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Approximately 1.5 million people develop a pleural effusion in the United States annually, and approximately 173,000 people (12%) undergo thoracentesis.¹ A recent review of thoracenteses performed at 234 University Health System Consortium hospitals between January 2010 and September 2013 demonstrated that 16% of 132,472 thoracenteses were performed by general internists and hospitalists, 33.1% were performed by interventional radiologists, and 20.3% were performed by pulmonologists.² The iatrogenic pneumothorax rate was not significantly different between interventional radiologists and internists (2.8% and 2.9% risk, respectively); however, the admissions associated with bedside thoracentesis were less expensive than the admissions associated with thoracentesis performed in radiology suites, even after controlling for clinical covariates.² In addition, the use of ultrasound guidance has been associated with a reduced risk of complications and cost of thoracentesis.^3,4 In most of the early published studies on ultrasound-guided thoracentesis, the procedures were performed by radiologists.^5-12 However, in 2010, the British Thoracic Society published guidelines on pleural procedures and thoracic ultrasound geared toward any trained provider.¹³ The purpose of this guideline is to review the literature and present evidence-based recommendations on the performance of ultrasound-guided thoracentesis at the bedside.

Detailed methods are described in Appendix 1. The Society of Hospital Medicine (SHM) Point-of-care Ultrasound (POCUS) Task Force was assembled to carry out this guideline development project under the direction of the SHM Board of Directors, Director of Education, and Education Committee. All expert panel members were physicians or advanced practice providers with expertise in POCUS. The expert panel members were divided into working group members, external peer reviewers, and a methodologist. All the Task Force members were required to disclose any potential conflicts of interests (Appendix 2). The literature search was conducted in two independent phases. The first phase included literature searches conducted by the four working group members themselves. Key clinical questions were prepared prior to conducting a systematic literature search by a medical librarian. The Medline, Embase, CINAHL, and Cochrane medical databases were searched from 1975 to September 2015 initially. Updated searches were conducted in November 2016 and in August 2017 (Appendix 3). All article abstracts were first screened for relevance by at least two members of the working group. Full-text versions of the screened articles were reviewed, and the articles focusing on the use of ultrasound to guide thoracentesis were selected. Articles that discussed thoracentesis without ultrasound guidance were excluded. In addition, the following article types were excluded: non-English language, nonhuman, subjects’ age <18 years, meeting abstracts, meeting posters, letters, and editorials. All relevant systematic reviews, meta-analyses, randomized controlled trials, and observational studies of ultrasound-guided thoracentesis were screened and selected. Final article selection was based on working group consensus, and the selected literature was incorporated into draft recommendations.

We used the RAND Appropriateness Method that required panel judgment and consensus.¹⁴ The 30 voting members of the SHM POCUS Task Force reviewed and voted on the draft recommendations considering the following five transforming factors: 1) Problem priority and importance, 2) Level of quality of evidence, 3) Benefit/harm balance, 4) Benefit/burden balance, and 5) Certainty/concerns about PEAF (Preferences/Equity Acceptability/Feasibility). Panel members participated in two rounds of electronic voting using an internet-based electronic data collection tool (Redcap™) in December 2016 and January 2017 (Appendix 4). Voting on appropriateness was conducted using a 9-point Likert scale, and the degree of consensus was assessed using the RAND algorithm. Establishing a recommendation required at least 70% agreement and a strong recommendation required 80% agreement according to the RAND rules (Appendix 1, Figure 1). Disagreement was defined as >30% of panelists voting outside of the zone of the median (appropriate, uncertain, inappropriate).

Literature search

A total of 1,556 references were pooled from the following four different sources: a search by a certified librarian in September 2015 (1066 citations) that was updated in November 2016 (165 citations) and again in August 2017 (9 citations), working group members’ literature searches (47 citations), and a search focused on training (269 citations). The final selection included 94 articles that were abstracted into a data table and incorporated into the draft recommendations. The details of the literature search strategy are given in Appendix 3.

Recommendations

Terminology

• Thoracentesis is a procedure of aspiration of fluid from the pleural space by percutaneous insertion of a needle through the chest wall with or without the insertion of a catheter.
• In this document, ultrasound guidance refers to static guidance and site marking performed at the bedside immediately before the procedure, as opposed to real-time (dynamic) ultrasound guidance or radiology performed site marking. The static method is the most commonly used method of ultrasound guidance and is supported by current evidence.

Clinical Outcomes

1.We recommend that ultrasound should be used to guide thoracentesis to reduce the risk of complications, the most common being pneumothorax.

Rationale: Both static ultrasound guidance and dynamic ultrasound guidance have been reported to be associated with a reduced risk of pneumothorax.^4-7,15-18 A meta-analysis of 24 studies that included 6,605 thoracenteses showed a significant decrease in the risk of postprocedure pneumothorax with the use of ultrasound guidance compared to the risk associated with thoracentesis performed based on landmarks alone (OR 0.3, 95% CI 0.2–0.7).³ The meta-analysis included both prospective and retrospective studies conducted using both static and dynamic ultrasound guidance.³ A large retrospective cohort study conducted by Mercaldi et al. comprising more than 61,000 patients who underwent thoracentesis also showed that ultrasound guidance was associated with reduced odds of pneumothorax (OR 0.8 [0.7–0.9]).⁴ When pneumothorax did occur during that hospitalization, the cost of hospitalization increased by $2800 and the length of stay increased by 1.5 days.⁴ A 2008 review of 19,339 thoracenteses conducted by Patel et al. also demonstrated an association between ultrasound guidance and reduced odds of pneumothorax (OR 0.8 [0.7–0.96]).¹⁸ Although these findings were significant, it is important to note that the studies of both Mercaldi et al. and Patel et al. were reviews of administrative databases conducted using the International Classification of Diseases, 9th Revision (ICD-9) codes for thoracentesis and Current Procedure Terminology–4^th edition (CPT) codes for the use of ultrasound.^4,18 Patel et al. identified pneumothorax using ICD-9 codes for “pneumothorax–iatrogenic” and “pneumothorax–not specified as due to the procedure.” The association between ultrasound guidance and the reduced odds of pneumothorax was driven by the latter code.¹⁸ However, as with most retrospective studies using administrative data, granular data about the patients, procedure, proceduralists, and complications were not available in these reviews and conclusions may be limited by erroneous coding or documentation.^4,18 In a third retrospective cohort study, Raptopoulos et al. compared 154 landmark-based thoracenteses performed by “clinical physicians” and 188 ultrasound-guided thoracenteses performed by radiologists and found that ultrasound-guided site selection reduced the rate of pneumothorax from 18% to 3% (P < .0001).⁶ Finally, one single-center randomized controlled trial of 160 thoracenteses performed by pulmonologists showed that ultrasound guidance reduced the relative risk of pneumothorax by 90% (12.5% vs 1.3%; P =.009) with a number needed to treat of 9.¹⁵ It was not possible to blind the operators to the use of ultrasound guidance, but the data analysis was blinded.¹⁵ Furthermore, while there was no explicit comparison of the intervention vs. the control groups, randomization would have presumably rendered both groups similar in terms of patient characteristics and effusion characteristics.¹⁵ Ultrasound may reduce the risk of pneumothorax through several mechanisms, including identifying patients in whom thoracentesis cannot be safely performed, allowing selection of the safest needle insertion site, and revealing the optimal depth of needle insertion.

2.We recommend that ultrasound guidance should be used to increase the success rate of thoracentesis.

Rationale: Thoracentesis guided by ultrasound has lower rates of failed attempts, or “dry taps,” compared to thoracentesis guided solely by physical examination. In 1977, Ravin described a method of using ultrasound to guide successful drainage of six complex pleural effusions (empyema or loculated effusion) after multiple (5–7) failed attempts by clinicians using physical examination alone.⁸ In a second study by radiologists, Weingardt et al. demonstrated that 20 of 26 failed landmark-based thoracenteses were due to incorrect site selection by physical examination–15 sites were below the diaphragm and 5 sites were above the pleural effusion or in the consolidated lung–and the use of ultrasound allowed successful sampling in 14 of 16 patients who had a failed landmark-based thoracentesis.⁹ Diacon et al. asked 30 physicians, ranging from junior housestaff to pulmonologists, to mark 172 potential thoracentesis sites in 67 patients with pleural effusions using physical examination alone. Ultrasound was then used to evaluate the proposed puncture sites. They found that using ultrasound would have avoided puncture on “dry chests” in 2% and avoided potential laceration of a solid organ in 10% of patients compared to site selection by physical examination alone.¹⁹ Finally, Perazzo et al. randomized 160 patients to landmark-based thoracentesis and ultrasound-guided thoracentesis and demonstrated that half of the eight dry taps that occurred in the control group could be successfully drained using subsequent ultrasound guidance.¹⁵

Technique

3. We recommend that ultrasound-guided thoracentesis should be performed or closely supervised by experienced operators.

Rationale: Current evidence suggests lower complication rates when thoracentesis is performed by experienced healthcare providers. A systematic review of 6,605 thoracenteses showed a significantly lower pneumothorax rate when thoracentesis was performed by pulmonology or radiology faculty versus resident physicians (3.9% vs 8.5%; P =.04), although this finding was not significant in the four studies that directly compared this factor.³ In a quality improvement study performed by Duncan et al., pulmonology and critical care physicians combining multiple quality improvement initiatives to achieve and maintain competency decreased the rate of pneumothorax from 8.6% to 1.1% (P =.0034).²⁰ Interventions included ultrasound training, performance of 10 thoracenteses under expert supervision, and restriction of privileges to proceduralists who perform 10 or more thoracenteses per year.²⁰ Finally, a series of 9,320 ultrasound-guided thoracenteses performed or supervised by a single expert internist over a period of 12 years resulted in a pneumothorax rate of 0.6% and a composite complication rate of 0.98% (pneumothorax, reexpansion pulmonary edema, hemothorax, site bleeding, hematoma, splenic laceration, and vasovagal reaction).²¹ Notably, pneumothorax rate in resident physician hands was reported to be 8.5% in the meta-analysis performed by Gordon et al., which is similar to the initial rate in the pulmonologists who participated in the study by Duncan et al.^3,20 However, after instituting formal ultrasound training and other initiatives aimed at maintaining competency, the pneumothorax rate in the study by Duncan et al. decreased to 1.1%, similar to the rate observed in the series by Ault et al.²¹ This suggests that training and supervision are necessary to achieve competency and reduce the rate of complications.^3,20,21

4. We suggest that ultrasound guidance be used to reduce the risk of complications from thoracentesis in mechanically ventilated patients.

Rationale: The rest of this guideline refers to ultrasound-guided thoracentesis performed in spontaneously breathing patients; however, this recommendation is specific to mechanically ventilated patients. Two prospective observational studies have shown no increase in complications when ultrasound-guided thoracentesis is performed on mechanically ventilated patients compared to patients not receiving positive pressure ventilation. A feasibility study of 45 thoracenteses performed on ventilated patients reported no complications,²² whereas another study on 232 patients reported a pneumothorax rate of 1.3%.²³ In a larger study conducted by Mayo et al., medicine housestaff performed thoracentesis under the supervision of intensivists who had undergone training in ultrasound prior to performing the procedure.²³ In both studies, most of the patients were in a supine position, although positioning and puncture site were at the discretion of the physician, and both studies employed use of static ultrasound guidance.^22,23 A large series of 9,320 ultrasound-guided thoracenteses that included 1,377 mechanically ventilated patients did not report a higher rate of pneumothorax (0.8%) compared to that in spontaneously breathing patients (0.61%).²¹ Finally, a meta-analysis of 19 observational studies comprising 1,124 mechanically ventilated patients who underwent pleural drainage procedures showed a low rate of pneumothorax (3.4%) and hemothorax (1.9%).²⁴ Although the rate of complication was reported to be low in this meta-analysis, ultrasound was not employed in all studies and its use was not associated with a significant reduction in pneumothorax.²⁴ This may be because 8 of the 19 studies used pigtail catheters or large-bore thoracostomy tubes which treat pneumothorax as they occur.²⁴

5. We recommend that ultrasound should be used to identify the chest wall, pleura, diaphragm, lung, and subdiaphragmatic organs throughout the respiratory cycle before selecting a needle insertion site.

Rationale: The use of ultrasound improves the selection of a safe needle insertion site because sites chosen without ultrasound guidance may be below the diaphragm, over solid organs,^9,19 or in locations that risk puncture of the lung.⁹ Visualization of the chest wall, diaphragm, and lung, which define the boundaries of a pleural effusion, allows the clinician to confirm the presence of a drainable pleural effusion and assess for other pathologies, such as ascites and tumor, that may be mistaken for a pleural effusion.^22,25,26 Hypoechoic lesions can represent small loculated pleural effusions but also pleural plaques, pleural masses, peripheral lung masses, or abscesses.^27,28

6. We recommend that ultrasound should be used to detect the presence or absence of an effusion and approximate the volume of pleural fluid to guide clinical decision-making.

Rationale: The presence and approximate size of pleural fluid collections are important determinants of whether thoracentesis, another procedure, or no procedure should be performed. Ultrasonography has higher sensitivity and specificity for detecting pleural effusions and better differentiates effusions from consolidations compared with chest radiography.^29-42 Ultrasound allows semiquantitative estimation of pleural fluid volume to determine whether thoracentesis should be performed.^41-45 When using ultrasound to choose a site for thoracentesis, the British Thoracic Society Pleural Disease guidelines recommend ≥10 mm of pleural fluid between the visceral and parietal pleura.¹³ Pleural effusions of <10–15 mm are considered too small to tap.^22,23 In a prospective study of 45 patients, a measurement of >9.9 cm by ultrasound between the chest wall and the “V-point,” the intersection of the diaphragm and the collapsed lung, correlated with a pleural fluid volume of >1 liter.⁴⁶ Another prospective study of 73 patients showed that a pleural effusion spanning >3 intercostal spaces by ultrasound also correlated with a pleural fluid volume of >1 liter.⁴⁷ Anticipating the volume of fluid to be removed may aid in preplanning and procurement of larger capacity drainage containers prior to starting the procedure. Lung ultrasound can also change the management if the characteristic of the effusion suggests that an invasive procedure is unsafe or another diagnostic or therapeutic option is more appropriate.³⁹ In a prospective cohort study of 189 mechanically ventilated patients, lung ultrasound guided the management in all patients with suspected effusion, leading to chest tube placement in 7 patients and thoracentesis in 34 patients.⁴⁸

7. We recommend that ultrasound should be used to detect complex sonographic features, such as septations, to guide clinical decision-making regarding the timing and method of pleural drainage.

Rationale: Pleural effusions can be broadly categorized sonographically as simple or complex. Complex effusions are further categorized as with or without septation. Simple effusions are anechoic and are often, but not invariably, transudative.^49-51 The use of sonography and computerized tomography (CT) is complementary, but features of complex pleural effusions (fibrin stranding and septations) may be better visualized by ultrasound than by CT of the thorax.⁵² Detection of complex features should prompt the consideration of pleural fluid sampling.^53,54 Exudative effusions from tuberculosis, malignancy, or other etiologies more often include debris, septations, or other complex features.^55,56 Certain features such as a swirling debris, pleural thickening, and nodularity may be more often associated with malignancy,^54,56 and advanced ultrasound techniques may be used to detect a trapped lung prior to attempting drainage of a malignant pleural effusion.⁵⁷ Two studies found complex septated pleural effusions to be invariably exudative^50,58 and drainage was unlikely to be successful without the placement of a chest tube.^50,58-60 Chest tube placement through fibrinolytic administration or video-assisted thoracoscopic surgery (VATS) may be more appropriate in the management of complex septated pleural effusions,^59-61 and expert consultation with a thoracic specialist is recommended in these cases.

8. We suggest that ultrasound can be used to measure the depth from the skin surface to the parietal pleura to help select an appropriate length needle and determine the maximum needle insertion depth.

Rationale: The distance from the skin to the parietal and visceral pleura can be measured by ultrasound to determine whether thoracentesis can be safely performed and to guide selection of an adequate length needle.³⁸ The length of needle required to penetrate the pleural space varies based on the thickness of the chest wall. Percussion of the chest wall is limited when there is more than 6 cm of subcutaneous tissue,⁶² making physical examination in obese patients unreliable for selecting an appropriate site or needle length for thoracentesis. Ultrasound allows visualization of deep soft tissues, well beyond the limits of percussion, and allows an accurate measurement of the chest wall.⁶³

9. We suggest that ultrasound can be used to evaluate normal lung sliding pre- and postprocedure to rule out pneumothorax.

Rationale: Normal lung sliding indicates normal apposition and movement of visceral and parietal pleura and rules out pneumothorax with a sensitivity that exceeds that of chest radiography, according to a meta-analysis of 20 studies using computed tomography or escape of intrapleural air at the time of drainage as the gold standard.⁶⁴ In this meta-analysis, the pooled sensitivity of ultrasound was reported to be 88% (85-91%) compared to 52% (49-55%) for radiography, although the analysis also suggests that the test characteristics are dependent on operator skill.⁶⁴ However, although lung sliding rules out pneumothorax, absence of lung sliding is not specific for pneumothorax and other conditions, including pleural adhesions, pleurodesis, and bronchial obstruction, can cause the absence of lung sliding.⁶⁴ Detection of a lung point conclusively rules in a pneumothorax.⁶⁵ Provided that the preprocedure lung ultrasound examination revealed normal lung sliding, a postprocedure examination can be performed to effectively evaluate for pneumothorax. This modality does not use ionizing radiation, is less expensive than computed tomography, can be performed faster than bedside chest radiography, and is more sensitive than supine or upright chest radiography.^64,66-71

10. We suggest avoiding delay or interval change in patient position between the time of marking the needle insertion site and performing the thoracentesis.

Rationale: Optimal patient positioning and ultrasound-guided site marking should be performed by the primary operator immediately before beginning an invasive procedure. Remote sonographic localization in which a radiologist marks a needle insertion site using ultrasound and the thoracentesis is performed at a later time by a different provider is an antiquated practice. Two early studies demonstrated that this practice is no safer than landmark-based thoracentesis.^6,72 One prospective study of 205 patients performed in 1986 showed no significant decrease in the incidence of complications from thoracentesis performed using remote sonographic localization versus landmark-based drainage.⁷² Complications in that study included a total of 22 pneumothoraces and 1 hematoma. The rate of complications in the group of patients who had site marking performed by radiology faculty and subsequent thoracentesis by medicine housestaff or attending physicians was 9.7% versus a complication rate of 12.7% in the landmark-based group.⁷² In addition, Raptopoulos et al. observed no significant difference in the pneumothorax rate between 106 patients with landmark-based thoracenteses and 48 patients who were sonographically marked by radiology faculty and then returned to the ward for completion of the thoracentesis by medicine housestaff (19% vs. 15%, respectively).⁶ Both groups had significantly higher rates of pneumothorax compared to those who underwent thoracentesis performed using real-time ultrasound guidance by radiology trainees (3%).⁶ The authors speculated that changing the patient’s position shifted the position of the pleural effusion, ultimately leading to the reliance on physical examination for the tap site.⁶

11. We recommend against performing routine postprocedure chest radiographs in patients who have undergone thoracentesis successfully with ultrasound guidance and are asymptomatic with normal lung sliding postprocedure.

Rationale: Chest radiography post-thoracentesis is unlikely to add information that changes management, especially if performed routinely, but does add expense, radiation, and inconvenience.⁷³ The most common serious complication of thoracentesis is pneumothorax, which is often accompanied by symptoms, particularly in those patients with pneumothorax large enough to warrant chest tube placement.^10,74,75 Pihlajamaa et al. retrospectively studied 264 ultrasound-guided thoracenteses performed by radiologists or radiology residents and noted that of 11 pneumothoraces, only 1 necessitated chest tube placement.¹⁰ Aleman et al. prospectively studied 506 ultrasound-guided and physical examination-guided thoracenteses and found that only 1% of asymptomatic patients developed a pneumothorax.⁷⁴ Eight of the 18 symptomatic patients required chest tube placement as opposed to 1 of the 488 asymptomatic patients.⁷⁴ A large prospective study of 941 ultrasound-guided thoracentesis reported that only 0.3% of asymptomatic patients with no suspicion of pneumothorax required tube thoracostomy.⁵ Postprocedure chest radiographs may be considered when thoracentesis is performed on mechanically ventilated patients, particularly when high airway pressures exist. In a study of 434 patients undergoing thoracentesis, only 10 patients had a pneumothorax (2.3%).¹¹ Six of these pneumothoraces occurred in 92 mechanically ventilated patients (6.5%), and 2 of these 6 patients required a chest tube.¹¹ None of the 4 spontaneously breathing patients with pneumothorax required a chest tube.¹¹

Training

12. We recommend that novices who use ultrasound guidance for thoracentesis should receive focused training in lung and pleural ultrasonography and hands-on practice in procedural technique.

Rationale: Healthcare providers have to gain various skills to safely perform ultrasound-guided thoracentesis independently. Trainees should learn how to use ultrasound to identify important structures (chest wall, ribs, lung, pleura, diaphragm, and subdiaphragmatic organs); detect pleural effusions with complex features, such as septations; identify consolidated lung tissue; and rule out a pneumothorax. Prospective studies done with novice learners have shown that focused training combining didactics and hands-on practice using simulation or live models improves skills to assess pleural effusions.^76-84 Several additional procedural techniques such as patient positioning and needle insertion are also important but are beyond the scope of these guidelines.

13. We suggest that novices undergo simulation-based training prior to performing ultrasound-guided thoracentesis on patients.

Rationale: Simulation-based training for thoracentesis has been studied in providers with different levels of medical training, ranging from medical students and internal medicine residents to practicing pulmonologists. Studies suggest that training in a zero-risk environment with simulation task trainers leads to increased knowledge and skills without subjecting the patients to inexperienced operators.^85-87 One study on simulator-based training in medical students showed skill retention at 6 months and these skills were at least partially transferred to increased competency on live patients.⁸⁸ Checklists to train providers in ultrasound-guided thoracentesis have been published.^89,90 An experiential training program for attending physicians that utilized task trainers, along with standardized equipment and procedural technique, resulted in a reduction in the pneumothorax rate from 8.6% to 1.1%.²⁰

14. Training curves for novices to become competent in lung ultrasound and ultrasound-guided thoracentesis are not completely understood. We recommend that training should be tailored to the skill acquisition of the learner and the resources of the institution.

Rationale: Understanding the rates at which novices progress from performing procedures under direct supervision to performing them independently would be highly desirable to ensure patient safety, guide supervision, and maximize efficiency of training. However, there is limited research describing the rate of progression of learners through these stages, either with regard to time or number of procedures performed. Two studies have shown that with brief training programs, medical students⁸⁸ and internal medicine residents⁸⁷ can achieve high levels of proficiency to perform thoracentesis on simulators, which is durable over time; however, whether these findings in a simulated environment translate into clinically significant outcomes is largely unknown, and neither of these studies incorporated the use of ultrasound guidance in their training curricula.^87,88 Another study of pulmonary and critical care physicians combined multiple quality improvement initiatives with a half day of ultrasound-guided thoracentesis training, a requirement to perform 10 supervised thoracenteses prior to independent practice, and an additional requirement to perform 10 thoracenteses per year to maintain privileges.²⁰ These interventions resulted in a concentration of competency among a few proceduralists, decreasing the rate of pneumothorax from 8.6% to 1.1%.²⁰ Degradation of skills with disuse may also occur⁸⁴; thus, procedures performed infrequently should at a minimum be subjected to increased supervision and/or retesting.

