A Research Agenda to Improve Outcomes in Patients with Chronic Obstructive Pulmonary Disease and Cardiovascular Disease: An Official American Thoracic Society Research Statement.

Background: Individuals with chronic obstructive pulmonary disease (COPD) are often at risk for or have comorbid cardiovascular disease and are likely to die of cardiovascular-related causes. Objectives: To prioritize a list of research topics related to the diagnosis and management of patients with COPD and comorbid cardiovascular diseases (heart failure, atherosclerotic vascular disease, and atrial fibrillation) by summarizing existing evidence and using consensus-based methods. Methods: A literature search was performed. References were reviewed by committee co-chairs. An international, multidisciplinary committee, including a patient advocate, met virtually to review evidence and identify research topics. A modified Delphi approach was used to prioritize topics in real time on the basis of their potential for advancing the field. Results: Gaps spanned the translational science spectrum from basic science to implementation: 1) disease mechanisms; 2) epidemiology; 3) subphenotyping; 4) diagnosis and management; 5) clinical trials; 6) care delivery; 7) medication access, adherence, and side effects; 8) risk factor mitigation; 9) cardiac and pulmonary rehabilitation; and 10) health equity. Seventeen experts participated, and quorum was achieved for all votes (>80%). Of 17 topics, ≥70% agreement was achieved for 12 topics after two rounds of voting. The range of summative Likert scores was -15 to 25. The highest priority was "Conduct pragmatic clinical trials with patient-centered outcomes that collect both pulmonary and cardiac data elements." Health equity was identified as an important topic that should be embedded within all research. Conclusions: We propose a prioritized research agenda with the purpose of stimulating high-impact research that will hopefully improve outcomes among people with COPD and cardiovascular disease.

Care Quality for Patients with Chronic Obstructive Pulmonary Disease in the Readmission Penalty Era.

Rationale: Chronic obstructive pulmonary disease (COPD) is the fifth-leading cause of admissions and third-leading cause of readmissions among U.S. adults. Recent policies instituted financial penalties for excessive COPD readmissions. Objectives: To evaluate changes in the quality of care for patients hospitalized for COPD after implementation of the Hospital Readmissions Reduction Program (HRRP). Methods: We conducted a retrospective cohort study of patients older than 40 years of age hospitalized for COPD across 995 U.S. hospitals (Premier Healthcare Database). Measurements and Main Results: Quality of care before and after HRRP implementation was measured via adherence to recommended inpatient care treatments for acute exacerbations of COPD (recommended care, nonrecommended care, "ideal care" [all recommended and no nonrecommended care]). We included 662,842 pre-HRRP (January 2010-September 2014) and 285,508 post-HRRP (October 2014-December 2018) admissions. Recommended care increased at a rate of 0.16% per month pre-HRRP and 0.01% per month post-HRRP (P < 0.001). Nonrecommended care decreased at a rate of 0.15% per month pre-HRRP and 0.13% per month post-HRRP. Ideal care increased at a rate of 0.24% per month pre-HRRP and 0.11% per month post-HRRP (P < 0.001). Conclusions: The pre-HRRP trends toward improving care quality for inpatient COPD care slowed after HRRP implementation. This suggests that financial penalties for readmissions did not stimulate higher quality of care for patients hospitalized with COPD. It remains unclear what policies or approaches will be effective to ensure high care quality for patients hospitalized with COPD exacerbations.

Inhaled Reliever Therapies for Asthma: A Systematic Review and Meta-Analysis.

