PRO

Observational, database studies provide a powerful QI supplement

The proposed rules by the Centers for Medicare & Medicaid Services (CMS), which will allow access to patient-protected Medicare data, will provide for greater transparency and for data that could be utilized toward comparative-effectiveness research (CER). Thus, these rules have the potential to improve the quality of healthcare and impact patient safety.

The Institute of Medicine in December 1999 issued its now-famous article “To Err is Human,” which reported that medical errors cause up to 98,000 deaths and more than 1 million injuries each year in the U.S.⁶ However, the evidence shows minimal impact on improving patient safety in the past 10 years.

A retrospective study of 10 North Carolina hospitals reported in the New England Journal of Medicine by Landrigan and colleagues found that harms resulting from medical care remained extremely common, with little evidence for improvement.⁷ It also is estimated that it takes 17 years on average for clinical research to become incorporated into the majority of clinical practices.⁸ Although the randomized control trial (RCT) is unquestionably the best research tool to explore simple components of clinical care (i.e. tests, drugs, and procedures), its translation into daily clinical practice remains difficult.

Improving the process of care leading to quality remains an extremely difficult proposition based on such sociological issues as resistance to change, the need for interdisciplinary teamwork, level of support staff, economic factors, information retrieval inadequacies, and, most important, the complexity of patients with multiple comorbidities that do not fit the parameters of the RCT.

Don Berwick, MD, the lead author in the landmark IOM report and currently CMS administrator, has stated “in such complex terrain, the RCT is an impoverished way to learn.”⁹ Factors that cause this chasm include:¹⁰

• Too narrowly focused RCT;
• More required resources, including financial and personnel support with RCT, compared with usually clinical practices;
• Lack of collaboration between academic medical center researchers and community clinicians; and
• Lack of expertise and experience to undertake quality improvement in healthcare.

CER has received a $1.1 billion investment with the passage of the American Recovery and Reinvestment Act to provide evidence on the effectiveness, benefits, and harms of various treatment options.¹¹ As part of this research to improve IOM’s goals to improve healthcare, better evidence is desperately needed to cross the translational gap between clinical research and the bedside.¹² Observational outcome studies based on registries or databases derived primarily from clinical care can provide a powerful supplement to quality improvement.¹³

Thus, the ability to combine Medicare claims with other data through the Availability of Medicare Data for Performance Measurement would supply a wealth of information to potentially impact quality. As a cautionary note, safeguards such as provider review and appeal, monitoring the validity of the information, and only using the data for quality improvement are vital.

Dr. Holder is medical director of hospitalist services and chief medical information officer at Decatur (Ill.) Memorial Hospital. He is a member of Team Hospitalist.

CON

Unanswered questions, risks make CMS plan a bad idea

On June 8, the Centers for Medicare & Medicaid Services (CMS) proposed a rule to allow “qualified entities” access to patient-protected Medicare data for provider performance publication. CMS allowed 60 days for public comment and a start date of Jan. 1, 2012. But this controversial rule appeared with short notice, little discussion, and abbreviated opportunity for comment.

CMS maintains this rule will result in higher quality and more cost-effective care. Considering the present volume of data published on multiple performance parameters for both hospitals and providers, it would seem prudent to have solid data for efficacy prior to implementing more required reporting and costs to the industry.^1,2,3

Physicians and hospitals will have 30 days to review and verify three years of CMS claims data before it is released. The burden and cost of review will be borne by the private practices involved.¹ This process will impose added administrative costs, and it is unlikely three years of data can be carefully reviewed in just 30 days. If practitioners find the review too cumbersome and expensive, which is likely, they will forgo review, putting the accuracy of the data in question.

Quality data already is published for both physicians and hospitals. Is there evidence this process will significantly increase transparency? Adding more layers of administrative work for both CMS and caregivers—higher overhead without defined benefit—seems an ill-conceived idea. From an evidence-based-practice standpoint, where is the evidence that this rule will improve “quality” and make care “cost-effective”? Have the risks (added bureaucracy, increased overhead, questionable data) and benefits (added transparency) been evaluated?

Additionally, it is unclear who will be monitoring the quality of the data published and who will provide oversight for the “entities” to ensure these data are fairly and accurately presented. Who will pay for this oversight, and what recourse will be afforded physicians and hospitals that feel they have been wronged?^4,5

The “qualified entities” will pay CMS to cover their cost of providing data, raising concerns that this practice could evolve into patient-data “purchasing.” Although it is likely the selected entities will be industry leaders (or at least initially) with the capability to protect data, is this not another opportunity for misuse or corruption in the system?

Other issues not clearly addressed include the nature of the patient-protected information and who will interpret this data in a clinical context. How will these data be adjusted for patient comorbidities and case mix, or will the data be published without regard to these important confounders?^1,3

Publishing clinical data for quality assurance and feedback purposes is essential for quality care. Transparency has increased consumer confidence in the healthcare system and, indeed, has increased the healthcare system’s responsiveness to quality concerns. Granting the benefits of transparency, published data must be precise, accurate, and managed with good oversight in order to ensure the process does not target providers or skew results. Another program, especially one being fast-tracked and making once-protected patient information available to unspecified entities, raises many questions. Who will be watching these agencies for a clear interpretation? Is this yet another layer of CMS bureaucracy? In an era of evidence-based medicine, where is the evidence that this program will improve the system for the better?

Dr. Brezina is a hospitalist at Durham Regional Hospital in North Carolina.

References

1. Under the magnifying glass (again): CMS proposes new access to Medicare data for public provider performance reports. Bass, Berry and Sims website. Available at: http://www.bassberry.com/communicationscenter/newsletters/. Accessed Aug. 31, 2011.
2. Controversial rule to allow access to Medicare data. Modern Health website. Available at: http://www.modernHealthcare.com. Accessed Aug. 31, 2011.
3. Physician report cards must give correct grades. American Medical News website. Available at: http://www.ama-assn.org/amednews/2011/09/05/edsa0905.htm. Accessed Sept. 12, 2011.
4. OIG identifies huge lapses in hospital security, shifts its focus from CMS to OCR. Atlantic Information Services Inc. website. Available at: http://www.AISHealth.com. Accessed Sept. 12, 2011.
5. Berry M. Insurers mishandle 1 in 5 claims, AMA finds. American Medical News website. Available at: http://www.ama-assn.org/amednews/2011/07/04/prl20704.htm. Accessed Sept. 12, 2011.
6. Kohn LT, Corrigan JM, Donaldson MS, eds. To error is human: building a safer health system. Washington: National Academies Press; 1999.
7. Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal trends in rates of patient harm resulting from medical care. N Engl J Med. 2010;363(22):2124-2134.
8. Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. Washington: National Academy Press; 2001:13.
9. Berwick DM. The science of improvement. JAMA. 2008;299(10):1182-1184.
10. Ting HH, Shojania KG, Montori VM, Bradley EH. Quality improvement science and action. Circulation. 2009;119:1962-1974.
11. Committee on Comparative Research Prioritization. Institute of Medicine Initial National Priorities for Comparative Effectiveness Research. Washington: National Academy Press; 2009.
12. Sullivan P, Goldman D. The promise of comparative effectiveness research. JAMA. 2011;305(4):400-401.
13. Washington AE, Lipstein SH. The patient-centered outcomes research institute: promoting better information, decisions and health. Sept. 28, 2011; DOI: 10.10.1056/NEJMp1109407.

PRO

Observational, database studies provide a powerful QI supplement

The proposed rules by the Centers for Medicare & Medicaid Services (CMS), which will allow access to patient-protected Medicare data, will provide for greater transparency and for data that could be utilized toward comparative-effectiveness research (CER). Thus, these rules have the potential to improve the quality of healthcare and impact patient safety.

The Institute of Medicine in December 1999 issued its now-famous article “To Err is Human,” which reported that medical errors cause up to 98,000 deaths and more than 1 million injuries each year in the U.S.⁶ However, the evidence shows minimal impact on improving patient safety in the past 10 years.

A retrospective study of 10 North Carolina hospitals reported in the New England Journal of Medicine by Landrigan and colleagues found that harms resulting from medical care remained extremely common, with little evidence for improvement.⁷ It also is estimated that it takes 17 years on average for clinical research to become incorporated into the majority of clinical practices.⁸ Although the randomized control trial (RCT) is unquestionably the best research tool to explore simple components of clinical care (i.e. tests, drugs, and procedures), its translation into daily clinical practice remains difficult.

Improving the process of care leading to quality remains an extremely difficult proposition based on such sociological issues as resistance to change, the need for interdisciplinary teamwork, level of support staff, economic factors, information retrieval inadequacies, and, most important, the complexity of patients with multiple comorbidities that do not fit the parameters of the RCT.

Don Berwick, MD, the lead author in the landmark IOM report and currently CMS administrator, has stated “in such complex terrain, the RCT is an impoverished way to learn.”⁹ Factors that cause this chasm include:¹⁰

• Too narrowly focused RCT;
• More required resources, including financial and personnel support with RCT, compared with usually clinical practices;
• Lack of collaboration between academic medical center researchers and community clinicians; and
• Lack of expertise and experience to undertake quality improvement in healthcare.

CER has received a $1.1 billion investment with the passage of the American Recovery and Reinvestment Act to provide evidence on the effectiveness, benefits, and harms of various treatment options.¹¹ As part of this research to improve IOM’s goals to improve healthcare, better evidence is desperately needed to cross the translational gap between clinical research and the bedside.¹² Observational outcome studies based on registries or databases derived primarily from clinical care can provide a powerful supplement to quality improvement.¹³

Thus, the ability to combine Medicare claims with other data through the Availability of Medicare Data for Performance Measurement would supply a wealth of information to potentially impact quality. As a cautionary note, safeguards such as provider review and appeal, monitoring the validity of the information, and only using the data for quality improvement are vital.

Dr. Holder is medical director of hospitalist services and chief medical information officer at Decatur (Ill.) Memorial Hospital. He is a member of Team Hospitalist.

CON

Unanswered questions, risks make CMS plan a bad idea

On June 8, the Centers for Medicare & Medicaid Services (CMS) proposed a rule to allow “qualified entities” access to patient-protected Medicare data for provider performance publication. CMS allowed 60 days for public comment and a start date of Jan. 1, 2012. But this controversial rule appeared with short notice, little discussion, and abbreviated opportunity for comment.

CMS maintains this rule will result in higher quality and more cost-effective care. Considering the present volume of data published on multiple performance parameters for both hospitals and providers, it would seem prudent to have solid data for efficacy prior to implementing more required reporting and costs to the industry.^1,2,3

Physicians and hospitals will have 30 days to review and verify three years of CMS claims data before it is released. The burden and cost of review will be borne by the private practices involved.¹ This process will impose added administrative costs, and it is unlikely three years of data can be carefully reviewed in just 30 days. If practitioners find the review too cumbersome and expensive, which is likely, they will forgo review, putting the accuracy of the data in question.

Quality data already is published for both physicians and hospitals. Is there evidence this process will significantly increase transparency? Adding more layers of administrative work for both CMS and caregivers—higher overhead without defined benefit—seems an ill-conceived idea. From an evidence-based-practice standpoint, where is the evidence that this rule will improve “quality” and make care “cost-effective”? Have the risks (added bureaucracy, increased overhead, questionable data) and benefits (added transparency) been evaluated?

Additionally, it is unclear who will be monitoring the quality of the data published and who will provide oversight for the “entities” to ensure these data are fairly and accurately presented. Who will pay for this oversight, and what recourse will be afforded physicians and hospitals that feel they have been wronged?^4,5

The “qualified entities” will pay CMS to cover their cost of providing data, raising concerns that this practice could evolve into patient-data “purchasing.” Although it is likely the selected entities will be industry leaders (or at least initially) with the capability to protect data, is this not another opportunity for misuse or corruption in the system?

Other issues not clearly addressed include the nature of the patient-protected information and who will interpret this data in a clinical context. How will these data be adjusted for patient comorbidities and case mix, or will the data be published without regard to these important confounders?^1,3

Publishing clinical data for quality assurance and feedback purposes is essential for quality care. Transparency has increased consumer confidence in the healthcare system and, indeed, has increased the healthcare system’s responsiveness to quality concerns. Granting the benefits of transparency, published data must be precise, accurate, and managed with good oversight in order to ensure the process does not target providers or skew results. Another program, especially one being fast-tracked and making once-protected patient information available to unspecified entities, raises many questions. Who will be watching these agencies for a clear interpretation? Is this yet another layer of CMS bureaucracy? In an era of evidence-based medicine, where is the evidence that this program will improve the system for the better?

Dr. Brezina is a hospitalist at Durham Regional Hospital in North Carolina.

