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1.  Stakeholder Priorities for Comparative Effectiveness Research in Chronic Obstructive Pulmonary Disease 
Comparative effectiveness research (CER) is intended to address the expressed needs of patients, clinicians, and other stakeholders. Representatives of 54 stakeholder groups with an interest in chronic obstructive pulmonary disease (COPD) participated in workshops convened by the COPD Outcomes-based Network for Clinical Effectiveness and Research Translation (CONCERT) over a 2-year period. Year 1 focused on chronic care and care coordination. Year 2 focused on acute care and transitions in care between healthcare settings. Discussions and provisional voting were conducted via teleconferences and e-mail exchanges before the workshop. Final prioritization votes occurred after in-person discussions at the workshop. We used a modified Delphi approach to facilitate discussions and consensus building. To more easily quantify preferences and to evaluate the internal consistency of rankings, the Analytic Hierarchy Process was incorporated in Year 2. Results of preworkshop and final workshop voting often differed, suggesting that prioritization efforts relying solely on requests for topics from stakeholder groups without in-person discussion may provide different research priorities. Research priorities varied across stakeholder groups, but generally focused on studies to evaluate different approaches to healthcare delivery (e.g., spirometry for diagnosis and treatment, integrated healthcare strategies during transitions in care) rather than head-to-head comparisons of medications. This research agenda may help to inform groups intending to respond to CER funding opportunities in COPD. The methodologies used, detailed in the online supplement, may also help to inform prioritization efforts for CER in other health conditions.
PMCID: PMC3603554  PMID: 23155144
health services research; research priorities; care coordination; stakeholders
2.  Effects of respiratory and non-respiratory factors on disability among older adults with airway obstruction: The Cardiovascular Health Study 
COPD  2013;10(5):588-596.
High rates of disability associated with chronic airway obstruction may be caused by impaired pulmonary function, pulmonary symptoms, other chronic diseases, or systemic inflammation.
We analyzed data from the Cardiovascular Health Study, a longitudinal cohort of 5888 older adults. Categories of lung function (normal; restricted; borderline, mild-moderate, and severe obstruction) were delineated by baseline spirometry (without bronchodilator). Disability-free years were calculated as total years alive and without self-report of difficulty performing ≥1 Instrumental Activities of Daily Living over 6 years of follow-up. Using linear regression, we compared disability-free years by lung disease category, adjusting for demographic factors, body mass index, smoking, cognition, and other chronic comorbidities. Among participants with airflow obstruction, we examined the association of respiratory factors (FEV1 and dyspnea) and non-respiratory factors (ischemic heart disease, congestive heart failure, diabetes, muscle weakness, osteoporosis, depression and cognitive impairment) on disability-free years.
The average disability free years were 4.0 out of a possible 6 years. Severe obstruction was associated with 1 fewer disability-free year compared to normal spirometry in the adjusted model. For the 1,048 participants with airway obstruction, both respiratory factors (FEV1 and dyspnea) and non-respiratory factors (heart disease, coronary artery disease, diabetes, depression, osteoporosis, cognitive function, and weakness) were associated with decreased disability-free years.
Severe obstruction is associated with greater disability compared to patients with normal spirometery. Both respiratory and non-respiratory factors contribute to disability in older adults with abnormal spirometry.
PMCID: PMC3903127  PMID: 23819728
Chronic airflow obstruction; instrumental activities of daily living; disability; disablement process
3.  Safety and Feasibility of Bronchial Thermoplasty in Asthma Patients with Very Severe Fixed Airflow Obstruction: A Case Series 
Bronchial thermoplasty (BT) can provide relief for patients with severe, uncontrolled asthma despite maximal medical therapy. However, it is unclear whether BT is safe in patients with very severe airflow obstruction.
We performed BT in eight patients with severe asthma as defined by Expert Panel Report 3 (EPR-3) guidelines who were poorly controlled despite step 5 therapy. Data were available on each subject for 1 year prior to and 15–72 weeks following BT.
The mean (±SEM) pre-bronchodilator forced expiratory volume in one second (FEV1) prior to BT was 51.8 ± 8.6% of predicted, and the mean (±SEM) number of hospitalizations for asthma in the year prior to BT was 2.9 ± 1.2. No subject had an unexpected severe adverse event due to BT. Among the eight patients with follow-up of at least 15 weeks, there was no significant decline in FEV1 (p = .4).
We suggest that BT may be safe for asthma patients with severe airflow obstruction and higher hospitalization rates than previously reported.
