John J. Mullon

Simulation-Based Objective Assessment Discerns Clinical Proficiency in Central Line Placement : A Construct Validation

BACKGROUND Central venous catheterization (CVC) is associated with patient risks known to be inversely related to clinician experience. We developed and evaluated a performance assessment tool for use in a simulation-based central line workshop. We hypothesized that instrument scores would discriminate between less experienced and more experienced clinicians. METHODS Participants included trainees enrolled in an institutionally mandated CVC workshop and a convenience sample of faculty attending physicians. The workshop integrated several experiential learning techniques, including practice on cadavers and part-task trainers. A group of clinical and education experts developed a 15-point CVC Proficiency Scale using national and institutional guidelines. After the workshop, participants completed a certification exercise in which they independently performed a CVC in a part-task trainer. Two authors reviewed videotapes of the certification exercise to rate performance using the CVC Proficiency Scale. Participants were grouped by self-reported CVC experience. RESULTS One hundred and five participants (92 trainees and 13 attending physicians) participated. Interrater reliability on a subset of 40 videos was 0.71, and Cronbach a was 0.81. The CVC Proficiency Scale Composite score varied significantly by experience: mean of 85%, median of 87% (range 47%-100%) for low experience (0-1 CVCs in the last 2 years, n = 27); mean of 88%, median of 87% (range 60%-100%) for moderate experience (2-49 CVCs, n = 62); and mean of 94%, median of 93% (range 73%-100%) for high experience (> 49 CVCs, n = 16) (P = .02, comparing low and high experience). CONCLUSIONS Evidence from multiple sources, including appropriate content, high interrater and internal consistency reliability, and confirmation of hypothesized relations to other variables, supports the validity of using scores from this 15-item scale for assessing trainee proficiency following a central line workshop.

Septic shock: A multidisciplinary response team and weekly feedback to clinicians improve the process of care and mortality

Objective:To evaluate the impact of weekly feedback to clinicians and the activation of a sepsis response team on the process of care and hospital mortality in patients with severe sepsis or septic shock. Design:Prospective, interventional cohort study. Setting:The medical intensive care unit of a tertiary, academic medical center. Study Subjects:Patients with severe sepsis or septic shock consecutively treated in a medical intensive care unit. Interventions:Daily auditing and weekly feedback, and sepsis response team activation. Measurements and Main Results:During a 33-month study period, from January 2007 through September 2009, we performed daily screening of patients for severe sepsis or septic shock. Study periods were divided into baseline (screening only), daily auditing with weekly feedback, and sepsis response team activation. Comparisons among the three periods were made by using univariate and multiple logistic regression analyses. Compliance with the overall sepsis resuscitation bundle and its individual elements and hospital mortality were used as outcome measures. A total of 984 episodes of severe sepsis and septic shock were identified during the study periods, severe sepsis in 52 (5.3%) and septic shock in 932 (94.7%). The compliance rate with all elements of the sepsis resuscitation bundle increased from 12.7% at baseline to 37.7% and 53.7% during the weekly feedback and sepsis response team activation periods, respectively (p < .001). Overall hospital mortality rate was 30.3%, 28.3%, and 22.0% during baseline, weekly feedback, and sepsis response team periods, respectively (p = .029). Multiple logistic regression analysis showed that the sepsis response team was associated with reduced risk of hospital death (odds ratio, 0.657; 95% confidence interval, 0.456–0.945; p = .023) whereas hepatic cirrhosis, hepatic failure, leukemia, multiple myeloma, transfer from the same hospital ward, do-not-resuscitate status at the recognition of severe sepsis/septic shock, and lactate level were associated with increased risk of death. Conclusions:In septic shock, the activation of the sepsis response team in combination with weekly feedback increases the compliance with the process of care and reduces hospital mortality rate.

