More than 200 hospitalists today took advantage of a unique opportunity to represent SHM and their institutions by advocating for physicians and patients as part of the annual  “Hospitalists on the Hill.” The initiative provided education and coaching, talking points, and advice on how to influence the political process and the direction of our health care system.

Hospitalists then had meetings on Capitol Hill with elected representatives from their respective districts. Hospitalists were armed with packets of information containing detailed information on the issues pertinent to hospitalists and their patients. The three major issues to be discussed with legislators and their staff members included the following:

• Repeal of the SGR (H.R. 574), which now dictates a 24% reduction in Medicare reimbursement (if implemented/not rescinded); The Medicare Physician Payment Innovation Act of 2013 fully repeals the SGR, stabilizes current payment rates, eliminates scheduled SGR cuts, creates updates for undervalued primary, preventive, inpatient E&M and coordinated care services, and sets out a clear path toward comprehensive payment reform.
• Medicare Observation Status and the Three-Day Rule (H.R. 1179, S.569), which requires three consecutive overnights as an inpatient in order to qualify for Medicare benefits at a skilled nursing facility (SNF). This bill (Improving Access to Medicare Coverage Act of 2013) would adjust Medicare rules to allow observation status days to count toward the three-day inpatient rule for coverage of SNF care. There is also some discussion about eliminating observation status altogether.
• Commitment to QI and AHRQ funding; AHRQ is the only federal agency concerned with improving health care services, and does so by providing evidence-based information about the measures and standards that result or reflect true quality. SHM urges Congress to provide $434 million for AHRQ in FY 2014, in order to continue important work in improving the safety, quality, efficiency, and effectiveness of health care for all Americans.

Ron Greeno, MD, FCCP, MHM, chair of SHM’s Public Policy Committee encouraged Hill-goers, commenting that advocacy is “meaningful work,” and that this year’s training sessions were the most formalized and detailed that had been provided thus far for hospitalists with respect to prior Hill Days.

Laura Allendorf, senior advisor for SHM Advocacy and Government Affairs, said that face-to-face visits by constituents (especially busy physicians who are taking time away from work) have significant impact, and urged hospitalists to use this opportunity to further the hospitalists’ message of our specialty’s importance in the delivery of healthcare in today’s environment. As the fastest growing discipline in medicine, she reiterated the importance of the hospitalist’s role in communicating our focus on quality care and highlighted the impact the organization has already made in communicating our “non-self-serving messages,” in helping our leaders in Washington make informed decisions about what health care will look like in the future.

Former legislative staffer Stephanie D. Vance, of Advocacy Associates, LLC, helped crystallize specific points about the political process and “how Washington works—or doesn’t.” For example:

• Out of the approximately 10,000 bills introduced each year, about 2,500 have to do with healthcare;
• Of the approximately 4% of bills that are ultimately passed, about 1/3 are concerned with renaming post offices and federal buildings;
• The primary influential factor in advocacy is a personal visit with a constituent (not a lobbyist).

Vance encouraged hospitalists to use their experience to communicate personal patient-related stories to have greater impact, and to explain the relevance of the story to the bill and how it relates to their work as hospitalists. TH

Dr. Hunter is a member of Team Hospitalist.

More than 200 hospitalists today took advantage of a unique opportunity to represent SHM and their institutions by advocating for physicians and patients as part of the annual  “Hospitalists on the Hill.” The initiative provided education and coaching, talking points, and advice on how to influence the political process and the direction of our health care system.

Hospitalists then had meetings on Capitol Hill with elected representatives from their respective districts. Hospitalists were armed with packets of information containing detailed information on the issues pertinent to hospitalists and their patients. The three major issues to be discussed with legislators and their staff members included the following:

• Repeal of the SGR (H.R. 574), which now dictates a 24% reduction in Medicare reimbursement (if implemented/not rescinded); The Medicare Physician Payment Innovation Act of 2013 fully repeals the SGR, stabilizes current payment rates, eliminates scheduled SGR cuts, creates updates for undervalued primary, preventive, inpatient E&M and coordinated care services, and sets out a clear path toward comprehensive payment reform.
• Medicare Observation Status and the Three-Day Rule (H.R. 1179, S.569), which requires three consecutive overnights as an inpatient in order to qualify for Medicare benefits at a skilled nursing facility (SNF). This bill (Improving Access to Medicare Coverage Act of 2013) would adjust Medicare rules to allow observation status days to count toward the three-day inpatient rule for coverage of SNF care. There is also some discussion about eliminating observation status altogether.
• Commitment to QI and AHRQ funding; AHRQ is the only federal agency concerned with improving health care services, and does so by providing evidence-based information about the measures and standards that result or reflect true quality. SHM urges Congress to provide $434 million for AHRQ in FY 2014, in order to continue important work in improving the safety, quality, efficiency, and effectiveness of health care for all Americans.

Ron Greeno, MD, FCCP, MHM, chair of SHM’s Public Policy Committee encouraged Hill-goers, commenting that advocacy is “meaningful work,” and that this year’s training sessions were the most formalized and detailed that had been provided thus far for hospitalists with respect to prior Hill Days.

Laura Allendorf, senior advisor for SHM Advocacy and Government Affairs, said that face-to-face visits by constituents (especially busy physicians who are taking time away from work) have significant impact, and urged hospitalists to use this opportunity to further the hospitalists’ message of our specialty’s importance in the delivery of healthcare in today’s environment. As the fastest growing discipline in medicine, she reiterated the importance of the hospitalist’s role in communicating our focus on quality care and highlighted the impact the organization has already made in communicating our “non-self-serving messages,” in helping our leaders in Washington make informed decisions about what health care will look like in the future.

Former legislative staffer Stephanie D. Vance, of Advocacy Associates, LLC, helped crystallize specific points about the political process and “how Washington works—or doesn’t.” For example:

• Out of the approximately 10,000 bills introduced each year, about 2,500 have to do with healthcare;
• Of the approximately 4% of bills that are ultimately passed, about 1/3 are concerned with renaming post offices and federal buildings;
• The primary influential factor in advocacy is a personal visit with a constituent (not a lobbyist).

Vance encouraged hospitalists to use their experience to communicate personal patient-related stories to have greater impact, and to explain the relevance of the story to the bill and how it relates to their work as hospitalists. TH

Dr. Hunter is a member of Team Hospitalist.

More than 200 hospitalists today took advantage of a unique opportunity to represent SHM and their institutions by advocating for physicians and patients as part of the annual  “Hospitalists on the Hill.” The initiative provided education and coaching, talking points, and advice on how to influence the political process and the direction of our health care system.

Hospitalists then had meetings on Capitol Hill with elected representatives from their respective districts. Hospitalists were armed with packets of information containing detailed information on the issues pertinent to hospitalists and their patients. The three major issues to be discussed with legislators and their staff members included the following:

• Repeal of the SGR (H.R. 574), which now dictates a 24% reduction in Medicare reimbursement (if implemented/not rescinded); The Medicare Physician Payment Innovation Act of 2013 fully repeals the SGR, stabilizes current payment rates, eliminates scheduled SGR cuts, creates updates for undervalued primary, preventive, inpatient E&M and coordinated care services, and sets out a clear path toward comprehensive payment reform.
• Medicare Observation Status and the Three-Day Rule (H.R. 1179, S.569), which requires three consecutive overnights as an inpatient in order to qualify for Medicare benefits at a skilled nursing facility (SNF). This bill (Improving Access to Medicare Coverage Act of 2013) would adjust Medicare rules to allow observation status days to count toward the three-day inpatient rule for coverage of SNF care. There is also some discussion about eliminating observation status altogether.
• Commitment to QI and AHRQ funding; AHRQ is the only federal agency concerned with improving health care services, and does so by providing evidence-based information about the measures and standards that result or reflect true quality. SHM urges Congress to provide $434 million for AHRQ in FY 2014, in order to continue important work in improving the safety, quality, efficiency, and effectiveness of health care for all Americans.

