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Patient-to-intensivist ratios can influence patient mortality
CLINICAL QUESTION: Is there variation in patient-to-intensivist ratios (PIR) across ICUs, and does that ratio affect hospital mortality?
BACKGROUND: Most studies show that intensivists improve ICU patient outcomes. With increasing ICU patients but stable intensivist staffing, patient-to-intensivist ratios are increasing. It is unclear if that rising ratio is adversely affecting patient mortality.
STUDY DESIGN: Multicenter retrospective cohort analysis.
SETTING: ICUs in the United Kingdom from 2010 to 2013.
The median PIR was 8.5 but varied substantially – PIRs were often larger. The association between PIR and mortality was U shaped. There was a decrease in mortality as the PIR reached 7.5, after which the mortality increased again. The higher mortality with very low PIRs could reflect a volume-outcome relationship. Less patients could mean less experience, different levels of ancillary staff, and so on.
This study did not take into account the possible differences in the multidisciplinary makeup of the ICU teams that would affect the intensivist’s level of responsibility.
BOTTOM LINE: There seems to be an optimal PIR for mortality, though that optimal number would likely depend on the ancillary staff, level of trainees, and patient acuity.
CITATIONS: Gershengorn HB, Harrison DA, Garland A, et al. “Association of Intensive Care Unit Patient-to-Intensivist Ratios With Hospital Mortality.” JAMA Intern Med. 2017 Mar 1;177(3):388-96.
Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.
CLINICAL QUESTION: Is there variation in patient-to-intensivist ratios (PIR) across ICUs, and does that ratio affect hospital mortality?
BACKGROUND: Most studies show that intensivists improve ICU patient outcomes. With increasing ICU patients but stable intensivist staffing, patient-to-intensivist ratios are increasing. It is unclear if that rising ratio is adversely affecting patient mortality.
STUDY DESIGN: Multicenter retrospective cohort analysis.
SETTING: ICUs in the United Kingdom from 2010 to 2013.
The median PIR was 8.5 but varied substantially – PIRs were often larger. The association between PIR and mortality was U shaped. There was a decrease in mortality as the PIR reached 7.5, after which the mortality increased again. The higher mortality with very low PIRs could reflect a volume-outcome relationship. Less patients could mean less experience, different levels of ancillary staff, and so on.
This study did not take into account the possible differences in the multidisciplinary makeup of the ICU teams that would affect the intensivist’s level of responsibility.
BOTTOM LINE: There seems to be an optimal PIR for mortality, though that optimal number would likely depend on the ancillary staff, level of trainees, and patient acuity.
CITATIONS: Gershengorn HB, Harrison DA, Garland A, et al. “Association of Intensive Care Unit Patient-to-Intensivist Ratios With Hospital Mortality.” JAMA Intern Med. 2017 Mar 1;177(3):388-96.
Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.
CLINICAL QUESTION: Is there variation in patient-to-intensivist ratios (PIR) across ICUs, and does that ratio affect hospital mortality?
BACKGROUND: Most studies show that intensivists improve ICU patient outcomes. With increasing ICU patients but stable intensivist staffing, patient-to-intensivist ratios are increasing. It is unclear if that rising ratio is adversely affecting patient mortality.
STUDY DESIGN: Multicenter retrospective cohort analysis.
SETTING: ICUs in the United Kingdom from 2010 to 2013.
The median PIR was 8.5 but varied substantially – PIRs were often larger. The association between PIR and mortality was U shaped. There was a decrease in mortality as the PIR reached 7.5, after which the mortality increased again. The higher mortality with very low PIRs could reflect a volume-outcome relationship. Less patients could mean less experience, different levels of ancillary staff, and so on.
This study did not take into account the possible differences in the multidisciplinary makeup of the ICU teams that would affect the intensivist’s level of responsibility.
BOTTOM LINE: There seems to be an optimal PIR for mortality, though that optimal number would likely depend on the ancillary staff, level of trainees, and patient acuity.
CITATIONS: Gershengorn HB, Harrison DA, Garland A, et al. “Association of Intensive Care Unit Patient-to-Intensivist Ratios With Hospital Mortality.” JAMA Intern Med. 2017 Mar 1;177(3):388-96.
Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.
Comparison of risk scoring systems for patients presenting with upper gastrointestinal bleeding
CLINICAL QUESTION: What are the accuracy and clinical utility of risk scoring systems in the assessment of patients with upper gastrointestinal (GI) bleeding?
BACKGROUND: There are several pre- and postendoscopy risk scores to predict clinically relevant outcomes such as transfusion, mortality, endoscopy treatment, surgery, and length of hospital stay for upper GI bleeding. The accuracy and applicability of these risk scores has not been well established.
STUDY DESIGN: International multicenter prospective study.
SETTING: Six large hospitals in Europe, North America, Asia, and Oceania.
SYNOPSIS: This is a prospective study comparing three pre-endoscopy scoring systems (Rockall, AIMS65, Glasgow Blatchford) and two postendoscopy scoring systems (PNED, full Rockall) in 3,012 patients with upper GI bleeding over six hospitals. It examined clinically relevant outcomes: intervention (transfusion, endoscopy, interventional radiology, surgery), mortality, rebleeding, and length of hospital stay.
The Glasgow Blatchford risk score was the most accurate at predicting the need for hospitalization and death across all hospitals, compared with the other scoring systems. It was determined that a Glasgow Blatchford score of less than 1 is an optimal threshold for outpatient management, with a 98.6% sensitivity in identifying those who would not require intervention or die. The utility of these scores to direct management in high-risk patients is limited and needs further studies. No scoring system predicted rebleeding or length of hospital stay.
A weakness of the study is that patients who bled while already inpatients were excluded.
BOTTOM LINE: The Glasgow Blatchford risk score can help direct care of very low risk patients (score, less than 1) with upper GI bleeding toward outpatient management.
CITATIONS: Stanley AJ, Laine L, Dalton HR, et al. “Comparison of risk scoring systems for patients presenting with upper gastrointestinal bleeding: International multicenter prospective study.” BMJ. 2017 Jan 4;356:i6432.
Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.
CLINICAL QUESTION: What are the accuracy and clinical utility of risk scoring systems in the assessment of patients with upper gastrointestinal (GI) bleeding?
BACKGROUND: There are several pre- and postendoscopy risk scores to predict clinically relevant outcomes such as transfusion, mortality, endoscopy treatment, surgery, and length of hospital stay for upper GI bleeding. The accuracy and applicability of these risk scores has not been well established.
STUDY DESIGN: International multicenter prospective study.
SETTING: Six large hospitals in Europe, North America, Asia, and Oceania.
SYNOPSIS: This is a prospective study comparing three pre-endoscopy scoring systems (Rockall, AIMS65, Glasgow Blatchford) and two postendoscopy scoring systems (PNED, full Rockall) in 3,012 patients with upper GI bleeding over six hospitals. It examined clinically relevant outcomes: intervention (transfusion, endoscopy, interventional radiology, surgery), mortality, rebleeding, and length of hospital stay.
The Glasgow Blatchford risk score was the most accurate at predicting the need for hospitalization and death across all hospitals, compared with the other scoring systems. It was determined that a Glasgow Blatchford score of less than 1 is an optimal threshold for outpatient management, with a 98.6% sensitivity in identifying those who would not require intervention or die. The utility of these scores to direct management in high-risk patients is limited and needs further studies. No scoring system predicted rebleeding or length of hospital stay.
A weakness of the study is that patients who bled while already inpatients were excluded.
BOTTOM LINE: The Glasgow Blatchford risk score can help direct care of very low risk patients (score, less than 1) with upper GI bleeding toward outpatient management.
CITATIONS: Stanley AJ, Laine L, Dalton HR, et al. “Comparison of risk scoring systems for patients presenting with upper gastrointestinal bleeding: International multicenter prospective study.” BMJ. 2017 Jan 4;356:i6432.
Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.
CLINICAL QUESTION: What are the accuracy and clinical utility of risk scoring systems in the assessment of patients with upper gastrointestinal (GI) bleeding?
BACKGROUND: There are several pre- and postendoscopy risk scores to predict clinically relevant outcomes such as transfusion, mortality, endoscopy treatment, surgery, and length of hospital stay for upper GI bleeding. The accuracy and applicability of these risk scores has not been well established.
STUDY DESIGN: International multicenter prospective study.
SETTING: Six large hospitals in Europe, North America, Asia, and Oceania.
SYNOPSIS: This is a prospective study comparing three pre-endoscopy scoring systems (Rockall, AIMS65, Glasgow Blatchford) and two postendoscopy scoring systems (PNED, full Rockall) in 3,012 patients with upper GI bleeding over six hospitals. It examined clinically relevant outcomes: intervention (transfusion, endoscopy, interventional radiology, surgery), mortality, rebleeding, and length of hospital stay.
The Glasgow Blatchford risk score was the most accurate at predicting the need for hospitalization and death across all hospitals, compared with the other scoring systems. It was determined that a Glasgow Blatchford score of less than 1 is an optimal threshold for outpatient management, with a 98.6% sensitivity in identifying those who would not require intervention or die. The utility of these scores to direct management in high-risk patients is limited and needs further studies. No scoring system predicted rebleeding or length of hospital stay.
A weakness of the study is that patients who bled while already inpatients were excluded.
BOTTOM LINE: The Glasgow Blatchford risk score can help direct care of very low risk patients (score, less than 1) with upper GI bleeding toward outpatient management.
CITATIONS: Stanley AJ, Laine L, Dalton HR, et al. “Comparison of risk scoring systems for patients presenting with upper gastrointestinal bleeding: International multicenter prospective study.” BMJ. 2017 Jan 4;356:i6432.
Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.
Unforgiveness
Her visit seemed uneventful enough. Back for the semester break of her senior year, Jenna came in for acne follow-up.
She seemed to be doing pretty well: just a couple of active papules on each cheek, as well as some residual fading red marks from old lesions. Still, Jenna was not happy with her situation.
“Some of the marks you have just haven’t had time to fade away yet,” I said. “But since you’re still getting new ones, perhaps we should change antibiotics. After 4 months, it’s not likely that the one you’re taking will clear you up as fully as you want. Perhaps a different one will, although complete clearing can be a hard goal to reach.”
I discussed alternative choices with Jenna, settling on one as being most likely to help and unlikely to cause problems while she was away at school. I encouraged her to continue the same topical treatment she was on – she had had “reactions” to several previous topical tries – to contact me with any problems, and to return in May.
As I wrote up her prescriptions, I asked her about her academic major.
“Electrical engineering,” she said. “My goal is to work for a couple of years, then get advanced degrees in both engineering and law. I want to fuse both disciplines in a business context.”
