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Endometrial Evaluation: Are You Still Relying on a Blind Biopsy?
One-third of patients who visit a gynecologist are there because of abnormal uterine bleeding (AUB), which is believed to account for more than 70% of gyneco¬logic consults in perimenopausal and postmenopausal women. The American College of Obstetricians and Gynecologists Practice Bulle¬tin on AUB now states that a negative blind endometrial biopsy is not a stopping point in persistent bleeding.
In this supplement, learn about the advantages of diagnosing AUB using a hysteroscope.
- Authors:
- Steven R. Goldstein, MD, CCD, NCMP, FACOG
- New York University Medical Center New York, New York
- Ted L. Anderson, MD, PhD
- Vanderbilt University Medical School Nashville, Tennessee
- Click here to read this supplement.
To access the posttest and evaluation, visit
www.worldclasscme.com/endometrialevaluation
One-third of patients who visit a gynecologist are there because of abnormal uterine bleeding (AUB), which is believed to account for more than 70% of gyneco¬logic consults in perimenopausal and postmenopausal women. The American College of Obstetricians and Gynecologists Practice Bulle¬tin on AUB now states that a negative blind endometrial biopsy is not a stopping point in persistent bleeding.
In this supplement, learn about the advantages of diagnosing AUB using a hysteroscope.
- Authors:
- Steven R. Goldstein, MD, CCD, NCMP, FACOG
- New York University Medical Center New York, New York
- Ted L. Anderson, MD, PhD
- Vanderbilt University Medical School Nashville, Tennessee
- Click here to read this supplement.
To access the posttest and evaluation, visit
www.worldclasscme.com/endometrialevaluation
One-third of patients who visit a gynecologist are there because of abnormal uterine bleeding (AUB), which is believed to account for more than 70% of gyneco¬logic consults in perimenopausal and postmenopausal women. The American College of Obstetricians and Gynecologists Practice Bulle¬tin on AUB now states that a negative blind endometrial biopsy is not a stopping point in persistent bleeding.
In this supplement, learn about the advantages of diagnosing AUB using a hysteroscope.
- Authors:
- Steven R. Goldstein, MD, CCD, NCMP, FACOG
- New York University Medical Center New York, New York
- Ted L. Anderson, MD, PhD
- Vanderbilt University Medical School Nashville, Tennessee
- Click here to read this supplement.
To access the posttest and evaluation, visit
www.worldclasscme.com/endometrialevaluation
Study shows childhood IBD increased cancer risk in adulthood
Children who had developed inflammatory bowel disease had an 18-fold greater risk of gastrointestinal cancers in later life, a new study suggests.
The cohort study found that the risk of all cancers was elevated in individuals with childhood-onset inflammatory bowel disease, but particularly in those with primary sclerosing cholangitis and ulcerative colitis.
Researchers followed 9,405 patients with childhood-onset inflammatory bowel disease to a mean age of 27 years using a Swedish national patient register (BMJ. 2017 Sep 21. doi: 10.1136/bmj.j3951).
Analysis revealed that individuals with childhood-onset inflammatory bowel disease had double the risk of any cancer, compared with the general population (hazard ratio, 2.2; 95% confidence interval, 2.0-2.5), and a 2.7-fold greater risk of developing cancer before the age of 18 years.
Primary sclerosing cholangitis was associated with a sixfold greater risk of cancer, ulcerative colitis was associated with a 2.6-fold greater risk, and patients who had had colitis for 10 years or more had a nearly fourfold greater risk of cancer (HR, 3.9).
The study also found that childhood-onset inflammatory bowel disease was associated with an 18-fold greater risk of gastrointestinal cancer, compared with the general population, matched for age, sex, birth year, and county.
The risk was particularly high in patients with ulcerative colitis, who showed a 33-fold higher risk of colorectal cancer, while patients with Crohn’s disease had a nearly 6-fold higher risk.
“Colorectal cancer is a major cause of cancer mortality in the population, and even a moderately increased incidence is likely to have a large effect on patients with inflammatory bowel disease,” wrote Ola Olén, MD, of Karolinska Institutet, Stockholm, and coauthors.
When the researchers looked in more detail at the type of cancers, they saw the greatest increases in risk were for colorectal cancer (HR, 19.5) and small intestinal cancer (HR, 12.8), while the risk of liver cancer was 134 times higher (95% CI, 59.6-382).
The researchers also saw a 2.7-fold increased risk of lymphoid neoplasms associated with childhood inflammatory bowel disease, particularly in individuals with ulcerative colitis or Crohn’s disease. The most common lymphoid neoplasms were non-Hodgkin lymphomas, followed by Hodgkin lymphomas.
Commenting on possible explanations for the associations seen in the study, the authors said that patients with inflammatory bowel disease may have their gastrointestinal cancers diagnosed earlier than the general population because of regular endoscopies.
They also said that thiopurines and TNF inhibitors – both used to treat inflammatory bowel disease – could not be ruled out as a possible cause of the increase in cancer risk, but their study was not powered to pick up such an effect.
“Instead, we suggest that extent and duration of chronic inflammation might be the main driving mechanisms underlying the increased risk of cancer,” they wrote.
The authors noted that their study did not include data on the smoking status of individuals, which could be significant, because smoking is known to reduce the risk of ulcerative colitis and increase the risk of Crohn’s disease and cancer. However, they pointed out that the majority of patients would not have been smoking at the time of their initial inflammatory bowel disease diagnosis, and would have been unlikely to take up the habit after their diagnosis.
With the observation that the risk of cancer in inflammatory bowel disease was higher in patients who were younger when diagnosed with the disease, the authors suggested that age of onset be considered when designing surveillance strategies for cancer in this group.
The Stockholm County Council and the Karolinska Institutet, the Swedish Cancer Society, the Swedish Research Council, and the Swedish Foundation for Strategic Research supported the study. One author received grants from the Swedish Medical Society, Magtarmfonden, the Jane and Dan Olsson Foundation, the Mjölkdroppen Foundation, the Bengt Ihre Research Fellowship in gastroenterology, and the Karolinska Institutet Foundations. No conflicts of interest were declared.
Children who had developed inflammatory bowel disease had an 18-fold greater risk of gastrointestinal cancers in later life, a new study suggests.
The cohort study found that the risk of all cancers was elevated in individuals with childhood-onset inflammatory bowel disease, but particularly in those with primary sclerosing cholangitis and ulcerative colitis.
Researchers followed 9,405 patients with childhood-onset inflammatory bowel disease to a mean age of 27 years using a Swedish national patient register (BMJ. 2017 Sep 21. doi: 10.1136/bmj.j3951).
Analysis revealed that individuals with childhood-onset inflammatory bowel disease had double the risk of any cancer, compared with the general population (hazard ratio, 2.2; 95% confidence interval, 2.0-2.5), and a 2.7-fold greater risk of developing cancer before the age of 18 years.
Primary sclerosing cholangitis was associated with a sixfold greater risk of cancer, ulcerative colitis was associated with a 2.6-fold greater risk, and patients who had had colitis for 10 years or more had a nearly fourfold greater risk of cancer (HR, 3.9).
The study also found that childhood-onset inflammatory bowel disease was associated with an 18-fold greater risk of gastrointestinal cancer, compared with the general population, matched for age, sex, birth year, and county.
The risk was particularly high in patients with ulcerative colitis, who showed a 33-fold higher risk of colorectal cancer, while patients with Crohn’s disease had a nearly 6-fold higher risk.
“Colorectal cancer is a major cause of cancer mortality in the population, and even a moderately increased incidence is likely to have a large effect on patients with inflammatory bowel disease,” wrote Ola Olén, MD, of Karolinska Institutet, Stockholm, and coauthors.
When the researchers looked in more detail at the type of cancers, they saw the greatest increases in risk were for colorectal cancer (HR, 19.5) and small intestinal cancer (HR, 12.8), while the risk of liver cancer was 134 times higher (95% CI, 59.6-382).
The researchers also saw a 2.7-fold increased risk of lymphoid neoplasms associated with childhood inflammatory bowel disease, particularly in individuals with ulcerative colitis or Crohn’s disease. The most common lymphoid neoplasms were non-Hodgkin lymphomas, followed by Hodgkin lymphomas.
Commenting on possible explanations for the associations seen in the study, the authors said that patients with inflammatory bowel disease may have their gastrointestinal cancers diagnosed earlier than the general population because of regular endoscopies.
They also said that thiopurines and TNF inhibitors – both used to treat inflammatory bowel disease – could not be ruled out as a possible cause of the increase in cancer risk, but their study was not powered to pick up such an effect.
“Instead, we suggest that extent and duration of chronic inflammation might be the main driving mechanisms underlying the increased risk of cancer,” they wrote.
The authors noted that their study did not include data on the smoking status of individuals, which could be significant, because smoking is known to reduce the risk of ulcerative colitis and increase the risk of Crohn’s disease and cancer. However, they pointed out that the majority of patients would not have been smoking at the time of their initial inflammatory bowel disease diagnosis, and would have been unlikely to take up the habit after their diagnosis.
With the observation that the risk of cancer in inflammatory bowel disease was higher in patients who were younger when diagnosed with the disease, the authors suggested that age of onset be considered when designing surveillance strategies for cancer in this group.
The Stockholm County Council and the Karolinska Institutet, the Swedish Cancer Society, the Swedish Research Council, and the Swedish Foundation for Strategic Research supported the study. One author received grants from the Swedish Medical Society, Magtarmfonden, the Jane and Dan Olsson Foundation, the Mjölkdroppen Foundation, the Bengt Ihre Research Fellowship in gastroenterology, and the Karolinska Institutet Foundations. No conflicts of interest were declared.
Children who had developed inflammatory bowel disease had an 18-fold greater risk of gastrointestinal cancers in later life, a new study suggests.
The cohort study found that the risk of all cancers was elevated in individuals with childhood-onset inflammatory bowel disease, but particularly in those with primary sclerosing cholangitis and ulcerative colitis.
Researchers followed 9,405 patients with childhood-onset inflammatory bowel disease to a mean age of 27 years using a Swedish national patient register (BMJ. 2017 Sep 21. doi: 10.1136/bmj.j3951).
Analysis revealed that individuals with childhood-onset inflammatory bowel disease had double the risk of any cancer, compared with the general population (hazard ratio, 2.2; 95% confidence interval, 2.0-2.5), and a 2.7-fold greater risk of developing cancer before the age of 18 years.
Primary sclerosing cholangitis was associated with a sixfold greater risk of cancer, ulcerative colitis was associated with a 2.6-fold greater risk, and patients who had had colitis for 10 years or more had a nearly fourfold greater risk of cancer (HR, 3.9).
The study also found that childhood-onset inflammatory bowel disease was associated with an 18-fold greater risk of gastrointestinal cancer, compared with the general population, matched for age, sex, birth year, and county.