Endobronchial Ultrasound Skills and Tasks Assessment Tool Assessing the Validity Evidence for a Test of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration Operator Skill

RATIONALE Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is becoming standard of care for the sampling of mediastinal adenopathy. The need for a safe, effective, accurate procedure makes EBUS-TBNA ideal for mastery training and testing. OBJECTIVES The Endobronchial Ultrasound Skills and Tasks Assessment Tool (EBUS-STAT) was created as an objective competency-oriented assessment tool of EBUS-TBNA skills and knowledge. This study demonstrates the reliability and validity evidence of this tool. METHODS The EBUS-STAT objectively scores the EBUS-TBNA operators skills, including atraumatic airway introduction and navigation, ultrasound image acquisition and optimization, identification of mediastinal nodal and vascular structures, EBUS-TBNA sampling, and recognition of EBUS/computed tomography images of mediastinal structures. It can be administered at the bedside or using combination of low- and high-fidelity simulation platforms. Two independent testers administered the EBUS-STAT to 24 operators at three levels of EBUS-TBNA experience (8 beginners, 8 intermediates, and 8 experienced) at three institutions; operators were also asked to self-assess their skills. Scores were analyzed for intertester reliability, correlation with prior EBUS-TBNA experience, and association with self-assessments. MEASUREMENTS AND MAIN RESULTS Intertester reliability between testers was very high (r = 0.9991, P < 0.00005). Mean EBUS-STAT scores for beginner, intermediate, and experienced groups, respectively, were 31.1, 74.9, and 93.6 out of 100 (F(2,21) = 118.6, P < 0.0001). Groups were nonoverlapping: post hoc tests showed each group differed significantly from the others (P < 0.001). Self-assessments corresponded closely to actual EBUS-STAT scores (r(2) = 0.81, P < 0.001). CONCLUSIONS The EBUS-STAT can be used to reliably and objectively score and classify EBUS-TBNA operators from novice to expert. Its use to assess and document the acquisition of knowledge and skill is a step toward the goal of mastery training in EBUS-TBNA.

Randomized Trial of Pleural Fluid Drainage Frequency in Patients with Malignant Pleural Effusions. The ASAP Trial

Rationale: Patients with malignant pleural effusions have significant dyspnea and shortened life expectancy. Indwelling pleural catheters allow patients to drain pleural fluid at home and can lead to autopleurodesis. The optimal drainage frequency to achieve autopleurodesis and freedom from catheter has not been determined. Objectives: To determine whether an aggressive daily drainage strategy is superior to the current standard every other day drainage of pleural fluid in achieving autopleurodesis. Methods: Patients were randomized to either an aggressive drainage (daily drainage; n = 73) or standard drainage (every other day drainage; n = 76) of pleural fluid via a tunneled pleural catheter. Measurements and Main Results: The primary outcome was the incidence of autopleurodesis following the placement of the indwelling pleural catheters. The rate of autopleurodesis, defined as complete or partial response based on symptomatic and radiographic changes, was greater in the aggressive drainage arm than the standard drainage arm (47% vs. 24%, respectively; P = 0.003). Median time to autopleurodesis was shorter in the aggressive arm (54 d; 95% confidence interval, 34‐83) as compared with the standard arm (90 d; 95% confidence interval, 70 to nonestimable). Rate of adverse events, quality of life, and patient satisfaction were not significantly different between the two arms. Conclusions: Among patients with malignant pleural effusion, daily drainage of pleural fluid via an indwelling pleural catheter led to a higher rate of autopleurodesis and faster time to liberty from catheter. Clinical trial registered with www.clinicaltrials.gov (NCT 00978939).

Interventional Pulmonology Fellowship Accreditation Standards: Executive Summary of the Multisociety Interventional Pulmonology Fellowship Accreditation Committee

&NA; Interventional pulmonology (IP) is a rapidly evolving subspecialty of pulmonary medicine. In the last 10 years, formal IP fellowships have increased substantially in number from five to now > 30. The vast majority of IP fellowship trainees are selected through the National Resident Matching Program, and validated in‐service and certification examinations for IP exist. Practice standards and training guidelines for IP fellowship programs have been published; however, considerable variability in the environment, curriculum, and experience offered by the various fellowship programs remains, and there is currently no formal accreditation process in place to standardize IP fellowship training. Recognizing the need for more uniform training across the various fellowship programs, a multisociety accreditation committee was formed with the intent to establish common accreditation standards for all IP fellowship programs in the United States. This article provides a summary of those standards and can serve as an accreditation template for training programs and their offices of graduate medical education as they move through the accreditation process.

