ORLANDO – Although higher systolic blood pressure and LDL cholesterol are traditional risk factors for cardiovascular disease, each may have a different effect on the cerebrovascular and coronary systems.

Pooled analysis of three landmark studies done on the cholesterol-lowering agent atorvastatin in high-risk patients showed that higher baseline systolic blood pressure is predictive of a significantly higher risk of stroke. Meanwhile, higher baseline LDL cholesterol is predictive of a significantly higher risk of coronary events, the analysis showed.

The findings have implications on both research design and clinical practice, Dr. Prakash C. Deedwania, the study’s lead author, said at the annual scientific sessions of the American Heart Association.

Patients who might be at risk of both stroke and coronary events should be treated aggressively to reduce systolic blood pressure and LDL cholesterol, he said.

Dr. Deedwania and his colleagues pooled data on 21,727 patients from three trials: Treating to New Targets (TNT), which compared 10 mg with 80 mg atorvastatin in patients with stable coronary heart disease and LDL levels below 130 mg/dL (N. Engl. J. Med. 2005;352:1425-35), Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL), which compared high-dose (80 mg) atorvastatin with normal-dose (20-40 mg) simvastatin in post-MI patients (JAMA 2005;294:2437-45), and the Collaborative Atorvastatin Diabetes Study (CARDS), which compared 20 mg atorvastatin with placebo in patients with type 2 diabetes and without established coronary heart disease (Lancet 2004;364:685-96).

Results showed that with each 10-mm Hg increase in baseline systolic blood pressure, the risk of a fatal or nonfatal stroke increased by 16%. Meanwhile, each 10-mg/dL increase in baseline LDL cholesterol increased the risk of coronary events by 5%. Both differences were significantly different.

Dr. Deedwania said that the reduction in LDL cholesterol has been associated with a decrease in the risk of stroke, "but perhaps by a different mechanism."

The authors also looked at a subgroup of patients with type 2 diabetes (5,408 patients from the three trials), and found results consistent with the larger cohort.

Although systolic blood pressure is known to be a powerful predictor of stroke, many clinicians may not be aware that LDL cholesterol is not associated with an increased risk of stroke, said Dr. Deedwania. "What predicts baseline risk is different than what happens in treatment, so there are yet many lessons to be learned from these trials."

Dr. Deedwania has received research grants from Pfizer. He has been a consultant to and on the advisory boards of Pfizer and Novartis.

ORLANDO – Although higher systolic blood pressure and LDL cholesterol are traditional risk factors for cardiovascular disease, each may have a different effect on the cerebrovascular and coronary systems.

Pooled analysis of three landmark studies done on the cholesterol-lowering agent atorvastatin in high-risk patients showed that higher baseline systolic blood pressure is predictive of a significantly higher risk of stroke. Meanwhile, higher baseline LDL cholesterol is predictive of a significantly higher risk of coronary events, the analysis showed.

The findings have implications on both research design and clinical practice, Dr. Prakash C. Deedwania, the study’s lead author, said at the annual scientific sessions of the American Heart Association.

Patients who might be at risk of both stroke and coronary events should be treated aggressively to reduce systolic blood pressure and LDL cholesterol, he said.

Dr. Deedwania and his colleagues pooled data on 21,727 patients from three trials: Treating to New Targets (TNT), which compared 10 mg with 80 mg atorvastatin in patients with stable coronary heart disease and LDL levels below 130 mg/dL (N. Engl. J. Med. 2005;352:1425-35), Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL), which compared high-dose (80 mg) atorvastatin with normal-dose (20-40 mg) simvastatin in post-MI patients (JAMA 2005;294:2437-45), and the Collaborative Atorvastatin Diabetes Study (CARDS), which compared 20 mg atorvastatin with placebo in patients with type 2 diabetes and without established coronary heart disease (Lancet 2004;364:685-96).

Results showed that with each 10-mm Hg increase in baseline systolic blood pressure, the risk of a fatal or nonfatal stroke increased by 16%. Meanwhile, each 10-mg/dL increase in baseline LDL cholesterol increased the risk of coronary events by 5%. Both differences were significantly different.

Dr. Deedwania said that the reduction in LDL cholesterol has been associated with a decrease in the risk of stroke, "but perhaps by a different mechanism."

The authors also looked at a subgroup of patients with type 2 diabetes (5,408 patients from the three trials), and found results consistent with the larger cohort.

Although systolic blood pressure is known to be a powerful predictor of stroke, many clinicians may not be aware that LDL cholesterol is not associated with an increased risk of stroke, said Dr. Deedwania. "What predicts baseline risk is different than what happens in treatment, so there are yet many lessons to be learned from these trials."

Dr. Deedwania has received research grants from Pfizer. He has been a consultant to and on the advisory boards of Pfizer and Novartis.

ORLANDO – Although higher systolic blood pressure and LDL cholesterol are traditional risk factors for cardiovascular disease, each may have a different effect on the cerebrovascular and coronary systems.

Pooled analysis of three landmark studies done on the cholesterol-lowering agent atorvastatin in high-risk patients showed that higher baseline systolic blood pressure is predictive of a significantly higher risk of stroke. Meanwhile, higher baseline LDL cholesterol is predictive of a significantly higher risk of coronary events, the analysis showed.

The findings have implications on both research design and clinical practice, Dr. Prakash C. Deedwania, the study’s lead author, said at the annual scientific sessions of the American Heart Association.

Patients who might be at risk of both stroke and coronary events should be treated aggressively to reduce systolic blood pressure and LDL cholesterol, he said.

Dr. Deedwania and his colleagues pooled data on 21,727 patients from three trials: Treating to New Targets (TNT), which compared 10 mg with 80 mg atorvastatin in patients with stable coronary heart disease and LDL levels below 130 mg/dL (N. Engl. J. Med. 2005;352:1425-35), Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL), which compared high-dose (80 mg) atorvastatin with normal-dose (20-40 mg) simvastatin in post-MI patients (JAMA 2005;294:2437-45), and the Collaborative Atorvastatin Diabetes Study (CARDS), which compared 20 mg atorvastatin with placebo in patients with type 2 diabetes and without established coronary heart disease (Lancet 2004;364:685-96).

Results showed that with each 10-mm Hg increase in baseline systolic blood pressure, the risk of a fatal or nonfatal stroke increased by 16%. Meanwhile, each 10-mg/dL increase in baseline LDL cholesterol increased the risk of coronary events by 5%. Both differences were significantly different.

Dr. Deedwania said that the reduction in LDL cholesterol has been associated with a decrease in the risk of stroke, "but perhaps by a different mechanism."

The authors also looked at a subgroup of patients with type 2 diabetes (5,408 patients from the three trials), and found results consistent with the larger cohort.

Although systolic blood pressure is known to be a powerful predictor of stroke, many clinicians may not be aware that LDL cholesterol is not associated with an increased risk of stroke, said Dr. Deedwania. "What predicts baseline risk is different than what happens in treatment, so there are yet many lessons to be learned from these trials."

Dr. Deedwania has received research grants from Pfizer. He has been a consultant to and on the advisory boards of Pfizer and Novartis.

Begin by thinking about this diagnosis. If you don’t consider immunodeficiency during your routine evaluations, you are likely to miss one of these relatively rare conditions. Screening is of the utmost importance with more than 175 pediatric primary immunodeficiencies identified.

Considering immunodeficiencies appropriately is important – they represent sharp needles in the pediatrician’s haystack. You might be thinking: How am I going to recognize these important needles in my busy practice? My advice is to look for the hallmarks – infections that are recurrent, severe, or unusual.

Courtesy Children's Hospital of Philadelphia

I use a Statue of Liberty analogy. Give me your five sickest kids – the ones who hound your triage nurse, the ones who always page you after hours – and then think about immunodeficiency as a possible diagnosis. A child with recurrent infections who requires and responds to antibiotics frequently is a likely candidate.

Upper and lower respiratory tract infections are common in this patient population. About half of children with an immunodeficiency will have antibodies and will most typically present with involvement of the sinuses and/or the ears, including in some cases, bronchitis or pneumonia.

Severe combined immunodeficiency syndrome (SCIDS) is particularly alarming. If you practice in one of the states that require newborn screening for this condition – California, Louisiana, Massachusetts, New York, or Wisconsin – you are likely to receive a call at some point from your state laboratory. The number of calls you get alerting you to a positive result will vary by the size of your practice: SCIDS affects about 1 in 50,000 live births. There was a case in Wisconsin where a baby with SCIDS was identified quickly and cured (J. Allergy Clin. Immunol. 2011;127:535-38).

A newborn with SCIDS lacks the capacity to make functional T cells, and there is a movement to expand this screening to all 50 states.

As with any confirmed immunodeficiency, working in concert with an immunologist becomes essential. Expertise is important because there are therapeutic options for almost every patient with a primary immunodeficiency diagnosis. A subspecialist can help you devise an effective management plan. It is a matter of pediatricians feeling empowered, not feeling that children with primary immunodeficiencies are too complex to manage.

I am fine with a pediatrician calling for a direct referral. It is appropriate not to manage the diagnostic evaluation of these children if you feel uncomfortable. With that said, there are opportunities for pediatricians to manage these patients as well. I know some pediatricians are as adept at this as I am.

For example, you can screen a child with a suspected immunodeficiency for the presence of antibodies. Keep quantity and quality in mind. Quantity is a check of how full the tank is; for example, assess their levels of IgG, IgM, and IgA.

Quality assessment can be more challenging, but there are appropriate, point-of-contact screenings you can perform without too much effort. Most importantly these would include checking the antibody titers against vaccines you have provided, such as a tetanus titer or pneumococcal titers.

A complete blood count with differential, for example, provides important information, including the percentage and number of lymphocytes and neutrophils. If the absolute levels are low, then it becomes relevant to think: Why? Viral suppression is a true cause, but it’s overrated, so be sure to reevaluate a low count and remember to consider immunodeficiency if a low value persists.

