Once-daily single-inhaler versus twice-daily multiple-inhaler triple therapy in patients with COPD: lung function and health status results from two replicate randomized controlled trials.

BACKGROUND: The comparative efficacy of inhaled corticosteroid/long-acting muscarinic antagonist/long-acting ß2-agonist (ICS/LAMA/LABA) triple therapy administered via single or multiple inhalers in patients with chronic obstructive pulmonary disease (COPD) has not been evaluated comprehensively. We conducted two replicate trials comparing single- with multiple-inhaler ICS/LAMA/LABA combination in COPD. METHODS: 207608 and 207609 were Phase IV, 12-week, randomized, double-blind, triple-dummy non-inferiority trials comparing once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 µg via Ellipta inhaler, with twice-daily budesonide/formoterol (BUD/FOR) 400/12 µg via metered-dose inhaler plus once-daily tiotropium (TIO) 18 µg via HandiHaler. Patients had symptomatic COPD and forced expiratory volume in 1 s (FEV1) < 50% predicted, or FEV1 < 80% predicted and ≥ 2 moderate or 1 severe exacerbations in the prior year. The primary endpoint in both trials was weighted mean change from baseline (wmCFB) in 0-24-h FEV1 at Week 12. Secondary endpoints included CFB in trough FEV1 at Day 84 and 85. Other endpoints included serial FEV1 and health status outcomes at Week 12. Safety was evaluated descriptively. RESULTS: The modified per-protocol population included 720 and 711 patients in studies 207608 and 207609 (intent-to-treat population: 728 and 732). FF/UMEC/VI was non-inferior to BUD/FOR+TIO for wmCFB in 0-24-h FEV1 at Week 12 (Study 207608 treatment difference [95% confidence interval]: 15 mL [- 13, 43]; Study 207609: 11 mL [- 20, 41]). FF/UMEC/VI improved trough FEV1 CFB versus BUD/FOR+TIO at Day 84 and 85 (Day 85 treatment difference: Study 207608: 38 mL [10, 66]; Study 207609: 51 mL [21, 82]) and FEV1 at 12 and 24 h post-morning dose at Week 12 in both studies. No treatment differences were seen in health status outcomes. Safety profiles were similar between treatments; pneumonia occurred in 7 (< 1%) patients with FF/UMEC/VI and 9 (1%) patients with BUD/FOR+TIO, across both studies. CONCLUSIONS: FF/UMEC/VI was non-inferior to BUD/FOR+TIO for wmCFB in 0-24-h FEV1 at Week 12 in patients with COPD. Greater improvements in trough and serial FEV1 measurements at Week 12 with FF/UMEC/VI versus BUD/FOR+TIO, together with similar health status improvements and safety outcomes including the incidence of pneumonia, suggest that once-daily single-inhaler FF/UMEC/VI triple therapy is a viable option for patients looking to simplify their treatment regimen. TRIAL REGISTRATION: GSK (207608/207609; NCT03478683/NCT03478696).

I Tweet, Therefore I Learn: An Analysis of Twitter Use Across Anesthesiology Conferences.