Importance: The optimal inhaled reliever therapy for asthma remains unclear. Objective: To compare short-acting ß agonists (SABA) alone with SABA combined with inhaled corticosteroids (ICS) and with the fast-onset, long-acting ß agonist formoterol combined with ICS for asthma. Data Sources: The MEDLINE, Embase, and CENTRAL databases were searched from January 1, 2020, to September 27, 2024, without language restrictions. Study Selection: Pairs of reviewers independently selected randomized clinical trials evaluating (1) SABA alone, (2) ICS with formoterol, and (3) ICS with SABA (combined or separate inhalers). Data Extraction and Synthesis: Two reviewers independently extracted data and assessed risk of bias. Random-effects meta-analyses synthesized outcomes. GRADE (Grading of Recommendations Assessment, Development, and Evaluation) was used to evaluate the certainty of evidence. Main Outcomes and Measures: Asthma symptom control (5-item Asthma Control Questionnaire; range, 0-6, lower scores indicate better asthma control; minimum important difference [MID], 0.5 points), asthma-related quality of life (Asthma Quality of Life Questionnaire; range, 1-7, higher scores indicate better quality of life; MID, 0.5 points), risk of severe exacerbations, and risk of serious adverse events. Results: A total of 27 randomized clinical trials (N = 50 496 adult and pediatric patients; mean age, 41.0 years; 20 288 male [40%]) were included. Compared with SABA alone, both ICS-containing relievers were associated with fewer severe exacerbations (ICS-formoterol risk ratio [RR], 0.65 [95% CI, 0.60-0.72]; risk difference [RD], -10.3% [95% CI, -11.8% to -8.3%]; ICS-SABA RR, 0.84 [95% CI, 0.73-0.95]; RD, -4.7% [95% CI, -8.0% to -1.5%]) with high certainty. Compared with SABA alone, both ICS-containing relievers were associated with improved asthma control (ICS-formoterol RR improvement [MID] in total score, 1.07 [95% CI, 1.04-1.10]; RD, 4.1% [95% CI, 2.3%-5.9%]; ICS-SABA RR, 1.09 [95% CI, 1.03-1.15]; RD, 5.4% [95% CI, 1.8%-8.5%]) with high certainty. In an indirect comparison with ICS-SABA, ICS-formoterol was associated with fewer severe exacerbations (RR, 0.78 [95% CI, 0.66-0.92]; RD, -5.5% [95% CI, -8.4% to -2.0%]) with moderate certainty. Compared with SABA alone, ICS-formoterol (RD, -0.6% [95% CI, -1.3% to 0%]) was not associated with increased risk of serious adverse events (high certainty) and ICS-SABA (RD, 0% [95% CI, -1.1% to 1.2%]) was not associated with increased risk of serious adverse events (moderate certainty). Conclusions and Relevance: In this network meta-analysis of patients with asthma, ICS combined with formoterol and ICS combined with SABA were each associated with reduced asthma exacerbations and improved asthma control compared with SABA alone.

Effectiveness of a Bundled Payments for Care Improvement Program for Chronic Obstructive Pulmonary Disease.

BACKGROUND: The Medicare Bundled Payments for Care Improvement (BPCI) program reimburses 90-day care episodes post-hospitalization. COPD is a leading cause of early readmissions making it a target for value-based payment reform. OBJECTIVE: Evaluate the financial impact of a COPD BPCI program. DESIGN, PARTICIPANTS, INTERVENTIONS: A single-site retrospective observational study evaluated the impact of an evidence-based transitions of care program on episode costs and readmission rates, comparing patients hospitalized for COPD exacerbations who received versus those who did not receive the intervention. MAIN MEASURES: Mean episode costs and readmissions. KEY RESULTS: Between October 2015 and September 2018, 132 received and 161 did not receive the program, respectively. Mean episode costs were below target for six out of eleven quarters for the intervention group, as opposed to only one out of twelve quarters for the control group. Overall, there were non-significant mean savings of $2551 (95% CI: - $811 to $5795) in episode costs relative to target costs for the intervention group, though results varied by index admission diagnosis-related group (DRG); there were additional costs of $4184 per episode for the least-complicated cohort (DRG 192), but savings of $1897 and $1753 for the most complicated index admissions (DRGs 191 and 190, respectively). A significant mean decrease of 0.24 readmissions per episode was observed in 90-day readmission rates for intervention relative to control. Readmissions and hospital discharges to skilled nursing facilities were factors of higher costs (mean increases of $9098 and $17,095 per episode respectively). CONCLUSIONS: Our COPD BPCI program had a non-significant cost-saving effect, although sample size limited study power. The differential impact of the intervention by DRG suggests that targeting interventions to more clinically complex patients could increase the financial impact of the program. Further evaluations are needed to determine if our BPCI program decreased care variation and improved quality of care. PRIMARY SOURCE OF FUNDING: This research was supported by NIH NIA grant #5T35AG029795-12.

