In about 2002, Dr. Gary Franklin realized the state of Washington might have a problem.

A big problem.

A state resident who’d suffered a back sprain and filed a workers’ compensation claim died 2 years later – not from heart disease or cancer or stroke, but from an unintentional prescription opioid overdose, recalled Dr. Franklin, medical director of the Washington State Department of Labor and Industries.

©andrewsafonov/Thinkstock

“I had never seen anything so sad,” he said.

The case prompted the neurologist and his colleagues to review Washington state workers’ compensation claims. What they uncovered was a local trend that would explode into a national scourge: a marked increase in opioid poisonings among Washington state residents with everyday aches and pains who, in the past, would never have been prescribed opioids.

The gateway drug turned out to be oxycodone (OxyContin), which was heavily marketed at the time as a safe choice for pain relief with little abuse potential. Purdue Pharma has since paid a $600 million federal fine for deceptive marketing.

“This is the worst man-made epidemic in modern medical history,” said Dr. Franklin, also a research professor at the University of Washington, Seattle. “It was made by modern medicine, and it’s up to modern medicine to turn it around.”

For the United States to recover from the opioid crisis, Dr. Franklin said, the medical community must reduce oral opioid prescriptions for noncancer pain. Others interviewed for this story said doctors also have to overcome their aversion to in-office addiction treatment, and find new options for everyday chronic pain.

The first step is “to forget everything you were told in 1999,” said Dr. Franklin. That includes the notions that addiction is rare, opioids are indicated for noncancer chronic pain, and doses should be increased if patients become tolerant.

Those messages led to overprescribing, which in turn “led to an oversupply problem that’s feeding misuse and diversion. It’s only recently that it has become a heroin problem; the vast majority of heroin users these days start on prescription opioids,” he said.

The Washington workers’ comp claims data triggered “a complete rethinking of our approach to chronic pain and a shift to other treatment strategies,” said Dr. David Tauben, chief of pain medicine at the University of Washington, Seattle.

In 2007, Washington became one of the first states to issue opioid treatment guidelines, which are updated regularly. Among other steps, prescribers were urged to limit doses and durations.

Since then, the state has seen a nearly 40% reduction in prescription opioid poisonings. “We also found that with dose reductions” for back pain, headaches, and similar noncancer issues, “pain subsides, function improves, and patient satisfaction” goes up, said Dr. Tauben, who was involved in creating the guidelines.

Clamping down, pushing back

The Centers for Disease Control and Prevention in March released similar guidelines, including a suggested 3-day limit for acute pain prescriptions and a cap of 90 morphine milligram equivalents per day for chronic noncancer pain – the amount in a single 60-mg oxycodone tablet.

Meanwhile, Food and Drug Administration officials are planning a regulatory overhaul to address opioid approval, labeling, and prescribing concerns. In many places, doctors are also facing new opioid training requirements.

The Washington state experience suggests that such efforts are likely to help reverse the opioid crisis.

It’s not about getting rid of the drugs, explained Dr. Gail D’Onofrio, chair of emergency medicine at Yale University in New Haven, Conn.

“Opioids are really good for certain things,” especially cancer pain and, for a few days, acute pain. But “we’ve kind of lost our way,” Dr. D’Onofrio said. “We don’t need to give people 3 months of narcotics for a knee replacement” or 3 weeks of narcotics for a wisdom tooth extraction.

“We are all guilty” of overprescribing, and “just like everywhere else, we’ve seen the problems; every year, it’s getting worse,” she added. In response, “we are changing how we use opioids, adapting the guidelines from the CDC and other groups,” and tailoring them to different services.

At the Yale emergency department, oral opioid prescriptions are now generally limited to 3 days, except for renal colic patients, who might get a few days more. “We do not fill opioid scripts and don’t reorder them for patients.” Instead, “we talk to the prescriber and tell them what’s going on,” Dr. D’Onofrio explained.

Yale’s not alone in cutting back. After years of growth, U.S. oral opioid sales appear to be declining. In fact, in some quarters, there’s concern the clampdown will go too far.

The CDC received more than 4,300 comments about the draft version of its guidelines. Some patients were worried about losing access to drugs that have helped them. And, while supportive of the goals, some professional groups questioned the evidence behind the proposals and worry about undertreatment of pain, among other issues.

“The problem with a lot of the guidelines is that they’re all around limiting prescribing. They don’t really tell doctors what to do instead,” said Dr. Peter Friedmann, an addiction treatment specialist in Springfield, Mass., and chief research officer for Baystate Health.

An alternative for chronic pain

For noncancer chronic pain, recent evidence supports multimodal therapy. Opioids might bring temporary relief, but “throwing drugs at people isn’t going to solve the problem,” said Dr. Tauben, the University of Washington pain expert.

“Multimodal therapy” means focusing more on the burden of pain instead of its intensity, with team-based care. Reducing the burden – anxiety, sleeplessness, reduced mobility, and other problems – seems to reduce the significance and intensity of pain to the point where it can be managed, if needed, with nonsteroidal anti-inflammatory drugs (NSAIDs), trigger-point injections, and other nonopioid options.

Depending on the patient’s needs, primary care physicians might find themselves coordinating services from psychologists, physical therapists, social workers, or others.

For the approach to work, the impact of pain has to be accurately gauged, along with underlying psychological or social issues; to save time, the University of Washington has patients complete an online survey prior to their office visit.

There are national efforts underway to support the approach, and a growing recognition that “by doing it right, you save downstream costs. Primary care must get involved; that’s where chronic pain presents,” Dr. Tauben said.

Batting cleanup

There’s a role for primary care when patients are hooked on opioids, too. Requests for early refills and higher doses are a clue.

“Given the stigma, a lot of doctors don’t want to deal with addiction, but we have to deal with it. We need to move addiction treatment into the mainstream of what we do in medicine,” Dr. Friedmann said. “These patients are no more or no less challenging than any other patients we deal with; the only way doctors are going to find that out is by starting to manage some of them.”

He estimates that about 60% of his patients do well on buprenorphine, a sublingual, partial opioid agonist that blocks the effects of full agonists and dulls withdrawal symptoms. Incorporating it into practice “is not something you need to figure out yourself,” Dr. Friedmann noted. There are training programs and people who can help.

There simply aren’t enough methadone clinics to handle the current situation, especially in suburbs and rural areas where drug dealers have found a new market for heroin. Another option, abstinence programs, “have contributed to the problem of overdose;” people lose their tolerance, reuse, and die, he said.

Buprenorphine treatment might soon get easier. The FDA is expected to make an approval decision soon on probuphine, a matchstick-size subdermal implant that delivers buprenorphine continuously for 6 months.

Dr. Friedmann disclosed relationships with Alkermes, Inavir, and Orexo. The other doctors had no relevant disclosures.

[email protected]

In about 2002, Dr. Gary Franklin realized the state of Washington might have a problem.

A big problem.

A state resident who’d suffered a back sprain and filed a workers’ compensation claim died 2 years later – not from heart disease or cancer or stroke, but from an unintentional prescription opioid overdose, recalled Dr. Franklin, medical director of the Washington State Department of Labor and Industries.

©andrewsafonov/Thinkstock

“I had never seen anything so sad,” he said.

The case prompted the neurologist and his colleagues to review Washington state workers’ compensation claims. What they uncovered was a local trend that would explode into a national scourge: a marked increase in opioid poisonings among Washington state residents with everyday aches and pains who, in the past, would never have been prescribed opioids.

The gateway drug turned out to be oxycodone (OxyContin), which was heavily marketed at the time as a safe choice for pain relief with little abuse potential. Purdue Pharma has since paid a $600 million federal fine for deceptive marketing.

“This is the worst man-made epidemic in modern medical history,” said Dr. Franklin, also a research professor at the University of Washington, Seattle. “It was made by modern medicine, and it’s up to modern medicine to turn it around.”

For the United States to recover from the opioid crisis, Dr. Franklin said, the medical community must reduce oral opioid prescriptions for noncancer pain. Others interviewed for this story said doctors also have to overcome their aversion to in-office addiction treatment, and find new options for everyday chronic pain.

The first step is “to forget everything you were told in 1999,” said Dr. Franklin. That includes the notions that addiction is rare, opioids are indicated for noncancer chronic pain, and doses should be increased if patients become tolerant.

Those messages led to overprescribing, which in turn “led to an oversupply problem that’s feeding misuse and diversion. It’s only recently that it has become a heroin problem; the vast majority of heroin users these days start on prescription opioids,” he said.

The Washington workers’ comp claims data triggered “a complete rethinking of our approach to chronic pain and a shift to other treatment strategies,” said Dr. David Tauben, chief of pain medicine at the University of Washington, Seattle.

In 2007, Washington became one of the first states to issue opioid treatment guidelines, which are updated regularly. Among other steps, prescribers were urged to limit doses and durations.

Since then, the state has seen a nearly 40% reduction in prescription opioid poisonings. “We also found that with dose reductions” for back pain, headaches, and similar noncancer issues, “pain subsides, function improves, and patient satisfaction” goes up, said Dr. Tauben, who was involved in creating the guidelines.

Clamping down, pushing back

The Centers for Disease Control and Prevention in March released similar guidelines, including a suggested 3-day limit for acute pain prescriptions and a cap of 90 morphine milligram equivalents per day for chronic noncancer pain – the amount in a single 60-mg oxycodone tablet.

Meanwhile, Food and Drug Administration officials are planning a regulatory overhaul to address opioid approval, labeling, and prescribing concerns. In many places, doctors are also facing new opioid training requirements.

The Washington state experience suggests that such efforts are likely to help reverse the opioid crisis.

It’s not about getting rid of the drugs, explained Dr. Gail D’Onofrio, chair of emergency medicine at Yale University in New Haven, Conn.

“Opioids are really good for certain things,” especially cancer pain and, for a few days, acute pain. But “we’ve kind of lost our way,” Dr. D’Onofrio said. “We don’t need to give people 3 months of narcotics for a knee replacement” or 3 weeks of narcotics for a wisdom tooth extraction.

“We are all guilty” of overprescribing, and “just like everywhere else, we’ve seen the problems; every year, it’s getting worse,” she added. In response, “we are changing how we use opioids, adapting the guidelines from the CDC and other groups,” and tailoring them to different services.

At the Yale emergency department, oral opioid prescriptions are now generally limited to 3 days, except for renal colic patients, who might get a few days more. “We do not fill opioid scripts and don’t reorder them for patients.” Instead, “we talk to the prescriber and tell them what’s going on,” Dr. D’Onofrio explained.

Yale’s not alone in cutting back. After years of growth, U.S. oral opioid sales appear to be declining. In fact, in some quarters, there’s concern the clampdown will go too far.

The CDC received more than 4,300 comments about the draft version of its guidelines. Some patients were worried about losing access to drugs that have helped them. And, while supportive of the goals, some professional groups questioned the evidence behind the proposals and worry about undertreatment of pain, among other issues.

“The problem with a lot of the guidelines is that they’re all around limiting prescribing. They don’t really tell doctors what to do instead,” said Dr. Peter Friedmann, an addiction treatment specialist in Springfield, Mass., and chief research officer for Baystate Health.

An alternative for chronic pain

For noncancer chronic pain, recent evidence supports multimodal therapy. Opioids might bring temporary relief, but “throwing drugs at people isn’t going to solve the problem,” said Dr. Tauben, the University of Washington pain expert.

“Multimodal therapy” means focusing more on the burden of pain instead of its intensity, with team-based care. Reducing the burden – anxiety, sleeplessness, reduced mobility, and other problems – seems to reduce the significance and intensity of pain to the point where it can be managed, if needed, with nonsteroidal anti-inflammatory drugs (NSAIDs), trigger-point injections, and other nonopioid options.

Depending on the patient’s needs, primary care physicians might find themselves coordinating services from psychologists, physical therapists, social workers, or others.

For the approach to work, the impact of pain has to be accurately gauged, along with underlying psychological or social issues; to save time, the University of Washington has patients complete an online survey prior to their office visit.

There are national efforts underway to support the approach, and a growing recognition that “by doing it right, you save downstream costs. Primary care must get involved; that’s where chronic pain presents,” Dr. Tauben said.

Batting cleanup

There’s a role for primary care when patients are hooked on opioids, too. Requests for early refills and higher doses are a clue.

“Given the stigma, a lot of doctors don’t want to deal with addiction, but we have to deal with it. We need to move addiction treatment into the mainstream of what we do in medicine,” Dr. Friedmann said. “These patients are no more or no less challenging than any other patients we deal with; the only way doctors are going to find that out is by starting to manage some of them.”

He estimates that about 60% of his patients do well on buprenorphine, a sublingual, partial opioid agonist that blocks the effects of full agonists and dulls withdrawal symptoms. Incorporating it into practice “is not something you need to figure out yourself,” Dr. Friedmann noted. There are training programs and people who can help.

There simply aren’t enough methadone clinics to handle the current situation, especially in suburbs and rural areas where drug dealers have found a new market for heroin. Another option, abstinence programs, “have contributed to the problem of overdose;” people lose their tolerance, reuse, and die, he said.

Buprenorphine treatment might soon get easier. The FDA is expected to make an approval decision soon on probuphine, a matchstick-size subdermal implant that delivers buprenorphine continuously for 6 months.

Dr. Friedmann disclosed relationships with Alkermes, Inavir, and Orexo. The other doctors had no relevant disclosures.

[email protected]

In about 2002, Dr. Gary Franklin realized the state of Washington might have a problem.

A big problem.

A state resident who’d suffered a back sprain and filed a workers’ compensation claim died 2 years later – not from heart disease or cancer or stroke, but from an unintentional prescription opioid overdose, recalled Dr. Franklin, medical director of the Washington State Department of Labor and Industries.

©andrewsafonov/Thinkstock

“I had never seen anything so sad,” he said.

The case prompted the neurologist and his colleagues to review Washington state workers’ compensation claims. What they uncovered was a local trend that would explode into a national scourge: a marked increase in opioid poisonings among Washington state residents with everyday aches and pains who, in the past, would never have been prescribed opioids.

