Current Landscape and Future Directions of Patient Education in Adults with Interstitial Lung Disease.

Background: Understandable, comprehensive, and accessible educational materials for patients with interstitial lung disease (ILD) are lacking. Patients consistently ask for improved access to evidence-based information about ILD. Nonetheless, few research studies focus directly on developing and evaluating interventions to improve patient knowledge. Objective: We describe the current landscape of patient education in ILD, identify gaps in current approaches to information delivery, and provide frameworks to address these challenges through novel educational tools. Methods: A literature review was conducted in collaboration with a medical librarian (M.R.D.) in April 2022 using Ovid MEDLINE (1946-), Embase (1947-), Cochrane Central (1993-), and CINAHL (1961-). Search terms included "interstitial lung disease," "pulmonary fibrosis," "patient education," and "information seeking behavior" (see the data supplement for full search terms). Reference lists from selected articles were used to identify additional studies. Results: Currently, patient education is commonly combined with exercise regimens in pulmonary rehabilitation programs in which benefits of the educational component alone are unclear. Few studies investigate improving knowledge access and acquisition for patients with ILD and their caregivers regarding self-management, oxygen use, and palliative care plans. Online distribution of health information through social media runs the risk of being unregulated and outdated, although it is an avenue of increasing accessibility. Conclusion: By expanding access to novel ILD-specific education programs and accounting for social determinants of health that impact healthcare access, patient education has the potential to become more attainable, improving patient-centered outcomes. Further research into optimal development, delivery, and efficacy testing of patient education modalities in ILD is warranted.

Meaningful Endpoints for Idiopathic Pulmonary Fibrosis (IPF) Clinical Trials: Emphasis on 'Feels, Functions, Survives'. Report of a Collaborative Discussion in a Symposium with Direct Engagement from Representatives of Patients, Investigators, the National Institutes of Health, a Patient Advocacy Organization, and a Regulatory Agency.

Background: Idiopathic pulmonary fibrosis (IPF) carries significant mortality and unpredictable progression, with limited therapeutic options. Designing trials with patient-meaningful endpoints, enhancing the reliability and interpretability of results, and streamlining the regulatory approval process are of critical importance to advancing clinical care in IPF. Methods: A landmark in-person symposium in June 2023 assembled 43 participants from the US and internationally, including patients with IPF, investigators, and regulatory representatives, to discuss the immediate future of IPF clinical trial endpoints. Patient advocates were central to discussions, which evaluated endpoints according to regulatory standards and the FDA's 'feels, functions, survives' criteria. Results: Three themes emerged: 1) consensus on endpoints mirroring the lived experiences of patients with IPF; 2) consideration of replacing forced vital capacity (FVC) as the primary endpoint, potentially by composite endpoints that include 'feels, functions, survives' measures or FVC as components; 3) support for simplified, user-friendly patient-reported outcomes (PROs) as either components of primary composite endpoints or key secondary endpoints, supplemented by functional tests as secondary endpoints and novel biomarkers as supportive measures (FDA Guidance for Industry (Multiple Endpoints in Clinical Trials) available at: https://www.fda.gov/media/162416/download). Conclusions: This report, detailing the proceedings of this pivotal symposium, suggests a potential turning point in designing future IPF clinical trials more attuned to outcomes meaningful to patients, and documents the collective agreement across multidisciplinary stakeholders on the importance of anchoring IPF trial endpoints on real patient experiences-namely, how they feel, function, and survive. There is considerable optimism that clinical care in IPF will progress through trials focused on patient-centric insights, ultimately guiding transformative treatment strategies to enhance patients' quality of life and survival.

Perspectives of Black Adults Living with Chronic Obstructive Pulmonary Disease on Barriers to Cardiovascular Disease Prevention.