If you suspect immunodeficiency in a baby, for example, check the infant’s lymphocyte count against the age-specific normal value. This varies, but the lower limit for normal for a healthy child under 1 year of age is about 3,500/mcL.

This might surprise you, but a child with low or no lymphocytes can quickly require emergency medical attention.

Other tests are more in the domain of the specialist or more appropriate in specific situations. In addition, the assay order forms and specialty laboratories can be tricky. Right next to IgG, for example, the IgG subclasses are often listed. These subclass evaluations are expensive and of little value in routine clinical assessment.

The bottom line is: Think about primary immunodeficiency. If you are uncomfortable in carrying forward a diagnostic evaluation – call an immunologist. We are happy to help. Statistically speaking, the needle is in your haystack. A pediatric practice looking after 10,000 children should be following 5 with primary immunodeficiency. Do you know who yours are?

This column, "Subspecialist Consult," appears regularly in Pediatric News, an Elsevier publication. Dr. Orange is a pediatric immunologist in the division of allergy and immunology at Children’s Hospital of Philadelphia. He disclosed that he is a medical adviser to the Immunodeficiency Foundation and a consultant to three manufacturers of immunoglobulin therapies: Baxter Healthcare, Talecris Biotherapeutics, and CSL Behring. He also receives research grants from Octapharma USA.

Begin by thinking about this diagnosis. If you don’t consider immunodeficiency during your routine evaluations, you are likely to miss one of these relatively rare conditions. Screening is of the utmost importance with more than 175 pediatric primary immunodeficiencies identified.

Considering immunodeficiencies appropriately is important – they represent sharp needles in the pediatrician’s haystack. You might be thinking: How am I going to recognize these important needles in my busy practice? My advice is to look for the hallmarks – infections that are recurrent, severe, or unusual.

Courtesy Children's Hospital of Philadelphia

I use a Statue of Liberty analogy. Give me your five sickest kids – the ones who hound your triage nurse, the ones who always page you after hours – and then think about immunodeficiency as a possible diagnosis. A child with recurrent infections who requires and responds to antibiotics frequently is a likely candidate.

Upper and lower respiratory tract infections are common in this patient population. About half of children with an immunodeficiency will have antibodies and will most typically present with involvement of the sinuses and/or the ears, including in some cases, bronchitis or pneumonia.

Severe combined immunodeficiency syndrome (SCIDS) is particularly alarming. If you practice in one of the states that require newborn screening for this condition – California, Louisiana, Massachusetts, New York, or Wisconsin – you are likely to receive a call at some point from your state laboratory. The number of calls you get alerting you to a positive result will vary by the size of your practice: SCIDS affects about 1 in 50,000 live births. There was a case in Wisconsin where a baby with SCIDS was identified quickly and cured (J. Allergy Clin. Immunol. 2011;127:535-38).

A newborn with SCIDS lacks the capacity to make functional T cells, and there is a movement to expand this screening to all 50 states.

As with any confirmed immunodeficiency, working in concert with an immunologist becomes essential. Expertise is important because there are therapeutic options for almost every patient with a primary immunodeficiency diagnosis. A subspecialist can help you devise an effective management plan. It is a matter of pediatricians feeling empowered, not feeling that children with primary immunodeficiencies are too complex to manage.

I am fine with a pediatrician calling for a direct referral. It is appropriate not to manage the diagnostic evaluation of these children if you feel uncomfortable. With that said, there are opportunities for pediatricians to manage these patients as well. I know some pediatricians are as adept at this as I am.

For example, you can screen a child with a suspected immunodeficiency for the presence of antibodies. Keep quantity and quality in mind. Quantity is a check of how full the tank is; for example, assess their levels of IgG, IgM, and IgA.

Quality assessment can be more challenging, but there are appropriate, point-of-contact screenings you can perform without too much effort. Most importantly these would include checking the antibody titers against vaccines you have provided, such as a tetanus titer or pneumococcal titers.

A complete blood count with differential, for example, provides important information, including the percentage and number of lymphocytes and neutrophils. If the absolute levels are low, then it becomes relevant to think: Why? Viral suppression is a true cause, but it’s overrated, so be sure to reevaluate a low count and remember to consider immunodeficiency if a low value persists.

If you suspect immunodeficiency in a baby, for example, check the infant’s lymphocyte count against the age-specific normal value. This varies, but the lower limit for normal for a healthy child under 1 year of age is about 3,500/mcL.

This might surprise you, but a child with low or no lymphocytes can quickly require emergency medical attention.

Other tests are more in the domain of the specialist or more appropriate in specific situations. In addition, the assay order forms and specialty laboratories can be tricky. Right next to IgG, for example, the IgG subclasses are often listed. These subclass evaluations are expensive and of little value in routine clinical assessment.

The bottom line is: Think about primary immunodeficiency. If you are uncomfortable in carrying forward a diagnostic evaluation – call an immunologist. We are happy to help. Statistically speaking, the needle is in your haystack. A pediatric practice looking after 10,000 children should be following 5 with primary immunodeficiency. Do you know who yours are?

This column, "Subspecialist Consult," appears regularly in Pediatric News, an Elsevier publication. Dr. Orange is a pediatric immunologist in the division of allergy and immunology at Children’s Hospital of Philadelphia. He disclosed that he is a medical adviser to the Immunodeficiency Foundation and a consultant to three manufacturers of immunoglobulin therapies: Baxter Healthcare, Talecris Biotherapeutics, and CSL Behring. He also receives research grants from Octapharma USA.

Begin by thinking about this diagnosis. If you don’t consider immunodeficiency during your routine evaluations, you are likely to miss one of these relatively rare conditions. Screening is of the utmost importance with more than 175 pediatric primary immunodeficiencies identified.

Considering immunodeficiencies appropriately is important – they represent sharp needles in the pediatrician’s haystack. You might be thinking: How am I going to recognize these important needles in my busy practice? My advice is to look for the hallmarks – infections that are recurrent, severe, or unusual.

Courtesy Children's Hospital of Philadelphia

I use a Statue of Liberty analogy. Give me your five sickest kids – the ones who hound your triage nurse, the ones who always page you after hours – and then think about immunodeficiency as a possible diagnosis. A child with recurrent infections who requires and responds to antibiotics frequently is a likely candidate.

Upper and lower respiratory tract infections are common in this patient population. About half of children with an immunodeficiency will have antibodies and will most typically present with involvement of the sinuses and/or the ears, including in some cases, bronchitis or pneumonia.

Severe combined immunodeficiency syndrome (SCIDS) is particularly alarming. If you practice in one of the states that require newborn screening for this condition – California, Louisiana, Massachusetts, New York, or Wisconsin – you are likely to receive a call at some point from your state laboratory. The number of calls you get alerting you to a positive result will vary by the size of your practice: SCIDS affects about 1 in 50,000 live births. There was a case in Wisconsin where a baby with SCIDS was identified quickly and cured (J. Allergy Clin. Immunol. 2011;127:535-38).

A newborn with SCIDS lacks the capacity to make functional T cells, and there is a movement to expand this screening to all 50 states.

As with any confirmed immunodeficiency, working in concert with an immunologist becomes essential. Expertise is important because there are therapeutic options for almost every patient with a primary immunodeficiency diagnosis. A subspecialist can help you devise an effective management plan. It is a matter of pediatricians feeling empowered, not feeling that children with primary immunodeficiencies are too complex to manage.

I am fine with a pediatrician calling for a direct referral. It is appropriate not to manage the diagnostic evaluation of these children if you feel uncomfortable. With that said, there are opportunities for pediatricians to manage these patients as well. I know some pediatricians are as adept at this as I am.

For example, you can screen a child with a suspected immunodeficiency for the presence of antibodies. Keep quantity and quality in mind. Quantity is a check of how full the tank is; for example, assess their levels of IgG, IgM, and IgA.

Quality assessment can be more challenging, but there are appropriate, point-of-contact screenings you can perform without too much effort. Most importantly these would include checking the antibody titers against vaccines you have provided, such as a tetanus titer or pneumococcal titers.

A complete blood count with differential, for example, provides important information, including the percentage and number of lymphocytes and neutrophils. If the absolute levels are low, then it becomes relevant to think: Why? Viral suppression is a true cause, but it’s overrated, so be sure to reevaluate a low count and remember to consider immunodeficiency if a low value persists.

If you suspect immunodeficiency in a baby, for example, check the infant’s lymphocyte count against the age-specific normal value. This varies, but the lower limit for normal for a healthy child under 1 year of age is about 3,500/mcL.

This might surprise you, but a child with low or no lymphocytes can quickly require emergency medical attention.

Other tests are more in the domain of the specialist or more appropriate in specific situations. In addition, the assay order forms and specialty laboratories can be tricky. Right next to IgG, for example, the IgG subclasses are often listed. These subclass evaluations are expensive and of little value in routine clinical assessment.

The bottom line is: Think about primary immunodeficiency. If you are uncomfortable in carrying forward a diagnostic evaluation – call an immunologist. We are happy to help. Statistically speaking, the needle is in your haystack. A pediatric practice looking after 10,000 children should be following 5 with primary immunodeficiency. Do you know who yours are?

This column, "Subspecialist Consult," appears regularly in Pediatric News, an Elsevier publication. Dr. Orange is a pediatric immunologist in the division of allergy and immunology at Children’s Hospital of Philadelphia. He disclosed that he is a medical adviser to the Immunodeficiency Foundation and a consultant to three manufacturers of immunoglobulin therapies: Baxter Healthcare, Talecris Biotherapeutics, and CSL Behring. He also receives research grants from Octapharma USA.

Clostridium difficile has been on the radar of infectious disease (ID) experts for the better part of a decade now. But how mindful are hospitalists of the problem, and how seriously are they taking it?

