Outcomes Important to Patients Diagnosed with Both COPD and Sleep Apnea: Findings from the O2VERLAP Study Focus Groups.

INTRODUCTION: Few studies have asked chronic obstructive pulmonary disease (COPD) -obstructive sleep apnea (OSA) overlap syndrome patients what outcomes of continuous positive airway pressure (CPAP) therapy are important to them, while also considering their self-reported CPAP adherence barriers and facilitators. This study conducted a series of focus groups to learn about those issues with the goal of applying these findings to the design of a larger Patient-Centered Outcomes Research Institute-funded scientific study, the O2VERLAP Study. METHODS: People previously diagnosed with both COPD and OSA, who were current or recent past users of the standard therapy for each condition (i.e., supplemental oxygen and CPAP, respectively), were included. Three qualitative focus groups were run using different communication modalities: (1) teleconference (audio only), (2) in-person, and (3) web-based. RESULTS: The focus groups included a total of 17 participants. The telephone and online focus groups resulted in more relevant and content-rich transcripts, while the in-person focus groups had far fewer excerpts able to be coded. Participants were most concerned about mask fit and comfort. Other key factors affecting CPAP use included nasal dryness and issues concerning insurance. The most important outcome to patients was daytime functioning. DISCUSSION: This work found that telephone and web-based qualitative focus groups resulted in greater topical discussions than in-person focus groups, likely due to the customary socializing that occurs in-person. The study identified: (1) CPAP use barriers and facilitators that helped guide intervention development for the larger study and, (2) daytime functioning as the most important outcome for patients.

Effect of Two Interventional Strategies on Improving Continuous Positive Airway Pressure Adherence in Existing COPD and Obstructive Sleep Apnea Patients: The O2VERLAP Study.

Background: Obstructive sleep apnea (OSA) is a sleep disorder prevalent in >10% of individuals diagnosed with chronic obstructive pulmonary disease (COPD). Continuous positive airway pressure (CPAP) is the first-line therapy for OSA, but many do not use it enough during sleep to effectively manage OSA. The O2VERLAP study compared proactive care (PC)-structured web-based peer-coaching education and support intervention versus reactive care (RC)-education and support based on limited scheduled interactions and patient-initiated contacts. Methods: Participants were primarily recruited from patient communities (COPD, OSA, and the National Patient-Centered Outcomes Research Network [PCORnet]) through electronic methods. Inclusion criteria: ≥40 years old, diagnosis of both COPD and OSA, and currently using CPAP. Participants were then randomly assigned to either the PC or RC group, with outcomes assessed at baseline and 6 and 12 weeks. The primary study outcome was CPAP adherence (hours of use/night) and secondary outcomes were daytime functioning, sleep quality, and daytime sleepiness. Changes in outcomes over time were examined using random effects models. Results: The study enrolled 332 participants of which 294 were randomized. While groups differed significantly in CPAP adherence at baseline (PC: 6.1±3.1, RC: 7.3±2.4 hours/night; P<0.001), there were no significant differences in change of primary and secondary outcomes at either 6 or 12 weeks. Conclusion: In this group of patients with both COPD and OSA on CPAP therapy, no difference was found between the provision of PC and RC. The study did find unexpectedly high baseline CPAP adherence levels, which suggests that any improvement from the intervention would have been very small and difficult to detect.

Self-reported COPD Medication Use and Adherence in the COPD Foundation Patient- Powered Registry Network.

PURPOSE: Pharmacotherapy is one cornerstone of Chronic Obstructive Pulmonary Disease (COPD) management. Published U.S. data seldom includes patient-reported COPD medication use and adherence. We add this patient perspective to the commonly reported administrative prescribing and fill data. METHODS: This survey study used inhaler and nebulizer pictures and lists of oral COPD medications to query members of the COPD Foundation Patient-Powered Research Network, a national self-reported online registry. Medications used, adherence, inhaler education, cost concerns, previous exacerbations, and COPD Assessment Test scores were assessed and summarized using simple descriptive statistics and hazard ratios controlling for age, gender, and disease burden. RESULTS: Respondents mean age was 68 years, 60% were women, >69% with the COPD Assessment Test (CAT) scores >15, and >50% reported 2 or more exacerbations in the past 12 months. Overall, >98% used one or more inhaled COPD medications, 7.6% rescue inhaler only, 17.8% used long-acting bronchodilator only therapy (11.1% dual), and 72.8% using corticosteroid therapies, including 53% triple therapy. Nebulizers were used by 59.4% and 34.8% use oral COPD medications. Reported adherence rates were high (80.1%), but 41% reported trouble paying for medications, with 20.1% reported missing medications due to cost. CONCLUSIONS: In this population, COPD had a high burden with >50% of respondents using triple therapy, and one in eight maintenance oral corticosteroids. Self-reported adherence was high, but with significant cost concerns reported resulting in missed medications.

