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Contact

Richard Rohr, MD

Milford Hospital

300 Seaside Avenue

Milford, CT 06460

Phone: 203-876-4000

richard.rohr@milfordhospital.org

Staff

Christine Chen, MD

Andrew Chow, MD

Renee Giometti, MD

Richard Rohr, MD

Michael Rudolph, MD

Keith Swan, MD

Yelena Titko, MD

The Milford Hospital Hospitalist Service program started in 1996 with 1 physician hired to provide coordination for inpatient medical care on weekdays. The hospital had previously offered only night coverage provided by moonlighting cardiology fellows. Milford Hospital has 100 beds, does not participate in any medical teaching programs, and competes with 5 teaching hospitals located within 10 miles. The community has traditionally preferred treatment in the local area, but concern about quality of medical services led many local residents to seek treatment at larger hospitals. The hospital had studied the hospitalist concept from its inception, but the medical staff did not immediately embrace the idea and feared encroachment upon their incomes. After several years of steadily increasing the role of the daytime care coordinator, the administration decided to convert the moonlighting positions in 2001 to 5 full-time employed physicians who provide 24-hour coverage in the facility. The medical staff has gradually become more comfortable with the hospitalist concept, although the internists still prefer to treat their own established patients. The community also recognizes the higher level of medical care provided, and the average daily census has nearly doubled since starting the program.

The service has been scheduled with 2 daytime physicians for 8 hours on each weekday, 1 daytime physician for 8 hours on Saturday and Sunday, and 1 physician for 16 hours every night. The staffing pattern was developed to accommodate an active joint replacement service with significant consultation needs on weekdays. The orthopedic service is expanding, and other surgeons have recognized the importance of immediate consultation, particularly as their malpractice premiums rise. The hospital administration has recognized the need for additional staffing, and the service will operate with 2 daytime physicians and 1 nighttime physician every day of the week starting in July 2005. An additional position has been created to meet the personnel needs.

The physicians are employed directly by the hospital and participate in the hospital’s benefit programs, including pension, disability insurance, life insurance, and a malpractice liability trust. There is presently no incentive plan, but the program has achieved a high level of effort from the staff. This is largely due to the culture of the hospital, which is highly collegial and patient-focused. Employees at all levels of the organization are treated well, and staff retention levels are quite high. Out of the first 10 full-time hospitalists hired, 4 are still in the program, 5 have pursued additional training, and 1 left to join her husband in California. One physician hired from a leading academic residency program found it difficult to adjust to a community hospital and resigned prior to year‘s end. The service has not experienced other personnel problems.

The program met its early staffing needs with physicians who had recently completed residency in internal medicine and were waiting to start a fellowship in 1 year. This type of staffing allowed the service to get started but required constant training in billing, continuity of care, and medical staff relations. As the program has become established in the region, it has attracted physicians who have previous experience with traditional private practice but have chosen to concentrate on inpatient care. This has allowed the program director to concentrate on advanced skill building with the staff and to spend less time on recruiting and scheduling.

Physicians are required to work 1,800 hours each year and may work additional hours for extra payment. The service admitted 600 patients (one-fourth of all medical admissions) in 2004 and provided consultation on 800 patients. The service also manages intensive care patients and handles emergencies throughout the hospital; there were 800 critical care visits last year. The staff performed a total of 6,200 billable patient visits in the past year and provided assistance to private physicians on 1,000 additional admissions. The number of billed admissions and visits has been constrained by limited weekend staffing. The service presently carries no more than 12 patients on weekends and up to 20 patients on weekdays. With the new staffing pattern, the service will round on up to 24 patients, with additional patients seen on a 1-time basis. Hospitalists normally admit patients who are not affiliated with a private physician on the hospital staff. When the hospital medicine service reaches its patient cap, private physicians must admit unaffiliated patients in rotation, as they did before the hospitalists were available. This accommodation will remain in place until the hospital medicine service is able to meet the entire demand for inpatient internal medicine services.

Postdischarge care coordination has been a major challenge. Approximately one-third of patients are discharged to nursing homes. Most of the others are affiliated with primary care physicians located in other communities who are not members of the Milford Hospital medical staff. Communication with these physicians has been improved by an electronic record management system that allows automated fax transmission of discharge summaries. Limited outpatient services are available for Medicaid patients and for those without insurance. The hospital medicine service does not provide outpatient care.

Another challenge involves care for critically ill patients. Although there are several physicians with training in pulmonary disease on the private staff, the hospital had not developed effective critical-care services. There are 2 hospitalists with critical-care training, and we have been working with the other staffers to improve their competence in critical care. The hospitalists provide 24-hour response to unstable patients throughout the hospital and have dramatically reduced unexpected mortality.

Future development will focus on improving hospitalist productivity with information technology. The hospital has undertaken installation of an integrated clinical-information system, which will include direct physician order entry and deployment of wireless technology. It is expected that many of the difficulties experienced by other hospitals with physician order entry will be ameliorated by hospitalist involvement, as the staff is comfortable with computer use. We also expect that the hospitalists will develop leadership roles within the medical staff and develop skills in quality improvement.

Contact

Richard Rohr, MD

Milford Hospital

300 Seaside Avenue

Milford, CT 06460

Phone: 203-876-4000

richard.rohr@milfordhospital.org

Staff

Christine Chen, MD

Andrew Chow, MD

Renee Giometti, MD

Richard Rohr, MD

Michael Rudolph, MD

Keith Swan, MD

Yelena Titko, MD

The Milford Hospital Hospitalist Service program started in 1996 with 1 physician hired to provide coordination for inpatient medical care on weekdays. The hospital had previously offered only night coverage provided by moonlighting cardiology fellows. Milford Hospital has 100 beds, does not participate in any medical teaching programs, and competes with 5 teaching hospitals located within 10 miles. The community has traditionally preferred treatment in the local area, but concern about quality of medical services led many local residents to seek treatment at larger hospitals. The hospital had studied the hospitalist concept from its inception, but the medical staff did not immediately embrace the idea and feared encroachment upon their incomes. After several years of steadily increasing the role of the daytime care coordinator, the administration decided to convert the moonlighting positions in 2001 to 5 full-time employed physicians who provide 24-hour coverage in the facility. The medical staff has gradually become more comfortable with the hospitalist concept, although the internists still prefer to treat their own established patients. The community also recognizes the higher level of medical care provided, and the average daily census has nearly doubled since starting the program.

The service has been scheduled with 2 daytime physicians for 8 hours on each weekday, 1 daytime physician for 8 hours on Saturday and Sunday, and 1 physician for 16 hours every night. The staffing pattern was developed to accommodate an active joint replacement service with significant consultation needs on weekdays. The orthopedic service is expanding, and other surgeons have recognized the importance of immediate consultation, particularly as their malpractice premiums rise. The hospital administration has recognized the need for additional staffing, and the service will operate with 2 daytime physicians and 1 nighttime physician every day of the week starting in July 2005. An additional position has been created to meet the personnel needs.

The physicians are employed directly by the hospital and participate in the hospital’s benefit programs, including pension, disability insurance, life insurance, and a malpractice liability trust. There is presently no incentive plan, but the program has achieved a high level of effort from the staff. This is largely due to the culture of the hospital, which is highly collegial and patient-focused. Employees at all levels of the organization are treated well, and staff retention levels are quite high. Out of the first 10 full-time hospitalists hired, 4 are still in the program, 5 have pursued additional training, and 1 left to join her husband in California. One physician hired from a leading academic residency program found it difficult to adjust to a community hospital and resigned prior to year‘s end. The service has not experienced other personnel problems.

The program met its early staffing needs with physicians who had recently completed residency in internal medicine and were waiting to start a fellowship in 1 year. This type of staffing allowed the service to get started but required constant training in billing, continuity of care, and medical staff relations. As the program has become established in the region, it has attracted physicians who have previous experience with traditional private practice but have chosen to concentrate on inpatient care. This has allowed the program director to concentrate on advanced skill building with the staff and to spend less time on recruiting and scheduling.

Physicians are required to work 1,800 hours each year and may work additional hours for extra payment. The service admitted 600 patients (one-fourth of all medical admissions) in 2004 and provided consultation on 800 patients. The service also manages intensive care patients and handles emergencies throughout the hospital; there were 800 critical care visits last year. The staff performed a total of 6,200 billable patient visits in the past year and provided assistance to private physicians on 1,000 additional admissions. The number of billed admissions and visits has been constrained by limited weekend staffing. The service presently carries no more than 12 patients on weekends and up to 20 patients on weekdays. With the new staffing pattern, the service will round on up to 24 patients, with additional patients seen on a 1-time basis. Hospitalists normally admit patients who are not affiliated with a private physician on the hospital staff. When the hospital medicine service reaches its patient cap, private physicians must admit unaffiliated patients in rotation, as they did before the hospitalists were available. This accommodation will remain in place until the hospital medicine service is able to meet the entire demand for inpatient internal medicine services.

Postdischarge care coordination has been a major challenge. Approximately one-third of patients are discharged to nursing homes. Most of the others are affiliated with primary care physicians located in other communities who are not members of the Milford Hospital medical staff. Communication with these physicians has been improved by an electronic record management system that allows automated fax transmission of discharge summaries. Limited outpatient services are available for Medicaid patients and for those without insurance. The hospital medicine service does not provide outpatient care.

Another challenge involves care for critically ill patients. Although there are several physicians with training in pulmonary disease on the private staff, the hospital had not developed effective critical-care services. There are 2 hospitalists with critical-care training, and we have been working with the other staffers to improve their competence in critical care. The hospitalists provide 24-hour response to unstable patients throughout the hospital and have dramatically reduced unexpected mortality.

Future development will focus on improving hospitalist productivity with information technology. The hospital has undertaken installation of an integrated clinical-information system, which will include direct physician order entry and deployment of wireless technology. It is expected that many of the difficulties experienced by other hospitals with physician order entry will be ameliorated by hospitalist involvement, as the staff is comfortable with computer use. We also expect that the hospitalists will develop leadership roles within the medical staff and develop skills in quality improvement.