“I think we’re getting there,” says Danielle Scheurer, MD, MSCR, SFHM, a hospitalist and medical director of quality at the Medical University of South Carolina in Charleston. But she adds, “Because the bugs are invisible, you feel a little bit disconnected from your direct role in all this.”

Stuart Cohen, MD, an ID expert at the University of California Davis and a fellow with the Infectious Diseases Society of America, says not everyone is as concerned about C. diff as they should be.

“I think most people still see C. diff as just basically being a nuisance, and so they don’t really take it quite so seriously. Until somebody sees a patient have to get a colectomy or die from C. diff, I don’t think that there’s necessarily an appreciation to the severity of the illness,” he says. “You don’t really get this sense that it’s anything other than, ‘Well, we’ll just give them some vancomycin or we’ll just give them some metronidazole and we’ll take care of it.’”

Ketino Kobaidze, MD, a hospitalist at Emory University Hospital Midtown in Atlanta, says she thinks hospitalists should be more involved in antibiotic stewardship efforts and in research efforts to combat C. diff.

“I’m sure everybody knows and everybody takes it into consideration,” she says. But she also says not all hospitalists view C. diff as an acute problem that warrants urgent treatment “or we might be in trouble,” she says. “I’m not sure about that.”

Dr. Scheurer says the solution to treating C. diff properly is keeping a mindset on the safety of your patients. “Then it can motivate you and your group,” she says. “Every single number affects a person. It’s not just a rate. Zero is the goal.”

Tom Collins is a freelance medical writer based in Florida.

 

Clostridium difficile has been on the radar of infectious disease (ID) experts for the better part of a decade now. But how mindful are hospitalists of the problem, and how seriously are they taking it?

“I think we’re getting there,” says Danielle Scheurer, MD, MSCR, SFHM, a hospitalist and medical director of quality at the Medical University of South Carolina in Charleston. But she adds, “Because the bugs are invisible, you feel a little bit disconnected from your direct role in all this.”

Stuart Cohen, MD, an ID expert at the University of California Davis and a fellow with the Infectious Diseases Society of America, says not everyone is as concerned about C. diff as they should be.

“I think most people still see C. diff as just basically being a nuisance, and so they don’t really take it quite so seriously. Until somebody sees a patient have to get a colectomy or die from C. diff, I don’t think that there’s necessarily an appreciation to the severity of the illness,” he says. “You don’t really get this sense that it’s anything other than, ‘Well, we’ll just give them some vancomycin or we’ll just give them some metronidazole and we’ll take care of it.’”

Ketino Kobaidze, MD, a hospitalist at Emory University Hospital Midtown in Atlanta, says she thinks hospitalists should be more involved in antibiotic stewardship efforts and in research efforts to combat C. diff.

“I’m sure everybody knows and everybody takes it into consideration,” she says. But she also says not all hospitalists view C. diff as an acute problem that warrants urgent treatment “or we might be in trouble,” she says. “I’m not sure about that.”

Dr. Scheurer says the solution to treating C. diff properly is keeping a mindset on the safety of your patients. “Then it can motivate you and your group,” she says. “Every single number affects a person. It’s not just a rate. Zero is the goal.”

Tom Collins is a freelance medical writer based in Florida.

 

Clostridium difficile has been on the radar of infectious disease (ID) experts for the better part of a decade now. But how mindful are hospitalists of the problem, and how seriously are they taking it?

“I think we’re getting there,” says Danielle Scheurer, MD, MSCR, SFHM, a hospitalist and medical director of quality at the Medical University of South Carolina in Charleston. But she adds, “Because the bugs are invisible, you feel a little bit disconnected from your direct role in all this.”

Stuart Cohen, MD, an ID expert at the University of California Davis and a fellow with the Infectious Diseases Society of America, says not everyone is as concerned about C. diff as they should be.

“I think most people still see C. diff as just basically being a nuisance, and so they don’t really take it quite so seriously. Until somebody sees a patient have to get a colectomy or die from C. diff, I don’t think that there’s necessarily an appreciation to the severity of the illness,” he says. “You don’t really get this sense that it’s anything other than, ‘Well, we’ll just give them some vancomycin or we’ll just give them some metronidazole and we’ll take care of it.’”

Ketino Kobaidze, MD, a hospitalist at Emory University Hospital Midtown in Atlanta, says she thinks hospitalists should be more involved in antibiotic stewardship efforts and in research efforts to combat C. diff.

“I’m sure everybody knows and everybody takes it into consideration,” she says. But she also says not all hospitalists view C. diff as an acute problem that warrants urgent treatment “or we might be in trouble,” she says. “I’m not sure about that.”

Dr. Scheurer says the solution to treating C. diff properly is keeping a mindset on the safety of your patients. “Then it can motivate you and your group,” she says. “Every single number affects a person. It’s not just a rate. Zero is the goal.”

Tom Collins is a freelance medical writer based in Florida.

 

The Schumacher Group, which bills itself as the third-largest emergency and HM management firm in the U.S., is incorporating the use of smartphone applications, or apps, through its EDs nationwide. A similar technology could soon be in the offing for its HM operation.

The Lafayette, La.-based firm announced late last month that it was partnering with iTriage, a company that produces a free healthcare app for consumers, at its ED operation at North Okaloosa Medical Center in Crestview, Fla. The app will let patients and others learn details about the hospital and its services. And while David Grace, MD, FHM, the firm’s senior medical officer for hospital medicine, says there are no immediate plans to expand the usage to HM, the topic is being discussed.

"We're investigating it," he says, adding he sees a multitude of potential uses for healthcare apps, especially if they empower HM patients to become more involved in their care.

"I think any information that we can supply patients, whether we supply it or it's supplied through some other media, I think is a good thing," he says. "It increases their engagement. And any time the patient is more engaged in their healthcare, I think you develop better plans, better outcomes."

He cautions that there are potential pitfalls for physicians and patients. Patients need to be realistic about their breadth of knowledge, and doctors need to understand that a patient is not second-guessing them, just being interactive in the process.

It can "almost be one more line of safety checks in the whole healthcare continuum," Dr. Grace says. "The last time I looked, I've not seen too many practices of individuals out there hit 100% of everything 100% of the time. And while the errors numbers may be small, if you're the one discharged after a stroke not on an anti-platelet agent and have a massive stroke, that 1% was a pretty substantial number in your case."

The Schumacher Group, which bills itself as the third-largest emergency and HM management firm in the U.S., is incorporating the use of smartphone applications, or apps, through its EDs nationwide. A similar technology could soon be in the offing for its HM operation.

The Lafayette, La.-based firm announced late last month that it was partnering with iTriage, a company that produces a free healthcare app for consumers, at its ED operation at North Okaloosa Medical Center in Crestview, Fla. The app will let patients and others learn details about the hospital and its services. And while David Grace, MD, FHM, the firm’s senior medical officer for hospital medicine, says there are no immediate plans to expand the usage to HM, the topic is being discussed.

"We're investigating it," he says, adding he sees a multitude of potential uses for healthcare apps, especially if they empower HM patients to become more involved in their care.

"I think any information that we can supply patients, whether we supply it or it's supplied through some other media, I think is a good thing," he says. "It increases their engagement. And any time the patient is more engaged in their healthcare, I think you develop better plans, better outcomes."

He cautions that there are potential pitfalls for physicians and patients. Patients need to be realistic about their breadth of knowledge, and doctors need to understand that a patient is not second-guessing them, just being interactive in the process.

It can "almost be one more line of safety checks in the whole healthcare continuum," Dr. Grace says. "The last time I looked, I've not seen too many practices of individuals out there hit 100% of everything 100% of the time. And while the errors numbers may be small, if you're the one discharged after a stroke not on an anti-platelet agent and have a massive stroke, that 1% was a pretty substantial number in your case."

The Schumacher Group, which bills itself as the third-largest emergency and HM management firm in the U.S., is incorporating the use of smartphone applications, or apps, through its EDs nationwide. A similar technology could soon be in the offing for its HM operation.

The Lafayette, La.-based firm announced late last month that it was partnering with iTriage, a company that produces a free healthcare app for consumers, at its ED operation at North Okaloosa Medical Center in Crestview, Fla. The app will let patients and others learn details about the hospital and its services. And while David Grace, MD, FHM, the firm’s senior medical officer for hospital medicine, says there are no immediate plans to expand the usage to HM, the topic is being discussed.

"We're investigating it," he says, adding he sees a multitude of potential uses for healthcare apps, especially if they empower HM patients to become more involved in their care.

"I think any information that we can supply patients, whether we supply it or it's supplied through some other media, I think is a good thing," he says. "It increases their engagement. And any time the patient is more engaged in their healthcare, I think you develop better plans, better outcomes."

He cautions that there are potential pitfalls for physicians and patients. Patients need to be realistic about their breadth of knowledge, and doctors need to understand that a patient is not second-guessing them, just being interactive in the process.

It can "almost be one more line of safety checks in the whole healthcare continuum," Dr. Grace says. "The last time I looked, I've not seen too many practices of individuals out there hit 100% of everything 100% of the time. And while the errors numbers may be small, if you're the one discharged after a stroke not on an anti-platelet agent and have a massive stroke, that 1% was a pretty substantial number in your case."

Clinical question: In patients with candidemia, what are the incidence, risk factors, and antifungal treatment outcomes for ocular candidiasis?

Background: The incidence and treatment outcomes of ocular candidiasis have not been studied extensively.

Study design: Randomized noninferiority trial.

Setting: Multicenter study of 370 patients.

Synopsis: This study randomized 370 non-neutropenic patients with candidemia in a 2:1 ratio to receive voriconazole monotherapy or amphotericin B followed by fluconazole. Patients were treated for at least two weeks after the last positive blood culture, for a maximum duration of eight weeks. Baseline and follow-up fundoscopic examinations were performed.

