Health Care Spending on Respiratory Diseases in the United States, 1996-2016.

Rationale: Respiratory conditions account for a large proportion of health care spending in the United States. A full characterization of spending across multiple conditions and over time has not been performed. Objectives: To estimate health care spending in the United States for 11 respiratory conditions from 1996 to 2016, providing detailed trends and an evaluation of factors associated with spending growth. Methods: We extracted data from the Institute of Health Metrics and Evaluation's Disease Expenditure Project Database, producing annual estimates in spending for 38 age and sex groups, 7 types of care, and 3 payer types. We performed a decomposition analysis to estimate the change in spending associated with changes in each of five factors (population growth, population aging, disease prevalence, service usage, and service price and intensity). Measurements and Main Results: Total spending across all respiratory conditions in 2016 was $170.8 billion (95% confidence interval [CI], $164.2-179.2 billion), increasing by $71.7 billion (95% CI, $63.2-80.8 billion) from 1996. The respiratory conditions with the highest spending in 2016 were asthma and chronic obstructive pulmonary disease, contributing $35.5 billion (95% CI, $32.4-38.2 billion) and $34.3 billion (95% CI, $31.5-37.3 billion), respectively. Increasing service price and intensity were associated with 81.4% (95% CI, 70.3-93.0%) growth from 1996 to 2016. Conclusions: U.S. spending on respiratory conditions is high, particularly for chronic conditions like asthma and chronic obstructive pulmonary disease. Our findings suggest that service price and intensity, particularly for pharmaceuticals, should be a key focus of attention for policymakers seeking to reduce health care spending growth.

Nurse and Social Worker Palliative Telecare Team and Quality of Life in Patients With COPD, Heart Failure, or Interstitial Lung Disease: The ADAPT Randomized Clinical Trial.

Importance: Many patients with chronic obstructive pulmonary disease (COPD), heart failure (HF), and interstitial lung disease (ILD) endure poor quality of life despite conventional therapy. Palliative care approaches may benefit this population prior to end of life. Objective: Determine the effect of a nurse and social worker palliative telecare team on quality of life in outpatients with COPD, HF, or ILD compared with usual care. Design, Setting, and Participants: Single-blind, 2-group, multisite randomized clinical trial with accrual between October 27, 2016, and April 2, 2020, in 2 Veterans Administration health care systems (Colorado and Washington), and including community-based outpatient clinics. Outpatients with COPD, HF, or ILD at high risk of hospitalization or death who reported poor quality of life participated. Intervention: The intervention involved 6 phone calls with a nurse to help with symptom management and 6 phone calls with a social worker to provide psychosocial care. The nurse and social worker met weekly with a study primary care and palliative care physician and as needed, a pulmonologist, and cardiologist. Usual care included an educational handout developed for the study that outlined self-care for COPD, ILD, or HF. Patients in both groups received care at the discretion of their clinicians, which could include care from nurses and social workers, and specialists in cardiology, pulmonology, palliative care, and mental health. Main Outcomes and Measures: The primary outcome was difference in change in quality of life from baseline to 6 months between the intervention and usual care groups (FACT-G score range, 0-100, with higher scores indicating better quality of life, clinically meaningful change ≥4 points). Secondary quality-of-life outcomes at 6 months included disease-specific health status (Clinical COPD Questionnaire; Kansas City Cardiomyopathy Questionnaire-12), depression (Patient Health Questionnaire-8) and anxiety (Generalized Anxiety Disorder-7) symptoms. Results: Among 306 randomized patients (mean [SD] age, 68.9 [7.7] years; 276 male [90.2%], 30 female [9.8%]; 245 White [80.1%]), 177 (57.8%) had COPD, 67 (21.9%) HF, 49 (16%) both COPD and HF, and 13 (4.2%) ILD. Baseline FACT-G scores were similar (intervention, 52.9; usual care, 52.7). FACT-G completion was 76% (intervention, 117 of 154; usual care, 116 of 152) at 6 months for both groups. Mean (SD) length of intervention was 115.1 (33.4) days and included a mean of 10.4 (3.3) intervention calls per patient. In the intervention group, 112 of 154 (73%) patients received the intervention as randomized. At 6 months, mean FACT-G score improved 6.0 points in the intervention group and 1.4 points in the usual care group (difference, 4.6 points [95% CI, 1.8-7.4]; P = .001; standardized mean difference, 0.41). The intervention also improved COPD health status (standardized mean difference, 0.44; P = .04), HF health status (standardized mean difference, 0.41; P = .01), depression (standardized mean difference, -0.50; P < .001), and anxiety (standardized mean difference, -0.51; P < .001) at 6 months. Conclusions and Relevance: For adults with COPD, HF, or ILD who were at high risk of death and had poor quality of life, a nurse and social worker palliative telecare team produced clinically meaningful improvements in quality of life at 6 months compared with usual care. Trial Registration: ClinicalTrials.gov Identifier: NCT02713347.