I congratulated her on her clarity of vision. Few college seniors have more than a vague notion of where they’re headed. I wished her well and left the room.
Because the encounter seemed pleasant and innocuous, I was taken aback when my secretary came in a couple of hours later.
“Jenna’s father has called twice,” she said. “He says he’s furious that you didn’t spend enough time with his daughter or answer all of her questions.”
Sighing inwardly, I sat down during a break and called her.
“This is Dr. Rockoff,” I said. “I understand that you were unhappy with your visit.”
“That’s right,” she said, evenly. “Very unhappy. You only spent five minutes with me. I forgot to ask you all my questions.”
“I’m sorry,” I said. “What questions did you forget to ask me?”
“I have marks on my back where the acne used to be, and they haven’t gone away.”
“I see,” I said. “I thought we had covered that in connection with the marks still on your face, but I’m sorry if I didn’t make that clear. The marks need to fade on their own, and they will, though it will probably take a few more months.”
“You didn’t give me enough time at my previous visit,” she said. “I give people the benefit of the doubt, so I gave you a second chance, and again you kept me waiting, and then you didn’t spend enough time with me.”
“I’m very sorry that I didn’t meet your expectations,” I said. “If you come back to see me, I will try to do a better job. If you decide you want to get care elsewhere, of course I’ll be happy to forward your records to another physician.”
“I gave you a second chance,” Jenna said, “and again you failed to spend adequate time or deliver satisfactory service.”
“Again, my apologies,” I said. I wished her luck and ended the call.
After all these years, I think I’m pretty good at picking up physical and verbal cues of anger and dissatisfaction, but clearly I missed them all in Jenna’s case. Like everyone else, I’ve had my share of unhappy patients, but I’m hard put to remember being laid out in lavender with such gusto before.
When I finally hang up my spurs, there are a lot of things about practicing medicine that I will miss. Being dressed-down by unforgiving kids less than a third my age will not be one of them.
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].
Her visit seemed uneventful enough. Back for the semester break of her senior year, Jenna came in for acne follow-up.
She seemed to be doing pretty well: just a couple of active papules on each cheek, as well as some residual fading red marks from old lesions. Still, Jenna was not happy with her situation.
“Some of the marks you have just haven’t had time to fade away yet,” I said. “But since you’re still getting new ones, perhaps we should change antibiotics. After 4 months, it’s not likely that the one you’re taking will clear you up as fully as you want. Perhaps a different one will, although complete clearing can be a hard goal to reach.”
I discussed alternative choices with Jenna, settling on one as being most likely to help and unlikely to cause problems while she was away at school. I encouraged her to continue the same topical treatment she was on – she had had “reactions” to several previous topical tries – to contact me with any problems, and to return in May.
As I wrote up her prescriptions, I asked her about her academic major.
“Electrical engineering,” she said. “My goal is to work for a couple of years, then get advanced degrees in both engineering and law. I want to fuse both disciplines in a business context.”
I congratulated her on her clarity of vision. Few college seniors have more than a vague notion of where they’re headed. I wished her well and left the room.
Because the encounter seemed pleasant and innocuous, I was taken aback when my secretary came in a couple of hours later.
“Jenna’s father has called twice,” she said. “He says he’s furious that you didn’t spend enough time with his daughter or answer all of her questions.”
Sighing inwardly, I sat down during a break and called her.
“This is Dr. Rockoff,” I said. “I understand that you were unhappy with your visit.”
“That’s right,” she said, evenly. “Very unhappy. You only spent five minutes with me. I forgot to ask you all my questions.”
“I’m sorry,” I said. “What questions did you forget to ask me?”
“I have marks on my back where the acne used to be, and they haven’t gone away.”
“I see,” I said. “I thought we had covered that in connection with the marks still on your face, but I’m sorry if I didn’t make that clear. The marks need to fade on their own, and they will, though it will probably take a few more months.”
“You didn’t give me enough time at my previous visit,” she said. “I give people the benefit of the doubt, so I gave you a second chance, and again you kept me waiting, and then you didn’t spend enough time with me.”
“I’m very sorry that I didn’t meet your expectations,” I said. “If you come back to see me, I will try to do a better job. If you decide you want to get care elsewhere, of course I’ll be happy to forward your records to another physician.”
“I gave you a second chance,” Jenna said, “and again you failed to spend adequate time or deliver satisfactory service.”
“Again, my apologies,” I said. I wished her luck and ended the call.
After all these years, I think I’m pretty good at picking up physical and verbal cues of anger and dissatisfaction, but clearly I missed them all in Jenna’s case. Like everyone else, I’ve had my share of unhappy patients, but I’m hard put to remember being laid out in lavender with such gusto before.
When I finally hang up my spurs, there are a lot of things about practicing medicine that I will miss. Being dressed-down by unforgiving kids less than a third my age will not be one of them.
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].
Her visit seemed uneventful enough. Back for the semester break of her senior year, Jenna came in for acne follow-up.
She seemed to be doing pretty well: just a couple of active papules on each cheek, as well as some residual fading red marks from old lesions. Still, Jenna was not happy with her situation.
“Some of the marks you have just haven’t had time to fade away yet,” I said. “But since you’re still getting new ones, perhaps we should change antibiotics. After 4 months, it’s not likely that the one you’re taking will clear you up as fully as you want. Perhaps a different one will, although complete clearing can be a hard goal to reach.”
I discussed alternative choices with Jenna, settling on one as being most likely to help and unlikely to cause problems while she was away at school. I encouraged her to continue the same topical treatment she was on – she had had “reactions” to several previous topical tries – to contact me with any problems, and to return in May.
As I wrote up her prescriptions, I asked her about her academic major.
“Electrical engineering,” she said. “My goal is to work for a couple of years, then get advanced degrees in both engineering and law. I want to fuse both disciplines in a business context.”
I congratulated her on her clarity of vision. Few college seniors have more than a vague notion of where they’re headed. I wished her well and left the room.
Because the encounter seemed pleasant and innocuous, I was taken aback when my secretary came in a couple of hours later.
“Jenna’s father has called twice,” she said. “He says he’s furious that you didn’t spend enough time with his daughter or answer all of her questions.”
Sighing inwardly, I sat down during a break and called her.
“This is Dr. Rockoff,” I said. “I understand that you were unhappy with your visit.”
“That’s right,” she said, evenly. “Very unhappy. You only spent five minutes with me. I forgot to ask you all my questions.”
“I’m sorry,” I said. “What questions did you forget to ask me?”
“I have marks on my back where the acne used to be, and they haven’t gone away.”
“I see,” I said. “I thought we had covered that in connection with the marks still on your face, but I’m sorry if I didn’t make that clear. The marks need to fade on their own, and they will, though it will probably take a few more months.”
“You didn’t give me enough time at my previous visit,” she said. “I give people the benefit of the doubt, so I gave you a second chance, and again you kept me waiting, and then you didn’t spend enough time with me.”
“I’m very sorry that I didn’t meet your expectations,” I said. “If you come back to see me, I will try to do a better job. If you decide you want to get care elsewhere, of course I’ll be happy to forward your records to another physician.”
“I gave you a second chance,” Jenna said, “and again you failed to spend adequate time or deliver satisfactory service.”
“Again, my apologies,” I said. I wished her luck and ended the call.
After all these years, I think I’m pretty good at picking up physical and verbal cues of anger and dissatisfaction, but clearly I missed them all in Jenna’s case. Like everyone else, I’ve had my share of unhappy patients, but I’m hard put to remember being laid out in lavender with such gusto before.
When I finally hang up my spurs, there are a lot of things about practicing medicine that I will miss. Being dressed-down by unforgiving kids less than a third my age will not be one of them.
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].
Don’t forget HIPAA
In the struggle to understand and comply with new regulations, it’s easy to neglect older ones. Recently, I suggested reviewing your practice for potential Occupational Safety and Health Administration violations, which can be far more costly than anything MACRA has in store.
The same goes for HIPAA since HIPAA violations can be just as costly, in view of renewed governmental enforcement and some disturbing trends in completely unrelated government agencies.
Your most basic review should be a yearly examination of every part of your office where patient information is handled to identify potential violations. Examples discovered in my office included computers at our front desk whose screens were visible to patients checking in or out; laptops that were left on counters overnight; emails between staff involving patients or their care; and documents slated for shredding that remained in a “to shred” bin for days. All of these issues were easily solved at minimal cost – respectively, screen protectors, locking all laptops after hours, new email rules, and eliminating the “to shred” bin, forcing immediate shredding of all sensitive documents. Make sure you correct any problems you find before the OCR auditors come calling. You can compare your office’s compliance status against the recommendations listed on the OCR website.
Where safeguarding protected health information is concerned, you must now assume the worst-case scenario: Previously, when protected health information was compromised, you would have to notify the affected patients (and the government) only if there was a “significant risk of financial or reputational harm.” But now, any incident involving patient records is assumed to be a breach, and must be reported. Failure to do so could subject your practice to significant fines.
The biggest vulnerability in most practices is probably mobile devices carrying patient data; and that’s where the disturbing new trend comes in: Governments, both foreign and domestic, have developed an interest in the personal data on your devices. Travelers, including American citizens, now are being pressured into giving Customs and Border Protection officers access to their cellphones and laptops at airports.
As a physician, you can invoke HIPAA in such situations, since your devices likely contain patient data in some form. But rules may vary depending on where you are traveling to or from, and officials in other countries are not bound by U.S. HIPAA constraints.
So, how do you protect patients’ (and your personal) information from invasive searches? First, encrypt all of your data; encryption software is cheap, readily available, and easy to use. (I recently posted a list of inexpensive encryption applications on the website.) Desktop apps such as BitLocker or Apple’s FileVault let you encrypt your entire hard drive, requiring a password for decryption. (As always, I have no financial interest in anything I mention here.) To avoid surrendering the password, write it down and give it to a friend, then contact that person after crossing the border. It is easier to say you didn’t memorize it, as opposed to refusing to provide it – and nobody can compel you to reveal a password you don’t know.
Experts also recommend disabling the fingerprint sensor on your smartphone; customs officials have successfully used warrants to compel people to unlock their cellphones with a fingerprint. Because of your right to remain silent, it would be difficult (but not impossible) for them to force you to share your phone’s passcode.
A better alternative, in my view, is to travel with devices that have never contained any of your patient or personal data in the first place. Invest in a cheap phone and computer to use only when you are abroad; you don’t want your nice equipment lost or stolen, anyway. A budget Android phone that works with foreign SIM cards can be had for about $100; basic laptops run $500 or less.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
In the struggle to understand and comply with new regulations, it’s easy to neglect older ones. Recently, I suggested reviewing your practice for potential Occupational Safety and Health Administration violations, which can be far more costly than anything MACRA has in store.