Sixty (16%) patients were diagnosed with ocular candidiasis, of which six (1.6%) were diagnosed with endophthalmitis and 34 (9%) with chorioretinitis. Patients with ocular candidiasis had a longer duration of candidemia, and were more likely to be infected with Candida albicans.

Outcomes were not available in 19 patients with ocular candidiasis due to death or loss of follow-up. There was no significant difference between the cure rate of voriconazole (93.5% [29/31]), compared with the amphotericin B group (100% [10/10]).

Bottom line: Ocular candidiasis occurs in approximately 16% of non-neutropenic patients with candidemia. A longer duration of candidemia and infection with C. albicans were associated with ocular candidiasis. Both voriconazole and amphotericin B/fluconazole are effective in patients with ocular candidiasis.

Citation: Oude Lashof AM, Rothova A, Sobel JD, et al. Ocular manifestations of candidemia. Clin Infect Dis. 2011;53:262-268.

For more physician reviews of HM-related literature, check out our website.

Clinical question: In patients with candidemia, what are the incidence, risk factors, and antifungal treatment outcomes for ocular candidiasis?

Background: The incidence and treatment outcomes of ocular candidiasis have not been studied extensively.

Study design: Randomized noninferiority trial.

Setting: Multicenter study of 370 patients.

Synopsis: This study randomized 370 non-neutropenic patients with candidemia in a 2:1 ratio to receive voriconazole monotherapy or amphotericin B followed by fluconazole. Patients were treated for at least two weeks after the last positive blood culture, for a maximum duration of eight weeks. Baseline and follow-up fundoscopic examinations were performed.

Sixty (16%) patients were diagnosed with ocular candidiasis, of which six (1.6%) were diagnosed with endophthalmitis and 34 (9%) with chorioretinitis. Patients with ocular candidiasis had a longer duration of candidemia, and were more likely to be infected with Candida albicans.

Outcomes were not available in 19 patients with ocular candidiasis due to death or loss of follow-up. There was no significant difference between the cure rate of voriconazole (93.5% [29/31]), compared with the amphotericin B group (100% [10/10]).

Bottom line: Ocular candidiasis occurs in approximately 16% of non-neutropenic patients with candidemia. A longer duration of candidemia and infection with C. albicans were associated with ocular candidiasis. Both voriconazole and amphotericin B/fluconazole are effective in patients with ocular candidiasis.

Citation: Oude Lashof AM, Rothova A, Sobel JD, et al. Ocular manifestations of candidemia. Clin Infect Dis. 2011;53:262-268.

For more physician reviews of HM-related literature, check out our website.

Clinical question: In patients with candidemia, what are the incidence, risk factors, and antifungal treatment outcomes for ocular candidiasis?

Background: The incidence and treatment outcomes of ocular candidiasis have not been studied extensively.

Study design: Randomized noninferiority trial.

Setting: Multicenter study of 370 patients.

Synopsis: This study randomized 370 non-neutropenic patients with candidemia in a 2:1 ratio to receive voriconazole monotherapy or amphotericin B followed by fluconazole. Patients were treated for at least two weeks after the last positive blood culture, for a maximum duration of eight weeks. Baseline and follow-up fundoscopic examinations were performed.

Sixty (16%) patients were diagnosed with ocular candidiasis, of which six (1.6%) were diagnosed with endophthalmitis and 34 (9%) with chorioretinitis. Patients with ocular candidiasis had a longer duration of candidemia, and were more likely to be infected with Candida albicans.

Outcomes were not available in 19 patients with ocular candidiasis due to death or loss of follow-up. There was no significant difference between the cure rate of voriconazole (93.5% [29/31]), compared with the amphotericin B group (100% [10/10]).

Bottom line: Ocular candidiasis occurs in approximately 16% of non-neutropenic patients with candidemia. A longer duration of candidemia and infection with C. albicans were associated with ocular candidiasis. Both voriconazole and amphotericin B/fluconazole are effective in patients with ocular candidiasis.

Citation: Oude Lashof AM, Rothova A, Sobel JD, et al. Ocular manifestations of candidemia. Clin Infect Dis. 2011;53:262-268.

For more physician reviews of HM-related literature, check out our website.

In the changing healthcare landscape, hospitalists are being asked to be leaders and managers in their day-to-day activities. Often, the HM director will need to help provide hospitalists in their groups with the skills they need to succeed, says Bryce Gartland, MD, FHM, associate director of the hospital medicine division and medical director of care coordination at Emory Healthcare in Atlanta.

“Critical to that is making sure you’ve got a standardized structure in place for ensuring their professional growth and development,” he says.

HM group directors can invite experts to conduct feedback sessions on particular areas of concern or send their hospitalists to outside training, he says. For example, SHM hosts a Leadership Academy that offers a “Foundation for Effective Leadership” course, along with two more advanced leadership seminars.

The American College of Physicians offers the “Leadership Enhancement and Development” (LEAD) program, and the Center for the Health Professions at the University of California at San Francisco offers several leadership initiatives.

It also is incumbent on HM directors to get their physicians training in quality improvement (QI), asserts John Bulger, DO, FACP, FHM, chief quality officer and director of the HM service line for Geisinger Health System in Danville, Pa. “In my view, quality improvement is really where hospitalists make their hay in being a value added to the hospital,” he says.

SHM’s Center for Hospital Innovation and Improvement offers a wide variety of tools and resources to educate hospitalists on QI. SHM also has a Quality Improvement Skills pre-course at its annual meeting in April in San Diego.

The Institute for Healthcare Improvement, a nonprofit organization based in Cambridge, Mass., that focuses on healthcare best practices, and the Institute for Health Care Delivery Research at InterMountain Healthcare in Salt Lake City, Utah, have respected QI training programs.

QI training also comes from mentorship and putting hospitalists on QI-related committees. “That really has a twofold benefit for the hospital medicine group, because you are also able to stretch your reach,” Dr. Bulger says. “Now you’ve got a hospitalist on that committee who can report back to you and tell you what’s going on, and help you be involved in the changes going on in the hospital.”

Lisa Ryan is a freelance writer based in New Jersey.

In the changing healthcare landscape, hospitalists are being asked to be leaders and managers in their day-to-day activities. Often, the HM director will need to help provide hospitalists in their groups with the skills they need to succeed, says Bryce Gartland, MD, FHM, associate director of the hospital medicine division and medical director of care coordination at Emory Healthcare in Atlanta.

“Critical to that is making sure you’ve got a standardized structure in place for ensuring their professional growth and development,” he says.

HM group directors can invite experts to conduct feedback sessions on particular areas of concern or send their hospitalists to outside training, he says. For example, SHM hosts a Leadership Academy that offers a “Foundation for Effective Leadership” course, along with two more advanced leadership seminars.

The American College of Physicians offers the “Leadership Enhancement and Development” (LEAD) program, and the Center for the Health Professions at the University of California at San Francisco offers several leadership initiatives.

It also is incumbent on HM directors to get their physicians training in quality improvement (QI), asserts John Bulger, DO, FACP, FHM, chief quality officer and director of the HM service line for Geisinger Health System in Danville, Pa. “In my view, quality improvement is really where hospitalists make their hay in being a value added to the hospital,” he says.

SHM’s Center for Hospital Innovation and Improvement offers a wide variety of tools and resources to educate hospitalists on QI. SHM also has a Quality Improvement Skills pre-course at its annual meeting in April in San Diego.

The Institute for Healthcare Improvement, a nonprofit organization based in Cambridge, Mass., that focuses on healthcare best practices, and the Institute for Health Care Delivery Research at InterMountain Healthcare in Salt Lake City, Utah, have respected QI training programs.

QI training also comes from mentorship and putting hospitalists on QI-related committees. “That really has a twofold benefit for the hospital medicine group, because you are also able to stretch your reach,” Dr. Bulger says. “Now you’ve got a hospitalist on that committee who can report back to you and tell you what’s going on, and help you be involved in the changes going on in the hospital.”

Lisa Ryan is a freelance writer based in New Jersey.

In the changing healthcare landscape, hospitalists are being asked to be leaders and managers in their day-to-day activities. Often, the HM director will need to help provide hospitalists in their groups with the skills they need to succeed, says Bryce Gartland, MD, FHM, associate director of the hospital medicine division and medical director of care coordination at Emory Healthcare in Atlanta.

“Critical to that is making sure you’ve got a standardized structure in place for ensuring their professional growth and development,” he says.

HM group directors can invite experts to conduct feedback sessions on particular areas of concern or send their hospitalists to outside training, he says. For example, SHM hosts a Leadership Academy that offers a “Foundation for Effective Leadership” course, along with two more advanced leadership seminars.

The American College of Physicians offers the “Leadership Enhancement and Development” (LEAD) program, and the Center for the Health Professions at the University of California at San Francisco offers several leadership initiatives.

It also is incumbent on HM directors to get their physicians training in quality improvement (QI), asserts John Bulger, DO, FACP, FHM, chief quality officer and director of the HM service line for Geisinger Health System in Danville, Pa. “In my view, quality improvement is really where hospitalists make their hay in being a value added to the hospital,” he says.

SHM’s Center for Hospital Innovation and Improvement offers a wide variety of tools and resources to educate hospitalists on QI. SHM also has a Quality Improvement Skills pre-course at its annual meeting in April in San Diego.

The Institute for Healthcare Improvement, a nonprofit organization based in Cambridge, Mass., that focuses on healthcare best practices, and the Institute for Health Care Delivery Research at InterMountain Healthcare in Salt Lake City, Utah, have respected QI training programs.

QI training also comes from mentorship and putting hospitalists on QI-related committees. “That really has a twofold benefit for the hospital medicine group, because you are also able to stretch your reach,” Dr. Bulger says. “Now you’ve got a hospitalist on that committee who can report back to you and tell you what’s going on, and help you be involved in the changes going on in the hospital.”

Lisa Ryan is a freelance writer based in New Jersey.

