Long-term safety and efficacy of elexacaftor/tezacaftor/ivacaftor in people with cystic fibrosis and at least one F508del allele: 144-week interim results from a 192-week open-label extension study.

BACKGROUND: In two pivotal phase 3 trials, up to 24 weeks of treatment with elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) was efficacious and safe in patients with cystic fibrosis (CF) ≥12 years of age who have at least one F508del allele. The aim of this study is to assess long-term safety and efficacy of ELX/TEZ/IVA in these patients. METHODS: In this phase 3, open-label, single-arm extension study, participants with F508del-minimal function (from a 24-week parent study; n=399) or F508del-F508del (from a 4-week parent study; n=107) genotypes receive ELX/TEZ/IVA at the same dose (ELX 200 mg once daily, TEZ 100 mg once daily and IVA 150 mg every 12 h). The primary end-point is safety and tolerability. A prespecified interim analysis was conducted when the last participant reached the Week 144 visit. RESULTS: At the Week 144 interim analysis, mean duration of exposure to ELX/TEZ/IVA in the extension study was 151.1 weeks. Exposure-adjusted rates of adverse events (AEs) (586.6 events per 100 participant-years) and serious AEs (22.4 events per 100 participant-years) were lower than in the ELX/TEZ/IVA treatment group in the 24-week parent study (1096.0 and 36.9 events per 100 participant-years, respectively); most participants had AEs classified as mild (16.4% of participants) or moderate (60.3% of participants) in severity. 14 participants (2.8%) had AEs that led to treatment discontinuation. Following initiation of ELX/TEZ/IVA, participants had increases in forced expiratory volume in 1 s (FEV1) percentage predicted, Cystic Fibrosis Questionnaire-Revised respiratory domain score and body mass index, and had decreases in sweat chloride concentration and pulmonary exacerbation rates that were maintained over the interim analysis period. The mean annualised rate of change in FEV1 % pred was +0.07 (95% CI -0.12-0.26) percentage points among the participants. CONCLUSIONS: ELX/TEZ/IVA was generally safe and well tolerated, with a safety profile consistent with the 24-week parent study. Participants had sustained improvements in lung function, respiratory symptoms, CF transmembrane conductance regulator function, pulmonary exacerbation rates and nutritional status. These results support the favourable safety profile and durable, disease-modifying clinical benefits of ELX/TEZ/IVA.

A Hybrid Effectiveness/Implementation Clinical Trial of Adherence to Long-Term Oxygen Therapy for Chronic Obstructive Pulmonary Disease.

Rationale: Interventions to promote adherence to long-term oxygen therapy (LTOT) in chronic obstructive pulmonary disease (COPD) are needed. Objectives: To examine the real-world effectiveness of phone-based peer coaching on LTOT adherence and other outcomes in a pragmatic trial of patients with COPD. Methods: In a hybrid effectiveness/implementation pragmatic trial, patients were randomized to receive phone-based proactive coaching (educational materials, five phone-based peer coaching sessions over 60 d), reactive coaching (educational materials, peer coaching when requested), or usual care. Study staff members collected baseline and outcome data via phone at 30, 60, and 90 days after randomization. Adherence to LTOT over 60 days, the primary effectiveness outcome, was defined as mean LTOT use ⩾17.7 h/d. LTOT use was calculated using information about home oxygen equipment use in worksheets completed by study participants. Comparisons of adherence to LTOT between each coaching group and the usual care group using multivariable logistic regression models were prespecified as the primary analyses. Secondary effectiveness outcomes included Patient Reported Outcome Management Information System measures for physical, emotional, and social health. We assessed early implementation domains in the reach, adoption, and implementation framework. Results: In 444 participants, the proportions who were adherent to LTOT at 60 days were 74% in usual care, 84% in reactive coaching, and 70% in proactive coaching groups. Although reach, adoption by stakeholder partners, and intervention fidelity were acceptable, complete LTOT adherence data were available in only 73% of participants. Reactive coaching (adjusted odds ratio, 1.77; 97.5% confidence interval, 0.80-3.90) and proactive coaching (adjusted odds ratio, 0.70; 97.5% confidence interval, 0.34-1.46) did not improve adherence to LTOT compared with usual care. However, proactive coaching significantly reduced depressive symptoms and sleep disturbance compared with usual care and reduced depressive symptoms compared with reactive coaching. Unexpectedly, LTOT adherence was significantly lower in the proactive compared with the reactive coaching group. Conclusions: The results were inconclusive about whether a phone-based peer coaching strategy changed LTOT adherence compared with usual care. Further studies are needed to confirm the potential benefits of proactive peer coaching on secondary effectiveness outcomes and differences in LTOT adherence between proactive and reactive peer coaching. Clinical trial registered with ClinicalTrials.gov (NCT02098369).