RATIONALE: Cardiovascular disease (CVD) is a leading cause of morbidity and mortality among individuals with chronic obstructive pulmonary disease (COPD). Black women with COPD are at elevated risk of CVD-related mortality compared to White women. CVD risk factors are undertreated in Black men and women. However, barriers to CVD prevention from the perspective of Black individuals living with COPD have not been previously identified. OBJECTIVE: To identify barriers and facilitators for CVD prevention among Black individuals living with COPD. METHODS: We conducted semi-structured interviews with Black participants living with COPD and attending clinics at two urban hospitals. Participants were included if they had physician confirmed COPD diagnosis and presence of CVD or CVD risk factors. Participants were interviewed until thematic saturation was reached, with additional interviews conducted to confirm saturation. Data were analyzed using thematic analysis, iteratively revising, and updating the codebook by consensus of the study team. Codes were grouped into categories, subthemes, and themes. Themes were organized using the social ecological framework into individual, interpersonal, health system, and societal levels. RESULTS: We interviewed 30 participants of mean age 67.8 ± 8.3 years; 17 (57%) were Black women and 13 (43%) were Black men. Individual-level themes were: living with COPD and resultant multimorbidity impacts CVD prevention (theme 1), and self-efficacy and advocacy impact care received (theme 2). At the interpersonal level: supportive relationships facilitate improved access to CVD prevention (theme 3). System level themes were: health systems are not designed to support patients with COPD and CVD (theme 4), and health systems do not deliver effective patient education (theme 5). At the societal level: structural barriers and racism prevent accessing care and adopting a healthy lifestyle (theme 6). CONCLUSIONS: We identified barriers to CVD prevention at all levels of the socio-ecological framework for Black individuals living with COPD. To maximize their impact, future interventions to prevent CVD among individuals with COPD can use these findings to target barriers at multiple levels.

Practice patterns in reporting interstitial lung abnormality at a tertiary academic medical center.

PURPOSE: Interstitial lung abnormality (ILA) is a common finding on chest CTs and is associated with higher all-cause mortality. The 2020 Fleischner Society position paper standardized the terminology and definition of ILA. Despite these published guidelines, the extent to which radiologists use this term is unknown. We evaluated practice patterns for identification of ILAs among radiologists at a tertiary academic medical center. METHODS: In this retrospective review, we identified 157 radiology reports between January 1, 2010 through December 31, 2021 containing the phrase "interstitial lung abnormality" or "interstitial abnormality". After exclusions, 125 CT scans were reviewed by thoracic-trained radiologists using the sequential reading method. RESULTS: Seventy-seven (62%) patients were found to have ILA (69% subpleural fibrotic, 19% subpleural non-fibrotic, and 6% non-subpleural), nine (7%) were equivocal for ILA and 39 (31%) had no ILA. The term ILA was used exclusively by thoracic-trained radiologists except for two cases. Use of the term ILA has rapidly increased since the position paper publication (none from 2010-2017, one case in 2018, 20 cases in 2019, 41 cases in 2020, and 73 cases in 2021), and cases were typically very mild (1-25% of the lung). CONCLUSION: While there has been increased use of the term ILA among thoracic-trained radiologists, non-thoracic radiologists have essentially not begun to use the term. Almost one-third of cases labeled ILA on clinical reads were re-classified as not having ILA on research reads.

Disparities in Guideline Concordant Statin Treatment in Individuals With Chronic Obstructive Pulmonary Disease.

Rationale: Cardiovascular disease (CVD) affects the prognosis of patients with chronic obstructive pulmonary disease (COPD). Black women with COPD have a disproportionate risk of CVD-related mortality, yet disparities in CVD prevention in COPD are unknown. Objectives: We aimed to identify race-sex differences in the receipt of statin treatment for CVD prevention, and whether these differences were explained by factors influencing health care utilization in the REasons for Geographic And Racial Differences in Stroke (REGARDS) COPD study sub-cohort. Methods: We conducted a cross-sectional analysis among REGARDS Medicare beneficiaries with COPD. Our primary outcome was the presence of statin on in-home pill bottle review among individuals with an indication. Prevalence ratios (PR) for statin treatment among race-sex groups compared to White men were estimated using Poisson regression with robust variance. We then adjusted for covariates previously shown to impact health care utilization. Results: Of the 2032 members within the COPD sub-cohort with sufficient data, 1435 participants (19% Black women, 14% Black men, 28% White women, and 39% White men) had a statin indication. All race-sex groups were less likely to receive statins than White men in unadjusted models. After adjusting for covariates that influence health care utilization, Black women (PR 0.76, 95% confidence interval [CI] 0.67 to 0.86) and White women (PR 0.84 95% CI 0.76 to 0.91) remained less likely to be treated compared to White men. Conclusions: All race-sex groups were less likely to receive statin treatment in the REGARDS COPD sub-cohort compared to White men. This difference persisted in women after controlling for individual health care utilization factors, suggesting structural interventions are needed.