The same goes for HIPAA since HIPAA violations can be just as costly, in view of renewed governmental enforcement and some disturbing trends in completely unrelated government agencies.
Your most basic review should be a yearly examination of every part of your office where patient information is handled to identify potential violations. Examples discovered in my office included computers at our front desk whose screens were visible to patients checking in or out; laptops that were left on counters overnight; emails between staff involving patients or their care; and documents slated for shredding that remained in a “to shred” bin for days. All of these issues were easily solved at minimal cost – respectively, screen protectors, locking all laptops after hours, new email rules, and eliminating the “to shred” bin, forcing immediate shredding of all sensitive documents. Make sure you correct any problems you find before the OCR auditors come calling. You can compare your office’s compliance status against the recommendations listed on the OCR website.
Where safeguarding protected health information is concerned, you must now assume the worst-case scenario: Previously, when protected health information was compromised, you would have to notify the affected patients (and the government) only if there was a “significant risk of financial or reputational harm.” But now, any incident involving patient records is assumed to be a breach, and must be reported. Failure to do so could subject your practice to significant fines.
The biggest vulnerability in most practices is probably mobile devices carrying patient data; and that’s where the disturbing new trend comes in: Governments, both foreign and domestic, have developed an interest in the personal data on your devices. Travelers, including American citizens, now are being pressured into giving Customs and Border Protection officers access to their cellphones and laptops at airports.
As a physician, you can invoke HIPAA in such situations, since your devices likely contain patient data in some form. But rules may vary depending on where you are traveling to or from, and officials in other countries are not bound by U.S. HIPAA constraints.
So, how do you protect patients’ (and your personal) information from invasive searches? First, encrypt all of your data; encryption software is cheap, readily available, and easy to use. (I recently posted a list of inexpensive encryption applications on the website.) Desktop apps such as BitLocker or Apple’s FileVault let you encrypt your entire hard drive, requiring a password for decryption. (As always, I have no financial interest in anything I mention here.) To avoid surrendering the password, write it down and give it to a friend, then contact that person after crossing the border. It is easier to say you didn’t memorize it, as opposed to refusing to provide it – and nobody can compel you to reveal a password you don’t know.
Experts also recommend disabling the fingerprint sensor on your smartphone; customs officials have successfully used warrants to compel people to unlock their cellphones with a fingerprint. Because of your right to remain silent, it would be difficult (but not impossible) for them to force you to share your phone’s passcode.
A better alternative, in my view, is to travel with devices that have never contained any of your patient or personal data in the first place. Invest in a cheap phone and computer to use only when you are abroad; you don’t want your nice equipment lost or stolen, anyway. A budget Android phone that works with foreign SIM cards can be had for about $100; basic laptops run $500 or less.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
In the struggle to understand and comply with new regulations, it’s easy to neglect older ones. Recently, I suggested reviewing your practice for potential Occupational Safety and Health Administration violations, which can be far more costly than anything MACRA has in store.
The same goes for HIPAA since HIPAA violations can be just as costly, in view of renewed governmental enforcement and some disturbing trends in completely unrelated government agencies.
Your most basic review should be a yearly examination of every part of your office where patient information is handled to identify potential violations. Examples discovered in my office included computers at our front desk whose screens were visible to patients checking in or out; laptops that were left on counters overnight; emails between staff involving patients or their care; and documents slated for shredding that remained in a “to shred” bin for days. All of these issues were easily solved at minimal cost – respectively, screen protectors, locking all laptops after hours, new email rules, and eliminating the “to shred” bin, forcing immediate shredding of all sensitive documents. Make sure you correct any problems you find before the OCR auditors come calling. You can compare your office’s compliance status against the recommendations listed on the OCR website.
Where safeguarding protected health information is concerned, you must now assume the worst-case scenario: Previously, when protected health information was compromised, you would have to notify the affected patients (and the government) only if there was a “significant risk of financial or reputational harm.” But now, any incident involving patient records is assumed to be a breach, and must be reported. Failure to do so could subject your practice to significant fines.
The biggest vulnerability in most practices is probably mobile devices carrying patient data; and that’s where the disturbing new trend comes in: Governments, both foreign and domestic, have developed an interest in the personal data on your devices. Travelers, including American citizens, now are being pressured into giving Customs and Border Protection officers access to their cellphones and laptops at airports.
As a physician, you can invoke HIPAA in such situations, since your devices likely contain patient data in some form. But rules may vary depending on where you are traveling to or from, and officials in other countries are not bound by U.S. HIPAA constraints.
So, how do you protect patients’ (and your personal) information from invasive searches? First, encrypt all of your data; encryption software is cheap, readily available, and easy to use. (I recently posted a list of inexpensive encryption applications on the website.) Desktop apps such as BitLocker or Apple’s FileVault let you encrypt your entire hard drive, requiring a password for decryption. (As always, I have no financial interest in anything I mention here.) To avoid surrendering the password, write it down and give it to a friend, then contact that person after crossing the border. It is easier to say you didn’t memorize it, as opposed to refusing to provide it – and nobody can compel you to reveal a password you don’t know.
Experts also recommend disabling the fingerprint sensor on your smartphone; customs officials have successfully used warrants to compel people to unlock their cellphones with a fingerprint. Because of your right to remain silent, it would be difficult (but not impossible) for them to force you to share your phone’s passcode.
A better alternative, in my view, is to travel with devices that have never contained any of your patient or personal data in the first place. Invest in a cheap phone and computer to use only when you are abroad; you don’t want your nice equipment lost or stolen, anyway. A budget Android phone that works with foreign SIM cards can be had for about $100; basic laptops run $500 or less.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
Antianginal agents underutilized after MI
WASHINGTON – Non–beta-blocker antianginal drugs are seriously underprescribed in patients with angina following percutaneous coronary intervention (PCI) for a myocardial infarction (MI), according to a large national study, Alexander C. Fanaroff, MD, said at the annual meeting of the American College of Cardiology.
Clinical practice in this regard appears to be largely out of touch with current evidence-based guidelines regarding angina management in patients with stable ischemic heart disease. Those ACC/American Heart Association guidelines recommend a stepwise approach beginning with a beta-blocker and sublingual nitroglycerin, adding a calcium channel blocker if the beta-blocker isn’t tolerated or effective, further adding a long-acting nitrate if symptoms persist, incorporating ranolazine (Ranexa) as needed, and finally turning to revascularization for symptomatic relief if multidrug therapy proves inadequate (J Am Coll Cardiol. 2012 Dec 18;60[24]:e44-e164).
“When you ask patients and physicians separately about the prevalence of angina, they tend to disagree, with physicians consistently thinking their patients have less angina than patients report themselves. Together, with our data, this indicates that strategies to improve clinician recognition and treatment of angina symptoms are needed,” he asserted.
TRANSLATE-ACS was a large, longitudinal, observational study of patients who underwent PCI at 233 U.S. hospitals during 2010-2012. Dr. Fanaroff focused on 12-month follow-up data on the 10,870 patients whose PCI was for treatment of an acute MI. In telephone interviews 6 weeks postdischarge which incorporated the validated Seattle Angina Questionnaire, 3,190 of these individuals (31%) with stable ischemic heart disease reported angina symptoms. Of those, 79% said their symptoms occurred at least monthly, 18% weekly, and 3% daily. Yet, only 1 in 5 patients with angina 6 weeks postdischarge were on a non–beta-blocker antianginal medication: 16% were on monotherapy with a calcium channel blocker or long-acting nitrate, 3% were on dual therapy, and less than 1% were on three non–beta-blockers for their angina.
The prevalence of angina dropped over time. At 6 months postdischarge, 40% of the original cohort of patients who had angina at 6 weeks still reported angina. At 12 months, it was 33%. Meanwhile, the use of non–beta-blocker antianginal agents crept up modestly over time, from 20% in patients with angina at 6 weeks postdischarge, to 22% in those with angina at 6 months, and 23% at 12 months.
On the other hand, 33% of patients with angina at 6 weeks had persistent angina through 12 months. Remarkably, 69% of these individuals never received a non–beta-blocker antianginal drug during all that time, including 61% of those who experienced daily or weekly angina.
The use of non–beta-blocker antianginal drugs was more frequent in patients with more severe angina: 25% of patients with daily or weekly angina at 6 weeks were on such medication, as were 34% at 6 months and 38% at 12 months, compared with 16%, 18%, and 22% of those with monthly angina. Still, most of these patients were on only a single non–beta-blocker antianginal agent.
Of patients with angina at 6 weeks, 12% subsequently underwent repeat PCI at some point during the first year postdischarge. Of these individuals, 19% were on a single non–beta-blocker antianginal drug at the time of their procedure, 6% were on two such drugs, and only 1% were on three.
Roughly 10% of patients with multivessel coronary disease who were identified angiographically at the time of their acute MI did not undergo multivessel PCI at that time. This was not predictive of angina 6 weeks post discharge, Dr. Fanaroff continued.
One audience member asked Dr. Fanaroff how he knows that the patients with self-reported angina didn’t actually have noncardiac chest pain, in which case their physicians’ decision not to prescribe second- and third-tier antianginal drugs would be appropriate.
Dr. Fanaroff responded that it’s possible, and even likely, that some patients with self-reported angina had a noncardiac source of their chest pain. However, they would be in the minority. The fact is that multiple studies have shown that patients who report experiencing angina after PCI for acute MI have about a 1.5-times increased risk of readmission and repeat revascularization, a 2-times increased risk of developing new depressive symptoms, and diminished quality of life scores.
The TRANSLATE-ACS study was sponsored by Eli Lilly. Dr. Fanaroff reported having no financial conflicts.
WASHINGTON – Non–beta-blocker antianginal drugs are seriously underprescribed in patients with angina following percutaneous coronary intervention (PCI) for a myocardial infarction (MI), according to a large national study, Alexander C. Fanaroff, MD, said at the annual meeting of the American College of Cardiology.
Clinical practice in this regard appears to be largely out of touch with current evidence-based guidelines regarding angina management in patients with stable ischemic heart disease. Those ACC/American Heart Association guidelines recommend a stepwise approach beginning with a beta-blocker and sublingual nitroglycerin, adding a calcium channel blocker if the beta-blocker isn’t tolerated or effective, further adding a long-acting nitrate if symptoms persist, incorporating ranolazine (Ranexa) as needed, and finally turning to revascularization for symptomatic relief if multidrug therapy proves inadequate (J Am Coll Cardiol. 2012 Dec 18;60[24]:e44-e164).
“When you ask patients and physicians separately about the prevalence of angina, they tend to disagree, with physicians consistently thinking their patients have less angina than patients report themselves. Together, with our data, this indicates that strategies to improve clinician recognition and treatment of angina symptoms are needed,” he asserted.
