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Rivaroxaban linked to more bleeding compared with dabigatran in elderly patients with nonvalvular AF
Rivaroxaban is associated with significantly more intra- and extracranial bleeding than dabigatran in patients ages 75 and older with nonvalvular atrial fibrillation (AF), according to a recent report published online in JAMA Internal Medicine. During the study period, rivaroxaban was used 2 to 3 times more often than dabigatran in AF patients in the United States. According to David J. Graham, MD, Center for Drug Evaluation and Research, FDA, that may be “partly because of prescriber misperceptions about bleeding risks with dabigatran, arising from FDA receipt of a large number of post-marketing case reports following its approval.” That’s ironic, according to Graham, since “we [now find] substantially higher bleeding risks with the use of rivaroxaban than dabigatran.” Further analysis on the data can be found in the article from Family Practice News: http://www.mdedge.com/familypracticenews/article/115021/acquired-cardiovascular-disease/rivaroxaban-linked-more-bleeding.
Rivaroxaban is associated with significantly more intra- and extracranial bleeding than dabigatran in patients ages 75 and older with nonvalvular atrial fibrillation (AF), according to a recent report published online in JAMA Internal Medicine. During the study period, rivaroxaban was used 2 to 3 times more often than dabigatran in AF patients in the United States. According to David J. Graham, MD, Center for Drug Evaluation and Research, FDA, that may be “partly because of prescriber misperceptions about bleeding risks with dabigatran, arising from FDA receipt of a large number of post-marketing case reports following its approval.” That’s ironic, according to Graham, since “we [now find] substantially higher bleeding risks with the use of rivaroxaban than dabigatran.” Further analysis on the data can be found in the article from Family Practice News: http://www.mdedge.com/familypracticenews/article/115021/acquired-cardiovascular-disease/rivaroxaban-linked-more-bleeding.
Rivaroxaban is associated with significantly more intra- and extracranial bleeding than dabigatran in patients ages 75 and older with nonvalvular atrial fibrillation (AF), according to a recent report published online in JAMA Internal Medicine. During the study period, rivaroxaban was used 2 to 3 times more often than dabigatran in AF patients in the United States. According to David J. Graham, MD, Center for Drug Evaluation and Research, FDA, that may be “partly because of prescriber misperceptions about bleeding risks with dabigatran, arising from FDA receipt of a large number of post-marketing case reports following its approval.” That’s ironic, according to Graham, since “we [now find] substantially higher bleeding risks with the use of rivaroxaban than dabigatran.” Further analysis on the data can be found in the article from Family Practice News: http://www.mdedge.com/familypracticenews/article/115021/acquired-cardiovascular-disease/rivaroxaban-linked-more-bleeding.
VIDEO: Bioresorbable Absorb unexpectedly humbled by metallic DES
WASHINGTON – The bioabsorbable vascular scaffold bubble suddenly burst with the first 3-year follow-up data from a randomized trial that unexpectedly showed that the Absorb device significantly underperformed compared with Xience, a widely-used, second-generation metallic drug-eluting stent.
“As a pioneer of BVS [bioresorbable vascular scaffold] I’m disappointed,” Patrick W. Serruys, MD, said at the Transcatheter Cardiovascular Therapeutics annual meeting. “The performance of the comparator stent was spectacular.”
Xience surpassed Absorb in several other secondary endpoints. For example, the in-device binary restenosis rate was 7.0% with Absorb and 0.7% with Xience; the in-segment binary restenosis rate was 8% with Absorb and 3% with Xience. Target-vessel MIs occurred in 7% of the Absorb patients and 1% of the Xience patients, while clinically indicated target-lesion revascularization occurred in 6% of the Absorb patients and 1% of the Xience patients.
Another notable finding was that definite or probable in-device thrombosis occurred in nine Absorb patents and in none of the Xience patients, a statistically significant difference. Six of the Absorb thrombotic events occurred more than 1 year after the device was placed, and in several instances these thromboses occurred more than 900 days after placement, when the BVS had largely resorbed.
“These thromboses are occurring at the late stages of BVS degradation,” Dr. Serruys noted. “The Absorb polymer is basically gone after 3 years, but it’s replaced by a proteoglycan, and some proteoglycans are quite thrombogenic,” a possible explanation for the “mysterious” very late thromboses, he said.
These “disappointing” results my be linked to inadequate lesion preparation, appropriate sizing of the BVS for the lesion, and inconsistent postdilatation of the BVS, three steps that became the guiding mantra for BVS use starting a couple of years ago, said Giulio G. Stefanini, MD, an interventional cardiologist at Humanitas Research Hospital in Milan and a discussant for the report at the meeting, which was sponsored by the Cardiovascular Research Foundation.
Dr. Stefanini said that even though the Absorb stent became available for routine use in Europe starting in 2012, the device gained little traction since then in his own practice and throughout Italy. Currently it’s used for fewer than 5% of coronary interventions in Italy, he estimated. That’s largely because “we have failed to identify a population that benefits.” Other issues include the extra time needed to place a BVS, and the need for longer treatment with dual antiplatelet therapy for patients who receive a BVS, compared with when they receive a modern metallic drug-eluting stent. The Absorb BVS received Food and Drug Administration approval for routine U.S. use in July 2016.
“It would be beautiful to have a fully bioresorbable stent. It’s a lovely concept, but we’re not there yet,” Dr. Stefanini observed.
ABSORB II was sponsored by Abbott Vascular, which markets the Absorb device. Dr. Serruys has received research support from Abbott Vascular and has been a consultant to several other device and drug companies. Dr. Stefanini has been a consultant to Boston Scientific, B.Braun, and Edwards.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
We were all disappointed by the ABSORB II 3-year results. It was really surprising that even the vasomotion endpoint was, if anything, a little better with Xience, which performed amazingly well in this trial. Both arms of the study did well out to 3 years, but the Xience patients did better.
The Absorb bioresorbable vascular scaffold (BVS) is an early-stage device, and based on these results I wouldn’t give up on the BVS concept. But we need to be very careful with Absorb and which patients we implant with it. We need to make sure we carefully use thorough lesion preparation, correct sizing, and postdilatation in every patient, and we need to carefully select the right patients.
The main issue with the Absorb BVS in this trial was scaffold thrombosis, so we need to use a BVS only in patients with the lowest thrombosis risk, which means younger patients without renal failure, calcified vessels, and a larger-diameter target coronary artery. Younger patients have the most to gain from receiving a BVS. Younger patients who need a coronary intervention often collect several stents over the balance of their life, and it’s in these patients where you’d prefer that the stents eventually disappear.
Paul S. Teirstein, MD , is chief of cardiology and director of interventional cardiology at the Scripps Clinic in La Jolla, Calif. He has received research support from and has been a consultant to Abbott Vascular, Boston Scientific, and Medtronic. He made these comments in an interview .
We were all disappointed by the ABSORB II 3-year results. It was really surprising that even the vasomotion endpoint was, if anything, a little better with Xience, which performed amazingly well in this trial. Both arms of the study did well out to 3 years, but the Xience patients did better.
The Absorb bioresorbable vascular scaffold (BVS) is an early-stage device, and based on these results I wouldn’t give up on the BVS concept. But we need to be very careful with Absorb and which patients we implant with it. We need to make sure we carefully use thorough lesion preparation, correct sizing, and postdilatation in every patient, and we need to carefully select the right patients.
The main issue with the Absorb BVS in this trial was scaffold thrombosis, so we need to use a BVS only in patients with the lowest thrombosis risk, which means younger patients without renal failure, calcified vessels, and a larger-diameter target coronary artery. Younger patients have the most to gain from receiving a BVS. Younger patients who need a coronary intervention often collect several stents over the balance of their life, and it’s in these patients where you’d prefer that the stents eventually disappear.
Paul S. Teirstein, MD , is chief of cardiology and director of interventional cardiology at the Scripps Clinic in La Jolla, Calif. He has received research support from and has been a consultant to Abbott Vascular, Boston Scientific, and Medtronic. He made these comments in an interview .
We were all disappointed by the ABSORB II 3-year results. It was really surprising that even the vasomotion endpoint was, if anything, a little better with Xience, which performed amazingly well in this trial. Both arms of the study did well out to 3 years, but the Xience patients did better.
The Absorb bioresorbable vascular scaffold (BVS) is an early-stage device, and based on these results I wouldn’t give up on the BVS concept. But we need to be very careful with Absorb and which patients we implant with it. We need to make sure we carefully use thorough lesion preparation, correct sizing, and postdilatation in every patient, and we need to carefully select the right patients.