Validity and Reliability of the Fatigue Severity Scale in a Real-World Interstitial Lung Disease Cohort.

Rationale: Fatigue is a common and debilitating symptom for people living with interstitial lung disease (ILD). Studies on fatigue in ILD are limited, and little headway has been made toward developing interventions targeting the alleviation of fatigue. A barrier to progress is a lack of knowledge around the performance characteristics of a patient-reported outcome measure to assess fatigue in patients with ILD. Objectives: To assess the validity and reliability of the Fatigue Severity Scale (FSS) for measuring fatigue in a national cohort of patients with ILD. Methods: FSS scores and several anchors were measured in 1,881 patients from the Pulmonary Fibrosis Foundation Patient Registry. Anchors included the Short Form 6D Health Utility Index (SF-6D) score and a single vitality question from the SF-6D; the University of California, San Diego, Shortness of Breath Questionnaire; FVC; DlCO; and 6-minute-walk distance. Internal consistency reliability, concurrent validity, and known-groups validity were assessed. Structural validity was assessed using confirmatory factor analysis. Measurements and Main Results: The FSS demonstrated high internal consistency (Cronbach's α = 0.96). There were moderate to strong correlations between FSS score and patient-reported anchors (vitality question from the SF-6D [r = 0.55] and University of California, San Diego, Shortness of Breath Questionnaire total score [r = 0.70]) and weak correlations between FSS score and physiological measures (FVC [r = -0.24], percentage predicted DlCO [r = -0.23], and 6-minute-walk distance [r = -0.29]). Higher mean FSS scores, indicating greater fatigue, were observed among patients using supplemental oxygen, those prescribed steroids, and those with lower percentage predicted FVC and percentage predicted DlCO. The confirmatory factor analysis results suggest that the nine questions of the FSS reflect one dimension of fatigue. Conclusions: Fatigue is an important patient-centered outcome in ILD that is poorly correlated with physiological measures of disease severity, including lung function and walk distance. These findings further support the need for a reliable and valid measure of patient-reported fatigue in ILD. The FSS possesses acceptable performance characteristics for assessing fatigue and distinguishing different degrees of fatigue among patients with ILD.

Assessing mortality differences across acute respiratory failure management strategies in Covid-19.

PURPOSE: Prolonged observation could avoid invasive mechanical ventilation (IMV) and related risks in patients with Covid-19 acute respiratory failure (ARF) compared to initiating early IMV. We aimed to determine the association between ARF management strategy and in-hospital mortality. MATERIALS AND METHODS: Patients in the Weill Cornell Covid-19 registry who developed ARF between March 5 - March 25, 2020 were exposed to an early IMV strategy; between March 26 - April 1, 2020 to an intermediate strategy; and after April 2 to prolonged observation. Cox proportional hazards regression was used to model in-hospital mortality and test an interaction between ARF management strategy and modified sequential organ failure assessment (mSOFA). RESULTS: Among 632 patients with ARF, 24% of patients in the early IMV strategy died versus 28% in prolonged observation. At lower mSOFA, prolonged observation was associated with lower mortality compared to early IMV (at mSOFA = 0, HR 0.16 [95% CI 0.04-0.57]). Mortality risk increased in the prolonged observation strategy group with each point increase in mSOFA score (HR 1.29 [95% CI 1.10-1.51], p = 0.002). CONCLUSION: In Covid-19 ARF, prolonged observation was associated with a mortality benefit at lower mSOFA scores, and increased mortality at higher mSOFA scores compared to early IMV.

Evolving Needs of Critical Care Trainees during the COVID-19 Pandemic: A Qualitative Study.

