Whitney McKnight

ORLANDO– Independent investigators eager to author studies that have notable impact on the field of inflammatory bowel disease have plenty of important paths to pursue, according to Dr. Jean-Frederic Colombel, a professor of gastroenterology at Mt. Sinai Hospital in New York.

“Over the next 3-5 years, we will have a lot of new drugs, which is nice, but we don’t yet know how to use them, or which ones to use,” Dr. Colombel said during a presentation on the future of the field at this year’s meeting of the annual Advances in Inflammatory Bowel Disease, sponsored by the Crohn’s and Colitis Foundation of America and endorsed by the American Gastroenterological Association.

Whitney McKnight/Frontline Medical Media

A host of biologics including vedolizumab, recently indicated by the U.S. Food and Drug Administration for ulcerative colitis and Crohn’s disease, and ustekinumab, currently in phase III studies for Crohn’s disease, are set to revolutionize treatment at a time when the field is already undergoing great change, according to Dr. Colombel. The result, he says, is that despite “formidable” challenges in recruitment and funding, “huge opportunities” exist for investigators willing to collaborate and be creative.

Studies that elucidate the natural history of Crohn’s disease and colitis offer insight into the efficacy of various treatment strategies, help determine whether to target symptoms or biomarkers, and answer whether combination therapies are safe and effective in certain patients are what Dr. Colombel says he hopes will help improve the field as the drug pipeline continues to grow.

He stipulated a caveat, however, “I strongly believe we need some new study designs.” Although he noted that trials needn’t be complicated, they should be long enough to collect sorely needed prospective data. “These can only be done in investigator-initiated trials because of the time frames,” Dr. Colombel urged the audience of young investigators.

A fieldwide shift in thinking about ulcerative colitis and Crohn’s disease as chronic, progressive diseases, rather than intermittent afflictions has already helped generate new study endpoints such as the Lémann Score, an index of progressive bowel damage that allows researchers to better track the history of IBD in patients, and thus provide a window of opportunity for interventions, said Dr. Colombel.

To wit, the CURE study, conducted by the French IBD society GITAID, is a 5-year, prospective study of patients whose early Crohn’s disease is treated with the biologic adalimumab. The Lémann Score is used to screen patients at the end of each successive year, in order to adjust their treatment to reach the final endpoint of deep remission by year 5 when several indicators are measured, including bowel image, level of disability, and whether there was the need for surgery. Dr. Colombel said the novel design of the study, which has already recruited 60 patients, shows it is “feasible” to collect longitudinal data.

The field also has a responsibility to conduct randomly assigned controlled trials to demonstrate the comparative effectiveness, safety, immunogenicity, and cost benefits of the rapidly emerging spate of biosimilars, particularly since there is not global agreement about their use, according to Dr. Colombel. Their approval for IBD in Europe is “highly disputable.... I think this could be a very nice topic for an investigator-initiated trial, in Canada and the U.S.”

Head-to-head trials that are well designed will help answer “very important questions” about which treatment strategies have the best outcomes, but doing so requires fortitude, according to Dr. Colombel. “The Dutch have the guts to conduct the LIRIC trial,” he said. In it, patients with Crohn’s disease in the terminal ileum, who have failed steroids or immune therapy, will be assigned randomly to either laparoscopic ileocolic resection or infliximab, the first available biosimilar. Sixty participants have enrolled to date, he said.

These types of studies could also help delineate how best to employ combination therapies. “What I propose for this kind of study is an intensive therapy combining biologics very early in patients with bad prognoses, and looking at the long-term outcome using bowel image,” Dr. Colombel said. These data, and others indicating the most appropriate length of treatment in patients with varying states of disease, are Dr. Colombel’s personal “top choice” for investigation. The excitement that personalized medicine has engendered across the specialities has so far not resulted in specific, validated treatments for IBD patients. However, the question of how to use personal characteristics and serologic and genetic markers to create predictive models for which patients will need either step-up or top-down therapies, accounting for their individual risk of complication, is what he said is among the most “important [question] we need to answer because the choice of early therapy will depend on this predictor,” according to Dr. Colombel.

The question of which treatment targets are best remains unclear but is important to decipher, according to Dr. Colombel, who said simple studies comparing outcomes when patients are treated to symptoms vs. treated to biomarker measurements are needed, as well as the importance of mucosal healing vs. symptom improvement. “This is important because there is discordance between endoscopy and histology,” said Dr. Colombel. “Persistent histologic inflammation is frequently associated with bad outcomes.”

However, endoscopic scoring itself is another area Dr. Colombel said is worth investigating, especially when it comes to validating endpoints such as those in the Crohn’s Disease Index of Severity (CDEIS), and Simple Endoscopic Score for Crohn’s Disease (SES-CD), which will help determine remission cutoffs. Also, endoscopic scoring in comparison with live video and imaging still need standardized approaches. “When you see how it is done in the U.S., it is generally very poor,” Dr. Colombel said.

The biggest obstacles of all when it comes to independent investigation in the United States, according to Frenchman Dr. Colombel, is heavy regulation and cost. “In France, [conducting trials] was considered part of my job. I was not compensated. It is different here.”

Dr. Colombel has numerous financial ties to the pharmaceutical industry, including AB Science, Amgen, Baxter, Bristol-Meyers Squibb, and Merck, among several others.

[email protected]


On Twitter @whitneymcknight

ORLANDO– Independent investigators eager to author studies that have notable impact on the field of inflammatory bowel disease have plenty of important paths to pursue, according to Dr. Jean-Frederic Colombel, a professor of gastroenterology at Mt. Sinai Hospital in New York.

“Over the next 3-5 years, we will have a lot of new drugs, which is nice, but we don’t yet know how to use them, or which ones to use,” Dr. Colombel said during a presentation on the future of the field at this year’s meeting of the annual Advances in Inflammatory Bowel Disease, sponsored by the Crohn’s and Colitis Foundation of America and endorsed by the American Gastroenterological Association.

Whitney McKnight/Frontline Medical Media

A host of biologics including vedolizumab, recently indicated by the U.S. Food and Drug Administration for ulcerative colitis and Crohn’s disease, and ustekinumab, currently in phase III studies for Crohn’s disease, are set to revolutionize treatment at a time when the field is already undergoing great change, according to Dr. Colombel. The result, he says, is that despite “formidable” challenges in recruitment and funding, “huge opportunities” exist for investigators willing to collaborate and be creative.

Studies that elucidate the natural history of Crohn’s disease and colitis offer insight into the efficacy of various treatment strategies, help determine whether to target symptoms or biomarkers, and answer whether combination therapies are safe and effective in certain patients are what Dr. Colombel says he hopes will help improve the field as the drug pipeline continues to grow.

He stipulated a caveat, however, “I strongly believe we need some new study designs.” Although he noted that trials needn’t be complicated, they should be long enough to collect sorely needed prospective data. “These can only be done in investigator-initiated trials because of the time frames,” Dr. Colombel urged the audience of young investigators.

A fieldwide shift in thinking about ulcerative colitis and Crohn’s disease as chronic, progressive diseases, rather than intermittent afflictions has already helped generate new study endpoints such as the Lémann Score, an index of progressive bowel damage that allows researchers to better track the history of IBD in patients, and thus provide a window of opportunity for interventions, said Dr. Colombel.

To wit, the CURE study, conducted by the French IBD society GITAID, is a 5-year, prospective study of patients whose early Crohn’s disease is treated with the biologic adalimumab. The Lémann Score is used to screen patients at the end of each successive year, in order to adjust their treatment to reach the final endpoint of deep remission by year 5 when several indicators are measured, including bowel image, level of disability, and whether there was the need for surgery. Dr. Colombel said the novel design of the study, which has already recruited 60 patients, shows it is “feasible” to collect longitudinal data.

The field also has a responsibility to conduct randomly assigned controlled trials to demonstrate the comparative effectiveness, safety, immunogenicity, and cost benefits of the rapidly emerging spate of biosimilars, particularly since there is not global agreement about their use, according to Dr. Colombel. Their approval for IBD in Europe is “highly disputable.... I think this could be a very nice topic for an investigator-initiated trial, in Canada and the U.S.”

Head-to-head trials that are well designed will help answer “very important questions” about which treatment strategies have the best outcomes, but doing so requires fortitude, according to Dr. Colombel. “The Dutch have the guts to conduct the LIRIC trial,” he said. In it, patients with Crohn’s disease in the terminal ileum, who have failed steroids or immune therapy, will be assigned randomly to either laparoscopic ileocolic resection or infliximab, the first available biosimilar. Sixty participants have enrolled to date, he said.

These types of studies could also help delineate how best to employ combination therapies. “What I propose for this kind of study is an intensive therapy combining biologics very early in patients with bad prognoses, and looking at the long-term outcome using bowel image,” Dr. Colombel said. These data, and others indicating the most appropriate length of treatment in patients with varying states of disease, are Dr. Colombel’s personal “top choice” for investigation. The excitement that personalized medicine has engendered across the specialities has so far not resulted in specific, validated treatments for IBD patients. However, the question of how to use personal characteristics and serologic and genetic markers to create predictive models for which patients will need either step-up or top-down therapies, accounting for their individual risk of complication, is what he said is among the most “important [question] we need to answer because the choice of early therapy will depend on this predictor,” according to Dr. Colombel.

The question of which treatment targets are best remains unclear but is important to decipher, according to Dr. Colombel, who said simple studies comparing outcomes when patients are treated to symptoms vs. treated to biomarker measurements are needed, as well as the importance of mucosal healing vs. symptom improvement. “This is important because there is discordance between endoscopy and histology,” said Dr. Colombel. “Persistent histologic inflammation is frequently associated with bad outcomes.”

However, endoscopic scoring itself is another area Dr. Colombel said is worth investigating, especially when it comes to validating endpoints such as those in the Crohn’s Disease Index of Severity (CDEIS), and Simple Endoscopic Score for Crohn’s Disease (SES-CD), which will help determine remission cutoffs. Also, endoscopic scoring in comparison with live video and imaging still need standardized approaches. “When you see how it is done in the U.S., it is generally very poor,” Dr. Colombel said.

The biggest obstacles of all when it comes to independent investigation in the United States, according to Frenchman Dr. Colombel, is heavy regulation and cost. “In France, [conducting trials] was considered part of my job. I was not compensated. It is different here.”

Dr. Colombel has numerous financial ties to the pharmaceutical industry, including AB Science, Amgen, Baxter, Bristol-Meyers Squibb, and Merck, among several others.

[email protected]


On Twitter @whitneymcknight

ORLANDO– Independent investigators eager to author studies that have notable impact on the field of inflammatory bowel disease have plenty of important paths to pursue, according to Dr. Jean-Frederic Colombel, a professor of gastroenterology at Mt. Sinai Hospital in New York.

“Over the next 3-5 years, we will have a lot of new drugs, which is nice, but we don’t yet know how to use them, or which ones to use,” Dr. Colombel said during a presentation on the future of the field at this year’s meeting of the annual Advances in Inflammatory Bowel Disease, sponsored by the Crohn’s and Colitis Foundation of America and endorsed by the American Gastroenterological Association.

Whitney McKnight/Frontline Medical Media

A host of biologics including vedolizumab, recently indicated by the U.S. Food and Drug Administration for ulcerative colitis and Crohn’s disease, and ustekinumab, currently in phase III studies for Crohn’s disease, are set to revolutionize treatment at a time when the field is already undergoing great change, according to Dr. Colombel. The result, he says, is that despite “formidable” challenges in recruitment and funding, “huge opportunities” exist for investigators willing to collaborate and be creative.

Studies that elucidate the natural history of Crohn’s disease and colitis offer insight into the efficacy of various treatment strategies, help determine whether to target symptoms or biomarkers, and answer whether combination therapies are safe and effective in certain patients are what Dr. Colombel says he hopes will help improve the field as the drug pipeline continues to grow.

He stipulated a caveat, however, “I strongly believe we need some new study designs.” Although he noted that trials needn’t be complicated, they should be long enough to collect sorely needed prospective data. “These can only be done in investigator-initiated trials because of the time frames,” Dr. Colombel urged the audience of young investigators.

A fieldwide shift in thinking about ulcerative colitis and Crohn’s disease as chronic, progressive diseases, rather than intermittent afflictions has already helped generate new study endpoints such as the Lémann Score, an index of progressive bowel damage that allows researchers to better track the history of IBD in patients, and thus provide a window of opportunity for interventions, said Dr. Colombel.

To wit, the CURE study, conducted by the French IBD society GITAID, is a 5-year, prospective study of patients whose early Crohn’s disease is treated with the biologic adalimumab. The Lémann Score is used to screen patients at the end of each successive year, in order to adjust their treatment to reach the final endpoint of deep remission by year 5 when several indicators are measured, including bowel image, level of disability, and whether there was the need for surgery. Dr. Colombel said the novel design of the study, which has already recruited 60 patients, shows it is “feasible” to collect longitudinal data.

The field also has a responsibility to conduct randomly assigned controlled trials to demonstrate the comparative effectiveness, safety, immunogenicity, and cost benefits of the rapidly emerging spate of biosimilars, particularly since there is not global agreement about their use, according to Dr. Colombel. Their approval for IBD in Europe is “highly disputable.... I think this could be a very nice topic for an investigator-initiated trial, in Canada and the U.S.”

Head-to-head trials that are well designed will help answer “very important questions” about which treatment strategies have the best outcomes, but doing so requires fortitude, according to Dr. Colombel. “The Dutch have the guts to conduct the LIRIC trial,” he said. In it, patients with Crohn’s disease in the terminal ileum, who have failed steroids or immune therapy, will be assigned randomly to either laparoscopic ileocolic resection or infliximab, the first available biosimilar. Sixty participants have enrolled to date, he said.

These types of studies could also help delineate how best to employ combination therapies. “What I propose for this kind of study is an intensive therapy combining biologics very early in patients with bad prognoses, and looking at the long-term outcome using bowel image,” Dr. Colombel said. These data, and others indicating the most appropriate length of treatment in patients with varying states of disease, are Dr. Colombel’s personal “top choice” for investigation. The excitement that personalized medicine has engendered across the specialities has so far not resulted in specific, validated treatments for IBD patients. However, the question of how to use personal characteristics and serologic and genetic markers to create predictive models for which patients will need either step-up or top-down therapies, accounting for their individual risk of complication, is what he said is among the most “important [question] we need to answer because the choice of early therapy will depend on this predictor,” according to Dr. Colombel.

The question of which treatment targets are best remains unclear but is important to decipher, according to Dr. Colombel, who said simple studies comparing outcomes when patients are treated to symptoms vs. treated to biomarker measurements are needed, as well as the importance of mucosal healing vs. symptom improvement. “This is important because there is discordance between endoscopy and histology,” said Dr. Colombel. “Persistent histologic inflammation is frequently associated with bad outcomes.”

However, endoscopic scoring itself is another area Dr. Colombel said is worth investigating, especially when it comes to validating endpoints such as those in the Crohn’s Disease Index of Severity (CDEIS), and Simple Endoscopic Score for Crohn’s Disease (SES-CD), which will help determine remission cutoffs. Also, endoscopic scoring in comparison with live video and imaging still need standardized approaches. “When you see how it is done in the U.S., it is generally very poor,” Dr. Colombel said.

The biggest obstacles of all when it comes to independent investigation in the United States, according to Frenchman Dr. Colombel, is heavy regulation and cost. “In France, [conducting trials] was considered part of my job. I was not compensated. It is different here.”

Dr. Colombel has numerous financial ties to the pharmaceutical industry, including AB Science, Amgen, Baxter, Bristol-Meyers Squibb, and Merck, among several others.

[email protected]


On Twitter @whitneymcknight

In just 1 year, 34 out of about 5,000 patients seen at the inflammatory bowel disease center at the University of Pittsburgh Medical Center cost more than $10 million to treat.

“Our health plan said, ‘You have to fix this,’” recalled Dr. Miguel Regueiro, codirector of the IBD center.