The main issue with the Absorb BVS in this trial was scaffold thrombosis, so we need to use a BVS only in patients with the lowest thrombosis risk, which means younger patients without renal failure, calcified vessels, and a larger-diameter target coronary artery. Younger patients have the most to gain from receiving a BVS. Younger patients who need a coronary intervention often collect several stents over the balance of their life, and it’s in these patients where you’d prefer that the stents eventually disappear.
Paul S. Teirstein, MD , is chief of cardiology and director of interventional cardiology at the Scripps Clinic in La Jolla, Calif. He has received research support from and has been a consultant to Abbott Vascular, Boston Scientific, and Medtronic. He made these comments in an interview .
WASHINGTON – The bioabsorbable vascular scaffold bubble suddenly burst with the first 3-year follow-up data from a randomized trial that unexpectedly showed that the Absorb device significantly underperformed compared with Xience, a widely-used, second-generation metallic drug-eluting stent.
“As a pioneer of BVS [bioresorbable vascular scaffold] I’m disappointed,” Patrick W. Serruys, MD, said at the Transcatheter Cardiovascular Therapeutics annual meeting. “The performance of the comparator stent was spectacular.”
Xience surpassed Absorb in several other secondary endpoints. For example, the in-device binary restenosis rate was 7.0% with Absorb and 0.7% with Xience; the in-segment binary restenosis rate was 8% with Absorb and 3% with Xience. Target-vessel MIs occurred in 7% of the Absorb patients and 1% of the Xience patients, while clinically indicated target-lesion revascularization occurred in 6% of the Absorb patients and 1% of the Xience patients.
Another notable finding was that definite or probable in-device thrombosis occurred in nine Absorb patents and in none of the Xience patients, a statistically significant difference. Six of the Absorb thrombotic events occurred more than 1 year after the device was placed, and in several instances these thromboses occurred more than 900 days after placement, when the BVS had largely resorbed.
“These thromboses are occurring at the late stages of BVS degradation,” Dr. Serruys noted. “The Absorb polymer is basically gone after 3 years, but it’s replaced by a proteoglycan, and some proteoglycans are quite thrombogenic,” a possible explanation for the “mysterious” very late thromboses, he said.
These “disappointing” results my be linked to inadequate lesion preparation, appropriate sizing of the BVS for the lesion, and inconsistent postdilatation of the BVS, three steps that became the guiding mantra for BVS use starting a couple of years ago, said Giulio G. Stefanini, MD, an interventional cardiologist at Humanitas Research Hospital in Milan and a discussant for the report at the meeting, which was sponsored by the Cardiovascular Research Foundation.
Dr. Stefanini said that even though the Absorb stent became available for routine use in Europe starting in 2012, the device gained little traction since then in his own practice and throughout Italy. Currently it’s used for fewer than 5% of coronary interventions in Italy, he estimated. That’s largely because “we have failed to identify a population that benefits.” Other issues include the extra time needed to place a BVS, and the need for longer treatment with dual antiplatelet therapy for patients who receive a BVS, compared with when they receive a modern metallic drug-eluting stent. The Absorb BVS received Food and Drug Administration approval for routine U.S. use in July 2016.
“It would be beautiful to have a fully bioresorbable stent. It’s a lovely concept, but we’re not there yet,” Dr. Stefanini observed.
ABSORB II was sponsored by Abbott Vascular, which markets the Absorb device. Dr. Serruys has received research support from Abbott Vascular and has been a consultant to several other device and drug companies. Dr. Stefanini has been a consultant to Boston Scientific, B.Braun, and Edwards.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
WASHINGTON – The bioabsorbable vascular scaffold bubble suddenly burst with the first 3-year follow-up data from a randomized trial that unexpectedly showed that the Absorb device significantly underperformed compared with Xience, a widely-used, second-generation metallic drug-eluting stent.
“As a pioneer of BVS [bioresorbable vascular scaffold] I’m disappointed,” Patrick W. Serruys, MD, said at the Transcatheter Cardiovascular Therapeutics annual meeting. “The performance of the comparator stent was spectacular.”
Xience surpassed Absorb in several other secondary endpoints. For example, the in-device binary restenosis rate was 7.0% with Absorb and 0.7% with Xience; the in-segment binary restenosis rate was 8% with Absorb and 3% with Xience. Target-vessel MIs occurred in 7% of the Absorb patients and 1% of the Xience patients, while clinically indicated target-lesion revascularization occurred in 6% of the Absorb patients and 1% of the Xience patients.
Another notable finding was that definite or probable in-device thrombosis occurred in nine Absorb patents and in none of the Xience patients, a statistically significant difference. Six of the Absorb thrombotic events occurred more than 1 year after the device was placed, and in several instances these thromboses occurred more than 900 days after placement, when the BVS had largely resorbed.
“These thromboses are occurring at the late stages of BVS degradation,” Dr. Serruys noted. “The Absorb polymer is basically gone after 3 years, but it’s replaced by a proteoglycan, and some proteoglycans are quite thrombogenic,” a possible explanation for the “mysterious” very late thromboses, he said.
These “disappointing” results my be linked to inadequate lesion preparation, appropriate sizing of the BVS for the lesion, and inconsistent postdilatation of the BVS, three steps that became the guiding mantra for BVS use starting a couple of years ago, said Giulio G. Stefanini, MD, an interventional cardiologist at Humanitas Research Hospital in Milan and a discussant for the report at the meeting, which was sponsored by the Cardiovascular Research Foundation.
Dr. Stefanini said that even though the Absorb stent became available for routine use in Europe starting in 2012, the device gained little traction since then in his own practice and throughout Italy. Currently it’s used for fewer than 5% of coronary interventions in Italy, he estimated. That’s largely because “we have failed to identify a population that benefits.” Other issues include the extra time needed to place a BVS, and the need for longer treatment with dual antiplatelet therapy for patients who receive a BVS, compared with when they receive a modern metallic drug-eluting stent. The Absorb BVS received Food and Drug Administration approval for routine U.S. use in July 2016.
“It would be beautiful to have a fully bioresorbable stent. It’s a lovely concept, but we’re not there yet,” Dr. Stefanini observed.
ABSORB II was sponsored by Abbott Vascular, which markets the Absorb device. Dr. Serruys has received research support from Abbott Vascular and has been a consultant to several other device and drug companies. Dr. Stefanini has been a consultant to Boston Scientific, B.Braun, and Edwards.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
Key clinical point:
Major finding: In-stent or in-scaffold late luminal loss averaged 0.25 mm with Xience and 0.37 mm with Absorb, a statistically significant difference.
Data source: ABSORB II, a multicenter, randomized trial that enrolled 501 patients.
Disclosures: ABSORB II was sponsored by Abbott Vascular, which markets the Absorb device. Dr. Serruys has received research support from Abbott Vascular and has been a consultant to several other device and drug companies. Dr. Stefanini has been a consultant to Boston Scientific, B.Braun and Edwards.
Does one particular cesarean technique confer better maternal and neonatal outcomes?
EXPERT COMMENTARY
John M. Thorp Jr, MD, McAllister Distinguished Professor, Division Director, General Obstetrics and Gynecology, Vice Chair of Research, Department of Ob-Gyn, University of North Carolina Schools of Medicine and Public Health, Chapel Hill.
Five years ago one of our interns operating with the director of labor and delivery challenged him as to why we were not using evidenced-based surgical techniques for cesarean delivery. Bruised by the formidable (and at times misleading) club of “evidence-based medicine” that is held as sacrosanct by the modern obstetrician, the director responded to the charge by researching a systematic review on abdominal delivery that amalgamated studies of poor quality with precious few trials. He unilaterally decided that we needed an opening in the transparent portion of the drape overlying the incision site so that we might use “evidence” to prevent operative site infection. The end result: No change in the incidence of wound infections, and adhesive drapes that did not adhere well, thereby displacing the effluent of amniotic fluid and blood that are part of a cesarean delivery back into the first assistant’s socks, shoes, and clothing. It was as if the clock had been turned back to my early years as an attending when we had cloth drapes. So much for having an evidence-based protocol. I was thus elated at reading the results of the CORONIS trial.