Ron Greeno, MD, FCCP, MHM, chair of SHM’s Public Policy Committee encouraged Hill-goers, commenting that advocacy is “meaningful work,” and that this year’s training sessions were the most formalized and detailed that had been provided thus far for hospitalists with respect to prior Hill Days.

Laura Allendorf, senior advisor for SHM Advocacy and Government Affairs, said that face-to-face visits by constituents (especially busy physicians who are taking time away from work) have significant impact, and urged hospitalists to use this opportunity to further the hospitalists’ message of our specialty’s importance in the delivery of healthcare in today’s environment. As the fastest growing discipline in medicine, she reiterated the importance of the hospitalist’s role in communicating our focus on quality care and highlighted the impact the organization has already made in communicating our “non-self-serving messages,” in helping our leaders in Washington make informed decisions about what health care will look like in the future.

Former legislative staffer Stephanie D. Vance, of Advocacy Associates, LLC, helped crystallize specific points about the political process and “how Washington works—or doesn’t.” For example:

• Out of the approximately 10,000 bills introduced each year, about 2,500 have to do with healthcare;
• Of the approximately 4% of bills that are ultimately passed, about 1/3 are concerned with renaming post offices and federal buildings;
• The primary influential factor in advocacy is a personal visit with a constituent (not a lobbyist).

Vance encouraged hospitalists to use their experience to communicate personal patient-related stories to have greater impact, and to explain the relevance of the story to the bill and how it relates to their work as hospitalists. TH

Dr. Hunter is a member of Team Hospitalist.

I attended the practice-management session with an intriguing title, “Hospitalist Workload: Is 15 the Right Number?” My own group, as I am sure many are, is struggling with this very question.

Henry Michtalik, assistant professor and hospitalist from Johns Hopkins and associate faculty at the Armstrong Institute for Patient Safety and Quality talked about physician perceptions of workload and the impact of that perception on patient safety. He noted that 40% of physicans report that their typical census exceeds “safe” levels at least monthly. Multiple factors impact that perception, including the physicians’ years of experience and the presence of housestaff, as well as the total amount of clinical time yearly. Other factors that can influence this perception include the type of hospital, the ancillary team make-up, and the patient’s payer mix and acuity. Twenty percent of physicians reported that workload negatively impacted the hospitalist’s ability to discuss the plan of care or delayed discharge.

The JAMA Internal Medicine article from April 2013 that he wrote also noted, most interestingly, that fixed census caps decreased the odds of reporting an unsafe census by 34%. Bring ’em on!

Daniel Elliott presented data from his role as acting associate chair for research and co-director of ambulatory research and Clinical Outcomes at Chistiana Care Department of Medicine in Wilmington, Del. He undertook a study designed to answer the question: What is the impact of increased workload on clinical outcomes? He looked at key variables of length of stay, continuity, 24-hour average occupancy, and turn-around time (i.e., time between ordering a test until the time completed on five most commonly ordered tests by hospitalists).

What he learned is that a higher physician workload is associated with increasing LOS, but notably this association decreases as hospital occupancy increases, meaning that a less-busy hospital means that LOS is a hospitalist dependent variable and MORE sensitive to workload. Conversely, a more busy hospital’s LOS is hospital dependent and LESS sensitive to physician workload. This reveals the importance in collaboration between hospitals and hospitalists, as they both contribute to outcomes that impact LOS.

Jill Menzel program manager for the hospitalist program business unit for Thedacare, said her group utilizes a balanced approach to evaluate workload, looking at safety/quality by evaluating 30-day readmission rates, financial stewardship by evaluating productivity (which she defines as units of service divided by the number of hours worked), and by evaluating people’s perception of the manageability of their workload, all surrounding the central tenet of the customer. They don’t look at a RVU metric, but instead focus on tracking the average amount of time to do work by provider. This tracking method allows them to accurately see where more help was needed and get it there.

And finally John Nelson, a hospitalist in suburban Seattle and practice management consultant summed up the session with the information that there is no clear correlation between a specific workload and burnout or stress, but there definitely IS a correlation between perceived workload and burnout. The take-home message? If you feel as if you are working too hard, then you are. A specific number is not clear.

Basically, there is no right number. But there is some data noting that higher workload leads to increased LOS, and that if you feel like you are working at an unsafe level your patients may be at risk of a longer hospitalization with less communication and more unnecessary tests, and you may personally be at risk for burnout. TH

Tracy Cardin is a nurse practitioner in the section of hospital medicine at the University of Chicago Hospital.

I attended the practice-management session with an intriguing title, “Hospitalist Workload: Is 15 the Right Number?” My own group, as I am sure many are, is struggling with this very question.

Henry Michtalik, assistant professor and hospitalist from Johns Hopkins and associate faculty at the Armstrong Institute for Patient Safety and Quality talked about physician perceptions of workload and the impact of that perception on patient safety. He noted that 40% of physicans report that their typical census exceeds “safe” levels at least monthly. Multiple factors impact that perception, including the physicians’ years of experience and the presence of housestaff, as well as the total amount of clinical time yearly. Other factors that can influence this perception include the type of hospital, the ancillary team make-up, and the patient’s payer mix and acuity. Twenty percent of physicians reported that workload negatively impacted the hospitalist’s ability to discuss the plan of care or delayed discharge.

The JAMA Internal Medicine article from April 2013 that he wrote also noted, most interestingly, that fixed census caps decreased the odds of reporting an unsafe census by 34%. Bring ’em on!

Daniel Elliott presented data from his role as acting associate chair for research and co-director of ambulatory research and Clinical Outcomes at Chistiana Care Department of Medicine in Wilmington, Del. He undertook a study designed to answer the question: What is the impact of increased workload on clinical outcomes? He looked at key variables of length of stay, continuity, 24-hour average occupancy, and turn-around time (i.e., time between ordering a test until the time completed on five most commonly ordered tests by hospitalists).

What he learned is that a higher physician workload is associated with increasing LOS, but notably this association decreases as hospital occupancy increases, meaning that a less-busy hospital means that LOS is a hospitalist dependent variable and MORE sensitive to workload. Conversely, a more busy hospital’s LOS is hospital dependent and LESS sensitive to physician workload. This reveals the importance in collaboration between hospitals and hospitalists, as they both contribute to outcomes that impact LOS.

Jill Menzel program manager for the hospitalist program business unit for Thedacare, said her group utilizes a balanced approach to evaluate workload, looking at safety/quality by evaluating 30-day readmission rates, financial stewardship by evaluating productivity (which she defines as units of service divided by the number of hours worked), and by evaluating people’s perception of the manageability of their workload, all surrounding the central tenet of the customer. They don’t look at a RVU metric, but instead focus on tracking the average amount of time to do work by provider. This tracking method allows them to accurately see where more help was needed and get it there.

And finally John Nelson, a hospitalist in suburban Seattle and practice management consultant summed up the session with the information that there is no clear correlation between a specific workload and burnout or stress, but there definitely IS a correlation between perceived workload and burnout. The take-home message? If you feel as if you are working too hard, then you are. A specific number is not clear.

Basically, there is no right number. But there is some data noting that higher workload leads to increased LOS, and that if you feel like you are working at an unsafe level your patients may be at risk of a longer hospitalization with less communication and more unnecessary tests, and you may personally be at risk for burnout. TH

Tracy Cardin is a nurse practitioner in the section of hospital medicine at the University of Chicago Hospital.

I attended the practice-management session with an intriguing title, “Hospitalist Workload: Is 15 the Right Number?” My own group, as I am sure many are, is struggling with this very question.