So, in addition to asking the insurer for ideas, Dr. Regueiro did the most cost conscious thing he could think of: He asked for ideas from his colleague, Dr. Eva Szigethy, a psychiatrist specializing in the treatment of pain and psychosocial issues faced by IBD patients.

“Nearly half of our patient population has some behavioral, stress, or mental health component that is driving their disease, [leading] to high health care utilization,” Dr. Regueiro said.

Dr. Szigethy’s work of late, both on her own and with others such as Dr. Douglas Drossman, an emeritus psychiatrist and gastroenterologist at the University of North Carolina at Chapel Hill, has focused on the so-called brain-gut axis and includes the impact of narcotics on the gastrointestinal tract, the correlation between inflammation and depression, the effectiveness of cognitive-behavioral therapy in IBD, and the use of self-hypnosis to manage chronic pain.

“The vast majority of IBD patients have mood disorders, depression, reactive adjustment disorder, anxiety both [before and after] their diagnosis, and chronic pain,” Dr. Szigethy said in an interview.

In practical terms, this means patients benefit from the partnership between Dr. Regueiro, who brings a deep medical knowledge of IBD, and Dr. Szigethy, who combines her research with her psychiatric skill for asking the kinds of questions that evoke the patient’s larger story. Together, said Dr. Szigethy, they assess patients as a whole, directly accounting for the emotional complexity inherent in IBD, with an eye toward helping patients regain control of their lives, often made chaotic by the unpredictable indignities that are the hallmarks of the disease.

“Often, if we listen in the lines and between the lines, our patients tell us exactly what other factors are involved: why their disease is not getting better, why they are getting headaches, why they have such continued suffering,” Dr. Szigethy said.

“You don’t need to know the basic science to understand the stress these patients feel,” Dr. Regueiro recounted to an audience at a recent Advances in IBD meeting in Orlando, sponsored by the Crohn’s and Colitis Foundation of America.

He shared with his audience the story of 45-year-old Anne, a Crohn’s disease sufferer treated at his center. Anne is not the patient’s real name. Despite her disease being inactive, Anne was hospitalized 23 times, and given 19 CT scans and seven endoscopic procedures in one calendar year alone, qualifying her as one of the center’s top 34 “health care frequent fliers.”

Empowering patients like Anne, whose costly care Dr. Szigethy and Dr. Regueiro recognized was attributable more to her psychosocial rather than medical IBD needs, not only improves their quality of life, it saves the system money.

This is why the same health plan representatives who told Dr. Regueiro they’d like to see cost reductions have partnered with him and Dr. Szigethy to develop a specialty care medical home pilot program that combines specialty, primary, and mental health care in one location. The program officially opened in mid-January of this year.

In the mid-1990s, the UPMC Health Plan was conceived by the medical center as a “strategic move to combine the intellectual capital of the provider system with that of the payer system,” according to Sandy McAnallen, UPMC Health Plan’s senior vice president for clinical affairs and quality performance.

The result, she said in an interview, is greater flexibility when it comes to what care is provided and how it is delivered. “The physicians are setting the evidence-based pathways on the kind of care that patients need to receive, and we have the ability to be very proactive with [how we pay for that] with this kind of relationship.”

Over the course of 2 years, Dr. Regueiro and Ms. McAnallen met several times to parse data on more effective ways to address the fractured way IBD patients, particularly those with undiagnosed psychosocial concerns, were seeking and receiving treatment. The pair also honed in on ways to cut the high cost of surgeries and pharmaceuticals with the overall goal being to create a healthier IBD patient population who perceived their care to be the best possible.

To develop their specialty medical home model, Dr. Regueiro, Dr. Szigethy, Ms. McAnallen, and other key UPMC hospital system and health plan administrators, as well as other IBD specialists, met many times over the course of 2 years to plan what Ms. McAnallen calls their proof of concept.

The program is offered automatically to those covered by the UPMC Health Plan, although anyone is welcome to opt out if they choose. Participants are asked, but not required, to submit to genetic sampling for IBD research purposes, and other data also are gathered with consent at the center. Those not covered by UPMC insurance also are welcome to participate. “The center is payer-agnostic,” Ms. McAnallen said.

Dr. Regueiro and his colleagues will be the primary doctors for all patients who want to be seen at the IBD center for their chronic condition, while episodic illnesses such as colds, flus, and rashes are treated by a newly added advance practice nurse. All patients are now offered behavioral and psychosocial support, depending on the concern, either from Dr. Szigethy, a psychologist, or a social worker who was added to the team for the pilot project.

“Part of what we are defining [with this project] is when a psychiatrist is needed, and what can be done by a less expensive, but well-trained behavioral health, medically trained person like a social worker,” said Dr. Szigethy, who is also a member of the department of psychiatry.

A new patient peer group offers patients the chance to discuss their IBD-related struggles with others who can empathize directly, and a nutritionist and pharmacist both specializing in IBD needs have been added to the payroll. A 24/7 call center also has been established.

“We want patients to be in the habit of calling one place where their entire history is known,” said Ms. McAnallen. “Whether they need primary care or specialty care, we want these patients to go to the specialty medical home.”

It’s a patient-centered, rather than an institution-based model, where the referrals are controlled by the payer, “but the system is value based not volume based,” said Dr. Regueiro.

To that end, Dr. Regueiro said he hopes the center will expand its use of telemedicine to further accommodate patients, who often find it difficult to take time off from work or school, find and afford child care, and travel long distances to their doctor appointments. “Right now, some patients have to drive hours to see us, but a lot of what we do for these patients is cognitive care,” he said.

The IBD center’s additional personnel have been paid for by the health plan, in order to cover the cost of adequately serving the approximately 725 IBD patients the insurer determined were the most expensive to treat out of the more than 5,000 IBD patients, a notably high number according to Dr. Szigethy, that the center serves.

In exchange for underwriting the cost of a portion of the staff, the health plan expects Dr. Regueiro and his team to cut treatment costs for this cohort. “If we save a certain amount on patients each year, the health plan will give that back to us,” Dr. Regueiro said.

One way Ms. McAnallen said the program is projected to save is by reducing the number of times frequent fliers of UPMC’s emergency department arrive with an IBD complaint.

“The ED specializes in all acute medical issues, but for IBD we need to focus in a different way,” said Ms. McAnallen.

To wit, in her health care high-utilization heyday, Anne’s treatment typically began in the emergency department, where she arrived seeking narcotics for her condition.

“She said she hated that the people in the ED treated her like a drug addict, but she hated the pain even more,” Dr. Regueiro told his Orlando audience.

This was particularly troublesome for Anne, since Dr. Szigethy determined she was a potential sufferer of narcotic bowel syndrome.

Although at present, much of the research into this phenomenon is still bench science, Dr. Szigethy said a growing body of evidence provided in part by advanced neuroimaging techniques indicates that chronic narcotic use changes opioid receptors in some human adults from creating an analgesic effect, to a hyperanalgesic one instead, where the narcotics themselves start to create pain and exacerbate any existing bowel issues.

“In Anne’s case, she was going up and up in her opiates, but her pain was getting worse,” Dr. Szigethy said.

Dr. Szigethy obtained permission from Anne’s insurer, which happened to be UPMC Health Plan, to give her a 5-day inpatient medical hospitalization during which time Anne was weaned from her narcotics. For 6 months prior to her detoxification from the opiates, Anne learned self-hypnosis techniques from Dr. Szigethy and her colleagues, which she used to support her withdrawal from the pain medication. Anne’s self-reported favorite technique was that whenever the pain would start, she would visualize filling a balloon with it, and then letting the balloon drift away until it eventually evaporated into the air.

“I know it sounds corny, but guess what? Last year, Anne had zero hospitalizations,” Dr. Regueiro said.

According to Dr. Szigethy, Anne still has occasional pain, “But she can deal with it.”The exact savings UPMC Health Plan expects to realize by way of reimbursing the IBD center for treatment models created in response to emerging research such as that of Dr. Szigethy is still unknown. But Ms. McAnallen is optimistic the program will meet its broader targets.

“We are at a point where costs are becoming out of control and the consumer can’t afford health care. You have to be in a position where you can rely on your physicians to develop evidence-based pathways for treatment of acute and chronic disease, which Eva and Miguel are doing, and to do be able to do so in a laboratory where you have the premium to support that,” Ms. McAnallen said, adding that had Dr. Regueiro approached an outside payer to help him create the medical home model, she doubted it would have come to fruition.

“Because we’re part of an integrated system, we’re all aligned with the same goals, which include improving the health status of our community and decreasing the cost of care so it’s affordable.”

Analysis of data collected on total cost and quality of care, and patient perception of care, will begin within the next 6 months, said Ms. McAnallen, who did not offer specific margins but noted that if gains are made, UPMC would look at how to apply this integrated approach to treating other chronic diseases such as rheumatoid arthritis and multiple sclerosis.

One central question the pilot program is expected to answer is whether it is feasible to do away with fee-for-service provider reimbursements, which Ms. McAnallen said are, in her opinion, at the crux of the current national health care crisis.

“You go to your physician, they do something, they submit a claim, they get a check. We haven’t put in a system that makes providers, whether hospitals or physicians, step back and say, ‘Let’s do this differently. I’m on a treadmill of fee for service. The more I produce, the more I get paid.’ This IBD pilot program is to really help us transform that payment structure.”

Intangible factors such as how much of a specialty medical home’s success is predicated on the verve of its leadership will also be evaluated. “If you don’t have a physician who will be the [medical home’s] champion, it will be very hard to replicate,” Ms. McAnallen said. Attracting ambitious specialists with the opportunity to create such an integrated care model could become a recruitment tool for UPMC, she added.

If the concept of a one-stop-doc-shop sounds slightly “what was old is new again,” harkening back to the days when physicians were called doctors, never “providers,” and largely were thought of as family friends who made house calls, said Dr. Szigethy, it’s because it is that model, amplified by modern means.

“We can’t go to patients’ homes because they’re even more widespread than they were back in the day of the village, but what we can do is provide care through the ancillary team members who are extraordinarily well trained, and can provide education on nutrition and medication. Whether it’s by telemedicine or face to face, patients are getting treated in an integrated way, and we’re doing it as efficaciously as possible. That is brand new.”

Dr. Regueiro said in an interview at least one other insurance company has expressed interest in learning more about the IBD center’s integrated approach, causing him to reassess the payer’s role in health care’s revolution. “There is more common ground between us than I once thought. Insurers are not the devil. They are central to improving value.”

[email protected]

On Twitter @whitneymcknight

In just 1 year, 34 out of about 5,000 patients seen at the inflammatory bowel disease center at the University of Pittsburgh Medical Center cost more than $10 million to treat.

“Our health plan said, ‘You have to fix this,’” recalled Dr. Miguel Regueiro, codirector of the IBD center.

So, in addition to asking the insurer for ideas, Dr. Regueiro did the most cost conscious thing he could think of: He asked for ideas from his colleague, Dr. Eva Szigethy, a psychiatrist specializing in the treatment of pain and psychosocial issues faced by IBD patients.

“Nearly half of our patient population has some behavioral, stress, or mental health component that is driving their disease, [leading] to high health care utilization,” Dr. Regueiro said.

Dr. Szigethy’s work of late, both on her own and with others such as Dr. Douglas Drossman, an emeritus psychiatrist and gastroenterologist at the University of North Carolina at Chapel Hill, has focused on the so-called brain-gut axis and includes the impact of narcotics on the gastrointestinal tract, the correlation between inflammation and depression, the effectiveness of cognitive-behavioral therapy in IBD, and the use of self-hypnosis to manage chronic pain.

“The vast majority of IBD patients have mood disorders, depression, reactive adjustment disorder, anxiety both [before and after] their diagnosis, and chronic pain,” Dr. Szigethy said in an interview.

In practical terms, this means patients benefit from the partnership between Dr. Regueiro, who brings a deep medical knowledge of IBD, and Dr. Szigethy, who combines her research with her psychiatric skill for asking the kinds of questions that evoke the patient’s larger story. Together, said Dr. Szigethy, they assess patients as a whole, directly accounting for the emotional complexity inherent in IBD, with an eye toward helping patients regain control of their lives, often made chaotic by the unpredictable indignities that are the hallmarks of the disease.

“Often, if we listen in the lines and between the lines, our patients tell us exactly what other factors are involved: why their disease is not getting better, why they are getting headaches, why they have such continued suffering,” Dr. Szigethy said.

“You don’t need to know the basic science to understand the stress these patients feel,” Dr. Regueiro recounted to an audience at a recent Advances in IBD meeting in Orlando, sponsored by the Crohn’s and Colitis Foundation of America.

He shared with his audience the story of 45-year-old Anne, a Crohn’s disease sufferer treated at his center. Anne is not the patient’s real name. Despite her disease being inactive, Anne was hospitalized 23 times, and given 19 CT scans and seven endoscopic procedures in one calendar year alone, qualifying her as one of the center’s top 34 “health care frequent fliers.”

Empowering patients like Anne, whose costly care Dr. Szigethy and Dr. Regueiro recognized was attributable more to her psychosocial rather than medical IBD needs, not only improves their quality of life, it saves the system money.

This is why the same health plan representatives who told Dr. Regueiro they’d like to see cost reductions have partnered with him and Dr. Szigethy to develop a specialty care medical home pilot program that combines specialty, primary, and mental health care in one location. The program officially opened in mid-January of this year.

In the mid-1990s, the UPMC Health Plan was conceived by the medical center as a “strategic move to combine the intellectual capital of the provider system with that of the payer system,” according to Sandy McAnallen, UPMC Health Plan’s senior vice president for clinical affairs and quality performance.

The result, she said in an interview, is greater flexibility when it comes to what care is provided and how it is delivered. “The physicians are setting the evidence-based pathways on the kind of care that patients need to receive, and we have the ability to be very proactive with [how we pay for that] with this kind of relationship.”

Over the course of 2 years, Dr. Regueiro and Ms. McAnallen met several times to parse data on more effective ways to address the fractured way IBD patients, particularly those with undiagnosed psychosocial concerns, were seeking and receiving treatment. The pair also honed in on ways to cut the high cost of surgeries and pharmaceuticals with the overall goal being to create a healthier IBD patient population who perceived their care to be the best possible.

To develop their specialty medical home model, Dr. Regueiro, Dr. Szigethy, Ms. McAnallen, and other key UPMC hospital system and health plan administrators, as well as other IBD specialists, met many times over the course of 2 years to plan what Ms. McAnallen calls their proof of concept.

The program is offered automatically to those covered by the UPMC Health Plan, although anyone is welcome to opt out if they choose. Participants are asked, but not required, to submit to genetic sampling for IBD research purposes, and other data also are gathered with consent at the center. Those not covered by UPMC insurance also are welcome to participate. “The center is payer-agnostic,” Ms. McAnallen said.

Dr. Regueiro and his colleagues will be the primary doctors for all patients who want to be seen at the IBD center for their chronic condition, while episodic illnesses such as colds, flus, and rashes are treated by a newly added advance practice nurse. All patients are now offered behavioral and psychosocial support, depending on the concern, either from Dr. Szigethy, a psychologist, or a social worker who was added to the team for the pilot project.

“Part of what we are defining [with this project] is when a psychiatrist is needed, and what can be done by a less expensive, but well-trained behavioral health, medically trained person like a social worker,” said Dr. Szigethy, who is also a member of the department of psychiatry.

A new patient peer group offers patients the chance to discuss their IBD-related struggles with others who can empathize directly, and a nutritionist and pharmacist both specializing in IBD needs have been added to the payroll. A 24/7 call center also has been established.

“We want patients to be in the habit of calling one place where their entire history is known,” said Ms. McAnallen. “Whether they need primary care or specialty care, we want these patients to go to the specialty medical home.”

It’s a patient-centered, rather than an institution-based model, where the referrals are controlled by the payer, “but the system is value based not volume based,” said Dr. Regueiro.