Symptom Burden and Medication Use Among Patients with Nontuberculous Mycobacterial Lung Disease.

PURPOSE: Respiratory diseases caused by nontuberculous mycobacteria (NTM) have become a significant concern for patients and health care providers. We aimed to compare symptoms experienced during the 2 week period, at a single point in time, by patients with NTM lung disease (NTMLD) who were currently on any medication to treat their NTMLD versus those not on any therapies. METHODS: We analyzed responses to a "Burden of NTM Survey" developed by the COPD Foundation. The study population included 266 individuals with NTMLD. Using adjusted penalized logistic regression models, we determined associations between the self-reported symptoms and the use of any medication to treat NTMLD. RESULTS: Based on available data, most respondents were aged 50 and older (95.1%), of female gender (93.1%), and had been living with NTMLD for more than 5 years (55.7%). Many respondents reported symptoms that bother them very often or daily. After adjustment for age and gender, duration of living with NTMLD, and other respiratory illnesses, patients on medication had significantly larger odds of reporting difficulty in walking 500 meters without stopping, difficulty in interacting with others, fatigue or lack of energy, feelings of sadness or depression related to illness, and shortness of breath, wheezing or other difficulties. CONCLUSION: In this study, patients currently on any medication to treat their NTMLD reported more symptoms associated with their NTMLD. Further investigations are needed to explore whether increased symptoms are related to differences in disease severity and/or medication effects.

Pilot Study of a Patient Experience with an ELLIPTA Inhaler Electronic Medication Monitor and Associated Integrated System: A Prospective Observational Study Using the COPD Patient-Powered Research Network.

BACKGROUND: Electronic medication monitors (EMMs) are associated with decreased rescue inhaler use, symptom burden, and increased medication adherence in asthma. However, the use of EMMs in people with chronic obstructive pulmonary disease (COPD) using the ELLIPTA dry powder inhaler has not been studied. METHODS: This was an open-label, single-arm, prospective observational study of EMMs and associated application (app) use over 12 weeks and up to 24 weeks (April-October 2019) in people with self-reported COPD aged ≥40 years enrolled in the COPD Patient-Powered Research Network, using an ELLIPTA inhaler. The primary outcome was daily active use of the app over 12 weeks. Treatment adherence, rescue inhaler use, and participant satisfaction were assessed over the same period. RESULTS: Among the 122 participants, mean (standard deviation [SD]) proportion of days participants opened the app was 59.5% (31.4), 51.1% (33.5) and 41.3% (34.2) for Days 1-30, 31-60 and 61-90, respectively. Mean (SD) adherence to maintenance medication remained stable: 80.2% (22.7) and 79.9% (26.7) for Days 1-30 and 61-90, respectively. In participants using a rescue inhaler and EMM, mean (SD) rescue-free days increased from 18.5 (10.0; Days 1-30, n=51) to 21.4 (9.6; Days 61-90, n=48). Participants reported high levels of confidence in using the EMM, valued app reminders highly and reported high system satisfaction (mean [SD] scale: 1=low, 5=high; 4.6 [1.1], 4.3 [1.1] and 4.1 [1.1], respectively). CONCLUSIONS: Use of an ELLIPTA EMM with frequent app engagement, high participant satisfaction and decreased rescue medication use may aid COPD management.

Understanding the Bariatric Patient Perspective in the National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study.

BACKGROUND: In 2016, the Patient-Centered Outcomes Research Institute funded the National Patient Centered Clinical Research Network (PCORnet) Bariatric Study (PBS). Understanding the experience of postoperative patients was a key component of this study. METHODS: Nine focus groups were conducted in Southern California, Louisiana, Pennsylvania, and Ohio and in a national advocacy conference for patients with obesity. Participants were identified and recruited in both clinical and community settings. Focus group transcripts were analyzed using an iterative inductive-deductive approach to identify global overarching themes. RESULTS: There were 76 focus group participants. Participants were mostly women (81.4%), had primarily undergone gastric sleeve (47.0%), were non-Hispanic white (51.4%), had some college education (44.3%), and made $100,000 annual income or less (65.7%). Qualitative findings included negative reactions patients received from friends, family, and co-workers once they disclosed that they had bariatric surgery to lose weight; and barriers to follow-up care included insurance coverage, emotional and situational challenges, and physical pain limiting mobility. CONCLUSIONS: These findings confirm the other qualitative findings in this area. The approach to bariatric surgery should be expanded to provide long-term comprehensive care that includes in-depth postoperative lifetime monitoring of emotional and physical health.

