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By L. Umul. Arizona State University. 2019.

The question for patients buy v-gel 30 gm low price herbals bestellen, clinicians buy v-gel 30gm with amex herbs thai bistro, scientists 30gm v-gel for sale herbals used for mood, and policy-makers is how the PCMH can be designed to address pain v-gel 30 gm on-line herbs to help sleep, the hallmark feature of SCD. This article provides a framework of pain management within the PCMH model. We present an overview of pain and pain management in SCD, gaps in pain management, and current care models used by patients and discuss core PCMH concepts and multidisciplinary team–based PCMH care strategies for SCD pain management. Pain is an the PCMH may vary depending on patient preference, patient proximity to providers, and access to hematologists. In 2011, the US Department of Health and Human on the health care system,9 quality of life,10 and lifelong productiv- Services designated SCD as a priority area, specifying that action ity. The estimated annual cost of medical care for the 70 000 was needed “to increase the availability of medical homes to 9 improve access to quality routine care. Although hydroxyurea may modulate underlying disease,11 it will implementation of PCMHs for individuals with SCD will be how not completely prevent SCD-related pain and carries its own set of this model of care can be effectively leveraged to improve pain considerations. Adults and children with SCD may seek care for pain management This article provides a framework of pain management within the in a variety of clinical care settings. First, we present an overview of pain and pain primary care providers with limited experience, ancillary support, management in SCD, gaps in pain management, and current care and time to manage SCD-related pain. Second, we present core PCMH concepts predominantly seek care in hospitals, where providers may be and discuss multidisciplinary team–based PCMH care strategies for emergency room (ER) physicians or hospitalists with varying SCD pain management. Care delivery initiatives, such as the establishment of day hospitals for acute SCD pain,13-15 have SCD-related pain syndromes provided adults and children with access to expert care and reduced Pain in SCD can be characterized as acute, chronic, neuropathic, or hospitalizations and length of stay. Acute pain may occur throughout the lifespan, presenting as improves the episodic nature of pain and does not address the unpredictable episodes of sharp and/or throbbing sensations with chronic, multidisciplinary challenges of SCD-related pain. Such centers provide diverse services and ongoing characterized as deep, achy, and persistent in nature, typically chronic disease management, including patient education, pain lasting 3 or more months in duration. However, the data on outcomes secondary to clear pathophysiologic events, including avascular are mixed and only a minority of adults and children with SCD have necrosis and leg ulcers, or may be the result of persistent or access to these centers or hematologists in general. Investigators postulate that chronic pain may The patient-centered medical home (PCMH) is emerging as the involve a process of central sensitization in which the pain threshold cornerstone of efforts to reform chronic disease management in the is decreased and hyperalgesia ensues. Neuropathic pain is also a US health care system and to transform primary care into a recognized form of pain attributable to SCD. It is characterized by centerpiece for improving health care quality. A minority of patients with adequate pain may be modulated by biological response, basic demographics, access are seen in comprehensive SCD centers. Patients may have a psychological factors, religious beliefs, culture, family responsibili- primary care provider with periodic referral to a hematologist. Other ties, occupation, and perceptions of disease severity. Recognizing individuals may receive episodic care primarily managed by a the important contribution of these factors enables clinicians to hematologist without a primary care provider. Individuals may also effectively tailor both pharmacologic and nonpharmacologic ap- have no primary care provider or regular hematologist coordinating proaches to pain management. Because there The PCMH is a widely endorsed delivery system innovation that is some support for the efficacy of these strategies, they offer 25,26 aims to redesign primary care as a centerpiece for integrated health patients proactive solutions to manage their pain. Pharmaco- care delivery, reduce care fragmentation, and decrease system logic management of SCD pain is composed of 3 major drug inefficiencies associated with chronic disease management in the classes: non-opioids, opioids, and adjuvants. The PCMH model proposes care that is accessible, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), continuous, patient centered, team based, and comprehensive, all in topical agents, and corticosteroids. Non-opioids are typically recom- 17 alignment with the patient’s family and community. NSAIDs in particular are effective at Principles were approved in 2007 by major primary care profes- relieving the inflammatory component of bone pain related to 32 sional organizations. The model has subsequently gained endorse- vasoocclusive episodes. Opioid analgesics consist of -antagonists, ment by specialty societies, all major national health plans, large mixed agonist/antagonists, and partial agonists. The Sickle Cell Disease Treat- cally used for moderate to severe pain or in situations where ment Demonstration Program (SCDTDP), which was created to NSAIDs are contraindicated. In a subset of patients, opioid therapy improve SCD management, also embraces many concepts of the can lead to dependence or addiction. Although most studies assessing the impact of the PCMH adults with SCD who demonstrate behavior consistent with sub- 27 on health outcomes have focused on heterogeneous populations, stance abuse is similar to that seen in the general population. Among adults Although