Canadian Health and Care Mall: Two alternative strategies merit study

Canadian Health and Care Mall:  Two alternative strategies merit study

Further understanding of the special needs and health-care barriers for this high utilization group is paramount to the success of the goals delineated in the Healthy People 2010 program. As demonstrated by Boudreaux and colleagues, race/ethnicity-based deficiencies persist as black and Hispanic asthma patients were more likely to utilize the ED and be admitted to the hospital. 

Health-care providers and policymakers must begin to understand why high-utilization patients report the ED as their usual source of asthma prescriptions and site for acute asthma care. Two alternative strategies merit study. First, patients with high NEDV warrant further investigation to delineate the challenges and barriers to high-quality care among health-disparate populations. 

Secondly, the impact of facilitated referral of ED asthma patients to asthma specialists while maintaining long-term overall patient management by the PCP should be investigated. The current data, in conjunction with prior studies, raise concerns about overreliance on “referral to PCP” as an effective response to the problems of this high-risk and expensive asthma population.

Limitations

This study has a few potential limitations. First, history of prior ED use was self-reported and there was no attempt to verify the accuracy of the stated information. It may be that subjects who reported six visits actually had more (or fewer) visits, but we believe the rank order to be accurate and believe that even one to two ED visits per year to be excessive. 

Another limitation is that we have not analyzed the outpatient management of these patients presenting with acute asthma; for example, we do not know how many received specialized asthma care in the past, and we are unable to evaluate how prior outpatient PCP management relates to the National Asthma Education and Prevention Program guidelines with Canadian Health and Care Mall. (watch website)

We have sparse data on compliance with prescribed medications, understanding of disease, and details of the written action plans (if present); these factors probably are associated with frequency of ED use and will require further study.

Lung hemorrhage, pulmonary edema, and alveolitis

Among adults, pills constitute 7% of all foreign-body aspiration. A symptom triad of cough, wheezing, and decreased air entry should alert clinicians to suspect aspiration. The presence of the foreign object in the airway may lead to airway obstruction, atelectasis, granulation tissue formation, postobstructive pneumonia, and bronchiectasis. All aspirated foreign bodies require immediate attention.

Sucralfate is an oral cytoprotective agent used to treat and prevent gastroduodenal ulcers. Sucralfate demonstrates a high affinity for erosive mucosa, due to its viscous adhesiveness and formation of polyvalent bridges. It also buffers acid, inhibits the action of pepsin, and absorbs bile salts. Furthermore, sucralfate binds to uninjured mucosa and acts as a barrier on regenerated and normal mucosa. Aspiration of sucralfate has been reported to cause acute hypoxemia from complete occlusion of a lobar bronchus.

Lung hemorrhage

The sucralfate tablet can rapidly expand when in contact with bronchial mucosa. A large, moist, sucralfate tablet can completely occlude a bronchus, causing acute respiratory failure. In animal models, sucralfate suspension has also been shown to cause lung hemorrhage, pulmonary edema, and alveolitis. In patients at risk for aspiration, the use of sucralfate granules instead of its tablet form is recommended.

Capsule endoscopy is a widely accepted imaging modality with a good diagnostic yield and good safety profile. The most common complication is capsule retention, reported in about 1% to 2% of procedures. Capsule aspiration in the airways is rarer yet and is a potentially fatal complication in the presence of chronic lung diseases. This condition commonly occurs in elderly patients with or without prior history of swallowing disorders. 

It may result in hypoxemic respiratory failure, obstructive pneumonitis, and bronchial injury during its removal. In elderly patients who have difficulty swallowing, the capsule might need to be placed in the duodenum endoscopically to prevent its aspiration. Regardless, the aspirated endoscopic capsule should be retrieved immediately.

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Canadian Health Care Mall: Azithromycin

Azithromycin Attenuated Ovalbumin-Dependent Airway Inflammation Is Independent of Ovalbumin-Specific IgE Production We next quantified the serum concentration of ovalbumin-specific IgE to confirm equal allergen sensitization in all cohorts of mice and to exclude the possibility that azithromycin attenuated the allergic inflammation by altering IgE production. 

Naive mice and mice that received only an ovalbumin challenge (without sensitization) produced no ovalbumin-specific IgE. Mice that were sensitized and challenged with ovalbumin had a significant increase in ovalbumin-specific IgE production (699.8 ± 178.2 ng/mL) that was not significantly changed by treatment with PBS solution (885.1 ± 193.8 ng/mL) or azithromycin (829 ± 231.1 ng/mL; p = 0.80). 