Health System Approach to Improve Chronic Obstructive Pulmonary Disease Care after Hospital Discharge: Stepped-Wedge Clinical Trial.

Rationale: Patients discharged from the hospital for chronic obstructive pulmonary disease (COPD) exacerbation have impaired quality of life and frequent readmission and death. Clinical trials to reduce readmission demonstrate inconsistent results, including some demonstrating potential harms. Objectives: We tested whether a pragmatic proactive interdisciplinary and virtual review of patients discharged after hospitalization for COPD exacerbation would improve quality of life, using the Clinical COPD Questionnaire, and reduce all-cause 180-day readmission and/or mortality. Methods: We performed a stepped-wedge clinical trial. We enrolled primary care providers and their patients after hospital discharge for COPD at two Department of Veterans Affairs medical centers and 10 outpatient clinics. A multidisciplinary team reviewed health records and developed treatment recommendations delivered to primary care providers via E-consult. We facilitated uptake by entering recommendations as unsigned orders that could be accepted, modified, or canceled. Providers and patients made all final treatment decisions. Measurements and Main Results: We enrolled 365 primary care providers. Over a 30-month period, 352 patients met eligibility criteria, with 191 (54.3%) patients participating in the control and 161 (45.7%) in the intervention. The intervention led to clinically significant better Clinical COPD Questionnaire scores (-0.47; 95% confidence interval [CI], -0.85 to -0.09; 52.6% missing) but did not reduce 180-day readmission and/or mortality (adjusted odds ratio, 0.83; 95% CI, 0.49 to 1.38), in part because of wide CIs. Among the 161 patients in the intervention group, we entered 519 recommendations as unsigned orders, of which 401 (77.3%) were endorsed. Conclusions: A pragmatic health system-level intervention that delivered proactive specialty supported care improved quality of life but did not reduce 180-day readmission or death. Clinical trial registered with www.clinicaltrials.gov (NCT02021955).

Impact of mail-based continuous positive airway pressure initiation on treatment usage and effectiveness.

PURPOSE: In-person visits with a trained therapist have been standard care for patients initiating continuous positive airway pressure (CPAP). These visits provide an opportunity for hands-on training and an in-person assessment of mask fit. However, to improve access, many health systems are shifting to remote CPAP initiation with equipment mailed to patients. While there are potential benefits of a mailed approach, relative patient outcomes are unclear. Specifically, many have concerns that a lack of in-person training may contribute to reduced CPAP adherence. To inform this knowledge gap, we aimed to compare treatment usage after in-person or mailed CPAP initiation. METHODS: Our medical center shifted from in-person to mailed CPAP dispensation in March 2020 during the COVID-19 pandemic. We assembled a cohort of patients with newly diagnosed obstructive sleep apnea (OSA) who initiated CPAP in the months before (n = 433) and after (n = 186) this shift. We compared 90-day adherence between groups. RESULTS: Mean nightly PAP usage was modest in both groups (in-person 145.2, mailed 140.6 min/night). We did not detect between-group differences in either unadjusted or adjusted analyses (adjusted difference - 0.2 min/night, 95% - 27.0 to + 26.5). CONCLUSIONS: Mail-based systems of CPAP initiation may be able to improve access without reducing CPAP usage. Future work should consider the impact of mailed CPAP on patient-reported outcomes and the impact of different remote setup strategies.

Informing Healthcare Decisions with Observational Research Assessing Causal Effect. An Official American Thoracic Society Research Statement.