The gateway drug turned out to be oxycodone (OxyContin), which was heavily marketed at the time as a safe choice for pain relief with little abuse potential. Purdue Pharma has since paid a $600 million federal fine for deceptive marketing.

“This is the worst man-made epidemic in modern medical history,” said Dr. Franklin, also a research professor at the University of Washington, Seattle. “It was made by modern medicine, and it’s up to modern medicine to turn it around.”

For the United States to recover from the opioid crisis, Dr. Franklin said, the medical community must reduce oral opioid prescriptions for noncancer pain. Others interviewed for this story said doctors also have to overcome their aversion to in-office addiction treatment, and find new options for everyday chronic pain.

The first step is “to forget everything you were told in 1999,” said Dr. Franklin. That includes the notions that addiction is rare, opioids are indicated for noncancer chronic pain, and doses should be increased if patients become tolerant.

Those messages led to overprescribing, which in turn “led to an oversupply problem that’s feeding misuse and diversion. It’s only recently that it has become a heroin problem; the vast majority of heroin users these days start on prescription opioids,” he said.

The Washington workers’ comp claims data triggered “a complete rethinking of our approach to chronic pain and a shift to other treatment strategies,” said Dr. David Tauben, chief of pain medicine at the University of Washington, Seattle.

In 2007, Washington became one of the first states to issue opioid treatment guidelines, which are updated regularly. Among other steps, prescribers were urged to limit doses and durations.

Since then, the state has seen a nearly 40% reduction in prescription opioid poisonings. “We also found that with dose reductions” for back pain, headaches, and similar noncancer issues, “pain subsides, function improves, and patient satisfaction” goes up, said Dr. Tauben, who was involved in creating the guidelines.

Clamping down, pushing back

The Centers for Disease Control and Prevention in March released similar guidelines, including a suggested 3-day limit for acute pain prescriptions and a cap of 90 morphine milligram equivalents per day for chronic noncancer pain – the amount in a single 60-mg oxycodone tablet.

Meanwhile, Food and Drug Administration officials are planning a regulatory overhaul to address opioid approval, labeling, and prescribing concerns. In many places, doctors are also facing new opioid training requirements.

The Washington state experience suggests that such efforts are likely to help reverse the opioid crisis.

It’s not about getting rid of the drugs, explained Dr. Gail D’Onofrio, chair of emergency medicine at Yale University in New Haven, Conn.

“Opioids are really good for certain things,” especially cancer pain and, for a few days, acute pain. But “we’ve kind of lost our way,” Dr. D’Onofrio said. “We don’t need to give people 3 months of narcotics for a knee replacement” or 3 weeks of narcotics for a wisdom tooth extraction.

“We are all guilty” of overprescribing, and “just like everywhere else, we’ve seen the problems; every year, it’s getting worse,” she added. In response, “we are changing how we use opioids, adapting the guidelines from the CDC and other groups,” and tailoring them to different services.

At the Yale emergency department, oral opioid prescriptions are now generally limited to 3 days, except for renal colic patients, who might get a few days more. “We do not fill opioid scripts and don’t reorder them for patients.” Instead, “we talk to the prescriber and tell them what’s going on,” Dr. D’Onofrio explained.

Yale’s not alone in cutting back. After years of growth, U.S. oral opioid sales appear to be declining. In fact, in some quarters, there’s concern the clampdown will go too far.

The CDC received more than 4,300 comments about the draft version of its guidelines. Some patients were worried about losing access to drugs that have helped them. And, while supportive of the goals, some professional groups questioned the evidence behind the proposals and worry about undertreatment of pain, among other issues.

“The problem with a lot of the guidelines is that they’re all around limiting prescribing. They don’t really tell doctors what to do instead,” said Dr. Peter Friedmann, an addiction treatment specialist in Springfield, Mass., and chief research officer for Baystate Health.

An alternative for chronic pain

For noncancer chronic pain, recent evidence supports multimodal therapy. Opioids might bring temporary relief, but “throwing drugs at people isn’t going to solve the problem,” said Dr. Tauben, the University of Washington pain expert.

“Multimodal therapy” means focusing more on the burden of pain instead of its intensity, with team-based care. Reducing the burden – anxiety, sleeplessness, reduced mobility, and other problems – seems to reduce the significance and intensity of pain to the point where it can be managed, if needed, with nonsteroidal anti-inflammatory drugs (NSAIDs), trigger-point injections, and other nonopioid options.

Depending on the patient’s needs, primary care physicians might find themselves coordinating services from psychologists, physical therapists, social workers, or others.

For the approach to work, the impact of pain has to be accurately gauged, along with underlying psychological or social issues; to save time, the University of Washington has patients complete an online survey prior to their office visit.

There are national efforts underway to support the approach, and a growing recognition that “by doing it right, you save downstream costs. Primary care must get involved; that’s where chronic pain presents,” Dr. Tauben said.

Batting cleanup

There’s a role for primary care when patients are hooked on opioids, too. Requests for early refills and higher doses are a clue.

“Given the stigma, a lot of doctors don’t want to deal with addiction, but we have to deal with it. We need to move addiction treatment into the mainstream of what we do in medicine,” Dr. Friedmann said. “These patients are no more or no less challenging than any other patients we deal with; the only way doctors are going to find that out is by starting to manage some of them.”

He estimates that about 60% of his patients do well on buprenorphine, a sublingual, partial opioid agonist that blocks the effects of full agonists and dulls withdrawal symptoms. Incorporating it into practice “is not something you need to figure out yourself,” Dr. Friedmann noted. There are training programs and people who can help.

There simply aren’t enough methadone clinics to handle the current situation, especially in suburbs and rural areas where drug dealers have found a new market for heroin. Another option, abstinence programs, “have contributed to the problem of overdose;” people lose their tolerance, reuse, and die, he said.

Buprenorphine treatment might soon get easier. The FDA is expected to make an approval decision soon on probuphine, a matchstick-size subdermal implant that delivers buprenorphine continuously for 6 months.

Dr. Friedmann disclosed relationships with Alkermes, Inavir, and Orexo. The other doctors had no relevant disclosures.

[email protected]

There is “limited or suggestive evidence” that links Agent Orange exposure to bladder cancer and hyperthyroidism according to the biennial review of the Committee to Review the Health Effects in Vietnam Veterans of Exposure to Herbicides. The committee reviewed results from a study of veterans of the Korean War who also served in the Vietnam War that suggested an association for bladder cancer and hypothyroidism. The evidence, along with supportive epidemiologic findings, led the committee to strengthen the association between Agent Orange exposure and bladder cancer and hyperthyroidism.

The report is the final in a series of reviews mandated by Congress on the evidence of health problems that can be linked to exposure to Agent Orange and other herbicides used during the Vietnam War. Bladder cancer joins a host of other cancers and cancer-related conditions associated with Agent Orange exposure, include:

• AL Amyloidosis;

• Chronic B-cell Leukemias;

• Hodgkin Disease;

• Multiple Myeloma;

• Non-Hodgkin Lymphoma;

• Prostate Cancer;

• Respiratory Cancers (including lung cancer);

• Cancers of the lung, larynx, trachea, and bronchus; and

• Soft Tissue Sarcomas.

The committee also concluded that there was not enough evidence to support an association between any birth defects and parental exposure to herbicides. According to the committee, “intensive investigation of possible heritable effects in animal models still has not demonstrated that herbicide exposure of adult males can produce birth defects in their offspring.” The committee downgraded spina bifida to the “inadequate or insufficient” evidence category—marking just the second time that a health outcome has been moved to a weaker category of association.

The committee also addressed the question of whether Parkinson-like symptoms should qualify the assignment of Parkinson disease to the limited or suggestive category of association with Agent Orange exposure. The committee determined that given “there is no rational basis for exclusion of individuals with Parkinson-like symptoms from the service-related category denoted as Parkinson disease.” The committee also suggested that “the onus should be on the VA on a case-by-case basis to definitively establish the role of a recognized factor other than the herbicides sprayed in Vietnam.”

In the final report, the committee urged the VA to:

• Continue epidemiologic studies of exposed veterans;

•  Develop protocols to investigate paternal transmission of adverse effects to offspring;

• Study the manifestations in humans of dioxin exposure and compromised immunity, which have been clearly demonstrated in animal models; and

• Review evidence to determine whether paternal exposure to any toxicant has definitively resulted in birth defects.

A complete list of diseases associated with Agent Orange can be found at: http://www.publichealth.va.gov/exposures/agentorange/conditions/#sthash.vJTT3VdU.dpuf

There is “limited or suggestive evidence” that links Agent Orange exposure to bladder cancer and hyperthyroidism according to the biennial review of the Committee to Review the Health Effects in Vietnam Veterans of Exposure to Herbicides. The committee reviewed results from a study of veterans of the Korean War who also served in the Vietnam War that suggested an association for bladder cancer and hypothyroidism. The evidence, along with supportive epidemiologic findings, led the committee to strengthen the association between Agent Orange exposure and bladder cancer and hyperthyroidism.

The report is the final in a series of reviews mandated by Congress on the evidence of health problems that can be linked to exposure to Agent Orange and other herbicides used during the Vietnam War. Bladder cancer joins a host of other cancers and cancer-related conditions associated with Agent Orange exposure, include:

• AL Amyloidosis;

• Chronic B-cell Leukemias;

• Hodgkin Disease;

• Multiple Myeloma;

• Non-Hodgkin Lymphoma;

• Prostate Cancer;

• Respiratory Cancers (including lung cancer);

• Cancers of the lung, larynx, trachea, and bronchus; and

• Soft Tissue Sarcomas.

The committee also concluded that there was not enough evidence to support an association between any birth defects and parental exposure to herbicides. According to the committee, “intensive investigation of possible heritable effects in animal models still has not demonstrated that herbicide exposure of adult males can produce birth defects in their offspring.” The committee downgraded spina bifida to the “inadequate or insufficient” evidence category—marking just the second time that a health outcome has been moved to a weaker category of association.

The committee also addressed the question of whether Parkinson-like symptoms should qualify the assignment of Parkinson disease to the limited or suggestive category of association with Agent Orange exposure. The committee determined that given “there is no rational basis for exclusion of individuals with Parkinson-like symptoms from the service-related category denoted as Parkinson disease.” The committee also suggested that “the onus should be on the VA on a case-by-case basis to definitively establish the role of a recognized factor other than the herbicides sprayed in Vietnam.”

In the final report, the committee urged the VA to:

• Continue epidemiologic studies of exposed veterans;

•  Develop protocols to investigate paternal transmission of adverse effects to offspring;

• Study the manifestations in humans of dioxin exposure and compromised immunity, which have been clearly demonstrated in animal models; and

• Review evidence to determine whether paternal exposure to any toxicant has definitively resulted in birth defects.

A complete list of diseases associated with Agent Orange can be found at: http://www.publichealth.va.gov/exposures/agentorange/conditions/#sthash.vJTT3VdU.dpuf

There is “limited or suggestive evidence” that links Agent Orange exposure to bladder cancer and hyperthyroidism according to the biennial review of the Committee to Review the Health Effects in Vietnam Veterans of Exposure to Herbicides. The committee reviewed results from a study of veterans of the Korean War who also served in the Vietnam War that suggested an association for bladder cancer and hypothyroidism. The evidence, along with supportive epidemiologic findings, led the committee to strengthen the association between Agent Orange exposure and bladder cancer and hyperthyroidism.

The report is the final in a series of reviews mandated by Congress on the evidence of health problems that can be linked to exposure to Agent Orange and other herbicides used during the Vietnam War. Bladder cancer joins a host of other cancers and cancer-related conditions associated with Agent Orange exposure, include:

• AL Amyloidosis;

• Chronic B-cell Leukemias;

• Hodgkin Disease;

• Multiple Myeloma;

• Non-Hodgkin Lymphoma;

• Prostate Cancer;

• Respiratory Cancers (including lung cancer);

• Cancers of the lung, larynx, trachea, and bronchus; and

• Soft Tissue Sarcomas.

The committee also concluded that there was not enough evidence to support an association between any birth defects and parental exposure to herbicides. According to the committee, “intensive investigation of possible heritable effects in animal models still has not demonstrated that herbicide exposure of adult males can produce birth defects in their offspring.” The committee downgraded spina bifida to the “inadequate or insufficient” evidence category—marking just the second time that a health outcome has been moved to a weaker category of association.

The committee also addressed the question of whether Parkinson-like symptoms should qualify the assignment of Parkinson disease to the limited or suggestive category of association with Agent Orange exposure. The committee determined that given “there is no rational basis for exclusion of individuals with Parkinson-like symptoms from the service-related category denoted as Parkinson disease.” The committee also suggested that “the onus should be on the VA on a case-by-case basis to definitively establish the role of a recognized factor other than the herbicides sprayed in Vietnam.”

In the final report, the committee urged the VA to:

• Continue epidemiologic studies of exposed veterans;

•  Develop protocols to investigate paternal transmission of adverse effects to offspring;

• Study the manifestations in humans of dioxin exposure and compromised immunity, which have been clearly demonstrated in animal models; and

• Review evidence to determine whether paternal exposure to any toxicant has definitively resulted in birth defects.

A complete list of diseases associated with Agent Orange can be found at: http://www.publichealth.va.gov/exposures/agentorange/conditions/#sthash.vJTT3VdU.dpuf

A review by researchers from Hôpital Sud, Rennes, France, and McGill University, Montreal showed that surgery by robot—rather than traditional open surgery—may improve outcomes in elderly patients with pelvic cancer, however the research is sparse. For instance, only 6 published studies specifically address surgery in the elderly with endometrial cancer, the most common gynecologic malignancy in the western world. However, because surgery is challenging for these often-frail patients, minimally invasive (or minimal access) surgery could be the answer. When comparing robotics to standard laparoscopy in treating endometrial cancer, the data suggest significantly less blood loss, reduced operative time, and higher node counts.

Related: A Team Approach to Nonmelanotic Skin Cancer Procedures

Similar to many others, the researchers’ academic center was slow to adopt minimally invasive standard (MIS) laparoscopy. But within 2 years of the introduction of robotic surgery in 2007, more than 95% of patients requiring surgery to treat endometrial cancer undergo MIS. Now, the surgery is offered to each operable patient unless the cancer cannot be extracted intact or in a 15-cm diameter endobag via the vagina.