addiction is a problem for a small subset of the SCD with diabetes, the PCMH has been shown to improve HgbA1C, population, a more pervasive concern is undermedication of those 28 blood pressure, and lipid control while lowering hospitalizations. Adjuvants act on excitatory neurotransmitters, Among adults with depression, implementation of a PCMH model inhibitory neurotransmitters, or neurotransmitters that modulate the has been associated with increased use of antidepressants and pain experience. Classes of psychotropic medications commonly psychotherapy, decreased depressive symptoms, and improved used in pain management consist of antidepressants, antiepileptic quality of life. Multiple actions at the federal level have increased the potential for Persistent gaps in pain management application of the PCMH model to individuals with SCD. The Over the past several years, the National Heart, Lung and Blood Affordable Care Act of 2010 set forth multiple provisions to Institute (NHLBI) has outlined a strategic plan to “… identify and increase access to primary care services. In 2011, the US Depart- understand the relationships of molecular events to pathophysi- 29 ment of Health and Human Services established a Sickle Cell ologic processes involved in vaso-occlusion. Despite the potential of the PCMH to improve Stroke (NINDS) to co-fund a request for application entitled chronic disease management, little is known about the extent to “Exploratory Studies in the Neurobiology of Pain in Sickle Cell which adults and children with SCD have PCMHs or whether Disease. NHLBI is also collaborating with the Clinical study assessed experience with PCMH care among children with and Translational Sciences Awards (CTSA) Pain Researchers 35 SCD. In this study, only 11% of children met the standards for Interest Group (CPRIG) to design and implement new clinical receiving care in a PCMH. Although 90% of children had a strategies to manage SCD-related pain. Lastly, the NHLBI will regular provider, they experienced deficiencies in multiple aspects shortly release new evidence-based guidelines for the management of care: comprehensive care (67%), family-centered care (59%), of SCD with pain management being a major focus. A related study demonstrated that children with SCD who experienced comprehensive care had lower Although there is increasing prioritization of molecular and transla- rates of ER encounters and hospitalizations compared with those tional research to address SCD-related pain, strategies to improve 36 who did not experience comprehensive care. Current literature documents deficiencies in pain man- agement and patient centeredness. Such a system may equate follow-up as major concerns. The PCMH resource Variable access to providers and shortages in hematologists in adult organization, TransforMED,37 has developed a detailed model of practice indicate that new models of care are needed to address the PCMH implementation. Currently, adults framework to model SCD pain management. Because multiple 434 American Society of Hematology Table 1. Application of the PCMH model to pain management PCMH element SCD pain management strategy Access to care and information Same-day appointments Same day appointments for early pain symptoms After-hours access coverage Extended office hours to prevent delays in care or avoidable emergency care use Phone triage to facilitate home pain management Accessible patient and laboratory information; online Online resources provided for nonpharmacologic pain management patient services Electronic visits Telehealth visits for pain management Group visits Interactive visits for coping with pain Practice-based services Comprehensive care for acute/chronic conditions Multidisciplinary approach to pain management Prevention screening and services Routine screening for precipitators of pain Ancillary therapeutic and support services Increased use of physicians assistants, nurse practitioners, and registered nurses for care Care management Population management Creation of SCD registry for practice site Wellness promotion Creation of clinical dashboards for SCD Patient engagement/education Distribution of hardcopy and online resources Leverage of automated technologies Routine reporting on pain-related outpatient visits, ER use, and hospitalizations Care coordination Community-based resources Connection with community pain support groups, therapy, patient forums Collaborative relationships with ER, hospitals, specialists, Individualized pain management plan has input from multiple providers pharmacies, physical therapy, case management Individualized pain management plan maintained across different sites of care Care transition Active involvement of outpatient team in discharge planning from ER, hospitalization Practice-based care team Clinician-led multidisciplinary team Inclusion of physicians assistants, nurse practitioners, registered nurses, social workers, child life specialists, psychologists on care team Shared mission and vision Active patient engagement on pain management Effective communication Multiple means for patient to communicate with team (in-person, telephone, texting, email) Task designation by skill set Tasks are delegated to team members with appropriate expertise Families made aware of which team members are responsible for specific tasks related to pain management AdaptedwithpermissionfromtheTransforMedPatientCenteredModel,availablefrom:http://www. Nonphysician providers may serve as the first line of proactive pain management through outpatient visits and telephone communica- Access to care and information tion. They may encourage and teach self-management skills, To prevent unnecessary delays in care and avoidable high-acuity including nonpharmacologic methods of pain reduction, stress health care utilization, patients must have appropriate access to management, and coping. They may also aid patients in identifying outpatient care. Patient-centered strategies to improve access to care precipitators of pain. In the PCMH model, nonphysicians in must include same-day appointments and extended office hours.