Contact

Richard Rohr, MD

Milford Hospital

300 Seaside Avenue

Milford, CT 06460

Phone: 203-876-4000

richard.rohr@milfordhospital.org

Staff

Christine Chen, MD

Andrew Chow, MD

Renee Giometti, MD

Richard Rohr, MD

Michael Rudolph, MD

Keith Swan, MD

Yelena Titko, MD

The Milford Hospital Hospitalist Service program started in 1996 with 1 physician hired to provide coordination for inpatient medical care on weekdays. The hospital had previously offered only night coverage provided by moonlighting cardiology fellows. Milford Hospital has 100 beds, does not participate in any medical teaching programs, and competes with 5 teaching hospitals located within 10 miles. The community has traditionally preferred treatment in the local area, but concern about quality of medical services led many local residents to seek treatment at larger hospitals. The hospital had studied the hospitalist concept from its inception, but the medical staff did not immediately embrace the idea and feared encroachment upon their incomes. After several years of steadily increasing the role of the daytime care coordinator, the administration decided to convert the moonlighting positions in 2001 to 5 full-time employed physicians who provide 24-hour coverage in the facility. The medical staff has gradually become more comfortable with the hospitalist concept, although the internists still prefer to treat their own established patients. The community also recognizes the higher level of medical care provided, and the average daily census has nearly doubled since starting the program.

The service has been scheduled with 2 daytime physicians for 8 hours on each weekday, 1 daytime physician for 8 hours on Saturday and Sunday, and 1 physician for 16 hours every night. The staffing pattern was developed to accommodate an active joint replacement service with significant consultation needs on weekdays. The orthopedic service is expanding, and other surgeons have recognized the importance of immediate consultation, particularly as their malpractice premiums rise. The hospital administration has recognized the need for additional staffing, and the service will operate with 2 daytime physicians and 1 nighttime physician every day of the week starting in July 2005. An additional position has been created to meet the personnel needs.

The physicians are employed directly by the hospital and participate in the hospital’s benefit programs, including pension, disability insurance, life insurance, and a malpractice liability trust. There is presently no incentive plan, but the program has achieved a high level of effort from the staff. This is largely due to the culture of the hospital, which is highly collegial and patient-focused. Employees at all levels of the organization are treated well, and staff retention levels are quite high. Out of the first 10 full-time hospitalists hired, 4 are still in the program, 5 have pursued additional training, and 1 left to join her husband in California. One physician hired from a leading academic residency program found it difficult to adjust to a community hospital and resigned prior to year‘s end. The service has not experienced other personnel problems.

The program met its early staffing needs with physicians who had recently completed residency in internal medicine and were waiting to start a fellowship in 1 year. This type of staffing allowed the service to get started but required constant training in billing, continuity of care, and medical staff relations. As the program has become established in the region, it has attracted physicians who have previous experience with traditional private practice but have chosen to concentrate on inpatient care. This has allowed the program director to concentrate on advanced skill building with the staff and to spend less time on recruiting and scheduling.

Physicians are required to work 1,800 hours each year and may work additional hours for extra payment. The service admitted 600 patients (one-fourth of all medical admissions) in 2004 and provided consultation on 800 patients. The service also manages intensive care patients and handles emergencies throughout the hospital; there were 800 critical care visits last year. The staff performed a total of 6,200 billable patient visits in the past year and provided assistance to private physicians on 1,000 additional admissions. The number of billed admissions and visits has been constrained by limited weekend staffing. The service presently carries no more than 12 patients on weekends and up to 20 patients on weekdays. With the new staffing pattern, the service will round on up to 24 patients, with additional patients seen on a 1-time basis. Hospitalists normally admit patients who are not affiliated with a private physician on the hospital staff. When the hospital medicine service reaches its patient cap, private physicians must admit unaffiliated patients in rotation, as they did before the hospitalists were available. This accommodation will remain in place until the hospital medicine service is able to meet the entire demand for inpatient internal medicine services.

Postdischarge care coordination has been a major challenge. Approximately one-third of patients are discharged to nursing homes. Most of the others are affiliated with primary care physicians located in other communities who are not members of the Milford Hospital medical staff. Communication with these physicians has been improved by an electronic record management system that allows automated fax transmission of discharge summaries. Limited outpatient services are available for Medicaid patients and for those without insurance. The hospital medicine service does not provide outpatient care.

Another challenge involves care for critically ill patients. Although there are several physicians with training in pulmonary disease on the private staff, the hospital had not developed effective critical-care services. There are 2 hospitalists with critical-care training, and we have been working with the other staffers to improve their competence in critical care. The hospitalists provide 24-hour response to unstable patients throughout the hospital and have dramatically reduced unexpected mortality.

Future development will focus on improving hospitalist productivity with information technology. The hospital has undertaken installation of an integrated clinical-information system, which will include direct physician order entry and deployment of wireless technology. It is expected that many of the difficulties experienced by other hospitals with physician order entry will be ameliorated by hospitalist involvement, as the staff is comfortable with computer use. We also expect that the hospitalists will develop leadership roles within the medical staff and develop skills in quality improvement.

At our exciting and energizing annual meeting in Chicago, I had the honor and privilege of sharing my goals for SHM for the coming year: to promote palliative care and research in SHM and hospital medicine. Research will maintain SHM’s role as the leader in defining hospital medicine, and palliative care will keep us connected to our fundamental mission, which is to provide the highest-quality care to our patients. Over the next year I will share my vision for why I think these initiatives are key for SHM and our field and how SHM will promote them.

Recently, family of Mrs. T., a 62-year-old woman with metastatic pancreatic cancer, asked me not to tell Mrs. T that she was dying of her disease. Mrs. T had been admitted with severe pain and nausea. She could not eat and had been losing weight. Her pain had gotten suddenly worse. We treated her pain and nausea aggressively and achieved good control of both. Before I saw Mrs. T, her husband and 2 daughters took me aside and told me that although they realized that she was dying of her disease, they feared that she would lose hope if I told her how sick she was. “Let her think that she can get chemo in the future,” they implored. I asked why. “So she will think she can get better,” they answered. I asked Mrs. T.’s family what they thought she thought was going on. “She knows she is sick but believes the chemo can make her better,” they said.

This was not the first time I had encountered such a request, but it always makes me uncomfortable. What if they are right? Couldn’t I hurt her by giving her bad news she doesn’t want to hear? But if they were wrong, wouldn’t I be denying her the opportunity to say good-bye and bring closure? I took the middle road. I promised the family I wouldn’t say anything the patient didn’t ask me to tell her, but I would offer her the opportunity to ask. My first question to her was a typical open-ended one: “How are things going for you?” Mrs. T. said, “Well my daughter spent the night with me in my room last night.” I nodded. “I think she did it because she thought I might die over night,” she said. Perhaps as I suspected, she understood more than her family thought. She worried about her husband and how he would do without her. She wanted chemotherapy but realized that the best it could do was prolong her life a few months. When I asked her what she hoped for, she told me she has hope in God. I explained that I had spoken with her family and told them what I had told her. I said that they were concerned about her and were afraid that this knowledge would be too much for her. We talked some more, and then she asked me to have her husband come to her. There were things they needed to talk about. Next she spoke with her daughters. All were grateful for the opportunity to talk openly about their grief, sadness, and love for each other. Mrs. T. died 2 days later.

I share this story because it reaffirmed for me the crucial role that I play as a hospitalist in the care of people with serious and terminal illness and the importance of palliative care in providing the highest quality of care to these people. Caring for Mrs. T. raised many issues: effective treatment of pain and nausea, discussion of prognosis, respect for cultural differences, exploration of spiritual issues, and a request from the family to withhold the truth. I felt like I was trying to delicately balance respecting the family’s wish while honoring my responsibility to the patient to tell her the truth. In the end, a careful conversation allowed me to bridge the gap and get Mrs. T. and her family talking. My conversation with her husband several days after she died reaffirmed the importance of raising these issues with Mrs. T.

As hospitalists, we encounter these situations regularly, maybe even daily. Half of Americans die in hospitals, and 98% of Medicare beneficiaries who die spend at least some time in a hospital in the year before death (School, 2000, #1006). We are the physicians who care for the seriously ill and the dying. The question is not whether we will take care of these patients; rather, when we do, will we be ready and able? A survey of hospitalists found that we recognize the importance of palliative care to our practice, but that we feel that our training did not adequately prepare us to provide this care (Plauth, 2001, #763). Our core curriculum, which you will see in early 2006 as a supplement to the 1st volume of the Journal of Hospital Medicine includes a chapter on palliative care.

In many ways palliative care is easy, and in many ways it is difficult. Yes, it takes time. Conversations like the ones with Mrs. T. cannot happen in 5 minutes. But an investment of time up front to talk with patients and their families about preferences for care can save many hours down the road. And yes, these discussions are challenging. It’s not just patients who don’t like to talk about death and dying, their families and physicians don’t like it either. But we can learn how to conduct these discussions better and can practice phrases that will help them go more smoothly. Pain and nausea can be difficult to control. Yet, palliative care experts report that pain can be relieved with simple medications like morphine in more than 95% of cases. As hospitalists, we can fulfill our sacred duty to the sickest patients by learning these critical palliative care skills.

SHM has provided learning about palliative care at most annual meetings and will continue to do so in the future. We will also work on providing many more educational materials targeted specifically at hospitalists. Many CME courses across the country focused on palliative care, including those sponsored by the American Academy of Hospice and Palliative Medicine (www.aahpm.org), which also offers many educational resources on its Web site. Many hospitalists have already participated in Education in Palliative and End-of-Life Care (EPEC) (epec.net), a comprehensive, well-regarded curriculum in palliative care that you can purchase on the web. There are textbooks in palliative care, including the Oxford Textbook of Palliative Medicine, 3rd edition, edited by Derek Doyle, Geoffrey Hanks, Nathan I. Cherny, and Kenneth Calman, and Palliative and Supportive Oncology, 2nd edition, edited by Ann Berger, Russell Portenoy and David Weissman.

With skills in palliative care, we can make a profound difference in the lives of our patients and their families. What is it worth to be able to say good-bye and “I love you” to your family? Mrs. T.’s husband was profoundly grateful for the opportunity to say those things and more to his wife before she died. And although his wife died in the hospital, he was exceedingly satisfied with the care she received. Relieving symptoms for seriously ill patients and talking with them about profound and important issues is not only good for patients; it is good for us, too. Providing high quality care to seriously and terminally ill patients can provide a deep sense of fulfillment and satisfaction through the real and intimate engagement with our fellow human beings. It also allows us to use our humanism and to connect directly to the reason that many of us chose medicine as a career— to help people. In this way it can also protect us against burnout.

