In the football-loving state of Michigan, legendary athletes take their cues from a coach and map their strategies for one big group effort. But Michigan is also home to what may be the first-ever homegrown regional consortium for patient safety and quality improvement—and in this case—after a huddle each team member gets to call his own plays.

The Hospitalists as Emerging Leaders in Patient Safety (HELPS) Consortium of Southeastern Michigan (funded by a grant from the Blue Cross Blue Shield of Michigan Foundation) includes representatives from nine regional hospitalist programs representing 11 hospitals and approximately 75,000 patients.1

The participants in this program identify proven patient safety practices and facilitate widespread dissemination of those practices among hospitalists.

The member institutions include academic medical centers, large private teaching and non-teaching hospitals, federal facilities, and urban and rural hospitals.

Each institution is represented by a hospitalist—usually the director of the hospitalist program or the individual most interested in and familiar with quality improvement—and a representative from quality improvement or patient safety. The issues they have addressed, which emerged from a variety of sources, such as the Agency of Healthcare Research and Quality, the National Quality Forum, and the Joint Commission on Accreditation of Healthcare Organizations, are those that are commonly encountered in hospitalist practice. These physicians “are bridging the gap between that which they know to be effective and that which is actually practiced.”1

HELPS builds on the experience of medical professionals who have united geographically dispersed physicians from the same specialty to boost quality. The HELPS consortium also aids participating institutions in evaluating outcomes after implementing a targeted patient safety practice, thereby allowing rapid cycle improvement while identifying factors associated with success.

“We have gotten the work that is being done by these different organizations out there, brought it up a notch in certain situations—we like to think—and have gotten it effectively disseminated to a larger group of hospitalists,” says Scott Flanders, MD, an associate professor of medicine at the University of Michigan (Ann Arbor), director of the hospital medicine program there, and an SHM board member.

Where They Are

The consortium is about three-quarters of the way through its overall estimated project period, says Dr. Flanders. It originally planned to have nine gatherings over two years. (See Table 1, p. 35.) To date the consortium has held seven of those sessions and have met roughly every two to three months. End-of-life care and the final wrap-up are the only sessions still to be completed.

The individual sites took on projects that included reducing errors with heparin use in hospitalized patients, reducing falls in hospitalized patients, improving care transitions (a collaborative multidisciplinary approach), reducing unnecessary ICU admission and preventing in-hospital cardiac arrests, reducing urinary catheter infections, improving rates of appropriate deep vein thrombosis prophylaxis, and implementing best practices for reducing central line infections. A national expert conducted a session on implementing a program to reduce perioperative cardiovascular events while ensuring the appropriate use of perioperative beta-blockers.

Challenges and Lessons Learned

From the outset, the HELPS group knew that its primary challenge would be to fulfill the intention to meet as a complete group four or five times per year. “There aren’t a lot of hospitalists who have big parts of their jobs carved out for dedicated time to work on quality improvement research or patient safety,” says Dr. Flanders. “It’s part of what we do in our day, but in terms of taking on a big project, designing it, implementing it, and measuring its effect, it is hard to do in the day-to-day job of most hospitalist groups.”

He suspects that hospitalists frequently help steering committees address certain issues, “but it may not be the individual hospitalist group that is managing or driving the quality issue for an entire hospital or health system.” The HELPS physicians knew that if they could surmount the scheduling challenge, however, they would have a terrific opportunity to learn from each other and move their individual institutional patient safety initiatives forward.

They also knew that the majority of hospitalized patients receive care in community hospitals and that the culture of a community hospital differed dramatically from a tertiary-care academic medical center. Interventions would need to be tried at varied settings, and HELPS would allow that to happen. In addition, few clinically active hospitalists have developed the research expertise to evaluate an intervention rigorously at their own institution, yet decision makers often require such an evaluation when they are considering adopting a new intervention. Using the resources of an academic center such as the University of Michigan, where evaluative and methodologic expertise is available, allowed them to facilitate a resolution for that problem. “As physicians, we are helping [smaller hospitals] by facilitating data collection and data analysis for their ongoing projects,” says Dr. Flanders.

Another challenge the hospitalists faced pertained to the relative instability of hospital medicine compared with other specialties. For instance, it is probably far easier for the members of the consortium of cardiology groups working on best practices for managing acute myocardial infarction to find time to work together. In contrast, because hospital medicine is a relatively new specialty, “we are seeing a certain amount of instability,” explains Dr. Flanders. “Of our nine involved health systems, at least two had dramatic organizational and structural changes within their hospital medicine group over the last year and a half.” One hospital medicine director left, with repercussions in several areas, and, in another group, the practice was sold to a large physician management company, which meant that the HELPS data that had been collected was no longer owned by the [original] group, making their activities more complex.

What They’ve Done So Far

Dr. Flanders is not aware of any other groups of physicians from another state who have undertaken such a project. The Institute for Healthcare Improvement’s “100,000 Lives Campaign” may be similar in some ways, focusing on a few key topic areas. The Michigan Keystone Project, which concentrated on various ICU patient safety topics, is another example of a regional consortium. “But the difference is that they basically drive the agenda,” he says. “They say, ‘This is what we want you all to do, and let’s figure out how we can all do it.’ In our case, we focused on some key areas, but we did not dictate what the project was.”

The following brief recaps represent some of the projects undertaken by consortium member sites.

Falls

The University of Michigan-affiliated Ann Arbor Veterans Affairs (VA) Hospital, where Sanjay Saint, MD, MPH, is a hospitalist, has many elderly and cognitively impaired patients, so preventing falls is a big issue. “My responsibility isn’t to prevent falls but to share these best practices with others in my organization,” he says. “In fact, each project team points out where to look with a certain problem but not necessarily what to do.”

Dr. Saint brought up the issue of mattresses with lipped/raised edges to prevent patients from rolling out of bed. Following that, at least one other consortium hospital suggested to its fall prevention group that they explore the use of these lipped mattresses.

Bed alarms were another problem. Participants shared a common problem: Often, nurses wouldn’t hear a patient’s alarm go off. Other providers might reset them, but if they neglected to let the assigned nurse know the patient was calling, the patient might get tired of waiting, attempt to get out of bed, and sustain a fall. Consequently, providers in most institutions thought the alarms were not useful. But one institution identified a novel way to use bed alarms: attaching them to the nurse’s pager. Now, when the alarm goes off, it alerts the appropriate nurse directly, and because that nurse is responsible for resetting the alarm, she knows that the patient has called and needs help.

Changing Names: CARE Assistants

To avoid the use of physical or chemical restraints, many institutions have resorted to hiring “sitters” who stay at the bedside of confused or delirious patients to calm them; if patients try to get out of bed, sitters are there to coax them back in. A number of HELPS institutions shared the idea that using the term “sitter” might have been inadvertently encouraging inactivity: Too many sitters were doing just that, sitting all day, often watching television.

One of the collaborative sites now calls these employees CARE assistants, an acronym for Caring Alternative to a Restraint-free Environment. The group has predicted that calling them something different will inspire these people to “do more caring and less sitting,” says Dr. Saint. After a HELPS session, Dr. Saint submitted this idea to the key decision makers at the VA. “I could have tried by myself to resolve this dilemma for years and not come up with that idea,” he says. “Why not just take what they’ve done and modify it to suit your own environment?”

