Global "systemness" in medical education: A rationale and framework to assess performance.

Healthcare is global. The challenges of the "triple aim" - achieving high-quality healthcare, maximal value, and an excellent patient experience and outcomes - are universal. Medical education is similarly global with worldwide efforts towards competency-based reform, the adoption and adaptation of accreditation standards, and the expansion of international collaborations between healthcare organizations (HCOs). The focus of many of these efforts centers around recognizing education as a talent pipeline to serve local and global healthcare needs. Accordingly, many U.S.-based academic medical centres are pursuing an increasingly global footprint by developing international partnerships between HCOs. The educational leadership at the Cleveland Clinic (an HCO that has ventured internationally in Canada, the United Kingdom, and the United Arab Emirates) has adopted a "systemness" approach to medical education collaboratives. Systemness describes the ability of academic health systems to leverage existing structures, expertise, and other resources to address broadly shared educational needs across geographies, disseminate best practices, and ultimately improve the care that is delivered. The rationale for systemness, a concept derived from the healthcare administration and business world, affords the opportunity to achieve educational outcomes through synergy that exceeds the capability of any single component of a system. In this perspective, we posit a "systemness" taxonomy to be used to assess the performance and success of international collaborations in medical education and provide examples of its application to existing international partnerships in medical education. This framework is grounded in developmental assessment approaches, akin to those used in assessing learner performance, and defines levels of educational collaboration proficiencies, ultimately towards the alignment of these efforts with the health needs of the communities they serve. As global medical education collaboratives advance, ongoing assessment of existing partnerships and further research will be needed to define competencies and integrative activities that define high-performing medical education partnerships.

Bedside Manner 2020: An Inventory of Best Practices.

Bedside manner, a doctor's deportment with a patient, encompasses all aspects of the patient interaction, including all verbal and nonverbal communication strategies. Bedside manner can be a powerful adjunct for healing. In academic medical centers, trainees generally learn bedside manner by observing their attendings and mentors-in other words, as part of the "hidden curriculum." Because bedside manner is a critical component in the art of healing, it can be threatened by pressures on time in managing inpatients and by the explosion of technology. This article assembles an inventory of best bedside practices for inpatient care. Eight best bedside practices were identified by reviewing the literature, collecting the personal experiences of the authors, and consulting a group of attendings whom the authors regarded as exemplary clinicians. This inventory is presented with the goal of expanding clinicians' repertoire of best practices and encouraging explicit teaching of these practices to optimize care.

Area Under the Expiratory Flow-Volume Curve (AEX): Assessing Bronchodilator Responsiveness.

BACKGROUND: Area under expiratory flow-volume curve (AEX) is a useful spirometric tool in stratifying respiratory impairment. The AEX approximations based on isovolumic flows can be used with reasonable accuracy when AEX is unavailable. We assessed here pre- to post-bronchodilator (BD) variability of AEX4 as a functional assessment tool for lung disorders. METHODS: The BD response was assessed in 4330 subjects by changes in FEV1, FVC, and AEX4, which were derived from FVC, peak expiratory flow, and forced expiratory flow at 25%, 50%, and 75% FVC. Newly proposed BD response categories (negative, minimal, mild, moderate and marked) have been investigated in addition to standard criteria. RESULTS: Using standard BD criteria, 24% of subjects had a positive response. Using the new BD response categories, only 23% of subjects had a negative response; 45% minimal, 18% mild, 9% moderate, and 5% had a marked BD response. Mean percent change of the square root AEX4 was 0.3% and 14.3% in the standard BD-negative and BD-positive response groups, respectively. In the new BD response categories of negative, minimal, mild, moderate, and marked, mean percent change of square root AEX4 was - 8.2%, 2.9%, 9.2%, 15.0%, and 24.8%, respectively. CONCLUSIONS: Mean pre- to post-BD variability of AEX4 was < 6% and stratified well between newly proposed categories of BD response (negative, minimal, mild, moderate and marked). We suggest that AEX4 (AEX) could become a useful measurement for stratifying dysfunction in obstructive lung disease and invite further investigation into indications for using bronchodilator agents or disease-modifying, anti-inflammatory therapies.

