Video

In December 2018, Federal Practitioner sat down with Surgeon General VADM Jerome M. Adams, MD, MPH to discuss recent initiatives to combat the opioid epidemic and to improve health care engagement and delivery in this exclusive video interview. During 2018, the Office of the Surgeon General took a number of steps to address the ongoing opioid crisis, releasing a public health advisory to urge increased use of naloxone, which can reverse the effects of an opioid overdose. In addition, the office of the Surgeon General released a postcard with 5 actions every person can take to address the opioid epidemic.

Increasing Health Care Engagement

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Next: Community health and economic prosperity, What health care providers can do for prevention, expanding the PHS mission, the Surgeon General's challenge on opioids

 

 

Community Health and Economic Prosperity

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Next: What health care providers can do for prevention, expanding the PHS mission, the Surgeon General's challenge on opioids

 

 

What Health Care Providers Can Do for Prevention

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Next: Expanding the PHS mission, the Surgeon General's challenge on opioids

 

 

Expanding the PHS Mission

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Next: The Surgeon General's challenge on opioids

 

 

The Surgeon General's Challenge on Opioids

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Postcard

In December 2018, Federal Practitioner sat down with Surgeon General VADM Jerome M. Adams, MD, MPH to discuss recent initiatives to combat the opioid epidemic and to improve health care engagement and delivery in this exclusive video interview. During 2018, the Office of the Surgeon General took a number of steps to address the ongoing opioid crisis, releasing a public health advisory to urge increased use of naloxone, which can reverse the effects of an opioid overdose. In addition, the office of the Surgeon General released a postcard with 5 actions every person can take to address the opioid epidemic.

Increasing Health Care Engagement

Vidyard Video

Next: Community health and economic prosperity, What health care providers can do for prevention, expanding the PHS mission, the Surgeon General's challenge on opioids

 

 

Community Health and Economic Prosperity

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Next: What health care providers can do for prevention, expanding the PHS mission, the Surgeon General's challenge on opioids

 

 

What Health Care Providers Can Do for Prevention

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Next: Expanding the PHS mission, the Surgeon General's challenge on opioids

 

 

Expanding the PHS Mission

Vidyard Video

Next: The Surgeon General's challenge on opioids

 

 

The Surgeon General's Challenge on Opioids

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Postcard

In December 2018, Federal Practitioner sat down with Surgeon General VADM Jerome M. Adams, MD, MPH to discuss recent initiatives to combat the opioid epidemic and to improve health care engagement and delivery in this exclusive video interview. During 2018, the Office of the Surgeon General took a number of steps to address the ongoing opioid crisis, releasing a public health advisory to urge increased use of naloxone, which can reverse the effects of an opioid overdose. In addition, the office of the Surgeon General released a postcard with 5 actions every person can take to address the opioid epidemic.

Increasing Health Care Engagement

Vidyard Video

Next: Community health and economic prosperity, What health care providers can do for prevention, expanding the PHS mission, the Surgeon General's challenge on opioids

 

 

Community Health and Economic Prosperity

Vidyard Video

Next: What health care providers can do for prevention, expanding the PHS mission, the Surgeon General's challenge on opioids

 

 

What Health Care Providers Can Do for Prevention

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Next: Expanding the PHS mission, the Surgeon General's challenge on opioids

 

 

Expanding the PHS Mission

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Next: The Surgeon General's challenge on opioids

 

 

The Surgeon General's Challenge on Opioids

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Postcard

Many hospitalists incorporate point-of-care ultrasound (POCUS) into their daily practice because it adds value to their bedside evaluation of patients. However, standards for training and assessing hospitalists in POCUS have not yet been established. Other acute care specialties, including emergency medicine and critical care medicine, have already incorporated POCUS into their graduate medical education training programs, but most internal medicine residency programs are only beginning to provide POCUS training.¹

Several features distinguish POCUS from comprehensive ultrasound examinations. First, POCUS is designed to answer focused questions, whereas comprehensive ultrasound examinations evaluate all organs in an anatomical region; for example, an abdominal POCUS exam may evaluate only for presence or absence of intraperitoneal free fluid, whereas a comprehensive examination of the right upper quadrant will evaluate the liver, gallbladder, and biliary ducts. Second, POCUS examinations are generally performed by the same clinician who generates the relevant clinical question to answer with POCUS and ultimately integrates the findings into the patient’s care.² By contrast, comprehensive ultrasound examinations involve multiple providers and steps: a clinician generates a relevant clinical question and requests an ultrasound examination that is acquired by a sonographer, interpreted by a radiologist, and reported back to the requesting clinician. Third, POCUS is often used to evaluate multiple body systems. For example, to evaluate a patient with undifferentiated hypotension, a multisystem POCUS examination of the heart, inferior vena cava, lungs, abdomen, and lower extremity veins is typically performed. Finally, POCUS examinations can be performed serially to investigate changes in clinical status or evaluate response to therapy, such as monitoring the heart, lungs, and inferior vena cava during fluid resuscitation.

The purpose of this position statement is to inform a broad audience about how hospitalists are using diagnostic and procedural applications of POCUS. This position statement does not mandate that hospitalists use POCUS. Rather, it is intended to provide guidance on the safe and effective use of POCUS by the hospitalists who use it and the administrators who oversee its use. We discuss POCUS (1) applications, (2) training, (3) assessments, and (4) program management. This position statement was reviewed and approved by the Society of Hospital Medicine (SHM) Executive Committee in March 2018.

Common diagnostic and procedural applications of POCUS used by hospitalists are listed in Table 1. Selected evidence supporting the use of these applications is described in the supplementary online content (Appendices 1–8 available at http://journalofhospitalmedicine.com) and SHM position statements on specific ultrasound-guided bedside procedures.^3,4 Additional applications not listed in Table 1 that may be performed by some hospitalists include assessment of the eyes, stomach, bowels, ovaries, pregnancy, and testicles, as well as performance of regional anesthesia. Moreover, hospitalists caring for pediatric and adolescent patients may use additional applications besides those listed here. Currently, many hospitalists already perform more complex and sophisticated POCUS examinations than those listed in Table 1. The scope of POCUS use by hospitalists continues to expand, and this position statement should not restrict that expansion.

As outlined in our earlier position statements,^3,4 ultrasound guidance lowers complication rates and increases success rates of invasive bedside procedures. Diagnostic POCUS can guide clinical decision making prior to bedside procedures. For instance, hospitalists may use POCUS to assess the size and character of a pleural effusion to help determine the most appropriate management strategy: observation, medical treatment, thoracentesis, chest tube placement, or surgical therapy. Furthermore, diagnostic POCUS can be used to rapidly assess for immediate postprocedural complications, such as pneumothorax, or if the patient develops new symptoms.

Basic Knowledge

Basic knowledge includes fundamentals of ultrasound physics; safety;⁴ anatomy; physiology; and device operation, including maintenance and cleaning. Basic knowledge can be taught by multiple methods, including live or recorded lectures, online modules, or directed readings.

Image Acquisition

Training should occur across multiple types of patients (eg, obese, cachectic, postsurgical) and clinical settings (eg, intensive care unit, general medicine wards, emergency department) when available. Training is largely hands-on because the relevant skills involve integration of 3D anatomy with spatial manipulation, hand-eye coordination, and fine motor movements. Virtual reality ultrasound simulators may accelerate mastery, particularly for cardiac image acquisition, and expose learners to standardized sets of pathologic findings. Real-time bedside feedback on image acquisition is ideal because understanding how ultrasound probe manipulation affects the images acquired is essential to learning.

Image Interpretation

Training in image interpretation relies on visual pattern recognition of normal and abnormal findings. Therefore, the normal to abnormal spectrum should be broad, and learners should maintain a log of what abnormalities have been identified. Giving real-time feedback at the bedside is ideal because of the connection between image acquisition and interpretation. Image interpretation can be taught through didactic sessions, image review sessions, or review of teaching files with annotated images.

Clinical Integration

Learners must interpret and integrate image findings with other clinical data considering the image quality, patient characteristics, and changing physiology. Clinical integration should be taught by instructors that share similar clinical knowledge as learners. Although sonographers are well suited to teach image acquisition, they should not be the sole instructors to teach hospitalists how to integrate ultrasound findings in clinical decision making. Likewise, emphasis should be placed on the appropriate use of POCUS within a provider’s skill set. Learners must appreciate the clinical significance of POCUS findings, including recognition of incidental findings that may require further workup. Supplemental training in clinical integration can occur through didactics that include complex patient scenarios.

Pathways

Clinical competency can be achieved with training adherent to five criteria. First, the training environment should be similar to where the trainee will practice. Second, training and feedback should occur in real time. Third, specific applications should be taught rather than broad training in “hospitalist POCUS.” Each application requires unique skills and knowledge, including image acquisition pitfalls and artifacts. Fourth, clinical competence must be achieved and demonstrated; it is not necessarily gained through experience. Fifth, once competency is achieved, continued education and feedback are necessary to ensure it is maintained.

Residency-based POCUS training pathways can best fulfill these criteria. They may eventually become commonplace, but until then alternative pathways must exist for hospitalist providers who are already in practice. There are three important attributes of such pathways. First, administrators’ expectations about learners’ clinical productivity must be realistically, but only temporarily, relaxed; otherwise, competing demands on time will likely overwhelm learners and subvert training. Second, training should begin through a local or national hands-on training program. The SHM POCUS certificate program consolidates training for common diagnostic POCUS applications for hospitalists.⁶ Other medical societies offer training for their respective clinical specialties.⁷ Third, once basic POCUS training has begun, longitudinal training should continue ideally with a local hospitalist POCUS expert.

In some settings, a subgroup of hospitalists may not desire, or be able to achieve, competency in the manual skills of POCUS image acquisition. Nevertheless, hospitalists may still find value in understanding POCUS nomenclature, image pattern recognition, and the evidence and pitfalls behind clinical integration of specific POCUS findings. This subset of POCUS skills allows hospitalists to communicate effectively with and understand the clinical decisions made by their colleagues who are competent in POCUS use.

The minimal skills a hospitalist should possess to serve as a POCUS trainer include proficiency of basic knowledge, image acquisition, image interpretation, and clinical integration of the POCUS applications being taught; effectiveness as a hands-on instructor to teach image acquisition skills; and an in-depth understanding of common POCUS pitfalls and limitations.

Assessment methods for POCUS can include the following: knowledge-based questions, image acquisition using task-specific checklists on human or simulation models, image interpretation using a series of videos or still images with normal and abnormal findings, clinical integration using “next best step” in a multiple choice format with POCUS images, and simulation-based clinical scenarios. Assessment methods should be aligned with local availability of resources and trainers.

Basic Knowledge

Basic knowledge can be assessed via multiple choice questions assessing knowledge of ultrasound physics, image optimization, relevant anatomy, and limitations of POCUS imaging. Basic knowledge lies primarily in the cognitive domain and does not assess manual skills.