To that end, Dr. Regueiro said he hopes the center will expand its use of telemedicine to further accommodate patients, who often find it difficult to take time off from work or school, find and afford child care, and travel long distances to their doctor appointments. “Right now, some patients have to drive hours to see us, but a lot of what we do for these patients is cognitive care,” he said.

The IBD center’s additional personnel have been paid for by the health plan, in order to cover the cost of adequately serving the approximately 725 IBD patients the insurer determined were the most expensive to treat out of the more than 5,000 IBD patients, a notably high number according to Dr. Szigethy, that the center serves.

In exchange for underwriting the cost of a portion of the staff, the health plan expects Dr. Regueiro and his team to cut treatment costs for this cohort. “If we save a certain amount on patients each year, the health plan will give that back to us,” Dr. Regueiro said.

One way Ms. McAnallen said the program is projected to save is by reducing the number of times frequent fliers of UPMC’s emergency department arrive with an IBD complaint.

“The ED specializes in all acute medical issues, but for IBD we need to focus in a different way,” said Ms. McAnallen.

To wit, in her health care high-utilization heyday, Anne’s treatment typically began in the emergency department, where she arrived seeking narcotics for her condition.

“She said she hated that the people in the ED treated her like a drug addict, but she hated the pain even more,” Dr. Regueiro told his Orlando audience.

This was particularly troublesome for Anne, since Dr. Szigethy determined she was a potential sufferer of narcotic bowel syndrome.

Although at present, much of the research into this phenomenon is still bench science, Dr. Szigethy said a growing body of evidence provided in part by advanced neuroimaging techniques indicates that chronic narcotic use changes opioid receptors in some human adults from creating an analgesic effect, to a hyperanalgesic one instead, where the narcotics themselves start to create pain and exacerbate any existing bowel issues.

“In Anne’s case, she was going up and up in her opiates, but her pain was getting worse,” Dr. Szigethy said.

Dr. Szigethy obtained permission from Anne’s insurer, which happened to be UPMC Health Plan, to give her a 5-day inpatient medical hospitalization during which time Anne was weaned from her narcotics. For 6 months prior to her detoxification from the opiates, Anne learned self-hypnosis techniques from Dr. Szigethy and her colleagues, which she used to support her withdrawal from the pain medication. Anne’s self-reported favorite technique was that whenever the pain would start, she would visualize filling a balloon with it, and then letting the balloon drift away until it eventually evaporated into the air.

“I know it sounds corny, but guess what? Last year, Anne had zero hospitalizations,” Dr. Regueiro said.

According to Dr. Szigethy, Anne still has occasional pain, “But she can deal with it.”The exact savings UPMC Health Plan expects to realize by way of reimbursing the IBD center for treatment models created in response to emerging research such as that of Dr. Szigethy is still unknown. But Ms. McAnallen is optimistic the program will meet its broader targets.

“We are at a point where costs are becoming out of control and the consumer can’t afford health care. You have to be in a position where you can rely on your physicians to develop evidence-based pathways for treatment of acute and chronic disease, which Eva and Miguel are doing, and to do be able to do so in a laboratory where you have the premium to support that,” Ms. McAnallen said, adding that had Dr. Regueiro approached an outside payer to help him create the medical home model, she doubted it would have come to fruition.

“Because we’re part of an integrated system, we’re all aligned with the same goals, which include improving the health status of our community and decreasing the cost of care so it’s affordable.”

Analysis of data collected on total cost and quality of care, and patient perception of care, will begin within the next 6 months, said Ms. McAnallen, who did not offer specific margins but noted that if gains are made, UPMC would look at how to apply this integrated approach to treating other chronic diseases such as rheumatoid arthritis and multiple sclerosis.

One central question the pilot program is expected to answer is whether it is feasible to do away with fee-for-service provider reimbursements, which Ms. McAnallen said are, in her opinion, at the crux of the current national health care crisis.

“You go to your physician, they do something, they submit a claim, they get a check. We haven’t put in a system that makes providers, whether hospitals or physicians, step back and say, ‘Let’s do this differently. I’m on a treadmill of fee for service. The more I produce, the more I get paid.’ This IBD pilot program is to really help us transform that payment structure.”

Intangible factors such as how much of a specialty medical home’s success is predicated on the verve of its leadership will also be evaluated. “If you don’t have a physician who will be the [medical home’s] champion, it will be very hard to replicate,” Ms. McAnallen said. Attracting ambitious specialists with the opportunity to create such an integrated care model could become a recruitment tool for UPMC, she added.

If the concept of a one-stop-doc-shop sounds slightly “what was old is new again,” harkening back to the days when physicians were called doctors, never “providers,” and largely were thought of as family friends who made house calls, said Dr. Szigethy, it’s because it is that model, amplified by modern means.

“We can’t go to patients’ homes because they’re even more widespread than they were back in the day of the village, but what we can do is provide care through the ancillary team members who are extraordinarily well trained, and can provide education on nutrition and medication. Whether it’s by telemedicine or face to face, patients are getting treated in an integrated way, and we’re doing it as efficaciously as possible. That is brand new.”

Dr. Regueiro said in an interview at least one other insurance company has expressed interest in learning more about the IBD center’s integrated approach, causing him to reassess the payer’s role in health care’s revolution. “There is more common ground between us than I once thought. Insurers are not the devil. They are central to improving value.”

[email protected]

On Twitter @whitneymcknight

In just 1 year, 34 out of about 5,000 patients seen at the inflammatory bowel disease center at the University of Pittsburgh Medical Center cost more than $10 million to treat.

“Our health plan said, ‘You have to fix this,’” recalled Dr. Miguel Regueiro, codirector of the IBD center.

So, in addition to asking the insurer for ideas, Dr. Regueiro did the most cost conscious thing he could think of: He asked for ideas from his colleague, Dr. Eva Szigethy, a psychiatrist specializing in the treatment of pain and psychosocial issues faced by IBD patients.

“Nearly half of our patient population has some behavioral, stress, or mental health component that is driving their disease, [leading] to high health care utilization,” Dr. Regueiro said.

Dr. Szigethy’s work of late, both on her own and with others such as Dr. Douglas Drossman, an emeritus psychiatrist and gastroenterologist at the University of North Carolina at Chapel Hill, has focused on the so-called brain-gut axis and includes the impact of narcotics on the gastrointestinal tract, the correlation between inflammation and depression, the effectiveness of cognitive-behavioral therapy in IBD, and the use of self-hypnosis to manage chronic pain.

“The vast majority of IBD patients have mood disorders, depression, reactive adjustment disorder, anxiety both [before and after] their diagnosis, and chronic pain,” Dr. Szigethy said in an interview.

In practical terms, this means patients benefit from the partnership between Dr. Regueiro, who brings a deep medical knowledge of IBD, and Dr. Szigethy, who combines her research with her psychiatric skill for asking the kinds of questions that evoke the patient’s larger story. Together, said Dr. Szigethy, they assess patients as a whole, directly accounting for the emotional complexity inherent in IBD, with an eye toward helping patients regain control of their lives, often made chaotic by the unpredictable indignities that are the hallmarks of the disease.

“Often, if we listen in the lines and between the lines, our patients tell us exactly what other factors are involved: why their disease is not getting better, why they are getting headaches, why they have such continued suffering,” Dr. Szigethy said.

“You don’t need to know the basic science to understand the stress these patients feel,” Dr. Regueiro recounted to an audience at a recent Advances in IBD meeting in Orlando, sponsored by the Crohn’s and Colitis Foundation of America.

He shared with his audience the story of 45-year-old Anne, a Crohn’s disease sufferer treated at his center. Anne is not the patient’s real name. Despite her disease being inactive, Anne was hospitalized 23 times, and given 19 CT scans and seven endoscopic procedures in one calendar year alone, qualifying her as one of the center’s top 34 “health care frequent fliers.”

Empowering patients like Anne, whose costly care Dr. Szigethy and Dr. Regueiro recognized was attributable more to her psychosocial rather than medical IBD needs, not only improves their quality of life, it saves the system money.

This is why the same health plan representatives who told Dr. Regueiro they’d like to see cost reductions have partnered with him and Dr. Szigethy to develop a specialty care medical home pilot program that combines specialty, primary, and mental health care in one location. The program officially opened in mid-January of this year.

In the mid-1990s, the UPMC Health Plan was conceived by the medical center as a “strategic move to combine the intellectual capital of the provider system with that of the payer system,” according to Sandy McAnallen, UPMC Health Plan’s senior vice president for clinical affairs and quality performance.

The result, she said in an interview, is greater flexibility when it comes to what care is provided and how it is delivered. “The physicians are setting the evidence-based pathways on the kind of care that patients need to receive, and we have the ability to be very proactive with [how we pay for that] with this kind of relationship.”

Over the course of 2 years, Dr. Regueiro and Ms. McAnallen met several times to parse data on more effective ways to address the fractured way IBD patients, particularly those with undiagnosed psychosocial concerns, were seeking and receiving treatment. The pair also honed in on ways to cut the high cost of surgeries and pharmaceuticals with the overall goal being to create a healthier IBD patient population who perceived their care to be the best possible.

To develop their specialty medical home model, Dr. Regueiro, Dr. Szigethy, Ms. McAnallen, and other key UPMC hospital system and health plan administrators, as well as other IBD specialists, met many times over the course of 2 years to plan what Ms. McAnallen calls their proof of concept.

The program is offered automatically to those covered by the UPMC Health Plan, although anyone is welcome to opt out if they choose. Participants are asked, but not required, to submit to genetic sampling for IBD research purposes, and other data also are gathered with consent at the center. Those not covered by UPMC insurance also are welcome to participate. “The center is payer-agnostic,” Ms. McAnallen said.

Dr. Regueiro and his colleagues will be the primary doctors for all patients who want to be seen at the IBD center for their chronic condition, while episodic illnesses such as colds, flus, and rashes are treated by a newly added advance practice nurse. All patients are now offered behavioral and psychosocial support, depending on the concern, either from Dr. Szigethy, a psychologist, or a social worker who was added to the team for the pilot project.

“Part of what we are defining [with this project] is when a psychiatrist is needed, and what can be done by a less expensive, but well-trained behavioral health, medically trained person like a social worker,” said Dr. Szigethy, who is also a member of the department of psychiatry.

A new patient peer group offers patients the chance to discuss their IBD-related struggles with others who can empathize directly, and a nutritionist and pharmacist both specializing in IBD needs have been added to the payroll. A 24/7 call center also has been established.

“We want patients to be in the habit of calling one place where their entire history is known,” said Ms. McAnallen. “Whether they need primary care or specialty care, we want these patients to go to the specialty medical home.”

It’s a patient-centered, rather than an institution-based model, where the referrals are controlled by the payer, “but the system is value based not volume based,” said Dr. Regueiro.

To that end, Dr. Regueiro said he hopes the center will expand its use of telemedicine to further accommodate patients, who often find it difficult to take time off from work or school, find and afford child care, and travel long distances to their doctor appointments. “Right now, some patients have to drive hours to see us, but a lot of what we do for these patients is cognitive care,” he said.

The IBD center’s additional personnel have been paid for by the health plan, in order to cover the cost of adequately serving the approximately 725 IBD patients the insurer determined were the most expensive to treat out of the more than 5,000 IBD patients, a notably high number according to Dr. Szigethy, that the center serves.

In exchange for underwriting the cost of a portion of the staff, the health plan expects Dr. Regueiro and his team to cut treatment costs for this cohort. “If we save a certain amount on patients each year, the health plan will give that back to us,” Dr. Regueiro said.

One way Ms. McAnallen said the program is projected to save is by reducing the number of times frequent fliers of UPMC’s emergency department arrive with an IBD complaint.

“The ED specializes in all acute medical issues, but for IBD we need to focus in a different way,” said Ms. McAnallen.

To wit, in her health care high-utilization heyday, Anne’s treatment typically began in the emergency department, where she arrived seeking narcotics for her condition.

“She said she hated that the people in the ED treated her like a drug addict, but she hated the pain even more,” Dr. Regueiro told his Orlando audience.

This was particularly troublesome for Anne, since Dr. Szigethy determined she was a potential sufferer of narcotic bowel syndrome.

Although at present, much of the research into this phenomenon is still bench science, Dr. Szigethy said a growing body of evidence provided in part by advanced neuroimaging techniques indicates that chronic narcotic use changes opioid receptors in some human adults from creating an analgesic effect, to a hyperanalgesic one instead, where the narcotics themselves start to create pain and exacerbate any existing bowel issues.

“In Anne’s case, she was going up and up in her opiates, but her pain was getting worse,” Dr. Szigethy said.

Dr. Szigethy obtained permission from Anne’s insurer, which happened to be UPMC Health Plan, to give her a 5-day inpatient medical hospitalization during which time Anne was weaned from her narcotics. For 6 months prior to her detoxification from the opiates, Anne learned self-hypnosis techniques from Dr. Szigethy and her colleagues, which she used to support her withdrawal from the pain medication. Anne’s self-reported favorite technique was that whenever the pain would start, she would visualize filling a balloon with it, and then letting the balloon drift away until it eventually evaporated into the air.

“I know it sounds corny, but guess what? Last year, Anne had zero hospitalizations,” Dr. Regueiro said.

According to Dr. Szigethy, Anne still has occasional pain, “But she can deal with it.”The exact savings UPMC Health Plan expects to realize by way of reimbursing the IBD center for treatment models created in response to emerging research such as that of Dr. Szigethy is still unknown. But Ms. McAnallen is optimistic the program will meet its broader targets.

“We are at a point where costs are becoming out of control and the consumer can’t afford health care. You have to be in a position where you can rely on your physicians to develop evidence-based pathways for treatment of acute and chronic disease, which Eva and Miguel are doing, and to do be able to do so in a laboratory where you have the premium to support that,” Ms. McAnallen said, adding that had Dr. Regueiro approached an outside payer to help him create the medical home model, she doubted it would have come to fruition.

“Because we’re part of an integrated system, we’re all aligned with the same goals, which include improving the health status of our community and decreasing the cost of care so it’s affordable.”

Analysis of data collected on total cost and quality of care, and patient perception of care, will begin within the next 6 months, said Ms. McAnallen, who did not offer specific margins but noted that if gains are made, UPMC would look at how to apply this integrated approach to treating other chronic diseases such as rheumatoid arthritis and multiple sclerosis.

One central question the pilot program is expected to answer is whether it is feasible to do away with fee-for-service provider reimbursements, which Ms. McAnallen said are, in her opinion, at the crux of the current national health care crisis.

“You go to your physician, they do something, they submit a claim, they get a check. We haven’t put in a system that makes providers, whether hospitals or physicians, step back and say, ‘Let’s do this differently. I’m on a treadmill of fee for service. The more I produce, the more I get paid.’ This IBD pilot program is to really help us transform that payment structure.”

Intangible factors such as how much of a specialty medical home’s success is predicated on the verve of its leadership will also be evaluated. “If you don’t have a physician who will be the [medical home’s] champion, it will be very hard to replicate,” Ms. McAnallen said. Attracting ambitious specialists with the opportunity to create such an integrated care model could become a recruitment tool for UPMC, she added.

If the concept of a one-stop-doc-shop sounds slightly “what was old is new again,” harkening back to the days when physicians were called doctors, never “providers,” and largely were thought of as family friends who made house calls, said Dr. Szigethy, it’s because it is that model, amplified by modern means.

“We can’t go to patients’ homes because they’re even more widespread than they were back in the day of the village, but what we can do is provide care through the ancillary team members who are extraordinarily well trained, and can provide education on nutrition and medication. Whether it’s by telemedicine or face to face, patients are getting treated in an integrated way, and we’re doing it as efficaciously as possible. That is brand new.”

Dr. Regueiro said in an interview at least one other insurance company has expressed interest in learning more about the IBD center’s integrated approach, causing him to reassess the payer’s role in health care’s revolution. “There is more common ground between us than I once thought. Insurers are not the devil. They are central to improving value.”