The process of developing these guidelines revealed important gaps in the literature regarding the use of ultrasound guidance for thoracentesis. First, it is uncertain whether the use of ultrasound reduces the risk of bleeding with thoracentesis. A retrospective cohort study of 19,339 thoracenteses suggests that ultrasound guidance is associated with a 38.7% relative reduction in the odds of hemorrhage, although this reduction did not reach statistical significance (OR 0.6 [0.4–1.04]).¹⁸ Ultrasound may reduce the risk of bleeding by reducing the number of attempts and needle passes and potentially avoiding tortuous intercostal vessels, which can be found especially in elderly patients and more cephalad rib spaces.⁹¹ In an observational study of 22 patients undergoing thoracentesis, the intercostal artery (ICA) was identified by a high-frequency ultrasound transducer in 74 of 88 intercostal spaces.⁹² The ICA is more exposed in the intercostal space within the first 6 cm lateral to the spinous processes and can be seen as far lateral as the midaxillary line.^92-95 Thus, the ICA will most likely be avoided if a procedure site is selected >6 cm lateral to the spinous processes and the needle is inserted above the rib.

Second, although all three studies conducted using real-time (dynamic) ultrasound guidance reported a pneumothorax rate of <1%, it is uncertain whether real-time ultrasound guidance confers any additional benefit compared to static guidance for site marking as direct comparisons were not made.^17,96,97 It is possible that real-time ultrasound guidance may be superior to static guidance in certain situations, such as small pleural effusions of <10–15 mm that have historically been considered too small to tap.^13,22,23,96

Third, although one study suggests that general internists can safely perform thoracentesis with low complication rates similar to those of interventional radiologists,² limited data exists on how to train practicing hospitalists to use ultrasound to guide thoracentesis. The effectiveness of different training protocols to acquire competence in ultrasound-guided thoracentesis has not been compared.

Finally, the impact of ultrasound use on patient experience has yet to be explored.

The use of ultrasound guidance for thoracentesis has been associated with increased success rates and decreased complication rates. Ultrasound can be used to estimate the pleural fluid volume, characterize the effusion as simple or complex, identify an optimal needle insertion site, and reduce the need for postprocedural chest radiographs. Training and experience are essential to reap the benefits of using ultrasound for thoracentesis, although our understanding of optimal educational strategies and learning curves is limited. Once training has occurred and competence is achieved, hospitalists can perform ultrasound-guided thoracentesis as safely as radiologists, pulmonologists, and other specialists.

Collaborators from the Society of Hospital Medicine Point-of-care Ultrasound Task Force: Saaid Abdel-Ghani, Robert Arntfield, Jeffrey Bates, Anjali Bhagra, Michael Blaivas, Daniel Brotman, Carolina Candotti, Richard Hoppmann, Susan Hunt, Trevor P. Jensen, Venkat Kalidindi, Ketino Kobaidze, Joshua Lenchus, Benji Mathews, Paul, Mayo, Satyen Nichani, Vicki Noble, Martin Perez, Aliaksei Pustavoitau, Kreegan Reierson, Sophia Rodgers, Gerard Salame, Kirk Spencer, Vivek Tayal, David M. Tierney.

Disclosures

Ricardo Franco-Sadud reports institutional funds received from the Society of Hospital Medicine Annual Meeting for travel expenses and accommodations outside the submitted work. Nitin Puri reports Payment for lectures including service on speakers bureaus from Fujifilm Sonosite and royalties from Elsevier, both outside the submitted work. All other authors have nothing to disclose.

Funding

Brian P Lucas: Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development and Dartmouth SYNERGY, National Institutes of Health, National Center for Translational Science (UL1TR001086). Nilam Soni: Department of Veterans Affairs, Quality Enhancement Research Initiative (QUERI) Partnered Evaluation Initiative Grant (HX002263-01A1)

Disclaimer

The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs or the United States Government.

The authors thank all the members of the Society of Hospital Medicine Point-of-care Ultrasound Task Force and the Education Committee members for their time and dedication to develop these guidelines.

CHAIRS: Nilam Soni, Ricardo Franco Sadud, Jeff Bates. WORKING GROUPS: Thoracentesis Working Group: Ria Dancel (chair), Daniel Schnobrich, Nitin Puri. Vascular Access Working Group: Ricardo Franco (chair), Benji Matthews, Saaid Abdel-Ghani, Sophia Rodgers, Martin Perez, Daniel Schnobrich. Paracentesis Working Group: Joel Cho (chair), Benji Matthews, Kreegan Reierson, Anjali Bhagra, Trevor P. Jensen. Lumbar puncture Working Group: Nilam Soni (chair), Ricardo Franco, Gerard Salame, Josh Lenchus, Venkat Kalidindi, Ketino Kobaidze. Credentialing Working Group: Brian P Lucas (chair), David Tierney, Trevor P. Jensen. PEER REVIEWERS: Robert Arntfield, Michael Blaivas, Richard Hoppmann, Paul Mayo, Vicki Noble, Aliaksei Pustavoitau, Kirk Spencer, Vivek Tayal. METHODOLOGIST: Mahmoud El Barbary. LIBRARIAN: Loretta Grikis. SOCIETY OF HOSPITAL MEDICINE EDUCATION COMMITTEE: Dan Brotman (past chair), Satyen Nichani (current chair), Susan Hunt. SOCIETY OF HOSPITAL MEDICINE STAFF: Nick Marzano.

Approximately 1.5 million people develop a pleural effusion in the United States annually, and approximately 173,000 people (12%) undergo thoracentesis.¹ A recent review of thoracenteses performed at 234 University Health System Consortium hospitals between January 2010 and September 2013 demonstrated that 16% of 132,472 thoracenteses were performed by general internists and hospitalists, 33.1% were performed by interventional radiologists, and 20.3% were performed by pulmonologists.² The iatrogenic pneumothorax rate was not significantly different between interventional radiologists and internists (2.8% and 2.9% risk, respectively); however, the admissions associated with bedside thoracentesis were less expensive than the admissions associated with thoracentesis performed in radiology suites, even after controlling for clinical covariates.² In addition, the use of ultrasound guidance has been associated with a reduced risk of complications and cost of thoracentesis.^3,4 In most of the early published studies on ultrasound-guided thoracentesis, the procedures were performed by radiologists.^5-12 However, in 2010, the British Thoracic Society published guidelines on pleural procedures and thoracic ultrasound geared toward any trained provider.¹³ The purpose of this guideline is to review the literature and present evidence-based recommendations on the performance of ultrasound-guided thoracentesis at the bedside.

Detailed methods are described in Appendix 1. The Society of Hospital Medicine (SHM) Point-of-care Ultrasound (POCUS) Task Force was assembled to carry out this guideline development project under the direction of the SHM Board of Directors, Director of Education, and Education Committee. All expert panel members were physicians or advanced practice providers with expertise in POCUS. The expert panel members were divided into working group members, external peer reviewers, and a methodologist. All the Task Force members were required to disclose any potential conflicts of interests (Appendix 2). The literature search was conducted in two independent phases. The first phase included literature searches conducted by the four working group members themselves. Key clinical questions were prepared prior to conducting a systematic literature search by a medical librarian. The Medline, Embase, CINAHL, and Cochrane medical databases were searched from 1975 to September 2015 initially. Updated searches were conducted in November 2016 and in August 2017 (Appendix 3). All article abstracts were first screened for relevance by at least two members of the working group. Full-text versions of the screened articles were reviewed, and the articles focusing on the use of ultrasound to guide thoracentesis were selected. Articles that discussed thoracentesis without ultrasound guidance were excluded. In addition, the following article types were excluded: non-English language, nonhuman, subjects’ age <18 years, meeting abstracts, meeting posters, letters, and editorials. All relevant systematic reviews, meta-analyses, randomized controlled trials, and observational studies of ultrasound-guided thoracentesis were screened and selected. Final article selection was based on working group consensus, and the selected literature was incorporated into draft recommendations.

We used the RAND Appropriateness Method that required panel judgment and consensus.¹⁴ The 30 voting members of the SHM POCUS Task Force reviewed and voted on the draft recommendations considering the following five transforming factors: 1) Problem priority and importance, 2) Level of quality of evidence, 3) Benefit/harm balance, 4) Benefit/burden balance, and 5) Certainty/concerns about PEAF (Preferences/Equity Acceptability/Feasibility). Panel members participated in two rounds of electronic voting using an internet-based electronic data collection tool (Redcap™) in December 2016 and January 2017 (Appendix 4). Voting on appropriateness was conducted using a 9-point Likert scale, and the degree of consensus was assessed using the RAND algorithm. Establishing a recommendation required at least 70% agreement and a strong recommendation required 80% agreement according to the RAND rules (Appendix 1, Figure 1). Disagreement was defined as >30% of panelists voting outside of the zone of the median (appropriate, uncertain, inappropriate).

Literature search

A total of 1,556 references were pooled from the following four different sources: a search by a certified librarian in September 2015 (1066 citations) that was updated in November 2016 (165 citations) and again in August 2017 (9 citations), working group members’ literature searches (47 citations), and a search focused on training (269 citations). The final selection included 94 articles that were abstracted into a data table and incorporated into the draft recommendations. The details of the literature search strategy are given in Appendix 3.

Recommendations

Terminology

• Thoracentesis is a procedure of aspiration of fluid from the pleural space by percutaneous insertion of a needle through the chest wall with or without the insertion of a catheter.
• In this document, ultrasound guidance refers to static guidance and site marking performed at the bedside immediately before the procedure, as opposed to real-time (dynamic) ultrasound guidance or radiology performed site marking. The static method is the most commonly used method of ultrasound guidance and is supported by current evidence.

Clinical Outcomes

1.We recommend that ultrasound should be used to guide thoracentesis to reduce the risk of complications, the most common being pneumothorax.

Rationale: Both static ultrasound guidance and dynamic ultrasound guidance have been reported to be associated with a reduced risk of pneumothorax.^4-7,15-18 A meta-analysis of 24 studies that included 6,605 thoracenteses showed a significant decrease in the risk of postprocedure pneumothorax with the use of ultrasound guidance compared to the risk associated with thoracentesis performed based on landmarks alone (OR 0.3, 95% CI 0.2–0.7).³ The meta-analysis included both prospective and retrospective studies conducted using both static and dynamic ultrasound guidance.³ A large retrospective cohort study conducted by Mercaldi et al. comprising more than 61,000 patients who underwent thoracentesis also showed that ultrasound guidance was associated with reduced odds of pneumothorax (OR 0.8 [0.7–0.9]).⁴ When pneumothorax did occur during that hospitalization, the cost of hospitalization increased by $2800 and the length of stay increased by 1.5 days.⁴ A 2008 review of 19,339 thoracenteses conducted by Patel et al. also demonstrated an association between ultrasound guidance and reduced odds of pneumothorax (OR 0.8 [0.7–0.96]).¹⁸ Although these findings were significant, it is important to note that the studies of both Mercaldi et al. and Patel et al. were reviews of administrative databases conducted using the International Classification of Diseases, 9th Revision (ICD-9) codes for thoracentesis and Current Procedure Terminology–4^th edition (CPT) codes for the use of ultrasound.^4,18 Patel et al. identified pneumothorax using ICD-9 codes for “pneumothorax–iatrogenic” and “pneumothorax–not specified as due to the procedure.” The association between ultrasound guidance and the reduced odds of pneumothorax was driven by the latter code.¹⁸ However, as with most retrospective studies using administrative data, granular data about the patients, procedure, proceduralists, and complications were not available in these reviews and conclusions may be limited by erroneous coding or documentation.^4,18 In a third retrospective cohort study, Raptopoulos et al. compared 154 landmark-based thoracenteses performed by “clinical physicians” and 188 ultrasound-guided thoracenteses performed by radiologists and found that ultrasound-guided site selection reduced the rate of pneumothorax from 18% to 3% (P < .0001).⁶ Finally, one single-center randomized controlled trial of 160 thoracenteses performed by pulmonologists showed that ultrasound guidance reduced the relative risk of pneumothorax by 90% (12.5% vs 1.3%; P =.009) with a number needed to treat of 9.¹⁵ It was not possible to blind the operators to the use of ultrasound guidance, but the data analysis was blinded.¹⁵ Furthermore, while there was no explicit comparison of the intervention vs. the control groups, randomization would have presumably rendered both groups similar in terms of patient characteristics and effusion characteristics.¹⁵ Ultrasound may reduce the risk of pneumothorax through several mechanisms, including identifying patients in whom thoracentesis cannot be safely performed, allowing selection of the safest needle insertion site, and revealing the optimal depth of needle insertion.

2.We recommend that ultrasound guidance should be used to increase the success rate of thoracentesis.

Rationale: Thoracentesis guided by ultrasound has lower rates of failed attempts, or “dry taps,” compared to thoracentesis guided solely by physical examination. In 1977, Ravin described a method of using ultrasound to guide successful drainage of six complex pleural effusions (empyema or loculated effusion) after multiple (5–7) failed attempts by clinicians using physical examination alone.⁸ In a second study by radiologists, Weingardt et al. demonstrated that 20 of 26 failed landmark-based thoracenteses were due to incorrect site selection by physical examination–15 sites were below the diaphragm and 5 sites were above the pleural effusion or in the consolidated lung–and the use of ultrasound allowed successful sampling in 14 of 16 patients who had a failed landmark-based thoracentesis.⁹ Diacon et al. asked 30 physicians, ranging from junior housestaff to pulmonologists, to mark 172 potential thoracentesis sites in 67 patients with pleural effusions using physical examination alone. Ultrasound was then used to evaluate the proposed puncture sites. They found that using ultrasound would have avoided puncture on “dry chests” in 2% and avoided potential laceration of a solid organ in 10% of patients compared to site selection by physical examination alone.¹⁹ Finally, Perazzo et al. randomized 160 patients to landmark-based thoracentesis and ultrasound-guided thoracentesis and demonstrated that half of the eight dry taps that occurred in the control group could be successfully drained using subsequent ultrasound guidance.¹⁵

Technique

3. We recommend that ultrasound-guided thoracentesis should be performed or closely supervised by experienced operators.

Rationale: Current evidence suggests lower complication rates when thoracentesis is performed by experienced healthcare providers. A systematic review of 6,605 thoracenteses showed a significantly lower pneumothorax rate when thoracentesis was performed by pulmonology or radiology faculty versus resident physicians (3.9% vs 8.5%; P =.04), although this finding was not significant in the four studies that directly compared this factor.³ In a quality improvement study performed by Duncan et al., pulmonology and critical care physicians combining multiple quality improvement initiatives to achieve and maintain competency decreased the rate of pneumothorax from 8.6% to 1.1% (P =.0034).²⁰ Interventions included ultrasound training, performance of 10 thoracenteses under expert supervision, and restriction of privileges to proceduralists who perform 10 or more thoracenteses per year.²⁰ Finally, a series of 9,320 ultrasound-guided thoracenteses performed or supervised by a single expert internist over a period of 12 years resulted in a pneumothorax rate of 0.6% and a composite complication rate of 0.98% (pneumothorax, reexpansion pulmonary edema, hemothorax, site bleeding, hematoma, splenic laceration, and vasovagal reaction).²¹ Notably, pneumothorax rate in resident physician hands was reported to be 8.5% in the meta-analysis performed by Gordon et al., which is similar to the initial rate in the pulmonologists who participated in the study by Duncan et al.^3,20 However, after instituting formal ultrasound training and other initiatives aimed at maintaining competency, the pneumothorax rate in the study by Duncan et al. decreased to 1.1%, similar to the rate observed in the series by Ault et al.²¹ This suggests that training and supervision are necessary to achieve competency and reduce the rate of complications.^3,20,21

4. We suggest that ultrasound guidance be used to reduce the risk of complications from thoracentesis in mechanically ventilated patients.

Rationale: The rest of this guideline refers to ultrasound-guided thoracentesis performed in spontaneously breathing patients; however, this recommendation is specific to mechanically ventilated patients. Two prospective observational studies have shown no increase in complications when ultrasound-guided thoracentesis is performed on mechanically ventilated patients compared to patients not receiving positive pressure ventilation. A feasibility study of 45 thoracenteses performed on ventilated patients reported no complications,²² whereas another study on 232 patients reported a pneumothorax rate of 1.3%.²³ In a larger study conducted by Mayo et al., medicine housestaff performed thoracentesis under the supervision of intensivists who had undergone training in ultrasound prior to performing the procedure.²³ In both studies, most of the patients were in a supine position, although positioning and puncture site were at the discretion of the physician, and both studies employed use of static ultrasound guidance.^22,23 A large series of 9,320 ultrasound-guided thoracenteses that included 1,377 mechanically ventilated patients did not report a higher rate of pneumothorax (0.8%) compared to that in spontaneously breathing patients (0.61%).²¹ Finally, a meta-analysis of 19 observational studies comprising 1,124 mechanically ventilated patients who underwent pleural drainage procedures showed a low rate of pneumothorax (3.4%) and hemothorax (1.9%).²⁴ Although the rate of complication was reported to be low in this meta-analysis, ultrasound was not employed in all studies and its use was not associated with a significant reduction in pneumothorax.²⁴ This may be because 8 of the 19 studies used pigtail catheters or large-bore thoracostomy tubes which treat pneumothorax as they occur.²⁴

5. We recommend that ultrasound should be used to identify the chest wall, pleura, diaphragm, lung, and subdiaphragmatic organs throughout the respiratory cycle before selecting a needle insertion site.

Rationale: The use of ultrasound improves the selection of a safe needle insertion site because sites chosen without ultrasound guidance may be below the diaphragm, over solid organs,^9,19 or in locations that risk puncture of the lung.⁹ Visualization of the chest wall, diaphragm, and lung, which define the boundaries of a pleural effusion, allows the clinician to confirm the presence of a drainable pleural effusion and assess for other pathologies, such as ascites and tumor, that may be mistaken for a pleural effusion.^22,25,26 Hypoechoic lesions can represent small loculated pleural effusions but also pleural plaques, pleural masses, peripheral lung masses, or abscesses.^27,28

6. We recommend that ultrasound should be used to detect the presence or absence of an effusion and approximate the volume of pleural fluid to guide clinical decision-making.

Rationale: The presence and approximate size of pleural fluid collections are important determinants of whether thoracentesis, another procedure, or no procedure should be performed. Ultrasonography has higher sensitivity and specificity for detecting pleural effusions and better differentiates effusions from consolidations compared with chest radiography.^29-42 Ultrasound allows semiquantitative estimation of pleural fluid volume to determine whether thoracentesis should be performed.^41-45 When using ultrasound to choose a site for thoracentesis, the British Thoracic Society Pleural Disease guidelines recommend ≥10 mm of pleural fluid between the visceral and parietal pleura.¹³ Pleural effusions of <10–15 mm are considered too small to tap.^22,23 In a prospective study of 45 patients, a measurement of >9.9 cm by ultrasound between the chest wall and the “V-point,” the intersection of the diaphragm and the collapsed lung, correlated with a pleural fluid volume of >1 liter.⁴⁶ Another prospective study of 73 patients showed that a pleural effusion spanning >3 intercostal spaces by ultrasound also correlated with a pleural fluid volume of >1 liter.⁴⁷ Anticipating the volume of fluid to be removed may aid in preplanning and procurement of larger capacity drainage containers prior to starting the procedure. Lung ultrasound can also change the management if the characteristic of the effusion suggests that an invasive procedure is unsafe or another diagnostic or therapeutic option is more appropriate.³⁹ In a prospective cohort study of 189 mechanically ventilated patients, lung ultrasound guided the management in all patients with suspected effusion, leading to chest tube placement in 7 patients and thoracentesis in 34 patients.⁴⁸

7. We recommend that ultrasound should be used to detect complex sonographic features, such as septations, to guide clinical decision-making regarding the timing and method of pleural drainage.

Rationale: Pleural effusions can be broadly categorized sonographically as simple or complex. Complex effusions are further categorized as with or without septation. Simple effusions are anechoic and are often, but not invariably, transudative.^49-51 The use of sonography and computerized tomography (CT) is complementary, but features of complex pleural effusions (fibrin stranding and septations) may be better visualized by ultrasound than by CT of the thorax.⁵² Detection of complex features should prompt the consideration of pleural fluid sampling.^53,54 Exudative effusions from tuberculosis, malignancy, or other etiologies more often include debris, septations, or other complex features.^55,56 Certain features such as a swirling debris, pleural thickening, and nodularity may be more often associated with malignancy,^54,56 and advanced ultrasound techniques may be used to detect a trapped lung prior to attempting drainage of a malignant pleural effusion.⁵⁷ Two studies found complex septated pleural effusions to be invariably exudative^50,58 and drainage was unlikely to be successful without the placement of a chest tube.^50,58-60 Chest tube placement through fibrinolytic administration or video-assisted thoracoscopic surgery (VATS) may be more appropriate in the management of complex septated pleural effusions,^59-61 and expert consultation with a thoracic specialist is recommended in these cases.

8. We suggest that ultrasound can be used to measure the depth from the skin surface to the parietal pleura to help select an appropriate length needle and determine the maximum needle insertion depth.

Rationale: The distance from the skin to the parietal and visceral pleura can be measured by ultrasound to determine whether thoracentesis can be safely performed and to guide selection of an adequate length needle.³⁸ The length of needle required to penetrate the pleural space varies based on the thickness of the chest wall. Percussion of the chest wall is limited when there is more than 6 cm of subcutaneous tissue,⁶² making physical examination in obese patients unreliable for selecting an appropriate site or needle length for thoracentesis. Ultrasound allows visualization of deep soft tissues, well beyond the limits of percussion, and allows an accurate measurement of the chest wall.⁶³

9. We suggest that ultrasound can be used to evaluate normal lung sliding pre- and postprocedure to rule out pneumothorax.

Rationale: Normal lung sliding indicates normal apposition and movement of visceral and parietal pleura and rules out pneumothorax with a sensitivity that exceeds that of chest radiography, according to a meta-analysis of 20 studies using computed tomography or escape of intrapleural air at the time of drainage as the gold standard.⁶⁴ In this meta-analysis, the pooled sensitivity of ultrasound was reported to be 88% (85-91%) compared to 52% (49-55%) for radiography, although the analysis also suggests that the test characteristics are dependent on operator skill.⁶⁴ However, although lung sliding rules out pneumothorax, absence of lung sliding is not specific for pneumothorax and other conditions, including pleural adhesions, pleurodesis, and bronchial obstruction, can cause the absence of lung sliding.⁶⁴ Detection of a lung point conclusively rules in a pneumothorax.⁶⁵ Provided that the preprocedure lung ultrasound examination revealed normal lung sliding, a postprocedure examination can be performed to effectively evaluate for pneumothorax. This modality does not use ionizing radiation, is less expensive than computed tomography, can be performed faster than bedside chest radiography, and is more sensitive than supine or upright chest radiography.^64,66-71

10. We suggest avoiding delay or interval change in patient position between the time of marking the needle insertion site and performing the thoracentesis.