The risk was particularly high in patients with ulcerative colitis, who showed a 33-fold higher risk of colorectal cancer, while patients with Crohn’s disease had a nearly 6-fold higher risk.
“Colorectal cancer is a major cause of cancer mortality in the population, and even a moderately increased incidence is likely to have a large effect on patients with inflammatory bowel disease,” wrote Ola Olén, MD, of Karolinska Institutet, Stockholm, and coauthors.
When the researchers looked in more detail at the type of cancers, they saw the greatest increases in risk were for colorectal cancer (HR, 19.5) and small intestinal cancer (HR, 12.8), while the risk of liver cancer was 134 times higher (95% CI, 59.6-382).
The researchers also saw a 2.7-fold increased risk of lymphoid neoplasms associated with childhood inflammatory bowel disease, particularly in individuals with ulcerative colitis or Crohn’s disease. The most common lymphoid neoplasms were non-Hodgkin lymphomas, followed by Hodgkin lymphomas.
Commenting on possible explanations for the associations seen in the study, the authors said that patients with inflammatory bowel disease may have their gastrointestinal cancers diagnosed earlier than the general population because of regular endoscopies.
They also said that thiopurines and TNF inhibitors – both used to treat inflammatory bowel disease – could not be ruled out as a possible cause of the increase in cancer risk, but their study was not powered to pick up such an effect.
“Instead, we suggest that extent and duration of chronic inflammation might be the main driving mechanisms underlying the increased risk of cancer,” they wrote.
The authors noted that their study did not include data on the smoking status of individuals, which could be significant, because smoking is known to reduce the risk of ulcerative colitis and increase the risk of Crohn’s disease and cancer. However, they pointed out that the majority of patients would not have been smoking at the time of their initial inflammatory bowel disease diagnosis, and would have been unlikely to take up the habit after their diagnosis.
With the observation that the risk of cancer in inflammatory bowel disease was higher in patients who were younger when diagnosed with the disease, the authors suggested that age of onset be considered when designing surveillance strategies for cancer in this group.
The Stockholm County Council and the Karolinska Institutet, the Swedish Cancer Society, the Swedish Research Council, and the Swedish Foundation for Strategic Research supported the study. One author received grants from the Swedish Medical Society, Magtarmfonden, the Jane and Dan Olsson Foundation, the Mjölkdroppen Foundation, the Bengt Ihre Research Fellowship in gastroenterology, and the Karolinska Institutet Foundations. No conflicts of interest were declared.
FROM BMJ
Key clinical point: Childhood inflammatory bowel disease was associated with significant increases in the risk of cancer – particularly gastrointestinal cancer – in later life.
Major finding: Individuals diagnosed with inflammatory bowel disease in childhood have an 18-fold greater risk of gastrointestinal cancer, and a twofold higher risk of any cancer, compared with the general population.
Data source: A cohort study of 9,405 patients with childhood-onset inflammatory bowel disease.
Disclosures: The Stockholm County Council and the Karolinska Institutet, the Swedish Cancer Society, the Swedish Research Council, and the Swedish Foundation for Strategic Research supported the study. One author received grants from the Swedish Medical Society, Magtarmfonden, the Jane and Dan Olsson Foundation, the Mjölkdroppen Foundation, the Bengt Ihre Research Fellowship in gastroenterology, and the Karolinska Institutet Foundations. No conflicts of interest were declared.
Everything We Say And Do: The physician patient
Editor’s note: “Everything We Say and Do” provides readers with thoughtful and actionable communication tactics that can positively impact patients’ experience of care. In the next series of columns, physicians will share how their experiences as patients have shaped their professional approach.
In May 2007, I received my acceptance letter for medical school. One month later, I was diagnosed with cancer.
The clinic visit was only supposed to be a routine postoperative follow-up after a simple cyst resection. I really hoped that my doctor was mistaken as he walked me through what to expect, and when he was finished, the desperate look in my eyes demanded answers.
After I fully absorbed the initial shock of the grave news, I eventually found the strength to analyze the situation at hand. Ultimately, I adopted a more positive outlook and fought cancer head on. Contending with cancer while tackling the rigors of medical school was tedious, but despite the hardships, my experience catalyzed my determination and molded my personality as a physician.
What I say and do
I employ active listening and practice patience, especially when it comes to family members.
As both a cancer survivor and a physician, I am able to integrate empathy and diligence by putting myself in my patients’ shoes. My experience in a hospital bed during medical school granted me an extremely intriguing perspective towards medicine.
Why I do it
When I was a patient, the most crucial thing to my family was information. Most physicians did not take the time to explain my course of care, which elevated my family’s angst and anxiety. The experience taught me the importance of patience and communication.
But there were good examples. I still remember the physician who comforted my mother and assuaged her concerns. She held my mother’s hand and showed empathy. When my mother cried, she cried. That physician taught me that it was acceptable for physicians to express emotions.
When my surgeon rounded on me in the morning after my procedure, she was not wearing a white coat, which made her appear relatable. Her contagious confidence and humble demeanor were endorsement enough for her capabilities, showing me that a physician’s persona supersedes the conventional coat.
How I do it
I try to put myself in my patients’ shoes. I rejoice with them. I mourn with them. My uninhibited display of emotions affirms empathy. I dissolve all barriers by not wearing a white coat and ask my patients for a partnership. After all, I once walked miles in those shoes.
Dr. Sharma is a chief hospitalist for Sound Physicians at the Sierra Campus of The Hospitals of Providence, El Paso, Texas. She is a columnist for the El Paso Times and the medical contributor for KVIA Channel 7 ABC News. Her work has appeared on kevinmd.com, Thrive Global, and in El Paso magazine.
Editor’s note: “Everything We Say and Do” provides readers with thoughtful and actionable communication tactics that can positively impact patients’ experience of care. In the next series of columns, physicians will share how their experiences as patients have shaped their professional approach.
In May 2007, I received my acceptance letter for medical school. One month later, I was diagnosed with cancer.
The clinic visit was only supposed to be a routine postoperative follow-up after a simple cyst resection. I really hoped that my doctor was mistaken as he walked me through what to expect, and when he was finished, the desperate look in my eyes demanded answers.
After I fully absorbed the initial shock of the grave news, I eventually found the strength to analyze the situation at hand. Ultimately, I adopted a more positive outlook and fought cancer head on. Contending with cancer while tackling the rigors of medical school was tedious, but despite the hardships, my experience catalyzed my determination and molded my personality as a physician.
What I say and do
I employ active listening and practice patience, especially when it comes to family members.
As both a cancer survivor and a physician, I am able to integrate empathy and diligence by putting myself in my patients’ shoes. My experience in a hospital bed during medical school granted me an extremely intriguing perspective towards medicine.
Why I do it
When I was a patient, the most crucial thing to my family was information. Most physicians did not take the time to explain my course of care, which elevated my family’s angst and anxiety. The experience taught me the importance of patience and communication.
But there were good examples. I still remember the physician who comforted my mother and assuaged her concerns. She held my mother’s hand and showed empathy. When my mother cried, she cried. That physician taught me that it was acceptable for physicians to express emotions.
When my surgeon rounded on me in the morning after my procedure, she was not wearing a white coat, which made her appear relatable. Her contagious confidence and humble demeanor were endorsement enough for her capabilities, showing me that a physician’s persona supersedes the conventional coat.
How I do it
I try to put myself in my patients’ shoes. I rejoice with them. I mourn with them. My uninhibited display of emotions affirms empathy. I dissolve all barriers by not wearing a white coat and ask my patients for a partnership. After all, I once walked miles in those shoes.
Dr. Sharma is a chief hospitalist for Sound Physicians at the Sierra Campus of The Hospitals of Providence, El Paso, Texas. She is a columnist for the El Paso Times and the medical contributor for KVIA Channel 7 ABC News. Her work has appeared on kevinmd.com, Thrive Global, and in El Paso magazine.
Editor’s note: “Everything We Say and Do” provides readers with thoughtful and actionable communication tactics that can positively impact patients’ experience of care. In the next series of columns, physicians will share how their experiences as patients have shaped their professional approach.
In May 2007, I received my acceptance letter for medical school. One month later, I was diagnosed with cancer.
The clinic visit was only supposed to be a routine postoperative follow-up after a simple cyst resection. I really hoped that my doctor was mistaken as he walked me through what to expect, and when he was finished, the desperate look in my eyes demanded answers.
After I fully absorbed the initial shock of the grave news, I eventually found the strength to analyze the situation at hand. Ultimately, I adopted a more positive outlook and fought cancer head on. Contending with cancer while tackling the rigors of medical school was tedious, but despite the hardships, my experience catalyzed my determination and molded my personality as a physician.
What I say and do
I employ active listening and practice patience, especially when it comes to family members.
As both a cancer survivor and a physician, I am able to integrate empathy and diligence by putting myself in my patients’ shoes. My experience in a hospital bed during medical school granted me an extremely intriguing perspective towards medicine.
Why I do it
When I was a patient, the most crucial thing to my family was information. Most physicians did not take the time to explain my course of care, which elevated my family’s angst and anxiety. The experience taught me the importance of patience and communication.
But there were good examples. I still remember the physician who comforted my mother and assuaged her concerns. She held my mother’s hand and showed empathy. When my mother cried, she cried. That physician taught me that it was acceptable for physicians to express emotions.
When my surgeon rounded on me in the morning after my procedure, she was not wearing a white coat, which made her appear relatable. Her contagious confidence and humble demeanor were endorsement enough for her capabilities, showing me that a physician’s persona supersedes the conventional coat.
How I do it
I try to put myself in my patients’ shoes. I rejoice with them. I mourn with them. My uninhibited display of emotions affirms empathy. I dissolve all barriers by not wearing a white coat and ask my patients for a partnership. After all, I once walked miles in those shoes.
Dr. Sharma is a chief hospitalist for Sound Physicians at the Sierra Campus of The Hospitals of Providence, El Paso, Texas. She is a columnist for the El Paso Times and the medical contributor for KVIA Channel 7 ABC News. Her work has appeared on kevinmd.com, Thrive Global, and in El Paso magazine.
Early ankylosing spondylitis treatment stops transition from inflammatory to bone-forming fatty lesions
Structural damage in axial and peripheral ankylosing spondylitis is the result of a combination of destruction and new bone formation, which can be halted if treated early and for long enough, according to Dirk Elewaut, MD, PhD.
“There is a longstanding paradox in the field of ankylosing spondylitis, as to whether there is a strict relationship between the inflammation that leads to the signs and symptoms in patients, and the structural progression,” said Dr. Elewaut, who spoke at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education. “ ”
One key reason why the early TNF inhibition trials showed no effect of treatment on structural progression stemmed from inadequate study design. “The original studies were underpowered, and the patients used NSAIDs,” he said. “We also know that the anti-inflammatory effect [of TNF inhibition] is not 100%. So you have a clear drop in inflammation with biologics, but it’s not completely stopped. This led to a lot of speculation as to whether inflammation and ankyloses are coupled or not.”