I encourage every hospitalist to embrace palliative care for the benefits it will bestow on our patients and their families, for the benefits it will bestow on us, and for the benefits it will bestow on our entire field. As president of SHM, I will do all I can to help SHM promote palliative care, beginning with the newly appointed Palliative Care Task Force. Ultimately, palliative care is about demonstrating caring for our patients and our families. It reminds us that life is precious and that it is important to choose how we spend our time. This last lesson is, perhaps, the greatest gift of palliative care— learning to make the most of the time we have, embodied in this anonymous poem I received from a friend via email:

Sing like no one is listening.

Dance like no one is watching.

Work like you don’t need the money.

Love like you’ve never been hurt.

At our exciting and energizing annual meeting in Chicago, I had the honor and privilege of sharing my goals for SHM for the coming year: to promote palliative care and research in SHM and hospital medicine. Research will maintain SHM’s role as the leader in defining hospital medicine, and palliative care will keep us connected to our fundamental mission, which is to provide the highest-quality care to our patients. Over the next year I will share my vision for why I think these initiatives are key for SHM and our field and how SHM will promote them.

Recently, family of Mrs. T., a 62-year-old woman with metastatic pancreatic cancer, asked me not to tell Mrs. T that she was dying of her disease. Mrs. T had been admitted with severe pain and nausea. She could not eat and had been losing weight. Her pain had gotten suddenly worse. We treated her pain and nausea aggressively and achieved good control of both. Before I saw Mrs. T, her husband and 2 daughters took me aside and told me that although they realized that she was dying of her disease, they feared that she would lose hope if I told her how sick she was. “Let her think that she can get chemo in the future,” they implored. I asked why. “So she will think she can get better,” they answered. I asked Mrs. T.’s family what they thought she thought was going on. “She knows she is sick but believes the chemo can make her better,” they said.

This was not the first time I had encountered such a request, but it always makes me uncomfortable. What if they are right? Couldn’t I hurt her by giving her bad news she doesn’t want to hear? But if they were wrong, wouldn’t I be denying her the opportunity to say good-bye and bring closure? I took the middle road. I promised the family I wouldn’t say anything the patient didn’t ask me to tell her, but I would offer her the opportunity to ask. My first question to her was a typical open-ended one: “How are things going for you?” Mrs. T. said, “Well my daughter spent the night with me in my room last night.” I nodded. “I think she did it because she thought I might die over night,” she said. Perhaps as I suspected, she understood more than her family thought. She worried about her husband and how he would do without her. She wanted chemotherapy but realized that the best it could do was prolong her life a few months. When I asked her what she hoped for, she told me she has hope in God. I explained that I had spoken with her family and told them what I had told her. I said that they were concerned about her and were afraid that this knowledge would be too much for her. We talked some more, and then she asked me to have her husband come to her. There were things they needed to talk about. Next she spoke with her daughters. All were grateful for the opportunity to talk openly about their grief, sadness, and love for each other. Mrs. T. died 2 days later.

I share this story because it reaffirmed for me the crucial role that I play as a hospitalist in the care of people with serious and terminal illness and the importance of palliative care in providing the highest quality of care to these people. Caring for Mrs. T. raised many issues: effective treatment of pain and nausea, discussion of prognosis, respect for cultural differences, exploration of spiritual issues, and a request from the family to withhold the truth. I felt like I was trying to delicately balance respecting the family’s wish while honoring my responsibility to the patient to tell her the truth. In the end, a careful conversation allowed me to bridge the gap and get Mrs. T. and her family talking. My conversation with her husband several days after she died reaffirmed the importance of raising these issues with Mrs. T.

As hospitalists, we encounter these situations regularly, maybe even daily. Half of Americans die in hospitals, and 98% of Medicare beneficiaries who die spend at least some time in a hospital in the year before death (School, 2000, #1006). We are the physicians who care for the seriously ill and the dying. The question is not whether we will take care of these patients; rather, when we do, will we be ready and able? A survey of hospitalists found that we recognize the importance of palliative care to our practice, but that we feel that our training did not adequately prepare us to provide this care (Plauth, 2001, #763). Our core curriculum, which you will see in early 2006 as a supplement to the 1st volume of the Journal of Hospital Medicine includes a chapter on palliative care.

In many ways palliative care is easy, and in many ways it is difficult. Yes, it takes time. Conversations like the ones with Mrs. T. cannot happen in 5 minutes. But an investment of time up front to talk with patients and their families about preferences for care can save many hours down the road. And yes, these discussions are challenging. It’s not just patients who don’t like to talk about death and dying, their families and physicians don’t like it either. But we can learn how to conduct these discussions better and can practice phrases that will help them go more smoothly. Pain and nausea can be difficult to control. Yet, palliative care experts report that pain can be relieved with simple medications like morphine in more than 95% of cases. As hospitalists, we can fulfill our sacred duty to the sickest patients by learning these critical palliative care skills.

SHM has provided learning about palliative care at most annual meetings and will continue to do so in the future. We will also work on providing many more educational materials targeted specifically at hospitalists. Many CME courses across the country focused on palliative care, including those sponsored by the American Academy of Hospice and Palliative Medicine (www.aahpm.org), which also offers many educational resources on its Web site. Many hospitalists have already participated in Education in Palliative and End-of-Life Care (EPEC) (epec.net), a comprehensive, well-regarded curriculum in palliative care that you can purchase on the web. There are textbooks in palliative care, including the Oxford Textbook of Palliative Medicine, 3rd edition, edited by Derek Doyle, Geoffrey Hanks, Nathan I. Cherny, and Kenneth Calman, and Palliative and Supportive Oncology, 2nd edition, edited by Ann Berger, Russell Portenoy and David Weissman.

With skills in palliative care, we can make a profound difference in the lives of our patients and their families. What is it worth to be able to say good-bye and “I love you” to your family? Mrs. T.’s husband was profoundly grateful for the opportunity to say those things and more to his wife before she died. And although his wife died in the hospital, he was exceedingly satisfied with the care she received. Relieving symptoms for seriously ill patients and talking with them about profound and important issues is not only good for patients; it is good for us, too. Providing high quality care to seriously and terminally ill patients can provide a deep sense of fulfillment and satisfaction through the real and intimate engagement with our fellow human beings. It also allows us to use our humanism and to connect directly to the reason that many of us chose medicine as a career— to help people. In this way it can also protect us against burnout.

I encourage every hospitalist to embrace palliative care for the benefits it will bestow on our patients and their families, for the benefits it will bestow on us, and for the benefits it will bestow on our entire field. As president of SHM, I will do all I can to help SHM promote palliative care, beginning with the newly appointed Palliative Care Task Force. Ultimately, palliative care is about demonstrating caring for our patients and our families. It reminds us that life is precious and that it is important to choose how we spend our time. This last lesson is, perhaps, the greatest gift of palliative care— learning to make the most of the time we have, embodied in this anonymous poem I received from a friend via email:

Sing like no one is listening.

Dance like no one is watching.

Work like you don’t need the money.

Love like you’ve never been hurt.

At our exciting and energizing annual meeting in Chicago, I had the honor and privilege of sharing my goals for SHM for the coming year: to promote palliative care and research in SHM and hospital medicine. Research will maintain SHM’s role as the leader in defining hospital medicine, and palliative care will keep us connected to our fundamental mission, which is to provide the highest-quality care to our patients. Over the next year I will share my vision for why I think these initiatives are key for SHM and our field and how SHM will promote them.

Recently, family of Mrs. T., a 62-year-old woman with metastatic pancreatic cancer, asked me not to tell Mrs. T that she was dying of her disease. Mrs. T had been admitted with severe pain and nausea. She could not eat and had been losing weight. Her pain had gotten suddenly worse. We treated her pain and nausea aggressively and achieved good control of both. Before I saw Mrs. T, her husband and 2 daughters took me aside and told me that although they realized that she was dying of her disease, they feared that she would lose hope if I told her how sick she was. “Let her think that she can get chemo in the future,” they implored. I asked why. “So she will think she can get better,” they answered. I asked Mrs. T.’s family what they thought she thought was going on. “She knows she is sick but believes the chemo can make her better,” they said.

This was not the first time I had encountered such a request, but it always makes me uncomfortable. What if they are right? Couldn’t I hurt her by giving her bad news she doesn’t want to hear? But if they were wrong, wouldn’t I be denying her the opportunity to say good-bye and bring closure? I took the middle road. I promised the family I wouldn’t say anything the patient didn’t ask me to tell her, but I would offer her the opportunity to ask. My first question to her was a typical open-ended one: “How are things going for you?” Mrs. T. said, “Well my daughter spent the night with me in my room last night.” I nodded. “I think she did it because she thought I might die over night,” she said. Perhaps as I suspected, she understood more than her family thought. She worried about her husband and how he would do without her. She wanted chemotherapy but realized that the best it could do was prolong her life a few months. When I asked her what she hoped for, she told me she has hope in God. I explained that I had spoken with her family and told them what I had told her. I said that they were concerned about her and were afraid that this knowledge would be too much for her. We talked some more, and then she asked me to have her husband come to her. There were things they needed to talk about. Next she spoke with her daughters. All were grateful for the opportunity to talk openly about their grief, sadness, and love for each other. Mrs. T. died 2 days later.

I share this story because it reaffirmed for me the crucial role that I play as a hospitalist in the care of people with serious and terminal illness and the importance of palliative care in providing the highest quality of care to these people. Caring for Mrs. T. raised many issues: effective treatment of pain and nausea, discussion of prognosis, respect for cultural differences, exploration of spiritual issues, and a request from the family to withhold the truth. I felt like I was trying to delicately balance respecting the family’s wish while honoring my responsibility to the patient to tell her the truth. In the end, a careful conversation allowed me to bridge the gap and get Mrs. T. and her family talking. My conversation with her husband several days after she died reaffirmed the importance of raising these issues with Mrs. T.

As hospitalists, we encounter these situations regularly, maybe even daily. Half of Americans die in hospitals, and 98% of Medicare beneficiaries who die spend at least some time in a hospital in the year before death (School, 2000, #1006). We are the physicians who care for the seriously ill and the dying. The question is not whether we will take care of these patients; rather, when we do, will we be ready and able? A survey of hospitalists found that we recognize the importance of palliative care to our practice, but that we feel that our training did not adequately prepare us to provide this care (Plauth, 2001, #763). Our core curriculum, which you will see in early 2006 as a supplement to the 1st volume of the Journal of Hospital Medicine includes a chapter on palliative care.