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 .).

Hepatic-targeted RNA interference provides robust and persistent knockdown of alpha-1 antitrypsin levels in ZZ patients.

BACKGROUND & AIMS: Alpha-1 antitrypsin deficiency (AATD) is a genetic disorder causing pulmonary and liver disease. The PiZ mutation in AAT (SERPINA1) results in mis-folded AAT protein (Z-AAT) accumulating in hepatocytes, leading to fibrosis and cirrhosis. RNAi-based therapeutics silencing production of hepatic Z-AAT might benefit patients with AATD-associated liver disease. This study evaluated an RNAi therapeutic to silence production of AAT. METHODS: Part A of this double-blind first-in-human study randomized 54 healthy volunteers (HVs) into single dose cohorts (two placebo: four active), receiving escalating doses of the investigational agent ARC-AAT from 0.38 to 8.0 mg/kg or placebo. Part B randomized 11 patients with PiZZ (homozygous for Z-AAT) genotype AATD, who received up to 4.0 mg/kg of ARC-AAT or placebo. Patients with baseline FibroScan® >11 kPa or forced expiratory volume in one second (FEV1) <60% were excluded. Assessments included safety, pharmacokinetics, and change in serum AAT concentrations. RESULTS: A total of 36 HVs received ARC-AAT and 18 received placebo (part A). Seven PiZZ individuals received ARC-AAT and four received placebo (part B). A dose response in serum AAT reduction was observed at doses ≥4 mg/kg with similar relative reductions in PiZZ patients and HVs at 4 mg/kg and a maximum reduction of 76.1% (HVs) vs. 78.8% (PiZZ) at this dose. The time it took for serum AAT to return to baseline was similar for HV and PiZZ. There were no notable differences between HV and PiZZ safety parameters. The study was terminated early because of toxicity findings related to the delivery vehicle (ARC-EX1) seen in a non-human primate study. CONCLUSION: PiZZ patients and HVs responded similarly to ARC-AAT. Deep and durable knockdown of hepatic AAT production based on observed reduction in serum AAT concentrations was demonstrated. LAY SUMMARY: Accumulation of abnormal proteins in the livers of patients with alpha-1 antitrypsin deficiency may lead to decreased liver function and potentially liver failure. Therapeutics targeting the production of these abnormal proteins may be used to prevent or treat liver disease in patients with alpha-1 antitrypsin deficiency. CLINICAL TRIAL REGISTRATION NUMBER: NCT02363946.

Supplemental oxygen in patients with stable chronic obstructive pulmonary disease: evidence from Nocturnal Oxygen Treatment Trial to Long-term Oxygen Treatment Trial.

PURPOSE OF REVIEW: Oxygen therapy was the first treatment shown to prolong life in patients with chronic obstructive pulmonary disease (COPD) and has been joined by lung volume reduction surgery in selected patients with emphysema, smoking cessation, and potentially noninvasive ventilation in chronic hypercapneic respiratory failure. Although there is consensus around the survival-enhancing effect of supplemental oxygen (SupplO2) for patients with chronic severe hypoxemia at rest, the impact of SupplO2 for COPD patients with moderate hypoxemia and exertional desaturation had been less clear. RECENT FINDINGS: The recently published Long-term Oxygen Treatment Trial (LOTT) showed no benefit of SupplO2 for the composite outcome of survival and all-cause hospitalizations, or for component outcomes, severe COPD exacerbations, or quality of life in COPD patients with moderate resting hypoxemia or room air normoxemia with exercise desaturation. SUMMARY: Results of the LOTT challenge the practice of prescribing SupplO2 for patients with COPD and moderate resting hypoxemia or isolated exertional desaturation. In the context that LOTT may not have recruited patients for whom SupplO2 conferred subjective benefit, there may be a role for short-term trials of SupplO2 with assessment of subjective benefit in such patients.

Assessing the kinetics of microbubble appearance in cirrhotic patients using transthoracic saline contrast-enhanced echocardiography.