Rationale: Decisions in medicine are made on the basis of knowledge and reasoning, often in shared conversations with patients and families in consideration of clinical practice guideline recommendations, individual preferences, and individual goals. Observational studies can provide valuable knowledge to inform guidelines, decisions, and policy.Objectives: The American Thoracic Society (ATS) created a multidisciplinary ad hoc committee to develop a research statement to clarify the role of observational studies-alongside randomized controlled trials (RCTs)-in informing clinical decisions in pulmonary, critical care, and sleep medicine.Methods: The committee examined the strengths of observational studies assessing causal effects, how they complement RCTs, factors that impact observational study quality, perceptions of observational research, and, finally, the practicalities of incorporating observational research into ATS clinical practice guidelines.Measurements and Main Results: There are strengths and weakness of observational studies as well as RCTs. Observational studies can provide evidence in representative and diverse patient populations. Quality observational studies should be sought in the development of ATS clinical practice guidelines, and medical decision-making in general, when 1) no RCTs are identified or RCTs are appraised as being of low- or very low-quality (replacement); 2) RCTs are of moderate quality because of indirectness, imprecision, or inconsistency, and observational studies mitigate the reason that RCT evidence was downgraded (complementary); or 3) RCTs do not provide evidence for outcomes that a guideline committee considers essential for decision-making (e.g., rare or long-term outcomes; "sequential").Conclusions: Observational studies should be considered in developing clinical practice guidelines and in making clinical decisions.

Distinct mechanisms of Drosophila CRYPTOCHROME-mediated light-evoked membrane depolarization and in vivo clock resetting.

Drosophila CRYPTOCHROME (dCRY) mediates electrophysiological depolarization and circadian clock resetting in response to blue or ultraviolet (UV) light. These light-evoked biological responses operate at different timescales and possibly through different mechanisms. Whether electron transfer down a conserved chain of tryptophan residues underlies biological responses following dCRY light activation has been controversial. To examine these issues in in vivo and in ex vivo whole-brain preparations, we generated transgenic flies expressing tryptophan mutant dCRYs in the conserved electron transfer chain and then measured neuronal electrophysiological phototransduction and behavioral responses to light. Electrophysiological-evoked potential analysis shows that dCRY mediates UV and blue-light-evoked depolarizations that are long lasting, persisting for nearly a minute. Surprisingly, dCRY appears to mediate red-light-evoked depolarization in wild-type flies, absent in both cry-null flies, and following acute treatment with the flavin-specific inhibitor diphenyleneiodonium in wild-type flies. This suggests a previously unsuspected functional signaling role for a neutral semiquinone flavin state (FADH•) for dCRY. The W420 tryptophan residue located closest to the FAD-dCRY interaction site is critical for blue- and UV-light-evoked electrophysiological responses, while other tryptophan residues within electron transfer distance to W420 do not appear to be required for light-evoked electrophysiological responses. Mutation of the dCRY tryptophan residue W342, more distant from the FAD interaction site, mimics the cry-null behavioral light response to constant light exposure. These data indicate that light-evoked dCRY electrical depolarization and clock resetting are mediated by distinct mechanisms.

Effect of a Remotely Delivered Self-directed Behavioral Intervention on Body Weight and Physical Health Status Among Adults With Obesity: The D-ELITE Randomized Clinical Trial.

Importance: The effectiveness of remotely delivered, self-directed, weight loss programs in routine clinical practice is largely unknown. Objective: To test whether a self-directed, remotely administered behavioral lifestyle intervention improves weight and self-reported general health status compared with usual care. Design, Setting, and Participants: In this randomized clinical trial, 511 adults with a body mass index (BMI) of 30 or more and less than 45 (based on electronic health record [EHR] weight and height), were enrolled from 30 Veterans Health Administration (VHA) sites between February 15, 2018, and December 18, 2018 (final follow-up February 18, 2021). Interventions: Participants were randomly assigned to the intervention group (n = 254) or the control group (n = 257). Both received usual care. Participants randomized to the intervention received Diabetes Prevention Program-based self-directed videos, handouts, and coaching messages via an online platform or US mail for 12 months. Main Outcomes and Measures: Coprimary outcomes were weight measured in primary care and recorded in the EHR and self-reported general health status using the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12) physical component score (PCS; higher scores are better [range, 0-100]) at the 12-month follow-up. The between-group minimal clinically important differences are 3 kg for weight and 5 points for the SF-12 PCS. Linear mixed models used weights and SF-12 PCS measured at either time point, with participants analyzed according to randomization assignment. Statistical significance for each coprimary outcome was based on a 2-sided α level of .025. Results: Among 511 participants randomized (mean age, 57.4 [SD, 13.9] years; 231 female [45%]), 429 (84.0%) had EHR-based weights and 410 (80.2%) had SF-12 PCS data at 12 months. The unadjusted mean weight at 12 months declined from 102.7 kg to 99.8 kg in the intervention group compared with 101.9 kg to 101.0 kg in the control group (adjusted between-group mean difference, -1.93 [97.5% CI, -3.24 to -0.61]; P = .001). At 12 months, the unadjusted mean SF-12 PCS scores declined from 44.8 to 44.3 among intervention participants compared with 44.5 to 43.2 among control participants (adjusted between-group mean difference, intervention minus control, 0.69 [97.5% CI, -1.11 to 2.49]; P = .39). Cardiovascular events represented the highest percentage of serious adverse events, accounting for 25% of events in the intervention group and 35% in the control group. Conclusions and Relevance: Among adults with obesity, a remotely delivered self-directed, behavioral lifestyle intervention, compared with usual care, resulted in statistically significantly greater weight loss at 12 months, although the difference was not clinically important. There was no significant difference in self-reported general physical health status at 12 months. Trial Registration: ClinicalTrials.gov Identifier: NCT03260140.