Background: Critical care trainees were integral in the coronavirus disease (COVID-19) pandemic response. Several perspective pieces have provided insight into the pandemic's impact on critical care training. Surveys of program directors and critical care trainees have focused on curricular impact. There is a lack of data from the trainee perspective on curricular enhancements, career development, and emotional and well-being needs to succeed in a critical care career in the ongoing COVID-19 pandemic. Objective: Our objective was to elicit perspectives from critical care trainees on their personal and professional needs as they continue to serve in the COVID-19 pandemic. Methods: This was a hypothesis-generating qualitative study. Individuals in a U.S. critical care training program during the COVID-19 pandemic participated in either focus groups or semistructured interviews. Interviews were conducted between July 2020 and March 2021 until data saturation was achieved. Audio recordings were professionally transcribed and analyzed using qualitative content analysis. A codebook was generated by two independent coders, with a third investigator reconciling codes when there were discrepancies. Themes and subthemes were identified from these codes. Results: Thirteen participants were interviewed. The major themes identified were as follows: 1) Curricular adaptation is necessary to address evolving changes in trainee needs; 2) COVID-19 impacted career development and highlighted that trainees need individualized help to meet their goals; 3) receiving social support at work from peers and leaders is vital for the sustained well-being of trainees; 4) fostering and maintaining a sense of meaning and humanity in one's work is important; and 5) trainees desire assistance and support to process their emotions and experiences. Conclusion: The needs expressed by critical care trainees are only partially captured in conceptual models of physician well-being. The need for multilevel workplace social networks and identifying meaning in one's work have been magnified in this pandemic. The themes discussing curricular gaps, career development needs, and skills to process work-related trauma are less well captured in preexisting conceptual models and point to areas where further research and intervention development are needed.

Health Related Quality of Life in Interstitial Lung Disease: Can We Use the Same Concepts Around the World?

Health-Related Quality of Life (HRQOL) is increasingly viewed as an important patient-centered outcome by leading health organizations, clinicians, and patients alike. This is especially true in the interstitial lung disease community where patients often struggle with progressive and debilitating disease with few therapeutic options. In order to test the effectiveness of new pharmacologic therapies and non-pharmacologic interventions globally in ILD, this will require expansion of clinical research studies to a multinational level and HRQOL will be an important endpoint to many. In order to successfully expand trials across multiple nations and compare the results of studies between different communities we must recognize that there are differences in the concepts of HRQOL across the world and have strategies to address these differences. In this review, we will describe the different global influences on HRQOL both generally and in the context of ILD, discuss the processes of linguistic translation and cross-cultural adaptation of HRQOL Patient Reported Outcome Measures (PROMs), and highlight the gaps and opportunities for improving HRQOL measurement in ILD across the world.

Barriers to antigen detection and avoidance in chronic hypersensitivity pneumonitis in the United States.

BACKGROUND: Chronic hypersensitivity pneumonitis (CHP) is an interstitial lung disease (ILD) caused by long term exposure to an offending antigen. Antigen avoidance is associated with improved outcomes. We are unable to identify the antigen source in approximately half of patients. When an antigen is successfully identified, patients have difficulty with avoidance. METHODS: We conducted three structured group discussions with US based ILD specialists utilizing the nominal group technique (NGT). Participants listed barriers to antigen detection and avoidance in CHP. Each participant ranked what they perceived to be the top three barriers in the list in terms of importance. The master list of barriers was consolidated across the three groups into themes that were prioritized based on receiving the highest rankings by participants. RESULTS: Twenty-five physicians participated; 56% had experience caring for CHP patients for ≥ 16 years. Sixty barriers to antigen detection were categorized into seven themes of which the top three were: 1. unclear significance of identified exposures; 2. gaps in clinical knowledge and testing capabilities; 3. there are many unknown and undiscovered antigens. Twenty-eight barriers to antigen avoidance were categorized into five themes of which the top three were: 1. patient limitations, financial barriers and lack of resources; 2. individual patient beliefs, emotions and attachments to the antigen source; and 3. gaps in clinical knowledge and testing capabilities. CONCLUSIONS: This study uncovered challenges at the individual patient, organizational, and societal levels and ranked them in terms of level of importance. These findings provide information to guide development and validation of multidisciplinary support and interventions geared towards antigen identification and avoidance in CHP.