References

1. Under the magnifying glass (again): CMS proposes new access to Medicare data for public provider performance reports. Bass, Berry and Sims website. Available at: http://www.bassberry.com/communicationscenter/newsletters/. Accessed Aug. 31, 2011.
2. Controversial rule to allow access to Medicare data. Modern Health website. Available at: http://www.modernHealthcare.com. Accessed Aug. 31, 2011.
3. Physician report cards must give correct grades. American Medical News website. Available at: http://www.ama-assn.org/amednews/2011/09/05/edsa0905.htm. Accessed Sept. 12, 2011.
4. OIG identifies huge lapses in hospital security, shifts its focus from CMS to OCR. Atlantic Information Services Inc. website. Available at: http://www.AISHealth.com. Accessed Sept. 12, 2011.
5. Berry M. Insurers mishandle 1 in 5 claims, AMA finds. American Medical News website. Available at: http://www.ama-assn.org/amednews/2011/07/04/prl20704.htm. Accessed Sept. 12, 2011.
6. Kohn LT, Corrigan JM, Donaldson MS, eds. To error is human: building a safer health system. Washington: National Academies Press; 1999.
7. Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal trends in rates of patient harm resulting from medical care. N Engl J Med. 2010;363(22):2124-2134.
8. Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. Washington: National Academy Press; 2001:13.
9. Berwick DM. The science of improvement. JAMA. 2008;299(10):1182-1184.
10. Ting HH, Shojania KG, Montori VM, Bradley EH. Quality improvement science and action. Circulation. 2009;119:1962-1974.
11. Committee on Comparative Research Prioritization. Institute of Medicine Initial National Priorities for Comparative Effectiveness Research. Washington: National Academy Press; 2009.
12. Sullivan P, Goldman D. The promise of comparative effectiveness research. JAMA. 2011;305(4):400-401.
13. Washington AE, Lipstein SH. The patient-centered outcomes research institute: promoting better information, decisions and health. Sept. 28, 2011; DOI: 10.10.1056/NEJMp1109407.

PRO

Observational, database studies provide a powerful QI supplement

The proposed rules by the Centers for Medicare & Medicaid Services (CMS), which will allow access to patient-protected Medicare data, will provide for greater transparency and for data that could be utilized toward comparative-effectiveness research (CER). Thus, these rules have the potential to improve the quality of healthcare and impact patient safety.

The Institute of Medicine in December 1999 issued its now-famous article “To Err is Human,” which reported that medical errors cause up to 98,000 deaths and more than 1 million injuries each year in the U.S.⁶ However, the evidence shows minimal impact on improving patient safety in the past 10 years.

A retrospective study of 10 North Carolina hospitals reported in the New England Journal of Medicine by Landrigan and colleagues found that harms resulting from medical care remained extremely common, with little evidence for improvement.⁷ It also is estimated that it takes 17 years on average for clinical research to become incorporated into the majority of clinical practices.⁸ Although the randomized control trial (RCT) is unquestionably the best research tool to explore simple components of clinical care (i.e. tests, drugs, and procedures), its translation into daily clinical practice remains difficult.

Improving the process of care leading to quality remains an extremely difficult proposition based on such sociological issues as resistance to change, the need for interdisciplinary teamwork, level of support staff, economic factors, information retrieval inadequacies, and, most important, the complexity of patients with multiple comorbidities that do not fit the parameters of the RCT.

Don Berwick, MD, the lead author in the landmark IOM report and currently CMS administrator, has stated “in such complex terrain, the RCT is an impoverished way to learn.”⁹ Factors that cause this chasm include:¹⁰

• Too narrowly focused RCT;
• More required resources, including financial and personnel support with RCT, compared with usually clinical practices;
• Lack of collaboration between academic medical center researchers and community clinicians; and
• Lack of expertise and experience to undertake quality improvement in healthcare.

CER has received a $1.1 billion investment with the passage of the American Recovery and Reinvestment Act to provide evidence on the effectiveness, benefits, and harms of various treatment options.¹¹ As part of this research to improve IOM’s goals to improve healthcare, better evidence is desperately needed to cross the translational gap between clinical research and the bedside.¹² Observational outcome studies based on registries or databases derived primarily from clinical care can provide a powerful supplement to quality improvement.¹³

Thus, the ability to combine Medicare claims with other data through the Availability of Medicare Data for Performance Measurement would supply a wealth of information to potentially impact quality. As a cautionary note, safeguards such as provider review and appeal, monitoring the validity of the information, and only using the data for quality improvement are vital.

Dr. Holder is medical director of hospitalist services and chief medical information officer at Decatur (Ill.) Memorial Hospital. He is a member of Team Hospitalist.

CON

Unanswered questions, risks make CMS plan a bad idea

On June 8, the Centers for Medicare & Medicaid Services (CMS) proposed a rule to allow “qualified entities” access to patient-protected Medicare data for provider performance publication. CMS allowed 60 days for public comment and a start date of Jan. 1, 2012. But this controversial rule appeared with short notice, little discussion, and abbreviated opportunity for comment.

CMS maintains this rule will result in higher quality and more cost-effective care. Considering the present volume of data published on multiple performance parameters for both hospitals and providers, it would seem prudent to have solid data for efficacy prior to implementing more required reporting and costs to the industry.^1,2,3

Physicians and hospitals will have 30 days to review and verify three years of CMS claims data before it is released. The burden and cost of review will be borne by the private practices involved.¹ This process will impose added administrative costs, and it is unlikely three years of data can be carefully reviewed in just 30 days. If practitioners find the review too cumbersome and expensive, which is likely, they will forgo review, putting the accuracy of the data in question.

Quality data already is published for both physicians and hospitals. Is there evidence this process will significantly increase transparency? Adding more layers of administrative work for both CMS and caregivers—higher overhead without defined benefit—seems an ill-conceived idea. From an evidence-based-practice standpoint, where is the evidence that this rule will improve “quality” and make care “cost-effective”? Have the risks (added bureaucracy, increased overhead, questionable data) and benefits (added transparency) been evaluated?

Additionally, it is unclear who will be monitoring the quality of the data published and who will provide oversight for the “entities” to ensure these data are fairly and accurately presented. Who will pay for this oversight, and what recourse will be afforded physicians and hospitals that feel they have been wronged?^4,5

The “qualified entities” will pay CMS to cover their cost of providing data, raising concerns that this practice could evolve into patient-data “purchasing.” Although it is likely the selected entities will be industry leaders (or at least initially) with the capability to protect data, is this not another opportunity for misuse or corruption in the system?

Other issues not clearly addressed include the nature of the patient-protected information and who will interpret this data in a clinical context. How will these data be adjusted for patient comorbidities and case mix, or will the data be published without regard to these important confounders?^1,3

Publishing clinical data for quality assurance and feedback purposes is essential for quality care. Transparency has increased consumer confidence in the healthcare system and, indeed, has increased the healthcare system’s responsiveness to quality concerns. Granting the benefits of transparency, published data must be precise, accurate, and managed with good oversight in order to ensure the process does not target providers or skew results. Another program, especially one being fast-tracked and making once-protected patient information available to unspecified entities, raises many questions. Who will be watching these agencies for a clear interpretation? Is this yet another layer of CMS bureaucracy? In an era of evidence-based medicine, where is the evidence that this program will improve the system for the better?

Dr. Brezina is a hospitalist at Durham Regional Hospital in North Carolina.

References

1. Under the magnifying glass (again): CMS proposes new access to Medicare data for public provider performance reports. Bass, Berry and Sims website. Available at: http://www.bassberry.com/communicationscenter/newsletters/. Accessed Aug. 31, 2011.
2. Controversial rule to allow access to Medicare data. Modern Health website. Available at: http://www.modernHealthcare.com. Accessed Aug. 31, 2011.
3. Physician report cards must give correct grades. American Medical News website. Available at: http://www.ama-assn.org/amednews/2011/09/05/edsa0905.htm. Accessed Sept. 12, 2011.
4. OIG identifies huge lapses in hospital security, shifts its focus from CMS to OCR. Atlantic Information Services Inc. website. Available at: http://www.AISHealth.com. Accessed Sept. 12, 2011.
5. Berry M. Insurers mishandle 1 in 5 claims, AMA finds. American Medical News website. Available at: http://www.ama-assn.org/amednews/2011/07/04/prl20704.htm. Accessed Sept. 12, 2011.
6. Kohn LT, Corrigan JM, Donaldson MS, eds. To error is human: building a safer health system. Washington: National Academies Press; 1999.
7. Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal trends in rates of patient harm resulting from medical care. N Engl J Med. 2010;363(22):2124-2134.
8. Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. Washington: National Academy Press; 2001:13.
9. Berwick DM. The science of improvement. JAMA. 2008;299(10):1182-1184.
10. Ting HH, Shojania KG, Montori VM, Bradley EH. Quality improvement science and action. Circulation. 2009;119:1962-1974.
11. Committee on Comparative Research Prioritization. Institute of Medicine Initial National Priorities for Comparative Effectiveness Research. Washington: National Academy Press; 2009.
12. Sullivan P, Goldman D. The promise of comparative effectiveness research. JAMA. 2011;305(4):400-401.
13. Washington AE, Lipstein SH. The patient-centered outcomes research institute: promoting better information, decisions and health. Sept. 28, 2011; DOI: 10.10.1056/NEJMp1109407.

Steve Jobs was right. Challenges create opportunity. What are the opportunities in hospital medicine today? Take a lesson from the iPhone: Give them what they need when they need it.

I was in a restaurant in Denver the night I saw the news on the TV. “Steve Jobs dead at the age of 56.” Was I surprised? Yes…and no. Everyone knew he was seriously ill; he acknowledged as much when he stepped down as Apple CEO. While not unexpected, his death was still surprising and an emotional jolt.

I quickly finished my meal and went back to my hotel room, where I turned on CNN. I sat back and watched Anderson Cooper talk about Jobs’ life and legacy. Apple co-founder Steve Wozniak was on the telephone with Cooper. Wozniak said when he heard the news, he felt numb, much like he did when he heard about the deaths of John Lennon or President Kennedy.

I felt the same way. I never knew Steve Jobs, but Steve Jobs knew me. He influenced my life in ways unimaginable.

A Revolutionary Persona

On the flight to Denver, I passed time watching a movie produced by Pixar, the movie studio he founded. When I landed, I used an app on my iPhone to find this restaurant, which was close to my hotel and had great reviews. I am typing this month’s column on my Macintosh laptop. How did I let someone I never knew get so close to me and have so much influence on my life?

This is Steve Jobs’ legacy. He did what others couldn’t do. He didn’t invent the personal computer, but he made one that was easy to use. He didn’t create animation, but he showed Hollywood how to create more intriguing movies faster and cheaper. (The smartest thing Disney did was to buy out Pixar before Pixar grew big enough to buy them.)

He revolutionized the music industry. Remember when Napster had the music industry on its heels? Recording labels were suing people and college kids were going to jail for downloading pirated songs. Seemed crazy to send kids off to jail for lifting a few songs, but it was happening. Then came the iPod and iTunes. Not only could I pay 99 cents for a song, I could carry my entire music library in my pocket. Duh … why didn’t I think of that? And he did it all while living with pancreatic neuroendocrine cancer!

One of the things I watched on CNN that evening was a segment from the commencement speech Jobs gave to Stanford University’s graduating class several years ago. He had just recovered from his surgery (visit http://news.stanford.edu/news/2005/june15/jobs-061505.html for the complete transcript). He described how his firing from Apple spurred creativity and resulted in innovation.

“Getting fired from Apple was the best thing that could have ever happened to me,” he said. “The heaviness of being successful was replaced by the lightness of being a beginner again, less sure about everything. It freed me to enter one of the most creative periods of my life.”

This made me think back to 1994, the year I graduated from medical school and about two years before Drs. Wachter and Goldman coined the term “hospitalist” in that fateful New England Journal of Medicine article.¹ In 1994, I could not have imagined the iPhone; I could not have predicted the field of hospital medicine. Don't worry if you couldn’t, either. I really think that if this is how we define innovation, we have set the bar too high. Innovation does not have to be complicated. In fact, the greatest innovations are simple. Hand your iPhone to a five-year-old and they can figure it out. Can you do that with a PC?

Challenges Ahead, Ongoing

How does this apply to hospital medicine? These are challenging times for hospitalists. American healthcare costs too much, and some people are saying hospitalists are part of the problem. Hospitalists are discharging more patients than ever from our nation’s hospitals, and more patients than ever are finding themselves readmitted within 30 days. Quality and process improvement is the mantra in healthcare today, and too many hospitalists have little understanding of what is necessary to participate in quality and process improvement.

Steve Jobs got fired from the company he created. Could hospitalists be removed from the program they started? Jobs was right. Challenges create opportunity. What are the opportunities in HM today? Take a lesson from the iPhone: Give them what they need when they need it.

For example, why do so many hospitalist programs staff in-house only during daytime hours? Patients don’t become acutely ill only during the day. Most of us will be hospitalized at some point in our lives. Will there be a hospitalist to see you when you are short of breath or having chest pain? Hospitalists need to be in house 24 hours a day, seven days a week, providing care when patients need it. I know that we don’t have enough money to pay for this and we don’t have enough hospitalists to staff 24/7, but that is the innovation part. I can assure you that while the iPhone is easy for the end-user, an incredible amount of infrastructure had to be created in order to support that easy-to-use experience for the consumer. Jobs and Apple overcame hurdles to create the iPhone. It’s our job to overcome the hurdles to provide safe, timely, and high-value care for our patients.

Steve Jobs’ legacy is Apple.

What is your legacy?

A Call for Research

Most of you are aware that Jobs died from pancreatic neuroendocrine cancer. This is a relatively rare disease, which is in dire need of additional research. Patients with rare diseases find themselves in the difficult position of trying to understand why little is being done to help them.