Infections associated with tunnelled indwelling pleural catheters in patients undergoing chemotherapy.

Background:Malignant pleural effusions are common complications of advanced malignancies and are associated with significant morbidity and reduced survival. Tunnelled indwelling pleural catheters (TIPCs) are implantable devices used for palliation of symptomatic malignant pleural effusions. Although complication rates are overall low, their use in the setting of concurrent chemotherapy has not been carefully reviewed. We report our experience with infectious complications directly attributable to TIPCs (pleural or local soft tissue infections) in those patients receiving concurrent chemotherapy. Methods:We conducted a retrospective analysis of patients who underwent TIPC placement for malignant pleural effusion in a 6-year period from November 2005 to March 2011. We reviewed the incidence of infection in these patients receiving catheter placement and attempted to determine whether chemotherapy was associated with an increased infectious risk. Results:A total of 262 TIPC procedures, performed in 243 patients, were included in the study. Out of 262, 173 (66%) TIPC were in the chemotherapy group and 89 TIPC were in the nonchemotherapy group. Infections developed in 16 of the 262 TIPC placements (6.1%). The rate of complications in the chemotherapy group was 9 of the 173 TIPCs (5.2%) compared with 7 of the 89 TIPCs (7.9%) in the other group, a difference that was not statistically different (P=0.4). Conclusions:The overall risk of infection in TIPC is low. Patients undergoing chemotherapy while the TIPC is in place do not seem to have an increased risk of infection, and therefore chemotherapy should not necessarily be viewed as a contraindication to TIPC insertion.

Feasibility and safety of outpatient medical thoracoscopy at a large tertiary medical center: A collaborative medical-surgical initiative

BACKGROUND Medical thoracoscopy (MT) is performed by relatively few pulmonologists in the United States. Recognizing that an outpatient minimally invasive procedure such as MT could provide a suitable alternative to hospitalization and surgery in patients with undiagnosed exudative pleural effusions, we initiated the Mayo Clinic outpatient MT program and herein report preliminary data on safety, feasibility, and outcomes. METHODS All consecutive patients referred for outpatient MT from October 2011 to August 2013 were included in this study. Demographic, radiographic, procedural, and histologic data were recorded prospectively and subsequently analyzed. RESULTS Outpatient MT was performed on 51 patients, with the most common indication being an undiagnosed lymphocytic exudative effusion in 86.3% of the cohort. Endoscopic findings included diffuse parietal pleural inflammation in 26 patients (51%), parietal pleural studding in 19 patients (37.3%), a normal examination in three patients (5.9%), diffuse parietal pleural thickening in two patients (3.9%), and a diaphragmatic defect in one patient (2%). Pleural malignancy was the most common histologic diagnosis in 24 patients (47.1%) and composed predominantly of mesothelioma in 14 (27.5%). Nonspecific pleuritis was the second most frequent diagnosis in 23 patients (45.1%). There were very few complications, with no significant cases of hemodynamic or respiratory compromise and no deaths. CONCLUSIONS Outpatient MT can be integrated successfully into a busy tertiary referral medical center through the combined efforts of interventional pulmonologists and thoracic surgeons. Outpatient MT may provide patients with a more convenient alternative to an inpatient surgical approach in the diagnosis of undiagnosed exudative pleural effusions while maintaining a high diagnostic yield and excellent safety.