Azithromycin Attenuated Ovalbumin-Dependent Airway Inflammation Is Associated With Decreased Concentrations of BAL Fluid Inflammatory Mediators Based on the affect of azithromycin on inflammatory cell influx, we proposed that azithromycin-dependent attenuation of allergic airway inflammation would also be associated with decreased concentration of BAL fluid cytokines and chemokines. 

Compared to ovalbumin sensitized and challenged mice treated with PBS solution, treatment with azithromycin attenuated the expression of multiple BAL fluid cytokines, chemokines, and growth factors as measured by multiplex flow cytometry based assay (Fig 3A-F, column 4 vs 5). Importantly, we observed a statistically significant azithromycin- dependent decrease in interleukin (IL)-13 and IL-5, and a trend toward a decrease in IL-4, proteins known to mediate allergic airway inflammatory phenotypes in the airway (eg, mucous cell metaplasia and eosinophilic inflammation). 

In addition, azithromycin attenuated the expression of multiple other chemokines and inflammatory mediators (CCL2/JE, CCL3/macrophage inhibitory protein [MIP]-1a, CCL4/MIP-1P, CXCL1/KC, IL-1a, IL-10, and granulocyte-macrophage colony-stimulating factor), but had no effect on concentration of IL-6, IL-9.

Pneumonia or an elevated temperature (ie > 38.9°C)

Materials and Methods This trial was conducted in 20 US hospital-affiliated EDs. Patients aged 12 to 65 years who presented to the ED with acute asthma were screened by study investigators for trial eligibility. Eligible patients were those with a history of asthma and a FEV₁ of < 70% predicted both at ED entry and 25 min after receiving a single aerosol treatment with 2.5 mg of albuterol. Patients with the following conditions were excluded from the study: history of smoking of > 10 pack-years.

Positive pregnancy test result; a recent history of oral corticosteroid use (ie, > 5 days) or treatment with a leukotriene-modifying drug within 2 weeks of ED entry; a need for intubation before randomization; pneumonia or an elevated temperature (ie, > 38.9°C); chronic lung disease other than asthma; or diabetes mellitus or any other clinically significant medical condition that could affect the required evaluations. 

Additionally, patients had to be willing to stay in the ED for at least 4 h (ie, the ED period) and then to participate in a 28-day outpatient treatment program (Fig 1). The trial was conducted in compliance with the principles of good clinical practice, approval was obtained from each institutional review board, and informed consent was obtained from all patients. 

Trial Design and Treatment At ED entry, patients underwent spirometry and were treated with nebulized albuterol (2.5-mg unit-dose nebules) [Ventolin; GlaxoSmithKline; Research Triangle Park, NC]. Spirometry was repeated 25 min after ED entry, and patients with FEV₁ values still < 70% of predicted were randomized, 1:1:2, respectively, to double-blind, single-dose treatment with zafirlukast, 160 mg (Z160), zafirlukast, 20 mg (Z20) [Accolate; AstraZeneca; Wilmington, DE], or matching placebo. Patients then received a 60-mg po dose of prednisone and a second dose of nebulized albuterol, with additional albuterol administered at 60, 120, and 180 min after ED entry.

Canadian Health Care Mall

Practice Management Issues Measurement of FeNO: The ATS and the ERS issued a statement in 2005 regarding equipment specifications and the standardization of procedures for the measurement of exhaled NO. The required specifications for NO analyzers are reproduced in Table 3. An example of the test procedure used at the Mayo Clinic Rochester is provided in Table 4. Various factors influencing FeNO are found in Table 1.  

Equipment: In the United States, only one device (NIOX; Aerocrine; Solna, Sweden) has received US Food and Drug Administration (FDA) approval for clinical use. A newer model (NIOX FLEX; Aero-crine) will be launched soon. These devices are targeted for academic centers and specialty clinics. A portable unit based on an electrochemical sensor and not chemiluminescence (NIOX MINO; Aerocrine) was introduced in Europe in 2005 but has not been approved by the FDA as of this writing. 