I, unfortunately, know something about this, as someone very close to me has this disease. Research requires funding. One way to honor Jobs’ legacy is to support pancreatic neuroendocrine cancer research. One organization I have personally supported is the Caring for Carcinoid Foundation. This foundation has contributed millions of dollars toward carcinoid and neuroendocrine tumor research.

If you want to learn more about the Caring for Carcinoid Foundation, visit www.caringforcarcinoid.org.

Dr. Li is president of SHM.

Reference

1. Wachter RM, Goldman L. The emerging role of “hospitalists” in the American healthcare system. N Engl J Med. 1996;335:514-517.

Steve Jobs was right. Challenges create opportunity. What are the opportunities in hospital medicine today? Take a lesson from the iPhone: Give them what they need when they need it.

I was in a restaurant in Denver the night I saw the news on the TV. “Steve Jobs dead at the age of 56.” Was I surprised? Yes…and no. Everyone knew he was seriously ill; he acknowledged as much when he stepped down as Apple CEO. While not unexpected, his death was still surprising and an emotional jolt.

I quickly finished my meal and went back to my hotel room, where I turned on CNN. I sat back and watched Anderson Cooper talk about Jobs’ life and legacy. Apple co-founder Steve Wozniak was on the telephone with Cooper. Wozniak said when he heard the news, he felt numb, much like he did when he heard about the deaths of John Lennon or President Kennedy.

I felt the same way. I never knew Steve Jobs, but Steve Jobs knew me. He influenced my life in ways unimaginable.

A Revolutionary Persona

On the flight to Denver, I passed time watching a movie produced by Pixar, the movie studio he founded. When I landed, I used an app on my iPhone to find this restaurant, which was close to my hotel and had great reviews. I am typing this month’s column on my Macintosh laptop. How did I let someone I never knew get so close to me and have so much influence on my life?

This is Steve Jobs’ legacy. He did what others couldn’t do. He didn’t invent the personal computer, but he made one that was easy to use. He didn’t create animation, but he showed Hollywood how to create more intriguing movies faster and cheaper. (The smartest thing Disney did was to buy out Pixar before Pixar grew big enough to buy them.)

He revolutionized the music industry. Remember when Napster had the music industry on its heels? Recording labels were suing people and college kids were going to jail for downloading pirated songs. Seemed crazy to send kids off to jail for lifting a few songs, but it was happening. Then came the iPod and iTunes. Not only could I pay 99 cents for a song, I could carry my entire music library in my pocket. Duh … why didn’t I think of that? And he did it all while living with pancreatic neuroendocrine cancer!

One of the things I watched on CNN that evening was a segment from the commencement speech Jobs gave to Stanford University’s graduating class several years ago. He had just recovered from his surgery (visit http://news.stanford.edu/news/2005/june15/jobs-061505.html for the complete transcript). He described how his firing from Apple spurred creativity and resulted in innovation.

“Getting fired from Apple was the best thing that could have ever happened to me,” he said. “The heaviness of being successful was replaced by the lightness of being a beginner again, less sure about everything. It freed me to enter one of the most creative periods of my life.”

This made me think back to 1994, the year I graduated from medical school and about two years before Drs. Wachter and Goldman coined the term “hospitalist” in that fateful New England Journal of Medicine article.¹ In 1994, I could not have imagined the iPhone; I could not have predicted the field of hospital medicine. Don't worry if you couldn’t, either. I really think that if this is how we define innovation, we have set the bar too high. Innovation does not have to be complicated. In fact, the greatest innovations are simple. Hand your iPhone to a five-year-old and they can figure it out. Can you do that with a PC?

Challenges Ahead, Ongoing

How does this apply to hospital medicine? These are challenging times for hospitalists. American healthcare costs too much, and some people are saying hospitalists are part of the problem. Hospitalists are discharging more patients than ever from our nation’s hospitals, and more patients than ever are finding themselves readmitted within 30 days. Quality and process improvement is the mantra in healthcare today, and too many hospitalists have little understanding of what is necessary to participate in quality and process improvement.

Steve Jobs got fired from the company he created. Could hospitalists be removed from the program they started? Jobs was right. Challenges create opportunity. What are the opportunities in HM today? Take a lesson from the iPhone: Give them what they need when they need it.

For example, why do so many hospitalist programs staff in-house only during daytime hours? Patients don’t become acutely ill only during the day. Most of us will be hospitalized at some point in our lives. Will there be a hospitalist to see you when you are short of breath or having chest pain? Hospitalists need to be in house 24 hours a day, seven days a week, providing care when patients need it. I know that we don’t have enough money to pay for this and we don’t have enough hospitalists to staff 24/7, but that is the innovation part. I can assure you that while the iPhone is easy for the end-user, an incredible amount of infrastructure had to be created in order to support that easy-to-use experience for the consumer. Jobs and Apple overcame hurdles to create the iPhone. It’s our job to overcome the hurdles to provide safe, timely, and high-value care for our patients.

Steve Jobs’ legacy is Apple.

What is your legacy?

A Call for Research

Most of you are aware that Jobs died from pancreatic neuroendocrine cancer. This is a relatively rare disease, which is in dire need of additional research. Patients with rare diseases find themselves in the difficult position of trying to understand why little is being done to help them.

I, unfortunately, know something about this, as someone very close to me has this disease. Research requires funding. One way to honor Jobs’ legacy is to support pancreatic neuroendocrine cancer research. One organization I have personally supported is the Caring for Carcinoid Foundation. This foundation has contributed millions of dollars toward carcinoid and neuroendocrine tumor research.

If you want to learn more about the Caring for Carcinoid Foundation, visit www.caringforcarcinoid.org.

Dr. Li is president of SHM.

Reference

1. Wachter RM, Goldman L. The emerging role of “hospitalists” in the American healthcare system. N Engl J Med. 1996;335:514-517.

Steve Jobs was right. Challenges create opportunity. What are the opportunities in hospital medicine today? Take a lesson from the iPhone: Give them what they need when they need it.

I was in a restaurant in Denver the night I saw the news on the TV. “Steve Jobs dead at the age of 56.” Was I surprised? Yes…and no. Everyone knew he was seriously ill; he acknowledged as much when he stepped down as Apple CEO. While not unexpected, his death was still surprising and an emotional jolt.

I quickly finished my meal and went back to my hotel room, where I turned on CNN. I sat back and watched Anderson Cooper talk about Jobs’ life and legacy. Apple co-founder Steve Wozniak was on the telephone with Cooper. Wozniak said when he heard the news, he felt numb, much like he did when he heard about the deaths of John Lennon or President Kennedy.

I felt the same way. I never knew Steve Jobs, but Steve Jobs knew me. He influenced my life in ways unimaginable.

A Revolutionary Persona

On the flight to Denver, I passed time watching a movie produced by Pixar, the movie studio he founded. When I landed, I used an app on my iPhone to find this restaurant, which was close to my hotel and had great reviews. I am typing this month’s column on my Macintosh laptop. How did I let someone I never knew get so close to me and have so much influence on my life?

This is Steve Jobs’ legacy. He did what others couldn’t do. He didn’t invent the personal computer, but he made one that was easy to use. He didn’t create animation, but he showed Hollywood how to create more intriguing movies faster and cheaper. (The smartest thing Disney did was to buy out Pixar before Pixar grew big enough to buy them.)

He revolutionized the music industry. Remember when Napster had the music industry on its heels? Recording labels were suing people and college kids were going to jail for downloading pirated songs. Seemed crazy to send kids off to jail for lifting a few songs, but it was happening. Then came the iPod and iTunes. Not only could I pay 99 cents for a song, I could carry my entire music library in my pocket. Duh … why didn’t I think of that? And he did it all while living with pancreatic neuroendocrine cancer!

One of the things I watched on CNN that evening was a segment from the commencement speech Jobs gave to Stanford University’s graduating class several years ago. He had just recovered from his surgery (visit http://news.stanford.edu/news/2005/june15/jobs-061505.html for the complete transcript). He described how his firing from Apple spurred creativity and resulted in innovation.

“Getting fired from Apple was the best thing that could have ever happened to me,” he said. “The heaviness of being successful was replaced by the lightness of being a beginner again, less sure about everything. It freed me to enter one of the most creative periods of my life.”

This made me think back to 1994, the year I graduated from medical school and about two years before Drs. Wachter and Goldman coined the term “hospitalist” in that fateful New England Journal of Medicine article.¹ In 1994, I could not have imagined the iPhone; I could not have predicted the field of hospital medicine. Don't worry if you couldn’t, either. I really think that if this is how we define innovation, we have set the bar too high. Innovation does not have to be complicated. In fact, the greatest innovations are simple. Hand your iPhone to a five-year-old and they can figure it out. Can you do that with a PC?

Challenges Ahead, Ongoing

How does this apply to hospital medicine? These are challenging times for hospitalists. American healthcare costs too much, and some people are saying hospitalists are part of the problem. Hospitalists are discharging more patients than ever from our nation’s hospitals, and more patients than ever are finding themselves readmitted within 30 days. Quality and process improvement is the mantra in healthcare today, and too many hospitalists have little understanding of what is necessary to participate in quality and process improvement.

Steve Jobs got fired from the company he created. Could hospitalists be removed from the program they started? Jobs was right. Challenges create opportunity. What are the opportunities in HM today? Take a lesson from the iPhone: Give them what they need when they need it.

For example, why do so many hospitalist programs staff in-house only during daytime hours? Patients don’t become acutely ill only during the day. Most of us will be hospitalized at some point in our lives. Will there be a hospitalist to see you when you are short of breath or having chest pain? Hospitalists need to be in house 24 hours a day, seven days a week, providing care when patients need it. I know that we don’t have enough money to pay for this and we don’t have enough hospitalists to staff 24/7, but that is the innovation part. I can assure you that while the iPhone is easy for the end-user, an incredible amount of infrastructure had to be created in order to support that easy-to-use experience for the consumer. Jobs and Apple overcame hurdles to create the iPhone. It’s our job to overcome the hurdles to provide safe, timely, and high-value care for our patients.

Steve Jobs’ legacy is Apple.

What is your legacy?

A Call for Research

Most of you are aware that Jobs died from pancreatic neuroendocrine cancer. This is a relatively rare disease, which is in dire need of additional research. Patients with rare diseases find themselves in the difficult position of trying to understand why little is being done to help them.

I, unfortunately, know something about this, as someone very close to me has this disease. Research requires funding. One way to honor Jobs’ legacy is to support pancreatic neuroendocrine cancer research. One organization I have personally supported is the Caring for Carcinoid Foundation. This foundation has contributed millions of dollars toward carcinoid and neuroendocrine tumor research.

If you want to learn more about the Caring for Carcinoid Foundation, visit www.caringforcarcinoid.org.

Dr. Li is president of SHM.

Reference

1. Wachter RM, Goldman L. The emerging role of “hospitalists” in the American healthcare system. N Engl J Med. 1996;335:514-517.

If today’s learners interact with grumpy, overworked, unsatisfied, marginalized intern-extenders, they will quickly up-regulate the gastroenterology gene, and the best and brightest will start to flow out of our pipeline.

Are hospitalists happy? Are we satisfied, stressed, burned out? How is this impacting our field? What can we do about it? The Hospitalist this month takes a hard look at the often overlooked issue of career satisfaction and its cousins burnout, stress, and turnover.

After a decade of taking a fly-by-the-seat-of-our-pants approach to building, managing, and remediating HM programs, we finally have some concrete data to help guide us in building our programs. In fact, no fewer than three research papers studying these issues have been published recently—two of them from my institution.^1,2,3 As such, I’ve been thinking about this a lot and what this means to the field in general and, more specifically, academic hospitalists.

Now I recognize that academic hospitalists make up but a fraction of the hospitalist work force; nonetheless, I believe it is an important fraction, even for community hospitalists. As I’ve written before, HM’s pipeline is dependent upon future hospitalists (commonly referred to as residents and students) engaging with fulfilled, satisfied, and successful academic hospitalists—the kind of specialists that look and feel like other specialists. If today’s learners interact with grumpy, overworked, unsatisfied, marginalized intern-extenders, they will quickly up-regulate the gastroenterology gene, and the best and brightest will start to flow out of our pipeline.

So what do these studies show? How do we assimilate these data into our programs, and how can we use it to produce more sustainable, effective, and productive academic HM groups? Here’s my take: a seven-step prescription of sorts for what ails academic HM.

Step 1: Honor Thy Mission

I was having dinner recently with a higher-level executive with a national hospitalist management company that primarily staffs community hospitals. An uncomfortable pause, followed by gasping sounds, ensued after I told him our starting academic salary. After collecting himself, he asked how on Earth I could recruit hospitalists at such a low salary—I think hoping to discover the fount to lower personnel costs. Simply put, some people are willing to sacrifice salary for the academic mission and all its trappings.

In fact, the only differential advantage academic programs have over their community brethren is the ability to be, well, academic—that is, to teach, develop, innovate, disseminate, and create the knowledge base that fuels our specialty. The academic mission is not for everyone. But there is a pool of individuals who are willing to forego financial compensation for compensation of a different sort. Take away the academic mission, and the two jobs start to look similar, salaries equilibrate, and people with academic leanings become unsatisfied.