More recently, researchers have honed in on the transition from acute inflammatory lesions visible on MRI by bone marrow edema to so-called fatty lesions, which are also visible on MRI. They have observed that fatty lesions are associated with new bone formation. “Lesions containing more fat are thought to be more difficult to modulate by biological therapy,” Dr. Elewaut said. “Once you have a fatty lesion, you have some kind of metabolic disease of the bone, and it’s a one-way road to the development of new syndesmophytes. So in other words, it is essential to assess the relationship between inflammation and new bone formation with both the STIR [short tau inversion recovery images] and T1-weighted MRI.”
A working hypothesis among AS researchers is that the effect of anti-TNF therapy on radiologic progression depends on the relative number of acute and mature inflammatory lesions that individual patients have. “Early diagnosis is a prerequisite for advances in disease modification,” he said. At least three “windows of opportunity” for disease modification exist, Dr. Elewaut continued. One is that the link between inflammation as measured by clinical parameters and new bone formation will be more evident in early AS. The second is that early treatment of patients with axial AS and spinal inflammation with anti-TNF agents will prevent new bone formation. The third is that reduction of new bone formation in established AS will be observed only with long-term anti-TNF therapy after mature lesions have resolved/repaired, and no new inflammatory lesions are being formed. One study found that patients with a delay of more than 10 years starting anti-TNF therapy were more likely to progress, compared with patients who received therapy earlier (odds ratio, 2.4; P = .03; see Arthritis Rheum. 2013;65:645-54). “The message here is quite clear,” Dr. Elewaut said. “The earlier we treat intensively, the better impact you have on structural outcomes.”
In a trial known as CRESPA (Clinical Remission in peripheral SPondyloArthritis), researchers including Dr. Elewaut evaluated the efficacy and safety of golimumab (Simponi) to induce clinical remission in patients with early, active peripheral AS (Ann Rheum Dis. 2017;76:1389-95). In all, 60 patients were randomized to golimumab or placebo for 24 weeks. At week 24, a significantly higher percentage of patients receiving golimumab achieved clinical remission, compared with placebo (75% vs. 20%, respectively; P less than .001). At week 12, similar results were observed (70% vs. 15%; P less than .001).
“These were very striking results in this early disease population,” Dr. Elewaut said. In a follow-up analysis, the researchers withdrew therapy in patients who reached clinical remission, to see what would happen. “At 1.5 years of follow-up, 57% of patients are in drug-free remission,” Dr. Elewaut said. “This is interesting and suggests that at least in a fraction of those patients, you can actually achieve a drug-free remission.” Predictors for relapse included pre-existing psoriasis and having more than five swollen joints.
Dr. Elewaut disclosed that he is a member of the speakers bureau for AbbVie, Novartis, Pfizer, and UCB. Global Academy for Medical Education and this news organization are owned by the same parent company.
Structural damage in axial and peripheral ankylosing spondylitis is the result of a combination of destruction and new bone formation, which can be halted if treated early and for long enough, according to Dirk Elewaut, MD, PhD.
“There is a longstanding paradox in the field of ankylosing spondylitis, as to whether there is a strict relationship between the inflammation that leads to the signs and symptoms in patients, and the structural progression,” said Dr. Elewaut, who spoke at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education. “ ”
One key reason why the early TNF inhibition trials showed no effect of treatment on structural progression stemmed from inadequate study design. “The original studies were underpowered, and the patients used NSAIDs,” he said. “We also know that the anti-inflammatory effect [of TNF inhibition] is not 100%. So you have a clear drop in inflammation with biologics, but it’s not completely stopped. This led to a lot of speculation as to whether inflammation and ankyloses are coupled or not.”
More recently, researchers have honed in on the transition from acute inflammatory lesions visible on MRI by bone marrow edema to so-called fatty lesions, which are also visible on MRI. They have observed that fatty lesions are associated with new bone formation. “Lesions containing more fat are thought to be more difficult to modulate by biological therapy,” Dr. Elewaut said. “Once you have a fatty lesion, you have some kind of metabolic disease of the bone, and it’s a one-way road to the development of new syndesmophytes. So in other words, it is essential to assess the relationship between inflammation and new bone formation with both the STIR [short tau inversion recovery images] and T1-weighted MRI.”
A working hypothesis among AS researchers is that the effect of anti-TNF therapy on radiologic progression depends on the relative number of acute and mature inflammatory lesions that individual patients have. “Early diagnosis is a prerequisite for advances in disease modification,” he said. At least three “windows of opportunity” for disease modification exist, Dr. Elewaut continued. One is that the link between inflammation as measured by clinical parameters and new bone formation will be more evident in early AS. The second is that early treatment of patients with axial AS and spinal inflammation with anti-TNF agents will prevent new bone formation. The third is that reduction of new bone formation in established AS will be observed only with long-term anti-TNF therapy after mature lesions have resolved/repaired, and no new inflammatory lesions are being formed. One study found that patients with a delay of more than 10 years starting anti-TNF therapy were more likely to progress, compared with patients who received therapy earlier (odds ratio, 2.4; P = .03; see Arthritis Rheum. 2013;65:645-54). “The message here is quite clear,” Dr. Elewaut said. “The earlier we treat intensively, the better impact you have on structural outcomes.”
In a trial known as CRESPA (Clinical Remission in peripheral SPondyloArthritis), researchers including Dr. Elewaut evaluated the efficacy and safety of golimumab (Simponi) to induce clinical remission in patients with early, active peripheral AS (Ann Rheum Dis. 2017;76:1389-95). In all, 60 patients were randomized to golimumab or placebo for 24 weeks. At week 24, a significantly higher percentage of patients receiving golimumab achieved clinical remission, compared with placebo (75% vs. 20%, respectively; P less than .001). At week 12, similar results were observed (70% vs. 15%; P less than .001).
“These were very striking results in this early disease population,” Dr. Elewaut said. In a follow-up analysis, the researchers withdrew therapy in patients who reached clinical remission, to see what would happen. “At 1.5 years of follow-up, 57% of patients are in drug-free remission,” Dr. Elewaut said. “This is interesting and suggests that at least in a fraction of those patients, you can actually achieve a drug-free remission.” Predictors for relapse included pre-existing psoriasis and having more than five swollen joints.
Dr. Elewaut disclosed that he is a member of the speakers bureau for AbbVie, Novartis, Pfizer, and UCB. Global Academy for Medical Education and this news organization are owned by the same parent company.
Structural damage in axial and peripheral ankylosing spondylitis is the result of a combination of destruction and new bone formation, which can be halted if treated early and for long enough, according to Dirk Elewaut, MD, PhD.
“There is a longstanding paradox in the field of ankylosing spondylitis, as to whether there is a strict relationship between the inflammation that leads to the signs and symptoms in patients, and the structural progression,” said Dr. Elewaut, who spoke at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education. “ ”
One key reason why the early TNF inhibition trials showed no effect of treatment on structural progression stemmed from inadequate study design. “The original studies were underpowered, and the patients used NSAIDs,” he said. “We also know that the anti-inflammatory effect [of TNF inhibition] is not 100%. So you have a clear drop in inflammation with biologics, but it’s not completely stopped. This led to a lot of speculation as to whether inflammation and ankyloses are coupled or not.”
More recently, researchers have honed in on the transition from acute inflammatory lesions visible on MRI by bone marrow edema to so-called fatty lesions, which are also visible on MRI. They have observed that fatty lesions are associated with new bone formation. “Lesions containing more fat are thought to be more difficult to modulate by biological therapy,” Dr. Elewaut said. “Once you have a fatty lesion, you have some kind of metabolic disease of the bone, and it’s a one-way road to the development of new syndesmophytes. So in other words, it is essential to assess the relationship between inflammation and new bone formation with both the STIR [short tau inversion recovery images] and T1-weighted MRI.”
A working hypothesis among AS researchers is that the effect of anti-TNF therapy on radiologic progression depends on the relative number of acute and mature inflammatory lesions that individual patients have. “Early diagnosis is a prerequisite for advances in disease modification,” he said. At least three “windows of opportunity” for disease modification exist, Dr. Elewaut continued. One is that the link between inflammation as measured by clinical parameters and new bone formation will be more evident in early AS. The second is that early treatment of patients with axial AS and spinal inflammation with anti-TNF agents will prevent new bone formation. The third is that reduction of new bone formation in established AS will be observed only with long-term anti-TNF therapy after mature lesions have resolved/repaired, and no new inflammatory lesions are being formed. One study found that patients with a delay of more than 10 years starting anti-TNF therapy were more likely to progress, compared with patients who received therapy earlier (odds ratio, 2.4; P = .03; see Arthritis Rheum. 2013;65:645-54). “The message here is quite clear,” Dr. Elewaut said. “The earlier we treat intensively, the better impact you have on structural outcomes.”
In a trial known as CRESPA (Clinical Remission in peripheral SPondyloArthritis), researchers including Dr. Elewaut evaluated the efficacy and safety of golimumab (Simponi) to induce clinical remission in patients with early, active peripheral AS (Ann Rheum Dis. 2017;76:1389-95). In all, 60 patients were randomized to golimumab or placebo for 24 weeks. At week 24, a significantly higher percentage of patients receiving golimumab achieved clinical remission, compared with placebo (75% vs. 20%, respectively; P less than .001). At week 12, similar results were observed (70% vs. 15%; P less than .001).
“These were very striking results in this early disease population,” Dr. Elewaut said. In a follow-up analysis, the researchers withdrew therapy in patients who reached clinical remission, to see what would happen. “At 1.5 years of follow-up, 57% of patients are in drug-free remission,” Dr. Elewaut said. “This is interesting and suggests that at least in a fraction of those patients, you can actually achieve a drug-free remission.” Predictors for relapse included pre-existing psoriasis and having more than five swollen joints.
Dr. Elewaut disclosed that he is a member of the speakers bureau for AbbVie, Novartis, Pfizer, and UCB. Global Academy for Medical Education and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM ANNUAL PERSPECTIVES IN RHEUMATIC DISEASES
Impact of elder program on delirium and LOS for abdominal surgery patients
Clinical question: Can a modified Hospital Elder Life Program (mHELP) reduce delirium and hospital LOS in older patients undergoing abdominal surgery?
Background: Development of delirium in the hospitalized patient, especially postsurgical patients, can have detrimental effects on the clinical recovery and LOS. Delirium occurs in 13%-50% of patients undergoing noncardiac surgery, and older surgical patients are at a higher risk.
Study design: Cluster randomized clinical trial.