Henry Michtalik, assistant professor and hospitalist from Johns Hopkins and associate faculty at the Armstrong Institute for Patient Safety and Quality talked about physician perceptions of workload and the impact of that perception on patient safety. He noted that 40% of physicans report that their typical census exceeds “safe” levels at least monthly. Multiple factors impact that perception, including the physicians’ years of experience and the presence of housestaff, as well as the total amount of clinical time yearly. Other factors that can influence this perception include the type of hospital, the ancillary team make-up, and the patient’s payer mix and acuity. Twenty percent of physicians reported that workload negatively impacted the hospitalist’s ability to discuss the plan of care or delayed discharge.

The JAMA Internal Medicine article from April 2013 that he wrote also noted, most interestingly, that fixed census caps decreased the odds of reporting an unsafe census by 34%. Bring ’em on!

Daniel Elliott presented data from his role as acting associate chair for research and co-director of ambulatory research and Clinical Outcomes at Chistiana Care Department of Medicine in Wilmington, Del. He undertook a study designed to answer the question: What is the impact of increased workload on clinical outcomes? He looked at key variables of length of stay, continuity, 24-hour average occupancy, and turn-around time (i.e., time between ordering a test until the time completed on five most commonly ordered tests by hospitalists).

What he learned is that a higher physician workload is associated with increasing LOS, but notably this association decreases as hospital occupancy increases, meaning that a less-busy hospital means that LOS is a hospitalist dependent variable and MORE sensitive to workload. Conversely, a more busy hospital’s LOS is hospital dependent and LESS sensitive to physician workload. This reveals the importance in collaboration between hospitals and hospitalists, as they both contribute to outcomes that impact LOS.

Jill Menzel program manager for the hospitalist program business unit for Thedacare, said her group utilizes a balanced approach to evaluate workload, looking at safety/quality by evaluating 30-day readmission rates, financial stewardship by evaluating productivity (which she defines as units of service divided by the number of hours worked), and by evaluating people’s perception of the manageability of their workload, all surrounding the central tenet of the customer. They don’t look at a RVU metric, but instead focus on tracking the average amount of time to do work by provider. This tracking method allows them to accurately see where more help was needed and get it there.

And finally John Nelson, a hospitalist in suburban Seattle and practice management consultant summed up the session with the information that there is no clear correlation between a specific workload and burnout or stress, but there definitely IS a correlation between perceived workload and burnout. The take-home message? If you feel as if you are working too hard, then you are. A specific number is not clear.

Basically, there is no right number. But there is some data noting that higher workload leads to increased LOS, and that if you feel like you are working at an unsafe level your patients may be at risk of a longer hospitalization with less communication and more unnecessary tests, and you may personally be at risk for burnout. TH

Tracy Cardin is a nurse practitioner in the section of hospital medicine at the University of Chicago Hospital.

NATIONAL HARBOR, MD—HM13 officially kicks off this morning, but the four-day confab already is well under way.

SHM's annual meeting began yesterday with eight day-long pre-courses. Today's schedule includes keynote addresses from hospitalist Patrick Conway, MD, MSc, FAAP, SFHM, chief medical officer of the Centers for Medicaid & Medicare Services (CMS); and patient-centerdness guru David Feinberg, MD, MBA, president of UCLA Health System in Los Angeles.

The meeting expects to attract 2,500 hospitalists and includes nearly 100 breakout sessions, the popular Research, Innovations, and Clinical Vignettes (RIV) poster competition, and induction of the latest class of fellows, senior fellows, and masters. New SHM president Eric Howell, MD, SFHM, will offer Saturday’s keynote address, and true to annual meeting tradition, HM pioneer Bob Wachter, MD, MHM, will wrap up this year's conference with a keynote focusing on quality and patient safety.

If that sounds like a blitzkrieg of social, business, and educational activities, well, that's exactly what lures attendees like Ibe Mbanu, MD, MBA, MPH, medical director of the adult hospitalist department at Bon Secours St. Mary's Hospital in Richmond, Va.

"The landscape in health care is rapidly evolving at a frantic pace," Dr. Mbanu says. "I essentially came here to get a condensed source of information on how to manage the changes that are coming through the pipeline, and how to effectively run my department."

Hospitalist Roman Cortez, MD, who helps run Inpatient Medical Service in Kailua, Hawaii, is at his second annual meeting. Last year was his first and he enjoyed it so much, he brought his business partners this year. And after just a few hours yesterday, he already was glad they made the 4,800-mile trek.

"This is definitely my priority conference every year," Dr. Cortez adds. "If I can only go to one conference, this is the one I will go to from now on."

NATIONAL HARBOR, MD—HM13 officially kicks off this morning, but the four-day confab already is well under way.

SHM's annual meeting began yesterday with eight day-long pre-courses. Today's schedule includes keynote addresses from hospitalist Patrick Conway, MD, MSc, FAAP, SFHM, chief medical officer of the Centers for Medicaid & Medicare Services (CMS); and patient-centerdness guru David Feinberg, MD, MBA, president of UCLA Health System in Los Angeles.

The meeting expects to attract 2,500 hospitalists and includes nearly 100 breakout sessions, the popular Research, Innovations, and Clinical Vignettes (RIV) poster competition, and induction of the latest class of fellows, senior fellows, and masters. New SHM president Eric Howell, MD, SFHM, will offer Saturday’s keynote address, and true to annual meeting tradition, HM pioneer Bob Wachter, MD, MHM, will wrap up this year's conference with a keynote focusing on quality and patient safety.

If that sounds like a blitzkrieg of social, business, and educational activities, well, that's exactly what lures attendees like Ibe Mbanu, MD, MBA, MPH, medical director of the adult hospitalist department at Bon Secours St. Mary's Hospital in Richmond, Va.

"The landscape in health care is rapidly evolving at a frantic pace," Dr. Mbanu says. "I essentially came here to get a condensed source of information on how to manage the changes that are coming through the pipeline, and how to effectively run my department."

Hospitalist Roman Cortez, MD, who helps run Inpatient Medical Service in Kailua, Hawaii, is at his second annual meeting. Last year was his first and he enjoyed it so much, he brought his business partners this year. And after just a few hours yesterday, he already was glad they made the 4,800-mile trek.

"This is definitely my priority conference every year," Dr. Cortez adds. "If I can only go to one conference, this is the one I will go to from now on."

NATIONAL HARBOR, MD—HM13 officially kicks off this morning, but the four-day confab already is well under way.

SHM's annual meeting began yesterday with eight day-long pre-courses. Today's schedule includes keynote addresses from hospitalist Patrick Conway, MD, MSc, FAAP, SFHM, chief medical officer of the Centers for Medicaid & Medicare Services (CMS); and patient-centerdness guru David Feinberg, MD, MBA, president of UCLA Health System in Los Angeles.

The meeting expects to attract 2,500 hospitalists and includes nearly 100 breakout sessions, the popular Research, Innovations, and Clinical Vignettes (RIV) poster competition, and induction of the latest class of fellows, senior fellows, and masters. New SHM president Eric Howell, MD, SFHM, will offer Saturday’s keynote address, and true to annual meeting tradition, HM pioneer Bob Wachter, MD, MHM, will wrap up this year's conference with a keynote focusing on quality and patient safety.

If that sounds like a blitzkrieg of social, business, and educational activities, well, that's exactly what lures attendees like Ibe Mbanu, MD, MBA, MPH, medical director of the adult hospitalist department at Bon Secours St. Mary's Hospital in Richmond, Va.

"The landscape in health care is rapidly evolving at a frantic pace," Dr. Mbanu says. "I essentially came here to get a condensed source of information on how to manage the changes that are coming through the pipeline, and how to effectively run my department."

Hospitalist Roman Cortez, MD, who helps run Inpatient Medical Service in Kailua, Hawaii, is at his second annual meeting. Last year was his first and he enjoyed it so much, he brought his business partners this year. And after just a few hours yesterday, he already was glad they made the 4,800-mile trek.

"This is definitely my priority conference every year," Dr. Cortez adds. "If I can only go to one conference, this is the one I will go to from now on."