In many ways palliative care is easy, and in many ways it is difficult. Yes, it takes time. Conversations like the ones with Mrs. T. cannot happen in 5 minutes. But an investment of time up front to talk with patients and their families about preferences for care can save many hours down the road. And yes, these discussions are challenging. It’s not just patients who don’t like to talk about death and dying, their families and physicians don’t like it either. But we can learn how to conduct these discussions better and can practice phrases that will help them go more smoothly. Pain and nausea can be difficult to control. Yet, palliative care experts report that pain can be relieved with simple medications like morphine in more than 95% of cases. As hospitalists, we can fulfill our sacred duty to the sickest patients by learning these critical palliative care skills.

SHM has provided learning about palliative care at most annual meetings and will continue to do so in the future. We will also work on providing many more educational materials targeted specifically at hospitalists. Many CME courses across the country focused on palliative care, including those sponsored by the American Academy of Hospice and Palliative Medicine (www.aahpm.org), which also offers many educational resources on its Web site. Many hospitalists have already participated in Education in Palliative and End-of-Life Care (EPEC) (epec.net), a comprehensive, well-regarded curriculum in palliative care that you can purchase on the web. There are textbooks in palliative care, including the Oxford Textbook of Palliative Medicine, 3rd edition, edited by Derek Doyle, Geoffrey Hanks, Nathan I. Cherny, and Kenneth Calman, and Palliative and Supportive Oncology, 2nd edition, edited by Ann Berger, Russell Portenoy and David Weissman.

With skills in palliative care, we can make a profound difference in the lives of our patients and their families. What is it worth to be able to say good-bye and “I love you” to your family? Mrs. T.’s husband was profoundly grateful for the opportunity to say those things and more to his wife before she died. And although his wife died in the hospital, he was exceedingly satisfied with the care she received. Relieving symptoms for seriously ill patients and talking with them about profound and important issues is not only good for patients; it is good for us, too. Providing high quality care to seriously and terminally ill patients can provide a deep sense of fulfillment and satisfaction through the real and intimate engagement with our fellow human beings. It also allows us to use our humanism and to connect directly to the reason that many of us chose medicine as a career— to help people. In this way it can also protect us against burnout.

I encourage every hospitalist to embrace palliative care for the benefits it will bestow on our patients and their families, for the benefits it will bestow on us, and for the benefits it will bestow on our entire field. As president of SHM, I will do all I can to help SHM promote palliative care, beginning with the newly appointed Palliative Care Task Force. Ultimately, palliative care is about demonstrating caring for our patients and our families. It reminds us that life is precious and that it is important to choose how we spend our time. This last lesson is, perhaps, the greatest gift of palliative care— learning to make the most of the time we have, embodied in this anonymous poem I received from a friend via email:

Sing like no one is listening.

Dance like no one is watching.

Work like you don’t need the money.

Love like you’ve never been hurt.

Appetite suppression and insomnia—both common, dose-related side effects of psychostimulants—can jeopardize treatment adherence for patients with attention-deficit/hyperactivity disorder (ADHD). The following strategies can minimize these effects.

First, wait and see

For most patients, the optimal psychostimulant dosage produces few or no side effects. Those that occur are usually minor, transient, and disappear as patients develop tolerance within days of starting medication.

The two most commonly used stimulants—methylphenidate and amphetamine—cause similar side effects.¹ No evidence suggests either is more effective or less tolerable than the other.

Fine-tune psychostimulants to the lowest dosage that produces maximum benefit and minimum side effects. If side effects persist beyond 7 to 10 days, the dosage is probably too high or the patient is taking another stimulating medication. Before you attribute insomnia or appetite suppression to psychostimulants, ask the patient if he or she is using a decongestant, caffeine, diet pills, systemic corticosteroids, systemic albuterol, or theophylline.

Countering appetite suppression

Approximately one-third of adult and pediatric ADHD patients report appetite suppression at therapeutic psychostimulant dosages, but in most patients this effect is transient or clinically insignificant. If a child taking psychostimulants is not eating or gaining weight appropriately:

• suggest that parents plan mealtimes before the patient’s next dose or give high-calorie snacks throughout the day. (This strategy, although recommended by the American Academy of Pediatrics, can be cumbersome and has limited long-term efficacy.)
• switch from amphetamine to methylphenidate or vice versa.
• add the antihistamine cyproheptadine, 4 mg, with morning and evening meals
• add mirtazapine, one-half of a 15-mg tablet at bedtime to stimulate appetite and initiate sleep.

If none of these interventions work, recommend drug holidays from ADHD medications as a last resort when impairment is lowest, such as during weekends, holidays, or summers.

Curbing insomnia

About 20% of prepubertal children and 75% to 80% of adults have difficulty falling asleep while taking ADHD medications.² For many patients it is not the medications but the mental and physical restlessness of ADHD that disturbs sleep. Take a careful baseline sleep history before starting psychostimulants to help you determine later if they are causing insomnia.

Avoid benzodiazepines, which may promote tolerance and dependence. I discourage using any hypnotic to treat insomnia that occurs as a side effect. Also avoid antihistamines (Benedryl, trazodone) that may leave the patient sedated the next day.

Try a trial nap. After fine-tuning the psychostimulant to the lowest optimal dosage, ask the patient to test his ability to sleep while on that dose by taking an afternoon nap. Most patients discover they can sleep well, proving to both patient and doctor that ADHD medications usually help sleep initiation or are sleep-neutral. A successful nap can ease a patient’s fear that her medication will keep her awake.

Even the longest extended-release psychostimulant formulations do not last the 14 to 16 hours of a typical waking day. This no-risk trial nap reassures patients that they can take supplemental doses as prescribed to assist them through even the longest workdays, without fear of sleep disruption.

Time-release formulations smooth the abrupt kinetics and rebound activation seen with immediate-release psychostimulants. But for patients taking immediate-release formulations, reducing the day’s last dose or taking the last dose earlier can often prevent medication-associated insomnia.

If insomnia persists, try:

• melatonin, 0.5 to 1.0 mg, at bedtime, 1 hour before bedtime, at sunset, or 6 hours before anticipated bedtime. I try to mimic the natural release of melatonin triggered by sunset, but no definitive data prove the most effective dosing time.
• alpha agonists such as clonidine, 0.1 to 0.2 mg at bedtime, or guanfacine, 1 to 2 mg at bedtime. These agents have proven efficacy for treating hyperactivity and sleep disturbances without causing tolerance but may be associated with nightmares in some children.³
• mirtazapine, one-half of a 15-mg tablet at bedtime.

Appetite suppression and insomnia—both common, dose-related side effects of psychostimulants—can jeopardize treatment adherence for patients with attention-deficit/hyperactivity disorder (ADHD). The following strategies can minimize these effects.

First, wait and see

For most patients, the optimal psychostimulant dosage produces few or no side effects. Those that occur are usually minor, transient, and disappear as patients develop tolerance within days of starting medication.

The two most commonly used stimulants—methylphenidate and amphetamine—cause similar side effects.¹ No evidence suggests either is more effective or less tolerable than the other.

Fine-tune psychostimulants to the lowest dosage that produces maximum benefit and minimum side effects. If side effects persist beyond 7 to 10 days, the dosage is probably too high or the patient is taking another stimulating medication. Before you attribute insomnia or appetite suppression to psychostimulants, ask the patient if he or she is using a decongestant, caffeine, diet pills, systemic corticosteroids, systemic albuterol, or theophylline.

Countering appetite suppression

Approximately one-third of adult and pediatric ADHD patients report appetite suppression at therapeutic psychostimulant dosages, but in most patients this effect is transient or clinically insignificant. If a child taking psychostimulants is not eating or gaining weight appropriately:

• suggest that parents plan mealtimes before the patient’s next dose or give high-calorie snacks throughout the day. (This strategy, although recommended by the American Academy of Pediatrics, can be cumbersome and has limited long-term efficacy.)
• switch from amphetamine to methylphenidate or vice versa.
• add the antihistamine cyproheptadine, 4 mg, with morning and evening meals
• add mirtazapine, one-half of a 15-mg tablet at bedtime to stimulate appetite and initiate sleep.

If none of these interventions work, recommend drug holidays from ADHD medications as a last resort when impairment is lowest, such as during weekends, holidays, or summers.

Curbing insomnia

About 20% of prepubertal children and 75% to 80% of adults have difficulty falling asleep while taking ADHD medications.² For many patients it is not the medications but the mental and physical restlessness of ADHD that disturbs sleep. Take a careful baseline sleep history before starting psychostimulants to help you determine later if they are causing insomnia.

Avoid benzodiazepines, which may promote tolerance and dependence. I discourage using any hypnotic to treat insomnia that occurs as a side effect. Also avoid antihistamines (Benedryl, trazodone) that may leave the patient sedated the next day.

Try a trial nap. After fine-tuning the psychostimulant to the lowest optimal dosage, ask the patient to test his ability to sleep while on that dose by taking an afternoon nap. Most patients discover they can sleep well, proving to both patient and doctor that ADHD medications usually help sleep initiation or are sleep-neutral. A successful nap can ease a patient’s fear that her medication will keep her awake.

Even the longest extended-release psychostimulant formulations do not last the 14 to 16 hours of a typical waking day. This no-risk trial nap reassures patients that they can take supplemental doses as prescribed to assist them through even the longest workdays, without fear of sleep disruption.

Time-release formulations smooth the abrupt kinetics and rebound activation seen with immediate-release psychostimulants. But for patients taking immediate-release formulations, reducing the day’s last dose or taking the last dose earlier can often prevent medication-associated insomnia.

If insomnia persists, try:

• melatonin, 0.5 to 1.0 mg, at bedtime, 1 hour before bedtime, at sunset, or 6 hours before anticipated bedtime. I try to mimic the natural release of melatonin triggered by sunset, but no definitive data prove the most effective dosing time.
• alpha agonists such as clonidine, 0.1 to 0.2 mg at bedtime, or guanfacine, 1 to 2 mg at bedtime. These agents have proven efficacy for treating hyperactivity and sleep disturbances without causing tolerance but may be associated with nightmares in some children.³
• mirtazapine, one-half of a 15-mg tablet at bedtime.