Synopsis: There were 377 older patients (65 years of age or older) who were admitted for elective abdominal surgery (gastrectomy, pancreaticoduodenectomy, or colectomy) with an expected LOS greater than 6 days enrolled and randomly assigned to mHELP group (197 patients) or control group (180 patients). The mHELP intervention consisted of three core nursing protocols that occurred daily by a trained nurse: orienting communication, oral and nutritional assistance, and early mobilization. Delirium developed in 13 cases (6.6%) in the mHELP group and in 27 cases (15.1%) in the control group. This is a risk reduction of 56% indicating the need to treat 11.8 patients to prevent one case of delirium. The mHELP group had a 2-day hospital LOS reduction, compared with the control group. The effect of mHELP could be underestimated as crossover effects were not accounted for in the study. Data were not collected on postoperative complications which can have a significant effect on delirium occurrence.
Bottom line: The three nursing protocols of mHELP reduced rates of delirium and hospital LOS in older adults undergoing abdominal surgeries and could be a quick intervention to reduce the most common surgical complication in older patients.
Citation: Chen CC, Li HC, Liang JT, et al. Effect of a modified hospital elder life program on delirium and length of hospital stay in patients undergoing abdominal surgery. JAMA Surg. Published online May 24, 2017. doi: 10.1001/jamasurg.2017.1083.
Dr. Newsom is a hospitalist at Ochsner Health System, New Orleans.
Clinical question: Can a modified Hospital Elder Life Program (mHELP) reduce delirium and hospital LOS in older patients undergoing abdominal surgery?
Background: Development of delirium in the hospitalized patient, especially postsurgical patients, can have detrimental effects on the clinical recovery and LOS. Delirium occurs in 13%-50% of patients undergoing noncardiac surgery, and older surgical patients are at a higher risk.
Study design: Cluster randomized clinical trial.
Synopsis: There were 377 older patients (65 years of age or older) who were admitted for elective abdominal surgery (gastrectomy, pancreaticoduodenectomy, or colectomy) with an expected LOS greater than 6 days enrolled and randomly assigned to mHELP group (197 patients) or control group (180 patients). The mHELP intervention consisted of three core nursing protocols that occurred daily by a trained nurse: orienting communication, oral and nutritional assistance, and early mobilization. Delirium developed in 13 cases (6.6%) in the mHELP group and in 27 cases (15.1%) in the control group. This is a risk reduction of 56% indicating the need to treat 11.8 patients to prevent one case of delirium. The mHELP group had a 2-day hospital LOS reduction, compared with the control group. The effect of mHELP could be underestimated as crossover effects were not accounted for in the study. Data were not collected on postoperative complications which can have a significant effect on delirium occurrence.
Bottom line: The three nursing protocols of mHELP reduced rates of delirium and hospital LOS in older adults undergoing abdominal surgeries and could be a quick intervention to reduce the most common surgical complication in older patients.
Citation: Chen CC, Li HC, Liang JT, et al. Effect of a modified hospital elder life program on delirium and length of hospital stay in patients undergoing abdominal surgery. JAMA Surg. Published online May 24, 2017. doi: 10.1001/jamasurg.2017.1083.
Dr. Newsom is a hospitalist at Ochsner Health System, New Orleans.
Clinical question: Can a modified Hospital Elder Life Program (mHELP) reduce delirium and hospital LOS in older patients undergoing abdominal surgery?
Background: Development of delirium in the hospitalized patient, especially postsurgical patients, can have detrimental effects on the clinical recovery and LOS. Delirium occurs in 13%-50% of patients undergoing noncardiac surgery, and older surgical patients are at a higher risk.
Study design: Cluster randomized clinical trial.
Synopsis: There were 377 older patients (65 years of age or older) who were admitted for elective abdominal surgery (gastrectomy, pancreaticoduodenectomy, or colectomy) with an expected LOS greater than 6 days enrolled and randomly assigned to mHELP group (197 patients) or control group (180 patients). The mHELP intervention consisted of three core nursing protocols that occurred daily by a trained nurse: orienting communication, oral and nutritional assistance, and early mobilization. Delirium developed in 13 cases (6.6%) in the mHELP group and in 27 cases (15.1%) in the control group. This is a risk reduction of 56% indicating the need to treat 11.8 patients to prevent one case of delirium. The mHELP group had a 2-day hospital LOS reduction, compared with the control group. The effect of mHELP could be underestimated as crossover effects were not accounted for in the study. Data were not collected on postoperative complications which can have a significant effect on delirium occurrence.
Bottom line: The three nursing protocols of mHELP reduced rates of delirium and hospital LOS in older adults undergoing abdominal surgeries and could be a quick intervention to reduce the most common surgical complication in older patients.
Citation: Chen CC, Li HC, Liang JT, et al. Effect of a modified hospital elder life program on delirium and length of hospital stay in patients undergoing abdominal surgery. JAMA Surg. Published online May 24, 2017. doi: 10.1001/jamasurg.2017.1083.
Dr. Newsom is a hospitalist at Ochsner Health System, New Orleans.
ECHO rheumatology programs increase access, improve care
As in many places throughout the country, rheumatologists are in short supply in southern Arizona. Patients frequently wait up to 6 months to visit a rheumatologist at Banner University Medical Center (BUMC) in Tucson, and many drive between 3 and 4 hours for the appointment, said Dominick G. Sudano, MD, a rheumatologist at BUMC, which is affiliated with the University of Arizona.
[polldaddy:9823712]
The high demand for rheumatologists and lack of timely access led the University of Arizona to develop a program that will train primary care providers at remote sites to treat rheumatic diseases. The program, a partnership between the university’s Arizona Telemedicine Program and the University of Arizona Center for Rural Health, will use the popular ECHO (Extension for Community Healthcare Outcomes) model, founded by the University of New Mexico in Albuquerque, which aims to increase workforce capacity by sharing medical knowledge.
A unique model of care
As part of the program, set to launch this month, Dr. Sudano will hold rheumatology training sessions via telemedicine for primary care physicians and other nonphysicians at four remote sites around Arizona. Participating sites include Canyonlands Healthcare, North County Healthcare, and Northern Arizona Healthcare – all located in the northern part of the state – and Copper Queen Community Hospital in southern Arizona.
The virtual sessions will include both educational topics and the opportunity for local doctors and health professionals to present patient cases to Dr. Sudano for guidance. The local doctors and health professionals will eventually treat rheumatic cases in their communities, while cases identified as severe will still be referred to rheumatologists.
The university’s Arizona Telemedicine Program was fortunate to receive a $17,700 grant from Lilly to launch the 1-year rheumatology ECHO pilot program, Dr. Sudano noted. The grant will enable the program to get off the ground, while administrators search for additional funding sources to become sustainable, he said.
Dr. Sudano credits the assistance and support of the University of New Mexico and its ECHO leaders for helping the University of Arizona build its ECHO rheumatology program and helping administrators address the details of setting up the program.
“[The University of New Mexico] was immensely helpful,” he said. “They have immersion sessions about once a month and you spend [time] working with their team. They work with you to get the logistics ironed out.”
A spreading movement
The University of New Mexico (UNM) has good reason to assist other health and academic medical centers in launching their own ECHO programs. UNM’s mission is to continue building the ECHO movement and accomplish its goal of “touching 1 billion lives” by 2025, said Sanjeev Arora, MD, a gastroenterologist at UNM and founder/director of the university’s Project ECHO.
“There was a great shortage of specialists to treat hepatitis C so I came up with this idea of ECHO to bring access to care to everyone in New Mexico who needed care,” he said. “The second part of the idea was, if we could do that for hepatitis C, we could do that for a lot of other problems like rheumatoid arthritis, like addiction, like diabetes.”
Project ECHO has now spread to medical centers and hospitals across the country, with programs that center on asthma, HIV infection, cardiac risk reduction, chronic pain management, geriatrics, palliative care, substance abuse, and obesity, among others. The model is now in 139 academic hubs in 24 countries with more than 65 health conditions targeted, according to Dr. Arora. Replication sites focus on four key principles of ECHO: technology used to leverage scarce health care expertise and resources; best practices shared to standardize care across disparate health care delivery systems; case-based learning used as the primary modality to build knowledge, confidence, and expertise; and evaluations conducted to monitor outcomes.
Data show the care patients receive via the ECHO model is equal to that of care provided by university-based specialists. A 2011 report published in the New England Journal of Medicine, for example, found that a sustained viral response to treatment for hepatitis C was achieved in 58% of patients managed at the university and by 58% of patients managed by primary care physicians at rural and prison sites who participated in Project ECHO (N Engl J Med. 2011;364:2199-2207). Response rates to different subtypes of hepatitis C also did not differ significantly between the two groups.
The ECHO model has also greatly improved access and outcomes for hepatitis C patients in Northern Arizona, said Colleen Hopkins, telehealth coordinator at North Country Healthcare in Flagstaff. North Country Healthcare has participated in a hepatitis C ECHO program since 2012, linking its chain of 14 community health centers with a hepatologist-educator at St. Joseph’s Hospital and Medical Center in Phoenix, 140 miles to the south.
“In 2011, more than 950 patients in the health system’s network had a hepatitis C diagnosis, but the majority did not have access to care,” Ms. Hopkins said in an interview.
“To date, over 500 patients have received care for their liver disease in rural Northern Arizona,” she said. “These numbers continue to climb as our awareness has caused an increase in screening and various outreach efforts ... Overall, our providers and patients are empowered by having access to specialty care; they are living longer healthier lives as well as keeping money in our communities.”
Rheumatology and the ECHO model
The volume of rheumatic conditions encountered by primary care physicians and the shortage of specialists make rheumatology a logical fit for the ECHO model, Dr. Arora said. Rheumatoid arthritis, osteoarthritis, osteoporosis, fibromyalgia, and joint pain account for as many as one in five visits to primary care doctors, he noted.
“Osteoporosis and rheumatoid arthritis produce massive disability in the world,” he said. “Treatment exists, but it’s not getting to patients. ECHO can fundamentally transform the field of rheumatology if it’s adopted widely.”
However, compared with other specialty ECHO models, there are not many rheumatology ECHO programs in operation. Dr. Arora is hopeful that as word spreads about how well rheumatology fits into the ECHO structure, more programs will develop, he said.
“We have found over the years that with our training these providers – both physicians and nonphysician – are able to function as well as a specially trained [rheumatologist],” Dr. Bankhurst said. “We help them as needed by our weekly teleconference where they present cases to us and those cases which appear to be most difficult, we see immediately in our clinics.”
The program has led to decreased referrals to the university from outlying areas and more care access for patients in rural areas, Dr. Bankhurst said. A university study is underway to analyze clinical outcomes for rheumatoid arthritis as conducted by distant provider sites compared with treatment at the university clinic.
“It’s my perspective, based on 12 years of experience, that they’ll be identical,” he said.
