Leadership is a skill that must be developed, and hospitalists are increasingly being thrust into leadership positions in hospitals across the country.

SHM’s Leadership Academy is made up of three separate courses, each especially designed to help hospitalists take on leadership positions with confidence—and to reach even higher.

Leadership Foundations

This four-day educational offering serves as a prerequisite to all other Leadership Academy courses. Attendees learn how to evaluate personal leadership strengths and weaknesses, create and execute a communication strategy for key team members, understand key hospital drivers, examine how hospital metrics are derived, and more. Participants are grouped at tables of 10, each with a skilled facilitator to ensure meaningful, relevant application of concepts to hands-on activities. Course objectives:

• Evaluate personal leadership strengths and weaknesses and apply them to everyday leadership and management challenges;
• Effectively advocate the value of their hospitalist programs;
• Predict and plan for the near-term challenges affecting the viability of their hospitalist programs;
• Improve patient outcomes through successful planning, allocation of resources, collaboration, teamwork, and execution;
• Create and execute a communication strategy for all key constituencies;
• Understand key hospital drivers and examine how hospital performance metrics are derived, as well as how hospital medicine practices can influence and impact these metrics;
• Implement methods of effective change through leadership, shared vision, and management of organizational culture; and
• Utilize strategic planning to define a vision for their programs, prioritize efforts, and achieve designated goals.

Advanced Leadership: Influential Management

Through world-renowned faculty and applied exercises, this course provides skill building around driving culture change through specific leadership behaviors and actions, financial storytelling, engagement in effective professional negotiation activities with proven techniques, and more. Prerequisites: Leadership Foundations or an advanced management degree. Course objectives:

• Drive culture change through specific leadership behaviors and actions;
• Use financial reports to drive clinical/operational practice decision making;
• Recruit and retain the best physicians for their groups;
• Build exceptional physician satisfaction; and
• Engage in effective professional negotiation activities using proven techniques.

Advanced Leadership: Mastering Teamwork

Developed in response to high demand from academy attendees, this course is focused on strengthening teams and institutions. Participants learn how to critically assess program growth opportunities and develop operational plans; lead, manage, and motivate teams in complex hospital environments; and communicate effectively. Prerequisite: Leadership Foundations or an advanced management degree. Course objectives:

• Apply communication strategies that allow others to fully experience your message;
• Lead teams in complex environments to achieve the best results;
• Invest in yourself as a leader to optimize your professional growth and career path; and
• Critically assess program growth opportunities and implement the necessary infrastructure for success.

Leadership is a skill that must be developed, and hospitalists are increasingly being thrust into leadership positions in hospitals across the country.

SHM’s Leadership Academy is made up of three separate courses, each especially designed to help hospitalists take on leadership positions with confidence—and to reach even higher.

Leadership Foundations

This four-day educational offering serves as a prerequisite to all other Leadership Academy courses. Attendees learn how to evaluate personal leadership strengths and weaknesses, create and execute a communication strategy for key team members, understand key hospital drivers, examine how hospital metrics are derived, and more. Participants are grouped at tables of 10, each with a skilled facilitator to ensure meaningful, relevant application of concepts to hands-on activities. Course objectives:

• Evaluate personal leadership strengths and weaknesses and apply them to everyday leadership and management challenges;
• Effectively advocate the value of their hospitalist programs;
• Predict and plan for the near-term challenges affecting the viability of their hospitalist programs;
• Improve patient outcomes through successful planning, allocation of resources, collaboration, teamwork, and execution;
• Create and execute a communication strategy for all key constituencies;
• Understand key hospital drivers and examine how hospital performance metrics are derived, as well as how hospital medicine practices can influence and impact these metrics;
• Implement methods of effective change through leadership, shared vision, and management of organizational culture; and
• Utilize strategic planning to define a vision for their programs, prioritize efforts, and achieve designated goals.

Advanced Leadership: Influential Management

Through world-renowned faculty and applied exercises, this course provides skill building around driving culture change through specific leadership behaviors and actions, financial storytelling, engagement in effective professional negotiation activities with proven techniques, and more. Prerequisites: Leadership Foundations or an advanced management degree. Course objectives:

• Drive culture change through specific leadership behaviors and actions;
• Use financial reports to drive clinical/operational practice decision making;
• Recruit and retain the best physicians for their groups;
• Build exceptional physician satisfaction; and
• Engage in effective professional negotiation activities using proven techniques.

Advanced Leadership: Mastering Teamwork

Developed in response to high demand from academy attendees, this course is focused on strengthening teams and institutions. Participants learn how to critically assess program growth opportunities and develop operational plans; lead, manage, and motivate teams in complex hospital environments; and communicate effectively. Prerequisite: Leadership Foundations or an advanced management degree. Course objectives:

• Apply communication strategies that allow others to fully experience your message;
• Lead teams in complex environments to achieve the best results;
• Invest in yourself as a leader to optimize your professional growth and career path; and
• Critically assess program growth opportunities and implement the necessary infrastructure for success.

Leadership is a skill that must be developed, and hospitalists are increasingly being thrust into leadership positions in hospitals across the country.

SHM’s Leadership Academy is made up of three separate courses, each especially designed to help hospitalists take on leadership positions with confidence—and to reach even higher.

Leadership Foundations

This four-day educational offering serves as a prerequisite to all other Leadership Academy courses. Attendees learn how to evaluate personal leadership strengths and weaknesses, create and execute a communication strategy for key team members, understand key hospital drivers, examine how hospital metrics are derived, and more. Participants are grouped at tables of 10, each with a skilled facilitator to ensure meaningful, relevant application of concepts to hands-on activities. Course objectives:

• Evaluate personal leadership strengths and weaknesses and apply them to everyday leadership and management challenges;
• Effectively advocate the value of their hospitalist programs;
• Predict and plan for the near-term challenges affecting the viability of their hospitalist programs;
• Improve patient outcomes through successful planning, allocation of resources, collaboration, teamwork, and execution;
• Create and execute a communication strategy for all key constituencies;
• Understand key hospital drivers and examine how hospital performance metrics are derived, as well as how hospital medicine practices can influence and impact these metrics;
• Implement methods of effective change through leadership, shared vision, and management of organizational culture; and
• Utilize strategic planning to define a vision for their programs, prioritize efforts, and achieve designated goals.

Advanced Leadership: Influential Management

Through world-renowned faculty and applied exercises, this course provides skill building around driving culture change through specific leadership behaviors and actions, financial storytelling, engagement in effective professional negotiation activities with proven techniques, and more. Prerequisites: Leadership Foundations or an advanced management degree. Course objectives:

• Drive culture change through specific leadership behaviors and actions;
• Use financial reports to drive clinical/operational practice decision making;
• Recruit and retain the best physicians for their groups;
• Build exceptional physician satisfaction; and
• Engage in effective professional negotiation activities using proven techniques.

Advanced Leadership: Mastering Teamwork

Developed in response to high demand from academy attendees, this course is focused on strengthening teams and institutions. Participants learn how to critically assess program growth opportunities and develop operational plans; lead, manage, and motivate teams in complex hospital environments; and communicate effectively. Prerequisite: Leadership Foundations or an advanced management degree. Course objectives:

• Apply communication strategies that allow others to fully experience your message;
• Lead teams in complex environments to achieve the best results;
• Invest in yourself as a leader to optimize your professional growth and career path; and
• Critically assess program growth opportunities and implement the necessary infrastructure for success.

Hyperglycemia is associated with poor outcomes in a broad range of hospitalized patients, and several studies demonstrate improved outcomes with improved glycemic control. Hospitalization presents a frequently missed opportunity to diagnose diabetes, identify those at risk for diabetes, and optimize the care of patients with diabetes via education and medical therapy.

Despite authoritative guidelines and effective methods to achieve good glycemic control safely, poor glycemic control, suboptimal medication regimens, incomplete patient education, and uneven communication with outpatient care providers are prevalent problems in medical centers.

SHM is accepting applications to the Fall 2014 Glycemic Control Mentored Implementation (GCMI) Program (www.hospitalmedicine.org/gcmi). Participants will work directly with SHM mentors, benchmark against other participants, and join the Glycemic Control Community to network with peers.

Hyperglycemia is associated with poor outcomes in a broad range of hospitalized patients, and several studies demonstrate improved outcomes with improved glycemic control. Hospitalization presents a frequently missed opportunity to diagnose diabetes, identify those at risk for diabetes, and optimize the care of patients with diabetes via education and medical therapy.

Despite authoritative guidelines and effective methods to achieve good glycemic control safely, poor glycemic control, suboptimal medication regimens, incomplete patient education, and uneven communication with outpatient care providers are prevalent problems in medical centers.

SHM is accepting applications to the Fall 2014 Glycemic Control Mentored Implementation (GCMI) Program (www.hospitalmedicine.org/gcmi). Participants will work directly with SHM mentors, benchmark against other participants, and join the Glycemic Control Community to network with peers.

Hyperglycemia is associated with poor outcomes in a broad range of hospitalized patients, and several studies demonstrate improved outcomes with improved glycemic control. Hospitalization presents a frequently missed opportunity to diagnose diabetes, identify those at risk for diabetes, and optimize the care of patients with diabetes via education and medical therapy.

Despite authoritative guidelines and effective methods to achieve good glycemic control safely, poor glycemic control, suboptimal medication regimens, incomplete patient education, and uneven communication with outpatient care providers are prevalent problems in medical centers.

SHM is accepting applications to the Fall 2014 Glycemic Control Mentored Implementation (GCMI) Program (www.hospitalmedicine.org/gcmi). Participants will work directly with SHM mentors, benchmark against other participants, and join the Glycemic Control Community to network with peers.

Reducing unnecessary readmissions continues to be a priority for hospitals across the country, which is why so many hospitals have already enrolled in SHM’s Project BOOST. Project BOOST is an award-winning program that pairs hospitals with the national experts in reducing readmissions and resources to implement programs that work in the real world.

Early research indicates that Project BOOST can be effective: According to research published in the Journal of Hospital Medicine last year, participation in Project BOOST among a small sample set of hospitals appeared to be associated with a decrease in readmission rates.

And hospitals reducing readmissions through Project BOOST are receiving attention from their local communities, too. Recently, Lakes Region General Hospital was featured in an article in the local newspaper, The Laconia Daily Sun, entitled “LRGH finds preventable readmissions program is paying off.”

SHM is accepting applications to the 2014 Project BOOST cohort through August. For more information, visit www.hospitalmedicine.org/boost.

Reducing unnecessary readmissions continues to be a priority for hospitals across the country, which is why so many hospitals have already enrolled in SHM’s Project BOOST. Project BOOST is an award-winning program that pairs hospitals with the national experts in reducing readmissions and resources to implement programs that work in the real world.

Early research indicates that Project BOOST can be effective: According to research published in the Journal of Hospital Medicine last year, participation in Project BOOST among a small sample set of hospitals appeared to be associated with a decrease in readmission rates.

And hospitals reducing readmissions through Project BOOST are receiving attention from their local communities, too. Recently, Lakes Region General Hospital was featured in an article in the local newspaper, The Laconia Daily Sun, entitled “LRGH finds preventable readmissions program is paying off.”

SHM is accepting applications to the 2014 Project BOOST cohort through August. For more information, visit www.hospitalmedicine.org/boost.

Reducing unnecessary readmissions continues to be a priority for hospitals across the country, which is why so many hospitals have already enrolled in SHM’s Project BOOST. Project BOOST is an award-winning program that pairs hospitals with the national experts in reducing readmissions and resources to implement programs that work in the real world.

Early research indicates that Project BOOST can be effective: According to research published in the Journal of Hospital Medicine last year, participation in Project BOOST among a small sample set of hospitals appeared to be associated with a decrease in readmission rates.

And hospitals reducing readmissions through Project BOOST are receiving attention from their local communities, too. Recently, Lakes Region General Hospital was featured in an article in the local newspaper, The Laconia Daily Sun, entitled “LRGH finds preventable readmissions program is paying off.”

SHM is accepting applications to the 2014 Project BOOST cohort through August. For more information, visit www.hospitalmedicine.org/boost.

Dr. Bulger

In 2013, SHM was the first medical specialty to submit two separate lists to the popular Choosing Wisely campaign, created by the ABIM Foundation. The lists—one for hospitalists treating adult patients and another for pediatric hospitalists—were developed to help providers have important conversations with their patients about providing the highest value care at the best time.

This year, SHM is asking hospitalists to show how they have implemented any one of the recommendations from SHM’s two lists. And SHM is offering up to $4,000 to the hospitalist/group that submits the best case study. The committee that developed SHM’s Choosing Wisely recommendations will judge the case studies.

“The competition gives hospitalists the opportunity to highlight the wonderful work they do every day aimed at creating patient-centered value,” says John Bulger, DO, MBA, FACP, SFHM, who chaired SHM’s Choosing Wisely committee. “By sharing, hospitalists have the chance to impact the care of larger populations outside of their own hospitals and help colleagues across the nation and around the globe. Finally, the cash prize adds a little extra incentive.”

According to Dr. Bulger, the activity should be centered around one of SHM’s adult or pediatric Choosing Wisely recommendations, and the improvement work should have started after Jan. 1, 2013. Submissions are due Sept. 9.

SHM’s Choosing Wisely case study competition is made possible by a grant awarded by the ABIM Foundation and the Robert Wood Johnson Foundation to help extend the reach of the Choosing Wisely campaign.

“We hope to spur interest in hospitals sharing their successes and challenges with implementing the Choosing Wisely guidelines,” Dr. Bulger adds. “Competition is sometimes a powerful motivator. In addition, we plan to broadly share the case studies we receive as part of a Compendium of Hospitalists Guide to Choosing Wisely.”

To submit a Choosing Wisely case study to SHM or to review SHM’s Choosing Wisely recommendations, visit www.hospitalmedicine.org/choosingwisely.

Dr. Bulger

In 2013, SHM was the first medical specialty to submit two separate lists to the popular Choosing Wisely campaign, created by the ABIM Foundation. The lists—one for hospitalists treating adult patients and another for pediatric hospitalists—were developed to help providers have important conversations with their patients about providing the highest value care at the best time.

This year, SHM is asking hospitalists to show how they have implemented any one of the recommendations from SHM’s two lists. And SHM is offering up to $4,000 to the hospitalist/group that submits the best case study. The committee that developed SHM’s Choosing Wisely recommendations will judge the case studies.

“The competition gives hospitalists the opportunity to highlight the wonderful work they do every day aimed at creating patient-centered value,” says John Bulger, DO, MBA, FACP, SFHM, who chaired SHM’s Choosing Wisely committee. “By sharing, hospitalists have the chance to impact the care of larger populations outside of their own hospitals and help colleagues across the nation and around the globe. Finally, the cash prize adds a little extra incentive.”

According to Dr. Bulger, the activity should be centered around one of SHM’s adult or pediatric Choosing Wisely recommendations, and the improvement work should have started after Jan. 1, 2013. Submissions are due Sept. 9.

SHM’s Choosing Wisely case study competition is made possible by a grant awarded by the ABIM Foundation and the Robert Wood Johnson Foundation to help extend the reach of the Choosing Wisely campaign.

“We hope to spur interest in hospitals sharing their successes and challenges with implementing the Choosing Wisely guidelines,” Dr. Bulger adds. “Competition is sometimes a powerful motivator. In addition, we plan to broadly share the case studies we receive as part of a Compendium of Hospitalists Guide to Choosing Wisely.”

To submit a Choosing Wisely case study to SHM or to review SHM’s Choosing Wisely recommendations, visit www.hospitalmedicine.org/choosingwisely.

Dr. Bulger

In 2013, SHM was the first medical specialty to submit two separate lists to the popular Choosing Wisely campaign, created by the ABIM Foundation. The lists—one for hospitalists treating adult patients and another for pediatric hospitalists—were developed to help providers have important conversations with their patients about providing the highest value care at the best time.

This year, SHM is asking hospitalists to show how they have implemented any one of the recommendations from SHM’s two lists. And SHM is offering up to $4,000 to the hospitalist/group that submits the best case study. The committee that developed SHM’s Choosing Wisely recommendations will judge the case studies.

“The competition gives hospitalists the opportunity to highlight the wonderful work they do every day aimed at creating patient-centered value,” says John Bulger, DO, MBA, FACP, SFHM, who chaired SHM’s Choosing Wisely committee. “By sharing, hospitalists have the chance to impact the care of larger populations outside of their own hospitals and help colleagues across the nation and around the globe. Finally, the cash prize adds a little extra incentive.”

According to Dr. Bulger, the activity should be centered around one of SHM’s adult or pediatric Choosing Wisely recommendations, and the improvement work should have started after Jan. 1, 2013. Submissions are due Sept. 9.

SHM’s Choosing Wisely case study competition is made possible by a grant awarded by the ABIM Foundation and the Robert Wood Johnson Foundation to help extend the reach of the Choosing Wisely campaign.

“We hope to spur interest in hospitals sharing their successes and challenges with implementing the Choosing Wisely guidelines,” Dr. Bulger adds. “Competition is sometimes a powerful motivator. In addition, we plan to broadly share the case studies we receive as part of a Compendium of Hospitalists Guide to Choosing Wisely.”