Interventional cardiologists' perceptions of percutaneous coronary intervention quality measurement and feedback.

BACKGROUND: Interventional cardiologists receive feedback on their clinical care from a variety of sources including registry-based quality measures, case conferences, and informal peer interactions. However, the impact of this feedback on clinical care is unclear. METHODS: We interviewed interventional cardiologists regarding the use of feedback to improve their care of percutaneous coronary intervention (PCI) patients. Interviews were assessed with template analysis using deductive and inductive techniques. RESULTS: Among 20 interventional cardiologists from private, academic, and Department of Veterans Affairs practice, 85% were male, 75% performed at least 100 PCIs annually, and 55% were in practice for 5 years or more. All reported receiving feedback on their practice, including formal quality measures and peer learning activities. Many respondents were critical of quality measure reporting, citing lack of trust in outcomes measures and poor applicability to clinical care. Some respondents reported the use of process measures such as contrast volume and fluoroscopy time for benchmarking their performance. Case conferences and informal peer feedback were perceived as timelier and more impactful on clinical care. Respondents identified facilitators of successful feedback interventions including transparent processes, respectful and reciprocal peer relationships, and integration of feedback into collective goals. Hierarchy and competitive environments inhibited useful feedback. CONCLUSIONS: Despite substantial resources dedicated to performance measurement and feedback for PCI, interventional cardiologists perceive existing quality measures to be of only modest value for improving clinical care. Catherization laboratories should seek to integrate quality measures into a holistic quality program that emphasizes peer learning, collective goals and mutual respect.

Pharmacologic Management of Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline.

Background: This document provides clinical recommendations for the pharmacologic treatment of chronic obstructive pulmonary disease (COPD). It represents a collaborative effort on the part of a panel of expert COPD clinicians and researchers along with a team of methodologists under the guidance of the American Thoracic Society.Methods: Comprehensive evidence syntheses were performed on all relevant studies that addressed the clinical questions and critical patient-centered outcomes agreed upon by the panel of experts. The evidence was appraised, rated, and graded, and recommendations were formulated using the Grading of Recommendations, Assessment, Development, and Evaluation approach.Results: After weighing the quality of evidence and balancing the desirable and undesirable effects, the guideline panel made the following recommendations: 1) a strong recommendation for the use of long-acting ß2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) combination therapy over LABA or LAMA monotherapy in patients with COPD and dyspnea or exercise intolerance; 2) a conditional recommendation for the use of triple therapy with inhaled corticosteroids (ICS)/LABA/LAMA over dual therapy with LABA/LAMA in patients with COPD and dyspnea or exercise intolerance who have experienced one or more exacerbations in the past year; 3) a conditional recommendation for ICS withdrawal for patients with COPD receiving triple therapy (ICS/LABA/LAMA) if the patient has had no exacerbations in the past year; 4) no recommendation for or against ICS as an additive therapy to long-acting bronchodilators in patients with COPD and blood eosinophilia, except for those patients with a history of one or more exacerbations in the past year requiring antibiotics or oral steroids or hospitalization, for whom ICS is conditionally recommended as an additive therapy; 5) a conditional recommendation against the use of maintenance oral corticosteroids in patients with COPD and a history of severe and frequent exacerbations; and 6) a conditional recommendation for opioid-based therapy in patients with COPD who experience advanced refractory dyspnea despite otherwise optimal therapy.Conclusions: The task force made recommendations regarding the pharmacologic treatment of COPD based on currently available evidence. Additional research in populations that are underrepresented in clinical trials is needed, including studies in patients with COPD 80 years of age and older, those with multiple chronic health conditions, and those with a codiagnosis of COPD and asthma.