TRANSLATE-ACS was a large, longitudinal, observational study of patients who underwent PCI at 233 U.S. hospitals during 2010-2012. Dr. Fanaroff focused on 12-month follow-up data on the 10,870 patients whose PCI was for treatment of an acute MI. In telephone interviews 6 weeks postdischarge which incorporated the validated Seattle Angina Questionnaire, 3,190 of these individuals (31%) with stable ischemic heart disease reported angina symptoms. Of those, 79% said their symptoms occurred at least monthly, 18% weekly, and 3% daily. Yet, only 1 in 5 patients with angina 6 weeks postdischarge were on a non–beta-blocker antianginal medication: 16% were on monotherapy with a calcium channel blocker or long-acting nitrate, 3% were on dual therapy, and less than 1% were on three non–beta-blockers for their angina.
The prevalence of angina dropped over time. At 6 months postdischarge, 40% of the original cohort of patients who had angina at 6 weeks still reported angina. At 12 months, it was 33%. Meanwhile, the use of non–beta-blocker antianginal agents crept up modestly over time, from 20% in patients with angina at 6 weeks postdischarge, to 22% in those with angina at 6 months, and 23% at 12 months.
On the other hand, 33% of patients with angina at 6 weeks had persistent angina through 12 months. Remarkably, 69% of these individuals never received a non–beta-blocker antianginal drug during all that time, including 61% of those who experienced daily or weekly angina.
The use of non–beta-blocker antianginal drugs was more frequent in patients with more severe angina: 25% of patients with daily or weekly angina at 6 weeks were on such medication, as were 34% at 6 months and 38% at 12 months, compared with 16%, 18%, and 22% of those with monthly angina. Still, most of these patients were on only a single non–beta-blocker antianginal agent.
Of patients with angina at 6 weeks, 12% subsequently underwent repeat PCI at some point during the first year postdischarge. Of these individuals, 19% were on a single non–beta-blocker antianginal drug at the time of their procedure, 6% were on two such drugs, and only 1% were on three.
Roughly 10% of patients with multivessel coronary disease who were identified angiographically at the time of their acute MI did not undergo multivessel PCI at that time. This was not predictive of angina 6 weeks post discharge, Dr. Fanaroff continued.
One audience member asked Dr. Fanaroff how he knows that the patients with self-reported angina didn’t actually have noncardiac chest pain, in which case their physicians’ decision not to prescribe second- and third-tier antianginal drugs would be appropriate.
Dr. Fanaroff responded that it’s possible, and even likely, that some patients with self-reported angina had a noncardiac source of their chest pain. However, they would be in the minority. The fact is that multiple studies have shown that patients who report experiencing angina after PCI for acute MI have about a 1.5-times increased risk of readmission and repeat revascularization, a 2-times increased risk of developing new depressive symptoms, and diminished quality of life scores.
The TRANSLATE-ACS study was sponsored by Eli Lilly. Dr. Fanaroff reported having no financial conflicts.
WASHINGTON – Non–beta-blocker antianginal drugs are seriously underprescribed in patients with angina following percutaneous coronary intervention (PCI) for a myocardial infarction (MI), according to a large national study, Alexander C. Fanaroff, MD, said at the annual meeting of the American College of Cardiology.
Clinical practice in this regard appears to be largely out of touch with current evidence-based guidelines regarding angina management in patients with stable ischemic heart disease. Those ACC/American Heart Association guidelines recommend a stepwise approach beginning with a beta-blocker and sublingual nitroglycerin, adding a calcium channel blocker if the beta-blocker isn’t tolerated or effective, further adding a long-acting nitrate if symptoms persist, incorporating ranolazine (Ranexa) as needed, and finally turning to revascularization for symptomatic relief if multidrug therapy proves inadequate (J Am Coll Cardiol. 2012 Dec 18;60[24]:e44-e164).
“When you ask patients and physicians separately about the prevalence of angina, they tend to disagree, with physicians consistently thinking their patients have less angina than patients report themselves. Together, with our data, this indicates that strategies to improve clinician recognition and treatment of angina symptoms are needed,” he asserted.
TRANSLATE-ACS was a large, longitudinal, observational study of patients who underwent PCI at 233 U.S. hospitals during 2010-2012. Dr. Fanaroff focused on 12-month follow-up data on the 10,870 patients whose PCI was for treatment of an acute MI. In telephone interviews 6 weeks postdischarge which incorporated the validated Seattle Angina Questionnaire, 3,190 of these individuals (31%) with stable ischemic heart disease reported angina symptoms. Of those, 79% said their symptoms occurred at least monthly, 18% weekly, and 3% daily. Yet, only 1 in 5 patients with angina 6 weeks postdischarge were on a non–beta-blocker antianginal medication: 16% were on monotherapy with a calcium channel blocker or long-acting nitrate, 3% were on dual therapy, and less than 1% were on three non–beta-blockers for their angina.
The prevalence of angina dropped over time. At 6 months postdischarge, 40% of the original cohort of patients who had angina at 6 weeks still reported angina. At 12 months, it was 33%. Meanwhile, the use of non–beta-blocker antianginal agents crept up modestly over time, from 20% in patients with angina at 6 weeks postdischarge, to 22% in those with angina at 6 months, and 23% at 12 months.
On the other hand, 33% of patients with angina at 6 weeks had persistent angina through 12 months. Remarkably, 69% of these individuals never received a non–beta-blocker antianginal drug during all that time, including 61% of those who experienced daily or weekly angina.
The use of non–beta-blocker antianginal drugs was more frequent in patients with more severe angina: 25% of patients with daily or weekly angina at 6 weeks were on such medication, as were 34% at 6 months and 38% at 12 months, compared with 16%, 18%, and 22% of those with monthly angina. Still, most of these patients were on only a single non–beta-blocker antianginal agent.
Of patients with angina at 6 weeks, 12% subsequently underwent repeat PCI at some point during the first year postdischarge. Of these individuals, 19% were on a single non–beta-blocker antianginal drug at the time of their procedure, 6% were on two such drugs, and only 1% were on three.
Roughly 10% of patients with multivessel coronary disease who were identified angiographically at the time of their acute MI did not undergo multivessel PCI at that time. This was not predictive of angina 6 weeks post discharge, Dr. Fanaroff continued.
One audience member asked Dr. Fanaroff how he knows that the patients with self-reported angina didn’t actually have noncardiac chest pain, in which case their physicians’ decision not to prescribe second- and third-tier antianginal drugs would be appropriate.
Dr. Fanaroff responded that it’s possible, and even likely, that some patients with self-reported angina had a noncardiac source of their chest pain. However, they would be in the minority. The fact is that multiple studies have shown that patients who report experiencing angina after PCI for acute MI have about a 1.5-times increased risk of readmission and repeat revascularization, a 2-times increased risk of developing new depressive symptoms, and diminished quality of life scores.
The TRANSLATE-ACS study was sponsored by Eli Lilly. Dr. Fanaroff reported having no financial conflicts.
AT ACC 17
Key clinical point:
Major finding: Only 31% of patients who reported persistent angina for the first 12 months post PCI for acute MI reported taking any non–beta-blocker antianginal drugs during that period.
Data source: An analysis of nearly 11,000 patients who underwent PCI for an acute MI at 233 U.S. hospitals in the longitudinal observational TRANSLATE-ACS study.
Disclosures: The TRANSLATE-ACS study was sponsored by Eli Lilly. The presenter reported having no financial conflicts.
Maternal antidepressants unrelated to autism in offspring
Maternal use of antidepressants during pregnancy is unrelated to autism spectrum disorder in the offspring, according to two separate, population-level cohort studies that used sophisticated statistical techniques to account for numerous confounding factors.
Both studies were reported online April 18 in JAMA.
Some previous studies have reported a possible link between in utero exposure to antidepressants, particularly SSRIs, and autism. But they had limited ability to control for key confounders, notably the mother’s underlying depression.
Overall, 1.1% of these children were diagnosed as having autism spectrum disorder. This prevalence is consistent with current population estimates, indicating that few if any cases of the disorder were missed, said Dr. Brown of Women’s College Research Institute in Toronto and the division of epidemiology, University of Toronto, and her associates.
In initial, unadjusted analyses of the data, the risk of autism was higher in exposed than in nonexposed children. However, that association disappeared once the data were adjusted to account for numerous potential confounders.
Further analysis comparing the exposed children with their unexposed siblings also found that after adjusting for confounding factors, prenatal exposure to antidepressants did not affect the risk of developing autism. In addition, this lack of association also was found in the subgroup of children whose mothers took antidepressants shortly before but not during pregnancy.
Taken together, these findings “suggest that confounding by indication for the medication may explain previously observed associations between in utero serotonergic antidepressant exposure and autism spectrum disorder,” Dr. Brown and her associates said (JAMA. 2017 Apr 18. doi: 10.1001.jama.2017.3415). In the other study, Ayesha C. Sujan and her associates analyzed data in several nationwide Swedish registries to examine whether first trimester exposure to any antidepressants raised the risk of a range of neurodevelopmental problems, including autism. This study involved 1,580,629 offspring, including 22,544 (1.4%) whose mothers took antidepressants during the first trimester.
As with Dr. Brown’s study, the initial unadjusted analysis showed an association between antidepressant exposure and autism, but that association disappeared once the data were adjusted to account for confounding factors. In the final data analysis, first trimester exposure was associated with preterm birth (odds ratio, 1.34) but not with small-for-gestational-age size (OR, 1.01), autism spectrum disorder (hazard ratio, 0.83), or attention deficit/hyperactivity disorder (HR, 0.99), said Ms. Sujan of the department of psychological and brain sciences, Indiana University, Bloomington, and her associates.
“These results are consistent with the hypothesis that genetic factors, familial environmental factors, or both, account for the population-wide associations between first-trimester antidepressant exposure and these outcomes,” they noted (JAMA. 2017 Apr 18. doi: 10.1001/jama.2017.3413).
These two studies add to the growing literature suggesting that any association between prenatal antidepressant exposure and autism spectrum disorder may not be causal.
Both reports should reassure both parents and clinicians.
And regardless of whether any such association reflects antidepressant effects, the mother’s underlying mental health, or other factors, efforts should focus on promoting optimal child health in ways that harness the child’s inherent developmental plasticity.
Tim F. Oberlander, MD, is in the division of developmental pediatrics at the University of British Columbia and at the British Columbia Children’s Hospital Research Institute, both in Vancouver. Lonnie Zwaigenbaum, MD, is in the department of pediatrics at the University of Alberta, Edmonton. They reported having no relevant financial disclosures. These remarks were excerpted from an editorial accompanying the two reports (JAMA. 2017;317[15]:1533-4).