Appetite suppression and insomnia—both common, dose-related side effects of psychostimulants—can jeopardize treatment adherence for patients with attention-deficit/hyperactivity disorder (ADHD). The following strategies can minimize these effects.

First, wait and see

For most patients, the optimal psychostimulant dosage produces few or no side effects. Those that occur are usually minor, transient, and disappear as patients develop tolerance within days of starting medication.

The two most commonly used stimulants—methylphenidate and amphetamine—cause similar side effects.¹ No evidence suggests either is more effective or less tolerable than the other.

Fine-tune psychostimulants to the lowest dosage that produces maximum benefit and minimum side effects. If side effects persist beyond 7 to 10 days, the dosage is probably too high or the patient is taking another stimulating medication. Before you attribute insomnia or appetite suppression to psychostimulants, ask the patient if he or she is using a decongestant, caffeine, diet pills, systemic corticosteroids, systemic albuterol, or theophylline.

Countering appetite suppression

Approximately one-third of adult and pediatric ADHD patients report appetite suppression at therapeutic psychostimulant dosages, but in most patients this effect is transient or clinically insignificant. If a child taking psychostimulants is not eating or gaining weight appropriately:

• suggest that parents plan mealtimes before the patient’s next dose or give high-calorie snacks throughout the day. (This strategy, although recommended by the American Academy of Pediatrics, can be cumbersome and has limited long-term efficacy.)
• switch from amphetamine to methylphenidate or vice versa.
• add the antihistamine cyproheptadine, 4 mg, with morning and evening meals
• add mirtazapine, one-half of a 15-mg tablet at bedtime to stimulate appetite and initiate sleep.

If none of these interventions work, recommend drug holidays from ADHD medications as a last resort when impairment is lowest, such as during weekends, holidays, or summers.

Curbing insomnia

About 20% of prepubertal children and 75% to 80% of adults have difficulty falling asleep while taking ADHD medications.² For many patients it is not the medications but the mental and physical restlessness of ADHD that disturbs sleep. Take a careful baseline sleep history before starting psychostimulants to help you determine later if they are causing insomnia.

Avoid benzodiazepines, which may promote tolerance and dependence. I discourage using any hypnotic to treat insomnia that occurs as a side effect. Also avoid antihistamines (Benedryl, trazodone) that may leave the patient sedated the next day.

Try a trial nap. After fine-tuning the psychostimulant to the lowest optimal dosage, ask the patient to test his ability to sleep while on that dose by taking an afternoon nap. Most patients discover they can sleep well, proving to both patient and doctor that ADHD medications usually help sleep initiation or are sleep-neutral. A successful nap can ease a patient’s fear that her medication will keep her awake.

Even the longest extended-release psychostimulant formulations do not last the 14 to 16 hours of a typical waking day. This no-risk trial nap reassures patients that they can take supplemental doses as prescribed to assist them through even the longest workdays, without fear of sleep disruption.

Time-release formulations smooth the abrupt kinetics and rebound activation seen with immediate-release psychostimulants. But for patients taking immediate-release formulations, reducing the day’s last dose or taking the last dose earlier can often prevent medication-associated insomnia.

If insomnia persists, try:

• melatonin, 0.5 to 1.0 mg, at bedtime, 1 hour before bedtime, at sunset, or 6 hours before anticipated bedtime. I try to mimic the natural release of melatonin triggered by sunset, but no definitive data prove the most effective dosing time.
• alpha agonists such as clonidine, 0.1 to 0.2 mg at bedtime, or guanfacine, 1 to 2 mg at bedtime. These agents have proven efficacy for treating hyperactivity and sleep disturbances without causing tolerance but may be associated with nightmares in some children.³
• mirtazapine, one-half of a 15-mg tablet at bedtime.

Worker claims therapist disclosed confidential information

Cook County (IL) Circuit Court

A public works employee in Illinois received psychotherapy through his city’s wellness program. After the man left his position, he claimed in court that the treating therapist met with his former co-workers, disclosed his receipt of therapy to them, and told them he was unstable and capable of harming himself or others. The former employee argued that the disclosures violated Illinois law, caused him emotional distress, and made him unable to trust mental health professionals.

The defense denied that the therapist had violated the law or had made any disclosures. Instead, the defense argued that the co-workers—not the therapist—had voiced concern about the plaintiff. The defense maintained that the co-workers were confused about who had discussed the plaintiff, and that the therapist had not discussed him.

• The jury found for the defense.
  

Dr. Grant’s observations

The courts have recognized and protected the fundamental importance of confidentiality in the therapist/patient relationship.^{How to avoid ‘foreseeable’ harm,” Current Psychiatry, March 2005, at www.currentpsychiatry.com).}

Here, the request for consultation might suggest that an honest error in judgment occurred—the psychiatrist was simply puzzled by the patient’s medical symptoms. Although several doctors failed to diagnose NMS, shouldn’t the psychiatrists have been able to diagnose it?

NMS is a side-effect risk of atypical and conventional neuroleptics,^{Pearls: Identifying NMS with FEVER,”).}

The psychiatrists in this case did not conform to the standard of care, and consulting with another doctor did not absolve them of liability.

Worker claims therapist disclosed confidential information

Cook County (IL) Circuit Court

A public works employee in Illinois received psychotherapy through his city’s wellness program. After the man left his position, he claimed in court that the treating therapist met with his former co-workers, disclosed his receipt of therapy to them, and told them he was unstable and capable of harming himself or others. The former employee argued that the disclosures violated Illinois law, caused him emotional distress, and made him unable to trust mental health professionals.

The defense denied that the therapist had violated the law or had made any disclosures. Instead, the defense argued that the co-workers—not the therapist—had voiced concern about the plaintiff. The defense maintained that the co-workers were confused about who had discussed the plaintiff, and that the therapist had not discussed him.

• The jury found for the defense.
  

Dr. Grant’s observations

The courts have recognized and protected the fundamental importance of confidentiality in the therapist/patient relationship.^{How to avoid ‘foreseeable’ harm,” Current Psychiatry, March 2005, at www.currentpsychiatry.com).}

Here, the request for consultation might suggest that an honest error in judgment occurred—the psychiatrist was simply puzzled by the patient’s medical symptoms. Although several doctors failed to diagnose NMS, shouldn’t the psychiatrists have been able to diagnose it?

NMS is a side-effect risk of atypical and conventional neuroleptics,^{Pearls: Identifying NMS with FEVER,”).}

The psychiatrists in this case did not conform to the standard of care, and consulting with another doctor did not absolve them of liability.

Worker claims therapist disclosed confidential information

Cook County (IL) Circuit Court

A public works employee in Illinois received psychotherapy through his city’s wellness program. After the man left his position, he claimed in court that the treating therapist met with his former co-workers, disclosed his receipt of therapy to them, and told them he was unstable and capable of harming himself or others. The former employee argued that the disclosures violated Illinois law, caused him emotional distress, and made him unable to trust mental health professionals.

The defense denied that the therapist had violated the law or had made any disclosures. Instead, the defense argued that the co-workers—not the therapist—had voiced concern about the plaintiff. The defense maintained that the co-workers were confused about who had discussed the plaintiff, and that the therapist had not discussed him.

• The jury found for the defense.
  

Dr. Grant’s observations

The courts have recognized and protected the fundamental importance of confidentiality in the therapist/patient relationship.^{How to avoid ‘foreseeable’ harm,” Current Psychiatry, March 2005, at www.currentpsychiatry.com).}

Here, the request for consultation might suggest that an honest error in judgment occurred—the psychiatrist was simply puzzled by the patient’s medical symptoms. Although several doctors failed to diagnose NMS, shouldn’t the psychiatrists have been able to diagnose it?

NMS is a side-effect risk of atypical and conventional neuroleptics,^{Pearls: Identifying NMS with FEVER,”).}

The psychiatrists in this case did not conform to the standard of care, and consulting with another doctor did not absolve them of liability.

“What’s the best treatment for comorbid ADHD/bipolar mania?” by Drs. Nick C. Patel and Floyd R. Sallee (Current Psychiatry, April 2005) was well-written and offers excellent treatment guidelines. However, the idea that patients can have comorbid bipolar disorder and attention-deficit/hyperactivity disorder (ADHD) is a fallacy.

I challenge any colleague, from the leading expert to the most recent graduate, to present a bona fide case of “comorbid” ADHD/bipolar disorder. I can prove that only one diagnosis is correct because:

• Bipolar disorder is more heritable than other psychiatric illnesses. Many patients labeled as having “comorbid” bipolar disorder and ADHD have parents with bipolar disorder or schizophrenia or are in foster care and their biological parents’ histories are unknown.
• I’ve seen hundreds of patients enter full-blown psychosis after another clinician put them on amphetamines or antidepressants while being treated for ADHD.
• Bipolar disorder can explain any so-called ADHD symptom.
• ADHD does not include moodiness or predatory aggression.

Over 10 years, I have diagnosed three or four patients as having comorbid bipolar disorder and ADHD. After a few years and inpatient treatments, these patients proved the second diagnosis wrong. We can decrease costs and avoid patients’ suffering by refining diagnostic criteria.

Manuel Mota-Castillo, MD, medical director
The Grove Academy, Sanford, FL
and Lake Mary Psychiatric Services
Lake Mary, FL

Drs. Patel and Sallee respond

Dr. Mota-Castillo’s argument is most often stated from the opposite point of view that bipolar symptoms, particularly in patients age <10, are almost indistinguishable from those of ADHD. Our article did not—and cannot—address this controversy.

Because the evidence has been inconclusive, it is unclear if comorbid bipolar disorder and ADHD result from overlapping DSM-IV-TR diagnostic criteria, or whether two concurrent disorders exist. Suffice it to say that ADHD and bipolar disorder have many phenotypes and are both highly—but distinctly—heritable.

Overlapping symptoms may confound clinical diagnosis and result in “false positives” but may not account for most bipolar youths with comorbid ADHD. In one study,¹ 56% of subjects with both disorders maintained a bipolar disorder diagnosis when overlapping ADHD symptoms were subtracted.