BACKGROUND: Twitter in anesthesiology conferences promotes rapid science dissemination, global audience participation, and real-time updates of simultaneous sessions. We designed this study to determine if an association exists between conference attendance/registration and 4 defined Twitter metrics. METHODS: Using publicly available data through the Symplur Healthcare Hashtags Project and the Symplur Signals, we collected data on total tweets, impressions, retweets, and replies as 4 primary outcome metrics for all registered anesthesiology conferences occurring from May 1, 2016 to April 30, 2017. The number of Twitter participants, defined as users who contributed a tweet, retweet, or reply 3 days before through 3 days after the conference, was collected. We also collected influencer data as determined by mentions (number of times a user is referenced). Two authors independently verified the categories for influencers assigned by Symplur. Conference demographic data were obtained by e-mail inquiries. Associations between meeting attendees/registrants and Twitter metrics, between Twitter participants and the metrics, and between physician influencers and Twitter participants were tested using Spearman rho. RESULTS: Fourteen conferences with 63,180 tweets were included. With the American Society of Anesthesiologists annual meeting included, the correlations between meeting attendance/registration and total tweets (rs = 0.588; P = .074), impressions (rs = 0.527; P = .117), and retweets (rs = 0.539; P = .108) were not statistically significant; for replies, it was moderately positive (rs = 0.648; P = .043). Without the American Society of Anesthesiologists annual meeting, total tweets (rs = 0.433; P = .244), impressions (rs = 0.350; P = .356), retweets (rs = 0.367; P = .332), and replies (rs = 0.517; P = .154) were not statistically significant. Secondary outcomes include a highly positive correlation between Twitter participation and total tweets (rs = 0.855; P < .001), very highly positive correlations between Twitter participation and impressions (rs = 0.938; P < .001), retweets (rs = 0.925; P < .001), and a moderately positive correlation between Twitter participation and replies (rs = 0.652; P = .044). Doctors were top influencers in 8 of 14 conferences, and the number of physician influencers in the top 10 influencers list at each conference had a moderately positive correlation with Twitter participation (rs = 0.602; P = .023). CONCLUSIONS: We observed that the number of Twitter participants for a conference is positively associated with Twitter activity metrics. No relationship between conference size and Twitter metrics was observed. Physician influencers may be an important driver of participants.

A Descriptive Survey of Anesthesiology Residency Simulation Programs: How Are Programs Preparing Residents for the New American Board of Anesthesiology APPLIED Certification Examination?

BACKGROUND: Anesthesiology residency programs may need new simulation-based programs to prepare residents for the new Objective Structured Clinical Examination (OSCE) component of the American Board of Anesthesiology (ABA) Primary Certification process. The design of such programs may require significant resources, including faculty time, expertise, and funding, as are currently needed for structured oral examination (SOE) preparation. This survey analyzed the current state of US-based anesthesiology residency programs regarding simulation-based educational programming for SOE and OSCE preparation. METHODS: An online survey was distributed to every anesthesiology residency program director in the United States. The survey included 15 to 46 questions, depending on each respondent's answers. The survey queried current practices and future plans regarding resident preparation specifically for the ABA APPLIED examination, with emphasis on the OSCE. Descriptive statistics were summarized. χ and Fisher exact tests were used to test the differences in proportions across groups. Spearman rank correlation was used to examine the association between ordinal variables. RESULTS: The responding 66 programs (49%) were a representative sample of all anesthesiology residencies (N = 136) in terms of geographical location (χ P = .58). There was a low response rate from small programs that have 12 or fewer clinical anesthesia residents. Ninety-one percent (95% confidence interval [CI], 84%-95%) of responders agreed that it is the responsibility of the program to specifically prepare residents for primary certification, and most agreed that it is important to practice SOEs (94%; 95% CI, 88%-97%) and OSCEs (89%; 95% CI, 83%-94%). While 100% of respondents reported providing mock SOEs, only 31% (95% CI, 24%-40%) of respondents provided mock OSCE experiences. Of those without an OSCE program, 75% (95% CI, 64%-83%) reported plans to start one. The most common reasons for not having an OSCE program already in place, and the perceived challenges for implementing an OSCE program, were the same: lack of time (faculty and residents), expertise in OSCE development and assessment, and funding. CONCLUSIONS: The results provide data from residency programs for benchmarking their simulation curriculum and ABA APPLIED Examination preparation offerings. Despite agreement that residency programs should prepare residents for the ABA APPLIED Examination, many programs have yet to implement an OSCE preparation program, in part due to lack of financial resources, faculty expertise, and time. Additionally, in contrast to the SOE, the OSCE is a new format for ABA primary certification. As a result, the lack of consensus concerning preparation needs could be related to the amount information that is available regarding the examination content and assessment process.

A Smartphone-based Decision Support Tool Improves Test Performance Concerning Application of the Guidelines for Managing Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy.

