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Cardiac Surgery Alone or in Combination with AADs or Catheter Ablation Restoration of 3 (181) RCT/Low Consistent Direct Precise SOE=High Sinus Rhythm OR 12 20mg cialis jelly for sale. Strength of evidence domains for rhythm-control procedures (continued) Domains Pertaining to SOE SOE and Number of Magnitude of Outcome Studies Risk of Consistency Directness Precision Effect (Subjects) Bias (95% CI) All-Cause 2 (88) RCT/Low Consistent Direct Imprecise SOE=Low Mortaltiy 2 studies showing no difference between groups CV Mortality 1 (97) RCT/ NA Direct Imprecise SOE=Insufficient Moderate Quality of Life 2 (229) RCT/Low Inconsistent Direct Imprecise SOE=Insufficient Stroke 2 (140) RCT/Low Consistent Direct Imprecise SOE=Low 2 studies showing no difference between groups Bleeding 1 (43) RCT/ NA Direct Imprecise SOE=Insufficient Events Moderate Abbreviations: AAD(s)=antiarrhythmic drug(s); AF=atrial fibrillation; CFAE=complex fractionated atrial electrogram; CI=confidence interval; CTI=cavotricuspid isthmus; CV=cardiovascular; NA=not applicable; OR=odds ratio; PV(s)=pulmonary vein(s); PVI=pulmonary vein isolation; RCT=randomized controlled trial; SOE=strength of evidence Table 21 cheap 20mg cialis jelly mastercard. Strength of evidence domains for pharmacological rhythm-control therapies Domains Pertaining to SOE SOE and Number of Magnitude of Outcome Studies Risk of Consistency Directness Precision Effect (Subjects) Bias (95% CI) Pharmacological Therapy in Which Electrical Cardioversion is a Key Component of the Treatment Maintenance of 1 (168) RCT/Low NA Direct Imprecise SOE=Insufficient Sinus Rhythm Recurrence of 4 (414) RCT/ Inconsistent Direct Imprecise SOE=Insufficient AF Moderate All-Cause 1 (168) RCT/Low NA Direct Imprecise SOE=Insufficient Mortality Quality of Life 1 (144) RCT/Low NA Direct Imprecise SOE=Insufficient Stroke 1 (168) RCT/Low NA Direct Imprecise SOE=Insufficient Comparison of Pharmacological Agents Maintenance of 9 (2,095) RCT/Low Consistent Direct Imprecise SOE=Low Sinus Rhythm Amiodarone appears better than sotalol, but no different from propafenone Recurrence of 10 (3,223) RCT/Low Inconsistent Direct Imprecise SOE=Low AF Amiodarone appears better than dronedarone or sotalol, but no different from propafenone All-Cause 5 (2,076) RCT/Low Inconsistent Direct Imprecise SOE=Insufficient Mortality CV Mortality 4 (1,664) RCT/Low Consistent Direct Imprecise SOE=Low No difference between study arms in arrhythmic deaths 95 Table 21. Strength of evidence domains for pharmacological rhythm-control therapies (continued) Domains Pertaining to SOE SOE and Number of Magnitude of Outcome Studies Risk of Consistency Directness Precision Effect (Subjects) Bias (95% CI) AF 1 (403) RCT/Low NA Direct Imprecise SOE=Low Hospitalizations Rate and mean length of stay of AF hospitalization were lower with amiodarone than with sotalol/ propafenone Control of AF 1 (403) RCT/Low NA Direct Imprecise SOE=Low Symptoms No difference between amiodarone versus sotalol or propafenone Quality of Life 2 (1,068) RCT/Low Consistent Direct Imprecise SOE=Low No significant difference in either study Stroke 2 (1,068) RCT/Low Inconsistent Direct Imprecise SOE=Insufficient Abbreviations: AF=atrial fibrillation; CI=confidence interval; CV=cardiovascular; NA=not applicable; RCT=randomized controlled trial; SOE=strength of evidence Key Question 6. Rate- Versus Rhythm-Control Therapies KQ 6: What are the comparative safety and effectiveness of rate-control therapies compared with rhythm-control therapies in patients with atrial fibrillation? Do the comparative safety and effectiveness of these therapies differ among specific patient subgroups of interest? Key Points • Based on evidence from 3 RCTs (2 good, 1 fair quality) involving 439 patients, pharmacological rate-control strategies with antiarrhythmic medications are superior to rhythm-control strategies in reducing cardiovascular hospitalizations (high strength of