Partnering With Patients With Sarcoidosis to Implement a Community Advisory Board.

BACKGROUND: Community advisory boards (CABs) are increasingly recognized as a means of incorporating patient experience into clinical practice and research. The power of CABs is derived from engaging with community members as equals throughout the research process. Despite this, little is known of community member experience and views on best practices for running a CAB in a rare pulmonary disease. RESEARCH QUESTION: What are CAB members' views on the best practices for CAB formation and maintenance in a rare pulmonary disease? STUDY DESIGN AND METHODS: In August 2021, we formed the Cleveland Clinic Sarcoidosis Health Partners (CC-HP) as a CAB to direct research and clinic improvement initiatives at a quaternary sarcoidosis center. We collaboratively evaluated our process for formation and maintenance of the CC-HP with the patient members of the group. Through the series of reflection/debriefing discussions, CAB patient members developed a consensus account of salient obstacles and facilitators of forming and maintaining a CAB in a rare pulmonary disease. RESULTS: Clinician and community members of the CC-HP found published guidelines to be an effective tool for structuring formation of a CAB in a rare pulmonary disease. Facilitators included a dedicated coordinator, collaborative development of projects, and a focus on improving clinical care. Obstacles to CAB functioning were formal structure, focus on projects with academic merit but no immediate impact to patients, and overreliance on digital resources. INTERPRETATION: By centering our evaluation of our CAB on community member experience, we were able to both identify facilitators and impediments to CAB as well as improve our own processes.

Race, Ethnicity, and Intensive Care Utilization for Common Pediatric Diagnoses: U.S. Pediatric Health Information System 2019 Database Study.

OBJECTIVES: Racial and ethnic disparities in healthcare delivery for acutely ill children are pervasive in the United States; it is unknown whether differential critical care utilization exists. DESIGN: Retrospective study of the Pediatric Health Information System (PHIS) database. SETTING: Multicenter database of academic children's hospitals in the United States. PATIENTS: Children discharged from a PHIS hospital in 2019 with one of the top ten medical conditions where PICU utilization was present in greater than or equal to 5% of hospitalizations. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Race and ethnicity categories included Asian, Black, Hispanic, White, and other. Primary outcomes of interest were differences in rate of PICU admission, and for children requiring PICU care, total hospital length of stay (LOS). One-quarter (n = 44,200) of the 178,134 hospital discharges included a PICU admission. In adjusted models, Black children had greater adjusted odds ratio (aOR [95% CI]) of PICU admission in bronchiolitis (aOR, 1.08 [95% CI, 1.02-1.14]; p = 0.01), respiratory failure (aOR, 1.18 [95% CI, 1.10-1.28]; p < 0.001), seizure (aOR, 1.28 [95% CI, 1.08-1.51]; p = 0.004), and diabetic ketoacidosis (DKA) (aOR, 1.18 [95% CI, 1.05-1.32]; p = 0.006). Together, Hispanic, Asian, and other race children had greater aOR of PICU admission in five of the diagnostic categories, compared with White children. The geometric mean (± sd) hospital LOS ranged from 47.7 hours (± 2.1 hr) in croup to 206.6 hours (± 2.8 hr) in sepsis. After adjusting for demographics and illness severity, non-White children had longer LOS in respiratory failure, pneumonia, DKA, and sepsis. CONCLUSIONS: The need for critical care to treat acute illness in children may be inequitable. Additional studies are needed to understand and eradicate differences in PICU utilization based on race and ethnicity.

Defining the Time-limited Trial for Patients with Critical Illness: An Official American Thoracic Society Workshop Report.