Variations in the Design and Use of Attention Control Groups in Type 2 Diabetes Randomized Controlled Trials: a Systematic Review.

PURPOSE OF REVIEW: In type 2 diabetes (T2D) research, the phrase "attention control group" (ACGs) has been used with varying descriptions. We aimed to systematically review the variations in the design and use of ACGs for T2D studies. RECENT FINDINGS: Twenty studies utilizing ACGs were included in the final evaluation. Control group activities had the potential to influence the primary outcome of the study in 13 of the 20 articles. Prevention of contamination across groups was not mentioned in 45% of the articles. Eighty-five percent of articles met or somewhat met the criteria for having comparable activities between the ACG and intervention arms. Wide variations in descriptions and the lack of standardization have led to an inaccurate use of the phrase "ACGs" when describing the control arm of trials, indicating a need for future research with focus on the adoption of uniform guidelines for use of ACGs in T2D RCTs.

Evaluating inhaler education interventions for hospitalized children with asthma: A randomized controlled trial.

BACKGROUND: Most children with asthma have poor inhaler technique, with detrimental morbidity effects. Guidelines recommend clinicians provide inhaler education at every opportunity, yet resources are limited. A low-cost, technology-based intervention-Virtual Teach-to-Goal (V-TTG)-was developed to deliver tailored inhaler technique education with high fidelity. OBJECTIVE: To evaluate whether V-TTG leads to less inhaler misuse among children with asthma who are hospitalized vs brief intervention (BI, reading steps aloud). METHODS: A single-center randomized controlled trial of V-TTG vs BI was conducted with 5-to-10-year-old children with asthma hospitalized between January 2019 and February 2020. Inhaler technique was assessed pre- and post-education using 12-step validated checklists (misuse: < 10 steps correct). RESULTS: Among 70 children enrolled, mean age was 7.8 years (SD = 1.6). Most (86%) were Black. Most had an emergency department visit (94%) or hospitalization (90%) in the previous year. At baseline, nearly all children misused inhalers (96%). The proportion of children with inhaler misuse decreased significantly in V-TTG (100%→74%, P = .002) and BI (92%→69%, P = .04) groups, with no difference between groups at both time points (P = .2 and .9). On average, children performed 1.5 more steps correctly (SD = 2.0), with greater improvement with V-TTG (mean [SD] = 1.7 [1.6]) vs BI (mean [SD] = 1.4 [2.3]), though not significant (P = .6). Concerning pre and post technique, older children were significantly more likely than younger children to show more correct steps (mean change = 1.9 vs 1.1, P = .002). CONCLUSION: A technology-based intervention for tailored inhaler education led to improved technique among children, similarly to reading steps aloud. Older children saw greater benefits. Future studies should evaluate the V-TTG intervention across diverse populations and disease severities to identify the greatest impact. CLINICAL TRIAL REGISTRATION: NCT04373499.

Estimated cost-savings from optimizing use of inhaled medications for inpatients with obstructive lung disease.

CONCLUSIONS: Models representing transitions from all-nebulized to nebulizer-plus-MDI respiratory medications resulted in cost savings, largely from the reduction of labor cost of nebulizer administration with nebs-only treatment. Therefore, transitioning from nebs to MDIs can lead to cost savings and could allow greater opportunities for inhaler education.

Video-Based Educational Interventions for Patients With Chronic Illnesses: Systematic Review.