Setting up such ECHO programs is not without challenges. Financial support for telecommunication equipment in all needed areas can be difficult, Dr. Bankhurst said. Recruiting individuals who are well motivated to participate in the program can also be a challenge.
“It needs a commitment by the administration,” he said. “It does take time from other activities. It requires dedicated time away from a busy clinic.”
agallegos@frontlinemedcom.com
On Twitter @legal_med
As in many places throughout the country, rheumatologists are in short supply in southern Arizona. Patients frequently wait up to 6 months to visit a rheumatologist at Banner University Medical Center (BUMC) in Tucson, and many drive between 3 and 4 hours for the appointment, said Dominick G. Sudano, MD, a rheumatologist at BUMC, which is affiliated with the University of Arizona.
[polldaddy:9823712]
The high demand for rheumatologists and lack of timely access led the University of Arizona to develop a program that will train primary care providers at remote sites to treat rheumatic diseases. The program, a partnership between the university’s Arizona Telemedicine Program and the University of Arizona Center for Rural Health, will use the popular ECHO (Extension for Community Healthcare Outcomes) model, founded by the University of New Mexico in Albuquerque, which aims to increase workforce capacity by sharing medical knowledge.
A unique model of care
As part of the program, set to launch this month, Dr. Sudano will hold rheumatology training sessions via telemedicine for primary care physicians and other nonphysicians at four remote sites around Arizona. Participating sites include Canyonlands Healthcare, North County Healthcare, and Northern Arizona Healthcare – all located in the northern part of the state – and Copper Queen Community Hospital in southern Arizona.
The virtual sessions will include both educational topics and the opportunity for local doctors and health professionals to present patient cases to Dr. Sudano for guidance. The local doctors and health professionals will eventually treat rheumatic cases in their communities, while cases identified as severe will still be referred to rheumatologists.
The university’s Arizona Telemedicine Program was fortunate to receive a $17,700 grant from Lilly to launch the 1-year rheumatology ECHO pilot program, Dr. Sudano noted. The grant will enable the program to get off the ground, while administrators search for additional funding sources to become sustainable, he said.
Dr. Sudano credits the assistance and support of the University of New Mexico and its ECHO leaders for helping the University of Arizona build its ECHO rheumatology program and helping administrators address the details of setting up the program.
“[The University of New Mexico] was immensely helpful,” he said. “They have immersion sessions about once a month and you spend [time] working with their team. They work with you to get the logistics ironed out.”
A spreading movement
The University of New Mexico (UNM) has good reason to assist other health and academic medical centers in launching their own ECHO programs. UNM’s mission is to continue building the ECHO movement and accomplish its goal of “touching 1 billion lives” by 2025, said Sanjeev Arora, MD, a gastroenterologist at UNM and founder/director of the university’s Project ECHO.
“There was a great shortage of specialists to treat hepatitis C so I came up with this idea of ECHO to bring access to care to everyone in New Mexico who needed care,” he said. “The second part of the idea was, if we could do that for hepatitis C, we could do that for a lot of other problems like rheumatoid arthritis, like addiction, like diabetes.”
Project ECHO has now spread to medical centers and hospitals across the country, with programs that center on asthma, HIV infection, cardiac risk reduction, chronic pain management, geriatrics, palliative care, substance abuse, and obesity, among others. The model is now in 139 academic hubs in 24 countries with more than 65 health conditions targeted, according to Dr. Arora. Replication sites focus on four key principles of ECHO: technology used to leverage scarce health care expertise and resources; best practices shared to standardize care across disparate health care delivery systems; case-based learning used as the primary modality to build knowledge, confidence, and expertise; and evaluations conducted to monitor outcomes.
Data show the care patients receive via the ECHO model is equal to that of care provided by university-based specialists. A 2011 report published in the New England Journal of Medicine, for example, found that a sustained viral response to treatment for hepatitis C was achieved in 58% of patients managed at the university and by 58% of patients managed by primary care physicians at rural and prison sites who participated in Project ECHO (N Engl J Med. 2011;364:2199-2207). Response rates to different subtypes of hepatitis C also did not differ significantly between the two groups.
The ECHO model has also greatly improved access and outcomes for hepatitis C patients in Northern Arizona, said Colleen Hopkins, telehealth coordinator at North Country Healthcare in Flagstaff. North Country Healthcare has participated in a hepatitis C ECHO program since 2012, linking its chain of 14 community health centers with a hepatologist-educator at St. Joseph’s Hospital and Medical Center in Phoenix, 140 miles to the south.
“In 2011, more than 950 patients in the health system’s network had a hepatitis C diagnosis, but the majority did not have access to care,” Ms. Hopkins said in an interview.
“To date, over 500 patients have received care for their liver disease in rural Northern Arizona,” she said. “These numbers continue to climb as our awareness has caused an increase in screening and various outreach efforts ... Overall, our providers and patients are empowered by having access to specialty care; they are living longer healthier lives as well as keeping money in our communities.”
Rheumatology and the ECHO model
The volume of rheumatic conditions encountered by primary care physicians and the shortage of specialists make rheumatology a logical fit for the ECHO model, Dr. Arora said. Rheumatoid arthritis, osteoarthritis, osteoporosis, fibromyalgia, and joint pain account for as many as one in five visits to primary care doctors, he noted.
“Osteoporosis and rheumatoid arthritis produce massive disability in the world,” he said. “Treatment exists, but it’s not getting to patients. ECHO can fundamentally transform the field of rheumatology if it’s adopted widely.”
However, compared with other specialty ECHO models, there are not many rheumatology ECHO programs in operation. Dr. Arora is hopeful that as word spreads about how well rheumatology fits into the ECHO structure, more programs will develop, he said.
“We have found over the years that with our training these providers – both physicians and nonphysician – are able to function as well as a specially trained [rheumatologist],” Dr. Bankhurst said. “We help them as needed by our weekly teleconference where they present cases to us and those cases which appear to be most difficult, we see immediately in our clinics.”
The program has led to decreased referrals to the university from outlying areas and more care access for patients in rural areas, Dr. Bankhurst said. A university study is underway to analyze clinical outcomes for rheumatoid arthritis as conducted by distant provider sites compared with treatment at the university clinic.
“It’s my perspective, based on 12 years of experience, that they’ll be identical,” he said.
Setting up such ECHO programs is not without challenges. Financial support for telecommunication equipment in all needed areas can be difficult, Dr. Bankhurst said. Recruiting individuals who are well motivated to participate in the program can also be a challenge.
“It needs a commitment by the administration,” he said. “It does take time from other activities. It requires dedicated time away from a busy clinic.”
agallegos@frontlinemedcom.com
On Twitter @legal_med
As in many places throughout the country, rheumatologists are in short supply in southern Arizona. Patients frequently wait up to 6 months to visit a rheumatologist at Banner University Medical Center (BUMC) in Tucson, and many drive between 3 and 4 hours for the appointment, said Dominick G. Sudano, MD, a rheumatologist at BUMC, which is affiliated with the University of Arizona.
[polldaddy:9823712]
The high demand for rheumatologists and lack of timely access led the University of Arizona to develop a program that will train primary care providers at remote sites to treat rheumatic diseases. The program, a partnership between the university’s Arizona Telemedicine Program and the University of Arizona Center for Rural Health, will use the popular ECHO (Extension for Community Healthcare Outcomes) model, founded by the University of New Mexico in Albuquerque, which aims to increase workforce capacity by sharing medical knowledge.
A unique model of care
As part of the program, set to launch this month, Dr. Sudano will hold rheumatology training sessions via telemedicine for primary care physicians and other nonphysicians at four remote sites around Arizona. Participating sites include Canyonlands Healthcare, North County Healthcare, and Northern Arizona Healthcare – all located in the northern part of the state – and Copper Queen Community Hospital in southern Arizona.
The virtual sessions will include both educational topics and the opportunity for local doctors and health professionals to present patient cases to Dr. Sudano for guidance. The local doctors and health professionals will eventually treat rheumatic cases in their communities, while cases identified as severe will still be referred to rheumatologists.
The university’s Arizona Telemedicine Program was fortunate to receive a $17,700 grant from Lilly to launch the 1-year rheumatology ECHO pilot program, Dr. Sudano noted. The grant will enable the program to get off the ground, while administrators search for additional funding sources to become sustainable, he said.
Dr. Sudano credits the assistance and support of the University of New Mexico and its ECHO leaders for helping the University of Arizona build its ECHO rheumatology program and helping administrators address the details of setting up the program.
“[The University of New Mexico] was immensely helpful,” he said. “They have immersion sessions about once a month and you spend [time] working with their team. They work with you to get the logistics ironed out.”
A spreading movement
The University of New Mexico (UNM) has good reason to assist other health and academic medical centers in launching their own ECHO programs. UNM’s mission is to continue building the ECHO movement and accomplish its goal of “touching 1 billion lives” by 2025, said Sanjeev Arora, MD, a gastroenterologist at UNM and founder/director of the university’s Project ECHO.
“There was a great shortage of specialists to treat hepatitis C so I came up with this idea of ECHO to bring access to care to everyone in New Mexico who needed care,” he said. “The second part of the idea was, if we could do that for hepatitis C, we could do that for a lot of other problems like rheumatoid arthritis, like addiction, like diabetes.”
Project ECHO has now spread to medical centers and hospitals across the country, with programs that center on asthma, HIV infection, cardiac risk reduction, chronic pain management, geriatrics, palliative care, substance abuse, and obesity, among others. The model is now in 139 academic hubs in 24 countries with more than 65 health conditions targeted, according to Dr. Arora. Replication sites focus on four key principles of ECHO: technology used to leverage scarce health care expertise and resources; best practices shared to standardize care across disparate health care delivery systems; case-based learning used as the primary modality to build knowledge, confidence, and expertise; and evaluations conducted to monitor outcomes.
Data show the care patients receive via the ECHO model is equal to that of care provided by university-based specialists. A 2011 report published in the New England Journal of Medicine, for example, found that a sustained viral response to treatment for hepatitis C was achieved in 58% of patients managed at the university and by 58% of patients managed by primary care physicians at rural and prison sites who participated in Project ECHO (N Engl J Med. 2011;364:2199-2207). Response rates to different subtypes of hepatitis C also did not differ significantly between the two groups.
The ECHO model has also greatly improved access and outcomes for hepatitis C patients in Northern Arizona, said Colleen Hopkins, telehealth coordinator at North Country Healthcare in Flagstaff. North Country Healthcare has participated in a hepatitis C ECHO program since 2012, linking its chain of 14 community health centers with a hepatologist-educator at St. Joseph’s Hospital and Medical Center in Phoenix, 140 miles to the south.
“In 2011, more than 950 patients in the health system’s network had a hepatitis C diagnosis, but the majority did not have access to care,” Ms. Hopkins said in an interview.
