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Did posthysterectomy hemorrhage cause woman’s brain damage?
Did posthysterectomy hemorrhage cause woman’s brain damage?
A 42-year-old woman underwent elective subtotal hysterectomy to treat a large uterine fibroid. In the recovery unit, she had extremely low blood pressure and tachycardia and lost consciousness for 15 minutes. She was given a blood transfusion, but was not returned to the operating room for emergency exploratory laparotomy until 3 hours later. Surgery revealed a hemorrhage from the left uterine artery requiring ligation.
PATIENT’S CLAIM:
The hemorrhage caused hypoxia resulting in an anoxic brain injury with memory and concentration difficulties. The gynecologist and hospital staff were negligent in delaying emergency treatment.
DEFENDANTS’ DEFENSE:
Postoperative bleeding is a known complication of hysterectomy. The patient was at increased risk of bleeding because of the numerous blood vessels feeding the fibroid. A morphine reaction is believed to be the cause of her becoming unconscious. The patient had not sustained an anoxic or hypoxic brain damage because she was alert and oriented immediately after the damage allegedly occurred.
VERDICT:
The Illinois jury deadlocked. The parties entered into a settlement agreement for a confidential sum before a mistrial was declared.
Related article:
7 Myomectomy myths debunked
Choriocarcinoma diagnosis missed
A 25-year-old woman had a miscarriage. A follow-up test to measure the patient’s human chorionic gonadotropin (hCG) hormone level test was not performed. The patient died from choriocarcinoma.
ESTATE’S CLAIM:
The ObGyn did not follow the standard of care: the patient’s hCG level should have been tested after the miscarriage. It is a well-known fact that an hCG level that does not return to zero after a miscarriage is cause for concern, especially from choriocarcinoma.
PHYSICIAN’S DEFENSE:
There was nothing that could have been done to save the woman’s life; choriocarcinoma is a quickly spreading cancer.
VERDICT:
A $1,800,000 Massachusetts settlement was reached.
Related article:
Manual vacuum aspiration: A safe and effective treatment for early miscarriage
Bowel perforation during hysterectomy: $860,000 verdict
A 58-year-old woman underwent laparoscopic hysterectomy and was discharged the next day although she had not urinated or defecated. After eating solid food that evening, she experienced immediate vomiting, nausea, and abdominal pain. When she saw her ObGyn the next morning, he immediately hospitalized her. During the next 8 days in the hospital, she was unable to pass gas, was febrile, and was given antibiotics. On postoperative day 11, a general surgeon transferred her to the intensive care unit due to shortness of breath and tachycardia. During exploratory abdominal surgery, several abscesses and a 1-cm injury to the rectosigmoid colon were discovered necessitating a colostomy. The patient underwent 5 additional abdominal washout procedures and was hospitalized for 40 days. Colostomy reversal surgery occurred 8 months later.
PATIENT’S CLAIM:
The ObGyn never provided an explanation of what went wrong; the patient was told the hysterectomy was accomplished without incident. An expert colorectal surgeon stated that the perforation likely occurred within 24 hours of surgery and was probably caused by the electromechanical device used during surgery.
DEFENDANTS’ DEFENSE:
The perforation was caused by a sudden rupture of a diverticulum 10 days after hysterectomy. The injury was treated in a timely manner.
VERDICT:
An $860,000 Virginia verdict was returned.
Related article:
How to avoid intestinal and urinary tract injuries during gynecologic laparoscopy
These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Did posthysterectomy hemorrhage cause woman’s brain damage?
A 42-year-old woman underwent elective subtotal hysterectomy to treat a large uterine fibroid. In the recovery unit, she had extremely low blood pressure and tachycardia and lost consciousness for 15 minutes. She was given a blood transfusion, but was not returned to the operating room for emergency exploratory laparotomy until 3 hours later. Surgery revealed a hemorrhage from the left uterine artery requiring ligation.
PATIENT’S CLAIM:
The hemorrhage caused hypoxia resulting in an anoxic brain injury with memory and concentration difficulties. The gynecologist and hospital staff were negligent in delaying emergency treatment.
DEFENDANTS’ DEFENSE:
Postoperative bleeding is a known complication of hysterectomy. The patient was at increased risk of bleeding because of the numerous blood vessels feeding the fibroid. A morphine reaction is believed to be the cause of her becoming unconscious. The patient had not sustained an anoxic or hypoxic brain damage because she was alert and oriented immediately after the damage allegedly occurred.
VERDICT:
The Illinois jury deadlocked. The parties entered into a settlement agreement for a confidential sum before a mistrial was declared.
Related article:
7 Myomectomy myths debunked
Choriocarcinoma diagnosis missed
A 25-year-old woman had a miscarriage. A follow-up test to measure the patient’s human chorionic gonadotropin (hCG) hormone level test was not performed. The patient died from choriocarcinoma.
ESTATE’S CLAIM:
The ObGyn did not follow the standard of care: the patient’s hCG level should have been tested after the miscarriage. It is a well-known fact that an hCG level that does not return to zero after a miscarriage is cause for concern, especially from choriocarcinoma.
PHYSICIAN’S DEFENSE:
There was nothing that could have been done to save the woman’s life; choriocarcinoma is a quickly spreading cancer.
VERDICT:
A $1,800,000 Massachusetts settlement was reached.
Related article:
Manual vacuum aspiration: A safe and effective treatment for early miscarriage
Bowel perforation during hysterectomy: $860,000 verdict
A 58-year-old woman underwent laparoscopic hysterectomy and was discharged the next day although she had not urinated or defecated. After eating solid food that evening, she experienced immediate vomiting, nausea, and abdominal pain. When she saw her ObGyn the next morning, he immediately hospitalized her. During the next 8 days in the hospital, she was unable to pass gas, was febrile, and was given antibiotics. On postoperative day 11, a general surgeon transferred her to the intensive care unit due to shortness of breath and tachycardia. During exploratory abdominal surgery, several abscesses and a 1-cm injury to the rectosigmoid colon were discovered necessitating a colostomy. The patient underwent 5 additional abdominal washout procedures and was hospitalized for 40 days. Colostomy reversal surgery occurred 8 months later.
PATIENT’S CLAIM:
The ObGyn never provided an explanation of what went wrong; the patient was told the hysterectomy was accomplished without incident. An expert colorectal surgeon stated that the perforation likely occurred within 24 hours of surgery and was probably caused by the electromechanical device used during surgery.
DEFENDANTS’ DEFENSE:
The perforation was caused by a sudden rupture of a diverticulum 10 days after hysterectomy. The injury was treated in a timely manner.
VERDICT:
An $860,000 Virginia verdict was returned.
Related article:
How to avoid intestinal and urinary tract injuries during gynecologic laparoscopy
These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Did posthysterectomy hemorrhage cause woman’s brain damage?
A 42-year-old woman underwent elective subtotal hysterectomy to treat a large uterine fibroid. In the recovery unit, she had extremely low blood pressure and tachycardia and lost consciousness for 15 minutes. She was given a blood transfusion, but was not returned to the operating room for emergency exploratory laparotomy until 3 hours later. Surgery revealed a hemorrhage from the left uterine artery requiring ligation.
PATIENT’S CLAIM:
The hemorrhage caused hypoxia resulting in an anoxic brain injury with memory and concentration difficulties. The gynecologist and hospital staff were negligent in delaying emergency treatment.
DEFENDANTS’ DEFENSE:
Postoperative bleeding is a known complication of hysterectomy. The patient was at increased risk of bleeding because of the numerous blood vessels feeding the fibroid. A morphine reaction is believed to be the cause of her becoming unconscious. The patient had not sustained an anoxic or hypoxic brain damage because she was alert and oriented immediately after the damage allegedly occurred.
VERDICT:
The Illinois jury deadlocked. The parties entered into a settlement agreement for a confidential sum before a mistrial was declared.
Related article:
7 Myomectomy myths debunked
Choriocarcinoma diagnosis missed
A 25-year-old woman had a miscarriage. A follow-up test to measure the patient’s human chorionic gonadotropin (hCG) hormone level test was not performed. The patient died from choriocarcinoma.
ESTATE’S CLAIM:
The ObGyn did not follow the standard of care: the patient’s hCG level should have been tested after the miscarriage. It is a well-known fact that an hCG level that does not return to zero after a miscarriage is cause for concern, especially from choriocarcinoma.
PHYSICIAN’S DEFENSE:
There was nothing that could have been done to save the woman’s life; choriocarcinoma is a quickly spreading cancer.
VERDICT:
A $1,800,000 Massachusetts settlement was reached.
Related article:
Manual vacuum aspiration: A safe and effective treatment for early miscarriage
Bowel perforation during hysterectomy: $860,000 verdict
A 58-year-old woman underwent laparoscopic hysterectomy and was discharged the next day although she had not urinated or defecated. After eating solid food that evening, she experienced immediate vomiting, nausea, and abdominal pain. When she saw her ObGyn the next morning, he immediately hospitalized her. During the next 8 days in the hospital, she was unable to pass gas, was febrile, and was given antibiotics. On postoperative day 11, a general surgeon transferred her to the intensive care unit due to shortness of breath and tachycardia. During exploratory abdominal surgery, several abscesses and a 1-cm injury to the rectosigmoid colon were discovered necessitating a colostomy. The patient underwent 5 additional abdominal washout procedures and was hospitalized for 40 days. Colostomy reversal surgery occurred 8 months later.
PATIENT’S CLAIM:
The ObGyn never provided an explanation of what went wrong; the patient was told the hysterectomy was accomplished without incident. An expert colorectal surgeon stated that the perforation likely occurred within 24 hours of surgery and was probably caused by the electromechanical device used during surgery.
DEFENDANTS’ DEFENSE:
The perforation was caused by a sudden rupture of a diverticulum 10 days after hysterectomy. The injury was treated in a timely manner.
VERDICT:
An $860,000 Virginia verdict was returned.
Related article:
How to avoid intestinal and urinary tract injuries during gynecologic laparoscopy
These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Two boys, a dog, and our electronic health records
“Speak clearly, if you speak at all; carve every word before you let it fall.” – Oliver Wendell Holmes Sr.
One of our favorite stories is that of two boys talking to one another with a dog sitting nearby. One boy says to the other, “I taught my dog how to whistle.” Skeptically, the other boy responds, “Really? I don’t hear him whistling.” The first boys then replies, “I said I taught him. I didn’t say he learned!”
We spend a lot of time as physicians going over information with our patients, yet, according to the best data available, they retain only a small portion of what we tell them. Medication adherence rates for chronic disease range from 30% to 70%, showing that many doses of important medications are missed. Patients often don’t even remember the last instructions we give them as they are walking out of the office. This raises questions about both the way we explain information and how we can use the tools at our disposal to enhance the communication so vital to patient outcomes.