Details of the study
The CORONIS trial, in which investigators randomly assigned almost 16,000 women from 7 countries (Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan), used a sophisticated factorial design and followed up 13,153 (84%) of the women for 3 years. The investigators tested an array of technical questions about 5 intervention pairs used during abdominal delivery and reported the main outcomes of interest for each intervention, including:
- blunt versus sharp abdominal entry—no evidence of a difference in risk of abdominal hernias (adjusted risk ratio [RR], 0.66; 95% confidence interval [CI], 0.39–1.11)
- exteriorization of the uterus versus intra-abdominal repair—no evidence of a difference in risk of infertility (RR, 0.91; 95% CI, 0.71–1.18) or of ectopic pregnancy (RR, 0.50; CI, 0.15–1.66)
- single- versus double-layer closure of the uterus—no evidence of a difference in maternal death (RR, 0.78; 95% CI, 0.46–1.32) or a composite of pregnancy complications (RR, 1.20; 95% CI, 0.75–1.90)
- closure versus nonclosure of the peritoneum—no evidence of a difference in any outcomes relating to symptoms associated with pelvic adhesions, such as infertility (RR, 0.8; 95% CI, 0.61–1.06)
- chromic catgut versus polyglactin-910 sutures—no evidence of a difference in the main comparisons for adverse pregnancy outcomes in a subsequent pregnancy, such as uterine rupture (RR, 3.05; 95% CI, 0.32–29.29).
Strengths and limitations. The CORONIS trial included a large number of participants and had comprehensive follow-up, a rigorous data collection process, and the participation of many countries. The trial’s participating centers, however, were mostly large referral hospitals with high research interest; adverse outcomes might have been higher in other settings. As well, a lower incidence of subsequent pregnancy among participants limited the study’s power to detect differences in outcomes between the intervention pairs.
Conclusions. None of the alternative techniques produced any real benefits despite syntheses-suggested benefit reported in systematic reviews. Surgeon preference for cesarean delivery techniques likely will continue to guide clinical practice along with economic and institution factors.
A word to the wise: Evidence is not created equally, and pushing it into lumps does not increase its value.
--John M. Thorp Jr, MD
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
EXPERT COMMENTARY
John M. Thorp Jr, MD, McAllister Distinguished Professor, Division Director, General Obstetrics and Gynecology, Vice Chair of Research, Department of Ob-Gyn, University of North Carolina Schools of Medicine and Public Health, Chapel Hill.
Five years ago one of our interns operating with the director of labor and delivery challenged him as to why we were not using evidenced-based surgical techniques for cesarean delivery. Bruised by the formidable (and at times misleading) club of “evidence-based medicine” that is held as sacrosanct by the modern obstetrician, the director responded to the charge by researching a systematic review on abdominal delivery that amalgamated studies of poor quality with precious few trials. He unilaterally decided that we needed an opening in the transparent portion of the drape overlying the incision site so that we might use “evidence” to prevent operative site infection. The end result: No change in the incidence of wound infections, and adhesive drapes that did not adhere well, thereby displacing the effluent of amniotic fluid and blood that are part of a cesarean delivery back into the first assistant’s socks, shoes, and clothing. It was as if the clock had been turned back to my early years as an attending when we had cloth drapes. So much for having an evidence-based protocol. I was thus elated at reading the results of the CORONIS trial.
Details of the study
The CORONIS trial, in which investigators randomly assigned almost 16,000 women from 7 countries (Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan), used a sophisticated factorial design and followed up 13,153 (84%) of the women for 3 years. The investigators tested an array of technical questions about 5 intervention pairs used during abdominal delivery and reported the main outcomes of interest for each intervention, including:
- blunt versus sharp abdominal entry—no evidence of a difference in risk of abdominal hernias (adjusted risk ratio [RR], 0.66; 95% confidence interval [CI], 0.39–1.11)
- exteriorization of the uterus versus intra-abdominal repair—no evidence of a difference in risk of infertility (RR, 0.91; 95% CI, 0.71–1.18) or of ectopic pregnancy (RR, 0.50; CI, 0.15–1.66)
- single- versus double-layer closure of the uterus—no evidence of a difference in maternal death (RR, 0.78; 95% CI, 0.46–1.32) or a composite of pregnancy complications (RR, 1.20; 95% CI, 0.75–1.90)
- closure versus nonclosure of the peritoneum—no evidence of a difference in any outcomes relating to symptoms associated with pelvic adhesions, such as infertility (RR, 0.8; 95% CI, 0.61–1.06)
- chromic catgut versus polyglactin-910 sutures—no evidence of a difference in the main comparisons for adverse pregnancy outcomes in a subsequent pregnancy, such as uterine rupture (RR, 3.05; 95% CI, 0.32–29.29).
Strengths and limitations. The CORONIS trial included a large number of participants and had comprehensive follow-up, a rigorous data collection process, and the participation of many countries. The trial’s participating centers, however, were mostly large referral hospitals with high research interest; adverse outcomes might have been higher in other settings. As well, a lower incidence of subsequent pregnancy among participants limited the study’s power to detect differences in outcomes between the intervention pairs.
Conclusions. None of the alternative techniques produced any real benefits despite syntheses-suggested benefit reported in systematic reviews. Surgeon preference for cesarean delivery techniques likely will continue to guide clinical practice along with economic and institution factors.
A word to the wise: Evidence is not created equally, and pushing it into lumps does not increase its value.
--John M. Thorp Jr, MD
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
EXPERT COMMENTARY
John M. Thorp Jr, MD, McAllister Distinguished Professor, Division Director, General Obstetrics and Gynecology, Vice Chair of Research, Department of Ob-Gyn, University of North Carolina Schools of Medicine and Public Health, Chapel Hill.
Five years ago one of our interns operating with the director of labor and delivery challenged him as to why we were not using evidenced-based surgical techniques for cesarean delivery. Bruised by the formidable (and at times misleading) club of “evidence-based medicine” that is held as sacrosanct by the modern obstetrician, the director responded to the charge by researching a systematic review on abdominal delivery that amalgamated studies of poor quality with precious few trials. He unilaterally decided that we needed an opening in the transparent portion of the drape overlying the incision site so that we might use “evidence” to prevent operative site infection. The end result: No change in the incidence of wound infections, and adhesive drapes that did not adhere well, thereby displacing the effluent of amniotic fluid and blood that are part of a cesarean delivery back into the first assistant’s socks, shoes, and clothing. It was as if the clock had been turned back to my early years as an attending when we had cloth drapes. So much for having an evidence-based protocol. I was thus elated at reading the results of the CORONIS trial.
Details of the study
The CORONIS trial, in which investigators randomly assigned almost 16,000 women from 7 countries (Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan), used a sophisticated factorial design and followed up 13,153 (84%) of the women for 3 years. The investigators tested an array of technical questions about 5 intervention pairs used during abdominal delivery and reported the main outcomes of interest for each intervention, including:
- blunt versus sharp abdominal entry—no evidence of a difference in risk of abdominal hernias (adjusted risk ratio [RR], 0.66; 95% confidence interval [CI], 0.39–1.11)
- exteriorization of the uterus versus intra-abdominal repair—no evidence of a difference in risk of infertility (RR, 0.91; 95% CI, 0.71–1.18) or of ectopic pregnancy (RR, 0.50; CI, 0.15–1.66)
- single- versus double-layer closure of the uterus—no evidence of a difference in maternal death (RR, 0.78; 95% CI, 0.46–1.32) or a composite of pregnancy complications (RR, 1.20; 95% CI, 0.75–1.90)
- closure versus nonclosure of the peritoneum—no evidence of a difference in any outcomes relating to symptoms associated with pelvic adhesions, such as infertility (RR, 0.8; 95% CI, 0.61–1.06)
- chromic catgut versus polyglactin-910 sutures—no evidence of a difference in the main comparisons for adverse pregnancy outcomes in a subsequent pregnancy, such as uterine rupture (RR, 3.05; 95% CI, 0.32–29.29).
Strengths and limitations. The CORONIS trial included a large number of participants and had comprehensive follow-up, a rigorous data collection process, and the participation of many countries. The trial’s participating centers, however, were mostly large referral hospitals with high research interest; adverse outcomes might have been higher in other settings. As well, a lower incidence of subsequent pregnancy among participants limited the study’s power to detect differences in outcomes between the intervention pairs.
Conclusions. None of the alternative techniques produced any real benefits despite syntheses-suggested benefit reported in systematic reviews. Surgeon preference for cesarean delivery techniques likely will continue to guide clinical practice along with economic and institution factors.
A word to the wise: Evidence is not created equally, and pushing it into lumps does not increase its value.
--John M. Thorp Jr, MD
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Your patients are talking: Isn’t it time you take responsibility for your online reputation?
In a web-focused world, it should not take much convincing that monitoring your online reputation is time well spent. For some of us, it may be hard to believe that online reviews have evolved beyond restaurants and plumbers, but today your patients are flocking to the Internet to read and leave reviews about you, your staff, and your services. What can you do to protect your online reputation?
We first addressed this topic in December 2014 (“Using the Internet in your practice. Part 4: Reputation management—how to gather kudos and combat negative online reviews”1). Have you implemented any of the tactics we offered then? We hope that you do take proactive steps to protect your online image.