To submit a Choosing Wisely case study to SHM or to review SHM’s Choosing Wisely recommendations, visit www.hospitalmedicine.org/choosingwisely.

Mark your calendars today! Now is the time to coordinate with colleagues, make early schedule arrangements, and consider a family vacation to the Washington, D.C., area around HM15 at the Gaylord National in National Harbor, Md., just minutes outside of the nation’s capital.

SHM’s annual meetings are the largest annual event in hospital medicine. Thousands of hospitalists from every corner of the country can attest to the professional and personal value they draw from the meetings. After HM14, more than nine out of 10 hospitalists say they would recommend the meeting to a friend; the same percentage say they plan on attending HM15.

“The Hospital Medicine 2015 planning committee is already hard at work to deliver the kind of career-advancing content that hospitalists have come to expect from SHM’s annual meeting,” says HM15 Committee Chair Efren Manjarrez, MD, SFHM. “We know that hospitalists come to our meetings not just for the CME credits, but for the clinical know-how, practice management ideas, firsthand perspectives from the leaders in healthcare, one-on-one networking, and energy that make the hospital medicine movement special.”

Hospitalists who have never attended an SHM annual meeting will enjoy the many educational opportunities offered in clinical work, practice management, quality improvement, and many other topics important to the hospital medicine movement.

And those who have attended year after year know that the meeting is never the same twice. New topics, new tracks, and new faces keep the meeting fresh for even the most experienced hospitalist.

“Every year has been bigger, better, and different from the last,” Dr. Manjarrez says. “We can’t wait to show hospitalists what will make HM15 a truly special event in healthcare.”

Brendon Shank is SHM’s associate vice president of communications.

Mark your calendars today! Now is the time to coordinate with colleagues, make early schedule arrangements, and consider a family vacation to the Washington, D.C., area around HM15 at the Gaylord National in National Harbor, Md., just minutes outside of the nation’s capital.

SHM’s annual meetings are the largest annual event in hospital medicine. Thousands of hospitalists from every corner of the country can attest to the professional and personal value they draw from the meetings. After HM14, more than nine out of 10 hospitalists say they would recommend the meeting to a friend; the same percentage say they plan on attending HM15.

“The Hospital Medicine 2015 planning committee is already hard at work to deliver the kind of career-advancing content that hospitalists have come to expect from SHM’s annual meeting,” says HM15 Committee Chair Efren Manjarrez, MD, SFHM. “We know that hospitalists come to our meetings not just for the CME credits, but for the clinical know-how, practice management ideas, firsthand perspectives from the leaders in healthcare, one-on-one networking, and energy that make the hospital medicine movement special.”

Hospitalists who have never attended an SHM annual meeting will enjoy the many educational opportunities offered in clinical work, practice management, quality improvement, and many other topics important to the hospital medicine movement.

And those who have attended year after year know that the meeting is never the same twice. New topics, new tracks, and new faces keep the meeting fresh for even the most experienced hospitalist.

“Every year has been bigger, better, and different from the last,” Dr. Manjarrez says. “We can’t wait to show hospitalists what will make HM15 a truly special event in healthcare.”

Brendon Shank is SHM’s associate vice president of communications.

Mark your calendars today! Now is the time to coordinate with colleagues, make early schedule arrangements, and consider a family vacation to the Washington, D.C., area around HM15 at the Gaylord National in National Harbor, Md., just minutes outside of the nation’s capital.

SHM’s annual meetings are the largest annual event in hospital medicine. Thousands of hospitalists from every corner of the country can attest to the professional and personal value they draw from the meetings. After HM14, more than nine out of 10 hospitalists say they would recommend the meeting to a friend; the same percentage say they plan on attending HM15.

“The Hospital Medicine 2015 planning committee is already hard at work to deliver the kind of career-advancing content that hospitalists have come to expect from SHM’s annual meeting,” says HM15 Committee Chair Efren Manjarrez, MD, SFHM. “We know that hospitalists come to our meetings not just for the CME credits, but for the clinical know-how, practice management ideas, firsthand perspectives from the leaders in healthcare, one-on-one networking, and energy that make the hospital medicine movement special.”

Hospitalists who have never attended an SHM annual meeting will enjoy the many educational opportunities offered in clinical work, practice management, quality improvement, and many other topics important to the hospital medicine movement.

And those who have attended year after year know that the meeting is never the same twice. New topics, new tracks, and new faces keep the meeting fresh for even the most experienced hospitalist.

“Every year has been bigger, better, and different from the last,” Dr. Manjarrez says. “We can’t wait to show hospitalists what will make HM15 a truly special event in healthcare.”

Brendon Shank is SHM’s associate vice president of communications.

Facebook, Twitter, Instagram, Snapchat, YouTube, blogs, webpages, Google+, LinkedIn. What do all of these social media outlets have in common? Each can get physicians in trouble under the Health Insurance Portability and Accountability Act (HIPAA), state privacy laws, and state medical laws, to name a few. It seems that all too often, news outlets are reporting data breaches generated in the medical community, many of which arise out of physicians’ use of social media, and most of which could have been avoided.

Physicians should be aware of the intersection of social media—both for personal and professional use—and HIPAA and state laws. Even an inadvertent, seemingly innocuous disclosure of a patient’s protected health information (PHI) through social media can be problematic.

PHI is defined under HIPAA, in part, as health information that (i) is created or received by a physician, (ii) relates to the health or condition of an individual, (iii) identifies the individual (or with respect to which there is a reasonable basis to believe the information can be used to identify the individual), and (iv) is transmitted by or maintained in electronic media, or transmitted or maintained in another form or medium. Under HIPAA, a physician may use and disclose PHI for “treatment, payment, or healthcare operations.” Generally, using or disclosing PHI through social media does not qualify as treatment, payment, or healthcare operations. If a physician were to use or disclose a patient’s PHI without permission, this would be a violation of HIPAA—and likely state law as well.

In order to use or disclose a patient’s PHI without obtaining the patient’s consent, a physician must de-identify the information so that the information does not identify the patient and there is no reasonable basis to believe that the information can be used to identify the patient. One option under HIPAA is to retain an expert to determine “that the risk is very small that the information could be used, alone or in combination with other reasonably available information, by an anticipated recipient to identify an individual who is the subject of the information.” Alternatively, and more commonly, a physician seeking to use or disclose patient PHI can remove the following identifiers from the PHI:

1. Names;
2. Geographic information;
3. Dates (e.g. birth date, admission date, discharge date, date of death);
4. Telephone numbers;
5. Fax numbers;
6. E-mail addresses;
7. Social Security numbers;
8. Medical record numbers;
9. Health plan beneficiary numbers;
10. Account numbers;
11. Certificate/license numbers;
12. Vehicle identifiers and serial numbers, including license plate numbers;
13. Device identifiers and serial numbers;
14. URLs;
15. IP address numbers;
16. Biometric identifiers (e.g. finger and voice prints);
17. Full-face photographic images and any comparable images; and
18. Other unique identifying numbers, characteristics, or codes.

Identifier #18 is the most difficult to comply with in light of the significant amount of personal information available on the Internet, particularly through search engines like Google. Inputting even a small amount of information into a search engine will generate relevant “hits” that make it increasingly difficult to comply with the de-identification standards under HIPAA. Even if the first 17 identifiers are carefully removed, the broadness of #18 can turn a seemingly harmless post on social media into a patient privacy violation.

Do not let the following examples be you:

Example 1: An ED physician in Rhode Island was fired, lost her hospital medical staff privileges, and was reprimanded by the Rhode Island Board of Medical Licensure and Discipline for posting information about a trauma patient on her personal Facebook page. According to the Rhode Island Board of Medical Licensure and Discipline, “[She] did not use patient names and had no intention to reveal any confidential patient information. However, because of the nature of one person’s injury … the patient was identified by unauthorized third parties. As soon as it was brought to [her] attention that this had occurred, [she] deleted her Facebook account.” Despite the physician leaving out all information she thought might make the patient identifiable, she apparently did not omit enough.

Example 2: An OB-GYN in St. Louis took to Facebook to complain about her frustration with a patient: “So I have a patient who has chosen to either no-show or be late (sometimes hours) for all of her prenatal visits, ultrasounds, and NSTs. She is now 3 hours late for her induction. May I show up late to her delivery?” Another physician then commented on this post: “If it’s elective, it’d be canceled!” The OB-GYN at issue then responded: “Here is the explanation why I have put up with it/not cancelled induction: prior stillbirth.”

Although the OB-GYN did not reveal the patient’s name, controversy erupted after someone posted a screenshot of the post and response comments to the hospital’s Facebook page. The hospital issued a statement indicating that its privacy compliance staff did not find the posting to be a breach of privacy, but the hospital added it would use this opportunity to educate its staff about the appropriate use of social media. Many believe this physician got off too easy.

The penalties for patient privacy violations (or even alleged patient privacy violations) are multifaceted. Not only can the federal government impose civil and criminal sanctions under HIPAA on the physician and his/her affiliated parties (e.g. physician’s employer), but states can also impose penalties. State-imposed penalties for patient privacy violations vary from state to state. Additionally, the patient may sue the violating physician and his/her affiliated parties for privacy violations. Although HIPAA does not afford patients the right to bring a private cause of action against a physician, state law often does grant patients such a right. Also, state medical boards often have the right to impose penalties, monetary and non-monetary, on a physician for privacy violations. These can include suspension or termination of medical licensure.

Recent reports indicate that people who “like,” “share,” “re-tweet,” or comment on inappropriate social media posts are also getting reprimanded. Finally, the reputational harm associated with an inappropriate post on social media is immeasurable, especially in light of the availability of information on the Internet. Unfortunately, when the physicians described above enter their names in a search engine, they do not see their professional accomplishments and prestigious educations; instead, their top hits are news articles reporting on their inappropriate posts.

Post with caution.

Steven M. Harris, Esq., is a nationally recognized healthcare attorney and a member of the law firm McDonald Hopkins LLC in Chicago. Write to him at [email protected].

Facebook, Twitter, Instagram, Snapchat, YouTube, blogs, webpages, Google+, LinkedIn. What do all of these social media outlets have in common? Each can get physicians in trouble under the Health Insurance Portability and Accountability Act (HIPAA), state privacy laws, and state medical laws, to name a few. It seems that all too often, news outlets are reporting data breaches generated in the medical community, many of which arise out of physicians’ use of social media, and most of which could have been avoided.

Physicians should be aware of the intersection of social media—both for personal and professional use—and HIPAA and state laws. Even an inadvertent, seemingly innocuous disclosure of a patient’s protected health information (PHI) through social media can be problematic.

PHI is defined under HIPAA, in part, as health information that (i) is created or received by a physician, (ii) relates to the health or condition of an individual, (iii) identifies the individual (or with respect to which there is a reasonable basis to believe the information can be used to identify the individual), and (iv) is transmitted by or maintained in electronic media, or transmitted or maintained in another form or medium. Under HIPAA, a physician may use and disclose PHI for “treatment, payment, or healthcare operations.” Generally, using or disclosing PHI through social media does not qualify as treatment, payment, or healthcare operations. If a physician were to use or disclose a patient’s PHI without permission, this would be a violation of HIPAA—and likely state law as well.

In order to use or disclose a patient’s PHI without obtaining the patient’s consent, a physician must de-identify the information so that the information does not identify the patient and there is no reasonable basis to believe that the information can be used to identify the patient. One option under HIPAA is to retain an expert to determine “that the risk is very small that the information could be used, alone or in combination with other reasonably available information, by an anticipated recipient to identify an individual who is the subject of the information.” Alternatively, and more commonly, a physician seeking to use or disclose patient PHI can remove the following identifiers from the PHI:

1. Names;
2. Geographic information;
3. Dates (e.g. birth date, admission date, discharge date, date of death);
4. Telephone numbers;
5. Fax numbers;
6. E-mail addresses;
7. Social Security numbers;
8. Medical record numbers;
9. Health plan beneficiary numbers;
10. Account numbers;
11. Certificate/license numbers;
12. Vehicle identifiers and serial numbers, including license plate numbers;
13. Device identifiers and serial numbers;
14. URLs;
15. IP address numbers;
16. Biometric identifiers (e.g. finger and voice prints);
17. Full-face photographic images and any comparable images; and
18. Other unique identifying numbers, characteristics, or codes.

Identifier #18 is the most difficult to comply with in light of the significant amount of personal information available on the Internet, particularly through search engines like Google. Inputting even a small amount of information into a search engine will generate relevant “hits” that make it increasingly difficult to comply with the de-identification standards under HIPAA. Even if the first 17 identifiers are carefully removed, the broadness of #18 can turn a seemingly harmless post on social media into a patient privacy violation.

Do not let the following examples be you:

Example 1: An ED physician in Rhode Island was fired, lost her hospital medical staff privileges, and was reprimanded by the Rhode Island Board of Medical Licensure and Discipline for posting information about a trauma patient on her personal Facebook page. According to the Rhode Island Board of Medical Licensure and Discipline, “[She] did not use patient names and had no intention to reveal any confidential patient information. However, because of the nature of one person’s injury … the patient was identified by unauthorized third parties. As soon as it was brought to [her] attention that this had occurred, [she] deleted her Facebook account.” Despite the physician leaving out all information she thought might make the patient identifiable, she apparently did not omit enough.

Example 2: An OB-GYN in St. Louis took to Facebook to complain about her frustration with a patient: “So I have a patient who has chosen to either no-show or be late (sometimes hours) for all of her prenatal visits, ultrasounds, and NSTs. She is now 3 hours late for her induction. May I show up late to her delivery?” Another physician then commented on this post: “If it’s elective, it’d be canceled!” The OB-GYN at issue then responded: “Here is the explanation why I have put up with it/not cancelled induction: prior stillbirth.”

Although the OB-GYN did not reveal the patient’s name, controversy erupted after someone posted a screenshot of the post and response comments to the hospital’s Facebook page. The hospital issued a statement indicating that its privacy compliance staff did not find the posting to be a breach of privacy, but the hospital added it would use this opportunity to educate its staff about the appropriate use of social media. Many believe this physician got off too easy.

The penalties for patient privacy violations (or even alleged patient privacy violations) are multifaceted. Not only can the federal government impose civil and criminal sanctions under HIPAA on the physician and his/her affiliated parties (e.g. physician’s employer), but states can also impose penalties. State-imposed penalties for patient privacy violations vary from state to state. Additionally, the patient may sue the violating physician and his/her affiliated parties for privacy violations. Although HIPAA does not afford patients the right to bring a private cause of action against a physician, state law often does grant patients such a right. Also, state medical boards often have the right to impose penalties, monetary and non-monetary, on a physician for privacy violations. These can include suspension or termination of medical licensure.

Recent reports indicate that people who “like,” “share,” “re-tweet,” or comment on inappropriate social media posts are also getting reprimanded. Finally, the reputational harm associated with an inappropriate post on social media is immeasurable, especially in light of the availability of information on the Internet. Unfortunately, when the physicians described above enter their names in a search engine, they do not see their professional accomplishments and prestigious educations; instead, their top hits are news articles reporting on their inappropriate posts.

Post with caution.

Steven M. Harris, Esq., is a nationally recognized healthcare attorney and a member of the law firm McDonald Hopkins LLC in Chicago. Write to him at [email protected].

Facebook, Twitter, Instagram, Snapchat, YouTube, blogs, webpages, Google+, LinkedIn. What do all of these social media outlets have in common? Each can get physicians in trouble under the Health Insurance Portability and Accountability Act (HIPAA), state privacy laws, and state medical laws, to name a few. It seems that all too often, news outlets are reporting data breaches generated in the medical community, many of which arise out of physicians’ use of social media, and most of which could have been avoided.

Physicians should be aware of the intersection of social media—both for personal and professional use—and HIPAA and state laws. Even an inadvertent, seemingly innocuous disclosure of a patient’s protected health information (PHI) through social media can be problematic.

PHI is defined under HIPAA, in part, as health information that (i) is created or received by a physician, (ii) relates to the health or condition of an individual, (iii) identifies the individual (or with respect to which there is a reasonable basis to believe the information can be used to identify the individual), and (iv) is transmitted by or maintained in electronic media, or transmitted or maintained in another form or medium. Under HIPAA, a physician may use and disclose PHI for “treatment, payment, or healthcare operations.” Generally, using or disclosing PHI through social media does not qualify as treatment, payment, or healthcare operations. If a physician were to use or disclose a patient’s PHI without permission, this would be a violation of HIPAA—and likely state law as well.

In order to use or disclose a patient’s PHI without obtaining the patient’s consent, a physician must de-identify the information so that the information does not identify the patient and there is no reasonable basis to believe that the information can be used to identify the patient. One option under HIPAA is to retain an expert to determine “that the risk is very small that the information could be used, alone or in combination with other reasonably available information, by an anticipated recipient to identify an individual who is the subject of the information.” Alternatively, and more commonly, a physician seeking to use or disclose patient PHI can remove the following identifiers from the PHI:

1. Names;
2. Geographic information;
3. Dates (e.g. birth date, admission date, discharge date, date of death);
4. Telephone numbers;
5. Fax numbers;
6. E-mail addresses;
7. Social Security numbers;
8. Medical record numbers;
9. Health plan beneficiary numbers;
10. Account numbers;
11. Certificate/license numbers;
12. Vehicle identifiers and serial numbers, including license plate numbers;
13. Device identifiers and serial numbers;
14. URLs;
15. IP address numbers;
16. Biometric identifiers (e.g. finger and voice prints);
17. Full-face photographic images and any comparable images; and
18. Other unique identifying numbers, characteristics, or codes.