Tanya Boldenow, MD, a hospitalist at St. Joseph Mercy Hospital in Ann Arbor, Mich., attended yesterday’s HM13 Quality Improvement pre-course because she had been inspired by SHM’s participation in the ABIM Foundation’s Choosing Wisely campaign that identifies common treatments worth questioning by physicians and patients.

“I feel that I got some quality training in residency and have some support for it at the hospital, but for taking that next step to actually implement a project, it was important for me to have additional training and tools,” Dr. Boldenow said. SHM’s five recommended treatments to question “were things that I had a sense we ought to be looking at,” she added, but they weren’t being actively pursued at her hospital.

The full-day pre-course offered a review of QI principles and techniques. Participants then planned how concepts could be applied to a project targeting one of the SHM recommendations.

Dr. Boldenow chose the practice of avoiding or removing unnecessary urinary catheters, with a focus on preventing catheter-related urinary tract infections. Her group discussed baseline data to collect and analyze, where and how to pilot an initiative in the hospital, how to mobilize electronic health records, and what might persuade other professionals to change their habits.“It’s important to keep our eyes on the prize,” noted faculty member Ian Jenkins, MD, a hospitalist at the University of California at San Diego. “What are we trying to reduce; catheters or catheter-related complications?”

Dr. Boldenow sent an email to her department head a month ago proposing such a project. “I got funding from the residency program to come to the pre-course,” she said, “with the idea that I’d go back and make a presentation to our core faculty—and initiate a quality project.”

Tanya Boldenow, MD, a hospitalist at St. Joseph Mercy Hospital in Ann Arbor, Mich., attended yesterday’s HM13 Quality Improvement pre-course because she had been inspired by SHM’s participation in the ABIM Foundation’s Choosing Wisely campaign that identifies common treatments worth questioning by physicians and patients.

“I feel that I got some quality training in residency and have some support for it at the hospital, but for taking that next step to actually implement a project, it was important for me to have additional training and tools,” Dr. Boldenow said. SHM’s five recommended treatments to question “were things that I had a sense we ought to be looking at,” she added, but they weren’t being actively pursued at her hospital.

The full-day pre-course offered a review of QI principles and techniques. Participants then planned how concepts could be applied to a project targeting one of the SHM recommendations.

Dr. Boldenow chose the practice of avoiding or removing unnecessary urinary catheters, with a focus on preventing catheter-related urinary tract infections. Her group discussed baseline data to collect and analyze, where and how to pilot an initiative in the hospital, how to mobilize electronic health records, and what might persuade other professionals to change their habits.“It’s important to keep our eyes on the prize,” noted faculty member Ian Jenkins, MD, a hospitalist at the University of California at San Diego. “What are we trying to reduce; catheters or catheter-related complications?”

Dr. Boldenow sent an email to her department head a month ago proposing such a project. “I got funding from the residency program to come to the pre-course,” she said, “with the idea that I’d go back and make a presentation to our core faculty—and initiate a quality project.”

Tanya Boldenow, MD, a hospitalist at St. Joseph Mercy Hospital in Ann Arbor, Mich., attended yesterday’s HM13 Quality Improvement pre-course because she had been inspired by SHM’s participation in the ABIM Foundation’s Choosing Wisely campaign that identifies common treatments worth questioning by physicians and patients.

“I feel that I got some quality training in residency and have some support for it at the hospital, but for taking that next step to actually implement a project, it was important for me to have additional training and tools,” Dr. Boldenow said. SHM’s five recommended treatments to question “were things that I had a sense we ought to be looking at,” she added, but they weren’t being actively pursued at her hospital.

The full-day pre-course offered a review of QI principles and techniques. Participants then planned how concepts could be applied to a project targeting one of the SHM recommendations.

Dr. Boldenow chose the practice of avoiding or removing unnecessary urinary catheters, with a focus on preventing catheter-related urinary tract infections. Her group discussed baseline data to collect and analyze, where and how to pilot an initiative in the hospital, how to mobilize electronic health records, and what might persuade other professionals to change their habits.“It’s important to keep our eyes on the prize,” noted faculty member Ian Jenkins, MD, a hospitalist at the University of California at San Diego. “What are we trying to reduce; catheters or catheter-related complications?”

Dr. Boldenow sent an email to her department head a month ago proposing such a project. “I got funding from the residency program to come to the pre-course,” she said, “with the idea that I’d go back and make a presentation to our core faculty—and initiate a quality project.”

Jennifer Myers, the patient safety officer at the Hospital of the University of Pennsylvania in Philadelphia,  and James Reilly, assistant professor of clinical medicine, at UPenn, expertly facilitated a hands-on workshop exploring cognitive biases and common heuristics encountered in the daily practice of hospital medicine. Techniques to identify potential cognitive errors and de-biasing strategies were explored.

Specific methods included:

• Ishikawa diagrams (aka, cause-and-effect diagram, fish-bone diagram);
• Review of common heuristics; and
• Four double-check questions we can ask ourselves on every patient (Is this a case where I need to “slow down”?, What else could it be? What doesn’t fit? Could there be more than one thing going on?).

My favorite recommendation was: Practice “worst-case scenario” medicine. Consider the life threatening even if you don’t immediately test for it. TH

Dr. Lindsey is COO and strategist of Synergy Surgicalists, lead consultant of Asynd Consulting, and a Team Hospitalist member

Jennifer Myers, the patient safety officer at the Hospital of the University of Pennsylvania in Philadelphia,  and James Reilly, assistant professor of clinical medicine, at UPenn, expertly facilitated a hands-on workshop exploring cognitive biases and common heuristics encountered in the daily practice of hospital medicine. Techniques to identify potential cognitive errors and de-biasing strategies were explored.

Specific methods included:

• Ishikawa diagrams (aka, cause-and-effect diagram, fish-bone diagram);
• Review of common heuristics; and
• Four double-check questions we can ask ourselves on every patient (Is this a case where I need to “slow down”?, What else could it be? What doesn’t fit? Could there be more than one thing going on?).

My favorite recommendation was: Practice “worst-case scenario” medicine. Consider the life threatening even if you don’t immediately test for it. TH

Dr. Lindsey is COO and strategist of Synergy Surgicalists, lead consultant of Asynd Consulting, and a Team Hospitalist member

Jennifer Myers, the patient safety officer at the Hospital of the University of Pennsylvania in Philadelphia,  and James Reilly, assistant professor of clinical medicine, at UPenn, expertly facilitated a hands-on workshop exploring cognitive biases and common heuristics encountered in the daily practice of hospital medicine. Techniques to identify potential cognitive errors and de-biasing strategies were explored.

Specific methods included:

• Ishikawa diagrams (aka, cause-and-effect diagram, fish-bone diagram);
• Review of common heuristics; and
• Four double-check questions we can ask ourselves on every patient (Is this a case where I need to “slow down”?, What else could it be? What doesn’t fit? Could there be more than one thing going on?).

My favorite recommendation was: Practice “worst-case scenario” medicine. Consider the life threatening even if you don’t immediately test for it. TH

Dr. Lindsey is COO and strategist of Synergy Surgicalists, lead consultant of Asynd Consulting, and a Team Hospitalist member

The authors conducted a 6-site mentored implementation study to assess the effects of implementing a best practice med-rec toolkit on unintentional medication discrepancies.

The best practice toolkit included a number of interventions:

• Provider education (how to take a good history, how to get an accurate med lists);
• Patient education (teach-back method on medication education and how to keep their own medication list); and
• Risk stratifying patients regarding their need for additional resources (based on what medications they are currently prescribed and the total number of medications).

Stay tuned for the outcomes which are currently being collected. Click here for the toolkit resources.

The authors conducted a 6-site mentored implementation study to assess the effects of implementing a best practice med-rec toolkit on unintentional medication discrepancies.