Obviously, we need to consider our words carefully and focus on teaching, not just speaking. What sets teaching apart from speaking is consideration of the learner. The better we understand our patients’ perspectives, the better the knowledge transfer will be. A simple way to address this may be better eye contact.
We have all heard the expression “the eyes are a window to the soul.” Yet, we now have computers that acts as a virtual shades, covering that window and drawing our gaze away from our patients. These shades can blind us to important clues, impeding communication and leading to misunderstanding, missed opportunity, and even patient harm. This is why some practices have chosen to use scribes to handle documentation, freeing up physicians’ eyes and addressing another obstacle to communication: time.
One of the most cited complaints from physicians is lack of time. There is an ever-growing demand on us to see more patients, manage more data, and “check off more boxes” to meet bureaucratic requirements. It should come as no surprise that these impede good patient care. We are thankful that attempts to modernize payment models are recognizing this problem. For example, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) helps to blaze the trail by focusing on care quality, practice improvement, and patient satisfaction for incentive payments. While these are early steps, they certainly point to a future more concerned with value than with volume.
As we move toward that future, we need to acknowledge that information technology can be both the problem and the answer. The current state of health IT is far from perfect. The tools we use have been designed, seemingly, around financial performance or developed to meet government requirements. It appears that neither physicians nor patients were consulted to ensure their usability or utility. Step No. 1 was getting EHRs out there. Steps 2-10 will be making them useful to clinicians, patients, and health care systems. Part of that utility will come in their ability to enhance communication.
Take patient portals, for example. The “meaningful use program” set as a requirement the ability for patients to “view, download, or transmit” their health information through electronic means. EHR vendors complied with this request but seem to have missed the intent of the measure. Patients accessing the information often are confronted with a morass of technical jargon and unfamiliar medical terms, which may even be offensive. For example, we recently spoke to a parent of a teenager with moderate intellectual disabilities. A hold-out ICD-9 code on the teen’s chart translated to her portal as “318.0 – Imbecile.” Her mother was appropriately upset, and she decided to leave the practice.
As we begin to understand technology’s advantages – and learn its pitfalls – we believe EHR vendors must enhance their offerings while engaging both providers and patients in the process of improvement. We also believe physicians need to leverage the entire care team to realize the software’s full potential. This approach may present new challenges in communication, but it also presents new opportunities. We hope that this collaborative approach will allow physicians to have more time to spend connecting with patients, leading to enhanced understanding and satisfaction.
Our knowledge of human health and disease is growing more sophisticated and so is the challenge of imparting that knowledge to patients. It is critical to find ways to do so that are relevant and understandable and give patients the tools they need to reinforce and remember what we say. This is one of the promises that we are just beginning to see fulfilled by modern EHR technology. Unlike the boy who was trying to teach his dog to whistle, our words have deep impact, and our roles as educators have never been more important.
This article was updated 3/24/17.
Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia.
“Speak clearly, if you speak at all; carve every word before you let it fall.” – Oliver Wendell Holmes Sr.
One of our favorite stories is that of two boys talking to one another with a dog sitting nearby. One boy says to the other, “I taught my dog how to whistle.” Skeptically, the other boy responds, “Really? I don’t hear him whistling.” The first boys then replies, “I said I taught him. I didn’t say he learned!”
We spend a lot of time as physicians going over information with our patients, yet, according to the best data available, they retain only a small portion of what we tell them. Medication adherence rates for chronic disease range from 30% to 70%, showing that many doses of important medications are missed. Patients often don’t even remember the last instructions we give them as they are walking out of the office. This raises questions about both the way we explain information and how we can use the tools at our disposal to enhance the communication so vital to patient outcomes.
Obviously, we need to consider our words carefully and focus on teaching, not just speaking. What sets teaching apart from speaking is consideration of the learner. The better we understand our patients’ perspectives, the better the knowledge transfer will be. A simple way to address this may be better eye contact.
We have all heard the expression “the eyes are a window to the soul.” Yet, we now have computers that acts as a virtual shades, covering that window and drawing our gaze away from our patients. These shades can blind us to important clues, impeding communication and leading to misunderstanding, missed opportunity, and even patient harm. This is why some practices have chosen to use scribes to handle documentation, freeing up physicians’ eyes and addressing another obstacle to communication: time.
One of the most cited complaints from physicians is lack of time. There is an ever-growing demand on us to see more patients, manage more data, and “check off more boxes” to meet bureaucratic requirements. It should come as no surprise that these impede good patient care. We are thankful that attempts to modernize payment models are recognizing this problem. For example, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) helps to blaze the trail by focusing on care quality, practice improvement, and patient satisfaction for incentive payments. While these are early steps, they certainly point to a future more concerned with value than with volume.
As we move toward that future, we need to acknowledge that information technology can be both the problem and the answer. The current state of health IT is far from perfect. The tools we use have been designed, seemingly, around financial performance or developed to meet government requirements. It appears that neither physicians nor patients were consulted to ensure their usability or utility. Step No. 1 was getting EHRs out there. Steps 2-10 will be making them useful to clinicians, patients, and health care systems. Part of that utility will come in their ability to enhance communication.
Take patient portals, for example. The “meaningful use program” set as a requirement the ability for patients to “view, download, or transmit” their health information through electronic means. EHR vendors complied with this request but seem to have missed the intent of the measure. Patients accessing the information often are confronted with a morass of technical jargon and unfamiliar medical terms, which may even be offensive. For example, we recently spoke to a parent of a teenager with moderate intellectual disabilities. A hold-out ICD-9 code on the teen’s chart translated to her portal as “318.0 – Imbecile.” Her mother was appropriately upset, and she decided to leave the practice.
As we begin to understand technology’s advantages – and learn its pitfalls – we believe EHR vendors must enhance their offerings while engaging both providers and patients in the process of improvement. We also believe physicians need to leverage the entire care team to realize the software’s full potential. This approach may present new challenges in communication, but it also presents new opportunities. We hope that this collaborative approach will allow physicians to have more time to spend connecting with patients, leading to enhanced understanding and satisfaction.
Our knowledge of human health and disease is growing more sophisticated and so is the challenge of imparting that knowledge to patients. It is critical to find ways to do so that are relevant and understandable and give patients the tools they need to reinforce and remember what we say. This is one of the promises that we are just beginning to see fulfilled by modern EHR technology. Unlike the boy who was trying to teach his dog to whistle, our words have deep impact, and our roles as educators have never been more important.
This article was updated 3/24/17.
Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia.
“Speak clearly, if you speak at all; carve every word before you let it fall.” – Oliver Wendell Holmes Sr.
One of our favorite stories is that of two boys talking to one another with a dog sitting nearby. One boy says to the other, “I taught my dog how to whistle.” Skeptically, the other boy responds, “Really? I don’t hear him whistling.” The first boys then replies, “I said I taught him. I didn’t say he learned!”
We spend a lot of time as physicians going over information with our patients, yet, according to the best data available, they retain only a small portion of what we tell them. Medication adherence rates for chronic disease range from 30% to 70%, showing that many doses of important medications are missed. Patients often don’t even remember the last instructions we give them as they are walking out of the office. This raises questions about both the way we explain information and how we can use the tools at our disposal to enhance the communication so vital to patient outcomes.
Obviously, we need to consider our words carefully and focus on teaching, not just speaking. What sets teaching apart from speaking is consideration of the learner. The better we understand our patients’ perspectives, the better the knowledge transfer will be. A simple way to address this may be better eye contact.
We have all heard the expression “the eyes are a window to the soul.” Yet, we now have computers that acts as a virtual shades, covering that window and drawing our gaze away from our patients. These shades can blind us to important clues, impeding communication and leading to misunderstanding, missed opportunity, and even patient harm. This is why some practices have chosen to use scribes to handle documentation, freeing up physicians’ eyes and addressing another obstacle to communication: time.
One of the most cited complaints from physicians is lack of time. There is an ever-growing demand on us to see more patients, manage more data, and “check off more boxes” to meet bureaucratic requirements. It should come as no surprise that these impede good patient care. We are thankful that attempts to modernize payment models are recognizing this problem. For example, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) helps to blaze the trail by focusing on care quality, practice improvement, and patient satisfaction for incentive payments. While these are early steps, they certainly point to a future more concerned with value than with volume.
As we move toward that future, we need to acknowledge that information technology can be both the problem and the answer. The current state of health IT is far from perfect. The tools we use have been designed, seemingly, around financial performance or developed to meet government requirements. It appears that neither physicians nor patients were consulted to ensure their usability or utility. Step No. 1 was getting EHRs out there. Steps 2-10 will be making them useful to clinicians, patients, and health care systems. Part of that utility will come in their ability to enhance communication.
Take patient portals, for example. The “meaningful use program” set as a requirement the ability for patients to “view, download, or transmit” their health information through electronic means. EHR vendors complied with this request but seem to have missed the intent of the measure. Patients accessing the information often are confronted with a morass of technical jargon and unfamiliar medical terms, which may even be offensive. For example, we recently spoke to a parent of a teenager with moderate intellectual disabilities. A hold-out ICD-9 code on the teen’s chart translated to her portal as “318.0 – Imbecile.” Her mother was appropriately upset, and she decided to leave the practice.
As we begin to understand technology’s advantages – and learn its pitfalls – we believe EHR vendors must enhance their offerings while engaging both providers and patients in the process of improvement. We also believe physicians need to leverage the entire care team to realize the software’s full potential. This approach may present new challenges in communication, but it also presents new opportunities. We hope that this collaborative approach will allow physicians to have more time to spend connecting with patients, leading to enhanced understanding and satisfaction.
Our knowledge of human health and disease is growing more sophisticated and so is the challenge of imparting that knowledge to patients. It is critical to find ways to do so that are relevant and understandable and give patients the tools they need to reinforce and remember what we say. This is one of the promises that we are just beginning to see fulfilled by modern EHR technology. Unlike the boy who was trying to teach his dog to whistle, our words have deep impact, and our roles as educators have never been more important.
This article was updated 3/24/17.
Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia.
Social media may be isolating young adults
Among young adults, those who most frequently use social media are more likely to feel socially isolated than are less frequent users, according to results of a survey of almost 1,800 respondents.
Adults aged 19-32 years who were in the highest quartile of social media use – 58 or more times a week – had an adjusted odds ratio of 3.4 for perceived social isolation, compared with those in the lowest quartile, who reported using social media less than 9 times a week, said Brian A. Primack, MD, PhD, of the University of Pittsburgh and his associates (Am J Prev Med. 2017 Mar 6. doi: 10.1016/j.amepre.2017.01.010).