Patient-centered Outcomes Research in Interstitial Lung Disease: An Official American Thoracic Society Research Statement.

Background: In the past two decades, many advances have been made to our understanding of interstitial lung disease (ILD) and the way we approach its treatment. Despite this, many questions remain unanswered, particularly those related to how the disease and its therapies impact outcomes that are most important to patients. There is currently a lack of guidance on how to best define and incorporate these patient-centered outcomes in ILD research. Objectives: To summarize the current state of patient-centered outcomes research in ILD, identify gaps in knowledge and research, and highlight opportunities and methods for future patient-centered research agendas in ILD. Methods: An international interdisciplinary group of experts was assembled. The group identified top patient-centered outcomes in ILD, reviewed available literature for each outcome, highlighted important discoveries and knowledge gaps, and formulated research recommendations. Results: The committee identified seven themes around patient-centered outcomes as the focus of the statement. After a review of the literature and expert committee discussion, we developed 28 research recommendations. Conclusions: Patient-centered outcomes are key to ascertaining whether and how ILD and interventions used to treat it affect the way patients feel and function in their daily lives. Ample opportunities exist to conduct additional work dedicated to elevating and incorporating patient-centered outcomes in ILD research.

Establishing content-validity of a disease-specific health-related quality of life instrument for patients with chronic hypersensitivity pneumonitis.

BACKGROUND: Chronic Hypersensitivity Pneumonitis (CHP) is caused by an immune mediated response in the lung tissue after exposure to an inhaled environmental antigenic stimulant. We previously documented the ways in which CHP impacts patients' lives and have now developed a disease-specific instrument, the CHP-HRQOL instrument, to measure health-related quality of life (HRQOL). The objective of this study was to assess content validity for the CHP-HRQOL. METHODS: Cognitive interviews were conducted among adults with CHP. The instrument was revised and refined between each round of interviews. Feedback was obtained on the instructions, items, response options, and recall period. Items where participants had difficulty with comprehension, wording, or misinterpretation were marked by the interviewer and participant feedback was reviewed to make revisions, add or delete items when appropriate. Readability statistics were calculated using Flesch-Kincaid grade level and reading ease scores. RESULTS: Ten participants were interviewed over three rounds, with revisions made to the questionnaire in an iterative process. In the initial 39 item instrument, we identified 7 items where two or more participants reported difficulty. Participants preferred a four-week recall period (compared to a two-week recall period) and response options with a 5-point response scale. The final version of the CHP-HRQOL includes 40 items with a median reading level between 6th and 7th grade. CONCLUSION: The CHP-HRQOL instrument demonstrated high content validity and is ready for psychometric testing in further validation studies.

Bronchoscopic intubation is an effective airway strategy in critically ill patients.

PURPOSE: American Society of Anesthesiologists guidelines recommend the use of bronchoscopic intubation as a rescue technique in critically ill patients. We sought to assess the safety and efficacy of bronchoscopic intubation as an initial approach in critically ill patients. METHODS: We performed a retrospective cohort study of patients who underwent endotracheal intubation in the medical intensive care unit of a tertiary urban referral center over 1 academic year. The primary outcome was first-pass success rate. MEASUREMENTS AND MAIN RESULTS: We identified 219 patients who underwent either bronchoscopic (n=52) or laryngoscopic guided (n=167) intubation as the initial attempt. There was a higher first-pass success rate in the bronchoscopic intubation group than in the laryngoscopic group (96% vs 78%; P=.003). The bronchoscopic intubation group had a higher body mass index (28.4 vs 25.9; P=.027) and higher preintubation fraction of inspired oxygen requirement (0.73±0.27 vs 0.63±0.30; P=.044) than the laryngoscopic group. There were no cases of right mainstem intubation, esophageal intubation, or pneumothorax with bronchoscopic intubation. Rates of postintubation hypotension and hypoxemia were similar in both groups. The association with first-pass success remained with multivariate and propensity matched analysis. CONCLUSIONS: Bronchoscopic intubation as an initial strategy in critically ill patients is associated with a higher first-pass success rate than laryngoscopic intubation, and is not associated with an increase in complications.