Identifier #18 is the most difficult to comply with in light of the significant amount of personal information available on the Internet, particularly through search engines like Google. Inputting even a small amount of information into a search engine will generate relevant “hits” that make it increasingly difficult to comply with the de-identification standards under HIPAA. Even if the first 17 identifiers are carefully removed, the broadness of #18 can turn a seemingly harmless post on social media into a patient privacy violation.

Do not let the following examples be you:

Example 1: An ED physician in Rhode Island was fired, lost her hospital medical staff privileges, and was reprimanded by the Rhode Island Board of Medical Licensure and Discipline for posting information about a trauma patient on her personal Facebook page. According to the Rhode Island Board of Medical Licensure and Discipline, “[She] did not use patient names and had no intention to reveal any confidential patient information. However, because of the nature of one person’s injury … the patient was identified by unauthorized third parties. As soon as it was brought to [her] attention that this had occurred, [she] deleted her Facebook account.” Despite the physician leaving out all information she thought might make the patient identifiable, she apparently did not omit enough.

Example 2: An OB-GYN in St. Louis took to Facebook to complain about her frustration with a patient: “So I have a patient who has chosen to either no-show or be late (sometimes hours) for all of her prenatal visits, ultrasounds, and NSTs. She is now 3 hours late for her induction. May I show up late to her delivery?” Another physician then commented on this post: “If it’s elective, it’d be canceled!” The OB-GYN at issue then responded: “Here is the explanation why I have put up with it/not cancelled induction: prior stillbirth.”

Although the OB-GYN did not reveal the patient’s name, controversy erupted after someone posted a screenshot of the post and response comments to the hospital’s Facebook page. The hospital issued a statement indicating that its privacy compliance staff did not find the posting to be a breach of privacy, but the hospital added it would use this opportunity to educate its staff about the appropriate use of social media. Many believe this physician got off too easy.

The penalties for patient privacy violations (or even alleged patient privacy violations) are multifaceted. Not only can the federal government impose civil and criminal sanctions under HIPAA on the physician and his/her affiliated parties (e.g. physician’s employer), but states can also impose penalties. State-imposed penalties for patient privacy violations vary from state to state. Additionally, the patient may sue the violating physician and his/her affiliated parties for privacy violations. Although HIPAA does not afford patients the right to bring a private cause of action against a physician, state law often does grant patients such a right. Also, state medical boards often have the right to impose penalties, monetary and non-monetary, on a physician for privacy violations. These can include suspension or termination of medical licensure.

Recent reports indicate that people who “like,” “share,” “re-tweet,” or comment on inappropriate social media posts are also getting reprimanded. Finally, the reputational harm associated with an inappropriate post on social media is immeasurable, especially in light of the availability of information on the Internet. Unfortunately, when the physicians described above enter their names in a search engine, they do not see their professional accomplishments and prestigious educations; instead, their top hits are news articles reporting on their inappropriate posts.

Post with caution.

Steven M. Harris, Esq., is a nationally recognized healthcare attorney and a member of the law firm McDonald Hopkins LLC in Chicago. Write to him at [email protected].

When diagnosing a patient, it can be tempting to run all types of tests to expedite the process—and protect yourself from litigation. Patients may push for more tests, too, thinking “the more the better.” But that may not be the best course of action. In fact, according to recommendations of the ABIM Foundations’ Choosing Wisely campaign, more tests can actually bring a host of negative consequences.

In an effort to help hospitalists decide which tests to perform and which to forgo, The Hospitalist asked medical societies that contributed to the Choosing Wisely campaign to tell us which one of their recommendations was the most applicable to hospitalists. Then, we asked some hospitalists to discuss how they might implement each recommendation.

1 American Gastroenterological Association (AGA)

Recommendation: For a patient with functional abdominal pain syndrome (as per Rome criteria), computed tomography (CT) scans should not be repeated unless there is a major change in clinical findings or symptoms.

When a patient first complains of abdominal pain, a CT scan usually is done prior to a gastroenterological consultation. Despite this initial scan, many patients with chronic abdominal pain receive unnecessary repeated CT scans to evaluate their pain even if they have previous negative studies.

“It is important for the hospitalist to know that functional abdominal pain can be managed without additional diagnostic studies,” says John M. Inadomi, MD, head of the division of gastroenterology at the University of Washington School of Medicine in Seattle. “Some doctors are uncomfortable with the uncertainty of a diagnosis of chronic abdominal pain without evidence of biochemical or structural disease [functional abdominal pain syndrome] and fear litigation.”

An abdominal CT scan is one of the higher radiation exposure tests, equivalent to three years of natural background radiation.¹

“Due to this risk and the high costs of this procedure, CT scans should be limited to situations in which they are likely to provide useful information that changes patient management,” Dr. Inadomi says.

According to Moises Auron, MD, FAAP, FACP, SFHM, assistant professor of medicine and pediatrics at Cleveland Clinic Lerner College of Medicine of Case Western University in Cleveland, Ohio, it should not be a difficult choice for hospitalists, “as the clinical context provides a safeguard to justify the rationale for a conservative approach. Hospitalists must be educated on the appropriate use of Rome criteria, as well as how to appropriately document it in the chart to justify a decision to avoid unnecessary testing.”

2 American College of Rheumatology (ACR)

Recommendation: Don’t test anti-nuclear antibody (ANA) sub-serologies without a positive ANA and clinical suspicion of immune-mediated disease.

“A fever of unknown origin is among the most common diagnoses the hospitalist encounters,” Dr. Auron says. “Nowadays, given the ease to order tests, as well as the increased awareness of patients with immune-mediated diseases, it may be tempting to order large panels of immunologic tests to minimize the risk of missing a diagnosis; however, because ANA has high sensitivity and poor specificity, it should only be ordered if the clinical context supports its use.”

Jinoos Yazdany, MD, MPH, assistant professor of medicine at the University of California at San Francisco and co-chair of the task force that developed the ACR’s Choosing Wisely list, points out that if you use ANAs as a broad screening test when the pretest probability of specific ANA-associated diseases is low, there is an increased chance of a false positive ANA result. This can lead to unnecessary further testing and additional costs. Furthermore, ANA sub-serologies are usually negative if the ANA (done by immunofluorescence) is negative.

“So it is recommended to order sub-serologies only once it is known that the ANA is positive,” she says. The exceptions to this are anti-SSA and anti-Jo-1 antibodies, which can sometimes be positive when the ANA is negative.

Mangla S. Gulati, MD, FACP, FHM, medical director for clinical effectiveness at the University of Maryland School of Medicine in Baltimore, says a positive ANA in conjunction with clinical information “will help to guide appropriate and cost-conscious testing. Hospitalists could implement this through a clinical decision support approach if using an electronic medical record.”

LISTEN NOW to Daniel Wolfson, MHSA, executive vice president and CEO of the ABIM Foundation, discuss how the Choosing Wisely campaign got started and its significance in U.S. healthcare.

3 American College of Physicians (ACP)

Recommendation: In patients with low pretest probability of venous thromboembolism (VTE), obtain a high-sensitive D-dimer measurement as the initial diagnostic test; don’t obtain imaging studies as the initial diagnostic test.

VTE, a common problem in hospitalized patients, has high mortality rates. “However, recent statistics suggest that we may be overdiagnosing non-clinically significant disease and exposing large numbers of patients to high doses of radiation unnecessarily in an attempt to rule out VTE disease,” says Cynthia D. Smith, MD, FACP, ACP senior medical associate for content development and adjunct associate professor of medicine at the Perelman School of Medicine in Philadelphia.

Instead, physicians should estimate pretest probability of disease using a validated risk assessment tool (i.e., Wells score). For patients with low clinical probability of VTE, hospitalists should use a negative high-sensitive D-dimer measurement as the initial diagnostic test.

Dr. Auron says the litigious environment of American medicine may trigger clinicians to order testing to minimize the risk of missing potential conditions; however, an adequate, evidence-based approach with appropriate documentation should be sufficient. In this case, that would entail using D-dimer testing to outline the low pretest probability of VTE and explaining to the patient the rationale for not pursuing further imaging.

Dr. Gulati adds that hospitalists should have little difficulty implementing this cost-effective approach.

“A reasonable way to justify the increased availability of the nuclear medicine department would be to document the number of CT chest scans done after hours in patients who would have instead had a V/Q scan.”

—Moises Auron, MD, FAAP, FACP, SFHM, assistant professor of medicine and pediatrics, Cleveland Clinic

4 American Geriatrics Society (AGS)

Recommendation: Don’t use antimicrobials to treat bacteriuria in older adults unless specific urinary tract symptoms are present.

Older adults with asymptomatic bacteriuria who received antimicrobial treatment show no benefit, according to multiple studies.² In fact, increased adverse antimicrobial effects occurred, such as greater resistance patterns and super-infections (e.g. Clostridium difficile).

The truth is that as many as 30% of frail elders (particularly women) have bacterial colonization of the urinary tract without infection, also known as asymptomatic bacteriuria, says Heidi Wald, MD, MSPH, associate professor of medicine and vice chair for quality in the department of medicine at the University of Colorado School of Medicine in Aurora. Therefore, before being prescribed antimicrobials, a patient should exhibit symptoms of urinary tract infection such as fever, frequent urination, urgency to urinate, painful urination, or suprapubic tenderness.

“Without localizing symptoms, you can’t assume bacteriuria equals infection,” Dr. Wald adds. “Too often, we make the urine a scapegoat for unrelated presentations, such as mild confusion.”

If the patient is stable and doesn’t have UTI symptoms, Dr. Wald says hospitalists should consider hydration and monitor the patient without antibiotics.

“This should not be difficult to implement,” Dr. Auron says, “as hospitalists are on the front lines of antibiotic stewardship in hospitals.”

LISTEN NOW to Linda Cox, MD, owner of Allergy and Asthma Center in Ft. Lauderdale, Fla., and president of American Academy of Allergy, Asthma & Immunology, discuss why it's important for hospitalists to not diagnose or manage asthma without spirometry.

5 American Society of Echocardiography (ASE)

Recommendation: Avoid echocardiograms for pre-operative/peri-operative assessment of patients with no history or symptoms of heart disease.

Echocardiography can diagnose all types of heart disease while being completely safe, inexpensive, and available at the bedside.

“These features may logically lead hospitalists to think, ‘Why not?’ Maybe there’s something going on and an echo can’t hurt,” says James D. Thomas, MD, FASE, FACC, FAHA, FESC, Moore Chair of Cardiovascular Imaging at Cleveland Clinic and ASE past president. “Unfortunately, tests can have false positive findings that lead to other, potentially more hazardous and invasive, tests downstream, as well as unnecessary delays.”

If a patient has no history of heart disease, no positive physical findings, or no symptoms, then an echo probably won’t be helpful. Hospitalists need to be aware of the lack of value of a presumed normal study, Dr. Auron says.

“Having appropriate standards of care allows clinicians in pre-operative areas to use risk stratification tools in an adequate fashion,” he notes.

6 American Society of Nephrology (ASN)

Recommendation: Do not place peripherally inserted central venous catheters (PICC) in stage three to five chronic kidney disease (CKD) patients without consulting nephrology.

Given the increase in patients with CKD in the later stages, as well as end-stage renal disease, clinicians need to protect patients’ upper extremity veins in order to be able to have an adequate vascular substrate for subsequent creation of an arteriovenous fistula (AVF), Dr. Auron maintains.

PICCs, along with other central venous catheters, damage veins and destroy sites for future hemodialysis vascular access, explains Amy W. Williams, MD, medical director of hospital operations and consultant in the division of nephrology and hypertension at Mayo Clinic in Rochester, Minn. If there are no options for AVF or grafts, patients starting or being maintained on hemodialysis will need a tunneled central venous catheter for dialysis access.

Studies have shown that AVFs have better patency rates and fewer complications compared to catheters, and there is a direct correlation of increased mortality and inadequate dialysis with tunneled central catheters.³ In addition, dialysis patients with a tunneled central venous catheter have a five-fold increase of infection compared to those with an AVF.⁴ The incidence of central venous stenosis associated with PICC lines has been shown to be 42% and the incidence of thrombosis 38%.^5,6 There is no significant difference in the rate of central venous complications based on the duration of catheter use or catheter size. In addition, prior PICC use has been shown to be an independent predictor of lack of a functioning AVF (odds ratio 2.8 [95 % CI, 1.5 to 5.5]).⁷

A better choice for extended venous access in patients with advanced CKD is a tunneled internal jugular vein catheter, which is associated with a lower risk of permanent vascular damage, says Dr. Williams, who is chair of the ASN’s Quality and Patient Safety Task Force.

Hospitalists who care for pediatric patients have the potential to significantly impact antibiotic overuse, as hospitalizations for respiratory illnesses due to viruses, such as bronchiolitis and croup, remain a leading cause of admission.

—James J. O’Callaghan, MD, FAAP, FHM, clinical assistant professor of pediatrics, Seattle Children’s Hospital at the University of Washington, Team Hospitalist member

7 The Society of Thoracic Surgeons (STS)

Recommendation: Patients who have no cardiac history and good functional status do not require pre-operative stress testing prior to non-cardiac thoracic surgery.

By eliminating routine stress testing prior to non-cardiac thoracic surgery for patients without a history of cardiac symptoms, hospitalists can reduce the burden of costs on patients and eliminate the possibility of adverse outcomes due to inappropriate testing.

“Functional status has been shown to be reliable to predict peri-operative and long-term cardiac events,” says Douglas E. Wood, MD, chief of the division of cardiothoracic surgery at the University of Washington in Seattle and president of the STS. “In highly functional asymptomatic patients, management is rarely changed by pre-operative stress testing. Furthermore, abnormalities identified in testing often require additional investigation, with negative consequences related to the risks of more procedures or tests, delays in therapies, and additional costs.”

Pre-operative stress testing should be reserved for patients with low functional capacity or clinical risk factors for cardiac complications. It is important to identify patients pre-operatively who are at risk for these complications by doing a thorough history, physical examination, and resting electrocardiogram.

8 Society of Nuclear Medicine and Molecular Imaging (SNMMI)

Recommendation: Avoid using a CT angiogram to diagnose pulmonary embolism (PE) in young women with a normal chest radiograph; consider a radionuclide lung (V/Q) study instead.

Hospitalists should be knowledgeable of the diagnostic options that will result in the lowest radiation exposure when evaluating young women for PE.

“When a chest radiograph is normal or nearly normal, a computed tomography angiogram or a V/Q lung scan can be used to evaluate these patients. While both exams have low radiation exposure, the V/Q lung scan results in less radiation to the breast tissue,” says society president Gary L. Dillehay, MD, FACNM, FACR, professor of radiology at Northwestern Memorial Hospital in Chicago. “Recent literature cites concerns over radiation exposure from mammography; therefore, reducing radiation exposure to breast tissue, when evaluating patients for suspected PE, is desirable.”

Hospitalists might have difficulty obtaining a V/Q lung scan when nuclear medicine departments are closed.

“The caveat is that CT scans are much more readily available,” Dr. Auron says. In addition, a CT scan provides additional information. But unless the differential diagnosis is much higher for PE than other possibilities, just having a V/Q scan should suffice.

Hospitalists could help implement protocols for chest pain evaluation in premenopausal women by having checklists for risk factors for coronary artery disease, connective tissue disease (essentially aortic dissection), and VTE (e.g. Wells and Geneva scores, use of oral contraceptives, smoking), Dr. Auron says. If the diagnostic branch supports the risk of PE, then nuclear imaging should be available.

“A reasonable way to justify the increased availability of the nuclear medicine department would be to document the number of CT chest scans done after hours in patients who would have instead had a V/Q scan,” he says.

LISTEN NOW to Rahul Shah, MD, FACS, FAAP, associate professor of otolaryngology and pediatrics at Children's National Medical Center in Washington, D.C, and co-chair of the American Academy of Otolaryngology-Head and Neck Surgery Foundation’s Patient Safety Quality Improvement Committee, explain why hospitalists should avoid routine radiographic imaging for patients who meet diagnostic criteria for uncomplicated acute rhinosinusitis.

9 American Academy of Pediatrics (AAP)

Recommendation: Antibiotics should not be used for apparent viral respiratory illnesses (sinusitis, pharyngitis, bronchitis).

Respiratory illnesses are the most common reason for hospitalization in pediatrics. Recent studies and surveys continue to demonstrate antibiotic overuse in the pediatric population, especially when prescribed for apparent viral respiratory illnesses.^8,9

“Hospitalists who care for pediatric patients have the potential to significantly impact antibiotic overuse, as hospitalizations for respiratory illnesses due to viruses such as bronchiolitis and croup remain a leading cause of admission,” says James J. O’Callaghan, MD, FAAP, FHM, clinical assistant professor of pediatrics at the University of Washington School of Medicine in Seattle.