These two studies add to the growing literature suggesting that any association between prenatal antidepressant exposure and autism spectrum disorder may not be causal.
Both reports should reassure both parents and clinicians.
And regardless of whether any such association reflects antidepressant effects, the mother’s underlying mental health, or other factors, efforts should focus on promoting optimal child health in ways that harness the child’s inherent developmental plasticity.
Tim F. Oberlander, MD, is in the division of developmental pediatrics at the University of British Columbia and at the British Columbia Children’s Hospital Research Institute, both in Vancouver. Lonnie Zwaigenbaum, MD, is in the department of pediatrics at the University of Alberta, Edmonton. They reported having no relevant financial disclosures. These remarks were excerpted from an editorial accompanying the two reports (JAMA. 2017;317[15]:1533-4).
These two studies add to the growing literature suggesting that any association between prenatal antidepressant exposure and autism spectrum disorder may not be causal.
Both reports should reassure both parents and clinicians.
And regardless of whether any such association reflects antidepressant effects, the mother’s underlying mental health, or other factors, efforts should focus on promoting optimal child health in ways that harness the child’s inherent developmental plasticity.
Tim F. Oberlander, MD, is in the division of developmental pediatrics at the University of British Columbia and at the British Columbia Children’s Hospital Research Institute, both in Vancouver. Lonnie Zwaigenbaum, MD, is in the department of pediatrics at the University of Alberta, Edmonton. They reported having no relevant financial disclosures. These remarks were excerpted from an editorial accompanying the two reports (JAMA. 2017;317[15]:1533-4).
Maternal use of antidepressants during pregnancy is unrelated to autism spectrum disorder in the offspring, according to two separate, population-level cohort studies that used sophisticated statistical techniques to account for numerous confounding factors.
Both studies were reported online April 18 in JAMA.
Some previous studies have reported a possible link between in utero exposure to antidepressants, particularly SSRIs, and autism. But they had limited ability to control for key confounders, notably the mother’s underlying depression.
Overall, 1.1% of these children were diagnosed as having autism spectrum disorder. This prevalence is consistent with current population estimates, indicating that few if any cases of the disorder were missed, said Dr. Brown of Women’s College Research Institute in Toronto and the division of epidemiology, University of Toronto, and her associates.
In initial, unadjusted analyses of the data, the risk of autism was higher in exposed than in nonexposed children. However, that association disappeared once the data were adjusted to account for numerous potential confounders.
Further analysis comparing the exposed children with their unexposed siblings also found that after adjusting for confounding factors, prenatal exposure to antidepressants did not affect the risk of developing autism. In addition, this lack of association also was found in the subgroup of children whose mothers took antidepressants shortly before but not during pregnancy.
Taken together, these findings “suggest that confounding by indication for the medication may explain previously observed associations between in utero serotonergic antidepressant exposure and autism spectrum disorder,” Dr. Brown and her associates said (JAMA. 2017 Apr 18. doi: 10.1001.jama.2017.3415). In the other study, Ayesha C. Sujan and her associates analyzed data in several nationwide Swedish registries to examine whether first trimester exposure to any antidepressants raised the risk of a range of neurodevelopmental problems, including autism. This study involved 1,580,629 offspring, including 22,544 (1.4%) whose mothers took antidepressants during the first trimester.
As with Dr. Brown’s study, the initial unadjusted analysis showed an association between antidepressant exposure and autism, but that association disappeared once the data were adjusted to account for confounding factors. In the final data analysis, first trimester exposure was associated with preterm birth (odds ratio, 1.34) but not with small-for-gestational-age size (OR, 1.01), autism spectrum disorder (hazard ratio, 0.83), or attention deficit/hyperactivity disorder (HR, 0.99), said Ms. Sujan of the department of psychological and brain sciences, Indiana University, Bloomington, and her associates.
“These results are consistent with the hypothesis that genetic factors, familial environmental factors, or both, account for the population-wide associations between first-trimester antidepressant exposure and these outcomes,” they noted (JAMA. 2017 Apr 18. doi: 10.1001/jama.2017.3413).
Maternal use of antidepressants during pregnancy is unrelated to autism spectrum disorder in the offspring, according to two separate, population-level cohort studies that used sophisticated statistical techniques to account for numerous confounding factors.
Both studies were reported online April 18 in JAMA.
Some previous studies have reported a possible link between in utero exposure to antidepressants, particularly SSRIs, and autism. But they had limited ability to control for key confounders, notably the mother’s underlying depression.
Overall, 1.1% of these children were diagnosed as having autism spectrum disorder. This prevalence is consistent with current population estimates, indicating that few if any cases of the disorder were missed, said Dr. Brown of Women’s College Research Institute in Toronto and the division of epidemiology, University of Toronto, and her associates.
In initial, unadjusted analyses of the data, the risk of autism was higher in exposed than in nonexposed children. However, that association disappeared once the data were adjusted to account for numerous potential confounders.
Further analysis comparing the exposed children with their unexposed siblings also found that after adjusting for confounding factors, prenatal exposure to antidepressants did not affect the risk of developing autism. In addition, this lack of association also was found in the subgroup of children whose mothers took antidepressants shortly before but not during pregnancy.
Taken together, these findings “suggest that confounding by indication for the medication may explain previously observed associations between in utero serotonergic antidepressant exposure and autism spectrum disorder,” Dr. Brown and her associates said (JAMA. 2017 Apr 18. doi: 10.1001.jama.2017.3415). In the other study, Ayesha C. Sujan and her associates analyzed data in several nationwide Swedish registries to examine whether first trimester exposure to any antidepressants raised the risk of a range of neurodevelopmental problems, including autism. This study involved 1,580,629 offspring, including 22,544 (1.4%) whose mothers took antidepressants during the first trimester.
As with Dr. Brown’s study, the initial unadjusted analysis showed an association between antidepressant exposure and autism, but that association disappeared once the data were adjusted to account for confounding factors. In the final data analysis, first trimester exposure was associated with preterm birth (odds ratio, 1.34) but not with small-for-gestational-age size (OR, 1.01), autism spectrum disorder (hazard ratio, 0.83), or attention deficit/hyperactivity disorder (HR, 0.99), said Ms. Sujan of the department of psychological and brain sciences, Indiana University, Bloomington, and her associates.
“These results are consistent with the hypothesis that genetic factors, familial environmental factors, or both, account for the population-wide associations between first-trimester antidepressant exposure and these outcomes,” they noted (JAMA. 2017 Apr 18. doi: 10.1001/jama.2017.3413).
FROM JAMA
Key clinical point: Maternal use of antidepressants during pregnancy is unrelated to autism spectrum disorder in offspring.
Major finding: Prenatal exposure to antidepressants was not associated with small-for-gestational-age size (OR, 1.01), autism spectrum disorder (HR, 0.83), or attention deficit/hyperactivity disorder (HR, 0.99).
Data source: Two separate retrospective cohort studies involving 35,906 births in Canada and 1,580,629 in Sweden.
Disclosures: Dr. Brown’s study was supported by the Institute for Clinical Evaluative Sciences and the Ontario Ministry of Health and Long-Term Care. Dr. Brown and her associates reported having no relevant financial disclosures. Dr. Sujan’s study was supported by the U.S. National Institute of Mental Health, the National Institute on Drug Abuse, the National Science Foundation, and others. Dr. Sujan reported having no relevant financial disclosures; her associates reported ties to numerous industry sources.
Liposomal bupivacaine cut need for opioids after gyn surgery
SAN ANTONIO – Liposomal bupivacaine reduced pain after midurethral sling surgery, compared with placebo in a randomized trial, but because of its cost it may be best to keep it in reserve for women who can’t, or shouldn’t, take opioids, said lead investigator Donna Mazloomdoost, MD, a gynecologic surgeon at Good Samaritan Hospital, Cincinnati.
Fifty-four women were randomized to receive liposomal bupivacaine (Exparel) injected into the two trocar paths and the vaginal incision at the end of the procedure; 55 others were injected with normal saline as a placebo.
Fewer women in the liposomal bupivacaine group took narcotics on postop day 2 (12 versus 27, P = .006). However, there was no difference in overall satisfaction with pain control at 1 and 2 weeks follow-up.
Even so, “for this common outpatient surgery, liposomal bupivacaine may be a beneficial addition for pain control,” the investigators concluded.
Liposomal bupivacaine is a local anesthetic with slow release over 72 hours, approved for treatment of postsurgical pain in 2011. “The cost is about $300 at our institution; the charge to the patient is about $1,000,” Dr. Mazloomdoost said at the annual scientific meeting of the Society of Gynecologic Surgeons.
Because of the expense, liposomal bupivacaine is restricted in many hospitals, and gynecologic surgeons are trying to figure out what role it has, if any, in low-pain outpatient procedures like midurethral slings.
“I don’t know if you can justify” routine use for low-pain procedures, “but if you are concerned about opioid” use after surgery – intolerance or addiction – “I would use this,” Dr. Mazloomdoost said.
The investigators expanded 20 mL of liposomal bupivacaine with 10 mL of normal saline for a total of 30 mL. It was split evenly between the two trocar sites and the vaginal epithelium; 10 mL was injected in each of the three sites shortly before the intervention women were roused from anesthesia. The needle was inserted as deeply as possible, and liposomal bupivacaine was injected as the needle was drawn back. Because of the viscosity, it takes at least a 25-gauge needle.
Surgeons knew that they were injecting liposomal bupivacaine instead of saline because of the thickness and color, but they weren’t the ones collecting data, and the women were blinded to the treatment.
Patients were a mean age of 52 years. The mean body mass index was 29.2 kg/m2 in the liposomal bupivacaine group, and 31.6 kg/m2 in the placebo group; there were otherwise no significant demographic differences. Fifty-two women in the liposomal bupivacaine group received midazolam during anesthesia induction versus 44 women receiving placebo, but there were no significant differences in operating time or the number of women in each group who had concomitant anterior or urethrocele repairs, and no differences in urinary retention, time to first bowel movement – about 2 days – or adverse events. The most common adverse events in both groups were nausea/vomiting, headache, and itching.
Women in both groups received intravenous acetaminophen before anesthesia induction, and ketorolac before leaving the operating room; 10 mL of lidocaine with epinephrine was injected into the trocar paths and vaginal epithelium prior to the first incision.
The investigators reported having no relevant financial disclosures.
* The meeting sponsor information was updated 6/9/2017.
SAN ANTONIO – Liposomal bupivacaine reduced pain after midurethral sling surgery, compared with placebo in a randomized trial, but because of its cost it may be best to keep it in reserve for women who can’t, or shouldn’t, take opioids, said lead investigator Donna Mazloomdoost, MD, a gynecologic surgeon at Good Samaritan Hospital, Cincinnati.