Weighty Problem: Heparin Dosing

One hospital in the consortium conducted a project on medication safety that focused on appropriate use of heparin in hospitalized patients. When the site’s hospitalists began studying the problems they were having, they realized that the weights they were using for dosing decisions were being generated in the emergency department (ED). Studying it further, they saw that, most of the time, those patients weren’t actually being weighed; nurses were simply estimating their weights. Having traced the problem to the ED, they were then able to intervene, fix the problem, and show that by doing so their rates of bleeding complications from inappropriate dosing of anticoagulants improved.

At his own institution, Dr. Flanders was participating in a group committee meeting discussing this problem. Consequently, “I was able to ask, ‘Have we looked at weights [being assessed] in the emergency department?’ Everyone involved with that project said, ‘No, why?’ And, sure enough, a similar problem existed.”

Care Transitions and Multidisciplinary Rounding

One member-team of the consortium was able to come up with a multidisciplinary team that met and rounded on patients each day and focused on the care transitions. They were able to dramatically improve staff communication, the overall discharge process, and patient satisfaction. As a result of what he learned of their successes, Dr. Flanders’ institution plans to use a similar strategy to enhance communication among healthcare providers involved in the discharge process on their hospitalist unit.

Rapid Response Teams and Input from Residents

“It’s very helpful to hear, from another site, the challenges and benefits of having hospitalists involved with the rapid response teams,” says Dr. Saint. “How did they operationalize it? What were the remaining challenges? What outcome measures did they use? How do you assess whether it’s worth the cost? What do residents think about this?

This last point turned out to be a valuable question to ask. The group included some residents at the site where this project was piloted and had a fruitful discussion. Adding the perspective of residents along with faculty, says Dr. Saint, as well as a couple of nurses and quality care managers, allows a synergy and combination of ideas that led to effective solutions. “Those are exactly the individuals who need to be around a table to overcome some of the challenges.” They have also considered inviting nursing students. “Before they get inculcated in thinking a certain way,” he says, “why not hear what they have to say?”

Dr. Saint believes, however, that this is not a step to be taken lightly. If you are going to include people, “then you have to act on their suggestions or at least hear them out and say why you’re not going to take their suggestions because a good way to get people to become jaded is to listen to their feedback and then just ignore it.”

click for large version

Calling in Outside Experts

To focus on the issue of preventing hospital-acquired urinary tract infections (UTIs), the consortium invited Russell Olmstead, MPH, an infection control expert and epidemiologist at one of the HELPS sites and past president of the Michigan Society of Infection Control.

“We’d like to do a Keystone[-type] UTI project,” says Dr. Saint, referring to the federally funded statewide three-year initiative, conducted in collaboration with the Michigan Hospital Association and Johns Hopkins Research and Safety Group, that focused on applying evidence-based medicine and quality improvement efforts to prevent ventilator-associated pneumonia and central line-related infections. “We’ve called it the Bladder Bundle; that is, you bundle a group of practices together, and you give the hospitalists who want to participate a toolkit in order to roll this out.”

Although the details still need to be finalized, the project would include ensuring that patients have appropriate indication for an indwelling catheter, that the indwelling catheter is inserted in an aseptic manner, that there was some type of assessment of discontinuation after a certain amount of time, and that alternatives to an indwelling catheter are considered.

Another expert consulting with the consortium was Peter Lindenauer, MD, MSc, with the Division of Healthcare Quality, Baystate Medical Center, Springfield, Mass., and the Department of Medicine, Tufts University School of Medicine, Boston. Dr. Lindenauer came to discuss lessons he and his colleagues have learned from efforts to improve appropriate perioperative beta blocker use.

The final HELPS wrap-up session for the group will include another nationally renowned expert in patient safety.

SHARP: Research Translated into Practice

Another project initiated by the Michigan hospitalists will generate and disseminate new knowledge in the realm of clinical research. The Specialist-Hospitalist Allied Research Program (SHARP), directed by Dr. Flanders and Brahmajee Nallamothu, MD, MPH, an interventional cardiologist, is the first specialist-hospitalist clinical research program in the United States. This hospitalist delivery model alters the way clinical problems are approached and creates opportunities and challenges in implementing best practices, including those surrounding drugs and devices. A successful clinical and translational research program will combine specialists and hospitalists working collaboratively to better understand the best ways to care for inpatients.

This project is similar to what cardiology and oncology specialties have done over the last several decades, says Dr. Saint. In the future, he foresees that the NIH will increasingly focus on translating research into practice in diverse settings. Both specialists and hospitalists who work in a particular area together—such as prevention of lower extremity clots or of nosocomial infections—can use the health consortium to roll out protocols and studies in order to tackle some of the important inpatient topics.

SHARP was awarded funding through the University of Michigan Department of Medicine and was scheduled to take off in February. “Our hope is that we will be able to take advantage of and build upon the health collaborative that we have and bring in our subspecialty expertise to help inform clinical investigations,” says Dr. Saint.

Where They’re Going

Both Dr. Flanders and Dr. Saint are pleased about the HELPS consortium’s progress so far. They believe that they have found a group of people who are interested in patient safety and are willing to learn from one another and that they have done an excellent job of disseminating the best practices they have been exploring.

Ultimately, their goal is to grow this into a “more robust clinical research consortium,” says Dr. Flanders. Instead of disseminating best practices and focusing on just a few targeted patient safety quality improvement areas, they will begin to take on studies that could center around patient safety and quality improvement but will also move toward multi-center projects that might address issues related to management of common clinical problems that hospitalists are now managing and focusing on.

“We’re really excited about what we have been able to accomplish,” he says. “We’ve learned a lot about the challenges of doing this, and of course it’s never perfect. We wish we could always do more, but we’ve learned why we can’t. That will be helpful in future projects and helpful for others who are trying to tackle this same problem.” TH

Reference

1. Flanders SA, Kaufman SR, Saint S. Hospitalists as emerging leaders in patient safety: targeting a few to affect many. J Patient Safety. 2005;1(2):78-82.

In the football-loving state of Michigan, legendary athletes take their cues from a coach and map their strategies for one big group effort. But Michigan is also home to what may be the first-ever homegrown regional consortium for patient safety and quality improvement—and in this case—after a huddle each team member gets to call his own plays.

The Hospitalists as Emerging Leaders in Patient Safety (HELPS) Consortium of Southeastern Michigan (funded by a grant from the Blue Cross Blue Shield of Michigan Foundation) includes representatives from nine regional hospitalist programs representing 11 hospitals and approximately 75,000 patients.1

The participants in this program identify proven patient safety practices and facilitate widespread dissemination of those practices among hospitalists.

The member institutions include academic medical centers, large private teaching and non-teaching hospitals, federal facilities, and urban and rural hospitals.

Each institution is represented by a hospitalist—usually the director of the hospitalist program or the individual most interested in and familiar with quality improvement—and a representative from quality improvement or patient safety. The issues they have addressed, which emerged from a variety of sources, such as the Agency of Healthcare Research and Quality, the National Quality Forum, and the Joint Commission on Accreditation of Healthcare Organizations, are those that are commonly encountered in hospitalist practice. These physicians “are bridging the gap between that which they know to be effective and that which is actually practiced.”1

HELPS builds on the experience of medical professionals who have united geographically dispersed physicians from the same specialty to boost quality. The HELPS consortium also aids participating institutions in evaluating outcomes after implementing a targeted patient safety practice, thereby allowing rapid cycle improvement while identifying factors associated with success.