Rationale: Optimal patient positioning and ultrasound-guided site marking should be performed by the primary operator immediately before beginning an invasive procedure. Remote sonographic localization in which a radiologist marks a needle insertion site using ultrasound and the thoracentesis is performed at a later time by a different provider is an antiquated practice. Two early studies demonstrated that this practice is no safer than landmark-based thoracentesis.^6,72 One prospective study of 205 patients performed in 1986 showed no significant decrease in the incidence of complications from thoracentesis performed using remote sonographic localization versus landmark-based drainage.⁷² Complications in that study included a total of 22 pneumothoraces and 1 hematoma. The rate of complications in the group of patients who had site marking performed by radiology faculty and subsequent thoracentesis by medicine housestaff or attending physicians was 9.7% versus a complication rate of 12.7% in the landmark-based group.⁷² In addition, Raptopoulos et al. observed no significant difference in the pneumothorax rate between 106 patients with landmark-based thoracenteses and 48 patients who were sonographically marked by radiology faculty and then returned to the ward for completion of the thoracentesis by medicine housestaff (19% vs. 15%, respectively).⁶ Both groups had significantly higher rates of pneumothorax compared to those who underwent thoracentesis performed using real-time ultrasound guidance by radiology trainees (3%).⁶ The authors speculated that changing the patient’s position shifted the position of the pleural effusion, ultimately leading to the reliance on physical examination for the tap site.⁶

11. We recommend against performing routine postprocedure chest radiographs in patients who have undergone thoracentesis successfully with ultrasound guidance and are asymptomatic with normal lung sliding postprocedure.

Rationale: Chest radiography post-thoracentesis is unlikely to add information that changes management, especially if performed routinely, but does add expense, radiation, and inconvenience.⁷³ The most common serious complication of thoracentesis is pneumothorax, which is often accompanied by symptoms, particularly in those patients with pneumothorax large enough to warrant chest tube placement.^10,74,75 Pihlajamaa et al. retrospectively studied 264 ultrasound-guided thoracenteses performed by radiologists or radiology residents and noted that of 11 pneumothoraces, only 1 necessitated chest tube placement.¹⁰ Aleman et al. prospectively studied 506 ultrasound-guided and physical examination-guided thoracenteses and found that only 1% of asymptomatic patients developed a pneumothorax.⁷⁴ Eight of the 18 symptomatic patients required chest tube placement as opposed to 1 of the 488 asymptomatic patients.⁷⁴ A large prospective study of 941 ultrasound-guided thoracentesis reported that only 0.3% of asymptomatic patients with no suspicion of pneumothorax required tube thoracostomy.⁵ Postprocedure chest radiographs may be considered when thoracentesis is performed on mechanically ventilated patients, particularly when high airway pressures exist. In a study of 434 patients undergoing thoracentesis, only 10 patients had a pneumothorax (2.3%).¹¹ Six of these pneumothoraces occurred in 92 mechanically ventilated patients (6.5%), and 2 of these 6 patients required a chest tube.¹¹ None of the 4 spontaneously breathing patients with pneumothorax required a chest tube.¹¹

Training

12. We recommend that novices who use ultrasound guidance for thoracentesis should receive focused training in lung and pleural ultrasonography and hands-on practice in procedural technique.

Rationale: Healthcare providers have to gain various skills to safely perform ultrasound-guided thoracentesis independently. Trainees should learn how to use ultrasound to identify important structures (chest wall, ribs, lung, pleura, diaphragm, and subdiaphragmatic organs); detect pleural effusions with complex features, such as septations; identify consolidated lung tissue; and rule out a pneumothorax. Prospective studies done with novice learners have shown that focused training combining didactics and hands-on practice using simulation or live models improves skills to assess pleural effusions.^76-84 Several additional procedural techniques such as patient positioning and needle insertion are also important but are beyond the scope of these guidelines.

13. We suggest that novices undergo simulation-based training prior to performing ultrasound-guided thoracentesis on patients.

Rationale: Simulation-based training for thoracentesis has been studied in providers with different levels of medical training, ranging from medical students and internal medicine residents to practicing pulmonologists. Studies suggest that training in a zero-risk environment with simulation task trainers leads to increased knowledge and skills without subjecting the patients to inexperienced operators.^85-87 One study on simulator-based training in medical students showed skill retention at 6 months and these skills were at least partially transferred to increased competency on live patients.⁸⁸ Checklists to train providers in ultrasound-guided thoracentesis have been published.^89,90 An experiential training program for attending physicians that utilized task trainers, along with standardized equipment and procedural technique, resulted in a reduction in the pneumothorax rate from 8.6% to 1.1%.²⁰

14. Training curves for novices to become competent in lung ultrasound and ultrasound-guided thoracentesis are not completely understood. We recommend that training should be tailored to the skill acquisition of the learner and the resources of the institution.

Rationale: Understanding the rates at which novices progress from performing procedures under direct supervision to performing them independently would be highly desirable to ensure patient safety, guide supervision, and maximize efficiency of training. However, there is limited research describing the rate of progression of learners through these stages, either with regard to time or number of procedures performed. Two studies have shown that with brief training programs, medical students⁸⁸ and internal medicine residents⁸⁷ can achieve high levels of proficiency to perform thoracentesis on simulators, which is durable over time; however, whether these findings in a simulated environment translate into clinically significant outcomes is largely unknown, and neither of these studies incorporated the use of ultrasound guidance in their training curricula.^87,88 Another study of pulmonary and critical care physicians combined multiple quality improvement initiatives with a half day of ultrasound-guided thoracentesis training, a requirement to perform 10 supervised thoracenteses prior to independent practice, and an additional requirement to perform 10 thoracenteses per year to maintain privileges.²⁰ These interventions resulted in a concentration of competency among a few proceduralists, decreasing the rate of pneumothorax from 8.6% to 1.1%.²⁰ Degradation of skills with disuse may also occur⁸⁴; thus, procedures performed infrequently should at a minimum be subjected to increased supervision and/or retesting.

The process of developing these guidelines revealed important gaps in the literature regarding the use of ultrasound guidance for thoracentesis. First, it is uncertain whether the use of ultrasound reduces the risk of bleeding with thoracentesis. A retrospective cohort study of 19,339 thoracenteses suggests that ultrasound guidance is associated with a 38.7% relative reduction in the odds of hemorrhage, although this reduction did not reach statistical significance (OR 0.6 [0.4–1.04]).¹⁸ Ultrasound may reduce the risk of bleeding by reducing the number of attempts and needle passes and potentially avoiding tortuous intercostal vessels, which can be found especially in elderly patients and more cephalad rib spaces.⁹¹ In an observational study of 22 patients undergoing thoracentesis, the intercostal artery (ICA) was identified by a high-frequency ultrasound transducer in 74 of 88 intercostal spaces.⁹² The ICA is more exposed in the intercostal space within the first 6 cm lateral to the spinous processes and can be seen as far lateral as the midaxillary line.^92-95 Thus, the ICA will most likely be avoided if a procedure site is selected >6 cm lateral to the spinous processes and the needle is inserted above the rib.

Second, although all three studies conducted using real-time (dynamic) ultrasound guidance reported a pneumothorax rate of <1%, it is uncertain whether real-time ultrasound guidance confers any additional benefit compared to static guidance for site marking as direct comparisons were not made.^17,96,97 It is possible that real-time ultrasound guidance may be superior to static guidance in certain situations, such as small pleural effusions of <10–15 mm that have historically been considered too small to tap.^13,22,23,96

Third, although one study suggests that general internists can safely perform thoracentesis with low complication rates similar to those of interventional radiologists,² limited data exists on how to train practicing hospitalists to use ultrasound to guide thoracentesis. The effectiveness of different training protocols to acquire competence in ultrasound-guided thoracentesis has not been compared.

Finally, the impact of ultrasound use on patient experience has yet to be explored.

The use of ultrasound guidance for thoracentesis has been associated with increased success rates and decreased complication rates. Ultrasound can be used to estimate the pleural fluid volume, characterize the effusion as simple or complex, identify an optimal needle insertion site, and reduce the need for postprocedural chest radiographs. Training and experience are essential to reap the benefits of using ultrasound for thoracentesis, although our understanding of optimal educational strategies and learning curves is limited. Once training has occurred and competence is achieved, hospitalists can perform ultrasound-guided thoracentesis as safely as radiologists, pulmonologists, and other specialists.

Collaborators from the Society of Hospital Medicine Point-of-care Ultrasound Task Force: Saaid Abdel-Ghani, Robert Arntfield, Jeffrey Bates, Anjali Bhagra, Michael Blaivas, Daniel Brotman, Carolina Candotti, Richard Hoppmann, Susan Hunt, Trevor P. Jensen, Venkat Kalidindi, Ketino Kobaidze, Joshua Lenchus, Benji Mathews, Paul, Mayo, Satyen Nichani, Vicki Noble, Martin Perez, Aliaksei Pustavoitau, Kreegan Reierson, Sophia Rodgers, Gerard Salame, Kirk Spencer, Vivek Tayal, David M. Tierney.

Disclosures

Ricardo Franco-Sadud reports institutional funds received from the Society of Hospital Medicine Annual Meeting for travel expenses and accommodations outside the submitted work. Nitin Puri reports Payment for lectures including service on speakers bureaus from Fujifilm Sonosite and royalties from Elsevier, both outside the submitted work. All other authors have nothing to disclose.

Funding

Brian P Lucas: Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development and Dartmouth SYNERGY, National Institutes of Health, National Center for Translational Science (UL1TR001086). Nilam Soni: Department of Veterans Affairs, Quality Enhancement Research Initiative (QUERI) Partnered Evaluation Initiative Grant (HX002263-01A1)

Disclaimer

The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs or the United States Government.

The authors thank all the members of the Society of Hospital Medicine Point-of-care Ultrasound Task Force and the Education Committee members for their time and dedication to develop these guidelines.

CHAIRS: Nilam Soni, Ricardo Franco Sadud, Jeff Bates. WORKING GROUPS: Thoracentesis Working Group: Ria Dancel (chair), Daniel Schnobrich, Nitin Puri. Vascular Access Working Group: Ricardo Franco (chair), Benji Matthews, Saaid Abdel-Ghani, Sophia Rodgers, Martin Perez, Daniel Schnobrich. Paracentesis Working Group: Joel Cho (chair), Benji Matthews, Kreegan Reierson, Anjali Bhagra, Trevor P. Jensen. Lumbar puncture Working Group: Nilam Soni (chair), Ricardo Franco, Gerard Salame, Josh Lenchus, Venkat Kalidindi, Ketino Kobaidze. Credentialing Working Group: Brian P Lucas (chair), David Tierney, Trevor P. Jensen. PEER REVIEWERS: Robert Arntfield, Michael Blaivas, Richard Hoppmann, Paul Mayo, Vicki Noble, Aliaksei Pustavoitau, Kirk Spencer, Vivek Tayal. METHODOLOGIST: Mahmoud El Barbary. LIBRARIAN: Loretta Grikis. SOCIETY OF HOSPITAL MEDICINE EDUCATION COMMITTEE: Dan Brotman (past chair), Satyen Nichani (current chair), Susan Hunt. SOCIETY OF HOSPITAL MEDICINE STAFF: Nick Marzano.

Approximately 1.5 million people develop a pleural effusion in the United States annually, and approximately 173,000 people (12%) undergo thoracentesis.¹ A recent review of thoracenteses performed at 234 University Health System Consortium hospitals between January 2010 and September 2013 demonstrated that 16% of 132,472 thoracenteses were performed by general internists and hospitalists, 33.1% were performed by interventional radiologists, and 20.3% were performed by pulmonologists.² The iatrogenic pneumothorax rate was not significantly different between interventional radiologists and internists (2.8% and 2.9% risk, respectively); however, the admissions associated with bedside thoracentesis were less expensive than the admissions associated with thoracentesis performed in radiology suites, even after controlling for clinical covariates.² In addition, the use of ultrasound guidance has been associated with a reduced risk of complications and cost of thoracentesis.^3,4 In most of the early published studies on ultrasound-guided thoracentesis, the procedures were performed by radiologists.^5-12 However, in 2010, the British Thoracic Society published guidelines on pleural procedures and thoracic ultrasound geared toward any trained provider.¹³ The purpose of this guideline is to review the literature and present evidence-based recommendations on the performance of ultrasound-guided thoracentesis at the bedside.

Detailed methods are described in Appendix 1. The Society of Hospital Medicine (SHM) Point-of-care Ultrasound (POCUS) Task Force was assembled to carry out this guideline development project under the direction of the SHM Board of Directors, Director of Education, and Education Committee. All expert panel members were physicians or advanced practice providers with expertise in POCUS. The expert panel members were divided into working group members, external peer reviewers, and a methodologist. All the Task Force members were required to disclose any potential conflicts of interests (Appendix 2). The literature search was conducted in two independent phases. The first phase included literature searches conducted by the four working group members themselves. Key clinical questions were prepared prior to conducting a systematic literature search by a medical librarian. The Medline, Embase, CINAHL, and Cochrane medical databases were searched from 1975 to September 2015 initially. Updated searches were conducted in November 2016 and in August 2017 (Appendix 3). All article abstracts were first screened for relevance by at least two members of the working group. Full-text versions of the screened articles were reviewed, and the articles focusing on the use of ultrasound to guide thoracentesis were selected. Articles that discussed thoracentesis without ultrasound guidance were excluded. In addition, the following article types were excluded: non-English language, nonhuman, subjects’ age <18 years, meeting abstracts, meeting posters, letters, and editorials. All relevant systematic reviews, meta-analyses, randomized controlled trials, and observational studies of ultrasound-guided thoracentesis were screened and selected. Final article selection was based on working group consensus, and the selected literature was incorporated into draft recommendations.

We used the RAND Appropriateness Method that required panel judgment and consensus.¹⁴ The 30 voting members of the SHM POCUS Task Force reviewed and voted on the draft recommendations considering the following five transforming factors: 1) Problem priority and importance, 2) Level of quality of evidence, 3) Benefit/harm balance, 4) Benefit/burden balance, and 5) Certainty/concerns about PEAF (Preferences/Equity Acceptability/Feasibility). Panel members participated in two rounds of electronic voting using an internet-based electronic data collection tool (Redcap™) in December 2016 and January 2017 (Appendix 4). Voting on appropriateness was conducted using a 9-point Likert scale, and the degree of consensus was assessed using the RAND algorithm. Establishing a recommendation required at least 70% agreement and a strong recommendation required 80% agreement according to the RAND rules (Appendix 1, Figure 1). Disagreement was defined as >30% of panelists voting outside of the zone of the median (appropriate, uncertain, inappropriate).

Literature search

A total of 1,556 references were pooled from the following four different sources: a search by a certified librarian in September 2015 (1066 citations) that was updated in November 2016 (165 citations) and again in August 2017 (9 citations), working group members’ literature searches (47 citations), and a search focused on training (269 citations). The final selection included 94 articles that were abstracted into a data table and incorporated into the draft recommendations. The details of the literature search strategy are given in Appendix 3.

Recommendations

Terminology

• Thoracentesis is a procedure of aspiration of fluid from the pleural space by percutaneous insertion of a needle through the chest wall with or without the insertion of a catheter.
• In this document, ultrasound guidance refers to static guidance and site marking performed at the bedside immediately before the procedure, as opposed to real-time (dynamic) ultrasound guidance or radiology performed site marking. The static method is the most commonly used method of ultrasound guidance and is supported by current evidence.

Clinical Outcomes

1.We recommend that ultrasound should be used to guide thoracentesis to reduce the risk of complications, the most common being pneumothorax.

Rationale: Both static ultrasound guidance and dynamic ultrasound guidance have been reported to be associated with a reduced risk of pneumothorax.^4-7,15-18 A meta-analysis of 24 studies that included 6,605 thoracenteses showed a significant decrease in the risk of postprocedure pneumothorax with the use of ultrasound guidance compared to the risk associated with thoracentesis performed based on landmarks alone (OR 0.3, 95% CI 0.2–0.7).³ The meta-analysis included both prospective and retrospective studies conducted using both static and dynamic ultrasound guidance.³ A large retrospective cohort study conducted by Mercaldi et al. comprising more than 61,000 patients who underwent thoracentesis also showed that ultrasound guidance was associated with reduced odds of pneumothorax (OR 0.8 [0.7–0.9]).⁴ When pneumothorax did occur during that hospitalization, the cost of hospitalization increased by $2800 and the length of stay increased by 1.5 days.⁴ A 2008 review of 19,339 thoracenteses conducted by Patel et al. also demonstrated an association between ultrasound guidance and reduced odds of pneumothorax (OR 0.8 [0.7–0.96]).¹⁸ Although these findings were significant, it is important to note that the studies of both Mercaldi et al. and Patel et al. were reviews of administrative databases conducted using the International Classification of Diseases, 9th Revision (ICD-9) codes for thoracentesis and Current Procedure Terminology–4^th edition (CPT) codes for the use of ultrasound.^4,18 Patel et al. identified pneumothorax using ICD-9 codes for “pneumothorax–iatrogenic” and “pneumothorax–not specified as due to the procedure.” The association between ultrasound guidance and the reduced odds of pneumothorax was driven by the latter code.¹⁸ However, as with most retrospective studies using administrative data, granular data about the patients, procedure, proceduralists, and complications were not available in these reviews and conclusions may be limited by erroneous coding or documentation.^4,18 In a third retrospective cohort study, Raptopoulos et al. compared 154 landmark-based thoracenteses performed by “clinical physicians” and 188 ultrasound-guided thoracenteses performed by radiologists and found that ultrasound-guided site selection reduced the rate of pneumothorax from 18% to 3% (P < .0001).⁶ Finally, one single-center randomized controlled trial of 160 thoracenteses performed by pulmonologists showed that ultrasound guidance reduced the relative risk of pneumothorax by 90% (12.5% vs 1.3%; P =.009) with a number needed to treat of 9.¹⁵ It was not possible to blind the operators to the use of ultrasound guidance, but the data analysis was blinded.¹⁵ Furthermore, while there was no explicit comparison of the intervention vs. the control groups, randomization would have presumably rendered both groups similar in terms of patient characteristics and effusion characteristics.¹⁵ Ultrasound may reduce the risk of pneumothorax through several mechanisms, including identifying patients in whom thoracentesis cannot be safely performed, allowing selection of the safest needle insertion site, and revealing the optimal depth of needle insertion.

2.We recommend that ultrasound guidance should be used to increase the success rate of thoracentesis.

Rationale: Thoracentesis guided by ultrasound has lower rates of failed attempts, or “dry taps,” compared to thoracentesis guided solely by physical examination. In 1977, Ravin described a method of using ultrasound to guide successful drainage of six complex pleural effusions (empyema or loculated effusion) after multiple (5–7) failed attempts by clinicians using physical examination alone.⁸ In a second study by radiologists, Weingardt et al. demonstrated that 20 of 26 failed landmark-based thoracenteses were due to incorrect site selection by physical examination–15 sites were below the diaphragm and 5 sites were above the pleural effusion or in the consolidated lung–and the use of ultrasound allowed successful sampling in 14 of 16 patients who had a failed landmark-based thoracentesis.⁹ Diacon et al. asked 30 physicians, ranging from junior housestaff to pulmonologists, to mark 172 potential thoracentesis sites in 67 patients with pleural effusions using physical examination alone. Ultrasound was then used to evaluate the proposed puncture sites. They found that using ultrasound would have avoided puncture on “dry chests” in 2% and avoided potential laceration of a solid organ in 10% of patients compared to site selection by physical examination alone.¹⁹ Finally, Perazzo et al. randomized 160 patients to landmark-based thoracentesis and ultrasound-guided thoracentesis and demonstrated that half of the eight dry taps that occurred in the control group could be successfully drained using subsequent ultrasound guidance.¹⁵

Technique

3. We recommend that ultrasound-guided thoracentesis should be performed or closely supervised by experienced operators.

Rationale: Current evidence suggests lower complication rates when thoracentesis is performed by experienced healthcare providers. A systematic review of 6,605 thoracenteses showed a significantly lower pneumothorax rate when thoracentesis was performed by pulmonology or radiology faculty versus resident physicians (3.9% vs 8.5%; P =.04), although this finding was not significant in the four studies that directly compared this factor.³ In a quality improvement study performed by Duncan et al., pulmonology and critical care physicians combining multiple quality improvement initiatives to achieve and maintain competency decreased the rate of pneumothorax from 8.6% to 1.1% (P =.0034).²⁰ Interventions included ultrasound training, performance of 10 thoracenteses under expert supervision, and restriction of privileges to proceduralists who perform 10 or more thoracenteses per year.²⁰ Finally, a series of 9,320 ultrasound-guided thoracenteses performed or supervised by a single expert internist over a period of 12 years resulted in a pneumothorax rate of 0.6% and a composite complication rate of 0.98% (pneumothorax, reexpansion pulmonary edema, hemothorax, site bleeding, hematoma, splenic laceration, and vasovagal reaction).²¹ Notably, pneumothorax rate in resident physician hands was reported to be 8.5% in the meta-analysis performed by Gordon et al., which is similar to the initial rate in the pulmonologists who participated in the study by Duncan et al.^3,20 However, after instituting formal ultrasound training and other initiatives aimed at maintaining competency, the pneumothorax rate in the study by Duncan et al. decreased to 1.1%, similar to the rate observed in the series by Ault et al.²¹ This suggests that training and supervision are necessary to achieve competency and reduce the rate of complications.^3,20,21

4. We suggest that ultrasound guidance be used to reduce the risk of complications from thoracentesis in mechanically ventilated patients.

Rationale: The rest of this guideline refers to ultrasound-guided thoracentesis performed in spontaneously breathing patients; however, this recommendation is specific to mechanically ventilated patients. Two prospective observational studies have shown no increase in complications when ultrasound-guided thoracentesis is performed on mechanically ventilated patients compared to patients not receiving positive pressure ventilation. A feasibility study of 45 thoracenteses performed on ventilated patients reported no complications,²² whereas another study on 232 patients reported a pneumothorax rate of 1.3%.²³ In a larger study conducted by Mayo et al., medicine housestaff performed thoracentesis under the supervision of intensivists who had undergone training in ultrasound prior to performing the procedure.²³ In both studies, most of the patients were in a supine position, although positioning and puncture site were at the discretion of the physician, and both studies employed use of static ultrasound guidance.^22,23 A large series of 9,320 ultrasound-guided thoracenteses that included 1,377 mechanically ventilated patients did not report a higher rate of pneumothorax (0.8%) compared to that in spontaneously breathing patients (0.61%).²¹ Finally, a meta-analysis of 19 observational studies comprising 1,124 mechanically ventilated patients who underwent pleural drainage procedures showed a low rate of pneumothorax (3.4%) and hemothorax (1.9%).²⁴ Although the rate of complication was reported to be low in this meta-analysis, ultrasound was not employed in all studies and its use was not associated with a significant reduction in pneumothorax.²⁴ This may be because 8 of the 19 studies used pigtail catheters or large-bore thoracostomy tubes which treat pneumothorax as they occur.²⁴

5. We recommend that ultrasound should be used to identify the chest wall, pleura, diaphragm, lung, and subdiaphragmatic organs throughout the respiratory cycle before selecting a needle insertion site.