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The Japanese patients were shown to have improved quality of life in both groups; no such analysis was undertaken for the Korean patients purchase 30gm v-gel otc herbs plants. Flavoxate buy v-gel 30gm with mastercard herbals for hair loss, scopolamine cheap 30gm v-gel otc potters 150ml herbal cough remover, and hyoscyamine • Head-to-head comparisons with flavoxate were poor quality and there were no head-to- head comparisons of scopolamine purchase v-gel 30gm without a prescription herbals and supplements, or hyoscyamine to another drug for OAB. Overactive bladder Page 15 of 73 Final Report Update 4 Drug Effectiveness Review Project Detailed Assessment We found no effectiveness trials of drugs for overactive bladder syndrome. The included trials assessed outcome measures related to efficacy and the trials were primarily short (8-12 weeks). Most of the randomized trials had fair internal validity but their applicability to community practice was difficult to determine. The studies generally excluded patients who would have been at risk of serious adverse events from anticholinergic drugs. Most of the treatment and control groups received standard doses of anticholinergic drugs but some studies compared doses at the higher end of the range of one drug with the lower end of the range of another. Of studies that stated their source of funding, all were funded by the pharmaceutical industry and industry employees often served as coauthors. While several fair- and good-quality systematic reviews examined aspects of treating patients with overactive bladder, only a few directly examined the questions posed here. We include the results of only 2 published systematic reviews in the sections below. One is a good- quality 2005 Cochrane review focused on comparing the effects of different anticholinergic drugs for overactive bladder syndrome using randomized controlled trials that compared 1 15 anticholinergic drug to another or 2 different doses of the same drug. The other was a fair- quality systematic review of the differences in tolerability, safety, and efficacy between 16 oxybutynin, tolterodine, trospium, darifenacin, and solifenacin. Both of these reviews have 16 17 15, 16 been updated since their original publications; here we use only the most recent versions. Three other reviews address questions similar to ours but these results are not discussed below because they do not address the question of comparative effectiveness and harms. The first is a 2008 broad systematic review of nonsurgical treatments for urinary incontinence in women. Oxybutynin immediate-release and tolterodine extended-release were compared to placebo, but 18 conclusions could not be drawn about the comparison. Another is more than 5 years old and as 19 a result includes almost exclusively placebo-controlled trials. Finally, a systematic review of anticholinergic drugs in patients with lower urinary tract symptoms suggestive of overactive 20 bladder and bladder outlet obstruction includes drugs and study designs not included here. For adult patients with urinary urge incontinence/overactive bladder, do anticholinergic drugs differ in effectiveness? We found 28 head-to-head trials of oxybutynin, tolterodine, trospium, flavoxate, solifenacin, 21-48 and/or darifenacin. All included studies and their respective post hoc analyses are summarized in Evidence Table 1. Quality assessments of the studies are presented in Evidence Table 2. One study comparing oxybutynin immediate-release 33 and tolterodine immediate-release, 2 studies comparing oxybutynin immediate- and extended- 41, 42 40, 48 release, and the only 2 flavoxate studies were assessed as poor-quality, and all others were fair-quality. The poor-quality studies suffered from lack of detail about randomization, allocation concealment, and baseline characteristics; lack of randomization; and differences in potentially important baseline characteristics. Eleven studies used an intention-to-treat analysis overall and 3 studies used an intention-to-treat analysis for adverse events, but not for efficacy. The poor-quality studies are not discussed here (see Evidence Tables 1 and 2). Since no fair- or good-quality head-to-head study of flavoxate was found, no results are presented for that drug. Overactive bladder Page 16 of 73 Final Report Update 4 Drug Effectiveness Review Project The included studies had similar eligibility and exclusion criteria, largely enrolling patients with urge incontinence. One trial involving trospium and oxybutynin included only 39 patients with a spinal cord injury. Some studies enrolled patients with combined stress and urge incontinence, with symptoms of urge predominant. The studies enrolled significantly more women than men, and although the age ranges of enrolled patients were wide, the mean age for most studies was approaching 60 years. These gender and age trends reflect the typical characteristics of the population with urge incontinence. Ten of 17 fair-quality studies were conducted at least in part in the US, while the others were conducted primarily in European countries, except for a few that were conducted in Asia and Canada. We found 6 fair-quality studies comparing an immediate-release formulation of one 21, 34, 37-39, 49 anticholinergic overactive bladder syndrome drug to another. Four of these studies compared oxybutynin to tolterodine and all were sponsored by Pharmacia, the maker of tolterodine. Tolterodine was dosed at 2 mg twice daily in all studies while oxybutynin was dosed 37, 38 21, 49 at 5 mg twice daily in 2 studies and 5 mg 3 times daily in 2 studies. Two studies compared immediate-release formulations of oxybutynin to trospium. One trial was sponsored by a company that makes trospium while the other did not report sponsorship. Two studies comparing extended-release formulations of oxybutynin and tolterodine 31, 44 were found. The OPERA trial enrolled 790 women to take either tolterodine extended- 31 release 4 mg or oxybutynin extended-release 10 mg daily for 12 weeks. The manufacturer of oxybutynin extended-release provided the funding for this study. In the second study, the ACET 44 trial, oxybutynin was dosed at 5 to 10 mg once daily and tolterodine at 2 to 4 mg once daily. The study design was unusual and problematic in that it consisted of 2 separate trials. One trial randomized patients to 1 of 2 doses of tolterodine in an open label (unblinded) fashion. The other randomized patients to 1 of 2 doses of oxybutynin. Other than the 2 drugs, the same protocol was used at each center. However, the choice of which trial (drug) each center was assigned appears to have been at the discretion of the investigators. Therefore, this cannot be considered a purely randomized trial. The authors state that centers were assigned based on geographic location and prescribing patterns for both drugs, with an effort to produce balance. The transdermal form of oxybutynin, which received US Food and Drug Administration approval in late February 2003, was studied compared to oxybutynin immediate-release and 30, 32 tolterodine extended-release in separate studies. The study of oxybutynin transdermal compared with oxybutynin oral immediate-release allowed dose titration via patch from 1. The other study randomized patients to oxybutynin transdermal 3. The manufacturer of the oxybutynin transdermal system funded both studies. Two studies comparing trospium chloride with oxybutynin immediate-release were found. The first trial conducted in multiple German centers compared trospium 20 mg twice daily (plus a mid-day placebo dose) to oxybutynin immediate-release 5 mg 3 times daily.