Many respiratory problems, such as bronchiolitis, asthma, and even some pneumonias are caused or exacerbated by viruses, points out Ricardo Quiñonez, MD, FAAP, FHM, section head of pediatric hospital medicine at the Children’s Hospital of San Antonio and the Baylor College of Medicine, and chair of the AAP’s section on hospital medicine. In particular, there are national guidelines for bronchiolitis and asthma that recommend against the use of systemic antibiotics.

This recommendation may be difficult for hospitalists to implement, because antibiotics are frequently started by other providers (PCP or ED), Dr. O’Callaghan admits. It can be tricky to change or stop therapy without undermining patients’ or parents’ confidence in their medical decision-making. Hospitalists may need to collaborate with new partners, such as community-wide antibiotic reduction campaigns, in order to affect this culture change.

“Echocardiography can diagnose all types of heart disease while being completely safe, inexpensive, and available at the bedside. These features may logically lead hospitalists to think, ‘Why not?’ Maybe there’s something going on and an echo can’t hurt. Unfortunately, tests can have false positive findings that lead to other, potentially more hazardous and invasive, tests downstream, as well as unnecessary delays.”

—James D. Thomas, MD, FASE, FACC, FAHA, FESC, Moore Chair of Cardiovascular Imaging at the Cleveland Clinic in Ohio and past president of the American Society of Echocardiography.

10 American College of Obstetricians and Gynecologists (ACOB)

Recommendation: Don’t schedule elective inductions prior to 39 weeks, and don’t schedule elective inductions of labor after 39 weeks without a favorable cervix.

Studies show an increased risk to newborns that are electively inducted between 37 and 39 weeks. Complications include increased admission to the neonatal intensive care unit, increased risk of respiratory distress and need for respiratory support, and increased incidence of infection and sepsis.

This recommendation may be difficult for hospitalists to implement, because obstetrical providers typically schedule elective inductions. Implementation of this recommendation would involve collaboration with obstetrical providers, with possible support from maternal-fetal and neonatal providers.

“Recent quality measures and initiatives from such organizations such as CMS and the National Quality Forum … may help to galvanize institutional support for its successful implementation,” says Dr. O’Callaghan, a Team Hospitalist member.

Elective surgeries should only be done in cases where there is a medical necessity, such as when the mother is diabetic or has hypertension, adds Rob Olson, MD, FACOG, an OB/GYN hospitalist for PeaceHealth at St. Joseph Medical Center in Bellingham, Wash. “Hospitalists should not give in to pressures from patients who are either tired of the discomforts of pregnancy or have family pressure to end the pregnancy early.”

Karen Appold is a freelance writer in Pennsylvania.

References

1. U.S. Food and Drug Administration. Reducing radiation from medical X-rays. Available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095505.htm. Accessed May 12, 2014.
2. Nicolle LE, Bradley S, Colgan R, et al. Infectious Diseases Society of America guidelines for the diagnosis and treatment of asymptomatic bacteriuria in adults. Clin Infect Dis. 2005;40(5):643-654.
3. Hoggard J, Saad T, Schon D, et al. Guidelines for venous access in patients with chronic kidney disease. A position statement from the American Society of Diagnostic and Interventional Nephrology, Clinical Practice Committee and the Association for Vascular Access. Semin Dial. 2008;21(2):186-191.
4. Rayner HC, Besarab A, Brown WW, Disney A, Saito A, Pisoni RL. Vascular access results from the dialysis outcomes and practice patterns study (DOPPS): Performance against kidney disease outcomes quality initiative (K/DOQI)clinical practice guidelines. Am J Kidney Dis. 2004;44(5 Suppl 2):22-26.
5. Gonsalves CF, Eschelman DJ, Sullivan KL, DuBois N, Bonn J. Incidence of central vein stenosis and occlusion following upper extremity PICC and port placement. Cardiovasc Intervent Radiol. 2003;26(2):123-127.
6. Allen AW, Megargell JL, Brown DB, et al. Venous thrombosis associated with the placement of peripherally inserted central catheters. J Vasc Interv Radiol. 2000;11(10):1309-1314.
7. El Ters M, Schears GJ, Taler SJ, et al. Association between prior peripherally inserted central catheters and lack of functioning ateriovenous fistulas: A case control study in hemodialysis patients. Am J Kidney Dis. 2012;60(4):601-608.
8. Hersh AL, Shapiro DJ, Pavia AT, Shah SS. Antibiotic prescribing in ambulatory pediatrics in the United States. Pediatrics. 2011;128(6):1053-1061.
9. Knapp JF, Simon SD, Sharma V. Quality of care for common pediatric respiratory illnesses in United States emergency departments: Analysis of 2005 National Hospital Ambulatory Medical Care Survey data. Pediatrics. 2008;122(6):1165-1170.

When diagnosing a patient, it can be tempting to run all types of tests to expedite the process—and protect yourself from litigation. Patients may push for more tests, too, thinking “the more the better.” But that may not be the best course of action. In fact, according to recommendations of the ABIM Foundations’ Choosing Wisely campaign, more tests can actually bring a host of negative consequences.

In an effort to help hospitalists decide which tests to perform and which to forgo, The Hospitalist asked medical societies that contributed to the Choosing Wisely campaign to tell us which one of their recommendations was the most applicable to hospitalists. Then, we asked some hospitalists to discuss how they might implement each recommendation.

1 American Gastroenterological Association (AGA)

Recommendation: For a patient with functional abdominal pain syndrome (as per Rome criteria), computed tomography (CT) scans should not be repeated unless there is a major change in clinical findings or symptoms.

When a patient first complains of abdominal pain, a CT scan usually is done prior to a gastroenterological consultation. Despite this initial scan, many patients with chronic abdominal pain receive unnecessary repeated CT scans to evaluate their pain even if they have previous negative studies.

“It is important for the hospitalist to know that functional abdominal pain can be managed without additional diagnostic studies,” says John M. Inadomi, MD, head of the division of gastroenterology at the University of Washington School of Medicine in Seattle. “Some doctors are uncomfortable with the uncertainty of a diagnosis of chronic abdominal pain without evidence of biochemical or structural disease [functional abdominal pain syndrome] and fear litigation.”

An abdominal CT scan is one of the higher radiation exposure tests, equivalent to three years of natural background radiation.¹

“Due to this risk and the high costs of this procedure, CT scans should be limited to situations in which they are likely to provide useful information that changes patient management,” Dr. Inadomi says.

According to Moises Auron, MD, FAAP, FACP, SFHM, assistant professor of medicine and pediatrics at Cleveland Clinic Lerner College of Medicine of Case Western University in Cleveland, Ohio, it should not be a difficult choice for hospitalists, “as the clinical context provides a safeguard to justify the rationale for a conservative approach. Hospitalists must be educated on the appropriate use of Rome criteria, as well as how to appropriately document it in the chart to justify a decision to avoid unnecessary testing.”

2 American College of Rheumatology (ACR)

Recommendation: Don’t test anti-nuclear antibody (ANA) sub-serologies without a positive ANA and clinical suspicion of immune-mediated disease.

“A fever of unknown origin is among the most common diagnoses the hospitalist encounters,” Dr. Auron says. “Nowadays, given the ease to order tests, as well as the increased awareness of patients with immune-mediated diseases, it may be tempting to order large panels of immunologic tests to minimize the risk of missing a diagnosis; however, because ANA has high sensitivity and poor specificity, it should only be ordered if the clinical context supports its use.”

Jinoos Yazdany, MD, MPH, assistant professor of medicine at the University of California at San Francisco and co-chair of the task force that developed the ACR’s Choosing Wisely list, points out that if you use ANAs as a broad screening test when the pretest probability of specific ANA-associated diseases is low, there is an increased chance of a false positive ANA result. This can lead to unnecessary further testing and additional costs. Furthermore, ANA sub-serologies are usually negative if the ANA (done by immunofluorescence) is negative.

“So it is recommended to order sub-serologies only once it is known that the ANA is positive,” she says. The exceptions to this are anti-SSA and anti-Jo-1 antibodies, which can sometimes be positive when the ANA is negative.

Mangla S. Gulati, MD, FACP, FHM, medical director for clinical effectiveness at the University of Maryland School of Medicine in Baltimore, says a positive ANA in conjunction with clinical information “will help to guide appropriate and cost-conscious testing. Hospitalists could implement this through a clinical decision support approach if using an electronic medical record.”

LISTEN NOW to Daniel Wolfson, MHSA, executive vice president and CEO of the ABIM Foundation, discuss how the Choosing Wisely campaign got started and its significance in U.S. healthcare.

3 American College of Physicians (ACP)

Recommendation: In patients with low pretest probability of venous thromboembolism (VTE), obtain a high-sensitive D-dimer measurement as the initial diagnostic test; don’t obtain imaging studies as the initial diagnostic test.

VTE, a common problem in hospitalized patients, has high mortality rates. “However, recent statistics suggest that we may be overdiagnosing non-clinically significant disease and exposing large numbers of patients to high doses of radiation unnecessarily in an attempt to rule out VTE disease,” says Cynthia D. Smith, MD, FACP, ACP senior medical associate for content development and adjunct associate professor of medicine at the Perelman School of Medicine in Philadelphia.

Instead, physicians should estimate pretest probability of disease using a validated risk assessment tool (i.e., Wells score). For patients with low clinical probability of VTE, hospitalists should use a negative high-sensitive D-dimer measurement as the initial diagnostic test.

Dr. Auron says the litigious environment of American medicine may trigger clinicians to order testing to minimize the risk of missing potential conditions; however, an adequate, evidence-based approach with appropriate documentation should be sufficient. In this case, that would entail using D-dimer testing to outline the low pretest probability of VTE and explaining to the patient the rationale for not pursuing further imaging.

Dr. Gulati adds that hospitalists should have little difficulty implementing this cost-effective approach.

“A reasonable way to justify the increased availability of the nuclear medicine department would be to document the number of CT chest scans done after hours in patients who would have instead had a V/Q scan.”

—Moises Auron, MD, FAAP, FACP, SFHM, assistant professor of medicine and pediatrics, Cleveland Clinic

4 American Geriatrics Society (AGS)

Recommendation: Don’t use antimicrobials to treat bacteriuria in older adults unless specific urinary tract symptoms are present.

Older adults with asymptomatic bacteriuria who received antimicrobial treatment show no benefit, according to multiple studies.² In fact, increased adverse antimicrobial effects occurred, such as greater resistance patterns and super-infections (e.g. Clostridium difficile).

The truth is that as many as 30% of frail elders (particularly women) have bacterial colonization of the urinary tract without infection, also known as asymptomatic bacteriuria, says Heidi Wald, MD, MSPH, associate professor of medicine and vice chair for quality in the department of medicine at the University of Colorado School of Medicine in Aurora. Therefore, before being prescribed antimicrobials, a patient should exhibit symptoms of urinary tract infection such as fever, frequent urination, urgency to urinate, painful urination, or suprapubic tenderness.

“Without localizing symptoms, you can’t assume bacteriuria equals infection,” Dr. Wald adds. “Too often, we make the urine a scapegoat for unrelated presentations, such as mild confusion.”

If the patient is stable and doesn’t have UTI symptoms, Dr. Wald says hospitalists should consider hydration and monitor the patient without antibiotics.

“This should not be difficult to implement,” Dr. Auron says, “as hospitalists are on the front lines of antibiotic stewardship in hospitals.”

LISTEN NOW to Linda Cox, MD, owner of Allergy and Asthma Center in Ft. Lauderdale, Fla., and president of American Academy of Allergy, Asthma & Immunology, discuss why it's important for hospitalists to not diagnose or manage asthma without spirometry.

5 American Society of Echocardiography (ASE)

Recommendation: Avoid echocardiograms for pre-operative/peri-operative assessment of patients with no history or symptoms of heart disease.

Echocardiography can diagnose all types of heart disease while being completely safe, inexpensive, and available at the bedside.

“These features may logically lead hospitalists to think, ‘Why not?’ Maybe there’s something going on and an echo can’t hurt,” says James D. Thomas, MD, FASE, FACC, FAHA, FESC, Moore Chair of Cardiovascular Imaging at Cleveland Clinic and ASE past president. “Unfortunately, tests can have false positive findings that lead to other, potentially more hazardous and invasive, tests downstream, as well as unnecessary delays.”

If a patient has no history of heart disease, no positive physical findings, or no symptoms, then an echo probably won’t be helpful. Hospitalists need to be aware of the lack of value of a presumed normal study, Dr. Auron says.

“Having appropriate standards of care allows clinicians in pre-operative areas to use risk stratification tools in an adequate fashion,” he notes.

6 American Society of Nephrology (ASN)

Recommendation: Do not place peripherally inserted central venous catheters (PICC) in stage three to five chronic kidney disease (CKD) patients without consulting nephrology.

Given the increase in patients with CKD in the later stages, as well as end-stage renal disease, clinicians need to protect patients’ upper extremity veins in order to be able to have an adequate vascular substrate for subsequent creation of an arteriovenous fistula (AVF), Dr. Auron maintains.

PICCs, along with other central venous catheters, damage veins and destroy sites for future hemodialysis vascular access, explains Amy W. Williams, MD, medical director of hospital operations and consultant in the division of nephrology and hypertension at Mayo Clinic in Rochester, Minn. If there are no options for AVF or grafts, patients starting or being maintained on hemodialysis will need a tunneled central venous catheter for dialysis access.

Studies have shown that AVFs have better patency rates and fewer complications compared to catheters, and there is a direct correlation of increased mortality and inadequate dialysis with tunneled central catheters.³ In addition, dialysis patients with a tunneled central venous catheter have a five-fold increase of infection compared to those with an AVF.⁴ The incidence of central venous stenosis associated with PICC lines has been shown to be 42% and the incidence of thrombosis 38%.^5,6 There is no significant difference in the rate of central venous complications based on the duration of catheter use or catheter size. In addition, prior PICC use has been shown to be an independent predictor of lack of a functioning AVF (odds ratio 2.8 [95 % CI, 1.5 to 5.5]).⁷

A better choice for extended venous access in patients with advanced CKD is a tunneled internal jugular vein catheter, which is associated with a lower risk of permanent vascular damage, says Dr. Williams, who is chair of the ASN’s Quality and Patient Safety Task Force.

Hospitalists who care for pediatric patients have the potential to significantly impact antibiotic overuse, as hospitalizations for respiratory illnesses due to viruses, such as bronchiolitis and croup, remain a leading cause of admission.

—James J. O’Callaghan, MD, FAAP, FHM, clinical assistant professor of pediatrics, Seattle Children’s Hospital at the University of Washington, Team Hospitalist member

7 The Society of Thoracic Surgeons (STS)

Recommendation: Patients who have no cardiac history and good functional status do not require pre-operative stress testing prior to non-cardiac thoracic surgery.

By eliminating routine stress testing prior to non-cardiac thoracic surgery for patients without a history of cardiac symptoms, hospitalists can reduce the burden of costs on patients and eliminate the possibility of adverse outcomes due to inappropriate testing.

“Functional status has been shown to be reliable to predict peri-operative and long-term cardiac events,” says Douglas E. Wood, MD, chief of the division of cardiothoracic surgery at the University of Washington in Seattle and president of the STS. “In highly functional asymptomatic patients, management is rarely changed by pre-operative stress testing. Furthermore, abnormalities identified in testing often require additional investigation, with negative consequences related to the risks of more procedures or tests, delays in therapies, and additional costs.”

Pre-operative stress testing should be reserved for patients with low functional capacity or clinical risk factors for cardiac complications. It is important to identify patients pre-operatively who are at risk for these complications by doing a thorough history, physical examination, and resting electrocardiogram.

8 Society of Nuclear Medicine and Molecular Imaging (SNMMI)

Recommendation: Avoid using a CT angiogram to diagnose pulmonary embolism (PE) in young women with a normal chest radiograph; consider a radionuclide lung (V/Q) study instead.

Hospitalists should be knowledgeable of the diagnostic options that will result in the lowest radiation exposure when evaluating young women for PE.

“When a chest radiograph is normal or nearly normal, a computed tomography angiogram or a V/Q lung scan can be used to evaluate these patients. While both exams have low radiation exposure, the V/Q lung scan results in less radiation to the breast tissue,” says society president Gary L. Dillehay, MD, FACNM, FACR, professor of radiology at Northwestern Memorial Hospital in Chicago. “Recent literature cites concerns over radiation exposure from mammography; therefore, reducing radiation exposure to breast tissue, when evaluating patients for suspected PE, is desirable.”

Hospitalists might have difficulty obtaining a V/Q lung scan when nuclear medicine departments are closed.

“The caveat is that CT scans are much more readily available,” Dr. Auron says. In addition, a CT scan provides additional information. But unless the differential diagnosis is much higher for PE than other possibilities, just having a V/Q scan should suffice.

Hospitalists could help implement protocols for chest pain evaluation in premenopausal women by having checklists for risk factors for coronary artery disease, connective tissue disease (essentially aortic dissection), and VTE (e.g. Wells and Geneva scores, use of oral contraceptives, smoking), Dr. Auron says. If the diagnostic branch supports the risk of PE, then nuclear imaging should be available.