Image Acquisition

Image acquisition can be assessed by observation and rating of image quality. Where resources allow, assessment of image acquisition is likely best done through a combination of developing an image portfolio with a minimum number of high quality images, plus direct observation of image acquisition by an expert. Various programs have utilized minimum numbers of images acquired to help define competence with image acquisition skills.^6–8 Although minimums may be a necessary step to gain competence, using them as a sole means to determine competence does not account for variable learning curves.⁹ As with other manual skills in hospital medicine, such as ultrasound-guided bedside procedures, minimum numbers are best used as a starting point for assessments.^3,10 In this regard, portfolio development with meticulous attention to the gain, depth, and proper tomographic plane of images can monitor a hospitalist’s progress toward competence by providing objective assessments and feedback. Simulation may also be used as it allows assessment of image acquisition skills and an opportunity to provide real-time feedback, similar to direct observation but without actual patients.

Image Interpretation

Image interpretation is best assessed by an expert observing the learner at bedside; however, when bedside assessment is not possible, image interpretation skills may be assessed using multiple choice or free text interpretation of archived ultrasound images with normal and abnormal findings. This is often incorporated into the portfolio development portion of a training program, as learners can submit their image interpretation along with the video clip. Both normal and abnormal images can be used to assess anatomic recognition and interpretation. Emphasis should be placed on determining when an image is suboptimal for diagnosis (eg, incomplete exam or poor-quality images). Quality assurance programs should incorporate structured feedback sessions.

Clinical Integration

Assessment of clinical integration can be completed through case scenarios that assess knowledge, interpretation of images, and integration of findings into clinical decision making, which is often delivered via a computer-based assessment. Assessments should combine specific POCUS applications to evaluate common clinical problems in hospital medicine, such as undifferentiated hypotension and dyspnea. High-fidelity simulators can be used to blend clinical case scenarios with image acquisition, image interpretation, and clinical integration. When feasible, comprehensive feedback on how providers acquire, interpret, and apply ultrasound at the bedside is likely the best mechanism to assess clinical integration. This process can be done with a hospitalist’s own patients.

General Assessment

A general assessment that includes a summative knowledge and hands-on skills assessment using task-specific checklists can be performed upon completion of training. A high-fidelity simulator with dynamic or virtual anatomy can provide reproducible standardized assessments with variation in the type and difficulty of cases. When available, we encourage the use of dynamic assessments on actual patients that have both normal and abnormal ultrasound findings because simulated patient scenarios have limitations, even with the use of high-fidelity simulators. Programs are recommended to use formative and summative assessments for evaluation. Quantitative scoring systems using checklists are likely the best framework.^11,12

A certificate of completion is proof of a provider’s participation in an educational activity; it does not equate with competency, though it may be a step toward it. Most POCUS training workshops and short courses provide certificates of completion. Certification of competency is an attestation of a hospitalist’s basic competence within a defined scope of practice (Table 2).¹³ However, without longitudinal supervision and feedback, skills can decay; therefore, we recommend a longitudinal training program that provides mentored feedback and incorporates periodic competency assessments. At present, no national board certification in POCUS is available to grant external certification of competency for hospitalists.

External Certificate

Certificates of completion can be external through a national organization. An external certificate of completion designed for hospitalists includes the POCUS Certificate of Completion offered by SHM in collaboration with CHEST.⁶ This certificate program provides regional training options and longitudinal portfolio development. Other external certificates are also available to hospitalists.^7,14,15

Most hospitalists are boarded by the American Board of Internal Medicine or the American Board of Family Medicine. These boards do not yet include certification of competency in POCUS. Other specialty boards, such as emergency medicine, include competency in POCUS. For emergency medicine, completion of an accredited residency training program and certification by the national board includes POCUS competency.

Internal Certificate

There are a few examples of successful local institutional programs that have provided internal certificates of competency.^12,14 Competency assessments require significant resources including investment by both faculty and learners. Ongoing evaluation of competency should be based on quality assurance processes.

Credentialing and Privileging

The American Medical Association (AMA) House of Delegates in 1999 passed a resolution (AMA HR. 802) recommending hospitals follow specialty-specific guidelines for privileging decisions related to POCUS use.¹⁷ The resolution included a statement that, “ultrasound imaging is within the scope of practice of appropriately trained physicians.”

Some institutions have begun to rely on a combination of internal and external certificate programs to grant privileges to hospitalists.¹⁰ Although specific privileges for POCUS may not be required in some hospitals, some institutions may require certification of training and assessments prior to granting permission to use POCUS.

Hospitalist programs are encouraged to evaluate ongoing POCUS use by their providers after granting initial permission. If privileging is instituted by a hospital, hospitalists must play a significant role in determining the requirements for privileging and ongoing maintenance of skills.

Maintenance of Skills

All medical skills can decay with disuse, including those associated with POCUS.^12,18 Thus, POCUS users should continue using POCUS regularly in clinical practice and participate in POCUS continuing medical education activities, ideally with ongoing assessments. Maintenance of skills may be confirmed through routine participation in a quality assurance program.

Use of POCUS in hospital medicine has unique considerations, and hospitalists should be integrally involved in decision making surrounding institutional POCUS program management. Appointing a dedicated POCUS director can help a program succeed.⁸

Equipment and Image Archiving

Several factors are important to consider when selecting an ultrasound machine: portability, screen size, and ease of use; integration with the electronic medical record and options for image archiving; manufacturer’s service plan, including technical and clinical support; and compliance with local infection control policies. The ability to easily archive and retrieve images is essential for quality assurance, continuing education, institutional quality improvement, documentation, and reimbursement. In certain scenarios, image archiving may not be possible (such as with personal handheld devices or in emergency situations) or necessary (such as with frequent serial examinations during fluid resuscitation). An image archive is ideally linked to reports, orders, and billing software.^10,19 If such linkages are not feasible, parallel external storage that complies with regulatory standards (ie, HIPAA compliance) may be suitable.²⁰

Documentation and Billing

Components of documentation include the indication and type of ultrasound examination performed, date and time of the examination, patient identifying information, name of provider(s) acquiring and interpreting the images, specific scanning protocols used, patient position, probe used, and findings. Documentation can occur through a standalone note or as part of another note, such as a progress note. Whenever possible, documentation should be timely to facilitate communication with other providers.

Billing is supported through the AMA Current Procedural Terminology codes for “focused” or “limited” ultrasound examinations (Appendix 9). The following three criteria must be satisfied for billing. First, images must be permanently stored. Specific requirements vary by insurance policy, though current practice suggests a minimum of one image demonstrating relevant anatomy and pathology for the ultrasound examination coded. For ultrasound-guided procedures that require needle insertion, images should be captured at the point of interest, and a procedure note should reflect that the needle was guided and visualized under ultrasound.²¹ Second, proper documentation must be entered in the medical record. Third, local institutional privileges for POCUS must be considered. Although privileges are not required to bill, some hospitals or payers may require them.

Quality Assurance

Published guidelines on quality assurance in POCUS are available from different specialty organizations, including emergency medicine, pediatric emergency medicine, critical care, anesthesiology, obstetrics, and cardiology.^8,22–28 Quality assurance is aimed at ensuring that physicians maintain basic competency in using POCUS to influence bedside decisions.

Quality assurance should be carried out by an individual or committee with expertise in POCUS. Multidisciplinary QA programs in which hospital medicine providers are working collaboratively with other POCUS providers have been demonstrated to be highly effective.¹⁰ Oversight includes ensuring that providers using POCUS are appropriately trained,^10,22,28 using the equipment correctly,^8,26,28 and documenting properly. Some programs have implemented mechanisms to review and provide feedback on image acquisition, interpretation, and clinical integration.^8,10 Other programs have compared POCUS findings with referral studies, such as comprehensive ultrasound examinations.

Practicing hospitalists must continue to collaborate with their institutions to build POCUS capabilities. In particular, they must work with their local privileging body to determine what credentials are required. The distinction between certificates of completion and certificates of competency, including whether those certificates are internal or external, is important in the credentialing process.

External certificates of competency are currently unavailable for most practicing hospitalists because ABIM certification does not include POCUS-related competencies. As internal medicine residency training programs begin to adopt POCUS training and certification into their educational curricula, we foresee a need to update the ABIM Policies and Procedures for Certification. Until then, we recommend that certificates of competency be defined and granted internally by local hospitalist groups.

Given the many advantages of POCUS over traditional tools, we anticipate its increasing implementation among hospitalists in the future. As with all medical technology, its role in clinical care should be continuously reexamined and redefined through health services research. Such information will be useful in developing practice guidelines, educational curricula, and training standards.

Acknowledgments

The authors would like to thank all members that participated in the discussion and finalization of this position statement during the Point-of-care Ultrasound Faculty Retreat at the 2018 Society of Hospital Medicine Annual Conference: Saaid Abdel-Ghani, Brandon Boesch, Joel Cho, Ria Dancel, Renee Dversdal, Ricardo Franco-Sadud, Benjamin Galen, Trevor P. Jensen, Mohit Jindal, Gordon Johnson, Linda M. Kurian, Gigi Liu, Charles M. LoPresti, Brian P. Lucas, Venkat Kalidindi, Benji Matthews, Anna Maw, Gregory Mints, Kreegan Reierson, Gerard Salame, Richard Schildhouse, Daniel Schnobrich, Nilam Soni, Kirk Spencer, Hiromizu Takahashi, David M. Tierney, Tanping Wong, and Toru Yamada.

Many hospitalists incorporate point-of-care ultrasound (POCUS) into their daily practice because it adds value to their bedside evaluation of patients. However, standards for training and assessing hospitalists in POCUS have not yet been established. Other acute care specialties, including emergency medicine and critical care medicine, have already incorporated POCUS into their graduate medical education training programs, but most internal medicine residency programs are only beginning to provide POCUS training.¹

Several features distinguish POCUS from comprehensive ultrasound examinations. First, POCUS is designed to answer focused questions, whereas comprehensive ultrasound examinations evaluate all organs in an anatomical region; for example, an abdominal POCUS exam may evaluate only for presence or absence of intraperitoneal free fluid, whereas a comprehensive examination of the right upper quadrant will evaluate the liver, gallbladder, and biliary ducts. Second, POCUS examinations are generally performed by the same clinician who generates the relevant clinical question to answer with POCUS and ultimately integrates the findings into the patient’s care.² By contrast, comprehensive ultrasound examinations involve multiple providers and steps: a clinician generates a relevant clinical question and requests an ultrasound examination that is acquired by a sonographer, interpreted by a radiologist, and reported back to the requesting clinician. Third, POCUS is often used to evaluate multiple body systems. For example, to evaluate a patient with undifferentiated hypotension, a multisystem POCUS examination of the heart, inferior vena cava, lungs, abdomen, and lower extremity veins is typically performed. Finally, POCUS examinations can be performed serially to investigate changes in clinical status or evaluate response to therapy, such as monitoring the heart, lungs, and inferior vena cava during fluid resuscitation.