[email protected]

On Twitter @whitneymcknight

SCOTTSDALE, ARIZ. – “It’s surprising to me today, when I go proctor or watch a case, how people don’t understand the impact of radiation,” Dr. Mark A. Farber, professor of surgery and radiology at the University of North Carolina, Chapel Hill, said at the Southern Association for Vascular Surgery annual meeting. “Many times, I see people’s hands underneath and on the fluoroscopy machine.”

This flouting of the so-called ALARA principle (as low as reasonably achievable) happens in part because the number of complex procedures performed by vascular surgeons is increasing, despite what presenter Dr. Melissa Kirkwood, a vascular surgeon at the University of Texas Southwestern Medical Center, Dallas, told the audience is a lack of training in radiation dose terminology and basic safety principals.

Yet, practicing excellent radiation safety protocols is “paramount” according to Dr. Farber who, along with Dr. Kirkwood, shared insights on how to minimize dose to both patients and vascular specialists, whether it be from primary, leakage, or scatter radiation.

Table up, top down

Minimizing the air gap by as little as 100 mm – from 700 mm to 600 mm, for example – can reduce the dose of radiation from 17% to 29%, whereas a 10-cm increase in the air gap can result in as much as a 20%-38% increase in the radiation skin dose. This is essentially the application of the inverse square law, according to Dr. Kirkwood.

Although Dr. Farber said that some of the newer, more advanced machines have sensors that automatically detect where the collector should be in relation to the patient, he cautioned that, if your machine doesn’t have these “bells and whistles … remember that the skin dose decreases as the air gap decreases.”

Slow the frame rate

Another advantage to using new imaging systems, according to Dr. Farber, is that they allow the use of pulsed fluoroscopy for as few as 2 or 3 pulses/sec. The selected pulse rate determines the number of fluoroscopic image frames that are generated by the machine per second. This is significant when the dose savings are essential or for when performing simpler procedures, he said. “If you go from 7.5 frames down to 3 frames/sec, you can decrease the exposure for both you and your patient.”

Use between 15 and 30 pulses/sec for critical procedures where precision is crucial, but reducing the rate to 7.5 pulses/sec may result is as much as 70% less of a skin dose.

Add barriers

Don’t just assume that the lead shielding is doing the job. “It’s important that you keep up on this and have it tested regularly,” said Dr. Farber, who recently discovered his thyroid shield was cracked and needed to be replaced.

Additionally, consider the lead shielding of your staff, which, even if it is not used as frequently as the physician’s, can suffer from improper handling. “They fold it or crinkle it up and drop it on the floor. This can lead to problems,” he said. And be sure to remember leaded glasses, lead drapes for the sides of the table, and leaded ceiling-mounted or standing shields.

For extra protection, Dr. Farber recommended the use of disposable protective drapes with cut-outs that allow access to the patient while helping to reduce the amount of scatter radiation exposure to the operator’s limbs. At a tally of anywhere from 1 to 10 mGy/hour, scatter radiation emanating from the patient is a particular risk to the operator’s legs from the knees down, said Dr. Kirkwood, “depending on how tall you are.”

Using the disposable drapes also can result in a 12-fold decrease in the amount of scatter on the eyes, a 25-fold decrease in thyroid exposure to scatter, and a 29-fold decrease in the hands being exposed.

“They can be cumbersome at times, I admit,” Dr. Farber said. “But there can be no substitute for using protective drapes.”

Leaded aprons also can help cut radiation transmission rates, even if they are not foolproof. Wearing two-piece leaded apron systems can help cut down the body strain from the weight of the aprons; however, Dr. Farber said that, at his institution, they now use a suspended body shield system operated by a boom so there is no physical stress on the clinician.

Because the weightless system also provides additional protection for the specialist’s head and limbs, Dr. Farber said that the hefty price tag (approximately $50,000) is justified.

“The way I sold it to the hospital was I told them I could stop doing procedures, or they could get me one of these systems so I could do more procedures,” he said, adding he has had a weightless system installed on each side of the table. “They’ll get their money’s worth by the fact that you’re not over your exposure limit.”

And finally, don’t forget to protect the anesthesiologist! A standing shield that gives broad coverage area should suffice, Dr. Farber said.

Vary the technique

Altering the angle can help ensure that one area of the patient’s body isn’t being overexposed to radiation. Since previously irradiated skin reacts abnormally when re-exposed to radiation because the regeneration and repair of the dermis can take up to several weeks after the initial insult, the timing of the intervals between exposures is critical, said Dr. Kirkwood, adding that the Joint Commission recently recommended that all doses of fluoroscopically guided interventions performed within the past 6-12 months should be considered when assessing potential skin injury risk.

Change the collimation

Making it tighter, for example, can help improve image quality and reduce the radiation dose to both the patient and the operator, as can varying the acquisition rates.

Exit the room during DSA

During digital subtraction angiography, Dr. Farber said to “get away from the table if you can! It’s a huge dose you don’t need to be exposed to if you don’t need to be right next to the machine.” Dr. Kirkwood agreed: “Angiography is 10-100 times more dose than fluoroscopy.”

De-mag

Using a larger monitor allows the operator to see more detail without increasing the magnification, which also increases the dose in the amount of the diameter over the diameter squared. “By not magnifying up [from a field of view of 14 to 28] you will save yourself a factor of at least 4,” Dr. Farber said. “And the actual dose may be even less.”

Optimize imaging

Today’s advanced imaging systems mean that it’s easy to produce many high-quality images – CT scans and ultrasounds – that allow a deeper, more complete picture.

Having the number of images it is now possible to have on screen at once is “practice changing” because it can help clinicians see more possibilities for “how to do the case,” said Dr. Farber. “I’ve never heard anyone say, ’Well, I wish I didn’t have that extra imaging next to me.’ ”

Save images

But once you get it, don’t forget to keep it. “Many times you do an acquisition, you move the machine, and you realize you forget to save the image and now you’ve got to go back and do it all over again,” Dr. Farber lamented. But by once again making technology your friend, with functions that allow auto-return to previous positions, among other auto-commands, you can save the needed information and reduce any unnecessary dose exposure for both yourself and the patient, he said.

Protect your eyes

Cataracts are still all too common in the field, according to Dr. Farber. “It’s important that you have side shields on your glasses to cut down on the amount of radiation that comes in and around the glasses.” Eschew glasses that don’t overtly hug your face, he said.

Know your geometry

Don’t forget that, if you’re standing on the side of the imaging source, the scattering effect will be greater than if you’re on the side of the image receptor. Once again, an understanding of the inverse square law can be protective, according to Dr. Kirkwood: “As x-rays exit the source, there is an exponential decrease in the number of x-rays per unit area as the distance from the source increases.”

“It’s simple stuff,” concluded Dr. Farber. “If you get in the habit of doing these things you will cut down your radiation exposure.”

Neither Dr. Farber nor Dr. Kirkwood had any relevant disclosures.

[email protected]

On Twitter @whitneymcknight

SCOTTSDALE, ARIZ. – “It’s surprising to me today, when I go proctor or watch a case, how people don’t understand the impact of radiation,” Dr. Mark A. Farber, professor of surgery and radiology at the University of North Carolina, Chapel Hill, said at the Southern Association for Vascular Surgery annual meeting. “Many times, I see people’s hands underneath and on the fluoroscopy machine.”

This flouting of the so-called ALARA principle (as low as reasonably achievable) happens in part because the number of complex procedures performed by vascular surgeons is increasing, despite what presenter Dr. Melissa Kirkwood, a vascular surgeon at the University of Texas Southwestern Medical Center, Dallas, told the audience is a lack of training in radiation dose terminology and basic safety principals.

Yet, practicing excellent radiation safety protocols is “paramount” according to Dr. Farber who, along with Dr. Kirkwood, shared insights on how to minimize dose to both patients and vascular specialists, whether it be from primary, leakage, or scatter radiation.

Table up, top down

Minimizing the air gap by as little as 100 mm – from 700 mm to 600 mm, for example – can reduce the dose of radiation from 17% to 29%, whereas a 10-cm increase in the air gap can result in as much as a 20%-38% increase in the radiation skin dose. This is essentially the application of the inverse square law, according to Dr. Kirkwood.

Although Dr. Farber said that some of the newer, more advanced machines have sensors that automatically detect where the collector should be in relation to the patient, he cautioned that, if your machine doesn’t have these “bells and whistles … remember that the skin dose decreases as the air gap decreases.”

Slow the frame rate

Another advantage to using new imaging systems, according to Dr. Farber, is that they allow the use of pulsed fluoroscopy for as few as 2 or 3 pulses/sec. The selected pulse rate determines the number of fluoroscopic image frames that are generated by the machine per second. This is significant when the dose savings are essential or for when performing simpler procedures, he said. “If you go from 7.5 frames down to 3 frames/sec, you can decrease the exposure for both you and your patient.”

Use between 15 and 30 pulses/sec for critical procedures where precision is crucial, but reducing the rate to 7.5 pulses/sec may result is as much as 70% less of a skin dose.

Add barriers

Don’t just assume that the lead shielding is doing the job. “It’s important that you keep up on this and have it tested regularly,” said Dr. Farber, who recently discovered his thyroid shield was cracked and needed to be replaced.

Additionally, consider the lead shielding of your staff, which, even if it is not used as frequently as the physician’s, can suffer from improper handling. “They fold it or crinkle it up and drop it on the floor. This can lead to problems,” he said. And be sure to remember leaded glasses, lead drapes for the sides of the table, and leaded ceiling-mounted or standing shields.

For extra protection, Dr. Farber recommended the use of disposable protective drapes with cut-outs that allow access to the patient while helping to reduce the amount of scatter radiation exposure to the operator’s limbs. At a tally of anywhere from 1 to 10 mGy/hour, scatter radiation emanating from the patient is a particular risk to the operator’s legs from the knees down, said Dr. Kirkwood, “depending on how tall you are.”

Using the disposable drapes also can result in a 12-fold decrease in the amount of scatter on the eyes, a 25-fold decrease in thyroid exposure to scatter, and a 29-fold decrease in the hands being exposed.

“They can be cumbersome at times, I admit,” Dr. Farber said. “But there can be no substitute for using protective drapes.”

Leaded aprons also can help cut radiation transmission rates, even if they are not foolproof. Wearing two-piece leaded apron systems can help cut down the body strain from the weight of the aprons; however, Dr. Farber said that, at his institution, they now use a suspended body shield system operated by a boom so there is no physical stress on the clinician.

Because the weightless system also provides additional protection for the specialist’s head and limbs, Dr. Farber said that the hefty price tag (approximately $50,000) is justified.

“The way I sold it to the hospital was I told them I could stop doing procedures, or they could get me one of these systems so I could do more procedures,” he said, adding he has had a weightless system installed on each side of the table. “They’ll get their money’s worth by the fact that you’re not over your exposure limit.”

And finally, don’t forget to protect the anesthesiologist! A standing shield that gives broad coverage area should suffice, Dr. Farber said.

Vary the technique

Altering the angle can help ensure that one area of the patient’s body isn’t being overexposed to radiation. Since previously irradiated skin reacts abnormally when re-exposed to radiation because the regeneration and repair of the dermis can take up to several weeks after the initial insult, the timing of the intervals between exposures is critical, said Dr. Kirkwood, adding that the Joint Commission recently recommended that all doses of fluoroscopically guided interventions performed within the past 6-12 months should be considered when assessing potential skin injury risk.

Change the collimation

Making it tighter, for example, can help improve image quality and reduce the radiation dose to both the patient and the operator, as can varying the acquisition rates.

Exit the room during DSA

During digital subtraction angiography, Dr. Farber said to “get away from the table if you can! It’s a huge dose you don’t need to be exposed to if you don’t need to be right next to the machine.” Dr. Kirkwood agreed: “Angiography is 10-100 times more dose than fluoroscopy.”

De-mag

Using a larger monitor allows the operator to see more detail without increasing the magnification, which also increases the dose in the amount of the diameter over the diameter squared. “By not magnifying up [from a field of view of 14 to 28] you will save yourself a factor of at least 4,” Dr. Farber said. “And the actual dose may be even less.”

Optimize imaging

Today’s advanced imaging systems mean that it’s easy to produce many high-quality images – CT scans and ultrasounds – that allow a deeper, more complete picture.

Having the number of images it is now possible to have on screen at once is “practice changing” because it can help clinicians see more possibilities for “how to do the case,” said Dr. Farber. “I’ve never heard anyone say, ’Well, I wish I didn’t have that extra imaging next to me.’ ”

Save images

But once you get it, don’t forget to keep it. “Many times you do an acquisition, you move the machine, and you realize you forget to save the image and now you’ve got to go back and do it all over again,” Dr. Farber lamented. But by once again making technology your friend, with functions that allow auto-return to previous positions, among other auto-commands, you can save the needed information and reduce any unnecessary dose exposure for both yourself and the patient, he said.

Protect your eyes

Cataracts are still all too common in the field, according to Dr. Farber. “It’s important that you have side shields on your glasses to cut down on the amount of radiation that comes in and around the glasses.” Eschew glasses that don’t overtly hug your face, he said.

Know your geometry

Don’t forget that, if you’re standing on the side of the imaging source, the scattering effect will be greater than if you’re on the side of the image receptor. Once again, an understanding of the inverse square law can be protective, according to Dr. Kirkwood: “As x-rays exit the source, there is an exponential decrease in the number of x-rays per unit area as the distance from the source increases.”

“It’s simple stuff,” concluded Dr. Farber. “If you get in the habit of doing these things you will cut down your radiation exposure.”

Neither Dr. Farber nor Dr. Kirkwood had any relevant disclosures.

[email protected]

On Twitter @whitneymcknight

SCOTTSDALE, ARIZ. – “It’s surprising to me today, when I go proctor or watch a case, how people don’t understand the impact of radiation,” Dr. Mark A. Farber, professor of surgery and radiology at the University of North Carolina, Chapel Hill, said at the Southern Association for Vascular Surgery annual meeting. “Many times, I see people’s hands underneath and on the fluoroscopy machine.”

This flouting of the so-called ALARA principle (as low as reasonably achievable) happens in part because the number of complex procedures performed by vascular surgeons is increasing, despite what presenter Dr. Melissa Kirkwood, a vascular surgeon at the University of Texas Southwestern Medical Center, Dallas, told the audience is a lack of training in radiation dose terminology and basic safety principals.

Yet, practicing excellent radiation safety protocols is “paramount” according to Dr. Farber who, along with Dr. Kirkwood, shared insights on how to minimize dose to both patients and vascular specialists, whether it be from primary, leakage, or scatter radiation.

Table up, top down

Minimizing the air gap by as little as 100 mm – from 700 mm to 600 mm, for example – can reduce the dose of radiation from 17% to 29%, whereas a 10-cm increase in the air gap can result in as much as a 20%-38% increase in the radiation skin dose. This is essentially the application of the inverse square law, according to Dr. Kirkwood.

Although Dr. Farber said that some of the newer, more advanced machines have sensors that automatically detect where the collector should be in relation to the patient, he cautioned that, if your machine doesn’t have these “bells and whistles … remember that the skin dose decreases as the air gap decreases.”

Slow the frame rate

Another advantage to using new imaging systems, according to Dr. Farber, is that they allow the use of pulsed fluoroscopy for as few as 2 or 3 pulses/sec. The selected pulse rate determines the number of fluoroscopic image frames that are generated by the machine per second. This is significant when the dose savings are essential or for when performing simpler procedures, he said. “If you go from 7.5 frames down to 3 frames/sec, you can decrease the exposure for both you and your patient.”

Use between 15 and 30 pulses/sec for critical procedures where precision is crucial, but reducing the rate to 7.5 pulses/sec may result is as much as 70% less of a skin dose.

Add barriers

Don’t just assume that the lead shielding is doing the job. “It’s important that you keep up on this and have it tested regularly,” said Dr. Farber, who recently discovered his thyroid shield was cracked and needed to be replaced.