Non-respiratory health-related quality of life in people with cystic fibrosis receiving elexacaftor/tezacaftor/ivacaftor.

Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) was shown to be safe and efficacious in people with cystic fibrosis (CF) heterozygous for F508del and a minimal function mutation (F/MF) or homozygous for F508del (F/F) in two pivotal Phase 3 trials, significantly improving percentage predicted forced expiratory volume in 1 second, Cystic Fibrosis Questionnaire-Revised, Respiratory Domain (CFQ-R RD) scores, and sweat chloride concentration. Here, we analyzed the 11 non-respiratory domains (non-RDs) of the CFQ-R, which assess general health-related quality of life (i.e., Physical Functioning, Role Functioning, Vitality, Health Perceptions, Emotional Functioning, and Social Functioning) and quality of life impacted by CF (i.e., Body Image, Eating Problems, Treatment Burden, Weight, and Digestive Symptoms), for participants in these two Phase 3 trials. ELX/TEZ/IVA treatment led to higher scores in all CFQ-R non-RDs, with improvements in most domains compared with control treatments. These findings demonstrate that ELX/TEZ/IVA improves a range of CF-specific symptoms and general functioning and well-being.

Pragmatic Clinical Trial to Improve Patient Experience Among Adults During Transitions from Hospital to Home: the PArTNER study.

INTRODUCTION: Minority-serving hospitals (MSHs) need evidence-based strategies tailored to the populations they serve to improve patient-centered outcomes after hospitalization. METHODS: We conducted a pragmatic randomized clinical trial (RCT) from October 2014 to January 2017 at a MSH comparing the effectiveness of a stakeholder-supported Navigator intervention vs. Usual care on post-hospital patient experience, outcomes, and healthcare utilization. Community health workers and peer coaches delivered the intervention which included (1) in-hospital visits to assess barriers to health/healthcare and to develop a personalized Discharge Patient Education Tool (DPET); (2) a home visit to review the DPET; and (3) telephone-based peer coaching. The co-primary outcomes were between-group comparisons of 30-day changes in Patient-Reported Outcomes Measurement Information System (PROMIS) measures of anxiety and informational support (minimum important difference is 2 to 5 units change); a p-value <0.025 was considered significant using intention-to-treat analysis. Secondary outcomes included death, ED visits, or readmissions and measures of emotional, social, and physical health at 30 and 60 days. RESULTS: We enrolled 1029 adults hospitalized with heart failure (28%), pneumonia (22%), MI (10%), COPD (11%), or sickle cell disease (29%). Over 80% were non-Hispanic Black. Overall, there were no significant between-group differences in the 30-day change in anxiety (adjusted difference: -1.6, 97.5% CI -3.3 to 0.1, p=0.03), informational support (adjusted difference: -0.01, 97.5% CI -2.0 to 1.9, p=0.99), or any secondary outcomes. Exploratory analyses suggested the Navigator intervention improved anxiety among participants with COPD, a primary care provider, a hospitalization in the past 12 months, or higher baseline anxiety; among participants without health insurance, the intervention improved informational support (all p-values <0.05). CONCLUSIONS: In this pragmatic RCT at a MSH, the Navigator intervention did not improve post-hospital anxiety, informational support, or other outcomes compared to Usual care. Benefits observed in participant subgroups should be confirmed in future studies. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02114515.