Combination pharmacotherapy is needed because mood stabilizers do not treat attention and neurocognitive problems associated with ADHD. Therefore, a psychostimulant trial may help euthymic bipolar children and adolescents. In a recent placebo-controlled study by Scheffer et al,² ADHD symptoms—as measured with the Clinical Global Impression of Improvement scale and based upon Conners’ Teachers and Parent Ratings—significantly improved among divalproex sodium responders receiving mixed amphetamine salts.

Dr. Mota-Castillo, however, brings up two important questions:

• Are childhood symptoms that result in ADHD diagnosis a prodromal manifestation of bipolar disorder in some patients? Data from the first 1,000 STEP-BD participants suggest that ADHD may be part of the developmental phenotype of bipolar disorder comorbidity. Participants with mood symptom onset before age 13 had higher rates of comorbid ADHD than did those whose mood symptoms surfaced later on.³
• Do psychostimulants hasten mood disorder onset in a child diagnosed with ADHD who has a high familial risk of a mood disorder? How these agents influence the course of bipolar disorder is unclear. DelBello et al⁴ reported that psychostimulant exposure may be a stressor in youths at risk for bipolar disorder, may progressively worsen affective symptoms over time, and may lead to earlier mood symptom onset.

Both questions need further exploration as the implications for clinical practice may be tremendous.

Results from numerous independent studies consistently suggest that patients can be diagnosed with comorbid bipolar disorder and ADHD. More research is needed, however, to solve this diagnostic conundrum.

Nick C. Patel, PharmD, PhD
Assistant professor
Departments of pharmacy practice and psychiatry
Floyd R. Sallee, MD, PhD
Professor, department of psychiatry
University of Cincinnati

“What’s the best treatment for comorbid ADHD/bipolar mania?” by Drs. Nick C. Patel and Floyd R. Sallee (Current Psychiatry, April 2005) was well-written and offers excellent treatment guidelines. However, the idea that patients can have comorbid bipolar disorder and attention-deficit/hyperactivity disorder (ADHD) is a fallacy.

I challenge any colleague, from the leading expert to the most recent graduate, to present a bona fide case of “comorbid” ADHD/bipolar disorder. I can prove that only one diagnosis is correct because:

• Bipolar disorder is more heritable than other psychiatric illnesses. Many patients labeled as having “comorbid” bipolar disorder and ADHD have parents with bipolar disorder or schizophrenia or are in foster care and their biological parents’ histories are unknown.
• I’ve seen hundreds of patients enter full-blown psychosis after another clinician put them on amphetamines or antidepressants while being treated for ADHD.
• Bipolar disorder can explain any so-called ADHD symptom.
• ADHD does not include moodiness or predatory aggression.

Over 10 years, I have diagnosed three or four patients as having comorbid bipolar disorder and ADHD. After a few years and inpatient treatments, these patients proved the second diagnosis wrong. We can decrease costs and avoid patients’ suffering by refining diagnostic criteria.

Manuel Mota-Castillo, MD, medical director
The Grove Academy, Sanford, FL
and Lake Mary Psychiatric Services
Lake Mary, FL

Drs. Patel and Sallee respond

Dr. Mota-Castillo’s argument is most often stated from the opposite point of view that bipolar symptoms, particularly in patients age <10, are almost indistinguishable from those of ADHD. Our article did not—and cannot—address this controversy.

Because the evidence has been inconclusive, it is unclear if comorbid bipolar disorder and ADHD result from overlapping DSM-IV-TR diagnostic criteria, or whether two concurrent disorders exist. Suffice it to say that ADHD and bipolar disorder have many phenotypes and are both highly—but distinctly—heritable.

Overlapping symptoms may confound clinical diagnosis and result in “false positives” but may not account for most bipolar youths with comorbid ADHD. In one study,¹ 56% of subjects with both disorders maintained a bipolar disorder diagnosis when overlapping ADHD symptoms were subtracted.

Combination pharmacotherapy is needed because mood stabilizers do not treat attention and neurocognitive problems associated with ADHD. Therefore, a psychostimulant trial may help euthymic bipolar children and adolescents. In a recent placebo-controlled study by Scheffer et al,² ADHD symptoms—as measured with the Clinical Global Impression of Improvement scale and based upon Conners’ Teachers and Parent Ratings—significantly improved among divalproex sodium responders receiving mixed amphetamine salts.

Dr. Mota-Castillo, however, brings up two important questions:

• Are childhood symptoms that result in ADHD diagnosis a prodromal manifestation of bipolar disorder in some patients? Data from the first 1,000 STEP-BD participants suggest that ADHD may be part of the developmental phenotype of bipolar disorder comorbidity. Participants with mood symptom onset before age 13 had higher rates of comorbid ADHD than did those whose mood symptoms surfaced later on.³
• Do psychostimulants hasten mood disorder onset in a child diagnosed with ADHD who has a high familial risk of a mood disorder? How these agents influence the course of bipolar disorder is unclear. DelBello et al⁴ reported that psychostimulant exposure may be a stressor in youths at risk for bipolar disorder, may progressively worsen affective symptoms over time, and may lead to earlier mood symptom onset.

Both questions need further exploration as the implications for clinical practice may be tremendous.

Results from numerous independent studies consistently suggest that patients can be diagnosed with comorbid bipolar disorder and ADHD. More research is needed, however, to solve this diagnostic conundrum.

Nick C. Patel, PharmD, PhD
Assistant professor
Departments of pharmacy practice and psychiatry
Floyd R. Sallee, MD, PhD
Professor, department of psychiatry
University of Cincinnati

“What’s the best treatment for comorbid ADHD/bipolar mania?” by Drs. Nick C. Patel and Floyd R. Sallee (Current Psychiatry, April 2005) was well-written and offers excellent treatment guidelines. However, the idea that patients can have comorbid bipolar disorder and attention-deficit/hyperactivity disorder (ADHD) is a fallacy.

I challenge any colleague, from the leading expert to the most recent graduate, to present a bona fide case of “comorbid” ADHD/bipolar disorder. I can prove that only one diagnosis is correct because:

• Bipolar disorder is more heritable than other psychiatric illnesses. Many patients labeled as having “comorbid” bipolar disorder and ADHD have parents with bipolar disorder or schizophrenia or are in foster care and their biological parents’ histories are unknown.
• I’ve seen hundreds of patients enter full-blown psychosis after another clinician put them on amphetamines or antidepressants while being treated for ADHD.
• Bipolar disorder can explain any so-called ADHD symptom.
• ADHD does not include moodiness or predatory aggression.

Over 10 years, I have diagnosed three or four patients as having comorbid bipolar disorder and ADHD. After a few years and inpatient treatments, these patients proved the second diagnosis wrong. We can decrease costs and avoid patients’ suffering by refining diagnostic criteria.

Manuel Mota-Castillo, MD, medical director
The Grove Academy, Sanford, FL
and Lake Mary Psychiatric Services
Lake Mary, FL

Drs. Patel and Sallee respond

Dr. Mota-Castillo’s argument is most often stated from the opposite point of view that bipolar symptoms, particularly in patients age <10, are almost indistinguishable from those of ADHD. Our article did not—and cannot—address this controversy.

Because the evidence has been inconclusive, it is unclear if comorbid bipolar disorder and ADHD result from overlapping DSM-IV-TR diagnostic criteria, or whether two concurrent disorders exist. Suffice it to say that ADHD and bipolar disorder have many phenotypes and are both highly—but distinctly—heritable.

Overlapping symptoms may confound clinical diagnosis and result in “false positives” but may not account for most bipolar youths with comorbid ADHD. In one study,¹ 56% of subjects with both disorders maintained a bipolar disorder diagnosis when overlapping ADHD symptoms were subtracted.

Combination pharmacotherapy is needed because mood stabilizers do not treat attention and neurocognitive problems associated with ADHD. Therefore, a psychostimulant trial may help euthymic bipolar children and adolescents. In a recent placebo-controlled study by Scheffer et al,² ADHD symptoms—as measured with the Clinical Global Impression of Improvement scale and based upon Conners’ Teachers and Parent Ratings—significantly improved among divalproex sodium responders receiving mixed amphetamine salts.

Dr. Mota-Castillo, however, brings up two important questions:

• Are childhood symptoms that result in ADHD diagnosis a prodromal manifestation of bipolar disorder in some patients? Data from the first 1,000 STEP-BD participants suggest that ADHD may be part of the developmental phenotype of bipolar disorder comorbidity. Participants with mood symptom onset before age 13 had higher rates of comorbid ADHD than did those whose mood symptoms surfaced later on.³
• Do psychostimulants hasten mood disorder onset in a child diagnosed with ADHD who has a high familial risk of a mood disorder? How these agents influence the course of bipolar disorder is unclear. DelBello et al⁴ reported that psychostimulant exposure may be a stressor in youths at risk for bipolar disorder, may progressively worsen affective symptoms over time, and may lead to earlier mood symptom onset.

Both questions need further exploration as the implications for clinical practice may be tremendous.

Results from numerous independent studies consistently suggest that patients can be diagnosed with comorbid bipolar disorder and ADHD. More research is needed, however, to solve this diagnostic conundrum.

Nick C. Patel, PharmD, PhD
Assistant professor
Departments of pharmacy practice and psychiatry
Floyd R. Sallee, MD, PhD
Professor, department of psychiatry
University of Cincinnati

BIRMINGHAM, ENGLAND — All patients with systemic lupus erythematosus who are taking 7.5 mg prednisone or more daily should be treated to prevent bone loss, Bevra Hahn, M.D., said at the joint meeting of the British Society for Rheumatology and the German Society for Rheumatology.

Almost everyone loses bone mass at that level of steroid treatment, and relatively rapidly. “We know most bone loss occurs in the first 12 months of steroid treatment, so there isn't any point … waiting until the disease goes into remission—and lupus hardly ever goes into true remission—or waiting until they are better or their drug regimen is simpler,” she said.

Despite the fact that estrogen therapy is “out,” there are still treatment options. Calcium plus vitamin D supplementation is a typical initial approach, and has a small but measurable impact on reducing the degree of bone loss.

Another choice would be to use a vitamin D metabolite such as calcitriol. “These are more effective, but if you use a vitamin D metabolite, don't give supplemental calcium and be sure to monitor for hypercalcemia and maybe even hypercalcuria if you are practicing in an area where there are a lot of renal stones,” said Dr. Hahn, professor of medicine and chief of rheumatology, University of California, Los Angeles. Hypercalcemia is particularly hazardous when patients are acutely ill and take to bed. The drug should be stopped at that time, she said.