Prioritizing Chinese medicine clinical research questions in cancer palliative care from patient and caregiver perspectives.

BACKGROUND: Chinese medicine (CM) modalities, including acupuncture and Chinese herbal medicine (CHM), are popular palliative interventions among patients with cancer, but further clinical research is required to assess their effectiveness and safety. OBJECTIVE: To prioritize top ten important CM clinical research questions from patients with cancer, cancer survivors and caregivers' perspectives via a face-to-face prioritization workshop in Hong Kong. METHODS: A list of 25 CM clinical research questions for cancer palliative care, which were identified from existing systematic reviews (SRs) and overview of SRs, was presented to 17 participants (patients with cancer [n = 5], cancer survivors [n = 6] and caregivers [n = 6]). The participants were then invited to establish consensus on prioritizing top ten research questions. RESULTS: Among the top ten priorities, five (50%) focused on acupuncture and related therapies, while five (50%) were on CHM. The three most important research priorities were (i) manual acupuncture plus opioids for relieving pain; (ii) CHM for improving quality of life among patients receiving chemotherapy; and (iii) concurrent use of CHM plus loperamide for reducing stomatitis. CONCLUSION: The top ten participant-endorsed CM clinical research priorities for cancer palliative care can guide local researchers on future direction. They can also inform local research funders on patient-centred allocation of limited funding. Under limited research funding, the most important co-prioritized research question from professional and patient perspectives may be addressed first. PATIENT OR PUBLIC CONTRIBUTION: Patients with cancer, cancer survivors and caregivers participated in conduct of the study to prioritize CM clinical research questions.

Overuse and Misuse of Inhaled Corticosteroids Among Veterans with COPD: a Cross-sectional Study Evaluating Targets for De-implementation.

BACKGROUND: Inhaled corticosteroid (ICS) use among patients with COPD increases the risk of pneumonia and other complications. Current recommendations limit ICS use to patients with frequent or severe COPD exacerbations. However, use of ICS among patients with COPD is common and may be occurring both among those with mild disease (overuse) and those misdiagnosed with COPD (misuse). OBJECTIVE: To identify patients without identifiable indication for ICS and assess patient and provider characteristics associated with potentially inappropriate to targeted in de-implementation efforts DESIGN: We performed a cross-sectional study of patients with COPD in the Veterans Affairs (VA) system with recent spirometry. PARTICIPANTS: After setting an index date, we identified individuals with a clinical diagnosis of COPD who had spirometry completed in the prior 5 years. We excluded individuals with an appropriate indication for ICS based on the 2017 GOLD statement, including asthma and a recent history of frequent or severe exacerbations. MAIN MEASURES: ICS use without identifiable indication KEY RESULTS: We identified 26,536 patients with COPD without an identifiable indication for ICS. Nearly » of patients (n = 6330) filled ≥2 prescriptions for ICS in the year prior to the index date. We found that older age (adjusted prevalence ratio [APR] 1.06 per decade, 95% confidence interval [CI] 1.04-1.08), white race (APR 1.11, 95% CI 1.05-1.19), and more primary care visits (APR 1.05 per visit, 95% CI 1.03-1.07) were associated with increased likelihood of potentially inappropriate use. Primary care clinic complexity and provider training were not associated with ICS use. Among patients misdiagnosed with COPD, we found that 14% used ICS. CONCLUSIONS: Potentially inappropriate ICS use is common among patients with and without airflow obstruction who are diagnosed with COPD. We identified patient comorbidities and patterns of healthcare utilization that increase the likelihood of ICS use that could be targeted for system-level de-implementation interventions.