The purpose of this position statement is to inform a broad audience about how hospitalists are using diagnostic and procedural applications of POCUS. This position statement does not mandate that hospitalists use POCUS. Rather, it is intended to provide guidance on the safe and effective use of POCUS by the hospitalists who use it and the administrators who oversee its use. We discuss POCUS (1) applications, (2) training, (3) assessments, and (4) program management. This position statement was reviewed and approved by the Society of Hospital Medicine (SHM) Executive Committee in March 2018.

Common diagnostic and procedural applications of POCUS used by hospitalists are listed in Table 1. Selected evidence supporting the use of these applications is described in the supplementary online content (Appendices 1–8 available at http://journalofhospitalmedicine.com) and SHM position statements on specific ultrasound-guided bedside procedures.^3,4 Additional applications not listed in Table 1 that may be performed by some hospitalists include assessment of the eyes, stomach, bowels, ovaries, pregnancy, and testicles, as well as performance of regional anesthesia. Moreover, hospitalists caring for pediatric and adolescent patients may use additional applications besides those listed here. Currently, many hospitalists already perform more complex and sophisticated POCUS examinations than those listed in Table 1. The scope of POCUS use by hospitalists continues to expand, and this position statement should not restrict that expansion.

As outlined in our earlier position statements,^3,4 ultrasound guidance lowers complication rates and increases success rates of invasive bedside procedures. Diagnostic POCUS can guide clinical decision making prior to bedside procedures. For instance, hospitalists may use POCUS to assess the size and character of a pleural effusion to help determine the most appropriate management strategy: observation, medical treatment, thoracentesis, chest tube placement, or surgical therapy. Furthermore, diagnostic POCUS can be used to rapidly assess for immediate postprocedural complications, such as pneumothorax, or if the patient develops new symptoms.

Basic Knowledge

Basic knowledge includes fundamentals of ultrasound physics; safety;⁴ anatomy; physiology; and device operation, including maintenance and cleaning. Basic knowledge can be taught by multiple methods, including live or recorded lectures, online modules, or directed readings.

Image Acquisition

Training should occur across multiple types of patients (eg, obese, cachectic, postsurgical) and clinical settings (eg, intensive care unit, general medicine wards, emergency department) when available. Training is largely hands-on because the relevant skills involve integration of 3D anatomy with spatial manipulation, hand-eye coordination, and fine motor movements. Virtual reality ultrasound simulators may accelerate mastery, particularly for cardiac image acquisition, and expose learners to standardized sets of pathologic findings. Real-time bedside feedback on image acquisition is ideal because understanding how ultrasound probe manipulation affects the images acquired is essential to learning.

Image Interpretation

Training in image interpretation relies on visual pattern recognition of normal and abnormal findings. Therefore, the normal to abnormal spectrum should be broad, and learners should maintain a log of what abnormalities have been identified. Giving real-time feedback at the bedside is ideal because of the connection between image acquisition and interpretation. Image interpretation can be taught through didactic sessions, image review sessions, or review of teaching files with annotated images.

Clinical Integration

Learners must interpret and integrate image findings with other clinical data considering the image quality, patient characteristics, and changing physiology. Clinical integration should be taught by instructors that share similar clinical knowledge as learners. Although sonographers are well suited to teach image acquisition, they should not be the sole instructors to teach hospitalists how to integrate ultrasound findings in clinical decision making. Likewise, emphasis should be placed on the appropriate use of POCUS within a provider’s skill set. Learners must appreciate the clinical significance of POCUS findings, including recognition of incidental findings that may require further workup. Supplemental training in clinical integration can occur through didactics that include complex patient scenarios.

Pathways

Clinical competency can be achieved with training adherent to five criteria. First, the training environment should be similar to where the trainee will practice. Second, training and feedback should occur in real time. Third, specific applications should be taught rather than broad training in “hospitalist POCUS.” Each application requires unique skills and knowledge, including image acquisition pitfalls and artifacts. Fourth, clinical competence must be achieved and demonstrated; it is not necessarily gained through experience. Fifth, once competency is achieved, continued education and feedback are necessary to ensure it is maintained.

Residency-based POCUS training pathways can best fulfill these criteria. They may eventually become commonplace, but until then alternative pathways must exist for hospitalist providers who are already in practice. There are three important attributes of such pathways. First, administrators’ expectations about learners’ clinical productivity must be realistically, but only temporarily, relaxed; otherwise, competing demands on time will likely overwhelm learners and subvert training. Second, training should begin through a local or national hands-on training program. The SHM POCUS certificate program consolidates training for common diagnostic POCUS applications for hospitalists.⁶ Other medical societies offer training for their respective clinical specialties.⁷ Third, once basic POCUS training has begun, longitudinal training should continue ideally with a local hospitalist POCUS expert.

In some settings, a subgroup of hospitalists may not desire, or be able to achieve, competency in the manual skills of POCUS image acquisition. Nevertheless, hospitalists may still find value in understanding POCUS nomenclature, image pattern recognition, and the evidence and pitfalls behind clinical integration of specific POCUS findings. This subset of POCUS skills allows hospitalists to communicate effectively with and understand the clinical decisions made by their colleagues who are competent in POCUS use.

The minimal skills a hospitalist should possess to serve as a POCUS trainer include proficiency of basic knowledge, image acquisition, image interpretation, and clinical integration of the POCUS applications being taught; effectiveness as a hands-on instructor to teach image acquisition skills; and an in-depth understanding of common POCUS pitfalls and limitations.

Assessment methods for POCUS can include the following: knowledge-based questions, image acquisition using task-specific checklists on human or simulation models, image interpretation using a series of videos or still images with normal and abnormal findings, clinical integration using “next best step” in a multiple choice format with POCUS images, and simulation-based clinical scenarios. Assessment methods should be aligned with local availability of resources and trainers.

Basic Knowledge

Basic knowledge can be assessed via multiple choice questions assessing knowledge of ultrasound physics, image optimization, relevant anatomy, and limitations of POCUS imaging. Basic knowledge lies primarily in the cognitive domain and does not assess manual skills.

Image Acquisition

Image acquisition can be assessed by observation and rating of image quality. Where resources allow, assessment of image acquisition is likely best done through a combination of developing an image portfolio with a minimum number of high quality images, plus direct observation of image acquisition by an expert. Various programs have utilized minimum numbers of images acquired to help define competence with image acquisition skills.^6–8 Although minimums may be a necessary step to gain competence, using them as a sole means to determine competence does not account for variable learning curves.⁹ As with other manual skills in hospital medicine, such as ultrasound-guided bedside procedures, minimum numbers are best used as a starting point for assessments.^3,10 In this regard, portfolio development with meticulous attention to the gain, depth, and proper tomographic plane of images can monitor a hospitalist’s progress toward competence by providing objective assessments and feedback. Simulation may also be used as it allows assessment of image acquisition skills and an opportunity to provide real-time feedback, similar to direct observation but without actual patients.

Image Interpretation

Image interpretation is best assessed by an expert observing the learner at bedside; however, when bedside assessment is not possible, image interpretation skills may be assessed using multiple choice or free text interpretation of archived ultrasound images with normal and abnormal findings. This is often incorporated into the portfolio development portion of a training program, as learners can submit their image interpretation along with the video clip. Both normal and abnormal images can be used to assess anatomic recognition and interpretation. Emphasis should be placed on determining when an image is suboptimal for diagnosis (eg, incomplete exam or poor-quality images). Quality assurance programs should incorporate structured feedback sessions.

Clinical Integration

Assessment of clinical integration can be completed through case scenarios that assess knowledge, interpretation of images, and integration of findings into clinical decision making, which is often delivered via a computer-based assessment. Assessments should combine specific POCUS applications to evaluate common clinical problems in hospital medicine, such as undifferentiated hypotension and dyspnea. High-fidelity simulators can be used to blend clinical case scenarios with image acquisition, image interpretation, and clinical integration. When feasible, comprehensive feedback on how providers acquire, interpret, and apply ultrasound at the bedside is likely the best mechanism to assess clinical integration. This process can be done with a hospitalist’s own patients.

General Assessment

A general assessment that includes a summative knowledge and hands-on skills assessment using task-specific checklists can be performed upon completion of training. A high-fidelity simulator with dynamic or virtual anatomy can provide reproducible standardized assessments with variation in the type and difficulty of cases. When available, we encourage the use of dynamic assessments on actual patients that have both normal and abnormal ultrasound findings because simulated patient scenarios have limitations, even with the use of high-fidelity simulators. Programs are recommended to use formative and summative assessments for evaluation. Quantitative scoring systems using checklists are likely the best framework.^11,12

A certificate of completion is proof of a provider’s participation in an educational activity; it does not equate with competency, though it may be a step toward it. Most POCUS training workshops and short courses provide certificates of completion. Certification of competency is an attestation of a hospitalist’s basic competence within a defined scope of practice (Table 2).¹³ However, without longitudinal supervision and feedback, skills can decay; therefore, we recommend a longitudinal training program that provides mentored feedback and incorporates periodic competency assessments. At present, no national board certification in POCUS is available to grant external certification of competency for hospitalists.

External Certificate

Certificates of completion can be external through a national organization. An external certificate of completion designed for hospitalists includes the POCUS Certificate of Completion offered by SHM in collaboration with CHEST.⁶ This certificate program provides regional training options and longitudinal portfolio development. Other external certificates are also available to hospitalists.^7,14,15

Most hospitalists are boarded by the American Board of Internal Medicine or the American Board of Family Medicine. These boards do not yet include certification of competency in POCUS. Other specialty boards, such as emergency medicine, include competency in POCUS. For emergency medicine, completion of an accredited residency training program and certification by the national board includes POCUS competency.

Internal Certificate

There are a few examples of successful local institutional programs that have provided internal certificates of competency.^12,14 Competency assessments require significant resources including investment by both faculty and learners. Ongoing evaluation of competency should be based on quality assurance processes.

Credentialing and Privileging

The American Medical Association (AMA) House of Delegates in 1999 passed a resolution (AMA HR. 802) recommending hospitals follow specialty-specific guidelines for privileging decisions related to POCUS use.¹⁷ The resolution included a statement that, “ultrasound imaging is within the scope of practice of appropriately trained physicians.”

Some institutions have begun to rely on a combination of internal and external certificate programs to grant privileges to hospitalists.¹⁰ Although specific privileges for POCUS may not be required in some hospitals, some institutions may require certification of training and assessments prior to granting permission to use POCUS.

Hospitalist programs are encouraged to evaluate ongoing POCUS use by their providers after granting initial permission. If privileging is instituted by a hospital, hospitalists must play a significant role in determining the requirements for privileging and ongoing maintenance of skills.

Maintenance of Skills

All medical skills can decay with disuse, including those associated with POCUS.^12,18 Thus, POCUS users should continue using POCUS regularly in clinical practice and participate in POCUS continuing medical education activities, ideally with ongoing assessments. Maintenance of skills may be confirmed through routine participation in a quality assurance program.