And burned out. I’d argue that career-fit mismatch is a main cause of academic hospitalist burnout—I come to academics to be academic but find in turn a community job in a teaching hospital. This is supported by data showing that 75% of academic hospitalists described their primary role as either teacher or investigator, yet most (52%) spent 40% or less of their time with learners, and 57% had 20% or less of their time protected for scholarly pursuits.1 This epitomizes career-fit mismatch, and likely explains why nearly a quarter of academic hospitalists are burned out.

Step 2: Man Cannot Live by wRVUs Alone

An extension of this idea is that academicians need time for scholarship. In fact, academic productivity cannot be measured in wRVUs alone. Don’t get me wrong; hospitalists need to support their salaries and see lots of patients. But teaching the next generation, developing and disseminating knowledge, and generating a promotable academic portfolio takes time—time that can’t be shoe-horned into 200-plus busy clinical shifts a year. This is supported by evidence showing that more than 20% of protected non-clinical time was one of the biggest predictors of academic productivity.²

Five thousand wRVUs? Way too much. Four thousand? Getting warmer. Three thousand? Try a little lower. I’d go out on a limb and say the right number is slightly below 3,000 wRVUs.

I suspect this will raise some eyebrows among hospital administrators who fund these programs—and I welcome the letters. But before you pick up your pen, consider this: What is the value of educating our future physicians (something most teaching hospitals are funded to do through graduate medical education dollars), discovery, scholarship, hospital quality improvement (QI), and sustainable faculty careers? Academic hospitalists have decided to value it with a pay cut. Are our administrators willing to make a similar sacrifice?

Step 3: Culture of Scholarship

Protected time comes with a responsibility to produce. Discovering, publishing, speaking, and presenting are hard work—so hard that the default of not doing it presents an all-too-often-enticing option. This in part explains why most academic hospitalists have not published a first-author, peer-reviewed paper (51% have not), given institutional medical grand rounds (74%), or presented at a national meeting (75%).¹

This is where cultivating a group culture of scholarship replete with expectations (# of publications/year), opportunities to present work (hospitalist Grand Rounds), faculty development, mentorship and institutional support (financial commitment and time to teach) are paramount.

Step 4: Academic Currency

Let me emphasize that last point. The majority of academic hospitalists lack formal fellowship training and, therefore, are not going to be funded or promoted based on research outputs. In fact, more than 90% of hospitalists will be promoted (or not) through the clinician-educator pathway. That means our academic currency is teaching and curriculum development.

That’s why the majority of academic hospitalists spending the majority of their time on non-teaching services is a major problem. It’s akin to an eternally unfunded researcher trying to get promoted as a clinician-investigator. It’s not going to happen.

Duty-hour restrictions, growing hospital services, PCP exodus from our hospitals, and the growth of comanagement are driving further hospitalist expansion in teaching hospitals. This means more mouths competing for a shrinking teaching pie. I don’t have the solution, but I suspect that those clinician-educators spending less than 25% of their time with learners will find it difficult to be sated, successful, and promotable in academia.

Step 5: Mentorship

Mentorship unquestionably is tied to publications, presentations, grant funding, job satisfaction, and, ultimately, academic promotion. Yet only 42% of academic hospitalists report having a mentor.² Of those with a mentor, the vast majority spend less than four hours a year with their mentor.² I can identify no more obvious and urgent problem to solve in academic HM.

Step 6: Job Structure

The single most powerful predictors of burnout and low satisfaction are a lack of work/life balance, autonomy, and control over one’s work environment. In fact, control over work schedule (odds ratio 5.35) and amount of personal time (OR 2.51) were the biggest predictors of burnout for academic hospitalists. Similarly, control over work schedule (OR 4.82) and amount of personal time (OR 2.37) predicted low satisfaction.¹ The bottom line is that flexibility, autonomy, and control are essential components to academic fulfillment.

Step 7: The Secret Sauce

There you have it—a prescription for success.

Well, it turns out we are still missing one thing—one final ingredient, something mysterious and all-too-often lacking. A magic potion that allows for the right people to be in the right places with the right tools to succeed. With it, our potential knows no bounds. Without it, we’ll continue to struggle. In fact, its absence is one of the single biggest predictors of low satisfaction for academic hospitalists.¹

What is “it”?

Leadership.

HM needs individuals to fill this prescription. The problem is that our leaders are often young, inexperienced, and raw. They are tasked with creating positions with an academic focus, reasonable clinical productivity expectations, a culture that promotes scholarship, sufficient non-clinical time, adequate time with learners, robust mentorship, and ample autonomy, work-life balance, and a chance to grow. To do this, they need direction, mentorship, a peer network, and skills development.

At least that’s what I need.

In fact, come to think of it, I think there is an eighth step for academic success—the need to develop an external academic peer network, to grow together, to actively engage, and depend on for help. As such, I hope you’ll partake in step No. 8 with me—at HM12, Academic Hospitalist Academy, Leadership Academies, and the Academic Summit. I hope to see you soon.

Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program. He is physician editor of The Hospitalist and course director of the SHM’s 2012 annual meeting (www.hospitalmedicine2012.org).

References

1. Glasheen JJ, Misky GJ, Reid MB, Harrison RA, Sharpe B, Auerbach A. Career satisfaction and burnout in academic hospital medicine. Arch Intern Med. 2011;171:782-785.
2. Reid MB, Misky GJ, Harrison RA, Sharpe B, Auerbach A, Glasheen JJ. Mentorship, productivity, and promotion among academic hospitalists. J Gen Intern Med. Epub online: Sept. 28, 2011.
3. Hinami K, Whelan CT, Wolosin RJ, Miller JA, Wetterneck T. Worklife and satisfaction of hospitalists: Toward flourishing careers. J Gen Intern Med. Epub online: July 20, 2011.

If today’s learners interact with grumpy, overworked, unsatisfied, marginalized intern-extenders, they will quickly up-regulate the gastroenterology gene, and the best and brightest will start to flow out of our pipeline.

Are hospitalists happy? Are we satisfied, stressed, burned out? How is this impacting our field? What can we do about it? The Hospitalist this month takes a hard look at the often overlooked issue of career satisfaction and its cousins burnout, stress, and turnover.

After a decade of taking a fly-by-the-seat-of-our-pants approach to building, managing, and remediating HM programs, we finally have some concrete data to help guide us in building our programs. In fact, no fewer than three research papers studying these issues have been published recently—two of them from my institution.^1,2,3 As such, I’ve been thinking about this a lot and what this means to the field in general and, more specifically, academic hospitalists.

Now I recognize that academic hospitalists make up but a fraction of the hospitalist work force; nonetheless, I believe it is an important fraction, even for community hospitalists. As I’ve written before, HM’s pipeline is dependent upon future hospitalists (commonly referred to as residents and students) engaging with fulfilled, satisfied, and successful academic hospitalists—the kind of specialists that look and feel like other specialists. If today’s learners interact with grumpy, overworked, unsatisfied, marginalized intern-extenders, they will quickly up-regulate the gastroenterology gene, and the best and brightest will start to flow out of our pipeline.

So what do these studies show? How do we assimilate these data into our programs, and how can we use it to produce more sustainable, effective, and productive academic HM groups? Here’s my take: a seven-step prescription of sorts for what ails academic HM.

Step 1: Honor Thy Mission

I was having dinner recently with a higher-level executive with a national hospitalist management company that primarily staffs community hospitals. An uncomfortable pause, followed by gasping sounds, ensued after I told him our starting academic salary. After collecting himself, he asked how on Earth I could recruit hospitalists at such a low salary—I think hoping to discover the fount to lower personnel costs. Simply put, some people are willing to sacrifice salary for the academic mission and all its trappings.

In fact, the only differential advantage academic programs have over their community brethren is the ability to be, well, academic—that is, to teach, develop, innovate, disseminate, and create the knowledge base that fuels our specialty. The academic mission is not for everyone. But there is a pool of individuals who are willing to forego financial compensation for compensation of a different sort. Take away the academic mission, and the two jobs start to look similar, salaries equilibrate, and people with academic leanings become unsatisfied.

And burned out. I’d argue that career-fit mismatch is a main cause of academic hospitalist burnout—I come to academics to be academic but find in turn a community job in a teaching hospital. This is supported by data showing that 75% of academic hospitalists described their primary role as either teacher or investigator, yet most (52%) spent 40% or less of their time with learners, and 57% had 20% or less of their time protected for scholarly pursuits.1 This epitomizes career-fit mismatch, and likely explains why nearly a quarter of academic hospitalists are burned out.

Step 2: Man Cannot Live by wRVUs Alone

An extension of this idea is that academicians need time for scholarship. In fact, academic productivity cannot be measured in wRVUs alone. Don’t get me wrong; hospitalists need to support their salaries and see lots of patients. But teaching the next generation, developing and disseminating knowledge, and generating a promotable academic portfolio takes time—time that can’t be shoe-horned into 200-plus busy clinical shifts a year. This is supported by evidence showing that more than 20% of protected non-clinical time was one of the biggest predictors of academic productivity.²

Five thousand wRVUs? Way too much. Four thousand? Getting warmer. Three thousand? Try a little lower. I’d go out on a limb and say the right number is slightly below 3,000 wRVUs.

I suspect this will raise some eyebrows among hospital administrators who fund these programs—and I welcome the letters. But before you pick up your pen, consider this: What is the value of educating our future physicians (something most teaching hospitals are funded to do through graduate medical education dollars), discovery, scholarship, hospital quality improvement (QI), and sustainable faculty careers? Academic hospitalists have decided to value it with a pay cut. Are our administrators willing to make a similar sacrifice?

Step 3: Culture of Scholarship

Protected time comes with a responsibility to produce. Discovering, publishing, speaking, and presenting are hard work—so hard that the default of not doing it presents an all-too-often-enticing option. This in part explains why most academic hospitalists have not published a first-author, peer-reviewed paper (51% have not), given institutional medical grand rounds (74%), or presented at a national meeting (75%).¹

This is where cultivating a group culture of scholarship replete with expectations (# of publications/year), opportunities to present work (hospitalist Grand Rounds), faculty development, mentorship and institutional support (financial commitment and time to teach) are paramount.

Step 4: Academic Currency

Let me emphasize that last point. The majority of academic hospitalists lack formal fellowship training and, therefore, are not going to be funded or promoted based on research outputs. In fact, more than 90% of hospitalists will be promoted (or not) through the clinician-educator pathway. That means our academic currency is teaching and curriculum development.

That’s why the majority of academic hospitalists spending the majority of their time on non-teaching services is a major problem. It’s akin to an eternally unfunded researcher trying to get promoted as a clinician-investigator. It’s not going to happen.

Duty-hour restrictions, growing hospital services, PCP exodus from our hospitals, and the growth of comanagement are driving further hospitalist expansion in teaching hospitals. This means more mouths competing for a shrinking teaching pie. I don’t have the solution, but I suspect that those clinician-educators spending less than 25% of their time with learners will find it difficult to be sated, successful, and promotable in academia.

Step 5: Mentorship

Mentorship unquestionably is tied to publications, presentations, grant funding, job satisfaction, and, ultimately, academic promotion. Yet only 42% of academic hospitalists report having a mentor.² Of those with a mentor, the vast majority spend less than four hours a year with their mentor.² I can identify no more obvious and urgent problem to solve in academic HM.

Step 6: Job Structure

The single most powerful predictors of burnout and low satisfaction are a lack of work/life balance, autonomy, and control over one’s work environment. In fact, control over work schedule (odds ratio 5.35) and amount of personal time (OR 2.51) were the biggest predictors of burnout for academic hospitalists. Similarly, control over work schedule (OR 4.82) and amount of personal time (OR 2.37) predicted low satisfaction.¹ The bottom line is that flexibility, autonomy, and control are essential components to academic fulfillment.

Step 7: The Secret Sauce

There you have it—a prescription for success.

Well, it turns out we are still missing one thing—one final ingredient, something mysterious and all-too-often lacking. A magic potion that allows for the right people to be in the right places with the right tools to succeed. With it, our potential knows no bounds. Without it, we’ll continue to struggle. In fact, its absence is one of the single biggest predictors of low satisfaction for academic hospitalists.¹

What is “it”?

Leadership.

HM needs individuals to fill this prescription. The problem is that our leaders are often young, inexperienced, and raw. They are tasked with creating positions with an academic focus, reasonable clinical productivity expectations, a culture that promotes scholarship, sufficient non-clinical time, adequate time with learners, robust mentorship, and ample autonomy, work-life balance, and a chance to grow. To do this, they need direction, mentorship, a peer network, and skills development.

At least that’s what I need.

In fact, come to think of it, I think there is an eighth step for academic success—the need to develop an external academic peer network, to grow together, to actively engage, and depend on for help. As such, I hope you’ll partake in step No. 8 with me—at HM12, Academic Hospitalist Academy, Leadership Academies, and the Academic Summit. I hope to see you soon.

Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program. He is physician editor of The Hospitalist and course director of the SHM’s 2012 annual meeting (www.hospitalmedicine2012.org).