Patient-Reported Consequences of Community-Acquired Pneumonia in Patients with Chronic Obstructive Pulmonary Disease.

Community acquired pneumonia (CAP) carries high morbidity, mortality, and economic burden, which is even higher in adults diagnosed with chronic obstructive pulmonary disease (COPD). While several studies have assessed the clinical burden and mortality risk of CAP and COPD, very few studies focus on CAP burden from a COPD patient perspective. Individuals recently diagnosed with CAP and with pre-existing COPD were recruited through the COPD Foundation. The CAP Burden of Illness Questionnaire (CAP-BIQ), a content validated questionnaire assessing CAP symptomatology, duration of symptoms and CAP impact on work, activities and family, was administered at baseline and at 30-days follow-up. Of the 490 participants recruited, 481 had data sufficient for analysis. The prevalence of respiratory-related symptoms was very high (>90%) at the time of diagnosis with other generalized symptoms such as fatigue, trouble sleeping, headaches and confusion present in more than 60% of participants. Mean duration of symptoms varied from approximately 2 weeks for headaches and fever to more than a month for fatigue, wheezing, dyspnea, and cough. Employed participants missed an average of 21 days of work and those not employed missed 36 days of usual activities. Over 84% required help from family, friends or care givers. CAP is a serious and burdensome condition for people with COPD, a condition that can impair activities for weeks, frequently requires care from family or friends, and includes lingering symptoms. The patient-reported impact of CAP reported in this study underscores the need for prevention strategies in this population.

Introducing the New COPD Pocket Consultant Guide App: Can A Digital Approach Improve Care? A Statement of the COPD Foundation.

The COPD Foundation has tried to address gaps in chronic obstructive pulmonary disease (COPD) care by providing COPD Pocket Consultant Guide cards to U.S. health care providers. Since launching the card in 2007, there have been numerous updates and more than 800,000 of these cards have been distributed at no charge to health care professionals. The most recent versions have concentrated on presenting an algorithm for COPD management based on 7 severity domains: spirometry, symptoms, exacerbations, oxygen requirements, the presence of chronic bronchitis or emphysema and comorbidities. To increase the usability and reach of this tool, the COPD Pocket Consultant Guide is now available as an app for iOS and Android. This updated version of the app includes new COPD and asthma/COPD overlap flow charts; an interactive therapy chart that takes into account modified Medical Research Council (mMRC), COPD Assessment Test (CAT), and spirometry scores; anxiety and depression screeners; up-to-date medication charts in both brand and generic formats; a checklist to aid in determining when a patient should be referred to a pulmonologist and more. Potential use of the COPD Pocket Consultant Guide app in clinical care is discussed.

US Patient-Centered Research Priorities and Roadmap for Bronchiectasis.

Noncystic fibrosis bronchiectasis (bronchiectasis) is an increasingly common chronic lung disease that is difficult to manage because of a lack of evidence on which to base treatment decision-making. We sought to develop a practical list of US-based patient-centered research priorities and an associated roadmap to guide bronchiectasis research. We designed and administered a web-based patient needs assessment survey to establish broad research priorities, convened three stakeholder webinars to confirm the top priorities, obtained written stakeholder feedback, and completed a final consensus survey of objectives. The stakeholder panel consisted of clinical research experts in bronchiectasis, a seven-member patient advisory panel, and representatives from the two key patient advocacy organizations: COPD Foundation and NTM Info and Research Inc. Based on survey results from 459 patients with bronchiectasis, the stakeholder panel identified 27 patient-centered research priorities for bronchiectasis in the areas of bronchiectasis treatment and prevention of exacerbations, improving treatment of exacerbations and infections, improving health-related quality of life, predictors of poor prognosis, understanding the impact of underlying conditions, and conducting patient-centered clinical trials. These priorities should further inform the development and evaluation of both new and previously unproven therapies, with particular attention to the inclusion of patient-reported outcomes. We anticipate a great deal of progress will be made in the field of bronchiectasis in the next decade.

The National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study Cohort: Rationale, Methods, and Baseline Characteristics.