BACKGROUND: The American Society of Regional Anesthesia and Pain Medicine (ASRA) consensus statement on regional anesthesia in the patient receiving antithrombotic or thrombolytic therapy is the standard for evaluation and management of these patients. The authors hypothesized that an electronic decision support tool (eDST) would improve test performance compared with native physician behavior concerning the application of this guideline. METHODS: Anesthesiology trainees and faculty at 8 institutions participated in a prospective, randomized trial in which they completed a 20-question test involving clinical scenarios related to the ASRA guidelines. The eDST group completed the test using an iOS app programmed to contain decision logic and content of the ASRA guidelines. The control group completed the test by using any resource in addition to the app. A generalized linear mixed-effects model was used to examine the effect of the intervention. RESULTS: After obtaining institutional review board's approval and informed consent, 259 participants were enrolled and randomized (eDST = 122; control = 137). The mean score was 92.4 ± 6.6% in the eDST group and 68.0 ± 15.8% in the control group (P < 0.001). eDST use increased the odds of selecting correct answers (7.8; 95% CI, 5.7 to 10.7). Most control group participants (63%) used some cognitive aid during the test, and they scored higher than those who tested from memory alone (76 ± 15% vs. 57 ± 18%, P < 0.001). There was no difference in time to completion of the test (P = 0.15) and no effect of training level (P = 0.56). CONCLUSIONS: eDST use improved application of the ASRA guidelines compared with the native clinician behavior in a testing environment.

Review of crisis resource management (CRM) principles in the setting of intraoperative malignant hyperthermia.

The practice of medicine is characterized by routine and typical cases whose management usually goes according to plan. However, the occasional case does arise which involves rare catastrophic emergencies, such as intraoperative malignant hyperthermia (MH), which require a comprehensive, coordinated, and resource-intensive treatment plan. Physicians are expected to provide expert quality care for routine, typical cases, but is it reasonable to expect the same standard of expertise and comprehensive management when the emergency involves a rare entity? Although physicians would like to say yes to this question, the reality is that no physician will ever amass the amount of experience in patient care needed to truly qualify as an expert in the management of a rare emergency entity, such as MH. However, physicians can become expert in the global process of managing emergencies by using the principles of crisis resource management (CRM). In this article, we review the key concepts of CRM, using a real life example of a team who utilized CRM principles to successfully manage an intraoperative MH crisis, despite there being no one on the team who had ever previously encountered a true MH crisis.

Cognitive processes in anesthesiology decision making.

The quality and safety of health care are under increasing scrutiny. Recent studies suggest that medical errors, practice variability, and guideline noncompliance are common, and that cognitive error contributes significantly to delayed or incorrect diagnoses. These observations have increased interest in understanding decision-making psychology.Many nonrational (i.e., not purely based in statistics) cognitive factors influence medical decisions and may lead to error. The most well-studied include heuristics, preferences for certainty, overconfidence, affective (emotional) influences, memory distortions, bias, and social forces such as fairness or blame.Although the extent to which such cognitive processes play a role in anesthesia practice is unknown, anesthesia care frequently requires rapid, complex decisions that are most susceptible to decision errors. This review will examine current theories of human decision behavior, identify effects of nonrational cognitive processes on decision making, describe characteristic anesthesia decisions in this context, and suggest strategies to improve decision making.

Effect of a cognitive aid on adherence to perioperative assessment and management guidelines for the cardiac evaluation of noncardiac surgical patients.