BACKGROUND: The number of cardiac cycles that need to be reviewed by echocardiography before a significant intrapulmonary shunt can be excluded remains unclear. METHODS: We retrospectively identified patients with cirrhosis who underwent technetium-99 m-labeled macroaggregated albumin scanning. The kinetics of bubble appearance after the injection of agitated saline during transthoracic echocardiograms were assessed in these patients. RESULTS: For the 64 eligible patients, the mean ± SD age was 56 ± 9 years. The median (IQR) shunt fraction by radionuclide scanning was 7.7% (2.8%-19.9%). Microbubbles were seen in the left atrium (LA) and left ventricle (LV) at a median (IQR) of 4 (2-5) and 4 (2-5) beats, respectively. The number of heart cycles before microbubbles appeared in the LA or LV was inversely associated with the nuclear scanning shunt fraction (R = -0.42, P = .001, R = -0.46, P < .001, respectively). If no microbubbles were detected by heart cycle 7, the shunt fraction was uniformly less than 3%. Patients with arterial oxygen <60 mm Hg, compared to ≥60 mm Hg, had earlier appearance of microbubbles in the left heart chambers (2.6 ± 1.9 vs 4.0 ± 2.3 beats, P = .046). CONCLUSIONS: In patients with advanced cirrhosis suspected of having hepatopulmonary syndrome, a greater shunt fraction during nuclear scanning was associated with more pronounced hypoxemia and a prompt and more intense appearance of microbubbles in the left-sided heart chambers. Patients with a shunt fraction above 3% have microbubbles in the LA or LV at some point during the first seven heart cycles.

An Official American Thoracic Society/European Respiratory Society Statement: Research questions in chronic obstructive pulmonary disease.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity, mortality, and resource use worldwide. The goal of this Official American Thoracic Society (ATS)/European Respiratory Society (ERS) Research Statement is to describe evidence related to diagnosis, assessment, and management; identify gaps in knowledge; and make recommendations for future research. It is not intended to provide clinical practice recommendations on COPD diagnosis and management. METHODS: Clinicians, researchers, and patient advocates with expertise in COPD were invited to participate. A literature search of Medline was performed, and studies deemed relevant were selected. The search was not a systematic review of the evidence. Existing evidence was appraised and summarized, and then salient knowledge gaps were identified. RESULTS: Recommendations for research that addresses important gaps in the evidence in all areas of COPD were formulated via discussion and consensus. CONCLUSIONS: Great strides have been made in the diagnosis, assessment, and management of COPD as well as understanding its pathogenesis. Despite this, many important questions remain unanswered. This ATS/ERS Research Statement highlights the types of research that leading clinicians, researchers, and patient advocates believe will have the greatest impact on patient-centered outcomes.

Physician leadership development at Cleveland Clinic: a brief review.

OBJECTIVE: We aim to describe the rationale for and spectrum of leadership development programs, highlighting experience at a large healthcare institution (Cleveland Clinic, Cleveland, Ohio, USA). CONCLUSIONS: Developing leaders is a universal priority to sustain organizational success. In health care, significant challenges of ensuring quality and access and making care affordable are widely shared internationally and demand effective physician leadership. Yet, leadership competencies differ from clinical and scientific competencies and features of selecting and training physicians-who have been called "heroic lone healers" -often conspire against physicians being effective leaders or followers. Thus, developing leadership competencies in physicians is critical.Leadership development programs have been signature features of successful organizations and various Australian organizations offer such training (e.g. The Australian Leadership Foundation and the University of South Australia), but relatively few health care organizations have adopted the practice of offering such training, both in Australia and elsewhere. As a United States example of one such integrated program, the Cleveland Clinic, a large, closed-staff physician-led group practice in Cleveland, Ohio has offered physician leadership training for over 15 years. This paper describes the rationale, structure, and some of the observed impacts associated with this program.

Developing leadership competencies among medical trainees: five-year experience at the Cleveland Clinic with a chief residents' training course.