BACKGROUND: With rising time constraints, health care professionals increasingly depend on technology to provide health advice and teach patients how to manage chronic disease. The effectiveness of video-based tools in improving knowledge, health behaviors, disease severity, and health care use for patients with major chronic illnesses is not well understood. OBJECTIVE: The aim of this study was to assess the current literature regarding the efficacy of video-based educational tools for patients in improving process and outcome measures across several chronic illnesses. METHODS: A systematic review was conducted using CINAHL and PubMed with predefined search terms. The search included studies published through October 2021. The eligible studies were intervention studies of video-based self-management patient education for an adult patient population with the following chronic health conditions: asthma, chronic kidney disease, chronic obstructive pulmonary disease, chronic pain syndromes, diabetes, heart failure, HIV infection, hypertension, inflammatory bowel disease, and rheumatologic disorders. The eligible papers underwent full extraction of study characteristics, study design, sample demographics, and results. Bias was assessed with the Cochrane risk-of-bias tools. Summary statistics were synthesized in Stata SE (StataCorp LLC). Data reporting was conducted per the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) checklist. RESULTS: Of the 112 studies fully extracted, 59 (52.7%) were deemed eligible for inclusion in this review. The majority of the included papers were superiority randomized controlled trials (RCTs; 39/59, 66%), with fewer pre-post studies (13/59, 22%) and noninferiority RCTs (7/59, 12%). The most represented conditions of interest were obstructive lung disease (18/59, 31%), diabetes (11/59, 19%), and heart failure (9/59, 15%). The plurality (28/59, 47%) of video-based interventions only occurred once and occurred alongside adjunct interventions that included printed materials, in-person counseling, and interactive modules. The most frequently studied outcomes were disease severity, health behavior, and patient knowledge. Video-based tools were the most effective in improving patient knowledge (30/40, 75%). Approximately half reported health behavior (21/38, 56%) and patient self-efficacy (12/23, 52%) outcomes were improved by video-based tools, and a minority of health care use (11/28, 39%) and disease severity (23/69, 33%) outcomes were improved by video-based tools. In total, 48% (22/46) of the superiority and noninferiority RCTs and 54% (7/13) of the pre-post trials had moderate or high risk of bias. CONCLUSIONS: There is robust evidence that video-based tools can improve patient knowledge across several chronic illnesses. These tools less consistently improve disease severity and health care use outcomes. Additional study is needed to identify features that maximize the efficacy of video-based interventions for patients across the spectrum of digital competencies to ensure optimized and equitable patient education and outcomes.

The Longer-Term Benefits and Harms of Glucagon-Like Peptide-1 Receptor Agonists: a Systematic Review and Meta-Analysis.

BACKGROUND: Previous meta-analyses of the benefits and harms of glucagon-like peptide-1 receptor agonists (GLP1RAs) have been limited to specific outcomes and comparisons and often included short-term results. We aimed to estimate the longer-term effects of GLP1RAs on cardiovascular risk factors, microvascular and macrovascular complications, mortality, and adverse events in patients with type 2 diabetes, compared to placebo and other anti-hyperglycemic medications. METHODS: We searched PubMed, Scopus, and clinicaltrials.gov (inception-July 2019) for randomized controlled trials ≥ 52 weeks' duration that compared a GLP1RA to placebo or other anti-hyperglycemic medication and included at least one outcome of interest. Outcomes included cardiovascular risk factors, microvascular and macrovascular complications, all-cause mortality, and treatment-related adverse events. We performed random effects meta-analyses to give summary estimates using weighted mean differences (MD) and pooled relative risks (RR). Risk of bias was assessed using the Cochrane Collaboration risk of bias in randomized trials tool. Quality of evidence was summarized using the Grading of Recommendations, Assessment, Development, and Evaluation approach. The study was registered a priori with PROSPERO (CRD42018090506). RESULTS: Forty-five trials with a mean duration of 1.7 years comprising 71,517 patients were included. Compared to placebo, GLP1RAs reduced cardiovascular risk factors, microvascular complications (including renal events, RR 0.85, 0.80-0.90), macrovascular complications (including stroke, RR 0.86, 0.78-0.95), and mortality (RR 0.89, 0.84-0.94). Compared to other anti-hyperglycemic medications, GLP1RAs only reduced cardiovascular risk factors. Increased gastrointestinal events causing treatment discontinuation were observed in both comparisons. DISCUSSION: GLP1RAs reduced cardiovascular risk factors and increased gastrointestinal events compared to placebo and other anti-hyperglycemic medications. GLP1RAs also reduced MACE, stroke, renal events, and mortality in comparisons with placebo; however, analyses were inconclusive for comparisons with other anti-hyperglycemic medications. Given the high costs of GLP1RAs, the lack of long-term evidence comparing GLP1RAs to other anti-hyperglycemic medications has significant policy and clinical practice implications.