Not all post-discharge clinics are established by hospitalist groups or their parent hospitals. As Tallahassee (Fla.) Memorial Hospital’s experience with a collaborative approach shows (see “Is a Post-Discharge Clinic in Your Hospital’s Future?”), health plans might take an interest in successful discharge protocols to prevent unnecessary readmissions. In other cases, medical specialty practices have established clinics for patients with specific diseases—CHF, COPD, even post-ICU delirium.

In Southern California, two large, established physician groups that assume financial risk or insurance functions see the potential benefit, given that their financial incentives are more obviously aligned to such clinics than are hospitals’. Cerritos, Calif.-based CareMore is a Medicare health plan that started out as a medical group and remains a care delivery system for Medicare Advantage patients, making significant use of hospitalists.

“We call ourselves ‘extensivists,’” says CareMore medical director and hospitalist Hyong Kim, MD. The company’s hospitalists generally

work mornings at an assigned hospital, then spend their afternoons either making rounds on CareMore patients at a skilled nursing facility or staffing one of the group’s post-discharge clinics, located in its disease-management-oriented comprehensive clinics. Hospitalists might even make take over from primary-care physicians (PCPs) the ongoing management of the most difficult or most frail patients, Dr. Kim says. That demands a change in mindset by the hospitalist to accept responsibility for the patient’s care across settings.

“This approach wouldn’t work in fee-for-service, but it works well in pre-paid environments. We pay our PCPs a capitated rate, and they continue to receive capitation after the hospitalist takes over the care,” he explains. “Our extensivists are salaried, with incentives based on readmissions.”

The company uses chronic-disease managers, who check in daily with the hospitalists. “We also have a house-call physician program, sending physicians and social workers to patients’ homes after discharge,” Dr. Kim says.

Torrance, Calif.-based HealthCare Partners, a large, physician-owned multispecialty medical group, operates in many ways like a health plan, says Tyler Jung, MD, medical director for hospitalists, high-risk groups, and post-discharge clinics. “We’re fully delegated. We accept financial risk from virtually all of the major health plans in the area,” he explains.

Dr. Jung’s team views the first 30 days after patients leave the hospital as “the riskiest time period for our members. We’ve had hospitalists for 15 to 20 years, and just recently we began looking at the post-discharge clinic option,” he says. “I’m still undecided: Is it a Band-Aid or something we need to intervene in the post-discharge period?”

HealthCare Partners operates six community care and disease management centers across Southern California, each of which houses a post-discharge clinic staffed by a doctor, social worker, and case manager. The post-discharge physicians are internists, not necessarily hospitalists, “although many moonlight in our hospitalist program and the most successful ones have hospitalist experience,” Dr. Jung says. “Our clinics are designed for 45-minute appointments: The patient meets with the doctor and maybe the social worker and case manager—a real multidisciplinary approach.”

Three-fourths of referrals are patients coming home from the hospital and a quarter are high-risk patients identified in primary-care clinics. “The first visit deals with medically complicated issues, but the next couple may have more to do with reinforcing the care plan that was established,” as well as looking at social issues, he says.

 

Finding the right physician is no easy task. “They’ve got to get it,” he says. “You need to be judicious about how long to keep the patient—versus referring them back to primary care—and setting limits is hard. We don’t have magic criteria for this. It’s mostly subjective right now.”

Another challenge is measuring success. “These clinics can be expensive to run, and we need to show the return on investment,” he says.

Larry Beresford is a freelance writer based in Oakland, Calif.

 

Not all post-discharge clinics are established by hospitalist groups or their parent hospitals. As Tallahassee (Fla.) Memorial Hospital’s experience with a collaborative approach shows (see “Is a Post-Discharge Clinic in Your Hospital’s Future?”), health plans might take an interest in successful discharge protocols to prevent unnecessary readmissions. In other cases, medical specialty practices have established clinics for patients with specific diseases—CHF, COPD, even post-ICU delirium.

In Southern California, two large, established physician groups that assume financial risk or insurance functions see the potential benefit, given that their financial incentives are more obviously aligned to such clinics than are hospitals’. Cerritos, Calif.-based CareMore is a Medicare health plan that started out as a medical group and remains a care delivery system for Medicare Advantage patients, making significant use of hospitalists.

“We call ourselves ‘extensivists,’” says CareMore medical director and hospitalist Hyong Kim, MD. The company’s hospitalists generally

work mornings at an assigned hospital, then spend their afternoons either making rounds on CareMore patients at a skilled nursing facility or staffing one of the group’s post-discharge clinics, located in its disease-management-oriented comprehensive clinics. Hospitalists might even make take over from primary-care physicians (PCPs) the ongoing management of the most difficult or most frail patients, Dr. Kim says. That demands a change in mindset by the hospitalist to accept responsibility for the patient’s care across settings.

“This approach wouldn’t work in fee-for-service, but it works well in pre-paid environments. We pay our PCPs a capitated rate, and they continue to receive capitation after the hospitalist takes over the care,” he explains. “Our extensivists are salaried, with incentives based on readmissions.”

The company uses chronic-disease managers, who check in daily with the hospitalists. “We also have a house-call physician program, sending physicians and social workers to patients’ homes after discharge,” Dr. Kim says.

Torrance, Calif.-based HealthCare Partners, a large, physician-owned multispecialty medical group, operates in many ways like a health plan, says Tyler Jung, MD, medical director for hospitalists, high-risk groups, and post-discharge clinics. “We’re fully delegated. We accept financial risk from virtually all of the major health plans in the area,” he explains.

Dr. Jung’s team views the first 30 days after patients leave the hospital as “the riskiest time period for our members. We’ve had hospitalists for 15 to 20 years, and just recently we began looking at the post-discharge clinic option,” he says. “I’m still undecided: Is it a Band-Aid or something we need to intervene in the post-discharge period?”

HealthCare Partners operates six community care and disease management centers across Southern California, each of which houses a post-discharge clinic staffed by a doctor, social worker, and case manager. The post-discharge physicians are internists, not necessarily hospitalists, “although many moonlight in our hospitalist program and the most successful ones have hospitalist experience,” Dr. Jung says. “Our clinics are designed for 45-minute appointments: The patient meets with the doctor and maybe the social worker and case manager—a real multidisciplinary approach.”

Three-fourths of referrals are patients coming home from the hospital and a quarter are high-risk patients identified in primary-care clinics. “The first visit deals with medically complicated issues, but the next couple may have more to do with reinforcing the care plan that was established,” as well as looking at social issues, he says.

 

Finding the right physician is no easy task. “They’ve got to get it,” he says. “You need to be judicious about how long to keep the patient—versus referring them back to primary care—and setting limits is hard. We don’t have magic criteria for this. It’s mostly subjective right now.”

Another challenge is measuring success. “These clinics can be expensive to run, and we need to show the return on investment,” he says.

Larry Beresford is a freelance writer based in Oakland, Calif.

 

Not all post-discharge clinics are established by hospitalist groups or their parent hospitals. As Tallahassee (Fla.) Memorial Hospital’s experience with a collaborative approach shows (see “Is a Post-Discharge Clinic in Your Hospital’s Future?”), health plans might take an interest in successful discharge protocols to prevent unnecessary readmissions. In other cases, medical specialty practices have established clinics for patients with specific diseases—CHF, COPD, even post-ICU delirium.

In Southern California, two large, established physician groups that assume financial risk or insurance functions see the potential benefit, given that their financial incentives are more obviously aligned to such clinics than are hospitals’. Cerritos, Calif.-based CareMore is a Medicare health plan that started out as a medical group and remains a care delivery system for Medicare Advantage patients, making significant use of hospitalists.

“We call ourselves ‘extensivists,’” says CareMore medical director and hospitalist Hyong Kim, MD. The company’s hospitalists generally

work mornings at an assigned hospital, then spend their afternoons either making rounds on CareMore patients at a skilled nursing facility or staffing one of the group’s post-discharge clinics, located in its disease-management-oriented comprehensive clinics. Hospitalists might even make take over from primary-care physicians (PCPs) the ongoing management of the most difficult or most frail patients, Dr. Kim says. That demands a change in mindset by the hospitalist to accept responsibility for the patient’s care across settings.

“This approach wouldn’t work in fee-for-service, but it works well in pre-paid environments. We pay our PCPs a capitated rate, and they continue to receive capitation after the hospitalist takes over the care,” he explains. “Our extensivists are salaried, with incentives based on readmissions.”

The company uses chronic-disease managers, who check in daily with the hospitalists. “We also have a house-call physician program, sending physicians and social workers to patients’ homes after discharge,” Dr. Kim says.

Torrance, Calif.-based HealthCare Partners, a large, physician-owned multispecialty medical group, operates in many ways like a health plan, says Tyler Jung, MD, medical director for hospitalists, high-risk groups, and post-discharge clinics. “We’re fully delegated. We accept financial risk from virtually all of the major health plans in the area,” he explains.

Dr. Jung’s team views the first 30 days after patients leave the hospital as “the riskiest time period for our members. We’ve had hospitalists for 15 to 20 years, and just recently we began looking at the post-discharge clinic option,” he says. “I’m still undecided: Is it a Band-Aid or something we need to intervene in the post-discharge period?”

HealthCare Partners operates six community care and disease management centers across Southern California, each of which houses a post-discharge clinic staffed by a doctor, social worker, and case manager. The post-discharge physicians are internists, not necessarily hospitalists, “although many moonlight in our hospitalist program and the most successful ones have hospitalist experience,” Dr. Jung says. “Our clinics are designed for 45-minute appointments: The patient meets with the doctor and maybe the social worker and case manager—a real multidisciplinary approach.”

Three-fourths of referrals are patients coming home from the hospital and a quarter are high-risk patients identified in primary-care clinics. “The first visit deals with medically complicated issues, but the next couple may have more to do with reinforcing the care plan that was established,” as well as looking at social issues, he says.