BACKGROUND: The 2007 American College of Cardiologists/American Heart Association Guidelines on Perioperative Cardiac Evaluation and Care for Noncardiac Surgery is the standard for perioperative cardiac evaluation. Recent work has shown that residents and anesthesiologists do not apply these guidelines when tested. This research hypothesized that a decision support tool would improve adherence to this consensus guideline. METHODS: Anesthesiology residents at four training programs participated in an unblinded, prospective, randomized, cross-over trial in which they completed two tests covering clinical scenarios. One quiz was completed from memory and one with the aid of an electronic decision support tool. Performance was evaluated by overall score (% correct), number of incorrect answers with possibly increased cost or risk of care, and the amount of time required to complete the quizzes both with and without the cognitive aid. The primary outcome was the proportion of correct responses attributable to the use of the decision support tool. RESULTS: All anesthesiology residents at four institutions were recruited and 111 residents participated. Use of the decision support tool resulted in a 25% improvement in adherence to guidelines compared with memory alone (P < 0.0001), and participants made 77% fewer incorrect responses that would have resulted in increased costs. Use of the tool was associated with a 3.4-min increase in time to complete the test (P < 0.001). CONCLUSIONS: Use of an electronic decision support tool significantly improved adherence to the guidelines as compared with memory alone. The decision support tool also prevented inappropriate management steps possibly associated with increased healthcare costs.

Threat and error management for anesthesiologists: a predictive risk taxonomy.

PURPOSE OF REVIEW: Patient care in the operating room is a dynamic interaction that requires cooperation among team members and reliance upon sophisticated technology. Most human factors research in medicine has been focused on analyzing errors and implementing system-wide changes to prevent them from recurring. We describe a set of techniques that has been used successfully by the aviation industry to analyze errors and adverse events and explain how these techniques can be applied to patient care. RECENT FINDINGS: Threat and error management (TEM) describes adverse events in terms of risks or challenges that are present in an operational environment (threats) and the actions of specific personnel that potentiate or exacerbate those threats (errors). TEM is a technique widely used in aviation, and can be adapted for the use in a medical setting to predict high-risk situations and prevent errors in the perioperative period. A threat taxonomy is a novel way of classifying and predicting the hazards that can occur in the operating room. TEM can be used to identify error-producing situations, analyze adverse events, and design training scenarios. SUMMARY: TEM offers a multifaceted strategy for identifying hazards, reducing errors, and training physicians. A threat taxonomy may improve analysis of critical events with subsequent development of specific interventions, and may also serve as a framework for training programs in risk mitigation.

No Miracles in Two Minutes: A Randomized Controlled Study on the Impact of Preparatory Expansive Posing on Anesthesiology Residents' Performance in Mock Structured Oral Examinations.

Background: The objective of this study was to evaluate the impact of engaging in preparatory expansive posing on the performance of anesthesiology trainees during a mock structured oral examination. Methods: A total of 38 clinical residents at a single institution participated in this prospective randomized controlled study. Participants were stratified by clinical anesthesia year and randomly assigned to 1 of 2 orientation rooms to prepare for the examination. The preparatory expansive posing participants stood for 2 minutes with their hands and arms above their heads and with their feet approximately 1 ft apart. Conversely, the control participants sat quietly in a chair for 2 minutes. All participants then received the same orientation and examination. Faculty evaluation of resident performance, residents' self-assessment of performance, and anxiety score were collected. Results: There was no evidence to support our primary hypothesis that residents who engaged in preparatory expansive posing for 2 minutes prior to a mock structured oral examination would score higher than their control counterparts (P = .68). There was no evidence to support our secondary hypotheses that preparatory expansive posing increases self-assessment of one's performance (P = .31) or reduces perceived anxiety during a mock structured oral examination (P = .85). Conclusions: Preparatory expansive posing did not improve anesthesiology residents' mock structured oral examination performance or self-assessment of their performance, nor did it reduce their perceived anxiety. Preparatory expansive posing is likely not a useful technique in improving the performance of residents in structured oral examinations.

Decision-making and safety in anesthesiology.