But there's no question in 2005 that bisphosphonate therapy is the most effective strategy to prevent bone loss in steroid-induced osteoporosis, she said. In fact, calcium plus ordinary vitamin D has been used as the placebo in a lot of the clinical trials of bisphosphonates.

“It doesn't matter which one you choose—whichever one you like. Now that Fosamax comes in a liquid I have a lot more patients who can tolerate bisphosphonate therapy,” she said. Liquid alendronate causes less esophageal irritation and gastric distress than the capsules, she said.

Another option for certain patients is treatment with the anabolic hormone PTH 1–34 (teriparatide, Forteo). This drug is useful for patients who have very low bone turnover and are continuing to fracture despite treatment with bisphosphonates, active vitamin D, and calcitonin, she said.

In some patients it isn't enough to turn the osteoclast off, which is how these drugs work. For these patients it's also necessary to turn the osteoblast on, which is what PTH does, she said.

PTH stimulates osteoblast accumulation and bone formation through receptor signals that modulate osteoblast proliferation and maturation. It also increases the lifespan and productivity of the osteoblast by preventing apoptosis (Treat. Endocrinol. 2002:1;175–90).

Unfortunately, patients don't like to take this drug because it's injectable and must be taken every day or every other day. But three other formulations, two injectable and one oral, are now in clinical trials (Expert Opin. Investig. Drugs 2005;14:251–64).

One caution is needed with using PTH in patients with lupus. “This is not recommended by anybody but me, but I think you should screen your patients for hyperparathyroidism before you start PTH. I have found elevated levels of parathyroid hormone in one-third of my lupus patients, and we shouldn't be giving PTH to people who already have primary hyperparathyroidism,” she said.

BIRMINGHAM, ENGLAND — All patients with systemic lupus erythematosus who are taking 7.5 mg prednisone or more daily should be treated to prevent bone loss, Bevra Hahn, M.D., said at the joint meeting of the British Society for Rheumatology and the German Society for Rheumatology.

Almost everyone loses bone mass at that level of steroid treatment, and relatively rapidly. “We know most bone loss occurs in the first 12 months of steroid treatment, so there isn't any point … waiting until the disease goes into remission—and lupus hardly ever goes into true remission—or waiting until they are better or their drug regimen is simpler,” she said.

Despite the fact that estrogen therapy is “out,” there are still treatment options. Calcium plus vitamin D supplementation is a typical initial approach, and has a small but measurable impact on reducing the degree of bone loss.

Another choice would be to use a vitamin D metabolite such as calcitriol. “These are more effective, but if you use a vitamin D metabolite, don't give supplemental calcium and be sure to monitor for hypercalcemia and maybe even hypercalcuria if you are practicing in an area where there are a lot of renal stones,” said Dr. Hahn, professor of medicine and chief of rheumatology, University of California, Los Angeles. Hypercalcemia is particularly hazardous when patients are acutely ill and take to bed. The drug should be stopped at that time, she said.

But there's no question in 2005 that bisphosphonate therapy is the most effective strategy to prevent bone loss in steroid-induced osteoporosis, she said. In fact, calcium plus ordinary vitamin D has been used as the placebo in a lot of the clinical trials of bisphosphonates.

“It doesn't matter which one you choose—whichever one you like. Now that Fosamax comes in a liquid I have a lot more patients who can tolerate bisphosphonate therapy,” she said. Liquid alendronate causes less esophageal irritation and gastric distress than the capsules, she said.

Another option for certain patients is treatment with the anabolic hormone PTH 1–34 (teriparatide, Forteo). This drug is useful for patients who have very low bone turnover and are continuing to fracture despite treatment with bisphosphonates, active vitamin D, and calcitonin, she said.

In some patients it isn't enough to turn the osteoclast off, which is how these drugs work. For these patients it's also necessary to turn the osteoblast on, which is what PTH does, she said.

PTH stimulates osteoblast accumulation and bone formation through receptor signals that modulate osteoblast proliferation and maturation. It also increases the lifespan and productivity of the osteoblast by preventing apoptosis (Treat. Endocrinol. 2002:1;175–90).

Unfortunately, patients don't like to take this drug because it's injectable and must be taken every day or every other day. But three other formulations, two injectable and one oral, are now in clinical trials (Expert Opin. Investig. Drugs 2005;14:251–64).

One caution is needed with using PTH in patients with lupus. “This is not recommended by anybody but me, but I think you should screen your patients for hyperparathyroidism before you start PTH. I have found elevated levels of parathyroid hormone in one-third of my lupus patients, and we shouldn't be giving PTH to people who already have primary hyperparathyroidism,” she said.

BIRMINGHAM, ENGLAND — All patients with systemic lupus erythematosus who are taking 7.5 mg prednisone or more daily should be treated to prevent bone loss, Bevra Hahn, M.D., said at the joint meeting of the British Society for Rheumatology and the German Society for Rheumatology.

Almost everyone loses bone mass at that level of steroid treatment, and relatively rapidly. “We know most bone loss occurs in the first 12 months of steroid treatment, so there isn't any point … waiting until the disease goes into remission—and lupus hardly ever goes into true remission—or waiting until they are better or their drug regimen is simpler,” she said.

Despite the fact that estrogen therapy is “out,” there are still treatment options. Calcium plus vitamin D supplementation is a typical initial approach, and has a small but measurable impact on reducing the degree of bone loss.

Another choice would be to use a vitamin D metabolite such as calcitriol. “These are more effective, but if you use a vitamin D metabolite, don't give supplemental calcium and be sure to monitor for hypercalcemia and maybe even hypercalcuria if you are practicing in an area where there are a lot of renal stones,” said Dr. Hahn, professor of medicine and chief of rheumatology, University of California, Los Angeles. Hypercalcemia is particularly hazardous when patients are acutely ill and take to bed. The drug should be stopped at that time, she said.

But there's no question in 2005 that bisphosphonate therapy is the most effective strategy to prevent bone loss in steroid-induced osteoporosis, she said. In fact, calcium plus ordinary vitamin D has been used as the placebo in a lot of the clinical trials of bisphosphonates.

“It doesn't matter which one you choose—whichever one you like. Now that Fosamax comes in a liquid I have a lot more patients who can tolerate bisphosphonate therapy,” she said. Liquid alendronate causes less esophageal irritation and gastric distress than the capsules, she said.

Another option for certain patients is treatment with the anabolic hormone PTH 1–34 (teriparatide, Forteo). This drug is useful for patients who have very low bone turnover and are continuing to fracture despite treatment with bisphosphonates, active vitamin D, and calcitonin, she said.

In some patients it isn't enough to turn the osteoclast off, which is how these drugs work. For these patients it's also necessary to turn the osteoblast on, which is what PTH does, she said.

PTH stimulates osteoblast accumulation and bone formation through receptor signals that modulate osteoblast proliferation and maturation. It also increases the lifespan and productivity of the osteoblast by preventing apoptosis (Treat. Endocrinol. 2002:1;175–90).

Unfortunately, patients don't like to take this drug because it's injectable and must be taken every day or every other day. But three other formulations, two injectable and one oral, are now in clinical trials (Expert Opin. Investig. Drugs 2005;14:251–64).

One caution is needed with using PTH in patients with lupus. “This is not recommended by anybody but me, but I think you should screen your patients for hyperparathyroidism before you start PTH. I have found elevated levels of parathyroid hormone in one-third of my lupus patients, and we shouldn't be giving PTH to people who already have primary hyperparathyroidism,” she said.

VIENNA — B-cell depletion with rituximab led to significant improvements in patients with CNS neuropsychiatric disability associated with systemic lupus erythematosus, according to a preliminary report presented by C. Michael Neuwelt, M.D., at the annual European congress of rheumatology.

In his investigation, Dr. Neuwelt, of the University of California, San Francisco, and Stanford University, Palo Alto, studied 22 patients who met American College of Rheumatology criteria for CNS-NPSLE disability.

In addition, at baseline, patients met at least one of three criteria: abnormal brain MRI, severe progression of cognitive impairment as shown by neuropsychological testing, or cerebrospinal fluid pleocytosis and/or intrathecal elevation of IgG synthesis and/or oligoclonal banding.

Among the participants in the single-center study, 12 were treated with rituximab monotherapy, 7 were treated with a combination of rituximab and IV cyclophosphamide (IV-CYC), and 3 patients received plasmapheresis synchronized with IV-CYC and were maintained on rituximab for prolonged B-cell suppression.

After up to 18 months' follow up, 72% of the 19 patients treated with either rituximab alone or in combination with IV-CYC showed improvement. The three patients on triple therapy did not improve and required new therapy regimens.

In addition to monitoring changes in the objective parameters, patient outcomes were measured using several standard SLE disease activity indices.

Dr. Neuwelt emphasized that in at least one case, the patient actually had a disease flare with worsening brain lesions following a switch from her prestudy regimen of IV-CYC to rituximab monotherapy. In her case, combination IV-CYC and rituximab led to significant improvements over baseline (see MRI images before and after combination therapy).

Further research is needed to identify the best candidates for rituximab monotherapy and which patients will require combination therapy, said Dr. Neuwelt, who is on the advisory board for Genentech Inc., the manufacturer of rituximab (Rituxan). However, he did not receive funding for his study.

Outcomes from his observational study of 22 patients compared well to earlier, published reports of similar patients treated with IV-CYC with and without plasmapheresis, Dr. Neuwelt explained at the meeting, sponsored by the European League Against Rheumatism.

Those previous reports, which defined outcome end points in the same manner as the current study, found a 61% rate of improvement among 31 severe CNS-NPSLE patients treated with IV-CYC (Am. J. Med. 1995;98:32–41). Another study, also conducted by Dr. Neuwelt, found a 74% rate of improvement among 26 severe CNS-NPSLE patients treated with plasmapheresis either alone or synchronized with cyclophosphamide (Ther. Apher. Dial. 2003;7:173–82).

The lack of head-to-head trials comparing rituximab to other therapies is indicative of the challenges facing lupus-therapy investigations. Clinical trials of lupus patients are notoriously difficult to conduct, given the heterogeneity of the patient population. And CNS effects are the most difficult aspect of lupus to pin down, Dr. Neuwelt said in an interview.