De-implementing Inhaled Corticosteroids to Improve Care and Safety in COPD Treatment: Primary Care Providers' Perspectives.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is among the most common medical diagnoses among Veterans. More than 50% of Veterans diagnosed with mild-to-moderate COPD are prescribed inhaled corticosteroids despite recommendations for use restricted to patients with frequent exacerbations. OBJECTIVE: We explored primary care providers' experiences prescribing inhaled corticosteroids among patients with mild-to-moderate COPD as part of a quality improvement initiative. DESIGN: We used a sequential mixed-methods evaluation approach to understand factors influencing primary care providers' inhaled corticosteroid prescribing for patients with mild-to-moderate COPD. Participants were recruited to participate in qualitative interviews and structured surveys. PARTICIPANTS: We used a purposive sample of primary care providers from 13 primary care clinics affiliated with two urban Veteran Health Administration healthcare systems. MAIN MEASURES: Interviews were transcribed and analyzed using content analysis. Qualitative findings informed a subsequent survey. Surveys were administered through REDCap and analyzed descriptively. Key qualitative and quantitative findings were compared. KEY RESULTS: Participants reported they were unaware of current evidence and recommendations for prescribing inhaled corticosteroids; for example, 46% of providers reported they were unaware of risks of pneumonia. Providers reported they are generally unable to keep up with the current literature due to the broad scope of primary care practice. We also found primary care providers may be reluctant to change inherited prescriptions, even if they thought inhaled corticosteroid therapy might not be appropriate. CONCLUSIONS: Inhaled corticosteroid prescribing in this patient population is partly due to primary care providers' lack of knowledge about the potential harms and availability of alternative therapies. Our findings suggest that efforts to expand access by increasing the number of prescribing providers a patient potentially sees could make it more difficult to de-implement harmful prescriptions. Our findings also corroborate prior findings that awareness of current evidence-based guidelines is likely an important part of medical overuse.

A Randomized Trial of Long-Term Oxygen for COPD with Moderate Desaturation.

BACKGROUND: Long-term treatment with supplemental oxygen has unknown efficacy in patients with stable chronic obstructive pulmonary disease (COPD) and resting or exercise-induced moderate desaturation. METHODS: We originally designed the trial to test whether long-term treatment with supplemental oxygen would result in a longer time to death than no use of supplemental oxygen among patients who had stable COPD with moderate resting desaturation (oxyhemoglobin saturation as measured by pulse oximetry [Spo2], 89 to 93%). After 7 months and the randomization of 34 patients, the trial was redesigned to also include patients who had stable COPD with moderate exercise-induced desaturation (during the 6-minute walk test, Spo2 ≥80% for ≥5 minutes and <90% for ≥10 seconds) and to incorporate the time to the first hospitalization for any cause into the new composite primary outcome. Patients were randomly assigned, in a 1:1 ratio, to receive long-term supplemental oxygen (supplemental-oxygen group) or no long-term supplemental oxygen (no-supplemental-oxygen group). In the supplemental-oxygen group, patients with resting desaturation were prescribed 24-hour oxygen, and those with desaturation only during exercise were prescribed oxygen during exercise and sleep. The trial-group assignment was not masked. RESULTS: A total of 738 patients at 42 centers were followed for 1 to 6 years. In a time-to-event analysis, we found no significant difference between the supplemental-oxygen group and the no-supplemental-oxygen group in the time to death or first hospitalization (hazard ratio, 0.94; 95% confidence interval [CI], 0.79 to 1.12; P=0.52), nor in the rates of all hospitalizations (rate ratio, 1.01; 95% CI, 0.91 to 1.13), COPD exacerbations (rate ratio, 1.08; 95% CI, 0.98 to 1.19), and COPD-related hospitalizations (rate ratio, 0.99; 95% CI, 0.83 to 1.17). We found no consistent between-group differences in measures of quality of life, lung function, and the distance walked in 6 minutes. CONCLUSIONS: In patients with stable COPD and resting or exercise-induced moderate desaturation, the prescription of long-term supplemental oxygen did not result in a longer time to death or first hospitalization than no long-term supplemental oxygen, nor did it provide sustained benefit with regard to any of the other measured outcomes. (Funded by the National Heart, Lung, and Blood Institute and the Centers for Medicare and Medicaid Services; LOTT ClinicalTrials.gov number, NCT00692198 .).

Challenges to Educating Smokers About Lung Cancer Screening: a Qualitative Study of Decision Making Experiences in Primary Care.