Additionally, consider the lead shielding of your staff, which, even if it is not used as frequently as the physician’s, can suffer from improper handling. “They fold it or crinkle it up and drop it on the floor. This can lead to problems,” he said. And be sure to remember leaded glasses, lead drapes for the sides of the table, and leaded ceiling-mounted or standing shields.

For extra protection, Dr. Farber recommended the use of disposable protective drapes with cut-outs that allow access to the patient while helping to reduce the amount of scatter radiation exposure to the operator’s limbs. At a tally of anywhere from 1 to 10 mGy/hour, scatter radiation emanating from the patient is a particular risk to the operator’s legs from the knees down, said Dr. Kirkwood, “depending on how tall you are.”

Using the disposable drapes also can result in a 12-fold decrease in the amount of scatter on the eyes, a 25-fold decrease in thyroid exposure to scatter, and a 29-fold decrease in the hands being exposed.

“They can be cumbersome at times, I admit,” Dr. Farber said. “But there can be no substitute for using protective drapes.”

Leaded aprons also can help cut radiation transmission rates, even if they are not foolproof. Wearing two-piece leaded apron systems can help cut down the body strain from the weight of the aprons; however, Dr. Farber said that, at his institution, they now use a suspended body shield system operated by a boom so there is no physical stress on the clinician.

Because the weightless system also provides additional protection for the specialist’s head and limbs, Dr. Farber said that the hefty price tag (approximately $50,000) is justified.

“The way I sold it to the hospital was I told them I could stop doing procedures, or they could get me one of these systems so I could do more procedures,” he said, adding he has had a weightless system installed on each side of the table. “They’ll get their money’s worth by the fact that you’re not over your exposure limit.”

And finally, don’t forget to protect the anesthesiologist! A standing shield that gives broad coverage area should suffice, Dr. Farber said.

Vary the technique

Altering the angle can help ensure that one area of the patient’s body isn’t being overexposed to radiation. Since previously irradiated skin reacts abnormally when re-exposed to radiation because the regeneration and repair of the dermis can take up to several weeks after the initial insult, the timing of the intervals between exposures is critical, said Dr. Kirkwood, adding that the Joint Commission recently recommended that all doses of fluoroscopically guided interventions performed within the past 6-12 months should be considered when assessing potential skin injury risk.

Change the collimation

Making it tighter, for example, can help improve image quality and reduce the radiation dose to both the patient and the operator, as can varying the acquisition rates.

Exit the room during DSA

During digital subtraction angiography, Dr. Farber said to “get away from the table if you can! It’s a huge dose you don’t need to be exposed to if you don’t need to be right next to the machine.” Dr. Kirkwood agreed: “Angiography is 10-100 times more dose than fluoroscopy.”

De-mag

Using a larger monitor allows the operator to see more detail without increasing the magnification, which also increases the dose in the amount of the diameter over the diameter squared. “By not magnifying up [from a field of view of 14 to 28] you will save yourself a factor of at least 4,” Dr. Farber said. “And the actual dose may be even less.”

Optimize imaging

Today’s advanced imaging systems mean that it’s easy to produce many high-quality images – CT scans and ultrasounds – that allow a deeper, more complete picture.

Having the number of images it is now possible to have on screen at once is “practice changing” because it can help clinicians see more possibilities for “how to do the case,” said Dr. Farber. “I’ve never heard anyone say, ’Well, I wish I didn’t have that extra imaging next to me.’ ”

Save images

But once you get it, don’t forget to keep it. “Many times you do an acquisition, you move the machine, and you realize you forget to save the image and now you’ve got to go back and do it all over again,” Dr. Farber lamented. But by once again making technology your friend, with functions that allow auto-return to previous positions, among other auto-commands, you can save the needed information and reduce any unnecessary dose exposure for both yourself and the patient, he said.

Protect your eyes

Cataracts are still all too common in the field, according to Dr. Farber. “It’s important that you have side shields on your glasses to cut down on the amount of radiation that comes in and around the glasses.” Eschew glasses that don’t overtly hug your face, he said.

Know your geometry

Don’t forget that, if you’re standing on the side of the imaging source, the scattering effect will be greater than if you’re on the side of the image receptor. Once again, an understanding of the inverse square law can be protective, according to Dr. Kirkwood: “As x-rays exit the source, there is an exponential decrease in the number of x-rays per unit area as the distance from the source increases.”

“It’s simple stuff,” concluded Dr. Farber. “If you get in the habit of doing these things you will cut down your radiation exposure.”

Neither Dr. Farber nor Dr. Kirkwood had any relevant disclosures.

[email protected]

On Twitter @whitneymcknight

PHOENIX – Pneumonia, dehydration, and septicemia topped the list of risk factors associated with the need for cardiopulmonary resuscitation during hospitalization for a major surgical procedure in 1 in 500 patients, a retrospective analysis found.

The large sample studied shows that having emergency rather than elective surgery, being older, being African American, and lacking health insurance were also associated with greater odds of needing CPR in this cohort, Dr. Ashima Das of Rainbow Children’s Hospital in Cleveland reported.

© KatarzynaBialasiewicz/Thinkstock

A review of 12,631,502 patient records found in the 2009 and 2010 National Inpatient Sample showed that 0.2% of all major surgery patients between 18 and 64 years went into cardiac arrest during their surgical hospitalization. Patients with postoperative pneumonia were at 3.05 (95% confidence interval = 2.75-3.39, P < .0001) times higher risk for needing CPR; meanwhile, major surgery patients with postoperative dehydration or other fluid and electrolyte disruptions faced an increased risk of 3.50 (95% CI = 3.18-3.85, P < .0001), Dr. Das reported at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

Septicemia posed a 2.60 greater risk (95% CI = 2.34-2.86, P < .0001). The odds ratio of needing CPR for patients with coagulopathy was 2.54 (95% CI = 2.30-2.81, P < .0001).

Dr. Das and her colleagues found that 80% of the 23,858 surgical procedures performed in patients who also needed CPR were emergent rather than elective. Patients’ risk of cardiac arrest increased by 1.02 ( 95% CI = 1.01-1.03, P < .0001) with every year of age, while African Americans had a slightly higher risk of needing CPR, compared with whites (OR, 1.51; 95% CI = 1.35-1.68; P < .0001), as did the uninsured, compared with the insured (P < .0001).

The authors of this study said they had no relevant financial disclosures.

[email protected]

On Twitter @whitneymcknight

PHOENIX – Pneumonia, dehydration, and septicemia topped the list of risk factors associated with the need for cardiopulmonary resuscitation during hospitalization for a major surgical procedure in 1 in 500 patients, a retrospective analysis found.

The large sample studied shows that having emergency rather than elective surgery, being older, being African American, and lacking health insurance were also associated with greater odds of needing CPR in this cohort, Dr. Ashima Das of Rainbow Children’s Hospital in Cleveland reported.

© KatarzynaBialasiewicz/Thinkstock

A review of 12,631,502 patient records found in the 2009 and 2010 National Inpatient Sample showed that 0.2% of all major surgery patients between 18 and 64 years went into cardiac arrest during their surgical hospitalization. Patients with postoperative pneumonia were at 3.05 (95% confidence interval = 2.75-3.39, P < .0001) times higher risk for needing CPR; meanwhile, major surgery patients with postoperative dehydration or other fluid and electrolyte disruptions faced an increased risk of 3.50 (95% CI = 3.18-3.85, P < .0001), Dr. Das reported at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

Septicemia posed a 2.60 greater risk (95% CI = 2.34-2.86, P < .0001). The odds ratio of needing CPR for patients with coagulopathy was 2.54 (95% CI = 2.30-2.81, P < .0001).

Dr. Das and her colleagues found that 80% of the 23,858 surgical procedures performed in patients who also needed CPR were emergent rather than elective. Patients’ risk of cardiac arrest increased by 1.02 ( 95% CI = 1.01-1.03, P < .0001) with every year of age, while African Americans had a slightly higher risk of needing CPR, compared with whites (OR, 1.51; 95% CI = 1.35-1.68; P < .0001), as did the uninsured, compared with the insured (P < .0001).

The authors of this study said they had no relevant financial disclosures.

[email protected]

On Twitter @whitneymcknight

PHOENIX – Pneumonia, dehydration, and septicemia topped the list of risk factors associated with the need for cardiopulmonary resuscitation during hospitalization for a major surgical procedure in 1 in 500 patients, a retrospective analysis found.

The large sample studied shows that having emergency rather than elective surgery, being older, being African American, and lacking health insurance were also associated with greater odds of needing CPR in this cohort, Dr. Ashima Das of Rainbow Children’s Hospital in Cleveland reported.

© KatarzynaBialasiewicz/Thinkstock

A review of 12,631,502 patient records found in the 2009 and 2010 National Inpatient Sample showed that 0.2% of all major surgery patients between 18 and 64 years went into cardiac arrest during their surgical hospitalization. Patients with postoperative pneumonia were at 3.05 (95% confidence interval = 2.75-3.39, P < .0001) times higher risk for needing CPR; meanwhile, major surgery patients with postoperative dehydration or other fluid and electrolyte disruptions faced an increased risk of 3.50 (95% CI = 3.18-3.85, P < .0001), Dr. Das reported at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

Septicemia posed a 2.60 greater risk (95% CI = 2.34-2.86, P < .0001). The odds ratio of needing CPR for patients with coagulopathy was 2.54 (95% CI = 2.30-2.81, P < .0001).

Dr. Das and her colleagues found that 80% of the 23,858 surgical procedures performed in patients who also needed CPR were emergent rather than elective. Patients’ risk of cardiac arrest increased by 1.02 ( 95% CI = 1.01-1.03, P < .0001) with every year of age, while African Americans had a slightly higher risk of needing CPR, compared with whites (OR, 1.51; 95% CI = 1.35-1.68; P < .0001), as did the uninsured, compared with the insured (P < .0001).

The authors of this study said they had no relevant financial disclosures.

[email protected]

On Twitter @whitneymcknight

Physicians should have a high degree of suspicion for measles when a patient presents with fever, rash, and other measles-related symptoms, CDC officials advised Jan. 29.

“I’m urging all health care professionals to think ‘measles’ when they’re evaluating patients with fever, rash, and other measles-related symptoms,” Dr. Anne Schuchat, the U.S. assistant surgeon general, and the director of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases, said during a press conference. “Health care professionals need to know the guidelines for infection control and reporting measles cases, and they should work to ensure that patients are getting the best protection possible against measles, which is on-time MMR [measles, mumps, and rubella] vaccination, to protect them whether at home or abroad.” 

Early symptoms include cough, runny nose and red, light-sensitive eyes. Two to four days later, a fine rash of red spots develops on the face and then gradually spreads down over the entire body. Fever, which can reach 103-105° F, comes with the rash. White spots, called Koplik spots, may appear on the inside of the cheeks. 

Measles is more contagious than almost any other disease. The virus that causes measles lives in the nose and throat of infected people and is sprayed into the air when an infected person sneezes, coughs or talks, and can stay in the air for up to 2 hours. People with measles can spread the disease starting 4 days before the rash begins until 4 days after it appears.

Courtesy CDC/NIP/Barbara Rice

At least 84 people across 14 states have been diagnosed recently with measles, including at least 67 who are thought to have been infected in mid- to late December while visiting Disneyland in Anaheim, Calif., Dr. Schuchat said. “We believe someone got infected [with measles] overseas, visited the Disneyland park, and spread the disease to others.” Those people went on to expose others in a variety of settings, including schools, day care centers, outpatient clinics, and airplanes, she added.

“This is not a problem of the measles vaccine not working, this is a problem of the measles vaccine not being used,” Dr. Schuchat said.

The CDC’s Advisory Committee on Immunization Practices recommends that children between 6 months and 12 months of age be vaccinated, particularly if they will be traveling, since many countries still experience measles on a much larger scale than in the United States.

For parents who balk at this, Dr Schuchat said, “The reason that MMR is recommended at 12 months routinely is because babies are exquisitely vulnerable to measles and the complications from measles.”

The CDC does not recommend the vaccine for children younger than 6 months and urged physicians to remind parents to have their children vaccinated with the recommended two additional doses after their children reach 12 months. “Between 6 and 12 months, it will protect, but it won’t last that long.”

The CDC is also urging adults to be sure of their vaccination status. Adults who are unsure whether they are immune to the virus, either through vaccination or from having had the disease, should get vaccinated or at the least discuss it with their physician. “There is no harm in getting another MMR vaccine if you’ve already been vaccinated,” Dr. Schuchat said.

The majority of measles cases over the past few years, she said, have been in persons who were unvaccinated, primarily because of personal beliefs. Others, however, were unvaccinated because of a missed opportunity.

“People were at the doctor’s office and didn’t get their vaccine because they had an illness, but we recommend you get vaccinated when you are there,” she said.

Already in January 2015, the United States has seen more than the median number of measles cases typically recorded annually since the virus was eliminated as a native disease. In 2014, a record number of 644 cases from 27 states reported to CDC’s National Center for Immunization and Respiratory Diseases.

“This is a wake-up call to make sure that we keep measles from gaining a foothold in our country,” Dr. Schuchat said.

The recommended vaccination schedules for children and adults can be found on the CDC website.

[email protected]

On Twitter @whitneymcknight

*Updated on 1/30/15

Physicians should have a high degree of suspicion for measles when a patient presents with fever, rash, and other measles-related symptoms, CDC officials advised Jan. 29.

“I’m urging all health care professionals to think ‘measles’ when they’re evaluating patients with fever, rash, and other measles-related symptoms,” Dr. Anne Schuchat, the U.S. assistant surgeon general, and the director of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases, said during a press conference. “Health care professionals need to know the guidelines for infection control and reporting measles cases, and they should work to ensure that patients are getting the best protection possible against measles, which is on-time MMR [measles, mumps, and rubella] vaccination, to protect them whether at home or abroad.” 

Early symptoms include cough, runny nose and red, light-sensitive eyes. Two to four days later, a fine rash of red spots develops on the face and then gradually spreads down over the entire body. Fever, which can reach 103-105° F, comes with the rash. White spots, called Koplik spots, may appear on the inside of the cheeks. 

Measles is more contagious than almost any other disease. The virus that causes measles lives in the nose and throat of infected people and is sprayed into the air when an infected person sneezes, coughs or talks, and can stay in the air for up to 2 hours. People with measles can spread the disease starting 4 days before the rash begins until 4 days after it appears.

Courtesy CDC/NIP/Barbara Rice

At least 84 people across 14 states have been diagnosed recently with measles, including at least 67 who are thought to have been infected in mid- to late December while visiting Disneyland in Anaheim, Calif., Dr. Schuchat said. “We believe someone got infected [with measles] overseas, visited the Disneyland park, and spread the disease to others.” Those people went on to expose others in a variety of settings, including schools, day care centers, outpatient clinics, and airplanes, she added.

“This is not a problem of the measles vaccine not working, this is a problem of the measles vaccine not being used,” Dr. Schuchat said.

The CDC’s Advisory Committee on Immunization Practices recommends that children between 6 months and 12 months of age be vaccinated, particularly if they will be traveling, since many countries still experience measles on a much larger scale than in the United States.

For parents who balk at this, Dr Schuchat said, “The reason that MMR is recommended at 12 months routinely is because babies are exquisitely vulnerable to measles and the complications from measles.”

The CDC does not recommend the vaccine for children younger than 6 months and urged physicians to remind parents to have their children vaccinated with the recommended two additional doses after their children reach 12 months. “Between 6 and 12 months, it will protect, but it won’t last that long.”

The CDC is also urging adults to be sure of their vaccination status. Adults who are unsure whether they are immune to the virus, either through vaccination or from having had the disease, should get vaccinated or at the least discuss it with their physician. “There is no harm in getting another MMR vaccine if you’ve already been vaccinated,” Dr. Schuchat said.