What is a physician’s most precious asset?
You might answer this question with, “my patients” or “the training and education that I have obtained to practice my craft.” But the real answer is that your most precious asset is your reputation.
Physicians live and die by their reputations. We spend our entire medical careers polishing and protecting this status. The Internet dramatically has altered the way people gather information. It is sad but true that a single comment that only takes a few seconds and a single mouse-click to post can be seen by thousands and ruin that life-long effort.
How are physicians rated on the web?
Online physician reviews are positive 70% to 90% of the time.2 Most physicians have 5 or fewer reviews on any one site.3 Of the approximately 30 sites that monitor physicians and hospitals online, one of the most popular is AngiesList.com. This site requires registration and a fee; a member can review a physician every 6 months. On free websites such as Yelp.com and doctorsscorecard.com the reviewer can comment once. Other sites such as vitals.com or DrScore.com limit the reviews from 1 source, which prevents an angry patient from stuffing the ballot box.2
Pay attention
At a minimum, physicians should be monitoring their reputation by conducting periodic searches—“Googling” their name and practice name—to identify what information is already online. You may find that 3, 4, or even 10 reviews appear on various sites. If you are lucky, these reviews will be positive. Don’t be surprised, however, if 1 or 2 are not. Let’s face it: even the most accredited and experienced physician cannot possibly satisfy every patient who walks through the door.
Neil Baum, MD, and Ron Romano have offered tips on ways to manage online reputations in the past,1 and they urge Ob-Gyns to take an active role in this process in order to increase positive exposure to patients and maintain an active practice. Is active reputation management something that ObGyns are spending their valuable time on? To find out, OBG Management reached out to its Virtual Editorial Board. We found that many readers are paying attention to patient satisfaction. Some are soliciting online reviews and maintaining active upkeep on their online reputation. Here are a few responses we received from practicing ObGyns across the United States.
William E. McGrath Jr, MD, of Fernandina Beach, Florida, says that his office provides patients with a list of 5 popular review websites during their visits, and that approximately 1 in 10 will follow up with a review. Patient reviews are also prominently posted on his practice’s website. The large, private, single-specialty group to which his practice belongs requires patient satisfaction surveys for quality assurance review and insurance contract negotiations. “It is all about physician-patient communication,” he says.
Keith S. Merlin, MD, of Brockton, Massachusetts, says that he has checked online reviews to ensure their accuracy. His practice uses surveys, a suggestion box, and a mystery shopper to measure patient satisfaction, a worthwhile effort he says to understand where the practice is doing well and what needs to be done better.
Wesley Hambright, MD, of Jacksonville, North Carolina, reports that he has established a Google Alert to monitor for new content relating to his practice.
Patrick Pevoto, MD, MBA, of Austin, Texas, informs us that he has just started to think about ways to manage his online reputation. He has created a website and is writing a monthly blog, which he posts on his site. He acknowledges the importance of assessing patient satisfaction in his practice but is not applying large-scale measurement techniques yet. To keep his patients happy, he handles concerns that arise on a personal, case-by-case basis.
John Armstrong, MD, MS, of Napa, California, also reports that management of his online reputation is in the beginning stages. He uses focus groups and feels that listening to his patients when they do comment on their experience is important to his overall practice. Listening helps to “identify areas to improve and reaffirms when we are doing well,” he says. To keep his patients happy, he strives to “give extraordinary care and simply be nice to people.” When issues arise, making it right and being polite are important elements, he asserts.
Delos J. Clow, DO, MS, of Chillicothe, Missouri, does measure patient satisfaction, and feels this is very important to his practice in order to identify and correct any negative trends. He does not actively monitor his practice reputation online.
Robert del Rosario, MD, of Camp Hill, Pennsylvania, similarly does not actively manage an online reputation, but does focus on patient satisfaction. To enhance satisfaction, he tries to de-emphasize the electronic medical record to “make visits more personal and less interrogative.” Additionally, his practice objectively gauges aspects of care that might be able to be improved upon.
Reference
- Romano R, Baum NH. Using the Internet in your practice. Part 4: Reputation management—how to gather kudos and combat negative online reviews. OBG Manag. 2014;26(12):23,24,26,28.
Tell your own story
As physicians, you may not have control over what others say about you, but you can take ownership of your online presence by establishing a website, blog, and social media platforms, ensuring your story is being properly communicated. Without an online presence, you are entirely at the mercy of directory and review sites.
Optimize your website
A site that successfully uses search engine optimization (SEO) will have the upper hand when patients hunt for a physician in your area because the information will be posted at the top of the search page, well above the reviews and listings left by patients and other third-party sources. This is a critical step for your online brand because it will be difficult for other sites to mask your credibility. This should motivate you to develop an online presence, regularly update information, and participate in Internet dialog with other sites.
Generate quality, natural reviews
If your site is in good standing in search results, the next step is to implement a patient reviews strategy to start acquiring positive online reviews. A third-party provider can work with you to launch a local search engine optimization strategy and a natural reviews management program tailored for your practice’s needs. For the most part, however, we do not recommend using an online reputation management company. It is far better and more economical to ask satisfied patients to provide reviews.
At first, you may be tempted to actively petition or solicit reviews through survey software, but this method is manipulative and can lead to reputation problems for your practice. Google actively tracks where reviews originate and uses advanced algorithms to determine the review’s integrity. A petitioned review is classified as less valid, and therefore Google will assume it was not written under the same pretense as a natural, unsolicited review.
Quality customer service and outstanding patient care are often what achieve the organic reviews you are striving for. To encourage a steady flow, administer a process that encourages your most satisfied, loyal patients to review your practice.
Keep the process simple. Capture positive compliments at the point of service. Before a patient leaves your office, hand her a card (FIGURE) with easy steps for posting an online review, or offer her a tablet that links directly to your website review section. If your patient is not computer savvy, ask her to complete a 4- to 5-question survey and give her a clipboard and a pen. Then have a staff member post it on your website.
In Dr. Baum’s practice, there is a poster in every exam room and in the reception area where patients can scan the quick response (QR) code and immediately submit a testimonial. Using this system, the practice is able to collect 3 to 5 positive reviews every day.
A patient pleased with your staff’s service will happily take 5 minutes to submit a review. Acquire 5 to 10 reviews monthly and within a year’s time you will have generated enough positive reviews to negate any damaging comments that inevitably will emerge from time to time.
CASE Patient criticizes physician in a review forum
A physician with a robust Internet presence will have his or her name and the practice appear at the top of search engine results pages (as is the case with Dr. Neil Baum when “urologist” plus “New Orleans” is typed into the Google search engine window). By far most of Dr. Baum’s reviews are positive. In one instance, however, a patient on a physician review website referred to Dr. Baum as “technologically advanced but more motivated to increase his income by performing too many diagnostic tests.”
If you find a negative comment in an online directory or review website, what should you do?
The Office for Civil Rights (OCR) within the US Department of Health and Human Services (HHS) is responsible for handling Health Insurance Portability and Accountability Act of 1996 (HIPAA)1 complaints. Deven McGraw, OCR’s deputy director of health information privacy, states that “just because patients have rated their health provider publicly doesn’t give their health provider permission to rate them in return.”2,3 In fact, some health care providers who responded to poor online reviews ran into trouble with privacy rules established by HIPAA.2,3
Mr. McGraw notes that, when responding to online reviews, health professionals should speak generally about the way they treat patients while complying with HIPAA regulations. He suggests, “If the complaint is about poor patient care … say, ‘I provide all of my patients with good patient care’ and ‘I’ve been reviewed in other contexts and have good reviews.’”2,3
According to Yelp’s senior director of litigation, Aaron Schur, most patient complaints center on practice-based concerns such as wait times, office staff, and billing, not about the medical service delivered. Although most physicians do not respond, says Mr. Schur, those who do, tend to ask patients to discuss the matter in private or to apologize.2,3
What are the consequences of a HIPAA violation?