“We have gotten the work that is being done by these different organizations out there, brought it up a notch in certain situations—we like to think—and have gotten it effectively disseminated to a larger group of hospitalists,” says Scott Flanders, MD, an associate professor of medicine at the University of Michigan (Ann Arbor), director of the hospital medicine program there, and an SHM board member.

Where They Are

The consortium is about three-quarters of the way through its overall estimated project period, says Dr. Flanders. It originally planned to have nine gatherings over two years. (See Table 1, p. 35.) To date the consortium has held seven of those sessions and have met roughly every two to three months. End-of-life care and the final wrap-up are the only sessions still to be completed.

The individual sites took on projects that included reducing errors with heparin use in hospitalized patients, reducing falls in hospitalized patients, improving care transitions (a collaborative multidisciplinary approach), reducing unnecessary ICU admission and preventing in-hospital cardiac arrests, reducing urinary catheter infections, improving rates of appropriate deep vein thrombosis prophylaxis, and implementing best practices for reducing central line infections. A national expert conducted a session on implementing a program to reduce perioperative cardiovascular events while ensuring the appropriate use of perioperative beta-blockers.

Challenges and Lessons Learned

From the outset, the HELPS group knew that its primary challenge would be to fulfill the intention to meet as a complete group four or five times per year. “There aren’t a lot of hospitalists who have big parts of their jobs carved out for dedicated time to work on quality improvement research or patient safety,” says Dr. Flanders. “It’s part of what we do in our day, but in terms of taking on a big project, designing it, implementing it, and measuring its effect, it is hard to do in the day-to-day job of most hospitalist groups.”

He suspects that hospitalists frequently help steering committees address certain issues, “but it may not be the individual hospitalist group that is managing or driving the quality issue for an entire hospital or health system.” The HELPS physicians knew that if they could surmount the scheduling challenge, however, they would have a terrific opportunity to learn from each other and move their individual institutional patient safety initiatives forward.

They also knew that the majority of hospitalized patients receive care in community hospitals and that the culture of a community hospital differed dramatically from a tertiary-care academic medical center. Interventions would need to be tried at varied settings, and HELPS would allow that to happen. In addition, few clinically active hospitalists have developed the research expertise to evaluate an intervention rigorously at their own institution, yet decision makers often require such an evaluation when they are considering adopting a new intervention. Using the resources of an academic center such as the University of Michigan, where evaluative and methodologic expertise is available, allowed them to facilitate a resolution for that problem. “As physicians, we are helping [smaller hospitals] by facilitating data collection and data analysis for their ongoing projects,” says Dr. Flanders.

Another challenge the hospitalists faced pertained to the relative instability of hospital medicine compared with other specialties. For instance, it is probably far easier for the members of the consortium of cardiology groups working on best practices for managing acute myocardial infarction to find time to work together. In contrast, because hospital medicine is a relatively new specialty, “we are seeing a certain amount of instability,” explains Dr. Flanders. “Of our nine involved health systems, at least two had dramatic organizational and structural changes within their hospital medicine group over the last year and a half.” One hospital medicine director left, with repercussions in several areas, and, in another group, the practice was sold to a large physician management company, which meant that the HELPS data that had been collected was no longer owned by the [original] group, making their activities more complex.

What They’ve Done So Far

Dr. Flanders is not aware of any other groups of physicians from another state who have undertaken such a project. The Institute for Healthcare Improvement’s “100,000 Lives Campaign” may be similar in some ways, focusing on a few key topic areas. The Michigan Keystone Project, which concentrated on various ICU patient safety topics, is another example of a regional consortium. “But the difference is that they basically drive the agenda,” he says. “They say, ‘This is what we want you all to do, and let’s figure out how we can all do it.’ In our case, we focused on some key areas, but we did not dictate what the project was.”

The following brief recaps represent some of the projects undertaken by consortium member sites.

Falls

The University of Michigan-affiliated Ann Arbor Veterans Affairs (VA) Hospital, where Sanjay Saint, MD, MPH, is a hospitalist, has many elderly and cognitively impaired patients, so preventing falls is a big issue. “My responsibility isn’t to prevent falls but to share these best practices with others in my organization,” he says. “In fact, each project team points out where to look with a certain problem but not necessarily what to do.”

Dr. Saint brought up the issue of mattresses with lipped/raised edges to prevent patients from rolling out of bed. Following that, at least one other consortium hospital suggested to its fall prevention group that they explore the use of these lipped mattresses.

Bed alarms were another problem. Participants shared a common problem: Often, nurses wouldn’t hear a patient’s alarm go off. Other providers might reset them, but if they neglected to let the assigned nurse know the patient was calling, the patient might get tired of waiting, attempt to get out of bed, and sustain a fall. Consequently, providers in most institutions thought the alarms were not useful. But one institution identified a novel way to use bed alarms: attaching them to the nurse’s pager. Now, when the alarm goes off, it alerts the appropriate nurse directly, and because that nurse is responsible for resetting the alarm, she knows that the patient has called and needs help.

Changing Names: CARE Assistants

To avoid the use of physical or chemical restraints, many institutions have resorted to hiring “sitters” who stay at the bedside of confused or delirious patients to calm them; if patients try to get out of bed, sitters are there to coax them back in. A number of HELPS institutions shared the idea that using the term “sitter” might have been inadvertently encouraging inactivity: Too many sitters were doing just that, sitting all day, often watching television.

One of the collaborative sites now calls these employees CARE assistants, an acronym for Caring Alternative to a Restraint-free Environment. The group has predicted that calling them something different will inspire these people to “do more caring and less sitting,” says Dr. Saint. After a HELPS session, Dr. Saint submitted this idea to the key decision makers at the VA. “I could have tried by myself to resolve this dilemma for years and not come up with that idea,” he says. “Why not just take what they’ve done and modify it to suit your own environment?”

Weighty Problem: Heparin Dosing

One hospital in the consortium conducted a project on medication safety that focused on appropriate use of heparin in hospitalized patients. When the site’s hospitalists began studying the problems they were having, they realized that the weights they were using for dosing decisions were being generated in the emergency department (ED). Studying it further, they saw that, most of the time, those patients weren’t actually being weighed; nurses were simply estimating their weights. Having traced the problem to the ED, they were then able to intervene, fix the problem, and show that by doing so their rates of bleeding complications from inappropriate dosing of anticoagulants improved.

At his own institution, Dr. Flanders was participating in a group committee meeting discussing this problem. Consequently, “I was able to ask, ‘Have we looked at weights [being assessed] in the emergency department?’ Everyone involved with that project said, ‘No, why?’ And, sure enough, a similar problem existed.”

Care Transitions and Multidisciplinary Rounding

One member-team of the consortium was able to come up with a multidisciplinary team that met and rounded on patients each day and focused on the care transitions. They were able to dramatically improve staff communication, the overall discharge process, and patient satisfaction. As a result of what he learned of their successes, Dr. Flanders’ institution plans to use a similar strategy to enhance communication among healthcare providers involved in the discharge process on their hospitalist unit.

Rapid Response Teams and Input from Residents

“It’s very helpful to hear, from another site, the challenges and benefits of having hospitalists involved with the rapid response teams,” says Dr. Saint. “How did they operationalize it? What were the remaining challenges? What outcome measures did they use? How do you assess whether it’s worth the cost? What do residents think about this?