Use of POCUS in hospital medicine has unique considerations, and hospitalists should be integrally involved in decision making surrounding institutional POCUS program management. Appointing a dedicated POCUS director can help a program succeed.⁸

Equipment and Image Archiving

Several factors are important to consider when selecting an ultrasound machine: portability, screen size, and ease of use; integration with the electronic medical record and options for image archiving; manufacturer’s service plan, including technical and clinical support; and compliance with local infection control policies. The ability to easily archive and retrieve images is essential for quality assurance, continuing education, institutional quality improvement, documentation, and reimbursement. In certain scenarios, image archiving may not be possible (such as with personal handheld devices or in emergency situations) or necessary (such as with frequent serial examinations during fluid resuscitation). An image archive is ideally linked to reports, orders, and billing software.^10,19 If such linkages are not feasible, parallel external storage that complies with regulatory standards (ie, HIPAA compliance) may be suitable.²⁰

Documentation and Billing

Components of documentation include the indication and type of ultrasound examination performed, date and time of the examination, patient identifying information, name of provider(s) acquiring and interpreting the images, specific scanning protocols used, patient position, probe used, and findings. Documentation can occur through a standalone note or as part of another note, such as a progress note. Whenever possible, documentation should be timely to facilitate communication with other providers.

Billing is supported through the AMA Current Procedural Terminology codes for “focused” or “limited” ultrasound examinations (Appendix 9). The following three criteria must be satisfied for billing. First, images must be permanently stored. Specific requirements vary by insurance policy, though current practice suggests a minimum of one image demonstrating relevant anatomy and pathology for the ultrasound examination coded. For ultrasound-guided procedures that require needle insertion, images should be captured at the point of interest, and a procedure note should reflect that the needle was guided and visualized under ultrasound.²¹ Second, proper documentation must be entered in the medical record. Third, local institutional privileges for POCUS must be considered. Although privileges are not required to bill, some hospitals or payers may require them.

Quality Assurance

Published guidelines on quality assurance in POCUS are available from different specialty organizations, including emergency medicine, pediatric emergency medicine, critical care, anesthesiology, obstetrics, and cardiology.^8,22–28 Quality assurance is aimed at ensuring that physicians maintain basic competency in using POCUS to influence bedside decisions.

Quality assurance should be carried out by an individual or committee with expertise in POCUS. Multidisciplinary QA programs in which hospital medicine providers are working collaboratively with other POCUS providers have been demonstrated to be highly effective.¹⁰ Oversight includes ensuring that providers using POCUS are appropriately trained,^10,22,28 using the equipment correctly,^8,26,28 and documenting properly. Some programs have implemented mechanisms to review and provide feedback on image acquisition, interpretation, and clinical integration.^8,10 Other programs have compared POCUS findings with referral studies, such as comprehensive ultrasound examinations.

Practicing hospitalists must continue to collaborate with their institutions to build POCUS capabilities. In particular, they must work with their local privileging body to determine what credentials are required. The distinction between certificates of completion and certificates of competency, including whether those certificates are internal or external, is important in the credentialing process.

External certificates of competency are currently unavailable for most practicing hospitalists because ABIM certification does not include POCUS-related competencies. As internal medicine residency training programs begin to adopt POCUS training and certification into their educational curricula, we foresee a need to update the ABIM Policies and Procedures for Certification. Until then, we recommend that certificates of competency be defined and granted internally by local hospitalist groups.

Given the many advantages of POCUS over traditional tools, we anticipate its increasing implementation among hospitalists in the future. As with all medical technology, its role in clinical care should be continuously reexamined and redefined through health services research. Such information will be useful in developing practice guidelines, educational curricula, and training standards.

Acknowledgments

The authors would like to thank all members that participated in the discussion and finalization of this position statement during the Point-of-care Ultrasound Faculty Retreat at the 2018 Society of Hospital Medicine Annual Conference: Saaid Abdel-Ghani, Brandon Boesch, Joel Cho, Ria Dancel, Renee Dversdal, Ricardo Franco-Sadud, Benjamin Galen, Trevor P. Jensen, Mohit Jindal, Gordon Johnson, Linda M. Kurian, Gigi Liu, Charles M. LoPresti, Brian P. Lucas, Venkat Kalidindi, Benji Matthews, Anna Maw, Gregory Mints, Kreegan Reierson, Gerard Salame, Richard Schildhouse, Daniel Schnobrich, Nilam Soni, Kirk Spencer, Hiromizu Takahashi, David M. Tierney, Tanping Wong, and Toru Yamada.

Many hospitalists incorporate point-of-care ultrasound (POCUS) into their daily practice because it adds value to their bedside evaluation of patients. However, standards for training and assessing hospitalists in POCUS have not yet been established. Other acute care specialties, including emergency medicine and critical care medicine, have already incorporated POCUS into their graduate medical education training programs, but most internal medicine residency programs are only beginning to provide POCUS training.¹

Several features distinguish POCUS from comprehensive ultrasound examinations. First, POCUS is designed to answer focused questions, whereas comprehensive ultrasound examinations evaluate all organs in an anatomical region; for example, an abdominal POCUS exam may evaluate only for presence or absence of intraperitoneal free fluid, whereas a comprehensive examination of the right upper quadrant will evaluate the liver, gallbladder, and biliary ducts. Second, POCUS examinations are generally performed by the same clinician who generates the relevant clinical question to answer with POCUS and ultimately integrates the findings into the patient’s care.² By contrast, comprehensive ultrasound examinations involve multiple providers and steps: a clinician generates a relevant clinical question and requests an ultrasound examination that is acquired by a sonographer, interpreted by a radiologist, and reported back to the requesting clinician. Third, POCUS is often used to evaluate multiple body systems. For example, to evaluate a patient with undifferentiated hypotension, a multisystem POCUS examination of the heart, inferior vena cava, lungs, abdomen, and lower extremity veins is typically performed. Finally, POCUS examinations can be performed serially to investigate changes in clinical status or evaluate response to therapy, such as monitoring the heart, lungs, and inferior vena cava during fluid resuscitation.

The purpose of this position statement is to inform a broad audience about how hospitalists are using diagnostic and procedural applications of POCUS. This position statement does not mandate that hospitalists use POCUS. Rather, it is intended to provide guidance on the safe and effective use of POCUS by the hospitalists who use it and the administrators who oversee its use. We discuss POCUS (1) applications, (2) training, (3) assessments, and (4) program management. This position statement was reviewed and approved by the Society of Hospital Medicine (SHM) Executive Committee in March 2018.

Common diagnostic and procedural applications of POCUS used by hospitalists are listed in Table 1. Selected evidence supporting the use of these applications is described in the supplementary online content (Appendices 1–8 available at http://journalofhospitalmedicine.com) and SHM position statements on specific ultrasound-guided bedside procedures.^3,4 Additional applications not listed in Table 1 that may be performed by some hospitalists include assessment of the eyes, stomach, bowels, ovaries, pregnancy, and testicles, as well as performance of regional anesthesia. Moreover, hospitalists caring for pediatric and adolescent patients may use additional applications besides those listed here. Currently, many hospitalists already perform more complex and sophisticated POCUS examinations than those listed in Table 1. The scope of POCUS use by hospitalists continues to expand, and this position statement should not restrict that expansion.

As outlined in our earlier position statements,^3,4 ultrasound guidance lowers complication rates and increases success rates of invasive bedside procedures. Diagnostic POCUS can guide clinical decision making prior to bedside procedures. For instance, hospitalists may use POCUS to assess the size and character of a pleural effusion to help determine the most appropriate management strategy: observation, medical treatment, thoracentesis, chest tube placement, or surgical therapy. Furthermore, diagnostic POCUS can be used to rapidly assess for immediate postprocedural complications, such as pneumothorax, or if the patient develops new symptoms.

Basic Knowledge

Basic knowledge includes fundamentals of ultrasound physics; safety;⁴ anatomy; physiology; and device operation, including maintenance and cleaning. Basic knowledge can be taught by multiple methods, including live or recorded lectures, online modules, or directed readings.

Image Acquisition

Training should occur across multiple types of patients (eg, obese, cachectic, postsurgical) and clinical settings (eg, intensive care unit, general medicine wards, emergency department) when available. Training is largely hands-on because the relevant skills involve integration of 3D anatomy with spatial manipulation, hand-eye coordination, and fine motor movements. Virtual reality ultrasound simulators may accelerate mastery, particularly for cardiac image acquisition, and expose learners to standardized sets of pathologic findings. Real-time bedside feedback on image acquisition is ideal because understanding how ultrasound probe manipulation affects the images acquired is essential to learning.

Image Interpretation

Training in image interpretation relies on visual pattern recognition of normal and abnormal findings. Therefore, the normal to abnormal spectrum should be broad, and learners should maintain a log of what abnormalities have been identified. Giving real-time feedback at the bedside is ideal because of the connection between image acquisition and interpretation. Image interpretation can be taught through didactic sessions, image review sessions, or review of teaching files with annotated images.

Clinical Integration

Learners must interpret and integrate image findings with other clinical data considering the image quality, patient characteristics, and changing physiology. Clinical integration should be taught by instructors that share similar clinical knowledge as learners. Although sonographers are well suited to teach image acquisition, they should not be the sole instructors to teach hospitalists how to integrate ultrasound findings in clinical decision making. Likewise, emphasis should be placed on the appropriate use of POCUS within a provider’s skill set. Learners must appreciate the clinical significance of POCUS findings, including recognition of incidental findings that may require further workup. Supplemental training in clinical integration can occur through didactics that include complex patient scenarios.

Pathways

Clinical competency can be achieved with training adherent to five criteria. First, the training environment should be similar to where the trainee will practice. Second, training and feedback should occur in real time. Third, specific applications should be taught rather than broad training in “hospitalist POCUS.” Each application requires unique skills and knowledge, including image acquisition pitfalls and artifacts. Fourth, clinical competence must be achieved and demonstrated; it is not necessarily gained through experience. Fifth, once competency is achieved, continued education and feedback are necessary to ensure it is maintained.

Residency-based POCUS training pathways can best fulfill these criteria. They may eventually become commonplace, but until then alternative pathways must exist for hospitalist providers who are already in practice. There are three important attributes of such pathways. First, administrators’ expectations about learners’ clinical productivity must be realistically, but only temporarily, relaxed; otherwise, competing demands on time will likely overwhelm learners and subvert training. Second, training should begin through a local or national hands-on training program. The SHM POCUS certificate program consolidates training for common diagnostic POCUS applications for hospitalists.⁶ Other medical societies offer training for their respective clinical specialties.⁷ Third, once basic POCUS training has begun, longitudinal training should continue ideally with a local hospitalist POCUS expert.

In some settings, a subgroup of hospitalists may not desire, or be able to achieve, competency in the manual skills of POCUS image acquisition. Nevertheless, hospitalists may still find value in understanding POCUS nomenclature, image pattern recognition, and the evidence and pitfalls behind clinical integration of specific POCUS findings. This subset of POCUS skills allows hospitalists to communicate effectively with and understand the clinical decisions made by their colleagues who are competent in POCUS use.