OBJECTIVES: Challenges in healthcare demand great leadership. In response, leadership training programs have been developed within academic medical centers, business schools, and healthcare organizations; however, we are unaware of any well-developed programs for physicians-in-training. METHODS: To address this gap, we developed a two-day leadership development course for chief residents (CRs) at the Cleveland Clinic, framed around the concept of emotional intelligence. This paper describes our five-year experience with the CRs leadership program. RESULTS: Since inception, 105 CRs took the course; 81 (77%) completed before-and-after evaluations. Participants indicated that they had relatively little prior knowledge of the concepts that were presented and that the workshop greatly enhanced their familiarity with leadership competencies. Qualitative analysis of open-ended responses indicated that attendees valued the training, especially in conflict resolution and teamwork, and indicated specific action plans for applying these skills. Furthermore, the workshop spurred some participants to express plans to learn more about leadership competencies. CONCLUSIONS: This study extends prior experience in offering an emotional intelligence-based leadership workshop for CRs. Though the program is novel, further research is needed to more fully understand the impact of leadership training for CRs and for the institutions and patients they serve.

An official American Thoracic Society/European Respiratory Society statement: research questions in COPD.

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity, mortality, and resource use worldwide. The goal of this official American Thoracic Society (ATS)/European Respiratory Society (ERS) research statement is to describe evidence related to diagnosis, assessment and management; identify gaps in knowledge; and make recommendations for future research. It is not intended to provide clinical practice recommendations on COPD diagnosis and management. Clinicians, researchers, and patient advocates with expertise in COPD were invited to participate. A literature search of Medline was performed, and studies deemed relevant were selected. The search was not a systematic review of the evidence. Existing evidence was appraised and summarised, and then salient knowledge gaps were identified. Recommendations for research that addresses important gaps in the evidence in all areas of COPD were formulated via discussion and consensus. Great strides have been made in the diagnosis, assessment and management of COPD, as well as understanding its pathogenesis. Despite this, many important questions remain unanswered. This ATS/ERS research statement highlights the types of research that leading clinicians, researchers, and patient advocates believe will have the greatest impact on patient-centred outcomes.

The natural history of lung function after lung transplantation for α(1)-antitrypsin deficiency.

RATIONALE: Lung transplantation (LT) is an established treatment for end-stage lung diseases, including chronic obstructive pulmonary disease (COPD) associated with α1-antitrypsin deficiency (AATD). OBJECTIVES: We sought to compare the post-transplantation course of patients with AATD and AAT-replete COPD. METHODS: Between June 1991 and January 2008, a total of 231 patients with AAT-replete COPD and 45 with AATD underwent LT at Cleveland Clinic. Data reviewed included baseline recipient, donor, and surgical data; all spirometry evaluations; acute cellular rejection (ACR) events; and survival data. Endpoints included temporal change in FEV1, severity of ACR, and survival. A longitudinal temporal decomposition model was used for analysis. MEASUREMENTS AND MAIN RESULTS: Comparison of overall rates of FEV1 decline in AATD and AAT-replete patients with COPD showed no significant differences (P > 0.09). However, although the single LT patients had similar trends in FEV1 in both groups, patients with AATD with double LT declined faster (P < 0.002) than the AAT-replete patients. No differences in the frequency or severity of ACR episodes were observed (P = 0.32). Furthermore, there was no difference in early or late mortality between patients with AATD and patients with AAT-replete COPD (P > 0.09). CONCLUSIONS: Although overall the post-LT FEV1 slope, severity of ACR, and survival among patients with AATD is similar to that of AAT-replete patients with COPD, patients with AATD with double LT have a faster rate of FEV1 decline. These findings support the eligibility of patients with AATD for LT, and suggest the need for additional studies to better understand the difference between single and double LT in AATD.

Detecting Alpha-1 Antitrypsin Deficiency: Current State, Impediments, Opportunities, and Future Directions.