“To date, over 500 patients have received care for their liver disease in rural Northern Arizona,” she said. “These numbers continue to climb as our awareness has caused an increase in screening and various outreach efforts ... Overall, our providers and patients are empowered by having access to specialty care; they are living longer healthier lives as well as keeping money in our communities.”
Rheumatology and the ECHO model
The volume of rheumatic conditions encountered by primary care physicians and the shortage of specialists make rheumatology a logical fit for the ECHO model, Dr. Arora said. Rheumatoid arthritis, osteoarthritis, osteoporosis, fibromyalgia, and joint pain account for as many as one in five visits to primary care doctors, he noted.
“Osteoporosis and rheumatoid arthritis produce massive disability in the world,” he said. “Treatment exists, but it’s not getting to patients. ECHO can fundamentally transform the field of rheumatology if it’s adopted widely.”
However, compared with other specialty ECHO models, there are not many rheumatology ECHO programs in operation. Dr. Arora is hopeful that as word spreads about how well rheumatology fits into the ECHO structure, more programs will develop, he said.
“We have found over the years that with our training these providers – both physicians and nonphysician – are able to function as well as a specially trained [rheumatologist],” Dr. Bankhurst said. “We help them as needed by our weekly teleconference where they present cases to us and those cases which appear to be most difficult, we see immediately in our clinics.”
The program has led to decreased referrals to the university from outlying areas and more care access for patients in rural areas, Dr. Bankhurst said. A university study is underway to analyze clinical outcomes for rheumatoid arthritis as conducted by distant provider sites compared with treatment at the university clinic.
“It’s my perspective, based on 12 years of experience, that they’ll be identical,” he said.
Setting up such ECHO programs is not without challenges. Financial support for telecommunication equipment in all needed areas can be difficult, Dr. Bankhurst said. Recruiting individuals who are well motivated to participate in the program can also be a challenge.
“It needs a commitment by the administration,” he said. “It does take time from other activities. It requires dedicated time away from a busy clinic.”
agallegos@frontlinemedcom.com
On Twitter @legal_med
The 3 Reasons Patients With Diabetes Don’t Get Eye Care
As diabetes becomes more prevalent, so do eye diseases. The good news is that many patients are aware of the risk. However, they may think that they do not need regular eye checkups. Patient awareness of the value of prevention is a key message in a study by researchers from the University of Lausanne in Switzerland.
In their study of 323 patients, 41% of patients with type 1 diabetes (T1DM) and 10% of those with type 2 diabetes (T2DM) had diabetic retinopathy. One-third of patients had myopia, astigmatism, and other common visual defects, 36% had cataract, and 13% had glaucoma. The patients with T1DM were about 5 times more likely to have more than 3 eye diseases than were those with type 2.
But all patients with T1DM and 95% of those with T2DM knew that diabetes could damage the eyes. Further, the “vast majority” of all the patients knew the benefit of maintaining good glycemic control and getting regular eye examinations by an ophthalmologist. About 91% of patients with T1DM and 85% of patients with T2DM knew that controlling blood pressure and lipids also was important. But one-quarter of the participants thought nothing could be done to prevent diabetic eye diseases—that they were the result of bad luck.
About 71% of the participants were examined by an ophthalmologist in the previous year. Exploring the reasons, the researchers found 3 main barriers: Patients said they had no visual symptoms, they felt they didn’t need an exam because their diabetes was well controlled, or they did not get recommendations from their family physician or diabetologist. The researchers say diabetic retinopathy may be underestimated because some patients are not getting eye exams.
Conversely, the 3 main reasons for regular eye exams, according to patient reports, were that health care professionals recommended them, patients were aware of the importance of regular controls, and they knew the risks of diabetes-related retinal problems.
The researchers say physicians can help by emphasizing that preventive care includes regular eye exams. They also suggest that it may be time to “broaden the diabetes education perspective” and include all significant diabetic eye diseases instead of focusing on diabetic retinopathy.
Source:
Konstantinidis L, Carron T, de Ancos E, et al. BMC Endocr Disord. 2017;17(1):56.
doi: 10.1186/s12902-017-0206-2.
As diabetes becomes more prevalent, so do eye diseases. The good news is that many patients are aware of the risk. However, they may think that they do not need regular eye checkups. Patient awareness of the value of prevention is a key message in a study by researchers from the University of Lausanne in Switzerland.
In their study of 323 patients, 41% of patients with type 1 diabetes (T1DM) and 10% of those with type 2 diabetes (T2DM) had diabetic retinopathy. One-third of patients had myopia, astigmatism, and other common visual defects, 36% had cataract, and 13% had glaucoma. The patients with T1DM were about 5 times more likely to have more than 3 eye diseases than were those with type 2.
But all patients with T1DM and 95% of those with T2DM knew that diabetes could damage the eyes. Further, the “vast majority” of all the patients knew the benefit of maintaining good glycemic control and getting regular eye examinations by an ophthalmologist. About 91% of patients with T1DM and 85% of patients with T2DM knew that controlling blood pressure and lipids also was important. But one-quarter of the participants thought nothing could be done to prevent diabetic eye diseases—that they were the result of bad luck.
About 71% of the participants were examined by an ophthalmologist in the previous year. Exploring the reasons, the researchers found 3 main barriers: Patients said they had no visual symptoms, they felt they didn’t need an exam because their diabetes was well controlled, or they did not get recommendations from their family physician or diabetologist. The researchers say diabetic retinopathy may be underestimated because some patients are not getting eye exams.
Conversely, the 3 main reasons for regular eye exams, according to patient reports, were that health care professionals recommended them, patients were aware of the importance of regular controls, and they knew the risks of diabetes-related retinal problems.
The researchers say physicians can help by emphasizing that preventive care includes regular eye exams. They also suggest that it may be time to “broaden the diabetes education perspective” and include all significant diabetic eye diseases instead of focusing on diabetic retinopathy.
Source:
Konstantinidis L, Carron T, de Ancos E, et al. BMC Endocr Disord. 2017;17(1):56.
doi: 10.1186/s12902-017-0206-2.
As diabetes becomes more prevalent, so do eye diseases. The good news is that many patients are aware of the risk. However, they may think that they do not need regular eye checkups. Patient awareness of the value of prevention is a key message in a study by researchers from the University of Lausanne in Switzerland.
In their study of 323 patients, 41% of patients with type 1 diabetes (T1DM) and 10% of those with type 2 diabetes (T2DM) had diabetic retinopathy. One-third of patients had myopia, astigmatism, and other common visual defects, 36% had cataract, and 13% had glaucoma. The patients with T1DM were about 5 times more likely to have more than 3 eye diseases than were those with type 2.
But all patients with T1DM and 95% of those with T2DM knew that diabetes could damage the eyes. Further, the “vast majority” of all the patients knew the benefit of maintaining good glycemic control and getting regular eye examinations by an ophthalmologist. About 91% of patients with T1DM and 85% of patients with T2DM knew that controlling blood pressure and lipids also was important. But one-quarter of the participants thought nothing could be done to prevent diabetic eye diseases—that they were the result of bad luck.
About 71% of the participants were examined by an ophthalmologist in the previous year. Exploring the reasons, the researchers found 3 main barriers: Patients said they had no visual symptoms, they felt they didn’t need an exam because their diabetes was well controlled, or they did not get recommendations from their family physician or diabetologist. The researchers say diabetic retinopathy may be underestimated because some patients are not getting eye exams.
Conversely, the 3 main reasons for regular eye exams, according to patient reports, were that health care professionals recommended them, patients were aware of the importance of regular controls, and they knew the risks of diabetes-related retinal problems.
The researchers say physicians can help by emphasizing that preventive care includes regular eye exams. They also suggest that it may be time to “broaden the diabetes education perspective” and include all significant diabetic eye diseases instead of focusing on diabetic retinopathy.
Source:
Konstantinidis L, Carron T, de Ancos E, et al. BMC Endocr Disord. 2017;17(1):56.
doi: 10.1186/s12902-017-0206-2.
Nearly Half of Patients Have HIV Under Control
More people living with HIV have the virus under control, according to the most recent national data. In 2014, CDC researchers say, of the estimated 1.1 million people with HIV in the U.S., 85% were diagnosed and 49% were controlling the virus through HIV treatment. By comparison, in 2010, 83% were diagnosed but only 28% were controlling the virus. The data were released recently in the CDC’s report, Monitoring Selected National HIV Prevention and Care Objectives by Using HIV Surveillance Data.
The CDC says making testing and treatment more available in addition to updated treatment guidelines released in 2012 that recommended treatment for all people with HIV infection, were “likely major contributors” to driving down annual infections by 18% between 2008-2014.
In 2014, 37,600 new infections were diagnosed. Of HIV infections diagnosed during 2015, 22% were classified as stage 3 (AIDS), although the percentages had declined from 2010. Nine out of 10 HIV infections are transmitted by people who are not diagnosed or are not in care. Young people are at highest risk. According to the CDC researchers’ estimates, only 56% of people aged 13-24 years with HIV were diagnosed and only 27% had the virus under control.
However, patients are getting appropriate care sooner and more often. Of 28,238 people who were diagnosed during 2015, 75% were linked to HIV medical care within 1 month of diagnosis, and 84% within 3 months.
“The Monitoring Report signals that we are making progress on most of our national HIV prevention, care and treatment goals,” said Richard Wolitski, PhD, director, Office of HIV/AIDS and Infectious Disease Policy in his blog on HIV.gov. “It also shows us where we need to do better and reassess our efforts, diagnose the problems and use this information to make the changes to our policies, programs, and services that are needed to turn the results around.”
More people living with HIV have the virus under control, according to the most recent national data. In 2014, CDC researchers say, of the estimated 1.1 million people with HIV in the U.S., 85% were diagnosed and 49% were controlling the virus through HIV treatment. By comparison, in 2010, 83% were diagnosed but only 28% were controlling the virus. The data were released recently in the CDC’s report, Monitoring Selected National HIV Prevention and Care Objectives by Using HIV Surveillance Data.
The CDC says making testing and treatment more available in addition to updated treatment guidelines released in 2012 that recommended treatment for all people with HIV infection, were “likely major contributors” to driving down annual infections by 18% between 2008-2014.
In 2014, 37,600 new infections were diagnosed. Of HIV infections diagnosed during 2015, 22% were classified as stage 3 (AIDS), although the percentages had declined from 2010. Nine out of 10 HIV infections are transmitted by people who are not diagnosed or are not in care. Young people are at highest risk. According to the CDC researchers’ estimates, only 56% of people aged 13-24 years with HIV were diagnosed and only 27% had the virus under control.
However, patients are getting appropriate care sooner and more often. Of 28,238 people who were diagnosed during 2015, 75% were linked to HIV medical care within 1 month of diagnosis, and 84% within 3 months.