 

Finding the right physician is no easy task. “They’ve got to get it,” he says. “You need to be judicious about how long to keep the patient—versus referring them back to primary care—and setting limits is hard. We don’t have magic criteria for this. It’s mostly subjective right now.”

Another challenge is measuring success. “These clinics can be expensive to run, and we need to show the return on investment,” he says.

Larry Beresford is a freelance writer based in Oakland, Calif.

 

San Francisco General Hospital opened its post-discharge transitional care clinic for many of the same reasons as other safety net hospitals, but through staff transitions a new role has emerged: the training of medicine residents. A nurse practitioner (NP), hired in 2007, first identified the large

number of patients who either did not have a primary care physician (PCP) or hadn’t seen one in a while, “but had a lot of complex care transition issues and were falling through the cracks,” explains Michelle Schneidermann, MD, hospitalist at SFGH.

In 2009, the NP established a “bridge clinic” five half-days a week within an existing hospital-based general medicine clinic. She encouraged referrals of any patients who needed post-discharge services and then triaged those at greatest risk into available clinic slots. But when she went on maternity leave, the clinic’s presence shrank to one half-day per week.

“It really made us take a step back and think philosophically about whether this was a necessary Band-Aid, or whether the system had changed enough that we no longer needed it,” Dr. Schneidermann says. “We found out through our assessment that things, unfortunately, hadn’t changed that much, and the need was still there for a bridge clinic.”

The “mini” bridge clinic collaborates with a new cadre of care coordinators working on discharge planning and with a new group of hospitalists to create an opportunity for medical residents to learn the challenges of care transitions hands-on. “What’s been interesting about this scaled-down version, which we call the mini-bridge clinic, is that it has made us more resourceful,” says SFGH’s Larissa Thomas, MD, MPH.

Dr. Schneidermann says the NP is planning to return in January, which will mean a new set of challenges. “We’ll need to coordinate with her around how to integrate these two approaches. But we find this is an incredible opportunity to teach future physicians about care transitions,” she says.

The challenge now, Dr. Thomas says, is to view transitional medicine in the 30 days following hospital discharge as an essential part of HM, and then build that into the training of residents. “We’re trying to reframe how we think about medicine and looking to create an integrated curriculum,” she says. “Not only will residents have the experience of the transitional care clinic, but when they’re on an inpatient rotation, they’ll be more mindful of the things that affect patient well-being after discharge.”

Larry Beresford is a freelance writer based in Oakland, Calif.

San Francisco General Hospital opened its post-discharge transitional care clinic for many of the same reasons as other safety net hospitals, but through staff transitions a new role has emerged: the training of medicine residents. A nurse practitioner (NP), hired in 2007, first identified the large

number of patients who either did not have a primary care physician (PCP) or hadn’t seen one in a while, “but had a lot of complex care transition issues and were falling through the cracks,” explains Michelle Schneidermann, MD, hospitalist at SFGH.

In 2009, the NP established a “bridge clinic” five half-days a week within an existing hospital-based general medicine clinic. She encouraged referrals of any patients who needed post-discharge services and then triaged those at greatest risk into available clinic slots. But when she went on maternity leave, the clinic’s presence shrank to one half-day per week.

“It really made us take a step back and think philosophically about whether this was a necessary Band-Aid, or whether the system had changed enough that we no longer needed it,” Dr. Schneidermann says. “We found out through our assessment that things, unfortunately, hadn’t changed that much, and the need was still there for a bridge clinic.”

The “mini” bridge clinic collaborates with a new cadre of care coordinators working on discharge planning and with a new group of hospitalists to create an opportunity for medical residents to learn the challenges of care transitions hands-on. “What’s been interesting about this scaled-down version, which we call the mini-bridge clinic, is that it has made us more resourceful,” says SFGH’s Larissa Thomas, MD, MPH.

Dr. Schneidermann says the NP is planning to return in January, which will mean a new set of challenges. “We’ll need to coordinate with her around how to integrate these two approaches. But we find this is an incredible opportunity to teach future physicians about care transitions,” she says.

The challenge now, Dr. Thomas says, is to view transitional medicine in the 30 days following hospital discharge as an essential part of HM, and then build that into the training of residents. “We’re trying to reframe how we think about medicine and looking to create an integrated curriculum,” she says. “Not only will residents have the experience of the transitional care clinic, but when they’re on an inpatient rotation, they’ll be more mindful of the things that affect patient well-being after discharge.”

Larry Beresford is a freelance writer based in Oakland, Calif.

San Francisco General Hospital opened its post-discharge transitional care clinic for many of the same reasons as other safety net hospitals, but through staff transitions a new role has emerged: the training of medicine residents. A nurse practitioner (NP), hired in 2007, first identified the large

number of patients who either did not have a primary care physician (PCP) or hadn’t seen one in a while, “but had a lot of complex care transition issues and were falling through the cracks,” explains Michelle Schneidermann, MD, hospitalist at SFGH.

In 2009, the NP established a “bridge clinic” five half-days a week within an existing hospital-based general medicine clinic. She encouraged referrals of any patients who needed post-discharge services and then triaged those at greatest risk into available clinic slots. But when she went on maternity leave, the clinic’s presence shrank to one half-day per week.

“It really made us take a step back and think philosophically about whether this was a necessary Band-Aid, or whether the system had changed enough that we no longer needed it,” Dr. Schneidermann says. “We found out through our assessment that things, unfortunately, hadn’t changed that much, and the need was still there for a bridge clinic.”

The “mini” bridge clinic collaborates with a new cadre of care coordinators working on discharge planning and with a new group of hospitalists to create an opportunity for medical residents to learn the challenges of care transitions hands-on. “What’s been interesting about this scaled-down version, which we call the mini-bridge clinic, is that it has made us more resourceful,” says SFGH’s Larissa Thomas, MD, MPH.

Dr. Schneidermann says the NP is planning to return in January, which will mean a new set of challenges. “We’ll need to coordinate with her around how to integrate these two approaches. But we find this is an incredible opportunity to teach future physicians about care transitions,” she says.

The challenge now, Dr. Thomas says, is to view transitional medicine in the 30 days following hospital discharge as an essential part of HM, and then build that into the training of residents. “We’re trying to reframe how we think about medicine and looking to create an integrated curriculum,” she says. “Not only will residents have the experience of the transitional care clinic, but when they’re on an inpatient rotation, they’ll be more mindful of the things that affect patient well-being after discharge.”

Larry Beresford is a freelance writer based in Oakland, Calif.

In a study of children who had traumatic brain injury, almost half of them experienced chronic headache months later.

Moreover, adolescents and girls are particularly likely to develop posttraumatic chronic headache, an "intriguing" pattern which parallels that for migraine and lends "support to the theory that the pathophysiology of posttraumatic headaches after TBI [traumatic brain injury] may share similarities with the pathophysiology" of primary headache disorders such as migraine, said Dr. Heidi K. Blume of the division of pediatric neurology at the University of Washington, Seattle, and her associates.

Given that more than 500,000 children and adolescents are assessed for TBI in hospitals every year in the United States, the study findings indicate that many pediatric patients suffer from TBI-associated chronic headaches, they noted in the report published online Dec. 5 in Pediatrics.

Chronic headaches that affect children "interfere with school, social function, [and] parental productivity, and are associated with poor quality of life," the researchers said.

Until now, little has been known about posttraumatic headache in children because most studies in the pediatric population have been small, retrospective, lacking a control population, or of short duration. Dr. Blume and her colleagues addressed these issues by analyzing data from the Child Health After Injury Study, a large, prospective study with 12 months of follow-up that included a control group of children who had sustained arm injuries (Pediatrics 2011 Dec. 5 [doi:10.1542/peds.2011-1742]).

The investigators determined the prevalence of chronic headache at 3 months and 12 months following mild, moderate, or severe TBI in 512 study subjects and 137 controls aged 5-17 years who were treated in the emergency departments at nine hospitals during an 18-month period. The facilities included two children’s, two university, and six community hospitals.

Postconcussive symptoms were common among children, and women are at higher risk of posttraumatic chronic headache than are men.

The researchers used the Centers for Disease Control and Prevention’s definition of TBI (a blunt or penetrating injury to the head that was documented in the medical record and was associated with a decreased level of consciousness, amnesia, an objective neurologic or neuropsychological abnormality, and/or an intracranial lesion).

Most TBIs in this study were sustained either in a fall or when the head struck an object; most of the moderate or severe TBIs were sustained in falls or in motor vehicle or bicycle accidents. Similarly, most arm injuries in the control group were sustained in falls.

At 3 months and 12 months after TBI, the subjects’ head pain during the preceding week was assessed by questioning the parents as well as the subjects themselves if they were aged 14 years or older and able to complete a short survey.

At 3 months, the overall prevalence of headache was 43% among children with mild TBI and 37% among those with moderate or severe TBI, compared with 26% among the control subjects.

At 3 months, chronic headache also was significantly more likely to affect adolescents than younger children, and to affect girls rather than boys. The frequency of headache also was elevated in children of all ages in the TBI group at 3 months, but was significantly elevated only in adolescents.

Similarly, serious headache was more common in children of all ages in the mild TBI group than it was in controls at 3 months, but only significantly so in girls, and it became more prevalent with increasing age. For example, the prevalence of serious headache among girls with mild TBI was 7% at age 5-7 years, 20% at age 8-10 years, 29% at age 11-13 years, and 45% at age 14-18 years, the investigators said. The prevalence of serious headache after moderate/severe TBI was significantly greater only for younger children, at 32%.

The findings were different at 12 months after TBI, with chronic headache reported in 41% of children with mild TBI, 34% of those with moderate or severe TBI, and 34% in the control group, which were nonsignificant differences. Girls were found to have a higher prevalence of headache (52%) than were boys (36%), but this difference did not reach statistical significance.

The subgroup of girls with mild TBI had a higher prevalence of severe headache (27%) than did controls (10%) at 12 months. Adolescent girls also reported more frequent headaches and more severe headaches than did adolescent control subjects, but although these differences were "substantial," they did not reach statistical significance because of small sample sizes in these subgroups.