Alpha-1 antitrypsin deficiency (AATD) is an under-recognized condition with only a small minority of affected individuals detected, long delays between initial symptoms and diagnosis, and evidence that affected individuals may see many physicians with suggestive symptoms before an initial diagnosis is made. In the context that failure to detect AATD confers harm and that specific therapy is currently available, there is a clear need for enhanced detection. Impediments to enhanced detection include inadequate knowledge about AATD by physicians caring for at-risk patients, inattention to guidelines which endorse testing, a sense of therapeutic nihilism among some physicians (i.e., the misimpression that because specific therapy is unavailable, there is no imperative to diagnose), and concerns about the cost of testing. Various measures have been undertaken to address these impediments and to enhance detection, including educational programs; targeted detection programs (some with free and home-based confidential testing); population-based, and newborn screening pilot programs, the latter not yet nationally endorsed for large-scale screening. Novel approaches are deploying features of the electronic medical record and of artificial intelligence to prompt testing in at-risk individuals. To the extent that under-recognition of AATD persists with stubbornly long, multi-year diagnostic delay intervals, none of the detection strategies deployed to date has been adequately successful. The path forward regards continued innovation with targeted detection approaches while continuing efforts to assess the impact of population-based screening, hopefully toward ultimate endorsement on a broad national scale.

Area under the inspiratory flow-volume curve (AIN): Proposed normative values.

RATIONALE: Area under expiratory flow-volume curve (AEX) has been shown to be a valuable functional measurement in respiratory physiology. Area under inspiratory flow-volume loop (AIN) also shows promise in characterizing upper and/or lower airflow obstruction. OBJECTIVES: we aimed here to develop normative reference values for AIN, able to ascertain deviations from normal. METHODS: We analyzed AIN in 4,980 spirometry tests recorded in non-smoking, healthy individuals in the Pulmonary Function Testing Laboratory. RESULTS: The mean (95% confidence interval, CI), standard deviation and median (25th-75th interquartile range) AIN were 16.05 (15.79-16.31), 9.08 and 14.72 (9.12-21.42) L2·sec-1, respectively. The mean (95% CI) and standard deviation of the best-trial measurements for square root of AIN (Sqrt AIN) were 3.84 (3.81-3.87) and 1.14; 4.15 (4.12-4.18) and 1.03 in men, and 2.68 (2.63-2.72) and 0.72 L·sec-1/2 in women. The mean (standard deviation) of pre- and post-bronchodilator Sqrt AIN were 3.71 (1.17) and 3.81 (1.19) L·sec-1/2, respectively. The mean (95% CI), standard deviation and lowest 5th percentile (lower limit of normal, LLN) of Sqrt AIN/Sqrt AEX (%) were 101.3 (100.82-101.88), 18.7, and 71.8%; stratified by gender, it was 102.2 (101.6-102.8), 18.6, and 72.8% in men, and 98 (96.9-99.2), 18.8, and 68.6% in women, respectively. CONCLUSIONS: The availability of area under the inspiratory flow-volume curve (AIN) and the derived indices offers a promising opportunity to assess upper airway disease (e.g., involvement of larynx, trachea or major bronchi), especially because some of these measurements appear to be independent of age, race, height, and weight.

An Electronic Health Record-Based Strategy to Enhance Detection of Alpha-1 Antitrypsin Deficiency.

BACKGROUND: Because alpha-1 antitrypsin deficiency is severely underrecognized and delayed diagnosis is associated with harm, strategies to enhance early detection of alpha-1 antitrypsin deficiency are needed. METHODS: The study intervention was placing a reminder to test for alpha-1 antitrypsin deficiency within an electronic medical record health maintenance dashboard that houses prompts to providers to implement guideline-based recommendations. This recommendation was for all patients assigned a diagnosis of COPD based on relevant International Classification of Diseases, Tenth Revision codes. The rate of testing for and detecting individuals with alpha-1 antitrypsin deficiency was assessed in 12 one-month intervals before and after implementing the dashboard. RESULTS: After the prompt, whereas testing was still performed in only a small percentage of guideline-concordant instances, the rate of testing for alpha-1 antitrypsin deficiency increased 3.8-fold (ie, from 1.2% to 4.6%, P < .05). This did not result in detection of new patients with alpha-1 antitrypsin deficiency. The rate of testing increased both for alpha-1 antitrypsin serum levels and genotypes in each month after the intervention, though the rate of genotype testing was 2-5-fold lower than the rate of testing for serum level. CONCLUSIONS: The results of this preliminary study of a detection strategy for alpha-1 antitrypsin deficiency show that placing a reminder to test for alpha-1 antitrypsin deficiency when indicated in an electronic medical record health maintenance dashboard significantly increased the frequency of testing. Still, that only 4.6% of those in whom testing for alpha-1 antitrypsin deficiency was indicated were tested in the post-intervention period shows that, as for all other alpha-1 antitrypsin deficiency-targeted detection interventions to date, the impact of the intervention was marginal and that other strategies remain needed to mitigate underrecognition. A focus on combining targeted detection strategies (eg, coupling enhanced awareness with free testing) and population-based screening for alpha-1 antitrypsin deficiency is suggested.