“The Monitoring Report signals that we are making progress on most of our national HIV prevention, care and treatment goals,” said Richard Wolitski, PhD, director, Office of HIV/AIDS and Infectious Disease Policy in his blog on HIV.gov. “It also shows us where we need to do better and reassess our efforts, diagnose the problems and use this information to make the changes to our policies, programs, and services that are needed to turn the results around.”
More people living with HIV have the virus under control, according to the most recent national data. In 2014, CDC researchers say, of the estimated 1.1 million people with HIV in the U.S., 85% were diagnosed and 49% were controlling the virus through HIV treatment. By comparison, in 2010, 83% were diagnosed but only 28% were controlling the virus. The data were released recently in the CDC’s report, Monitoring Selected National HIV Prevention and Care Objectives by Using HIV Surveillance Data.
The CDC says making testing and treatment more available in addition to updated treatment guidelines released in 2012 that recommended treatment for all people with HIV infection, were “likely major contributors” to driving down annual infections by 18% between 2008-2014.
In 2014, 37,600 new infections were diagnosed. Of HIV infections diagnosed during 2015, 22% were classified as stage 3 (AIDS), although the percentages had declined from 2010. Nine out of 10 HIV infections are transmitted by people who are not diagnosed or are not in care. Young people are at highest risk. According to the CDC researchers’ estimates, only 56% of people aged 13-24 years with HIV were diagnosed and only 27% had the virus under control.
However, patients are getting appropriate care sooner and more often. Of 28,238 people who were diagnosed during 2015, 75% were linked to HIV medical care within 1 month of diagnosis, and 84% within 3 months.
“The Monitoring Report signals that we are making progress on most of our national HIV prevention, care and treatment goals,” said Richard Wolitski, PhD, director, Office of HIV/AIDS and Infectious Disease Policy in his blog on HIV.gov. “It also shows us where we need to do better and reassess our efforts, diagnose the problems and use this information to make the changes to our policies, programs, and services that are needed to turn the results around.”
Mutations impact outcomes in AML, MDS
Researchers say they have identified genetic mutations that can significantly affect treatment outcomes in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
The findings come from a clinical trial in which the team examined whether combining vorinostat with azacitidine could improve survival in patients with AML and MDS.
The results showed no additional benefit with the combination, when compared to azacitidine alone.
However, researchers did find that patients had significantly shorter survival times if they had mutations in CDKN2A, IDH1, or TP53.
“This important trial . . . has rapidly answered the important question of whether combining azacitidine with vorinostat improves outcomes for people with AML and MDS and emphasizes the need for further studies with new drug partners for azacitidine,” said Charles Craddock, DPhil, of the Queen Elizabeth Hospital in Birmingham, UK.
“Importantly, the linked molecular studies have shed new light on which people will benefit most from azacitidine. Furthermore, discovering that the CDKN2A gene mutation affects treatment response may be hugely valuable in helping doctors to design new treatment combinations in the future.”
Dr Craddock and his colleagues reported their discoveries in Clinical Cancer Research.
Previous, smaller trials had suggested that adding vorinostat to treatment with azacitidine could improve outcomes for patients with AML and MDS.
To test this idea, Dr Craddock and his colleagues enrolled 259 patients in the current trial. Most of these patients (n=217) had AML—111 were newly diagnosed, 73 had relapsed AML, and 33 had refractory disease.
The remaining 42 patients had MDS—36 were newly diagnosed, 5 had relapsed MDS, and 1 had refractory disease.
Half of patients (n=130) received azacitidine and vorinostat, and the other half received azacitidine alone (n=129).
In both arms, azacitidine was given at 75 mg/m2 on a 5-2-2 schedule, beginning on day 1 of a 28-day cycle for up to 6 cycles. In the combination arm, patients also received vorinostat at 300 mg twice daily for 7 consecutive days, beginning on day 3 of each cycle.
Results
The combination did not significantly improve response rates or survival times.
The overall response rate was 41% in the azacitidine arm and 42% in the combination arm (odds ratio [OR]=1.05, P=0.84).
The rate of compete response (CR)/CR with incomplete count recovery/marrow CR was 22% in the azacitidine arm and 26% in the combination arm (OR=0.82, P=0.49).
The median overall survival (OS) was 9.6 months in the azacitidine arm and 11.0 months in the combination arm (hazard ratio[HR]=1.15, P=0.32).
Impact of mutations
In a multivariable analysis adjusted for all clinical variables, mutations in NPM1 were associated with reduced overall response (OR=8.6, P=0.012).
In another multivariate analysis, mutations in CDKN2A, IDH1, and TP53 were associated with decreased OS. The HRs were 10.0 (P<0.001), 3.6 (P=0.001), and 4.7 (P<0.001), respectively.
The median OS was 4.5 months in patients with CDKN2A mutations and 11.0 months in patients without them.
The median OS was 7.6 months in patients with TP53 mutations and 11.3 months in patients without them.
And the median OS was 5.6 months in patients with IDH1 mutations and 11.1 months in patients without them.
The researchers believe that testing patients newly diagnosed with AML and MDS for CDKN2A, IDH1, and TP53 mutations could help doctors tailor treatment for patients who are less likely to do well.
The team also said the information gleaned from this trial will guide the choice of new drug partners with the potential to increase azacitidine’s clinical activity. 
Researchers say they have identified genetic mutations that can significantly affect treatment outcomes in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
The findings come from a clinical trial in which the team examined whether combining vorinostat with azacitidine could improve survival in patients with AML and MDS.
The results showed no additional benefit with the combination, when compared to azacitidine alone.
However, researchers did find that patients had significantly shorter survival times if they had mutations in CDKN2A, IDH1, or TP53.
“This important trial . . . has rapidly answered the important question of whether combining azacitidine with vorinostat improves outcomes for people with AML and MDS and emphasizes the need for further studies with new drug partners for azacitidine,” said Charles Craddock, DPhil, of the Queen Elizabeth Hospital in Birmingham, UK.
“Importantly, the linked molecular studies have shed new light on which people will benefit most from azacitidine. Furthermore, discovering that the CDKN2A gene mutation affects treatment response may be hugely valuable in helping doctors to design new treatment combinations in the future.”
Dr Craddock and his colleagues reported their discoveries in Clinical Cancer Research.
Previous, smaller trials had suggested that adding vorinostat to treatment with azacitidine could improve outcomes for patients with AML and MDS.
To test this idea, Dr Craddock and his colleagues enrolled 259 patients in the current trial. Most of these patients (n=217) had AML—111 were newly diagnosed, 73 had relapsed AML, and 33 had refractory disease.
The remaining 42 patients had MDS—36 were newly diagnosed, 5 had relapsed MDS, and 1 had refractory disease.
Half of patients (n=130) received azacitidine and vorinostat, and the other half received azacitidine alone (n=129).
In both arms, azacitidine was given at 75 mg/m2 on a 5-2-2 schedule, beginning on day 1 of a 28-day cycle for up to 6 cycles. In the combination arm, patients also received vorinostat at 300 mg twice daily for 7 consecutive days, beginning on day 3 of each cycle.
Results
The combination did not significantly improve response rates or survival times.
The overall response rate was 41% in the azacitidine arm and 42% in the combination arm (odds ratio [OR]=1.05, P=0.84).
The rate of compete response (CR)/CR with incomplete count recovery/marrow CR was 22% in the azacitidine arm and 26% in the combination arm (OR=0.82, P=0.49).
The median overall survival (OS) was 9.6 months in the azacitidine arm and 11.0 months in the combination arm (hazard ratio[HR]=1.15, P=0.32).
Impact of mutations
In a multivariable analysis adjusted for all clinical variables, mutations in NPM1 were associated with reduced overall response (OR=8.6, P=0.012).
In another multivariate analysis, mutations in CDKN2A, IDH1, and TP53 were associated with decreased OS. The HRs were 10.0 (P<0.001), 3.6 (P=0.001), and 4.7 (P<0.001), respectively.
The median OS was 4.5 months in patients with CDKN2A mutations and 11.0 months in patients without them.
The median OS was 7.6 months in patients with TP53 mutations and 11.3 months in patients without them.
And the median OS was 5.6 months in patients with IDH1 mutations and 11.1 months in patients without them.
The researchers believe that testing patients newly diagnosed with AML and MDS for CDKN2A, IDH1, and TP53 mutations could help doctors tailor treatment for patients who are less likely to do well.
The team also said the information gleaned from this trial will guide the choice of new drug partners with the potential to increase azacitidine’s clinical activity.
Researchers say they have identified genetic mutations that can significantly affect treatment outcomes in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
The findings come from a clinical trial in which the team examined whether combining vorinostat with azacitidine could improve survival in patients with AML and MDS.
The results showed no additional benefit with the combination, when compared to azacitidine alone.
However, researchers did find that patients had significantly shorter survival times if they had mutations in CDKN2A, IDH1, or TP53.
“This important trial . . . has rapidly answered the important question of whether combining azacitidine with vorinostat improves outcomes for people with AML and MDS and emphasizes the need for further studies with new drug partners for azacitidine,” said Charles Craddock, DPhil, of the Queen Elizabeth Hospital in Birmingham, UK.
“Importantly, the linked molecular studies have shed new light on which people will benefit most from azacitidine. Furthermore, discovering that the CDKN2A gene mutation affects treatment response may be hugely valuable in helping doctors to design new treatment combinations in the future.”
Dr Craddock and his colleagues reported their discoveries in Clinical Cancer Research.
Previous, smaller trials had suggested that adding vorinostat to treatment with azacitidine could improve outcomes for patients with AML and MDS.
To test this idea, Dr Craddock and his colleagues enrolled 259 patients in the current trial. Most of these patients (n=217) had AML—111 were newly diagnosed, 73 had relapsed AML, and 33 had refractory disease.
The remaining 42 patients had MDS—36 were newly diagnosed, 5 had relapsed MDS, and 1 had refractory disease.
Half of patients (n=130) received azacitidine and vorinostat, and the other half received azacitidine alone (n=129).
In both arms, azacitidine was given at 75 mg/m2 on a 5-2-2 schedule, beginning on day 1 of a 28-day cycle for up to 6 cycles. In the combination arm, patients also received vorinostat at 300 mg twice daily for 7 consecutive days, beginning on day 3 of each cycle.
Results
The combination did not significantly improve response rates or survival times.
The overall response rate was 41% in the azacitidine arm and 42% in the combination arm (odds ratio [OR]=1.05, P=0.84).
The rate of compete response (CR)/CR with incomplete count recovery/marrow CR was 22% in the azacitidine arm and 26% in the combination arm (OR=0.82, P=0.49).
The median overall survival (OS) was 9.6 months in the azacitidine arm and 11.0 months in the combination arm (hazard ratio[HR]=1.15, P=0.32).