Overall, the study results accord with those of other recent studies reporting that postconcussive symptoms were common among children and that women are at higher risk of posttraumatic chronic headache than are men.

 

"Although only a fraction of children and adolescents with TBI develop chronic headaches related to their injury, because thousands of children sustain TBI each year, our findings indicate that many children and adolescents suffer from TBI-associated headaches each year," Dr. Blume and her associates said.

This study was limited in that it could not account for the possibility that because of anxiety or cultural expectations about head injuries, parents of children with TBI might be more likely to report headaches – and to rate them as severe or frequent – than were parents of children with arm injuries. In addition, the survey in this study asked about headaches during the preceding week, and may have missed important information about less-frequent but more-significant headaches that occurred outside that 7-day window, the researchers noted.

Dr. Blume and her associates said they had no relevant financial disclosures.

In a study of children who had traumatic brain injury, almost half of them experienced chronic headache months later.

Moreover, adolescents and girls are particularly likely to develop posttraumatic chronic headache, an "intriguing" pattern which parallels that for migraine and lends "support to the theory that the pathophysiology of posttraumatic headaches after TBI [traumatic brain injury] may share similarities with the pathophysiology" of primary headache disorders such as migraine, said Dr. Heidi K. Blume of the division of pediatric neurology at the University of Washington, Seattle, and her associates.

Given that more than 500,000 children and adolescents are assessed for TBI in hospitals every year in the United States, the study findings indicate that many pediatric patients suffer from TBI-associated chronic headaches, they noted in the report published online Dec. 5 in Pediatrics.

Chronic headaches that affect children "interfere with school, social function, [and] parental productivity, and are associated with poor quality of life," the researchers said.

Until now, little has been known about posttraumatic headache in children because most studies in the pediatric population have been small, retrospective, lacking a control population, or of short duration. Dr. Blume and her colleagues addressed these issues by analyzing data from the Child Health After Injury Study, a large, prospective study with 12 months of follow-up that included a control group of children who had sustained arm injuries (Pediatrics 2011 Dec. 5 [doi:10.1542/peds.2011-1742]).

The investigators determined the prevalence of chronic headache at 3 months and 12 months following mild, moderate, or severe TBI in 512 study subjects and 137 controls aged 5-17 years who were treated in the emergency departments at nine hospitals during an 18-month period. The facilities included two children’s, two university, and six community hospitals.

Postconcussive symptoms were common among children, and women are at higher risk of posttraumatic chronic headache than are men.

The researchers used the Centers for Disease Control and Prevention’s definition of TBI (a blunt or penetrating injury to the head that was documented in the medical record and was associated with a decreased level of consciousness, amnesia, an objective neurologic or neuropsychological abnormality, and/or an intracranial lesion).

Most TBIs in this study were sustained either in a fall or when the head struck an object; most of the moderate or severe TBIs were sustained in falls or in motor vehicle or bicycle accidents. Similarly, most arm injuries in the control group were sustained in falls.

At 3 months and 12 months after TBI, the subjects’ head pain during the preceding week was assessed by questioning the parents as well as the subjects themselves if they were aged 14 years or older and able to complete a short survey.

At 3 months, the overall prevalence of headache was 43% among children with mild TBI and 37% among those with moderate or severe TBI, compared with 26% among the control subjects.

At 3 months, chronic headache also was significantly more likely to affect adolescents than younger children, and to affect girls rather than boys. The frequency of headache also was elevated in children of all ages in the TBI group at 3 months, but was significantly elevated only in adolescents.

Similarly, serious headache was more common in children of all ages in the mild TBI group than it was in controls at 3 months, but only significantly so in girls, and it became more prevalent with increasing age. For example, the prevalence of serious headache among girls with mild TBI was 7% at age 5-7 years, 20% at age 8-10 years, 29% at age 11-13 years, and 45% at age 14-18 years, the investigators said. The prevalence of serious headache after moderate/severe TBI was significantly greater only for younger children, at 32%.

The findings were different at 12 months after TBI, with chronic headache reported in 41% of children with mild TBI, 34% of those with moderate or severe TBI, and 34% in the control group, which were nonsignificant differences. Girls were found to have a higher prevalence of headache (52%) than were boys (36%), but this difference did not reach statistical significance.

The subgroup of girls with mild TBI had a higher prevalence of severe headache (27%) than did controls (10%) at 12 months. Adolescent girls also reported more frequent headaches and more severe headaches than did adolescent control subjects, but although these differences were "substantial," they did not reach statistical significance because of small sample sizes in these subgroups.

Overall, the study results accord with those of other recent studies reporting that postconcussive symptoms were common among children and that women are at higher risk of posttraumatic chronic headache than are men.

 

"Although only a fraction of children and adolescents with TBI develop chronic headaches related to their injury, because thousands of children sustain TBI each year, our findings indicate that many children and adolescents suffer from TBI-associated headaches each year," Dr. Blume and her associates said.

This study was limited in that it could not account for the possibility that because of anxiety or cultural expectations about head injuries, parents of children with TBI might be more likely to report headaches – and to rate them as severe or frequent – than were parents of children with arm injuries. In addition, the survey in this study asked about headaches during the preceding week, and may have missed important information about less-frequent but more-significant headaches that occurred outside that 7-day window, the researchers noted.

Dr. Blume and her associates said they had no relevant financial disclosures.

In a study of children who had traumatic brain injury, almost half of them experienced chronic headache months later.

Moreover, adolescents and girls are particularly likely to develop posttraumatic chronic headache, an "intriguing" pattern which parallels that for migraine and lends "support to the theory that the pathophysiology of posttraumatic headaches after TBI [traumatic brain injury] may share similarities with the pathophysiology" of primary headache disorders such as migraine, said Dr. Heidi K. Blume of the division of pediatric neurology at the University of Washington, Seattle, and her associates.

Given that more than 500,000 children and adolescents are assessed for TBI in hospitals every year in the United States, the study findings indicate that many pediatric patients suffer from TBI-associated chronic headaches, they noted in the report published online Dec. 5 in Pediatrics.

Chronic headaches that affect children "interfere with school, social function, [and] parental productivity, and are associated with poor quality of life," the researchers said.

Until now, little has been known about posttraumatic headache in children because most studies in the pediatric population have been small, retrospective, lacking a control population, or of short duration. Dr. Blume and her colleagues addressed these issues by analyzing data from the Child Health After Injury Study, a large, prospective study with 12 months of follow-up that included a control group of children who had sustained arm injuries (Pediatrics 2011 Dec. 5 [doi:10.1542/peds.2011-1742]).

The investigators determined the prevalence of chronic headache at 3 months and 12 months following mild, moderate, or severe TBI in 512 study subjects and 137 controls aged 5-17 years who were treated in the emergency departments at nine hospitals during an 18-month period. The facilities included two children’s, two university, and six community hospitals.

Postconcussive symptoms were common among children, and women are at higher risk of posttraumatic chronic headache than are men.

The researchers used the Centers for Disease Control and Prevention’s definition of TBI (a blunt or penetrating injury to the head that was documented in the medical record and was associated with a decreased level of consciousness, amnesia, an objective neurologic or neuropsychological abnormality, and/or an intracranial lesion).

Most TBIs in this study were sustained either in a fall or when the head struck an object; most of the moderate or severe TBIs were sustained in falls or in motor vehicle or bicycle accidents. Similarly, most arm injuries in the control group were sustained in falls.

At 3 months and 12 months after TBI, the subjects’ head pain during the preceding week was assessed by questioning the parents as well as the subjects themselves if they were aged 14 years or older and able to complete a short survey.

At 3 months, the overall prevalence of headache was 43% among children with mild TBI and 37% among those with moderate or severe TBI, compared with 26% among the control subjects.

At 3 months, chronic headache also was significantly more likely to affect adolescents than younger children, and to affect girls rather than boys. The frequency of headache also was elevated in children of all ages in the TBI group at 3 months, but was significantly elevated only in adolescents.

Similarly, serious headache was more common in children of all ages in the mild TBI group than it was in controls at 3 months, but only significantly so in girls, and it became more prevalent with increasing age. For example, the prevalence of serious headache among girls with mild TBI was 7% at age 5-7 years, 20% at age 8-10 years, 29% at age 11-13 years, and 45% at age 14-18 years, the investigators said. The prevalence of serious headache after moderate/severe TBI was significantly greater only for younger children, at 32%.

The findings were different at 12 months after TBI, with chronic headache reported in 41% of children with mild TBI, 34% of those with moderate or severe TBI, and 34% in the control group, which were nonsignificant differences. Girls were found to have a higher prevalence of headache (52%) than were boys (36%), but this difference did not reach statistical significance.

The subgroup of girls with mild TBI had a higher prevalence of severe headache (27%) than did controls (10%) at 12 months. Adolescent girls also reported more frequent headaches and more severe headaches than did adolescent control subjects, but although these differences were "substantial," they did not reach statistical significance because of small sample sizes in these subgroups.

Overall, the study results accord with those of other recent studies reporting that postconcussive symptoms were common among children and that women are at higher risk of posttraumatic chronic headache than are men.

 

"Although only a fraction of children and adolescents with TBI develop chronic headaches related to their injury, because thousands of children sustain TBI each year, our findings indicate that many children and adolescents suffer from TBI-associated headaches each year," Dr. Blume and her associates said.

This study was limited in that it could not account for the possibility that because of anxiety or cultural expectations about head injuries, parents of children with TBI might be more likely to report headaches – and to rate them as severe or frequent – than were parents of children with arm injuries. In addition, the survey in this study asked about headaches during the preceding week, and may have missed important information about less-frequent but more-significant headaches that occurred outside that 7-day window, the researchers noted.

Dr. Blume and her associates said they had no relevant financial disclosures.