Rapidly progressive cystic lung disease in a patient with a scalp lesion.

We describe an elderly patient presenting with pneumothorax, cystic lung disease and a scalp lesion. The pneumothorax resolved after placing a chest tube and suction but recurred within a week. Progression of cystic features was also seen, and biopsies of the lung and scalp lesions were performed. Immunohistochemistry was positive for markers of endothelial cells (CD31 and ERG) and negative for markers expected to be positive in alveolar cells (keratin AE1/AE3 and TTF-1), supporting the diagnosis of metastatic angiosarcoma. Palliative chemotherapy did not prevent progression and the patient expired soon after. In describing the clinico-radiological correlation of metastatic angiosarcoma, we also briefly describe the approach to cystic lung disease. Understanding the pathophysiology of cyst formation in metastatic angiosarcoma may help clinicians to better appreciate and manage the full spectrum of cystic lung disease, especially with atypical features.

A review of α1-antitrypsin deficiency.

α(1)-Antitrypsin (AAT) deficiency is an underrecognized genetic condition that affects approximately 1 in 2,000 to 1 in 5,000 individuals and predisposes to liver disease and early-onset emphysema. AAT is mainly produced in the liver and functions to protect the lung against proteolytic damage (e.g., from neutrophil elastase). Among the approximately 120 variant alleles described to date, the Z allele is most commonly responsible for severe deficiency and disease. Z-type AAT molecules polymerize within the hepatocyte, precluding secretion into the blood and causing low serum AAT levels (∼ 3-7 µM with normal serum levels of 20-53 µM). A serum AAT level of 11 µM represents the protective threshold value below which the risk of emphysema is believed to increase. In addition to the usual treatments for emphysema, infusion of purified AAT from pooled human plasma-so-called "augmentation therapy"-represents a specific therapy for AAT deficiency and raises serum levels above the protective threshold. Although definitive evidence from randomized controlled trials of augmentation therapy is lacking and therapy is expensive, the available evidence suggests that this approach is safe and can slow the decline of lung function and emphysema progression. Promising novel therapies are under active investigation.

A comprehensive care management program to prevent chronic obstructive pulmonary disease hospitalizations: a randomized, controlled trial.