“We are inherently social creatures, but modern life tends to compartmentalize us instead of bringing us together. While it may seem that social media presents opportunities to fill that social void, I think this study suggests that it may not be the solution people were hoping for,” Dr. Primack said in a separate written statement.
The cross-sectional survey was conducted in October and November 2014, and the 11 social media platforms included were Facebook, Twitter, Google+, YouTube, LinkedIn, Instagram, Pinterest, Tumblr, Vine, Snapchat, and Reddit.
Among young adults, those who most frequently use social media are more likely to feel socially isolated than are less frequent users, according to results of a survey of almost 1,800 respondents.
Adults aged 19-32 years who were in the highest quartile of social media use – 58 or more times a week – had an adjusted odds ratio of 3.4 for perceived social isolation, compared with those in the lowest quartile, who reported using social media less than 9 times a week, said Brian A. Primack, MD, PhD, of the University of Pittsburgh and his associates (Am J Prev Med. 2017 Mar 6. doi: 10.1016/j.amepre.2017.01.010).
“We are inherently social creatures, but modern life tends to compartmentalize us instead of bringing us together. While it may seem that social media presents opportunities to fill that social void, I think this study suggests that it may not be the solution people were hoping for,” Dr. Primack said in a separate written statement.
The cross-sectional survey was conducted in October and November 2014, and the 11 social media platforms included were Facebook, Twitter, Google+, YouTube, LinkedIn, Instagram, Pinterest, Tumblr, Vine, Snapchat, and Reddit.
Among young adults, those who most frequently use social media are more likely to feel socially isolated than are less frequent users, according to results of a survey of almost 1,800 respondents.
Adults aged 19-32 years who were in the highest quartile of social media use – 58 or more times a week – had an adjusted odds ratio of 3.4 for perceived social isolation, compared with those in the lowest quartile, who reported using social media less than 9 times a week, said Brian A. Primack, MD, PhD, of the University of Pittsburgh and his associates (Am J Prev Med. 2017 Mar 6. doi: 10.1016/j.amepre.2017.01.010).
“We are inherently social creatures, but modern life tends to compartmentalize us instead of bringing us together. While it may seem that social media presents opportunities to fill that social void, I think this study suggests that it may not be the solution people were hoping for,” Dr. Primack said in a separate written statement.
The cross-sectional survey was conducted in October and November 2014, and the 11 social media platforms included were Facebook, Twitter, Google+, YouTube, LinkedIn, Instagram, Pinterest, Tumblr, Vine, Snapchat, and Reddit.
FROM THE AMERICAN JOURNAL OF PREVENTIVE MEDICINE
FDA approves first dedicated bifurcation device to treat coronary bifurcation lesions
Tryton Medical announced on March 6 that the Food and Drug Administration has approved Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches, becoming the first dedicated bifurcation device to receive regulatory approval in the U.S.
In a post hoc analysis of a randomized clinical trial, treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (stent greater than 2.5mm) reduced the need for additional bailout stenting (0.7% vs. 5.6%, P = .02). It led to significantly lower side branch percent diameter stenosis at a 9-month follow-up (30.4% vs. 40.6%, P = .004) when compared with provisional stenting. The analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates when compared with provisional stenting at 3 years.
“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Aaron Kaplan, MD, Professor of Medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., and Chief Medical Officer of Tryton Medical, in a press release. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”
There have been no randomized studies to compare the results of percutaneous coronary interventions (PCI) with coronary artery bypass grafting in a bifurcation-only patient population. But this new device should benefit results from treatment using PCI.
Coronary artery disease is the leading cause of death in the U.S. in both men and women, and often results in bifurcation. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.
Read more on Tryton Side Branch Stent on Tryton’s website.
Tryton Medical announced on March 6 that the Food and Drug Administration has approved Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches, becoming the first dedicated bifurcation device to receive regulatory approval in the U.S.
In a post hoc analysis of a randomized clinical trial, treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (stent greater than 2.5mm) reduced the need for additional bailout stenting (0.7% vs. 5.6%, P = .02). It led to significantly lower side branch percent diameter stenosis at a 9-month follow-up (30.4% vs. 40.6%, P = .004) when compared with provisional stenting. The analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates when compared with provisional stenting at 3 years.
“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Aaron Kaplan, MD, Professor of Medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., and Chief Medical Officer of Tryton Medical, in a press release. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”
There have been no randomized studies to compare the results of percutaneous coronary interventions (PCI) with coronary artery bypass grafting in a bifurcation-only patient population. But this new device should benefit results from treatment using PCI.
Coronary artery disease is the leading cause of death in the U.S. in both men and women, and often results in bifurcation. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.
Read more on Tryton Side Branch Stent on Tryton’s website.
Tryton Medical announced on March 6 that the Food and Drug Administration has approved Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches, becoming the first dedicated bifurcation device to receive regulatory approval in the U.S.
In a post hoc analysis of a randomized clinical trial, treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (stent greater than 2.5mm) reduced the need for additional bailout stenting (0.7% vs. 5.6%, P = .02). It led to significantly lower side branch percent diameter stenosis at a 9-month follow-up (30.4% vs. 40.6%, P = .004) when compared with provisional stenting. The analysis also showed comparable major adverse cardiovascular events and myocardial infarction rates when compared with provisional stenting at 3 years.
“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Aaron Kaplan, MD, Professor of Medicine at Dartmouth Hitchcock Medical Center, Lebanon, N.H., and Chief Medical Officer of Tryton Medical, in a press release. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”
There have been no randomized studies to compare the results of percutaneous coronary interventions (PCI) with coronary artery bypass grafting in a bifurcation-only patient population. But this new device should benefit results from treatment using PCI.
Coronary artery disease is the leading cause of death in the U.S. in both men and women, and often results in bifurcation. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.
Read more on Tryton Side Branch Stent on Tryton’s website.
Malpractice bill would impose $250,000 damages cap
New legislation approved by the House Judiciary Committee could mean legal relief for health providers in the form of capped damages and a tighter time frame for lawsuits.
The House Judiciary Committee passed the Protecting Access to Care Act of 2017 (H.R. 1215) on Feb. 28 by a vote of 18-17. The bill, modeled after California’s Medical Injury Compensation Reform Act (MICRA), would limit noneconomic damages in medical malpractice cases to $250,000, restrict contingency fees charged by attorneys, and enforce a 3-year statute of limitations for liability lawsuits from the date of alleged injury. The bill also includes a “fair share” rule in which defendants are liable only for the damages in direct proportion to their percentage of responsibility.
The bill is the first significant medical professional liability reform legislation to be approved by the committee since 2011, said Brian K. Atchinson, president and CEO of PIAA, a national trade association for medical liability insurers.
“Unlike previous federal bills, the bill is focused solely on health care professionals and entities, includes detailed flexibility for states for all its reforms, and is linked with the expenditure of federal dollars to address states’ rights concerns,” Mr. Atchinson said in a statement. “H.R. 1215 will help ensure fair and timely compensation to injured patients, improve access to patient care, and promote affordable and accessible medical liability insurance coverage.”
The proposed statute would apply to any patient who receives medical care provided via a federal program, such as Medicare or Medicaid, or via a subsidy or tax benefit, such as coverage purchased under the Affordable Care Act or a future* replacement. Medical care paid by employer health plans would fall under the legislation’s umbrella since insurance premiums receive federal tax exemptions. The bill would not preempt state medical malpractice laws that impose damage caps, whether higher or lower than $250,000, nor would the legislation affect the availability of economic damages, according to bill language.
As part of the H.R. 1215, courts could limit how much attorneys receive from a patient’s ultimate award. Specifically, courts would have the power to restrict payments from a plaintiff’s damage recovery to an attorney who claims a financial stake in the outcome by virtue of a contingent fee.
“The Protecting Access to Care Act will help keep the rising costs of health care from being passed along to the American people,” Rep. Goodlatte said in a statement. “The Congressional Budget Office estimates that the reforms contained in the bill would lower health care costs by tens of billions of dollars.”
Public Citizen, a consumer rights group, criticized the legislation as misleading to consumers and harmful to patients.
“Proposals to shield providers from liability are nothing but a giveaway to industry,” Lisa Gilbert, director of Public Citizen’s Congress Watch, said in a statement. “Members supporting this bill would further harm those who are suffering from doctors’ mistakes and abandon the GOP’s supposedly unwavering commitment to state’s rights.”
“There are so many moving parts to this bill, I think the likelihood of its being passed as is is low,” said Dr. Segal, founder of Medical Justice, a company that works to deter frivolous medical malpractice lawsuits. “The biggest challenge will be whether the Republicans have to get eight Democratic senators to join the bill. To make it more palatable, something will need to give. Such provisions on tort reform are likely to be the first items offered for sacrifice.”
[email protected]
On Twitter @legal_med
New legislation approved by the House Judiciary Committee could mean legal relief for health providers in the form of capped damages and a tighter time frame for lawsuits.
The House Judiciary Committee passed the Protecting Access to Care Act of 2017 (H.R. 1215) on Feb. 28 by a vote of 18-17. The bill, modeled after California’s Medical Injury Compensation Reform Act (MICRA), would limit noneconomic damages in medical malpractice cases to $250,000, restrict contingency fees charged by attorneys, and enforce a 3-year statute of limitations for liability lawsuits from the date of alleged injury. The bill also includes a “fair share” rule in which defendants are liable only for the damages in direct proportion to their percentage of responsibility.
The bill is the first significant medical professional liability reform legislation to be approved by the committee since 2011, said Brian K. Atchinson, president and CEO of PIAA, a national trade association for medical liability insurers.
“Unlike previous federal bills, the bill is focused solely on health care professionals and entities, includes detailed flexibility for states for all its reforms, and is linked with the expenditure of federal dollars to address states’ rights concerns,” Mr. Atchinson said in a statement. “H.R. 1215 will help ensure fair and timely compensation to injured patients, improve access to patient care, and promote affordable and accessible medical liability insurance coverage.”
The proposed statute would apply to any patient who receives medical care provided via a federal program, such as Medicare or Medicaid, or via a subsidy or tax benefit, such as coverage purchased under the Affordable Care Act or a future* replacement. Medical care paid by employer health plans would fall under the legislation’s umbrella since insurance premiums receive federal tax exemptions. The bill would not preempt state medical malpractice laws that impose damage caps, whether higher or lower than $250,000, nor would the legislation affect the availability of economic damages, according to bill language.
As part of the H.R. 1215, courts could limit how much attorneys receive from a patient’s ultimate award. Specifically, courts would have the power to restrict payments from a plaintiff’s damage recovery to an attorney who claims a financial stake in the outcome by virtue of a contingent fee.