Related: Solid-Organ Transplant Recipients May Be at Greater Risk for Cancer

The researchers note that the MIS procedure has some unique risks. For example, once the patient is “docked” to the robot, the Trendelenburg position can’t be reversed without undocking. This may adversely affect the respiratory and cardiovascular system. Despite case reports about such adverse effects, though, the researchers say most data support the safety of robotic surgery in the elderly. Moreover, the newest versions of robots allow for multiple quadrant access without the need to undock.

Related:Gene Expression Signatures in Breast Cancer: A Surgical Oncologist’s Perspective

The oncologic safety of robotic surgery seems similar to that of open surgery or laparoscopic surgery. After 2 years of follow-up in 1 study, rates of progression-free survival were similar for the different methods. The researchers advise surgeons to work toward improving preoperative frailty assessments that will help tailor the right surgery for the right subgroup of elderly patients.

Lavoué V, Gotlieb W. Cancers (Basel). 2016;8(1):E12.
doi: 10.3390/cancers8010012.

A review by researchers from Hôpital Sud, Rennes, France, and McGill University, Montreal showed that surgery by robot—rather than traditional open surgery—may improve outcomes in elderly patients with pelvic cancer, however the research is sparse. For instance, only 6 published studies specifically address surgery in the elderly with endometrial cancer, the most common gynecologic malignancy in the western world. However, because surgery is challenging for these often-frail patients, minimally invasive (or minimal access) surgery could be the answer. When comparing robotics to standard laparoscopy in treating endometrial cancer, the data suggest significantly less blood loss, reduced operative time, and higher node counts.

Related: A Team Approach to Nonmelanotic Skin Cancer Procedures

Similar to many others, the researchers’ academic center was slow to adopt minimally invasive standard (MIS) laparoscopy. But within 2 years of the introduction of robotic surgery in 2007, more than 95% of patients requiring surgery to treat endometrial cancer undergo MIS. Now, the surgery is offered to each operable patient unless the cancer cannot be extracted intact or in a 15-cm diameter endobag via the vagina.

Related: Solid-Organ Transplant Recipients May Be at Greater Risk for Cancer

The researchers note that the MIS procedure has some unique risks. For example, once the patient is “docked” to the robot, the Trendelenburg position can’t be reversed without undocking. This may adversely affect the respiratory and cardiovascular system. Despite case reports about such adverse effects, though, the researchers say most data support the safety of robotic surgery in the elderly. Moreover, the newest versions of robots allow for multiple quadrant access without the need to undock.

Related:Gene Expression Signatures in Breast Cancer: A Surgical Oncologist’s Perspective

The oncologic safety of robotic surgery seems similar to that of open surgery or laparoscopic surgery. After 2 years of follow-up in 1 study, rates of progression-free survival were similar for the different methods. The researchers advise surgeons to work toward improving preoperative frailty assessments that will help tailor the right surgery for the right subgroup of elderly patients.

Lavoué V, Gotlieb W. Cancers (Basel). 2016;8(1):E12.
doi: 10.3390/cancers8010012.

A review by researchers from Hôpital Sud, Rennes, France, and McGill University, Montreal showed that surgery by robot—rather than traditional open surgery—may improve outcomes in elderly patients with pelvic cancer, however the research is sparse. For instance, only 6 published studies specifically address surgery in the elderly with endometrial cancer, the most common gynecologic malignancy in the western world. However, because surgery is challenging for these often-frail patients, minimally invasive (or minimal access) surgery could be the answer. When comparing robotics to standard laparoscopy in treating endometrial cancer, the data suggest significantly less blood loss, reduced operative time, and higher node counts.

Related: A Team Approach to Nonmelanotic Skin Cancer Procedures

Similar to many others, the researchers’ academic center was slow to adopt minimally invasive standard (MIS) laparoscopy. But within 2 years of the introduction of robotic surgery in 2007, more than 95% of patients requiring surgery to treat endometrial cancer undergo MIS. Now, the surgery is offered to each operable patient unless the cancer cannot be extracted intact or in a 15-cm diameter endobag via the vagina.

Related: Solid-Organ Transplant Recipients May Be at Greater Risk for Cancer

The researchers note that the MIS procedure has some unique risks. For example, once the patient is “docked” to the robot, the Trendelenburg position can’t be reversed without undocking. This may adversely affect the respiratory and cardiovascular system. Despite case reports about such adverse effects, though, the researchers say most data support the safety of robotic surgery in the elderly. Moreover, the newest versions of robots allow for multiple quadrant access without the need to undock.

Related:Gene Expression Signatures in Breast Cancer: A Surgical Oncologist’s Perspective

The oncologic safety of robotic surgery seems similar to that of open surgery or laparoscopic surgery. After 2 years of follow-up in 1 study, rates of progression-free survival were similar for the different methods. The researchers advise surgeons to work toward improving preoperative frailty assessments that will help tailor the right surgery for the right subgroup of elderly patients.

Lavoué V, Gotlieb W. Cancers (Basel). 2016;8(1):E12.
doi: 10.3390/cancers8010012.

The incident that perhaps most fully impressed the potential dangers of electronic health records (EHRs) on hospitalist pioneer Robert Wachter, MD, MHM, came two years ago. It started, innocently and well-intentioned enough, years earlier with the installation of EHR systems at the University of California at San Francisco (UCSF). Flash-forward to 2013 and a 16-year-old boy’s admission to UCSF’s Benioff Children’s Hospital for a routine colonoscopy related to his NEMO deficiency syndrome, a rare genetic disease that affects the bowels. For his nightly medications that evening, the boy was supposed to take a single dose of Septra, a common antibiotic that hospitalists and internists across the nation routinely prescribe for urinary and skin infections.

But this boy took 38.5 doses, one pill at a time.

How could that possibly happen? Hospitalists might rightly ask.

Because the EHR told everyone involved that’s what the dose should be. So every physician, pharmacist, and nurse involved in the boy’s treatment carried out the order to a T, discovering the error only when the teenager later complained of anxiety, mild confusion, and tingling so acute he felt “numb all over.”

In an era when EHR is king, an adverse event such as a 39-fold overdose is just another example of the unintended consequences technology has foisted upon hospitalists and other providers in America’s massive healthcare system. It is the unfortunate underbelly of healthcare’s rapid-fire introduction to EHR, thanks to a flood of federal funding over the past 10 years, Dr. Wachter says.

“Most fields that go digital do so over the course of 10 or 20 years in a very organic way, with the early adopters, the rank and file, and then the laggards,” Dr. Wachter said at SHM’s 2015 annual meeting in Washington, D.C., where he recounted the UCSF overdose in a keynote address. “In that kind of organic adoption curve, you see problems arise, and people begin to deal with them and understand them and mitigate them. What the federal intervention did was essentially turbocharge the digitization of healthcare.”

And with the relative speed of digitization comes unintended consequences, including:

• Unfriendly user interfaces that stymie and frustrate physicians accustomed to comparatively intuitive smartphones and tablets;
• Limited applicability of EHRs to quality improvement (QI) projects, as the systems are, in essence, first constructed as billing and coding constructs;
• Alert fatigue tied to EHRs and such medical devices as ventilators, blood pressure monitors, and electrocardiograms desensitize physicians to true concerns; and
• The “cut-and-paste” phenomenon of transferring daily notes or other orders that’s only growing as EHRs become more ubiquitous (see “CTRL-C + CTRL-V = DANGER”).

“Health IT [HIT] is not the panacea that many have touted it as, and it’s really a question of a reassessment of where exactly we are right now compared with where we thought we would be,” says Kendall Rogers, MD, CPE, SFHM, chief of the division of hospital medicine at the University of New Mexico Health Sciences Center in Albuquerque and chair of SHM’s Information Technology Committee. “I think our endpoint—that we’re going to get to—this is all going to result in better care. But we’re in that middle period of extreme danger right now where we could actually be doing harm to our patients but certainly are frustrating our providers.”

Funding Failure?

HIT’s rapid evolution starts with the creation of the Office of the National Coordinator for Health Information Technology (ONC) in 2004, which began receiving funding in 2009 to the tune of $30 billion to improve health information exchanges between physicians and institutions.

The money “spent in adoption should have been spent in innovation and development and research to show what works and what doesn’t well before you started pushing adoption,” Dr. Rogers says. “But at this stage, we can’t go backward … the plan is in flight, and we have to try to repair it in the air at this point.”

To that end, The Joint Commission in March 2015 issued a Sentinel Event Alert to highlight that the safest use of HIT still needs structural improvement. The Joint Commission analyzed 120 sentinel events (which it defines as unexpected occurrences involving death or serious physical or psychological injury or the risk thereof) that were HIT-related between Jan. 1, 2010, and June 30, 2013. Eighty percent were issues with human-computer interface, workflow and communication, or design or data issues tied to clinical content or decision support.

“As health IT adoption spreads and becomes a critical component of organizational infrastructure, the potential for health IT-related harm will likely increase unless risk-reducing measures are put into place,” the alert stated.

To that end, The Joint Commission recommends:

1. Focusing on creating and maintaining a safety culture;
2. Developing a proactive approach to process improvement that includes assessing patient safety risk; and
3. Enlisting physicians and administrators from multiple disciplines to oversee HIT planning, implementation, and evaluation.

Terry Edwards, chief executive officer of PerfectServe, a Knoxville, Tenn., firm that works on healthcare communications systems, says that a survey his firm conducted in 2015 found that, among clinicians needing to communicate with an in-house colleague about “complex or in-depth information,” an EHR is used 12% of the time. Just 8% of hospitalists surveyed used it. The rest used workarounds, face-to-face conversations, and myriad customized solutions to communicate.

“Workarounds happen all the time in healthcare because many of the tools and technologies impede rather than enhance a clinician’s efficiency,” Edwards says in an email to The Hospitalist. “It’s pretty clear that many physicians are frustrated by EHR technology.”

Backwards Revolution

The natural question around unintended consequences: Why didn’t physicians or others see them coming as EHRs and HIT were burgeoning the past decade? Dr. Rogers says that hospitalists and physicians weren’t involved enough on the front-end design of EHRs.

So instead of systems that have been built to be intuitive to the real-time workflow of hospitalists, nurse practitioners, and physician assistants, the systems are built more for back-office administrative functions, he adds.

“When we have programmers and non-clinical people trying to build products for us, they’re dictating our workflow,” Dr. Rogers says. “In many cases, they don’t understand our workflow, and in many more cases, our workflow differs from the last person or the last hospital they worked at.

“This is where we get into issues around usability.”

Take the overdose patient at UCSF. One wrong number typed into a single field led to the oversize dosage. Safety redundancies built in the system flagged the excessive dosage each time, but at each point, a human decided to keep the dosage at the incorrect size because, essentially, everyone trusted the EHR.

All of those red flags come with their own unintended consequence: alert fatigue.

“When people really get fatigued with all of these alerts, they start to ignore them,” says hospitalist Cheng-Kai Kao, MD, medical director of informatics at the University of Chicago Medicine. “So now here comes the question: How do we properly set the limit or threshold?”

In the airline industry, alerts are often tiered to give pilots an immediate sense of their importance. But Dr. Kao says the typical EHR interface is not that advanced, an often frustrating trait to younger physicians accustomed to user-friendly iPhones and web applications. The same frustration often is found with the litany of medical devices hospitalists interact with each day.

“Everything is a fundamental question: How do we set up an optimal environment for humans to interact with computers?” Dr. Kao adds. “We are talking about usability. We are talking about optimizing the IT system that blends into people’s daily workflow so they don’t feel disrupted and have to develop a workaround.”

Solutions Wanted

One EHR critic suggests that the proliferation of workarounds could be solved by a moratorium on further implementation and rollout of EHR systems.

“During that moratorium, there needs to be a complete rethinking of roles, i.e., who does what with these systems, and what needs to be severely rethought are the roles of who gets to do what, including data entry,” says Scot Silverstein, a health IT consultant in Philadelphia. “There’s just no way you can make entry of information into complex computer systems rapid with multiple computer screens that have to be navigated through ad infinitum. There’s just no way you can make that anywhere near as efficient, and you can’t make it less distracting and untiring compared to paper.

“I’m advocating not a return to paper but a consideration of where a paper intermediary—such as specialized forms—between clinicians and information system are appropriate.”

Silverstein says that the relatively rushed overlay of computer systems on medicine meant that corporate computing models were simply pushed into healthcare, a world that operates very differently than most other industries. He says that is why adverse events will continue to occur; why The Joint Commission felt the need to issue an alert; and why the ECRI Institute, a quasi-Consumer Reports organization for healthcare, listed “data integrity failures with health information technology systems” atop its Top 10 Patient Safety Concerns for 2014. Other EHR concerns have been on the list the past several years as well.

“The business computing model, which dates back to the days of card-punch tabulators that IBM developed in the 1920s and ’30s, really has a completely wrong model of medicine,” Silverstein adds. “Medicine is not a predictable, controlled, regular environment. It is an environment of emergencies, irregular events, unpredictability, poor boundaries. Every possible thing in the world can and does go wrong.”

Dr. Rogers agrees that HIT is not optimal, but he sees little point in a moratorium or trying to stop whatever positive progress has already occurred.

“The train has left,” he says. The best approach now is twofold.

First, Dr. Rogers urges hospitalists to formalize their HIT duties by seeing if they would qualify to take the exam for board certification in medical informatics, which was created in 2013 by the American Board of Medical Specialties (ABMS). The more hospitalists who are recognized for the work they already do with EHRs, the more they can then use their positions to help lobby their institutions for changes.

Second, Dr. Rogers wants hospitalists to work as much as possible with vendors, other clinical informaticians, and related stakeholders to help improve the existing system as much as possible. In particular, improvements could help EHRs integrate clinical decision support better, which could then serve as the foundation for research and quality improvement.

Dr. Rogers uses VTE prophylaxis as an example. Before digitalization, “we were able to build all those flow diagrams onto a sheet of paper that would have logical branching points.” Now, pull-down menus and long, one-dimensional order sets regiment what can be input, and medical logic is not the primary concern.