Longer-term Benefits and Risks of Sodium-Glucose Cotransporter-2 Inhibitors in Type 2 Diabetes: a Systematic Review and Meta-analysis.

BACKGROUND: Sodium-glucose cotransporter-2 inhibitors (SGLT2Is) are a recent class of medication approved for the treatment of type 2 diabetes (T2D). Previous meta-analyses have quantified the benefits and harms of SGLT2Is; however, these analyses have been limited to specific outcomes and comparisons and included trials of short duration. We comprehensively reviewed the longer-term benefits and harms of SGLT2Is compared to placebo or other anti-hyperglycemic medications. METHODS: We searched PubMed, Scopus, and clinicaltrials.gov from inception to July 2019 for randomized controlled trials of minimum 52 weeks' duration that enrolled adults with T2D, compared an SGLT2I to either placebo or other anti-hyperglycemic medications, and reported at least one outcome of interest including cardiovascular risk factors, microvascular and macrovascular complications, mortality, and adverse events. We conducted random effects meta-analyses to provide summary estimates using weighted mean differences (MD) and pooled relative risks (RR). The study was registered a priori with PROSPERO (CRD42018090506). RESULTS: Fifty articles describing 39 trials (vs. placebo, n = 28; vs. other anti-hyperglycemic medication, n = 12; vs. both, n = 1) and 112,128 patients were included in our analyses. Compared to placebo, SGLT2Is reduced cardiovascular risk factors (e.g., hemoglobin A1c, MD - 0.55%, 95% CI - 0.62, - 0.49), macrovascular outcomes (e.g., hospitalization for heart failure, RR 0.70, 95% CI 0.62, 0.78), and mortality (RR 0.87, 95% CI 0.80, 0.94). Compared to other anti-hyperglycemic medications, SGLT2Is reduced cardiovascular risk factors, but insufficient data existed for other outcomes. About a fourfold increased risk of genital yeast infections for both genders was observed for comparisons vs. placebo and other anti-hyperglycemic medications. DISCUSSION: We found that SGLT2Is led to durable reductions in cardiovascular risk factors compared to both placebo and other anti-hyperglycemic medications. Reductions in macrovascular complications and mortality were only observed in comparisons with placebo, although trials comparing SGLT2Is vs. other anti-hyperglycemic medications were not designed to assess longer-term outcomes.

The Productivity Requirements of Implementing a Medical Scribe Program.

BACKGROUND: Economic analyses of medical scribes have been limited to individual, specialty-specific clinics. OBJECTIVE: To determine the number of additional patient visits various specialties would need to recover the costs of implementing scribes in their practice at 1 year. DESIGN: Modeling study based on 2015 data from the Centers for Medicare & Medicaid Services (CMS) and National Ambulatory Medical Care Survey. Scribe costs were based on literature review and a third-party contractor model. Revenue was calculated from direct visit billing, CPT (Current Procedural Terminology) billing, and data from the National Ambulatory Medical Care Survey. DATA SOURCES: 2015 data from CMS and the National Ambulatory Medical Care Survey. TARGET POPULATION: Health care providers. TIME HORIZON: 1 year. PERSPECTIVE: Office-based clinic. OUTCOME MEASURES: The number of additional patient visits a physician must have to recover the costs of a scribe program at 1 year. RESULTS OF BASE-CASE ANALYSIS: An average of 1.34 additional new patient visits per day (295 per year) were required to recover scribe costs (range, 0.89 [cardiology] to 1.80 [orthopedic surgery] new patient visits per day). For returning patients, an average of 2.15 additional visits per day (472 per year) were required (range, 1.65 [cardiology] to 2.78 [orthopedic surgery] returning visits per day). The addition of 2 new patient (or 3 returning) visits per day was profitable for all specialties. RESULTS OF SENSITIVITY ANALYSIS: Results were not sensitive to most inputs, with the exception of hourly scribe cost and inclusion of CPT revenue. LIMITATION: Use of Medicare data and failure to account for indirect costs, downstream revenue, or changes in documentation quality. CONCLUSION: For all specialties, modest increases in productivity due to scribes may allow physicians to see more patients and offset scribe costs, making scribe programs revenue-neutral. PRIMARY FUNDING SOURCE: University of Chicago Medicine's Center for Healthcare Delivery Science and Innovation and the Bucksbaum Institute.