Impact of mutations
In a multivariable analysis adjusted for all clinical variables, mutations in NPM1 were associated with reduced overall response (OR=8.6, P=0.012).
In another multivariate analysis, mutations in CDKN2A, IDH1, and TP53 were associated with decreased OS. The HRs were 10.0 (P<0.001), 3.6 (P=0.001), and 4.7 (P<0.001), respectively.
The median OS was 4.5 months in patients with CDKN2A mutations and 11.0 months in patients without them.
The median OS was 7.6 months in patients with TP53 mutations and 11.3 months in patients without them.
And the median OS was 5.6 months in patients with IDH1 mutations and 11.1 months in patients without them.
The researchers believe that testing patients newly diagnosed with AML and MDS for CDKN2A, IDH1, and TP53 mutations could help doctors tailor treatment for patients who are less likely to do well.
The team also said the information gleaned from this trial will guide the choice of new drug partners with the potential to increase azacitidine’s clinical activity.
Genotype-guided warfarin appears safer
Genotype-guided warfarin dosing is safer than clinically guided dosing for patients undergoing elective hip or knee arthroplasty, according to a study published in JAMA.
Investigators found that genotype-guided dosing reduced a patient’s combined risk of experiencing major bleeding, having an international normalized ratio (INR) of 4 or greater, and developing venous thromboembolism (VTE).
Death was also included in this combined endpoint, but there were no deaths in either dosing group.
“Physicians have been prescribing warfarin since the Eisenhower administration,” said study author Brian F. Gage, MD, of Washington University School of Medicine in St. Louis.
“It’s a widely used anticoagulant, but it causes more major adverse events than any other oral drug. Thousands of patients end up in the emergency department or hospital because of warfarin-induced bleeding, but we continue to prescribe it because it is highly effective, reversible, and inexpensive. So our goal is to make warfarin safer.”
With this in mind, Dr Gage and his colleagues set out to determine if genotype-guided dosing would be safer for patients starting warfarin because of elective hip or knee replacement.
The investigators noted that earlier studies of genotype-guided warfarin dosing had produced conflicting results. However, these studies were smaller and included fewer genetic variants than the current trial, known as GIFT.
The GIFT study included 1650 patients, age 65 and older. They were genotyped for the following polymorphisms: VKORC1-1639G>A, CYP2C9*2, CYP2C9*3, and CYP4F2 V433M.
Then, patients were randomized to clinically guided (n=789) or genotype-guided warfarin dosing (n=808) on days 1 through 11 of therapy and to a target INR of either 1.8 or 2.5. (Clinically guided dosing was based on standard factors such as age, height, and weight, while genotype-guided dosing was influenced by clinical factors plus the aforementioned genetic variants.)
Results
The primary endpoint was a combination of major bleeding, INR of 4 or greater, VTE, and death.
This endpoint was met by 10.8% (n=87) of patients in the genotype-guided group and 14.7% (n=116) of patients in the clinically guided warfarin group. The relative rate (RR) was 0.73 (P=0.02).
The incidence of major bleeding on days 1 to 30 was 0.2% (n=2) in the genotype-guided group and 1.0% (n=8) in the clinically guided group. The RR was 0.24 (P=0.06).
The proportion of patients with an INR of 4 or greater on days 1 to 30 was 6.9% (n=56) in the genotype-guided group and 9.8% (n=77) in the clinically guided group. The RR was 2.8 (P=0.04).
The incidence of VTE on days 1 to 60 was similar—4.1% (n=33) in the genotype-guided group and 4.8% the clinically guided group. The RR was 0.85 (P=0.48).
There were no deaths in either group (on days 1 to 30).
The investigators noted that this study has limitations. In particular, the benefits of genotype-guided dosing may differ when applied to patients of other ages or to general clinical practice.
The team also said additional research is needed to determine the cost-effectiveness of personalized warfarin dosing.
“Although genetic testing is more expensive than clinical dosing, the cost is falling,” Dr Gage said. “In our study, we estimated that genetic testing costs less than $200 per person, which is less than 1 month of a newer anticoagulant.”
Finally, the investigators said future studies should assess the impact of additional genetic variants.
“There are additional genetic variants that may help to guide warfarin dosing, especially among patients with African ancestry,” Dr Gage said. “In the future, we hope to quantify how these variants affect warfarin.”
Genotype-guided warfarin dosing is safer than clinically guided dosing for patients undergoing elective hip or knee arthroplasty, according to a study published in JAMA.
Investigators found that genotype-guided dosing reduced a patient’s combined risk of experiencing major bleeding, having an international normalized ratio (INR) of 4 or greater, and developing venous thromboembolism (VTE).
Death was also included in this combined endpoint, but there were no deaths in either dosing group.
“Physicians have been prescribing warfarin since the Eisenhower administration,” said study author Brian F. Gage, MD, of Washington University School of Medicine in St. Louis.
“It’s a widely used anticoagulant, but it causes more major adverse events than any other oral drug. Thousands of patients end up in the emergency department or hospital because of warfarin-induced bleeding, but we continue to prescribe it because it is highly effective, reversible, and inexpensive. So our goal is to make warfarin safer.”
With this in mind, Dr Gage and his colleagues set out to determine if genotype-guided dosing would be safer for patients starting warfarin because of elective hip or knee replacement.
The investigators noted that earlier studies of genotype-guided warfarin dosing had produced conflicting results. However, these studies were smaller and included fewer genetic variants than the current trial, known as GIFT.
The GIFT study included 1650 patients, age 65 and older. They were genotyped for the following polymorphisms: VKORC1-1639G>A, CYP2C9*2, CYP2C9*3, and CYP4F2 V433M.
Then, patients were randomized to clinically guided (n=789) or genotype-guided warfarin dosing (n=808) on days 1 through 11 of therapy and to a target INR of either 1.8 or 2.5. (Clinically guided dosing was based on standard factors such as age, height, and weight, while genotype-guided dosing was influenced by clinical factors plus the aforementioned genetic variants.)
Results
The primary endpoint was a combination of major bleeding, INR of 4 or greater, VTE, and death.
This endpoint was met by 10.8% (n=87) of patients in the genotype-guided group and 14.7% (n=116) of patients in the clinically guided warfarin group. The relative rate (RR) was 0.73 (P=0.02).
The incidence of major bleeding on days 1 to 30 was 0.2% (n=2) in the genotype-guided group and 1.0% (n=8) in the clinically guided group. The RR was 0.24 (P=0.06).
The proportion of patients with an INR of 4 or greater on days 1 to 30 was 6.9% (n=56) in the genotype-guided group and 9.8% (n=77) in the clinically guided group. The RR was 2.8 (P=0.04).
The incidence of VTE on days 1 to 60 was similar—4.1% (n=33) in the genotype-guided group and 4.8% the clinically guided group. The RR was 0.85 (P=0.48).
There were no deaths in either group (on days 1 to 30).
The investigators noted that this study has limitations. In particular, the benefits of genotype-guided dosing may differ when applied to patients of other ages or to general clinical practice.
The team also said additional research is needed to determine the cost-effectiveness of personalized warfarin dosing.
“Although genetic testing is more expensive than clinical dosing, the cost is falling,” Dr Gage said. “In our study, we estimated that genetic testing costs less than $200 per person, which is less than 1 month of a newer anticoagulant.”
Finally, the investigators said future studies should assess the impact of additional genetic variants.
“There are additional genetic variants that may help to guide warfarin dosing, especially among patients with African ancestry,” Dr Gage said. “In the future, we hope to quantify how these variants affect warfarin.”
Genotype-guided warfarin dosing is safer than clinically guided dosing for patients undergoing elective hip or knee arthroplasty, according to a study published in JAMA.
Investigators found that genotype-guided dosing reduced a patient’s combined risk of experiencing major bleeding, having an international normalized ratio (INR) of 4 or greater, and developing venous thromboembolism (VTE).
Death was also included in this combined endpoint, but there were no deaths in either dosing group.
“Physicians have been prescribing warfarin since the Eisenhower administration,” said study author Brian F. Gage, MD, of Washington University School of Medicine in St. Louis.
“It’s a widely used anticoagulant, but it causes more major adverse events than any other oral drug. Thousands of patients end up in the emergency department or hospital because of warfarin-induced bleeding, but we continue to prescribe it because it is highly effective, reversible, and inexpensive. So our goal is to make warfarin safer.”
With this in mind, Dr Gage and his colleagues set out to determine if genotype-guided dosing would be safer for patients starting warfarin because of elective hip or knee replacement.
The investigators noted that earlier studies of genotype-guided warfarin dosing had produced conflicting results. However, these studies were smaller and included fewer genetic variants than the current trial, known as GIFT.
The GIFT study included 1650 patients, age 65 and older. They were genotyped for the following polymorphisms: VKORC1-1639G>A, CYP2C9*2, CYP2C9*3, and CYP4F2 V433M.
Then, patients were randomized to clinically guided (n=789) or genotype-guided warfarin dosing (n=808) on days 1 through 11 of therapy and to a target INR of either 1.8 or 2.5. (Clinically guided dosing was based on standard factors such as age, height, and weight, while genotype-guided dosing was influenced by clinical factors plus the aforementioned genetic variants.)
Results
The primary endpoint was a combination of major bleeding, INR of 4 or greater, VTE, and death.
This endpoint was met by 10.8% (n=87) of patients in the genotype-guided group and 14.7% (n=116) of patients in the clinically guided warfarin group. The relative rate (RR) was 0.73 (P=0.02).
The incidence of major bleeding on days 1 to 30 was 0.2% (n=2) in the genotype-guided group and 1.0% (n=8) in the clinically guided group. The RR was 0.24 (P=0.06).
The proportion of patients with an INR of 4 or greater on days 1 to 30 was 6.9% (n=56) in the genotype-guided group and 9.8% (n=77) in the clinically guided group. The RR was 2.8 (P=0.04).
The incidence of VTE on days 1 to 60 was similar—4.1% (n=33) in the genotype-guided group and 4.8% the clinically guided group. The RR was 0.85 (P=0.48).
There were no deaths in either group (on days 1 to 30).
The investigators noted that this study has limitations. In particular, the benefits of genotype-guided dosing may differ when applied to patients of other ages or to general clinical practice.
The team also said additional research is needed to determine the cost-effectiveness of personalized warfarin dosing.
“Although genetic testing is more expensive than clinical dosing, the cost is falling,” Dr Gage said. “In our study, we estimated that genetic testing costs less than $200 per person, which is less than 1 month of a newer anticoagulant.”
Finally, the investigators said future studies should assess the impact of additional genetic variants.
“There are additional genetic variants that may help to guide warfarin dosing, especially among patients with African ancestry,” Dr Gage said. “In the future, we hope to quantify how these variants affect warfarin.”