Often, EHR providers will say issues are tied to a lack of training.

“When a vendor repeatedly says this is a training issue, I guarantee that there is a design issue that can be improved,” Dr. Rogers says.

Instead, he and others urge third-party vendors be allowed to design programs and software that can help. He likens it to independent application developers building programs for iPhones and Androids, as opposed to firms like Apple saying that only their internally developed applications would be used.

“Apple would be nowhere right now” had they done that, Dr. Rogers says. “What made them successful was creating a marketplace that all of these individuals out there—thousands of people—could start designing innovations and applications that would fit what that population needed, no matter how small that population was.”

He says a single system, applicable across all healthcare settings, would make an “even playing field for third-party vendors.”

“I think we could get there much faster,” he says. “Within a five-year period of time, I think we could solve a lot of these issues that we’re having right now.” TH

Richard Quinn is a freelance writer in New Jersey.

CTRL-C + CTRL-V = DANGER

Cut-and-paste is as basic a technique as there is in word processing. But with electronic health records (EHRs), that simple maneuver is becoming a danger as repetitive orders, outdated diagnoses, and other inaccurate information is just moved forward unwittingly.

“It’s almost ubiquitous in many cases,” says Kendall Rogers, MD, CPE, SFHM, chief of the division of hospital medicine at the University of New Mexico Health Sciences Center in Albuquerque and chair of SHM’s Information Technology Committee. “Certainly, almost every note that I see in our EHR has some portion of cut-and-paste in it.”

The phenomenon is one borne of a simple workaround. Much of the daily note input on an admitted patient’s screen is repetitive and time-consuming, says hospitalist Cheng-Kai Kao, MD, medical director of informatics at the University of Chicago Medicine. So it might seem to make sense to reuse yesterday’s note today.

But if the note called for a test or a treatment, mistakes can happen.

“We are trying to create new note templates that allow extracting discrete data for billing and research purposes,” Dr. Kao says. “We don’t allow [users] to copy easily, but we do try to make it much easier for them to write a note. So they wouldn’t be copying exactly the same notes from yesterday, but in the meantime, they are able to put in some meaningful information each day.”

Put more simply: “When the right things are made easier to do, people tend to do the right thing. And that is our goal.”

Dr. Rogers suggests keeping the dangers of cut-and-paste errors front of mind and, similar to other EHR documentation issues, lobbying for improvements to the system itself.

“Copy-and-paste is our workaround for poorly designed documentation systems,” he adds. “That does not make it right to use it, but the way to eradicate it is to build better systems that allow documentation to become a part of providing care.”

—Richard Quinn

The incident that perhaps most fully impressed the potential dangers of electronic health records (EHRs) on hospitalist pioneer Robert Wachter, MD, MHM, came two years ago. It started, innocently and well-intentioned enough, years earlier with the installation of EHR systems at the University of California at San Francisco (UCSF). Flash-forward to 2013 and a 16-year-old boy’s admission to UCSF’s Benioff Children’s Hospital for a routine colonoscopy related to his NEMO deficiency syndrome, a rare genetic disease that affects the bowels. For his nightly medications that evening, the boy was supposed to take a single dose of Septra, a common antibiotic that hospitalists and internists across the nation routinely prescribe for urinary and skin infections.

But this boy took 38.5 doses, one pill at a time.

How could that possibly happen? Hospitalists might rightly ask.

Because the EHR told everyone involved that’s what the dose should be. So every physician, pharmacist, and nurse involved in the boy’s treatment carried out the order to a T, discovering the error only when the teenager later complained of anxiety, mild confusion, and tingling so acute he felt “numb all over.”

In an era when EHR is king, an adverse event such as a 39-fold overdose is just another example of the unintended consequences technology has foisted upon hospitalists and other providers in America’s massive healthcare system. It is the unfortunate underbelly of healthcare’s rapid-fire introduction to EHR, thanks to a flood of federal funding over the past 10 years, Dr. Wachter says.

“Most fields that go digital do so over the course of 10 or 20 years in a very organic way, with the early adopters, the rank and file, and then the laggards,” Dr. Wachter said at SHM’s 2015 annual meeting in Washington, D.C., where he recounted the UCSF overdose in a keynote address. “In that kind of organic adoption curve, you see problems arise, and people begin to deal with them and understand them and mitigate them. What the federal intervention did was essentially turbocharge the digitization of healthcare.”

And with the relative speed of digitization comes unintended consequences, including:

• Unfriendly user interfaces that stymie and frustrate physicians accustomed to comparatively intuitive smartphones and tablets;
• Limited applicability of EHRs to quality improvement (QI) projects, as the systems are, in essence, first constructed as billing and coding constructs;
• Alert fatigue tied to EHRs and such medical devices as ventilators, blood pressure monitors, and electrocardiograms desensitize physicians to true concerns; and
• The “cut-and-paste” phenomenon of transferring daily notes or other orders that’s only growing as EHRs become more ubiquitous (see “CTRL-C + CTRL-V = DANGER”).

“Health IT [HIT] is not the panacea that many have touted it as, and it’s really a question of a reassessment of where exactly we are right now compared with where we thought we would be,” says Kendall Rogers, MD, CPE, SFHM, chief of the division of hospital medicine at the University of New Mexico Health Sciences Center in Albuquerque and chair of SHM’s Information Technology Committee. “I think our endpoint—that we’re going to get to—this is all going to result in better care. But we’re in that middle period of extreme danger right now where we could actually be doing harm to our patients but certainly are frustrating our providers.”

Funding Failure?

HIT’s rapid evolution starts with the creation of the Office of the National Coordinator for Health Information Technology (ONC) in 2004, which began receiving funding in 2009 to the tune of $30 billion to improve health information exchanges between physicians and institutions.

The money “spent in adoption should have been spent in innovation and development and research to show what works and what doesn’t well before you started pushing adoption,” Dr. Rogers says. “But at this stage, we can’t go backward … the plan is in flight, and we have to try to repair it in the air at this point.”

To that end, The Joint Commission in March 2015 issued a Sentinel Event Alert to highlight that the safest use of HIT still needs structural improvement. The Joint Commission analyzed 120 sentinel events (which it defines as unexpected occurrences involving death or serious physical or psychological injury or the risk thereof) that were HIT-related between Jan. 1, 2010, and June 30, 2013. Eighty percent were issues with human-computer interface, workflow and communication, or design or data issues tied to clinical content or decision support.

“As health IT adoption spreads and becomes a critical component of organizational infrastructure, the potential for health IT-related harm will likely increase unless risk-reducing measures are put into place,” the alert stated.

To that end, The Joint Commission recommends:

1. Focusing on creating and maintaining a safety culture;
2. Developing a proactive approach to process improvement that includes assessing patient safety risk; and
3. Enlisting physicians and administrators from multiple disciplines to oversee HIT planning, implementation, and evaluation.

Terry Edwards, chief executive officer of PerfectServe, a Knoxville, Tenn., firm that works on healthcare communications systems, says that a survey his firm conducted in 2015 found that, among clinicians needing to communicate with an in-house colleague about “complex or in-depth information,” an EHR is used 12% of the time. Just 8% of hospitalists surveyed used it. The rest used workarounds, face-to-face conversations, and myriad customized solutions to communicate.

“Workarounds happen all the time in healthcare because many of the tools and technologies impede rather than enhance a clinician’s efficiency,” Edwards says in an email to The Hospitalist. “It’s pretty clear that many physicians are frustrated by EHR technology.”

Backwards Revolution

The natural question around unintended consequences: Why didn’t physicians or others see them coming as EHRs and HIT were burgeoning the past decade? Dr. Rogers says that hospitalists and physicians weren’t involved enough on the front-end design of EHRs.

So instead of systems that have been built to be intuitive to the real-time workflow of hospitalists, nurse practitioners, and physician assistants, the systems are built more for back-office administrative functions, he adds.

“When we have programmers and non-clinical people trying to build products for us, they’re dictating our workflow,” Dr. Rogers says. “In many cases, they don’t understand our workflow, and in many more cases, our workflow differs from the last person or the last hospital they worked at.

“This is where we get into issues around usability.”

Take the overdose patient at UCSF. One wrong number typed into a single field led to the oversize dosage. Safety redundancies built in the system flagged the excessive dosage each time, but at each point, a human decided to keep the dosage at the incorrect size because, essentially, everyone trusted the EHR.

All of those red flags come with their own unintended consequence: alert fatigue.

“When people really get fatigued with all of these alerts, they start to ignore them,” says hospitalist Cheng-Kai Kao, MD, medical director of informatics at the University of Chicago Medicine. “So now here comes the question: How do we properly set the limit or threshold?”

In the airline industry, alerts are often tiered to give pilots an immediate sense of their importance. But Dr. Kao says the typical EHR interface is not that advanced, an often frustrating trait to younger physicians accustomed to user-friendly iPhones and web applications. The same frustration often is found with the litany of medical devices hospitalists interact with each day.

“Everything is a fundamental question: How do we set up an optimal environment for humans to interact with computers?” Dr. Kao adds. “We are talking about usability. We are talking about optimizing the IT system that blends into people’s daily workflow so they don’t feel disrupted and have to develop a workaround.”

Solutions Wanted

One EHR critic suggests that the proliferation of workarounds could be solved by a moratorium on further implementation and rollout of EHR systems.

“During that moratorium, there needs to be a complete rethinking of roles, i.e., who does what with these systems, and what needs to be severely rethought are the roles of who gets to do what, including data entry,” says Scot Silverstein, a health IT consultant in Philadelphia. “There’s just no way you can make entry of information into complex computer systems rapid with multiple computer screens that have to be navigated through ad infinitum. There’s just no way you can make that anywhere near as efficient, and you can’t make it less distracting and untiring compared to paper.

“I’m advocating not a return to paper but a consideration of where a paper intermediary—such as specialized forms—between clinicians and information system are appropriate.”

Silverstein says that the relatively rushed overlay of computer systems on medicine meant that corporate computing models were simply pushed into healthcare, a world that operates very differently than most other industries. He says that is why adverse events will continue to occur; why The Joint Commission felt the need to issue an alert; and why the ECRI Institute, a quasi-Consumer Reports organization for healthcare, listed “data integrity failures with health information technology systems” atop its Top 10 Patient Safety Concerns for 2014. Other EHR concerns have been on the list the past several years as well.

“The business computing model, which dates back to the days of card-punch tabulators that IBM developed in the 1920s and ’30s, really has a completely wrong model of medicine,” Silverstein adds. “Medicine is not a predictable, controlled, regular environment. It is an environment of emergencies, irregular events, unpredictability, poor boundaries. Every possible thing in the world can and does go wrong.”

Dr. Rogers agrees that HIT is not optimal, but he sees little point in a moratorium or trying to stop whatever positive progress has already occurred.

“The train has left,” he says. The best approach now is twofold.

First, Dr. Rogers urges hospitalists to formalize their HIT duties by seeing if they would qualify to take the exam for board certification in medical informatics, which was created in 2013 by the American Board of Medical Specialties (ABMS). The more hospitalists who are recognized for the work they already do with EHRs, the more they can then use their positions to help lobby their institutions for changes.

Second, Dr. Rogers wants hospitalists to work as much as possible with vendors, other clinical informaticians, and related stakeholders to help improve the existing system as much as possible. In particular, improvements could help EHRs integrate clinical decision support better, which could then serve as the foundation for research and quality improvement.

Dr. Rogers uses VTE prophylaxis as an example. Before digitalization, “we were able to build all those flow diagrams onto a sheet of paper that would have logical branching points.” Now, pull-down menus and long, one-dimensional order sets regiment what can be input, and medical logic is not the primary concern.

Often, EHR providers will say issues are tied to a lack of training.

“When a vendor repeatedly says this is a training issue, I guarantee that there is a design issue that can be improved,” Dr. Rogers says.

Instead, he and others urge third-party vendors be allowed to design programs and software that can help. He likens it to independent application developers building programs for iPhones and Androids, as opposed to firms like Apple saying that only their internally developed applications would be used.

“Apple would be nowhere right now” had they done that, Dr. Rogers says. “What made them successful was creating a marketplace that all of these individuals out there—thousands of people—could start designing innovations and applications that would fit what that population needed, no matter how small that population was.”

He says a single system, applicable across all healthcare settings, would make an “even playing field for third-party vendors.”

“I think we could get there much faster,” he says. “Within a five-year period of time, I think we could solve a lot of these issues that we’re having right now.” TH

Richard Quinn is a freelance writer in New Jersey.

CTRL-C + CTRL-V = DANGER

Cut-and-paste is as basic a technique as there is in word processing. But with electronic health records (EHRs), that simple maneuver is becoming a danger as repetitive orders, outdated diagnoses, and other inaccurate information is just moved forward unwittingly.

“It’s almost ubiquitous in many cases,” says Kendall Rogers, MD, CPE, SFHM, chief of the division of hospital medicine at the University of New Mexico Health Sciences Center in Albuquerque and chair of SHM’s Information Technology Committee. “Certainly, almost every note that I see in our EHR has some portion of cut-and-paste in it.”

The phenomenon is one borne of a simple workaround. Much of the daily note input on an admitted patient’s screen is repetitive and time-consuming, says hospitalist Cheng-Kai Kao, MD, medical director of informatics at the University of Chicago Medicine. So it might seem to make sense to reuse yesterday’s note today.

But if the note called for a test or a treatment, mistakes can happen.

“We are trying to create new note templates that allow extracting discrete data for billing and research purposes,” Dr. Kao says. “We don’t allow [users] to copy easily, but we do try to make it much easier for them to write a note. So they wouldn’t be copying exactly the same notes from yesterday, but in the meantime, they are able to put in some meaningful information each day.”

Put more simply: “When the right things are made easier to do, people tend to do the right thing. And that is our goal.”

Dr. Rogers suggests keeping the dangers of cut-and-paste errors front of mind and, similar to other EHR documentation issues, lobbying for improvements to the system itself.