PMCID: PMC3842587  PMID: 23252954
airway smooth muscle; persistent airflow obstruction; poorly controlled asthma; radiofrequency ablation; refractory asthma
4.  Teaching the Use of Respiratory Inhalers to Hospitalized Patients with Asthma or COPD: a Randomized Trial 
Journal of General Internal Medicine  2012;27(10):1317-1325.
Hospitalized patients frequently misuse their respiratory inhalers, yet it is unclear what the most effective hospital-based educational intervention is for this population.
To compare two strategies for teaching inhaler use to hospitalized patients with asthma or chronic obstructive pulmonary disease (COPD).
A Phase-II randomized controlled clinical trial enrolled hospitalized adults with physician diagnosed asthma or COPD.
Hospitalized adults (age 18 years or older) with asthma or COPD.
Participants were randomized to brief intervention [BI]: single-set of verbal and written step-by-step instructions, or, teach-to-goal [TTG]: BI plus repeated demonstrations of inhaler use and participant comprehension assessments (teach-back).
The primary outcome was metered-dose inhaler (MDI) misuse post-intervention (<75% steps correct). Secondary outcomes included Diskus® misuse, self-reported inhaler technique confidence and prevalence of 30-day health-related events.
Of 80 eligible participants, fifty (63%) were enrolled (BI n = 26, TTG n = 24). While the majority of participants reported being confident with their inhaler technique (MDI 70%, Diskus® 94%), most misused their inhalers pre-intervention (MDI 62%, Diskus® 78%). Post-intervention MDI misuse was significantly lower after TTG vs. BI (12.5 vs. 46%, p = 0.01). The results for Diskus® were similar and approached significance (25 vs. 80%, p = 0.05). Participants with 30-day acute health-related events were less common in the group receiving TTG vs. BI (1 vs. 8, p = 0.02).
TTG appears to be more effective compared with BI. Patients over-estimate their inhaler technique, emphasizing the need for hospital-based interventions to correct inhaler misuse. Although TTG was associated with fewer post-hospitalization health-related events, larger, multi-centered studies are needed to evaluate the durability and clinical outcomes associated with this hospital-based education.
PMCID: PMC3445679  PMID: 22592354
respiratory inhalers; teach-to-goal; hospitalized patients; health literacy; asthma; COPD
5.  Maternal asthma and microRNA regulation of soluble HLA-G in the airway. 
We previously reported an interaction between maternal asthma and the child’s HLA-G genotype on the child’s subsequent risk for asthma. The implicated SNP at +3142 disrupted a target site for the microRNA (miR)-152 family. We hypothesized that the interaction effect may be mediated by these miRs
The objective of this study was to test this hypothesis in adults with asthma who are a subset of the same subjects who participated in our earlier family-based studies.
We measured soluble (s)HLA-G concentrations in bronchial alveolar lavage (BAL) fluid (N=36) and plasma (N=57) from adult asthmatics with and without a mother with asthma, and HLA-G and miR-152 family (miR-148a, -148b, and -152) transcript levels in airway epithelial cells from the same individuals.
miR-148b levels were significantly elevated in airway epithelial cells from asthmatics with an asthmatic mother compared to asthmatics without an asthmatic mother, and +3142 genotypes were associated with sHLA-G concentrations in BAL fluid among asthmatic individuals with an asthmatic mother but not among those with a non-asthmatic mother. Neither effect was observed in the plasma (sHLA-G) or white blood cells (miRNA).
These combined results are consistent with +3142 allele-specific targeting of HLA-G by the miR-152 family, and support our hypothesis that miRNA regulation of sHLA-G in the airway is influenced by both the asthma status of the subject’s mother and the subject’s genotype. Moreover, we demonstrate that the effects of maternal asthma on the gene regulatory landscape in the airways of her children persist into adulthood.
PMCID: PMC3779062  PMID: 23534973
Asthma; maternal asthma; microRNA; Human Leukocyte Antigen
6.  Patient factors associated with hospital discharge to care facility following critical illness 
Many critically ill (CI) patients are transferred to other care facilities instead of to home at hospital discharge.
To identify patient factors associated with hospital discharge to care facility following CI, and to estimate the magnitude of risk associated with each factor.
Retrospective cohort study conducted in a medical intensive care unit. We studied 548 survivors of CI. Multivariable logistic regression was employed to identify independent risk factors for discharge to care facility. Only the first 72 hours of intensive care were analyzed.