A Mixed-methods Study Examining Inhaler Carry and Use among Children at School.

Objective: Asthma self-management depends partly on access to inhalers; for children, this includes independent inhaler carry and use at school ("self-carry"). Although laws and policies support self-carry, little is known about practices within schools. This study aimed to identify factors associated with inhaler self-carry among children and examine barriers and facilitators to self-carry.Methods: This mixed-methods observational study included child-parent dyads and nurses from four Chicago schools. Children and parents answered questions about asthma care and morbidity, confidence in self-carry skills, and facilitators and barriers to self-carry. Nurses reported asthma documentation on file and their confidence in children's self-carry skills. Analysis utilized logistic regression. Thematic analysis was performed for open-ended questions.Results: Of 65 children enrolled (mean = 10.66 years), 45 (69.2%) reported having quick-relief medication at school, primarily inhalers, and 35 (53.8%) reported self-carry. Inhaler self-carry was associated with controller medication use and parent confidence in child's self-carry skills. Children and parents identified several facilitators to self-carry: child's asthma knowledge, inhaler characteristics, and need for easy inhaler access. Barriers included child's limited understanding of asthma and inhalers, perception that inhaler is not needed, and limited inhaler access. Children also emphasized social relationships as facilitators and barriers, while parents described children's responsibility as a facilitator and inconsistent policy implementation as a barrier.Conclusions: Efforts to improve inhaler self-carry at school should focus on educating children about asthma and inhaler use, creating supportive environments for self-carry among peers and teachers, and fostering consistent implementation and communication about asthma policy among schools and families.

Evaluating the Need to Address Digital Literacy Among Hospitalized Patients: Cross-Sectional Observational Study.

BACKGROUND: Technology is a potentially powerful tool to assist patients with transitions of care during and after hospitalization. Patients with low health literacy who are predisposed to poor health outcomes are particularly poised to benefit from such interventions. However, this population may lack the ability to effectively engage with technology. Although prior research studied the role of health literacy in technology access/use among outpatients, hospitalized patient populations have not been investigated in this context. Further, with the rapid uptake of technology, access may no longer be pertinent, and differences in technological capabilities may drive the current digital divide. Thus, characterizing the digital literacy of hospitalized patients across health literacy levels is paramount. OBJECTIVE: We sought to determine the relationship between health literacy level and technological access, use, and capability among hospitalized patients. METHODS: Adult inpatients completed a technology survey that asked about technology access/use and online capabilities as part of an ongoing quality of care study. Participants' health literacy level was assessed utilizing the 3-question Brief Health Literacy Screen. Descriptive statistics, bivariate chi-squared analyses, and multivariate logistic regression analyses (adjusting for age, race, gender, and education level) were performed. Using Bonferroni correction for the 18 tests, the threshold P value for significance was <.003. RESULTS: Among 502 enrolled participants, the mean age was 51 years, 71.3% (358/502) were African American, half (265/502, 52.8%) were female, and half (253/502, 50.4%) had at least some college education. Over one-third (191/502, 38.0%) of participants had low health literacy. The majority of participants owned devices (owned a smartphone: 116/173, 67.1% low health literacy versus 235/300, 78.3% adequate health literacy, P=.007) and had used the Internet previously (143/189, 75.7% low health literacy versus 281/309, 90.9% adequate health literacy, P<.001). Participants with low health literacy were more likely to report needing help performing online tasks (133/189, 70.4% low health literacy versus 135/303, 44.6% adequate health literacy, P<.001). In the multivariate analysis, when adjusting for age, race, gender, and education level, we found that low health literacy was not significantly associated with a lower likelihood of owning smartphones (OR: 0.8, 95% CI 0.5-1.4; P=.52) or using the internet ever (OR: 0.5, 95% CI 0.2-0.9; P=.02). However, low health literacy remained significantly associated with a higher likelihood of needing help performing any online task (OR: 2.2, 95% CI 1.3-3.6; P=.002). CONCLUSIONS: The majority of participants with low health literacy had access to technological devices and had used the internet previously, but they were unable to perform online tasks without assistance. The barriers patients face in using online health information and other health information technology may be more related to online capabilities rather than to technology access. When designing and implementing technological tools for hospitalized patients, it is important to ensure that patients across digital literacy levels can both understand and use them.