References

1. Glasheen JJ, Misky GJ, Reid MB, Harrison RA, Sharpe B, Auerbach A. Career satisfaction and burnout in academic hospital medicine. Arch Intern Med. 2011;171:782-785.
2. Reid MB, Misky GJ, Harrison RA, Sharpe B, Auerbach A, Glasheen JJ. Mentorship, productivity, and promotion among academic hospitalists. J Gen Intern Med. Epub online: Sept. 28, 2011.
3. Hinami K, Whelan CT, Wolosin RJ, Miller JA, Wetterneck T. Worklife and satisfaction of hospitalists: Toward flourishing careers. J Gen Intern Med. Epub online: July 20, 2011.

If today’s learners interact with grumpy, overworked, unsatisfied, marginalized intern-extenders, they will quickly up-regulate the gastroenterology gene, and the best and brightest will start to flow out of our pipeline.

Are hospitalists happy? Are we satisfied, stressed, burned out? How is this impacting our field? What can we do about it? The Hospitalist this month takes a hard look at the often overlooked issue of career satisfaction and its cousins burnout, stress, and turnover.

After a decade of taking a fly-by-the-seat-of-our-pants approach to building, managing, and remediating HM programs, we finally have some concrete data to help guide us in building our programs. In fact, no fewer than three research papers studying these issues have been published recently—two of them from my institution.^1,2,3 As such, I’ve been thinking about this a lot and what this means to the field in general and, more specifically, academic hospitalists.

Now I recognize that academic hospitalists make up but a fraction of the hospitalist work force; nonetheless, I believe it is an important fraction, even for community hospitalists. As I’ve written before, HM’s pipeline is dependent upon future hospitalists (commonly referred to as residents and students) engaging with fulfilled, satisfied, and successful academic hospitalists—the kind of specialists that look and feel like other specialists. If today’s learners interact with grumpy, overworked, unsatisfied, marginalized intern-extenders, they will quickly up-regulate the gastroenterology gene, and the best and brightest will start to flow out of our pipeline.

So what do these studies show? How do we assimilate these data into our programs, and how can we use it to produce more sustainable, effective, and productive academic HM groups? Here’s my take: a seven-step prescription of sorts for what ails academic HM.

Step 1: Honor Thy Mission

I was having dinner recently with a higher-level executive with a national hospitalist management company that primarily staffs community hospitals. An uncomfortable pause, followed by gasping sounds, ensued after I told him our starting academic salary. After collecting himself, he asked how on Earth I could recruit hospitalists at such a low salary—I think hoping to discover the fount to lower personnel costs. Simply put, some people are willing to sacrifice salary for the academic mission and all its trappings.

In fact, the only differential advantage academic programs have over their community brethren is the ability to be, well, academic—that is, to teach, develop, innovate, disseminate, and create the knowledge base that fuels our specialty. The academic mission is not for everyone. But there is a pool of individuals who are willing to forego financial compensation for compensation of a different sort. Take away the academic mission, and the two jobs start to look similar, salaries equilibrate, and people with academic leanings become unsatisfied.

And burned out. I’d argue that career-fit mismatch is a main cause of academic hospitalist burnout—I come to academics to be academic but find in turn a community job in a teaching hospital. This is supported by data showing that 75% of academic hospitalists described their primary role as either teacher or investigator, yet most (52%) spent 40% or less of their time with learners, and 57% had 20% or less of their time protected for scholarly pursuits.1 This epitomizes career-fit mismatch, and likely explains why nearly a quarter of academic hospitalists are burned out.

Step 2: Man Cannot Live by wRVUs Alone

An extension of this idea is that academicians need time for scholarship. In fact, academic productivity cannot be measured in wRVUs alone. Don’t get me wrong; hospitalists need to support their salaries and see lots of patients. But teaching the next generation, developing and disseminating knowledge, and generating a promotable academic portfolio takes time—time that can’t be shoe-horned into 200-plus busy clinical shifts a year. This is supported by evidence showing that more than 20% of protected non-clinical time was one of the biggest predictors of academic productivity.²

Five thousand wRVUs? Way too much. Four thousand? Getting warmer. Three thousand? Try a little lower. I’d go out on a limb and say the right number is slightly below 3,000 wRVUs.

I suspect this will raise some eyebrows among hospital administrators who fund these programs—and I welcome the letters. But before you pick up your pen, consider this: What is the value of educating our future physicians (something most teaching hospitals are funded to do through graduate medical education dollars), discovery, scholarship, hospital quality improvement (QI), and sustainable faculty careers? Academic hospitalists have decided to value it with a pay cut. Are our administrators willing to make a similar sacrifice?

Step 3: Culture of Scholarship

Protected time comes with a responsibility to produce. Discovering, publishing, speaking, and presenting are hard work—so hard that the default of not doing it presents an all-too-often-enticing option. This in part explains why most academic hospitalists have not published a first-author, peer-reviewed paper (51% have not), given institutional medical grand rounds (74%), or presented at a national meeting (75%).¹

This is where cultivating a group culture of scholarship replete with expectations (# of publications/year), opportunities to present work (hospitalist Grand Rounds), faculty development, mentorship and institutional support (financial commitment and time to teach) are paramount.

Step 4: Academic Currency

Let me emphasize that last point. The majority of academic hospitalists lack formal fellowship training and, therefore, are not going to be funded or promoted based on research outputs. In fact, more than 90% of hospitalists will be promoted (or not) through the clinician-educator pathway. That means our academic currency is teaching and curriculum development.

That’s why the majority of academic hospitalists spending the majority of their time on non-teaching services is a major problem. It’s akin to an eternally unfunded researcher trying to get promoted as a clinician-investigator. It’s not going to happen.

Duty-hour restrictions, growing hospital services, PCP exodus from our hospitals, and the growth of comanagement are driving further hospitalist expansion in teaching hospitals. This means more mouths competing for a shrinking teaching pie. I don’t have the solution, but I suspect that those clinician-educators spending less than 25% of their time with learners will find it difficult to be sated, successful, and promotable in academia.

Step 5: Mentorship

Mentorship unquestionably is tied to publications, presentations, grant funding, job satisfaction, and, ultimately, academic promotion. Yet only 42% of academic hospitalists report having a mentor.² Of those with a mentor, the vast majority spend less than four hours a year with their mentor.² I can identify no more obvious and urgent problem to solve in academic HM.

Step 6: Job Structure

The single most powerful predictors of burnout and low satisfaction are a lack of work/life balance, autonomy, and control over one’s work environment. In fact, control over work schedule (odds ratio 5.35) and amount of personal time (OR 2.51) were the biggest predictors of burnout for academic hospitalists. Similarly, control over work schedule (OR 4.82) and amount of personal time (OR 2.37) predicted low satisfaction.¹ The bottom line is that flexibility, autonomy, and control are essential components to academic fulfillment.

Step 7: The Secret Sauce

There you have it—a prescription for success.

Well, it turns out we are still missing one thing—one final ingredient, something mysterious and all-too-often lacking. A magic potion that allows for the right people to be in the right places with the right tools to succeed. With it, our potential knows no bounds. Without it, we’ll continue to struggle. In fact, its absence is one of the single biggest predictors of low satisfaction for academic hospitalists.¹

What is “it”?

Leadership.

HM needs individuals to fill this prescription. The problem is that our leaders are often young, inexperienced, and raw. They are tasked with creating positions with an academic focus, reasonable clinical productivity expectations, a culture that promotes scholarship, sufficient non-clinical time, adequate time with learners, robust mentorship, and ample autonomy, work-life balance, and a chance to grow. To do this, they need direction, mentorship, a peer network, and skills development.

At least that’s what I need.

In fact, come to think of it, I think there is an eighth step for academic success—the need to develop an external academic peer network, to grow together, to actively engage, and depend on for help. As such, I hope you’ll partake in step No. 8 with me—at HM12, Academic Hospitalist Academy, Leadership Academies, and the Academic Summit. I hope to see you soon.

Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program. He is physician editor of The Hospitalist and course director of the SHM’s 2012 annual meeting (www.hospitalmedicine2012.org).

References

1. Glasheen JJ, Misky GJ, Reid MB, Harrison RA, Sharpe B, Auerbach A. Career satisfaction and burnout in academic hospital medicine. Arch Intern Med. 2011;171:782-785.
2. Reid MB, Misky GJ, Harrison RA, Sharpe B, Auerbach A, Glasheen JJ. Mentorship, productivity, and promotion among academic hospitalists. J Gen Intern Med. Epub online: Sept. 28, 2011.
3. Hinami K, Whelan CT, Wolosin RJ, Miller JA, Wetterneck T. Worklife and satisfaction of hospitalists: Toward flourishing careers. J Gen Intern Med. Epub online: July 20, 2011.

I recently became chief medical officer (CMO) of our hospital. When a hospitalist’s case comes to our patient-care committee, is it appropriate to inform the patient’s primary-care physician (PCP) of the quality issues? Our hospitalists are independent. There are questions of HIPAA. However, several committee members feel that the PCP, who does not come to the hospital, should be informed. Thank you.

K.A., M.D.

Dr. Hospitalist responds:

Good question. While I’ve participated in similar scenarios, keep in mind that I’m a hospitalist like you, not a lawyer. So, with that rejoinder in mind, let’s take this discussion a few steps further and see what happens.

You state: “when a hospitalist’s case comes to our patient-care committee.” Does that mean peer review? If it does, and what you are describing is a committee that handles privileged and confidential information, then you cannot inform the PCP because you would be violating the basic tenets of peer review.

The principle behind peer review is that it allows physicians to confidentially review the cases of their peers. This is to prevent the information contained in peer review from becoming available to a lawyer by subpoena or by discovery in the courts. The Joint Commission has mandated hospital peer review committees since 1952, and the federal government included language regarding peer-review protection in the Health Care Quality Improvement Act of 1986.

Every state has a law on the books, but the specifics and effectiveness of peer review will vary from state to state (see Florida’s Amendment 7, Kentucky, and Massachusetts). The whole idea is to allow for a process to evaluate physician practice or quality concerns without the fear of discovery or subsequent lawsuit. Even the act of referring a case to peer review is considered a confidential action in my state, so just the referral itself may not be discussed. So if you are referring to peer review, the answer is no, you cannot inform the patient’s PCP. HIPAA does not come into the picture here.

On the other hand, let’s assume, for sake of discussion, that you’ve heard a complaint (or several) about a certain hospitalist, Dr. Nogood. You could, if you desired, refer these complaints to peer review.

If so, then you are immediately bound by those rules of confidentiality. If you don’t refer the case, then you could inform the PCP that you have heard a complaint involving Dr. Nogood and that PCP’s patient.

I can’t see how that would violate HIPAA, because the PCP has an established relationship with that patient, and you might be only reporting facts (the complaint), not passing judgment on the quality of care. And I would not even go that far.

Why stop there? Why not tell that PCP exactly what you think of Dr. Nogood and his clinical practice, the details of the complaints against him, and how you think maybe that PCP should send his patients to someone else for better care? Well, you’re the CMO for the hospital. If you go beyond reporting facts and start reporting opinions, then you’ve just opened yourself up to accusations of restraint of trade by Dr. Nogood.

No matter what you may think of Dr. Nogood’s patient care, unless it falls outside the boundaries of acceptable practice (which can only be determined by a peer review committee), then you should not say anything.

Unless, of course, you want to be accused of spreading rumors, hearsay, and innuendo. Remember, we are talking about an independent practitioner, not a hospital employee.

Overall, it’s a bit of a sticky wicket. If you think the complaint has merit, then it should be sent to peer review—and you may speak no more of it. If you think the complaint is baseless, then why sustain it and tell the PCP?

Peer review is an exceptional process, and the physicians who serve on such committees perform a difficult and selfless service. We should all do our best to uphold its integrity.

I recently became chief medical officer (CMO) of our hospital. When a hospitalist’s case comes to our patient-care committee, is it appropriate to inform the patient’s primary-care physician (PCP) of the quality issues? Our hospitalists are independent. There are questions of HIPAA. However, several committee members feel that the PCP, who does not come to the hospital, should be informed. Thank you.

K.A., M.D.

Dr. Hospitalist responds:

Good question. While I’ve participated in similar scenarios, keep in mind that I’m a hospitalist like you, not a lawyer. So, with that rejoinder in mind, let’s take this discussion a few steps further and see what happens.

You state: “when a hospitalist’s case comes to our patient-care committee.” Does that mean peer review? If it does, and what you are describing is a committee that handles privileged and confidential information, then you cannot inform the PCP because you would be violating the basic tenets of peer review.

The principle behind peer review is that it allows physicians to confidentially review the cases of their peers. This is to prevent the information contained in peer review from becoming available to a lawyer by subpoena or by discovery in the courts. The Joint Commission has mandated hospital peer review committees since 1952, and the federal government included language regarding peer-review protection in the Health Care Quality Improvement Act of 1986.

Every state has a law on the books, but the specifics and effectiveness of peer review will vary from state to state (see Florida’s Amendment 7, Kentucky, and Massachusetts). The whole idea is to allow for a process to evaluate physician practice or quality concerns without the fear of discovery or subsequent lawsuit. Even the act of referring a case to peer review is considered a confidential action in my state, so just the referral itself may not be discussed. So if you are referring to peer review, the answer is no, you cannot inform the patient’s PCP. HIPAA does not come into the picture here.