Fifty-four women were randomized to receive liposomal bupivacaine (Exparel) injected into the two trocar paths and the vaginal incision at the end of the procedure; 55 others were injected with normal saline as a placebo.
Fewer women in the liposomal bupivacaine group took narcotics on postop day 2 (12 versus 27, P = .006). However, there was no difference in overall satisfaction with pain control at 1 and 2 weeks follow-up.
Even so, “for this common outpatient surgery, liposomal bupivacaine may be a beneficial addition for pain control,” the investigators concluded.
Liposomal bupivacaine is a local anesthetic with slow release over 72 hours, approved for treatment of postsurgical pain in 2011. “The cost is about $300 at our institution; the charge to the patient is about $1,000,” Dr. Mazloomdoost said at the annual scientific meeting of the Society of Gynecologic Surgeons.
Because of the expense, liposomal bupivacaine is restricted in many hospitals, and gynecologic surgeons are trying to figure out what role it has, if any, in low-pain outpatient procedures like midurethral slings.
“I don’t know if you can justify” routine use for low-pain procedures, “but if you are concerned about opioid” use after surgery – intolerance or addiction – “I would use this,” Dr. Mazloomdoost said.
The investigators expanded 20 mL of liposomal bupivacaine with 10 mL of normal saline for a total of 30 mL. It was split evenly between the two trocar sites and the vaginal epithelium; 10 mL was injected in each of the three sites shortly before the intervention women were roused from anesthesia. The needle was inserted as deeply as possible, and liposomal bupivacaine was injected as the needle was drawn back. Because of the viscosity, it takes at least a 25-gauge needle.
Surgeons knew that they were injecting liposomal bupivacaine instead of saline because of the thickness and color, but they weren’t the ones collecting data, and the women were blinded to the treatment.
Patients were a mean age of 52 years. The mean body mass index was 29.2 kg/m2 in the liposomal bupivacaine group, and 31.6 kg/m2 in the placebo group; there were otherwise no significant demographic differences. Fifty-two women in the liposomal bupivacaine group received midazolam during anesthesia induction versus 44 women receiving placebo, but there were no significant differences in operating time or the number of women in each group who had concomitant anterior or urethrocele repairs, and no differences in urinary retention, time to first bowel movement – about 2 days – or adverse events. The most common adverse events in both groups were nausea/vomiting, headache, and itching.
Women in both groups received intravenous acetaminophen before anesthesia induction, and ketorolac before leaving the operating room; 10 mL of lidocaine with epinephrine was injected into the trocar paths and vaginal epithelium prior to the first incision.
The investigators reported having no relevant financial disclosures.
* The meeting sponsor information was updated 6/9/2017.
SAN ANTONIO – Liposomal bupivacaine reduced pain after midurethral sling surgery, compared with placebo in a randomized trial, but because of its cost it may be best to keep it in reserve for women who can’t, or shouldn’t, take opioids, said lead investigator Donna Mazloomdoost, MD, a gynecologic surgeon at Good Samaritan Hospital, Cincinnati.
Fifty-four women were randomized to receive liposomal bupivacaine (Exparel) injected into the two trocar paths and the vaginal incision at the end of the procedure; 55 others were injected with normal saline as a placebo.
Fewer women in the liposomal bupivacaine group took narcotics on postop day 2 (12 versus 27, P = .006). However, there was no difference in overall satisfaction with pain control at 1 and 2 weeks follow-up.
Even so, “for this common outpatient surgery, liposomal bupivacaine may be a beneficial addition for pain control,” the investigators concluded.
Liposomal bupivacaine is a local anesthetic with slow release over 72 hours, approved for treatment of postsurgical pain in 2011. “The cost is about $300 at our institution; the charge to the patient is about $1,000,” Dr. Mazloomdoost said at the annual scientific meeting of the Society of Gynecologic Surgeons.
Because of the expense, liposomal bupivacaine is restricted in many hospitals, and gynecologic surgeons are trying to figure out what role it has, if any, in low-pain outpatient procedures like midurethral slings.
“I don’t know if you can justify” routine use for low-pain procedures, “but if you are concerned about opioid” use after surgery – intolerance or addiction – “I would use this,” Dr. Mazloomdoost said.
The investigators expanded 20 mL of liposomal bupivacaine with 10 mL of normal saline for a total of 30 mL. It was split evenly between the two trocar sites and the vaginal epithelium; 10 mL was injected in each of the three sites shortly before the intervention women were roused from anesthesia. The needle was inserted as deeply as possible, and liposomal bupivacaine was injected as the needle was drawn back. Because of the viscosity, it takes at least a 25-gauge needle.
Surgeons knew that they were injecting liposomal bupivacaine instead of saline because of the thickness and color, but they weren’t the ones collecting data, and the women were blinded to the treatment.
Patients were a mean age of 52 years. The mean body mass index was 29.2 kg/m2 in the liposomal bupivacaine group, and 31.6 kg/m2 in the placebo group; there were otherwise no significant demographic differences. Fifty-two women in the liposomal bupivacaine group received midazolam during anesthesia induction versus 44 women receiving placebo, but there were no significant differences in operating time or the number of women in each group who had concomitant anterior or urethrocele repairs, and no differences in urinary retention, time to first bowel movement – about 2 days – or adverse events. The most common adverse events in both groups were nausea/vomiting, headache, and itching.
Women in both groups received intravenous acetaminophen before anesthesia induction, and ketorolac before leaving the operating room; 10 mL of lidocaine with epinephrine was injected into the trocar paths and vaginal epithelium prior to the first incision.
The investigators reported having no relevant financial disclosures.
* The meeting sponsor information was updated 6/9/2017.
AT SGS 2017
Key clinical point:
Major finding: Pain scores, assessed by diary, were lower in the liposomal bupivacaine group 4 hours after discharge on a 100-mm visual analogue scale (3.5 mm versus 13 mm, P = .014).
Data source: Randomized trial with 109 women at Good Samaritan Hospital, Cincinnati.
Disclosures: The investigators reported having no relevant financial disclosures.
Obinutuzumab vs. rituximab weighed as follicular lymphoma therapy
NEW YORK – Does obinutuzumab have a leg up over rituximab for treating follicular lymphoma?
A strict reading of the efficacy records of the two anti-CD20 antibodies when they went head-to-head suggests that obinutuzumab (Gazyva) edged out rituximab (Rituxan), but a broader view leaves the door open for rituximab as a still viable option depending on a patient’s status and priorities, experts said at the conference held by Imedex.
While conceding that quality of life correlates with progression-free survival (PFS), he stressed that it also correlates with treatment toxicities, treatment duration, and disease-related side effects.
Trial results have indicated that patients with newly diagnosed follicular lymphoma are reasonably treated with rituximab alone, or with rituximab plus bendamustine, without need for maintenance therapy, Dr. Leonard said.
In contrast, GALLIUM, a phase III trial that compared rituximab against obinutuzumab, used a maintenance phase of monotherapy with each of these two drugs following an induction phase when each of the drugs was combined with chemotherapy.
“If you use this approach [tested in GALLIUM] you need to use maintenance therapy,” and it was in GALLIUM that the most dramatic efficacy advantage for obinutuzumab over rituximab appeared, in the form of longer PFS although, so far, without demonstrated advantage in overall survival. The GALLIUM results, reported in December 2016 at the American Society of Hematology meeting, showed a 3-year PFS rate of 80% among patients treated with obinutuzumab and 73% among those treated with rituximab, a hazard ratio of 0.66 in favor of obinutuzumab that was statistically significant (P = .001) for the study’s primary endpoint (Blood. 2016 Dec 4;abstract 6).
“If you follow this study, you commit the patient to maintenance. We need to talk with patients about the pros and cons of maintenance, the pros and cons of chemotherapy, and the pros and cons of single agent therapy” with one of these anti-CD20 antibodies, Dr. Leonard said. “Right now, I think it’s unclear which antibody is best,” he concluded
To further buttress the case for obinutuzumab, he also cited the higher response rate among relapsed patients when single-agent obinutuzumab went against single-agent rituximab (J Clin Oncol. 2015 Oct 20:33[30]:3467-74), and the overall survival advantage that obinutuzumab gave patients when combined with bendamustine in patients refractory to rituximab (Blood. 2016 Dec 5; abstract 615).
Agreeing that the design of GALLIUM focused on combining an anti-CD20 antibody with chemotherapy, Dr. Friedberg acknowledged that, as initial therapy, “using rituximab monotherapy is very reasonable for many patients. I divide [follicular lymphoma] patients into those who are very symptomatic” (for example, those with hydronephrosis) “and need chemotherapy, and those who are not that symptomatic for whom single-agent rituximab is very reasonable,” he said in an interview.
Tumor aggressiveness is another way to identify patients who need chemotherapy plus an antibody, he added. “If the patient is not symptomatic, I generally first observe them, and if the growth is slow, you can sometimes intervene with rituximab alone, but, if the growth is fast, you also need chemotherapy,” Dr. Friedberg said.
Cost may soon become another consideration now that the U.S. patent on rituximab has expired leading to the ongoing development of several biosimilar versions of the antibody. If biosimilar formulations of rituximab soon appear on the U.S. market and if they result in a significant drop in drug price, it would introduce yet another significant variable. “Presuming biosimilar rituximab lowers the cost, that would be another important treatment decision,” he said.
Dr. Friedberg has been a consultant to Bayer. Dr. Leonard has been a consultant to 13 drug companies. Neither disclosed a relationship with the companies that market obinutuzumab or rituximab.
[email protected]
On Twitter @mitchelzoler
NEW YORK – Does obinutuzumab have a leg up over rituximab for treating follicular lymphoma?
A strict reading of the efficacy records of the two anti-CD20 antibodies when they went head-to-head suggests that obinutuzumab (Gazyva) edged out rituximab (Rituxan), but a broader view leaves the door open for rituximab as a still viable option depending on a patient’s status and priorities, experts said at the conference held by Imedex.
While conceding that quality of life correlates with progression-free survival (PFS), he stressed that it also correlates with treatment toxicities, treatment duration, and disease-related side effects.
Trial results have indicated that patients with newly diagnosed follicular lymphoma are reasonably treated with rituximab alone, or with rituximab plus bendamustine, without need for maintenance therapy, Dr. Leonard said.
In contrast, GALLIUM, a phase III trial that compared rituximab against obinutuzumab, used a maintenance phase of monotherapy with each of these two drugs following an induction phase when each of the drugs was combined with chemotherapy.