OCR Director Jocelyn Samuels says that the office’s primary role is to help health providers follow HIPAA regulations.2,5 The OCR can resolve HIPPA violations privately and informally, impose fines of up to $50,000 per violation, or it can file criminal charges against violators.2,4
The majority of the office’s investigation and enforcement of HIPAA has been against large medical data breaches.2,5 Small privacy breaches by large health care providers (eg, CVS, Walmart, Lab Corp, Quest Diagnostics, and others) generally do not result in legal consequences; the providers are privately warned. According to ProPublica, even repeated HIPAA violations tend not to be fined.2,4
Small-scale infractions can be more damaging on a personal level to both patients and physicians. However, the OCR does not typically become involved in privacy breaches that include only a few individuals. Health care providers are rarely punished for small HIPPA breaches; instead, the OCR typically settles for pledges to fix any problems and issues reminders of HIPPA requirements.2,5
Although the OCR is often the only place patients can go to seek vindication, HIPAA does not support the right to sue for violation of personal privacy. People who seek a legal remedy must find another means, which is easier in some states than in others.2,5
Health care providers have tried myriad ways to attempt to combat negative reviews. Some have sued patients, attracting a flood of attention but achieving little legal success. Others have asked patients to remove their complaints.2,3
Best practices
Create and circulate a policy. Medical privacy breaches involving sensitive health details can occur when office or hospital staff share patient information due to personal hostility or lack of understanding of HIPPA policy.2,5 Have a practice policy for responding to online reviews by patients, and make sure the staff members who have access to the practice’s online accounts understand your policy and the possible repercussions of not following it. Teach and continue to remind your staff about HIPPA regulations and hold them to a high ethical level of privacy.
Solicit reviews on an ongoing basis. Jeffrey Segal, a review site critic, says that all reviews are valuable. Physicians should respond carefully to negative comments and encourage satisfied patients to post positive reviews. “’For doctors who get bent out of shape to get rid of negative reviews, it’s a denominator problem,’ he said. ‘If they only have three reviews and two are negative, the denominator is the problem. … If you can figure out a way to cultivate reviews from hundreds of patients rather than a few patients, the problem is solved.’”2,3
CASE Resolved
Dr. Baum never responded directly to the negative patient review, and others he has received. He balances the rare negative response with numerous and plentiful positive responses by making it a practice to encourage reviews from all of his patients.
References
- HIPAA for Professionals. US Department of Health & Human Services. http://www.hhs.gov/hipaa/for-professionals/index.html. Accessed October 11, 2016.
- Hall SD. Providers responding to Yelp reviews must be mindful of HIPAA. FierceHealthcare. http://www.fiercehealthcare.com/it/providers-responding-to-yelp-reviews-must-be-mindful-hipaa. Published May 31, 2016. Accessed October 7, 2016.
- Ornstein C. Stung by Yelp reviews, health providers spill patient secrets. ProPublica. https://www.propublica.org/article/stung-by-yelp-reviews-health -providers-spill-patient-secrets. Published May 27, 2016. Accessed October 11, 2016.
- Ornstein C, Waldman A. Few consequences for health privacy law’s repeat offenders. ProPublica. https://www.propublica.org/article/few-consequences-for-health-privacy-law-repeat-offenders. Published December 29, 2015. Accessed October 11, 2016.
- Ornstein C. Small-scale violations of medical privacy often cause the most harm. ProPublica. https://www.propublica.org/article/small-scale-violations-of-medical-privacy-often-cause-the-most-harm. Published December 10, 2015. Accessed October 11, 2016.
The bottom line
Patients are seeking and leaving reviews about you and your practice online and you need to actively manage your online reputation. Do not let one disgruntled patient ruin your reputation. Our advice: Do not wait for a negative review to begin your reputation management. Take an active role and generate positive reviews to drown out negative remarks made by an occasional patient. This is an inexpensive process that does work.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Romano R, Baum NH. Using the Internet in your practice. Part 4: Reputation management-how to gather kudos and combat negative online reviews. OBG Manag. 2014;26(12):23,24,26,28.
- Lagu T, Hannon NS, Rothberg MB, Lindenauer PK. Patients' evaluations of health care providers in the era of social networking: an analysis of physician rating websites. J Gen Intern Med. 2010;25(9):942-946.
- Gunter J. For better or maybe, worse, patients are judging your care online. OBG Manag. 2011;23(3):47-51.
In a web-focused world, it should not take much convincing that monitoring your online reputation is time well spent. For some of us, it may be hard to believe that online reviews have evolved beyond restaurants and plumbers, but today your patients are flocking to the Internet to read and leave reviews about you, your staff, and your services. What can you do to protect your online reputation?
We first addressed this topic in December 2014 (“Using the Internet in your practice. Part 4: Reputation management—how to gather kudos and combat negative online reviews”1). Have you implemented any of the tactics we offered then? We hope that you do take proactive steps to protect your online image.
What is a physician’s most precious asset?
You might answer this question with, “my patients” or “the training and education that I have obtained to practice my craft.” But the real answer is that your most precious asset is your reputation.
Physicians live and die by their reputations. We spend our entire medical careers polishing and protecting this status. The Internet dramatically has altered the way people gather information. It is sad but true that a single comment that only takes a few seconds and a single mouse-click to post can be seen by thousands and ruin that life-long effort.
How are physicians rated on the web?
Online physician reviews are positive 70% to 90% of the time.2 Most physicians have 5 or fewer reviews on any one site.3 Of the approximately 30 sites that monitor physicians and hospitals online, one of the most popular is AngiesList.com. This site requires registration and a fee; a member can review a physician every 6 months. On free websites such as Yelp.com and doctorsscorecard.com the reviewer can comment once. Other sites such as vitals.com or DrScore.com limit the reviews from 1 source, which prevents an angry patient from stuffing the ballot box.2
Pay attention
At a minimum, physicians should be monitoring their reputation by conducting periodic searches—“Googling” their name and practice name—to identify what information is already online. You may find that 3, 4, or even 10 reviews appear on various sites. If you are lucky, these reviews will be positive. Don’t be surprised, however, if 1 or 2 are not. Let’s face it: even the most accredited and experienced physician cannot possibly satisfy every patient who walks through the door.
Neil Baum, MD, and Ron Romano have offered tips on ways to manage online reputations in the past,1 and they urge Ob-Gyns to take an active role in this process in order to increase positive exposure to patients and maintain an active practice. Is active reputation management something that ObGyns are spending their valuable time on? To find out, OBG Management reached out to its Virtual Editorial Board. We found that many readers are paying attention to patient satisfaction. Some are soliciting online reviews and maintaining active upkeep on their online reputation. Here are a few responses we received from practicing ObGyns across the United States.
William E. McGrath Jr, MD, of Fernandina Beach, Florida, says that his office provides patients with a list of 5 popular review websites during their visits, and that approximately 1 in 10 will follow up with a review. Patient reviews are also prominently posted on his practice’s website. The large, private, single-specialty group to which his practice belongs requires patient satisfaction surveys for quality assurance review and insurance contract negotiations. “It is all about physician-patient communication,” he says.
Keith S. Merlin, MD, of Brockton, Massachusetts, says that he has checked online reviews to ensure their accuracy. His practice uses surveys, a suggestion box, and a mystery shopper to measure patient satisfaction, a worthwhile effort he says to understand where the practice is doing well and what needs to be done better.
Wesley Hambright, MD, of Jacksonville, North Carolina, reports that he has established a Google Alert to monitor for new content relating to his practice.
Patrick Pevoto, MD, MBA, of Austin, Texas, informs us that he has just started to think about ways to manage his online reputation. He has created a website and is writing a monthly blog, which he posts on his site. He acknowledges the importance of assessing patient satisfaction in his practice but is not applying large-scale measurement techniques yet. To keep his patients happy, he handles concerns that arise on a personal, case-by-case basis.
John Armstrong, MD, MS, of Napa, California, also reports that management of his online reputation is in the beginning stages. He uses focus groups and feels that listening to his patients when they do comment on their experience is important to his overall practice. Listening helps to “identify areas to improve and reaffirms when we are doing well,” he says. To keep his patients happy, he strives to “give extraordinary care and simply be nice to people.” When issues arise, making it right and being polite are important elements, he asserts.
Delos J. Clow, DO, MS, of Chillicothe, Missouri, does measure patient satisfaction, and feels this is very important to his practice in order to identify and correct any negative trends. He does not actively monitor his practice reputation online.
Robert del Rosario, MD, of Camp Hill, Pennsylvania, similarly does not actively manage an online reputation, but does focus on patient satisfaction. To enhance satisfaction, he tries to de-emphasize the electronic medical record to “make visits more personal and less interrogative.” Additionally, his practice objectively gauges aspects of care that might be able to be improved upon.
Reference
- Romano R, Baum NH. Using the Internet in your practice. Part 4: Reputation management—how to gather kudos and combat negative online reviews. OBG Manag. 2014;26(12):23,24,26,28.
Tell your own story
As physicians, you may not have control over what others say about you, but you can take ownership of your online presence by establishing a website, blog, and social media platforms, ensuring your story is being properly communicated. Without an online presence, you are entirely at the mercy of directory and review sites.