PURPOSE OF REVIEW: Anesthesiologists work in a complex environment that is intolerant of errors. Cognitive errors, or errors in thought processes, are mistakes that a clinician makes despite 'knowing better'. Several new studies provide a better understanding of how to manage risk while making better decisions. RECENT FINDINGS: Heuristics, or mental shortcuts, allow physicians to make decisions quickly and efficiently but may be responsible for errors in diagnosis and treatment. Using simple 'decision-making checklists' can help healthcare providers to make the correct decisions by monitoring their own thought processes. Anesthesiologists can adopt risk assessment tools that were originally developed for use by pilots to determine the hazards associated with a particular clinical management strategy. SUMMARY: Effective decision-making and risk management reduce the risk of adverse events in the operating room. This article proposes several new decision-making and risk assessment tools for use in the operating room.

Evaluating Triple Therapy Treatment Pathways in Chronic Obstructive Pulmonary Disease (COPD): A Machine-Learning Predictive Model.

Purpose: Inhaled triple therapy (TT) comprising a long-acting muscarinic antagonist, long-acting ß2 agonist, and inhaled corticosteroid is recommended for symptomatic chronic obstructive pulmonary disease (COPD) patients, or those at risk of exacerbation. However, it is not well understood which patient characteristics contribute most to future exacerbation risk. This study assessed patient predictors associated with future exacerbation time following initiation of TT. Patients and Methods: This retrospective cohort study used data from the Optum™ Clinformatics™ Data Mart, a large health claims database in the United States. COPD patients who initiated TT between January 2008 and March 2018 (index) were eligible. Patients were required to be aged ≥18 years at index and have continuous enrollment for the 12 months prior to index (baseline) and the 12 months following index (follow-up). Patients who had received TT during baseline were excluded. Data from eligible patients were analyzed using a reverse engineering forward simulation machine learning platform to predict future COPD exacerbation time. Results: Data from 73,625 patients were included. The model found that prior exacerbation was largely correlated with post-index exacerbation time; patients who had ≥4 exacerbation episodes during baseline had an average increase of 32.4 days post-index exacerbation, compared with patients with no exacerbations during baseline. Likewise, ≥2 inpatient visits (effect size 27.1 days), the use of xanthines (effect size 11.5 days), or rheumatoid arthritis (effect size 6.4 days) during baseline were associated with increased exacerbation time. Conversely, diagnosis of anemia (effect size -5.68 days), or oral corticosteroids in the past month (effect size -3.43 days) were associated with reduced exacerbation time. Conclusion: Frequent prior exacerbations, healthcare resource utilization, xanthine use, and rheumatoid arthritis were the strongest factors predicting the future increase of exacerbations. These results improve our understanding of exacerbation risk among COPD patients initiating triple therapy.

The Burden of Nocturnal Symptoms in Patients with Chronic Obstructive Pulmonary Disease: Results of a Real-World Survey in the USA.

INTRODUCTION: Patients with chronic obstructive pulmonary disease (COPD) often have poor sleep quality and report a worsening of respiratory symptoms during night-time. However, current clinical guidelines for COPD management do not specifically consider nocturnal symptoms when recommending pharmacological treatment. This study aimed to better understand the burden of nocturnal symptoms in patients with COPD, and to evaluate the importance of nocturnal symptom control compared with daytime and overall symptom control. METHODS: Data were analyzed from the Adelphi Respiratory Disease Specific Programme, a point-in-time survey of physicians and their patients, conducted in the USA in 2019. Primary care physicians and pulmonologists who managed three or more patients with COPD per month were eligible for inclusion; eligible patients were ≥ 18 years old, with a physician-confirmed diagnosis of COPD. RESULTS: Surveys from 171 physicians and 800 patients were analyzed. Everyday symptoms were reported in 14% of patients. In total, 88% of patients reported daytime symptoms, and 74% of patients experienced nocturnal symptoms, with 7% reporting daily nocturnal symptoms. Patients experiencing nocturnal symptoms every day had the greatest impairment in their activity as per the Work Productivity and Activity Impairment questionnaire (mean total activity impairment, 66.9%; nocturnal symptoms once or twice a week, 41.1%; no nocturnal symptoms, 26.4%). Patients experiencing daily nocturnal symptoms also had the lowest quality of life (QoL) as per the EuroQoL 5-Dimension 3-Level score. Physicians reported prescribing therapy based on sustained 24-h symptomatic relief for the majority of patients (78%). They reported nocturnal symptom control as a factor in their choice of therapy for 38% of patients, and daytime symptom control as a reason for 61% of patients. CONCLUSION: Daytime and nocturnal symptoms are common among patients with COPD. Frequency of nocturnal symptoms is related to a significant impairment in activity and health-related QoL.