“If you use this approach [tested in GALLIUM] you need to use maintenance therapy,” and it was in GALLIUM that the most dramatic efficacy advantage for obinutuzumab over rituximab appeared, in the form of longer PFS although, so far, without demonstrated advantage in overall survival. The GALLIUM results, reported in December 2016 at the American Society of Hematology meeting, showed a 3-year PFS rate of 80% among patients treated with obinutuzumab and 73% among those treated with rituximab, a hazard ratio of 0.66 in favor of obinutuzumab that was statistically significant (P = .001) for the study’s primary endpoint (Blood. 2016 Dec 4;abstract 6).
“If you follow this study, you commit the patient to maintenance. We need to talk with patients about the pros and cons of maintenance, the pros and cons of chemotherapy, and the pros and cons of single agent therapy” with one of these anti-CD20 antibodies, Dr. Leonard said. “Right now, I think it’s unclear which antibody is best,” he concluded
To further buttress the case for obinutuzumab, he also cited the higher response rate among relapsed patients when single-agent obinutuzumab went against single-agent rituximab (J Clin Oncol. 2015 Oct 20:33[30]:3467-74), and the overall survival advantage that obinutuzumab gave patients when combined with bendamustine in patients refractory to rituximab (Blood. 2016 Dec 5; abstract 615).
Agreeing that the design of GALLIUM focused on combining an anti-CD20 antibody with chemotherapy, Dr. Friedberg acknowledged that, as initial therapy, “using rituximab monotherapy is very reasonable for many patients. I divide [follicular lymphoma] patients into those who are very symptomatic” (for example, those with hydronephrosis) “and need chemotherapy, and those who are not that symptomatic for whom single-agent rituximab is very reasonable,” he said in an interview.
Tumor aggressiveness is another way to identify patients who need chemotherapy plus an antibody, he added. “If the patient is not symptomatic, I generally first observe them, and if the growth is slow, you can sometimes intervene with rituximab alone, but, if the growth is fast, you also need chemotherapy,” Dr. Friedberg said.
Cost may soon become another consideration now that the U.S. patent on rituximab has expired leading to the ongoing development of several biosimilar versions of the antibody. If biosimilar formulations of rituximab soon appear on the U.S. market and if they result in a significant drop in drug price, it would introduce yet another significant variable. “Presuming biosimilar rituximab lowers the cost, that would be another important treatment decision,” he said.
Dr. Friedberg has been a consultant to Bayer. Dr. Leonard has been a consultant to 13 drug companies. Neither disclosed a relationship with the companies that market obinutuzumab or rituximab.
[email protected]
On Twitter @mitchelzoler
NEW YORK – Does obinutuzumab have a leg up over rituximab for treating follicular lymphoma?
A strict reading of the efficacy records of the two anti-CD20 antibodies when they went head-to-head suggests that obinutuzumab (Gazyva) edged out rituximab (Rituxan), but a broader view leaves the door open for rituximab as a still viable option depending on a patient’s status and priorities, experts said at the conference held by Imedex.
While conceding that quality of life correlates with progression-free survival (PFS), he stressed that it also correlates with treatment toxicities, treatment duration, and disease-related side effects.
Trial results have indicated that patients with newly diagnosed follicular lymphoma are reasonably treated with rituximab alone, or with rituximab plus bendamustine, without need for maintenance therapy, Dr. Leonard said.
In contrast, GALLIUM, a phase III trial that compared rituximab against obinutuzumab, used a maintenance phase of monotherapy with each of these two drugs following an induction phase when each of the drugs was combined with chemotherapy.
“If you use this approach [tested in GALLIUM] you need to use maintenance therapy,” and it was in GALLIUM that the most dramatic efficacy advantage for obinutuzumab over rituximab appeared, in the form of longer PFS although, so far, without demonstrated advantage in overall survival. The GALLIUM results, reported in December 2016 at the American Society of Hematology meeting, showed a 3-year PFS rate of 80% among patients treated with obinutuzumab and 73% among those treated with rituximab, a hazard ratio of 0.66 in favor of obinutuzumab that was statistically significant (P = .001) for the study’s primary endpoint (Blood. 2016 Dec 4;abstract 6).
“If you follow this study, you commit the patient to maintenance. We need to talk with patients about the pros and cons of maintenance, the pros and cons of chemotherapy, and the pros and cons of single agent therapy” with one of these anti-CD20 antibodies, Dr. Leonard said. “Right now, I think it’s unclear which antibody is best,” he concluded
To further buttress the case for obinutuzumab, he also cited the higher response rate among relapsed patients when single-agent obinutuzumab went against single-agent rituximab (J Clin Oncol. 2015 Oct 20:33[30]:3467-74), and the overall survival advantage that obinutuzumab gave patients when combined with bendamustine in patients refractory to rituximab (Blood. 2016 Dec 5; abstract 615).
Agreeing that the design of GALLIUM focused on combining an anti-CD20 antibody with chemotherapy, Dr. Friedberg acknowledged that, as initial therapy, “using rituximab monotherapy is very reasonable for many patients. I divide [follicular lymphoma] patients into those who are very symptomatic” (for example, those with hydronephrosis) “and need chemotherapy, and those who are not that symptomatic for whom single-agent rituximab is very reasonable,” he said in an interview.
Tumor aggressiveness is another way to identify patients who need chemotherapy plus an antibody, he added. “If the patient is not symptomatic, I generally first observe them, and if the growth is slow, you can sometimes intervene with rituximab alone, but, if the growth is fast, you also need chemotherapy,” Dr. Friedberg said.
Cost may soon become another consideration now that the U.S. patent on rituximab has expired leading to the ongoing development of several biosimilar versions of the antibody. If biosimilar formulations of rituximab soon appear on the U.S. market and if they result in a significant drop in drug price, it would introduce yet another significant variable. “Presuming biosimilar rituximab lowers the cost, that would be another important treatment decision,” he said.
Dr. Friedberg has been a consultant to Bayer. Dr. Leonard has been a consultant to 13 drug companies. Neither disclosed a relationship with the companies that market obinutuzumab or rituximab.
[email protected]
On Twitter @mitchelzoler
EXPERT ANALYSIS FROM A MEETING ON HEMATOLOGIC MALIGNANCIES
Skin testing and decision support can clarify penicillin allergy
Penicillin allergy skin testing or a computerized guideline app with decision support can increase the use of penicillin or cephalosporin among inpatients reporting penicillin allergy.
“Despite a reported penicillin allergy, more than 95% of patients evaluated for such allergy are found penicillin and cephalosporin tolerant,” wrote Kimberly G. Blumenthal, MD, of Massachusetts General Hospital, Boston, and her coauthors.
In this study, they recruited 625 patients reporting penicillin allergy and explored three approaches over three periods of time. These were standard of care, in which penicillin skin testing and test dose challenge is performed only after allergy/immunology consultation; penicillin skin testing performed in all patients not otherwise ineligible for skin testing; and a computerized guideline available on any computer or mobile device within the hospital.
Researchers saw a significant 80% increase in the odds of penicillin or cephalosporin use overall during the period in which the computerized guidelines were available (P = .02).
“The guideline empowered inpatient providers to group allergic reactions into hypersensitivity type, then recommended if and how specific beta-lactam antibiotics [should] be used (i.e. very low risk: full doses; low risk: test doses; medium to high risk: Allergy/Immunology consultation; serious type II-IV hypersensitivity reactions: avoidance),” the authors wrote.
While patients during the skin testing period did not have a significantly increased odds of receiving the antibiotics overall, the adjusted per-protocol analysis showed a nearly sixfold higher odds of receiving penicillin or cephalosporin (odds ratio, 5.7; P less than .001).
Among the 278 patients present during the skin-testing period, 179 (64%) were eligible for skin testing, in that they did not have penicillin intolerances such as gastrointestinal upset, were not taking medications that interfered with skin testing, didn’t have multiple beta-lactam allergies, had not experienced penicillin anaphylaxis in the last 5 years, or had a type II-IV hypersensitivity reaction to penicillin. Of these, 43 (24%) were tested, none of whom were allergic.
The per-protocol analysis of skin testing also showed a 2.5-fold increase in the odds of discharge use of penicillin or cephalosporin (P = .04).
“Since the impact of overreporting penicillin allergy is felt beyond antibiotic utilization to resultant readmissions, treatment failures, and adverse events, safely increasing the use of penicillin and cephalosporin antibiotics in this patient population is a crucial first step towards improved quality of care and reduced cost,” the authors wrote.
The study was supported by the Brigham Care Redesign Incubator and Start-Up Program. No conflicts of interest were declared.
Penicillin allergy skin testing or a computerized guideline app with decision support can increase the use of penicillin or cephalosporin among inpatients reporting penicillin allergy.
“Despite a reported penicillin allergy, more than 95% of patients evaluated for such allergy are found penicillin and cephalosporin tolerant,” wrote Kimberly G. Blumenthal, MD, of Massachusetts General Hospital, Boston, and her coauthors.
In this study, they recruited 625 patients reporting penicillin allergy and explored three approaches over three periods of time. These were standard of care, in which penicillin skin testing and test dose challenge is performed only after allergy/immunology consultation; penicillin skin testing performed in all patients not otherwise ineligible for skin testing; and a computerized guideline available on any computer or mobile device within the hospital.
Researchers saw a significant 80% increase in the odds of penicillin or cephalosporin use overall during the period in which the computerized guidelines were available (P = .02).
“The guideline empowered inpatient providers to group allergic reactions into hypersensitivity type, then recommended if and how specific beta-lactam antibiotics [should] be used (i.e. very low risk: full doses; low risk: test doses; medium to high risk: Allergy/Immunology consultation; serious type II-IV hypersensitivity reactions: avoidance),” the authors wrote.
While patients during the skin testing period did not have a significantly increased odds of receiving the antibiotics overall, the adjusted per-protocol analysis showed a nearly sixfold higher odds of receiving penicillin or cephalosporin (odds ratio, 5.7; P less than .001).
Among the 278 patients present during the skin-testing period, 179 (64%) were eligible for skin testing, in that they did not have penicillin intolerances such as gastrointestinal upset, were not taking medications that interfered with skin testing, didn’t have multiple beta-lactam allergies, had not experienced penicillin anaphylaxis in the last 5 years, or had a type II-IV hypersensitivity reaction to penicillin. Of these, 43 (24%) were tested, none of whom were allergic.
The per-protocol analysis of skin testing also showed a 2.5-fold increase in the odds of discharge use of penicillin or cephalosporin (P = .04).
“Since the impact of overreporting penicillin allergy is felt beyond antibiotic utilization to resultant readmissions, treatment failures, and adverse events, safely increasing the use of penicillin and cephalosporin antibiotics in this patient population is a crucial first step towards improved quality of care and reduced cost,” the authors wrote.