On a recent visit to the campus of my alma mater, I had a chance to visit some of the biomedical research laboratories. One of those is under the direction of a tenured professor who is making new biodegradable blood vessels the size of a coronary artery that will last long enough to allow for new fibrous tissue to form and replace the degrading substance. Even more exciting is the fact that the new vessel does not initiate an inflammatory reaction, since the vessel lumen will not be a site for platelet activation and in-situ thrombosis.

The professor was just as excited that a venture capitalist had just obtained the license to develop the technology and was about to begin human testing of the vessel in Asia.

Unfortunately, that is where a host of new devices and drugs are being tested.

Compared with the pharmaceutical industry trials, which have used a mixture of domestic and international sites for new drugs research, device trials have used international and particularly European sites for the development of new products. The development of new stents, for instance, was almost exclusive to Europe, and provided this therapy to Europeans far earlier than to Americans. This migration is a result of a more-receptive approval environment and the fact that human testing in Europe and Asia is recruitment for trials is faster and less expensive.

Since 1999, the number of new Premarket Approvals (PMAs) – the Food and Drug Administration’s regulatory process that is required before a novel device with significant patient health risks can get to market – has decrease significantly. In 2000, the FDA approved approximately 60 PMAs; by 2009, the number of approvals had decreased to 15. According to a device industry–supported survey of 176 of 750 potential medical technology companies (FDA Impact on U.S. Medical Technology Innovation, November 2010), the approval process for a PMA was 54 months in the United States and 11 months in Europe. The survey enumerates a number of process problems that confront the FDA, but the major issue noted by the companies surveyed was that the FDA has become much more risk averse and concerned about safety.

The rush to market, of course, is the driving force behind the increased concern of these delays. Venture capitalists that provide the resources for many small device companies see time as money. They are driven more by their desire to get their product to market quickly and they have a limited concern or appreciation for patient safety. Despite the spate of recent safety problems both in cardiology and orthopedics, they tend to minimize the importance of those problems. The safety aspects of many devices may not, of course, be knowable in the short term and not be measurable in the time frame of an 18- or 24-month clinical trial, but may lie in the distant future.

Much of this overseas migration of science is a result of the significantly lower infrastructure costs in Europe and – especially – in Asia. The per-patient costs in India, for instance, are a fraction of what they are in the United States, and the access to patients who can participate in trials is much more easily obtained. This is largely a result of closer physician involvement in the recruiting of patients, and the reluctance of both patients and doctors in the United States to participate in the clinical research trials. Patients hesitate because of a suspicious environment about clinical trials, and doctors are reluctant because they are too busy and are underpaid for their participation. The paradox of this process is that devices and drugs that are tested outside the United States may, because of their cost, be available only to U.S. patients. Whether clinical data obtained in foreign populations are applicable to the U.S. population is also uncertain.

A recent letter from 41 members of Congress, including 6 from Minnesota (which is the U.S. capital of new device companies), has placed increased pressure on the FDA to expedite the approval process and to bring the testing home to the United States ("Members of Minn. delegation urge FDA to speed medical device approvals," Minnesota Independent, Nov. 8, 2011). Of course the return of testing to our shores would be very advantageous to the approval process, but that same acceleration of the process could result in significant patient hazards. The balance between expeditious approval and safety has been an issue that has been going back and forth for the last 20 years, and will continue to be played out in the future.

On a recent visit to the campus of my alma mater, I had a chance to visit some of the biomedical research laboratories. One of those is under the direction of a tenured professor who is making new biodegradable blood vessels the size of a coronary artery that will last long enough to allow for new fibrous tissue to form and replace the degrading substance. Even more exciting is the fact that the new vessel does not initiate an inflammatory reaction, since the vessel lumen will not be a site for platelet activation and in-situ thrombosis.

The professor was just as excited that a venture capitalist had just obtained the license to develop the technology and was about to begin human testing of the vessel in Asia.

Unfortunately, that is where a host of new devices and drugs are being tested.

Compared with the pharmaceutical industry trials, which have used a mixture of domestic and international sites for new drugs research, device trials have used international and particularly European sites for the development of new products. The development of new stents, for instance, was almost exclusive to Europe, and provided this therapy to Europeans far earlier than to Americans. This migration is a result of a more-receptive approval environment and the fact that human testing in Europe and Asia is recruitment for trials is faster and less expensive.

Since 1999, the number of new Premarket Approvals (PMAs) – the Food and Drug Administration’s regulatory process that is required before a novel device with significant patient health risks can get to market – has decrease significantly. In 2000, the FDA approved approximately 60 PMAs; by 2009, the number of approvals had decreased to 15. According to a device industry–supported survey of 176 of 750 potential medical technology companies (FDA Impact on U.S. Medical Technology Innovation, November 2010), the approval process for a PMA was 54 months in the United States and 11 months in Europe. The survey enumerates a number of process problems that confront the FDA, but the major issue noted by the companies surveyed was that the FDA has become much more risk averse and concerned about safety.

The rush to market, of course, is the driving force behind the increased concern of these delays. Venture capitalists that provide the resources for many small device companies see time as money. They are driven more by their desire to get their product to market quickly and they have a limited concern or appreciation for patient safety. Despite the spate of recent safety problems both in cardiology and orthopedics, they tend to minimize the importance of those problems. The safety aspects of many devices may not, of course, be knowable in the short term and not be measurable in the time frame of an 18- or 24-month clinical trial, but may lie in the distant future.

Much of this overseas migration of science is a result of the significantly lower infrastructure costs in Europe and – especially – in Asia. The per-patient costs in India, for instance, are a fraction of what they are in the United States, and the access to patients who can participate in trials is much more easily obtained. This is largely a result of closer physician involvement in the recruiting of patients, and the reluctance of both patients and doctors in the United States to participate in the clinical research trials. Patients hesitate because of a suspicious environment about clinical trials, and doctors are reluctant because they are too busy and are underpaid for their participation. The paradox of this process is that devices and drugs that are tested outside the United States may, because of their cost, be available only to U.S. patients. Whether clinical data obtained in foreign populations are applicable to the U.S. population is also uncertain.

A recent letter from 41 members of Congress, including 6 from Minnesota (which is the U.S. capital of new device companies), has placed increased pressure on the FDA to expedite the approval process and to bring the testing home to the United States ("Members of Minn. delegation urge FDA to speed medical device approvals," Minnesota Independent, Nov. 8, 2011). Of course the return of testing to our shores would be very advantageous to the approval process, but that same acceleration of the process could result in significant patient hazards. The balance between expeditious approval and safety has been an issue that has been going back and forth for the last 20 years, and will continue to be played out in the future.

On a recent visit to the campus of my alma mater, I had a chance to visit some of the biomedical research laboratories. One of those is under the direction of a tenured professor who is making new biodegradable blood vessels the size of a coronary artery that will last long enough to allow for new fibrous tissue to form and replace the degrading substance. Even more exciting is the fact that the new vessel does not initiate an inflammatory reaction, since the vessel lumen will not be a site for platelet activation and in-situ thrombosis.

The professor was just as excited that a venture capitalist had just obtained the license to develop the technology and was about to begin human testing of the vessel in Asia.

Unfortunately, that is where a host of new devices and drugs are being tested.

Compared with the pharmaceutical industry trials, which have used a mixture of domestic and international sites for new drugs research, device trials have used international and particularly European sites for the development of new products. The development of new stents, for instance, was almost exclusive to Europe, and provided this therapy to Europeans far earlier than to Americans. This migration is a result of a more-receptive approval environment and the fact that human testing in Europe and Asia is recruitment for trials is faster and less expensive.

Since 1999, the number of new Premarket Approvals (PMAs) – the Food and Drug Administration’s regulatory process that is required before a novel device with significant patient health risks can get to market – has decrease significantly. In 2000, the FDA approved approximately 60 PMAs; by 2009, the number of approvals had decreased to 15. According to a device industry–supported survey of 176 of 750 potential medical technology companies (FDA Impact on U.S. Medical Technology Innovation, November 2010), the approval process for a PMA was 54 months in the United States and 11 months in Europe. The survey enumerates a number of process problems that confront the FDA, but the major issue noted by the companies surveyed was that the FDA has become much more risk averse and concerned about safety.

The rush to market, of course, is the driving force behind the increased concern of these delays. Venture capitalists that provide the resources for many small device companies see time as money. They are driven more by their desire to get their product to market quickly and they have a limited concern or appreciation for patient safety. Despite the spate of recent safety problems both in cardiology and orthopedics, they tend to minimize the importance of those problems. The safety aspects of many devices may not, of course, be knowable in the short term and not be measurable in the time frame of an 18- or 24-month clinical trial, but may lie in the distant future.

Much of this overseas migration of science is a result of the significantly lower infrastructure costs in Europe and – especially – in Asia. The per-patient costs in India, for instance, are a fraction of what they are in the United States, and the access to patients who can participate in trials is much more easily obtained. This is largely a result of closer physician involvement in the recruiting of patients, and the reluctance of both patients and doctors in the United States to participate in the clinical research trials. Patients hesitate because of a suspicious environment about clinical trials, and doctors are reluctant because they are too busy and are underpaid for their participation. The paradox of this process is that devices and drugs that are tested outside the United States may, because of their cost, be available only to U.S. patients. Whether clinical data obtained in foreign populations are applicable to the U.S. population is also uncertain.

A recent letter from 41 members of Congress, including 6 from Minnesota (which is the U.S. capital of new device companies), has placed increased pressure on the FDA to expedite the approval process and to bring the testing home to the United States ("Members of Minn. delegation urge FDA to speed medical device approvals," Minnesota Independent, Nov. 8, 2011). Of course the return of testing to our shores would be very advantageous to the approval process, but that same acceleration of the process could result in significant patient hazards. The balance between expeditious approval and safety has been an issue that has been going back and forth for the last 20 years, and will continue to be played out in the future.