Approximately one-quarter of the survivors of CI were discharged to a care facility instead of to home (143/548, 26.1%). This event occurred more commonly in older patients, even after adjustment for severity of illness and comorbidities (odds ratio [OR] 1.8 for patients ≥ 65 years of age versus patients < 65 years; 95% confidence interval [CI] 1.1–3.1, p=0.02). The risk was greatest for patients who received mechanical ventilation (OR 3.4; 95% CI 2.0–5.8; p<0.001) or had hospitalizations characterized by severe cognitive dysfunction (OR 8.1; 95% CI 1.3–50.6; p=0.02) or poor strength and/or mobility (OR 31.7; 95% CI 6.4–157.3; p<0.001). The model showed good discrimination (area under the curve 0.82; 95% CI 0.77–0.86).
Our model, which did not include baseline function or social variables, provided good discrimination between patients discharged to care facility following CI and patients discharged to home. These results suggest that future research should focus on the debilitating effects of respiratory failure and on conditions with cognitive and neuromuscular sequelae.
PMCID: PMC3735167  PMID: 21885459
critical illness; critical care nursing; chronic disease; long term care; nursing homes
7.  Outcomes of Noninvasive Ventilation for Acute Exacerbations of Chronic Obstructive Pulmonary Disease in the United States, 1998–2008 
Rationale: The patterns and outcomes of noninvasive, positive-pressure ventilation (NIPPV) use in patients hospitalized for acute exacerbations of chronic obstructive pulmonary disease (COPD) nationwide are unknown.
Objectives: To determine the prevalence and trends of noninvasive ventilation for acute COPD.
Methods: We used data from the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample to assess the pattern and outcomes of NIPPV use for acute exacerbations of COPD from 1998 to 2008.
Measurements and Main Results: An estimated 7,511,267 admissions for acute exacerbations occurred from 1998 to 2008. There was a 462% increase in NIPPV use (from 1.0 to 4.5% of all admissions) and a 42% decline in invasive mechanical ventilation (IMV) use (from 6.0 to 3.5% of all admissions) during these years. This was accompanied by an increase in the size of a small cohort of patients requiring transition from NIPPV to IMV. In-hospital mortality in this group appeared to be worsening over time. By 2008, these patients had a high mortality rate (29.3%), which represented 61% higher odds of death compared with patients directly placed on IMV (95% confidence interval, 24–109%) and 677% greater odds of death compared with patients treated with NIPPV alone (95% confidence interval, 475–948%). With the exception of patients transitioned from NIPPV to IMV, in-hospital outcomes were favorable and improved steadily year by year.
Conclusions: The use of NIPPV has increased significantly over time among patients hospitalized for acute exacerbations of COPD, whereas the need for intubation and in-hospital mortality has declined. However, the rising mortality rate in a small but expanding group of patients requiring invasive mechanical ventilation after treatment with noninvasive ventilation needs further investigation.
PMCID: PMC3297087  PMID: 22016446
COPD; positive-pressure ventilation; artificial respiration; epidemiology
8.  Adherence to inhaled corticosteroids: An ancillary study of the Childhood Asthma Management Program clinical trial 
Information comparing subjective and objective measurements of adherence to study medications and the effects of adherence on treatment-related differences in asthma clinical trials are limited.
We sought to compare subjective and objective measurements of children’s adherence to inhaled corticosteroids or placebo and to determine whether adherence to study medications modified treatment-related differences in outcomes.
In an ancillary study conducted in 3 of 8 Childhood Asthma Management Program Clinical Centers, adherence was assessed by using self-reported and objective data in 5- to 12-year-old children with mild or moderate asthma who were randomly assigned to 200 μg of inhaled budesonide twice per day (n = 84) or placebo (n = 56) for 4 years. The κ statistic was used to evaluate agreement between self-reported adherence (daily diary cards) and objectively measured adherence (number of doses left in study inhalers). Multivariable analyses were used to determine whether adherence to study treatment modified treatment-related differences in outcomes.
Adherence of less than 80% was seen in 75% of 140 children when adherence was measured objectively but only in 6% of children when measured by means of self-report. There was poor agreement between objective and subjective measurements of adherence of at least 80% (κ = 0.00; 95% CI, −0.05 to 0.04); self-reported adherence over the 4-year period generally overestimated objectively measured adherence (93.6% vs 60.8%, P < .0001). There was little evidence to indicate that adherence modified treatment-related differences in outcomes.
Researchers should use objective rather than self-reported adherence data to identify clinical trial participants with low levels of adherence to study treatment.
PMCID: PMC3350797  PMID: 22104610
Asthma; adherence; compliance; children; lung growth; inhaled corticosteroids; budesonide; clinical trial
9.  Large-scale international validation of the ADO index in subjects with COPD: an individual subject data analysis of 10 cohorts 
BMJ Open  2012;2(6):e002152.