This last point turned out to be a valuable question to ask. The group included some residents at the site where this project was piloted and had a fruitful discussion. Adding the perspective of residents along with faculty, says Dr. Saint, as well as a couple of nurses and quality care managers, allows a synergy and combination of ideas that led to effective solutions. “Those are exactly the individuals who need to be around a table to overcome some of the challenges.” They have also considered inviting nursing students. “Before they get inculcated in thinking a certain way,” he says, “why not hear what they have to say?”

Dr. Saint believes, however, that this is not a step to be taken lightly. If you are going to include people, “then you have to act on their suggestions or at least hear them out and say why you’re not going to take their suggestions because a good way to get people to become jaded is to listen to their feedback and then just ignore it.”

click for large version

Calling in Outside Experts

To focus on the issue of preventing hospital-acquired urinary tract infections (UTIs), the consortium invited Russell Olmstead, MPH, an infection control expert and epidemiologist at one of the HELPS sites and past president of the Michigan Society of Infection Control.

“We’d like to do a Keystone[-type] UTI project,” says Dr. Saint, referring to the federally funded statewide three-year initiative, conducted in collaboration with the Michigan Hospital Association and Johns Hopkins Research and Safety Group, that focused on applying evidence-based medicine and quality improvement efforts to prevent ventilator-associated pneumonia and central line-related infections. “We’ve called it the Bladder Bundle; that is, you bundle a group of practices together, and you give the hospitalists who want to participate a toolkit in order to roll this out.”

Although the details still need to be finalized, the project would include ensuring that patients have appropriate indication for an indwelling catheter, that the indwelling catheter is inserted in an aseptic manner, that there was some type of assessment of discontinuation after a certain amount of time, and that alternatives to an indwelling catheter are considered.

Another expert consulting with the consortium was Peter Lindenauer, MD, MSc, with the Division of Healthcare Quality, Baystate Medical Center, Springfield, Mass., and the Department of Medicine, Tufts University School of Medicine, Boston. Dr. Lindenauer came to discuss lessons he and his colleagues have learned from efforts to improve appropriate perioperative beta blocker use.

The final HELPS wrap-up session for the group will include another nationally renowned expert in patient safety.

SHARP: Research Translated into Practice

Another project initiated by the Michigan hospitalists will generate and disseminate new knowledge in the realm of clinical research. The Specialist-Hospitalist Allied Research Program (SHARP), directed by Dr. Flanders and Brahmajee Nallamothu, MD, MPH, an interventional cardiologist, is the first specialist-hospitalist clinical research program in the United States. This hospitalist delivery model alters the way clinical problems are approached and creates opportunities and challenges in implementing best practices, including those surrounding drugs and devices. A successful clinical and translational research program will combine specialists and hospitalists working collaboratively to better understand the best ways to care for inpatients.

This project is similar to what cardiology and oncology specialties have done over the last several decades, says Dr. Saint. In the future, he foresees that the NIH will increasingly focus on translating research into practice in diverse settings. Both specialists and hospitalists who work in a particular area together—such as prevention of lower extremity clots or of nosocomial infections—can use the health consortium to roll out protocols and studies in order to tackle some of the important inpatient topics.

SHARP was awarded funding through the University of Michigan Department of Medicine and was scheduled to take off in February. “Our hope is that we will be able to take advantage of and build upon the health collaborative that we have and bring in our subspecialty expertise to help inform clinical investigations,” says Dr. Saint.

Where They’re Going

Both Dr. Flanders and Dr. Saint are pleased about the HELPS consortium’s progress so far. They believe that they have found a group of people who are interested in patient safety and are willing to learn from one another and that they have done an excellent job of disseminating the best practices they have been exploring.

Ultimately, their goal is to grow this into a “more robust clinical research consortium,” says Dr. Flanders. Instead of disseminating best practices and focusing on just a few targeted patient safety quality improvement areas, they will begin to take on studies that could center around patient safety and quality improvement but will also move toward multi-center projects that might address issues related to management of common clinical problems that hospitalists are now managing and focusing on.

“We’re really excited about what we have been able to accomplish,” he says. “We’ve learned a lot about the challenges of doing this, and of course it’s never perfect. We wish we could always do more, but we’ve learned why we can’t. That will be helpful in future projects and helpful for others who are trying to tackle this same problem.” TH

Reference

1. Flanders SA, Kaufman SR, Saint S. Hospitalists as emerging leaders in patient safety: targeting a few to affect many. J Patient Safety. 2005;1(2):78-82.

In the football-loving state of Michigan, legendary athletes take their cues from a coach and map their strategies for one big group effort. But Michigan is also home to what may be the first-ever homegrown regional consortium for patient safety and quality improvement—and in this case—after a huddle each team member gets to call his own plays.

The Hospitalists as Emerging Leaders in Patient Safety (HELPS) Consortium of Southeastern Michigan (funded by a grant from the Blue Cross Blue Shield of Michigan Foundation) includes representatives from nine regional hospitalist programs representing 11 hospitals and approximately 75,000 patients.1

The participants in this program identify proven patient safety practices and facilitate widespread dissemination of those practices among hospitalists.

The member institutions include academic medical centers, large private teaching and non-teaching hospitals, federal facilities, and urban and rural hospitals.

Each institution is represented by a hospitalist—usually the director of the hospitalist program or the individual most interested in and familiar with quality improvement—and a representative from quality improvement or patient safety. The issues they have addressed, which emerged from a variety of sources, such as the Agency of Healthcare Research and Quality, the National Quality Forum, and the Joint Commission on Accreditation of Healthcare Organizations, are those that are commonly encountered in hospitalist practice. These physicians “are bridging the gap between that which they know to be effective and that which is actually practiced.”1

HELPS builds on the experience of medical professionals who have united geographically dispersed physicians from the same specialty to boost quality. The HELPS consortium also aids participating institutions in evaluating outcomes after implementing a targeted patient safety practice, thereby allowing rapid cycle improvement while identifying factors associated with success.

“We have gotten the work that is being done by these different organizations out there, brought it up a notch in certain situations—we like to think—and have gotten it effectively disseminated to a larger group of hospitalists,” says Scott Flanders, MD, an associate professor of medicine at the University of Michigan (Ann Arbor), director of the hospital medicine program there, and an SHM board member.

Where They Are

The consortium is about three-quarters of the way through its overall estimated project period, says Dr. Flanders. It originally planned to have nine gatherings over two years. (See Table 1, p. 35.) To date the consortium has held seven of those sessions and have met roughly every two to three months. End-of-life care and the final wrap-up are the only sessions still to be completed.

The individual sites took on projects that included reducing errors with heparin use in hospitalized patients, reducing falls in hospitalized patients, improving care transitions (a collaborative multidisciplinary approach), reducing unnecessary ICU admission and preventing in-hospital cardiac arrests, reducing urinary catheter infections, improving rates of appropriate deep vein thrombosis prophylaxis, and implementing best practices for reducing central line infections. A national expert conducted a session on implementing a program to reduce perioperative cardiovascular events while ensuring the appropriate use of perioperative beta-blockers.

Challenges and Lessons Learned

From the outset, the HELPS group knew that its primary challenge would be to fulfill the intention to meet as a complete group four or five times per year. “There aren’t a lot of hospitalists who have big parts of their jobs carved out for dedicated time to work on quality improvement research or patient safety,” says Dr. Flanders. “It’s part of what we do in our day, but in terms of taking on a big project, designing it, implementing it, and measuring its effect, it is hard to do in the day-to-day job of most hospitalist groups.”