Patient and Clinical Demographics of New Users to Single-Inhaler Triple Therapy in Patients with Chronic Obstructive Pulmonary Disease.

INTRODUCTION: Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy was approved by the United States Food and Drug Administration in 2017 as a maintenance therapy for chronic obstructive pulmonary disease (COPD). Patient characteristics and treatment patterns prior to initiating FF/UMEC/VI are currently unknown. This study assessed patient characteristics, exacerbation, and medication history in patients with COPD before the initiation of FF/UMEC/VI or multiple-inhaler triple therapy (MITT). METHODS: This was a retrospective study using the Optum Clinformatics® Data Mart. Patients who initiated FF/UMEC/VI triple therapy or MITT (consisting of a long-acting muscarinic antagonist [LAMA], long-acting ß2-agonist [LABA], and inhaled corticosteroid [ICS]) between October 2017 and September 2018, were enrolled in commercial or Medicare Advantage Prescription Drug plans, were aged > 40 years, and had a COPD diagnosis were eligible. Patient characteristics, comorbidities, COPD medication use, exacerbations, and eosinophil counts were assessed in the 12-month baseline period prior to initiation of FF/UMEC/VI triple therapy or MITT. RESULTS: The study population included 3933 FF/UMEC/VI users and 18,244 MITT users. Mean (standard deviation) patient age was 72.2 (8.6) years in FF/UMEC/VI users and 70.7 (9.7) years in MITT users. Prior to initiating triple therapy, the majority of FF/UMEC/VI (89.1%) and MITT (93.8%) users experienced a moderate or severe exacerbation or used a COPD maintenance therapy during the baseline period. In addition, 41.2% of FF/UMEC/VI users received overlapping ICS/LAMA/LABA, 20.3% received ICS/LABA, and 9.7% received LAMA/LABA. CONCLUSION: In this population of COPD patients, triple therapy was frequently initiated after previous maintenance medication use or an exacerbation, in line with treatment guideline recommendations.

Treatment Patterns for Chronic Obstructive Pulmonary Disease (COPD) in the United States: Results from an Observational Cross-Sectional Physician and Patient Survey.

Purpose: There is a high prevalence of chronic obstructive pulmonary disease (COPD) in the United States (US). Although guidelines are available for the treatment of COPD, evidence suggests that management of COPD in clinical practice is not always aligned with this guidance. This study aimed to further understand the current use of COPD maintenance medication in the US. Patients and Methods: This study was an analysis of data from the Adelphi Respiratory Disease Specific Programme (DSP™) 2019. Point-in-time data were collected from participating US physicians and their COPD patients. Physicians were either primary care physicians (PCPs) or pulmonologists, with a minimum workload of ≥3 COPD patients per month. Patients were aged ≥18 years with a physician-confirmed diagnosis of COPD. Results: In total, 171 physicians completed the survey (92 PCPs and 79 pulmonologists). Mean patient age was 66.4 years, 45% were female, with moderate COPD in 49.4% of patients and severe/very severe in 19.3%. Pulmonologists more frequently prescribed dual bronchodilation and triple therapy than PCPs, whereas inhaled corticosteroid/long-acting ß2-agonist was more frequently prescribed by PCPs than pulmonologists. For both physician types, the most common reason for prescribing their patients' current treatment was 24-hour symptom relief. The majority of PCPs (70.1%) and pulmonologists (71.9%) reported referring to COPD guidelines when making treatment decisions. Conclusion: Prescribing patterns for COPD patients were found to differ between PCPs and pulmonologists. Improved physician understanding of how to tailor treatment for each patient, based on current symptoms and exacerbation risk, could help optimize patient care in COPD.