Little evidence on the validity of simple and widely applicable tools to predict mortality in patients with chronic obstructive pulmonary disease (COPD) exists.
To conduct a large international study to validate the ADO index that uses age, dyspnoea and FEV1 to predict 3-year mortality and to update it in order to make prediction of mortality in COPD patients as generalisable as possible.
Individual subject data analysis of 10 European and American cohorts (n=13 914).
Population-based, primary, secondary and tertiary care.
COPD GOLD stages I–IV.
We validated the original ADO index. We then obtained an updated ADO index in half of our cohorts to improve its predictive accuracy, which in turn was validated comprehensively in the remaining cohorts using discrimination, calibration and decision curve analysis and a number of sensitivity analyses.
1350 (9.7%) of all subjects with COPD (60% male, mean age 61 years, mean FEV1 66% predicted) had died at 3 years. The original ADO index showed high discrimination but poor calibration (p<0.001 for difference between predicted and observed risk). The updated ADO index (scores from 0 to 14) preserved excellent discrimination (area under curve 0.81, 95% CI 0.80 to 0.82) but showed much improved calibration with predicted 3-year risks from 0.7% (95% CI 0.6% to 0.9%, score of 0) to 64.5% (61.2% to 67.7%, score of 14). The ADO index showed higher net benefit in subjects at low-to-moderate risk of 3-year mortality than FEV1 alone.
The updated 15-point ADO index accurately predicts 3-year mortality across the COPD severity spectrum and can be used to inform patients about their prognosis, clinical trial study design or benefit harm assessment of medical interventions.
PMCID: PMC3533065  PMID: 23242246
Pulmonary Disease, Chronic Obstructive; Mortality; Prognosis; Validation Studies
10.  Confirmatory spirometry for adults hospitalized with a diagnosis of asthma or chronic obstructive pulmonary disease exacerbation 
Objective measurement of airflow obstruction by spirometry is an essential part of the diagnosis of asthma or COPD. During exacerbations, the feasibility and utility of spirometry to confirm the diagnosis of asthma or chronic obstructive pulmonary disease (COPD) are unclear. Addressing these gaps in knowledge may help define the need for confirmatory testing in clinical care and quality improvement efforts. This study was designed to determine the feasibility of spirometry and to determine its utility to confirm the diagnosis in patients hospitalized with a physician diagnosis of asthma or COPD exacerbation.
Multi-center study of four academic healthcare institutions. Spirometry was performed in 113 adults admitted to general medicine wards with a physician diagnosis of asthma or COPD exacerbation. Two board-certified pulmonologists evaluated the spirometry tracings to determine the proportion of patients able to produce adequate quality spirometry data. Findings were interpreted to evaluate the utility of spirometry to confirm the presence of obstructive lung disease, according to the 2005 European Respiratory Society/American Thoracic Society recommendations.
There was an almost perfect agreement for acceptability (κ = 0.92) and reproducibility (κ =0.93) of spirometry tracings. Three-quarters (73%) of the tests were interpreted by both pulmonologists as being of adequate quality. Of these adequate quality tests, 22% did not present objective evidence of obstructive lung disease. Obese patients (BMI ≥30 kg/m2) were more likely to produce spirometry tracings with no evidence of obstructive lung disease, compared to non-obese patients (33% vs. 8%, p = 0.007).
Adequate quality spirometry can be obtained in most hospitalized adults with a physician diagnosis of asthma or COPD exacerbation. Confirmatory spirometry could be a useful tool to help reduce overdiagnosis of obstructive lung disease, especially among obese patients.
PMCID: PMC3538708  PMID: 23217023
Asthma; COPD; Exacerbation; Hospitalization; Spirometry; Quality improvement
11.  Comparative effectiveness research in chronic obstructive pulmonary disease 
Chronic obstructive pulmonary disease affects millions worldwide. It is America’s third leading cause of death, and results in significant morbidity and cost. Although many therapies exist and are being developed to alleviate symptoms and decrease morbidity and mortality in chronic obstructive pulmonary disease, most have only been studied in placebo-controlled efficacy studies in highly selected populations. Comparative effectiveness and translational research in chronic obstructive pulmonary disease will require the development of infrastructures to support collaboration between researchers and the stakeholders who generate, disseminate and use new knowledge. Methodologies need to evolve to both prioritize research questions and to conduct collaborative comparative effectiveness research studies. Given the impracticality of testing every clinical intervention in comparative pragmatic trials for comparative effectiveness research in chronic obstructive pulmonary disease, we advocate expanding methodology that includes the use of observational databases with serially performed effectiveness analyses and quasi-experimental designs that include following healthcare changes longitudinally over time to assess benefit, harm, subgroups and cost.