“A reasonable way to justify the increased availability of the nuclear medicine department would be to document the number of CT chest scans done after hours in patients who would have instead had a V/Q scan,” he says.

LISTEN NOW to Rahul Shah, MD, FACS, FAAP, associate professor of otolaryngology and pediatrics at Children's National Medical Center in Washington, D.C, and co-chair of the American Academy of Otolaryngology-Head and Neck Surgery Foundation’s Patient Safety Quality Improvement Committee, explain why hospitalists should avoid routine radiographic imaging for patients who meet diagnostic criteria for uncomplicated acute rhinosinusitis.

9 American Academy of Pediatrics (AAP)

Recommendation: Antibiotics should not be used for apparent viral respiratory illnesses (sinusitis, pharyngitis, bronchitis).

Respiratory illnesses are the most common reason for hospitalization in pediatrics. Recent studies and surveys continue to demonstrate antibiotic overuse in the pediatric population, especially when prescribed for apparent viral respiratory illnesses.^8,9

“Hospitalists who care for pediatric patients have the potential to significantly impact antibiotic overuse, as hospitalizations for respiratory illnesses due to viruses such as bronchiolitis and croup remain a leading cause of admission,” says James J. O’Callaghan, MD, FAAP, FHM, clinical assistant professor of pediatrics at the University of Washington School of Medicine in Seattle.

Many respiratory problems, such as bronchiolitis, asthma, and even some pneumonias are caused or exacerbated by viruses, points out Ricardo Quiñonez, MD, FAAP, FHM, section head of pediatric hospital medicine at the Children’s Hospital of San Antonio and the Baylor College of Medicine, and chair of the AAP’s section on hospital medicine. In particular, there are national guidelines for bronchiolitis and asthma that recommend against the use of systemic antibiotics.

This recommendation may be difficult for hospitalists to implement, because antibiotics are frequently started by other providers (PCP or ED), Dr. O’Callaghan admits. It can be tricky to change or stop therapy without undermining patients’ or parents’ confidence in their medical decision-making. Hospitalists may need to collaborate with new partners, such as community-wide antibiotic reduction campaigns, in order to affect this culture change.

“Echocardiography can diagnose all types of heart disease while being completely safe, inexpensive, and available at the bedside. These features may logically lead hospitalists to think, ‘Why not?’ Maybe there’s something going on and an echo can’t hurt. Unfortunately, tests can have false positive findings that lead to other, potentially more hazardous and invasive, tests downstream, as well as unnecessary delays.”

—James D. Thomas, MD, FASE, FACC, FAHA, FESC, Moore Chair of Cardiovascular Imaging at the Cleveland Clinic in Ohio and past president of the American Society of Echocardiography.

10 American College of Obstetricians and Gynecologists (ACOB)

Recommendation: Don’t schedule elective inductions prior to 39 weeks, and don’t schedule elective inductions of labor after 39 weeks without a favorable cervix.

Studies show an increased risk to newborns that are electively inducted between 37 and 39 weeks. Complications include increased admission to the neonatal intensive care unit, increased risk of respiratory distress and need for respiratory support, and increased incidence of infection and sepsis.

This recommendation may be difficult for hospitalists to implement, because obstetrical providers typically schedule elective inductions. Implementation of this recommendation would involve collaboration with obstetrical providers, with possible support from maternal-fetal and neonatal providers.

“Recent quality measures and initiatives from such organizations such as CMS and the National Quality Forum … may help to galvanize institutional support for its successful implementation,” says Dr. O’Callaghan, a Team Hospitalist member.

Elective surgeries should only be done in cases where there is a medical necessity, such as when the mother is diabetic or has hypertension, adds Rob Olson, MD, FACOG, an OB/GYN hospitalist for PeaceHealth at St. Joseph Medical Center in Bellingham, Wash. “Hospitalists should not give in to pressures from patients who are either tired of the discomforts of pregnancy or have family pressure to end the pregnancy early.”

Karen Appold is a freelance writer in Pennsylvania.

References

1. U.S. Food and Drug Administration. Reducing radiation from medical X-rays. Available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095505.htm. Accessed May 12, 2014.
2. Nicolle LE, Bradley S, Colgan R, et al. Infectious Diseases Society of America guidelines for the diagnosis and treatment of asymptomatic bacteriuria in adults. Clin Infect Dis. 2005;40(5):643-654.
3. Hoggard J, Saad T, Schon D, et al. Guidelines for venous access in patients with chronic kidney disease. A position statement from the American Society of Diagnostic and Interventional Nephrology, Clinical Practice Committee and the Association for Vascular Access. Semin Dial. 2008;21(2):186-191.
4. Rayner HC, Besarab A, Brown WW, Disney A, Saito A, Pisoni RL. Vascular access results from the dialysis outcomes and practice patterns study (DOPPS): Performance against kidney disease outcomes quality initiative (K/DOQI)clinical practice guidelines. Am J Kidney Dis. 2004;44(5 Suppl 2):22-26.
5. Gonsalves CF, Eschelman DJ, Sullivan KL, DuBois N, Bonn J. Incidence of central vein stenosis and occlusion following upper extremity PICC and port placement. Cardiovasc Intervent Radiol. 2003;26(2):123-127.
6. Allen AW, Megargell JL, Brown DB, et al. Venous thrombosis associated with the placement of peripherally inserted central catheters. J Vasc Interv Radiol. 2000;11(10):1309-1314.
7. El Ters M, Schears GJ, Taler SJ, et al. Association between prior peripherally inserted central catheters and lack of functioning ateriovenous fistulas: A case control study in hemodialysis patients. Am J Kidney Dis. 2012;60(4):601-608.
8. Hersh AL, Shapiro DJ, Pavia AT, Shah SS. Antibiotic prescribing in ambulatory pediatrics in the United States. Pediatrics. 2011;128(6):1053-1061.
9. Knapp JF, Simon SD, Sharma V. Quality of care for common pediatric respiratory illnesses in United States emergency departments: Analysis of 2005 National Hospital Ambulatory Medical Care Survey data. Pediatrics. 2008;122(6):1165-1170.

When diagnosing a patient, it can be tempting to run all types of tests to expedite the process—and protect yourself from litigation. Patients may push for more tests, too, thinking “the more the better.” But that may not be the best course of action. In fact, according to recommendations of the ABIM Foundations’ Choosing Wisely campaign, more tests can actually bring a host of negative consequences.

In an effort to help hospitalists decide which tests to perform and which to forgo, The Hospitalist asked medical societies that contributed to the Choosing Wisely campaign to tell us which one of their recommendations was the most applicable to hospitalists. Then, we asked some hospitalists to discuss how they might implement each recommendation.

1 American Gastroenterological Association (AGA)

Recommendation: For a patient with functional abdominal pain syndrome (as per Rome criteria), computed tomography (CT) scans should not be repeated unless there is a major change in clinical findings or symptoms.

When a patient first complains of abdominal pain, a CT scan usually is done prior to a gastroenterological consultation. Despite this initial scan, many patients with chronic abdominal pain receive unnecessary repeated CT scans to evaluate their pain even if they have previous negative studies.

“It is important for the hospitalist to know that functional abdominal pain can be managed without additional diagnostic studies,” says John M. Inadomi, MD, head of the division of gastroenterology at the University of Washington School of Medicine in Seattle. “Some doctors are uncomfortable with the uncertainty of a diagnosis of chronic abdominal pain without evidence of biochemical or structural disease [functional abdominal pain syndrome] and fear litigation.”

An abdominal CT scan is one of the higher radiation exposure tests, equivalent to three years of natural background radiation.¹

“Due to this risk and the high costs of this procedure, CT scans should be limited to situations in which they are likely to provide useful information that changes patient management,” Dr. Inadomi says.

According to Moises Auron, MD, FAAP, FACP, SFHM, assistant professor of medicine and pediatrics at Cleveland Clinic Lerner College of Medicine of Case Western University in Cleveland, Ohio, it should not be a difficult choice for hospitalists, “as the clinical context provides a safeguard to justify the rationale for a conservative approach. Hospitalists must be educated on the appropriate use of Rome criteria, as well as how to appropriately document it in the chart to justify a decision to avoid unnecessary testing.”

2 American College of Rheumatology (ACR)

Recommendation: Don’t test anti-nuclear antibody (ANA) sub-serologies without a positive ANA and clinical suspicion of immune-mediated disease.

“A fever of unknown origin is among the most common diagnoses the hospitalist encounters,” Dr. Auron says. “Nowadays, given the ease to order tests, as well as the increased awareness of patients with immune-mediated diseases, it may be tempting to order large panels of immunologic tests to minimize the risk of missing a diagnosis; however, because ANA has high sensitivity and poor specificity, it should only be ordered if the clinical context supports its use.”

Jinoos Yazdany, MD, MPH, assistant professor of medicine at the University of California at San Francisco and co-chair of the task force that developed the ACR’s Choosing Wisely list, points out that if you use ANAs as a broad screening test when the pretest probability of specific ANA-associated diseases is low, there is an increased chance of a false positive ANA result. This can lead to unnecessary further testing and additional costs. Furthermore, ANA sub-serologies are usually negative if the ANA (done by immunofluorescence) is negative.

“So it is recommended to order sub-serologies only once it is known that the ANA is positive,” she says. The exceptions to this are anti-SSA and anti-Jo-1 antibodies, which can sometimes be positive when the ANA is negative.

Mangla S. Gulati, MD, FACP, FHM, medical director for clinical effectiveness at the University of Maryland School of Medicine in Baltimore, says a positive ANA in conjunction with clinical information “will help to guide appropriate and cost-conscious testing. Hospitalists could implement this through a clinical decision support approach if using an electronic medical record.”

LISTEN NOW to Daniel Wolfson, MHSA, executive vice president and CEO of the ABIM Foundation, discuss how the Choosing Wisely campaign got started and its significance in U.S. healthcare.

3 American College of Physicians (ACP)

Recommendation: In patients with low pretest probability of venous thromboembolism (VTE), obtain a high-sensitive D-dimer measurement as the initial diagnostic test; don’t obtain imaging studies as the initial diagnostic test.

VTE, a common problem in hospitalized patients, has high mortality rates. “However, recent statistics suggest that we may be overdiagnosing non-clinically significant disease and exposing large numbers of patients to high doses of radiation unnecessarily in an attempt to rule out VTE disease,” says Cynthia D. Smith, MD, FACP, ACP senior medical associate for content development and adjunct associate professor of medicine at the Perelman School of Medicine in Philadelphia.

Instead, physicians should estimate pretest probability of disease using a validated risk assessment tool (i.e., Wells score). For patients with low clinical probability of VTE, hospitalists should use a negative high-sensitive D-dimer measurement as the initial diagnostic test.

Dr. Auron says the litigious environment of American medicine may trigger clinicians to order testing to minimize the risk of missing potential conditions; however, an adequate, evidence-based approach with appropriate documentation should be sufficient. In this case, that would entail using D-dimer testing to outline the low pretest probability of VTE and explaining to the patient the rationale for not pursuing further imaging.

Dr. Gulati adds that hospitalists should have little difficulty implementing this cost-effective approach.

“A reasonable way to justify the increased availability of the nuclear medicine department would be to document the number of CT chest scans done after hours in patients who would have instead had a V/Q scan.”

—Moises Auron, MD, FAAP, FACP, SFHM, assistant professor of medicine and pediatrics, Cleveland Clinic

4 American Geriatrics Society (AGS)

Recommendation: Don’t use antimicrobials to treat bacteriuria in older adults unless specific urinary tract symptoms are present.

Older adults with asymptomatic bacteriuria who received antimicrobial treatment show no benefit, according to multiple studies.² In fact, increased adverse antimicrobial effects occurred, such as greater resistance patterns and super-infections (e.g. Clostridium difficile).

The truth is that as many as 30% of frail elders (particularly women) have bacterial colonization of the urinary tract without infection, also known as asymptomatic bacteriuria, says Heidi Wald, MD, MSPH, associate professor of medicine and vice chair for quality in the department of medicine at the University of Colorado School of Medicine in Aurora. Therefore, before being prescribed antimicrobials, a patient should exhibit symptoms of urinary tract infection such as fever, frequent urination, urgency to urinate, painful urination, or suprapubic tenderness.

“Without localizing symptoms, you can’t assume bacteriuria equals infection,” Dr. Wald adds. “Too often, we make the urine a scapegoat for unrelated presentations, such as mild confusion.”

If the patient is stable and doesn’t have UTI symptoms, Dr. Wald says hospitalists should consider hydration and monitor the patient without antibiotics.

“This should not be difficult to implement,” Dr. Auron says, “as hospitalists are on the front lines of antibiotic stewardship in hospitals.”

LISTEN NOW to Linda Cox, MD, owner of Allergy and Asthma Center in Ft. Lauderdale, Fla., and president of American Academy of Allergy, Asthma & Immunology, discuss why it's important for hospitalists to not diagnose or manage asthma without spirometry.

5 American Society of Echocardiography (ASE)

Recommendation: Avoid echocardiograms for pre-operative/peri-operative assessment of patients with no history or symptoms of heart disease.

Echocardiography can diagnose all types of heart disease while being completely safe, inexpensive, and available at the bedside.

“These features may logically lead hospitalists to think, ‘Why not?’ Maybe there’s something going on and an echo can’t hurt,” says James D. Thomas, MD, FASE, FACC, FAHA, FESC, Moore Chair of Cardiovascular Imaging at Cleveland Clinic and ASE past president. “Unfortunately, tests can have false positive findings that lead to other, potentially more hazardous and invasive, tests downstream, as well as unnecessary delays.”

If a patient has no history of heart disease, no positive physical findings, or no symptoms, then an echo probably won’t be helpful. Hospitalists need to be aware of the lack of value of a presumed normal study, Dr. Auron says.

“Having appropriate standards of care allows clinicians in pre-operative areas to use risk stratification tools in an adequate fashion,” he notes.

6 American Society of Nephrology (ASN)

Recommendation: Do not place peripherally inserted central venous catheters (PICC) in stage three to five chronic kidney disease (CKD) patients without consulting nephrology.

Given the increase in patients with CKD in the later stages, as well as end-stage renal disease, clinicians need to protect patients’ upper extremity veins in order to be able to have an adequate vascular substrate for subsequent creation of an arteriovenous fistula (AVF), Dr. Auron maintains.

PICCs, along with other central venous catheters, damage veins and destroy sites for future hemodialysis vascular access, explains Amy W. Williams, MD, medical director of hospital operations and consultant in the division of nephrology and hypertension at Mayo Clinic in Rochester, Minn. If there are no options for AVF or grafts, patients starting or being maintained on hemodialysis will need a tunneled central venous catheter for dialysis access.

Studies have shown that AVFs have better patency rates and fewer complications compared to catheters, and there is a direct correlation of increased mortality and inadequate dialysis with tunneled central catheters.³ In addition, dialysis patients with a tunneled central venous catheter have a five-fold increase of infection compared to those with an AVF.⁴ The incidence of central venous stenosis associated with PICC lines has been shown to be 42% and the incidence of thrombosis 38%.^5,6 There is no significant difference in the rate of central venous complications based on the duration of catheter use or catheter size. In addition, prior PICC use has been shown to be an independent predictor of lack of a functioning AVF (odds ratio 2.8 [95 % CI, 1.5 to 5.5]).⁷

A better choice for extended venous access in patients with advanced CKD is a tunneled internal jugular vein catheter, which is associated with a lower risk of permanent vascular damage, says Dr. Williams, who is chair of the ASN’s Quality and Patient Safety Task Force.

Hospitalists who care for pediatric patients have the potential to significantly impact antibiotic overuse, as hospitalizations for respiratory illnesses due to viruses, such as bronchiolitis and croup, remain a leading cause of admission.

—James J. O’Callaghan, MD, FAAP, FHM, clinical assistant professor of pediatrics, Seattle Children’s Hospital at the University of Washington, Team Hospitalist member

7 The Society of Thoracic Surgeons (STS)

Recommendation: Patients who have no cardiac history and good functional status do not require pre-operative stress testing prior to non-cardiac thoracic surgery.

By eliminating routine stress testing prior to non-cardiac thoracic surgery for patients without a history of cardiac symptoms, hospitalists can reduce the burden of costs on patients and eliminate the possibility of adverse outcomes due to inappropriate testing.

“Functional status has been shown to be reliable to predict peri-operative and long-term cardiac events,” says Douglas E. Wood, MD, chief of the division of cardiothoracic surgery at the University of Washington in Seattle and president of the STS. “In highly functional asymptomatic patients, management is rarely changed by pre-operative stress testing. Furthermore, abnormalities identified in testing often require additional investigation, with negative consequences related to the risks of more procedures or tests, delays in therapies, and additional costs.”

Pre-operative stress testing should be reserved for patients with low functional capacity or clinical risk factors for cardiac complications. It is important to identify patients pre-operatively who are at risk for these complications by doing a thorough history, physical examination, and resting electrocardiogram.

8 Society of Nuclear Medicine and Molecular Imaging (SNMMI)

Recommendation: Avoid using a CT angiogram to diagnose pulmonary embolism (PE) in young women with a normal chest radiograph; consider a radionuclide lung (V/Q) study instead.