The best practice toolkit included a number of interventions:

• Provider education (how to take a good history, how to get an accurate med lists);
• Patient education (teach-back method on medication education and how to keep their own medication list); and
• Risk stratifying patients regarding their need for additional resources (based on what medications they are currently prescribed and the total number of medications).

Stay tuned for the outcomes which are currently being collected. Click here for the toolkit resources.

The authors conducted a 6-site mentored implementation study to assess the effects of implementing a best practice med-rec toolkit on unintentional medication discrepancies.

The best practice toolkit included a number of interventions:

• Provider education (how to take a good history, how to get an accurate med lists);
• Patient education (teach-back method on medication education and how to keep their own medication list); and
• Risk stratifying patients regarding their need for additional resources (based on what medications they are currently prescribed and the total number of medications).

Stay tuned for the outcomes which are currently being collected. Click here for the toolkit resources.

Diagnostic reasoning is an essential skill for all physicians. There are multiple tools to refine this skill in physicians and to teach diagnostic reasoning to learners.

The session “Strategies for Promoting Clinical Reasoning to Avoid Diagnostic Errors” sought to review these skills in depth. According to Mary Ottolini, MD, of Children’s National Medical Center, the fundamentals of diagnostic reasoning are 1) Co-selection, in which 2-3 hypotheses or diagnoses are actively considered, 2) looking at the “big picture”, and 3) analyzing the information.

Looking at the big picture includes using appropriate adjectives to describe the patient and the illness presentation in medical and efficient terms. A well worded “one-liner” can frame the patient well for the team and for the next steps in diagnosis. Careful problem representation promotes thoughtful case presentations.

Analyzing the information includes comparing and contrasting key findings. Discriminating features should be discussed and competing evidence should be acknowledged.

Illness scripts is a method of looking at an illness in its entirety as a diagnosis is approached. The four parts of an illness script are mechanism of disease, epidemiology, clinical presentation (signs and symptoms), and time course.

Presentations can include diagnostic reasoning. The PBEAR format consists of:

• P- Problem Presentation
• BE – Background Evidence
• A- Analysis (including differential diagnoses)
• R- Recommendations (including goals and plan)

Key Takeaways:

• Diagnostic reasoning during case presentations is a valuable tool for patient care.
• Three fundamentals of diagnostic reasoning are 1) Co-selection of potential diagnoses, 2) looking at the “big picture”, and 3) analyzing the information.
• The PBEAR format (Problem Presentation, Background Evidence, Analysis , and Recommendations) can streamline presentations.
• Illness scripts (mechanism of disease, epidemiology, clinical presentation, and time course) are a helpful approach in diagnosis.

Dr. Hale is a pediatric hospitalist at the Floating Hospital for Children at Tufts Medical Center in Boston

Diagnostic reasoning is an essential skill for all physicians. There are multiple tools to refine this skill in physicians and to teach diagnostic reasoning to learners.

The session “Strategies for Promoting Clinical Reasoning to Avoid Diagnostic Errors” sought to review these skills in depth. According to Mary Ottolini, MD, of Children’s National Medical Center, the fundamentals of diagnostic reasoning are 1) Co-selection, in which 2-3 hypotheses or diagnoses are actively considered, 2) looking at the “big picture”, and 3) analyzing the information.

Looking at the big picture includes using appropriate adjectives to describe the patient and the illness presentation in medical and efficient terms. A well worded “one-liner” can frame the patient well for the team and for the next steps in diagnosis. Careful problem representation promotes thoughtful case presentations.

Analyzing the information includes comparing and contrasting key findings. Discriminating features should be discussed and competing evidence should be acknowledged.

Illness scripts is a method of looking at an illness in its entirety as a diagnosis is approached. The four parts of an illness script are mechanism of disease, epidemiology, clinical presentation (signs and symptoms), and time course.

Presentations can include diagnostic reasoning. The PBEAR format consists of:

• P- Problem Presentation
• BE – Background Evidence
• A- Analysis (including differential diagnoses)
• R- Recommendations (including goals and plan)

Key Takeaways:

• Diagnostic reasoning during case presentations is a valuable tool for patient care.
• Three fundamentals of diagnostic reasoning are 1) Co-selection of potential diagnoses, 2) looking at the “big picture”, and 3) analyzing the information.
• The PBEAR format (Problem Presentation, Background Evidence, Analysis , and Recommendations) can streamline presentations.
• Illness scripts (mechanism of disease, epidemiology, clinical presentation, and time course) are a helpful approach in diagnosis.

Dr. Hale is a pediatric hospitalist at the Floating Hospital for Children at Tufts Medical Center in Boston

Diagnostic reasoning is an essential skill for all physicians. There are multiple tools to refine this skill in physicians and to teach diagnostic reasoning to learners.

The session “Strategies for Promoting Clinical Reasoning to Avoid Diagnostic Errors” sought to review these skills in depth. According to Mary Ottolini, MD, of Children’s National Medical Center, the fundamentals of diagnostic reasoning are 1) Co-selection, in which 2-3 hypotheses or diagnoses are actively considered, 2) looking at the “big picture”, and 3) analyzing the information.

Looking at the big picture includes using appropriate adjectives to describe the patient and the illness presentation in medical and efficient terms. A well worded “one-liner” can frame the patient well for the team and for the next steps in diagnosis. Careful problem representation promotes thoughtful case presentations.

Analyzing the information includes comparing and contrasting key findings. Discriminating features should be discussed and competing evidence should be acknowledged.

Illness scripts is a method of looking at an illness in its entirety as a diagnosis is approached. The four parts of an illness script are mechanism of disease, epidemiology, clinical presentation (signs and symptoms), and time course.

Presentations can include diagnostic reasoning. The PBEAR format consists of:

• P- Problem Presentation
• BE – Background Evidence
• A- Analysis (including differential diagnoses)
• R- Recommendations (including goals and plan)

Key Takeaways:

• Diagnostic reasoning during case presentations is a valuable tool for patient care.
• Three fundamentals of diagnostic reasoning are 1) Co-selection of potential diagnoses, 2) looking at the “big picture”, and 3) analyzing the information.
• The PBEAR format (Problem Presentation, Background Evidence, Analysis , and Recommendations) can streamline presentations.
• Illness scripts (mechanism of disease, epidemiology, clinical presentation, and time course) are a helpful approach in diagnosis.

Dr. Hale is a pediatric hospitalist at the Floating Hospital for Children at Tufts Medical Center in Boston

I attended a presentation titled, “Overdoses and Other Taxing Toxicology,” presented by Kennon Heard, MD, of the University of Colorado Department of Emergency Medicine and the Rocky Mountain Poison and Drug Center. He updated HM13 attendees on current overdose management in a rapid-fire, question-and-answer format.

Here is a summary of Dr. Heard’s key points:

• Modest QTc prolongation can be common after many overdoses, but most do not require prolonged cardiac monitoring. The key is to optimize electrolytes, such as magnesium, phosphorus, and potassium, and to treat other effects caused by the overdose, such as central nervous depression.
• Bath salts are not truly bath salts or plant food, but are actually substituted amphetamines. Treatment is mainly supportive, similar to methamphetamine overdose. Most patients do not require treatment, but providers may need to treat for agitation, seizures or rhabdomyolysis.

Key Takeaways

• Physicians need to remember to treat the symptoms, not necessarily the poisons. First, you may not always be able to accurately identify the poison--there can be both false positives and false negatives on toxicology screens. Second, co-ingestions are common and again may not be easily identified. Toxidromes are specific, but not sensitive.
• Current acetaminophen overdose management is to treat based on clinical endpoints, rather than on a time-based protocol. Treat until all acetaminophen has been metabolized and markers of liver injury, such as liver enzymes and coagulation factors, are improving. TH

Dr. O’Callaghan is pediatric hospitalist and clinical assistant professor of pediatrics at Seattle Children’s Hospital and the University of Washington School of Medicine. He also is a Team Hospitalist member.