Rationale: The use of ultrasound improves the selection of a safe needle insertion site because sites chosen without ultrasound guidance may be below the diaphragm, over solid organs,^9,19 or in locations that risk puncture of the lung.⁹ Visualization of the chest wall, diaphragm, and lung, which define the boundaries of a pleural effusion, allows the clinician to confirm the presence of a drainable pleural effusion and assess for other pathologies, such as ascites and tumor, that may be mistaken for a pleural effusion.^22,25,26 Hypoechoic lesions can represent small loculated pleural effusions but also pleural plaques, pleural masses, peripheral lung masses, or abscesses.^27,28

6. We recommend that ultrasound should be used to detect the presence or absence of an effusion and approximate the volume of pleural fluid to guide clinical decision-making.

Rationale: The presence and approximate size of pleural fluid collections are important determinants of whether thoracentesis, another procedure, or no procedure should be performed. Ultrasonography has higher sensitivity and specificity for detecting pleural effusions and better differentiates effusions from consolidations compared with chest radiography.^29-42 Ultrasound allows semiquantitative estimation of pleural fluid volume to determine whether thoracentesis should be performed.^41-45 When using ultrasound to choose a site for thoracentesis, the British Thoracic Society Pleural Disease guidelines recommend ≥10 mm of pleural fluid between the visceral and parietal pleura.¹³ Pleural effusions of <10–15 mm are considered too small to tap.^22,23 In a prospective study of 45 patients, a measurement of >9.9 cm by ultrasound between the chest wall and the “V-point,” the intersection of the diaphragm and the collapsed lung, correlated with a pleural fluid volume of >1 liter.⁴⁶ Another prospective study of 73 patients showed that a pleural effusion spanning >3 intercostal spaces by ultrasound also correlated with a pleural fluid volume of >1 liter.⁴⁷ Anticipating the volume of fluid to be removed may aid in preplanning and procurement of larger capacity drainage containers prior to starting the procedure. Lung ultrasound can also change the management if the characteristic of the effusion suggests that an invasive procedure is unsafe or another diagnostic or therapeutic option is more appropriate.³⁹ In a prospective cohort study of 189 mechanically ventilated patients, lung ultrasound guided the management in all patients with suspected effusion, leading to chest tube placement in 7 patients and thoracentesis in 34 patients.⁴⁸

7. We recommend that ultrasound should be used to detect complex sonographic features, such as septations, to guide clinical decision-making regarding the timing and method of pleural drainage.

Rationale: Pleural effusions can be broadly categorized sonographically as simple or complex. Complex effusions are further categorized as with or without septation. Simple effusions are anechoic and are often, but not invariably, transudative.^49-51 The use of sonography and computerized tomography (CT) is complementary, but features of complex pleural effusions (fibrin stranding and septations) may be better visualized by ultrasound than by CT of the thorax.⁵² Detection of complex features should prompt the consideration of pleural fluid sampling.^53,54 Exudative effusions from tuberculosis, malignancy, or other etiologies more often include debris, septations, or other complex features.^55,56 Certain features such as a swirling debris, pleural thickening, and nodularity may be more often associated with malignancy,^54,56 and advanced ultrasound techniques may be used to detect a trapped lung prior to attempting drainage of a malignant pleural effusion.⁵⁷ Two studies found complex septated pleural effusions to be invariably exudative^50,58 and drainage was unlikely to be successful without the placement of a chest tube.^50,58-60 Chest tube placement through fibrinolytic administration or video-assisted thoracoscopic surgery (VATS) may be more appropriate in the management of complex septated pleural effusions,^59-61 and expert consultation with a thoracic specialist is recommended in these cases.

8. We suggest that ultrasound can be used to measure the depth from the skin surface to the parietal pleura to help select an appropriate length needle and determine the maximum needle insertion depth.

Rationale: The distance from the skin to the parietal and visceral pleura can be measured by ultrasound to determine whether thoracentesis can be safely performed and to guide selection of an adequate length needle.³⁸ The length of needle required to penetrate the pleural space varies based on the thickness of the chest wall. Percussion of the chest wall is limited when there is more than 6 cm of subcutaneous tissue,⁶² making physical examination in obese patients unreliable for selecting an appropriate site or needle length for thoracentesis. Ultrasound allows visualization of deep soft tissues, well beyond the limits of percussion, and allows an accurate measurement of the chest wall.⁶³

9. We suggest that ultrasound can be used to evaluate normal lung sliding pre- and postprocedure to rule out pneumothorax.

Rationale: Normal lung sliding indicates normal apposition and movement of visceral and parietal pleura and rules out pneumothorax with a sensitivity that exceeds that of chest radiography, according to a meta-analysis of 20 studies using computed tomography or escape of intrapleural air at the time of drainage as the gold standard.⁶⁴ In this meta-analysis, the pooled sensitivity of ultrasound was reported to be 88% (85-91%) compared to 52% (49-55%) for radiography, although the analysis also suggests that the test characteristics are dependent on operator skill.⁶⁴ However, although lung sliding rules out pneumothorax, absence of lung sliding is not specific for pneumothorax and other conditions, including pleural adhesions, pleurodesis, and bronchial obstruction, can cause the absence of lung sliding.⁶⁴ Detection of a lung point conclusively rules in a pneumothorax.⁶⁵ Provided that the preprocedure lung ultrasound examination revealed normal lung sliding, a postprocedure examination can be performed to effectively evaluate for pneumothorax. This modality does not use ionizing radiation, is less expensive than computed tomography, can be performed faster than bedside chest radiography, and is more sensitive than supine or upright chest radiography.^64,66-71

10. We suggest avoiding delay or interval change in patient position between the time of marking the needle insertion site and performing the thoracentesis.

Rationale: Optimal patient positioning and ultrasound-guided site marking should be performed by the primary operator immediately before beginning an invasive procedure. Remote sonographic localization in which a radiologist marks a needle insertion site using ultrasound and the thoracentesis is performed at a later time by a different provider is an antiquated practice. Two early studies demonstrated that this practice is no safer than landmark-based thoracentesis.^6,72 One prospective study of 205 patients performed in 1986 showed no significant decrease in the incidence of complications from thoracentesis performed using remote sonographic localization versus landmark-based drainage.⁷² Complications in that study included a total of 22 pneumothoraces and 1 hematoma. The rate of complications in the group of patients who had site marking performed by radiology faculty and subsequent thoracentesis by medicine housestaff or attending physicians was 9.7% versus a complication rate of 12.7% in the landmark-based group.⁷² In addition, Raptopoulos et al. observed no significant difference in the pneumothorax rate between 106 patients with landmark-based thoracenteses and 48 patients who were sonographically marked by radiology faculty and then returned to the ward for completion of the thoracentesis by medicine housestaff (19% vs. 15%, respectively).⁶ Both groups had significantly higher rates of pneumothorax compared to those who underwent thoracentesis performed using real-time ultrasound guidance by radiology trainees (3%).⁶ The authors speculated that changing the patient’s position shifted the position of the pleural effusion, ultimately leading to the reliance on physical examination for the tap site.⁶

11. We recommend against performing routine postprocedure chest radiographs in patients who have undergone thoracentesis successfully with ultrasound guidance and are asymptomatic with normal lung sliding postprocedure.

Rationale: Chest radiography post-thoracentesis is unlikely to add information that changes management, especially if performed routinely, but does add expense, radiation, and inconvenience.⁷³ The most common serious complication of thoracentesis is pneumothorax, which is often accompanied by symptoms, particularly in those patients with pneumothorax large enough to warrant chest tube placement.^10,74,75 Pihlajamaa et al. retrospectively studied 264 ultrasound-guided thoracenteses performed by radiologists or radiology residents and noted that of 11 pneumothoraces, only 1 necessitated chest tube placement.¹⁰ Aleman et al. prospectively studied 506 ultrasound-guided and physical examination-guided thoracenteses and found that only 1% of asymptomatic patients developed a pneumothorax.⁷⁴ Eight of the 18 symptomatic patients required chest tube placement as opposed to 1 of the 488 asymptomatic patients.⁷⁴ A large prospective study of 941 ultrasound-guided thoracentesis reported that only 0.3% of asymptomatic patients with no suspicion of pneumothorax required tube thoracostomy.⁵ Postprocedure chest radiographs may be considered when thoracentesis is performed on mechanically ventilated patients, particularly when high airway pressures exist. In a study of 434 patients undergoing thoracentesis, only 10 patients had a pneumothorax (2.3%).¹¹ Six of these pneumothoraces occurred in 92 mechanically ventilated patients (6.5%), and 2 of these 6 patients required a chest tube.¹¹ None of the 4 spontaneously breathing patients with pneumothorax required a chest tube.¹¹

Training

12. We recommend that novices who use ultrasound guidance for thoracentesis should receive focused training in lung and pleural ultrasonography and hands-on practice in procedural technique.

Rationale: Healthcare providers have to gain various skills to safely perform ultrasound-guided thoracentesis independently. Trainees should learn how to use ultrasound to identify important structures (chest wall, ribs, lung, pleura, diaphragm, and subdiaphragmatic organs); detect pleural effusions with complex features, such as septations; identify consolidated lung tissue; and rule out a pneumothorax. Prospective studies done with novice learners have shown that focused training combining didactics and hands-on practice using simulation or live models improves skills to assess pleural effusions.^76-84 Several additional procedural techniques such as patient positioning and needle insertion are also important but are beyond the scope of these guidelines.

13. We suggest that novices undergo simulation-based training prior to performing ultrasound-guided thoracentesis on patients.

Rationale: Simulation-based training for thoracentesis has been studied in providers with different levels of medical training, ranging from medical students and internal medicine residents to practicing pulmonologists. Studies suggest that training in a zero-risk environment with simulation task trainers leads to increased knowledge and skills without subjecting the patients to inexperienced operators.^85-87 One study on simulator-based training in medical students showed skill retention at 6 months and these skills were at least partially transferred to increased competency on live patients.⁸⁸ Checklists to train providers in ultrasound-guided thoracentesis have been published.^89,90 An experiential training program for attending physicians that utilized task trainers, along with standardized equipment and procedural technique, resulted in a reduction in the pneumothorax rate from 8.6% to 1.1%.²⁰

14. Training curves for novices to become competent in lung ultrasound and ultrasound-guided thoracentesis are not completely understood. We recommend that training should be tailored to the skill acquisition of the learner and the resources of the institution.

Rationale: Understanding the rates at which novices progress from performing procedures under direct supervision to performing them independently would be highly desirable to ensure patient safety, guide supervision, and maximize efficiency of training. However, there is limited research describing the rate of progression of learners through these stages, either with regard to time or number of procedures performed. Two studies have shown that with brief training programs, medical students⁸⁸ and internal medicine residents⁸⁷ can achieve high levels of proficiency to perform thoracentesis on simulators, which is durable over time; however, whether these findings in a simulated environment translate into clinically significant outcomes is largely unknown, and neither of these studies incorporated the use of ultrasound guidance in their training curricula.^87,88 Another study of pulmonary and critical care physicians combined multiple quality improvement initiatives with a half day of ultrasound-guided thoracentesis training, a requirement to perform 10 supervised thoracenteses prior to independent practice, and an additional requirement to perform 10 thoracenteses per year to maintain privileges.²⁰ These interventions resulted in a concentration of competency among a few proceduralists, decreasing the rate of pneumothorax from 8.6% to 1.1%.²⁰ Degradation of skills with disuse may also occur⁸⁴; thus, procedures performed infrequently should at a minimum be subjected to increased supervision and/or retesting.

The process of developing these guidelines revealed important gaps in the literature regarding the use of ultrasound guidance for thoracentesis. First, it is uncertain whether the use of ultrasound reduces the risk of bleeding with thoracentesis. A retrospective cohort study of 19,339 thoracenteses suggests that ultrasound guidance is associated with a 38.7% relative reduction in the odds of hemorrhage, although this reduction did not reach statistical significance (OR 0.6 [0.4–1.04]).¹⁸ Ultrasound may reduce the risk of bleeding by reducing the number of attempts and needle passes and potentially avoiding tortuous intercostal vessels, which can be found especially in elderly patients and more cephalad rib spaces.⁹¹ In an observational study of 22 patients undergoing thoracentesis, the intercostal artery (ICA) was identified by a high-frequency ultrasound transducer in 74 of 88 intercostal spaces.⁹² The ICA is more exposed in the intercostal space within the first 6 cm lateral to the spinous processes and can be seen as far lateral as the midaxillary line.^92-95 Thus, the ICA will most likely be avoided if a procedure site is selected >6 cm lateral to the spinous processes and the needle is inserted above the rib.

Second, although all three studies conducted using real-time (dynamic) ultrasound guidance reported a pneumothorax rate of <1%, it is uncertain whether real-time ultrasound guidance confers any additional benefit compared to static guidance for site marking as direct comparisons were not made.^17,96,97 It is possible that real-time ultrasound guidance may be superior to static guidance in certain situations, such as small pleural effusions of <10–15 mm that have historically been considered too small to tap.^13,22,23,96

Third, although one study suggests that general internists can safely perform thoracentesis with low complication rates similar to those of interventional radiologists,² limited data exists on how to train practicing hospitalists to use ultrasound to guide thoracentesis. The effectiveness of different training protocols to acquire competence in ultrasound-guided thoracentesis has not been compared.

Finally, the impact of ultrasound use on patient experience has yet to be explored.

The use of ultrasound guidance for thoracentesis has been associated with increased success rates and decreased complication rates. Ultrasound can be used to estimate the pleural fluid volume, characterize the effusion as simple or complex, identify an optimal needle insertion site, and reduce the need for postprocedural chest radiographs. Training and experience are essential to reap the benefits of using ultrasound for thoracentesis, although our understanding of optimal educational strategies and learning curves is limited. Once training has occurred and competence is achieved, hospitalists can perform ultrasound-guided thoracentesis as safely as radiologists, pulmonologists, and other specialists.

Collaborators from the Society of Hospital Medicine Point-of-care Ultrasound Task Force: Saaid Abdel-Ghani, Robert Arntfield, Jeffrey Bates, Anjali Bhagra, Michael Blaivas, Daniel Brotman, Carolina Candotti, Richard Hoppmann, Susan Hunt, Trevor P. Jensen, Venkat Kalidindi, Ketino Kobaidze, Joshua Lenchus, Benji Mathews, Paul, Mayo, Satyen Nichani, Vicki Noble, Martin Perez, Aliaksei Pustavoitau, Kreegan Reierson, Sophia Rodgers, Gerard Salame, Kirk Spencer, Vivek Tayal, David M. Tierney.

Disclosures

Ricardo Franco-Sadud reports institutional funds received from the Society of Hospital Medicine Annual Meeting for travel expenses and accommodations outside the submitted work. Nitin Puri reports Payment for lectures including service on speakers bureaus from Fujifilm Sonosite and royalties from Elsevier, both outside the submitted work. All other authors have nothing to disclose.

Funding

Brian P Lucas: Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development and Dartmouth SYNERGY, National Institutes of Health, National Center for Translational Science (UL1TR001086). Nilam Soni: Department of Veterans Affairs, Quality Enhancement Research Initiative (QUERI) Partnered Evaluation Initiative Grant (HX002263-01A1)

Disclaimer

The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs or the United States Government.

The authors thank all the members of the Society of Hospital Medicine Point-of-care Ultrasound Task Force and the Education Committee members for their time and dedication to develop these guidelines.

CHAIRS: Nilam Soni, Ricardo Franco Sadud, Jeff Bates. WORKING GROUPS: Thoracentesis Working Group: Ria Dancel (chair), Daniel Schnobrich, Nitin Puri. Vascular Access Working Group: Ricardo Franco (chair), Benji Matthews, Saaid Abdel-Ghani, Sophia Rodgers, Martin Perez, Daniel Schnobrich. Paracentesis Working Group: Joel Cho (chair), Benji Matthews, Kreegan Reierson, Anjali Bhagra, Trevor P. Jensen. Lumbar puncture Working Group: Nilam Soni (chair), Ricardo Franco, Gerard Salame, Josh Lenchus, Venkat Kalidindi, Ketino Kobaidze. Credentialing Working Group: Brian P Lucas (chair), David Tierney, Trevor P. Jensen. PEER REVIEWERS: Robert Arntfield, Michael Blaivas, Richard Hoppmann, Paul Mayo, Vicki Noble, Aliaksei Pustavoitau, Kirk Spencer, Vivek Tayal. METHODOLOGIST: Mahmoud El Barbary. LIBRARIAN: Loretta Grikis. SOCIETY OF HOSPITAL MEDICINE EDUCATION COMMITTEE: Dan Brotman (past chair), Satyen Nichani (current chair), Susan Hunt. SOCIETY OF HOSPITAL MEDICINE STAFF: Nick Marzano.

Peripherally inserted central catheters (PICCs) are integral to the care of hospitalized patients in the United States.¹ Consequently, utilization of these devices in acutely ill patients has steadily increased in the past decade.² Although originally designed to support the delivery of total parenteral nutrition, PICCs have found broader applications in the hospital setting given the ease and safety of placement, the advances in technology that facilitate insertion, and the growing availability of specially trained vascular nurses that place these devices at the bedside.³ Furthermore, because they are placed in deeper veins of the arm, PICCs are more durable than peripheral catheters and can support venous access for extended durations.^4-6

However, the growing use of PICCs has led to the realization that these devices are not without attendant risks. For example, PICCs are associated with venous thromboembolism (VTE) and central-line associated blood stream infection (CLABSI).^7,8 Additionally, complications such as catheter occlusion and tip migration commonly occur and may interrupt care or necessitate device removal.^9-11 Hence, thoughtful weighing of the risks against the benefits of PICC use prior to placement is necessary. To facilitate such decision-making, we developed the Michigan Appropriateness Guide for Intravenous (IV) Catheters (MAGIC) criteria,¹² which is an evidence-based tool that defines when the use of a PICC is appropriate in hospitalized adults.

The use of PICCs for infusion of peripherally compatible therapies for 5 or fewer days is rated as inappropriate by MAGIC.¹² This strategy is also endorsed by the Centers for Disease Control and Prevention’s (CDC) guidelines for the prevention of catheter-related infections.¹³ Despite these recommendations, short-term PICC use remains common. For example, a study conducted at a tertiary pediatric care center reported a trend toward shorter PICC dwell times and increasing rates of early removal.² However, factors that prompt such short-term PICC use are poorly understood. Without understanding drivers and outcomes of short-term PICC use, interventions to prevent such practice are unlikely to succeed.

Therefore, by using data from a multicenter cohort study, we examined patterns of short-term PICC use and sought to identify which patient, provider, and device factors were associated with such use. We hypothesized that short-term placement would be associated with difficult venous access and would also be associated with the risk of major and minor complications.

Study Setting and Design

We used data from the Michigan Hospital Medicine Safety (HMS) Consortium to examine patterns and predictors of short-term PICC use.¹⁴ As a multi-institutional clinical quality initiative sponsored by Blue Cross Blue Shield of Michigan and Blue Care Network, HMS aims to improve the quality of care by preventing adverse events in hospitalized medical patients.^4,15-17 In January of 2014, dedicated, trained abstractors started collecting data on PICC placements at participating HMS hospitals by using a standard protocol and template for data collection. Patients who received PICCs while admitted to either a general medicine unit or an intensive care unit (ICU) during clinical care were eligible for inclusion. Patients were excluded if they were (a) under the age of 18 years, (b) pregnant, (c) admitted to a nonmedical service (eg, surgery), or (d) admitted under observation status.

Every 14 days, each hospital collected data on the first 17 eligible patients that received a PICC, with at least 7 of these placements occurring in an ICU setting. All patients were prospectively followed until the PICC was removed, death, or until 70 days after insertion, whichever occurred first. For patients who had their PICC removed prior to hospital discharge, follow-up occurred via a review of medical records. For those discharged with a PICC in place, both medical record review and telephone follow-up were performed. To ensure data quality, annual random audits at each participating hospital were performed by the coordinating center at the University of Michigan.

For this analysis, we included all available data as of June 30, 2016. However, HMS hospitals continue to collect data on PICC use and outcomes as part of an ongoing clinical quality initiative to reduce the incidence of PICC-related complications.

Patient, Provider, and Device Data

Patient characteristics, including demographics, detailed medical history, comorbidities, physical findings, laboratory results, and medications were abstracted directly from medical records. To estimate the comorbidity burden, the Charlson-Deyo comorbidity score was calculated for each patient by using data available in the medical record at the time of PICC placement.¹⁸ Data, such as the documented indication for PICC insertion and the reason for removal, were obtained directly from medical records. Provider characteristics, including the specialty of the attending physician at the time of insertion and the type of operator who inserted the PICC, were also collected. Institutional characteristics, such as total number of beds, teaching versus nonteaching, and urban versus rural, were obtained from hospital publicly reported data and semiannual surveys of HMS sites.^19,20 Data on device characteristics, such as catheter gauge, coating, insertion attempts, tip location, and number of lumens, were abstracted from PICC insertion notes.

Outcomes of Interest

The outcome of interest was short-term PICC use, defined as PICCs removed within 5 days of insertion. Patients who expired with a PICC in situ were excluded. Secondary outcomes of interest included PICC-related complications, categorized as major (eg, symptomatic VTE and CLABSI) or minor (eg, catheter occlusion, superficial thrombosis, mechanical complications [kinking, coiling], exit site infection, and tip migration). Symptomatic VTE was defined as clinically diagnosed deep venous thrombosis (DVT) and/or pulmonary embolism (PE) not present at the time of PICC placement and confirmed via imaging (ultrasound or venogram for DVT; computed tomography scan, ventilation perfusion scan, or pulmonary angiogram for PE). CLABSI was defined in accordance with the CDC’s National Healthcare Safety Network criteria or according to Infectious Diseases Society of America recommendations.^21,22 All minor PICC complications were defined in accordance with prior published definitions.⁴

Statistical Analysis

Cases of short-term PICC use were identified and compared with patients with a PICC dwell time of 6 or more days by patient, provider, and device characteristics. The initial analyses for the associations of putative factors with short-term PICC use were performed using χ2 or Wilcoxon tests for categorical and continuous variables, respectively. Univariable mixed effect logistic regression models (with a random hospital-specific intercept) were then used to control for hospital-level clustering. Next, a mixed effects multivariable logistic regression model was used to identify factors associated with short-term PICC use. Variables with P ≤ .25 were considered as candidate predictors for the final multivariable model, which was chosen through a stepwise variable selection algorithm performed on 1000 bootstrapped data sets.²³ Variables in the final model were retained based on their frequency of selection in the bootstrapped samples, significance level, and contribution to the overall model likelihood. Results were expressed as odds ratios (OR) with corresponding 95% confidence intervals (CI). SAS for Windows (version 9.3, SAS Institute Inc., Cary, NC) was used for analyses.

Ethical and Regulatory Oversight

The study was classified as “not regulated” by the Institutional Review Board at the University of Michigan (HUM00078730).

Overall Characteristics of the Study Cohort

Characteristics of Short-Term Peripherally Inserted Central Catheter Use

Of the 15,397 PICCs included, we identified 3902 PICCs (25.3%) with a dwell time of ≤5 days (median = 3 days; IQR, 2-4 days). When compared to PICCs that were in place for longer durations, no significant differences in age or comorbidity scores were observed. Importantly, despite recommendations to avoid PICCs in patients with moderate to severe chronic kidney disease (glomerular filtration rate [GFR] ≤ 59 ml/min), 1292 (33.1%) short-term PICCs occurred in patients that met such criteria.