On the other hand, let’s assume, for sake of discussion, that you’ve heard a complaint (or several) about a certain hospitalist, Dr. Nogood. You could, if you desired, refer these complaints to peer review.

If so, then you are immediately bound by those rules of confidentiality. If you don’t refer the case, then you could inform the PCP that you have heard a complaint involving Dr. Nogood and that PCP’s patient.

I can’t see how that would violate HIPAA, because the PCP has an established relationship with that patient, and you might be only reporting facts (the complaint), not passing judgment on the quality of care. And I would not even go that far.

Why stop there? Why not tell that PCP exactly what you think of Dr. Nogood and his clinical practice, the details of the complaints against him, and how you think maybe that PCP should send his patients to someone else for better care? Well, you’re the CMO for the hospital. If you go beyond reporting facts and start reporting opinions, then you’ve just opened yourself up to accusations of restraint of trade by Dr. Nogood.

No matter what you may think of Dr. Nogood’s patient care, unless it falls outside the boundaries of acceptable practice (which can only be determined by a peer review committee), then you should not say anything.

Unless, of course, you want to be accused of spreading rumors, hearsay, and innuendo. Remember, we are talking about an independent practitioner, not a hospital employee.

Overall, it’s a bit of a sticky wicket. If you think the complaint has merit, then it should be sent to peer review—and you may speak no more of it. If you think the complaint is baseless, then why sustain it and tell the PCP?

Peer review is an exceptional process, and the physicians who serve on such committees perform a difficult and selfless service. We should all do our best to uphold its integrity.

I recently became chief medical officer (CMO) of our hospital. When a hospitalist’s case comes to our patient-care committee, is it appropriate to inform the patient’s primary-care physician (PCP) of the quality issues? Our hospitalists are independent. There are questions of HIPAA. However, several committee members feel that the PCP, who does not come to the hospital, should be informed. Thank you.

K.A., M.D.

Dr. Hospitalist responds:

Good question. While I’ve participated in similar scenarios, keep in mind that I’m a hospitalist like you, not a lawyer. So, with that rejoinder in mind, let’s take this discussion a few steps further and see what happens.

You state: “when a hospitalist’s case comes to our patient-care committee.” Does that mean peer review? If it does, and what you are describing is a committee that handles privileged and confidential information, then you cannot inform the PCP because you would be violating the basic tenets of peer review.

The principle behind peer review is that it allows physicians to confidentially review the cases of their peers. This is to prevent the information contained in peer review from becoming available to a lawyer by subpoena or by discovery in the courts. The Joint Commission has mandated hospital peer review committees since 1952, and the federal government included language regarding peer-review protection in the Health Care Quality Improvement Act of 1986.

Every state has a law on the books, but the specifics and effectiveness of peer review will vary from state to state (see Florida’s Amendment 7, Kentucky, and Massachusetts). The whole idea is to allow for a process to evaluate physician practice or quality concerns without the fear of discovery or subsequent lawsuit. Even the act of referring a case to peer review is considered a confidential action in my state, so just the referral itself may not be discussed. So if you are referring to peer review, the answer is no, you cannot inform the patient’s PCP. HIPAA does not come into the picture here.

On the other hand, let’s assume, for sake of discussion, that you’ve heard a complaint (or several) about a certain hospitalist, Dr. Nogood. You could, if you desired, refer these complaints to peer review.

If so, then you are immediately bound by those rules of confidentiality. If you don’t refer the case, then you could inform the PCP that you have heard a complaint involving Dr. Nogood and that PCP’s patient.

I can’t see how that would violate HIPAA, because the PCP has an established relationship with that patient, and you might be only reporting facts (the complaint), not passing judgment on the quality of care. And I would not even go that far.

Why stop there? Why not tell that PCP exactly what you think of Dr. Nogood and his clinical practice, the details of the complaints against him, and how you think maybe that PCP should send his patients to someone else for better care? Well, you’re the CMO for the hospital. If you go beyond reporting facts and start reporting opinions, then you’ve just opened yourself up to accusations of restraint of trade by Dr. Nogood.

No matter what you may think of Dr. Nogood’s patient care, unless it falls outside the boundaries of acceptable practice (which can only be determined by a peer review committee), then you should not say anything.

Unless, of course, you want to be accused of spreading rumors, hearsay, and innuendo. Remember, we are talking about an independent practitioner, not a hospital employee.

Overall, it’s a bit of a sticky wicket. If you think the complaint has merit, then it should be sent to peer review—and you may speak no more of it. If you think the complaint is baseless, then why sustain it and tell the PCP?

Peer review is an exceptional process, and the physicians who serve on such committees perform a difficult and selfless service. We should all do our best to uphold its integrity.

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SAN FRANCISCO – Several areas of active research are improving the outlook for adults with acute lymphoblastic leukemia, Dr. Partow Kebriaei told attendees of the annual Oncology Congress here.

Investigators are exploring the impact of treatment intensification, stem cell transplantation, use of minimal residual disease to guide therapy, and a host of new agents, according to Dr. Kebriaei of the department of stem cell transplantation and cellular therapy at the University of Texas M.D. Anderson Cancer Center, Houston.

More effective and less toxic treatments are especially needed in this age group, she explained at the congress, which is presented by Reed Medical Education. "We have had great success in eradicating acute lymphoblastic leukemia (ALL) in children but still have a ways to go in adults," Dr. Kebraiei said.

In particular, although both incidence and mortality increase sharply over the age of 50 years, the median age of enrollees in major ALL adult trials has been 30-40 years. "So one thing that we need to think about as we devise more new therapies is how to make them more tolerable or relevant to the older patient," she commented.

Intensified Treatment for Young Adults

The observation that younger adults with ALL, up to the age of 40, have better long-term remission when treated with the more intensive pediatric regimens vs. adult regimens has raised interest in this approach for adults generally, Dr. Kebriaei noted.

A trial of intensified chemotherapy in adults found a significantly better response rate, event-free survival, and overall survival compared with outcomes seen historically with standard-intensity chemotherapy (J. Clin. Oncol. 2009;27:911-8).

But in age-stratified analyses, any survival benefit among patients older than 45 was offset by higher treatment-related mortality. "So, for that older subgroup, treatment intensification still does not really impact outcome favorably," she said.

Additionally, a caveat for the younger adults was that the trial allowed crossover to transplantation for patients having a donor. "So it’s a little bit difficult to ascertain whether these improved results are from the availability of transplant or the intensification of treatment," Dr. Kebriaei commented. "But, I think in general, one can conclude that treatment intensification is effective up to a certain age."

Stem Cell Transplantation

The International ALL Trial assessed the role of stem cell transplantation in adults with ALL in first complete remission. Patients younger than 55 years of age having a sibling donor were allocated to allogeneic transplantation, whereas older patients or those without a donor were randomized to autologous transplantation or chemotherapy.

Among patients not having the Philadelphia chromosome, which confers poorer prognosis, those with a donor were less likely to have a relapse than were those without a donor, whether they had standard- or high-risk disease (Blood 2008;111:1827-33). But treatment-related mortality was increased; it canceled out the relapse benefit in the high-risk group, so that in contrast to the standard-risk group, there was no net improvement in survival.

The higher treatment-related mortality was mainly due to higher rates of infection and graft-vs.-host disease. "So if we want transplant to afford a better outcome to all patients, we are going to have to impact these complications," Dr. Kebriaei maintained.

Of note, in additional trial analyses, chemotherapy was associated with significantly better event-free and overall survival than autologous transplantation.

Efforts to reduce the treatment-related mortality of transplantation include reduced-intensity conditioning regimens that, for example, omit total-body irradiation. Studies of this approach have indeed found that compared with the standard one including total-body irradiation, it achieves a lower rate of deaths due to treatment, and among patients transplanted in first remission, similar overall survival.

"But the most important thing is that if you look at the median age of patients [in these studies], we are now approaching 55, which is more reflective of what we see in the clinic," she noted.

Use of MRD in Risk-Oriented Therapy

"Minimal residual disease [MRD] really defines a submicroscopic ALL and in patients that we would normally term as remission patients," Dr. Kebriaei explained. "It is evaluated by multichannel flow cytometry or PCR [polymerase chain reaction], and it’s really becoming one of the most significant prognostic markers that we have."

For example, in the International ALL Trial, persistent MRD after induction or early consolidation was significantly associated with an increased risk of relapse in patients receiving chemotherapy alone (Br. J. Haematol. 2010;148:80-9). Yet, that was not the whole story.

"Interestingly, here, when they looked at MRD in patients prior to going forward on allogeneic stem cell transplant, they did not see any impact of MRD," she noted. "They also didn’t see an impact of MRD in helping to predict which patients would develop CNS relapse."

Targeted Therapies

Several therapies that target tumors’ molecular vulnerabilities are being incorporated into the treatment of adult ALL to clinical benefit. "I think the most dramatic improvement has been seen with the use of tyrosine kinase inhibitors (TKIs) for the Philadelphia chromosome–positive subset," Dr. Kebriaei commented.

In trials, use of TKIs in these patients has led to higher rates of complete remission, transplantation eligibility, and survival without transplantation. "Now all of these trials allowed transplant as well, so it’s hard to ascertain how much of this impact is coming from more transplant eligibility and how much of it is coming from the impact of the TKIs," she cautioned.

The SWOG S0805 Intergroup trial, open to patients up 50 years old with newly diagnosed Philadelphia chromosome–positive ALL, is looking more closely at the issue, as well as the issue of using TKIs as maintenance therapy. Patients receive dasatinib (Sprycel)-containing induction therapy and, if they undergo transplantation, dasatinib thereafter as well.

In clinical practice, "there is great variation in practice patterns, ranging from providing no TKI in maintenance all the way up to providing 2 years of TKI," Dr. Kebriaei observed. "And unfortunately, there isn’t good data yet published to determine what the best approach will be."

A second targeted therapy being used is rituximab (Rituxan), for ALL expressing CD20, another poor prognostic marker. Adding rituximab to the hyper-CVAD regimen significantly improves survival for patients younger than 60 years (J. Clin. Oncol. 2010;28:3880-9). But in older patients, there was no survival benefit, in part because of increased induction-related mortality.

Novel Agents and Cellular Therapies

The Food and Drug Administration has approved three novel agents for ALL treatment: pegylated asparaginase (Oncaspar), clofarabine (Clolar), and nelarabine (Arranon), and has received a new drug application for liposomal vincristine (Marqibo).

Nelarabine, for example, is a prodrug of ara-G that achieves good response and survival rates in patients with relapsed T-cell ALL, with a dose-limiting toxicity of neurotoxicity. It is now being evaluated when added to hyper-CVAD up front for patients with T-cell ALL, according to Dr. Kebriaei.

The investigational agent inotuzumab ozogamicin, an anti-CD22 antibody conjugated to calicheamicin, achieves an overall response rate of 61% when used as monotherapy in a trial among patients with refractory ALL (Jabbour et al. ASCO 2011 meeting. Abstract 6507).

"Interestingly, almost half of these patients were then able to go on to transplant in complete remission," she noted. Adverse effects included hepatotoxicity and veno-occlusive disease.

Another investigational antibody, blinatumomab, redirects T cells toward lysis of CD19-expressing cells and has been found to achieve complete remission in 13 of 16 patients with precursor B-ALL having persistent MRD (Topp et al. ASH 2009 meeting. Abstract 840).

A final novel strategy being tested is cellular therapy using chimeric antigen receptors (CARs), which are produced by fusing an extracellular single-chain antibody to an intracellular signaling domain. When expressed in T cells, these receptors redirect the cells’ antigen recognition toward a desired target, such as CD19.

"What’s very effective and interesting about this CAR strategy is that it doesn’t rely on preexisting antitumor immunity to generate an antitumor effector response," Dr. Kebriaei noted. "This is particularly important in the setting of ALL, where you have immune dysfunction."

Trials are assessing the use of CARs in the setting of stem cell transplantation, whereby donor T cells are transduced with anti-CD19 CARs and given as a targeted donor lymphocyte infusion.

"Perhaps by incorporating these targeted therapies and cellular therapies with the traditional cytotoxic therapies, we may be able to improve treatment outcomes without adding toxicity," concluded Dr. Kebriaei, who reported having no conflicts of interest related to her presentation.

The Oncology Congress is presented by Reed Medical Education. Reed Medical Education and this news organization are owned by Reed Elsevier Inc.

SAN FRANCISCO – Several areas of active research are improving the outlook for adults with acute lymphoblastic leukemia, Dr. Partow Kebriaei told attendees of the annual Oncology Congress here.

Investigators are exploring the impact of treatment intensification, stem cell transplantation, use of minimal residual disease to guide therapy, and a host of new agents, according to Dr. Kebriaei of the department of stem cell transplantation and cellular therapy at the University of Texas M.D. Anderson Cancer Center, Houston.

More effective and less toxic treatments are especially needed in this age group, she explained at the congress, which is presented by Reed Medical Education. "We have had great success in eradicating acute lymphoblastic leukemia (ALL) in children but still have a ways to go in adults," Dr. Kebraiei said.