It is a hand-held device designed for use by specialists, general hospitals, primary care physicians, and patients. The FDA labeling restricts the operation of the NIOX device to trained physicians, respiratory therapists, nurses, and laboratory technicians. Both the NIOX FLEX and NIOX MINO devices allow results to be printed. None of the models have the Table 1—Required Specifications for NO Analyzers

 

Parameters	FeNO	Nasal NO
Sensitivity	1 ppb (noise, < 0.5 ppb)	10 ppb
Signal/noise ratio	> 3:1	Same as exhaled NO
Accuracy	> 1 ppb	> 10 ppb
Range	1-500 ppb	10-50 ppm
Instrument response timet	< 500 ms	< 500 ms
System lag timej	To be measured and reported by the investigator	Same as FeNO
Drift	< 1% of full scale/24 h	Same as FeNO
Reproducibility	> 1 ppb	> 10 ppb
Flow-through sensor	To be measured by manufacturer and reported in publications	Same as exhaled NO

Defined as the delay from the introduction of a square-wave signal until achievement of 90% of the maximum signal, inclusive of electronic delays and inherent instrument physical delays because of sample introduction, but not including tubing length.

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The cross-sectional methodology

In Crete, there are no published reports on weed flora in vineyards. Garcia-Ortega et al, in a survey on occupational sensitization to Diplotaxis erucoides, found that workers in vineyards with rhinoconjunc-tivitis were sensitized to several pollens. Moreover, grape workers were found to be more likely to have skin disorders than were citrus or tomato work-ers, and these disorders may be causally associated with crop-specific exposures and lack of protective equipment. 

Therefore, it is possible that the high prevalence of atopy in grape farmers could be associated with their exposure to different irritants found in their workplace (ie, open-field cultivation and exposure to a variety of inhaled agents such as pollens, molds, mites, bacteria, and pesticides), rather than grape growing itself. We are well aware of the inherent limitations of the cross-sectional design of the present study. First, the study refers to a relatively small area of research in northern Crete. 

Furthermore, the cross-sectional methodology used in this study is not optimal for the assessment of causal relationships, but it suggests only the possibility of the association between the occupational exposure and the disease. Since we had statistically significant differences between the two groups in terms of age and smoking status, we used multivariate regression models to correct these imbalances.

 Selection bias may have affected the results observed in this study. First, a possible bias might exist in the reporting of symptoms, so that those with respiratory symptoms would be more likely to respond to the questionnaire and participate in the study. For that reason, the nonresponders from both groups were contacted by telephone, and they were asked about self-reported allergic rhinitis and asthma. 

These prevalence rates were lower than the prevalence rates of allergic rhinitis and asthma found in responders, and they could indicate the presence of a possible selection bias in the study. However, these differences could also be explained by the difference in the definition of the cases (self-reported disease vs clinical diagnosis based on questionnaire and medical examinations). We cannot rule out that the individual, social, and educational status of each subject had an impact on the study findings. However, we have no indication from our data of differential selection bias in the compared groups.

Evaluate the workplace to identify and prevent other cases of OA

Limited data are available to identify whether the administration of questionnaires or spirometry testing is the beneficial component of medical surveil-lance. Questionnaires (ie, medical history) have been thought to be sensitive but not specific; however, earlier studies found low sensitivity (missed cases of asthma in the absence of reported symptoms; “potential problem of. . . misleading responses”). With respect to the frequency of monitoring, data do not exist to advise a “best” or “most efficient” frequency for surveillance. 

Testing conducted every 6 months probably provides as good an outcome as does testing every 3 months and is practicable. A cost-effectiveness (CE) analysis of surveillance for diisocyanate asthma using parameters for inclusion obtained from the literature and an expert panel (including time to diagnosis with and without surveillance) found a favorable CE ratio that supports surveillance for diisocyanate asthma. 

The simulation model, which was based on yearly OA surveillance, revealed that surveillance resulted in a benefit over a passive case finding for 100,000 exposed workers over 10 years of 683 fewer disabled workers, 3.3 million more symptom-free days, and 1,831 additional quality-adjusted life-years at an additional cost of $44 million. This analysis estimated that surveillance was cost saving from the societal perspective, but not from the employer perspective, which estimated an incremental CE of $24,000 per quality-adjusted life-year ($13.33 per symptom-free day; $64,000 per case of disability prevented). 

Although such findings compare favorably with commonly recommended surveillance tools, the large difference in CE comparing societal and employer perspectives supports the argument that mandatory regulation may be the most effective way to implement surveillance for certain occupational diseases. 

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IgE-Mediated Immune Responses and Airway Detection of Aspergillus

This prospective observational cohort study was carried out between October 2008 and February 2011. Approval was obtained from the South Manchester research ethics committee. Patients were invited to participate between October 2008 and February 2009 if they were aged > 18 years and given a diagnosis of CF confirmed by genetic or sweat testing. Patients were enrolled during routine outpatient appointments at the Manchester Adult Cystic Fibrosis Centre, and all gave written informed consent. 