We sought to qualitatively explore how those at highest risk for lung cancer, current smokers, experienced, understood, and made decisions about participation in lung cancer screening (LCS) after being offered in the target setting for implementation, routine primary care visits. Thirty-seven current smokers were identified within 4 weeks of being offered LCS at seven sites participating in the Veterans Health Administration Clinical Demonstration Project and interviewed via telephone using semi-structured qualitative interviews. Transcripts were coded by two raters and analyzed thematically using iterative inductive content analysis. Five challenges to smokers' decision-making lead to overestimated benefits and minimized risks of LCS: fear of lung cancer fixated focus on inflated screening benefits; shame, regret, and low self-esteem stemming from continued smoking situated screening as less averse and more beneficial; screening was mistakenly believed to provide general evaluation of lungs and reassurance was sought about potential damage caused by smoking; decision-making was deferred to providers; and indifference about numerical educational information that was poorly understood. Biased understanding of risks and benefits was complicated by emotion-driven, uninformed decision-making. Emotional and cognitive biases may interfere with educating and supporting smokers' decision-making and may require interventions tailored for their unique needs.

Accessing Care Through the Veterans Choice Program: The Veteran Experience.

BACKGROUND: The Veterans Choice Program (VCP) was implemented to improve healthcare access by expanding healthcare options for Veterans Health Administration (VHA) enrollees. OBJECTIVES: To understand Veterans' experience accessing VCP care. DESIGN: Qualitative content analysis. SUBJECTS: Forty-seven veterans from three medical centers in three of the five VA geographical regions. APPROACH: We used semi-structured telephone interviews designed to elicit descriptions of Veterans' experiences. Data was analyzed using iterative, inductive, and deductive content analysis. Broad themes were identified based on representative interview responses. KEY RESULTS: We identified six themes: general impressions (concept and frustration); preferred source of care (institution, specialty, and individual provider); facilitators (VA staff facilitation and proactive Veterans); barriers (complexity, lack of responsiveness, lack of local providers, and poor coordination); perceived sources of VCP problems (learning curve, leadership and staff, and politics); and unintended negative impact (responsibility for costs of care and discontinued access to community care). DISCUSSION: Most Veterans who had received care through the VCP felt that it improved their access to care. However, accessing care through the VCP is a complex process that requires proactive Veterans and active support from the VA, third-party administrators, and availability of participating community providers. Veterans' abilities to navigate this process and the level of support provided varied widely. Even patients who did receive care through VCP found the process challenging. Greater support is needed for some Veterans to successfully access VCP care because Veterans who need care the most may be the least able to access it.

Patient and Clinician Perspectives on Shared Decision-making in Early Adopting Lung Cancer Screening Programs: a Qualitative Study.

BACKGROUND: Guidelines recommend, and Medicare requires, shared decision-making between patients and clinicians before referring individuals at high risk of lung cancer for chest CT screening. However, little is known about the extent to which shared decision-making about lung cancer screening is achieved in real-world settings. OBJECTIVE: To characterize patient and clinician impressions of early experiences with communication and decision-making about lung cancer screening and perceived barriers to achieving shared decision-making. DESIGN: Qualitative study entailing semi-structured interviews and focus groups. PARTICIPANTS: We enrolled 36 clinicians who refer patients for lung cancer screening and 49 patients who had undergone lung cancer screening in the prior year. Participants were recruited from lung cancer screening programs at four hospitals (three Veterans Health Administration, one urban safety net). APPROACH: Using content analysis, we analyzed transcripts to characterize communication and decision-making about lung cancer screening. Our analysis focused on the recommended components of shared decision-making (information sharing, deliberation, and decision aid use) and barriers to achieving shared decision-making. KEY RESULTS: Clinicians varied in the information shared with patients, and did not consistently incorporate decision aids. Clinicians believed they explained the rationale and gave some (often purposely limited) information about the trade-offs of lung cancer screening. By contrast, some patients reported receiving little information about screening or its trade-offs and did not realize the CT was intended as a screening test for lung cancer. Clinicians and patients alike did not perceive that significant deliberation typically occurred. Clinicians perceived insufficient time, competing priorities, difficulty accessing decision aids, limited patient comprehension, and anticipated patient emotions as barriers to realizing shared decision-making. CONCLUSIONS: Due to multiple perceived barriers, patient-clinician conversations about lung cancer screening may fall short of guideline-recommended shared decision-making supported by a decision aid. Consequently, patients may be left uncertain about lung cancer screening's rationale, trade-offs, and process.

Quality of Care Delivered to Veterans with COPD Exacerbation and the Association with 30-Day Readmission and Death.