PMCID: PMC3479302  PMID: 23105965
chronic obstructive pulmonary disease; comparative effectiveness research; data warehouse; emphysema; health services research; outcome research; quasi-experimental design; registry; translational research
12.  Comparative Effectiveness Research in Lung Diseases and Sleep Disorders 
The Division of Lung Diseases of the National Heart, Lung, and Blood Institute (NHLBI) held a workshop to develop recommendations on topics, methodologies, and resources for comparative effectiveness research (CER) that will guide clinical decision making about available treatment options for lung diseases and sleep disorders. A multidisciplinary group of experts with experience in efficacy, effectiveness, implementation, and economic research identified (a) what types of studies the domain of CER in lung diseases and sleep disorders should include, (b) the criteria and process for setting priorities, and (c) current resources for and barriers to CER in lung diseases. Key recommendations were to (1) increase efforts to engage stakeholders in developing CER questions and study designs; (2) invest in further development of databases and other infrastructure, including efficient methods for data sharing; (3) make full use of a broad range of study designs; (4) increase the appropriate use of observational designs and the support of methodologic research; (5) ensure that committees that review CER grant applications include persons with appropriate perspective and expertise; and (6) further develop the workforce for CER by supporting training opportunities that focus on the methodologic and practical skills needed.
PMCID: PMC3265273  PMID: 21965016
randomized controlled trials; observational studies; implementation; study designs; methodology
13.  The prevalence of clinically-relevant comorbid conditions in patients with physician-diagnosed COPD: a cross-sectional study using data from NHANES 1999–2008 
Treatment of chronic diseases such as chronic obstructive pulmonary disease (COPD) is complicated by the presence of comorbidities. The objective of this analysis was to estimate the prevalence of comorbidity in COPD using nationally-representative data.
This study draws from a multi-year analytic sample of 14,828 subjects aged 45+, including 995 with COPD, from the National Health and Nutrition Examination Survey (NHANES), 1999–2008. COPD was defined by self-reported physician diagnosis of chronic bronchitis or emphysema; patients who reported a diagnosis of asthma were excluded. Using population weights, we estimated the age-and-gender-stratified prevalence of 22 comorbid conditions that may influence COPD and its treatment.
Subjects 45+ with physician-diagnosed COPD were more likely than subjects without physician-diagnosed COPD to have coexisting arthritis (54.6% vs. 36.9%), depression (20.6% vs. 12.5%), osteoporosis (16.9% vs. 8.5%), cancer (16.5% vs. 9.9%), coronary heart disease (12.7% vs. 6.1%), congestive heart failure (12.1% vs. 3.9%), and stroke (8.9% vs. 4.6%). Subjects with COPD were also more likely to report mobility difficulty (55.6% vs. 32.5%), use of >4 prescription medications (51.8% vs. 32.1), dizziness/balance problems (41.1% vs. 23.8%), urinary incontinence (34.9% vs. 27.3%), memory problems (18.5% vs. 8.8%), low glomerular filtration rate (16.2% vs. 10.5%), and visual impairment (14.0% vs. 9.6%). All reported comparisons have p < 0.05.
Our study indicates that COPD management may need to take into account a complex spectrum of comorbidities. This work identifies which conditions are most common in a nationally-representative set of COPD patients (physician-diagnosed), a necessary step for setting research priorities and developing clinical practice guidelines that address COPD within the context of comorbidity.
PMCID: PMC3461433  PMID: 22695054
14.  Misuse of Respiratory Inhalers in Hospitalized Patients with Asthma or COPD 
Patients are asked to assume greater responsibility for care, including use of medications, during transitions from hospital to home. Unfortunately, medications dispensed via respiratory inhalers to patients with asthma or chronic obstructive pulmonary disease (COPD) can be difficult to use.
To examine rates of inhaler misuse and to determine if patients with asthma or COPD differed in their ability to learn how to use inhalers correctly.
A cross-sectional and pre/post intervention study at two urban academic hospitals.
Hospitalized patients with asthma or COPD.
A subset of participants received instruction about the correct use of respiratory inhalers.
Use of metered dose inhaler (MDI) and Diskus® devices was assessed using checklists. Misuse and mastery of each device were defined as <75% and 100% of steps correct, respectively. Insufficient vision was defined as worse than 20/50 in both eyes. Less-than adequate health literacy was defined as a score of <23/36 on The Short Test of Functional Health Literacy in Adults (S-TOFHLA).