In critical care, the specific, structured approach to patient care known as a "time-limited trial" has been promoted in the literature to help patients, surrogate decision makers, and clinicians navigate consequential decisions about life-sustaining therapy in the face of uncertainty. Despite promotion of the time-limited trial approach, a lack of consensus about its definition and essential elements prevents optimal clinical use and rigorous evaluation of its impact. The objectives of this American Thoracic Society Workshop Committee were to establish a consensus definition of a time-limited trial in critical care, identify the essential elements for conducting a time-limited trial, and prioritize directions for future work. We achieved these objectives through a structured search of the literature, a modified Delphi process with 100 interdisciplinary and interprofessional stakeholders, and iterative committee discussions. We conclude that a time-limited trial for patients with critical illness is a collaborative plan among clinicians and a patient and/or their surrogate decision makers to use life-sustaining therapy for a defined duration, after which the patient's response to therapy informs the decision to continue care directed toward recovery, transition to care focused exclusively on comfort, or extend the trial's duration. The plan's 16 essential elements follow four sequential phases: consider, plan, support, and reassess. We acknowledge considerable gaps in evidence about the impact of time-limited trials and highlight a concern that if inadequately implemented, time-limited trials may perpetuate unintended harm. Future work is needed to better implement this defined, specific approach to care in practice through a person-centered equity lens and to evaluate its impact on patients, surrogates, and clinicians.

Perception of burden of oral and inhaled corticosteroid adverse effects on asthma-specific quality of life.

BACKGROUND: A multistakeholder core outcome set created for asthma trials showed that asthma-specific quality of life (QoL) was a critically meaningful outcome. However, the definition and measurement methods were undetermined. The adverse effects (AEs) of corticosteroids may be a vital clinical trial outcome. Nevertheless, the AE burden from the patient perspective has not yet been elucidated in an asthma population. OBJECTIVE: To characterize patient burden of AEs in oral (OCS) and inhaled corticosteroids (ICS) and how this relates to QoL within an asthma population. METHODS: We used a convergent parallel mixed-methods design with quantitative surveys of known ICS and OCS AEs that were distributed through the Allergy & Asthma Network database, social channels, and the Asthma UK newsletter. Participants rated the AEs that were (1) most burdensome and (2) most desired to be eliminated. Qualitative interviews and focus groups were performed to better understand patient views on barriers reported in the quantitative data, and to identify patient-important barriers that were not a part of the quantitative survey. RESULTS: The 3 most burdensome AEs for OCS were bone mineral density, infectious complications, and weight gain, whereas weight gain was the most desired to be eliminated. The 3 most burdensome AEs for ICS were pneumonia, hoarse voice, and oral thrush, with concordant results for the most desired to be eliminated. In the focus groups, OCS AEs were concordant with quantitative findings. Focus groups identified unmeasured psychosocial effects, such as embarrassment. CONCLUSION: The most burdensome AEs may not be those that would cause patients to stop therapy. Furthermore, qualitative focus groups suggest a psychosocial burden associated with ICS, which needs further investigation.

Strategies to Assess the Effect of Continuous Positive Airway Pressure on Long-Term Clinically Important Outcomes among Patients with Symptomatic Obstructive Sleep Apnea: An Official American Thoracic Society Workshop Report.

Continuous positive airway pressure (CPAP) is the first-line treatment for obstructive sleep apnea (OSA). Although CPAP improves symptoms (e.g., daytime sleepiness), there is a lack of high-quality evidence that CPAP prevents many long-term outcomes, including cognitive impairment, myocardial infarction, and stroke. Observational studies suggest that patients with symptoms may be particularly likely to experience these preventive benefits with CPAP, but ethical and practical concerns limited the participation of such patients in prior long-term randomized trials. As a result, there is uncertainty about the full benefits of CPAP, and resolving this uncertainty is a key priority for the field. This workshop assembled clinicians, researchers, ethicists, and patients to identify strategies to understand the causal effects of CPAP on long-term clinically important outcomes among patients with symptomatic OSA. Quasi-experimental designs can provide valuable information and are less time and resource intensive than trials. Under specific conditions and assumptions, quasi-experimental studies may be able to provide causal estimates of CPAP's effectiveness from generalizable observational cohorts. However, randomized trials represent the most reliable approach to understanding the causal effects of CPAP among patients with symptoms. Randomized trials of CPAP can ethically include patients with symptomatic OSA, as long as there is outcome-specific equipoise, adequate informed consent, and a plan to maximize safety while minimizing harm (e.g., monitoring for pathologic sleepiness). Furthermore, multiple strategies exist to ensure the generalizability and practicality of future randomized trials of CPAP. These strategies include reducing the burden of trial procedures, improving patient-centeredness, and engaging historically excluded and underserved populations.