BACKGROUND: Although bariatric procedures are commonly performed in clinical practice, long-term data on the comparative effectiveness and safety of different procedures on sustained weight loss, comorbidities, and adverse effects are limited, especially in important patient subgroups (eg, individuals with diabetes, older patients, adolescents, and minority patients). OBJECTIVE: The objective of this study was to create a population-based cohort of patients who underwent 3 commonly performed bariatric procedures-adjustable gastric band (AGB), Roux-en-Y gastric bypass (RYGB), and sleeve gastrectomy (SG)-to examine the long-term comparative effectiveness and safety of these procedures in both adults and adolescents. METHODS: We identified adults (20 to 79 years old) and adolescents (12 to 19 years old) who underwent a primary (first observed) AGB, RYGB, or SG procedure between January 1, 2005 and September 30, 2015 from 42 health systems participating in the Clinical Data Research Networks within the National Patient-Centered Clinical Research Network (PCORnet). We extracted information on patient demographics, encounters with healthcare providers, diagnoses recorded and procedures performed during these encounters, vital signs, and laboratory test results from patients' electronic health records (EHRs). The outcomes of interest included weight change, incidence of major surgery-related adverse events, and diabetes remission and relapse, collected for up to 10 years after the initial bariatric procedure. RESULTS: A total of 65,093 adults and 777 adolescents met the eligibility criteria of the study. The adult subcohort had a mean age of 45 years and was predominantly female (79.30%, 51,619/65,093). Among adult patients with non-missing race or ethnicity information, 72.08% (41,248/57,227) were White, 21.13% (12,094/57,227) were Black, and 20.58% (13,094/63,637) were Hispanic. The average highest body mass index (BMI) recorded in the year prior to surgery was 49 kg/m2. RYGB was the most common bariatric procedure among adults (49.48%, 32,208/65,093), followed by SG (45.62%, 29,693/65,093) and AGB (4.90%, 3192/65,093). The mean age of the adolescent subcohort was 17 years and 77.5% (602/777) were female. Among adolescent patients with known race or ethnicity information, 67.3% (473/703) were White, 22.6% (159/703) were Black, and 18.0% (124/689) were Hispanic. The average highest recorded BMI in the year preceding surgery was 53 kg/m2. The majority of the adolescent patients received SG (60.4%, 469/777), followed by RYGB (30.8%, 239/777) and AGB (8.9%, 69/777). A BMI measurement (proxy for follow-up) was available in 84.31% (44,978/53,351), 68.09% (20,783/30,521), and 68.56% (7159/10,442) of the eligible adult patients at 1, 3, and 5 years of follow-up, respectively. The corresponding proportion was 82.0% (524/639), 49.9% (174/349), and 38.8% (47/121) in the adolescent subcohort. CONCLUSIONS: Our study cohort is one of the largest cohorts of patients with bariatric procedures in the United States. Patients are geographically and demographically diverse, which improves the generalizability of the research findings and allows examination of treatment effect heterogeneity. Ongoing and planned investigations will provide real-world evidence on the long-term benefits and risks of these most commonly used bariatric procedures in current clinical practice.

Pharmacotherapy for Non-Cystic Fibrosis Bronchiectasis: Results From an NTM Info & Research Patient Survey and the Bronchiectasis and NTM Research Registry.

BACKGROUND: Non-cystic fibrosis bronchiectasis ("bronchiectasis") is a chronic inflammatory lung disease often associated with nontuberculous mycobacteria (NTM) infection. Very little data exist to guide bronchiectasis management decisions. We sought to describe patterns of inhaled corticosteroid (ICS) and antibiotic therapy in the United States. METHODS: We invited 2,000 patients through NTM Info & Research (NTMir) to complete an anonymous electronic survey. We separately queried baseline clinical and laboratory data from the US Bronchiectasis and NTM Research Registry (BRR). RESULTS: Among 511 NTMir survey responders with bronchiectasis, whose median age was 67 years, 85 (17%) reported asthma and 99 (19%) reported COPD. History of ICS use was reported by 282 (55%), 171 (61%) of whom were treated 1 year or longer, and 150 (53%) were currently taking ICSs. Fewer reported ever taking azithromycin for non-NTM bronchiectasis (203 responders [40%]) or inhaled tobramycin (78 responders [15%]). The median age of 1,912 BRR patients was 69 years; 528 (28%) had asthma and 360 (19%) had COPD. Among 740 patients (42%) without NTM, 314 were taking ICSs at baseline. Among patients without NTM who were taking ICSs, only 178 (57%) had a concurrent diagnosis of COPD or asthma that could explain ICS use. Fewer were taking suppressive macrolides (96 patients [13%]), and of the 70 patients (10%) taking inhaled suppressive antibiotics, 48 (68%) had chronic Pseudomonas aeruginosa infection. CONCLUSIONS: ICS use was common in two national samples of patients with bronchiectasis, with relatively few patients taking suppressive antibiotic therapies. Further research is needed to clarify the safety and effectiveness of these therapies in patients with bronchiectasis.