In particular, although both incidence and mortality increase sharply over the age of 50 years, the median age of enrollees in major ALL adult trials has been 30-40 years. "So one thing that we need to think about as we devise more new therapies is how to make them more tolerable or relevant to the older patient," she commented.

Intensified Treatment for Young Adults

The observation that younger adults with ALL, up to the age of 40, have better long-term remission when treated with the more intensive pediatric regimens vs. adult regimens has raised interest in this approach for adults generally, Dr. Kebriaei noted.

A trial of intensified chemotherapy in adults found a significantly better response rate, event-free survival, and overall survival compared with outcomes seen historically with standard-intensity chemotherapy (J. Clin. Oncol. 2009;27:911-8).

But in age-stratified analyses, any survival benefit among patients older than 45 was offset by higher treatment-related mortality. "So, for that older subgroup, treatment intensification still does not really impact outcome favorably," she said.

Additionally, a caveat for the younger adults was that the trial allowed crossover to transplantation for patients having a donor. "So it’s a little bit difficult to ascertain whether these improved results are from the availability of transplant or the intensification of treatment," Dr. Kebriaei commented. "But, I think in general, one can conclude that treatment intensification is effective up to a certain age."

Stem Cell Transplantation

The International ALL Trial assessed the role of stem cell transplantation in adults with ALL in first complete remission. Patients younger than 55 years of age having a sibling donor were allocated to allogeneic transplantation, whereas older patients or those without a donor were randomized to autologous transplantation or chemotherapy.

Among patients not having the Philadelphia chromosome, which confers poorer prognosis, those with a donor were less likely to have a relapse than were those without a donor, whether they had standard- or high-risk disease (Blood 2008;111:1827-33). But treatment-related mortality was increased; it canceled out the relapse benefit in the high-risk group, so that in contrast to the standard-risk group, there was no net improvement in survival.

The higher treatment-related mortality was mainly due to higher rates of infection and graft-vs.-host disease. "So if we want transplant to afford a better outcome to all patients, we are going to have to impact these complications," Dr. Kebriaei maintained.

Of note, in additional trial analyses, chemotherapy was associated with significantly better event-free and overall survival than autologous transplantation.

Efforts to reduce the treatment-related mortality of transplantation include reduced-intensity conditioning regimens that, for example, omit total-body irradiation. Studies of this approach have indeed found that compared with the standard one including total-body irradiation, it achieves a lower rate of deaths due to treatment, and among patients transplanted in first remission, similar overall survival.

"But the most important thing is that if you look at the median age of patients [in these studies], we are now approaching 55, which is more reflective of what we see in the clinic," she noted.

Use of MRD in Risk-Oriented Therapy

"Minimal residual disease [MRD] really defines a submicroscopic ALL and in patients that we would normally term as remission patients," Dr. Kebriaei explained. "It is evaluated by multichannel flow cytometry or PCR [polymerase chain reaction], and it’s really becoming one of the most significant prognostic markers that we have."

For example, in the International ALL Trial, persistent MRD after induction or early consolidation was significantly associated with an increased risk of relapse in patients receiving chemotherapy alone (Br. J. Haematol. 2010;148:80-9). Yet, that was not the whole story.

"Interestingly, here, when they looked at MRD in patients prior to going forward on allogeneic stem cell transplant, they did not see any impact of MRD," she noted. "They also didn’t see an impact of MRD in helping to predict which patients would develop CNS relapse."

Targeted Therapies

Several therapies that target tumors’ molecular vulnerabilities are being incorporated into the treatment of adult ALL to clinical benefit. "I think the most dramatic improvement has been seen with the use of tyrosine kinase inhibitors (TKIs) for the Philadelphia chromosome–positive subset," Dr. Kebriaei commented.

In trials, use of TKIs in these patients has led to higher rates of complete remission, transplantation eligibility, and survival without transplantation. "Now all of these trials allowed transplant as well, so it’s hard to ascertain how much of this impact is coming from more transplant eligibility and how much of it is coming from the impact of the TKIs," she cautioned.

The SWOG S0805 Intergroup trial, open to patients up 50 years old with newly diagnosed Philadelphia chromosome–positive ALL, is looking more closely at the issue, as well as the issue of using TKIs as maintenance therapy. Patients receive dasatinib (Sprycel)-containing induction therapy and, if they undergo transplantation, dasatinib thereafter as well.

In clinical practice, "there is great variation in practice patterns, ranging from providing no TKI in maintenance all the way up to providing 2 years of TKI," Dr. Kebriaei observed. "And unfortunately, there isn’t good data yet published to determine what the best approach will be."

A second targeted therapy being used is rituximab (Rituxan), for ALL expressing CD20, another poor prognostic marker. Adding rituximab to the hyper-CVAD regimen significantly improves survival for patients younger than 60 years (J. Clin. Oncol. 2010;28:3880-9). But in older patients, there was no survival benefit, in part because of increased induction-related mortality.

Novel Agents and Cellular Therapies

The Food and Drug Administration has approved three novel agents for ALL treatment: pegylated asparaginase (Oncaspar), clofarabine (Clolar), and nelarabine (Arranon), and has received a new drug application for liposomal vincristine (Marqibo).

Nelarabine, for example, is a prodrug of ara-G that achieves good response and survival rates in patients with relapsed T-cell ALL, with a dose-limiting toxicity of neurotoxicity. It is now being evaluated when added to hyper-CVAD up front for patients with T-cell ALL, according to Dr. Kebriaei.

The investigational agent inotuzumab ozogamicin, an anti-CD22 antibody conjugated to calicheamicin, achieves an overall response rate of 61% when used as monotherapy in a trial among patients with refractory ALL (Jabbour et al. ASCO 2011 meeting. Abstract 6507).

"Interestingly, almost half of these patients were then able to go on to transplant in complete remission," she noted. Adverse effects included hepatotoxicity and veno-occlusive disease.

Another investigational antibody, blinatumomab, redirects T cells toward lysis of CD19-expressing cells and has been found to achieve complete remission in 13 of 16 patients with precursor B-ALL having persistent MRD (Topp et al. ASH 2009 meeting. Abstract 840).

A final novel strategy being tested is cellular therapy using chimeric antigen receptors (CARs), which are produced by fusing an extracellular single-chain antibody to an intracellular signaling domain. When expressed in T cells, these receptors redirect the cells’ antigen recognition toward a desired target, such as CD19.

"What’s very effective and interesting about this CAR strategy is that it doesn’t rely on preexisting antitumor immunity to generate an antitumor effector response," Dr. Kebriaei noted. "This is particularly important in the setting of ALL, where you have immune dysfunction."

Trials are assessing the use of CARs in the setting of stem cell transplantation, whereby donor T cells are transduced with anti-CD19 CARs and given as a targeted donor lymphocyte infusion.

"Perhaps by incorporating these targeted therapies and cellular therapies with the traditional cytotoxic therapies, we may be able to improve treatment outcomes without adding toxicity," concluded Dr. Kebriaei, who reported having no conflicts of interest related to her presentation.

The Oncology Congress is presented by Reed Medical Education. Reed Medical Education and this news organization are owned by Reed Elsevier Inc.

SAN FRANCISCO – Several areas of active research are improving the outlook for adults with acute lymphoblastic leukemia, Dr. Partow Kebriaei told attendees of the annual Oncology Congress here.

Investigators are exploring the impact of treatment intensification, stem cell transplantation, use of minimal residual disease to guide therapy, and a host of new agents, according to Dr. Kebriaei of the department of stem cell transplantation and cellular therapy at the University of Texas M.D. Anderson Cancer Center, Houston.

More effective and less toxic treatments are especially needed in this age group, she explained at the congress, which is presented by Reed Medical Education. "We have had great success in eradicating acute lymphoblastic leukemia (ALL) in children but still have a ways to go in adults," Dr. Kebraiei said.

In particular, although both incidence and mortality increase sharply over the age of 50 years, the median age of enrollees in major ALL adult trials has been 30-40 years. "So one thing that we need to think about as we devise more new therapies is how to make them more tolerable or relevant to the older patient," she commented.

Intensified Treatment for Young Adults

The observation that younger adults with ALL, up to the age of 40, have better long-term remission when treated with the more intensive pediatric regimens vs. adult regimens has raised interest in this approach for adults generally, Dr. Kebriaei noted.

A trial of intensified chemotherapy in adults found a significantly better response rate, event-free survival, and overall survival compared with outcomes seen historically with standard-intensity chemotherapy (J. Clin. Oncol. 2009;27:911-8).

But in age-stratified analyses, any survival benefit among patients older than 45 was offset by higher treatment-related mortality. "So, for that older subgroup, treatment intensification still does not really impact outcome favorably," she said.

Additionally, a caveat for the younger adults was that the trial allowed crossover to transplantation for patients having a donor. "So it’s a little bit difficult to ascertain whether these improved results are from the availability of transplant or the intensification of treatment," Dr. Kebriaei commented. "But, I think in general, one can conclude that treatment intensification is effective up to a certain age."

Stem Cell Transplantation

The International ALL Trial assessed the role of stem cell transplantation in adults with ALL in first complete remission. Patients younger than 55 years of age having a sibling donor were allocated to allogeneic transplantation, whereas older patients or those without a donor were randomized to autologous transplantation or chemotherapy.

Among patients not having the Philadelphia chromosome, which confers poorer prognosis, those with a donor were less likely to have a relapse than were those without a donor, whether they had standard- or high-risk disease (Blood 2008;111:1827-33). But treatment-related mortality was increased; it canceled out the relapse benefit in the high-risk group, so that in contrast to the standard-risk group, there was no net improvement in survival.

The higher treatment-related mortality was mainly due to higher rates of infection and graft-vs.-host disease. "So if we want transplant to afford a better outcome to all patients, we are going to have to impact these complications," Dr. Kebriaei maintained.

Of note, in additional trial analyses, chemotherapy was associated with significantly better event-free and overall survival than autologous transplantation.

Efforts to reduce the treatment-related mortality of transplantation include reduced-intensity conditioning regimens that, for example, omit total-body irradiation. Studies of this approach have indeed found that compared with the standard one including total-body irradiation, it achieves a lower rate of deaths due to treatment, and among patients transplanted in first remission, similar overall survival.

"But the most important thing is that if you look at the median age of patients [in these studies], we are now approaching 55, which is more reflective of what we see in the clinic," she noted.

Use of MRD in Risk-Oriented Therapy

"Minimal residual disease [MRD] really defines a submicroscopic ALL and in patients that we would normally term as remission patients," Dr. Kebriaei explained. "It is evaluated by multichannel flow cytometry or PCR [polymerase chain reaction], and it’s really becoming one of the most significant prognostic markers that we have."

For example, in the International ALL Trial, persistent MRD after induction or early consolidation was significantly associated with an increased risk of relapse in patients receiving chemotherapy alone (Br. J. Haematol. 2010;148:80-9). Yet, that was not the whole story.

"Interestingly, here, when they looked at MRD in patients prior to going forward on allogeneic stem cell transplant, they did not see any impact of MRD," she noted. "They also didn’t see an impact of MRD in helping to predict which patients would develop CNS relapse."

Targeted Therapies

Several therapies that target tumors’ molecular vulnerabilities are being incorporated into the treatment of adult ALL to clinical benefit. "I think the most dramatic improvement has been seen with the use of tyrosine kinase inhibitors (TKIs) for the Philadelphia chromosome–positive subset," Dr. Kebriaei commented.

In trials, use of TKIs in these patients has led to higher rates of complete remission, transplantation eligibility, and survival without transplantation. "Now all of these trials allowed transplant as well, so it’s hard to ascertain how much of this impact is coming from more transplant eligibility and how much of it is coming from the impact of the TKIs," she cautioned.

The SWOG S0805 Intergroup trial, open to patients up 50 years old with newly diagnosed Philadelphia chromosome–positive ALL, is looking more closely at the issue, as well as the issue of using TKIs as maintenance therapy. Patients receive dasatinib (Sprycel)-containing induction therapy and, if they undergo transplantation, dasatinib thereafter as well.

In clinical practice, "there is great variation in practice patterns, ranging from providing no TKI in maintenance all the way up to providing 2 years of TKI," Dr. Kebriaei observed. "And unfortunately, there isn’t good data yet published to determine what the best approach will be."

A second targeted therapy being used is rituximab (Rituxan), for ALL expressing CD20, another poor prognostic marker. Adding rituximab to the hyper-CVAD regimen significantly improves survival for patients younger than 60 years (J. Clin. Oncol. 2010;28:3880-9). But in older patients, there was no survival benefit, in part because of increased induction-related mortality.

Novel Agents and Cellular Therapies

The Food and Drug Administration has approved three novel agents for ALL treatment: pegylated asparaginase (Oncaspar), clofarabine (Clolar), and nelarabine (Arranon), and has received a new drug application for liposomal vincristine (Marqibo).

Nelarabine, for example, is a prodrug of ara-G that achieves good response and survival rates in patients with relapsed T-cell ALL, with a dose-limiting toxicity of neurotoxicity. It is now being evaluated when added to hyper-CVAD up front for patients with T-cell ALL, according to Dr. Kebriaei.