“Copy-and-paste is our workaround for poorly designed documentation systems,” he adds. “That does not make it right to use it, but the way to eradicate it is to build better systems that allow documentation to become a part of providing care.”

—Richard Quinn

The incident that perhaps most fully impressed the potential dangers of electronic health records (EHRs) on hospitalist pioneer Robert Wachter, MD, MHM, came two years ago. It started, innocently and well-intentioned enough, years earlier with the installation of EHR systems at the University of California at San Francisco (UCSF). Flash-forward to 2013 and a 16-year-old boy’s admission to UCSF’s Benioff Children’s Hospital for a routine colonoscopy related to his NEMO deficiency syndrome, a rare genetic disease that affects the bowels. For his nightly medications that evening, the boy was supposed to take a single dose of Septra, a common antibiotic that hospitalists and internists across the nation routinely prescribe for urinary and skin infections.

But this boy took 38.5 doses, one pill at a time.

How could that possibly happen? Hospitalists might rightly ask.

Because the EHR told everyone involved that’s what the dose should be. So every physician, pharmacist, and nurse involved in the boy’s treatment carried out the order to a T, discovering the error only when the teenager later complained of anxiety, mild confusion, and tingling so acute he felt “numb all over.”

In an era when EHR is king, an adverse event such as a 39-fold overdose is just another example of the unintended consequences technology has foisted upon hospitalists and other providers in America’s massive healthcare system. It is the unfortunate underbelly of healthcare’s rapid-fire introduction to EHR, thanks to a flood of federal funding over the past 10 years, Dr. Wachter says.

“Most fields that go digital do so over the course of 10 or 20 years in a very organic way, with the early adopters, the rank and file, and then the laggards,” Dr. Wachter said at SHM’s 2015 annual meeting in Washington, D.C., where he recounted the UCSF overdose in a keynote address. “In that kind of organic adoption curve, you see problems arise, and people begin to deal with them and understand them and mitigate them. What the federal intervention did was essentially turbocharge the digitization of healthcare.”

And with the relative speed of digitization comes unintended consequences, including:

• Unfriendly user interfaces that stymie and frustrate physicians accustomed to comparatively intuitive smartphones and tablets;
• Limited applicability of EHRs to quality improvement (QI) projects, as the systems are, in essence, first constructed as billing and coding constructs;
• Alert fatigue tied to EHRs and such medical devices as ventilators, blood pressure monitors, and electrocardiograms desensitize physicians to true concerns; and
• The “cut-and-paste” phenomenon of transferring daily notes or other orders that’s only growing as EHRs become more ubiquitous (see “CTRL-C + CTRL-V = DANGER”).

“Health IT [HIT] is not the panacea that many have touted it as, and it’s really a question of a reassessment of where exactly we are right now compared with where we thought we would be,” says Kendall Rogers, MD, CPE, SFHM, chief of the division of hospital medicine at the University of New Mexico Health Sciences Center in Albuquerque and chair of SHM’s Information Technology Committee. “I think our endpoint—that we’re going to get to—this is all going to result in better care. But we’re in that middle period of extreme danger right now where we could actually be doing harm to our patients but certainly are frustrating our providers.”

Funding Failure?

HIT’s rapid evolution starts with the creation of the Office of the National Coordinator for Health Information Technology (ONC) in 2004, which began receiving funding in 2009 to the tune of $30 billion to improve health information exchanges between physicians and institutions.

The money “spent in adoption should have been spent in innovation and development and research to show what works and what doesn’t well before you started pushing adoption,” Dr. Rogers says. “But at this stage, we can’t go backward … the plan is in flight, and we have to try to repair it in the air at this point.”

To that end, The Joint Commission in March 2015 issued a Sentinel Event Alert to highlight that the safest use of HIT still needs structural improvement. The Joint Commission analyzed 120 sentinel events (which it defines as unexpected occurrences involving death or serious physical or psychological injury or the risk thereof) that were HIT-related between Jan. 1, 2010, and June 30, 2013. Eighty percent were issues with human-computer interface, workflow and communication, or design or data issues tied to clinical content or decision support.

“As health IT adoption spreads and becomes a critical component of organizational infrastructure, the potential for health IT-related harm will likely increase unless risk-reducing measures are put into place,” the alert stated.

To that end, The Joint Commission recommends:

1. Focusing on creating and maintaining a safety culture;
2. Developing a proactive approach to process improvement that includes assessing patient safety risk; and
3. Enlisting physicians and administrators from multiple disciplines to oversee HIT planning, implementation, and evaluation.

Terry Edwards, chief executive officer of PerfectServe, a Knoxville, Tenn., firm that works on healthcare communications systems, says that a survey his firm conducted in 2015 found that, among clinicians needing to communicate with an in-house colleague about “complex or in-depth information,” an EHR is used 12% of the time. Just 8% of hospitalists surveyed used it. The rest used workarounds, face-to-face conversations, and myriad customized solutions to communicate.

“Workarounds happen all the time in healthcare because many of the tools and technologies impede rather than enhance a clinician’s efficiency,” Edwards says in an email to The Hospitalist. “It’s pretty clear that many physicians are frustrated by EHR technology.”

Backwards Revolution

The natural question around unintended consequences: Why didn’t physicians or others see them coming as EHRs and HIT were burgeoning the past decade? Dr. Rogers says that hospitalists and physicians weren’t involved enough on the front-end design of EHRs.

So instead of systems that have been built to be intuitive to the real-time workflow of hospitalists, nurse practitioners, and physician assistants, the systems are built more for back-office administrative functions, he adds.

“When we have programmers and non-clinical people trying to build products for us, they’re dictating our workflow,” Dr. Rogers says. “In many cases, they don’t understand our workflow, and in many more cases, our workflow differs from the last person or the last hospital they worked at.

“This is where we get into issues around usability.”

Take the overdose patient at UCSF. One wrong number typed into a single field led to the oversize dosage. Safety redundancies built in the system flagged the excessive dosage each time, but at each point, a human decided to keep the dosage at the incorrect size because, essentially, everyone trusted the EHR.

All of those red flags come with their own unintended consequence: alert fatigue.

“When people really get fatigued with all of these alerts, they start to ignore them,” says hospitalist Cheng-Kai Kao, MD, medical director of informatics at the University of Chicago Medicine. “So now here comes the question: How do we properly set the limit or threshold?”

In the airline industry, alerts are often tiered to give pilots an immediate sense of their importance. But Dr. Kao says the typical EHR interface is not that advanced, an often frustrating trait to younger physicians accustomed to user-friendly iPhones and web applications. The same frustration often is found with the litany of medical devices hospitalists interact with each day.

“Everything is a fundamental question: How do we set up an optimal environment for humans to interact with computers?” Dr. Kao adds. “We are talking about usability. We are talking about optimizing the IT system that blends into people’s daily workflow so they don’t feel disrupted and have to develop a workaround.”

Solutions Wanted

One EHR critic suggests that the proliferation of workarounds could be solved by a moratorium on further implementation and rollout of EHR systems.

“During that moratorium, there needs to be a complete rethinking of roles, i.e., who does what with these systems, and what needs to be severely rethought are the roles of who gets to do what, including data entry,” says Scot Silverstein, a health IT consultant in Philadelphia. “There’s just no way you can make entry of information into complex computer systems rapid with multiple computer screens that have to be navigated through ad infinitum. There’s just no way you can make that anywhere near as efficient, and you can’t make it less distracting and untiring compared to paper.

“I’m advocating not a return to paper but a consideration of where a paper intermediary—such as specialized forms—between clinicians and information system are appropriate.”

Silverstein says that the relatively rushed overlay of computer systems on medicine meant that corporate computing models were simply pushed into healthcare, a world that operates very differently than most other industries. He says that is why adverse events will continue to occur; why The Joint Commission felt the need to issue an alert; and why the ECRI Institute, a quasi-Consumer Reports organization for healthcare, listed “data integrity failures with health information technology systems” atop its Top 10 Patient Safety Concerns for 2014. Other EHR concerns have been on the list the past several years as well.

“The business computing model, which dates back to the days of card-punch tabulators that IBM developed in the 1920s and ’30s, really has a completely wrong model of medicine,” Silverstein adds. “Medicine is not a predictable, controlled, regular environment. It is an environment of emergencies, irregular events, unpredictability, poor boundaries. Every possible thing in the world can and does go wrong.”

Dr. Rogers agrees that HIT is not optimal, but he sees little point in a moratorium or trying to stop whatever positive progress has already occurred.

“The train has left,” he says. The best approach now is twofold.

First, Dr. Rogers urges hospitalists to formalize their HIT duties by seeing if they would qualify to take the exam for board certification in medical informatics, which was created in 2013 by the American Board of Medical Specialties (ABMS). The more hospitalists who are recognized for the work they already do with EHRs, the more they can then use their positions to help lobby their institutions for changes.

Second, Dr. Rogers wants hospitalists to work as much as possible with vendors, other clinical informaticians, and related stakeholders to help improve the existing system as much as possible. In particular, improvements could help EHRs integrate clinical decision support better, which could then serve as the foundation for research and quality improvement.

Dr. Rogers uses VTE prophylaxis as an example. Before digitalization, “we were able to build all those flow diagrams onto a sheet of paper that would have logical branching points.” Now, pull-down menus and long, one-dimensional order sets regiment what can be input, and medical logic is not the primary concern.

Often, EHR providers will say issues are tied to a lack of training.

“When a vendor repeatedly says this is a training issue, I guarantee that there is a design issue that can be improved,” Dr. Rogers says.

Instead, he and others urge third-party vendors be allowed to design programs and software that can help. He likens it to independent application developers building programs for iPhones and Androids, as opposed to firms like Apple saying that only their internally developed applications would be used.

“Apple would be nowhere right now” had they done that, Dr. Rogers says. “What made them successful was creating a marketplace that all of these individuals out there—thousands of people—could start designing innovations and applications that would fit what that population needed, no matter how small that population was.”

He says a single system, applicable across all healthcare settings, would make an “even playing field for third-party vendors.”

“I think we could get there much faster,” he says. “Within a five-year period of time, I think we could solve a lot of these issues that we’re having right now.” TH

Richard Quinn is a freelance writer in New Jersey.

CTRL-C + CTRL-V = DANGER

Cut-and-paste is as basic a technique as there is in word processing. But with electronic health records (EHRs), that simple maneuver is becoming a danger as repetitive orders, outdated diagnoses, and other inaccurate information is just moved forward unwittingly.

“It’s almost ubiquitous in many cases,” says Kendall Rogers, MD, CPE, SFHM, chief of the division of hospital medicine at the University of New Mexico Health Sciences Center in Albuquerque and chair of SHM’s Information Technology Committee. “Certainly, almost every note that I see in our EHR has some portion of cut-and-paste in it.”

The phenomenon is one borne of a simple workaround. Much of the daily note input on an admitted patient’s screen is repetitive and time-consuming, says hospitalist Cheng-Kai Kao, MD, medical director of informatics at the University of Chicago Medicine. So it might seem to make sense to reuse yesterday’s note today.

But if the note called for a test or a treatment, mistakes can happen.

“We are trying to create new note templates that allow extracting discrete data for billing and research purposes,” Dr. Kao says. “We don’t allow [users] to copy easily, but we do try to make it much easier for them to write a note. So they wouldn’t be copying exactly the same notes from yesterday, but in the meantime, they are able to put in some meaningful information each day.”

Put more simply: “When the right things are made easier to do, people tend to do the right thing. And that is our goal.”

Dr. Rogers suggests keeping the dangers of cut-and-paste errors front of mind and, similar to other EHR documentation issues, lobbying for improvements to the system itself.

“Copy-and-paste is our workaround for poorly designed documentation systems,” he adds. “That does not make it right to use it, but the way to eradicate it is to build better systems that allow documentation to become a part of providing care.”

—Richard Quinn

SHM’s implementation tool kits provide hospitalists the information and tools they need to lead quality improvement projects on specific clinical topics, including two recent releases focused on anemia and congestive heart failure.

One third of the world’s population suffers from anemia, and SHM’s Center for Hospital Innovation and Improvement recently released a tool kit to improve outcomes by providing a framework for hospital-based anemia management quality improvement projects. It reviews each step of the process from forming a multidisciplinary team, obtaining institutional support, assessing baseline performance, and defining key metrics to implementing changes and monitoring their effects, with a focus on blood transfusion best practices.

Such projects can be expected to improve patient outcomes, improve the utilization of scarce resources such as allogeneic blood, and decrease transfusion-related adverse events, enabling hospitals to provide a better quality of care at a lower cost. In today’s competitive healthcare environment, these are quality gains and cost savings that hospitals cannot afford to miss.

Another recent release from the center, the congestive heart failure implementation guide, reviews methods to optimize heart failure care during and after hospital admission episodes. Congestive heart failure is responsible for 11 million physician visits annually and more hospitalizations than all forms of cancer combined.

Other recently added tool kits cover COPD, glycemic control, opioid monitoring, delirium, and pain management.

For more information on these tool kits and how the Center for Hospital Innovation and Improvement can share its proven best practices with your hospital, visit www.hospitalmedicine.org/CenterTJ16.

SHM’s implementation tool kits provide hospitalists the information and tools they need to lead quality improvement projects on specific clinical topics, including two recent releases focused on anemia and congestive heart failure.

One third of the world’s population suffers from anemia, and SHM’s Center for Hospital Innovation and Improvement recently released a tool kit to improve outcomes by providing a framework for hospital-based anemia management quality improvement projects. It reviews each step of the process from forming a multidisciplinary team, obtaining institutional support, assessing baseline performance, and defining key metrics to implementing changes and monitoring their effects, with a focus on blood transfusion best practices.

Such projects can be expected to improve patient outcomes, improve the utilization of scarce resources such as allogeneic blood, and decrease transfusion-related adverse events, enabling hospitals to provide a better quality of care at a lower cost. In today’s competitive healthcare environment, these are quality gains and cost savings that hospitals cannot afford to miss.

Another recent release from the center, the congestive heart failure implementation guide, reviews methods to optimize heart failure care during and after hospital admission episodes. Congestive heart failure is responsible for 11 million physician visits annually and more hospitalizations than all forms of cancer combined.