evidence). This 96 finding is based on evidence from 4 RCTs (2 good, 2 fair quality) involving 1,700 patients (low strength of evidence). Description of Included Studies A total of 14 RCTs were included in our analysis (Appendix Table F-6), 12 that explored a 155,156,159,295- rhythm-control strategy using pharmacological therapy versus a rate-control strategy, 303 and 2 that compared a rhythm-control strategy with PVI versus a rate-control strategy that 304 involved AVN ablation and implantation of a pacemaker in one case and rate-controlling 305 medications in the other (poor-quality) study. Eleven 155,156,159,295,296,299-302,304,305 298 included outpatients, one included inpatients, and two did not report 297,303 156,159,295-300,303,305 information on setting. Ten studies were conducted in Europe; one was 155 302 conducted in the United States and Canada only; one was conducted in Asia only; one was 301 conducted in the United States, Canada, South America, and Israel; and one did not report the 304 155,156,159,296,297,299-301,304 location. Nine studies were of good quality, three were of fair 295,298,302 303,305 quality, and two were of poor quality. The funding source was the government for 155,299,305 295,297,302 three studies, industry for three studies, government and industry for three 156,301,304 159,296,298,300,303 studies, and not reported for five studies. Studies enrolled patients between 305 155 1995 and 2009. The number of patients included ranged from 41 to 4,060 for a total of 302 7,556 patients across the 14 studies. The mean age of study participants ranged from 39 years 300 155,295,299,301,302 to 72 years. When reported, study duration varied from 2 years to 6 years. Duration of AF at 297 295 baseline ranged from 103 days to 3,285 days. Four studies included only patients with heart 300,301,304,305 155,156,159,295- failure. None of the remaining studies was limited to a special population. Six studies allowed different rate-controlling medications in the rate-control strategy (usually digoxin, beta blockers and calcium channel blockers), and different antiarrhythmic medications, along with electrical cardioversion when needed, in the rhythm-control strategy. The latter strategy restricts the use of some of these antiarrhythmic medications based on the presence of absence of structural heart 155,156,296,299,301,303 disease like heart failure and/or coronary artery disease. Two studies mandated AVN ablation and pacemaker as the rate-controlling strategy and allowed different 159,295 antiarrhythmic medications for rhythm control. In one of these two studies, AVN ablation with VVIR pacing was specified as the rate-control strategy, and AVN ablation with DDDR 159 pacing and use of antiarrhythmic medication was specified as the rhythm-control strategy. One study specified using amiodarone with or without electrical cardioversion in the rhythm-control 97 298 group versus digoxin or metoprolol in the rate-control group. One study specified using placebo versus amiodarone in the rhythm-control group, with or without cardioversion, and 302 diltiazem in the rate-control group. One study specified using digoxin or beta blockers in the rate-control group versus amiodarone with or without electrical cardioversion in the rhythm- 300 control group. One study compared PVI as the rhythm-control strategy with AVN ablation and 304 pacemaker as the rate-control strategy. Finally, one poor-quality study compared PVI as the 305 rhythm-control strategy versus rate-controlling medications. Detailed Synthesis Comparison 1: Rate-Control Strategy Versus Rhythm-Control Strategy Using Antiarrhythmic Drugs Quantitative Analysis This analysis addressed the comparative safety and effectiveness of a rate-control strategy versus a rhythm-control strategy using pharmacological agents. We identified 12 RCTs for this comparison, and the available data were deemed appropriate for meta-analysis for the following outcomes: maintenance of sinus rhythm, all-cause