Triple Therapy for Cystic Fibrosis Phe508del-Gating and -Residual Function Genotypes.

BACKGROUND: Elexacaftor-tezacaftor-ivacaftor is a small-molecule cystic fibrosis transmembrane conductance regulator (CFTR) modulator regimen shown to be efficacious in patients with at least one Phe508del allele, which indicates that this combination can modulate a single Phe508del allele. In patients whose other CFTR allele contains a gating or residual function mutation that is already effectively treated with previous CFTR modulators (ivacaftor or tezacaftor-ivacaftor), the potential for additional benefit from restoring Phe508del CFTR protein function is unclear. METHODS: We conducted a phase 3, double-blind, randomized, active-controlled trial involving patients 12 years of age or older with cystic fibrosis and Phe508del-gating or Phe508del-residual function genotypes. After a 4-week run-in period with ivacaftor or tezacaftor-ivacaftor, patients were randomly assigned to receive elexacaftor-tezacaftor-ivacaftor or active control for 8 weeks. The primary end point was the absolute change in the percentage of predicted forced expiratory volume in 1 second (FEV1) from baseline through week 8 in the elexacaftor-tezacaftor-ivacaftor group. RESULTS: After the run-in period, 132 patients received elexacaftor-tezacaftor-ivacaftor and 126 received active control. Elexacaftor-tezacaftor-ivacaftor resulted in a percentage of predicted FEV1 that was higher by 3.7 percentage points (95% confidence interval [CI], 2.8 to 4.6) relative to baseline and higher by 3.5 percentage points (95% CI, 2.2 to 4.7) relative to active control and a sweat chloride concentration that was lower by 22.3 mmol per liter (95% CI, 20.2 to 24.5) relative to baseline and lower by 23.1 mmol per liter (95% CI, 20.1 to 26.1) relative to active control (P<0.001 for all comparisons). The change from baseline in the Cystic Fibrosis Questionnaire-Revised respiratory domain score (range, 0 to 100, with higher scores indicating better quality of life) with elexacaftor-tezacaftor-ivacaftor was 10.3 points (95% CI, 8.0 to 12.7) and with active control was 1.6 points (95% CI, -0.8 to 4.1). The incidence of adverse events was similar in the two groups; adverse events led to treatment discontinuation in one patient (elevated aminotransferase level) in the elexacaftor-tezacaftor-ivacaftor group and in two patients (anxiety or depression and pulmonary exacerbation) in the active control group. CONCLUSIONS: Elexacaftor-tezacaftor-ivacaftor was efficacious and safe in patients with Phe508del-gating or Phe508del-residual function genotypes and conferred additional benefit relative to previous CFTR modulators. (Funded by Vertex Pharmaceuticals; VX18-445-104 ClinicalTrials.gov number, NCT04058353.).

A Systematic Review of the Effect of Physical Activity on Asthma Outcomes.

BACKGROUND: Asthma is a chronic respiratory disease that affects millions worldwide. Medication management is the current mainstay of treatment; however, there is evidence to suggest additional benefit with lifestyle changes, particularly with increased physical activity. OBJECTIVE: To discover and evaluate the effects of physical activity on asthma outcomes. METHODS: Systematic search of PubMed, Excerpta Medica database, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Rehabilitation and Sports Medicine Source, Scopus, and Web of Science identified 11,155 results. Thirty-five articles met our inclusion criteria spanning 20 studies. Data extraction was conducted by 6 independent reviewers, and final results were evaluated by a seventh reviewer and the senior author. RESULTS: Wide variation among selected studies, including the heterogeneity of interventions and outcome variables, did not support a meta-analysis. Mixed results of the effects of physical activity on asthma outcomes were found. Most studies suggest that physical activity improves asthma control, quality of life, lung function parameters, and inflammatory serologies, whereas 3 found no improvements in any of these outcomes. No studies reported worsening asthma outcomes. CONCLUSIONS: This review highlights the emerging and promising role of physical activity as a nonpharmacologic treatment for asthma. Additional high-quality randomized controlled trials are needed to overcome the problems of measurement heterogeneity and the dilution of outcome effect size measurement related to physical activity interventions for asthma.