Health Disparities: Interventions for Pulmonary Disease - A Narrative Review.

There is expansive literature documenting the presence of health disparities, but there are disproportionately few studies describing interventions to reduce disparity. In this narrative review, we categorize interventions to reduce health disparity in pulmonary disease within the US health care system to support future initiatives to reduce disparity. We identified 211 articles describing interventions to reduce disparity in pulmonary disease related to race, income, or sex. We grouped the studies into the following four categories: biologic, educational, behavioral, and structural. We identified the following five main themes: (1) there were few interventional trials compared with the breadth of studies describing health disparities, and trials involving patients with asthma who were Black, low income, and living in an urban setting were overrepresented; (2) race or socioeconomic status was not an effective marker of individual pharmacologic treatment response; (3) telehealth enabled scaling of care, but more work is needed to understand how to leverage telehealth to improve outcomes in marginalized communities; (4) future interventions must explicitly target societal drivers of disparity, rather than focusing on individual behavior alone; and (5) individual interventions will only be maximally effective when specifically tailored to local needs. Much work has been done to catalog health disparities in pulmonary disease. Notable gaps in the identified literature include few interventional trials, the need for research in diseases outside of asthma, the need for high quality effectiveness trials, and an understanding of how to implement proven interventions balancing fidelity to the original protocol and the need to adapt to local barriers to care.

Moving toward Equitable Care for Sleep Apnea in the United States: Positive Airway Pressure Adherence Thresholds: An Official American Thoracic Society Policy Statement.

Background: Positive airway pressure (PAP) is a highly effective treatment for obstructive sleep apnea (OSA), but adherence limits its efficacy. In addition, coverage of PAP by CMS (Centers for Medicare & Medicaid Services) and other insurers in the United States depends on adherence. This leaves many beneficiaries without PAP, disproportionally impacting non-white and low socioeconomic position patients with OSA and exacerbating sleep health disparities. Methods: An inter-professional, multidisciplinary, international committee with various stakeholders was formed. Three working groups (the historical policy origins, impact of current policy, and international PAP coverage models) met and performed literature reviews and discussions. Using surveys and an iterative discussion-based consensus process, the policy statement recommendations were created. Results: In this position paper, we advocate for policy change to CMS PAP coverage requirements to reduce inequities and align with patient-centered goals. We specifically call for eradicating repeat polysomnography, eliminating the 4-hour rule, and focusing on patient-oriented outcomes such as improved sleepiness and sleep quality. Conclusions: Modifications to the current policies for PAP insurance coverage could improve health disparities.

Experiences with Continuous Positive Airway Pressure Among African American Patients and their Bed Partners.

RATIONALE: Despite having a higher prevalence and severity of obstructive sleep apnea (OSA), African Americans have lower adherence to continuous positive airway pressure (CPAP) compared to other groups. Information regarding challenges faced by African Americans prescribed CPAP are lacking. OBJECTIVES: To determine the barriers and facilitators to optimal management of OSA with CPAP among African Americans and to understand the role bed partners may play. METHODS: We conducted semi-structured in-depth interviews via video conferencing with African American patients of an urban safety-net health care system with OSA prescribed CPAP and their bed partners. Recruitment continued until theoretical saturation was achieved. Verbatim transcripts were analyzed using the principles of thematic analysis. RESULTS: 15 patients (12 women) diagnosed with OSA and prescribed CPAP a mean 2.6 years prior along with 15 bed partners (3 women) were individually interviewed. Four themes emerged regarding impediments to CPAP use: 1) inadequate education and support, 2) CPAP maintenance and hygiene, 3) inconvenient design of CPAP interfaces, and 4) impediment to intimacy. Four themes emerged as facilitators to CPAP use: 1) provider and technical support, 2) properly fitted CPAP masks, 3) active support from partner and family, and 4) experiencing positive results from CPAP. CONCLUSIONS: African American patients with OSA and their bed partners identified several unique barriers and facilitators to CPAP use. Active involvement by bed partners was considered by both patients and partners as helpful in improving CPAP adherence. Interventions to improve OSA outcomes in this population should focus on patients and their bed partners.