“The Protecting Access to Care Act will help keep the rising costs of health care from being passed along to the American people,” Rep. Goodlatte said in a statement. “The Congressional Budget Office estimates that the reforms contained in the bill would lower health care costs by tens of billions of dollars.”
Public Citizen, a consumer rights group, criticized the legislation as misleading to consumers and harmful to patients.
“Proposals to shield providers from liability are nothing but a giveaway to industry,” Lisa Gilbert, director of Public Citizen’s Congress Watch, said in a statement. “Members supporting this bill would further harm those who are suffering from doctors’ mistakes and abandon the GOP’s supposedly unwavering commitment to state’s rights.”
“There are so many moving parts to this bill, I think the likelihood of its being passed as is is low,” said Dr. Segal, founder of Medical Justice, a company that works to deter frivolous medical malpractice lawsuits. “The biggest challenge will be whether the Republicans have to get eight Democratic senators to join the bill. To make it more palatable, something will need to give. Such provisions on tort reform are likely to be the first items offered for sacrifice.”
[email protected]
On Twitter @legal_med
New legislation approved by the House Judiciary Committee could mean legal relief for health providers in the form of capped damages and a tighter time frame for lawsuits.
The House Judiciary Committee passed the Protecting Access to Care Act of 2017 (H.R. 1215) on Feb. 28 by a vote of 18-17. The bill, modeled after California’s Medical Injury Compensation Reform Act (MICRA), would limit noneconomic damages in medical malpractice cases to $250,000, restrict contingency fees charged by attorneys, and enforce a 3-year statute of limitations for liability lawsuits from the date of alleged injury. The bill also includes a “fair share” rule in which defendants are liable only for the damages in direct proportion to their percentage of responsibility.
The bill is the first significant medical professional liability reform legislation to be approved by the committee since 2011, said Brian K. Atchinson, president and CEO of PIAA, a national trade association for medical liability insurers.
“Unlike previous federal bills, the bill is focused solely on health care professionals and entities, includes detailed flexibility for states for all its reforms, and is linked with the expenditure of federal dollars to address states’ rights concerns,” Mr. Atchinson said in a statement. “H.R. 1215 will help ensure fair and timely compensation to injured patients, improve access to patient care, and promote affordable and accessible medical liability insurance coverage.”
The proposed statute would apply to any patient who receives medical care provided via a federal program, such as Medicare or Medicaid, or via a subsidy or tax benefit, such as coverage purchased under the Affordable Care Act or a future* replacement. Medical care paid by employer health plans would fall under the legislation’s umbrella since insurance premiums receive federal tax exemptions. The bill would not preempt state medical malpractice laws that impose damage caps, whether higher or lower than $250,000, nor would the legislation affect the availability of economic damages, according to bill language.
As part of the H.R. 1215, courts could limit how much attorneys receive from a patient’s ultimate award. Specifically, courts would have the power to restrict payments from a plaintiff’s damage recovery to an attorney who claims a financial stake in the outcome by virtue of a contingent fee.
“The Protecting Access to Care Act will help keep the rising costs of health care from being passed along to the American people,” Rep. Goodlatte said in a statement. “The Congressional Budget Office estimates that the reforms contained in the bill would lower health care costs by tens of billions of dollars.”
Public Citizen, a consumer rights group, criticized the legislation as misleading to consumers and harmful to patients.
“Proposals to shield providers from liability are nothing but a giveaway to industry,” Lisa Gilbert, director of Public Citizen’s Congress Watch, said in a statement. “Members supporting this bill would further harm those who are suffering from doctors’ mistakes and abandon the GOP’s supposedly unwavering commitment to state’s rights.”
“There are so many moving parts to this bill, I think the likelihood of its being passed as is is low,” said Dr. Segal, founder of Medical Justice, a company that works to deter frivolous medical malpractice lawsuits. “The biggest challenge will be whether the Republicans have to get eight Democratic senators to join the bill. To make it more palatable, something will need to give. Such provisions on tort reform are likely to be the first items offered for sacrifice.”
[email protected]
On Twitter @legal_med
TAVR can be performed safely within 30 days of PCI
WASHINGTON – The risk of adverse events from a transcatheter aortic valve replacement (TAVR) does not appear to be significantly increased in those who have undergone a recent percutaneous intervention (PCI), according to a matched retrospective analysis.
“PCI prior to TAVR in patients with severe aortic stenosis and significant coronary artery disease appears to be feasible and safe,” reported Ashwat S. Dhillon, MD, a cardiology fellow at the University of Southern California, Los Angeles, at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The conclusion that PCI can be performed safely prior to TAVR was drawn from a series of 286 patients treated with TAVR over a nearly 5-year period. Within this group, 29 patients underwent PCI for CAD within 30 days prior to TAVR. They were matched in a 1:1 fashion based on age, sex, history of prior myocardial infarction, and left ventricular ejection fraction to patients undergoing PCI without subsequent TAVR.
The primary endpoint of the analysis was a composite of major in-hospital adverse cardiovascular events (MACE) that included MI and stroke. In addition, the two groups were compared for mortality and readmission rates 30 days after TAVR.
Most of the patients (69%) were male, and the mean age was 77 years. About 20% had a prior MI, roughly 30% had a prior coronary artery bypass graft procedure, and approximately 30% had a prior PCI. There were numerical differences in the rates of hypertension, chronic kidney disease, and diabetes when the two groups were compared, but none were statistically significant.
The procedural details of the PCI were also similar, according to Dr. Dhillon. Although there was a significantly greater proportion of patients treated for lesions in the left circumflex artery in the group that did not undergo TAVR (31.03% vs. 3.45%; P = .02), there were no significant differences in procedures performed in other arteries. There were also no significant differences in the average number of stents and the average total stent length for those who underwent TAVR relative to those who did not.
The rate of in-hospital MI was 14% in both groups. No patient in either group had a stroke. At 30 days, mortality was 3% in each group. Although 30-day readmissions were higher in the group that underwent both PCI and TAVR than those who underwent PCI alone (10% vs. 0%), the difference did not reach significance.
Data evaluating the safety of performing PCI and TAVR procedures in close proximity is needed because “a significant proportion of patients with severe aortic stenosis have coexisting and significant CAD,” Dr. Dhillon explained. Although he suggested that a larger pool of data is needed to confirm the preliminary findings of this study, he suggested that these data are reassuring.
WASHINGTON – The risk of adverse events from a transcatheter aortic valve replacement (TAVR) does not appear to be significantly increased in those who have undergone a recent percutaneous intervention (PCI), according to a matched retrospective analysis.
“PCI prior to TAVR in patients with severe aortic stenosis and significant coronary artery disease appears to be feasible and safe,” reported Ashwat S. Dhillon, MD, a cardiology fellow at the University of Southern California, Los Angeles, at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The conclusion that PCI can be performed safely prior to TAVR was drawn from a series of 286 patients treated with TAVR over a nearly 5-year period. Within this group, 29 patients underwent PCI for CAD within 30 days prior to TAVR. They were matched in a 1:1 fashion based on age, sex, history of prior myocardial infarction, and left ventricular ejection fraction to patients undergoing PCI without subsequent TAVR.
The primary endpoint of the analysis was a composite of major in-hospital adverse cardiovascular events (MACE) that included MI and stroke. In addition, the two groups were compared for mortality and readmission rates 30 days after TAVR.
Most of the patients (69%) were male, and the mean age was 77 years. About 20% had a prior MI, roughly 30% had a prior coronary artery bypass graft procedure, and approximately 30% had a prior PCI. There were numerical differences in the rates of hypertension, chronic kidney disease, and diabetes when the two groups were compared, but none were statistically significant.
The procedural details of the PCI were also similar, according to Dr. Dhillon. Although there was a significantly greater proportion of patients treated for lesions in the left circumflex artery in the group that did not undergo TAVR (31.03% vs. 3.45%; P = .02), there were no significant differences in procedures performed in other arteries. There were also no significant differences in the average number of stents and the average total stent length for those who underwent TAVR relative to those who did not.
The rate of in-hospital MI was 14% in both groups. No patient in either group had a stroke. At 30 days, mortality was 3% in each group. Although 30-day readmissions were higher in the group that underwent both PCI and TAVR than those who underwent PCI alone (10% vs. 0%), the difference did not reach significance.
Data evaluating the safety of performing PCI and TAVR procedures in close proximity is needed because “a significant proportion of patients with severe aortic stenosis have coexisting and significant CAD,” Dr. Dhillon explained. Although he suggested that a larger pool of data is needed to confirm the preliminary findings of this study, he suggested that these data are reassuring.
WASHINGTON – The risk of adverse events from a transcatheter aortic valve replacement (TAVR) does not appear to be significantly increased in those who have undergone a recent percutaneous intervention (PCI), according to a matched retrospective analysis.
“PCI prior to TAVR in patients with severe aortic stenosis and significant coronary artery disease appears to be feasible and safe,” reported Ashwat S. Dhillon, MD, a cardiology fellow at the University of Southern California, Los Angeles, at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
The conclusion that PCI can be performed safely prior to TAVR was drawn from a series of 286 patients treated with TAVR over a nearly 5-year period. Within this group, 29 patients underwent PCI for CAD within 30 days prior to TAVR. They were matched in a 1:1 fashion based on age, sex, history of prior myocardial infarction, and left ventricular ejection fraction to patients undergoing PCI without subsequent TAVR.
The primary endpoint of the analysis was a composite of major in-hospital adverse cardiovascular events (MACE) that included MI and stroke. In addition, the two groups were compared for mortality and readmission rates 30 days after TAVR.
Most of the patients (69%) were male, and the mean age was 77 years. About 20% had a prior MI, roughly 30% had a prior coronary artery bypass graft procedure, and approximately 30% had a prior PCI. There were numerical differences in the rates of hypertension, chronic kidney disease, and diabetes when the two groups were compared, but none were statistically significant.
The procedural details of the PCI were also similar, according to Dr. Dhillon. Although there was a significantly greater proportion of patients treated for lesions in the left circumflex artery in the group that did not undergo TAVR (31.03% vs. 3.45%; P = .02), there were no significant differences in procedures performed in other arteries. There were also no significant differences in the average number of stents and the average total stent length for those who underwent TAVR relative to those who did not.
The rate of in-hospital MI was 14% in both groups. No patient in either group had a stroke. At 30 days, mortality was 3% in each group. Although 30-day readmissions were higher in the group that underwent both PCI and TAVR than those who underwent PCI alone (10% vs. 0%), the difference did not reach significance.
Data evaluating the safety of performing PCI and TAVR procedures in close proximity is needed because “a significant proportion of patients with severe aortic stenosis have coexisting and significant CAD,” Dr. Dhillon explained. Although he suggested that a larger pool of data is needed to confirm the preliminary findings of this study, he suggested that these data are reassuring.