Home Oxygen Evaluation by Respiratory Therapists in Patients Hospitalized for COPD Exacerbations: The RIsOTTO Study.

BACKGROUND: The majority of prescriptions for supplemental oxygen are written when patients are discharged to home from the hospital and the evaluation of these patients is inconsistent. Respiratory Therapists receive training in the evaluation and management of patients needing oxygen. The primary goal of the study was to estimate the frequency with which respiratory therapists (RTs) evaluate the need for home oxygen in patients hospitalized for COPD exacerbations before discharge. METHODS: An online questionnaire was distributed to RTs in the United States by the American Association for Respiratory Care. RTs were asked to indicate how frequently they evaluate the need for home oxygen on an ordinal scale: Never, Rarely/occasionally, Sometimes, Most of the time, Almost every time, or Every time. Consistent evaluation for home oxygen was defined as performing an evaluation for home oxygen therapy Almost every time or Every time (ie, > 75% of the time). Bivariate and multivariable analyses were assessed using the Fisher exact test and logistic regression models. RESULTS: Of 611 respondents, 490 were eligible for analysis. Fifty-eight percent of RTs reported consistently evaluating patients for home oxygen at rest, whereas 43% reported doing so during activity and 14% during sleep. Consistent evaluation for home oxygen requirements at rest was significantly associated with more years of practice (P = .03; highest among RTs with ≥ 30 y of practice at 40%), region of practice (P = .001; highest in the Midwest at 44%), and greater familiarity with criteria for home oxygen (P < .001; highest among RTs who selected Very familiar with guidelines from the Centers for Medicare and Medicaid Services at 58%). Practice in the Midwest and greater familiarity with criteria for home oxygen was associated with consistent evaluation for home oxygen during activity. Practice in the Midwest (vs Northeast; adjusted odds ratio 2.56, P < .001) and being very familiar with home oxygen criteria (vs not at all familiar; adjusted odds ratio 5.66, P < .001) were independently associated with a higher odds of evaluating for home oxygen at rest and with activity. Only 25% of RTs were involved in making decisions about home oxygen equipment. CONCLUSIONS: RTs do not consistently evaluate patients hospitalized for COPD exacerbations for home oxygen prior to discharge, and only a minority of RTs are involved in selecting home oxygen equipment.

Home Oxygen Therapy for Adults with Chronic Lung Disease. An Official American Thoracic Society Clinical Practice Guideline.

Background: Evidence-based guidelines are needed for effective delivery of home oxygen therapy to appropriate patients with chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD).Methods: The multidisciplinary panel created six research questions using a modified Delphi approach. A systematic review of the literature was completed, and the Grading of Recommendations Assessment, Development and Evaluation approach was used to formulate clinical recommendations.Recommendations: The panel found varying quality and availability of evidence and made the following judgments: 1) strong recommendations for long-term oxygen use in patients with COPD (moderate-quality evidence) or ILD (low-quality evidence) with severe chronic resting hypoxemia, 2) a conditional recommendation against long-term oxygen use in patients with COPD with moderate chronic resting hypoxemia, 3) conditional recommendations for ambulatory oxygen use in patients with COPD (moderate-quality evidence) or ILD (low-quality evidence) with severe exertional hypoxemia, 4) a conditional recommendation for ambulatory liquid-oxygen use in patients who are mobile outside the home and require >3 L/min of continuous-flow oxygen during exertion (very-low-quality evidence), and 5) a recommendation that patients and their caregivers receive education on oxygen equipment and safety (best-practice statement).Conclusions: These guidelines provide the basis for evidence-based use of home oxygen therapy in adults with COPD or ILD but also highlight the need for additional research to guide clinical practice.

The Burden of Cough and Phlegm in People With COPD: A COPD Patient-Powered Research Network Study.