The minimal skills a hospitalist should possess to serve as a POCUS trainer include proficiency of basic knowledge, image acquisition, image interpretation, and clinical integration of the POCUS applications being taught; effectiveness as a hands-on instructor to teach image acquisition skills; and an in-depth understanding of common POCUS pitfalls and limitations.

Assessment methods for POCUS can include the following: knowledge-based questions, image acquisition using task-specific checklists on human or simulation models, image interpretation using a series of videos or still images with normal and abnormal findings, clinical integration using “next best step” in a multiple choice format with POCUS images, and simulation-based clinical scenarios. Assessment methods should be aligned with local availability of resources and trainers.

Basic Knowledge

Basic knowledge can be assessed via multiple choice questions assessing knowledge of ultrasound physics, image optimization, relevant anatomy, and limitations of POCUS imaging. Basic knowledge lies primarily in the cognitive domain and does not assess manual skills.

Image Acquisition

Image acquisition can be assessed by observation and rating of image quality. Where resources allow, assessment of image acquisition is likely best done through a combination of developing an image portfolio with a minimum number of high quality images, plus direct observation of image acquisition by an expert. Various programs have utilized minimum numbers of images acquired to help define competence with image acquisition skills.^6–8 Although minimums may be a necessary step to gain competence, using them as a sole means to determine competence does not account for variable learning curves.⁹ As with other manual skills in hospital medicine, such as ultrasound-guided bedside procedures, minimum numbers are best used as a starting point for assessments.^3,10 In this regard, portfolio development with meticulous attention to the gain, depth, and proper tomographic plane of images can monitor a hospitalist’s progress toward competence by providing objective assessments and feedback. Simulation may also be used as it allows assessment of image acquisition skills and an opportunity to provide real-time feedback, similar to direct observation but without actual patients.

Image Interpretation

Image interpretation is best assessed by an expert observing the learner at bedside; however, when bedside assessment is not possible, image interpretation skills may be assessed using multiple choice or free text interpretation of archived ultrasound images with normal and abnormal findings. This is often incorporated into the portfolio development portion of a training program, as learners can submit their image interpretation along with the video clip. Both normal and abnormal images can be used to assess anatomic recognition and interpretation. Emphasis should be placed on determining when an image is suboptimal for diagnosis (eg, incomplete exam or poor-quality images). Quality assurance programs should incorporate structured feedback sessions.

Clinical Integration

Assessment of clinical integration can be completed through case scenarios that assess knowledge, interpretation of images, and integration of findings into clinical decision making, which is often delivered via a computer-based assessment. Assessments should combine specific POCUS applications to evaluate common clinical problems in hospital medicine, such as undifferentiated hypotension and dyspnea. High-fidelity simulators can be used to blend clinical case scenarios with image acquisition, image interpretation, and clinical integration. When feasible, comprehensive feedback on how providers acquire, interpret, and apply ultrasound at the bedside is likely the best mechanism to assess clinical integration. This process can be done with a hospitalist’s own patients.

General Assessment

A general assessment that includes a summative knowledge and hands-on skills assessment using task-specific checklists can be performed upon completion of training. A high-fidelity simulator with dynamic or virtual anatomy can provide reproducible standardized assessments with variation in the type and difficulty of cases. When available, we encourage the use of dynamic assessments on actual patients that have both normal and abnormal ultrasound findings because simulated patient scenarios have limitations, even with the use of high-fidelity simulators. Programs are recommended to use formative and summative assessments for evaluation. Quantitative scoring systems using checklists are likely the best framework.^11,12

A certificate of completion is proof of a provider’s participation in an educational activity; it does not equate with competency, though it may be a step toward it. Most POCUS training workshops and short courses provide certificates of completion. Certification of competency is an attestation of a hospitalist’s basic competence within a defined scope of practice (Table 2).¹³ However, without longitudinal supervision and feedback, skills can decay; therefore, we recommend a longitudinal training program that provides mentored feedback and incorporates periodic competency assessments. At present, no national board certification in POCUS is available to grant external certification of competency for hospitalists.

External Certificate

Certificates of completion can be external through a national organization. An external certificate of completion designed for hospitalists includes the POCUS Certificate of Completion offered by SHM in collaboration with CHEST.⁶ This certificate program provides regional training options and longitudinal portfolio development. Other external certificates are also available to hospitalists.^7,14,15

Most hospitalists are boarded by the American Board of Internal Medicine or the American Board of Family Medicine. These boards do not yet include certification of competency in POCUS. Other specialty boards, such as emergency medicine, include competency in POCUS. For emergency medicine, completion of an accredited residency training program and certification by the national board includes POCUS competency.

Internal Certificate

There are a few examples of successful local institutional programs that have provided internal certificates of competency.^12,14 Competency assessments require significant resources including investment by both faculty and learners. Ongoing evaluation of competency should be based on quality assurance processes.

Credentialing and Privileging

The American Medical Association (AMA) House of Delegates in 1999 passed a resolution (AMA HR. 802) recommending hospitals follow specialty-specific guidelines for privileging decisions related to POCUS use.¹⁷ The resolution included a statement that, “ultrasound imaging is within the scope of practice of appropriately trained physicians.”

Some institutions have begun to rely on a combination of internal and external certificate programs to grant privileges to hospitalists.¹⁰ Although specific privileges for POCUS may not be required in some hospitals, some institutions may require certification of training and assessments prior to granting permission to use POCUS.

Hospitalist programs are encouraged to evaluate ongoing POCUS use by their providers after granting initial permission. If privileging is instituted by a hospital, hospitalists must play a significant role in determining the requirements for privileging and ongoing maintenance of skills.

Maintenance of Skills

All medical skills can decay with disuse, including those associated with POCUS.^12,18 Thus, POCUS users should continue using POCUS regularly in clinical practice and participate in POCUS continuing medical education activities, ideally with ongoing assessments. Maintenance of skills may be confirmed through routine participation in a quality assurance program.

Use of POCUS in hospital medicine has unique considerations, and hospitalists should be integrally involved in decision making surrounding institutional POCUS program management. Appointing a dedicated POCUS director can help a program succeed.⁸

Equipment and Image Archiving

Several factors are important to consider when selecting an ultrasound machine: portability, screen size, and ease of use; integration with the electronic medical record and options for image archiving; manufacturer’s service plan, including technical and clinical support; and compliance with local infection control policies. The ability to easily archive and retrieve images is essential for quality assurance, continuing education, institutional quality improvement, documentation, and reimbursement. In certain scenarios, image archiving may not be possible (such as with personal handheld devices or in emergency situations) or necessary (such as with frequent serial examinations during fluid resuscitation). An image archive is ideally linked to reports, orders, and billing software.^10,19 If such linkages are not feasible, parallel external storage that complies with regulatory standards (ie, HIPAA compliance) may be suitable.²⁰

Documentation and Billing

Components of documentation include the indication and type of ultrasound examination performed, date and time of the examination, patient identifying information, name of provider(s) acquiring and interpreting the images, specific scanning protocols used, patient position, probe used, and findings. Documentation can occur through a standalone note or as part of another note, such as a progress note. Whenever possible, documentation should be timely to facilitate communication with other providers.

Billing is supported through the AMA Current Procedural Terminology codes for “focused” or “limited” ultrasound examinations (Appendix 9). The following three criteria must be satisfied for billing. First, images must be permanently stored. Specific requirements vary by insurance policy, though current practice suggests a minimum of one image demonstrating relevant anatomy and pathology for the ultrasound examination coded. For ultrasound-guided procedures that require needle insertion, images should be captured at the point of interest, and a procedure note should reflect that the needle was guided and visualized under ultrasound.²¹ Second, proper documentation must be entered in the medical record. Third, local institutional privileges for POCUS must be considered. Although privileges are not required to bill, some hospitals or payers may require them.

Quality Assurance

Published guidelines on quality assurance in POCUS are available from different specialty organizations, including emergency medicine, pediatric emergency medicine, critical care, anesthesiology, obstetrics, and cardiology.^8,22–28 Quality assurance is aimed at ensuring that physicians maintain basic competency in using POCUS to influence bedside decisions.

Quality assurance should be carried out by an individual or committee with expertise in POCUS. Multidisciplinary QA programs in which hospital medicine providers are working collaboratively with other POCUS providers have been demonstrated to be highly effective.¹⁰ Oversight includes ensuring that providers using POCUS are appropriately trained,^10,22,28 using the equipment correctly,^8,26,28 and documenting properly. Some programs have implemented mechanisms to review and provide feedback on image acquisition, interpretation, and clinical integration.^8,10 Other programs have compared POCUS findings with referral studies, such as comprehensive ultrasound examinations.

Practicing hospitalists must continue to collaborate with their institutions to build POCUS capabilities. In particular, they must work with their local privileging body to determine what credentials are required. The distinction between certificates of completion and certificates of competency, including whether those certificates are internal or external, is important in the credentialing process.

External certificates of competency are currently unavailable for most practicing hospitalists because ABIM certification does not include POCUS-related competencies. As internal medicine residency training programs begin to adopt POCUS training and certification into their educational curricula, we foresee a need to update the ABIM Policies and Procedures for Certification. Until then, we recommend that certificates of competency be defined and granted internally by local hospitalist groups.

Given the many advantages of POCUS over traditional tools, we anticipate its increasing implementation among hospitalists in the future. As with all medical technology, its role in clinical care should be continuously reexamined and redefined through health services research. Such information will be useful in developing practice guidelines, educational curricula, and training standards.

Acknowledgments

The authors would like to thank all members that participated in the discussion and finalization of this position statement during the Point-of-care Ultrasound Faculty Retreat at the 2018 Society of Hospital Medicine Annual Conference: Saaid Abdel-Ghani, Brandon Boesch, Joel Cho, Ria Dancel, Renee Dversdal, Ricardo Franco-Sadud, Benjamin Galen, Trevor P. Jensen, Mohit Jindal, Gordon Johnson, Linda M. Kurian, Gigi Liu, Charles M. LoPresti, Brian P. Lucas, Venkat Kalidindi, Benji Matthews, Anna Maw, Gregory Mints, Kreegan Reierson, Gerard Salame, Richard Schildhouse, Daniel Schnobrich, Nilam Soni, Kirk Spencer, Hiromizu Takahashi, David M. Tierney, Tanping Wong, and Toru Yamada.

SAN DIEGO – There was a mountain of data presented at the annual meeting of the American Society of Hematology on the use of novel agents – both as frontline therapy and in combination – for the treatment of chronic lymphocytic leukemia (CLL).

In a video interview at the meeting, Brian T. Hill, MD, PhD, of the Cleveland Clinic and Anthony Mato, MD, of Memorial Sloan Kettering Cancer Center, New York, summed up the key studies and what they mean in practice. They also looked ahead at what data are still missing that could aid in making important treatment decisions.