One-hundred participants were enrolled (COPD n = 40; asthma n = 60). Overall, misuse was common (86% MDI, 71% Diskus®), and rates of inhaler misuse for participants with COPD versus asthma were similar. Participants with COPD versus asthma were twice as likely to have insufficient vision (43% vs. 20%, p = 0.02) and three-times as likely to have less-than- adequate health literacy (61% vs. 19%, p = 0.001). Participants with insufficient vision were more likely to misuse Diskus® devices (95% vs. 61%, p = 0.004). All participants (100%) were able to achieve mastery for both MDI and Diskus® devices.
Inhaler misuse is common, but correctable in hospitalized patients with COPD or asthma. Hospitals should implement a program to assess and teach appropriate inhaler technique that can overcome barriers to patient self-management, including insufficient vision, during transitions from hospital to home.
PMCID: PMC3101982  PMID: 21249463
asthma; pulmonary disease; chronic disease; hospital medicine; health literacy
16.  Effect of a Community-Wide Asthma Intervention on Appropriate Use of Inhaled Corticosteroids 
Individuals with asthma living in the inner city experience increased asthma morbidity and mortality compared to the US average. The Controlling Asthma in America’s Cities Project’s Chicago site used a multifaceted approach to improve asthma care. The diverse scope of this project’s interventions necessitated the use of novel methods to assess the effect of these interventions on the entire study area. Asthma-related medication-dispensing data were obtained from a large pharmacy chain for prescriptions filled in calendar years 2004–2006 for all individuals aged 5–17 years living in Chicago who filled at least four asthma-related medications within a 12-month period. Inhaled corticosteroid (ICS) use was considered inadequate if an individual had four or more dispensings of a short-acting beta-agonist without at least four dispensings of an ICS agent. Logistic regression was used to compare adequate ICS use in individuals within the intervention area with ICS use in the remainder of the city, after controlling for gender, insurance status, race, and poverty. A significant difference in adequate ICS use was found in years 2 (2005) and 3 (2006) of the project for individuals aged 5–9 in the intervention area (odds ratios for adequate ICS use—year 2, 1.26; CI, 1.04–1.53, p = 0.04; year 3, 1.30; CI, 1.08–1.55, p = 0.008) compared to individuals aged 5–9 in the remainder of the city. There was no similar significant difference in the 10–17 age group. These findings suggest an effect of a large multifaceted asthma intervention in improving medication use in the targeted age group. This methodology might also prove useful in the future for assessing the effect of similar interventions.
PMCID: PMC3042072  PMID: 21337060
Asthma outcomes; Pharmicoepidemiology; Asthma intervention
17.  A call for action: comparative effectiveness research in asthma 
Comparative effectiveness research (CER) has received considerable research attention in recent months, and efforts to promote CER are part of the newly enacted Patient Protection and Affordable Care Act. In this paper, we define CER, how it complements traditional efficacy research in asthma, and discuss how CER can help provide the basis for rational decision-making about the care of individual patients with asthma and how best to deliver this care in real-world settings. We present information about the challenges and opportunities to conduct CER, including enhanced patient registries for observational CER and effectiveness trials (also called pragmatic trials). We discuss the urgent need to define the appropriate methodologies for CER and to develop and prioritize a research agenda for CER studies in asthma with the help of a diverse group of stakeholders.
PMCID: PMC3017678  PMID: 20855111
Comparative effectiveness research; comparative clinical effectiveness research; observational studies; effectiveness trials; efficacy trials; pragmatic trials; explanatory trials; asthma
18.  High frequency chest wall oscillation for asthma and chronic obstructive pulmonary disease exacerbations: a randomized sham-controlled clinical trial 
Respiratory Research  2011;12(1):120.
High frequency chest wall oscillation (HFCWO) is used for airway mucus clearance. The objective of this study was to evaluate the use of HFCWO early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (COPD).
Randomized, multi-center, double-masked phase II clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or COPD at four academic medical centers. Patients received active or sham treatment for 15 minutes three times a day for four treatments. Medical management was standardized across groups. The primary outcomes were patient adherence to therapy after four treatments (minutes used/60 minutes prescribed) and satisfaction. Secondary outcomes included change in Borg dyspnea score (≥ 1 unit indicates a clinically significant change), spontaneously expectorated sputum volume, and forced expired volume in 1 second.
Fifty-two participants were randomized to active (n = 25) or sham (n = 27) treatment. Patient adherence was similarly high in both groups (91% vs. 93%; p = 0.70). Patient satisfaction was also similarly high in both groups. After four treatments, a higher proportion of patients in the active treatment group had a clinically significant improvement in dyspnea (70.8% vs. 42.3%, p = 0.04). There were no significant differences in other secondary outcomes.