RATIONALE: Cough and phlegm are common symptoms of chronic obstructive pulmonary disease (COPD) and may significantly affect quality of life. This study assessed the burden of cough and phlegm on clinical outcomes and quality of life among people with a self-reported physician diagnosis of COPD. METHODS: Patient-reported data from the COPD Foundation's Patient-Powered Research Network (COPD PPRN) were utilized. Cough and phlegm severity and frequency were assessed by responses to questions on the COPD Assessment Test (CAT) and categorized into none/low, moderate and severe. Quality of life domains were evaluated using the Patient-Reported Outcome Measurement Information System (PROMIS-29). Associations between cough and phlegm levels and PROMIS-29 domains were examined using multivariate analysis of variance (MANOVA). RESULTS: The 5286 participants were average age 64.4 years (SD=11.4), 87.9% white, 60.4% female, 51.2% married, and 42.2% with caregivers. Approximately three-fourths of the participants had moderate or severe cough or phlegm levels. Respondents with moderate and high cough or phlegm had significantly worse dyspnea (p<0.0001), more exacerbations in the previous one year (p<0.0001), worse physical and social functioning, and more symptoms of anxiety and depression on PROMIS-29 compared to those with no/low cough and phlegm. CONCLUSIONS: In this group of people with COPD, higher levels of cough and phlegm are associated with worse clinical and quality of life outcomes.

Home Oxygen Therapy for Patients With COPD: Time for a Reboot.

Just over 100 years ago, John Scott Haldane published a seminal report about the therapeutic potential of supplemental oxygen to treat hypoxemia. In the 1980s, a pair of clinical trials confirmed the benefit of long-term oxygen therapy in improving survival in patients with COPD associated with severe resting hypoxemia. This review provides a summary of evidence supporting long-term and short-term oxygen therapy, as well as the various types of oxygen equipment commonly used in homes to deliver supplemental oxygen. Because the majority of orders for home oxygen occur at hospital discharge following acute illness, a typical conversation between a patient and their pulmonologist following a COPD exacerbation is presented. The SHERLOCK Consortium, a multi-stakeholder group established following the publication of the COPD National Action Plan in 2017 is also detailed. Interim results of the SHERLOCK Consortium, which suggest a chain of care involving 9 steps to ensure that patients are successfully initiated on home oxygen therapy during transitions from hospital to home, are presented. Recommendations to support evidence-based policies in this high-risk population are provided.

Daily Physical Activity in Patients With COPD After Hospital Discharge in a Minority Population.

BACKGROUND: Low physical activity in patients with chronic obstructive pulmonary disease (COPD) is associated with increased morbidity and mortality. To inform the design of a home-based physical activity promotion program for patients with COPD recently discharged from a minority-serving hospital, we conducted a cohort study to evaluate objectively measured daily physical activity and patient-reported outcomes. METHODS: This was a 12-week prospective cohort study of patients with a physician diagnosis of COPD recently hospitalized (≤ 12 weeks) for respiratory symptoms. Daily physical activity was recorded using wrist-based and "clip-on" pedometers, and analyzed as mean daily step counts averaged over 7 days. RESULTS: Twenty-two patients were enrolled a median (interquartile range, [IQR]) of 14 (7 to 29) days after hospital discharge. The median daily step count (IQR) in the first week after enrollment (week 1) was 3710 (1565 to 5129) steps. The median within-person change in daily step count (IQR) from week 1 to week 12 was 314 (-30 to 858) steps (p=0.28). Within-person correlation of week-to-week daily step counts was high (r ≥ 0.75). Time from hospital discharge to enrollment was not correlated with mean daily step counts on week 1 (r= -0.13) and only weakly correlated with change in mean daily step counts from week 1 to week 12 (r=0.37). CONCLUSIONS: Daily physical activity was variable in this cohort of recently hospitalized patients with COPD, but with little within-person change over a 12-week period. These observations highlight the need for flexible physical activity promotion programs addressing the needs of a heterogeneous patient population.

Design of the patient navigator to Reduce Readmissions (PArTNER) study: A pragmatic clinical effectiveness trial.