The study was supported by the Brigham Care Redesign Incubator and Start-Up Program. No conflicts of interest were declared.
Penicillin allergy skin testing or a computerized guideline app with decision support can increase the use of penicillin or cephalosporin among inpatients reporting penicillin allergy.
“Despite a reported penicillin allergy, more than 95% of patients evaluated for such allergy are found penicillin and cephalosporin tolerant,” wrote Kimberly G. Blumenthal, MD, of Massachusetts General Hospital, Boston, and her coauthors.
In this study, they recruited 625 patients reporting penicillin allergy and explored three approaches over three periods of time. These were standard of care, in which penicillin skin testing and test dose challenge is performed only after allergy/immunology consultation; penicillin skin testing performed in all patients not otherwise ineligible for skin testing; and a computerized guideline available on any computer or mobile device within the hospital.
Researchers saw a significant 80% increase in the odds of penicillin or cephalosporin use overall during the period in which the computerized guidelines were available (P = .02).
“The guideline empowered inpatient providers to group allergic reactions into hypersensitivity type, then recommended if and how specific beta-lactam antibiotics [should] be used (i.e. very low risk: full doses; low risk: test doses; medium to high risk: Allergy/Immunology consultation; serious type II-IV hypersensitivity reactions: avoidance),” the authors wrote.
While patients during the skin testing period did not have a significantly increased odds of receiving the antibiotics overall, the adjusted per-protocol analysis showed a nearly sixfold higher odds of receiving penicillin or cephalosporin (odds ratio, 5.7; P less than .001).
Among the 278 patients present during the skin-testing period, 179 (64%) were eligible for skin testing, in that they did not have penicillin intolerances such as gastrointestinal upset, were not taking medications that interfered with skin testing, didn’t have multiple beta-lactam allergies, had not experienced penicillin anaphylaxis in the last 5 years, or had a type II-IV hypersensitivity reaction to penicillin. Of these, 43 (24%) were tested, none of whom were allergic.
The per-protocol analysis of skin testing also showed a 2.5-fold increase in the odds of discharge use of penicillin or cephalosporin (P = .04).
“Since the impact of overreporting penicillin allergy is felt beyond antibiotic utilization to resultant readmissions, treatment failures, and adverse events, safely increasing the use of penicillin and cephalosporin antibiotics in this patient population is a crucial first step towards improved quality of care and reduced cost,” the authors wrote.
The study was supported by the Brigham Care Redesign Incubator and Start-Up Program. No conflicts of interest were declared.
FROM THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
Key clinical point: Penicillin skin testing or a computerized guideline app with decision support can increase the use of penicillin or cephalosporin among inpatients reporting penicillin allergy.
Major finding: Skin testing and computerized decision support increased the odds of patients’ receiving penicillin or cephalosporin 1.8-5.7 fold.
Data source: A prospective study of 625 inpatients patients reporting penicillin allergy.
Disclosures: The Brigham Care Redesign Incubator and Startup Program supported the study. No conflicts of interest were declared.
Honored Guest Speaker General (Ret.) Stanley A. McChrystal
A transformational leader with a remarkable record of achievement, General Stanley A. McChrystal was called “one of America’s greatest warriors” by Secretary of Defense Robert Gates. A retired four-star general, he is the former commander of U.S. and International Security Assistance Forces (ISAF) Afghanistan and the former commander of the premier military counter-terrorism force, Joint Special Operations Command (JSOC). He is best known for developing and implementing the current counter-insurgency strategy in Afghanistan, and for creating a comprehensive counter-terrorism organization that revolutionized the interagency operating culture. 
The son of Major General McChrystal, General Stanley McChrystal graduated from West Point in 1976 and joined the infantry. He began his military career as a platoon commander in the 82nd Airborne Division at Fort Bragg, North Carolina. Over the course of his career, he held several leadership and staff positions in the Army Special Forces, Army Rangers, 82nd Airborne Division and the XVIII Army Airborne Corp and the Joint Staff. He is a graduate of the US Naval War College and he completed fellowships at Harvard’s John F. Kennedy School of Government in 1997 and at the Council on Foreign Relations in 2000.
After 9/11 until his retirement in 2010, General McChrystal spent more than 7 years deployed to combat in a variety of leadership positions. In 2002, he was the chief of staff for military operations in Afghanistan. A year later he was selected to deliver nationally televised Pentagon briefings about military operations in Iraq. From 2003 to 2008, McChrystal commanded JSOC where he led the US Military’s counter-terrorism efforts all over the world. From the summer of 2008 until June of 2009, General McChrystal was the Director of the Joint Staff. In June of 2009, the President of the United States and the Secretary General of NATO appointed General McChrystal to be the Commander of US Forces Afghanistan and NATO ISAF. His command included more than 150,000 troops from 45 allied countries. On August 1 of 2010 General McChrystal retired from the US Army.
General McChrystal is a senior fellow at Yale University’s Jackson Institute for Global Affairs where he teaches a course on Leadership in Operation. He sits on the board of the Yellow Ribbon Fund, Navistar International Corporation and JetBlue Airways. He is also the chair of Service Year Alliance, a project of Be The Change and the Aspen Institute, which envisions a future in which a service year is a cultural expectation and common opportunity for every young American.
General McChrystal co-founded the McChrystal Group in January of 2011 where he is currently a partner. McChrystal Group’s mission is to deliver innovative leadership solutions to American businesses to help them transform and succeed in challenging and dynamic environments.
General McChrystal resides in Alexandria, Virginia with his wife of 39 years, Annie.
Monday, May 1
Team of Teams – Rules of Engagement for a Complex World
9:45 a.m. - 10:25 a.m.
A transformational leader with a remarkable record of achievement, General Stanley A. McChrystal was called “one of America’s greatest warriors” by Secretary of Defense Robert Gates. A retired four-star general, he is the former commander of U.S. and International Security Assistance Forces (ISAF) Afghanistan and the former commander of the premier military counter-terrorism force, Joint Special Operations Command (JSOC). He is best known for developing and implementing the current counter-insurgency strategy in Afghanistan, and for creating a comprehensive counter-terrorism organization that revolutionized the interagency operating culture.
The son of Major General McChrystal, General Stanley McChrystal graduated from West Point in 1976 and joined the infantry. He began his military career as a platoon commander in the 82nd Airborne Division at Fort Bragg, North Carolina. Over the course of his career, he held several leadership and staff positions in the Army Special Forces, Army Rangers, 82nd Airborne Division and the XVIII Army Airborne Corp and the Joint Staff. He is a graduate of the US Naval War College and he completed fellowships at Harvard’s John F. Kennedy School of Government in 1997 and at the Council on Foreign Relations in 2000.
After 9/11 until his retirement in 2010, General McChrystal spent more than 7 years deployed to combat in a variety of leadership positions. In 2002, he was the chief of staff for military operations in Afghanistan. A year later he was selected to deliver nationally televised Pentagon briefings about military operations in Iraq. From 2003 to 2008, McChrystal commanded JSOC where he led the US Military’s counter-terrorism efforts all over the world. From the summer of 2008 until June of 2009, General McChrystal was the Director of the Joint Staff. In June of 2009, the President of the United States and the Secretary General of NATO appointed General McChrystal to be the Commander of US Forces Afghanistan and NATO ISAF. His command included more than 150,000 troops from 45 allied countries. On August 1 of 2010 General McChrystal retired from the US Army.
General McChrystal is a senior fellow at Yale University’s Jackson Institute for Global Affairs where he teaches a course on Leadership in Operation. He sits on the board of the Yellow Ribbon Fund, Navistar International Corporation and JetBlue Airways. He is also the chair of Service Year Alliance, a project of Be The Change and the Aspen Institute, which envisions a future in which a service year is a cultural expectation and common opportunity for every young American.
General McChrystal co-founded the McChrystal Group in January of 2011 where he is currently a partner. McChrystal Group’s mission is to deliver innovative leadership solutions to American businesses to help them transform and succeed in challenging and dynamic environments.
General McChrystal resides in Alexandria, Virginia with his wife of 39 years, Annie.
Monday, May 1
Team of Teams – Rules of Engagement for a Complex World
9:45 a.m. - 10:25 a.m.
A transformational leader with a remarkable record of achievement, General Stanley A. McChrystal was called “one of America’s greatest warriors” by Secretary of Defense Robert Gates. A retired four-star general, he is the former commander of U.S. and International Security Assistance Forces (ISAF) Afghanistan and the former commander of the premier military counter-terrorism force, Joint Special Operations Command (JSOC). He is best known for developing and implementing the current counter-insurgency strategy in Afghanistan, and for creating a comprehensive counter-terrorism organization that revolutionized the interagency operating culture.
The son of Major General McChrystal, General Stanley McChrystal graduated from West Point in 1976 and joined the infantry. He began his military career as a platoon commander in the 82nd Airborne Division at Fort Bragg, North Carolina. Over the course of his career, he held several leadership and staff positions in the Army Special Forces, Army Rangers, 82nd Airborne Division and the XVIII Army Airborne Corp and the Joint Staff. He is a graduate of the US Naval War College and he completed fellowships at Harvard’s John F. Kennedy School of Government in 1997 and at the Council on Foreign Relations in 2000.
After 9/11 until his retirement in 2010, General McChrystal spent more than 7 years deployed to combat in a variety of leadership positions. In 2002, he was the chief of staff for military operations in Afghanistan. A year later he was selected to deliver nationally televised Pentagon briefings about military operations in Iraq. From 2003 to 2008, McChrystal commanded JSOC where he led the US Military’s counter-terrorism efforts all over the world. From the summer of 2008 until June of 2009, General McChrystal was the Director of the Joint Staff. In June of 2009, the President of the United States and the Secretary General of NATO appointed General McChrystal to be the Commander of US Forces Afghanistan and NATO ISAF. His command included more than 150,000 troops from 45 allied countries. On August 1 of 2010 General McChrystal retired from the US Army.
General McChrystal is a senior fellow at Yale University’s Jackson Institute for Global Affairs where he teaches a course on Leadership in Operation. He sits on the board of the Yellow Ribbon Fund, Navistar International Corporation and JetBlue Airways. He is also the chair of Service Year Alliance, a project of Be The Change and the Aspen Institute, which envisions a future in which a service year is a cultural expectation and common opportunity for every young American.
General McChrystal co-founded the McChrystal Group in January of 2011 where he is currently a partner. McChrystal Group’s mission is to deliver innovative leadership solutions to American businesses to help them transform and succeed in challenging and dynamic environments.
General McChrystal resides in Alexandria, Virginia with his wife of 39 years, Annie.
Monday, May 1
Team of Teams – Rules of Engagement for a Complex World
9:45 a.m. - 10:25 a.m.