The majority of measles cases over the past few years, she said, have been in persons who were unvaccinated, primarily because of personal beliefs. Others, however, were unvaccinated because of a missed opportunity.

“People were at the doctor’s office and didn’t get their vaccine because they had an illness, but we recommend you get vaccinated when you are there,” she said.

Already in January 2015, the United States has seen more than the median number of measles cases typically recorded annually since the virus was eliminated as a native disease. In 2014, a record number of 644 cases from 27 states reported to CDC’s National Center for Immunization and Respiratory Diseases.

“This is a wake-up call to make sure that we keep measles from gaining a foothold in our country,” Dr. Schuchat said.

The recommended vaccination schedules for children and adults can be found on the CDC website.

[email protected]

On Twitter @whitneymcknight

*Updated on 1/30/15

Physicians should have a high degree of suspicion for measles when a patient presents with fever, rash, and other measles-related symptoms, CDC officials advised Jan. 29.

“I’m urging all health care professionals to think ‘measles’ when they’re evaluating patients with fever, rash, and other measles-related symptoms,” Dr. Anne Schuchat, the U.S. assistant surgeon general, and the director of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases, said during a press conference. “Health care professionals need to know the guidelines for infection control and reporting measles cases, and they should work to ensure that patients are getting the best protection possible against measles, which is on-time MMR [measles, mumps, and rubella] vaccination, to protect them whether at home or abroad.” 

Early symptoms include cough, runny nose and red, light-sensitive eyes. Two to four days later, a fine rash of red spots develops on the face and then gradually spreads down over the entire body. Fever, which can reach 103-105° F, comes with the rash. White spots, called Koplik spots, may appear on the inside of the cheeks. 

Measles is more contagious than almost any other disease. The virus that causes measles lives in the nose and throat of infected people and is sprayed into the air when an infected person sneezes, coughs or talks, and can stay in the air for up to 2 hours. People with measles can spread the disease starting 4 days before the rash begins until 4 days after it appears.

Courtesy CDC/NIP/Barbara Rice

At least 84 people across 14 states have been diagnosed recently with measles, including at least 67 who are thought to have been infected in mid- to late December while visiting Disneyland in Anaheim, Calif., Dr. Schuchat said. “We believe someone got infected [with measles] overseas, visited the Disneyland park, and spread the disease to others.” Those people went on to expose others in a variety of settings, including schools, day care centers, outpatient clinics, and airplanes, she added.

“This is not a problem of the measles vaccine not working, this is a problem of the measles vaccine not being used,” Dr. Schuchat said.

The CDC’s Advisory Committee on Immunization Practices recommends that children between 6 months and 12 months of age be vaccinated, particularly if they will be traveling, since many countries still experience measles on a much larger scale than in the United States.

For parents who balk at this, Dr Schuchat said, “The reason that MMR is recommended at 12 months routinely is because babies are exquisitely vulnerable to measles and the complications from measles.”

The CDC does not recommend the vaccine for children younger than 6 months and urged physicians to remind parents to have their children vaccinated with the recommended two additional doses after their children reach 12 months. “Between 6 and 12 months, it will protect, but it won’t last that long.”

The CDC is also urging adults to be sure of their vaccination status. Adults who are unsure whether they are immune to the virus, either through vaccination or from having had the disease, should get vaccinated or at the least discuss it with their physician. “There is no harm in getting another MMR vaccine if you’ve already been vaccinated,” Dr. Schuchat said.

The majority of measles cases over the past few years, she said, have been in persons who were unvaccinated, primarily because of personal beliefs. Others, however, were unvaccinated because of a missed opportunity.

“People were at the doctor’s office and didn’t get their vaccine because they had an illness, but we recommend you get vaccinated when you are there,” she said.

Already in January 2015, the United States has seen more than the median number of measles cases typically recorded annually since the virus was eliminated as a native disease. In 2014, a record number of 644 cases from 27 states reported to CDC’s National Center for Immunization and Respiratory Diseases.

“This is a wake-up call to make sure that we keep measles from gaining a foothold in our country,” Dr. Schuchat said.

The recommended vaccination schedules for children and adults can be found on the CDC website.

[email protected]

On Twitter @whitneymcknight

*Updated on 1/30/15

PHOENIX – Adding a protocol of bundled nonpharmacologic interventions to the currently recommended standard of care nearly halved the amount of time patients spent delirious in the intensive care unit, a study has shown.

The combination of soothing music, natural light, routine cognitive stimulation, and the use of any necessary patient vision or hearing aids, added to standard ICU mobility and sedation protocols, also reduced the odds of developing any delirium, when researchers controlled for age, dementia, APACHE II score, and mechanical ventilation.

The data are from a prospective pre- and post–quality improvement cohort evaluation of the percentage of time patients spent delirious during their total medical ICU stay, rather than just the prevalence of delirium.

“We think this study really brings something unique to the knowledge of ICU delirium,” Ryan Rivosecchi, Pharm.D., a second-year resident at the University of Pittsburgh, said at the Critical Care Congress, sponsored by the Society for Critical Care Medicine. “Delirium is a disease of a waxing and waning nature, and purely going on its prevalence may not tell the full story.”

Currently, the recommendation with the highest level of evidence for preventing ICU delirium, as noted in the 2013 updated SCCM guidelines for pain, agitation, and delirium, is early mobilization. There are scant other evidence-based recommendations for how to prevent and treat the condition, leaving “a lot of practitioners wondering how they should take care of their delirious patients,” Dr. Rivosecchi said.

Delirium experienced during ICU stays has been associated with some form of residual cognitive impairment in more than 70% of patients and increases in lengths of stay by as many as 15 days. Delirium in the ICU has also been associated with a nearly 20% increase in mortality rates 6 months after admission to the ICU.

Noting that his institution already adhered to the standard recommendations for early mobility and sedation algorithms, Dr. Rivosecchi said he and his colleagues conducted the study at the University of Pittsburgh’s 24-bed medical ICU, in hopes of providing an additional evidence-based intervention to reduce ICU delirium.

Among 729 adult patients screened between September 2013 and April 2014, 230 patients who had not been in the ICU prior to MICU admission, and who did not present with delirium or baseline cognitive impairment, were chosen for the pre–quality improvement phase.

The post–quality improvement arm of the study comprised 253 patients who met the same criteria as did those in the first arm. The median age for both groups was 59 years. Slightly more than half of all patients were male.

The primary outcome was the total time a patient spent delirious throughout the entire MICU stay, as measured six times daily, every 4 hours, via the Intensive Care Delirium Screening Checklist. “Patients evaluated as ‘delirious’ at time point A were considered delirious for the next 4 hours until they were evaluated again at time point B,” Dr. Rivosecchi said.

During the first 3 months of the study, nurses on the MICU floor were unaware that baseline data about their unit were being collected. In the fourth month, the investigators discussed their observations with the nursing staff, and with the nursing director and clinician on the unit.

Several unique interventions, distilled from these meetings and a review of protocols already in place, were combined with findings from a systematic review of the literature, into one preventive protocol named M.O.R.E.: Music; Opening of blinds; Reorientation and cognitive stimulation; Eye and ear protocol.

After the nurse meetings, another month passed before the post–quality improvement phase of the study began. The nurses were once again unaware data were being collected; however, according to Dr. Rivosecchi, not only did the entire medical staff, including the pharmacists, embrace the new protocol, but the nurses were so enthusiastic about it they collaborated on a poem to express their intentions to the patients and the patients’ families. Copies of the poem were placed in zippered pouches that included a sleep mask, ear plugs, and headphones, distributed to each MICU patient to help them block out unnecessary stimulation.

“The delirium prevention care bag was an idea the nurses came up with on their own to really help the patients out,” Dr. Rivosecchi said.

Signage detailing the specific actions included in the mnemonic M.O.R.E. was posted throughout the MICU to make it easier for the nursing staff to remember, although how the nurses implemented the protocol was left to them, Dr. Rivosecchi said.

The signs advised that MICU patients be exposed to at least 1 hour of “relaxing/soothing” music per nurse shift, and that if the patient were not actually viewing the television, it be kept off.

To help patients maintain a normal diurnal rhythm, nurses were advised to angle patients so that they could have a view of a window that was kept open from morning until evening to allow in as much natural light as possible.

Rather than employ the typical “alert and orient times three” protocol, the staff was instructed to create mental tasks for the patients, such as asking them their names and how they preferred to be addressed, and to reorient patients by discussing with them the status of their hospitalization.

If patients were accustomed to wearing visual or hearing aids, the nurses were asked to encourage them to use the aids while in the MICU.

The group of 230 studied before M.O.R.E. was in place had 36 patients who experienced delirium, compared with 24 of the 253 patients observed after the interventions were instituted.

The total reduction in the amount of time these patients spent in delirious states was 40.4%. The first arm’s total time spent delirious was 16.1% (1,088 out of 6,747 hours), compared with 9.6% (485 out of 5, 071 hours) of the total time in the second arm (P < .001).

The typical length of stay for the first arm was 58 hours, and 68 hours in the second.

At baseline, there was a statistically significant difference in illness severity as measured by APACHE II scores between the groups: The first had a score of 15, while the second had a score of 17 (P = .002), although according to Dr. Rivosecchi, both arms followed the same predictive value of mortality at 24 hours (7.5% vs. 11.1%, P = .21).

Also of note, Dr. Rivosecchi said, was that there was a higher use of the benzodiazepines lorazepam and midazolam, commonly associated with higher rates of delirium, in the second phase of the study.

In a subanalysis using risk factors reported in the literature, the investigators determined that age, severity of illness, the use of mechanical ventilation, home anticholinergic use, and home antipsychotic use increased the odds of delirium, as did baseline depression or respiratory disease. After the researchers controlled for these factors, the M.O.R.E. protocol reduced the risk of developing delirium by 57% (odds ratio, 0.43, 95% confidence interval 0.24 - 0.77).

Statistically significant predictors of delirium were mechanical ventilation (OR 2.09, CI 1.11-3.91, P = .022), APACHE II score (1.07, CI 1.02 -1.11, P = .002) and dementia (5.12, CI 1.8 -14.3, P = .91).

“I was extremely surprised by the results, particularly since we had greater benzodiazepine use and arguably a sicker patient population in the post phase,” said Dr. Rivosecchi. “I definitely did not expect a 40% reduction.”

Despite the nurses’ enthusiasm, the study did not actually track their adherence to the protocol, a weakness Dr. Rivosecchi said he and his colleagues hoped to address in future evaluations of the protocol.

Meanwhile, according to Pamela Smithburger, Pharm.D., Dr. Rivosecchi’s mentor and the senior author on the paper, use of the M.O.R.E. protocol is now being rolled out across all ICUs within the University of Pittsburgh Medical Center’s entire system, which includes 13 hospitals, and that as the implementation continues, she will be collecting data on patient outcomes systemwide.

“Each ICU will be able to modify the M.O.R.E. protocol to best fit their work flow, culture, and environment,” Dr. Smithburger said in an interview.

The cost to do so comes down to time and staff education. “We utilized tools and resources already available, but by combining them into one protocol, improved outcomes.”

[email protected]

On Twitter @whitneymcknight

PHOENIX – Adding a protocol of bundled nonpharmacologic interventions to the currently recommended standard of care nearly halved the amount of time patients spent delirious in the intensive care unit, a study has shown.

The combination of soothing music, natural light, routine cognitive stimulation, and the use of any necessary patient vision or hearing aids, added to standard ICU mobility and sedation protocols, also reduced the odds of developing any delirium, when researchers controlled for age, dementia, APACHE II score, and mechanical ventilation.

The data are from a prospective pre- and post–quality improvement cohort evaluation of the percentage of time patients spent delirious during their total medical ICU stay, rather than just the prevalence of delirium.

“We think this study really brings something unique to the knowledge of ICU delirium,” Ryan Rivosecchi, Pharm.D., a second-year resident at the University of Pittsburgh, said at the Critical Care Congress, sponsored by the Society for Critical Care Medicine. “Delirium is a disease of a waxing and waning nature, and purely going on its prevalence may not tell the full story.”

Currently, the recommendation with the highest level of evidence for preventing ICU delirium, as noted in the 2013 updated SCCM guidelines for pain, agitation, and delirium, is early mobilization. There are scant other evidence-based recommendations for how to prevent and treat the condition, leaving “a lot of practitioners wondering how they should take care of their delirious patients,” Dr. Rivosecchi said.

Delirium experienced during ICU stays has been associated with some form of residual cognitive impairment in more than 70% of patients and increases in lengths of stay by as many as 15 days. Delirium in the ICU has also been associated with a nearly 20% increase in mortality rates 6 months after admission to the ICU.

Noting that his institution already adhered to the standard recommendations for early mobility and sedation algorithms, Dr. Rivosecchi said he and his colleagues conducted the study at the University of Pittsburgh’s 24-bed medical ICU, in hopes of providing an additional evidence-based intervention to reduce ICU delirium.

Among 729 adult patients screened between September 2013 and April 2014, 230 patients who had not been in the ICU prior to MICU admission, and who did not present with delirium or baseline cognitive impairment, were chosen for the pre–quality improvement phase.

The post–quality improvement arm of the study comprised 253 patients who met the same criteria as did those in the first arm. The median age for both groups was 59 years. Slightly more than half of all patients were male.

The primary outcome was the total time a patient spent delirious throughout the entire MICU stay, as measured six times daily, every 4 hours, via the Intensive Care Delirium Screening Checklist. “Patients evaluated as ‘delirious’ at time point A were considered delirious for the next 4 hours until they were evaluated again at time point B,” Dr. Rivosecchi said.

During the first 3 months of the study, nurses on the MICU floor were unaware that baseline data about their unit were being collected. In the fourth month, the investigators discussed their observations with the nursing staff, and with the nursing director and clinician on the unit.

Several unique interventions, distilled from these meetings and a review of protocols already in place, were combined with findings from a systematic review of the literature, into one preventive protocol named M.O.R.E.: Music; Opening of blinds; Reorientation and cognitive stimulation; Eye and ear protocol.

After the nurse meetings, another month passed before the post–quality improvement phase of the study began. The nurses were once again unaware data were being collected; however, according to Dr. Rivosecchi, not only did the entire medical staff, including the pharmacists, embrace the new protocol, but the nurses were so enthusiastic about it they collaborated on a poem to express their intentions to the patients and the patients’ families. Copies of the poem were placed in zippered pouches that included a sleep mask, ear plugs, and headphones, distributed to each MICU patient to help them block out unnecessary stimulation.

“The delirium prevention care bag was an idea the nurses came up with on their own to really help the patients out,” Dr. Rivosecchi said.

Signage detailing the specific actions included in the mnemonic M.O.R.E. was posted throughout the MICU to make it easier for the nursing staff to remember, although how the nurses implemented the protocol was left to them, Dr. Rivosecchi said.

The signs advised that MICU patients be exposed to at least 1 hour of “relaxing/soothing” music per nurse shift, and that if the patient were not actually viewing the television, it be kept off.

To help patients maintain a normal diurnal rhythm, nurses were advised to angle patients so that they could have a view of a window that was kept open from morning until evening to allow in as much natural light as possible.

Rather than employ the typical “alert and orient times three” protocol, the staff was instructed to create mental tasks for the patients, such as asking them their names and how they preferred to be addressed, and to reorient patients by discussing with them the status of their hospitalization.

If patients were accustomed to wearing visual or hearing aids, the nurses were asked to encourage them to use the aids while in the MICU.

The group of 230 studied before M.O.R.E. was in place had 36 patients who experienced delirium, compared with 24 of the 253 patients observed after the interventions were instituted.

The total reduction in the amount of time these patients spent in delirious states was 40.4%. The first arm’s total time spent delirious was 16.1% (1,088 out of 6,747 hours), compared with 9.6% (485 out of 5, 071 hours) of the total time in the second arm (P < .001).

The typical length of stay for the first arm was 58 hours, and 68 hours in the second.