The Role for Tunneled Indwelling Pleural Catheters in Patients With Persistent Benign Chylothorax

Background:Utilization of tunneled indwelling pleural catheters (TIPCs) for persistent pleural effusions is increasingly more common; however, the presence of chylothorax is generally considered a contraindication for utilization of a TIPC due to concerns regarding potential nutritional, immunologic and hemodynamic complications. Therefore, in this study, a cohort of patients with persistent benign chylothorax managed with TIPCs is described. Methods:A retrospective analysis of patients with persistent benign chylothorax managed with a TIPC at the study center between January 1, 2008, and March 1, 2012, was completed. Extracted data included patient characteristics, chylothorax etiologies, prior interventions, outcomes and complications. Results:Eleven patients (14 hemithoraces) had persistent benign chylothorax treated with placement of a TIPC during the inclusion time frame. Etiology of the chylothorax was nontraumatic in 8 of the 11 patients, with the remaining 3 secondary to thoracic surgery. Pleurodesis was achieved in 9 of the 14 hemithoraces, with a median time to pleurodesis of 176 days. All procedures were well tolerated, and no immediate periprocedural complications were reported. One serious complication was encountered in the form of a postoperative pulmonary embolism after replacement of an occluded TIPC, resulting in the patient’s death. Two patients had transient occlusions of their TIPCs successfully treated with intracatheter thrombolytic therapy. No significant adverse nutritional, hemodynamic or immunologic outcomes were reported during follow-up for any included patient. Conclusions:Utilization of a TIPC for the management of persistent benign chylothorax should be considered early because pleurodesis may be frequently and safely achieved in this patient population.

Impact of pleural manometry on the development of chest discomfort during thoracentesis: a symptom-based study.

Background:Routine manometry is recommended to prevent complications during therapeutic thoracentesis, but has not definitively been shown to prevent pneumothorax or reexpansion pulmonary edema. As chest discomfort correlates with negative pleural pressures, we aimed to determine whether the use of manometry could anticipate the development of chest discomfort during therapeutic thoracentesis. Methods:A retrospective chart review of 214 consecutive adults who underwent outpatient therapeutic thoracentesis at our institution between January 1, 2011 and June 30, 2013 was performed. We compared preprocedural to postprocedural discomfort (using a linear analog scale from 0 to 10) in patients undergoing thoracentesis with or without manometry. We used a multivariate model to adjust for possible confounders. Changes of dyspnea scores were also analyzed. Results:Manometry was performed in 82/214 patients (38%). On univariate and multivariate analyses, neither the change in chest discomfort nor dyspnea scores was significantly different in the manometry versus the control group (P=0.12 and 0.24, respectively). Similar results were also found in the subgroup of large-volume thoracentesis (P=0.32 for discomfort, P=1.0 for dyspnea). Conclusions:In our retrospective study, the use of manometry did not appear to anticipate the development of chest discomfort during therapeutic thoracentesis. Prospective studies are needed to confirm these findings.

Granulomatous inflammation detected by endobronchial ultrasound-guided transbronchial needle aspiration in patients with a concurrent diagnosis of cancer: a clinical conundrum.

Background:Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is increasingly used for evaluating mediastinal and/or hilar lymphadenopathy in patients with malignancy. Granulomatous inflammation is occasionally identified in this setting and has unclear clinical implications. Therefore, we set out to describe a cohort of patients found to have evidence of granulomatous inflammation during EBUS-TBNA done for diagnosis and/or staging of concurrent cancer. Methods:A retrospective analysis of all EBUS-TBNA cases performed over 32 months at our institution was completed. Patients with evidence of granulomatous inflammation during EBUS-TBNA that was not attributable to an infectious etiology or prior sarcoidosis and a concurrent diagnosis of cancer were included. Results:Granulomatous inflammation was identified in 154/1275 patients (12.1%), of whom 12/154 (7.8%) had a concurrent diagnosis of cancer. Primary cancer diagnoses varied, but the primary site of malignancy was in or near the thorax in 10/12 cases (83.3%). When available, 7/8 cases (87.5%) of granulomatous lymphadenopathy were detectable by positron emission tomography. The most common histologic pattern consisted of well-formed non-necrotizing granulomas without fibrosis in 6/12 patients (50%). Conclusions:Granulomatous inflammation is occasionally identified in mediastinal and/or hilar lymphadenopathy in patients with concurrent malignancy. Although the clinical implications of this phenomenon remain to be clarified, these findings emphasize the importance of histologic confirmation of suspected lymph node involvement and suggest that the presence of granulomatous inflammation on EBUS-TBNA may occasionally be consistent with active malignancy and prompt further investigations.