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NCS Page 15 of 71 Final Report Update 1 Drug Effectiveness Review Project Table 4 cheap 30 gm v-gel with mastercard herbs de provence substitute. Seasonal allergic rhinitis trial characteristics Trial Eligibility criteria Allowed concomitant treatments Symptom severity 24-month Positive skin prick scores history test Antihistamines Immunotherapy Kaiser generic 30 gm v-gel mastercard zigma herbals, 2004 TNSS • 42 ¥ ¥ Gross buy cheap v-gel 30 gm on line herbals for hair growth, 2002 TNSS • 42 ¥ ¥ ¥ Ratner generic v-gel 30gm fast delivery 3-1 herbals letter draft, 1992 INSS • 200 ¥ ¥ ¥ a Graft, 1996 TNSS ” 2 ¥ ¥ ¥ McArthur, 1994 ¥ Langrick, 1984 ¥ Ratner, 1996 TSS = 2-7 ¥ ¥ ¥ ¥ Welsh, 1987 ¥ ¥ ¥ ¥ Stern, 1997 ¥ ¥ ¥ Greenbaum, 1988 ¥ ¥ ¥ TSS • 6; congestion • 2 Hebert, 1996 + one other ¥ ¥ ¥ ¥ symptom (INSS) Lumry, 2003 RIS • 24 ¥ ¥ ¥ ¥ Small, 1997 RIS • 24 ¥ ¥ ¥ LaForce, 1994 INSS • 200 ¥ ¥ Bronsky, 1987 EENT • 8 ¥ ¥ a Prophylaxis trial TNSS=Total Nasal Symptom Score; INSS=Individual Nasal Symptom Score; TSS=Total Symptom Score; RIS=Rhinitis Index Score; EENT=Eye, Ear, Nose & Throat Noseasonalallergicrhinitistrial was rated good quality. The only trial rated poor, Greenbaum 1988, suffered from multiple flaws including inadequately described randomization and allocation concealment methods, a complete lack of inclusion criteria and reporting of baseline demographics, and excluded a number of patients 24 from the outcome assessment. The majority of the trials were sponsored by the pharmaceutical 20 24, 26, 29 industry. Sponsor information was not reported in 1 trial and 3 trials did not acknowledge receiving funding but had authors employed by pharmaceutical companies. No head-to-head trials in seasonal allergic rhinitis patients of the new drugs included in this update, ciclesonide and fluticasone furoate were identified through searches. One unpublished abstract of a head-to-head trial of fluticasone furoate 110 mcg/day compared with fluticasone 200 mcg/day provided by the manufacturer of fluticasone furoate suggested that 30 fluticasone furoate was non-inferior to fluticasone in terms of efficacy and safety. A published, peer reviewed report of these findings was not identified through literature searches, therefore these results should be considered inconclusive. Results oftrials oftreatment in adults with seasonal allergic rhinitis 1. Direct comparisons Similar proportions of patients experienced significant global improvements in rhinitis symptoms after 3 to 7 weeks of treatment based on physician assessment in head-to-head trials of nasal corticosteroids (Table 5). Physician assessment of global improvement was the most commonly reported outcome, was defined differently across trials, and was generally based on NCS Page 16 of 71 Final Report Update 1 Drug Effectiveness Review Project patient diary ratings (0=none; 3=severe) of nasal symptom severity of rhinorrhea, stuffiness/congestion, nasal itching, and sneezing. The lowest rates of patient improvement were observed in a 7-week trial of flunisolide 200 mcg 20 compared with beclomethasone 400 mcg (29% compared with 34%, NS). Reasons for why the rates in this trial differed from the others may have been that the mean age was noticeably higher at 66. Rates of patient improvement were also quite low in the only trial to 26 prohibit concomitant usage of both antihistamines and immunotherapy. The third lowest patient improvement rates came from the trial with the shortest treatment period of only 2 weeks. Patient improvement rates may have been lower in this trial because the treatments may not have 16 reached their maximum effect within that time. Only 2 trials pre-specified a primary outcome measure, which was the mean change in 14, 15 composite rhinitis symptom score. Measurement of change in composite symptom scores was also the second most commonly reported outcome; however, these were defined differently across trials (Table 5). There were no significant differences between any 2 nasal corticosteroids 13-15, 17, 19, 21-23, 29 in any of the trials that reported these outcomes for the treatment periods overall. Therewasadifferencein1trialwhenprimary outcome scores were analyzed only on 3 14 days when the pollen count was greater than 10 grains/m. Results of this trial demonstrated that budesonide 256 mcg per day was superior in reducing combined symptom scores, as well as the individual scores for sneezing and runny nose when compared to fluticasone 200 mcg and 14 budesonide 128 mcg daily. Rhinitis symptom assessment outcomes in adults with seasonal allergic rhinitis Study Age Physician-rated global Sample size % evaluation of % Change in total Trial duration female Treatment A Treatment B improvement (% pts) symptom score McArthur, 1994 27 Noticeably, very or total Budesonide Beclomethasone N=77 years effective: 85% compared NR 200 mcg 200 mcg 3 weeks 51% with 82%, NS Langrick, 1984 66. RQLQ items are organized into 7 dimensions (activities, emotions, eye symptoms, nasal symptoms, non-hay fever problems, practical problems, and sleep) and each are rated using a 7-point Likert Scale (0 to 6; lower scores indicate better QOL). Triamcinolone AQ 220 mcg was associated with similar mean 19 reductions in RQLQ total score after 3 weeks relative to beclomethasone and fluticasone (Table 23, 27 6). NCS Page 18 of 71 Final Report Update 1 Drug Effectiveness Review Project Table 6. Mean change