mortality, cardiovascular mortality, cardiovascular hospitalizations, heart failure symptoms, stroke, mixed embolic events including stroke, and bleeding events. Maintenance of Sinus Rhythm Seven studies representing 1,473 patients were included in our meta-analysis of maintenance 156,159,295,296,299,302,303 of sinus rhythm. Figure 19 shows that the OR of rate control versus rhythm control for maintenance of sinus rhythm was 0. There was evidence of heterogeneity; however, the demonstration of a benefit of rhythm-control strategies was consistent, and therefore this heterogeneity did not reduce the strength of evidence rating. Forest plot of maintenance of sinus rhythm for rate- versus rhythm-control strategies Study name Odds ratio and 95% CI Odds Lower Upper ratio limit limit Brignole, 2002 0. In one, ventricular rate control was significantly better in the rhythm-control group than in the rate-control group 156 (mean±SD, 79. In the other study, the mean heart rate in the resting state was significantly better during rhythm control (73±18 bpm) than during rate control (82±16 bpm) (low strength of evidence). All-Cause Mortality Eight studies representing 6,413 patients were included in our meta-analysis of all-cause 155,159,296,298,299,301-303 mortality. Figure 20 shows that the OR of rate control versus rhythm control for all-cause mortality was 1. In addition, 6 of the 8 studies had ORs that crossed 1, including 6,069 (95%) of the patients. We therefore assessed these eight studies as demonstrating comparable efficacy between rate and rhythm control strategies for all-cause mortality (moderate strength of evidence). Forest plot of all-cause mortality for rate- versus rhythm-control strategies Study name Statistics for each study Odds ratio and 95% CI Odds Lower Upper ratio l i mi t l i mi t Wyse, 2002 0. Figure 21 shows that the OR of rate control versus rhythm control for cardiac mortality was 0. Although the point estimates were inconsistent and confidence intervals wide for two of the included 296,299 studies, there was no evidence of heterogeneity, and therefore our strength of evidence rating was not lowered. Forest plot of cardiovascular mortality for rate- versus rhythm-control strategies Study name Odds ratio and 95% CI Odds Lower Upper ratio l imit l imit Van Gelder, 2002 1. This outcome was examined by only one other 159 study, which also showed no significant difference between rate control and rhythm control (5. The small number of studies and sample size resulted in a low strength of evidence rating. Cardiovascular Hospitalizations 159,295,296 A meta-analysis of three studies representing 439 patients found an OR of 0. Forest plot of cardiovascular hospitalizations for rate- versus rhythm-control strategies Study name Odds ratio and 95% CI Odds Lower Upper ratio limit limit Brignole, 2002 0. After 3 years of followup, AF hospitalizations were significantly higher in the rhythm-control group than in the rate-control group (14% vs. Heart Failure Symptoms Four studies representing 1,700 patients were included in our meta-analysis of the presence 159,295,301,302 or worsening of heart failure symptoms. Figure 23 shows that the OR of rate control versus rhythm control for presence or worsening of heart failure symptoms was 0. Forest plot of heart failure symptoms for rate- versus rhythm-control strategies Study name Odds ratio and 95% CI Odds Lower Upper ratio limit limit Brignole, 2002 0. Two of these studies demonstrated a statistically significant benefit of rhythm-control strategies on quality of life or functional status. None of the other studies demonstrated a significant difference between the two strategies. The variation in metrics and findings resulted in an insufficient strength of evidence rating for this outcome. Stroke Eight studies representing 6,424 patients were included in our meta-analysis of 155,159,295,296,298,299,301,303 stroke. Figure 24 shows that the OR of rate control versus rhythm control for stroke was 0.