Among short-term PICCs, 3618 (92.7%) were power-capable devices, 2785 (71.4%) were 5-French, and 2813 (72.1%) were multilumen. Indications for the use of short-term PICCs differed from longer term devices in important ways (P <  .001). For example, the most common documented indication for short-term PICC use was difficult venous access (28.2%), while for long-term PICCs, it was antibiotic administration (39.8%). General internists and hospitalists were the most common attending physicians for patients with short-term and long-term PICCs (65.1% and 65.5%, respectively [P = .73]). Also, the proportion of critical care physicians responsible for patients with short versus long-term PICC use was similar (14.0% vs 15.0%, respectively [P = .123]). Of the short-term PICCs, 2583 (66.2%) were inserted by vascular access nurses, 795 (20.4%) by interventional radiologists, and 439 (11.3%) by advance practice professionals. Almost all of the PICCs placed ≤5 days (95.5%) were removed during hospitalization.

Complications Associated with Short-Term Peripherally Inserted Central Catheter Use

This large, multisite prospective cohort study is the first to examine patterns and predictors of short-term PICC use in hospitalized adults. By examining clinically granular data derived from the medical records of patients across 52 hospitals, we found that short-term use was common, representing 25% of all PICCs placed. Almost all such PICCs were removed prior to discharge, suggesting that they were placed primarily to meet acute needs during hospitalization. Multivariable models indicated that patients with difficult venous access, multilumen devices, and teaching hospital settings were associated with short-term use. Given that (a) short term PICC use is not recommended by published evidence-based guidelines,^12,13 (b) both major and minor complications were not uncommon despite brief exposure, and (c) specific factors might be targeted to avoid such use, strategies to improve PICC decision-making in the hospital appear increasingly necessary.

In our study, difficult venous access was the most common documented indication for short-term PICC placement. For patients in whom an anticipated catheter dwell time of 5 days or less is expected, MAGIC recommends the consideration of midline or peripheral IV catheters placed under ultrasound guidance.¹² A midline is a type of peripheral IV catheter that is about 7.5 cm to 25 cm in length and is typically inserted in the larger diameter veins of the upper extremity, such as the cephalic or basilic veins, with the tip terminating distal to the subclavian vein.^7,12 While there is a paucity of information that directly compares PICCs to midlines, some data suggest a lower risk of bloodstream infection and thrombosis associated with the latter.^24-26 For example, at one quaternary teaching hospital, house staff who are trained to insert midline catheters under ultrasound guidance in critically ill patients with difficult venous access reported no CLABSI and DVT events.²⁶

Interestingly, multilumen catheters were used twice as often as single lumen catheters in patients with short-term PICCs. In these instances, the use of additional lumens is questionable, as infusion of multiple incompatible fluids was not commonly listed as an indication prompting PICC use. Because multilumen PICCs are associated with higher risks of both VTE and CLABSI compared to single lumen devices, such use represents an important safety concern.^27-29 Institutional efforts that not only limit the use of multilumen PICCs but also fundamentally define when use of a PICC is appropriate may substantially improve outcomes related to vascular access.^28,30,31We observed that short-term PICCs were more common in teaching compared to nonteaching hospitals. While the design of the present study precludes understanding the reasons for such a difference, some plausible theories include the presence of physician trainees who may not appreciate the risks of PICC use, diminishing peripheral IV access securement skills, and the lack of alternatives to PICC use. Educating trainees who most often order PICCs in teaching settings as to when they should or should not consider this device may represent an important quality improvement opportunity.³² Similarly, auditing and assessing the clinical skills of those entrusted to place peripheral IVs might prove helpful.^33,34 Finally, the introduction of a midline program, or similar programs that expand the scope of vascular access teams to place alternative devices, should be explored as a means to improve PICC use and patient safety.

Our study also found that a third of patients who received PICCs for 5 or fewer days had moderate to severe chronic kidney disease. In these patients who may require renal replacement therapy, prior PICC placement is among the strongest predictors of arteriovenous fistula failure.^35,36 Therefore, even though national guidelines discourage the use of PICCs in these patients and recommend alternative routes of venous access,^12,37,38 such practice is clearly not happening. System-based interventions that begin by identifying patients who require vein preservation (eg, those with a GFR < 45 ml/min) and are therefore not appropriate for a PICC would be a welcomed first step in improving care for such patients.^37,38Our study has limitations. First, the observational nature of the study limits the ability to assess for causality or to account for the effects of unmeasured confounders. Second, while the use of medical records to collect granular data is valuable, differences in documentation patterns within and across hospitals, including patterns of missing data, may produce a misclassification of covariates or outcomes. Third, while we found that higher rates of short-term PICC use were associated with teaching hospitals and patients with difficult venous access, we were unable to determine the precise reasons for this practice trend. Qualitative or mixed-methods approaches to understand provider decision-making in these settings would be welcomed.

Our study also has several strengths. First, to our knowledge, this is the first study to systematically describe and evaluate patterns and predictors of short-term PICC use. The finding that PICCs placed for difficult venous access is a dominant category of short-term placement confirms clinical suspicions regarding inappropriate use and strengthens the need for pathways or protocols to manage such patients. Second, the inclusion of medical patients in diverse institutions offers not only real-world insights related to PICC use, but also offers findings that should be generalizable to other hospitals and health systems. Third, the use of a robust data collection strategy that emphasized standardized data collection, dedicated trained abstractors, and random audits to ensure data quality strengthen the findings of this work. Finally, our findings highlight an urgent need to develop policies related to PICC use, including limiting the use of multiple lumens and avoidance in patients with moderate to severe kidney disease.

In conclusion, short-term use of PICCs is prevalent and associated with key patient, provider, and device factors. Such use is also associated with complications, such as catheter occlusion, tip migration, VTE, and CLABSI. Limiting the use of multiple-lumen PICCs, enhancing education for when a PICC should be used, and defining strategies for patients with difficult access may help reduce inappropriate PICC use and improve patient safety. Future studies to examine implementation of such interventions would be welcomed.

Disclosure: Drs. Paje, Conlon, Swaminathan, and Boldenow disclose no conflicts of interest. Dr. Chopra has received honoraria for talks at hospitals as a visiting professor. Dr. Flanders discloses consultancies for the Institute for Healthcare Improvement and the Society of Hospital Medicine, royalties from Wiley Publishing, honoraria for various talks at hospitals as a visiting professor, grants from the CDC Foundation, Agency for Healthcare Research and Quality, Blue Cross Blue Shield of Michigan (BCBSM), and Michigan Hospital Association, and expert witness testimony. Dr. Bernstein discloses consultancies for Blue Care Network and grants from BCBSM, Department of Veterans Affairs, and National Institutes of Health. Dr. Kaatz discloses no relevant conflicts of interest. BCBSM and Blue Care Network provided support for the Michigan HMS Consortium as part of the BCBSM Value Partnerships program. Although BCBSM and HMS work collaboratively, the opinions, beliefs, and viewpoints expressed by the author do not necessarily reflect the opinions, beliefs, and viewpoints of BCBSM or any of its employees. Dr. Chopra is supported by a career development award from the Agency for Healthcare Research and Quality (1-K08-HS022835-01). BCBSM and Blue Care Network supported data collection at each participating site and funded the data coordinating center but had no role in study concept, interpretation of findings, or in the preparation, final approval, or decision to submit the manuscript.

Peripherally inserted central catheters (PICCs) are integral to the care of hospitalized patients in the United States.¹ Consequently, utilization of these devices in acutely ill patients has steadily increased in the past decade.² Although originally designed to support the delivery of total parenteral nutrition, PICCs have found broader applications in the hospital setting given the ease and safety of placement, the advances in technology that facilitate insertion, and the growing availability of specially trained vascular nurses that place these devices at the bedside.³ Furthermore, because they are placed in deeper veins of the arm, PICCs are more durable than peripheral catheters and can support venous access for extended durations.^4-6

However, the growing use of PICCs has led to the realization that these devices are not without attendant risks. For example, PICCs are associated with venous thromboembolism (VTE) and central-line associated blood stream infection (CLABSI).^7,8 Additionally, complications such as catheter occlusion and tip migration commonly occur and may interrupt care or necessitate device removal.^9-11 Hence, thoughtful weighing of the risks against the benefits of PICC use prior to placement is necessary. To facilitate such decision-making, we developed the Michigan Appropriateness Guide for Intravenous (IV) Catheters (MAGIC) criteria,¹² which is an evidence-based tool that defines when the use of a PICC is appropriate in hospitalized adults.

The use of PICCs for infusion of peripherally compatible therapies for 5 or fewer days is rated as inappropriate by MAGIC.¹² This strategy is also endorsed by the Centers for Disease Control and Prevention’s (CDC) guidelines for the prevention of catheter-related infections.¹³ Despite these recommendations, short-term PICC use remains common. For example, a study conducted at a tertiary pediatric care center reported a trend toward shorter PICC dwell times and increasing rates of early removal.² However, factors that prompt such short-term PICC use are poorly understood. Without understanding drivers and outcomes of short-term PICC use, interventions to prevent such practice are unlikely to succeed.

Therefore, by using data from a multicenter cohort study, we examined patterns of short-term PICC use and sought to identify which patient, provider, and device factors were associated with such use. We hypothesized that short-term placement would be associated with difficult venous access and would also be associated with the risk of major and minor complications.

Study Setting and Design

We used data from the Michigan Hospital Medicine Safety (HMS) Consortium to examine patterns and predictors of short-term PICC use.¹⁴ As a multi-institutional clinical quality initiative sponsored by Blue Cross Blue Shield of Michigan and Blue Care Network, HMS aims to improve the quality of care by preventing adverse events in hospitalized medical patients.^4,15-17 In January of 2014, dedicated, trained abstractors started collecting data on PICC placements at participating HMS hospitals by using a standard protocol and template for data collection. Patients who received PICCs while admitted to either a general medicine unit or an intensive care unit (ICU) during clinical care were eligible for inclusion. Patients were excluded if they were (a) under the age of 18 years, (b) pregnant, (c) admitted to a nonmedical service (eg, surgery), or (d) admitted under observation status.

Every 14 days, each hospital collected data on the first 17 eligible patients that received a PICC, with at least 7 of these placements occurring in an ICU setting. All patients were prospectively followed until the PICC was removed, death, or until 70 days after insertion, whichever occurred first. For patients who had their PICC removed prior to hospital discharge, follow-up occurred via a review of medical records. For those discharged with a PICC in place, both medical record review and telephone follow-up were performed. To ensure data quality, annual random audits at each participating hospital were performed by the coordinating center at the University of Michigan.

For this analysis, we included all available data as of June 30, 2016. However, HMS hospitals continue to collect data on PICC use and outcomes as part of an ongoing clinical quality initiative to reduce the incidence of PICC-related complications.

Patient, Provider, and Device Data

Patient characteristics, including demographics, detailed medical history, comorbidities, physical findings, laboratory results, and medications were abstracted directly from medical records. To estimate the comorbidity burden, the Charlson-Deyo comorbidity score was calculated for each patient by using data available in the medical record at the time of PICC placement.¹⁸ Data, such as the documented indication for PICC insertion and the reason for removal, were obtained directly from medical records. Provider characteristics, including the specialty of the attending physician at the time of insertion and the type of operator who inserted the PICC, were also collected. Institutional characteristics, such as total number of beds, teaching versus nonteaching, and urban versus rural, were obtained from hospital publicly reported data and semiannual surveys of HMS sites.^19,20 Data on device characteristics, such as catheter gauge, coating, insertion attempts, tip location, and number of lumens, were abstracted from PICC insertion notes.

Outcomes of Interest

The outcome of interest was short-term PICC use, defined as PICCs removed within 5 days of insertion. Patients who expired with a PICC in situ were excluded. Secondary outcomes of interest included PICC-related complications, categorized as major (eg, symptomatic VTE and CLABSI) or minor (eg, catheter occlusion, superficial thrombosis, mechanical complications [kinking, coiling], exit site infection, and tip migration). Symptomatic VTE was defined as clinically diagnosed deep venous thrombosis (DVT) and/or pulmonary embolism (PE) not present at the time of PICC placement and confirmed via imaging (ultrasound or venogram for DVT; computed tomography scan, ventilation perfusion scan, or pulmonary angiogram for PE). CLABSI was defined in accordance with the CDC’s National Healthcare Safety Network criteria or according to Infectious Diseases Society of America recommendations.^21,22 All minor PICC complications were defined in accordance with prior published definitions.⁴

Statistical Analysis

Cases of short-term PICC use were identified and compared with patients with a PICC dwell time of 6 or more days by patient, provider, and device characteristics. The initial analyses for the associations of putative factors with short-term PICC use were performed using χ2 or Wilcoxon tests for categorical and continuous variables, respectively. Univariable mixed effect logistic regression models (with a random hospital-specific intercept) were then used to control for hospital-level clustering. Next, a mixed effects multivariable logistic regression model was used to identify factors associated with short-term PICC use. Variables with P ≤ .25 were considered as candidate predictors for the final multivariable model, which was chosen through a stepwise variable selection algorithm performed on 1000 bootstrapped data sets.²³ Variables in the final model were retained based on their frequency of selection in the bootstrapped samples, significance level, and contribution to the overall model likelihood. Results were expressed as odds ratios (OR) with corresponding 95% confidence intervals (CI). SAS for Windows (version 9.3, SAS Institute Inc., Cary, NC) was used for analyses.

Ethical and Regulatory Oversight

The study was classified as “not regulated” by the Institutional Review Board at the University of Michigan (HUM00078730).

Overall Characteristics of the Study Cohort

Characteristics of Short-Term Peripherally Inserted Central Catheter Use

Of the 15,397 PICCs included, we identified 3902 PICCs (25.3%) with a dwell time of ≤5 days (median = 3 days; IQR, 2-4 days). When compared to PICCs that were in place for longer durations, no significant differences in age or comorbidity scores were observed. Importantly, despite recommendations to avoid PICCs in patients with moderate to severe chronic kidney disease (glomerular filtration rate [GFR] ≤ 59 ml/min), 1292 (33.1%) short-term PICCs occurred in patients that met such criteria.

Among short-term PICCs, 3618 (92.7%) were power-capable devices, 2785 (71.4%) were 5-French, and 2813 (72.1%) were multilumen. Indications for the use of short-term PICCs differed from longer term devices in important ways (P <  .001). For example, the most common documented indication for short-term PICC use was difficult venous access (28.2%), while for long-term PICCs, it was antibiotic administration (39.8%). General internists and hospitalists were the most common attending physicians for patients with short-term and long-term PICCs (65.1% and 65.5%, respectively [P = .73]). Also, the proportion of critical care physicians responsible for patients with short versus long-term PICC use was similar (14.0% vs 15.0%, respectively [P = .123]). Of the short-term PICCs, 2583 (66.2%) were inserted by vascular access nurses, 795 (20.4%) by interventional radiologists, and 439 (11.3%) by advance practice professionals. Almost all of the PICCs placed ≤5 days (95.5%) were removed during hospitalization.

Complications Associated with Short-Term Peripherally Inserted Central Catheter Use

This large, multisite prospective cohort study is the first to examine patterns and predictors of short-term PICC use in hospitalized adults. By examining clinically granular data derived from the medical records of patients across 52 hospitals, we found that short-term use was common, representing 25% of all PICCs placed. Almost all such PICCs were removed prior to discharge, suggesting that they were placed primarily to meet acute needs during hospitalization. Multivariable models indicated that patients with difficult venous access, multilumen devices, and teaching hospital settings were associated with short-term use. Given that (a) short term PICC use is not recommended by published evidence-based guidelines,^12,13 (b) both major and minor complications were not uncommon despite brief exposure, and (c) specific factors might be targeted to avoid such use, strategies to improve PICC decision-making in the hospital appear increasingly necessary.

In our study, difficult venous access was the most common documented indication for short-term PICC placement. For patients in whom an anticipated catheter dwell time of 5 days or less is expected, MAGIC recommends the consideration of midline or peripheral IV catheters placed under ultrasound guidance.¹² A midline is a type of peripheral IV catheter that is about 7.5 cm to 25 cm in length and is typically inserted in the larger diameter veins of the upper extremity, such as the cephalic or basilic veins, with the tip terminating distal to the subclavian vein.^7,12 While there is a paucity of information that directly compares PICCs to midlines, some data suggest a lower risk of bloodstream infection and thrombosis associated with the latter.^24-26 For example, at one quaternary teaching hospital, house staff who are trained to insert midline catheters under ultrasound guidance in critically ill patients with difficult venous access reported no CLABSI and DVT events.²⁶

Interestingly, multilumen catheters were used twice as often as single lumen catheters in patients with short-term PICCs. In these instances, the use of additional lumens is questionable, as infusion of multiple incompatible fluids was not commonly listed as an indication prompting PICC use. Because multilumen PICCs are associated with higher risks of both VTE and CLABSI compared to single lumen devices, such use represents an important safety concern.^27-29 Institutional efforts that not only limit the use of multilumen PICCs but also fundamentally define when use of a PICC is appropriate may substantially improve outcomes related to vascular access.^28,30,31We observed that short-term PICCs were more common in teaching compared to nonteaching hospitals. While the design of the present study precludes understanding the reasons for such a difference, some plausible theories include the presence of physician trainees who may not appreciate the risks of PICC use, diminishing peripheral IV access securement skills, and the lack of alternatives to PICC use. Educating trainees who most often order PICCs in teaching settings as to when they should or should not consider this device may represent an important quality improvement opportunity.³² Similarly, auditing and assessing the clinical skills of those entrusted to place peripheral IVs might prove helpful.^33,34 Finally, the introduction of a midline program, or similar programs that expand the scope of vascular access teams to place alternative devices, should be explored as a means to improve PICC use and patient safety.

Our study also found that a third of patients who received PICCs for 5 or fewer days had moderate to severe chronic kidney disease. In these patients who may require renal replacement therapy, prior PICC placement is among the strongest predictors of arteriovenous fistula failure.^35,36 Therefore, even though national guidelines discourage the use of PICCs in these patients and recommend alternative routes of venous access,^12,37,38 such practice is clearly not happening. System-based interventions that begin by identifying patients who require vein preservation (eg, those with a GFR < 45 ml/min) and are therefore not appropriate for a PICC would be a welcomed first step in improving care for such patients.^37,38Our study has limitations. First, the observational nature of the study limits the ability to assess for causality or to account for the effects of unmeasured confounders. Second, while the use of medical records to collect granular data is valuable, differences in documentation patterns within and across hospitals, including patterns of missing data, may produce a misclassification of covariates or outcomes. Third, while we found that higher rates of short-term PICC use were associated with teaching hospitals and patients with difficult venous access, we were unable to determine the precise reasons for this practice trend. Qualitative or mixed-methods approaches to understand provider decision-making in these settings would be welcomed.

Our study also has several strengths. First, to our knowledge, this is the first study to systematically describe and evaluate patterns and predictors of short-term PICC use. The finding that PICCs placed for difficult venous access is a dominant category of short-term placement confirms clinical suspicions regarding inappropriate use and strengthens the need for pathways or protocols to manage such patients. Second, the inclusion of medical patients in diverse institutions offers not only real-world insights related to PICC use, but also offers findings that should be generalizable to other hospitals and health systems. Third, the use of a robust data collection strategy that emphasized standardized data collection, dedicated trained abstractors, and random audits to ensure data quality strengthen the findings of this work. Finally, our findings highlight an urgent need to develop policies related to PICC use, including limiting the use of multiple lumens and avoidance in patients with moderate to severe kidney disease.

In conclusion, short-term use of PICCs is prevalent and associated with key patient, provider, and device factors. Such use is also associated with complications, such as catheter occlusion, tip migration, VTE, and CLABSI. Limiting the use of multiple-lumen PICCs, enhancing education for when a PICC should be used, and defining strategies for patients with difficult access may help reduce inappropriate PICC use and improve patient safety. Future studies to examine implementation of such interventions would be welcomed.

Disclosure: Drs. Paje, Conlon, Swaminathan, and Boldenow disclose no conflicts of interest. Dr. Chopra has received honoraria for talks at hospitals as a visiting professor. Dr. Flanders discloses consultancies for the Institute for Healthcare Improvement and the Society of Hospital Medicine, royalties from Wiley Publishing, honoraria for various talks at hospitals as a visiting professor, grants from the CDC Foundation, Agency for Healthcare Research and Quality, Blue Cross Blue Shield of Michigan (BCBSM), and Michigan Hospital Association, and expert witness testimony. Dr. Bernstein discloses consultancies for Blue Care Network and grants from BCBSM, Department of Veterans Affairs, and National Institutes of Health. Dr. Kaatz discloses no relevant conflicts of interest. BCBSM and Blue Care Network provided support for the Michigan HMS Consortium as part of the BCBSM Value Partnerships program. Although BCBSM and HMS work collaboratively, the opinions, beliefs, and viewpoints expressed by the author do not necessarily reflect the opinions, beliefs, and viewpoints of BCBSM or any of its employees. Dr. Chopra is supported by a career development award from the Agency for Healthcare Research and Quality (1-K08-HS022835-01). BCBSM and Blue Care Network supported data collection at each participating site and funded the data coordinating center but had no role in study concept, interpretation of findings, or in the preparation, final approval, or decision to submit the manuscript.

Peripherally inserted central catheters (PICCs) are integral to the care of hospitalized patients in the United States.¹ Consequently, utilization of these devices in acutely ill patients has steadily increased in the past decade.² Although originally designed to support the delivery of total parenteral nutrition, PICCs have found broader applications in the hospital setting given the ease and safety of placement, the advances in technology that facilitate insertion, and the growing availability of specially trained vascular nurses that place these devices at the bedside.³ Furthermore, because they are placed in deeper veins of the arm, PICCs are more durable than peripheral catheters and can support venous access for extended durations.^4-6

However, the growing use of PICCs has led to the realization that these devices are not without attendant risks. For example, PICCs are associated with venous thromboembolism (VTE) and central-line associated blood stream infection (CLABSI).^7,8 Additionally, complications such as catheter occlusion and tip migration commonly occur and may interrupt care or necessitate device removal.^9-11 Hence, thoughtful weighing of the risks against the benefits of PICC use prior to placement is necessary. To facilitate such decision-making, we developed the Michigan Appropriateness Guide for Intravenous (IV) Catheters (MAGIC) criteria,¹² which is an evidence-based tool that defines when the use of a PICC is appropriate in hospitalized adults.

The use of PICCs for infusion of peripherally compatible therapies for 5 or fewer days is rated as inappropriate by MAGIC.¹² This strategy is also endorsed by the Centers for Disease Control and Prevention’s (CDC) guidelines for the prevention of catheter-related infections.¹³ Despite these recommendations, short-term PICC use remains common. For example, a study conducted at a tertiary pediatric care center reported a trend toward shorter PICC dwell times and increasing rates of early removal.² However, factors that prompt such short-term PICC use are poorly understood. Without understanding drivers and outcomes of short-term PICC use, interventions to prevent such practice are unlikely to succeed.