Harmonized outcome measures for use in asthma patient registries and clinical practice.

BACKGROUND: Asthma, a common chronic airway disorder, affects an estimated 25 million persons in the United States and 330 million persons worldwide. Although many asthma patient registries exist, the ability to link and compare data across registries is hindered by a lack of harmonization in the outcome measures collected by each registry. OBJECTIVES: The purpose of this project was to develop a minimum set of patient- and provider-relevant standardized outcome measures that could be collected in asthma patient registries and clinical practice. METHODS: Asthma registries were identified through multiple sources and invited to join the workgroup and submit outcome measures. Additional measures were identified through literature searches and reviews of quality measures and consensus statements. Outcome measures were categorized by using the Agency for Healthcare Research and Quality's supported Outcome Measures Framework. A minimum set of broadly relevant measures was identified. Measure definitions were harmonized through in-person and virtual meetings. RESULTS: Forty-six outcome measures, including those identified from 13 registries, were curated and harmonized into a minimum set of 21 measures in the Outcome Measures Framework categories of survival, clinical response, events of interest, patient-reported outcomes, resource utilization, and experience of care. The harmonized definitions build on existing consensus statements and are appropriate for adult and pediatric patients. CONCLUSIONS: The harmonized measures represent a minimum set of outcomes that are relevant in asthma research and clinical practice. Routine and consistent collection of these measures in registries and other systems would support creation of a national research infrastructure to efficiently address new questions and improve patient management and outcomes.

A qualitative study of parent perspectives on barriers, facilitators and expectations for school asthma care among urban, African-American children.

Objectives: Minority children experience the disproportionate burden of asthma and its consequences. Studies suggest ethnic groups may experience asthma differently with varied perceptions and expectations among parents of African-American and Latino children. Because parents coordinate asthma care with the school, where children spend a significant amount of their day, this study's goal was to determine parents' perspectives on school asthma management. Methods: Focus groups were conducted with parents of children with asthma at four urban schools whose student population is predominantly African-American. A semi-structured guide was utilized focusing on barriers, facilitators and expectations for asthma care at school. Grounded theory principles were applied in this study. Results: Twenty-two parents (91% females) representing 13 elementary and 10 middle school children with asthma (61% boys) participated in four focus groups. Most children (87%) had persistent asthma. The identified barriers to effective school-based asthma care included limited awareness of children with asthma by teachers/staff, communication issues (e.g. school/parent, within school), inadequate education and lack of management plans or systems in place. In contrast, the identified facilitators included steps that fostered education, communication and awareness, as supported by management plans and parent initiative. Parents described their expectations for increased communication and education about asthma, better systems for identifying children with asthma, and a trained asthma point person for school-based asthma care. Conclusions: Parents of children with asthma identified important barriers, facilitators and expectations that must be considered to advance school asthma management. Improved school-based asthma care could lead to better health and academic outcomes.

Student perspectives on asthma management in schools: a mixed-methods study examining experiences, facilitators, and barriers to care.

Objective: Children spend nearly a third of their day at school, making it a critical point of intervention for those with asthma. This study aimed to illuminate minority students' experiences with asthma at school and perceptions of facilitators and barriers to care. Methods: A mixed-methods study was conducted with elementary students with asthma. Participants completed a 24-question survey, drawing exercise to depict experiences caring for their asthma at school, and focus group discussion. Drawings were analyzed for narrative and pictorial themes. Discussions were audio-recorded, transcribed, and independently coded for themes. Results: Fifteen children with asthma (8-11 years) participated from two Chicago schools with predominately African-American populations. Most students (79%) indicated they had control of asthma at school, while 85% identified asthma as a problem when exercising. Half (53%) received help with asthma care at school. Drawings depicted cooperative management with adults or peers and the central role of inhalers as part of everyday asthma care in school. Finally, focus groups produced six key themes within the domains of facilitators: 1) support of others, 2) self-efficacy; 3) perception of being normal; and barriers: 4) lack of support from others; 5) difficulty accessing inhaler; 6) perception of being different. Conclusions: This study suggests asthma care plays an important role in students' school experiences. Stigma around inhaler use, lack of concern by school staff, and limited access to medications remain as barriers to school-based asthma management. Although facilitators, such as support from teachers and peers, do exist, future interventions must address existing barriers.