Previous work indicates the potential for community health workers and peer coaches serving as patient navigators to improve processes of care and health outcomes during care transitions, but have not been sufficiently tested to determine if such programs improve measures of patient experience in minority serving institutions. The objectives of the Patient Navigator to Reduce Readmissions (PArTNER) study was to: 1) conduct a pragmatic clinical effectiveness trial comparing a multi-faceted, stakeholder-supported Navigator intervention (in-person CHW visits in the hospital and after hospital discharge, plus telephone-based peer coaching) versus usual care on the experience of hospital-to-home care transitions in patients hospitalized with heart failure, pneumonia, chronic obstructive pulmonary disease, myocardial infarction, or sickle cell disease; 2) examine the effectiveness of the Navigator intervention in patient subgroups; and 3) understand the barriers and facilitators of successfully implementing the Navigator intervention across patient populations. The co-primary outcomes are the 30-day changes in: 1) Patient Reported Outcomes Measurement Information System (PROMIS) emotional distress-anxiety, and 2) PROMIS informational support. Secondary outcomes at 30 and 60 days include other PROMIS health measures and hospital readmissions. Innovative features of the PArTNER study include early and continuous engagement of patients, their caregivers, clinicians, health system administrators, and other stakeholders to inform the design and implementation of the Navigator intervention. In this report, we describe the design of the PArTNER study.

Optimizing Home Oxygen Therapy. An Official American Thoracic Society Workshop Report.

More than 1.5 million adults in the United States use supplemental oxygen for a variety of respiratory disorders to improve their quality of life and prolong survival. This document describes recommendations from a multidisciplinary workshop convened at the ATS International Conference in 2017 with the goal of optimizing home oxygen therapy for adults. Ideal supplemental oxygen therapy is patient-specific, provided by a qualified clinician, includes an individualized prescription and therapeutic education program, and offers oxygen systems that are safe, promote mobility, and treat hypoxemia. Recently, patients and clinicians report a growing number of problems with home oxygen in the United States. Oxygen users experience significant functional, mechanical, and financial problems and a lack of education related to their oxygen equipment-problems that impact their quality of life. Health care providers report a lack of readily accessible resources needed to prescribe oxygen systems correctly and efficiently. Patients with certain lung diseases are affected more than others because of physically unmanageable or inadequate portable systems. Analysis is needed to quantify the unintended impact that the Centers for Medicare and Medicaid Services Competitive Bidding Program has had on patients receiving supplemental oxygen from durable medical equipment providers. Studies using effectiveness and implementation research designs are needed to develop and evaluate new models for patient education, identify effective ways for stakeholders to interface, determine the economic benefit of having respiratory therapists perform in-home education and follow-up testing, and collaborate with technology companies to improve portable oxygen devices. Generation of additional evidence of the benefit of supplemental oxygen across the spectrum of advanced lung diseases and the development of clinical practice guidelines should both be prioritized.

Thoracic splenosis: History is the key.

Splenosis is an acquired ectopic autotransplantation of splenic tissue; that occurs after traumatic splenic rupture and splenectomy [1]. Splenosis is a rare but benign disease, and the diagnosis can be challenging as the multiple incidentally found nodules could mimic malignancy [2]. Abdominopelvic Splenosis is thought to occur in as many as 65% of cases of splenic rupture [1]. However, Thoracic Splenosis is rare and usually involve the left parietal and visceral pleura [1,2]. Intraparenchymal lesions are less common but have been reported in cases of parenchymal and diaphragm laceration [1,2]. Taking a thorough history is of utmost importance, as these patients usually present more than two decades after the splenic traumatic rupture. The use of commonly available nuclear studies will further confirm the diagnosis [3]. This will help to avoid unnecessary procedures, like biopsies; and prevent the potential complications. We present a case of Thoracic Splenosis that highlights the importance of taking a detailed history; and the importance of using nuclear studies for the diagnosis. Further adding to its uniqueness, this case showed with multiple intraparenchymal nodules which is a less common presentation of Splenosis.

Evaluation and Documentation of Supplemental Oxygen Requirements is Rarely Performed in Patients Hospitalized With COPD.