Therefore, by using data from a multicenter cohort study, we examined patterns of short-term PICC use and sought to identify which patient, provider, and device factors were associated with such use. We hypothesized that short-term placement would be associated with difficult venous access and would also be associated with the risk of major and minor complications.

Study Setting and Design

We used data from the Michigan Hospital Medicine Safety (HMS) Consortium to examine patterns and predictors of short-term PICC use.¹⁴ As a multi-institutional clinical quality initiative sponsored by Blue Cross Blue Shield of Michigan and Blue Care Network, HMS aims to improve the quality of care by preventing adverse events in hospitalized medical patients.^4,15-17 In January of 2014, dedicated, trained abstractors started collecting data on PICC placements at participating HMS hospitals by using a standard protocol and template for data collection. Patients who received PICCs while admitted to either a general medicine unit or an intensive care unit (ICU) during clinical care were eligible for inclusion. Patients were excluded if they were (a) under the age of 18 years, (b) pregnant, (c) admitted to a nonmedical service (eg, surgery), or (d) admitted under observation status.

Every 14 days, each hospital collected data on the first 17 eligible patients that received a PICC, with at least 7 of these placements occurring in an ICU setting. All patients were prospectively followed until the PICC was removed, death, or until 70 days after insertion, whichever occurred first. For patients who had their PICC removed prior to hospital discharge, follow-up occurred via a review of medical records. For those discharged with a PICC in place, both medical record review and telephone follow-up were performed. To ensure data quality, annual random audits at each participating hospital were performed by the coordinating center at the University of Michigan.

For this analysis, we included all available data as of June 30, 2016. However, HMS hospitals continue to collect data on PICC use and outcomes as part of an ongoing clinical quality initiative to reduce the incidence of PICC-related complications.

Patient, Provider, and Device Data

Patient characteristics, including demographics, detailed medical history, comorbidities, physical findings, laboratory results, and medications were abstracted directly from medical records. To estimate the comorbidity burden, the Charlson-Deyo comorbidity score was calculated for each patient by using data available in the medical record at the time of PICC placement.¹⁸ Data, such as the documented indication for PICC insertion and the reason for removal, were obtained directly from medical records. Provider characteristics, including the specialty of the attending physician at the time of insertion and the type of operator who inserted the PICC, were also collected. Institutional characteristics, such as total number of beds, teaching versus nonteaching, and urban versus rural, were obtained from hospital publicly reported data and semiannual surveys of HMS sites.^19,20 Data on device characteristics, such as catheter gauge, coating, insertion attempts, tip location, and number of lumens, were abstracted from PICC insertion notes.

Outcomes of Interest

The outcome of interest was short-term PICC use, defined as PICCs removed within 5 days of insertion. Patients who expired with a PICC in situ were excluded. Secondary outcomes of interest included PICC-related complications, categorized as major (eg, symptomatic VTE and CLABSI) or minor (eg, catheter occlusion, superficial thrombosis, mechanical complications [kinking, coiling], exit site infection, and tip migration). Symptomatic VTE was defined as clinically diagnosed deep venous thrombosis (DVT) and/or pulmonary embolism (PE) not present at the time of PICC placement and confirmed via imaging (ultrasound or venogram for DVT; computed tomography scan, ventilation perfusion scan, or pulmonary angiogram for PE). CLABSI was defined in accordance with the CDC’s National Healthcare Safety Network criteria or according to Infectious Diseases Society of America recommendations.^21,22 All minor PICC complications were defined in accordance with prior published definitions.⁴

Statistical Analysis

Cases of short-term PICC use were identified and compared with patients with a PICC dwell time of 6 or more days by patient, provider, and device characteristics. The initial analyses for the associations of putative factors with short-term PICC use were performed using χ2 or Wilcoxon tests for categorical and continuous variables, respectively. Univariable mixed effect logistic regression models (with a random hospital-specific intercept) were then used to control for hospital-level clustering. Next, a mixed effects multivariable logistic regression model was used to identify factors associated with short-term PICC use. Variables with P ≤ .25 were considered as candidate predictors for the final multivariable model, which was chosen through a stepwise variable selection algorithm performed on 1000 bootstrapped data sets.²³ Variables in the final model were retained based on their frequency of selection in the bootstrapped samples, significance level, and contribution to the overall model likelihood. Results were expressed as odds ratios (OR) with corresponding 95% confidence intervals (CI). SAS for Windows (version 9.3, SAS Institute Inc., Cary, NC) was used for analyses.

Ethical and Regulatory Oversight

The study was classified as “not regulated” by the Institutional Review Board at the University of Michigan (HUM00078730).

Overall Characteristics of the Study Cohort

Characteristics of Short-Term Peripherally Inserted Central Catheter Use

Of the 15,397 PICCs included, we identified 3902 PICCs (25.3%) with a dwell time of ≤5 days (median = 3 days; IQR, 2-4 days). When compared to PICCs that were in place for longer durations, no significant differences in age or comorbidity scores were observed. Importantly, despite recommendations to avoid PICCs in patients with moderate to severe chronic kidney disease (glomerular filtration rate [GFR] ≤ 59 ml/min), 1292 (33.1%) short-term PICCs occurred in patients that met such criteria.

Among short-term PICCs, 3618 (92.7%) were power-capable devices, 2785 (71.4%) were 5-French, and 2813 (72.1%) were multilumen. Indications for the use of short-term PICCs differed from longer term devices in important ways (P <  .001). For example, the most common documented indication for short-term PICC use was difficult venous access (28.2%), while for long-term PICCs, it was antibiotic administration (39.8%). General internists and hospitalists were the most common attending physicians for patients with short-term and long-term PICCs (65.1% and 65.5%, respectively [P = .73]). Also, the proportion of critical care physicians responsible for patients with short versus long-term PICC use was similar (14.0% vs 15.0%, respectively [P = .123]). Of the short-term PICCs, 2583 (66.2%) were inserted by vascular access nurses, 795 (20.4%) by interventional radiologists, and 439 (11.3%) by advance practice professionals. Almost all of the PICCs placed ≤5 days (95.5%) were removed during hospitalization.

Complications Associated with Short-Term Peripherally Inserted Central Catheter Use

This large, multisite prospective cohort study is the first to examine patterns and predictors of short-term PICC use in hospitalized adults. By examining clinically granular data derived from the medical records of patients across 52 hospitals, we found that short-term use was common, representing 25% of all PICCs placed. Almost all such PICCs were removed prior to discharge, suggesting that they were placed primarily to meet acute needs during hospitalization. Multivariable models indicated that patients with difficult venous access, multilumen devices, and teaching hospital settings were associated with short-term use. Given that (a) short term PICC use is not recommended by published evidence-based guidelines,^12,13 (b) both major and minor complications were not uncommon despite brief exposure, and (c) specific factors might be targeted to avoid such use, strategies to improve PICC decision-making in the hospital appear increasingly necessary.

In our study, difficult venous access was the most common documented indication for short-term PICC placement. For patients in whom an anticipated catheter dwell time of 5 days or less is expected, MAGIC recommends the consideration of midline or peripheral IV catheters placed under ultrasound guidance.¹² A midline is a type of peripheral IV catheter that is about 7.5 cm to 25 cm in length and is typically inserted in the larger diameter veins of the upper extremity, such as the cephalic or basilic veins, with the tip terminating distal to the subclavian vein.^7,12 While there is a paucity of information that directly compares PICCs to midlines, some data suggest a lower risk of bloodstream infection and thrombosis associated with the latter.^24-26 For example, at one quaternary teaching hospital, house staff who are trained to insert midline catheters under ultrasound guidance in critically ill patients with difficult venous access reported no CLABSI and DVT events.²⁶

Interestingly, multilumen catheters were used twice as often as single lumen catheters in patients with short-term PICCs. In these instances, the use of additional lumens is questionable, as infusion of multiple incompatible fluids was not commonly listed as an indication prompting PICC use. Because multilumen PICCs are associated with higher risks of both VTE and CLABSI compared to single lumen devices, such use represents an important safety concern.^27-29 Institutional efforts that not only limit the use of multilumen PICCs but also fundamentally define when use of a PICC is appropriate may substantially improve outcomes related to vascular access.^28,30,31We observed that short-term PICCs were more common in teaching compared to nonteaching hospitals. While the design of the present study precludes understanding the reasons for such a difference, some plausible theories include the presence of physician trainees who may not appreciate the risks of PICC use, diminishing peripheral IV access securement skills, and the lack of alternatives to PICC use. Educating trainees who most often order PICCs in teaching settings as to when they should or should not consider this device may represent an important quality improvement opportunity.³² Similarly, auditing and assessing the clinical skills of those entrusted to place peripheral IVs might prove helpful.^33,34 Finally, the introduction of a midline program, or similar programs that expand the scope of vascular access teams to place alternative devices, should be explored as a means to improve PICC use and patient safety.

Our study also found that a third of patients who received PICCs for 5 or fewer days had moderate to severe chronic kidney disease. In these patients who may require renal replacement therapy, prior PICC placement is among the strongest predictors of arteriovenous fistula failure.^35,36 Therefore, even though national guidelines discourage the use of PICCs in these patients and recommend alternative routes of venous access,^12,37,38 such practice is clearly not happening. System-based interventions that begin by identifying patients who require vein preservation (eg, those with a GFR < 45 ml/min) and are therefore not appropriate for a PICC would be a welcomed first step in improving care for such patients.^37,38Our study has limitations. First, the observational nature of the study limits the ability to assess for causality or to account for the effects of unmeasured confounders. Second, while the use of medical records to collect granular data is valuable, differences in documentation patterns within and across hospitals, including patterns of missing data, may produce a misclassification of covariates or outcomes. Third, while we found that higher rates of short-term PICC use were associated with teaching hospitals and patients with difficult venous access, we were unable to determine the precise reasons for this practice trend. Qualitative or mixed-methods approaches to understand provider decision-making in these settings would be welcomed.

Our study also has several strengths. First, to our knowledge, this is the first study to systematically describe and evaluate patterns and predictors of short-term PICC use. The finding that PICCs placed for difficult venous access is a dominant category of short-term placement confirms clinical suspicions regarding inappropriate use and strengthens the need for pathways or protocols to manage such patients. Second, the inclusion of medical patients in diverse institutions offers not only real-world insights related to PICC use, but also offers findings that should be generalizable to other hospitals and health systems. Third, the use of a robust data collection strategy that emphasized standardized data collection, dedicated trained abstractors, and random audits to ensure data quality strengthen the findings of this work. Finally, our findings highlight an urgent need to develop policies related to PICC use, including limiting the use of multiple lumens and avoidance in patients with moderate to severe kidney disease.

In conclusion, short-term use of PICCs is prevalent and associated with key patient, provider, and device factors. Such use is also associated with complications, such as catheter occlusion, tip migration, VTE, and CLABSI. Limiting the use of multiple-lumen PICCs, enhancing education for when a PICC should be used, and defining strategies for patients with difficult access may help reduce inappropriate PICC use and improve patient safety. Future studies to examine implementation of such interventions would be welcomed.

Disclosure: Drs. Paje, Conlon, Swaminathan, and Boldenow disclose no conflicts of interest. Dr. Chopra has received honoraria for talks at hospitals as a visiting professor. Dr. Flanders discloses consultancies for the Institute for Healthcare Improvement and the Society of Hospital Medicine, royalties from Wiley Publishing, honoraria for various talks at hospitals as a visiting professor, grants from the CDC Foundation, Agency for Healthcare Research and Quality, Blue Cross Blue Shield of Michigan (BCBSM), and Michigan Hospital Association, and expert witness testimony. Dr. Bernstein discloses consultancies for Blue Care Network and grants from BCBSM, Department of Veterans Affairs, and National Institutes of Health. Dr. Kaatz discloses no relevant conflicts of interest. BCBSM and Blue Care Network provided support for the Michigan HMS Consortium as part of the BCBSM Value Partnerships program. Although BCBSM and HMS work collaboratively, the opinions, beliefs, and viewpoints expressed by the author do not necessarily reflect the opinions, beliefs, and viewpoints of BCBSM or any of its employees. Dr. Chopra is supported by a career development award from the Agency for Healthcare Research and Quality (1-K08-HS022835-01). BCBSM and Blue Care Network supported data collection at each participating site and funded the data coordinating center but had no role in study concept, interpretation of findings, or in the preparation, final approval, or decision to submit the manuscript.

Successful treatment of pneumonia depends on timely diagnosis and administration of antibiotics. Multidrug-resistant organisms (MDROs) complicate antibiotic therapies by rendering some antibiotic agents ineffective. Inappropriate initial therapy has been associated with a more than 2-fold increase in the risk of mortality.¹ Because culture results are not available immediately, clinicians prescribe antibiotics empirically and must rely on guidelines and knowledge of risk factors associated with MDRO infection to make these selections.

Treatment guidelines exist for hospital-acquired and ventilator-associated pneumonia (HAP/VAP) and community-acquired pneumonia (CAP) to assist with empiric antibiotic selection. For HAP/VAP, 2 to 3 antibiotics with a broad-spectrum of activity are used due to increased prevalence of MDROs in hospitals, whereastreatment of CAP involves more narrow coverage because bacteria that cause this infection typically have fewer antibiotic resistances.^2,3 The HAP/VAP guidelines stratify the risk of pneumonia due to the presence of a MDRO acquired during a hospitalization. However, neither the CAP nor HAP/VAP guidelines offer risk-stratification guidance for nonhospitalized patients who develop pneumonia but who may have become colonized with a MDRO during a previous hospitalization or from another exposure to a health care facility.

Health care-associated pneumonia (HCAP) was first described in the 2005 American Thoracic Society and the Infectious Diseases Society of America (ATS/IDSA) nosocomial pneumonia guidelines and was associated with criteria intended to aid clinician identification of nonhospitalized patients at risk for MDRO pneumonia, which warranted empiric broad-spectrum antibiotic therapy.² According to these guidelines, patients were classified as having HCAP if they had been hospitalized for at least 48 hours in the past 90 days, admitted from a nursing home, received recent intravenous antibiotics, had hemodialysis in the past 30 days, had a history of home infusion therapy or wound care, received intravenous chemotherapy, or had a family member with MDRO colonization.

Since publication of the 2005 guidelines, HCAP has been criticized as being a poor predictor of MDRO infection. A 2014 meta-analysis of 24 studies investigated the discriminating ability of HCAP and reported that the specificity and sensitivity for MDRO infections was 71.2% and 53.7%, respectively.³ In 2016, the ATS/IDSA guidelines were updated to remove HCAP due to the risk of antibiotic overprescribing.⁴

Literature Review

Although criteria previously defining a patient as having HCAP have been shown to be a poor discriminator of MDRO pneumonia as a whole, MDRO infections still pose a threat to nonhospitalized patients who have exposure to the health care system. A literature review was performed to identify independent HCAP risk factors that may increase the risk of MDRO pneumonia infecting a nonhospitalized patient needing empiric broad-spectrum antibiotic therapy. All included studies were prospective or retrospective observational cohort studies that performed logistic regression analyses to assess the association between MDRO isolation and the previously defined HCAP risk factors (Table 1).

Five studies examined the risk of MDRO infection in patients with a previous hospital admission of 2 days or more in the past 90 days. Shindo and colleagues found a significant increase in MDRO infections by about 2-fold (adjusted odds ratio [AOR], 2.1; 95% confidence interval [CI], 1.2-3.4).⁵ Shorr and colleagues found a 4-fold increase in likelihood of identifying a MDRO in HCAP (AOR, 4.2; 95% CI, 2.9-6.3).⁶ Nseir and colleagues and Jung and colleagues found similar results (AOR 3.9, 95% CI 1.7-8.8; AOR 2.7, 95% CI 1.3-5.5, respectively).^7,8 Conflicting results were reported by Gross and colleagues who did not find a significant relationship between previous hospitalization and MDRO isolation (AOR 1.2, 95% CI, 0.5-3.2).⁹

In patients with pneumonia admitted from a nursing home, MDRO infection risk also was evaluated in these 5 studies. Shorr and colleagues, Nseir and colleagues, and Gross and colleagues found significant AORs of 2.7 (95% CI 1.7-4.3), 2.0 (95% CI 1.1-3.7), and 4.2 (95% CI 1.6-11.3), respectively.^6,7,9 Shindo and colleagues (AOR 1.1; 95% CI, 0.6-2.0) and Jung and colleagues (AOR 1.9, 95% CI, 0.5-6.9) found this risk factor not significant.⁵

Receipt of antibiotics within the previous 90 days was assessed in 3 studies. Shindo and colleagues, Nseir and colleagues, and Gross and colleagues all found significant AORs of 2.5 (95% CI 1.2-4.0), 2.3 (95% CI 1.2-4.3), and 2.9 (95% CI 1.1-7.5), respectively.^5,7,9 Antibiotic therapy within the previous 90 days is an established risk factor for MDRO pneumonia, and the 2016 ATS/IDSA guidelines consider this a risk factor for HAP and VAP, including pneumonia caused by methicillin resistant Staphylococcus aureus and Pseudomonas aeruginosa.⁴

The impact of hemodialysis in the previous month on acquisition of MDRO pneumonia was investigated in 4 studies. Shindo and colleagues, Jung and colleagues, and Gross and colleagues concluded that this risk factor was not significantly related to MDRO infection, reporting AORs of 2.2 (95% CI 0.5-9.7), 2.8 (95% CI 0.9-9.2) and 0.7 (95% CI 0.1-5.1), respectively.^5,8,9 Shorr and colleagues, however, found a significant AOR of 2.1 (95% CI 1.0-4.3).⁶

Shindo and colleagues investigated the impact of home infusion therapy on acquisition of pneumonia due to a MDRO and reported a nonsignificant AOR of 0.8 (95% CI 0.4-1.8).⁵ Gross and colleagues also found a nonsignificant AOR of 0 (P = .1).⁹ In the Shindo and colleagues study, resistance was found in 107 of 679 patients who did not receive infusion therapy, and 12 of 55 patients who were receiving infusion therapy.⁵ Gross and colleagues reported that home-infusion therapy was received by 0 of 20 patients with MDRO infection and 4 of the 501 patients without MDRO infection.⁹

Shindo and colleagues reported that home wound care was not found to be significantly related to MDRO pneumonia as well as did Gross and colleagues: AORs of 3.8 (0.8-18.4) and 1.4 (95% CI 0.5-4.4), respectively.^5,9 Jung and colleagues examined IV chemotherapy in the past 30 days, and found this to not significantly impact the odds of MDRO isolation (AOR = 0.62, 95% CI 0.2-1.8).⁸ No data were available reflecting the risk of a family member with a MDRO.

Limitations

The variables on which logistic regression were performed differed among the studies. Therefore, results cannot be averaged or compared quantitatively, as AORs varied, depending on the variables included. In addition, data were drawn from multiple geographic locations that may impact MDRO prevalence within each patient population. Finally, this review examines the utility of the risk factors formerly included in HCAP. However, other risk factors for MDRO pneumonia outlined by the ATS/IDSA guidelines still should be considered when evaluating patient risk. The 2016 guidelines recommend local incidence of resistant strains be considered when initiating empiric therapy. Review of medical records for previous positive cultures and duration of current hospitalization also should be considered. Although the 2016 ATS/IDSA HAP guidelines are not intended for immunosuppressed patients, this risk factor also may be taken into account.

Conclusion

Review and synthesis of published literature found previous hospital admission (of ≥ 2 days in the past 90 days), admission from a nursing home, and IV antibiotic therapy in the last 90 days to be independent risk factors for identification of MDRO pneumonia in previously nonhospitalized patients (Table 2). Additionally, although no data were found to support this risk factor, existence of an in-home (close contact) source of MDROs would provide ample opportunity for transmission, so evaluation of known exposure to MDROs from contacts should be considered. When choosing empiric antibiotic therapy for patients admitted to the hospital for treatment of pneumonia, consideration of patient history and risk factors that may contribute to infection with a MDRO are recommended.

Successful treatment of pneumonia depends on timely diagnosis and administration of antibiotics. Multidrug-resistant organisms (MDROs) complicate antibiotic therapies by rendering some antibiotic agents ineffective. Inappropriate initial therapy has been associated with a more than 2-fold increase in the risk of mortality.¹ Because culture results are not available immediately, clinicians prescribe antibiotics empirically and must rely on guidelines and knowledge of risk factors associated with MDRO infection to make these selections.

Treatment guidelines exist for hospital-acquired and ventilator-associated pneumonia (HAP/VAP) and community-acquired pneumonia (CAP) to assist with empiric antibiotic selection. For HAP/VAP, 2 to 3 antibiotics with a broad-spectrum of activity are used due to increased prevalence of MDROs in hospitals, whereastreatment of CAP involves more narrow coverage because bacteria that cause this infection typically have fewer antibiotic resistances.^2,3 The HAP/VAP guidelines stratify the risk of pneumonia due to the presence of a MDRO acquired during a hospitalization. However, neither the CAP nor HAP/VAP guidelines offer risk-stratification guidance for nonhospitalized patients who develop pneumonia but who may have become colonized with a MDRO during a previous hospitalization or from another exposure to a health care facility.

Health care-associated pneumonia (HCAP) was first described in the 2005 American Thoracic Society and the Infectious Diseases Society of America (ATS/IDSA) nosocomial pneumonia guidelines and was associated with criteria intended to aid clinician identification of nonhospitalized patients at risk for MDRO pneumonia, which warranted empiric broad-spectrum antibiotic therapy.² According to these guidelines, patients were classified as having HCAP if they had been hospitalized for at least 48 hours in the past 90 days, admitted from a nursing home, received recent intravenous antibiotics, had hemodialysis in the past 30 days, had a history of home infusion therapy or wound care, received intravenous chemotherapy, or had a family member with MDRO colonization.

Since publication of the 2005 guidelines, HCAP has been criticized as being a poor predictor of MDRO infection. A 2014 meta-analysis of 24 studies investigated the discriminating ability of HCAP and reported that the specificity and sensitivity for MDRO infections was 71.2% and 53.7%, respectively.³ In 2016, the ATS/IDSA guidelines were updated to remove HCAP due to the risk of antibiotic overprescribing.⁴

Literature Review

Although criteria previously defining a patient as having HCAP have been shown to be a poor discriminator of MDRO pneumonia as a whole, MDRO infections still pose a threat to nonhospitalized patients who have exposure to the health care system. A literature review was performed to identify independent HCAP risk factors that may increase the risk of MDRO pneumonia infecting a nonhospitalized patient needing empiric broad-spectrum antibiotic therapy. All included studies were prospective or retrospective observational cohort studies that performed logistic regression analyses to assess the association between MDRO isolation and the previously defined HCAP risk factors (Table 1).