Adherence and persistence to once-daily single-inhaler versus multiple-inhaler triple therapy among patients with chronic obstructive pulmonary disease in the USA: A real-world study.

BACKGROUND: Triple therapy comprising an inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting ß2 agonist (ICS/LAMA/LABA) is recommended for chronic obstructive pulmonary disease (COPD) patients at risk of exacerbation. Multiple-inhaler triple therapy (MITT) is associated with poor adherence and persistence; however, these outcomes have not been evaluated for single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI). METHODS: This retrospective analysis of the IQVIA PharMetrics Plus claims database identified patients with COPD initiating triple therapy between 18 September 2017 and 30 June 2019. The first date of single-inhaler FF/UMEC/VI dispensing, or first day of overlapping ICS, LAMA, and LABA medications for MITT users, defined the index date. Patients were ≥40 years, had ≥12 months of continuous insurance coverage pre-index (baseline) and ≥6 months' coverage post-index; those with MITT during baseline were excluded. Inverse probability weighting was used to balance baseline characteristics. Adherence was assessed using proportion of days covered (PDC) and was evaluated using linear and log-binomial models. Persistence (non-persistence identified as >30-day gap between fills) was evaluated using Cox models. RESULTS: 9942 patients (FF/UMEC/VI: 2782; MITT: 7160) were included. Adherence was significantly higher for FF/UMEC/VI versus MITT users (mean PDC, 0.66 vs. 0.48; p < 0.001), and FF/UMEC/VI users were twice as likely to be adherent (PDC ≥0.8) than MITT users (46.5% vs. 22.3%; risk ratio [95% CI]: 2.08 [1.85-2.30]; p < 0.001). After 12 months, significantly more FF/UMEC/VI users persisted on therapy than MITT users (35.7% vs. 13.9%; hazard ratio [95% CI]: 1.91 [1.81-2.01]; p < 0.001). CONCLUSIONS: COPD patients initiating single-inhaler FF/UMEC/VI had significantly improved adherence and persistence compared with MITT.

Benefit of Prompt versus Delayed Use of Single-Inhaler Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Following a COPD Exacerbation.

Purpose: Triple therapy (TT; inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting ß2-agonist) is recommended for patients with chronic obstructive pulmonary disease (COPD) at risk of exacerbation, although the optimum timing of TT initiation remains unclear. This study evaluated the impact of prompt versus delayed initiation of single-inhaler TT (fluticasone furoate, umeclidinium, and vilanterol [FF/UMEC/VI]) following a COPD exacerbation. Patients and Methods: This retrospective cohort study used data from the IQVIA PharMetrics® Plus database. Patients initiating FF/UMEC/VI following a COPD exacerbation between September 18, 2017 and September 30, 2019 (exacerbation = index date) were categorized as prompt (within 30 days of index) or delayed (31-180 days after index) FF/UMEC/VI initiators. Patients were aged ≥40 years at index, had ≥12 months' continuous health insurance coverage before index (baseline), and ≥6 months' coverage after index (follow-up). Patients with a COPD exacerbation or claim for FF/UMEC/VI during baseline were excluded. Inverse probability weighting was used to adjust for differences in baseline characteristics between cohorts. Exacerbations (overall, moderate, and severe), healthcare costs, and readmissions were evaluated during follow-up. Results: A total of 1904 patients (prompt: 529; delayed: 1375) were included. After weighting, baseline characteristics were well balanced between cohorts. Patients in the prompt cohort had significantly lower rates per person-year (PPY) of overall (0.98 vs 1.23; rate ratio [RR] [95% CI] = 0.79 [0.65-0.94], p = 0.004), moderate (0.86 vs 1.03; RR [95% CI] = 0.84 [0.69-0.99], p = 0.038), and severe (0.11 vs 0.20; RR [95% CI] = 0.57 [0.37-0.79], p = 0.002) exacerbations, compared with delayed initiators. Mean all-cause and COPD-related healthcare costs were significantly lower among prompt initiators (all-cause: $26,107 vs $32,400 PPY, p = 0.014; COPD-related: $12,694 vs $17,640 PPY, p = 0.002). Conclusion: Prompt initiation of FF/UMEC/VI following a moderate or severe COPD exacerbation was associated with significant reductions in exacerbations and healthcare costs relative to delayed initiation.