Optimize your website
A site that successfully uses search engine optimization (SEO) will have the upper hand when patients hunt for a physician in your area because the information will be posted at the top of the search page, well above the reviews and listings left by patients and other third-party sources. This is a critical step for your online brand because it will be difficult for other sites to mask your credibility. This should motivate you to develop an online presence, regularly update information, and participate in Internet dialog with other sites.
Generate quality, natural reviews
If your site is in good standing in search results, the next step is to implement a patient reviews strategy to start acquiring positive online reviews. A third-party provider can work with you to launch a local search engine optimization strategy and a natural reviews management program tailored for your practice’s needs. For the most part, however, we do not recommend using an online reputation management company. It is far better and more economical to ask satisfied patients to provide reviews.
At first, you may be tempted to actively petition or solicit reviews through survey software, but this method is manipulative and can lead to reputation problems for your practice. Google actively tracks where reviews originate and uses advanced algorithms to determine the review’s integrity. A petitioned review is classified as less valid, and therefore Google will assume it was not written under the same pretense as a natural, unsolicited review.
Quality customer service and outstanding patient care are often what achieve the organic reviews you are striving for. To encourage a steady flow, administer a process that encourages your most satisfied, loyal patients to review your practice.
Keep the process simple. Capture positive compliments at the point of service. Before a patient leaves your office, hand her a card (FIGURE) with easy steps for posting an online review, or offer her a tablet that links directly to your website review section. If your patient is not computer savvy, ask her to complete a 4- to 5-question survey and give her a clipboard and a pen. Then have a staff member post it on your website.
In Dr. Baum’s practice, there is a poster in every exam room and in the reception area where patients can scan the quick response (QR) code and immediately submit a testimonial. Using this system, the practice is able to collect 3 to 5 positive reviews every day.
A patient pleased with your staff’s service will happily take 5 minutes to submit a review. Acquire 5 to 10 reviews monthly and within a year’s time you will have generated enough positive reviews to negate any damaging comments that inevitably will emerge from time to time.
CASE Patient criticizes physician in a review forum
A physician with a robust Internet presence will have his or her name and the practice appear at the top of search engine results pages (as is the case with Dr. Neil Baum when “urologist” plus “New Orleans” is typed into the Google search engine window). By far most of Dr. Baum’s reviews are positive. In one instance, however, a patient on a physician review website referred to Dr. Baum as “technologically advanced but more motivated to increase his income by performing too many diagnostic tests.”
If you find a negative comment in an online directory or review website, what should you do?
The Office for Civil Rights (OCR) within the US Department of Health and Human Services (HHS) is responsible for handling Health Insurance Portability and Accountability Act of 1996 (HIPAA)1 complaints. Deven McGraw, OCR’s deputy director of health information privacy, states that “just because patients have rated their health provider publicly doesn’t give their health provider permission to rate them in return.”2,3 In fact, some health care providers who responded to poor online reviews ran into trouble with privacy rules established by HIPAA.2,3
Mr. McGraw notes that, when responding to online reviews, health professionals should speak generally about the way they treat patients while complying with HIPAA regulations. He suggests, “If the complaint is about poor patient care … say, ‘I provide all of my patients with good patient care’ and ‘I’ve been reviewed in other contexts and have good reviews.’”2,3
According to Yelp’s senior director of litigation, Aaron Schur, most patient complaints center on practice-based concerns such as wait times, office staff, and billing, not about the medical service delivered. Although most physicians do not respond, says Mr. Schur, those who do, tend to ask patients to discuss the matter in private or to apologize.2,3
What are the consequences of a HIPAA violation?
OCR Director Jocelyn Samuels says that the office’s primary role is to help health providers follow HIPAA regulations.2,5 The OCR can resolve HIPPA violations privately and informally, impose fines of up to $50,000 per violation, or it can file criminal charges against violators.2,4
The majority of the office’s investigation and enforcement of HIPAA has been against large medical data breaches.2,5 Small privacy breaches by large health care providers (eg, CVS, Walmart, Lab Corp, Quest Diagnostics, and others) generally do not result in legal consequences; the providers are privately warned. According to ProPublica, even repeated HIPAA violations tend not to be fined.2,4
Small-scale infractions can be more damaging on a personal level to both patients and physicians. However, the OCR does not typically become involved in privacy breaches that include only a few individuals. Health care providers are rarely punished for small HIPPA breaches; instead, the OCR typically settles for pledges to fix any problems and issues reminders of HIPPA requirements.2,5
Although the OCR is often the only place patients can go to seek vindication, HIPAA does not support the right to sue for violation of personal privacy. People who seek a legal remedy must find another means, which is easier in some states than in others.2,5
Health care providers have tried myriad ways to attempt to combat negative reviews. Some have sued patients, attracting a flood of attention but achieving little legal success. Others have asked patients to remove their complaints.2,3
Best practices
Create and circulate a policy. Medical privacy breaches involving sensitive health details can occur when office or hospital staff share patient information due to personal hostility or lack of understanding of HIPPA policy.2,5 Have a practice policy for responding to online reviews by patients, and make sure the staff members who have access to the practice’s online accounts understand your policy and the possible repercussions of not following it. Teach and continue to remind your staff about HIPPA regulations and hold them to a high ethical level of privacy.
Solicit reviews on an ongoing basis. Jeffrey Segal, a review site critic, says that all reviews are valuable. Physicians should respond carefully to negative comments and encourage satisfied patients to post positive reviews. “’For doctors who get bent out of shape to get rid of negative reviews, it’s a denominator problem,’ he said. ‘If they only have three reviews and two are negative, the denominator is the problem. … If you can figure out a way to cultivate reviews from hundreds of patients rather than a few patients, the problem is solved.’”2,3
CASE Resolved
Dr. Baum never responded directly to the negative patient review, and others he has received. He balances the rare negative response with numerous and plentiful positive responses by making it a practice to encourage reviews from all of his patients.
References
- HIPAA for Professionals. US Department of Health & Human Services. http://www.hhs.gov/hipaa/for-professionals/index.html. Accessed October 11, 2016.
- Hall SD. Providers responding to Yelp reviews must be mindful of HIPAA. FierceHealthcare. http://www.fiercehealthcare.com/it/providers-responding-to-yelp-reviews-must-be-mindful-hipaa. Published May 31, 2016. Accessed October 7, 2016.
- Ornstein C. Stung by Yelp reviews, health providers spill patient secrets. ProPublica. https://www.propublica.org/article/stung-by-yelp-reviews-health -providers-spill-patient-secrets. Published May 27, 2016. Accessed October 11, 2016.
- Ornstein C, Waldman A. Few consequences for health privacy law’s repeat offenders. ProPublica. https://www.propublica.org/article/few-consequences-for-health-privacy-law-repeat-offenders. Published December 29, 2015. Accessed October 11, 2016.
- Ornstein C. Small-scale violations of medical privacy often cause the most harm. ProPublica. https://www.propublica.org/article/small-scale-violations-of-medical-privacy-often-cause-the-most-harm. Published December 10, 2015. Accessed October 11, 2016.
The bottom line
Patients are seeking and leaving reviews about you and your practice online and you need to actively manage your online reputation. Do not let one disgruntled patient ruin your reputation. Our advice: Do not wait for a negative review to begin your reputation management. Take an active role and generate positive reviews to drown out negative remarks made by an occasional patient. This is an inexpensive process that does work.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
In a web-focused world, it should not take much convincing that monitoring your online reputation is time well spent. For some of us, it may be hard to believe that online reviews have evolved beyond restaurants and plumbers, but today your patients are flocking to the Internet to read and leave reviews about you, your staff, and your services. What can you do to protect your online reputation?
We first addressed this topic in December 2014 (“Using the Internet in your practice. Part 4: Reputation management—how to gather kudos and combat negative online reviews”1). Have you implemented any of the tactics we offered then? We hope that you do take proactive steps to protect your online image.
What is a physician’s most precious asset?
You might answer this question with, “my patients” or “the training and education that I have obtained to practice my craft.” But the real answer is that your most precious asset is your reputation.
Physicians live and die by their reputations. We spend our entire medical careers polishing and protecting this status. The Internet dramatically has altered the way people gather information. It is sad but true that a single comment that only takes a few seconds and a single mouse-click to post can be seen by thousands and ruin that life-long effort.
How are physicians rated on the web?