“We don't know a lot about the pathogenic mechanisms” that lead to neuropsychiatric manifestations of SLE. “That's an area that we know the least about,” and yet it takes a considerable toll on quality of life, he said. There are no exact end points to measure changes in this manifestation, which makes it a difficult aspect of SLE to study.

He added that better tools to measure patient-centered outcomes in SLE—specifically, ones targeting neuropsychiatric markers—need to be developed.

The justification for trying rituximab in a CNS-NPSLE population is speculative at this time. However, similarities between lupus of the brain and multiple sclerosis exist. In MS, B cells and antibody-mediated demyelination comes from histopathologic studies of CNS tissue and analysis of CSF. Similar studies need to be done in the CNS tissue and CSF of CNS-NPSLE patients, Dr. Neuwelt said.

The prevalence of neuropsychiatric disorders in SLE has been found to range from 37% to 95% in various studies. The most common effects are cognitive dysfunction (55%–80%), headache (24%–72%), mood disorder (14%–57%), cerebrovascular disease (5%–18%), seizures (6%–51%), polyneuropathy (3%–28%), anxiety (7%–24%), and psychosis (0%–8%), according to John Hanly, M.D., head of the rheumatology division at Dalhousie University, Halifax, Nova Scotia. Dr. Hanly also presented on CNS-NPSLE at the meeting.

A 45-year-old woman was switched from IV CYC to rituximab monotherapy. Shortly after the switch, the patient's disease flared and a brain MRI in April (left) showed progression of her lesions. IV CYC was then added back to her regimen. A follow-up MRI in July showed the number of lesions was reduced on the combination. Photos courtesy Dr. C. Michael Neuwelt

VIENNA — B-cell depletion with rituximab led to significant improvements in patients with CNS neuropsychiatric disability associated with systemic lupus erythematosus, according to a preliminary report presented by C. Michael Neuwelt, M.D., at the annual European congress of rheumatology.

In his investigation, Dr. Neuwelt, of the University of California, San Francisco, and Stanford University, Palo Alto, studied 22 patients who met American College of Rheumatology criteria for CNS-NPSLE disability.

In addition, at baseline, patients met at least one of three criteria: abnormal brain MRI, severe progression of cognitive impairment as shown by neuropsychological testing, or cerebrospinal fluid pleocytosis and/or intrathecal elevation of IgG synthesis and/or oligoclonal banding.

Among the participants in the single-center study, 12 were treated with rituximab monotherapy, 7 were treated with a combination of rituximab and IV cyclophosphamide (IV-CYC), and 3 patients received plasmapheresis synchronized with IV-CYC and were maintained on rituximab for prolonged B-cell suppression.

After up to 18 months' follow up, 72% of the 19 patients treated with either rituximab alone or in combination with IV-CYC showed improvement. The three patients on triple therapy did not improve and required new therapy regimens.

In addition to monitoring changes in the objective parameters, patient outcomes were measured using several standard SLE disease activity indices.

Dr. Neuwelt emphasized that in at least one case, the patient actually had a disease flare with worsening brain lesions following a switch from her prestudy regimen of IV-CYC to rituximab monotherapy. In her case, combination IV-CYC and rituximab led to significant improvements over baseline (see MRI images before and after combination therapy).

Further research is needed to identify the best candidates for rituximab monotherapy and which patients will require combination therapy, said Dr. Neuwelt, who is on the advisory board for Genentech Inc., the manufacturer of rituximab (Rituxan). However, he did not receive funding for his study.

Outcomes from his observational study of 22 patients compared well to earlier, published reports of similar patients treated with IV-CYC with and without plasmapheresis, Dr. Neuwelt explained at the meeting, sponsored by the European League Against Rheumatism.

Those previous reports, which defined outcome end points in the same manner as the current study, found a 61% rate of improvement among 31 severe CNS-NPSLE patients treated with IV-CYC (Am. J. Med. 1995;98:32–41). Another study, also conducted by Dr. Neuwelt, found a 74% rate of improvement among 26 severe CNS-NPSLE patients treated with plasmapheresis either alone or synchronized with cyclophosphamide (Ther. Apher. Dial. 2003;7:173–82).

The lack of head-to-head trials comparing rituximab to other therapies is indicative of the challenges facing lupus-therapy investigations. Clinical trials of lupus patients are notoriously difficult to conduct, given the heterogeneity of the patient population. And CNS effects are the most difficult aspect of lupus to pin down, Dr. Neuwelt said in an interview.

“We don't know a lot about the pathogenic mechanisms” that lead to neuropsychiatric manifestations of SLE. “That's an area that we know the least about,” and yet it takes a considerable toll on quality of life, he said. There are no exact end points to measure changes in this manifestation, which makes it a difficult aspect of SLE to study.

He added that better tools to measure patient-centered outcomes in SLE—specifically, ones targeting neuropsychiatric markers—need to be developed.

The justification for trying rituximab in a CNS-NPSLE population is speculative at this time. However, similarities between lupus of the brain and multiple sclerosis exist. In MS, B cells and antibody-mediated demyelination comes from histopathologic studies of CNS tissue and analysis of CSF. Similar studies need to be done in the CNS tissue and CSF of CNS-NPSLE patients, Dr. Neuwelt said.

The prevalence of neuropsychiatric disorders in SLE has been found to range from 37% to 95% in various studies. The most common effects are cognitive dysfunction (55%–80%), headache (24%–72%), mood disorder (14%–57%), cerebrovascular disease (5%–18%), seizures (6%–51%), polyneuropathy (3%–28%), anxiety (7%–24%), and psychosis (0%–8%), according to John Hanly, M.D., head of the rheumatology division at Dalhousie University, Halifax, Nova Scotia. Dr. Hanly also presented on CNS-NPSLE at the meeting.

A 45-year-old woman was switched from IV CYC to rituximab monotherapy. Shortly after the switch, the patient's disease flared and a brain MRI in April (left) showed progression of her lesions. IV CYC was then added back to her regimen. A follow-up MRI in July showed the number of lesions was reduced on the combination. Photos courtesy Dr. C. Michael Neuwelt

VIENNA — B-cell depletion with rituximab led to significant improvements in patients with CNS neuropsychiatric disability associated with systemic lupus erythematosus, according to a preliminary report presented by C. Michael Neuwelt, M.D., at the annual European congress of rheumatology.

In his investigation, Dr. Neuwelt, of the University of California, San Francisco, and Stanford University, Palo Alto, studied 22 patients who met American College of Rheumatology criteria for CNS-NPSLE disability.

In addition, at baseline, patients met at least one of three criteria: abnormal brain MRI, severe progression of cognitive impairment as shown by neuropsychological testing, or cerebrospinal fluid pleocytosis and/or intrathecal elevation of IgG synthesis and/or oligoclonal banding.

Among the participants in the single-center study, 12 were treated with rituximab monotherapy, 7 were treated with a combination of rituximab and IV cyclophosphamide (IV-CYC), and 3 patients received plasmapheresis synchronized with IV-CYC and were maintained on rituximab for prolonged B-cell suppression.

After up to 18 months' follow up, 72% of the 19 patients treated with either rituximab alone or in combination with IV-CYC showed improvement. The three patients on triple therapy did not improve and required new therapy regimens.

In addition to monitoring changes in the objective parameters, patient outcomes were measured using several standard SLE disease activity indices.

Dr. Neuwelt emphasized that in at least one case, the patient actually had a disease flare with worsening brain lesions following a switch from her prestudy regimen of IV-CYC to rituximab monotherapy. In her case, combination IV-CYC and rituximab led to significant improvements over baseline (see MRI images before and after combination therapy).

Further research is needed to identify the best candidates for rituximab monotherapy and which patients will require combination therapy, said Dr. Neuwelt, who is on the advisory board for Genentech Inc., the manufacturer of rituximab (Rituxan). However, he did not receive funding for his study.

Outcomes from his observational study of 22 patients compared well to earlier, published reports of similar patients treated with IV-CYC with and without plasmapheresis, Dr. Neuwelt explained at the meeting, sponsored by the European League Against Rheumatism.

Those previous reports, which defined outcome end points in the same manner as the current study, found a 61% rate of improvement among 31 severe CNS-NPSLE patients treated with IV-CYC (Am. J. Med. 1995;98:32–41). Another study, also conducted by Dr. Neuwelt, found a 74% rate of improvement among 26 severe CNS-NPSLE patients treated with plasmapheresis either alone or synchronized with cyclophosphamide (Ther. Apher. Dial. 2003;7:173–82).

The lack of head-to-head trials comparing rituximab to other therapies is indicative of the challenges facing lupus-therapy investigations. Clinical trials of lupus patients are notoriously difficult to conduct, given the heterogeneity of the patient population. And CNS effects are the most difficult aspect of lupus to pin down, Dr. Neuwelt said in an interview.

“We don't know a lot about the pathogenic mechanisms” that lead to neuropsychiatric manifestations of SLE. “That's an area that we know the least about,” and yet it takes a considerable toll on quality of life, he said. There are no exact end points to measure changes in this manifestation, which makes it a difficult aspect of SLE to study.

He added that better tools to measure patient-centered outcomes in SLE—specifically, ones targeting neuropsychiatric markers—need to be developed.

The justification for trying rituximab in a CNS-NPSLE population is speculative at this time. However, similarities between lupus of the brain and multiple sclerosis exist. In MS, B cells and antibody-mediated demyelination comes from histopathologic studies of CNS tissue and analysis of CSF. Similar studies need to be done in the CNS tissue and CSF of CNS-NPSLE patients, Dr. Neuwelt said.

The prevalence of neuropsychiatric disorders in SLE has been found to range from 37% to 95% in various studies. The most common effects are cognitive dysfunction (55%–80%), headache (24%–72%), mood disorder (14%–57%), cerebrovascular disease (5%–18%), seizures (6%–51%), polyneuropathy (3%–28%), anxiety (7%–24%), and psychosis (0%–8%), according to John Hanly, M.D., head of the rheumatology division at Dalhousie University, Halifax, Nova Scotia. Dr. Hanly also presented on CNS-NPSLE at the meeting.

A 45-year-old woman was switched from IV CYC to rituximab monotherapy. Shortly after the switch, the patient's disease flared and a brain MRI in April (left) showed progression of her lesions. IV CYC was then added back to her regimen. A follow-up MRI in July showed the number of lesions was reduced on the combination. Photos courtesy Dr. C. Michael Neuwelt