I attended a presentation titled, “Overdoses and Other Taxing Toxicology,” presented by Kennon Heard, MD, of the University of Colorado Department of Emergency Medicine and the Rocky Mountain Poison and Drug Center. He updated HM13 attendees on current overdose management in a rapid-fire, question-and-answer format.

Here is a summary of Dr. Heard’s key points:

• Modest QTc prolongation can be common after many overdoses, but most do not require prolonged cardiac monitoring. The key is to optimize electrolytes, such as magnesium, phosphorus, and potassium, and to treat other effects caused by the overdose, such as central nervous depression.
• Bath salts are not truly bath salts or plant food, but are actually substituted amphetamines. Treatment is mainly supportive, similar to methamphetamine overdose. Most patients do not require treatment, but providers may need to treat for agitation, seizures or rhabdomyolysis.

Key Takeaways

• Physicians need to remember to treat the symptoms, not necessarily the poisons. First, you may not always be able to accurately identify the poison--there can be both false positives and false negatives on toxicology screens. Second, co-ingestions are common and again may not be easily identified. Toxidromes are specific, but not sensitive.
• Current acetaminophen overdose management is to treat based on clinical endpoints, rather than on a time-based protocol. Treat until all acetaminophen has been metabolized and markers of liver injury, such as liver enzymes and coagulation factors, are improving. TH

Dr. O’Callaghan is pediatric hospitalist and clinical assistant professor of pediatrics at Seattle Children’s Hospital and the University of Washington School of Medicine. He also is a Team Hospitalist member.

I attended a presentation titled, “Overdoses and Other Taxing Toxicology,” presented by Kennon Heard, MD, of the University of Colorado Department of Emergency Medicine and the Rocky Mountain Poison and Drug Center. He updated HM13 attendees on current overdose management in a rapid-fire, question-and-answer format.

Here is a summary of Dr. Heard’s key points:

• Modest QTc prolongation can be common after many overdoses, but most do not require prolonged cardiac monitoring. The key is to optimize electrolytes, such as magnesium, phosphorus, and potassium, and to treat other effects caused by the overdose, such as central nervous depression.
• Bath salts are not truly bath salts or plant food, but are actually substituted amphetamines. Treatment is mainly supportive, similar to methamphetamine overdose. Most patients do not require treatment, but providers may need to treat for agitation, seizures or rhabdomyolysis.

Key Takeaways

• Physicians need to remember to treat the symptoms, not necessarily the poisons. First, you may not always be able to accurately identify the poison--there can be both false positives and false negatives on toxicology screens. Second, co-ingestions are common and again may not be easily identified. Toxidromes are specific, but not sensitive.
• Current acetaminophen overdose management is to treat based on clinical endpoints, rather than on a time-based protocol. Treat until all acetaminophen has been metabolized and markers of liver injury, such as liver enzymes and coagulation factors, are improving. TH

Dr. O’Callaghan is pediatric hospitalist and clinical assistant professor of pediatrics at Seattle Children’s Hospital and the University of Washington School of Medicine. He also is a Team Hospitalist member.

BETHESDA, MD. – The Food and Drug Administration has designated stool for transplant as a biologic drug, necessitating that any gastroenterologist performing fecal microbiota transplants obtain an Investigational New Drug permit.

By designating stool for transplant as a biologic drug, anyone who performs fecal microbiota transplants (FMTs) – whether they perform a single transplant for one patient or recruit dozens for a study – needs to have an IND permit.

The announcement was made at a 2-day public workshop convened by the National Institutes of Health and the Food and Drug Administration to sift through some of the evidence surrounding FMTs.

The intent of the IND requirement, said Dr. Jay Slater, director of FDA’s Division of Bacterial, Parasitic, and Allergenic Products, is not to stamp out the care that patients can now receive, but to make sure it’s safe, effective, and data driven.

Courtesy of Dr. Lawrence Brandt

"This is a low-tech procedure that already has a CPT code. A ‘how-to’ guide recently appeared online, and it walks you right through how to do the procedure. There are a very large number of people doing this off the grid. What we need are long-term controlled trials on this that will enhance our understanding of its safety and efficacy."

Although neither the biologic designation nor the IND requirement is brand new, they have not been well publicized, according to one of the innovators of FMT, Dr. Lawrence Brandt, of Albert Einstein Medical Center in New York.

"I am struck by the fact that FDA wants these INDs and yet FDA has never publicly set forth any message on it. So from this moment on, all of us who continue to do this without an IND are violating FDA’s policy," he said at the meeting.

One of the primary concerns now, according to Dr. Brandt, is a burgeoning public interest in FMTs, even to the point of do-it-yourself treatments. With online instructions for self-treatment, and a procedure that is rife with variations, regulators can no longer tacitly ignore the issue.

There’s no standardization of how the stool is prepared and filtered – it could be blended in a kitchen blender or by hand with a tongue depressor, or strained through gauze or a coffee filter, he said. Dosing is all over the place, listed as spoonfuls, grams, and milliliters. Different institutions screen donors in different ways. Some patients get a bowel prep, which can be mild or aggressive, and some don’t get one at all. Should the stool be fresh, and if so, how fresh? Is frozen okay? These are all issues that need to be examined from a safety and efficacy perspective and standardized.

Even the method of delivery varies. The transplant can be administered via nasogastric tube or colonoscope, or by enema. There’s no standardization of data collection either. Some large institutions keep records of everything from the first workup to the last visit. Doctors who perform transplants occasionally may not be as conscientious. And no one knows anything about the do-it-yourselfers, at home with a family member’s donation and a squeeze enema.

Dr. Brandt – and a number of clinicians at the meeting – agreed that answers must be found for all these questions. And they agree that well-conducted clinical trials are the best way to go forward.

Dr. Colleen Kelly, one of the gastroenterologists launching one of 22 currently recruiting studies on FMT, started doing the procedure 5 years ago. Her first patient was a 26-year-old medical student with recurrent bouts of a Clostridium difficile infection.

"I’d heard of [FMT], but never, ever thought of doing one," said Dr. Kelly, of Brown University Medical Center, Providence, R.I. "I thought it was something at the far fringes of medicine."

At her patient’s insistence, Dr. Kelly contacted Dr. Brandt and learned about his process for performing FMT. The following year, she performed 10 FMTs. She is now undertaking a study with Dr. Brandt to recruit about 48 patients with relapsing C. difficile to be randomized to FMT or to a sham treatment with their own stool. Patients who have clinical failure in the sham group will be offered FMT; patients in the active arm who fail on initial FMT will get another FMT from a different donor.

While most trials are examining the utility of FMT in patients with recurrent C. difficile, a few are investigating FMT for use in patients with Crohn’s disease and inflammatory bowel disease. Some clinicians and individual patients are now using FMTs for this condition outside a clinical trial, with no understanding of how a compromised intestinal mucosa might react to transplanted stool.

It will take years to accumulate the data necessary to fully understand FMT and all its implications, Dr. Kelly said. In the interim, the IND requirement will likely shrink the already-small pool of gastroenterologists performing FMTs. "Some will be motivated to get an IND, but the average person in practice won’t," she predicted. "You need to put hours and hours of work into it, and then you’re still under FDA’s oversight because this is not an approved therapy. So that means you have to submit adverse events reports, keep records, and report annually on your program. And at any time, without any warning, [the FDA] can come and inspect your facility."

Dr. Brandt agreed. "It’s a huge amount of paperwork documentation, record-keeping, and follow-up that the average practitioner is simply not going to do." The requirement for an IND means there are simply going to be fewer and fewer physicians who do them, he said.

Admittedly, though, the risks of no regulation can endanger patients, Dr. Kelly said. "If things go on completely unregulated, stupid things will happen," including the spread of infectious diseases like hepatitis C and parasitic infestations.