AT CRT 2017
Key clinical point: Adverse outcomes from transcatheter aortic valve replacement are not increased in patients who had a recent percutaneous intervention.
Major finding: Rates of in-hospital MI (14%), stroke (0%), and 30-day mortality (3%) were exactly the same for those with or without prior PCI.
Data source: A nonrandomized, retrospective, matched analysis.
Disclosures: Dr. Dhillon reported no financial relationships to disclose.
Expert provides deeper insight into tocilizumab for giant cell arteritis
SNOWMASS, COLO. – The sustained remission rate in patients with giant cell arteritis was three times better with subcutaneous tocilizumab than with long-term prednisone in the landmark GiACTA trial, John H. Stone, MD, reported at the Winter Rheumatology Symposium sponsored by the American College of Rheumatology.
Moreover, the serious adverse event rate was significantly lower with the interleukin-6 receptor inhibitor tocilizumab (Actemra). This finding serves to underscore the pronounced, yet sometimes stealthy, toxicity of long-term, high-dose prednisone. Many rheumatologists have underplayed these side effects for lack of a better treatment option, because until the randomized, double-blind GiACTA trial, corticosteroids were the standard of care and only known effective therapy for giant cell arteritis (GCA), observed Dr. Stone, professor of medicine at Harvard Medical School, Boston.
“There’s finally something new in giant cell arteritis,” the rheumatologist declared. “The era of unending steroid therapy with no viable alternative is over.”
Dr. Stone was global principal investigator in GiACTA, a 14-country study including 251 GCA patients, roughly evenly divided between newly diagnosed patients and those with previously treated relapsing disease. GiACTA, he noted, was a study of several firsts: the first-ever clinical trial in any disease to utilize a blinded variable-dose steroid regimen, the first to feature a double-blind steroid-tapering regimen, and the first prospective study of 1 full year of tapered-dose prednisone.
The primary outcome was sustained remission as defined by absence of flare during study weeks 12-52 coupled with normalization of the C-reactive protein level to less than 1 mg/dL. This sustained remission endpoint was achieved in 14% of patients on 26 weeks of prednisone plus placebo and 17.6% of those on 52 weeks of prednisone and placebo.
“The results in the two steroid arms are lousy,” the rheumatologist pointed out. “This is I think one of the most astounding things about the trial.”
In sharp contrast, the sustained remission rate was 56% with 162 mg of subcutaneous tocilizumab once weekly plus 26 weeks of prednisone, and 53.1% with 162 mg of the humanized monoclonal antibody every 2 weeks plus 26 weeks of prednisone.
Tocilizumab’s steroid-sparing capability was impressive. The mean cumulative prednisone dose was 4,199 mg in patients on a 52-week prednisone taper plus placebo – a steroid regimen that most closely mimics what most rheumatologists have until now considered standard practice – versus only 2,098 mg in patients on once-weekly tocilizumab plus a 26-week prednisone taper.
Serious adverse events occurred in 24% of patients on prednisone-only, compared with less than 15% of those on tocilizumab. Quality of life scores as measured on the physical component score of the Short Form–36 were significantly better in the tocilizumab recipients.
“I think this speaks again to corticosteroid toxicity,” Dr. Stone said.
Another corticosteroid toxicity underscored in GiACTA was weight gain. At enrollment, patients with newly diagnosed GCA weighed significantly less than did those with previously diagnosed, relapsing disease for which they’d already been on long-term steroids. This body weight disparity was particularly pronounced in men. Men with relapsing GCA weighed a mean of 18.6 pounds more at baseline – nearly three additional body mass index points – than did newly diagnosed men who hadn’t been on aggressive steroid therapy.
“This is a steroid toxicity that I think sneaks up on us,” Dr. Stone observed.
The ongoing GiACTA study is continuing for an additional 2 years of open-label tocilizumab restricted to participants who flared during the initial double-blind phase or thereafter.
Joel M. Kremer, MD, rose from the audience to pronounce GiACTA “a home run.”
“I thought this was the most important study presented at the 2016 ACR annual meeting,” added Dr. Kremer, professor of medicine at the University of Albany (N.Y.) and president and founder of CORRONA, the Consortium of Rheumatology Researchers of North America.
The Snowmass symposium afforded Dr. Stone the opportunity to delve into aspects of GiACTA that time didn’t permit him to address at the 2016 ACR annual meeting:
• What’s the best dose of tocilizumab?
Weekly therapy appears to be preferable, although that’s a decision for the regulatory agencies. Time to first relapse post steroid taper was significantly longer with weekly than with biweekly tocilizumab, a result driven primarily by a markedly better result in the baseline relapser group. The pharmacokinetic data also support weekly dosing: Although patients randomized to weekly tocilizumab got twice as much of the biologic over the course of 52 weeks, their serum trough levels were actually six times higher than in those on biweekly therapy.
“This has implications for control of acute phase reactants,” the rheumatologist noted.
• Which patients with GCA should receive tocilizumab, and for how long?
The GiACTA finding that patients on 52 weeks of prednisone were only one-third as likely to be in continuous remission at 1 year is a deal breaker for the traditional therapy so far as Dr. Stone is concerned, he said in response to an audience question.
“I would treat almost everyone with tocilizumab right out of the gate, and I think the goal is to get them off concomitant prednisone fast. I think we can probably achieve that in less than the 6 months we used in GiACTA,” he said.
The ongoing second, open-label phase of the study will be informative regarding optimal treatment duration. In the meantime, the rheumatologist said, “I would treat patients for 12 months and then follow them to see what they need. We treat ANCA-associated vasculitis with rituximab and steroids, and some of them go into remission that lasts 5 years. I think some giant cell arteritis patients will be the same way, and others will flare right after you stop tocilizumab or maybe even while they’re still on it. Tocilizumab is not a cure, and these patients will still need to be followed closely.”
• What about intravenous tocilizumab, the far less costly option under Medicare?
The Food and Drug Administration will consider approval only for subcutaneous tocilizumab in GCA, since that what was used in GiACTA, although Dr. Stone is convinced based upon personal experience that the subcutaneous and intravenous formulations act identically. Roche/Genentech officials have told him they will pursue a separate approval process for the intravenous formulation.
• How about Takayasu’s arteritis?
It looks like a separate approval process, including a new study, will be required for this form of large-vessel vasculitis, Dr. Stone said.
• Intriguing baseline clinical features in GiACTA:
Mouth pain/jaw claudication was present in 34% of the GCA patients at enrollment.
“Jaw claudication is, I think, vastly underestimated as a very important symptom in giant cell arteritis. Of course, patients don’t say, ‘I have jaw claudication today, doc.’ You have to ask about it specifically. It’s not part of the ACR criteria, and I think it should be,” Dr. Stone said.
Also, cranial symptoms were present in only 79% of patients at enrollment.
“I think that’s important for physicians to know: One-fifth of patients had no cranial symptoms when they were enrolled in the study,” he continued.
Another key finding: Only 67% of GCA patients had a new-onset headache at enrollment.
“We think of headache as being so crucial in this disease, and it is important, but only two-thirds of patients in this trial had it,” the rheumatologist said.
Also, 62% of GCA patients had polymyalgia rheumatica at enrollment. More interestingly, 21% of patients with confirmed GCA had only polymyalgia rheumatica, with no cranial symptoms at all.
Dr. Stone reported receiving research grants from and serving as a consultant to Roche/Genentech, which sponsored GiACTA and markets tocilizumab for the treatment of rheumatoid arthritis and juvenile idiopathic arthritis.
SNOWMASS, COLO. – The sustained remission rate in patients with giant cell arteritis was three times better with subcutaneous tocilizumab than with long-term prednisone in the landmark GiACTA trial, John H. Stone, MD, reported at the Winter Rheumatology Symposium sponsored by the American College of Rheumatology.
Moreover, the serious adverse event rate was significantly lower with the interleukin-6 receptor inhibitor tocilizumab (Actemra). This finding serves to underscore the pronounced, yet sometimes stealthy, toxicity of long-term, high-dose prednisone. Many rheumatologists have underplayed these side effects for lack of a better treatment option, because until the randomized, double-blind GiACTA trial, corticosteroids were the standard of care and only known effective therapy for giant cell arteritis (GCA), observed Dr. Stone, professor of medicine at Harvard Medical School, Boston.
“There’s finally something new in giant cell arteritis,” the rheumatologist declared. “The era of unending steroid therapy with no viable alternative is over.”
Dr. Stone was global principal investigator in GiACTA, a 14-country study including 251 GCA patients, roughly evenly divided between newly diagnosed patients and those with previously treated relapsing disease. GiACTA, he noted, was a study of several firsts: the first-ever clinical trial in any disease to utilize a blinded variable-dose steroid regimen, the first to feature a double-blind steroid-tapering regimen, and the first prospective study of 1 full year of tapered-dose prednisone.
The primary outcome was sustained remission as defined by absence of flare during study weeks 12-52 coupled with normalization of the C-reactive protein level to less than 1 mg/dL. This sustained remission endpoint was achieved in 14% of patients on 26 weeks of prednisone plus placebo and 17.6% of those on 52 weeks of prednisone and placebo.
“The results in the two steroid arms are lousy,” the rheumatologist pointed out. “This is I think one of the most astounding things about the trial.”
In sharp contrast, the sustained remission rate was 56% with 162 mg of subcutaneous tocilizumab once weekly plus 26 weeks of prednisone, and 53.1% with 162 mg of the humanized monoclonal antibody every 2 weeks plus 26 weeks of prednisone.
Tocilizumab’s steroid-sparing capability was impressive. The mean cumulative prednisone dose was 4,199 mg in patients on a 52-week prednisone taper plus placebo – a steroid regimen that most closely mimics what most rheumatologists have until now considered standard practice – versus only 2,098 mg in patients on once-weekly tocilizumab plus a 26-week prednisone taper.
Serious adverse events occurred in 24% of patients on prednisone-only, compared with less than 15% of those on tocilizumab. Quality of life scores as measured on the physical component score of the Short Form–36 were significantly better in the tocilizumab recipients.
“I think this speaks again to corticosteroid toxicity,” Dr. Stone said.
Another corticosteroid toxicity underscored in GiACTA was weight gain. At enrollment, patients with newly diagnosed GCA weighed significantly less than did those with previously diagnosed, relapsing disease for which they’d already been on long-term steroids. This body weight disparity was particularly pronounced in men. Men with relapsing GCA weighed a mean of 18.6 pounds more at baseline – nearly three additional body mass index points – than did newly diagnosed men who hadn’t been on aggressive steroid therapy.
“This is a steroid toxicity that I think sneaks up on us,” Dr. Stone observed.