Dr. Hill highlighted the late-breaking abstract on the ECOG-ACRIN Cancer Research Group E1912 trial comparing ibrutinib-rituximab to a chemotherapy regimen of fludarabine, cyclophosphamide, and rituximab (FCR) in previously untreated patients under age 70 years (Abstract LBA-4). Not only was there a progression-free survival benefit with the use of the ibrutinib regimen, but there was an overall survival benefit as well, he noted.

Dr. Mato pointed to notable results from the Alliance A041202 trial of older patients with previously untreated disease that compared ibrutinib alone or in combination with rituximab, with bendamustine plus rituximab (Abstract #6). The ibrutinib-containing regimens resulted in superior progression-free survival.

The two trials taken together show a movement away from chemotherapy in the frontline setting and toward targeted agents for CLL, Dr. Mato said. “What that agent or combination of agents will be, remains to be seen,” he said. “We have now a real message about the fact that we’re ending, potentially, the era of chemotherapy for patients with CLL, which is a very welcome change.”

Dr. Mato and Dr. Hill will be discussing these trials and more CLL data during a Twitter chat on Jan. 31, 2019, from 7 p.m. to 8 p.m. EST. Join in the conversation by using and following #MDedgeChats.

[email protected]

SAN DIEGO – There was a mountain of data presented at the annual meeting of the American Society of Hematology on the use of novel agents – both as frontline therapy and in combination – for the treatment of chronic lymphocytic leukemia (CLL).

In a video interview at the meeting, Brian T. Hill, MD, PhD, of the Cleveland Clinic and Anthony Mato, MD, of Memorial Sloan Kettering Cancer Center, New York, summed up the key studies and what they mean in practice. They also looked ahead at what data are still missing that could aid in making important treatment decisions.

Dr. Hill highlighted the late-breaking abstract on the ECOG-ACRIN Cancer Research Group E1912 trial comparing ibrutinib-rituximab to a chemotherapy regimen of fludarabine, cyclophosphamide, and rituximab (FCR) in previously untreated patients under age 70 years (Abstract LBA-4). Not only was there a progression-free survival benefit with the use of the ibrutinib regimen, but there was an overall survival benefit as well, he noted.

Dr. Mato pointed to notable results from the Alliance A041202 trial of older patients with previously untreated disease that compared ibrutinib alone or in combination with rituximab, with bendamustine plus rituximab (Abstract #6). The ibrutinib-containing regimens resulted in superior progression-free survival.

The two trials taken together show a movement away from chemotherapy in the frontline setting and toward targeted agents for CLL, Dr. Mato said. “What that agent or combination of agents will be, remains to be seen,” he said. “We have now a real message about the fact that we’re ending, potentially, the era of chemotherapy for patients with CLL, which is a very welcome change.”

Dr. Mato and Dr. Hill will be discussing these trials and more CLL data during a Twitter chat on Jan. 31, 2019, from 7 p.m. to 8 p.m. EST. Join in the conversation by using and following #MDedgeChats.

[email protected]

SAN DIEGO – There was a mountain of data presented at the annual meeting of the American Society of Hematology on the use of novel agents – both as frontline therapy and in combination – for the treatment of chronic lymphocytic leukemia (CLL).

In a video interview at the meeting, Brian T. Hill, MD, PhD, of the Cleveland Clinic and Anthony Mato, MD, of Memorial Sloan Kettering Cancer Center, New York, summed up the key studies and what they mean in practice. They also looked ahead at what data are still missing that could aid in making important treatment decisions.

Dr. Hill highlighted the late-breaking abstract on the ECOG-ACRIN Cancer Research Group E1912 trial comparing ibrutinib-rituximab to a chemotherapy regimen of fludarabine, cyclophosphamide, and rituximab (FCR) in previously untreated patients under age 70 years (Abstract LBA-4). Not only was there a progression-free survival benefit with the use of the ibrutinib regimen, but there was an overall survival benefit as well, he noted.

Dr. Mato pointed to notable results from the Alliance A041202 trial of older patients with previously untreated disease that compared ibrutinib alone or in combination with rituximab, with bendamustine plus rituximab (Abstract #6). The ibrutinib-containing regimens resulted in superior progression-free survival.

The two trials taken together show a movement away from chemotherapy in the frontline setting and toward targeted agents for CLL, Dr. Mato said. “What that agent or combination of agents will be, remains to be seen,” he said. “We have now a real message about the fact that we’re ending, potentially, the era of chemotherapy for patients with CLL, which is a very welcome change.”

Dr. Mato and Dr. Hill will be discussing these trials and more CLL data during a Twitter chat on Jan. 31, 2019, from 7 p.m. to 8 p.m. EST. Join in the conversation by using and following #MDedgeChats.

[email protected]

SAN ANTONIO – Data continue to underscore the benefits of lifestyle interventions in women with breast cancer, but questions remain about their effects on recurrence, according to Jennifer Ligibel, MD.

Findings from the EBBA-II trial as presented at the San Antonio Breast Cancer Symposium, for example, showed that exercise improves cardiorespiratory fitness in women with early breast cancer, and findings from the SUCCESS C study showed that breast cancer patients who completed a weight-loss intervention showed some improvements, compared with those who did not, said Dr. Ligibel of Dana-Farber Cancer Institute in Boston, who was the discussant for those and other lifestyle-intervention studies at the symposium.

SUCCESS C failed to show an overall reduction in breast cancer recurrence or survival, but weight loss among intervention-group participants was modest, and more than half of the participants dropped out of the study, so it’s hard to make any firm conclusions, she said.

Overall, the findings – in the context of what is already known about lifestyle interventions among women with breast cancer – provide “yet another reason to tell women that it’s important to exercise during treatment,” she said.

Vidyard Video

In this video interview, Dr. Ligibel discussed the studies and the implications of the findings, and also mentioned an ongoing study for which she is an investigator. In that study – the Breast Cancer Weight Loss study (BWEL) – adherence among the approximately 1,700 women enrolled has been high. “So we’re hoping that this study in a few years will give us a bit more information about the power of weight loss to potentially reduce recurrence.”

For now, the available data show that there are “lots of concrete benefits” associated with improving lifestyle in women with breast cancer, she said, noting that she tells all of her patients to live as healthy a lifestyle as possible, and especially to exercise.

[email protected]

SAN ANTONIO – Data continue to underscore the benefits of lifestyle interventions in women with breast cancer, but questions remain about their effects on recurrence, according to Jennifer Ligibel, MD.

Findings from the EBBA-II trial as presented at the San Antonio Breast Cancer Symposium, for example, showed that exercise improves cardiorespiratory fitness in women with early breast cancer, and findings from the SUCCESS C study showed that breast cancer patients who completed a weight-loss intervention showed some improvements, compared with those who did not, said Dr. Ligibel of Dana-Farber Cancer Institute in Boston, who was the discussant for those and other lifestyle-intervention studies at the symposium.

SUCCESS C failed to show an overall reduction in breast cancer recurrence or survival, but weight loss among intervention-group participants was modest, and more than half of the participants dropped out of the study, so it’s hard to make any firm conclusions, she said.

Overall, the findings – in the context of what is already known about lifestyle interventions among women with breast cancer – provide “yet another reason to tell women that it’s important to exercise during treatment,” she said.

Vidyard Video

In this video interview, Dr. Ligibel discussed the studies and the implications of the findings, and also mentioned an ongoing study for which she is an investigator. In that study – the Breast Cancer Weight Loss study (BWEL) – adherence among the approximately 1,700 women enrolled has been high. “So we’re hoping that this study in a few years will give us a bit more information about the power of weight loss to potentially reduce recurrence.”

For now, the available data show that there are “lots of concrete benefits” associated with improving lifestyle in women with breast cancer, she said, noting that she tells all of her patients to live as healthy a lifestyle as possible, and especially to exercise.

[email protected]

SAN ANTONIO – Data continue to underscore the benefits of lifestyle interventions in women with breast cancer, but questions remain about their effects on recurrence, according to Jennifer Ligibel, MD.

Findings from the EBBA-II trial as presented at the San Antonio Breast Cancer Symposium, for example, showed that exercise improves cardiorespiratory fitness in women with early breast cancer, and findings from the SUCCESS C study showed that breast cancer patients who completed a weight-loss intervention showed some improvements, compared with those who did not, said Dr. Ligibel of Dana-Farber Cancer Institute in Boston, who was the discussant for those and other lifestyle-intervention studies at the symposium.

SUCCESS C failed to show an overall reduction in breast cancer recurrence or survival, but weight loss among intervention-group participants was modest, and more than half of the participants dropped out of the study, so it’s hard to make any firm conclusions, she said.

Overall, the findings – in the context of what is already known about lifestyle interventions among women with breast cancer – provide “yet another reason to tell women that it’s important to exercise during treatment,” she said.

Vidyard Video

In this video interview, Dr. Ligibel discussed the studies and the implications of the findings, and also mentioned an ongoing study for which she is an investigator. In that study – the Breast Cancer Weight Loss study (BWEL) – adherence among the approximately 1,700 women enrolled has been high. “So we’re hoping that this study in a few years will give us a bit more information about the power of weight loss to potentially reduce recurrence.”

For now, the available data show that there are “lots of concrete benefits” associated with improving lifestyle in women with breast cancer, she said, noting that she tells all of her patients to live as healthy a lifestyle as possible, and especially to exercise.

[email protected]

SAN ANTONIO – Extending aromatase inhibitor (AI) therapy an additional 5 years reduces breast cancer recurrence risk, particularly in patients with node involvement, but the benefits vary based on prior treatment and must be weighed against the risk of bone fracture, according to findings from a meta-analysis involving more than 22,000 women.

The rate of any recurrence after 10 years in almost 7,500 women treated with 5 years of tamoxifen and then randomized to 5 additional years of AI treatment was reduced by 35%, compared with the rate in those who did not receive 5 additional years of AI therapy (recurrence rate, 10.7% vs. 7.1%, respectively; relative risk, 0.67), and the difference was “very highly significant,” Richard Gray, MD, reported at the San Antonio Breast Cancer Symposium.

The distant recurrence rate and mortality rate were also significantly improved in those who received 5 years of AI therapy (rr, 0.77 for each), but the difference in mortality was of borderline significance, Dr. Gray, professor of medical statistics at the University of Oxford, London, reported on behalf of the Early Breast Cancer Trialists’ Collaborative Group.

However, in many of the trials included in the analysis, control group patients crossed over to the treatment group, which likely reduced the effect, he noted.

In about 12,000 women who were treated with 2-3 years of tamoxifen followed by 2-3 years of an AI and who were then randomized to an additional 3-5 years of AI therapy, the effects were less pronounced, with about a 20% reduced risk of any recurrence after 10 years vs. the rate in those without extended therapy (recurrence rate, 9.2% vs. 7.1%), he said.

The differences in the rates of distant recurrence and breast cancer mortality were not statistically significant in this group, but again, follow-up was short, he said.

Similarly, in about 3,300 women treated with an AI followed by an additional 5 years of AI therapy, recurrence risk was reduced by about 25% vs. the rate in those who did not receive extended therapy, and no difference was seen in the rates of distant recurrence or breast cancer mortality.