Five studies examined the risk of MDRO infection in patients with a previous hospital admission of 2 days or more in the past 90 days. Shindo and colleagues found a significant increase in MDRO infections by about 2-fold (adjusted odds ratio [AOR], 2.1; 95% confidence interval [CI], 1.2-3.4).⁵ Shorr and colleagues found a 4-fold increase in likelihood of identifying a MDRO in HCAP (AOR, 4.2; 95% CI, 2.9-6.3).⁶ Nseir and colleagues and Jung and colleagues found similar results (AOR 3.9, 95% CI 1.7-8.8; AOR 2.7, 95% CI 1.3-5.5, respectively).^7,8 Conflicting results were reported by Gross and colleagues who did not find a significant relationship between previous hospitalization and MDRO isolation (AOR 1.2, 95% CI, 0.5-3.2).⁹

In patients with pneumonia admitted from a nursing home, MDRO infection risk also was evaluated in these 5 studies. Shorr and colleagues, Nseir and colleagues, and Gross and colleagues found significant AORs of 2.7 (95% CI 1.7-4.3), 2.0 (95% CI 1.1-3.7), and 4.2 (95% CI 1.6-11.3), respectively.^6,7,9 Shindo and colleagues (AOR 1.1; 95% CI, 0.6-2.0) and Jung and colleagues (AOR 1.9, 95% CI, 0.5-6.9) found this risk factor not significant.⁵

Receipt of antibiotics within the previous 90 days was assessed in 3 studies. Shindo and colleagues, Nseir and colleagues, and Gross and colleagues all found significant AORs of 2.5 (95% CI 1.2-4.0), 2.3 (95% CI 1.2-4.3), and 2.9 (95% CI 1.1-7.5), respectively.^5,7,9 Antibiotic therapy within the previous 90 days is an established risk factor for MDRO pneumonia, and the 2016 ATS/IDSA guidelines consider this a risk factor for HAP and VAP, including pneumonia caused by methicillin resistant Staphylococcus aureus and Pseudomonas aeruginosa.⁴

The impact of hemodialysis in the previous month on acquisition of MDRO pneumonia was investigated in 4 studies. Shindo and colleagues, Jung and colleagues, and Gross and colleagues concluded that this risk factor was not significantly related to MDRO infection, reporting AORs of 2.2 (95% CI 0.5-9.7), 2.8 (95% CI 0.9-9.2) and 0.7 (95% CI 0.1-5.1), respectively.^5,8,9 Shorr and colleagues, however, found a significant AOR of 2.1 (95% CI 1.0-4.3).⁶

Shindo and colleagues investigated the impact of home infusion therapy on acquisition of pneumonia due to a MDRO and reported a nonsignificant AOR of 0.8 (95% CI 0.4-1.8).⁵ Gross and colleagues also found a nonsignificant AOR of 0 (P = .1).⁹ In the Shindo and colleagues study, resistance was found in 107 of 679 patients who did not receive infusion therapy, and 12 of 55 patients who were receiving infusion therapy.⁵ Gross and colleagues reported that home-infusion therapy was received by 0 of 20 patients with MDRO infection and 4 of the 501 patients without MDRO infection.⁹

Shindo and colleagues reported that home wound care was not found to be significantly related to MDRO pneumonia as well as did Gross and colleagues: AORs of 3.8 (0.8-18.4) and 1.4 (95% CI 0.5-4.4), respectively.^5,9 Jung and colleagues examined IV chemotherapy in the past 30 days, and found this to not significantly impact the odds of MDRO isolation (AOR = 0.62, 95% CI 0.2-1.8).⁸ No data were available reflecting the risk of a family member with a MDRO.

Limitations

The variables on which logistic regression were performed differed among the studies. Therefore, results cannot be averaged or compared quantitatively, as AORs varied, depending on the variables included. In addition, data were drawn from multiple geographic locations that may impact MDRO prevalence within each patient population. Finally, this review examines the utility of the risk factors formerly included in HCAP. However, other risk factors for MDRO pneumonia outlined by the ATS/IDSA guidelines still should be considered when evaluating patient risk. The 2016 guidelines recommend local incidence of resistant strains be considered when initiating empiric therapy. Review of medical records for previous positive cultures and duration of current hospitalization also should be considered. Although the 2016 ATS/IDSA HAP guidelines are not intended for immunosuppressed patients, this risk factor also may be taken into account.

Conclusion

Review and synthesis of published literature found previous hospital admission (of ≥ 2 days in the past 90 days), admission from a nursing home, and IV antibiotic therapy in the last 90 days to be independent risk factors for identification of MDRO pneumonia in previously nonhospitalized patients (Table 2). Additionally, although no data were found to support this risk factor, existence of an in-home (close contact) source of MDROs would provide ample opportunity for transmission, so evaluation of known exposure to MDROs from contacts should be considered. When choosing empiric antibiotic therapy for patients admitted to the hospital for treatment of pneumonia, consideration of patient history and risk factors that may contribute to infection with a MDRO are recommended.

Successful treatment of pneumonia depends on timely diagnosis and administration of antibiotics. Multidrug-resistant organisms (MDROs) complicate antibiotic therapies by rendering some antibiotic agents ineffective. Inappropriate initial therapy has been associated with a more than 2-fold increase in the risk of mortality.¹ Because culture results are not available immediately, clinicians prescribe antibiotics empirically and must rely on guidelines and knowledge of risk factors associated with MDRO infection to make these selections.

Treatment guidelines exist for hospital-acquired and ventilator-associated pneumonia (HAP/VAP) and community-acquired pneumonia (CAP) to assist with empiric antibiotic selection. For HAP/VAP, 2 to 3 antibiotics with a broad-spectrum of activity are used due to increased prevalence of MDROs in hospitals, whereastreatment of CAP involves more narrow coverage because bacteria that cause this infection typically have fewer antibiotic resistances.^2,3 The HAP/VAP guidelines stratify the risk of pneumonia due to the presence of a MDRO acquired during a hospitalization. However, neither the CAP nor HAP/VAP guidelines offer risk-stratification guidance for nonhospitalized patients who develop pneumonia but who may have become colonized with a MDRO during a previous hospitalization or from another exposure to a health care facility.

Health care-associated pneumonia (HCAP) was first described in the 2005 American Thoracic Society and the Infectious Diseases Society of America (ATS/IDSA) nosocomial pneumonia guidelines and was associated with criteria intended to aid clinician identification of nonhospitalized patients at risk for MDRO pneumonia, which warranted empiric broad-spectrum antibiotic therapy.² According to these guidelines, patients were classified as having HCAP if they had been hospitalized for at least 48 hours in the past 90 days, admitted from a nursing home, received recent intravenous antibiotics, had hemodialysis in the past 30 days, had a history of home infusion therapy or wound care, received intravenous chemotherapy, or had a family member with MDRO colonization.

Since publication of the 2005 guidelines, HCAP has been criticized as being a poor predictor of MDRO infection. A 2014 meta-analysis of 24 studies investigated the discriminating ability of HCAP and reported that the specificity and sensitivity for MDRO infections was 71.2% and 53.7%, respectively.³ In 2016, the ATS/IDSA guidelines were updated to remove HCAP due to the risk of antibiotic overprescribing.⁴

Literature Review

Although criteria previously defining a patient as having HCAP have been shown to be a poor discriminator of MDRO pneumonia as a whole, MDRO infections still pose a threat to nonhospitalized patients who have exposure to the health care system. A literature review was performed to identify independent HCAP risk factors that may increase the risk of MDRO pneumonia infecting a nonhospitalized patient needing empiric broad-spectrum antibiotic therapy. All included studies were prospective or retrospective observational cohort studies that performed logistic regression analyses to assess the association between MDRO isolation and the previously defined HCAP risk factors (Table 1).

Five studies examined the risk of MDRO infection in patients with a previous hospital admission of 2 days or more in the past 90 days. Shindo and colleagues found a significant increase in MDRO infections by about 2-fold (adjusted odds ratio [AOR], 2.1; 95% confidence interval [CI], 1.2-3.4).⁵ Shorr and colleagues found a 4-fold increase in likelihood of identifying a MDRO in HCAP (AOR, 4.2; 95% CI, 2.9-6.3).⁶ Nseir and colleagues and Jung and colleagues found similar results (AOR 3.9, 95% CI 1.7-8.8; AOR 2.7, 95% CI 1.3-5.5, respectively).^7,8 Conflicting results were reported by Gross and colleagues who did not find a significant relationship between previous hospitalization and MDRO isolation (AOR 1.2, 95% CI, 0.5-3.2).⁹

In patients with pneumonia admitted from a nursing home, MDRO infection risk also was evaluated in these 5 studies. Shorr and colleagues, Nseir and colleagues, and Gross and colleagues found significant AORs of 2.7 (95% CI 1.7-4.3), 2.0 (95% CI 1.1-3.7), and 4.2 (95% CI 1.6-11.3), respectively.^6,7,9 Shindo and colleagues (AOR 1.1; 95% CI, 0.6-2.0) and Jung and colleagues (AOR 1.9, 95% CI, 0.5-6.9) found this risk factor not significant.⁵

Receipt of antibiotics within the previous 90 days was assessed in 3 studies. Shindo and colleagues, Nseir and colleagues, and Gross and colleagues all found significant AORs of 2.5 (95% CI 1.2-4.0), 2.3 (95% CI 1.2-4.3), and 2.9 (95% CI 1.1-7.5), respectively.^5,7,9 Antibiotic therapy within the previous 90 days is an established risk factor for MDRO pneumonia, and the 2016 ATS/IDSA guidelines consider this a risk factor for HAP and VAP, including pneumonia caused by methicillin resistant Staphylococcus aureus and Pseudomonas aeruginosa.⁴

The impact of hemodialysis in the previous month on acquisition of MDRO pneumonia was investigated in 4 studies. Shindo and colleagues, Jung and colleagues, and Gross and colleagues concluded that this risk factor was not significantly related to MDRO infection, reporting AORs of 2.2 (95% CI 0.5-9.7), 2.8 (95% CI 0.9-9.2) and 0.7 (95% CI 0.1-5.1), respectively.^5,8,9 Shorr and colleagues, however, found a significant AOR of 2.1 (95% CI 1.0-4.3).⁶

Shindo and colleagues investigated the impact of home infusion therapy on acquisition of pneumonia due to a MDRO and reported a nonsignificant AOR of 0.8 (95% CI 0.4-1.8).⁵ Gross and colleagues also found a nonsignificant AOR of 0 (P = .1).⁹ In the Shindo and colleagues study, resistance was found in 107 of 679 patients who did not receive infusion therapy, and 12 of 55 patients who were receiving infusion therapy.⁵ Gross and colleagues reported that home-infusion therapy was received by 0 of 20 patients with MDRO infection and 4 of the 501 patients without MDRO infection.⁹

Shindo and colleagues reported that home wound care was not found to be significantly related to MDRO pneumonia as well as did Gross and colleagues: AORs of 3.8 (0.8-18.4) and 1.4 (95% CI 0.5-4.4), respectively.^5,9 Jung and colleagues examined IV chemotherapy in the past 30 days, and found this to not significantly impact the odds of MDRO isolation (AOR = 0.62, 95% CI 0.2-1.8).⁸ No data were available reflecting the risk of a family member with a MDRO.

Limitations

The variables on which logistic regression were performed differed among the studies. Therefore, results cannot be averaged or compared quantitatively, as AORs varied, depending on the variables included. In addition, data were drawn from multiple geographic locations that may impact MDRO prevalence within each patient population. Finally, this review examines the utility of the risk factors formerly included in HCAP. However, other risk factors for MDRO pneumonia outlined by the ATS/IDSA guidelines still should be considered when evaluating patient risk. The 2016 guidelines recommend local incidence of resistant strains be considered when initiating empiric therapy. Review of medical records for previous positive cultures and duration of current hospitalization also should be considered. Although the 2016 ATS/IDSA HAP guidelines are not intended for immunosuppressed patients, this risk factor also may be taken into account.

Conclusion

Review and synthesis of published literature found previous hospital admission (of ≥ 2 days in the past 90 days), admission from a nursing home, and IV antibiotic therapy in the last 90 days to be independent risk factors for identification of MDRO pneumonia in previously nonhospitalized patients (Table 2). Additionally, although no data were found to support this risk factor, existence of an in-home (close contact) source of MDROs would provide ample opportunity for transmission, so evaluation of known exposure to MDROs from contacts should be considered. When choosing empiric antibiotic therapy for patients admitted to the hospital for treatment of pneumonia, consideration of patient history and risk factors that may contribute to infection with a MDRO are recommended.

Boehringer Ingelheim

LOS ANGELES—A real-world analysis has quantified the risks of stroke and major bleeding in patients with non-valvular atrial fibrillation (NVAF) starting treatment with novel oral anticoagulants (NOACs).

The data showed that patients receiving dabigatran had a significantly lower rate of major bleeding but a similar rate of stroke as patients receiving rivaroxaban.

Rates of stroke and major bleeding were not significantly different in patients receiving dabigatran and those receiving apixaban.

These findings were presented at the International Stroke Conference 2018 (abstract 100). This research was supported by Boehringer Ingelheim, makers of dabigatran. The researchers are employed by, or have received payments from, the company.

“With an increasing number of the 2.7 million Americans living with atrial fibrillation being treated with NOACs, real-world analyses like this that compare their effectiveness and safety are important,” said lead investigator Todd C. Villines, MD, of Walter Reed National Military Medical Center in Bethesda, Maryland.

“As a researcher and treating physician, I hope that this large-scale, US practice-based comparison will provide additional insight on available NOAC therapies . . . .”

In this retrospective, observational study, Dr Villines and his colleagues assessed the safety and effectiveness of NOACs in NVAF patients treated through the US Department of Defense Military Health System.

The researchers analyzed data from patients newly initiating treatment with apixaban, dabigatran, or rivaroxaban.

The team examined 2 cohorts. One resulted in 12,763 propensity-score-matched patients receiving dabigatran (150 mg bid) or rivaroxaban (20 mg daily). The other resulted in 4802 propensity-score- matched patients receiving dabigatran (150 mg bid) or apixaban (5 mg bid).

The primary outcomes in this study were the risk of major bleeding and stroke.

Dabigatran-treated patients had a significantly lower rate of major bleeding than rivaroxaban-treated patients—2.08% (266/12,763) and 2.53% (323/12,763), respectively (hazard ratio [HR]=0.82; 95% confidence interval [CI], 0.70-0.97; P=0.0182).

However, rates of stroke were not significantly different in the dabigatran and rivaroxaban groups—0.60% (77/12,763) and 0.78% (100/12,763), respectively (HR=0.77; 95% CI 0.57-1.04; P=0.0844).

Likewise, there was no significant difference in stroke rates for patients receiving dabigatran and apixaban—0.44% (21/4802) and 0.35% (17/4802), respectively (HR=1.26; 95% CI, 0.66-2.39; P=0.4892].

And there was no significant difference in major bleeding—1.60% (77/4802) and 1.21% (58/4802), respectively (HR=1.37; 95% CI, 0.97-1.94; P=0.0702).

The researchers said limitations of this study include the potential for residual confounding as an observational, on-treatment study. In addition, the study included data from electronic health records, which may not have been optimal to identify baseline risk and outcomes. Finally, there were limited dabigatran users available for matching with apixaban users.

Boehringer Ingelheim

LOS ANGELES—A real-world analysis has quantified the risks of stroke and major bleeding in patients with non-valvular atrial fibrillation (NVAF) starting treatment with novel oral anticoagulants (NOACs).

The data showed that patients receiving dabigatran had a significantly lower rate of major bleeding but a similar rate of stroke as patients receiving rivaroxaban.

Rates of stroke and major bleeding were not significantly different in patients receiving dabigatran and those receiving apixaban.

These findings were presented at the International Stroke Conference 2018 (abstract 100). This research was supported by Boehringer Ingelheim, makers of dabigatran. The researchers are employed by, or have received payments from, the company.

“With an increasing number of the 2.7 million Americans living with atrial fibrillation being treated with NOACs, real-world analyses like this that compare their effectiveness and safety are important,” said lead investigator Todd C. Villines, MD, of Walter Reed National Military Medical Center in Bethesda, Maryland.

“As a researcher and treating physician, I hope that this large-scale, US practice-based comparison will provide additional insight on available NOAC therapies . . . .”

In this retrospective, observational study, Dr Villines and his colleagues assessed the safety and effectiveness of NOACs in NVAF patients treated through the US Department of Defense Military Health System.

The researchers analyzed data from patients newly initiating treatment with apixaban, dabigatran, or rivaroxaban.

The team examined 2 cohorts. One resulted in 12,763 propensity-score-matched patients receiving dabigatran (150 mg bid) or rivaroxaban (20 mg daily). The other resulted in 4802 propensity-score- matched patients receiving dabigatran (150 mg bid) or apixaban (5 mg bid).

The primary outcomes in this study were the risk of major bleeding and stroke.

Dabigatran-treated patients had a significantly lower rate of major bleeding than rivaroxaban-treated patients—2.08% (266/12,763) and 2.53% (323/12,763), respectively (hazard ratio [HR]=0.82; 95% confidence interval [CI], 0.70-0.97; P=0.0182).

However, rates of stroke were not significantly different in the dabigatran and rivaroxaban groups—0.60% (77/12,763) and 0.78% (100/12,763), respectively (HR=0.77; 95% CI 0.57-1.04; P=0.0844).

Likewise, there was no significant difference in stroke rates for patients receiving dabigatran and apixaban—0.44% (21/4802) and 0.35% (17/4802), respectively (HR=1.26; 95% CI, 0.66-2.39; P=0.4892].

And there was no significant difference in major bleeding—1.60% (77/4802) and 1.21% (58/4802), respectively (HR=1.37; 95% CI, 0.97-1.94; P=0.0702).

The researchers said limitations of this study include the potential for residual confounding as an observational, on-treatment study. In addition, the study included data from electronic health records, which may not have been optimal to identify baseline risk and outcomes. Finally, there were limited dabigatran users available for matching with apixaban users.

Boehringer Ingelheim

LOS ANGELES—A real-world analysis has quantified the risks of stroke and major bleeding in patients with non-valvular atrial fibrillation (NVAF) starting treatment with novel oral anticoagulants (NOACs).

The data showed that patients receiving dabigatran had a significantly lower rate of major bleeding but a similar rate of stroke as patients receiving rivaroxaban.

Rates of stroke and major bleeding were not significantly different in patients receiving dabigatran and those receiving apixaban.

These findings were presented at the International Stroke Conference 2018 (abstract 100). This research was supported by Boehringer Ingelheim, makers of dabigatran. The researchers are employed by, or have received payments from, the company.

“With an increasing number of the 2.7 million Americans living with atrial fibrillation being treated with NOACs, real-world analyses like this that compare their effectiveness and safety are important,” said lead investigator Todd C. Villines, MD, of Walter Reed National Military Medical Center in Bethesda, Maryland.

“As a researcher and treating physician, I hope that this large-scale, US practice-based comparison will provide additional insight on available NOAC therapies . . . .”

In this retrospective, observational study, Dr Villines and his colleagues assessed the safety and effectiveness of NOACs in NVAF patients treated through the US Department of Defense Military Health System.

The researchers analyzed data from patients newly initiating treatment with apixaban, dabigatran, or rivaroxaban.

The team examined 2 cohorts. One resulted in 12,763 propensity-score-matched patients receiving dabigatran (150 mg bid) or rivaroxaban (20 mg daily). The other resulted in 4802 propensity-score- matched patients receiving dabigatran (150 mg bid) or apixaban (5 mg bid).

The primary outcomes in this study were the risk of major bleeding and stroke.

Dabigatran-treated patients had a significantly lower rate of major bleeding than rivaroxaban-treated patients—2.08% (266/12,763) and 2.53% (323/12,763), respectively (hazard ratio [HR]=0.82; 95% confidence interval [CI], 0.70-0.97; P=0.0182).

However, rates of stroke were not significantly different in the dabigatran and rivaroxaban groups—0.60% (77/12,763) and 0.78% (100/12,763), respectively (HR=0.77; 95% CI 0.57-1.04; P=0.0844).

Likewise, there was no significant difference in stroke rates for patients receiving dabigatran and apixaban—0.44% (21/4802) and 0.35% (17/4802), respectively (HR=1.26; 95% CI, 0.66-2.39; P=0.4892].

And there was no significant difference in major bleeding—1.60% (77/4802) and 1.21% (58/4802), respectively (HR=1.37; 95% CI, 0.97-1.94; P=0.0702).

The researchers said limitations of this study include the potential for residual confounding as an observational, on-treatment study. In addition, the study included data from electronic health records, which may not have been optimal to identify baseline risk and outcomes. Finally, there were limited dabigatran users available for matching with apixaban users.

Image from NIAID

Engineered T cells can produce durable responses in patients with Epstein Barr virus–positive (EBV+), relapsed/refractory Hodgkin lymphoma (HL), according to research published in the Journal of Clinical Oncology.

These T cells, known as DNRII-LSTs, produced responses in 4 of the 8 patients studied.

This included 3 complete responses (CRs), the longest of which has exceeded 7 years.

What’s more, these responses were achieved without the use of lymphodepleting chemotherapy.

“While the study is small, its findings are incredibly encouraging for our [patients’] families and for the cancer field,” said study author Catherine M. Bollard, MD, MBChB, of Children’s National Health System in Washington, DC.

To engineer the DNRII-LSTs, Dr Bollard and her colleagues forced expression of a dominant-negative TGF-beta receptor type 2 (DNRII) on LMP-specific T cells (LSTs), which are T cells directed to the EBV latency-associated antigens LMP-1 and LMP-2.

The goal of forcing DNRII expression was to enable the LSTs to resist the hostile tumor environment so they could seek out and kill the tumor cells.

Dr Bollard and her colleagues administered DNRII-LSTs to 8 patients with EBV+ HL. The patients ranged in age from 27 to 47.

Seven of the 8 patients had active disease at the time of DNRII-LST infusion. Two patients had stage IVB HL, 1 had stage IIIB, and 2 had stage IIB. Four patients had nodular-sclerosing HL.

Six patients had relapsed twice. The remaining 2 patients had relapsed 3 and 4 times, respectively. All patients had previously received an autologous stem cell transplant and a range of multi-agent chemotherapy regimens (eg, ABVD, R-ICE, and MOPP).

For this study, the patients received 2 to 12 infusions of DNRII-LSTs, at doses ranging from 2 × 10⁷ to 1.5 × 10⁸ cells/m².

Results

The researchers found that autologous DNRII-LSTs (given to 7 patients) did not cause autoimmunity, and donor-derived DNRII-LSTs (n=1) did not induce graft-vs-host disease.

The team also noted there were no toxicities resulting from cytokine release syndrome.

Four patients achieved a response to treatment—3 CRs and a partial response.

All complete responders are still in CR, but the partial responder progressed at 19 months and ultimately died of sepsis (2 years after the first dose of DNRII-LSTs).

The other 4 patients had stable disease (SD) for 4 months to 13 months after treatment with DNRII-LSTs.

One patient with SD died of disease progression 2 years after receiving DNRII-LSTs, and another died of transplant complications less than 2 years after the last dose of DNRII-LSTs.

One patient with SD went on to receive additional therapy and is still alive more than 6 years after receiving DNRII-LSTs (currently receiving nivolumab). Another SD patient went on to receive additional therapy, achieved a CR, and is still alive.

One of the patients who achieved a CR to DNRII-LSTs remains in CR more than 7 years after the last dose. Another patient’s CR has exceeded 2 years, and another’s has exceeded 5 years.

All 3 of these patients received doses of 2 × 10⁷ cells/m². The patients with the longest and shortest CRs each received 2 infusions of DNRII-LSTs. The patient with the CR exceeding 5 years received 12 infusions.

“These results come 18 years after this revolutionary approach was first conceptualized,” Dr Bollard said. “I started work in this area in 2000. At that time, the oncology community had little enthusiasm for the use of T-cell therapies to treat cancer.”