Online physician reviews are positive 70% to 90% of the time.2 Most physicians have 5 or fewer reviews on any one site.3 Of the approximately 30 sites that monitor physicians and hospitals online, one of the most popular is AngiesList.com. This site requires registration and a fee; a member can review a physician every 6 months. On free websites such as Yelp.com and doctorsscorecard.com the reviewer can comment once. Other sites such as vitals.com or DrScore.com limit the reviews from 1 source, which prevents an angry patient from stuffing the ballot box.2
Pay attention
At a minimum, physicians should be monitoring their reputation by conducting periodic searches—“Googling” their name and practice name—to identify what information is already online. You may find that 3, 4, or even 10 reviews appear on various sites. If you are lucky, these reviews will be positive. Don’t be surprised, however, if 1 or 2 are not. Let’s face it: even the most accredited and experienced physician cannot possibly satisfy every patient who walks through the door.
Neil Baum, MD, and Ron Romano have offered tips on ways to manage online reputations in the past,1 and they urge Ob-Gyns to take an active role in this process in order to increase positive exposure to patients and maintain an active practice. Is active reputation management something that ObGyns are spending their valuable time on? To find out, OBG Management reached out to its Virtual Editorial Board. We found that many readers are paying attention to patient satisfaction. Some are soliciting online reviews and maintaining active upkeep on their online reputation. Here are a few responses we received from practicing ObGyns across the United States.
William E. McGrath Jr, MD, of Fernandina Beach, Florida, says that his office provides patients with a list of 5 popular review websites during their visits, and that approximately 1 in 10 will follow up with a review. Patient reviews are also prominently posted on his practice’s website. The large, private, single-specialty group to which his practice belongs requires patient satisfaction surveys for quality assurance review and insurance contract negotiations. “It is all about physician-patient communication,” he says.
Keith S. Merlin, MD, of Brockton, Massachusetts, says that he has checked online reviews to ensure their accuracy. His practice uses surveys, a suggestion box, and a mystery shopper to measure patient satisfaction, a worthwhile effort he says to understand where the practice is doing well and what needs to be done better.
Wesley Hambright, MD, of Jacksonville, North Carolina, reports that he has established a Google Alert to monitor for new content relating to his practice.
Patrick Pevoto, MD, MBA, of Austin, Texas, informs us that he has just started to think about ways to manage his online reputation. He has created a website and is writing a monthly blog, which he posts on his site. He acknowledges the importance of assessing patient satisfaction in his practice but is not applying large-scale measurement techniques yet. To keep his patients happy, he handles concerns that arise on a personal, case-by-case basis.
John Armstrong, MD, MS, of Napa, California, also reports that management of his online reputation is in the beginning stages. He uses focus groups and feels that listening to his patients when they do comment on their experience is important to his overall practice. Listening helps to “identify areas to improve and reaffirms when we are doing well,” he says. To keep his patients happy, he strives to “give extraordinary care and simply be nice to people.” When issues arise, making it right and being polite are important elements, he asserts.
Delos J. Clow, DO, MS, of Chillicothe, Missouri, does measure patient satisfaction, and feels this is very important to his practice in order to identify and correct any negative trends. He does not actively monitor his practice reputation online.
Robert del Rosario, MD, of Camp Hill, Pennsylvania, similarly does not actively manage an online reputation, but does focus on patient satisfaction. To enhance satisfaction, he tries to de-emphasize the electronic medical record to “make visits more personal and less interrogative.” Additionally, his practice objectively gauges aspects of care that might be able to be improved upon.
Reference
- Romano R, Baum NH. Using the Internet in your practice. Part 4: Reputation management—how to gather kudos and combat negative online reviews. OBG Manag. 2014;26(12):23,24,26,28.
Tell your own story
As physicians, you may not have control over what others say about you, but you can take ownership of your online presence by establishing a website, blog, and social media platforms, ensuring your story is being properly communicated. Without an online presence, you are entirely at the mercy of directory and review sites.
Optimize your website
A site that successfully uses search engine optimization (SEO) will have the upper hand when patients hunt for a physician in your area because the information will be posted at the top of the search page, well above the reviews and listings left by patients and other third-party sources. This is a critical step for your online brand because it will be difficult for other sites to mask your credibility. This should motivate you to develop an online presence, regularly update information, and participate in Internet dialog with other sites.
Generate quality, natural reviews
If your site is in good standing in search results, the next step is to implement a patient reviews strategy to start acquiring positive online reviews. A third-party provider can work with you to launch a local search engine optimization strategy and a natural reviews management program tailored for your practice’s needs. For the most part, however, we do not recommend using an online reputation management company. It is far better and more economical to ask satisfied patients to provide reviews.
At first, you may be tempted to actively petition or solicit reviews through survey software, but this method is manipulative and can lead to reputation problems for your practice. Google actively tracks where reviews originate and uses advanced algorithms to determine the review’s integrity. A petitioned review is classified as less valid, and therefore Google will assume it was not written under the same pretense as a natural, unsolicited review.
Quality customer service and outstanding patient care are often what achieve the organic reviews you are striving for. To encourage a steady flow, administer a process that encourages your most satisfied, loyal patients to review your practice.
Keep the process simple. Capture positive compliments at the point of service. Before a patient leaves your office, hand her a card (FIGURE) with easy steps for posting an online review, or offer her a tablet that links directly to your website review section. If your patient is not computer savvy, ask her to complete a 4- to 5-question survey and give her a clipboard and a pen. Then have a staff member post it on your website.
In Dr. Baum’s practice, there is a poster in every exam room and in the reception area where patients can scan the quick response (QR) code and immediately submit a testimonial. Using this system, the practice is able to collect 3 to 5 positive reviews every day.
A patient pleased with your staff’s service will happily take 5 minutes to submit a review. Acquire 5 to 10 reviews monthly and within a year’s time you will have generated enough positive reviews to negate any damaging comments that inevitably will emerge from time to time.
CASE Patient criticizes physician in a review forum
A physician with a robust Internet presence will have his or her name and the practice appear at the top of search engine results pages (as is the case with Dr. Neil Baum when “urologist” plus “New Orleans” is typed into the Google search engine window). By far most of Dr. Baum’s reviews are positive. In one instance, however, a patient on a physician review website referred to Dr. Baum as “technologically advanced but more motivated to increase his income by performing too many diagnostic tests.”
If you find a negative comment in an online directory or review website, what should you do?
The Office for Civil Rights (OCR) within the US Department of Health and Human Services (HHS) is responsible for handling Health Insurance Portability and Accountability Act of 1996 (HIPAA)1 complaints. Deven McGraw, OCR’s deputy director of health information privacy, states that “just because patients have rated their health provider publicly doesn’t give their health provider permission to rate them in return.”2,3 In fact, some health care providers who responded to poor online reviews ran into trouble with privacy rules established by HIPAA.2,3
Mr. McGraw notes that, when responding to online reviews, health professionals should speak generally about the way they treat patients while complying with HIPAA regulations. He suggests, “If the complaint is about poor patient care … say, ‘I provide all of my patients with good patient care’ and ‘I’ve been reviewed in other contexts and have good reviews.’”2,3
According to Yelp’s senior director of litigation, Aaron Schur, most patient complaints center on practice-based concerns such as wait times, office staff, and billing, not about the medical service delivered. Although most physicians do not respond, says Mr. Schur, those who do, tend to ask patients to discuss the matter in private or to apologize.2,3
What are the consequences of a HIPAA violation?
OCR Director Jocelyn Samuels says that the office’s primary role is to help health providers follow HIPAA regulations.2,5 The OCR can resolve HIPPA violations privately and informally, impose fines of up to $50,000 per violation, or it can file criminal charges against violators.2,4
The majority of the office’s investigation and enforcement of HIPAA has been against large medical data breaches.2,5 Small privacy breaches by large health care providers (eg, CVS, Walmart, Lab Corp, Quest Diagnostics, and others) generally do not result in legal consequences; the providers are privately warned. According to ProPublica, even repeated HIPAA violations tend not to be fined.2,4
Small-scale infractions can be more damaging on a personal level to both patients and physicians. However, the OCR does not typically become involved in privacy breaches that include only a few individuals. Health care providers are rarely punished for small HIPPA breaches; instead, the OCR typically settles for pledges to fix any problems and issues reminders of HIPPA requirements.2,5
Although the OCR is often the only place patients can go to seek vindication, HIPAA does not support the right to sue for violation of personal privacy. People who seek a legal remedy must find another means, which is easier in some states than in others.2,5
Health care providers have tried myriad ways to attempt to combat negative reviews. Some have sued patients, attracting a flood of attention but achieving little legal success. Others have asked patients to remove their complaints.2,3
Best practices
Create and circulate a policy. Medical privacy breaches involving sensitive health details can occur when office or hospital staff share patient information due to personal hostility or lack of understanding of HIPPA policy.2,5 Have a practice policy for responding to online reviews by patients, and make sure the staff members who have access to the practice’s online accounts understand your policy and the possible repercussions of not following it. Teach and continue to remind your staff about HIPPA regulations and hold them to a high ethical level of privacy.