BACKGROUND: Improving a patient's ability to self-monitor and manage changes in chronic obstructive pulmonary disease (COPD) symptoms may improve outcomes. OBJECTIVE: To determine the efficacy of a comprehensive care management program (CCMP) in reducing the risk for COPD hospitalization. DESIGN: A randomized, controlled trial comparing CCMP with guideline-based usual care. (ClinicalTrials.gov registration number: NCT00395083) SETTING: 20 Veterans Affairs hospital-based outpatient clinics. PARTICIPANTS: Patients hospitalized for COPD in the past year. INTERVENTION: The CCMP included COPD education during 4 individual sessions and 1 group session, an action plan for identification and treatment of exacerbations, and scheduled proactive telephone calls for case management. Patients in both the intervention and usual care groups received a COPD informational booklet; their primary care providers received a copy of COPD guidelines and were advised to manage their patients according to these guidelines. Patients were randomly assigned, stratifying by site based on random, permuted blocks of variable size. MEASUREMENTS: The primary outcome was time to first COPD hospitalization. Staff blinded to study group performed telephone-based assessment of COPD exacerbations and hospitalizations, and all hospitalizations were blindly adjudicated. Secondary outcomes included non-COPD health care use, all-cause mortality, health-related quality of life, patient satisfaction, disease knowledge, and self-efficacy. RESULTS: Of the eligible patients, 209 were randomly assigned to the intervention group and 217 to the usual care group. Citing serious safety concerns, the data monitoring committee terminated the intervention before the trial's planned completion after 426 (44%) of the planned total of 960 patients were enrolled. Mean follow-up was 250 days. When the study was stopped, the 1-year cumulative incidence of COPD-related hospitalization was 27% in the intervention group and 24% in the usual care group (hazard ratio, 1.13 [95% CI, 0.70 to 1.80]; P= 0.62). There were 28 deaths from all causes in the intervention group versus 10 in the usual care group (hazard ratio, 3.00 [CI, 1.46 to 6.17]; P= 0.003). Cause could be assigned in 27 (71%) deaths. Deaths due to COPD accounted for the largest difference: 10 in the intervention group versus 3 in the usual care group (hazard ratio, 3.60 [CI, 0.99 to 13.08]; P= 0.053). LIMITATIONS: Available data could not fully explain the excess mortality in the intervention group. Ability to assess the quality of the educational sessions provided by the case managers was limited. CONCLUSION: A CCMP in patients with severe COPD had not decreased COPD-related hospitalizations when the trial was stopped prematurely. The CCMP was associated with unanticipated excess mortality, results that differ markedly from similar previous trials. A data monitoring committee should be considered in the design of clinical trials involving behavioral interventions.

Emotional intelligence competencies provide a developmental curriculum for medical training.

Since healthcare faces challenges of access, quality, and cost, effective leadership for healthcare is needed. This need is especially acute among physicians, whose demanding training focuses on scientific and clinical skills, eclipsing attention to leadership development. Among the competencies needed by leaders, emotional intelligence (EI) - defined as the ability to understand and manage oneself and to understand others and manage relationships - has been shown to differentiate between great and average leaders. In this context, teaching EI as part of the medical training curriculum is recommended. Furthermore, because physicians' developmental needs evolve over the course of prolonged training, specific components of EI (e.g., teambuilding, empathy, and negotiation) should be taught at various phases of medical training. Consistent with the concept of a spiral curriculum, such EI competencies should be revisited iteratively throughout training, with differing emphasis and increasing sophistication to meet evolving needs. For example, teamwork training is needed early in undergraduate medical curricula to prompt collaborative learning. Teamwork training is also needed during residency, when physicians participate with differing roles on patient care teams. Training in EI should also extend beyond graduate medical training to confer the skills needed by clinicians and by faculty in academic medical centers.

The challenge of detecting alpha-1 antitrypsin deficiency.

Alpha-1 antitrypsin deficiency (AATD) is relatively common but under-recognized. Indeed, fewer than 10% of the estimated 100,000 Americans with AATD have been diagnosed currently, with common reports of long delays between initial symptoms and first detection and the need to see multiple physicians before diagnosis. Because detection can confer benefits (e.g., identification of at-risk family members, lower smoking likelihood, consideration of augmentation therapy), targeted detection of AATD in at-risk groups such as all symptomatic adults with COPD has been endorsed. Two general approaches to detection have been studied: population-based screening (in which testing is performed in a group for whom no increased risk of having AATD exists) and targeted detection or case-finding (in which testing is confined to those with an attributable condition such as COPD or chronic liver disease). Studies to date have suggested that population-based screening is not cost-effective, whereas targeted detection of AATD has been advocated by official society guidelines. Efforts to enhance detection of AATD individuals have included various approaches, including educational campaigns, provision of free test kits, issuance of reminders with medical reports or within an electronic medical record, and empowering respiratory therapists to conduct testing for AATD in pulmonary function laboratories. Such programs have identified individuals with severe deficiency of alpha-1 antitrypsin in up to 12% of subjects, with considerable variation across series by testing criteria. Overall, the persistence of under-recognition of AATD underscores the need for continued efforts to optimize detection of this potentially debilitating genetic disease.