At baseline, there was a statistically significant difference in illness severity as measured by APACHE II scores between the groups: The first had a score of 15, while the second had a score of 17 (P = .002), although according to Dr. Rivosecchi, both arms followed the same predictive value of mortality at 24 hours (7.5% vs. 11.1%, P = .21).

Also of note, Dr. Rivosecchi said, was that there was a higher use of the benzodiazepines lorazepam and midazolam, commonly associated with higher rates of delirium, in the second phase of the study.

In a subanalysis using risk factors reported in the literature, the investigators determined that age, severity of illness, the use of mechanical ventilation, home anticholinergic use, and home antipsychotic use increased the odds of delirium, as did baseline depression or respiratory disease. After the researchers controlled for these factors, the M.O.R.E. protocol reduced the risk of developing delirium by 57% (odds ratio, 0.43, 95% confidence interval 0.24 - 0.77).

Statistically significant predictors of delirium were mechanical ventilation (OR 2.09, CI 1.11-3.91, P = .022), APACHE II score (1.07, CI 1.02 -1.11, P = .002) and dementia (5.12, CI 1.8 -14.3, P = .91).

“I was extremely surprised by the results, particularly since we had greater benzodiazepine use and arguably a sicker patient population in the post phase,” said Dr. Rivosecchi. “I definitely did not expect a 40% reduction.”

Despite the nurses’ enthusiasm, the study did not actually track their adherence to the protocol, a weakness Dr. Rivosecchi said he and his colleagues hoped to address in future evaluations of the protocol.

Meanwhile, according to Pamela Smithburger, Pharm.D., Dr. Rivosecchi’s mentor and the senior author on the paper, use of the M.O.R.E. protocol is now being rolled out across all ICUs within the University of Pittsburgh Medical Center’s entire system, which includes 13 hospitals, and that as the implementation continues, she will be collecting data on patient outcomes systemwide.

“Each ICU will be able to modify the M.O.R.E. protocol to best fit their work flow, culture, and environment,” Dr. Smithburger said in an interview.

The cost to do so comes down to time and staff education. “We utilized tools and resources already available, but by combining them into one protocol, improved outcomes.”

[email protected]

On Twitter @whitneymcknight

PHOENIX – Adding a protocol of bundled nonpharmacologic interventions to the currently recommended standard of care nearly halved the amount of time patients spent delirious in the intensive care unit, a study has shown.

The combination of soothing music, natural light, routine cognitive stimulation, and the use of any necessary patient vision or hearing aids, added to standard ICU mobility and sedation protocols, also reduced the odds of developing any delirium, when researchers controlled for age, dementia, APACHE II score, and mechanical ventilation.

The data are from a prospective pre- and post–quality improvement cohort evaluation of the percentage of time patients spent delirious during their total medical ICU stay, rather than just the prevalence of delirium.

“We think this study really brings something unique to the knowledge of ICU delirium,” Ryan Rivosecchi, Pharm.D., a second-year resident at the University of Pittsburgh, said at the Critical Care Congress, sponsored by the Society for Critical Care Medicine. “Delirium is a disease of a waxing and waning nature, and purely going on its prevalence may not tell the full story.”

Currently, the recommendation with the highest level of evidence for preventing ICU delirium, as noted in the 2013 updated SCCM guidelines for pain, agitation, and delirium, is early mobilization. There are scant other evidence-based recommendations for how to prevent and treat the condition, leaving “a lot of practitioners wondering how they should take care of their delirious patients,” Dr. Rivosecchi said.

Delirium experienced during ICU stays has been associated with some form of residual cognitive impairment in more than 70% of patients and increases in lengths of stay by as many as 15 days. Delirium in the ICU has also been associated with a nearly 20% increase in mortality rates 6 months after admission to the ICU.

Noting that his institution already adhered to the standard recommendations for early mobility and sedation algorithms, Dr. Rivosecchi said he and his colleagues conducted the study at the University of Pittsburgh’s 24-bed medical ICU, in hopes of providing an additional evidence-based intervention to reduce ICU delirium.

Among 729 adult patients screened between September 2013 and April 2014, 230 patients who had not been in the ICU prior to MICU admission, and who did not present with delirium or baseline cognitive impairment, were chosen for the pre–quality improvement phase.

The post–quality improvement arm of the study comprised 253 patients who met the same criteria as did those in the first arm. The median age for both groups was 59 years. Slightly more than half of all patients were male.

The primary outcome was the total time a patient spent delirious throughout the entire MICU stay, as measured six times daily, every 4 hours, via the Intensive Care Delirium Screening Checklist. “Patients evaluated as ‘delirious’ at time point A were considered delirious for the next 4 hours until they were evaluated again at time point B,” Dr. Rivosecchi said.

During the first 3 months of the study, nurses on the MICU floor were unaware that baseline data about their unit were being collected. In the fourth month, the investigators discussed their observations with the nursing staff, and with the nursing director and clinician on the unit.

Several unique interventions, distilled from these meetings and a review of protocols already in place, were combined with findings from a systematic review of the literature, into one preventive protocol named M.O.R.E.: Music; Opening of blinds; Reorientation and cognitive stimulation; Eye and ear protocol.

After the nurse meetings, another month passed before the post–quality improvement phase of the study began. The nurses were once again unaware data were being collected; however, according to Dr. Rivosecchi, not only did the entire medical staff, including the pharmacists, embrace the new protocol, but the nurses were so enthusiastic about it they collaborated on a poem to express their intentions to the patients and the patients’ families. Copies of the poem were placed in zippered pouches that included a sleep mask, ear plugs, and headphones, distributed to each MICU patient to help them block out unnecessary stimulation.

“The delirium prevention care bag was an idea the nurses came up with on their own to really help the patients out,” Dr. Rivosecchi said.

Signage detailing the specific actions included in the mnemonic M.O.R.E. was posted throughout the MICU to make it easier for the nursing staff to remember, although how the nurses implemented the protocol was left to them, Dr. Rivosecchi said.

The signs advised that MICU patients be exposed to at least 1 hour of “relaxing/soothing” music per nurse shift, and that if the patient were not actually viewing the television, it be kept off.

To help patients maintain a normal diurnal rhythm, nurses were advised to angle patients so that they could have a view of a window that was kept open from morning until evening to allow in as much natural light as possible.

Rather than employ the typical “alert and orient times three” protocol, the staff was instructed to create mental tasks for the patients, such as asking them their names and how they preferred to be addressed, and to reorient patients by discussing with them the status of their hospitalization.

If patients were accustomed to wearing visual or hearing aids, the nurses were asked to encourage them to use the aids while in the MICU.

The group of 230 studied before M.O.R.E. was in place had 36 patients who experienced delirium, compared with 24 of the 253 patients observed after the interventions were instituted.

The total reduction in the amount of time these patients spent in delirious states was 40.4%. The first arm’s total time spent delirious was 16.1% (1,088 out of 6,747 hours), compared with 9.6% (485 out of 5, 071 hours) of the total time in the second arm (P < .001).

The typical length of stay for the first arm was 58 hours, and 68 hours in the second.

At baseline, there was a statistically significant difference in illness severity as measured by APACHE II scores between the groups: The first had a score of 15, while the second had a score of 17 (P = .002), although according to Dr. Rivosecchi, both arms followed the same predictive value of mortality at 24 hours (7.5% vs. 11.1%, P = .21).

Also of note, Dr. Rivosecchi said, was that there was a higher use of the benzodiazepines lorazepam and midazolam, commonly associated with higher rates of delirium, in the second phase of the study.

In a subanalysis using risk factors reported in the literature, the investigators determined that age, severity of illness, the use of mechanical ventilation, home anticholinergic use, and home antipsychotic use increased the odds of delirium, as did baseline depression or respiratory disease. After the researchers controlled for these factors, the M.O.R.E. protocol reduced the risk of developing delirium by 57% (odds ratio, 0.43, 95% confidence interval 0.24 - 0.77).

Statistically significant predictors of delirium were mechanical ventilation (OR 2.09, CI 1.11-3.91, P = .022), APACHE II score (1.07, CI 1.02 -1.11, P = .002) and dementia (5.12, CI 1.8 -14.3, P = .91).

“I was extremely surprised by the results, particularly since we had greater benzodiazepine use and arguably a sicker patient population in the post phase,” said Dr. Rivosecchi. “I definitely did not expect a 40% reduction.”

Despite the nurses’ enthusiasm, the study did not actually track their adherence to the protocol, a weakness Dr. Rivosecchi said he and his colleagues hoped to address in future evaluations of the protocol.

Meanwhile, according to Pamela Smithburger, Pharm.D., Dr. Rivosecchi’s mentor and the senior author on the paper, use of the M.O.R.E. protocol is now being rolled out across all ICUs within the University of Pittsburgh Medical Center’s entire system, which includes 13 hospitals, and that as the implementation continues, she will be collecting data on patient outcomes systemwide.

“Each ICU will be able to modify the M.O.R.E. protocol to best fit their work flow, culture, and environment,” Dr. Smithburger said in an interview.

The cost to do so comes down to time and staff education. “We utilized tools and resources already available, but by combining them into one protocol, improved outcomes.”

[email protected]

On Twitter @whitneymcknight

ORLANDO – Studies with small patient populations but large effect sizes are the backbone of an independent investigator’s success. Rigorous patient selection doesn’t hurt, either.

“We often hide behind the words ‘pilot and feasibility’ to justify what was not a very good study,” Dr. Joshua Korzenik, director of Harvard Medical School’s Crohn’s and Colitis Center, Boston, said at a conference on inflammatory bowel diseases sponsored by the Crohn’s and Colitis Foundation of America. “The term can indicate something was not statistically significant, and that can be legitimate, but ‘pilot’ should not be a substitute for not sizing the study appropriately.”

Sample size consideration is important with respect to data analysis and endpoints, said Dr. Korzenik, but disciplined selection criteria strictly applied sweetens the odds for a study’s impact. Cultivating a cohort that is the “most homogeneous, cleanest, and clearest ... will give you the best insight.” Consider choosing patients according to disease subtype, bio- and genetic markers, a history of at least 3 consecutive months of disease, and a history of certain medication failures.

Steer clear of the assumption that just because you already treat a certain number of patients, you will be able to recruit them. “Some patients won’t want to commit to a study,” warned Dr. Korzenik. “You need to think more carefully.”

And don’t forget the “tremendous” impact of standard deviation on sample size. Dr. Korzenik recommended the “usual” power of .8 with a P value less than .05 for early phase studies.

For the neophyte independent investigator, sweating over what to write in his or her hypothesis, and struggling against temptation to justify sample size by stretching how small the placebo response will be vs. how great the efficacy rate is only to find actual results are not nearly what was predicted, can be devastating. “Then you’ve shot yourself in the foot,” said Dr. Korzenik.

One problem is that few, if any, previous data exist for these kinds of studies. And preclinical data “tends not to be helpful at all,” Dr. Korzenik opined.

Even in trials for anti–tumor necrosis factor drugs, what Dr. Korzenik argued are the most revolutionary treatments to yet impact the field, the question of placebo effect on sample size was tricky. “For the most part, anti-TNFs are about 20% better than placebo for inducing remission. That’s a pretty high bar to set, and most investigator-sponsored studies set the bar even higher, making it very difficult.”

If, for example, an investigator hopes to achieve a 50% reduction in calprotectin, and so sets a “modest” rate of 20% for placebo and 35% for the test drug, that means the investigator must recruit 136 patients per arm. “Yikes!”

But estimating at 15% vs. 40% for the drug, with 47 in each arm, may push the benefit of the study drug “too much.” Using a placebo effect size of 10% vs. 50% for the drug, with 17 patients per arm, the investigator runs the risk of overestimating what’s possible. “You might need to look for another endpoint, or some other set of collaborators,” Dr. Korzenik said.

Open-label studies can be useful for helping with sample size, particularly if the study is to evaluate a novel approach to treatment, but things can still go wobbly. “Open-label trials have limitations we don’t fully understand,” Dr. Korzenik said.

To wit, open-label trials on the use of the helminth Trichuris suis to treat Crohn’s disease showed robust response remission rates, but a successive, placebo-controlled trial did not achieve these results. For independent investigators conducting a placebo-controlled trial using a comparator for the control group, Dr. Korzenik suggested ways to keep the placebo response lower. These included, among other strategies, recruiting patients with higher disease activity and keeping trials as short as possible. “When you do longer studies, the placebo response remission rates go up. Keep that in mind.”

And, don’t forget: Not all small studies with impact need focus on pharmaceuticals. Possibilities Dr. Korzenik suggested include alternative interventions such as marijuana, curcumin, and aloe vera. “These things have been done, but deserve further study,” he said, adding that nutritional interventions are “undervalued, and although difficult to study, are very important.”

The role of depression, fatigue, and other psychosocial impacts of inflammatory bowel disease are also worthy of study, as are the utility of telemedicine and social media for helping patients, he said.

Because investigators will want to protect their resources – namely, the goodwill of the patients they painstakingly recruited – Dr. Korzenik advised using telemedicine to interact with study participants whenever possible, and to consider using smartphone apps to record symptom data. “Remember that repeated evaluations become an enormous burden on the patient.”

Dr. Korzenik urged young investigators not to be intimidated, and to see their inexperience as liberation from having preconceived notions of what the correct approaches are to studying IBD. Still, finding a mentor “who can help shape your ideas and help develop techniques,” can be confidence building.

“You don’t necessarily need to have a final piece of work that can stand on its own,” Dr. Korzenik concluded. “You’re learning how to do a clinical trial and get your career moving forward.”

[email protected]

On Twitter @whitneymcknight

ORLANDO – Studies with small patient populations but large effect sizes are the backbone of an independent investigator’s success. Rigorous patient selection doesn’t hurt, either.

“We often hide behind the words ‘pilot and feasibility’ to justify what was not a very good study,” Dr. Joshua Korzenik, director of Harvard Medical School’s Crohn’s and Colitis Center, Boston, said at a conference on inflammatory bowel diseases sponsored by the Crohn’s and Colitis Foundation of America. “The term can indicate something was not statistically significant, and that can be legitimate, but ‘pilot’ should not be a substitute for not sizing the study appropriately.”

Sample size consideration is important with respect to data analysis and endpoints, said Dr. Korzenik, but disciplined selection criteria strictly applied sweetens the odds for a study’s impact. Cultivating a cohort that is the “most homogeneous, cleanest, and clearest ... will give you the best insight.” Consider choosing patients according to disease subtype, bio- and genetic markers, a history of at least 3 consecutive months of disease, and a history of certain medication failures.

Steer clear of the assumption that just because you already treat a certain number of patients, you will be able to recruit them. “Some patients won’t want to commit to a study,” warned Dr. Korzenik. “You need to think more carefully.”

And don’t forget the “tremendous” impact of standard deviation on sample size. Dr. Korzenik recommended the “usual” power of .8 with a P value less than .05 for early phase studies.

For the neophyte independent investigator, sweating over what to write in his or her hypothesis, and struggling against temptation to justify sample size by stretching how small the placebo response will be vs. how great the efficacy rate is only to find actual results are not nearly what was predicted, can be devastating. “Then you’ve shot yourself in the foot,” said Dr. Korzenik.

One problem is that few, if any, previous data exist for these kinds of studies. And preclinical data “tends not to be helpful at all,” Dr. Korzenik opined.

Even in trials for anti–tumor necrosis factor drugs, what Dr. Korzenik argued are the most revolutionary treatments to yet impact the field, the question of placebo effect on sample size was tricky. “For the most part, anti-TNFs are about 20% better than placebo for inducing remission. That’s a pretty high bar to set, and most investigator-sponsored studies set the bar even higher, making it very difficult.”

If, for example, an investigator hopes to achieve a 50% reduction in calprotectin, and so sets a “modest” rate of 20% for placebo and 35% for the test drug, that means the investigator must recruit 136 patients per arm. “Yikes!”