Rationale: Patients hospitalized with chronic obstructive pulmonary disease (COPD) who require supplemental oxygen (O2) are at increased risk of hospital readmissions. There is a paucity of information regarding quality of evaluation and documentation regarding the need for supplemental O2 in this population.  Objective: To determine the extent to which evaluation and documentation regarding the need for supplemental O2 occurs prior to hospital discharge in patients with COPD.  Methods: We conducted a two-center retrospective cohort study of hospitalized adults with a physician diagnosis of COPD.  We reviewed electronic health records to ascertain whether patients underwent evaluation beyond rest oximetry documenting hypoxemia and if there was adequate documentation of supplemental O2 requirements prior to discharge. Results:  Of 526 patients hospitalized with a primary or secondary discharge diagnosis of COPD, 335 patients (mean age 69 years, 78% with diagnosis of COPD exacerbation) met eligibility criteria. Overall, 1 in 5 (22%, 73/335) hospitalized patients with COPD had an evaluation beyond rest oximetry for supplemental O2 requirements during admission.  Adequate documentation of supplemental O2 requirements occurred in even fewer patients (16%, 54/335). Both evaluation (26% versus 5%, p=0.002) and documentation (19% versus 4%, p=0.001) of supplemental O2 requirements were more common in patients hospitalized for a COPD exacerbation compared to those hospitalized with COPD but without an exacerbation. Conclusions: Evaluation and documentation of supplemental O2 requirements beyond rest oximetry occur infrequently in patients hospitalized with COPD.

Engaging Patients and Caregivers to Design Transitional Care Management Services at a Minority Serving Institution.

Limited socioeconomic resources contribute to high readmission rates at minority serving institutions (MSIs). A better understanding of patient-level factors and need for patient navigators could inform approaches to enhance care transitions tailored to these vulnerable patient populations. We sought to understand the perspectives of patients and their caregivers about hospital to home transitions from an MSI, as well as their attitudes about patient navigators to facilitate care transitions. We conducted qualitative research using focus groups (FGs)-five disease-specific patient FGs and two caregiver FGs, including 23 patients and 10 caregivers. Findings support the need for additional services to address: (1) gaps in the hospital discharge; (2) socioeconomic resources; (3) access to post-discharge care; (4) patient's health care seeking behaviors; (5) patient anxiety; (6) self-management education; and (7) social supports for patients and caregivers. While caregivers uniformly expressed interest in patient navigators, support for navigators among patients was more variable.

Can Commercially Available Pedometers Be Used For Physical Activity Monitoring In Patients With COPD Following Exacerbations?

BACKGROUND: Commercially available pedometers have been used as tools to measure endpoints in studies evaluating physical activity promotion programs. However, their accuracy in patients recovering from COPD exacerbations is unknown. The objectives of this study were to 1) assess the relative accuracy of different commercially available pedometers in healthy volunteers and 2) evaluate the accuracy of the top-performing commercially available pedometer in patients recovering from COPD exacerbations following hospital discharge. METHODS: Twelve healthy volunteers wore 2 pedometers, 2 smartphones with pedometer apps and an accelerometer for 15 minutes of indoor activity. The top-performing device in healthy volunteers was evaluated in 4 patients recovering from COPD exacerbations following hospital discharge during 6 minutes of walking performed at home. Bland-Altman plots were employed to evaluate accuracy of each device compared with direct observation (the reference standard). RESULTS: In healthy volunteers, the mean percent error compared to direct observation of the various devices ranged from -49% to +1%. The mean percent error [95% confidence interval (CI)] of the top-performing device in healthy volunteers, the Fitbit Zip®, was +1% [-33 to +35%], significantly lower than that of the accelerometer (-13% [-56 to +29%], p=0.01). The mean percent error [95% CI] for the Fitbit Zip® in patients recovering from COPD exacerbations was -3% [-7 to +12%]. CONCLUSIONS: The accuracy of commercially available pedometers in healthy volunteers is highly variable. The top-performing pedometer in our study, the Fitbit Zip,® accurately measures step counts in both healthy volunteers and patients recovering from COPD exacerbations.