The investigational agent inotuzumab ozogamicin, an anti-CD22 antibody conjugated to calicheamicin, achieves an overall response rate of 61% when used as monotherapy in a trial among patients with refractory ALL (Jabbour et al. ASCO 2011 meeting. Abstract 6507).

"Interestingly, almost half of these patients were then able to go on to transplant in complete remission," she noted. Adverse effects included hepatotoxicity and veno-occlusive disease.

Another investigational antibody, blinatumomab, redirects T cells toward lysis of CD19-expressing cells and has been found to achieve complete remission in 13 of 16 patients with precursor B-ALL having persistent MRD (Topp et al. ASH 2009 meeting. Abstract 840).

A final novel strategy being tested is cellular therapy using chimeric antigen receptors (CARs), which are produced by fusing an extracellular single-chain antibody to an intracellular signaling domain. When expressed in T cells, these receptors redirect the cells’ antigen recognition toward a desired target, such as CD19.

"What’s very effective and interesting about this CAR strategy is that it doesn’t rely on preexisting antitumor immunity to generate an antitumor effector response," Dr. Kebriaei noted. "This is particularly important in the setting of ALL, where you have immune dysfunction."

Trials are assessing the use of CARs in the setting of stem cell transplantation, whereby donor T cells are transduced with anti-CD19 CARs and given as a targeted donor lymphocyte infusion.

"Perhaps by incorporating these targeted therapies and cellular therapies with the traditional cytotoxic therapies, we may be able to improve treatment outcomes without adding toxicity," concluded Dr. Kebriaei, who reported having no conflicts of interest related to her presentation.

The Oncology Congress is presented by Reed Medical Education. Reed Medical Education and this news organization are owned by Reed Elsevier Inc.

An analysis of long-term outcomes for elderly patients with advanced hematologic malignancies suggests they do as well as younger patients when treated with allogeneic hematopoietic cell transplantation following nonmyeloablative conditioning.

In patients aged 60-75 years, the protocol yielded a 5-year overall survival rate of 35% and a progression-free survival rate of 32%, according to a report in the Nov. 2 issue of JAMA. The overall 5-year survival rate was as high as 69% among the patients who had the lowest comorbidity scores and lowest disease risk.

Half of these older patients never required hospitalization either during or after treatment, and two-thirds of the survivors returned to normal or near-normal physical functioning, said Dr. Mohamed L. Sorror of the transplantation biology program at the Fred Hutchinson Cancer Research Center, Seattle, and his associates.

"These results are encouraging given the poor outcomes with nontransplantation treatments, especially for patients with high-risk acute myeloid leukemia, fludarabine-refractory chronic lymphocytic leukemia, or progressive lymphoma," the investigators noted. They assessed outcomes in 372 patients aged 60-75 years who were enrolled in prospective clinical trials of the therapy at 18 medical centers in 1998-2008. The study subjects were being treated for hematologic malignancies including leukemia, myelodysplastic syndromes, myeloproliferative diseases, multiple myeloma, and lymphoma.

Since older patients are not eligible for the intense cytotoxic conditioning regimens that precede high-dose allogeneic hematopoietic cell transplantation, these patients instead underwent nonmyeloablative conditioning that relies on graft-versus-tumor effects to cure the cancer. This included fludarabine and a low dose of total-body irradiation before transplantation and a course of immunosuppression with mycophenolate mofetil and a calcineurin inhibitor (cyclosporine or tacrolimus) afterward.

"These findings should help allay reluctance in entering older patients with hematologic cancers in non- myeloablative [transplant] protocols."

After a median follow-up of 55 months (range, 12-133 months), 133 patients were still alive. Overall 5-year survival was 35%, and 5-year progression-free survival was 32%.

When the data were analyzed by patient age, 5-year overall survival was 38% for those aged 60-64 years, 33% for those aged 65-69, and 25% for those aged 70 and older. "Regardless of age, 5-year survivals ranged from 23% in patients with high comorbidity scores and high disease risk to 69% in patients with low comorbidity scores and low disease risk," Dr. Sorror and his colleagues said (JAMA 2011;306:1874-83).

Approximately two-thirds of the survivors at 5 years had complete resolution of their graft-versus-host disease (GVHD) symptoms and were able to discontinue immunosuppressive medications after a median of 2.5 years. Both the incidence and the resolution of GVHD in these older study subjects were comparable to those reported in the literature for younger patients treated with high-dose hematopoietic cell transplantation.

"These findings, together with the normal to near-normal performance status of surviving patients, should help allay reluctance in entering older patients with hematologic cancers in nonmyeloablative [transplant] protocols," the researchers noted.

Disease progression and relapse accounted for most (135) of the 239 deaths. Relapse rates were 33% at 1 year and 41% at 5 years. Most nonrelapse deaths were attributed to multiple organ failure, GVHD, and infections.

Dr. Sorror and his associates noted that hematologic malignancies are predominantly diseases of the elderly, and the incidence is expected to increase up to 77% during the next 20 years, due in part to the aging of the general population. Yet the latest figures show that only 12% of patients treated with hematopoietic cell transplantation in recent years were older than 60 years.

"This clearly highlights the reluctance of physicians to offer allogeneic hematopoietic cell transplantation to elderly patients," they said.

The investigators are now starting a multicenter longitudinal study to follow such patients from diagnosis onward, in the hope of elucidating "the reasons behind the low rate of referral of older patients to transplantation, [as well as] how nonmyeloablative [transplantation] outcomes compare with those after conventional therapies."

This study was supported by the National Institutes of Health and the Leukemia & Lymphoma Society. Dr. Sorror’s associates reported numerous ties to industry sources.

An analysis of long-term outcomes for elderly patients with advanced hematologic malignancies suggests they do as well as younger patients when treated with allogeneic hematopoietic cell transplantation following nonmyeloablative conditioning.

In patients aged 60-75 years, the protocol yielded a 5-year overall survival rate of 35% and a progression-free survival rate of 32%, according to a report in the Nov. 2 issue of JAMA. The overall 5-year survival rate was as high as 69% among the patients who had the lowest comorbidity scores and lowest disease risk.

Half of these older patients never required hospitalization either during or after treatment, and two-thirds of the survivors returned to normal or near-normal physical functioning, said Dr. Mohamed L. Sorror of the transplantation biology program at the Fred Hutchinson Cancer Research Center, Seattle, and his associates.

"These results are encouraging given the poor outcomes with nontransplantation treatments, especially for patients with high-risk acute myeloid leukemia, fludarabine-refractory chronic lymphocytic leukemia, or progressive lymphoma," the investigators noted. They assessed outcomes in 372 patients aged 60-75 years who were enrolled in prospective clinical trials of the therapy at 18 medical centers in 1998-2008. The study subjects were being treated for hematologic malignancies including leukemia, myelodysplastic syndromes, myeloproliferative diseases, multiple myeloma, and lymphoma.

Since older patients are not eligible for the intense cytotoxic conditioning regimens that precede high-dose allogeneic hematopoietic cell transplantation, these patients instead underwent nonmyeloablative conditioning that relies on graft-versus-tumor effects to cure the cancer. This included fludarabine and a low dose of total-body irradiation before transplantation and a course of immunosuppression with mycophenolate mofetil and a calcineurin inhibitor (cyclosporine or tacrolimus) afterward.

"These findings should help allay reluctance in entering older patients with hematologic cancers in non- myeloablative [transplant] protocols."

After a median follow-up of 55 months (range, 12-133 months), 133 patients were still alive. Overall 5-year survival was 35%, and 5-year progression-free survival was 32%.

When the data were analyzed by patient age, 5-year overall survival was 38% for those aged 60-64 years, 33% for those aged 65-69, and 25% for those aged 70 and older. "Regardless of age, 5-year survivals ranged from 23% in patients with high comorbidity scores and high disease risk to 69% in patients with low comorbidity scores and low disease risk," Dr. Sorror and his colleagues said (JAMA 2011;306:1874-83).

Approximately two-thirds of the survivors at 5 years had complete resolution of their graft-versus-host disease (GVHD) symptoms and were able to discontinue immunosuppressive medications after a median of 2.5 years. Both the incidence and the resolution of GVHD in these older study subjects were comparable to those reported in the literature for younger patients treated with high-dose hematopoietic cell transplantation.

"These findings, together with the normal to near-normal performance status of surviving patients, should help allay reluctance in entering older patients with hematologic cancers in nonmyeloablative [transplant] protocols," the researchers noted.

Disease progression and relapse accounted for most (135) of the 239 deaths. Relapse rates were 33% at 1 year and 41% at 5 years. Most nonrelapse deaths were attributed to multiple organ failure, GVHD, and infections.

Dr. Sorror and his associates noted that hematologic malignancies are predominantly diseases of the elderly, and the incidence is expected to increase up to 77% during the next 20 years, due in part to the aging of the general population. Yet the latest figures show that only 12% of patients treated with hematopoietic cell transplantation in recent years were older than 60 years.

"This clearly highlights the reluctance of physicians to offer allogeneic hematopoietic cell transplantation to elderly patients," they said.

The investigators are now starting a multicenter longitudinal study to follow such patients from diagnosis onward, in the hope of elucidating "the reasons behind the low rate of referral of older patients to transplantation, [as well as] how nonmyeloablative [transplantation] outcomes compare with those after conventional therapies."

This study was supported by the National Institutes of Health and the Leukemia & Lymphoma Society. Dr. Sorror’s associates reported numerous ties to industry sources.

An analysis of long-term outcomes for elderly patients with advanced hematologic malignancies suggests they do as well as younger patients when treated with allogeneic hematopoietic cell transplantation following nonmyeloablative conditioning.

In patients aged 60-75 years, the protocol yielded a 5-year overall survival rate of 35% and a progression-free survival rate of 32%, according to a report in the Nov. 2 issue of JAMA. The overall 5-year survival rate was as high as 69% among the patients who had the lowest comorbidity scores and lowest disease risk.

Half of these older patients never required hospitalization either during or after treatment, and two-thirds of the survivors returned to normal or near-normal physical functioning, said Dr. Mohamed L. Sorror of the transplantation biology program at the Fred Hutchinson Cancer Research Center, Seattle, and his associates.

"These results are encouraging given the poor outcomes with nontransplantation treatments, especially for patients with high-risk acute myeloid leukemia, fludarabine-refractory chronic lymphocytic leukemia, or progressive lymphoma," the investigators noted. They assessed outcomes in 372 patients aged 60-75 years who were enrolled in prospective clinical trials of the therapy at 18 medical centers in 1998-2008. The study subjects were being treated for hematologic malignancies including leukemia, myelodysplastic syndromes, myeloproliferative diseases, multiple myeloma, and lymphoma.

Since older patients are not eligible for the intense cytotoxic conditioning regimens that precede high-dose allogeneic hematopoietic cell transplantation, these patients instead underwent nonmyeloablative conditioning that relies on graft-versus-tumor effects to cure the cancer. This included fludarabine and a low dose of total-body irradiation before transplantation and a course of immunosuppression with mycophenolate mofetil and a calcineurin inhibitor (cyclosporine or tacrolimus) afterward.

"These findings should help allay reluctance in entering older patients with hematologic cancers in non- myeloablative [transplant] protocols."

After a median follow-up of 55 months (range, 12-133 months), 133 patients were still alive. Overall 5-year survival was 35%, and 5-year progression-free survival was 32%.

When the data were analyzed by patient age, 5-year overall survival was 38% for those aged 60-64 years, 33% for those aged 65-69, and 25% for those aged 70 and older. "Regardless of age, 5-year survivals ranged from 23% in patients with high comorbidity scores and high disease risk to 69% in patients with low comorbidity scores and low disease risk," Dr. Sorror and his colleagues said (JAMA 2011;306:1874-83).

Approximately two-thirds of the survivors at 5 years had complete resolution of their graft-versus-host disease (GVHD) symptoms and were able to discontinue immunosuppressive medications after a median of 2.5 years. Both the incidence and the resolution of GVHD in these older study subjects were comparable to those reported in the literature for younger patients treated with high-dose hematopoietic cell transplantation.

"These findings, together with the normal to near-normal performance status of surviving patients, should help allay reluctance in entering older patients with hematologic cancers in nonmyeloablative [transplant] protocols," the researchers noted.

Disease progression and relapse accounted for most (135) of the 239 deaths. Relapse rates were 33% at 1 year and 41% at 5 years. Most nonrelapse deaths were attributed to multiple organ failure, GVHD, and infections.

Dr. Sorror and his associates noted that hematologic malignancies are predominantly diseases of the elderly, and the incidence is expected to increase up to 77% during the next 20 years, due in part to the aging of the general population. Yet the latest figures show that only 12% of patients treated with hematopoietic cell transplantation in recent years were older than 60 years.

"This clearly highlights the reluctance of physicians to offer allogeneic hematopoietic cell transplantation to elderly patients," they said.

The investigators are now starting a multicenter longitudinal study to follow such patients from diagnosis onward, in the hope of elucidating "the reasons behind the low rate of referral of older patients to transplantation, [as well as] how nonmyeloablative [transplantation] outcomes compare with those after conventional therapies."

This study was supported by the National Institutes of Health and the Leukemia & Lymphoma Society. Dr. Sorror’s associates reported numerous ties to industry sources.