Hospitalists should be knowledgeable of the diagnostic options that will result in the lowest radiation exposure when evaluating young women for PE.

“When a chest radiograph is normal or nearly normal, a computed tomography angiogram or a V/Q lung scan can be used to evaluate these patients. While both exams have low radiation exposure, the V/Q lung scan results in less radiation to the breast tissue,” says society president Gary L. Dillehay, MD, FACNM, FACR, professor of radiology at Northwestern Memorial Hospital in Chicago. “Recent literature cites concerns over radiation exposure from mammography; therefore, reducing radiation exposure to breast tissue, when evaluating patients for suspected PE, is desirable.”

Hospitalists might have difficulty obtaining a V/Q lung scan when nuclear medicine departments are closed.

“The caveat is that CT scans are much more readily available,” Dr. Auron says. In addition, a CT scan provides additional information. But unless the differential diagnosis is much higher for PE than other possibilities, just having a V/Q scan should suffice.

Hospitalists could help implement protocols for chest pain evaluation in premenopausal women by having checklists for risk factors for coronary artery disease, connective tissue disease (essentially aortic dissection), and VTE (e.g. Wells and Geneva scores, use of oral contraceptives, smoking), Dr. Auron says. If the diagnostic branch supports the risk of PE, then nuclear imaging should be available.

“A reasonable way to justify the increased availability of the nuclear medicine department would be to document the number of CT chest scans done after hours in patients who would have instead had a V/Q scan,” he says.

LISTEN NOW to Rahul Shah, MD, FACS, FAAP, associate professor of otolaryngology and pediatrics at Children's National Medical Center in Washington, D.C, and co-chair of the American Academy of Otolaryngology-Head and Neck Surgery Foundation’s Patient Safety Quality Improvement Committee, explain why hospitalists should avoid routine radiographic imaging for patients who meet diagnostic criteria for uncomplicated acute rhinosinusitis.

9 American Academy of Pediatrics (AAP)

Recommendation: Antibiotics should not be used for apparent viral respiratory illnesses (sinusitis, pharyngitis, bronchitis).

Respiratory illnesses are the most common reason for hospitalization in pediatrics. Recent studies and surveys continue to demonstrate antibiotic overuse in the pediatric population, especially when prescribed for apparent viral respiratory illnesses.^8,9

“Hospitalists who care for pediatric patients have the potential to significantly impact antibiotic overuse, as hospitalizations for respiratory illnesses due to viruses such as bronchiolitis and croup remain a leading cause of admission,” says James J. O’Callaghan, MD, FAAP, FHM, clinical assistant professor of pediatrics at the University of Washington School of Medicine in Seattle.

Many respiratory problems, such as bronchiolitis, asthma, and even some pneumonias are caused or exacerbated by viruses, points out Ricardo Quiñonez, MD, FAAP, FHM, section head of pediatric hospital medicine at the Children’s Hospital of San Antonio and the Baylor College of Medicine, and chair of the AAP’s section on hospital medicine. In particular, there are national guidelines for bronchiolitis and asthma that recommend against the use of systemic antibiotics.

This recommendation may be difficult for hospitalists to implement, because antibiotics are frequently started by other providers (PCP or ED), Dr. O’Callaghan admits. It can be tricky to change or stop therapy without undermining patients’ or parents’ confidence in their medical decision-making. Hospitalists may need to collaborate with new partners, such as community-wide antibiotic reduction campaigns, in order to affect this culture change.

“Echocardiography can diagnose all types of heart disease while being completely safe, inexpensive, and available at the bedside. These features may logically lead hospitalists to think, ‘Why not?’ Maybe there’s something going on and an echo can’t hurt. Unfortunately, tests can have false positive findings that lead to other, potentially more hazardous and invasive, tests downstream, as well as unnecessary delays.”

—James D. Thomas, MD, FASE, FACC, FAHA, FESC, Moore Chair of Cardiovascular Imaging at the Cleveland Clinic in Ohio and past president of the American Society of Echocardiography.

10 American College of Obstetricians and Gynecologists (ACOB)

Recommendation: Don’t schedule elective inductions prior to 39 weeks, and don’t schedule elective inductions of labor after 39 weeks without a favorable cervix.

Studies show an increased risk to newborns that are electively inducted between 37 and 39 weeks. Complications include increased admission to the neonatal intensive care unit, increased risk of respiratory distress and need for respiratory support, and increased incidence of infection and sepsis.

This recommendation may be difficult for hospitalists to implement, because obstetrical providers typically schedule elective inductions. Implementation of this recommendation would involve collaboration with obstetrical providers, with possible support from maternal-fetal and neonatal providers.

“Recent quality measures and initiatives from such organizations such as CMS and the National Quality Forum … may help to galvanize institutional support for its successful implementation,” says Dr. O’Callaghan, a Team Hospitalist member.

Elective surgeries should only be done in cases where there is a medical necessity, such as when the mother is diabetic or has hypertension, adds Rob Olson, MD, FACOG, an OB/GYN hospitalist for PeaceHealth at St. Joseph Medical Center in Bellingham, Wash. “Hospitalists should not give in to pressures from patients who are either tired of the discomforts of pregnancy or have family pressure to end the pregnancy early.”

Karen Appold is a freelance writer in Pennsylvania.

References

1. U.S. Food and Drug Administration. Reducing radiation from medical X-rays. Available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095505.htm. Accessed May 12, 2014.
2. Nicolle LE, Bradley S, Colgan R, et al. Infectious Diseases Society of America guidelines for the diagnosis and treatment of asymptomatic bacteriuria in adults. Clin Infect Dis. 2005;40(5):643-654.
3. Hoggard J, Saad T, Schon D, et al. Guidelines for venous access in patients with chronic kidney disease. A position statement from the American Society of Diagnostic and Interventional Nephrology, Clinical Practice Committee and the Association for Vascular Access. Semin Dial. 2008;21(2):186-191.
4. Rayner HC, Besarab A, Brown WW, Disney A, Saito A, Pisoni RL. Vascular access results from the dialysis outcomes and practice patterns study (DOPPS): Performance against kidney disease outcomes quality initiative (K/DOQI)clinical practice guidelines. Am J Kidney Dis. 2004;44(5 Suppl 2):22-26.
5. Gonsalves CF, Eschelman DJ, Sullivan KL, DuBois N, Bonn J. Incidence of central vein stenosis and occlusion following upper extremity PICC and port placement. Cardiovasc Intervent Radiol. 2003;26(2):123-127.
6. Allen AW, Megargell JL, Brown DB, et al. Venous thrombosis associated with the placement of peripherally inserted central catheters. J Vasc Interv Radiol. 2000;11(10):1309-1314.
7. El Ters M, Schears GJ, Taler SJ, et al. Association between prior peripherally inserted central catheters and lack of functioning ateriovenous fistulas: A case control study in hemodialysis patients. Am J Kidney Dis. 2012;60(4):601-608.
8. Hersh AL, Shapiro DJ, Pavia AT, Shah SS. Antibiotic prescribing in ambulatory pediatrics in the United States. Pediatrics. 2011;128(6):1053-1061.
9. Knapp JF, Simon SD, Sharma V. Quality of care for common pediatric respiratory illnesses in United States emergency departments: Analysis of 2005 National Hospital Ambulatory Medical Care Survey data. Pediatrics. 2008;122(6):1165-1170.

CHICAGO – The investigational drug lenvatinib significantly prolonged progression-free survival and produced high response rates compared with placebo in patients with iodine-refractory differentiated thyroid cancer.

In a randomized trial, the median progression-free survival (PFS) among patients assigned to lenvatinib was 18.3 months, compared with 3.6 months for placebo. The hazard ratio for lenvatinib was 0.21 (P less than .0001), Dr. Martin Schlumberger reported at the annual meeting of the American Society of Clinical Oncology.

"We had a high objective response rate – about 65% – with some complete responses. Interestingly, the time to objective response was only 2 months, so responses occur very quickly after the first treatment," Dr. Schlumberger, a professor of oncology at the University Paris-Sud, France, said at a media briefing prior to his presentation of the data in a plenary session.

"It’s really rewarding to see another active drug in this disease, where a year ago we really had no active therapy," commented Dr. Gregory A. Masters from the Helen F. Graham Cancer Center in Newark, Delaware.

Dr. Masters moderated the briefing but was not involved in the study.

Patients with relapsed or refractory differentiated thyroid cancer that is resistant to treatment with iodine-131 (¹³¹I) have few treatment choices and a 10-year survival rate of just 10%, Dr. Schlumberger noted.

There is evidence, however, showing that vascular endothelial growth factor (VEGF) signaling is associated with aggressive thyroid cancer and its propensity for metastasis, prompting researchers to explore VEGF-receptor inhibitors.

Lenvatinib is an oral multi–tyrosine kinase inhibitor of VEGF receptors 1-3, fibroblast growth factor receptors 1-4, platelet-derived growth factor receptor–alpha, and the RET and KIT kinases.

In a phase II study, the drug showed clinical activity against ¹³¹I-refractory differentiated thyroid cancer, prompting investigators to launch the phase III SELECT trial (Study of E7080 Lenvatinib in Differentiated Cancer of the Thyroid) in this population.

They enrolled 392 patients with measurable disease and evidence of progression within the previous 13 months of treatment, which could include one prior VEGF or VEGF-receptor inhibitor.

The patients were randomized on a 2:1 basis to either oral lenvatinib 24 mg daily or placebo, with treatment continuing until disease progression according to RECIST (Response Evaluation Criteria in Solid Tumor) criteria. At the time of confirmed disease progression, patients originally assigned to placebo could be crossed over to the active drug.

As noted above, median PFS was significantly better for the 261 patients assigned to lenvatinib, at 18.3 months, vs. 3.6 months for the 121 assigned to placebo. The median PFS for patients who had previously received another VEGF inhibitor was 15.1 months, compared with 18.7 months for those who had not been treated with an anti-VEGF agent (P value not shown). Median overall survival has not yet been reached.

The overall response rates were 65% for lenvatinib, versus 2% for placebo (P less than .0001). In the lenvatinib group, there were 4 complete responses, 165 partial responses, 40 cases with stable disease of at least 23 weeks’ duration, and 18 cases of progressive disease. Among placebo-treated patients, there were no complete responses, 2 partial responses, 39 cases of stable disease, and 52 of progressive disease. Only 1.5% of patients, all in the lenvatinib group, had a complete response, compared with none in the placebo group.

The median time to an objective response was 2 months. The median duration of response had not been reached by the last analysis. Approximately 75% of responders had an objective response last for more than 9.4 months, Dr. Schlumberger said.

As is common with other VEGF inhibitors, treatment-emergent adverse events were common, occurring in 97% of patients treated with lenvatinib, compared with 60% of patients on placebo.

The most common events were hypertension, occurring in 68% of patients vs. 9% on placebo, diarrhea (60% vs. 8%), fatigue/asthenia (59% vs. 28%), decreased appetite (50% vs. 12%), and nausea/vomiting (51% vs. 24%).

Adverse events requiring dose reductions occurred in 68% of patients on lenvatinib, dose interruptions in 82%, and discontinuation in 14%. In contrast, only 5% of patients on placebo had a dose reduction, 18% had an interruption, and 5% discontinued therapy.

Also of concern to investigators was the fact that of the 20 patients on lenvatinib who died during the trial, 6 of the deaths were determined by investigators to be treatment related. One of these patients died from a hemorrhagic stroke, one from a pulmonary embolism, and four from general health deterioration.

Hematologic complications are a class effect of the anti-VEGF tyrosine kinase inhibitors, said coauthor Dr. Lori Wirth, medical director of the center for head and neck cancers at Massachusetts General Hospital, Boston.

"The other thing about the toxicity profile overall is that it’s an extremely important thing to consider in patients with thyroid cancer, because many patients do have quite indolent disease. But the patients who were enrolled in the placebo arm had a progression-free survival of less than 4 months, and these are the people who go on to die from their disease when it’s that rapidly progressive. So we do need effective treatments that, unfortunately, do come with some toxicities," she said in an interview.

Although the toxicities of therapy were "considerable," most could be managed through either dose adjustment or additional medications, Dr. Schlumberger said.

The study was sponsored by Eisai. Dr. Schlumberger disclosed receiving honoraria and research funding and acting in an advisory role to the company. Dr. Masters and Dr. Wirth reported having no relevant relationships to disclose.

CHICAGO – The investigational drug lenvatinib significantly prolonged progression-free survival and produced high response rates compared with placebo in patients with iodine-refractory differentiated thyroid cancer.

In a randomized trial, the median progression-free survival (PFS) among patients assigned to lenvatinib was 18.3 months, compared with 3.6 months for placebo. The hazard ratio for lenvatinib was 0.21 (P less than .0001), Dr. Martin Schlumberger reported at the annual meeting of the American Society of Clinical Oncology.

"We had a high objective response rate – about 65% – with some complete responses. Interestingly, the time to objective response was only 2 months, so responses occur very quickly after the first treatment," Dr. Schlumberger, a professor of oncology at the University Paris-Sud, France, said at a media briefing prior to his presentation of the data in a plenary session.

"It’s really rewarding to see another active drug in this disease, where a year ago we really had no active therapy," commented Dr. Gregory A. Masters from the Helen F. Graham Cancer Center in Newark, Delaware.

Dr. Masters moderated the briefing but was not involved in the study.

Patients with relapsed or refractory differentiated thyroid cancer that is resistant to treatment with iodine-131 (¹³¹I) have few treatment choices and a 10-year survival rate of just 10%, Dr. Schlumberger noted.

There is evidence, however, showing that vascular endothelial growth factor (VEGF) signaling is associated with aggressive thyroid cancer and its propensity for metastasis, prompting researchers to explore VEGF-receptor inhibitors.

Lenvatinib is an oral multi–tyrosine kinase inhibitor of VEGF receptors 1-3, fibroblast growth factor receptors 1-4, platelet-derived growth factor receptor–alpha, and the RET and KIT kinases.

In a phase II study, the drug showed clinical activity against ¹³¹I-refractory differentiated thyroid cancer, prompting investigators to launch the phase III SELECT trial (Study of E7080 Lenvatinib in Differentiated Cancer of the Thyroid) in this population.

They enrolled 392 patients with measurable disease and evidence of progression within the previous 13 months of treatment, which could include one prior VEGF or VEGF-receptor inhibitor.

The patients were randomized on a 2:1 basis to either oral lenvatinib 24 mg daily or placebo, with treatment continuing until disease progression according to RECIST (Response Evaluation Criteria in Solid Tumor) criteria. At the time of confirmed disease progression, patients originally assigned to placebo could be crossed over to the active drug.

As noted above, median PFS was significantly better for the 261 patients assigned to lenvatinib, at 18.3 months, vs. 3.6 months for the 121 assigned to placebo. The median PFS for patients who had previously received another VEGF inhibitor was 15.1 months, compared with 18.7 months for those who had not been treated with an anti-VEGF agent (P value not shown). Median overall survival has not yet been reached.

The overall response rates were 65% for lenvatinib, versus 2% for placebo (P less than .0001). In the lenvatinib group, there were 4 complete responses, 165 partial responses, 40 cases with stable disease of at least 23 weeks’ duration, and 18 cases of progressive disease. Among placebo-treated patients, there were no complete responses, 2 partial responses, 39 cases of stable disease, and 52 of progressive disease. Only 1.5% of patients, all in the lenvatinib group, had a complete response, compared with none in the placebo group.

The median time to an objective response was 2 months. The median duration of response had not been reached by the last analysis. Approximately 75% of responders had an objective response last for more than 9.4 months, Dr. Schlumberger said.

As is common with other VEGF inhibitors, treatment-emergent adverse events were common, occurring in 97% of patients treated with lenvatinib, compared with 60% of patients on placebo.

The most common events were hypertension, occurring in 68% of patients vs. 9% on placebo, diarrhea (60% vs. 8%), fatigue/asthenia (59% vs. 28%), decreased appetite (50% vs. 12%), and nausea/vomiting (51% vs. 24%).

Adverse events requiring dose reductions occurred in 68% of patients on lenvatinib, dose interruptions in 82%, and discontinuation in 14%. In contrast, only 5% of patients on placebo had a dose reduction, 18% had an interruption, and 5% discontinued therapy.

Also of concern to investigators was the fact that of the 20 patients on lenvatinib who died during the trial, 6 of the deaths were determined by investigators to be treatment related. One of these patients died from a hemorrhagic stroke, one from a pulmonary embolism, and four from general health deterioration.

Hematologic complications are a class effect of the anti-VEGF tyrosine kinase inhibitors, said coauthor Dr. Lori Wirth, medical director of the center for head and neck cancers at Massachusetts General Hospital, Boston.

"The other thing about the toxicity profile overall is that it’s an extremely important thing to consider in patients with thyroid cancer, because many patients do have quite indolent disease. But the patients who were enrolled in the placebo arm had a progression-free survival of less than 4 months, and these are the people who go on to die from their disease when it’s that rapidly progressive. So we do need effective treatments that, unfortunately, do come with some toxicities," she said in an interview.

Although the toxicities of therapy were "considerable," most could be managed through either dose adjustment or additional medications, Dr. Schlumberger said.