Improving the Affordability of Prescription Medications for People with Chronic Respiratory Disease. An Official American Thoracic Society Policy Statement.

BACKGROUND: Mounting evidence indicates that out-of-pocket costs for prescription medications, particularly among low- and middle-income patients with chronic diseases, are imposing financial burden, reducing medication adherence, and worsening health outcomes. This problem is exacerbated by a paucity of generic alternatives for prevalent lung diseases, such as asthma and chronic obstructive pulmonary disease, as well as high-cost medicines for rare diseases, such as cystic fibrosis. Affordability and access challenges are especially salient in the United States, as citizens of many other countries pay lower prices for and have greater access to prescription medications. METHODS: The American Thoracic Society convened a multidisciplinary committee comprising experts in health policy pharmacoeconomics, behavioral sciences, and clinical care, along with individuals providing industry and patient perspectives. The report and its recommendation were iteratively developed over a year of in-person, telephonic, and electronic deliberation. RESULTS: The committee unanimously recommended the establishment of a publicly funded, politically independent, impartial entity to systematically draft evidence-based pharmaceutical policy recommendations. The goal of this entity would be to generate evidence and action steps to ensure people have equitable and affordable access to prescription medications, to maximize the value of public and private pharmaceutical expenditures on health, to support novel drug development within a market-based economy, and to preserve clinician and patient choice regarding personalized treatment. An immediate priority is to examine the evidence and make recommendations regarding the need to have essential medicines with established clinical benefit from each drug class in all Tier 1 formularies and propose recommendations to reduce barriers to timely generic drug availability. CONCLUSIONS: By making explicit, evidence-based recommendations, the entity can support the establishment of coherent national policies that expand access to affordable medications, improve the health of patients with chronic disease, and optimize the use of public and private resources.

Using Video Telehealth to Facilitate Inhaler Training in Rural Patients with Obstructive Lung Disease.

BACKGROUND: Proper inhaler technique is important for effective drug delivery and symptom control in chronic obstructive pulmonary disease (COPD) and asthma, yet not all patients receive inhaler instructions. INTRODUCTION: Using a retrospective chart review of participants in a video telehealth inhaler training program, the study compared inhaler technique within and between monthly telehealth visits and reports associated with patient satisfaction. MATERIALS AND METHODS: Seventy-four (N = 74) rural patients prescribed ≥1 inhaler participated in three to four pharmacist telehealth inhaler training sessions using teach-to-goal (TTG) methodology. Within and between visit inhaler technique scores are compared, with descriptive statistics of pre- and postprogram survey results including program satisfaction and computer technical issues. Healthcare utilization is compared between pre- and post-training periods. RESULTS: Sixty-nine (93%) patients completed all three to four video telehealth inhaler training sessions. During the initial visit, patients demonstrated improvement in inhaler technique for metered dose inhalers (albuterol, budesonide/formoterol), dry powder inhalers (formoterol, mometasone, tiotropium), and soft mist inhalers (ipratropium/albuterol) (p < 0.01 for all). Improved inhaler technique was sustained at 2 months (p < 0.01). Ninety-four percent of participants were satisfied with the program. Although technical issues were common, occurring among 63% of attempted visits, most of these visits (87%) could be completed. There was no significant difference in emergency department visits and hospitalizations pre- and post-training. DISCUSSION: This study demonstrated high patient acceptance of video telehealth training and objective improvement in inhaler technique. CONCLUSIONS: Video telehealth inhaler training using the TTG methodology is a promising program that improved inhaler technique and access to inhaler teaching for rural patients with COPD or asthma.