Patient-Centered Research Priorities for Pulmonary Nontuberculous Mycobacteria (NTM) Infection. An NTM Research Consortium Workshop Report.

Nontuberculous mycobacteria (NTM) cause an increasingly important chronic and debilitating lung disease in older adults. Diagnosis is often delayed, although awareness among clinicians and patients is increasing. When necessary, treatment often lasts 18-24 months and consists of three or four antibiotics that can have serious side effects. Relapses are common and commonly require resumption of prolonged therapy. Given the need for improved diagnostic techniques and clinical trials to identify new therapies or to improve existing therapies, a group of North American clinicians and researchers formed the NTM Research Consortium (NTMRC) in 2014. The NTMRC recognized the importance of including the patient voice in determining research priorities for NTM. In November 2015, patients, caregivers, patient advocates, clinical experts, and researchers gathered for a 1-day meeting in Portland, Oregon funded by the Patient-Centered Outcomes Research Institute. The meeting goal was to define patient-centered research priorities for NTM lung infections. Patients expressed frustration with the number of people who have endured years of missed diagnoses or inadequate treatment of NTM. Participants identified as top research priorities the prevention of NTM infection; approval of more effective treatments with fewer side effects and easier administration; understanding the best chest physiotherapy methods; validating and using tools to measure quality of life; and developing a disease-specific activity and severity assessment tool. Workshop participants agreed that two complementary objectives are critical to ensure the best achievable outcomes for patients: (1) additional clinician education to improve screening and diagnosis of NTM infections; and (2) development of a geographically distributed network of experts in NTM disease to offer consultation or direct therapy after a diagnosis is made.

Characteristics of Chronic Obstructive Pulmonary Disease (COPD) Patients Reporting Alpha-1 Antitrypsin Deficiency in the WebMD Lung Health Check Database.

Objectives: This study compared characteristics of chronic obstructive pulmonary disease (COPD) among patients with and without alpha-1 antitrypsin deficiency (A1AD). Methods: Data from WebMD's Lung Disease Health Check was analyzed for participants who self-reported a COPD diagnosis (N=177,865) and whether or not they had an A1AD diagnosis (based on a positive response to the question "Do you have alpha-1 antitrypsin deficiency?"). We used regression modeling to determine the relation between A1AD status and demographic characteristics, symptoms, lung function, quality of life, comorbidities, and smoking habits. Results: Out of 177,865 participants who reported a COPD diagnosis, 1,619 (0.92%) also reported an A1AD diagnosis. When compared to the total COPD population, those with A1AD were less likely to be female (odds ratio [OR]=0.68, 95% confidence interval [CI] 0.61, 0.75) or current smokers (OR 0.72, 95% CI 0.62, 0.83), and more likely to know their lung function value (OR=3.44, 95% CI 3.07, 3.87). With regard to symptoms, those with A1AD were less likely to report wheezing (OR=0.82, 95% CI 0.75, 0.91) and chronic cough (OR=0.81, 95% CI 0.73, 0.89) and more likely to report tightness in the chest (OR= 1.19, 95% CI 1.08, 1.32). Overall, A1AD participants had a lower quality of life with a higher proportion reporting severe impairment in work life (OR=1.55, 95% CI 1.39, 1.7), home life (OR=1.40, 95% CI 1.26, 1.56), and personal relationships (OR=1.48, 95% CI 1.32, 1.65). Conclusions: COPD patients with A1AD report significantly worse quality of life relative to the non-A1AD COPD population.

The COPD Foundation: Celebrating a Decade of Progress and Looking Ahead to a Cure.

Chronic obstructive pulmonary disease (COPD) affects 15-25 million Americans and over 300 million people around the world. The COPD Foundation is a global organization whose mission is to prevent and cure COPD and to improve the lives of all people affected by it. The year 2014 marks the 10th anniversary of the COPD Foundation. The Foundation works to accomplish its mission through a unique partnership between patients, patient families, health care providers, investigators, academic institutions, government agencies and industry. This partnership has led to real progress in awareness, advocacy, education, and research, but much more needs to be done.