Other recently added tool kits cover COPD, glycemic control, opioid monitoring, delirium, and pain management.

For more information on these tool kits and how the Center for Hospital Innovation and Improvement can share its proven best practices with your hospital, visit www.hospitalmedicine.org/CenterTJ16.

SHM’s implementation tool kits provide hospitalists the information and tools they need to lead quality improvement projects on specific clinical topics, including two recent releases focused on anemia and congestive heart failure.

One third of the world’s population suffers from anemia, and SHM’s Center for Hospital Innovation and Improvement recently released a tool kit to improve outcomes by providing a framework for hospital-based anemia management quality improvement projects. It reviews each step of the process from forming a multidisciplinary team, obtaining institutional support, assessing baseline performance, and defining key metrics to implementing changes and monitoring their effects, with a focus on blood transfusion best practices.

Such projects can be expected to improve patient outcomes, improve the utilization of scarce resources such as allogeneic blood, and decrease transfusion-related adverse events, enabling hospitals to provide a better quality of care at a lower cost. In today’s competitive healthcare environment, these are quality gains and cost savings that hospitals cannot afford to miss.

Another recent release from the center, the congestive heart failure implementation guide, reviews methods to optimize heart failure care during and after hospital admission episodes. Congestive heart failure is responsible for 11 million physician visits annually and more hospitalizations than all forms of cancer combined.

Other recently added tool kits cover COPD, glycemic control, opioid monitoring, delirium, and pain management.

For more information on these tool kits and how the Center for Hospital Innovation and Improvement can share its proven best practices with your hospital, visit www.hospitalmedicine.org/CenterTJ16.

NEW YORK (Reuters Health) - Certain older patients on warfarin therapy are at greater risk than others for traumatic intracranial bleeding, Veterans Affairs researchers have reported.

In their study of elderly adults receiving warfarin for atrial fibrillation (AF), five factors - dementia, anemia, depression, anticonvulsant use, and labile international normalized ratio - each made patients more vulnerable to traumatic intracranial bleeding.

"Advanced age is a powerful risk factor for thromboembolic stroke in patients with AF, and oral anticoagulation reduces this risk by almost two-thirds in patients at risk," the authors wrote. "However, up to half of the eligible older adults with AF are not treated with anticoagulant therapy due to health care professionals' concerns about potential treatment-related harms."

The research team reviewed medical and administrative data for 31,951 U.S. veterans with AF. Patients were 75 or older andwere newly referred to an anticoagulation clinic for warfarin therapy. Most had comorbidities, including hypertension (82.5%), coronary artery disease (42.6%) and diabetes (33.8%).

During the 11-year study period, 2002 through 2012, the incidence rate of hospitalization for traumatic intracranial bleeding was 4.80 per 1,000 person-years. The incidence rates for any intracranial bleeding and ischemic stroke were 14.58 and 13.44, respectively, per 1,000 person-years, the researchers reported online March 9 in JAMA Cardiology.

After adjusting for age, sex, race/ethnicity, and common comorbidities, significant predictors for traumatic intracranial bleeding were dementia (hazard ratio 1.76, p<0.01), anemia (HR 1.23, p<0.05), depression (HR 1.30, p<0.05), anticonvulsant use (HR 1.35, p<0.05), and labile international normalized ratio (HR 1.33, p<0.05).

"The differential risk between traumatic intracranial bleeding and ischemic stroke for those on warfarin therapy was lower than in prior studies, although the rate of ischemic stroke in our population was still considerable," senior author Dr. John Dodson, director of the Geriatric Cardiology Program at New York University School of Medicine, New York City, told Reuters Health by email.

"Of note, the most commonly used stroke risk score, CHA2S2-VASc, does a poor job of predicting risk for traumatic intracranial bleeding," he added. "Therefore, the risk factors appear to be distinct."

"For the practicing clinician, I think our findings underscore the need for a personalized approach to patients, potentially incorporating the risk factors we identified for traumatic intracranial bleeding in conversations around the risk versus benefit of warfarin therapy," Dr. Dodson said.

Dr. Dodson further noted that several oral anticoagulants have been approved in recent years that don't require the dose adjustment and monitoring needed with warfarin. "When we began this study, these drugs were very new and we therefore did not have a sufficient length of observation to generate a large enough sample of patients taking these medications."

"There are also implantable devices that have recently been approved that exclude the left atrial appendage, which is where most cerebroembolic phenomena originate from the circulation. We cannot comment on the relative harms of either of these strategies compared with warfarin in our data set," he acknowledged."

The final option would be to not treat - that is, taking a conservative approach with no medications or procedure - in a patient at particularly high risk for treatment-related harms, if this is concordant with the patient's own preferences," he concluded.

Dr. Vivek Reddy, director of Cardiac Arrhythmia Services at the Mount Sinai Health System and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City, also noted that clinicians have alternatives to warfarin. "We now have new oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban), but since they are also anticoagulants, it is unknown if the risk of traumatic bleeding would be lower in these patients," he told Reuters Health by email.

Of the mechanical left atrial appendage closure device, Dr. Reddy, who was not involved in the study, stated, "the data is quite compelling for patients that are not good candidates for oral anticoagulation - and the elderly population seems to be a population that would particularly benefit."

Dr. Reddy also pointed out, as did the authors, that the findings may not be applicable to women because 98% of those studied were men. He also observed that "virtually all (participants) were Caucasian, so it's not known if there would be differences for other ethnicities."

The National Institutes of Health and a number of other organizations supported this research. One coauthor reported disclosures.

NEW YORK (Reuters Health) - Certain older patients on warfarin therapy are at greater risk than others for traumatic intracranial bleeding, Veterans Affairs researchers have reported.

In their study of elderly adults receiving warfarin for atrial fibrillation (AF), five factors - dementia, anemia, depression, anticonvulsant use, and labile international normalized ratio - each made patients more vulnerable to traumatic intracranial bleeding.

"Advanced age is a powerful risk factor for thromboembolic stroke in patients with AF, and oral anticoagulation reduces this risk by almost two-thirds in patients at risk," the authors wrote. "However, up to half of the eligible older adults with AF are not treated with anticoagulant therapy due to health care professionals' concerns about potential treatment-related harms."

The research team reviewed medical and administrative data for 31,951 U.S. veterans with AF. Patients were 75 or older andwere newly referred to an anticoagulation clinic for warfarin therapy. Most had comorbidities, including hypertension (82.5%), coronary artery disease (42.6%) and diabetes (33.8%).

During the 11-year study period, 2002 through 2012, the incidence rate of hospitalization for traumatic intracranial bleeding was 4.80 per 1,000 person-years. The incidence rates for any intracranial bleeding and ischemic stroke were 14.58 and 13.44, respectively, per 1,000 person-years, the researchers reported online March 9 in JAMA Cardiology.

After adjusting for age, sex, race/ethnicity, and common comorbidities, significant predictors for traumatic intracranial bleeding were dementia (hazard ratio 1.76, p<0.01), anemia (HR 1.23, p<0.05), depression (HR 1.30, p<0.05), anticonvulsant use (HR 1.35, p<0.05), and labile international normalized ratio (HR 1.33, p<0.05).

"The differential risk between traumatic intracranial bleeding and ischemic stroke for those on warfarin therapy was lower than in prior studies, although the rate of ischemic stroke in our population was still considerable," senior author Dr. John Dodson, director of the Geriatric Cardiology Program at New York University School of Medicine, New York City, told Reuters Health by email.

"Of note, the most commonly used stroke risk score, CHA2S2-VASc, does a poor job of predicting risk for traumatic intracranial bleeding," he added. "Therefore, the risk factors appear to be distinct."

"For the practicing clinician, I think our findings underscore the need for a personalized approach to patients, potentially incorporating the risk factors we identified for traumatic intracranial bleeding in conversations around the risk versus benefit of warfarin therapy," Dr. Dodson said.

Dr. Dodson further noted that several oral anticoagulants have been approved in recent years that don't require the dose adjustment and monitoring needed with warfarin. "When we began this study, these drugs were very new and we therefore did not have a sufficient length of observation to generate a large enough sample of patients taking these medications."

"There are also implantable devices that have recently been approved that exclude the left atrial appendage, which is where most cerebroembolic phenomena originate from the circulation. We cannot comment on the relative harms of either of these strategies compared with warfarin in our data set," he acknowledged."

The final option would be to not treat - that is, taking a conservative approach with no medications or procedure - in a patient at particularly high risk for treatment-related harms, if this is concordant with the patient's own preferences," he concluded.

Dr. Vivek Reddy, director of Cardiac Arrhythmia Services at the Mount Sinai Health System and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City, also noted that clinicians have alternatives to warfarin. "We now have new oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban), but since they are also anticoagulants, it is unknown if the risk of traumatic bleeding would be lower in these patients," he told Reuters Health by email.

Of the mechanical left atrial appendage closure device, Dr. Reddy, who was not involved in the study, stated, "the data is quite compelling for patients that are not good candidates for oral anticoagulation - and the elderly population seems to be a population that would particularly benefit."

Dr. Reddy also pointed out, as did the authors, that the findings may not be applicable to women because 98% of those studied were men. He also observed that "virtually all (participants) were Caucasian, so it's not known if there would be differences for other ethnicities."

The National Institutes of Health and a number of other organizations supported this research. One coauthor reported disclosures.

NEW YORK (Reuters Health) - Certain older patients on warfarin therapy are at greater risk than others for traumatic intracranial bleeding, Veterans Affairs researchers have reported.

In their study of elderly adults receiving warfarin for atrial fibrillation (AF), five factors - dementia, anemia, depression, anticonvulsant use, and labile international normalized ratio - each made patients more vulnerable to traumatic intracranial bleeding.

"Advanced age is a powerful risk factor for thromboembolic stroke in patients with AF, and oral anticoagulation reduces this risk by almost two-thirds in patients at risk," the authors wrote. "However, up to half of the eligible older adults with AF are not treated with anticoagulant therapy due to health care professionals' concerns about potential treatment-related harms."

The research team reviewed medical and administrative data for 31,951 U.S. veterans with AF. Patients were 75 or older andwere newly referred to an anticoagulation clinic for warfarin therapy. Most had comorbidities, including hypertension (82.5%), coronary artery disease (42.6%) and diabetes (33.8%).

During the 11-year study period, 2002 through 2012, the incidence rate of hospitalization for traumatic intracranial bleeding was 4.80 per 1,000 person-years. The incidence rates for any intracranial bleeding and ischemic stroke were 14.58 and 13.44, respectively, per 1,000 person-years, the researchers reported online March 9 in JAMA Cardiology.

After adjusting for age, sex, race/ethnicity, and common comorbidities, significant predictors for traumatic intracranial bleeding were dementia (hazard ratio 1.76, p<0.01), anemia (HR 1.23, p<0.05), depression (HR 1.30, p<0.05), anticonvulsant use (HR 1.35, p<0.05), and labile international normalized ratio (HR 1.33, p<0.05).

"The differential risk between traumatic intracranial bleeding and ischemic stroke for those on warfarin therapy was lower than in prior studies, although the rate of ischemic stroke in our population was still considerable," senior author Dr. John Dodson, director of the Geriatric Cardiology Program at New York University School of Medicine, New York City, told Reuters Health by email.

"Of note, the most commonly used stroke risk score, CHA2S2-VASc, does a poor job of predicting risk for traumatic intracranial bleeding," he added. "Therefore, the risk factors appear to be distinct."

"For the practicing clinician, I think our findings underscore the need for a personalized approach to patients, potentially incorporating the risk factors we identified for traumatic intracranial bleeding in conversations around the risk versus benefit of warfarin therapy," Dr. Dodson said.

Dr. Dodson further noted that several oral anticoagulants have been approved in recent years that don't require the dose adjustment and monitoring needed with warfarin. "When we began this study, these drugs were very new and we therefore did not have a sufficient length of observation to generate a large enough sample of patients taking these medications."

"There are also implantable devices that have recently been approved that exclude the left atrial appendage, which is where most cerebroembolic phenomena originate from the circulation. We cannot comment on the relative harms of either of these strategies compared with warfarin in our data set," he acknowledged."

The final option would be to not treat - that is, taking a conservative approach with no medications or procedure - in a patient at particularly high risk for treatment-related harms, if this is concordant with the patient's own preferences," he concluded.

Dr. Vivek Reddy, director of Cardiac Arrhythmia Services at the Mount Sinai Health System and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City, also noted that clinicians have alternatives to warfarin. "We now have new oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban), but since they are also anticoagulants, it is unknown if the risk of traumatic bleeding would be lower in these patients," he told Reuters Health by email.

Of the mechanical left atrial appendage closure device, Dr. Reddy, who was not involved in the study, stated, "the data is quite compelling for patients that are not good candidates for oral anticoagulation - and the elderly population seems to be a population that would particularly benefit."

Dr. Reddy also pointed out, as did the authors, that the findings may not be applicable to women because 98% of those studied were men. He also observed that "virtually all (participants) were Caucasian, so it's not known if there would be differences for other ethnicities."

The National Institutes of Health and a number of other organizations supported this research. One coauthor reported disclosures.

Beginning March 1 and running through December 31, all active SHM members can earn 2017–2018 dues credits and special recognition for recruiting new physician, physician assistant, nurse practitioner, pharmacist, or affiliate members. Active members will be eligible for:

• A $35 credit toward 2017–2018 dues when recruiting 1 new member
• A $50 credit toward 2017–2018 dues when recruiting 2–4 new members
• A $75 credit toward 2017–2018 dues when recruiting 5–9 new members
• A $125 credit toward 2017–2018 dues when recruiting 10+ new members

For each member recruited, individuals will receive one entry into a grand-prize drawing to receive complimentary registration to HM17 in Las Vegas.

To be counted as a referral, the new member referral must:

• Be a brand-new member to SHM (past members whose membership has lapsed do not qualify)
• Register as a physician, physician assistant, nurse practitioner, pharmacist, or affiliate member
• Include an active member’s name in the “referred by” field on a printed application or the online join form
• Join between March 1, 2016, and December 31, 2016

SHM members are not eligible for dues credits through this program for member referrals attributed to free memberships received as a result of HM17 registrations.