Indeed, Dr. Alexander Khoruts of the University of Minnesota, Minneapolis, who spoke at the workshop, described the case of an FMT "do-it-yourselfer" who called for some advice on improving her outcomes. Specifically, she had mixed stool from a neighbor and her son’s mother-in-law and administered it to herself without results. "She wanted to know if maybe the chlorine in the water killed off everything. ... Six months later she called me back and said her C. diff was gone, but now she had parasites."

"There are already predatory practices out there [performing FMTs]," Dr. Khoruts said. "I got an e-mail from someone who couldn’t make the drive up to see me, but she found someone near her who would do it for $10,000."

Courtesy of Dr. Colleen Kelly

Well-designed and well-executed studies would not only address these immediate safety questions, but would also examine the more nebulous concerns about the long-term effects of tampering with an individual’s unique ecosystem of gut microbes. In recent years, research has begun to document how the balance and proportion of microbial species in the gut can either protect from – or predispose to – metabolic syndrome, obesity, diabetes, cardiovascular disease, arthritis, and even cognitive disorders.

An engrafting microbial transplant could predispose the recipient to develop illnesses that would otherwise never have been destined to occur, Dr. Slater said. "All of the evidence we have suggests that manipulating the gut microbiome is a powerful act that may have long-reaching and subtle effects."

The move toward a standardized FMT product and process is inevitable, Dr. Brandt said. "We’re not going to be doing fecal transplants much longer. This is a temporary situation. We’re already developing compounds that will do the same thing."

Researchers at the University of Guelph, Ontario, have developed a machine that distills and cultures microbes from human feces, producing a kind of super-probiotic that can be used in place of fresh stool.

Also, the Canadian biotech company Rebiotix is working on a similar product, which it intends to test in a phase II randomized controlled trial.

But until those machine-made products are available, physicians and patients with have to stay with the man-made version. "We have access to a substance that is free and has a virtually unlimited supply," Dr. Kelly said. "We cannot deny this effective therapy to these patients who’ve failed all other available treatments."

None of the sources quoted in this article had any financial declarations.

[email protected]

BETHESDA, MD. – The Food and Drug Administration has designated stool for transplant as a biologic drug, necessitating that any gastroenterologist performing fecal microbiota transplants obtain an Investigational New Drug permit.

By designating stool for transplant as a biologic drug, anyone who performs fecal microbiota transplants (FMTs) – whether they perform a single transplant for one patient or recruit dozens for a study – needs to have an IND permit.

The announcement was made at a 2-day public workshop convened by the National Institutes of Health and the Food and Drug Administration to sift through some of the evidence surrounding FMTs.

The intent of the IND requirement, said Dr. Jay Slater, director of FDA’s Division of Bacterial, Parasitic, and Allergenic Products, is not to stamp out the care that patients can now receive, but to make sure it’s safe, effective, and data driven.

Courtesy of Dr. Lawrence Brandt

"This is a low-tech procedure that already has a CPT code. A ‘how-to’ guide recently appeared online, and it walks you right through how to do the procedure. There are a very large number of people doing this off the grid. What we need are long-term controlled trials on this that will enhance our understanding of its safety and efficacy."

Although neither the biologic designation nor the IND requirement is brand new, they have not been well publicized, according to one of the innovators of FMT, Dr. Lawrence Brandt, of Albert Einstein Medical Center in New York.

"I am struck by the fact that FDA wants these INDs and yet FDA has never publicly set forth any message on it. So from this moment on, all of us who continue to do this without an IND are violating FDA’s policy," he said at the meeting.

One of the primary concerns now, according to Dr. Brandt, is a burgeoning public interest in FMTs, even to the point of do-it-yourself treatments. With online instructions for self-treatment, and a procedure that is rife with variations, regulators can no longer tacitly ignore the issue.

There’s no standardization of how the stool is prepared and filtered – it could be blended in a kitchen blender or by hand with a tongue depressor, or strained through gauze or a coffee filter, he said. Dosing is all over the place, listed as spoonfuls, grams, and milliliters. Different institutions screen donors in different ways. Some patients get a bowel prep, which can be mild or aggressive, and some don’t get one at all. Should the stool be fresh, and if so, how fresh? Is frozen okay? These are all issues that need to be examined from a safety and efficacy perspective and standardized.

Even the method of delivery varies. The transplant can be administered via nasogastric tube or colonoscope, or by enema. There’s no standardization of data collection either. Some large institutions keep records of everything from the first workup to the last visit. Doctors who perform transplants occasionally may not be as conscientious. And no one knows anything about the do-it-yourselfers, at home with a family member’s donation and a squeeze enema.

Dr. Brandt – and a number of clinicians at the meeting – agreed that answers must be found for all these questions. And they agree that well-conducted clinical trials are the best way to go forward.

Dr. Colleen Kelly, one of the gastroenterologists launching one of 22 currently recruiting studies on FMT, started doing the procedure 5 years ago. Her first patient was a 26-year-old medical student with recurrent bouts of a Clostridium difficile infection.

"I’d heard of [FMT], but never, ever thought of doing one," said Dr. Kelly, of Brown University Medical Center, Providence, R.I. "I thought it was something at the far fringes of medicine."

At her patient’s insistence, Dr. Kelly contacted Dr. Brandt and learned about his process for performing FMT. The following year, she performed 10 FMTs. She is now undertaking a study with Dr. Brandt to recruit about 48 patients with relapsing C. difficile to be randomized to FMT or to a sham treatment with their own stool. Patients who have clinical failure in the sham group will be offered FMT; patients in the active arm who fail on initial FMT will get another FMT from a different donor.

While most trials are examining the utility of FMT in patients with recurrent C. difficile, a few are investigating FMT for use in patients with Crohn’s disease and inflammatory bowel disease. Some clinicians and individual patients are now using FMTs for this condition outside a clinical trial, with no understanding of how a compromised intestinal mucosa might react to transplanted stool.

It will take years to accumulate the data necessary to fully understand FMT and all its implications, Dr. Kelly said. In the interim, the IND requirement will likely shrink the already-small pool of gastroenterologists performing FMTs. "Some will be motivated to get an IND, but the average person in practice won’t," she predicted. "You need to put hours and hours of work into it, and then you’re still under FDA’s oversight because this is not an approved therapy. So that means you have to submit adverse events reports, keep records, and report annually on your program. And at any time, without any warning, [the FDA] can come and inspect your facility."

Dr. Brandt agreed. "It’s a huge amount of paperwork documentation, record-keeping, and follow-up that the average practitioner is simply not going to do." The requirement for an IND means there are simply going to be fewer and fewer physicians who do them, he said.

Admittedly, though, the risks of no regulation can endanger patients, Dr. Kelly said. "If things go on completely unregulated, stupid things will happen," including the spread of infectious diseases like hepatitis C and parasitic infestations.

Indeed, Dr. Alexander Khoruts of the University of Minnesota, Minneapolis, who spoke at the workshop, described the case of an FMT "do-it-yourselfer" who called for some advice on improving her outcomes. Specifically, she had mixed stool from a neighbor and her son’s mother-in-law and administered it to herself without results. "She wanted to know if maybe the chlorine in the water killed off everything. ... Six months later she called me back and said her C. diff was gone, but now she had parasites."

"There are already predatory practices out there [performing FMTs]," Dr. Khoruts said. "I got an e-mail from someone who couldn’t make the drive up to see me, but she found someone near her who would do it for $10,000."

Courtesy of Dr. Colleen Kelly

Well-designed and well-executed studies would not only address these immediate safety questions, but would also examine the more nebulous concerns about the long-term effects of tampering with an individual’s unique ecosystem of gut microbes. In recent years, research has begun to document how the balance and proportion of microbial species in the gut can either protect from – or predispose to – metabolic syndrome, obesity, diabetes, cardiovascular disease, arthritis, and even cognitive disorders.

