. Features of clinical leadership from these two cases These two cases illustrate a well-developed pattern of clinical leadership in strategic and operational commissioning arenas, with mechanisms put in place to engage with clinicians in operational delivery roles. Although the latter mechanisms appear to have been problematic, this CCG illustrates some key features of clinical leadership in commissioning. Collaboration between clinical and non-clinical leaders The working relationships between clinicians and managers working within both strategic and operational commissioning arenas in this case study were built on high levels of trust and mutual respect. Clinical leadership was seen as not just desirable but a core defining characteristic of what made the CCG successful. A strong emphasis was placed on face-to-face meetings, and the conversational style in these meetings was informal and friendly. This enabled significant challenges and passionate debates to be voiced in ways that were usually not perceived to be threatening. And actually, bring an added level of vigour and rigour in relation to that process. Senior manager They also spoke explicitly about the ways in which clinical leaders had more traction with their colleagues than non-clinical managers. They tended to be effective at turning what might be perceived to be a managerial issue (such as a budget overspend) into a clinical one. Challenging established assumptions Many of the GPs in leadership roles in strategic and operational commissioning roles in this CCG had a long history of anti-establishment radicalism. They used this identity to differentiate themselves and thereby to create a strong ethos of common cause based on consistent principles. It appeared that they actually enjoyed challenging governmental authority and NHS bureaucracy. There was some evidence that clinicians were encouraging their managerial colleagues to also push back on directives from NHSE, empowering them to do what they thought was right rather than what they were told they must do. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals 67 provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. FINDINGS FROM THE CASE STUDIES They had started to question the medicalisation of the health service and were beginning to have discussions about how they might influence the broader determinants of health. The clinical leaders in the locality were much less interested in defining detailed care processes than they perceived non-clinical managers had been in the past, placing a strong emphasis on outcomes and leaving clinical teams to determine how to deliver them. Both the clinical and non-clinical leaders saw merit in the development of local networks of practices as ways to engage clinicians. Radical changes in ways of managing unacceptable performance and incentivising collective behaviours were introduced: You cannot federate unless you really seriously tackle the very poor performance. GP In another example of professionally led challenge, clinicians countered the threatened withdrawal of the Minimum Practice Income Guarantee funding for struggling practices, launching a high-profile public campaign to highlight the problems of government policy in this area, and this appeared to have been successful in securing additional resources. Indeed, the number of partnership-related initiatives in the CCG suggested a strong commitment to looking outside the boundaries of the CCG and of primary care. Much of this approach was driven by a strong clinical voice, supported by a robust strategy developed in partnership with non-clinical managers: I think what would be very powerful. We want to reduce our bed base, we want to get people out of hospital, but we can only do it if your primary care is up to scratch and you deliver it for us. Leadership roles among clinicians were therefore the norm, rather than the exception, and it is possible that this may be helpful in removing any suggestion of elitism among those who are appointed to formal leadership roles. Several informants described how their model of change would be difficult to replicate in other parts of the country which did not have a long history of focused effort.

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