in RQLQ total score Study Sample size Age Trial duration % female Treatments Point reductions Lumry, 2003 Triamcinolone AQ 220 mcg 37 years N=147 compared with beclomethasone 336 -1. Out of those 9 trials, only 5 reported the raw data for comparison of numerical reduction in symptom severity and no differences between nasal corticosteroids were 13, 14, 17, 19, 26 reported. When the reduction in eye symptoms is compared to the reduction for other symptoms of seasonal allergic rhinitis in these head-to-head trials it tends to be less dramatic. Indirect comparisons As no published head-to-head trials were identified through searches, the evidence on the effectiveness of ciclesonide and fluticasone furoate in seasonal allergic rhinitis patients is limited to placebo-controlled trials. Two trials comparing ciclesonide 200 µg/day to placebo had similar patient populations 31, 32 and primary outcomes (Table 7 and Evidence Table 1a). In both trials, ciclesonide 200 µg/day was associated with a significant improvement in morning and evening reflective TNSS relative to placebo. The sole trial that included other doses (25, 50, and 100 µg/day) of ciclesonide found it to be significantly more effective than placebo in improving TNSS only at 31 the 100 µg/day dose. Physician-rated evaluation of symptom improvement was reported qualitatively in 1 trial and quantitatively in the other; both found that ciclesonide appeared to be associated with some symptom improvement when compared to placebo. Patients taking ciclesonide experienced a mean change in RQLQ score of -1. However, at 2 weeks, RQLQ was significantly better with ciclesonide use relative to placebo (P=0. An additional small, short-term (7 day) placebo-controlled crossover trial in 24 asymptomatic seasonal allergic rhinitis patients comparing the effect on nasal symptoms following intranasal administration of pollen extracts found that there was less immediate nasal 33 irritation (itching, rhinorrhea) following ciclesonide use relative to placebo. NCS Page 19 of 71 Final Report Update 1 Drug Effectiveness Review Project Table 7. Efficacy outcomes in trials of ciclesonide compared with placebo Study Change from baseline in Physician-rated Sample size Mean age total symptom score global evaluation Change in RQLQ; a Duration % female Interventions (TNSS) of improvement point reductions Ciclesonide 25 µg/day: -4. Ratner 2006a used the sum of morning and evening scores as a baseline measurement, while Ratner 2006b used the mean of morning and evening scores as a baseline measurement. Evidenceregardingtheefficacyoffluticasonefuroate in seasonal allergic rhinitis patients 34-36 comes from 3 well-designed placebo-controlled trials. In the 3 trials, fluticasone furoate was significantly better than placebo at ameliorating the nasal and ocular symptoms associated with seasonal allergic rhinitis based on reflective TNSS and TOSS and in improving RQLQ scores (Evidence Table 1a; Table 8). NCS Page 20 of 71 Final Report Update 1 Drug Effectiveness Review Project Table 8. Efficacy outcomes in trials of fluticasone furoate compared with placebo Study Proportion of Sample size Change from Change from patients reporting Duration baseline in total baseline in total improvement in Change Mean age symptom score ocular symptom overall response to (improvement) in % female Interventions (TNSS) score (TOSS) therapy RQLQ Fokkens, 2007 Fluticasone Fluticasone furoate - Fluticasone furoate - Fluticasone furoate Fluticasone furoate N= 285 furoate 100 4. Results of prophylaxis trials in adults with seasonal allergic rhinitis Mometasone was associated with significantly lower levels of rhinitis symptom severity in the peak- and pre-seasons relative to beclomethasone in the only head-to-head trial of seasonal allergic rhinitis prophylaxis. This double-blind, parallel-group trial was conducted throughout 9 centers in the United States for adult and adolescent patients ranging in age from 12 to 69 years 25 of age. The patients were required to be free of symptoms (nasal and non-nasal) at the baseline visit in order to be randomized to receive either beclomethasone 168 mcg twice daily or mometasone 200 mcg once daily plus placebo in the evening for 8 weeks. The patients in this trial starting taking the nasal corticosteroids, on average, 23 days before the onset of ragweed season and recorded the severity of their symptoms twice daily in a diary. A physician evaluated the severity of the patient’s symptoms at screening, day 1 (baseline), and days 8, 22, 29, 36, 50, and 57. The patients in the mometasone and beclomethasone groups had comparable severity scores at baseline; however, the mometasone group had a lower mean nasal symptom score from baseline to the start of the season when compared to beclomethasone treated patients. This is significant because the patients started taking the medication before the start of pollen season, so the mometasone may have conferred some early benefit for patients. The authors concluded that the proportion of minimal symptom days (total nasal symptom score ” 2) were similar between treatment groups at all time points assessed. NCS Page 21 of 71 Final Report Update 1 Drug Effectiveness Review Project II. Direct comparisons Physician-rated total nasal symptom score reductions were similar for mometasone and beclomethasone after 4 weeks in the only head-to-head trial of children with seasonal allergic 37 rhinitis (N=679) (Evidence Tables 1 and 2).