Of note, the benefits in those who received tamoxifen were seen immediately, whereas the benefits in those receiving AIs in the first 5 years emerged after about 2 years of extended therapy, Dr. Gray said, explaining that this was likely due to “carry-over benefits” of the earlier AI therapy.

The downside with extended AI therapy was a 25% increase in fracture risk, as well as bone pain, which can reduce quality of life.

Therefore, decisions about extended therapy should involve careful risk-benefit analyses, he said, adding that the findings of this meta-analysis of 12 trials, which included postmenopausal women – 99% of whom had estrogen receptor–positive disease – provide “the most reliable assessment of the available evidence ... [for] guiding decisions about endocrine therapy.”

In this video interview, he further discussed the details and limitations of the study, the effects of nodal status on outcomes, implications of the findings for clinical practice, the need for further follow-up on all of the studies included in the analysis, and plans for incorporating new data from the AERAS trial, which were also presented at the symposium and which complement and reinforce the current findings.

Dr. Gray reported having no disclosures.

SOURCE: Gray R et al., SABCS 2018: Abstract GS3-03.

SAN ANTONIO – Extending aromatase inhibitor (AI) therapy an additional 5 years reduces breast cancer recurrence risk, particularly in patients with node involvement, but the benefits vary based on prior treatment and must be weighed against the risk of bone fracture, according to findings from a meta-analysis involving more than 22,000 women.

The rate of any recurrence after 10 years in almost 7,500 women treated with 5 years of tamoxifen and then randomized to 5 additional years of AI treatment was reduced by 35%, compared with the rate in those who did not receive 5 additional years of AI therapy (recurrence rate, 10.7% vs. 7.1%, respectively; relative risk, 0.67), and the difference was “very highly significant,” Richard Gray, MD, reported at the San Antonio Breast Cancer Symposium.

The distant recurrence rate and mortality rate were also significantly improved in those who received 5 years of AI therapy (rr, 0.77 for each), but the difference in mortality was of borderline significance, Dr. Gray, professor of medical statistics at the University of Oxford, London, reported on behalf of the Early Breast Cancer Trialists’ Collaborative Group.

However, in many of the trials included in the analysis, control group patients crossed over to the treatment group, which likely reduced the effect, he noted.

In about 12,000 women who were treated with 2-3 years of tamoxifen followed by 2-3 years of an AI and who were then randomized to an additional 3-5 years of AI therapy, the effects were less pronounced, with about a 20% reduced risk of any recurrence after 10 years vs. the rate in those without extended therapy (recurrence rate, 9.2% vs. 7.1%), he said.

The differences in the rates of distant recurrence and breast cancer mortality were not statistically significant in this group, but again, follow-up was short, he said.

Similarly, in about 3,300 women treated with an AI followed by an additional 5 years of AI therapy, recurrence risk was reduced by about 25% vs. the rate in those who did not receive extended therapy, and no difference was seen in the rates of distant recurrence or breast cancer mortality.

Of note, the benefits in those who received tamoxifen were seen immediately, whereas the benefits in those receiving AIs in the first 5 years emerged after about 2 years of extended therapy, Dr. Gray said, explaining that this was likely due to “carry-over benefits” of the earlier AI therapy.

The downside with extended AI therapy was a 25% increase in fracture risk, as well as bone pain, which can reduce quality of life.

Therefore, decisions about extended therapy should involve careful risk-benefit analyses, he said, adding that the findings of this meta-analysis of 12 trials, which included postmenopausal women – 99% of whom had estrogen receptor–positive disease – provide “the most reliable assessment of the available evidence ... [for] guiding decisions about endocrine therapy.”

In this video interview, he further discussed the details and limitations of the study, the effects of nodal status on outcomes, implications of the findings for clinical practice, the need for further follow-up on all of the studies included in the analysis, and plans for incorporating new data from the AERAS trial, which were also presented at the symposium and which complement and reinforce the current findings.

Dr. Gray reported having no disclosures.

SOURCE: Gray R et al., SABCS 2018: Abstract GS3-03.

SAN ANTONIO – Extending aromatase inhibitor (AI) therapy an additional 5 years reduces breast cancer recurrence risk, particularly in patients with node involvement, but the benefits vary based on prior treatment and must be weighed against the risk of bone fracture, according to findings from a meta-analysis involving more than 22,000 women.

The rate of any recurrence after 10 years in almost 7,500 women treated with 5 years of tamoxifen and then randomized to 5 additional years of AI treatment was reduced by 35%, compared with the rate in those who did not receive 5 additional years of AI therapy (recurrence rate, 10.7% vs. 7.1%, respectively; relative risk, 0.67), and the difference was “very highly significant,” Richard Gray, MD, reported at the San Antonio Breast Cancer Symposium.

The distant recurrence rate and mortality rate were also significantly improved in those who received 5 years of AI therapy (rr, 0.77 for each), but the difference in mortality was of borderline significance, Dr. Gray, professor of medical statistics at the University of Oxford, London, reported on behalf of the Early Breast Cancer Trialists’ Collaborative Group.

However, in many of the trials included in the analysis, control group patients crossed over to the treatment group, which likely reduced the effect, he noted.

In about 12,000 women who were treated with 2-3 years of tamoxifen followed by 2-3 years of an AI and who were then randomized to an additional 3-5 years of AI therapy, the effects were less pronounced, with about a 20% reduced risk of any recurrence after 10 years vs. the rate in those without extended therapy (recurrence rate, 9.2% vs. 7.1%), he said.

The differences in the rates of distant recurrence and breast cancer mortality were not statistically significant in this group, but again, follow-up was short, he said.

Similarly, in about 3,300 women treated with an AI followed by an additional 5 years of AI therapy, recurrence risk was reduced by about 25% vs. the rate in those who did not receive extended therapy, and no difference was seen in the rates of distant recurrence or breast cancer mortality.

Of note, the benefits in those who received tamoxifen were seen immediately, whereas the benefits in those receiving AIs in the first 5 years emerged after about 2 years of extended therapy, Dr. Gray said, explaining that this was likely due to “carry-over benefits” of the earlier AI therapy.

The downside with extended AI therapy was a 25% increase in fracture risk, as well as bone pain, which can reduce quality of life.

Therefore, decisions about extended therapy should involve careful risk-benefit analyses, he said, adding that the findings of this meta-analysis of 12 trials, which included postmenopausal women – 99% of whom had estrogen receptor–positive disease – provide “the most reliable assessment of the available evidence ... [for] guiding decisions about endocrine therapy.”

In this video interview, he further discussed the details and limitations of the study, the effects of nodal status on outcomes, implications of the findings for clinical practice, the need for further follow-up on all of the studies included in the analysis, and plans for incorporating new data from the AERAS trial, which were also presented at the symposium and which complement and reinforce the current findings.

Dr. Gray reported having no disclosures.

SOURCE: Gray R et al., SABCS 2018: Abstract GS3-03.

Norman JE, Heazell AE, Rodriguez A, et al; for the AFFIRM investigators. Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial. Lancet. 2018;392:1629-1638.

Norman JE, Heazell AE, Rodriguez A, et al; for the AFFIRM investigators. Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial. Lancet. 2018;392:1629-1638.

Norman JE, Heazell AE, Rodriguez A, et al; for the AFFIRM investigators. Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial. Lancet. 2018;392:1629-1638.

SAN DIEGO – Patients with newly diagnosed multiple myeloma who were ineligible for transplant had a 44% reduction in the risk of disease progression or death when they were treated with the anti-CD38 monoclonal antibody daratumumab (Darzalex) added to lenalidomide (Revlimid) and dexamethasone, compared with lenalidomide-dexamethasone alone, an interim analysis from the MAIA trial showed.

Among 737 patients in a phase 3 trial, median progression-free survival – the primary endpoint – had not been reached after a median follow-up of 28 months for patients randomized to daratumumab, lenalidomide, and dexamethasone (DRd), versus 31.9 months for patients randomized to lenalidomide and dexamethasone (Rd).

The 30-month PFS rate in the DRd arm was 71%, compared with 56% for the Rd arm. This difference translated into a hazard ratio (HR) for progression of 0.56 (P less than .0001), reported Thierry Facon, MD, of Hôpital Claude Huriez and the University of Lille, France.

“These results support DRd as a new standard of care for elderly patients with myeloma who are ineligible for transplant,” he said at the annual meeting of the American Society of Hematology.

Dr. Facon and his colleagues had previously shown in the FIRST trial that in newly diagnosed transplant-ineligible patients, continuous treatment with lenalidomide and low-dose dexamethasone was associated with significant overall survival and PFS benefits, compared with melphalan-prednisone-thalidomide.

In the POLLUX trial, investigators reported that in patients with multiple myeloma that was refractory or had relapsed after at least one prior line of therapy, the DRd combination was associated with a 63% reduction in the risk for disease progression or death, compared with Rd alone.
 

MAIA details

The MAIA trial is a pivotal, phase 3 study pitting DRd against Rd in transplant-ineligible patients with newly diagnosed multiple myeloma.

Patients with untreated disease who had Eastern Cooperative Oncology Group (ECOG) status of 0-2 and creatinine clearance rates of at least 30 mL/min were enrolled. Patients were randomly assigned to either DRd, with intravenous daratumumab 16 mg/kg weekly for cycles 1 and 2, every other week for cycles 3 through 6, and every 4 weeks from cycle 7 until disease progression, plus lenalidomide 25 mg orally per day on days 1-21 until disease progression, and dexamethasone 40 mg orally or intravenously weekly until disease progression; or to the same regimen without daratumumab.

The median patient age was 73 years and 99% of all patients were aged 65 years or older. Demographic and clinical characteristics were well balanced between the treatment arms.

The primary endpoint of progression-free survival was superior with DRd.

DRd also was associated with a significantly higher overall response rate (93% vs. 81%), complete response rate (48% vs. 25%), very good partial response or better rate (79% vs. 53%), and minimal residual disease (MRD) negativity rate (24% vs. 7%; P less than .0001 for all comparisons).

The DRd combination was associated with infusion-related reactions in 41% of patients, but only 3% were grade 3 or 4 in severity.

Hematologic treatment-emergent adverse events (TEAE) grade 3 or greater that were more common with DRd included neutropenia (50% vs. 35%) and lymphopenia (15% vs. 11%). Conversely, thrombocytopenia (7% vs. 9%, grade 3 or 4) and anemia (12% vs. 20%) were more frequent with Rd.

Nonhematologic TEAEs that were more frequent with DRd included diarrhea, constipation, fatigue, peripheral edema, and pneumonia. Rates of asthenia, back pain, nausea, and deep vein thrombosis/pulmonary embolism were similar between the study arms.

Janssen funded the study. Dr. Facon reported speakers bureau and advisory board participation for Celgene, Janssen, and Takeda; and advisory board participation for Sanofi, Amgen, Karyopharm, and Oncopeptides.

SOURCE: Facon T et al. ASH 2018, Abstract LBA-2.