The study was sponsored by Eisai. Dr. Schlumberger disclosed receiving honoraria and research funding and acting in an advisory role to the company. Dr. Masters and Dr. Wirth reported having no relevant relationships to disclose.

CHICAGO – The investigational drug lenvatinib significantly prolonged progression-free survival and produced high response rates compared with placebo in patients with iodine-refractory differentiated thyroid cancer.

In a randomized trial, the median progression-free survival (PFS) among patients assigned to lenvatinib was 18.3 months, compared with 3.6 months for placebo. The hazard ratio for lenvatinib was 0.21 (P less than .0001), Dr. Martin Schlumberger reported at the annual meeting of the American Society of Clinical Oncology.

"We had a high objective response rate – about 65% – with some complete responses. Interestingly, the time to objective response was only 2 months, so responses occur very quickly after the first treatment," Dr. Schlumberger, a professor of oncology at the University Paris-Sud, France, said at a media briefing prior to his presentation of the data in a plenary session.

"It’s really rewarding to see another active drug in this disease, where a year ago we really had no active therapy," commented Dr. Gregory A. Masters from the Helen F. Graham Cancer Center in Newark, Delaware.

Dr. Masters moderated the briefing but was not involved in the study.

Patients with relapsed or refractory differentiated thyroid cancer that is resistant to treatment with iodine-131 (¹³¹I) have few treatment choices and a 10-year survival rate of just 10%, Dr. Schlumberger noted.

There is evidence, however, showing that vascular endothelial growth factor (VEGF) signaling is associated with aggressive thyroid cancer and its propensity for metastasis, prompting researchers to explore VEGF-receptor inhibitors.

Lenvatinib is an oral multi–tyrosine kinase inhibitor of VEGF receptors 1-3, fibroblast growth factor receptors 1-4, platelet-derived growth factor receptor–alpha, and the RET and KIT kinases.

In a phase II study, the drug showed clinical activity against ¹³¹I-refractory differentiated thyroid cancer, prompting investigators to launch the phase III SELECT trial (Study of E7080 Lenvatinib in Differentiated Cancer of the Thyroid) in this population.

They enrolled 392 patients with measurable disease and evidence of progression within the previous 13 months of treatment, which could include one prior VEGF or VEGF-receptor inhibitor.

The patients were randomized on a 2:1 basis to either oral lenvatinib 24 mg daily or placebo, with treatment continuing until disease progression according to RECIST (Response Evaluation Criteria in Solid Tumor) criteria. At the time of confirmed disease progression, patients originally assigned to placebo could be crossed over to the active drug.

As noted above, median PFS was significantly better for the 261 patients assigned to lenvatinib, at 18.3 months, vs. 3.6 months for the 121 assigned to placebo. The median PFS for patients who had previously received another VEGF inhibitor was 15.1 months, compared with 18.7 months for those who had not been treated with an anti-VEGF agent (P value not shown). Median overall survival has not yet been reached.

The overall response rates were 65% for lenvatinib, versus 2% for placebo (P less than .0001). In the lenvatinib group, there were 4 complete responses, 165 partial responses, 40 cases with stable disease of at least 23 weeks’ duration, and 18 cases of progressive disease. Among placebo-treated patients, there were no complete responses, 2 partial responses, 39 cases of stable disease, and 52 of progressive disease. Only 1.5% of patients, all in the lenvatinib group, had a complete response, compared with none in the placebo group.

The median time to an objective response was 2 months. The median duration of response had not been reached by the last analysis. Approximately 75% of responders had an objective response last for more than 9.4 months, Dr. Schlumberger said.

As is common with other VEGF inhibitors, treatment-emergent adverse events were common, occurring in 97% of patients treated with lenvatinib, compared with 60% of patients on placebo.

The most common events were hypertension, occurring in 68% of patients vs. 9% on placebo, diarrhea (60% vs. 8%), fatigue/asthenia (59% vs. 28%), decreased appetite (50% vs. 12%), and nausea/vomiting (51% vs. 24%).

Adverse events requiring dose reductions occurred in 68% of patients on lenvatinib, dose interruptions in 82%, and discontinuation in 14%. In contrast, only 5% of patients on placebo had a dose reduction, 18% had an interruption, and 5% discontinued therapy.

Also of concern to investigators was the fact that of the 20 patients on lenvatinib who died during the trial, 6 of the deaths were determined by investigators to be treatment related. One of these patients died from a hemorrhagic stroke, one from a pulmonary embolism, and four from general health deterioration.

Hematologic complications are a class effect of the anti-VEGF tyrosine kinase inhibitors, said coauthor Dr. Lori Wirth, medical director of the center for head and neck cancers at Massachusetts General Hospital, Boston.

"The other thing about the toxicity profile overall is that it’s an extremely important thing to consider in patients with thyroid cancer, because many patients do have quite indolent disease. But the patients who were enrolled in the placebo arm had a progression-free survival of less than 4 months, and these are the people who go on to die from their disease when it’s that rapidly progressive. So we do need effective treatments that, unfortunately, do come with some toxicities," she said in an interview.

Although the toxicities of therapy were "considerable," most could be managed through either dose adjustment or additional medications, Dr. Schlumberger said.

The study was sponsored by Eisai. Dr. Schlumberger disclosed receiving honoraria and research funding and acting in an advisory role to the company. Dr. Masters and Dr. Wirth reported having no relevant relationships to disclose.

This month in our issue, 10 medical specialty groups offer Choosing Wisely guidelines for hospitalists. Among them, Dr. Linda Cox notes why comprehensive pulmonary assessment, including spirometry, is important to diagnosing or ruling out asthma; and otolaryngologist Dr. Rahul Shah tells why hospitalists should stop routine radiographic imaging for patients who meet the diagnostic criteria for uncomplicated acute rhinosinusitis. Meanwhile, ABIM Foundation executive vice president and CEO Daniel Wolfson talks about why the Choosing Wisely campaign is not just another attempt at cost-containment.

Also in this issue, legal advice for hospitalists on the intersection of social media and HIPAA rules, clinical practice guidelines on red blood cell transfusions, and our Key Clinical Question explores which patients should be screened for hepatitis C infection.

Click here to listen to the June highlights Podcast.

This month in our issue, 10 medical specialty groups offer Choosing Wisely guidelines for hospitalists. Among them, Dr. Linda Cox notes why comprehensive pulmonary assessment, including spirometry, is important to diagnosing or ruling out asthma; and otolaryngologist Dr. Rahul Shah tells why hospitalists should stop routine radiographic imaging for patients who meet the diagnostic criteria for uncomplicated acute rhinosinusitis. Meanwhile, ABIM Foundation executive vice president and CEO Daniel Wolfson talks about why the Choosing Wisely campaign is not just another attempt at cost-containment.

Also in this issue, legal advice for hospitalists on the intersection of social media and HIPAA rules, clinical practice guidelines on red blood cell transfusions, and our Key Clinical Question explores which patients should be screened for hepatitis C infection.

Click here to listen to the June highlights Podcast.

This month in our issue, 10 medical specialty groups offer Choosing Wisely guidelines for hospitalists. Among them, Dr. Linda Cox notes why comprehensive pulmonary assessment, including spirometry, is important to diagnosing or ruling out asthma; and otolaryngologist Dr. Rahul Shah tells why hospitalists should stop routine radiographic imaging for patients who meet the diagnostic criteria for uncomplicated acute rhinosinusitis. Meanwhile, ABIM Foundation executive vice president and CEO Daniel Wolfson talks about why the Choosing Wisely campaign is not just another attempt at cost-containment.

Also in this issue, legal advice for hospitalists on the intersection of social media and HIPAA rules, clinical practice guidelines on red blood cell transfusions, and our Key Clinical Question explores which patients should be screened for hepatitis C infection.

Click here to listen to the June highlights Podcast.

THE CASE

A 46-year-old Caucasian female with a history of epilepsy came into our family medicine center complaining of weakness, fatigue, and arthralgia that made it difficult for her to walk. She’d had these symptoms for 6 months and reported having amenorrhea and hot flashes for the past 2 years.

The patient’s blood pressure was 133/72 mm Hg, heart rate was 82 beats per min, and respiratory rate was 20 breaths per min. Her skin was dry without hyperpigmentation, and her sclerae were anicteric. A musculoskeletal examination revealed tenderness of the metacarpophalangeal and metatarsophalangeal joints without edema, deformity, or evidence of synovitis.

She had no history of skin bronzing, jaundice, transfusions, hepatitis, abdominal pain, or diabetes and denied using tobacco, alcohol, or illicit drugs. Her medications included lamotrigine (250 mg BID) and over-the-counter iron supplementation. She had no family history of rheumatoid arthritis, lupus, cirrhosis, hemochromatosis, or other liver disease. Her mother died from colorectal cancer and her father’s cause of death was unknown; her sisters did not have any medical issues. The patient’s lab tests were normal, except for the following: aspartate aminotransferase, 89 U/L (normal, 13-45 U/L); alanine aminotransferase, 80 U/L (normal, 5-57 U/L); and alkaline phosphatase, 132 U/L (normal, 39-117 U/L). Her coagulation panel revealed a prothrombin time of 13.1 seconds, and an international normalized ratio of 1.3. Serology was negative for hepatitis A, B, and C. Additional testing revealed the following: ferritin, 4014.1 ng/dL (normal, 7-282 ng/dL); iron, 210 mg/dL (normal, 40-170 mg/dL); total iron binding capacity, 258 mg/dL (normal, 260-445 mg/dL); and transferrin saturation, 81% (normal, 20%-55%).

Abdominal ultrasonography revealed gallstones, an enlarged spleen, a dilated portal vein, and a fatty liver consistent with cirrhosis. X-rays showed soft-tissue swelling and demineralization in her hands consistent with osteopenia and degenerative arthritis in both feet.

THE DIAGNOSIS

Based on our patient’s complaints of fatigue, weakness, arthralgia, and amenorrhea, as well as her abnormal iron levels, we suspected hereditary hemochromatosis (HH). We ordered HFE genotyping, and the results indicated that the patient was homozygous for the C282Y mutation, confirming our diagnosis.

DISCUSSION

HH is an autosomal recessive disorder of iron homeostasis characterized by increased gastrointestinal iron absorption and tissue deposition of iron. It is caused by mutations in the HFE gene (C282Y or H63D) located on chromosome 6 (locus 6p21) and commonly seen in Northern European Caucasians.¹ Approximately 85% of patients with HH are homozygous for C282Y; the H63D mutation can cause HH when in the presence of a single C282Y mutation.¹ Men manifest HH symptoms usually between the ages of 40 and 60 years,² although women may be affected at a later age than men because physiologic blood loss from menstruation and parturition limit the rate at which excess iron is accumulated.²

Signs and symptoms of HH include depression, fatigue, restless legs syndrome, weakness, and weight loss.³ In advanced HH, patients may develop progressive skin pigmentation or bronzing, and hypogonadism. Advanced HH can affect the patient’s organs, including the pancreas (diabetes), liver (hepatomegaly, abnormal liver function tests), pituitary gland (amenorrhea, decreased libido, erectile dysfunction), and heart (arrhythmias, congestive heart failure), as well as the musculoskeletal system (joint pain).^3,4 The spleen can also be affected after cirrhosis develops. Cirrhosis, hepatocellular carcinoma, and cardiomyopathy can reduce life expectancy.⁴

Testing for HH

Because symptoms of HH are common and nonspecific, a high degree of clinical suspicion is required for early diagnosis. The differential diagnosis includes conditions related to chronic liver disease or iron overload (TABLE).⁵ If the diagnosis goes undetected until complications arise, the risk of morbidity and mortality are greatly increased.⁵

The diagnosis of HH usually is confirmed by molecular testing for the C282Y and H63D mutations.If HH is suspected, serum ferritin concentration and fasting serum transferrin saturation (the ratio of serum iron level to total iron-binding capacity × 100) are recommended as initial tests.⁵ The normal range of transferrin saturation for males is 15% to 50% and the normal range for females is 12% to 45%. If the transferrin saturation exceeds 50% in women or 60% in men, further evaluation is warranted (FIGURE 1).^6,7 The sensitivity and specificity of elevated transferrin saturation for HH are 92% and 93%, respectively.⁵ These transferrin saturation cutoffs don’t apply to patients with a history of frequent blood transfusion (ie, patients with sickle cell disease or thalassemia).

Additional testing for patients in whom you suspect HH includes:
• a complete blood count, metabolic panel, and coagulation panel
• hepatitis serologies
• imaging (abdominal ultrasound, skeletal radiographs, echocardiogram, abdominal magnetic resonance imaging [MRI])
• a liver biopsy with iron staining and quantitative iron measurements.

The gold standard. Performing a liver biopsy to measure hepatic iron concentration by staining is considered the gold standard test for HH.⁸ But since genetic testing has become more readily available, liver biopsies aren’t widely used to confirm the diagnosis.⁸ The diagnosis of HH usually is confirmed by molecular testing for the C282Y and H63D mutations. Liver biopsy may be recommended to document the degree of fibrosis in all homozygotes over age 40 with elevated serum transaminase levels, clinical evidence of liver disease, or a serum ferritin level >1000 mcg/L.⁷

Phlebotomy helps lower iron levels

Treatment should not be delayed until symptoms develop.³ The mainstay of therapy is phlebotomy.⁹ If phlebotomy is started before the onset of organ damage, patients can anticipate a normal lifespan.⁹ Without treatment death may occur from cirrhosis, hepatocellular carcinoma, or cardiomyopathy.

Removal of 1 unit of red blood cells (450-500 mL) results in the loss of approximately 200 mg of iron. Serum ferritin level testing is the most reliable and least expensive method to monitor therapy.⁹ Iron depletion is complete when the serum ferritin level is 10 to 20 g/L, when the hemoglobin concentration is <11 g/dL, or the hematocrit is <33% for >3 weeks. HH patients need to undergo lifelong phlebotomy to maintain a serum ferritin level <50 g/L. Encourage patients to take in an adequate amount of dietary protein, vitamin B12, and folate to support the accelerated level of erythropoiesis that occurs during therapy.⁹

Chelation therapy is reserved for patients with advanced disease (eg, those with organ damage) or those who do not respond to phlebotomy.¹⁰ Deferoxamine given intravenously (IV) or subcutaneously has been the standard chelation agent. It’s usually administered by continuous subcutaneous infusion using a battery-operated pump at a dose of 40 mg/kg/d for 8 to 12 hours nightly for 5 to 7 nights weekly. A dose of approximately 2 g per 24 hours usually achieves maximal urinary iron excretion.

If phlebotomy is started before the onset of organ damage, patients with hereditary hemochromatosis can anticipate a normal lifespan.The use of deferoxamine therapy is limited by cost as well as the need for parenteral therapy, discomfort, inconvenience, and neurotoxicity.⁵ The US Food and Drug Administration recently approved an oral ironchelating agent, deferasirox, for the treatment of secondary iron overload due to ineffective erythropoiesis. Studies are ongoing to evaluate its potential use in HH.^5,9

Our patient’s outcome

Our patient declined liver biopsy and her sisters declined HFE genotyping. Our patient did, however, complete 7 phlebotomies over 4 months. Two months later, she reported shortness of breath during exertion, leg swelling, and palpitations. A chest x-ray revealed a right-sided pleural effusion and an electrocardiogram showed atrial fibrillation with rapid ventricular response. Our patient was admitted for telemetry monitoring and started on diltiazem IV. Echocardiogram showed a restrictive cardiomyopathy, with an ejection fraction of 15% (normal range >55%).

Six weeks later, her ejection fraction decreased to 10%. An MRI of her abdomen showed iron deposition in her liver, pancreas, and lymph nodes (FIGURE 2). She was started on deferoxamine IV and transferred to the coronary care unit for 3 weeks. She was discharged with a diagnosis of class IV heart failure and admitted 2 weeks later for exacerbation of heart failure symptoms. She did not want to pursue a heart transplant. Her condition deteriorated and she expired after a fatal cardiac arrhythmia.

THE TAKEAWAY

Patients with abnormal iron studies and those with evidence of liver disease should be evaluated for HH⁵ (strength of recommendation [SOR]: A). Fasting serum transferrin saturation and serum ferritin concentration are recommended as initial tests for HH¹¹ (SOR C). Liver biopsy is the gold standard for diagnosis of HH, but the diagnosis usually is confirmed by genetic testing8 (SOR C). Phlebotomy is the mainstay of therapy⁹ (SOR B). Chelation therapy is reserved for patients with advanced disease or for those who do not respond to phlebotomy¹⁰ (SOR C).

Strength of recommendation (SOR)
A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series

THE CASE

A 46-year-old Caucasian female with a history of epilepsy came into our family medicine center complaining of weakness, fatigue, and arthralgia that made it difficult for her to walk. She’d had these symptoms for 6 months and reported having amenorrhea and hot flashes for the past 2 years.

The patient’s blood pressure was 133/72 mm Hg, heart rate was 82 beats per min, and respiratory rate was 20 breaths per min. Her skin was dry without hyperpigmentation, and her sclerae were anicteric. A musculoskeletal examination revealed tenderness of the metacarpophalangeal and metatarsophalangeal joints without edema, deformity, or evidence of synovitis.