HFCWO is well tolerated in adults hospitalized for acute asthma or COPD and significantly improves dyspnea. The high levels of patient satisfaction in both treatment groups justify the need for sham controls when evaluating the use of HFCWO on patient-reported outcomes. Additional studies are needed to more fully evaluate the role of HFCWO in improving in-hospital and post-discharge outcomes in this population.
Trial Registration NCT00181285
PMCID: PMC3179725  PMID: 21906390
asthma; chronic obstructive pulmonary disease; high frequency chest wall oscillation; airway mucus clearance
19.  An umbrella review: Corticosteroid therapy for adults with acute asthma 
The American journal of medicine  2009;122(11):977-991.
The objective of this ‘umbrella’ review is to synthesize the evidence and provide clinicians a single report which summarizes the state of knowledge regarding the use of corticosteroids in adults with acute asthma. Systematic reviews in the Cochrane Library and additional clinical trials published in English from 1966 to 2007 in MEDLINE, EMBASE, CINAHL, and Cochrane CENTRAL and references from bibliographies of pertinent articles were reviewed. Results indicate that the evidence base is frequently limited to small, single-center studies. Findings suggest that therapy with systemic corticosteroids accelerates resolution of acute asthma and reduces the risk of relapse. There is no evidence that corticosteroid doses higher than standard doses (prednisone 50–100 mg equivalent) are beneficial. Oral and intravenous corticosteroids, as well as intramuscular and oral corticosteroid regimens appear to be similarly effective. A non-tapered 5–10 day course of corticosteroid therapy appears to be sufficient for most discharged patients. Combinations of oral and inhaled corticosteroids on emergency department/hospital discharge may minimize the risk of relapse.
PMCID: PMC2768615  PMID: 19854321
asthma; asthma exacerbation; adults; acute asthma; corticosteroids; treatment; hospital; emergency department; review
20.  Are Physician Estimates of Asthma Severity Less Accurate in Black than in White Patients? 
Racial differences in asthma care are not fully explained by socioeconomic status, care access, and insurance status. Appropriate care requires accurate physician estimates of severity. It is unknown if accuracy of physician estimates differs between black and white patients, and how this relates to asthma care disparities.
We hypothesized that: 1) physician underestimation of asthma severity is more frequent among black patients; 2) among black patients, physician underestimation of severity is associated with poorer quality asthma care.
Design, Setting and Patients
We conducted a cross-sectional survey among adult patients with asthma cared for in 15 managed care organizations in the United States. We collected physicians’ estimates of their patients’ asthma severity. Physicians’ estimates of patients’ asthma as being less severe than patient-reported symptoms were classified as underestimates of severity.
Frequency of underestimation, asthma care, and communication.
Three thousand four hundred and ninety-four patients participated (13% were black). Blacks were significantly more likely than white patients to have their asthma severity underestimated (OR = 1.39, 95% CI 1.08–1.79). Among black patients, underestimation was associated with less use of daily inhaled corticosteroids (13% vs 20%, p < .05), less physician instruction on management of asthma flare-ups (33% vs 41%, p < .0001), and lower ratings of asthma care (p = .01) and physician communication (p = .04).
Biased estimates of asthma severity may contribute to racially disparate asthma care. Interventions to improve physicians’ assessments of asthma severity and patient–physician communication may minimize racial disparities in asthma care.
PMCID: PMC2583798  PMID: 17453263
asthma; racial disparities; patient–physician communication
21.  Mortality in Patients Hospitalized for Asthma Exacerbations in the United States 
Rationale: Hospitalizations for asthma exacerbations are common in the United States, but there are no national estimates of outcomes in this population. It is also not known if race disparities in asthma deaths exist among hospitalized patients.
Objectives: To estimate outcomes of patients hospitalized for asthma in the United States and to determine if the risk of death in this population is higher among black patients compared with white patients.
Methods: We used the Nationwide Inpatient Sample for 2000. Admissions for asthma exacerbations among patients > 5 yr of age were included. Mortality was the primary outcome; secondary outcomes were length of stay and total hospital charges.
Measurements and Main Results: In-hospital asthma mortality was 0.5% (99% confidence interval [CI], 0.4–0.6), with mean hospital stay of 2.7 d (99% CI, 2.6–2.8 d) and $9,078 (99% CI, $8,300–9,855) in hospital charges. Deaths in this population accounted for about one-third of all asthma deaths reported in the United States. Black patients hospitalized for asthma exacerbations were less likely to die when compared with white patients (0.3 vs. 0.6%; p < 0.001). However, in multivariable analyses, there were no significant race differences in hospital deaths.