Quality of chronic obstructive pulmonary disease (COPD) care is thought to be an important intermediate process to improve the well-being of patients admitted to hospital for exacerbation. We sought to examine the quality of inpatient COPD care and the associations with readmission and mortality. We performed a cohort study of 2,364 veterans aged over 40 and hospitalized for COPD between 2005 and 2011 at five Department of Veterans Affairs hospitals. We examined whether patients received six guideline recommended care items including short-acting bronchodilators, corticosteroids, antibiotics, positive-pressure ventilation (in cases of acute hypercarbic respiratory failure), chest imaging, and arterial blood gas measurement. Our primary outcome was all-cause hospital readmission or death within 30 days. Overall quality of care was not significantly associated with readmission or death (acute care aOR 0.98; 95% CI 0.87-1.11; ICU aOR 0.89; 95% CI 0.71-1.13). Delivery of corticosteroids and antibiotics was associated with reduced odds of readmission and death (aOR 0.77; 95% CI 0.61-0.92). Few patients received all of the recommended care items (18% of acute care, 38% of ICU patients). Quality of care did not vary by race or sex but did vary significantly across sites and did not improve over time. Our composite measure of COPD care quality was not associated with readmission or death. Further efforts are needed to improve care delivery to patients hospitalized with COPD.

An Official American Thoracic Society Research Statement: Implementation Science in Pulmonary, Critical Care, and Sleep Medicine.

BACKGROUND: Many advances in health care fail to reach patients. Implementation science is the study of novel approaches to mitigate this evidence-to-practice gap. METHODS: The American Thoracic Society (ATS) created a multidisciplinary ad hoc committee to develop a research statement on implementation science in pulmonary, critical care, and sleep medicine. The committee used an iterative consensus process to define implementation science and review the use of conceptual frameworks to guide implementation science for the pulmonary, critical care, and sleep community and to explore how professional medical societies such as the ATS can promote implementation science. RESULTS: The committee defined implementation science as the study of the mechanisms by which effective health care interventions are either adopted or not adopted in clinical and community settings. The committee also distinguished implementation science from the act of implementation. Ideally, implementation science should include early and continuous stakeholder involvement and the use of conceptual frameworks (i.e., models to systematize the conduct of studies and standardize the communication of findings). Multiple conceptual frameworks are available, and we suggest the selection of one or more frameworks on the basis of the specific research question and setting. Professional medical societies such as the ATS can have an important role in promoting implementation science. Recommendations for professional societies to consider include: unifying implementation science activities through a single organizational structure, linking front-line clinicians with implementation scientists, seeking collaborations to prioritize and conduct implementation science studies, supporting implementation science projects through funding opportunities, working with research funding bodies to set the research agenda in the field, collaborating with external bodies responsible for health care delivery, disseminating results of implementation science through scientific journals and conferences, and teaching the next generation about implementation science through courses and other media. CONCLUSIONS: Implementation science plays an increasingly important role in health care. Through support of implementation science, the ATS and other professional medical societies can work with other stakeholders to lead this effort.

Evaluation of the Veterans Health Administration's Specialty Care Transformational Initiatives to Promote Patient-Centered Delivery of Specialty Care: A Mixed-Methods Approach.

INTRODUCTION: Veteran's Affairs Office of Specialty Care (OSC) launched four national initiatives (Electronic-Consults [e-Consults], Specialty Care Access Networks-Extension for Community Healthcare Outcomes [SCAN-ECHO], Mini-Residencies, and Specialty Care Neighborhood) to improve specialty care delivery and funded a center to evaluate the initiatives. METHODS: The evaluation, guided by two implementation frameworks, provides formative (administrator/provider interviews and surveys) and summative data (quantitative data on patterns of use) about the initiatives to OSC. RESULTS: Evaluation of initiative implementation is assessed through CFIR (Consolidated Framework for Implementation Research)-grounded qualitative interviews to identify barriers/facilitators. Depending on high or low implementation, factors such as receiving workload credit, protected time, existing workflow/systems compatibility, leadership engagement, and access to information/resources were considered implementation barriers or facilitators. Findings were shared with OSC and used to further refine implementation at additional sites. Evaluation of other initiatives is ongoing. CONCLUSIONS: The mixed-methods approach has provided timely information to OSC about initiative effect and impacted OSC policies on implementation at additional sites.