He suspects that hospitalists frequently help steering committees address certain issues, “but it may not be the individual hospitalist group that is managing or driving the quality issue for an entire hospital or health system.” The HELPS physicians knew that if they could surmount the scheduling challenge, however, they would have a terrific opportunity to learn from each other and move their individual institutional patient safety initiatives forward.

They also knew that the majority of hospitalized patients receive care in community hospitals and that the culture of a community hospital differed dramatically from a tertiary-care academic medical center. Interventions would need to be tried at varied settings, and HELPS would allow that to happen. In addition, few clinically active hospitalists have developed the research expertise to evaluate an intervention rigorously at their own institution, yet decision makers often require such an evaluation when they are considering adopting a new intervention. Using the resources of an academic center such as the University of Michigan, where evaluative and methodologic expertise is available, allowed them to facilitate a resolution for that problem. “As physicians, we are helping [smaller hospitals] by facilitating data collection and data analysis for their ongoing projects,” says Dr. Flanders.

Another challenge the hospitalists faced pertained to the relative instability of hospital medicine compared with other specialties. For instance, it is probably far easier for the members of the consortium of cardiology groups working on best practices for managing acute myocardial infarction to find time to work together. In contrast, because hospital medicine is a relatively new specialty, “we are seeing a certain amount of instability,” explains Dr. Flanders. “Of our nine involved health systems, at least two had dramatic organizational and structural changes within their hospital medicine group over the last year and a half.” One hospital medicine director left, with repercussions in several areas, and, in another group, the practice was sold to a large physician management company, which meant that the HELPS data that had been collected was no longer owned by the [original] group, making their activities more complex.

What They’ve Done So Far

Dr. Flanders is not aware of any other groups of physicians from another state who have undertaken such a project. The Institute for Healthcare Improvement’s “100,000 Lives Campaign” may be similar in some ways, focusing on a few key topic areas. The Michigan Keystone Project, which concentrated on various ICU patient safety topics, is another example of a regional consortium. “But the difference is that they basically drive the agenda,” he says. “They say, ‘This is what we want you all to do, and let’s figure out how we can all do it.’ In our case, we focused on some key areas, but we did not dictate what the project was.”

The following brief recaps represent some of the projects undertaken by consortium member sites.

Falls

The University of Michigan-affiliated Ann Arbor Veterans Affairs (VA) Hospital, where Sanjay Saint, MD, MPH, is a hospitalist, has many elderly and cognitively impaired patients, so preventing falls is a big issue. “My responsibility isn’t to prevent falls but to share these best practices with others in my organization,” he says. “In fact, each project team points out where to look with a certain problem but not necessarily what to do.”

Dr. Saint brought up the issue of mattresses with lipped/raised edges to prevent patients from rolling out of bed. Following that, at least one other consortium hospital suggested to its fall prevention group that they explore the use of these lipped mattresses.

Bed alarms were another problem. Participants shared a common problem: Often, nurses wouldn’t hear a patient’s alarm go off. Other providers might reset them, but if they neglected to let the assigned nurse know the patient was calling, the patient might get tired of waiting, attempt to get out of bed, and sustain a fall. Consequently, providers in most institutions thought the alarms were not useful. But one institution identified a novel way to use bed alarms: attaching them to the nurse’s pager. Now, when the alarm goes off, it alerts the appropriate nurse directly, and because that nurse is responsible for resetting the alarm, she knows that the patient has called and needs help.

Changing Names: CARE Assistants

To avoid the use of physical or chemical restraints, many institutions have resorted to hiring “sitters” who stay at the bedside of confused or delirious patients to calm them; if patients try to get out of bed, sitters are there to coax them back in. A number of HELPS institutions shared the idea that using the term “sitter” might have been inadvertently encouraging inactivity: Too many sitters were doing just that, sitting all day, often watching television.

One of the collaborative sites now calls these employees CARE assistants, an acronym for Caring Alternative to a Restraint-free Environment. The group has predicted that calling them something different will inspire these people to “do more caring and less sitting,” says Dr. Saint. After a HELPS session, Dr. Saint submitted this idea to the key decision makers at the VA. “I could have tried by myself to resolve this dilemma for years and not come up with that idea,” he says. “Why not just take what they’ve done and modify it to suit your own environment?”

Weighty Problem: Heparin Dosing

One hospital in the consortium conducted a project on medication safety that focused on appropriate use of heparin in hospitalized patients. When the site’s hospitalists began studying the problems they were having, they realized that the weights they were using for dosing decisions were being generated in the emergency department (ED). Studying it further, they saw that, most of the time, those patients weren’t actually being weighed; nurses were simply estimating their weights. Having traced the problem to the ED, they were then able to intervene, fix the problem, and show that by doing so their rates of bleeding complications from inappropriate dosing of anticoagulants improved.

At his own institution, Dr. Flanders was participating in a group committee meeting discussing this problem. Consequently, “I was able to ask, ‘Have we looked at weights [being assessed] in the emergency department?’ Everyone involved with that project said, ‘No, why?’ And, sure enough, a similar problem existed.”

Care Transitions and Multidisciplinary Rounding

One member-team of the consortium was able to come up with a multidisciplinary team that met and rounded on patients each day and focused on the care transitions. They were able to dramatically improve staff communication, the overall discharge process, and patient satisfaction. As a result of what he learned of their successes, Dr. Flanders’ institution plans to use a similar strategy to enhance communication among healthcare providers involved in the discharge process on their hospitalist unit.

Rapid Response Teams and Input from Residents

“It’s very helpful to hear, from another site, the challenges and benefits of having hospitalists involved with the rapid response teams,” says Dr. Saint. “How did they operationalize it? What were the remaining challenges? What outcome measures did they use? How do you assess whether it’s worth the cost? What do residents think about this?

This last point turned out to be a valuable question to ask. The group included some residents at the site where this project was piloted and had a fruitful discussion. Adding the perspective of residents along with faculty, says Dr. Saint, as well as a couple of nurses and quality care managers, allows a synergy and combination of ideas that led to effective solutions. “Those are exactly the individuals who need to be around a table to overcome some of the challenges.” They have also considered inviting nursing students. “Before they get inculcated in thinking a certain way,” he says, “why not hear what they have to say?”

Dr. Saint believes, however, that this is not a step to be taken lightly. If you are going to include people, “then you have to act on their suggestions or at least hear them out and say why you’re not going to take their suggestions because a good way to get people to become jaded is to listen to their feedback and then just ignore it.”

click for large version

Calling in Outside Experts

To focus on the issue of preventing hospital-acquired urinary tract infections (UTIs), the consortium invited Russell Olmstead, MPH, an infection control expert and epidemiologist at one of the HELPS sites and past president of the Michigan Society of Infection Control.

“We’d like to do a Keystone[-type] UTI project,” says Dr. Saint, referring to the federally funded statewide three-year initiative, conducted in collaboration with the Michigan Hospital Association and Johns Hopkins Research and Safety Group, that focused on applying evidence-based medicine and quality improvement efforts to prevent ventilator-associated pneumonia and central line-related infections. “We’ve called it the Bladder Bundle; that is, you bundle a group of practices together, and you give the hospitalists who want to participate a toolkit in order to roll this out.”