Palliative Care Early in the Care Continuum among Patients with Serious Respiratory Illness: An Official ATS/AAHPM/HPNA/SWHPN Policy Statement.

Background: Patients with serious respiratory illness and their caregivers suffer considerable burdens, and palliative care is a fundamental right for anyone who needs it. However, the overwhelming majority of patients do not receive timely palliative care before the end of life, despite robust evidence for improved outcomes. Goals: This policy statement by the American Thoracic Society (ATS) and partnering societies advocates for improved integration of high-quality palliative care early in the care continuum for patients with serious respiratory illness and their caregivers and provides clinicians and policymakers with a framework to accomplish this. Methods: An international and interprofessional expert committee, including patients and caregivers, achieved consensus across a diverse working group representing pulmonary-critical care, palliative care, bioethics, health law and policy, geriatrics, nursing, physiotherapy, social work, pharmacy, patient advocacy, psychology, and sociology. Results: The committee developed fundamental values, principles, and policy recommendations for integrating palliative care in serious respiratory illness care across seven domains: 1) delivery models, 2) comprehensive symptom assessment and management, 3) advance care planning and goals of care discussions, 4) caregiver support, 5) health disparities, 6) mass casualty events and emergency preparedness, and 7) research priorities. The recommendations encourage timely integration of palliative care, promote innovative primary and secondary or specialist palliative care delivery models, and advocate for research and policy initiatives to improve the availability and quality of palliative care for patients and their caregivers. Conclusions: This multisociety policy statement establishes a framework for early palliative care in serious respiratory illness and provides guidance for pulmonary-critical care clinicians and policymakers for its proactive integration.

The Impact of an Electronic Health Record Intervention on Spirometry Completion in Patients with Chronic Obstructive Pulmonary Disease.

Spirometry is necessary to diagnose chronic obstructive pulmonary disease (COPD), yet a large proportion of patients are diagnosed and treated without having received testing. This study explored whether the effects of interventions using the electronic health record (EHR) to target patients diagnosed with COPD without confirmatory spirometry impacted the incidence rates of spirometry referrals and completions. This retrospective before and after study assessed the impact of provider-facing clinical decision support that identified patients who had a diagnosis of COPD but had not received spirometry. Spirometry referrals, completions, and results were ascertained 1.5 years prior to and 1.5 years after the interventions were initiated. Inhaler prescriptions by class were also tallied. There were 10,949 unique patients with a diagnosis of COPD who were eligible for inclusion. 4,895 patients (44.7%) were excluded because they had completed spirometry prior to the cohort start dates. The pre-intervention cohort consisted of 2,622 patients, while the post-intervention cohort had 3,392. Spirometry referral rates pre-intervention were 20.2% compared to 31.6% post-intervention (p < 0.001). Spirometry completion rates rose from 13.2% pre-intervention to 19.3% afterwards (p < 0.001). 61.7% (585 of 948) had no evidence of airflow obstruction. After excluding patients with a diagnosis of asthma, 25.8% (126 of 488) patients who had no evidence of airflow obstruction had prescriptions for long-acting bronchodilators or inhaled steroids. A concerted EHR intervention modestly increased spirometry referral and completion rates in patients with a diagnosis of COPD without prior spirometry and decreased misclassification of disease.

Differences in Symptoms and Severity of Obstructive Sleep Apnea between Black and White Patients.