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Another twin pair study mans (98) and in animal models (1 cialis jelly 20mg discount,62 generic cialis jelly 20mg visa,89). The fetal effects of nicotine may be (72% versus 28%). Genetic factors also appeared important greater during the later stages of pregnancy, a finding sug- for the appearance of alcohol dependence (55% versus gesting the first trimester is the most desirable period for 45%), consistent with a common genetic vulnerability and NRT during pregnancy. Based on the rat data, it may be showing that nicotine and alcohol dependence occur to- preferable to introduce NRTs early in pregnancy to try to gether (60). Environmental factors more strongly deter- reduce the fetal exposure to nicotine before the second or mined age of first use of tobacco and alcohol, whereas la- third trimester. In the rat models, episodic nicotine delivery, tency between first use and patterns of regular use were as happens with smoking, is associated with less nicotine more genetically determined (54). A major genetic influence exposure to the fetus than continuous exposure from a nico- accounting for about 70% of the variance in risk in a group tine patch. Of course, fetal exposure to tobacco smoke pre- of Vietnam era twin pairs is consistent with other studies sents a host of other toxins besides nicotine. Cognitive defi- Genetically determined dopamine receptor functional cits, behavioral problems in childhood, particularly atten- differences and genetic variation in hepatic enzyme activity tion-deficit/hyperactivity disorders, conduct disorders, and important in metabolizing nicotine suggest possible mecha- substance abuse in the exposed children are associated with nisms. Individuals with TaqIA alleles (A1 and A2) and maternal smoking. Children whose mothers smoked ten or TaqIB (B1 and B2) of the D2 dopamine receptor gene had more cigarettes daily during pregnancy had a fourfold in- earlier onset of smoking, smoked more, and made fewer creased risk of prepubertal-onset conduct disorder in boys attempts to quit (58). Specific gene mutations, including and a fivefold risk in adolescent-onset drug dependence in those associated with dopamine D2 receptors (23) and do- girls (98). The outcomes are not explained by other risk pamine transporter proteins (95), have been implicated as factors. Maternal prenatal smoking appeared to be related possible determinants for nicotine addiction. People lacking to future criminal behavior in male children, with a a fully functional genetically variable enzyme CYP2A6 im- dose–response relationship between intensity of third portant in the metabolism of nicotine to cotinine are slow trimester smoking and arrest history of 34-year-old men nicotine metabolizers (30). This genotype may be important whose mothers smoked during pregnancy (63). Although in protecting against tobacco dependence because of im- such studies are limited by retrospective maternal reports paired nicotine metabolism and may be important as well of smoking behaviors during pregnancy, there is a consis- in determining dose and response to NRTs. Tobacco and Nicotine Exposure During Pregnancy MANAGEMENT AND THERAPEUTICS OF In the United States, about 25% of pregnant women smoke NICOTINE ADDICTION cigarettes, and so each year about 1 million babies are ex- posed in utero to tobacco smoke (89). Within those countries, smokers Tobacco smoking has long been known to present consider- have the lowest income, are the least educated, and have able fetal risks (59). Less well appreciated is that nicotine the poorest access to health care. Thus, from a world view, itself is a neuroteratogen (89). Nicotine given to rats during cost of therapeutics and access become important considera- gestation or adolescence at levels assumed to be consistent tions. Prevention is obviously an important strategy, but with those in human smokers alters gene expression and strategies to prevent tobacco addiction must deal with a produces long-lasting central nervous system cellular dam- politically powerful and wealthy multinational industry pro- age, by reducing cell number and impairing synaptic activity moting use of tobacco (64). The tobacco industry in the and cell signaling (62). Developing brain cells appear partic- United States alone spent 6 billion dollars in 1998 to market ularly vulnerable. In adult rats, similar exposure stimulates cigarettes, about 18 million dollars each day. More is spent nicotinic cholinergic receptors without lasting cellular promoting tobacco use elsewhere in the world. Individual or group behavioral treatments appear Contemporaneous reviews of tobacco addiction thera- almost equally effective. Intensive treatment programs are peutics (59,70–73) and an extensive report on tobacco ad- effective in assisting even very dependent smokers to stop diction pharmacology and therapeutics from the Royal Col- for a few months. However, as with other addictions, relapse lege of Physicians (49) offered similar conclusions. Initial quitting rates of 50% to 60% summary review from the Cochrane Tobacco Addiction Re- at 1 month typically decrease to 20% to 30% at 1 year. Details of the 20 None has proven clearly effective. Most tobacco addicts re- systematic reviews are available on the Internet in the Coch- peat the quitting process on average every 3. The reviews used a similar strategy and three or four times before finally stopping forever (66). In reviewed much the same literature on tobacco addiction that respect, stopping smoking is similar to overcoming ad- therapeutics as did the Public Health Service review. Tobacco addiction The Cochrane reviews considered the results from ran- treatment programs are cost-effective. Average treatment domized controlled trials having at least 6 months of follow- costs per year of life saved are $1,000 to $2,000 per year up (91). Sustained abstinence or point prevalence quit rates for brief