But estimating at 15% vs. 40% for the drug, with 47 in each arm, may push the benefit of the study drug “too much.” Using a placebo effect size of 10% vs. 50% for the drug, with 17 patients per arm, the investigator runs the risk of overestimating what’s possible. “You might need to look for another endpoint, or some other set of collaborators,” Dr. Korzenik said.

Open-label studies can be useful for helping with sample size, particularly if the study is to evaluate a novel approach to treatment, but things can still go wobbly. “Open-label trials have limitations we don’t fully understand,” Dr. Korzenik said.

To wit, open-label trials on the use of the helminth Trichuris suis to treat Crohn’s disease showed robust response remission rates, but a successive, placebo-controlled trial did not achieve these results. For independent investigators conducting a placebo-controlled trial using a comparator for the control group, Dr. Korzenik suggested ways to keep the placebo response lower. These included, among other strategies, recruiting patients with higher disease activity and keeping trials as short as possible. “When you do longer studies, the placebo response remission rates go up. Keep that in mind.”

And, don’t forget: Not all small studies with impact need focus on pharmaceuticals. Possibilities Dr. Korzenik suggested include alternative interventions such as marijuana, curcumin, and aloe vera. “These things have been done, but deserve further study,” he said, adding that nutritional interventions are “undervalued, and although difficult to study, are very important.”

The role of depression, fatigue, and other psychosocial impacts of inflammatory bowel disease are also worthy of study, as are the utility of telemedicine and social media for helping patients, he said.

Because investigators will want to protect their resources – namely, the goodwill of the patients they painstakingly recruited – Dr. Korzenik advised using telemedicine to interact with study participants whenever possible, and to consider using smartphone apps to record symptom data. “Remember that repeated evaluations become an enormous burden on the patient.”

Dr. Korzenik urged young investigators not to be intimidated, and to see their inexperience as liberation from having preconceived notions of what the correct approaches are to studying IBD. Still, finding a mentor “who can help shape your ideas and help develop techniques,” can be confidence building.

“You don’t necessarily need to have a final piece of work that can stand on its own,” Dr. Korzenik concluded. “You’re learning how to do a clinical trial and get your career moving forward.”

[email protected]

On Twitter @whitneymcknight

ORLANDO – Studies with small patient populations but large effect sizes are the backbone of an independent investigator’s success. Rigorous patient selection doesn’t hurt, either.

“We often hide behind the words ‘pilot and feasibility’ to justify what was not a very good study,” Dr. Joshua Korzenik, director of Harvard Medical School’s Crohn’s and Colitis Center, Boston, said at a conference on inflammatory bowel diseases sponsored by the Crohn’s and Colitis Foundation of America. “The term can indicate something was not statistically significant, and that can be legitimate, but ‘pilot’ should not be a substitute for not sizing the study appropriately.”

Sample size consideration is important with respect to data analysis and endpoints, said Dr. Korzenik, but disciplined selection criteria strictly applied sweetens the odds for a study’s impact. Cultivating a cohort that is the “most homogeneous, cleanest, and clearest ... will give you the best insight.” Consider choosing patients according to disease subtype, bio- and genetic markers, a history of at least 3 consecutive months of disease, and a history of certain medication failures.

Steer clear of the assumption that just because you already treat a certain number of patients, you will be able to recruit them. “Some patients won’t want to commit to a study,” warned Dr. Korzenik. “You need to think more carefully.”

And don’t forget the “tremendous” impact of standard deviation on sample size. Dr. Korzenik recommended the “usual” power of .8 with a P value less than .05 for early phase studies.

For the neophyte independent investigator, sweating over what to write in his or her hypothesis, and struggling against temptation to justify sample size by stretching how small the placebo response will be vs. how great the efficacy rate is only to find actual results are not nearly what was predicted, can be devastating. “Then you’ve shot yourself in the foot,” said Dr. Korzenik.

One problem is that few, if any, previous data exist for these kinds of studies. And preclinical data “tends not to be helpful at all,” Dr. Korzenik opined.

Even in trials for anti–tumor necrosis factor drugs, what Dr. Korzenik argued are the most revolutionary treatments to yet impact the field, the question of placebo effect on sample size was tricky. “For the most part, anti-TNFs are about 20% better than placebo for inducing remission. That’s a pretty high bar to set, and most investigator-sponsored studies set the bar even higher, making it very difficult.”

If, for example, an investigator hopes to achieve a 50% reduction in calprotectin, and so sets a “modest” rate of 20% for placebo and 35% for the test drug, that means the investigator must recruit 136 patients per arm. “Yikes!”

But estimating at 15% vs. 40% for the drug, with 47 in each arm, may push the benefit of the study drug “too much.” Using a placebo effect size of 10% vs. 50% for the drug, with 17 patients per arm, the investigator runs the risk of overestimating what’s possible. “You might need to look for another endpoint, or some other set of collaborators,” Dr. Korzenik said.

Open-label studies can be useful for helping with sample size, particularly if the study is to evaluate a novel approach to treatment, but things can still go wobbly. “Open-label trials have limitations we don’t fully understand,” Dr. Korzenik said.

To wit, open-label trials on the use of the helminth Trichuris suis to treat Crohn’s disease showed robust response remission rates, but a successive, placebo-controlled trial did not achieve these results. For independent investigators conducting a placebo-controlled trial using a comparator for the control group, Dr. Korzenik suggested ways to keep the placebo response lower. These included, among other strategies, recruiting patients with higher disease activity and keeping trials as short as possible. “When you do longer studies, the placebo response remission rates go up. Keep that in mind.”

And, don’t forget: Not all small studies with impact need focus on pharmaceuticals. Possibilities Dr. Korzenik suggested include alternative interventions such as marijuana, curcumin, and aloe vera. “These things have been done, but deserve further study,” he said, adding that nutritional interventions are “undervalued, and although difficult to study, are very important.”

The role of depression, fatigue, and other psychosocial impacts of inflammatory bowel disease are also worthy of study, as are the utility of telemedicine and social media for helping patients, he said.

Because investigators will want to protect their resources – namely, the goodwill of the patients they painstakingly recruited – Dr. Korzenik advised using telemedicine to interact with study participants whenever possible, and to consider using smartphone apps to record symptom data. “Remember that repeated evaluations become an enormous burden on the patient.”

Dr. Korzenik urged young investigators not to be intimidated, and to see their inexperience as liberation from having preconceived notions of what the correct approaches are to studying IBD. Still, finding a mentor “who can help shape your ideas and help develop techniques,” can be confidence building.

“You don’t necessarily need to have a final piece of work that can stand on its own,” Dr. Korzenik concluded. “You’re learning how to do a clinical trial and get your career moving forward.”

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AUSTIN, TEX. – Smokers offered home oxygen therapy were found to be at twice the risk for burn injuries, based on data from a retrospective study.

Even so, almost all the home oxygen therapy (HOT) burn victims were discharged with a prescription for oxygen, including the 15% of patients who had incurred similar injuries at least once, and in some cases, three times.

“I have a problem with this,” said Dr. Mary Baker, a critical care fellow at Indiana University and a medical ethics fellow at the university’s Richard M. Fairbanks Burn Center at Wishard-Eskenazi Health, both in Indianapolis. Dr. Baker presented the findings at the annual meeting of the American College of Chest Physicians.

Whitney McKnight/Frontline Medical News

“Should we be prescribing oxygen to patients who smoke? Maybe the bigger question is [whether] it is ever ethically defensible to take oxygen away once someone has sustained a combustion injury from smoking while using HOT,” she said.

Dr. Baker and her colleagues conducted a chart review of patients admitted to a single site for home oxygen–related burns between 2008 and 2013. They found that 55 of all such burn unit admissions were smokers, representing 4% of the center’s annual admissions rate and twice that of the national burn rate for smokers in general. Nearly all the patients, a balance of men and women with a median age of 61 years, were using HOT for chronic obstructive pulmonary disease.

“The location of the burns, probably not surprisingly, was the face. Probably the most common was the nasal cannula,” Dr. Baker said.

Although nearly three-quarters of the 55-member cohort had less than a 5% total body surface–area burn, Dr. Baker said that in a patient population with baseline respiratory compromise and respiratory failure, this was an alarming rate of morbidity, particularly since half of the injured were intubated, and bronchonscopic exam revealed a third of these patients also had inhalation injuries.

“And here’s the kicker,” said Dr. Baker. “Eight deaths over 5 years. This is huge. So when these [individuals] get burned, it’s often really bad. Several of them had house fires, and we were able to find in the chart where other people [in the home] were burned and admitted to the hospital.”

Still, after a median 5-day stay, almost all the patients who survived were discharged with prescriptions for HOT, including the so-called “repeat offenders.” Because nearly half of all surviving smoking-related HOT patients were discharged to a higher level of care, this cohort tended to have higher health care utilization rates as well, Dr. Baker noted.

A surprise finding was that more than a quarter of the cohort had either current or concomitant problems with substance abuse. “We were not expecting that, and it has not been previously reported,” Dr. Baker said.

The data demonstrate a need for the screening of HOT patients as to whether they smoke and whether they have substance use issues, she said. If either condition applies, then faster follow-up and, potentially, counseling could be offered, including better education about the risks of oxygen therapy. “Currently, we have no formalized way to educate patients on the dangers of those tanks in the home,” said Dr. Baker.

The data raise questions about the risk-benefit ratio of prescribing any breathing aid to COPD patients who are also smokers.

“I don’t know how much sense it makes to keep throwing these inhalers, which cost hundreds of dollars a month, at people who continue to smoke,” Dr. Baker said in an interview. “We take all comers, and we think oxygen therapy helps, and prolongs life, but when you factor in smoking, we don’t really know what the risks and benefits are.”

A large study population would be needed to determine the risks and benefits, she added.

[email protected]

On Twitter @whitneymcknight

AUSTIN, TEX. – Smokers offered home oxygen therapy were found to be at twice the risk for burn injuries, based on data from a retrospective study.

Even so, almost all the home oxygen therapy (HOT) burn victims were discharged with a prescription for oxygen, including the 15% of patients who had incurred similar injuries at least once, and in some cases, three times.

“I have a problem with this,” said Dr. Mary Baker, a critical care fellow at Indiana University and a medical ethics fellow at the university’s Richard M. Fairbanks Burn Center at Wishard-Eskenazi Health, both in Indianapolis. Dr. Baker presented the findings at the annual meeting of the American College of Chest Physicians.

Whitney McKnight/Frontline Medical News

“Should we be prescribing oxygen to patients who smoke? Maybe the bigger question is [whether] it is ever ethically defensible to take oxygen away once someone has sustained a combustion injury from smoking while using HOT,” she said.

Dr. Baker and her colleagues conducted a chart review of patients admitted to a single site for home oxygen–related burns between 2008 and 2013. They found that 55 of all such burn unit admissions were smokers, representing 4% of the center’s annual admissions rate and twice that of the national burn rate for smokers in general. Nearly all the patients, a balance of men and women with a median age of 61 years, were using HOT for chronic obstructive pulmonary disease.

“The location of the burns, probably not surprisingly, was the face. Probably the most common was the nasal cannula,” Dr. Baker said.

Although nearly three-quarters of the 55-member cohort had less than a 5% total body surface–area burn, Dr. Baker said that in a patient population with baseline respiratory compromise and respiratory failure, this was an alarming rate of morbidity, particularly since half of the injured were intubated, and bronchonscopic exam revealed a third of these patients also had inhalation injuries.

“And here’s the kicker,” said Dr. Baker. “Eight deaths over 5 years. This is huge. So when these [individuals] get burned, it’s often really bad. Several of them had house fires, and we were able to find in the chart where other people [in the home] were burned and admitted to the hospital.”

Still, after a median 5-day stay, almost all the patients who survived were discharged with prescriptions for HOT, including the so-called “repeat offenders.” Because nearly half of all surviving smoking-related HOT patients were discharged to a higher level of care, this cohort tended to have higher health care utilization rates as well, Dr. Baker noted.

A surprise finding was that more than a quarter of the cohort had either current or concomitant problems with substance abuse. “We were not expecting that, and it has not been previously reported,” Dr. Baker said.

The data demonstrate a need for the screening of HOT patients as to whether they smoke and whether they have substance use issues, she said. If either condition applies, then faster follow-up and, potentially, counseling could be offered, including better education about the risks of oxygen therapy. “Currently, we have no formalized way to educate patients on the dangers of those tanks in the home,” said Dr. Baker.

The data raise questions about the risk-benefit ratio of prescribing any breathing aid to COPD patients who are also smokers.

“I don’t know how much sense it makes to keep throwing these inhalers, which cost hundreds of dollars a month, at people who continue to smoke,” Dr. Baker said in an interview. “We take all comers, and we think oxygen therapy helps, and prolongs life, but when you factor in smoking, we don’t really know what the risks and benefits are.”

A large study population would be needed to determine the risks and benefits, she added.

[email protected]

On Twitter @whitneymcknight

AUSTIN, TEX. – Smokers offered home oxygen therapy were found to be at twice the risk for burn injuries, based on data from a retrospective study.

Even so, almost all the home oxygen therapy (HOT) burn victims were discharged with a prescription for oxygen, including the 15% of patients who had incurred similar injuries at least once, and in some cases, three times.

“I have a problem with this,” said Dr. Mary Baker, a critical care fellow at Indiana University and a medical ethics fellow at the university’s Richard M. Fairbanks Burn Center at Wishard-Eskenazi Health, both in Indianapolis. Dr. Baker presented the findings at the annual meeting of the American College of Chest Physicians.

Whitney McKnight/Frontline Medical News

“Should we be prescribing oxygen to patients who smoke? Maybe the bigger question is [whether] it is ever ethically defensible to take oxygen away once someone has sustained a combustion injury from smoking while using HOT,” she said.

Dr. Baker and her colleagues conducted a chart review of patients admitted to a single site for home oxygen–related burns between 2008 and 2013. They found that 55 of all such burn unit admissions were smokers, representing 4% of the center’s annual admissions rate and twice that of the national burn rate for smokers in general. Nearly all the patients, a balance of men and women with a median age of 61 years, were using HOT for chronic obstructive pulmonary disease.

“The location of the burns, probably not surprisingly, was the face. Probably the most common was the nasal cannula,” Dr. Baker said.

Although nearly three-quarters of the 55-member cohort had less than a 5% total body surface–area burn, Dr. Baker said that in a patient population with baseline respiratory compromise and respiratory failure, this was an alarming rate of morbidity, particularly since half of the injured were intubated, and bronchonscopic exam revealed a third of these patients also had inhalation injuries.

“And here’s the kicker,” said Dr. Baker. “Eight deaths over 5 years. This is huge. So when these [individuals] get burned, it’s often really bad. Several of them had house fires, and we were able to find in the chart where other people [in the home] were burned and admitted to the hospital.”

Still, after a median 5-day stay, almost all the patients who survived were discharged with prescriptions for HOT, including the so-called “repeat offenders.” Because nearly half of all surviving smoking-related HOT patients were discharged to a higher level of care, this cohort tended to have higher health care utilization rates as well, Dr. Baker noted.

A surprise finding was that more than a quarter of the cohort had either current or concomitant problems with substance abuse. “We were not expecting that, and it has not been previously reported,” Dr. Baker said.

The data demonstrate a need for the screening of HOT patients as to whether they smoke and whether they have substance use issues, she said. If either condition applies, then faster follow-up and, potentially, counseling could be offered, including better education about the risks of oxygen therapy. “Currently, we have no formalized way to educate patients on the dangers of those tanks in the home,” said Dr. Baker.

The data raise questions about the risk-benefit ratio of prescribing any breathing aid to COPD patients who are also smokers.

“I don’t know how much sense it makes to keep throwing these inhalers, which cost hundreds of dollars a month, at people who continue to smoke,” Dr. Baker said in an interview. “We take all comers, and we think oxygen therapy helps, and prolongs life, but when you factor in smoking, we don’t really know what the risks and benefits are.”

A large study population would be needed to determine the risks and benefits, she added.

[email protected]

On Twitter @whitneymcknight