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The question for patients purchase 30gm v-gel with amex herbs to grow indoors, clinicians discount v-gel 30gm visa herbals for horses, scientists order v-gel 30 gm with amex neem himalaya herbals 60 kapsuliu, and policy-makers is how the PCMH can be designed to address pain 30gm v-gel mastercard herbs used for anxiety, the hallmark feature of SCD. This article provides a framework of pain management within the PCMH model. We present an overview of pain and pain management in SCD, gaps in pain management, and current care models used by patients and discuss core PCMH concepts and multidisciplinary team–based PCMH care strategies for SCD pain management. Pain is an the PCMH may vary depending on patient preference, patient proximity to providers, and access to hematologists. In 2011, the US Department of Health and Human on the health care system,9 quality of life,10 and lifelong productiv- Services designated SCD as a priority area, specifying that action ity. The estimated annual cost of medical care for the 70 000 was needed “to increase the availability of medical homes to 9 improve access to quality routine care. Although hydroxyurea may modulate underlying disease,11 it will implementation of PCMHs for individuals with SCD will be how not completely prevent SCD-related pain and carries its own set of this model of care can be effectively leveraged to improve pain considerations. Adults and children with SCD may seek care for pain management This article provides a framework of pain management within the in a variety of clinical care settings. First, we present an overview of pain and pain primary care providers with limited experience, ancillary support, management in SCD, gaps in pain management, and current care and time to manage SCD-related pain. Second, we present core PCMH concepts predominantly seek care in hospitals, where providers may be and discuss multidisciplinary team–based PCMH care strategies for emergency room (ER) physicians or hospitalists with varying SCD pain management. Care delivery initiatives, such as the establishment of day hospitals for acute SCD pain,13-15 have SCD-related pain syndromes provided adults and children with access to expert care and reduced Pain in SCD can be characterized as acute, chronic, neuropathic, or hospitalizations and length of stay. Acute pain may occur throughout the lifespan, presenting as improves the episodic nature of pain and does not address the unpredictable episodes of sharp and/or throbbing sensations with chronic, multidisciplinary challenges of SCD-related pain. Such centers provide diverse services and ongoing characterized as deep, achy, and persistent in nature, typically chronic disease management, including patient education, pain lasting 3 or more months in duration. However, the data on outcomes secondary to clear pathophysiologic events, including avascular are mixed and only a minority of adults and children with SCD have necrosis and leg ulcers, or may be the result of persistent or access to these centers or hematologists in general. Investigators postulate that chronic pain may The patient-centered medical home (PCMH) is emerging as the involve a process of central sensitization in which the pain threshold cornerstone of efforts to reform chronic disease management in the is decreased and hyperalgesia ensues. Neuropathic pain is also a US health care system and to transform primary care into a recognized form of pain attributable to SCD. It is characterized by centerpiece for improving health care quality. A minority of patients with adequate pain may be modulated by biological response, basic demographics, access are seen in comprehensive SCD centers. Patients may have a psychological factors, religious beliefs, culture, family responsibili- primary care provider with periodic referral to a hematologist. Other ties, occupation, and perceptions of disease severity. Recognizing individuals may receive episodic care primarily managed by a the important contribution of these factors enables clinicians to hematologist without a primary care provider. Individuals may also effectively tailor both pharmacologic and nonpharmacologic ap- have no primary care provider or regular hematologist coordinating proaches to pain management. Because there The PCMH is a widely endorsed delivery system innovation that is some support for the efficacy of these strategies, they offer 25,26 aims to redesign primary care as a centerpiece for integrated health patients proactive solutions to manage their pain. Pharmaco- care delivery, reduce care fragmentation, and decrease system logic management of SCD pain is composed of 3 major drug inefficiencies associated with chronic disease management in the classes: non-opioids, opioids, and adjuvants. The PCMH model proposes care that is accessible, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), continuous, patient centered, team based, and comprehensive, all in topical agents, and corticosteroids. Non-opioids are typically recom- 17 alignment with the patient’s family and community. NSAIDs in particular are effective at Principles were approved in 2007 by major primary care profes- relieving the inflammatory component of bone pain related to 32 sional organizations. The model has subsequently gained endorse- vasoocclusive episodes. Opioid analgesics consist of -antagonists, ment by specialty societies, all major national health plans, large mixed agonist/antagonists, and partial agonists. The Sickle Cell Disease Treat- cally used for moderate to severe pain or in situations where ment Demonstration Program (SCDTDP), which was created to NSAIDs are contraindicated. In a subset of patients, opioid therapy improve SCD management, also embraces many concepts of the can lead to dependence or addiction. Although most studies assessing the impact of the PCMH adults with SCD who demonstrate behavior consistent with sub- 27 on health outcomes have focused on heterogeneous populations, stance abuse is similar to that seen in the