The ongoing GiACTA study is continuing for an additional 2 years of open-label tocilizumab restricted to participants who flared during the initial double-blind phase or thereafter.
Joel M. Kremer, MD, rose from the audience to pronounce GiACTA “a home run.”
“I thought this was the most important study presented at the 2016 ACR annual meeting,” added Dr. Kremer, professor of medicine at the University of Albany (N.Y.) and president and founder of CORRONA, the Consortium of Rheumatology Researchers of North America.
The Snowmass symposium afforded Dr. Stone the opportunity to delve into aspects of GiACTA that time didn’t permit him to address at the 2016 ACR annual meeting:
• What’s the best dose of tocilizumab?
Weekly therapy appears to be preferable, although that’s a decision for the regulatory agencies. Time to first relapse post steroid taper was significantly longer with weekly than with biweekly tocilizumab, a result driven primarily by a markedly better result in the baseline relapser group. The pharmacokinetic data also support weekly dosing: Although patients randomized to weekly tocilizumab got twice as much of the biologic over the course of 52 weeks, their serum trough levels were actually six times higher than in those on biweekly therapy.
“This has implications for control of acute phase reactants,” the rheumatologist noted.
• Which patients with GCA should receive tocilizumab, and for how long?
The GiACTA finding that patients on 52 weeks of prednisone were only one-third as likely to be in continuous remission at 1 year is a deal breaker for the traditional therapy so far as Dr. Stone is concerned, he said in response to an audience question.
“I would treat almost everyone with tocilizumab right out of the gate, and I think the goal is to get them off concomitant prednisone fast. I think we can probably achieve that in less than the 6 months we used in GiACTA,” he said.
The ongoing second, open-label phase of the study will be informative regarding optimal treatment duration. In the meantime, the rheumatologist said, “I would treat patients for 12 months and then follow them to see what they need. We treat ANCA-associated vasculitis with rituximab and steroids, and some of them go into remission that lasts 5 years. I think some giant cell arteritis patients will be the same way, and others will flare right after you stop tocilizumab or maybe even while they’re still on it. Tocilizumab is not a cure, and these patients will still need to be followed closely.”
• What about intravenous tocilizumab, the far less costly option under Medicare?
The Food and Drug Administration will consider approval only for subcutaneous tocilizumab in GCA, since that what was used in GiACTA, although Dr. Stone is convinced based upon personal experience that the subcutaneous and intravenous formulations act identically. Roche/Genentech officials have told him they will pursue a separate approval process for the intravenous formulation.
• How about Takayasu’s arteritis?
It looks like a separate approval process, including a new study, will be required for this form of large-vessel vasculitis, Dr. Stone said.
• Intriguing baseline clinical features in GiACTA:
Mouth pain/jaw claudication was present in 34% of the GCA patients at enrollment.
“Jaw claudication is, I think, vastly underestimated as a very important symptom in giant cell arteritis. Of course, patients don’t say, ‘I have jaw claudication today, doc.’ You have to ask about it specifically. It’s not part of the ACR criteria, and I think it should be,” Dr. Stone said.
Also, cranial symptoms were present in only 79% of patients at enrollment.
“I think that’s important for physicians to know: One-fifth of patients had no cranial symptoms when they were enrolled in the study,” he continued.
Another key finding: Only 67% of GCA patients had a new-onset headache at enrollment.
“We think of headache as being so crucial in this disease, and it is important, but only two-thirds of patients in this trial had it,” the rheumatologist said.
Also, 62% of GCA patients had polymyalgia rheumatica at enrollment. More interestingly, 21% of patients with confirmed GCA had only polymyalgia rheumatica, with no cranial symptoms at all.
Dr. Stone reported receiving research grants from and serving as a consultant to Roche/Genentech, which sponsored GiACTA and markets tocilizumab for the treatment of rheumatoid arthritis and juvenile idiopathic arthritis.
SNOWMASS, COLO. – The sustained remission rate in patients with giant cell arteritis was three times better with subcutaneous tocilizumab than with long-term prednisone in the landmark GiACTA trial, John H. Stone, MD, reported at the Winter Rheumatology Symposium sponsored by the American College of Rheumatology.
Moreover, the serious adverse event rate was significantly lower with the interleukin-6 receptor inhibitor tocilizumab (Actemra). This finding serves to underscore the pronounced, yet sometimes stealthy, toxicity of long-term, high-dose prednisone. Many rheumatologists have underplayed these side effects for lack of a better treatment option, because until the randomized, double-blind GiACTA trial, corticosteroids were the standard of care and only known effective therapy for giant cell arteritis (GCA), observed Dr. Stone, professor of medicine at Harvard Medical School, Boston.
“There’s finally something new in giant cell arteritis,” the rheumatologist declared. “The era of unending steroid therapy with no viable alternative is over.”
Dr. Stone was global principal investigator in GiACTA, a 14-country study including 251 GCA patients, roughly evenly divided between newly diagnosed patients and those with previously treated relapsing disease. GiACTA, he noted, was a study of several firsts: the first-ever clinical trial in any disease to utilize a blinded variable-dose steroid regimen, the first to feature a double-blind steroid-tapering regimen, and the first prospective study of 1 full year of tapered-dose prednisone.
The primary outcome was sustained remission as defined by absence of flare during study weeks 12-52 coupled with normalization of the C-reactive protein level to less than 1 mg/dL. This sustained remission endpoint was achieved in 14% of patients on 26 weeks of prednisone plus placebo and 17.6% of those on 52 weeks of prednisone and placebo.
“The results in the two steroid arms are lousy,” the rheumatologist pointed out. “This is I think one of the most astounding things about the trial.”
In sharp contrast, the sustained remission rate was 56% with 162 mg of subcutaneous tocilizumab once weekly plus 26 weeks of prednisone, and 53.1% with 162 mg of the humanized monoclonal antibody every 2 weeks plus 26 weeks of prednisone.
Tocilizumab’s steroid-sparing capability was impressive. The mean cumulative prednisone dose was 4,199 mg in patients on a 52-week prednisone taper plus placebo – a steroid regimen that most closely mimics what most rheumatologists have until now considered standard practice – versus only 2,098 mg in patients on once-weekly tocilizumab plus a 26-week prednisone taper.
Serious adverse events occurred in 24% of patients on prednisone-only, compared with less than 15% of those on tocilizumab. Quality of life scores as measured on the physical component score of the Short Form–36 were significantly better in the tocilizumab recipients.
“I think this speaks again to corticosteroid toxicity,” Dr. Stone said.
Another corticosteroid toxicity underscored in GiACTA was weight gain. At enrollment, patients with newly diagnosed GCA weighed significantly less than did those with previously diagnosed, relapsing disease for which they’d already been on long-term steroids. This body weight disparity was particularly pronounced in men. Men with relapsing GCA weighed a mean of 18.6 pounds more at baseline – nearly three additional body mass index points – than did newly diagnosed men who hadn’t been on aggressive steroid therapy.
“This is a steroid toxicity that I think sneaks up on us,” Dr. Stone observed.
The ongoing GiACTA study is continuing for an additional 2 years of open-label tocilizumab restricted to participants who flared during the initial double-blind phase or thereafter.
Joel M. Kremer, MD, rose from the audience to pronounce GiACTA “a home run.”
“I thought this was the most important study presented at the 2016 ACR annual meeting,” added Dr. Kremer, professor of medicine at the University of Albany (N.Y.) and president and founder of CORRONA, the Consortium of Rheumatology Researchers of North America.
The Snowmass symposium afforded Dr. Stone the opportunity to delve into aspects of GiACTA that time didn’t permit him to address at the 2016 ACR annual meeting:
• What’s the best dose of tocilizumab?
Weekly therapy appears to be preferable, although that’s a decision for the regulatory agencies. Time to first relapse post steroid taper was significantly longer with weekly than with biweekly tocilizumab, a result driven primarily by a markedly better result in the baseline relapser group. The pharmacokinetic data also support weekly dosing: Although patients randomized to weekly tocilizumab got twice as much of the biologic over the course of 52 weeks, their serum trough levels were actually six times higher than in those on biweekly therapy.
“This has implications for control of acute phase reactants,” the rheumatologist noted.
• Which patients with GCA should receive tocilizumab, and for how long?
The GiACTA finding that patients on 52 weeks of prednisone were only one-third as likely to be in continuous remission at 1 year is a deal breaker for the traditional therapy so far as Dr. Stone is concerned, he said in response to an audience question.
“I would treat almost everyone with tocilizumab right out of the gate, and I think the goal is to get them off concomitant prednisone fast. I think we can probably achieve that in less than the 6 months we used in GiACTA,” he said.
The ongoing second, open-label phase of the study will be informative regarding optimal treatment duration. In the meantime, the rheumatologist said, “I would treat patients for 12 months and then follow them to see what they need. We treat ANCA-associated vasculitis with rituximab and steroids, and some of them go into remission that lasts 5 years. I think some giant cell arteritis patients will be the same way, and others will flare right after you stop tocilizumab or maybe even while they’re still on it. Tocilizumab is not a cure, and these patients will still need to be followed closely.”
• What about intravenous tocilizumab, the far less costly option under Medicare?
The Food and Drug Administration will consider approval only for subcutaneous tocilizumab in GCA, since that what was used in GiACTA, although Dr. Stone is convinced based upon personal experience that the subcutaneous and intravenous formulations act identically. Roche/Genentech officials have told him they will pursue a separate approval process for the intravenous formulation.
• How about Takayasu’s arteritis?
It looks like a separate approval process, including a new study, will be required for this form of large-vessel vasculitis, Dr. Stone said.
• Intriguing baseline clinical features in GiACTA:
Mouth pain/jaw claudication was present in 34% of the GCA patients at enrollment.
“Jaw claudication is, I think, vastly underestimated as a very important symptom in giant cell arteritis. Of course, patients don’t say, ‘I have jaw claudication today, doc.’ You have to ask about it specifically. It’s not part of the ACR criteria, and I think it should be,” Dr. Stone said.
Also, cranial symptoms were present in only 79% of patients at enrollment.
“I think that’s important for physicians to know: One-fifth of patients had no cranial symptoms when they were enrolled in the study,” he continued.
Another key finding: Only 67% of GCA patients had a new-onset headache at enrollment.
“We think of headache as being so crucial in this disease, and it is important, but only two-thirds of patients in this trial had it,” the rheumatologist said.
Also, 62% of GCA patients had polymyalgia rheumatica at enrollment. More interestingly, 21% of patients with confirmed GCA had only polymyalgia rheumatica, with no cranial symptoms at all.