Begin your journey as an SHM Ambassador today at www.hospitalmedicine.org/MAP.

Beginning March 1 and running through December 31, all active SHM members can earn 2017–2018 dues credits and special recognition for recruiting new physician, physician assistant, nurse practitioner, pharmacist, or affiliate members. Active members will be eligible for:

• A $35 credit toward 2017–2018 dues when recruiting 1 new member
• A $50 credit toward 2017–2018 dues when recruiting 2–4 new members
• A $75 credit toward 2017–2018 dues when recruiting 5–9 new members
• A $125 credit toward 2017–2018 dues when recruiting 10+ new members

For each member recruited, individuals will receive one entry into a grand-prize drawing to receive complimentary registration to HM17 in Las Vegas.

To be counted as a referral, the new member referral must:

• Be a brand-new member to SHM (past members whose membership has lapsed do not qualify)
• Register as a physician, physician assistant, nurse practitioner, pharmacist, or affiliate member
• Include an active member’s name in the “referred by” field on a printed application or the online join form
• Join between March 1, 2016, and December 31, 2016

SHM members are not eligible for dues credits through this program for member referrals attributed to free memberships received as a result of HM17 registrations.

Begin your journey as an SHM Ambassador today at www.hospitalmedicine.org/MAP.

Beginning March 1 and running through December 31, all active SHM members can earn 2017–2018 dues credits and special recognition for recruiting new physician, physician assistant, nurse practitioner, pharmacist, or affiliate members. Active members will be eligible for:

• A $35 credit toward 2017–2018 dues when recruiting 1 new member
• A $50 credit toward 2017–2018 dues when recruiting 2–4 new members
• A $75 credit toward 2017–2018 dues when recruiting 5–9 new members
• A $125 credit toward 2017–2018 dues when recruiting 10+ new members

For each member recruited, individuals will receive one entry into a grand-prize drawing to receive complimentary registration to HM17 in Las Vegas.

To be counted as a referral, the new member referral must:

• Be a brand-new member to SHM (past members whose membership has lapsed do not qualify)
• Register as a physician, physician assistant, nurse practitioner, pharmacist, or affiliate member
• Include an active member’s name in the “referred by” field on a printed application or the online join form
• Join between March 1, 2016, and December 31, 2016

SHM members are not eligible for dues credits through this program for member referrals attributed to free memberships received as a result of HM17 registrations.

Begin your journey as an SHM Ambassador today at www.hospitalmedicine.org/MAP.

Blood sample

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has deemed a hospital-based test for the Zika virus “high risk,” as the test has not been cleared by the FDA.

The test was developed by scientists at Texas Children’s Hospital and Houston Methodist Hospital. It has been available at both hospitals since last month.

The FDA has requested more information on the test but has not asked the hospitals to stop using it.

According to the hospitals, the test identifies virus-specific RNA sequences to detect the Zika virus. It can distinguish Zika infection from dengue, West Nile, or chikungunya infections. And it can be performed on blood, amniotic fluid, urine, or spinal fluid.

In a letter to the hospitals, the FDA said this test appears to meet the definition of a device, as defined in section 201(h) of the Federal Food Drug and Cosmetic Act. Yet the test has not been granted premarket clearance, approval, or Emergency Use Authorization review by the FDA.

Therefore, the FDA has asked for information on the test’s design, validation, and performance characteristics. The agency said the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services asked the FDA to review the science behind the test.

The FDA has not asked the hospitals to stop using the test while the review is underway, according to a statement from Texas Children’s Hospital.

Nevertheless, the Association for Molecular Pathology (AMP) said it is “concerned and disappointed” to see the FDA taking enforcement action regarding this test. The AMP said these types of tests are critical for patient care and should be made available to patients in need.

In fact, the AMP said this is an example of how FDA regulation of laboratory developed procedures would hinder patient access to vital medical services. That’s because the FDA’s Emergency Use Authorization for antibody testing at the CDC or state public health labs does not provide results in the timely fashion needed for immediate patient care.

The FDA recently issued Emergency Use Authorization for the Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA), which was developed by the CDC.

The test was distributed to labs in the US and abroad, but it was not made available in US hospitals or other primary care settings.

Blood sample

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has deemed a hospital-based test for the Zika virus “high risk,” as the test has not been cleared by the FDA.

The test was developed by scientists at Texas Children’s Hospital and Houston Methodist Hospital. It has been available at both hospitals since last month.

The FDA has requested more information on the test but has not asked the hospitals to stop using it.

According to the hospitals, the test identifies virus-specific RNA sequences to detect the Zika virus. It can distinguish Zika infection from dengue, West Nile, or chikungunya infections. And it can be performed on blood, amniotic fluid, urine, or spinal fluid.

In a letter to the hospitals, the FDA said this test appears to meet the definition of a device, as defined in section 201(h) of the Federal Food Drug and Cosmetic Act. Yet the test has not been granted premarket clearance, approval, or Emergency Use Authorization review by the FDA.

Therefore, the FDA has asked for information on the test’s design, validation, and performance characteristics. The agency said the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services asked the FDA to review the science behind the test.

The FDA has not asked the hospitals to stop using the test while the review is underway, according to a statement from Texas Children’s Hospital.

Nevertheless, the Association for Molecular Pathology (AMP) said it is “concerned and disappointed” to see the FDA taking enforcement action regarding this test. The AMP said these types of tests are critical for patient care and should be made available to patients in need.

In fact, the AMP said this is an example of how FDA regulation of laboratory developed procedures would hinder patient access to vital medical services. That’s because the FDA’s Emergency Use Authorization for antibody testing at the CDC or state public health labs does not provide results in the timely fashion needed for immediate patient care.

The FDA recently issued Emergency Use Authorization for the Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA), which was developed by the CDC.

The test was distributed to labs in the US and abroad, but it was not made available in US hospitals or other primary care settings.

Blood sample

Photo by Juan D. Alfonso

The US Food and Drug Administration (FDA) has deemed a hospital-based test for the Zika virus “high risk,” as the test has not been cleared by the FDA.

The test was developed by scientists at Texas Children’s Hospital and Houston Methodist Hospital. It has been available at both hospitals since last month.

The FDA has requested more information on the test but has not asked the hospitals to stop using it.

According to the hospitals, the test identifies virus-specific RNA sequences to detect the Zika virus. It can distinguish Zika infection from dengue, West Nile, or chikungunya infections. And it can be performed on blood, amniotic fluid, urine, or spinal fluid.

In a letter to the hospitals, the FDA said this test appears to meet the definition of a device, as defined in section 201(h) of the Federal Food Drug and Cosmetic Act. Yet the test has not been granted premarket clearance, approval, or Emergency Use Authorization review by the FDA.

Therefore, the FDA has asked for information on the test’s design, validation, and performance characteristics. The agency said the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services asked the FDA to review the science behind the test.

The FDA has not asked the hospitals to stop using the test while the review is underway, according to a statement from Texas Children’s Hospital.

Nevertheless, the Association for Molecular Pathology (AMP) said it is “concerned and disappointed” to see the FDA taking enforcement action regarding this test. The AMP said these types of tests are critical for patient care and should be made available to patients in need.

In fact, the AMP said this is an example of how FDA regulation of laboratory developed procedures would hinder patient access to vital medical services. That’s because the FDA’s Emergency Use Authorization for antibody testing at the CDC or state public health labs does not provide results in the timely fashion needed for immediate patient care.

The FDA recently issued Emergency Use Authorization for the Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA), which was developed by the CDC.

The test was distributed to labs in the US and abroad, but it was not made available in US hospitals or other primary care settings.

Antihemophilic factor

A large study suggests that, despite treatment advances, men with severe hemophilia have not seen great reductions in bleeding events.

Data on more than 7000 men with hemophilia revealed substantial differences in the care received by men born before 1958 and those born between 1983

and 1992.

However, the data also showed that frequent bleeding was common in patients with severe hemophilia, regardless of when they were born.

These data were published in Blood.

“Our analysis provides a snapshot of how improvements in care have translated into outcomes across different generations of men with hemophilia,” said study author Paul E. Monahan, MD, of The University of North Carolina-Chapel Hill.

“While there is reason to be pleased with the progress we’ve made, our data show some surprising deficits and suggest that efforts are needed to more consistently apply the integration of standard-of-care multidisciplinary services and preventive blood clotting factor treatments to further normalize the lives of men living with hemophilia.”

Dr Monahan and his colleagues analyzed data on 7486 men—4899 with severe hemophilia (65.4%), 2587 with mild hemophilia (34.6%), 6094 with hemophilia A (81.4%), and 1392 with hemophilia B (18.6%).

The data were collected prospectively by the US Centers for Disease Control and Prevention and 130 federally supported Hemophilia Treatment Centers (HTCs) between 1998 and 2011. This represents the largest database of men living with hemophilia.

The researchers grouped the men into 4 eras (birth cohorts) to evaluate how outcomes—access to care, physical and social functioning, complications, and mortality—have changed over the last 50 years.

The cohorts were as follows:

• Era A: born before 1958 (median age 58)
• Era B: born between 1958 and 1975 (median age 40)
• Era C: born between 1976 and 1982 (median age 28)
• Era D: born between 1983 and 1992 (median age 21).

Access to care

The researchers found that the proportion of men who started home infusions before age 6 was far greater in Era D than Era A—50.4% and 2%, respectively. And the proportion of patients reporting a first HTC visit before age 2 rose nearly 10-fold from Era A to Era D—8.8% and 100%, respectively.

In addition, the use of a continuous prophylactic regimen was nearly 3-fold greater in Era D than Era A—46.7% and 16%, respectively.

However, patients in the youngest 2 birth cohorts were more likely than their older counterparts to be uninsured. The proportion of uninsured patients was 16.4% in Era D, 20.5% in Era C, 11.1% in Era B, and 5.7% in Era A.

Bleeding events

The proportion of patients reporting frequent bleeds decreased from Era A to Era D. However, frequent bleeding was common in men with severe hemophilia regardless of when they were born.

Even men from Era D—who had access to effective, safe clotting therapies and multidisciplinary care throughout their lifetimes—reported frequent bleeds.

The proportion of patients with severe hemophilia reporting 5 or more joint bleeds in the last 6 months was 42.6% in Era A and 35.5% in Era D. The proportion of patients with a joint affected by recurrent bleeding was 32.6% and 24.9%, respectively.

Functioning

The researchers also discovered that patients with severe hemophilia were 3 times as likely to report limitations in their activities or to be disabled, when compared to patients with mild hemophilia, regardless of when they were born.

Still, men from Era A were more likely to report limitations in their overall activity level—68.8% of severe hemophilia patients and 21.1% of mild hemophilia patients—than men from Era D—14.9% of severe hemophilia patients and 4.3% of mild hemophilia patients.

Men with severe hemophilia were more likely than men with mild hemophilia to report missing more than 10 days of work or school during the previous year. In Era A, the proportions were 6.9% and 2.6%, respectively. In Era D, the proportions were 5.6% and 3%, respectively.

“Clear disparities remain in terms of frequent bleeding and disability between men with severe hemophilia and mild hemophilia across every decade of adult life,” Dr Monahan said.

“We thought the difference in functional outcomes would have narrowed over the years. That is, men with severe hemophilia should look more like those with

mild disorder, given improved therapeutics and access to care, but this wasn’t the case.”

“What needs examination is why, despite widespread availability of preventive and on-demand therapies for home use, we still see disparities. It speaks to the need for continued disease surveillance to monitor and inform hemophilia interventions and outcomes.”

Mortality

There were 551 deaths during the study period. The Era A and B cohorts accounted for 82% of the deaths in the severe hemophilia population and 96% of the deaths in the mild hemophilia population.

The researchers noted that liver failure has surpassed bleeding issues and HIV as the leading cause of death among US men with hemophilia.

Although there were no liver-related deaths in the 2 youngest cohorts, liver failure was the most commonly reported cause of death across all the cohorts, for both severe hemophilia (33% of deaths) and mild hemophilia (26% of deaths).

The researchers said this finding underscores the need to swiftly evaluate and treat HCV infections.

“Liver disease worsens bleeding, so eradicating hepatitis C infections needs to be a priority, especially as we now have remarkably effective therapies,” Dr Monahan said.

Across all the birth cohorts, hemophilia-related deaths accounted for 14.6% of deaths in patients with severe hemophilia and 10.7% of deaths in those with mild hemophilia.

Antihemophilic factor

A large study suggests that, despite treatment advances, men with severe hemophilia have not seen great reductions in bleeding events.

Data on more than 7000 men with hemophilia revealed substantial differences in the care received by men born before 1958 and those born between 1983

and 1992.

However, the data also showed that frequent bleeding was common in patients with severe hemophilia, regardless of when they were born.

These data were published in Blood.

“Our analysis provides a snapshot of how improvements in care have translated into outcomes across different generations of men with hemophilia,” said study author Paul E. Monahan, MD, of The University of North Carolina-Chapel Hill.

“While there is reason to be pleased with the progress we’ve made, our data show some surprising deficits and suggest that efforts are needed to more consistently apply the integration of standard-of-care multidisciplinary services and preventive blood clotting factor treatments to further normalize the lives of men living with hemophilia.”

Dr Monahan and his colleagues analyzed data on 7486 men—4899 with severe hemophilia (65.4%), 2587 with mild hemophilia (34.6%), 6094 with hemophilia A (81.4%), and 1392 with hemophilia B (18.6%).

The data were collected prospectively by the US Centers for Disease Control and Prevention and 130 federally supported Hemophilia Treatment Centers (HTCs) between 1998 and 2011. This represents the largest database of men living with hemophilia.

The researchers grouped the men into 4 eras (birth cohorts) to evaluate how outcomes—access to care, physical and social functioning, complications, and mortality—have changed over the last 50 years.

The cohorts were as follows:

• Era A: born before 1958 (median age 58)
• Era B: born between 1958 and 1975 (median age 40)
• Era C: born between 1976 and 1982 (median age 28)
• Era D: born between 1983 and 1992 (median age 21).