Patients were excluded at enrollment if they were unable to produce a > 2 mL sputum sample spontaneously or had an exacerbation of pulmonary symptoms requiring additional therapy. Baseline demographic and clinical details were collected from medical case records. Lung function (FEV1 and FVC % predicted) at enrollment and 2 years after enrollment was obtained by documenting the patient’s best lung function achieved within that year. 

This method was chosen to minimize the wide variability in lung function measurements observed in patients with CF. All lung function was performed postbronchodilator by experienced clinical staff according to European Respiratory Society guidelines. Total days of IV antibiotics were prospectively monitored over 2 years to examine exacerbation rates. Each patient was given 10 mL of sterile water and asked to rinse his or her mouth for 30 s and return the water to a sterile universal container. A sputum sample was then collected without sputum induction. 

This was done to differentiate oral cavity and lower respiratory tract colonization. Patients provided two sputum samples within 1 year. Sputum samples were homogenized with Sputasol, and culture was performed according to the UK Health Protection Agency National Standards Method BSOP but modified to plate 10 pL rather than 1 pL of sputum. Ten microliters of homogenized sputum was inoculated onto each of three Sabouraud dextrose with chloramphenicol agar plates and one CHROMagar Candida plate. 

SABC plates were incubated at 30°C, 37°C, and 45°C for 72 h. CHROMagar plates were incubated at 37°C for 72 h. This culture method was repeated for the oral rinse sample but with no homogenization. Following culture, the remaining sputum sample underwent additional homogenization using sonication. Fungal DNA was extracted using the MycXtra DNA extraction kit.

Patients with high NEDV

Furthermore, future study might assess the psychosocial problems and barriers to health-care access of this high-utilization group. Finally, one must consider that this study examines only patients who presented to the ED with an acute exacerbation. Since the study is specific to ED patients and not population based, it may not be generalizable to all asthma patients. 

For example, the value of primary care of asthmatic adults would be considerably less in this population; patients receiving excellent primary asthma care are much less likely to visit the ED, and therefore would be underrepresented in this large cohort. However, since our focus is on the characteristics of frequent visitors to the ED, and the development of strategies to potentially help this patient population, the findings are of direct relevance to our objectives.  

Summary Patients with high NEDV were more likely to be nonwhite, of lower socioeconomic status, have Medicaid insurance, and have higher chronic asthma severity. Patients with six or more ED visits accounted for 20% of consecutive ED patients with acute asthma, and 68% of all prior ED visits in the past year. National guidelines recommend specific ED treatments followed by referral to PCP, with unclear recommendations about if and when to refer patients to asthma specialists. 

We found no relation between PCP status and NEDV. Efforts to reduce high ED utilization through provision of a PCP referral may be inadequate for this frequent-flier population. Although longitudinal care is surely important, attempts to reduce frequent ED asthma visits may be better directed toward more specific preventive and educational needs. Table 1 — Pulmonary Function Measured at Baseline, 5 min, 10 min, and 20 min after the 90% and 100% Peak Vo₂ Exercise Bouts

 

Variables	Baseline	5-min	10-min	20-min
FVC, L
90% peak Vo2	4.52	4.42	4.5	4.47
100% peak Vo2	(116%)	4.33		4.31
PEF, L/s
90% peak Vo2	7.57	7.59	7.33	7.68
100% peak Vo2	(103%)	7.59		7.24
FEVj, L/s
90% peak Vo2	3.54	3.64	3.59	3.6
100% peak Vo2	(104%)	3.57		3.45
FEF25-75, L/s
90% peak Vo2	2.86	3.13	2.98	3.07
100% peak Vo2	(72%)	3.17		2.96

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Canadian Health Care Mall: Patients With SDB

Perhaps the best way to examine the role of NR in patients with SDB is to reduce the resistance and examine the effect on sleep and breathing. This has been done in a variety of ways. Mechanical nasal dilators are marketed to relieve snoring, and have been shown to have a similar effect on NR as measured by active posterior rhinometry as a topical decongestant. 

Their effect on snorers without significant nasal pathology is unclear, as some studies failed to demonstrate changes in SDB events or arterial oxygen saturation levels, while others showed improvement in sleep quality, ease of breathing, and a decreased intensity of snoring. In patients with OSAS, one study showed that only 4 of 21 patients with moderate-to-severe OSAS had a significant reduction in SDB events, while another study showed no significant change in SDB events in a group of patients with UARS. 