Dr. Stone reported receiving research grants from and serving as a consultant to Roche/Genentech, which sponsored GiACTA and markets tocilizumab for the treatment of rheumatoid arthritis and juvenile idiopathic arthritis.
EXPERT ANALYSIS FROM THE WINTER RHEUMATOLOGY SYMPOSIUM
VIDEO: Grading tools help set alopecia treatment expectations and monitor progress
ORLANDO – Two hair loss clinical grading tools can help physicians and their female androgenetic alopecia patients set medical treatment expectations, and make tracking progress both easier and more accurate, according to the dermatologist who developed the scales.
The five-point clinical grading scale helps physicians with diagnosing female pattern hair loss and grading the severity, Rodney Sinclair, MD, said in a video interview at the annual meeting of the American Academy of Dermatology. “And you can use that clinical grading scale to monitor the response to treatment” and show patients what to expect with treatment, added Dr. Sinclair, professor and chairman, department of dermatology, Epworth Hospital, Melbourne.
He also discussed a validated hair shedding scale, “a really simple and easy test to use,” with six photographs to help patients determine how much hair they are shedding on a daily basis. “Most women don’t know what’s a normal amount of hair to shed,” he said. In the interview, Dr. Sinclair explains more about the two scales, and how they can be used to obtain clinically relevant information to help guide treatment – and shares his tips for how to work with women who are anxious about their hair loss improvement.
Dr. Sinclair owns the copyrights for the Sinclair Severity Scale. He has no other relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @whitneymcknight
ORLANDO – Two hair loss clinical grading tools can help physicians and their female androgenetic alopecia patients set medical treatment expectations, and make tracking progress both easier and more accurate, according to the dermatologist who developed the scales.
The five-point clinical grading scale helps physicians with diagnosing female pattern hair loss and grading the severity, Rodney Sinclair, MD, said in a video interview at the annual meeting of the American Academy of Dermatology. “And you can use that clinical grading scale to monitor the response to treatment” and show patients what to expect with treatment, added Dr. Sinclair, professor and chairman, department of dermatology, Epworth Hospital, Melbourne.
He also discussed a validated hair shedding scale, “a really simple and easy test to use,” with six photographs to help patients determine how much hair they are shedding on a daily basis. “Most women don’t know what’s a normal amount of hair to shed,” he said. In the interview, Dr. Sinclair explains more about the two scales, and how they can be used to obtain clinically relevant information to help guide treatment – and shares his tips for how to work with women who are anxious about their hair loss improvement.
Dr. Sinclair owns the copyrights for the Sinclair Severity Scale. He has no other relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @whitneymcknight
ORLANDO – Two hair loss clinical grading tools can help physicians and their female androgenetic alopecia patients set medical treatment expectations, and make tracking progress both easier and more accurate, according to the dermatologist who developed the scales.
The five-point clinical grading scale helps physicians with diagnosing female pattern hair loss and grading the severity, Rodney Sinclair, MD, said in a video interview at the annual meeting of the American Academy of Dermatology. “And you can use that clinical grading scale to monitor the response to treatment” and show patients what to expect with treatment, added Dr. Sinclair, professor and chairman, department of dermatology, Epworth Hospital, Melbourne.
He also discussed a validated hair shedding scale, “a really simple and easy test to use,” with six photographs to help patients determine how much hair they are shedding on a daily basis. “Most women don’t know what’s a normal amount of hair to shed,” he said. In the interview, Dr. Sinclair explains more about the two scales, and how they can be used to obtain clinically relevant information to help guide treatment – and shares his tips for how to work with women who are anxious about their hair loss improvement.
Dr. Sinclair owns the copyrights for the Sinclair Severity Scale. He has no other relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @whitneymcknight
AT AAD 17
Health care costs higher after prolonged ventilation
Postadmission health care costs varied considerably by the duration of patients’ in-hospital mechanical ventilation, according to a study of Canadian administrative databases.
Critically ill patients in the province of Ontario who received mechanical ventilation for more than 21 days (n = 3,891) had a median health care cost of $42,784 (all costs are in Canadian dollars) in the year after their discharge, compared with $13,005 for patients who were ventilated for 21 or fewer days (n = 78,984), reported Andrea D. Hill, PhD, of Sunnybrook Health Sciences Centre, Toronto, and her associates (Ann Am Thorac Soc. 2017;14[3]:355-62).
Dr. Hill and her associates also found that patients with longer-term ventilation were less likely to be discharged home (15% vs. 57%) and more likely to be readmitted after 6 months (36% vs. 29%) or 1 year (47% vs. 38%), but were not more likely to have an emergency department visit after 6 months (46% vs. 45%).
All patients received ventilation from April 1, 2002, to March 31, 2013. The population-based cohort study used four databases: the Canadian Institute of Health Information Discharge Abstract Database, the Ontario Health Insurance Plan database, the National Ambulatory Care Reporting System database, and the Ontario Registered Persons Database.
Postadmission health care costs varied considerably by the duration of patients’ in-hospital mechanical ventilation, according to a study of Canadian administrative databases.
Critically ill patients in the province of Ontario who received mechanical ventilation for more than 21 days (n = 3,891) had a median health care cost of $42,784 (all costs are in Canadian dollars) in the year after their discharge, compared with $13,005 for patients who were ventilated for 21 or fewer days (n = 78,984), reported Andrea D. Hill, PhD, of Sunnybrook Health Sciences Centre, Toronto, and her associates (Ann Am Thorac Soc. 2017;14[3]:355-62).
Dr. Hill and her associates also found that patients with longer-term ventilation were less likely to be discharged home (15% vs. 57%) and more likely to be readmitted after 6 months (36% vs. 29%) or 1 year (47% vs. 38%), but were not more likely to have an emergency department visit after 6 months (46% vs. 45%).
All patients received ventilation from April 1, 2002, to March 31, 2013. The population-based cohort study used four databases: the Canadian Institute of Health Information Discharge Abstract Database, the Ontario Health Insurance Plan database, the National Ambulatory Care Reporting System database, and the Ontario Registered Persons Database.
Postadmission health care costs varied considerably by the duration of patients’ in-hospital mechanical ventilation, according to a study of Canadian administrative databases.
Critically ill patients in the province of Ontario who received mechanical ventilation for more than 21 days (n = 3,891) had a median health care cost of $42,784 (all costs are in Canadian dollars) in the year after their discharge, compared with $13,005 for patients who were ventilated for 21 or fewer days (n = 78,984), reported Andrea D. Hill, PhD, of Sunnybrook Health Sciences Centre, Toronto, and her associates (Ann Am Thorac Soc. 2017;14[3]:355-62).
Dr. Hill and her associates also found that patients with longer-term ventilation were less likely to be discharged home (15% vs. 57%) and more likely to be readmitted after 6 months (36% vs. 29%) or 1 year (47% vs. 38%), but were not more likely to have an emergency department visit after 6 months (46% vs. 45%).
All patients received ventilation from April 1, 2002, to March 31, 2013. The population-based cohort study used four databases: the Canadian Institute of Health Information Discharge Abstract Database, the Ontario Health Insurance Plan database, the National Ambulatory Care Reporting System database, and the Ontario Registered Persons Database.
FROM ANNALS OF THE AMERICAN THORACIC SOCIETY
Hydroxychloroquine dosage recommendations often ignored
Evidence continues to mount that some North American rheumatologists are not following practice recommendations for minimizing the retinal toxicity risk of patients on long-term hydroxychloroquine treatment.
An audit of 100 patients seen at any of nine Canadian rheumatology clinics during early 2016 showed that 30% of patients were not on appropriate weight-based hydroxychloroquine dosages, and 13% of patients on the drug had not received a baseline retinal assessment during their first year of treatment, Sahil Koppikar, MD, reported in a poster presented at the annual meeting of the Canadian Rheumatology Association in Ottawa in February.
In a second recently reported study, researchers from the Chicago area documented that roughly half of the 554 rheumatology patients on hydroxychloroquine (HCQ) in a regional health system and seen by an ophthalmologist during 2009-2016 received an excessive dosage of the drug (Ophthalmology. 2017 Jan 30. doi: 10.1016/j.ophtha.2016.12.021).
Although his study did not examine reasons for the compliance shortfall, Dr. Koppikar proposed some possible factors.
HCQ comes only as 200-mg tablets, and prescribing intermediate dosages can be a challenge (although veteran clinicians know that a safe and easy way to dial down a dosage is to have the patient periodically skip a dose). Also, “it is more convenient to prescribe 400 mg daily rather than calculate an exact dosage,” Dr. Koppikar said in an interview. In addition, rheumatologists may be unaware that the prevalence of retinopathy in patients on HCQ is fairly common (about 8% in one large recent study), assessment for risk factors that heighten sensitivity to the drug isn’t always done, and appointments for retinal screening can fall through the cracks.
“It behooves rheumatologists to adopt the [HCQ] recommendations of the American Academy of Ophthalmology [AAO] because there is more toxicity than we previously appreciated,” he added. A new version of the AAO’s recommendations came out in March 2016.
The Committee on Rheumatologic Care of the American College of Rheumatology (ACR) has regularly updated the ACR’s position statement on screening for HCQ retinopathy and appropriate dosages, with the most recent version out in August 2016. The August statement “is very similar” to the AAO’s 2016 recommendations, said Vinicius Domingues, MD, a member of the committee and an ACR spokesman for the revision. The ACR statement acknowledges and cites the AAO 2016 recommendations.
The ACR’s 2016 statement also does not fully endorse the AAO’s 2016 firm statement that “all patients using HCQ keep daily dosage less than 5.0 mg/kg real weight,” aside from “rare instances” when a higher dosage is needed to treat a “life-threatening disease.”
The ACR 2016 statement goes on to note that other authors have recommended a dosage of 6.5 mg/kg of actual body weight but capped at 400 mg/day and adjusted for renal insufficiency, and the ACR statement stops short of specifying which dosage strategy it recommends.
“The AAO recommendations are much more definitive and state more specifically what screening is recommended and what is a safe dosage,” commented Dr. Rosenbaum.
Dr. Domingues agreed that rheumatologist compliance with HCQ best practices has been spotty.
“In the past few years, more studies have used new ways to detect macular abnormalities and have identified a higher-than-expected incidence of maculopathy. Through lectures, CME, and articles, rheumatologists have received a tremendous amount of information with regard to screening and preventing retinal toxicity,” he said in an interview. “There are still gaps, and some rheumatologists still prescribe HCQ without taking into consideration the patient’s weight.”