Rationale: Prior work suggests that Black patients have more severe obstructive sleep apnea (OSA) upon clinical presentation. However, the extent to which this may reflect differences in symptoms or other standard measures of OSA risk is unclear. Objectives: We assessed for racial disparities in OSA characteristics at time of initial clinical diagnosis. Methods: Data from 890 newly diagnosed patients with OSA at an urban academic sleep center were included in this analysis. All patients completed a standardized questionnaire on demographics and sleep-related symptoms and underwent laboratory polysomnography. Symptom severity at the time of evaluation was compared across race and sex. Results: Black men were underrepresented in the sleep lab, making up only 15.8% of the cohort and 31.3% of Black participants (P < 0.001). Despite this, Black men had the most severe OSA with a mean apnea hypopnea index of 52.4 ± 39.4 events/hour, compared with 39.0 ± 28.9 in White men, 33.4 ± 32.3 in Black women, and 26.2 ± 23.8 in White women (P < 0.001 for test of homogeneity). Black men also had the greatest burden of OSA symptoms with the highest mean Epworth Sleepiness Scale score (12.2 ± 5.9 versus 9.4 ± 5.2 in White men, 11.2 ± 5.9, in Black women, and 9.8 ± 5.6 in White women; P < 0.001). Compared with White men, Black men were 1.61 (95% CI [1.04-2.51]) times more likely to have witnessed apneas and 1.56 (95% CI [1.00-2.46]) times more likely to have drowsy driving at the time of OSA diagnosis. Conclusions: At the time of clinical diagnosis, Black men have greater disease severity, suggesting delay in diagnosis. Further, the greater burden of classic OSA symptoms suggests the delayed diagnosis of OSA in Black men is not due to atypical presentation. Further research is needed to identify why screening methods for OSA are not equitably implemented in the care of Black men.

Social Factors Predictive of Intensive Care Utilization in Technology-Dependent Children, a Retrospective Multicenter Cohort Study.

Objective: Technology-dependent children with medical complexity (CMC) are frequently admitted to the pediatric intensive care unit (PICU). The social risk factors for high PICU utilization in these children are not well described. The objective of this study was to describe the relationship between race, ethnicity, insurance status, estimated household income, and PICU admission following the placement of a tracheostomy and/or gastrostomy (GT) in CMC. Study Design: This was a retrospective multicenter study of children <19 years requiring tracheostomy and/or GT placement discharged from a hospital contributing to the Pediatric Health Information System (PHIS) database between January 2016 and March 2019. Primary predictors included estimated household income, insurance status, and race/ethnicity. Additional predictor variables collected included patient age, sex, number of chronic complex conditions (CCC), history of prematurity, and discharge disposition following index hospitalization. The primary outcome was need for PICU readmission within 30 days of hospital discharge. Secondary outcomes included repeated PICU admissions and total hospital costs within 1 year of tracheostomy and/or GT placement. Results: Patients requiring a PICU readmission within 30 days of index hospitalization for tracheostomy or GT placement accounted for 6% of the 20,085 included subjects. In multivariate analyses, public insurance [OR 1.28 (95% C.I. 1.12-1.47), p < 0.001] was associated with PICU readmission within 30 days of hospital discharge while living below the federal poverty threshold (FPT) was associated with a lower odds of 30-day PICU readmission [OR 0.7 (95% C.I. 0.51-0.95), p = 0.0267]. Over 20% (n = 4,197) of children required multiple (>1) PICU admissions within one year from index hospitalization. In multivariate analysis, Black children [OR 1.20 (95% C.I. 1.10-1.32), p < 0.001] and those with public insurance [OR 1.34 (95% C.I. 1.24-1.46), p < 0.001] had higher odds of multiple PICU admissions. Social risk factors were not associated with total hospital costs accrued within 1 year of tracheostomy and/or GT placement. Conclusions: In a multicenter cohort study, Black children and those with public insurance had higher PICU utilization following tracheostomy and/or GT placement. Future research should target improving healthcare outcomes in these high-risk populations.

Barriers to Care among Patients with Sarcoidosis: A Qualitative Study.

Rationale: Lower-income patients with sarcoidosis experience worse outcomes than those with higher incomes. The reasons for these disparities are not well understood. Objectives: To identify patient-reported barriers to and facilitators of self-empowered care among patients with sarcoidosis residing in high- and low-median-income zip-code areas. Methods: Patients with biopsy-proven sarcoidosis who had received pharmacologic treatment within the past year and who were cared for in a sarcoidosis clinic of a large, urban medical system were included. Focus groups were stratified by high- and low-median-income zip-code areas. Transcriptions were analyzed using grounded theory. Results: Five focus groups were created; two included patients living in zip-code areas with high median incomes ($84,263; interquartile range [IQR], $79,334-$89,795), and three included patients living in zip-code areas with low median incomes ($27,470; IQR, $22,412-27,597). Patients with sarcoidosis from low-income and high-income zip-code areas reported remarkably similar experiences. Patients reported that sarcoidosis was a burden owing to its disease manifestations and the adverse effects of treatment, which led to a compromised ability to perform their activities of daily living at home or at work. Reported barriers to care included perceived inadequate knowledge about sarcoidosis among providers, communication barriers with providers, and the high cost of treatment. Patients from low-income zip-code areas experienced discrimination related to race and income, which served to compound their mistrust. Patients sought to overcome these barriers through self-empowerment, including independent learning, self-advocacy, medication nonadherence, and use of alternative therapies. Conclusions: Patients with sarcoidosis who lived in high- and low-income zip-code areas expressed similar overall concerns regarding sarcoidosis care. However, patients from low-income zip-code areas more frequently expressed concerns about racial and income-based discrimination. Patients from both groups addressed these barriers through self-empowerment, which included not adhering to prescribed therapies. Future work should focus on the effects of culturally and socioeconomically congruent, community-engaged interventions for quality of life of patients with sarcoidosis.