An engrafting microbial transplant could predispose the recipient to develop illnesses that would otherwise never have been destined to occur, Dr. Slater said. "All of the evidence we have suggests that manipulating the gut microbiome is a powerful act that may have long-reaching and subtle effects."

The move toward a standardized FMT product and process is inevitable, Dr. Brandt said. "We’re not going to be doing fecal transplants much longer. This is a temporary situation. We’re already developing compounds that will do the same thing."

Researchers at the University of Guelph, Ontario, have developed a machine that distills and cultures microbes from human feces, producing a kind of super-probiotic that can be used in place of fresh stool.

Also, the Canadian biotech company Rebiotix is working on a similar product, which it intends to test in a phase II randomized controlled trial.

But until those machine-made products are available, physicians and patients with have to stay with the man-made version. "We have access to a substance that is free and has a virtually unlimited supply," Dr. Kelly said. "We cannot deny this effective therapy to these patients who’ve failed all other available treatments."

None of the sources quoted in this article had any financial declarations.

[email protected]

BETHESDA, MD. – The Food and Drug Administration has designated stool for transplant as a biologic drug, necessitating that any gastroenterologist performing fecal microbiota transplants obtain an Investigational New Drug permit.

By designating stool for transplant as a biologic drug, anyone who performs fecal microbiota transplants (FMTs) – whether they perform a single transplant for one patient or recruit dozens for a study – needs to have an IND permit.

The announcement was made at a 2-day public workshop convened by the National Institutes of Health and the Food and Drug Administration to sift through some of the evidence surrounding FMTs.

The intent of the IND requirement, said Dr. Jay Slater, director of FDA’s Division of Bacterial, Parasitic, and Allergenic Products, is not to stamp out the care that patients can now receive, but to make sure it’s safe, effective, and data driven.

Courtesy of Dr. Lawrence Brandt

"This is a low-tech procedure that already has a CPT code. A ‘how-to’ guide recently appeared online, and it walks you right through how to do the procedure. There are a very large number of people doing this off the grid. What we need are long-term controlled trials on this that will enhance our understanding of its safety and efficacy."

Although neither the biologic designation nor the IND requirement is brand new, they have not been well publicized, according to one of the innovators of FMT, Dr. Lawrence Brandt, of Albert Einstein Medical Center in New York.

"I am struck by the fact that FDA wants these INDs and yet FDA has never publicly set forth any message on it. So from this moment on, all of us who continue to do this without an IND are violating FDA’s policy," he said at the meeting.

One of the primary concerns now, according to Dr. Brandt, is a burgeoning public interest in FMTs, even to the point of do-it-yourself treatments. With online instructions for self-treatment, and a procedure that is rife with variations, regulators can no longer tacitly ignore the issue.

There’s no standardization of how the stool is prepared and filtered – it could be blended in a kitchen blender or by hand with a tongue depressor, or strained through gauze or a coffee filter, he said. Dosing is all over the place, listed as spoonfuls, grams, and milliliters. Different institutions screen donors in different ways. Some patients get a bowel prep, which can be mild or aggressive, and some don’t get one at all. Should the stool be fresh, and if so, how fresh? Is frozen okay? These are all issues that need to be examined from a safety and efficacy perspective and standardized.

Even the method of delivery varies. The transplant can be administered via nasogastric tube or colonoscope, or by enema. There’s no standardization of data collection either. Some large institutions keep records of everything from the first workup to the last visit. Doctors who perform transplants occasionally may not be as conscientious. And no one knows anything about the do-it-yourselfers, at home with a family member’s donation and a squeeze enema.

Dr. Brandt – and a number of clinicians at the meeting – agreed that answers must be found for all these questions. And they agree that well-conducted clinical trials are the best way to go forward.

Dr. Colleen Kelly, one of the gastroenterologists launching one of 22 currently recruiting studies on FMT, started doing the procedure 5 years ago. Her first patient was a 26-year-old medical student with recurrent bouts of a Clostridium difficile infection.

"I’d heard of [FMT], but never, ever thought of doing one," said Dr. Kelly, of Brown University Medical Center, Providence, R.I. "I thought it was something at the far fringes of medicine."

At her patient’s insistence, Dr. Kelly contacted Dr. Brandt and learned about his process for performing FMT. The following year, she performed 10 FMTs. She is now undertaking a study with Dr. Brandt to recruit about 48 patients with relapsing C. difficile to be randomized to FMT or to a sham treatment with their own stool. Patients who have clinical failure in the sham group will be offered FMT; patients in the active arm who fail on initial FMT will get another FMT from a different donor.

While most trials are examining the utility of FMT in patients with recurrent C. difficile, a few are investigating FMT for use in patients with Crohn’s disease and inflammatory bowel disease. Some clinicians and individual patients are now using FMTs for this condition outside a clinical trial, with no understanding of how a compromised intestinal mucosa might react to transplanted stool.

It will take years to accumulate the data necessary to fully understand FMT and all its implications, Dr. Kelly said. In the interim, the IND requirement will likely shrink the already-small pool of gastroenterologists performing FMTs. "Some will be motivated to get an IND, but the average person in practice won’t," she predicted. "You need to put hours and hours of work into it, and then you’re still under FDA’s oversight because this is not an approved therapy. So that means you have to submit adverse events reports, keep records, and report annually on your program. And at any time, without any warning, [the FDA] can come and inspect your facility."

Dr. Brandt agreed. "It’s a huge amount of paperwork documentation, record-keeping, and follow-up that the average practitioner is simply not going to do." The requirement for an IND means there are simply going to be fewer and fewer physicians who do them, he said.

Admittedly, though, the risks of no regulation can endanger patients, Dr. Kelly said. "If things go on completely unregulated, stupid things will happen," including the spread of infectious diseases like hepatitis C and parasitic infestations.

Indeed, Dr. Alexander Khoruts of the University of Minnesota, Minneapolis, who spoke at the workshop, described the case of an FMT "do-it-yourselfer" who called for some advice on improving her outcomes. Specifically, she had mixed stool from a neighbor and her son’s mother-in-law and administered it to herself without results. "She wanted to know if maybe the chlorine in the water killed off everything. ... Six months later she called me back and said her C. diff was gone, but now she had parasites."

"There are already predatory practices out there [performing FMTs]," Dr. Khoruts said. "I got an e-mail from someone who couldn’t make the drive up to see me, but she found someone near her who would do it for $10,000."

Courtesy of Dr. Colleen Kelly

Well-designed and well-executed studies would not only address these immediate safety questions, but would also examine the more nebulous concerns about the long-term effects of tampering with an individual’s unique ecosystem of gut microbes. In recent years, research has begun to document how the balance and proportion of microbial species in the gut can either protect from – or predispose to – metabolic syndrome, obesity, diabetes, cardiovascular disease, arthritis, and even cognitive disorders.

An engrafting microbial transplant could predispose the recipient to develop illnesses that would otherwise never have been destined to occur, Dr. Slater said. "All of the evidence we have suggests that manipulating the gut microbiome is a powerful act that may have long-reaching and subtle effects."

The move toward a standardized FMT product and process is inevitable, Dr. Brandt said. "We’re not going to be doing fecal transplants much longer. This is a temporary situation. We’re already developing compounds that will do the same thing."

Researchers at the University of Guelph, Ontario, have developed a machine that distills and cultures microbes from human feces, producing a kind of super-probiotic that can be used in place of fresh stool.

Also, the Canadian biotech company Rebiotix is working on a similar product, which it intends to test in a phase II randomized controlled trial.

But until those machine-made products are available, physicians and patients with have to stay with the man-made version. "We have access to a substance that is free and has a virtually unlimited supply," Dr. Kelly said. "We cannot deny this effective therapy to these patients who’ve failed all other available treatments."

None of the sources quoted in this article had any financial declarations.

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