Access to care

The researchers found that the proportion of men who started home infusions before age 6 was far greater in Era D than Era A—50.4% and 2%, respectively. And the proportion of patients reporting a first HTC visit before age 2 rose nearly 10-fold from Era A to Era D—8.8% and 100%, respectively.

In addition, the use of a continuous prophylactic regimen was nearly 3-fold greater in Era D than Era A—46.7% and 16%, respectively.

However, patients in the youngest 2 birth cohorts were more likely than their older counterparts to be uninsured. The proportion of uninsured patients was 16.4% in Era D, 20.5% in Era C, 11.1% in Era B, and 5.7% in Era A.

Bleeding events

The proportion of patients reporting frequent bleeds decreased from Era A to Era D. However, frequent bleeding was common in men with severe hemophilia regardless of when they were born.

Even men from Era D—who had access to effective, safe clotting therapies and multidisciplinary care throughout their lifetimes—reported frequent bleeds.

The proportion of patients with severe hemophilia reporting 5 or more joint bleeds in the last 6 months was 42.6% in Era A and 35.5% in Era D. The proportion of patients with a joint affected by recurrent bleeding was 32.6% and 24.9%, respectively.

Functioning

The researchers also discovered that patients with severe hemophilia were 3 times as likely to report limitations in their activities or to be disabled, when compared to patients with mild hemophilia, regardless of when they were born.

Still, men from Era A were more likely to report limitations in their overall activity level—68.8% of severe hemophilia patients and 21.1% of mild hemophilia patients—than men from Era D—14.9% of severe hemophilia patients and 4.3% of mild hemophilia patients.

Men with severe hemophilia were more likely than men with mild hemophilia to report missing more than 10 days of work or school during the previous year. In Era A, the proportions were 6.9% and 2.6%, respectively. In Era D, the proportions were 5.6% and 3%, respectively.

“Clear disparities remain in terms of frequent bleeding and disability between men with severe hemophilia and mild hemophilia across every decade of adult life,” Dr Monahan said.

“We thought the difference in functional outcomes would have narrowed over the years. That is, men with severe hemophilia should look more like those with

mild disorder, given improved therapeutics and access to care, but this wasn’t the case.”

“What needs examination is why, despite widespread availability of preventive and on-demand therapies for home use, we still see disparities. It speaks to the need for continued disease surveillance to monitor and inform hemophilia interventions and outcomes.”

Mortality

There were 551 deaths during the study period. The Era A and B cohorts accounted for 82% of the deaths in the severe hemophilia population and 96% of the deaths in the mild hemophilia population.

The researchers noted that liver failure has surpassed bleeding issues and HIV as the leading cause of death among US men with hemophilia.

Although there were no liver-related deaths in the 2 youngest cohorts, liver failure was the most commonly reported cause of death across all the cohorts, for both severe hemophilia (33% of deaths) and mild hemophilia (26% of deaths).

The researchers said this finding underscores the need to swiftly evaluate and treat HCV infections.

“Liver disease worsens bleeding, so eradicating hepatitis C infections needs to be a priority, especially as we now have remarkably effective therapies,” Dr Monahan said.

Across all the birth cohorts, hemophilia-related deaths accounted for 14.6% of deaths in patients with severe hemophilia and 10.7% of deaths in those with mild hemophilia.

Antihemophilic factor

A large study suggests that, despite treatment advances, men with severe hemophilia have not seen great reductions in bleeding events.

Data on more than 7000 men with hemophilia revealed substantial differences in the care received by men born before 1958 and those born between 1983

and 1992.

However, the data also showed that frequent bleeding was common in patients with severe hemophilia, regardless of when they were born.

These data were published in Blood.

“Our analysis provides a snapshot of how improvements in care have translated into outcomes across different generations of men with hemophilia,” said study author Paul E. Monahan, MD, of The University of North Carolina-Chapel Hill.

“While there is reason to be pleased with the progress we’ve made, our data show some surprising deficits and suggest that efforts are needed to more consistently apply the integration of standard-of-care multidisciplinary services and preventive blood clotting factor treatments to further normalize the lives of men living with hemophilia.”

Dr Monahan and his colleagues analyzed data on 7486 men—4899 with severe hemophilia (65.4%), 2587 with mild hemophilia (34.6%), 6094 with hemophilia A (81.4%), and 1392 with hemophilia B (18.6%).

The data were collected prospectively by the US Centers for Disease Control and Prevention and 130 federally supported Hemophilia Treatment Centers (HTCs) between 1998 and 2011. This represents the largest database of men living with hemophilia.

The researchers grouped the men into 4 eras (birth cohorts) to evaluate how outcomes—access to care, physical and social functioning, complications, and mortality—have changed over the last 50 years.

The cohorts were as follows:

• Era A: born before 1958 (median age 58)
• Era B: born between 1958 and 1975 (median age 40)
• Era C: born between 1976 and 1982 (median age 28)
• Era D: born between 1983 and 1992 (median age 21).

Access to care

The researchers found that the proportion of men who started home infusions before age 6 was far greater in Era D than Era A—50.4% and 2%, respectively. And the proportion of patients reporting a first HTC visit before age 2 rose nearly 10-fold from Era A to Era D—8.8% and 100%, respectively.

In addition, the use of a continuous prophylactic regimen was nearly 3-fold greater in Era D than Era A—46.7% and 16%, respectively.

However, patients in the youngest 2 birth cohorts were more likely than their older counterparts to be uninsured. The proportion of uninsured patients was 16.4% in Era D, 20.5% in Era C, 11.1% in Era B, and 5.7% in Era A.

Bleeding events

The proportion of patients reporting frequent bleeds decreased from Era A to Era D. However, frequent bleeding was common in men with severe hemophilia regardless of when they were born.

Even men from Era D—who had access to effective, safe clotting therapies and multidisciplinary care throughout their lifetimes—reported frequent bleeds.

The proportion of patients with severe hemophilia reporting 5 or more joint bleeds in the last 6 months was 42.6% in Era A and 35.5% in Era D. The proportion of patients with a joint affected by recurrent bleeding was 32.6% and 24.9%, respectively.

Functioning

The researchers also discovered that patients with severe hemophilia were 3 times as likely to report limitations in their activities or to be disabled, when compared to patients with mild hemophilia, regardless of when they were born.

Still, men from Era A were more likely to report limitations in their overall activity level—68.8% of severe hemophilia patients and 21.1% of mild hemophilia patients—than men from Era D—14.9% of severe hemophilia patients and 4.3% of mild hemophilia patients.

Men with severe hemophilia were more likely than men with mild hemophilia to report missing more than 10 days of work or school during the previous year. In Era A, the proportions were 6.9% and 2.6%, respectively. In Era D, the proportions were 5.6% and 3%, respectively.

“Clear disparities remain in terms of frequent bleeding and disability between men with severe hemophilia and mild hemophilia across every decade of adult life,” Dr Monahan said.

“We thought the difference in functional outcomes would have narrowed over the years. That is, men with severe hemophilia should look more like those with

mild disorder, given improved therapeutics and access to care, but this wasn’t the case.”

“What needs examination is why, despite widespread availability of preventive and on-demand therapies for home use, we still see disparities. It speaks to the need for continued disease surveillance to monitor and inform hemophilia interventions and outcomes.”

Mortality

There were 551 deaths during the study period. The Era A and B cohorts accounted for 82% of the deaths in the severe hemophilia population and 96% of the deaths in the mild hemophilia population.

The researchers noted that liver failure has surpassed bleeding issues and HIV as the leading cause of death among US men with hemophilia.

Although there were no liver-related deaths in the 2 youngest cohorts, liver failure was the most commonly reported cause of death across all the cohorts, for both severe hemophilia (33% of deaths) and mild hemophilia (26% of deaths).

The researchers said this finding underscores the need to swiftly evaluate and treat HCV infections.

“Liver disease worsens bleeding, so eradicating hepatitis C infections needs to be a priority, especially as we now have remarkably effective therapies,” Dr Monahan said.

Across all the birth cohorts, hemophilia-related deaths accounted for 14.6% of deaths in patients with severe hemophilia and 10.7% of deaths in those with mild hemophilia.

Cancer patient

receiving treatment

Photo by Rhoda Baer

An analysis of nearly 20 million cancer survivors showed that almost 29% had financial burdens as a result of their cancer diagnosis and/or treatment.

In other words, they borrowed money, declared bankruptcy, worried about paying large medical bills, were unable to cover the cost of medical visits, or made other financial sacrifices.

Furthermore, such hardships could have lasting effects on a cancer survivor’s quality of life (QOL).

Hrishikesh Kale and Norman Carroll, PhD, both of Virginia Commonwealth University School of Pharmacy in Richmond, reported these findings in Cancer.

The pair analyzed 2011 Medical Expenditure Panel Survey data on 19.6 million cancer survivors, assessing financial burden and QOL.

Subjects were considered to have financial burden if they reported 1 of the following problems: borrowed money/declared bankruptcy, worried about paying large medical bills, unable to cover the cost of medical care visits, or other financial sacrifices.

Nearly 29% of the cancer survivors reported at least 1 financial problem resulting from cancer diagnosis, treatment, or lasting effects of that treatment.

Of all the cancer survivors in the analysis, 20.9% worried about paying large medical bills, 11.5% were unable to cover the cost of medical care visits, 7.6% reported borrowing money or going into debt, 1.4% declared bankruptcy, and 8.6% reported other financial sacrifices.

Cancer survivors who faced such financial difficulties had lower physical and mental health-related QOL, higher risk for depressed mood and psychological distress, and were more likely to worry about cancer recurrence, when compared with cancer survivors who did not face financial problems.

In addition, as the number of financial problems reported by cancer survivors increased, their QOL continued to decrease. And their risk for depressed mood, psychological distress, and worries about cancer recurrence continued to increase.

“Our results suggest that policies and practices that minimize cancer patients’ out-of-pocket costs can improve survivors’ health-related quality of life and psychological health,” Dr Carroll said.

“Reducing the financial burden of cancer care requires integrated efforts, and the study findings are useful for survivorship care programs, oncologists, payers, pharmaceutical companies, and patients and their family members.”

Cancer patient

receiving treatment

Photo by Rhoda Baer

An analysis of nearly 20 million cancer survivors showed that almost 29% had financial burdens as a result of their cancer diagnosis and/or treatment.

In other words, they borrowed money, declared bankruptcy, worried about paying large medical bills, were unable to cover the cost of medical visits, or made other financial sacrifices.

Furthermore, such hardships could have lasting effects on a cancer survivor’s quality of life (QOL).

Hrishikesh Kale and Norman Carroll, PhD, both of Virginia Commonwealth University School of Pharmacy in Richmond, reported these findings in Cancer.

The pair analyzed 2011 Medical Expenditure Panel Survey data on 19.6 million cancer survivors, assessing financial burden and QOL.

Subjects were considered to have financial burden if they reported 1 of the following problems: borrowed money/declared bankruptcy, worried about paying large medical bills, unable to cover the cost of medical care visits, or other financial sacrifices.

Nearly 29% of the cancer survivors reported at least 1 financial problem resulting from cancer diagnosis, treatment, or lasting effects of that treatment.

Of all the cancer survivors in the analysis, 20.9% worried about paying large medical bills, 11.5% were unable to cover the cost of medical care visits, 7.6% reported borrowing money or going into debt, 1.4% declared bankruptcy, and 8.6% reported other financial sacrifices.

Cancer survivors who faced such financial difficulties had lower physical and mental health-related QOL, higher risk for depressed mood and psychological distress, and were more likely to worry about cancer recurrence, when compared with cancer survivors who did not face financial problems.

In addition, as the number of financial problems reported by cancer survivors increased, their QOL continued to decrease. And their risk for depressed mood, psychological distress, and worries about cancer recurrence continued to increase.

“Our results suggest that policies and practices that minimize cancer patients’ out-of-pocket costs can improve survivors’ health-related quality of life and psychological health,” Dr Carroll said.

“Reducing the financial burden of cancer care requires integrated efforts, and the study findings are useful for survivorship care programs, oncologists, payers, pharmaceutical companies, and patients and their family members.”

Cancer patient

receiving treatment

Photo by Rhoda Baer

An analysis of nearly 20 million cancer survivors showed that almost 29% had financial burdens as a result of their cancer diagnosis and/or treatment.

In other words, they borrowed money, declared bankruptcy, worried about paying large medical bills, were unable to cover the cost of medical visits, or made other financial sacrifices.

Furthermore, such hardships could have lasting effects on a cancer survivor’s quality of life (QOL).

Hrishikesh Kale and Norman Carroll, PhD, both of Virginia Commonwealth University School of Pharmacy in Richmond, reported these findings in Cancer.

The pair analyzed 2011 Medical Expenditure Panel Survey data on 19.6 million cancer survivors, assessing financial burden and QOL.

Subjects were considered to have financial burden if they reported 1 of the following problems: borrowed money/declared bankruptcy, worried about paying large medical bills, unable to cover the cost of medical care visits, or other financial sacrifices.

Nearly 29% of the cancer survivors reported at least 1 financial problem resulting from cancer diagnosis, treatment, or lasting effects of that treatment.

Of all the cancer survivors in the analysis, 20.9% worried about paying large medical bills, 11.5% were unable to cover the cost of medical care visits, 7.6% reported borrowing money or going into debt, 1.4% declared bankruptcy, and 8.6% reported other financial sacrifices.

Cancer survivors who faced such financial difficulties had lower physical and mental health-related QOL, higher risk for depressed mood and psychological distress, and were more likely to worry about cancer recurrence, when compared with cancer survivors who did not face financial problems.

In addition, as the number of financial problems reported by cancer survivors increased, their QOL continued to decrease. And their risk for depressed mood, psychological distress, and worries about cancer recurrence continued to increase.

“Our results suggest that policies and practices that minimize cancer patients’ out-of-pocket costs can improve survivors’ health-related quality of life and psychological health,” Dr Carroll said.

“Reducing the financial burden of cancer care requires integrated efforts, and the study findings are useful for survivorship care programs, oncologists, payers, pharmaceutical companies, and patients and their family members.”