Higher COPD Assessment Test Score Associated With Greater Exacerbations Risk: A Post Hoc Analysis of the IMPACT Trial.

BACKGROUND: In the InforMing the PAthway of COPD Treatment (IMPACT) trial, single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) reduced moderate/severe exacerbation rates versus FF/VI and UMEC/VI in patients with chronic obstructive pulmonary disease (COPD). This post hoc analysis tested the relationship between baseline health status, risk of future exacerbations, and efficacy outcomes. METHODS: IMPACT was a Phase 3, double-blind, 52-week trial in patients with symptomatic COPD (COPD Assessment Test [CAT] score ≥10) and ≥1 moderate/severe exacerbation in the prior year randomized 2:2:1 to FF/UMEC/VI 100/62.5/25mcg, FF/VI 100/25mcg, or UMEC/VI 62.5/25mcg. Annual rate of on-treatment moderate/severe exacerbations, lung function, and safety were analyzed by continuous baseline CAT score. RESULTS: Moderate/severe exacerbation rates increased with increasing baseline CAT scores in FF/UMEC/VI and UMEC/VI arms. There was a very small increase in on-treatment pneumonia rates at higher baseline CAT scores across all treatment arms. FF/UMEC/VI reduced moderate/severe exacerbation rates versus UMEC/VI (i.e., the inhaled corticosteroid effect) consistently across the range of CAT scores. The reduction with FF/UMEC/VI versus FF/VI (i.e., the long-acting muscarinic antagonist effect) was greatest at lower CAT scores and appeared lesser at higher CAT scores. Improvements in lung function were observed with FF/UMEC/VI versus FF/VI and UMEC/VI, regardless of baseline CAT score. CONCLUSIONS: The CAT score was predictive of exacerbation risk. Worse baseline health status was associated with higher moderate/severe exacerbation and pneumonia rates. Irrespective of baseline CAT score, FF/UMEC/VI improved lung function, and reduced the annual moderate/severe exacerbation rates versus dual therapy. Results indicate an overall favorable benefit-risk profile of triple versus dual therapy, irrespective of CAT score. Clinical Trial Registration:GSK (CTT116855/NCT02164513).

Anesthesiology residents' performance of pediatric resuscitation during a simulated hyperkalemic cardiac arrest.

BACKGROUND: Anesthesiologists are responsible for the management of perioperative cardiopulmonary arrest in children. This study used simulation to assess the pediatric resuscitation skills of experienced anesthesia residents. METHODS: Nineteen anesthesia residents were evaluated using a pediatric pulseless electrical activity scenario. The authors used a standardized checklist to evaluate the residents' diagnostic and therapeutic interventions. RESULTS: After the onset of pulseless electrical activity, 79% of residents initiated cardiopulmonary resuscitation within 1 min. Approximately one third (31%) performed chest compressions at the recommended rate. Epinephrine was administered by 95% of residents, but only one third used the correct pediatric dose. All residents administered fluid boluses, but only 16% administered the recommended volume. Only one fourth of the residents considered hyperkalemia as a cause of pulseless electrical activity. None of the residents asked for dosing aids. CONCLUSION: During this simulated pediatric emergency, anesthesia residents demonstrated an acceptable knowledge of general resuscitation maneuvers. However, a subset of resuscitation skills was incorrectly performed, mostly related to age or weight. Importantly, many residents did not consider the full differential diagnosis of pulseless electrical activity. Anesthesia residents may benefit from additional pediatric resuscitation training and practice using cognitive aids to access dosages and complicated diagnostic algorithms.