SAN DIEGO – Patients with newly diagnosed multiple myeloma who were ineligible for transplant had a 44% reduction in the risk of disease progression or death when they were treated with the anti-CD38 monoclonal antibody daratumumab (Darzalex) added to lenalidomide (Revlimid) and dexamethasone, compared with lenalidomide-dexamethasone alone, an interim analysis from the MAIA trial showed.

Among 737 patients in a phase 3 trial, median progression-free survival – the primary endpoint – had not been reached after a median follow-up of 28 months for patients randomized to daratumumab, lenalidomide, and dexamethasone (DRd), versus 31.9 months for patients randomized to lenalidomide and dexamethasone (Rd).

The 30-month PFS rate in the DRd arm was 71%, compared with 56% for the Rd arm. This difference translated into a hazard ratio (HR) for progression of 0.56 (P less than .0001), reported Thierry Facon, MD, of Hôpital Claude Huriez and the University of Lille, France.

“These results support DRd as a new standard of care for elderly patients with myeloma who are ineligible for transplant,” he said at the annual meeting of the American Society of Hematology.

Dr. Facon and his colleagues had previously shown in the FIRST trial that in newly diagnosed transplant-ineligible patients, continuous treatment with lenalidomide and low-dose dexamethasone was associated with significant overall survival and PFS benefits, compared with melphalan-prednisone-thalidomide.

In the POLLUX trial, investigators reported that in patients with multiple myeloma that was refractory or had relapsed after at least one prior line of therapy, the DRd combination was associated with a 63% reduction in the risk for disease progression or death, compared with Rd alone.
 

MAIA details

The MAIA trial is a pivotal, phase 3 study pitting DRd against Rd in transplant-ineligible patients with newly diagnosed multiple myeloma.

Patients with untreated disease who had Eastern Cooperative Oncology Group (ECOG) status of 0-2 and creatinine clearance rates of at least 30 mL/min were enrolled. Patients were randomly assigned to either DRd, with intravenous daratumumab 16 mg/kg weekly for cycles 1 and 2, every other week for cycles 3 through 6, and every 4 weeks from cycle 7 until disease progression, plus lenalidomide 25 mg orally per day on days 1-21 until disease progression, and dexamethasone 40 mg orally or intravenously weekly until disease progression; or to the same regimen without daratumumab.

The median patient age was 73 years and 99% of all patients were aged 65 years or older. Demographic and clinical characteristics were well balanced between the treatment arms.

The primary endpoint of progression-free survival was superior with DRd.

DRd also was associated with a significantly higher overall response rate (93% vs. 81%), complete response rate (48% vs. 25%), very good partial response or better rate (79% vs. 53%), and minimal residual disease (MRD) negativity rate (24% vs. 7%; P less than .0001 for all comparisons).

The DRd combination was associated with infusion-related reactions in 41% of patients, but only 3% were grade 3 or 4 in severity.

Hematologic treatment-emergent adverse events (TEAE) grade 3 or greater that were more common with DRd included neutropenia (50% vs. 35%) and lymphopenia (15% vs. 11%). Conversely, thrombocytopenia (7% vs. 9%, grade 3 or 4) and anemia (12% vs. 20%) were more frequent with Rd.

Nonhematologic TEAEs that were more frequent with DRd included diarrhea, constipation, fatigue, peripheral edema, and pneumonia. Rates of asthenia, back pain, nausea, and deep vein thrombosis/pulmonary embolism were similar between the study arms.

Janssen funded the study. Dr. Facon reported speakers bureau and advisory board participation for Celgene, Janssen, and Takeda; and advisory board participation for Sanofi, Amgen, Karyopharm, and Oncopeptides.

SOURCE: Facon T et al. ASH 2018, Abstract LBA-2.

SAN DIEGO – Patients with newly diagnosed multiple myeloma who were ineligible for transplant had a 44% reduction in the risk of disease progression or death when they were treated with the anti-CD38 monoclonal antibody daratumumab (Darzalex) added to lenalidomide (Revlimid) and dexamethasone, compared with lenalidomide-dexamethasone alone, an interim analysis from the MAIA trial showed.

Among 737 patients in a phase 3 trial, median progression-free survival – the primary endpoint – had not been reached after a median follow-up of 28 months for patients randomized to daratumumab, lenalidomide, and dexamethasone (DRd), versus 31.9 months for patients randomized to lenalidomide and dexamethasone (Rd).

The 30-month PFS rate in the DRd arm was 71%, compared with 56% for the Rd arm. This difference translated into a hazard ratio (HR) for progression of 0.56 (P less than .0001), reported Thierry Facon, MD, of Hôpital Claude Huriez and the University of Lille, France.

“These results support DRd as a new standard of care for elderly patients with myeloma who are ineligible for transplant,” he said at the annual meeting of the American Society of Hematology.

Dr. Facon and his colleagues had previously shown in the FIRST trial that in newly diagnosed transplant-ineligible patients, continuous treatment with lenalidomide and low-dose dexamethasone was associated with significant overall survival and PFS benefits, compared with melphalan-prednisone-thalidomide.

In the POLLUX trial, investigators reported that in patients with multiple myeloma that was refractory or had relapsed after at least one prior line of therapy, the DRd combination was associated with a 63% reduction in the risk for disease progression or death, compared with Rd alone.
 

MAIA details

The MAIA trial is a pivotal, phase 3 study pitting DRd against Rd in transplant-ineligible patients with newly diagnosed multiple myeloma.

Patients with untreated disease who had Eastern Cooperative Oncology Group (ECOG) status of 0-2 and creatinine clearance rates of at least 30 mL/min were enrolled. Patients were randomly assigned to either DRd, with intravenous daratumumab 16 mg/kg weekly for cycles 1 and 2, every other week for cycles 3 through 6, and every 4 weeks from cycle 7 until disease progression, plus lenalidomide 25 mg orally per day on days 1-21 until disease progression, and dexamethasone 40 mg orally or intravenously weekly until disease progression; or to the same regimen without daratumumab.

The median patient age was 73 years and 99% of all patients were aged 65 years or older. Demographic and clinical characteristics were well balanced between the treatment arms.

The primary endpoint of progression-free survival was superior with DRd.

DRd also was associated with a significantly higher overall response rate (93% vs. 81%), complete response rate (48% vs. 25%), very good partial response or better rate (79% vs. 53%), and minimal residual disease (MRD) negativity rate (24% vs. 7%; P less than .0001 for all comparisons).

The DRd combination was associated with infusion-related reactions in 41% of patients, but only 3% were grade 3 or 4 in severity.

Hematologic treatment-emergent adverse events (TEAE) grade 3 or greater that were more common with DRd included neutropenia (50% vs. 35%) and lymphopenia (15% vs. 11%). Conversely, thrombocytopenia (7% vs. 9%, grade 3 or 4) and anemia (12% vs. 20%) were more frequent with Rd.

Nonhematologic TEAEs that were more frequent with DRd included diarrhea, constipation, fatigue, peripheral edema, and pneumonia. Rates of asthenia, back pain, nausea, and deep vein thrombosis/pulmonary embolism were similar between the study arms.

Janssen funded the study. Dr. Facon reported speakers bureau and advisory board participation for Celgene, Janssen, and Takeda; and advisory board participation for Sanofi, Amgen, Karyopharm, and Oncopeptides.

SOURCE: Facon T et al. ASH 2018, Abstract LBA-2.

SAN DIEGO – Want to have influence on social media? Dr. Amber Yates advises physicians to be authentic.

“People want to see that you’re a person and not strictly a physician,” said Dr. Yates, a pediatric hematologist at Texas Children’s Hospital in Houston, who has had an active Twitter presence for the last few years.

Dr. Yates – whose Twitter handle is @sicklecelldoc – said she dipped a toe in the social media waters because she wanted to bring accurate medical information to patients in the arena where they are seeking information.

“I want families to understand their condition as well as they can on whatever level they can, and so I just found this to be another way to do that ... outside of my clinic,” she said during an interview at the annual meeting of the American Society of Hematology.

But beyond correcting misinformation and serving as an advocate for patients, Dr. Yates said she gets professional benefits from being on Twitter. For instance, she uses the platform to find relevant articles as soon as they publish, without wading through all the journals.

“It’s allowed me to kind of streamline what I read,” she said.

Dr. Yates said Twitter is her social media platform of choice because it provides a simple, succinct way to communicate and provide links to more in-depth resources.

While social media can be fun and rewarding for physicians, Dr. Yates said think before you post. Ask yourself, “would you tell your chairperson this?”

Dr. Yates reported having no relevant financial disclosures.

[email protected]

SAN DIEGO – Want to have influence on social media? Dr. Amber Yates advises physicians to be authentic.

“People want to see that you’re a person and not strictly a physician,” said Dr. Yates, a pediatric hematologist at Texas Children’s Hospital in Houston, who has had an active Twitter presence for the last few years.

Dr. Yates – whose Twitter handle is @sicklecelldoc – said she dipped a toe in the social media waters because she wanted to bring accurate medical information to patients in the arena where they are seeking information.

“I want families to understand their condition as well as they can on whatever level they can, and so I just found this to be another way to do that ... outside of my clinic,” she said during an interview at the annual meeting of the American Society of Hematology.

But beyond correcting misinformation and serving as an advocate for patients, Dr. Yates said she gets professional benefits from being on Twitter. For instance, she uses the platform to find relevant articles as soon as they publish, without wading through all the journals.

“It’s allowed me to kind of streamline what I read,” she said.

Dr. Yates said Twitter is her social media platform of choice because it provides a simple, succinct way to communicate and provide links to more in-depth resources.

While social media can be fun and rewarding for physicians, Dr. Yates said think before you post. Ask yourself, “would you tell your chairperson this?”

Dr. Yates reported having no relevant financial disclosures.

[email protected]

SAN DIEGO – Want to have influence on social media? Dr. Amber Yates advises physicians to be authentic.

“People want to see that you’re a person and not strictly a physician,” said Dr. Yates, a pediatric hematologist at Texas Children’s Hospital in Houston, who has had an active Twitter presence for the last few years.

Dr. Yates – whose Twitter handle is @sicklecelldoc – said she dipped a toe in the social media waters because she wanted to bring accurate medical information to patients in the arena where they are seeking information.

“I want families to understand their condition as well as they can on whatever level they can, and so I just found this to be another way to do that ... outside of my clinic,” she said during an interview at the annual meeting of the American Society of Hematology.

But beyond correcting misinformation and serving as an advocate for patients, Dr. Yates said she gets professional benefits from being on Twitter. For instance, she uses the platform to find relevant articles as soon as they publish, without wading through all the journals.

“It’s allowed me to kind of streamline what I read,” she said.

Dr. Yates said Twitter is her social media platform of choice because it provides a simple, succinct way to communicate and provide links to more in-depth resources.

While social media can be fun and rewarding for physicians, Dr. Yates said think before you post. Ask yourself, “would you tell your chairperson this?”

Dr. Yates reported having no relevant financial disclosures.

[email protected]