“Even then, when T-cell therapy was in its relative infancy, some research institutions began to see more than 90% complete responses and cure rates in some settings. This most recent study points to the potential of specialized T cells to fight even more types of immune-evading tumors.”

Image from NIAID

Engineered T cells can produce durable responses in patients with Epstein Barr virus–positive (EBV+), relapsed/refractory Hodgkin lymphoma (HL), according to research published in the Journal of Clinical Oncology.

These T cells, known as DNRII-LSTs, produced responses in 4 of the 8 patients studied.

This included 3 complete responses (CRs), the longest of which has exceeded 7 years.

What’s more, these responses were achieved without the use of lymphodepleting chemotherapy.

“While the study is small, its findings are incredibly encouraging for our [patients’] families and for the cancer field,” said study author Catherine M. Bollard, MD, MBChB, of Children’s National Health System in Washington, DC.

To engineer the DNRII-LSTs, Dr Bollard and her colleagues forced expression of a dominant-negative TGF-beta receptor type 2 (DNRII) on LMP-specific T cells (LSTs), which are T cells directed to the EBV latency-associated antigens LMP-1 and LMP-2.

The goal of forcing DNRII expression was to enable the LSTs to resist the hostile tumor environment so they could seek out and kill the tumor cells.

Dr Bollard and her colleagues administered DNRII-LSTs to 8 patients with EBV+ HL. The patients ranged in age from 27 to 47.

Seven of the 8 patients had active disease at the time of DNRII-LST infusion. Two patients had stage IVB HL, 1 had stage IIIB, and 2 had stage IIB. Four patients had nodular-sclerosing HL.

Six patients had relapsed twice. The remaining 2 patients had relapsed 3 and 4 times, respectively. All patients had previously received an autologous stem cell transplant and a range of multi-agent chemotherapy regimens (eg, ABVD, R-ICE, and MOPP).

For this study, the patients received 2 to 12 infusions of DNRII-LSTs, at doses ranging from 2 × 10⁷ to 1.5 × 10⁸ cells/m².

Results

The researchers found that autologous DNRII-LSTs (given to 7 patients) did not cause autoimmunity, and donor-derived DNRII-LSTs (n=1) did not induce graft-vs-host disease.

The team also noted there were no toxicities resulting from cytokine release syndrome.

Four patients achieved a response to treatment—3 CRs and a partial response.

All complete responders are still in CR, but the partial responder progressed at 19 months and ultimately died of sepsis (2 years after the first dose of DNRII-LSTs).

The other 4 patients had stable disease (SD) for 4 months to 13 months after treatment with DNRII-LSTs.

One patient with SD died of disease progression 2 years after receiving DNRII-LSTs, and another died of transplant complications less than 2 years after the last dose of DNRII-LSTs.

One patient with SD went on to receive additional therapy and is still alive more than 6 years after receiving DNRII-LSTs (currently receiving nivolumab). Another SD patient went on to receive additional therapy, achieved a CR, and is still alive.

One of the patients who achieved a CR to DNRII-LSTs remains in CR more than 7 years after the last dose. Another patient’s CR has exceeded 2 years, and another’s has exceeded 5 years.

All 3 of these patients received doses of 2 × 10⁷ cells/m². The patients with the longest and shortest CRs each received 2 infusions of DNRII-LSTs. The patient with the CR exceeding 5 years received 12 infusions.

“These results come 18 years after this revolutionary approach was first conceptualized,” Dr Bollard said. “I started work in this area in 2000. At that time, the oncology community had little enthusiasm for the use of T-cell therapies to treat cancer.”

“Even then, when T-cell therapy was in its relative infancy, some research institutions began to see more than 90% complete responses and cure rates in some settings. This most recent study points to the potential of specialized T cells to fight even more types of immune-evading tumors.”

Image from NIAID

Engineered T cells can produce durable responses in patients with Epstein Barr virus–positive (EBV+), relapsed/refractory Hodgkin lymphoma (HL), according to research published in the Journal of Clinical Oncology.

These T cells, known as DNRII-LSTs, produced responses in 4 of the 8 patients studied.

This included 3 complete responses (CRs), the longest of which has exceeded 7 years.

What’s more, these responses were achieved without the use of lymphodepleting chemotherapy.

“While the study is small, its findings are incredibly encouraging for our [patients’] families and for the cancer field,” said study author Catherine M. Bollard, MD, MBChB, of Children’s National Health System in Washington, DC.

To engineer the DNRII-LSTs, Dr Bollard and her colleagues forced expression of a dominant-negative TGF-beta receptor type 2 (DNRII) on LMP-specific T cells (LSTs), which are T cells directed to the EBV latency-associated antigens LMP-1 and LMP-2.

The goal of forcing DNRII expression was to enable the LSTs to resist the hostile tumor environment so they could seek out and kill the tumor cells.

Dr Bollard and her colleagues administered DNRII-LSTs to 8 patients with EBV+ HL. The patients ranged in age from 27 to 47.

Seven of the 8 patients had active disease at the time of DNRII-LST infusion. Two patients had stage IVB HL, 1 had stage IIIB, and 2 had stage IIB. Four patients had nodular-sclerosing HL.

Six patients had relapsed twice. The remaining 2 patients had relapsed 3 and 4 times, respectively. All patients had previously received an autologous stem cell transplant and a range of multi-agent chemotherapy regimens (eg, ABVD, R-ICE, and MOPP).

For this study, the patients received 2 to 12 infusions of DNRII-LSTs, at doses ranging from 2 × 10⁷ to 1.5 × 10⁸ cells/m².

Results

The researchers found that autologous DNRII-LSTs (given to 7 patients) did not cause autoimmunity, and donor-derived DNRII-LSTs (n=1) did not induce graft-vs-host disease.

The team also noted there were no toxicities resulting from cytokine release syndrome.

Four patients achieved a response to treatment—3 CRs and a partial response.

All complete responders are still in CR, but the partial responder progressed at 19 months and ultimately died of sepsis (2 years after the first dose of DNRII-LSTs).

The other 4 patients had stable disease (SD) for 4 months to 13 months after treatment with DNRII-LSTs.

One patient with SD died of disease progression 2 years after receiving DNRII-LSTs, and another died of transplant complications less than 2 years after the last dose of DNRII-LSTs.

One patient with SD went on to receive additional therapy and is still alive more than 6 years after receiving DNRII-LSTs (currently receiving nivolumab). Another SD patient went on to receive additional therapy, achieved a CR, and is still alive.

One of the patients who achieved a CR to DNRII-LSTs remains in CR more than 7 years after the last dose. Another patient’s CR has exceeded 2 years, and another’s has exceeded 5 years.

All 3 of these patients received doses of 2 × 10⁷ cells/m². The patients with the longest and shortest CRs each received 2 infusions of DNRII-LSTs. The patient with the CR exceeding 5 years received 12 infusions.

“These results come 18 years after this revolutionary approach was first conceptualized,” Dr Bollard said. “I started work in this area in 2000. At that time, the oncology community had little enthusiasm for the use of T-cell therapies to treat cancer.”

“Even then, when T-cell therapy was in its relative infancy, some research institutions began to see more than 90% complete responses and cure rates in some settings. This most recent study points to the potential of specialized T cells to fight even more types of immune-evading tumors.”

Photo by Rhoda Baer

Treatment costs are the greatest threat to the growth of cancer programs, according to a survey of nearly 300 cancer program administrators and providers.

Sixty-eight percent of survey respondents said treatment costs were among the biggest threats to future cancer program growth at their organization.

Other top threats to growth included physician alignment around services and program goals—cited by 47% of respondents—and changes in healthcare coverage—cited by 46%.

This survey—the “2017 Trending Now in Cancer Care Survey”—was conducted by the Association of Community Cancer Centers (ACCC) and Advisory Board’s Oncology Roundtable. It was supported by Pfizer Oncology.

The survey was distributed via email on July 24, 2017. Respondents included 293 cancer program administrators and providers from 209 institutions. They submitted responses over 6 weeks.

Respondents identified the following “biggest threats” to cancer program growth:

• Cost of drugs and/or new treatment modalities—68%
• Physician alignment around services and program goals—47%
• Changes in healthcare coverage—46%
• Cuts to fee-for-service reimbursement—44%
• Shifting reimbursement to value-based care—43%
• Marketplace competition—35%
• Workforce planning (eg, managing staff shortages)—34%
• Network strategy and integration—33%
• Site of care policies issued by private payers—27%
• Access to capital—26%
• Quality reporting requirements—22%
• Health information technology—21%
• Other—6%.

When asked to identify their greatest opportunities for cost savings, respondents overwhelmingly pointed toward clinical standardization (63%) and drugs (62%).

Other opportunities included:

• Supplies—28%
• Capital expenses (eg, imaging technology)—24%
• Non-clinical staff (eg, billing and coding specialists)—22%
• Technology maintenance—20%
• Clinical staff—16%
• Retail pharmacy—14%
• Clinical research—10%
• Support services (eg, acupuncture)—9%
• Other—4%.

Respondents also said the investments most likely to yield a return for their cancer program were:

• Increasing the number of sub-specialists (eg, breast surgeons)—59%
• Marketing—41%
• Specialty pharmacy—36%
• Increasing the number of general oncology physicians—34%
• Screening services (eg, mobile screening unit)—29%
• Capital investments—24%
• Clinical research—16%
• Support services—15%
• Retail pharmacy—14%
• Building upgrades—14%.

More details on the “2017 Trending Now in Cancer Care Survey” can be found on the ACCC website.

Photo by Rhoda Baer

Treatment costs are the greatest threat to the growth of cancer programs, according to a survey of nearly 300 cancer program administrators and providers.

Sixty-eight percent of survey respondents said treatment costs were among the biggest threats to future cancer program growth at their organization.

Other top threats to growth included physician alignment around services and program goals—cited by 47% of respondents—and changes in healthcare coverage—cited by 46%.

This survey—the “2017 Trending Now in Cancer Care Survey”—was conducted by the Association of Community Cancer Centers (ACCC) and Advisory Board’s Oncology Roundtable. It was supported by Pfizer Oncology.

The survey was distributed via email on July 24, 2017. Respondents included 293 cancer program administrators and providers from 209 institutions. They submitted responses over 6 weeks.

Respondents identified the following “biggest threats” to cancer program growth:

• Cost of drugs and/or new treatment modalities—68%
• Physician alignment around services and program goals—47%
• Changes in healthcare coverage—46%
• Cuts to fee-for-service reimbursement—44%
• Shifting reimbursement to value-based care—43%
• Marketplace competition—35%
• Workforce planning (eg, managing staff shortages)—34%
• Network strategy and integration—33%
• Site of care policies issued by private payers—27%
• Access to capital—26%
• Quality reporting requirements—22%
• Health information technology—21%
• Other—6%.

When asked to identify their greatest opportunities for cost savings, respondents overwhelmingly pointed toward clinical standardization (63%) and drugs (62%).

Other opportunities included:

• Supplies—28%
• Capital expenses (eg, imaging technology)—24%
• Non-clinical staff (eg, billing and coding specialists)—22%
• Technology maintenance—20%
• Clinical staff—16%
• Retail pharmacy—14%
• Clinical research—10%
• Support services (eg, acupuncture)—9%
• Other—4%.

Respondents also said the investments most likely to yield a return for their cancer program were:

• Increasing the number of sub-specialists (eg, breast surgeons)—59%
• Marketing—41%
• Specialty pharmacy—36%
• Increasing the number of general oncology physicians—34%
• Screening services (eg, mobile screening unit)—29%
• Capital investments—24%
• Clinical research—16%
• Support services—15%
• Retail pharmacy—14%
• Building upgrades—14%.

More details on the “2017 Trending Now in Cancer Care Survey” can be found on the ACCC website.

Photo by Rhoda Baer

Treatment costs are the greatest threat to the growth of cancer programs, according to a survey of nearly 300 cancer program administrators and providers.

Sixty-eight percent of survey respondents said treatment costs were among the biggest threats to future cancer program growth at their organization.

Other top threats to growth included physician alignment around services and program goals—cited by 47% of respondents—and changes in healthcare coverage—cited by 46%.

This survey—the “2017 Trending Now in Cancer Care Survey”—was conducted by the Association of Community Cancer Centers (ACCC) and Advisory Board’s Oncology Roundtable. It was supported by Pfizer Oncology.

The survey was distributed via email on July 24, 2017. Respondents included 293 cancer program administrators and providers from 209 institutions. They submitted responses over 6 weeks.

Respondents identified the following “biggest threats” to cancer program growth:

• Cost of drugs and/or new treatment modalities—68%
• Physician alignment around services and program goals—47%
• Changes in healthcare coverage—46%
• Cuts to fee-for-service reimbursement—44%
• Shifting reimbursement to value-based care—43%
• Marketplace competition—35%
• Workforce planning (eg, managing staff shortages)—34%
• Network strategy and integration—33%
• Site of care policies issued by private payers—27%
• Access to capital—26%
• Quality reporting requirements—22%
• Health information technology—21%
• Other—6%.

When asked to identify their greatest opportunities for cost savings, respondents overwhelmingly pointed toward clinical standardization (63%) and drugs (62%).

Other opportunities included:

• Supplies—28%
• Capital expenses (eg, imaging technology)—24%
• Non-clinical staff (eg, billing and coding specialists)—22%
• Technology maintenance—20%
• Clinical staff—16%
• Retail pharmacy—14%
• Clinical research—10%
• Support services (eg, acupuncture)—9%
• Other—4%.

Respondents also said the investments most likely to yield a return for their cancer program were:

• Increasing the number of sub-specialists (eg, breast surgeons)—59%
• Marketing—41%
• Specialty pharmacy—36%
• Increasing the number of general oncology physicians—34%
• Screening services (eg, mobile screening unit)—29%
• Capital investments—24%
• Clinical research—16%
• Support services—15%
• Retail pharmacy—14%
• Building upgrades—14%.

More details on the “2017 Trending Now in Cancer Care Survey” can be found on the ACCC website.

ATLANTA – There were a lot of new data presented during the annual meeting of the American Society of Hematology. But what findings could actually change the way you practice?

Robert A. Brodsky, MD, director of the division of hematology at Johns Hopkins University in Baltimore and the moderator for the late-breaking abstract session at ASH, highlighted results from two studies.

Data from the MURANO trial showed robust results for a combination of venetoclax and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). At a median follow-up of 23.8 months, median progression-free survival -had not been reached in patients randomized to venetoclax/rituximab, while patients who received bendamustine plus rituximab had a median PFS of 17 months.

The venetoclax/rituximab combination will “probably emerge as a new standard therapy” for refractory CLL based on the data presented, Dr. Brodsky said.

Another “enormously exciting and practice-changing” finding is that direct oral anticoagulants can be used safely in patients with cancer, Dr. Brodsky said in an interview.

In a randomized, open-label study, 12 months of daily treatment with edoxaban was noninferior to standard subcutaneous therapy with dalteparin for treatment of venous thromboembolism in cancer patients.

[email protected]

ATLANTA – There were a lot of new data presented during the annual meeting of the American Society of Hematology. But what findings could actually change the way you practice?

Robert A. Brodsky, MD, director of the division of hematology at Johns Hopkins University in Baltimore and the moderator for the late-breaking abstract session at ASH, highlighted results from two studies.

Data from the MURANO trial showed robust results for a combination of venetoclax and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). At a median follow-up of 23.8 months, median progression-free survival -had not been reached in patients randomized to venetoclax/rituximab, while patients who received bendamustine plus rituximab had a median PFS of 17 months.

The venetoclax/rituximab combination will “probably emerge as a new standard therapy” for refractory CLL based on the data presented, Dr. Brodsky said.

Another “enormously exciting and practice-changing” finding is that direct oral anticoagulants can be used safely in patients with cancer, Dr. Brodsky said in an interview.

In a randomized, open-label study, 12 months of daily treatment with edoxaban was noninferior to standard subcutaneous therapy with dalteparin for treatment of venous thromboembolism in cancer patients.

[email protected]

ATLANTA – There were a lot of new data presented during the annual meeting of the American Society of Hematology. But what findings could actually change the way you practice?

Robert A. Brodsky, MD, director of the division of hematology at Johns Hopkins University in Baltimore and the moderator for the late-breaking abstract session at ASH, highlighted results from two studies.

Data from the MURANO trial showed robust results for a combination of venetoclax and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). At a median follow-up of 23.8 months, median progression-free survival -had not been reached in patients randomized to venetoclax/rituximab, while patients who received bendamustine plus rituximab had a median PFS of 17 months.

The venetoclax/rituximab combination will “probably emerge as a new standard therapy” for refractory CLL based on the data presented, Dr. Brodsky said.

Another “enormously exciting and practice-changing” finding is that direct oral anticoagulants can be used safely in patients with cancer, Dr. Brodsky said in an interview.

In a randomized, open-label study, 12 months of daily treatment with edoxaban was noninferior to standard subcutaneous therapy with dalteparin for treatment of venous thromboembolism in cancer patients.

[email protected]

Ofatumumab (Arzerra), a monoclonal antibody treatment for chronic lymphocytic leukemia, will soon be available outside the United States through compassionate use programs only. The drug will continue to be widely available in the United States.

Novartis announced in January that it would begin limiting the availability of the drug outside of the United States and would work with regulatory authorities to set up compassionate use programs for patients who are currently being treated with the drug. Patients who use these programs will receive the drug for free.

The decision was driven by the surge in CLL drugs that have become available over the last 5 years, according to Novartis.

The decision to pull the drug from international markets will not affect its use in ongoing clinical trials, particularly two phase 3 studies in relapsing multiple sclerosis and indolent non-Hodgkin lymphoma.

[email protected]

Ofatumumab (Arzerra), a monoclonal antibody treatment for chronic lymphocytic leukemia, will soon be available outside the United States through compassionate use programs only. The drug will continue to be widely available in the United States.

Novartis announced in January that it would begin limiting the availability of the drug outside of the United States and would work with regulatory authorities to set up compassionate use programs for patients who are currently being treated with the drug. Patients who use these programs will receive the drug for free.

The decision was driven by the surge in CLL drugs that have become available over the last 5 years, according to Novartis.

The decision to pull the drug from international markets will not affect its use in ongoing clinical trials, particularly two phase 3 studies in relapsing multiple sclerosis and indolent non-Hodgkin lymphoma.

[email protected]

Ofatumumab (Arzerra), a monoclonal antibody treatment for chronic lymphocytic leukemia, will soon be available outside the United States through compassionate use programs only. The drug will continue to be widely available in the United States.

Novartis announced in January that it would begin limiting the availability of the drug outside of the United States and would work with regulatory authorities to set up compassionate use programs for patients who are currently being treated with the drug. Patients who use these programs will receive the drug for free.

The decision was driven by the surge in CLL drugs that have become available over the last 5 years, according to Novartis.

The decision to pull the drug from international markets will not affect its use in ongoing clinical trials, particularly two phase 3 studies in relapsing multiple sclerosis and indolent non-Hodgkin lymphoma.

[email protected]

LAS VEGAS – Emergent colectomies for ulcerative colitis in the United States decreased more than 7% annually between 2000 and 2014, a large database analysis has shown.

“Despite advances in medical therapy for ulcerative colitis (UC), many patients still need surgery,” Ryan C. Ungaro, MD, said at the Crohn’s & Colitis Congress, a partnership of the  Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Prior epidemiologic studies have demonstrated a decline in colectomy rates over time, particularly comparing the pre- and postbiologic eras, but less is known about rates of emergent colectomy over time,” he said. In particular, he continued, data on UC colectomy and ileal pouch anal anastomosis (IPAA) surgery rates in the United States are limited.

In an effort to examine UC emergent colectomy rates and IPAA over time, Dr. Ungaro, of the division of gastroenterology at the Icahn School of Medicine at Mount Sinai, New York, and his associates analyzed data from the U.S. Nationwide Inpatient Sample from 2000 through 2014. They defined emergent colectomy cases as admission through the emergency department and used the ICD-9-CM code for subtotal colectomy (45.8) as the outcome variable, and defined a second cohort of UC patients admitted electively with an outcome variable of ICD-9-CM code for IPAA (45.95). To evaluate temporal trends of colectomy and IPAA, the researchers used joinpoint regression analysis with calculation of annual percentage change.

*This story was updated on 3/26.

[email protected]

SOURCE: Ungaro RC et al. Crohn’s & Colitis Congress, Clinical Abstract 23.

LAS VEGAS – Emergent colectomies for ulcerative colitis in the United States decreased more than 7% annually between 2000 and 2014, a large database analysis has shown.

“Despite advances in medical therapy for ulcerative colitis (UC), many patients still need surgery,” Ryan C. Ungaro, MD, said at the Crohn’s & Colitis Congress, a partnership of the  Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Prior epidemiologic studies have demonstrated a decline in colectomy rates over time, particularly comparing the pre- and postbiologic eras, but less is known about rates of emergent colectomy over time,” he said. In particular, he continued, data on UC colectomy and ileal pouch anal anastomosis (IPAA) surgery rates in the United States are limited.

In an effort to examine UC emergent colectomy rates and IPAA over time, Dr. Ungaro, of the division of gastroenterology at the Icahn School of Medicine at Mount Sinai, New York, and his associates analyzed data from the U.S. Nationwide Inpatient Sample from 2000 through 2014. They defined emergent colectomy cases as admission through the emergency department and used the ICD-9-CM code for subtotal colectomy (45.8) as the outcome variable, and defined a second cohort of UC patients admitted electively with an outcome variable of ICD-9-CM code for IPAA (45.95). To evaluate temporal trends of colectomy and IPAA, the researchers used joinpoint regression analysis with calculation of annual percentage change.

*This story was updated on 3/26.

[email protected]

SOURCE: Ungaro RC et al. Crohn’s & Colitis Congress, Clinical Abstract 23.

LAS VEGAS – Emergent colectomies for ulcerative colitis in the United States decreased more than 7% annually between 2000 and 2014, a large database analysis has shown.

“Despite advances in medical therapy for ulcerative colitis (UC), many patients still need surgery,” Ryan C. Ungaro, MD, said at the Crohn’s & Colitis Congress, a partnership of the  Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Prior epidemiologic studies have demonstrated a decline in colectomy rates over time, particularly comparing the pre- and postbiologic eras, but less is known about rates of emergent colectomy over time,” he said. In particular, he continued, data on UC colectomy and ileal pouch anal anastomosis (IPAA) surgery rates in the United States are limited.

In an effort to examine UC emergent colectomy rates and IPAA over time, Dr. Ungaro, of the division of gastroenterology at the Icahn School of Medicine at Mount Sinai, New York, and his associates analyzed data from the U.S. Nationwide Inpatient Sample from 2000 through 2014. They defined emergent colectomy cases as admission through the emergency department and used the ICD-9-CM code for subtotal colectomy (45.8) as the outcome variable, and defined a second cohort of UC patients admitted electively with an outcome variable of ICD-9-CM code for IPAA (45.95). To evaluate temporal trends of colectomy and IPAA, the researchers used joinpoint regression analysis with calculation of annual percentage change.

*This story was updated on 3/26.

[email protected]

SOURCE: Ungaro RC et al. Crohn’s & Colitis Congress, Clinical Abstract 23.