general population. Among adults Although addiction is a problem for a small subset of the SCD with diabetes, the PCMH has been shown to improve HgbA1C, population, a more pervasive concern is undermedication of those 28 blood pressure, and lipid control while lowering hospitalizations. Adjuvants act on excitatory neurotransmitters, Among adults with depression, implementation of a PCMH model inhibitory neurotransmitters, or neurotransmitters that modulate the has been associated with increased use of antidepressants and pain experience. Classes of psychotropic medications commonly psychotherapy, decreased depressive symptoms, and improved used in pain management consist of antidepressants, antiepileptic quality of life. Multiple actions at the federal level have increased the potential for Persistent gaps in pain management application of the PCMH model to individuals with SCD. The Over the past several years, the National Heart, Lung and Blood Affordable Care Act of 2010 set forth multiple provisions to Institute (NHLBI) has outlined a strategic plan to “… identify and increase access to primary care services. In 2011, the US Depart- understand the relationships of molecular events to pathophysi- 29 ment of Health and Human Services established a Sickle Cell ologic processes involved in vaso-occlusion. Despite the potential of the PCMH to improve Stroke (NINDS) to co-fund a request for application entitled chronic disease management, little is known about the extent to “Exploratory Studies in the Neurobiology of Pain in Sickle Cell which adults and children with SCD have PCMHs or whether Disease. NHLBI is also collaborating with the Clinical study assessed experience with PCMH care among children with and Translational Sciences Awards (CTSA) Pain Researchers 35 SCD. In this study, only 11% of children met the standards for Interest Group (CPRIG) to design and implement new clinical receiving care in a PCMH. Although 90% of children had a strategies to manage SCD-related pain. Lastly, the NHLBI will regular provider, they experienced deficiencies in multiple aspects shortly release new evidence-based guidelines for the management of care: comprehensive care (67%), family-centered care (59%), of SCD with pain management being a major focus. A related study demonstrated that children with SCD who experienced comprehensive care had lower Although there is increasing prioritization of molecular and transla- rates of ER encounters and hospitalizations compared with those tional research to address SCD-related pain, strategies to improve 36 who did not experience comprehensive care. Current literature documents deficiencies in pain man- agement and patient centeredness. Such a system may equate follow-up as major concerns. The PCMH resource Variable access to providers and shortages in hematologists in adult organization, TransforMED,37 has developed a detailed model of practice indicate that new models of care are needed to address the PCMH implementation. Currently, adults framework to model SCD pain management. Because multiple 434 American Society of Hematology Table 1. Application of the PCMH model to pain management PCMH element SCD pain management strategy Access to care and information Same-day appointments Same day appointments for early pain symptoms After-hours access coverage Extended office hours to prevent delays in care or avoidable emergency care use Phone triage to facilitate home pain management Accessible patient and laboratory information; online Online resources provided for nonpharmacologic pain management patient services Electronic visits Telehealth visits for pain management Group visits Interactive visits for coping with pain Practice-based services Comprehensive care for acute/chronic conditions Multidisciplinary approach to pain management Prevention screening and services Routine screening for precipitators of pain Ancillary therapeutic and support services Increased use of physicians assistants, nurse practitioners, and registered nurses for care Care management Population management Creation of SCD registry for practice site Wellness promotion Creation of clinical dashboards for SCD Patient engagement/education Distribution of hardcopy and online resources Leverage of automated technologies Routine reporting on pain-related outpatient visits, ER use, and hospitalizations Care coordination Community-based resources Connection with community pain support groups, therapy, patient forums Collaborative relationships with ER, hospitals, specialists, Individualized pain management plan has input from multiple providers pharmacies, physical therapy, case management Individualized pain management plan maintained across different sites of care Care transition Active involvement of outpatient team in discharge planning from ER, hospitalization Practice-based care team Clinician-led multidisciplinary team Inclusion of physicians assistants, nurse practitioners, registered nurses, social workers, child life specialists, psychologists on care team Shared mission and vision Active patient engagement on pain management Effective communication Multiple means for patient to communicate with team (in-person, telephone, texting, email) Task designation by skill set Tasks are delegated to team members with appropriate expertise Families made aware of which team members are responsible for specific tasks related to pain management AdaptedwithpermissionfromtheTransforMedPatientCenteredModel,availablefrom:http://www. Nonphysician providers may serve as the first line of proactive pain management through outpatient visits and telephone communica- Access to care and information tion. They may encourage and teach self-management skills, To prevent unnecessary delays in care and avoidable high-acuity including nonpharmacologic methods of pain reduction, stress health care utilization, patients must have appropriate access to management, and coping. They may also aid patients in identifying outpatient care. Patient-centered strategies to improve access to care precipitators of pain.