That was a key finding in the poster presented at the Canadian Rheumatology Association by Dr. Koppikar and his collaborator on the study, Henry Averns, MD. The 100 patients assessed through the nine-clinic audit process averaged 58 years old, 81% were women, and patients had been taking HCQ for an average of just over 6 years, primarily for rheumatoid arthritis or systemic lupus erythematosus. Nearly two-thirds had a high risk for retinal toxicity. Based on the 2011 recommendations from the AAO and ACR, 17% of the patients were receiving an HCQ overdose that was more than 10% above the recommended dosage, and another 13% received a smaller overdose. If the 2016 dosage guidelines were applied, the extent of overdosing might be even greater, Dr. Koppikar said.
Dr. Koppikar and Dr. Averns said they believe that one way to address HCQ overdosing is by giving clinicians a dosing chart to easily find the right dosage for a patient’s weight. They have distributed these charts to the practices they audited and plan to do a follow-up audit to measure the effect of the intervention on HCQ prescribing.
Results from the initial clinical audit showed that “clinicians were not meeting standards, and we needed an intervention [a dosing chart] to implement a change,” Dr. Koppikar said. “Clinical audits are easy to implement, cost effective, and help improve patient care.”
Dr. Koppikar, Dr. Rosenbaum, Dr. Domingues, and Dr. Averns had no relevant financial disclosures.
[email protected]
On Twitter @mitchelzoler
Evidence continues to mount that some North American rheumatologists are not following practice recommendations for minimizing the retinal toxicity risk of patients on long-term hydroxychloroquine treatment.
An audit of 100 patients seen at any of nine Canadian rheumatology clinics during early 2016 showed that 30% of patients were not on appropriate weight-based hydroxychloroquine dosages, and 13% of patients on the drug had not received a baseline retinal assessment during their first year of treatment, Sahil Koppikar, MD, reported in a poster presented at the annual meeting of the Canadian Rheumatology Association in Ottawa in February.
In a second recently reported study, researchers from the Chicago area documented that roughly half of the 554 rheumatology patients on hydroxychloroquine (HCQ) in a regional health system and seen by an ophthalmologist during 2009-2016 received an excessive dosage of the drug (Ophthalmology. 2017 Jan 30. doi: 10.1016/j.ophtha.2016.12.021).
Although his study did not examine reasons for the compliance shortfall, Dr. Koppikar proposed some possible factors.
HCQ comes only as 200-mg tablets, and prescribing intermediate dosages can be a challenge (although veteran clinicians know that a safe and easy way to dial down a dosage is to have the patient periodically skip a dose). Also, “it is more convenient to prescribe 400 mg daily rather than calculate an exact dosage,” Dr. Koppikar said in an interview. In addition, rheumatologists may be unaware that the prevalence of retinopathy in patients on HCQ is fairly common (about 8% in one large recent study), assessment for risk factors that heighten sensitivity to the drug isn’t always done, and appointments for retinal screening can fall through the cracks.
“It behooves rheumatologists to adopt the [HCQ] recommendations of the American Academy of Ophthalmology [AAO] because there is more toxicity than we previously appreciated,” he added. A new version of the AAO’s recommendations came out in March 2016.
The Committee on Rheumatologic Care of the American College of Rheumatology (ACR) has regularly updated the ACR’s position statement on screening for HCQ retinopathy and appropriate dosages, with the most recent version out in August 2016. The August statement “is very similar” to the AAO’s 2016 recommendations, said Vinicius Domingues, MD, a member of the committee and an ACR spokesman for the revision. The ACR statement acknowledges and cites the AAO 2016 recommendations.
The ACR’s 2016 statement also does not fully endorse the AAO’s 2016 firm statement that “all patients using HCQ keep daily dosage less than 5.0 mg/kg real weight,” aside from “rare instances” when a higher dosage is needed to treat a “life-threatening disease.”
The ACR 2016 statement goes on to note that other authors have recommended a dosage of 6.5 mg/kg of actual body weight but capped at 400 mg/day and adjusted for renal insufficiency, and the ACR statement stops short of specifying which dosage strategy it recommends.
“The AAO recommendations are much more definitive and state more specifically what screening is recommended and what is a safe dosage,” commented Dr. Rosenbaum.
Dr. Domingues agreed that rheumatologist compliance with HCQ best practices has been spotty.
“In the past few years, more studies have used new ways to detect macular abnormalities and have identified a higher-than-expected incidence of maculopathy. Through lectures, CME, and articles, rheumatologists have received a tremendous amount of information with regard to screening and preventing retinal toxicity,” he said in an interview. “There are still gaps, and some rheumatologists still prescribe HCQ without taking into consideration the patient’s weight.”
That was a key finding in the poster presented at the Canadian Rheumatology Association by Dr. Koppikar and his collaborator on the study, Henry Averns, MD. The 100 patients assessed through the nine-clinic audit process averaged 58 years old, 81% were women, and patients had been taking HCQ for an average of just over 6 years, primarily for rheumatoid arthritis or systemic lupus erythematosus. Nearly two-thirds had a high risk for retinal toxicity. Based on the 2011 recommendations from the AAO and ACR, 17% of the patients were receiving an HCQ overdose that was more than 10% above the recommended dosage, and another 13% received a smaller overdose. If the 2016 dosage guidelines were applied, the extent of overdosing might be even greater, Dr. Koppikar said.
Dr. Koppikar and Dr. Averns said they believe that one way to address HCQ overdosing is by giving clinicians a dosing chart to easily find the right dosage for a patient’s weight. They have distributed these charts to the practices they audited and plan to do a follow-up audit to measure the effect of the intervention on HCQ prescribing.
Results from the initial clinical audit showed that “clinicians were not meeting standards, and we needed an intervention [a dosing chart] to implement a change,” Dr. Koppikar said. “Clinical audits are easy to implement, cost effective, and help improve patient care.”
Dr. Koppikar, Dr. Rosenbaum, Dr. Domingues, and Dr. Averns had no relevant financial disclosures.
[email protected]
On Twitter @mitchelzoler
Evidence continues to mount that some North American rheumatologists are not following practice recommendations for minimizing the retinal toxicity risk of patients on long-term hydroxychloroquine treatment.
An audit of 100 patients seen at any of nine Canadian rheumatology clinics during early 2016 showed that 30% of patients were not on appropriate weight-based hydroxychloroquine dosages, and 13% of patients on the drug had not received a baseline retinal assessment during their first year of treatment, Sahil Koppikar, MD, reported in a poster presented at the annual meeting of the Canadian Rheumatology Association in Ottawa in February.
In a second recently reported study, researchers from the Chicago area documented that roughly half of the 554 rheumatology patients on hydroxychloroquine (HCQ) in a regional health system and seen by an ophthalmologist during 2009-2016 received an excessive dosage of the drug (Ophthalmology. 2017 Jan 30. doi: 10.1016/j.ophtha.2016.12.021).
Although his study did not examine reasons for the compliance shortfall, Dr. Koppikar proposed some possible factors.
HCQ comes only as 200-mg tablets, and prescribing intermediate dosages can be a challenge (although veteran clinicians know that a safe and easy way to dial down a dosage is to have the patient periodically skip a dose). Also, “it is more convenient to prescribe 400 mg daily rather than calculate an exact dosage,” Dr. Koppikar said in an interview. In addition, rheumatologists may be unaware that the prevalence of retinopathy in patients on HCQ is fairly common (about 8% in one large recent study), assessment for risk factors that heighten sensitivity to the drug isn’t always done, and appointments for retinal screening can fall through the cracks.
“It behooves rheumatologists to adopt the [HCQ] recommendations of the American Academy of Ophthalmology [AAO] because there is more toxicity than we previously appreciated,” he added. A new version of the AAO’s recommendations came out in March 2016.
The Committee on Rheumatologic Care of the American College of Rheumatology (ACR) has regularly updated the ACR’s position statement on screening for HCQ retinopathy and appropriate dosages, with the most recent version out in August 2016. The August statement “is very similar” to the AAO’s 2016 recommendations, said Vinicius Domingues, MD, a member of the committee and an ACR spokesman for the revision. The ACR statement acknowledges and cites the AAO 2016 recommendations.
The ACR’s 2016 statement also does not fully endorse the AAO’s 2016 firm statement that “all patients using HCQ keep daily dosage less than 5.0 mg/kg real weight,” aside from “rare instances” when a higher dosage is needed to treat a “life-threatening disease.”
The ACR 2016 statement goes on to note that other authors have recommended a dosage of 6.5 mg/kg of actual body weight but capped at 400 mg/day and adjusted for renal insufficiency, and the ACR statement stops short of specifying which dosage strategy it recommends.
“The AAO recommendations are much more definitive and state more specifically what screening is recommended and what is a safe dosage,” commented Dr. Rosenbaum.
Dr. Domingues agreed that rheumatologist compliance with HCQ best practices has been spotty.
“In the past few years, more studies have used new ways to detect macular abnormalities and have identified a higher-than-expected incidence of maculopathy. Through lectures, CME, and articles, rheumatologists have received a tremendous amount of information with regard to screening and preventing retinal toxicity,” he said in an interview. “There are still gaps, and some rheumatologists still prescribe HCQ without taking into consideration the patient’s weight.”
That was a key finding in the poster presented at the Canadian Rheumatology Association by Dr. Koppikar and his collaborator on the study, Henry Averns, MD. The 100 patients assessed through the nine-clinic audit process averaged 58 years old, 81% were women, and patients had been taking HCQ for an average of just over 6 years, primarily for rheumatoid arthritis or systemic lupus erythematosus. Nearly two-thirds had a high risk for retinal toxicity. Based on the 2011 recommendations from the AAO and ACR, 17% of the patients were receiving an HCQ overdose that was more than 10% above the recommended dosage, and another 13% received a smaller overdose. If the 2016 dosage guidelines were applied, the extent of overdosing might be even greater, Dr. Koppikar said.
Dr. Koppikar and Dr. Averns said they believe that one way to address HCQ overdosing is by giving clinicians a dosing chart to easily find the right dosage for a patient’s weight. They have distributed these charts to the practices they audited and plan to do a follow-up audit to measure the effect of the intervention on HCQ prescribing.
Results from the initial clinical audit showed that “clinicians were not meeting standards, and we needed an intervention [a dosing chart] to implement a change,” Dr. Koppikar said. “Clinical audits are easy to implement, cost effective, and help improve patient care.”
Dr. Koppikar, Dr. Rosenbaum, Dr. Domingues, and Dr. Averns had no relevant financial disclosures.
[email protected]
On Twitter @mitchelzoler
Key clinical point:
Major finding: A practice audit showed that 30% of rheumatology patients treated with hydroxychloroquine received an excessive dosage.
Data source: An audit of 100 rheumatology patients seen at any of nine rheumatology clinics in Eastern Ontario, Canada.
Disclosures: Dr. Koppikar, Dr. Rosenbaum, Dr. Domingues, and Dr. Averns had no relevant financial disclosures.