Although the details still need to be finalized, the project would include ensuring that patients have appropriate indication for an indwelling catheter, that the indwelling catheter is inserted in an aseptic manner, that there was some type of assessment of discontinuation after a certain amount of time, and that alternatives to an indwelling catheter are considered.

Another expert consulting with the consortium was Peter Lindenauer, MD, MSc, with the Division of Healthcare Quality, Baystate Medical Center, Springfield, Mass., and the Department of Medicine, Tufts University School of Medicine, Boston. Dr. Lindenauer came to discuss lessons he and his colleagues have learned from efforts to improve appropriate perioperative beta blocker use.

The final HELPS wrap-up session for the group will include another nationally renowned expert in patient safety.

SHARP: Research Translated into Practice

Another project initiated by the Michigan hospitalists will generate and disseminate new knowledge in the realm of clinical research. The Specialist-Hospitalist Allied Research Program (SHARP), directed by Dr. Flanders and Brahmajee Nallamothu, MD, MPH, an interventional cardiologist, is the first specialist-hospitalist clinical research program in the United States. This hospitalist delivery model alters the way clinical problems are approached and creates opportunities and challenges in implementing best practices, including those surrounding drugs and devices. A successful clinical and translational research program will combine specialists and hospitalists working collaboratively to better understand the best ways to care for inpatients.

This project is similar to what cardiology and oncology specialties have done over the last several decades, says Dr. Saint. In the future, he foresees that the NIH will increasingly focus on translating research into practice in diverse settings. Both specialists and hospitalists who work in a particular area together—such as prevention of lower extremity clots or of nosocomial infections—can use the health consortium to roll out protocols and studies in order to tackle some of the important inpatient topics.

SHARP was awarded funding through the University of Michigan Department of Medicine and was scheduled to take off in February. “Our hope is that we will be able to take advantage of and build upon the health collaborative that we have and bring in our subspecialty expertise to help inform clinical investigations,” says Dr. Saint.

Where They’re Going

Both Dr. Flanders and Dr. Saint are pleased about the HELPS consortium’s progress so far. They believe that they have found a group of people who are interested in patient safety and are willing to learn from one another and that they have done an excellent job of disseminating the best practices they have been exploring.

Ultimately, their goal is to grow this into a “more robust clinical research consortium,” says Dr. Flanders. Instead of disseminating best practices and focusing on just a few targeted patient safety quality improvement areas, they will begin to take on studies that could center around patient safety and quality improvement but will also move toward multi-center projects that might address issues related to management of common clinical problems that hospitalists are now managing and focusing on.

“We’re really excited about what we have been able to accomplish,” he says. “We’ve learned a lot about the challenges of doing this, and of course it’s never perfect. We wish we could always do more, but we’ve learned why we can’t. That will be helpful in future projects and helpful for others who are trying to tackle this same problem.” TH

Reference

1. Flanders SA, Kaufman SR, Saint S. Hospitalists as emerging leaders in patient safety: targeting a few to affect many. J Patient Safety. 2005;1(2):78-82.

Supplement Editor:
Guy M. Chisolm III, PhD

Contents

From the editor
The rapidly changing landscape of biomedical conflicts of interest
Guy M. Chisolm III, PhD, Vice Chairman, Lerner Research Institute, and Professor, Department of Cell Biology, Cleveland Clinic

Opening comments
The mandate of innovation management
Delos M. Cosgrove, MD, CEO and President, Cleveland Clinic

Research, Innovation, and Safety: Doing the Right Thing
Prologue: A case study in biomedical conflicts
Nina Totenberg, Legal Affairs Correspondent, National Public Radio

Fostering innovation without compromising integrity
Philip A. Pizzo, MD, Dean and Professor of Pediatrics and of Microbiology and Immunology, Stanford University School of Medicine

Innovation and industry-academia interactions:Where conflicts arise and measures to avoid them
P. Roy Vagelos, MD, Chairman, Regeneron Pharmaceuticals, Inc.; Chairman, Theravance, Inc.; Former CEO, Merck & Co., Inc.

Overregulation of conflicts hinders medical progress
Thomas P. Stossel, MD, Professor of Medicine, Harvard Medical School

Panel discussion: Research, innovation, and safety: Doing the right thing
Moderated by Nina Totenberg, Legal Affairs Correspondent, National Public Radio
Panelists: Philip A. Pizzo, MD; Thomas P. Stossel, MD; and P. Roy Vagelos, MD

Guiding Principles:Where Are We Headed?
Conflict-of-interest management: Efforts and insights from the Association of American Medical Colleges
Darrell G. Kirch, MD, President and CEO, Association of American Medical Colleges

Medical devices and conflict of interest: Unique issues and an industry code to address them
Paul A. LaViolette, MBA, Chief Operating Officer, Boston Scientific Corporation; Member, Board of Directors, and Chairman, Special Committee on Codes of Ethics, AdvaMed

The challenge for NIH ethics policies: Preserving public trust and biomedical progress
Norka Ruiz Bravo, PhD, Deputy Director for Extramural Research, National Institutes of Health

Panel discussion: Guiding principles:Where are we headed?
Moderated by Nina Totenberg, Legal Affairs Correspondent, National Public Radio
Panelists: Darrell G. Kirch, MD; Paul A. LaViolette, MBA; and Norka Ruiz Bravo, PhD

Keynote Address
Building and retaining trust in the biomedical community
Dick Thornburgh, Counsel, K & L Gates; Former Governor of Pennsylvania; Former Attorney General of the United States

Applications in the Real World: Defining Boundaries and Managing Innovation
Interactions of the public and private sectors in drug development: Boundaries to protect scientific values while preserving innovation
Gail H. Cassell, PhD, DSc (hon), Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company

Beyond disclosure: The necessity of trust in biomedical research
Jeffrey P. Kahn, PhD, MPH, Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota

Panel discussion: Applications in the real world: Case studies in defining boundaries and managing innovation
Moderated by Claudia R. Adkison, JD, PhD, Executive Associate Dean, Administration and Faculty Affairs, Emory University School of Medicine
Case studies submitted by Michael J. Meehan, Esq., Senior Counsel and Corporate Assistant Secretary, Cleveland Clinic, and Claudia R. Adkison, JD, PhD
Panelists: Gail H. Cassell, PhD, DSc (hon); Jeffrey P. Kahn, PhD, MPH; Philip A. Pizzo, MD; and Thomas P. Stossel, MD

Conflicts, Compliance, and Enforcement: Government Priorities and Initiatives
Protecting subjects without hampering research progress: Guidance from the Office for Human Research Protections
Bernard A. Schwetz, DVM, PhD, Director, Office for Human Research Protections, US Department of Health and Human Services

Fraud, conflict of interest, and other enforcement issues in clinical research
James G. Sheehan, Associate US Attorney, US Attorney’s Office, US Department of Justice

Panel discussion: Conflicts, compliance, and enforcement: Government priorities and initiatives
Moderated by Jeffrey P. Kahn, PhD, MPH, Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota
Panelists: Bernard A. Schwetz, DVM, PhD, and James G. Sheehan

Guidelines and Performance: Creating a Culture of Ethics
Creating an institutional conflict-of-interest policy at Johns Hopkins: Progress and lessons learned
Edward D. Miller, MD, Dean of the Medical Faculty, Johns Hopkins School of Medicine; CEO, Johns Hopkins Medicine

Managing ethical performance in organizations: Insights from the corporate world
Edward Soule, CPA, PhD, Associate Professor, McDonough School of Business, Georgetown University

Panel discussion: Guidelines and performance: Creating a culture of ethics
Moderated by Susan H. Ehringhaus, JD, Associate General Counsel for Regulatory Affairs, Association of American Medical Colleges
Panelists: Edward D. Miller, MD, and Edward Soule, CPA, PhD

Articles in these proceedings were developed by the Cleveland Clinic Journal of Medicine staff from transcripts of audiotaped presentations at the “National Dialogue on Biomedical Conflicts of Interest and Innovation Management” and then reviewed and revised by the respective speakers.