Conclusions: Mortality among patients hospitalized for asthma exacerbations accounts for one-third of all deaths from asthma. The higher overall risk of death from asthma in black patients compared with white patients in the United States is not explained by race differences in hospital deaths and therefore is attributable to factors preceding hospitalization.
PMCID: PMC2648055  PMID: 16778163
costs; epidemiology; length of stay; mortality; race
22.  Tidal Volume Reduction in Patients with Acute Lung Injury When Plateau Pressures Are Not High 
Use of a volume- and pressure-limited mechanical ventilation strategy improves clinical outcomes of patients with acute lung injury and acute respiratory distress syndrome (ALI/ARDS). However, the extent to which tidal volumes and inspiratory airway pressures should be reduced to optimize clinical outcomes is a controversial topic. This article addresses the question, “Is there a safe upper limit to inspiratory plateau pressure in patients with ALI/ARDS?” We reviewed data from animal models with and without preexisting lung injury, studies of normal human respiratory system mechanics, and the results of five clinical trials of lung-protective mechanical ventilation strategies. We also present an original analysis of data from the largest of the five clinical trials. The available data from each of these assessments do not support the commonly held view that inspiratory plateau pressures of 30 to 35 cm H2O are safe. We could not identify a safe upper limit for plateau pressures in patients with ALI/ARDS.
PMCID: PMC2718413  PMID: 16081547
acute respiratory distress syndrome; acute lung injury; plateau; mechanical ventilation
23.  Tailored Education May Reduce Health Literacy Disparities in Asthma Self-Management 
Rationale: Although inadequate health literacy has been associated with lower asthma medication knowledge and worse metered-dose inhaler (MDI) technique, the relationship between health literacy and the capacity to learn asthma self-management skills is unknown.
Objectives: In this prospective cohort study of adults hospitalized for severe asthma exacerbations at two inner-city hospitals, we examined the relationship between inadequate health literacy and difficulties learning and retaining instructions about discharge medications and appropriate MDI technique.
Methods: At hospital discharge, participants received one-on-one, 30-min, guideline-based, written and oral instruction about their asthma discharge regimen as well as appropriate MDI technique.
Measurements and Main Results: Seventy-three patients were enrolled. Inadequate health literacy was identified in 16 (22%) participants. Before instruction, inadequate health literacy was associated with lower asthma medication knowledge (5.2/10 vs. 7.2/10, p < 0.001) and worse MDI technique (3.2/6 vs. 3.9/6, p =0.03). However, inadequate health literacy was not associated with difficulty learning (p =0.33) or retaining (p =0.35) instructions about the discharge regimen. Similarly, inadequate health literacy was not associated with difficulty learning (p =0.26) or retaining (p =0.97) appropriate MDI technique. Results were similar in multivariable models adjusted for demographic characteristics and asthma severity indicators.
Conclusions: These findings suggest that inadequate health literacy is a surmountable barrier to learning and remembering key asthma self-management skills.
PMCID: PMC2718412  PMID: 16081544
asthma; education; functional health literacy
24.  Lessons Learned for the Study of Childhood Asthma from the Centers for Children’s Environmental Health and Disease Prevention Research 
Environmental Health Perspectives  2005;113(10):1430-1436.
The National Children’s Study will address, among other illnesses, the environmental causes of both incident asthma and exacerbations of asthma in children. Seven of the Centers for Children’s Environmental Health and Disease Prevention Research (Children’s Centers), funded by the National Institute of Environmental Health Sciences and the U.S. Environmental Protection Agency, conducted studies relating to asthma. The design of these studies was diverse and included cohorts, longitudinal studies of older children, and intervention trials involving asthmatic children. In addition to the general lessons provided regarding the conduct of clinical studies in both urban and rural populations, these studies provide important lessons regarding the successful conduct of community research addressing asthma. They demonstrate that it is necessary and feasible to conduct repeated evaluation of environmental exposures in the home to address environmental exposures relevant to asthma. The time and staff required were usually underestimated by the investigators, but through resourceful efforts, the studies were completed with a remarkably high completion rate. The definition of asthma and assessment of disease severity proved to be complex and required a combination of questionnaires, pulmonary function tests, and biologic samples for markers of immune response and disease activity. The definition of asthma was particularly problematic in younger children, who may exhibit typical asthma symptoms sporadically with respiratory infections without developing chronic asthma. Medications confounded the definition of asthma disease activity, and must be repeatedly and systematically estimated. Despite these many challenges, the Children’s Centers successfully conducted long-term studies of asthma.
PMCID: PMC1281292  PMID: 16203259
asthma; children; Children’s Centers; environmental health; National Children’s Study; pregnancy

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