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Virological response: <1000 copies/ml (Grabar 2000) or <500 copies/ml (Moore 2005) or <50 copies (Tan 2008) Therapies can be virologically successful without immunological improvement; despite undetectable viral load purchase v-gel 30gm herbs los gatos, CD4 T cell counts remain low (Piketty 1998 30 gm v-gel with amex herbals in your mouth, Grabar 2000 v-gel 30gm without a prescription wtf herbals, Moore 2005 buy 30 gm v-gel visa equine herbals, Tan 2007). Conversely, ART may be extremely effective immuno- logically and induce significant increases in the CD4 T cell count, while viral load remains detectable. Although therapies have constantly improved, discordant responses appear in one fourth of all treatment-naïve patients. Goals and principles of therapy 149 groups showing virological success but little immunological improvement, it is often not clear how to continue therapy. Mortality seems to be slightly higher in this patient group, but has not been related to AIDS diseases (Gilson 2010). If there is any increase of AIDS incidence in the setting of discordant response, this is restricted to the first six months (Zoufaly 2011). Different CD4 T cell response kinetics are shown in Figures 1a-1d. The risk factors for a lack of immunologic response can often not be influenced and are also heterogenic (Review: Aiuti 2006). Low CD4 counts at baseline, as well as a low viral load at treatment initiation are only two factors (Florence 2003, Kaufmann 2005, Moore 2005, Kelley 2009). In older patients, immuno- logic response is often only moderate, mainly due to thymic degeneration (Lederman 2000, Grabar 2004). Various studies have demonstrated that the probability of not achieving a rise in CD4 count increases with patient age and with progressive decrease in thymus size as detected by CT (Goetz 2001, Piketty 2001, Teixera 2001). Regulatory T cells (Tregs) may also play a role (Saison 2014). Other possible causes for a lack of immunological response, despite good viral sup- pression, may be immuno- or myelosuppressive concomitant therapies. We have seen patients with less than 50 CD4 T cells/µl for more than a decade, despite viro- logical suppression. A significant immune reconstitution only set in after removing prophylaxis with ganciclovir or cotrimoxazole. Other causes may be autoimmune diseases (Crohn’s disease, lupus erythematosus) or liver cirrhosis. Figures 1a-d: CD4 T cells over years in four selected patients on ART. In all of them, HIV RNA remained fully suppressed for years. The dark line indicates the absolute CD4 T cells/μl (primary axis left), the grey line the relative CD4 T cells % (secondary axis right). Of note, the relative CD4 T cells show a slow increase. It remains questionable if this plateau truly represents his individual ranges prior to HIV infection. Note the broad intraindividual ranges of both the absolute and relative T cells 150 ART However, there is some evidence that certain antiretroviral regimens have unfavor- able effects on immune reconstitution. Significant drops in CD4 T cell count were observed in patients with a suppressed viremia who switched to a simplified regimen of TDF+ddI plus nevirapine (Negredo 2004). The reason for this is still not under- stood, but seems to be related to negative interactions between ddI and tenofovir. Where possible, this combination should be avoided, especially in primary therapy. In two other studies, the CD4 T cell increase with abacavir+3TC or TDF+FTC was significantly better than with AZT+3TC (all combined with efavirenz), despite com- parable virological success. This may be related to the myelotoxicity of AZT (DeJesus 2004, Pozniak 2006). In the Swiss cohort, patients on an AZT-containing regimen had 60 CD4 T cells less than patients without AZT over a period of two years (Huttner 2007). Whether it makes sense for patients showing poor immunologic success to switch to AZT-free regimens is an open question. There is no difference between NNRTIs and PIs regarding immune reconstitution and a switch is ineffective (Torti 2011). One meta-analysis showed that an increase of CD4 T cells on maraviroc was better than with other agents, and led to several other studies (Wilkin 2008). In these studies patients with poor immune reconstitution received an additional dose of maraviroc. The results were disappointing (Lanzafame 2009, Stepanyuk 2009, Wilkin 2010, Vitiello 2012, Hunt 2013). The same applies to ralte- gravir (Byakwaga 2011, Hatano 2011, Negredo 2013) and T-20 (Joly 2010), none of them showing any positive effects on immune reconstitution. Some reports show that the thymic function and corresponding immune reconsti- tution can be stimulated by growth hormone (Tesselaar 2008, Napolitano 2008). Such approaches are still experimental and not recommended as routine. Whether higher CD4 T cell counts have clinical benefits or not remains unknown. However, the example with interleukin-2 (see section on immune therapy) may call for caution, as in this case higher CD4 T cell counts had no positive effect on the frequency of opportunistic infections. Practical considerations in dealing with viral load and CD4 count • Viral load (VL) is the most important parameter in treatment monitoring. With higher CD4 counts, values may vary considerably from one measurement to the next (which may mislead the patient to either a false sense of euphoria or unneces- sary concern). Goals and principles of therapy 151 Clinical treatment success and failure Clinical treatment success is dependent on virologic and immunologic therapeutic success. In individual patients, clinical response is not always easy to assess. After all, there is no way to show what might have occurred if treatment had not been started. As an asymptomatic patient cannot feel much better, it may be difficult to find good arguments to continue treatment in the presence of side effects, which, at least temporarily, may affect quality of life. Clinical success is almost always evaluated via clinical endpoints (AIDS-defining ill- nesses, death), although the improvement on ART in a patient with considerable constitutional symptoms should also be seen as clinical success. With regard to risk of disease progression, the immunologic response is at least as important as the viro- logic response. However, the extent of virologic success is of great significance. In the Swiss Cohort, of those with a constantly undetectable viral load, the proportion of patients who went on to develop AIDS or die was 6. In con- trast, this proportion was 9% in patients with viral rebound and up to 20% if the viral load was never suppressed to undetectable levels (Ledergerber 1999). The impor- tance of a sustained virological treatment success for clinical benefit has also been reported from other cohorts (Thiebaud 2000, Lohse 2006). However, illness is not always indicative of clinical treatment failure. This is particularly true for the immune reconstitution inflammatory syndrome (IRIS), where a pre-existing, subclinical infection becomes apparent during the first weeks after ART initiation (see chapter on AIDS). An OI with increased CD4 T cells does not necessarily mean that the ART has failed, but that the immune system is doing its job, to put it in simple terms. On the other hand, if a patient develops serious side effects or dies, this should clearly be evaluated as a clinical failure.

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