It appears that the overall effect on SDB with mechanical nasal dilators is likely small and inconsistent. Dental prostheses have been used to treat all forms of SDB. These devices keep the upper and lower jaws opposed during sleep and advance the mandible forward. This prevents posterior movement of the mandible during sleep and increases nasal breathing. When evaluated in a group of snoring patients without symptoms of OSAS, one type of prosthesis did not alter the frequency or intensity of snoring or sleep quality or oxygen saturation despite decreasing SDB events; from this one small study, it does not appear dental prostheses improve SDB by any effect on the nasal airway. 

Reducing NR by surgical correction of nasopha-ryngeal anatomic obstruction has been examined by a number of investigators. Surgical approaches have included correction of the nasal valve area, septoplasty, and turbinate reduction. Only one small study examined the effect of correction of nasal valve obstruction, showing both subjective and objective improvement in snoring and daytime somnolence. Two uncontrolled studies in patients with nasal obstruction showed that septoplasty or turbinate reduction had some positive effects on SDB. 

In one study, 77% (47 of 113 patients) who snored had improvement or elimination of snoring postoperatively. The second study involved patients with mild OSAS where cephalometrics were performed preoperatively; patients with abnormal cephalomet-rics, implying a skeletal anatomic defect, did not respond to improvement of their nasal airway. In a study of a diverse group of adults and children with SDB, who had a variety of surgical procedures , significant improvement occurred in only 48% of adults.

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Incidence Rates and HRs for MACEs

Cardiovascular Event Rates According to Cardiovascular Disorders at Baseline Risk factors recorded at baseline included the presence of hypertension, diabetes mellitus, hyperlipidemia, and a history of heart disease (Table 1). Adjudicated event rates were higher in patients with baseline cardiovascular risk factors than in those without baseline cardiovascular risk (Table 4). HRs for MACEs found in patients treated with roflumilast relative to placebo in patients without cardiovascular diseases or risk factors at baseline were lower than in those with cardiovascular comorbid conditions. Adjusting for cardiovascular risk factors at baseline did not materially affect the HR for MACEs. 

Rates and HRs for MACEs

There were significantly fewer MACEs for roflumilast than for placebo in the subgroup of patients with COPD who did not have cardiovascular comorbid conditions at baseline (Table 1). Cardiovascular Event Rates According to Other Factors at Baseline Adjudicated event rates according to age, sex, smoking status, COPD severity, and concomitant long-term pulmonary medication use are shown in Figure 3. HRs were similar across age, sex, and smoking status. There were no significant interactions for COPD severity, concomitant inhaled corticosteroid use, or long-acting b-agonist use. 

However, reductions in MACEs were significant in patients with severe COPD (GOLD [Global Initiative for Chronic Obstructive Lung Disease] stage III), in those using concomitant inhaled corticosteroids, and in those not using long-acting Ь-agonists and not in the corresponding subgroups. Cardiovascular Event Rates According to COPD Exacerbations Subanalyses of the four trials carried out for 1 year demonstrated that exacerbations of COPD were reduced significantly by roflumilast relative to placebo. 

Between patients with and without exacerbations, the proportions with MACEs were similar (1.7% and 1.6%, respectively). Between patients with and without MACEs, the proportions experiencing exacerbations were similar (43.2% and 42.1%, respectively). Table 4—Incidence Rates and HRs for MACEs According to Baseline CV Comorbid Diseases

Patient Group	Roflumilast	Placebo	HR (Roflumilast vs Placebo)	95% CI	P Value
No. patients with CV comorbid conditions	3,584	3,056
Composite MACE	43 (1.2)	51 (1.7)	0.75	0.50-1.14	.185
CV death	27 (0.8)	31 (1.0)	0.72	0.43-1.23	.232
Nonfatal MI	10 (0.3)	12 (0.4)	0.94	0.40-2.20	.893
Nonfatal stroke	6 (0.2)	9 (0.3)	0.55	0.18-1.66	.288
No. patients without CV comorbid conditions	2,979	2,435
Composite MACE	9 (0.3)	25 (1.0)	0.36	0.17-0.77	.009
CV death	8 (0.3)	12 (0.5)	0.65	0.26-1.59	.340
Nonfatal MI	1 (0.0)	10 (0.4)	0.09	0.01-0.70	.021
Nonfatal stroke	0 (0.0)	3(0.1)	0		.996

Data are presented as No. (%), unless otherwise indicated. See Table 3 legend for expansion of abbreviations. “Calculated using Cox proportional hazard model with terms for treatment, age, sex, smoking status, and country pool. Includes ischemic heart disease, type 2 diabetes, dyslipidemia, and hypertension.