Evaluating the Performance of Driver's License Agencies Using a Standardized Donor Ratio.

Department of Motor Vehicles (DMV) facilities are assessed based on the proportion of patrons who consent to donate. To evaluate the individual characteristics that may influence donation consent, we analyzed the most recent transactions of 9,767,839 patrons of 203 Ohio DMVs between January 1, 2014 and November 17, 2018. Patron age, gender, donor designation, and DMV location were linked via patron zip codes with census tract data on race, ethnicity, income, and education. The Standardized Donor Designation Ratio (SDDR) (the observed number of donors at each DMV divided by the expected number of donors based on patron demographic characteristics) was calculated. Altogether 5,769,561 DMV patrons (59.1%) were designated as donors. Donor designation was independently associated with younger age, female gender, nonblack race, Hispanic ethnicity, and higher income. Across 203 DMVs, the percent donors ranged from 33% to 73%, and SDDRs ranged from 0.7 to 1.61. The correlation between the 2 measures demonstrated that 47% of the variation in SDDR was explained by percent donors. In conclusion, across DMVs there is substantial variation in organ donor designation rates. SDDRs that adjust for DMV patron characteristics may distinctly and more accurately describe individual DMV facility success in promoting organ donation.

Making Medical Treatment Decisions for Unrepresented Patients in the ICU. An Official American Thoracic Society/American Geriatrics Society Policy Statement.

Background and Rationale: ICU clinicians regularly care for patients who lack capacity, an applicable advance directive, and an available surrogate decision-maker. Although there is no consensus on terminology, we refer to these patients as "unrepresented." There is considerable controversy about how to make treatment decisions for these patients, and there is significant variability in both law and clinical practice.Purpose and Objectives: This multisociety statement provides clinicians and hospital administrators with recommendations for decision-making on behalf of unrepresented patients in the critical care setting.Methods: An interprofessional, multidisciplinary expert committee developed this policy statement by using an iterative consensus process with a diverse working group representing critical care medicine, palliative care, pediatric medicine, nursing, social work, gerontology, geriatrics, patient advocacy, bioethics, philosophy, elder law, and health law.Main Results: The committee designed its policy recommendations to promote five ethical goals: 1) to protect highly vulnerable patients, 2) to demonstrate respect for persons, 3) to provide appropriate medical care, 4) to safeguard against unacceptable discrimination, and 5) to avoid undue influence of competing obligations and conflicting interests. These recommendations also are intended to strike an appropriate balance between excessive and insufficient procedural safeguards. The committee makes the following recommendations: 1) institutions should offer advance care planning to prevent patients at high risk for becoming unrepresented from meeting this definition; 2) institutions should implement strategies to determine whether seemingly unrepresented patients are actually unrepresented, including careful capacity assessments and diligent searches for potential surrogates; 3) institutions should manage decision-making for unrepresented patients using input from a diverse interprofessional, multidisciplinary committee rather than ad hoc by treating clinicians; 4) institutions should use all available information on the patient's preferences and values to guide treatment decisions; 5) institutions should manage decision-making for unrepresented patients using a fair process that comports with procedural due process; 6) institutions should employ this fair process even when state law authorizes procedures with less oversight.Conclusions: This multisociety statement provides guidance for clinicians and hospital administrators on medical decision-making for unrepresented patients in the critical care setting.