counseling alone and $2,000 to $4,000 per year were used in the metaanalysis as necessary. Simple advice of life saved with more intensive counseling and pharmaco- from physicians presented during routine care was studied therapy to aid in smoking cessation (34,67). Smoking cessa- in 31 trials that included 26,000 smokers in a variety of tion treatments are less costly per year of life saved than are clinical settings. Brief advice increased quit rate more than generally accepted therapies for hypertension, hypercholes- no advice (odds ratio, 1. Individual counseling was better than brief advice or usual care. Group therapy was more effective than self- Therapeutics: Clinical Guidelines help materials alone but not consistently better than inter- ventions with more personal contact. Self-help informa- Guidelines for treating tobacco dependence were published tional material and printed descriptions of behavioral strate- in 2000 by the United States Public Health Service (2,13). The detailed report resulted from critical review of approxi- mately 6,000 peer-reviewed articles on tobacco addiction therapeutics and 50 metaanalyses based on that literature Nicotine Replacement Therapeutics (69). NRT decreases the discomfort of nicotine withdrawal. The The major general conclusions were as follows: relatively stable brain nicotine levels resulting from NRT 1. Tobacco dependence is a chronic condition warranting should facilitate a desensitized state for some nicotinic cho- repeated treatment until abstinence is achieved. All are more desensitized than others, both nicotine agonistic tobacco users should be offered treatment. Clinicians and health care systems must institutionalize NRT. In a nicotine-induced desensitized state, norepineph- consistent identification, documentation, and treatment rine release normally stimulated by endogenous acetylcho- of every tobacco user at every visit. Every normally stimulated by endogenous acetylcholine could be tobacco user should be offered at least brief treatment. There is a strong relationship between the intensity of mood states in itself could be rewarding. In addition, some tobacco dependence counseling and effectiveness. Three types of counseling are especially effective: practi- ing cessation lapses is likely during NRT. However, the cal counseling, social support as a part of treatment, and mechanisms of NRT still remain uncertain because the in- social support outside of treatment. Five pharmacotherapies for tobacco dependence are ef- for ultimately stopping smoking (3). Even though with- fective: nicotine gum, nicotine inhaler, nicotine nasal drawal symptoms can be diminished by NRT, other mecha- spray, nicotine patch, and bupropion. At least one of nisms, learning coping skills, and replacing some of the these medications should be prescribed in the absence positive effects of nicotine are important as well. Tobacco dependence treatments are cost-effective when ing smokers to quit (70). Health insurance plans should include as a transdermal nicotine patches, nasal spray, and inhalers con- Chapter 107: Therapeutics for Nicotine Addiction 1539 cluded that NRT enhanced early cessation and reduced early quences of chronic nicotine exposure have similarities to relapse when compared with placebo (75,91). All products the effects of some antidepressants (16,52,84).

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This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed discount 20mg cialis jelly free shipping, the full report) may be included in professional journals 55 provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising generic cialis jelly 20 mg. 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 Patients were signposted to the hub by GPs from six GP practices. Users could also self-refer if they lived in the locality. Once initial contact was made with the hub they then underwent a triage process. This triage service was staffed on an alternating basis by individuals from one of the five spoke services. That there were five spoke services sharing the triage function (1 day a week each) was a result of the lack of funding and the abundance of goodwill to make the model work. There were disruptions in the sharing of data between spokes and inconsistencies in their approach to triage. These data were important because they were used to evaluate the success of the arrangement and, ultimately, whether or not it could be justifiably commissioned on a continuing basis. This indicates that, running alongside powerful clinical leadership in terms of vision, plans and advocacy, if a new service is to be maintained over the long run it also requires efficient and competent administrative and managerial support services. One of the organisations which offered one of the spoke services (the main mental health trust) eventually exhausted its goodwill and it withdrew its service. It was stated that the lack of funding was an obvious hindrance. However, additionally, the oversight and measurement regime proved to be too demanding. It was just impossible to make sure that every patient that came from the Hub. The point was to provide an alternative, even preventative, and holistic service for well-being, rather than treatment for mental health issues per se. In addition, from a strict commissioning perspective, its inclusion as a spoke was problematic if the hub was deemed successful enough to be a commissionable service because it could be viewed as a competitor. The CCG was widely seen to have been supportive of the hub throughout its development. Indeed, as our study at this site was concluding in late 2016, further funding was agreed to keep the service operating. In fact, there was an upgrade in that the central triage was to be staffed by a qualified psychotherapist. The new service was to be more holistic, 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.

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