Supplement Editor:
Guy M. Chisolm III, PhD

Contents

From the editor
The rapidly changing landscape of biomedical conflicts of interest
Guy M. Chisolm III, PhD, Vice Chairman, Lerner Research Institute, and Professor, Department of Cell Biology, Cleveland Clinic

Opening comments
The mandate of innovation management
Delos M. Cosgrove, MD, CEO and President, Cleveland Clinic

Research, Innovation, and Safety: Doing the Right Thing
Prologue: A case study in biomedical conflicts
Nina Totenberg, Legal Affairs Correspondent, National Public Radio

Fostering innovation without compromising integrity
Philip A. Pizzo, MD, Dean and Professor of Pediatrics and of Microbiology and Immunology, Stanford University School of Medicine

Innovation and industry-academia interactions:Where conflicts arise and measures to avoid them
P. Roy Vagelos, MD, Chairman, Regeneron Pharmaceuticals, Inc.; Chairman, Theravance, Inc.; Former CEO, Merck & Co., Inc.

Overregulation of conflicts hinders medical progress
Thomas P. Stossel, MD, Professor of Medicine, Harvard Medical School

Panel discussion: Research, innovation, and safety: Doing the right thing
Moderated by Nina Totenberg, Legal Affairs Correspondent, National Public Radio
Panelists: Philip A. Pizzo, MD; Thomas P. Stossel, MD; and P. Roy Vagelos, MD

Guiding Principles:Where Are We Headed?
Conflict-of-interest management: Efforts and insights from the Association of American Medical Colleges
Darrell G. Kirch, MD, President and CEO, Association of American Medical Colleges

Medical devices and conflict of interest: Unique issues and an industry code to address them
Paul A. LaViolette, MBA, Chief Operating Officer, Boston Scientific Corporation; Member, Board of Directors, and Chairman, Special Committee on Codes of Ethics, AdvaMed

The challenge for NIH ethics policies: Preserving public trust and biomedical progress
Norka Ruiz Bravo, PhD, Deputy Director for Extramural Research, National Institutes of Health

Panel discussion: Guiding principles:Where are we headed?
Moderated by Nina Totenberg, Legal Affairs Correspondent, National Public Radio
Panelists: Darrell G. Kirch, MD; Paul A. LaViolette, MBA; and Norka Ruiz Bravo, PhD

Keynote Address
Building and retaining trust in the biomedical community
Dick Thornburgh, Counsel, K & L Gates; Former Governor of Pennsylvania; Former Attorney General of the United States

Applications in the Real World: Defining Boundaries and Managing Innovation
Interactions of the public and private sectors in drug development: Boundaries to protect scientific values while preserving innovation
Gail H. Cassell, PhD, DSc (hon), Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company

Beyond disclosure: The necessity of trust in biomedical research
Jeffrey P. Kahn, PhD, MPH, Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota

Panel discussion: Applications in the real world: Case studies in defining boundaries and managing innovation
Moderated by Claudia R. Adkison, JD, PhD, Executive Associate Dean, Administration and Faculty Affairs, Emory University School of Medicine
Case studies submitted by Michael J. Meehan, Esq., Senior Counsel and Corporate Assistant Secretary, Cleveland Clinic, and Claudia R. Adkison, JD, PhD
Panelists: Gail H. Cassell, PhD, DSc (hon); Jeffrey P. Kahn, PhD, MPH; Philip A. Pizzo, MD; and Thomas P. Stossel, MD

Conflicts, Compliance, and Enforcement: Government Priorities and Initiatives
Protecting subjects without hampering research progress: Guidance from the Office for Human Research Protections
Bernard A. Schwetz, DVM, PhD, Director, Office for Human Research Protections, US Department of Health and Human Services

Fraud, conflict of interest, and other enforcement issues in clinical research
James G. Sheehan, Associate US Attorney, US Attorney’s Office, US Department of Justice

Panel discussion: Conflicts, compliance, and enforcement: Government priorities and initiatives
Moderated by Jeffrey P. Kahn, PhD, MPH, Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota
Panelists: Bernard A. Schwetz, DVM, PhD, and James G. Sheehan

Guidelines and Performance: Creating a Culture of Ethics
Creating an institutional conflict-of-interest policy at Johns Hopkins: Progress and lessons learned
Edward D. Miller, MD, Dean of the Medical Faculty, Johns Hopkins School of Medicine; CEO, Johns Hopkins Medicine

Managing ethical performance in organizations: Insights from the corporate world
Edward Soule, CPA, PhD, Associate Professor, McDonough School of Business, Georgetown University

Panel discussion: Guidelines and performance: Creating a culture of ethics
Moderated by Susan H. Ehringhaus, JD, Associate General Counsel for Regulatory Affairs, Association of American Medical Colleges
Panelists: Edward D. Miller, MD, and Edward Soule, CPA, PhD

Articles in these proceedings were developed by the Cleveland Clinic Journal of Medicine staff from transcripts of audiotaped presentations at the “National Dialogue on Biomedical Conflicts of Interest and Innovation Management” and then reviewed and revised by the respective speakers.

Supplement Editor:
Guy M. Chisolm III, PhD

Contents

From the editor
The rapidly changing landscape of biomedical conflicts of interest
Guy M. Chisolm III, PhD, Vice Chairman, Lerner Research Institute, and Professor, Department of Cell Biology, Cleveland Clinic

Opening comments
The mandate of innovation management
Delos M. Cosgrove, MD, CEO and President, Cleveland Clinic

Research, Innovation, and Safety: Doing the Right Thing
Prologue: A case study in biomedical conflicts
Nina Totenberg, Legal Affairs Correspondent, National Public Radio

Fostering innovation without compromising integrity
Philip A. Pizzo, MD, Dean and Professor of Pediatrics and of Microbiology and Immunology, Stanford University School of Medicine

Innovation and industry-academia interactions:Where conflicts arise and measures to avoid them
P. Roy Vagelos, MD, Chairman, Regeneron Pharmaceuticals, Inc.; Chairman, Theravance, Inc.; Former CEO, Merck & Co., Inc.