She had no history of skin bronzing, jaundice, transfusions, hepatitis, abdominal pain, or diabetes and denied using tobacco, alcohol, or illicit drugs. Her medications included lamotrigine (250 mg BID) and over-the-counter iron supplementation. She had no family history of rheumatoid arthritis, lupus, cirrhosis, hemochromatosis, or other liver disease. Her mother died from colorectal cancer and her father’s cause of death was unknown; her sisters did not have any medical issues. The patient’s lab tests were normal, except for the following: aspartate aminotransferase, 89 U/L (normal, 13-45 U/L); alanine aminotransferase, 80 U/L (normal, 5-57 U/L); and alkaline phosphatase, 132 U/L (normal, 39-117 U/L). Her coagulation panel revealed a prothrombin time of 13.1 seconds, and an international normalized ratio of 1.3. Serology was negative for hepatitis A, B, and C. Additional testing revealed the following: ferritin, 4014.1 ng/dL (normal, 7-282 ng/dL); iron, 210 mg/dL (normal, 40-170 mg/dL); total iron binding capacity, 258 mg/dL (normal, 260-445 mg/dL); and transferrin saturation, 81% (normal, 20%-55%).

Abdominal ultrasonography revealed gallstones, an enlarged spleen, a dilated portal vein, and a fatty liver consistent with cirrhosis. X-rays showed soft-tissue swelling and demineralization in her hands consistent with osteopenia and degenerative arthritis in both feet.

THE DIAGNOSIS

Based on our patient’s complaints of fatigue, weakness, arthralgia, and amenorrhea, as well as her abnormal iron levels, we suspected hereditary hemochromatosis (HH). We ordered HFE genotyping, and the results indicated that the patient was homozygous for the C282Y mutation, confirming our diagnosis.

DISCUSSION

HH is an autosomal recessive disorder of iron homeostasis characterized by increased gastrointestinal iron absorption and tissue deposition of iron. It is caused by mutations in the HFE gene (C282Y or H63D) located on chromosome 6 (locus 6p21) and commonly seen in Northern European Caucasians.¹ Approximately 85% of patients with HH are homozygous for C282Y; the H63D mutation can cause HH when in the presence of a single C282Y mutation.¹ Men manifest HH symptoms usually between the ages of 40 and 60 years,² although women may be affected at a later age than men because physiologic blood loss from menstruation and parturition limit the rate at which excess iron is accumulated.²

Signs and symptoms of HH include depression, fatigue, restless legs syndrome, weakness, and weight loss.³ In advanced HH, patients may develop progressive skin pigmentation or bronzing, and hypogonadism. Advanced HH can affect the patient’s organs, including the pancreas (diabetes), liver (hepatomegaly, abnormal liver function tests), pituitary gland (amenorrhea, decreased libido, erectile dysfunction), and heart (arrhythmias, congestive heart failure), as well as the musculoskeletal system (joint pain).^3,4 The spleen can also be affected after cirrhosis develops. Cirrhosis, hepatocellular carcinoma, and cardiomyopathy can reduce life expectancy.⁴

Testing for HH

Because symptoms of HH are common and nonspecific, a high degree of clinical suspicion is required for early diagnosis. The differential diagnosis includes conditions related to chronic liver disease or iron overload (TABLE).⁵ If the diagnosis goes undetected until complications arise, the risk of morbidity and mortality are greatly increased.⁵

The diagnosis of HH usually is confirmed by molecular testing for the C282Y and H63D mutations.If HH is suspected, serum ferritin concentration and fasting serum transferrin saturation (the ratio of serum iron level to total iron-binding capacity × 100) are recommended as initial tests.⁵ The normal range of transferrin saturation for males is 15% to 50% and the normal range for females is 12% to 45%. If the transferrin saturation exceeds 50% in women or 60% in men, further evaluation is warranted (FIGURE 1).^6,7 The sensitivity and specificity of elevated transferrin saturation for HH are 92% and 93%, respectively.⁵ These transferrin saturation cutoffs don’t apply to patients with a history of frequent blood transfusion (ie, patients with sickle cell disease or thalassemia).

Additional testing for patients in whom you suspect HH includes:
• a complete blood count, metabolic panel, and coagulation panel
• hepatitis serologies
• imaging (abdominal ultrasound, skeletal radiographs, echocardiogram, abdominal magnetic resonance imaging [MRI])
• a liver biopsy with iron staining and quantitative iron measurements.

The gold standard. Performing a liver biopsy to measure hepatic iron concentration by staining is considered the gold standard test for HH.⁸ But since genetic testing has become more readily available, liver biopsies aren’t widely used to confirm the diagnosis.⁸ The diagnosis of HH usually is confirmed by molecular testing for the C282Y and H63D mutations. Liver biopsy may be recommended to document the degree of fibrosis in all homozygotes over age 40 with elevated serum transaminase levels, clinical evidence of liver disease, or a serum ferritin level >1000 mcg/L.⁷

Phlebotomy helps lower iron levels

Treatment should not be delayed until symptoms develop.³ The mainstay of therapy is phlebotomy.⁹ If phlebotomy is started before the onset of organ damage, patients can anticipate a normal lifespan.⁹ Without treatment death may occur from cirrhosis, hepatocellular carcinoma, or cardiomyopathy.

Removal of 1 unit of red blood cells (450-500 mL) results in the loss of approximately 200 mg of iron. Serum ferritin level testing is the most reliable and least expensive method to monitor therapy.⁹ Iron depletion is complete when the serum ferritin level is 10 to 20 g/L, when the hemoglobin concentration is <11 g/dL, or the hematocrit is <33% for >3 weeks. HH patients need to undergo lifelong phlebotomy to maintain a serum ferritin level <50 g/L. Encourage patients to take in an adequate amount of dietary protein, vitamin B12, and folate to support the accelerated level of erythropoiesis that occurs during therapy.⁹

Chelation therapy is reserved for patients with advanced disease (eg, those with organ damage) or those who do not respond to phlebotomy.¹⁰ Deferoxamine given intravenously (IV) or subcutaneously has been the standard chelation agent. It’s usually administered by continuous subcutaneous infusion using a battery-operated pump at a dose of 40 mg/kg/d for 8 to 12 hours nightly for 5 to 7 nights weekly. A dose of approximately 2 g per 24 hours usually achieves maximal urinary iron excretion.

If phlebotomy is started before the onset of organ damage, patients with hereditary hemochromatosis can anticipate a normal lifespan.The use of deferoxamine therapy is limited by cost as well as the need for parenteral therapy, discomfort, inconvenience, and neurotoxicity.⁵ The US Food and Drug Administration recently approved an oral ironchelating agent, deferasirox, for the treatment of secondary iron overload due to ineffective erythropoiesis. Studies are ongoing to evaluate its potential use in HH.^5,9

Our patient’s outcome

Our patient declined liver biopsy and her sisters declined HFE genotyping. Our patient did, however, complete 7 phlebotomies over 4 months. Two months later, she reported shortness of breath during exertion, leg swelling, and palpitations. A chest x-ray revealed a right-sided pleural effusion and an electrocardiogram showed atrial fibrillation with rapid ventricular response. Our patient was admitted for telemetry monitoring and started on diltiazem IV. Echocardiogram showed a restrictive cardiomyopathy, with an ejection fraction of 15% (normal range >55%).

Six weeks later, her ejection fraction decreased to 10%. An MRI of her abdomen showed iron deposition in her liver, pancreas, and lymph nodes (FIGURE 2). She was started on deferoxamine IV and transferred to the coronary care unit for 3 weeks. She was discharged with a diagnosis of class IV heart failure and admitted 2 weeks later for exacerbation of heart failure symptoms. She did not want to pursue a heart transplant. Her condition deteriorated and she expired after a fatal cardiac arrhythmia.

THE TAKEAWAY

Patients with abnormal iron studies and those with evidence of liver disease should be evaluated for HH⁵ (strength of recommendation [SOR]: A). Fasting serum transferrin saturation and serum ferritin concentration are recommended as initial tests for HH¹¹ (SOR C). Liver biopsy is the gold standard for diagnosis of HH, but the diagnosis usually is confirmed by genetic testing8 (SOR C). Phlebotomy is the mainstay of therapy⁹ (SOR B). Chelation therapy is reserved for patients with advanced disease or for those who do not respond to phlebotomy¹⁰ (SOR C).

Strength of recommendation (SOR)
A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series

THE CASE

A 46-year-old Caucasian female with a history of epilepsy came into our family medicine center complaining of weakness, fatigue, and arthralgia that made it difficult for her to walk. She’d had these symptoms for 6 months and reported having amenorrhea and hot flashes for the past 2 years.

The patient’s blood pressure was 133/72 mm Hg, heart rate was 82 beats per min, and respiratory rate was 20 breaths per min. Her skin was dry without hyperpigmentation, and her sclerae were anicteric. A musculoskeletal examination revealed tenderness of the metacarpophalangeal and metatarsophalangeal joints without edema, deformity, or evidence of synovitis.

She had no history of skin bronzing, jaundice, transfusions, hepatitis, abdominal pain, or diabetes and denied using tobacco, alcohol, or illicit drugs. Her medications included lamotrigine (250 mg BID) and over-the-counter iron supplementation. She had no family history of rheumatoid arthritis, lupus, cirrhosis, hemochromatosis, or other liver disease. Her mother died from colorectal cancer and her father’s cause of death was unknown; her sisters did not have any medical issues. The patient’s lab tests were normal, except for the following: aspartate aminotransferase, 89 U/L (normal, 13-45 U/L); alanine aminotransferase, 80 U/L (normal, 5-57 U/L); and alkaline phosphatase, 132 U/L (normal, 39-117 U/L). Her coagulation panel revealed a prothrombin time of 13.1 seconds, and an international normalized ratio of 1.3. Serology was negative for hepatitis A, B, and C. Additional testing revealed the following: ferritin, 4014.1 ng/dL (normal, 7-282 ng/dL); iron, 210 mg/dL (normal, 40-170 mg/dL); total iron binding capacity, 258 mg/dL (normal, 260-445 mg/dL); and transferrin saturation, 81% (normal, 20%-55%).

Abdominal ultrasonography revealed gallstones, an enlarged spleen, a dilated portal vein, and a fatty liver consistent with cirrhosis. X-rays showed soft-tissue swelling and demineralization in her hands consistent with osteopenia and degenerative arthritis in both feet.

THE DIAGNOSIS

Based on our patient’s complaints of fatigue, weakness, arthralgia, and amenorrhea, as well as her abnormal iron levels, we suspected hereditary hemochromatosis (HH). We ordered HFE genotyping, and the results indicated that the patient was homozygous for the C282Y mutation, confirming our diagnosis.

DISCUSSION

HH is an autosomal recessive disorder of iron homeostasis characterized by increased gastrointestinal iron absorption and tissue deposition of iron. It is caused by mutations in the HFE gene (C282Y or H63D) located on chromosome 6 (locus 6p21) and commonly seen in Northern European Caucasians.¹ Approximately 85% of patients with HH are homozygous for C282Y; the H63D mutation can cause HH when in the presence of a single C282Y mutation.¹ Men manifest HH symptoms usually between the ages of 40 and 60 years,² although women may be affected at a later age than men because physiologic blood loss from menstruation and parturition limit the rate at which excess iron is accumulated.²

Signs and symptoms of HH include depression, fatigue, restless legs syndrome, weakness, and weight loss.³ In advanced HH, patients may develop progressive skin pigmentation or bronzing, and hypogonadism. Advanced HH can affect the patient’s organs, including the pancreas (diabetes), liver (hepatomegaly, abnormal liver function tests), pituitary gland (amenorrhea, decreased libido, erectile dysfunction), and heart (arrhythmias, congestive heart failure), as well as the musculoskeletal system (joint pain).^3,4 The spleen can also be affected after cirrhosis develops. Cirrhosis, hepatocellular carcinoma, and cardiomyopathy can reduce life expectancy.⁴

Testing for HH

Because symptoms of HH are common and nonspecific, a high degree of clinical suspicion is required for early diagnosis. The differential diagnosis includes conditions related to chronic liver disease or iron overload (TABLE).⁵ If the diagnosis goes undetected until complications arise, the risk of morbidity and mortality are greatly increased.⁵

The diagnosis of HH usually is confirmed by molecular testing for the C282Y and H63D mutations.If HH is suspected, serum ferritin concentration and fasting serum transferrin saturation (the ratio of serum iron level to total iron-binding capacity × 100) are recommended as initial tests.⁵ The normal range of transferrin saturation for males is 15% to 50% and the normal range for females is 12% to 45%. If the transferrin saturation exceeds 50% in women or 60% in men, further evaluation is warranted (FIGURE 1).^6,7 The sensitivity and specificity of elevated transferrin saturation for HH are 92% and 93%, respectively.⁵ These transferrin saturation cutoffs don’t apply to patients with a history of frequent blood transfusion (ie, patients with sickle cell disease or thalassemia).

Additional testing for patients in whom you suspect HH includes:
• a complete blood count, metabolic panel, and coagulation panel
• hepatitis serologies
• imaging (abdominal ultrasound, skeletal radiographs, echocardiogram, abdominal magnetic resonance imaging [MRI])
• a liver biopsy with iron staining and quantitative iron measurements.

The gold standard. Performing a liver biopsy to measure hepatic iron concentration by staining is considered the gold standard test for HH.⁸ But since genetic testing has become more readily available, liver biopsies aren’t widely used to confirm the diagnosis.⁸ The diagnosis of HH usually is confirmed by molecular testing for the C282Y and H63D mutations. Liver biopsy may be recommended to document the degree of fibrosis in all homozygotes over age 40 with elevated serum transaminase levels, clinical evidence of liver disease, or a serum ferritin level >1000 mcg/L.⁷

Phlebotomy helps lower iron levels

Treatment should not be delayed until symptoms develop.³ The mainstay of therapy is phlebotomy.⁹ If phlebotomy is started before the onset of organ damage, patients can anticipate a normal lifespan.⁹ Without treatment death may occur from cirrhosis, hepatocellular carcinoma, or cardiomyopathy.

Removal of 1 unit of red blood cells (450-500 mL) results in the loss of approximately 200 mg of iron. Serum ferritin level testing is the most reliable and least expensive method to monitor therapy.⁹ Iron depletion is complete when the serum ferritin level is 10 to 20 g/L, when the hemoglobin concentration is <11 g/dL, or the hematocrit is <33% for >3 weeks. HH patients need to undergo lifelong phlebotomy to maintain a serum ferritin level <50 g/L. Encourage patients to take in an adequate amount of dietary protein, vitamin B12, and folate to support the accelerated level of erythropoiesis that occurs during therapy.⁹

Chelation therapy is reserved for patients with advanced disease (eg, those with organ damage) or those who do not respond to phlebotomy.¹⁰ Deferoxamine given intravenously (IV) or subcutaneously has been the standard chelation agent. It’s usually administered by continuous subcutaneous infusion using a battery-operated pump at a dose of 40 mg/kg/d for 8 to 12 hours nightly for 5 to 7 nights weekly. A dose of approximately 2 g per 24 hours usually achieves maximal urinary iron excretion.

If phlebotomy is started before the onset of organ damage, patients with hereditary hemochromatosis can anticipate a normal lifespan.The use of deferoxamine therapy is limited by cost as well as the need for parenteral therapy, discomfort, inconvenience, and neurotoxicity.⁵ The US Food and Drug Administration recently approved an oral ironchelating agent, deferasirox, for the treatment of secondary iron overload due to ineffective erythropoiesis. Studies are ongoing to evaluate its potential use in HH.^5,9

Our patient’s outcome

Our patient declined liver biopsy and her sisters declined HFE genotyping. Our patient did, however, complete 7 phlebotomies over 4 months. Two months later, she reported shortness of breath during exertion, leg swelling, and palpitations. A chest x-ray revealed a right-sided pleural effusion and an electrocardiogram showed atrial fibrillation with rapid ventricular response. Our patient was admitted for telemetry monitoring and started on diltiazem IV. Echocardiogram showed a restrictive cardiomyopathy, with an ejection fraction of 15% (normal range >55%).

Six weeks later, her ejection fraction decreased to 10%. An MRI of her abdomen showed iron deposition in her liver, pancreas, and lymph nodes (FIGURE 2). She was started on deferoxamine IV and transferred to the coronary care unit for 3 weeks. She was discharged with a diagnosis of class IV heart failure and admitted 2 weeks later for exacerbation of heart failure symptoms. She did not want to pursue a heart transplant. Her condition deteriorated and she expired after a fatal cardiac arrhythmia.

THE TAKEAWAY

Patients with abnormal iron studies and those with evidence of liver disease should be evaluated for HH⁵ (strength of recommendation [SOR]: A). Fasting serum transferrin saturation and serum ferritin concentration are recommended as initial tests for HH¹¹ (SOR C). Liver biopsy is the gold standard for diagnosis of HH, but the diagnosis usually is confirmed by genetic testing8 (SOR C). Phlebotomy is the mainstay of therapy⁹ (SOR B). Chelation therapy is reserved for patients with advanced disease or for those who do not respond to phlebotomy¹⁰ (SOR C).

Strength of recommendation (SOR)
A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series