Overregulation of conflicts hinders medical progress
Thomas P. Stossel, MD, Professor of Medicine, Harvard Medical School

Panel discussion: Research, innovation, and safety: Doing the right thing
Moderated by Nina Totenberg, Legal Affairs Correspondent, National Public Radio
Panelists: Philip A. Pizzo, MD; Thomas P. Stossel, MD; and P. Roy Vagelos, MD

Guiding Principles:Where Are We Headed?
Conflict-of-interest management: Efforts and insights from the Association of American Medical Colleges
Darrell G. Kirch, MD, President and CEO, Association of American Medical Colleges

Medical devices and conflict of interest: Unique issues and an industry code to address them
Paul A. LaViolette, MBA, Chief Operating Officer, Boston Scientific Corporation; Member, Board of Directors, and Chairman, Special Committee on Codes of Ethics, AdvaMed

The challenge for NIH ethics policies: Preserving public trust and biomedical progress
Norka Ruiz Bravo, PhD, Deputy Director for Extramural Research, National Institutes of Health

Panel discussion: Guiding principles:Where are we headed?
Moderated by Nina Totenberg, Legal Affairs Correspondent, National Public Radio
Panelists: Darrell G. Kirch, MD; Paul A. LaViolette, MBA; and Norka Ruiz Bravo, PhD

Keynote Address
Building and retaining trust in the biomedical community
Dick Thornburgh, Counsel, K & L Gates; Former Governor of Pennsylvania; Former Attorney General of the United States

Applications in the Real World: Defining Boundaries and Managing Innovation
Interactions of the public and private sectors in drug development: Boundaries to protect scientific values while preserving innovation
Gail H. Cassell, PhD, DSc (hon), Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company

Beyond disclosure: The necessity of trust in biomedical research
Jeffrey P. Kahn, PhD, MPH, Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota

Panel discussion: Applications in the real world: Case studies in defining boundaries and managing innovation
Moderated by Claudia R. Adkison, JD, PhD, Executive Associate Dean, Administration and Faculty Affairs, Emory University School of Medicine
Case studies submitted by Michael J. Meehan, Esq., Senior Counsel and Corporate Assistant Secretary, Cleveland Clinic, and Claudia R. Adkison, JD, PhD
Panelists: Gail H. Cassell, PhD, DSc (hon); Jeffrey P. Kahn, PhD, MPH; Philip A. Pizzo, MD; and Thomas P. Stossel, MD

Conflicts, Compliance, and Enforcement: Government Priorities and Initiatives
Protecting subjects without hampering research progress: Guidance from the Office for Human Research Protections
Bernard A. Schwetz, DVM, PhD, Director, Office for Human Research Protections, US Department of Health and Human Services

Fraud, conflict of interest, and other enforcement issues in clinical research
James G. Sheehan, Associate US Attorney, US Attorney’s Office, US Department of Justice

Panel discussion: Conflicts, compliance, and enforcement: Government priorities and initiatives
Moderated by Jeffrey P. Kahn, PhD, MPH, Maas Family Chair in Bioethics and Director, Center for Bioethics, University of Minnesota
Panelists: Bernard A. Schwetz, DVM, PhD, and James G. Sheehan

Guidelines and Performance: Creating a Culture of Ethics
Creating an institutional conflict-of-interest policy at Johns Hopkins: Progress and lessons learned
Edward D. Miller, MD, Dean of the Medical Faculty, Johns Hopkins School of Medicine; CEO, Johns Hopkins Medicine

Managing ethical performance in organizations: Insights from the corporate world
Edward Soule, CPA, PhD, Associate Professor, McDonough School of Business, Georgetown University

Panel discussion: Guidelines and performance: Creating a culture of ethics
Moderated by Susan H. Ehringhaus, JD, Associate General Counsel for Regulatory Affairs, Association of American Medical Colleges
Panelists: Edward D. Miller, MD, and Edward Soule, CPA, PhD

Articles in these proceedings were developed by the Cleveland Clinic Journal of Medicine staff from transcripts of audiotaped presentations at the “National Dialogue on Biomedical Conflicts of Interest and Innovation Management” and then reviewed and revised by the respective speakers.

Hemoglobin concentrations in the high normal range in patients with anemia due to chronic kidney disease result in an excess risk of major adverse events, reported Arintaya Phrommintikul, MD, and colleagues from Monash University, Melbourne, Australia.

Adverse events include death, arteriovenous access thrombosis, and poorly controlled hypertension.

The investigators conducted a meta-analysis of 9 randomized controlled studies that enrolled 5143 patients treated with recombinant human erythropoietin.

Patients in the group targeted for a higher hemoglobin level (120-160 g/L) had a higher risk for all-cause mortality than patients in the lower hemoglobin target group (< 120 g/L) (risk ratio 1.17, P = 0.031).

There was also a higher risk for arteriovenous access thrombosis (risk ratio 1.34, P=0.0001) as well as a significantly higher risk of poorly controlled blood pressure (risk ratio 1.27, P=0.004) in the higher hemoglobin target group. The incidence of myocardial infarction was similar in the two groups.

Current guidelines recommend the maintenance of hemoglobin concentrations at 110 g/L or higher, based mainly on evidence of benefit in quality-of-life measures.

Current guidelines do not include an upper limit for the target hemoglobin concentration. The authors suggest that an upper limit should be added in future revisions of guideline recommendations.

The study was published in the 3 February 2007 issue of Lancet. 

Hemoglobin concentrations in the high normal range in patients with anemia due to chronic kidney disease result in an excess risk of major adverse events, reported Arintaya Phrommintikul, MD, and colleagues from Monash University, Melbourne, Australia.

Adverse events include death, arteriovenous access thrombosis, and poorly controlled hypertension.

The investigators conducted a meta-analysis of 9 randomized controlled studies that enrolled 5143 patients treated with recombinant human erythropoietin.

Patients in the group targeted for a higher hemoglobin level (120-160 g/L) had a higher risk for all-cause mortality than patients in the lower hemoglobin target group (< 120 g/L) (risk ratio 1.17, P = 0.031).

There was also a higher risk for arteriovenous access thrombosis (risk ratio 1.34, P=0.0001) as well as a significantly higher risk of poorly controlled blood pressure (risk ratio 1.27, P=0.004) in the higher hemoglobin target group. The incidence of myocardial infarction was similar in the two groups.

Current guidelines recommend the maintenance of hemoglobin concentrations at 110 g/L or higher, based mainly on evidence of benefit in quality-of-life measures.

Current guidelines do not include an upper limit for the target hemoglobin concentration. The authors suggest that an upper limit should be added in future revisions of guideline recommendations.

The study was published in the 3 February 2007 issue of Lancet. 

Hemoglobin concentrations in the high normal range in patients with anemia due to chronic kidney disease result in an excess risk of major adverse events, reported Arintaya Phrommintikul, MD, and colleagues from Monash University, Melbourne, Australia.

Adverse events include death, arteriovenous access thrombosis, and poorly controlled hypertension.

The investigators conducted a meta-analysis of 9 randomized controlled studies that enrolled 5143 patients treated with recombinant human erythropoietin.

Patients in the group targeted for a higher hemoglobin level (120-160 g/L) had a higher risk for all-cause mortality than patients in the lower hemoglobin target group (< 120 g/L) (risk ratio 1.17, P = 0.031).

There was also a higher risk for arteriovenous access thrombosis (risk ratio 1.34, P=0.0001) as well as a significantly higher risk of poorly controlled blood pressure (risk ratio 1.27, P=0.004) in the higher hemoglobin target group. The incidence of myocardial infarction was similar in the two groups.

Current guidelines recommend the maintenance of hemoglobin concentrations at 110 g/L or higher, based mainly on evidence of benefit in quality-of-life measures.

Current guidelines do not include an upper limit for the target hemoglobin concentration. The authors suggest that an upper limit should be added in future revisions of guideline recommendations.

The study was published in the 3 February 2007 issue of Lancet.