Solicit reviews on an ongoing basis. Jeffrey Segal, a review site critic, says that all reviews are valuable. Physicians should respond carefully to negative comments and encourage satisfied patients to post positive reviews. “’For doctors who get bent out of shape to get rid of negative reviews, it’s a denominator problem,’ he said. ‘If they only have three reviews and two are negative, the denominator is the problem. … If you can figure out a way to cultivate reviews from hundreds of patients rather than a few patients, the problem is solved.’”2,3
CASE Resolved
Dr. Baum never responded directly to the negative patient review, and others he has received. He balances the rare negative response with numerous and plentiful positive responses by making it a practice to encourage reviews from all of his patients.
References
- HIPAA for Professionals. US Department of Health & Human Services. http://www.hhs.gov/hipaa/for-professionals/index.html. Accessed October 11, 2016.
- Hall SD. Providers responding to Yelp reviews must be mindful of HIPAA. FierceHealthcare. http://www.fiercehealthcare.com/it/providers-responding-to-yelp-reviews-must-be-mindful-hipaa. Published May 31, 2016. Accessed October 7, 2016.
- Ornstein C. Stung by Yelp reviews, health providers spill patient secrets. ProPublica. https://www.propublica.org/article/stung-by-yelp-reviews-health -providers-spill-patient-secrets. Published May 27, 2016. Accessed October 11, 2016.
- Ornstein C, Waldman A. Few consequences for health privacy law’s repeat offenders. ProPublica. https://www.propublica.org/article/few-consequences-for-health-privacy-law-repeat-offenders. Published December 29, 2015. Accessed October 11, 2016.
- Ornstein C. Small-scale violations of medical privacy often cause the most harm. ProPublica. https://www.propublica.org/article/small-scale-violations-of-medical-privacy-often-cause-the-most-harm. Published December 10, 2015. Accessed October 11, 2016.
The bottom line
Patients are seeking and leaving reviews about you and your practice online and you need to actively manage your online reputation. Do not let one disgruntled patient ruin your reputation. Our advice: Do not wait for a negative review to begin your reputation management. Take an active role and generate positive reviews to drown out negative remarks made by an occasional patient. This is an inexpensive process that does work.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Romano R, Baum NH. Using the Internet in your practice. Part 4: Reputation management-how to gather kudos and combat negative online reviews. OBG Manag. 2014;26(12):23,24,26,28.
- Lagu T, Hannon NS, Rothberg MB, Lindenauer PK. Patients' evaluations of health care providers in the era of social networking: an analysis of physician rating websites. J Gen Intern Med. 2010;25(9):942-946.
- Gunter J. For better or maybe, worse, patients are judging your care online. OBG Manag. 2011;23(3):47-51.
- Romano R, Baum NH. Using the Internet in your practice. Part 4: Reputation management-how to gather kudos and combat negative online reviews. OBG Manag. 2014;26(12):23,24,26,28.
- Lagu T, Hannon NS, Rothberg MB, Lindenauer PK. Patients' evaluations of health care providers in the era of social networking: an analysis of physician rating websites. J Gen Intern Med. 2010;25(9):942-946.
- Gunter J. For better or maybe, worse, patients are judging your care online. OBG Manag. 2011;23(3):47-51.
In this Article
- How your peers manage online reputation
- Should you respond to a negative review?
- Generate quality, natural reviews
Consider Rx metformin to prevent metabolic syndrome
Many atypical antipsychotics, particularly clozapine and olanzapine, are associated with weight gain, insulin resistance, and metabolic syndrome. Metabolic syndrome is associated with type 2 diabetes mellitus (T2DM) and cardiovascular disease, which are among the leading causes of morbidity and mortality in persons with severe mental illness.1
Clinicians should take measures to prevent T2DM and weight gain in individuals taking antipsychotics before these conditions develop. Metformin re-sensitizes the body to insulin and is a first-line treatment for T2DM. Adding metformin when patients start metabolically high-risk antipsychotics or shortly after they begin gaining weight is an evidence-based strategy to prevent metabolic syndrome.
Evaluate the evidence
In randomized controlled trials, metformin was associated with modest weight loss and improvement in metabolic parameters (eg, fasting blood glucose, serum triglycerides, and total cholesterol) in patients with schizophrenia receiving antipsychotics.1,2 Metformin is effective for preventing metabolic syndrome and as a treatment intervention; therefore, it may prove most beneficial early in treatment before weight gain or insulin resistance develop.
Importantly, weight gain and metabolic syndrome are risk factors for cardiovascular disease, but the number needed to treat for metformin to prevent cardiovascular outcomes, such as myocardial infarction, is not known. Also, metformin is not FDA-approved for this indication. Clinicians should discuss with the patient the risks and benefits of prophylactic metformin, and consider his (her) treatment preferences.
Tolerability and adverse effects
Metformin generally is well-tolerated. Gastrointestinal (GI) symptoms, including nausea and vomiting (14%) and diarrhea (7%), are the most common adverse effects.2 Lactic acidosis is rare and is associated with alcohol use disorders and impaired renal, hepatic, or cardiopulmonary function.3 Because metformin is excreted renally, toxicity could occur in patients with impaired renal function.
Before initiating prophylactic metformin, confirm that the patient does not have T2DM (eg, hemoglobin A1c <6.5%). A thorough medical history, including alcohol use and kidney and liver function tests, are needed to reduce the risk of lactic acidosis.3
Dosing
Although metformin has been studied at many dosages,2 we recommend gradual titration to 1,000 mg, twice daily, taken with meals to reduce the risk of GI effects.
Additional interventions
Metformin alone is not sufficient to mitigate metabolic risk. Providers should address dietary interventions, exercise, and smoking cessation at each visit, and communicate actively with other providers to create a comprehensive treatment plan.
1. Jarskog LF, Hamer RF, Catellier DJ, et al; METS Investigators. Metformin for weight loss and metabolic control in overweight patients with schizophrenia and schizoaffective disorder. Am J Psychiatry. 2013;170(9):1032-1040.
2. Zheng W, Li X-B, Tang Y-L, et al. Metformin for weight gain and metabolic abnormalities associated with antipsychotic treatment: meta-analysis of randomized placebo-controlled trials. J Clin Psychopharmacol. 2015;35(5):499-509.
3. Wang M, Tong J-H, Zhu G, et al. Metformin for treatment of antipsychotic-induced weight gain: a randomized, placebo-controlled study. Schizophr Res. 2012;138(1):54-57.
Many atypical antipsychotics, particularly clozapine and olanzapine, are associated with weight gain, insulin resistance, and metabolic syndrome. Metabolic syndrome is associated with type 2 diabetes mellitus (T2DM) and cardiovascular disease, which are among the leading causes of morbidity and mortality in persons with severe mental illness.1
Clinicians should take measures to prevent T2DM and weight gain in individuals taking antipsychotics before these conditions develop. Metformin re-sensitizes the body to insulin and is a first-line treatment for T2DM. Adding metformin when patients start metabolically high-risk antipsychotics or shortly after they begin gaining weight is an evidence-based strategy to prevent metabolic syndrome.
Evaluate the evidence
In randomized controlled trials, metformin was associated with modest weight loss and improvement in metabolic parameters (eg, fasting blood glucose, serum triglycerides, and total cholesterol) in patients with schizophrenia receiving antipsychotics.1,2 Metformin is effective for preventing metabolic syndrome and as a treatment intervention; therefore, it may prove most beneficial early in treatment before weight gain or insulin resistance develop.
Importantly, weight gain and metabolic syndrome are risk factors for cardiovascular disease, but the number needed to treat for metformin to prevent cardiovascular outcomes, such as myocardial infarction, is not known. Also, metformin is not FDA-approved for this indication. Clinicians should discuss with the patient the risks and benefits of prophylactic metformin, and consider his (her) treatment preferences.
Tolerability and adverse effects
Metformin generally is well-tolerated. Gastrointestinal (GI) symptoms, including nausea and vomiting (14%) and diarrhea (7%), are the most common adverse effects.2 Lactic acidosis is rare and is associated with alcohol use disorders and impaired renal, hepatic, or cardiopulmonary function.3 Because metformin is excreted renally, toxicity could occur in patients with impaired renal function.
Before initiating prophylactic metformin, confirm that the patient does not have T2DM (eg, hemoglobin A1c <6.5%). A thorough medical history, including alcohol use and kidney and liver function tests, are needed to reduce the risk of lactic acidosis.3
Dosing
Although metformin has been studied at many dosages,2 we recommend gradual titration to 1,000 mg, twice daily, taken with meals to reduce the risk of GI effects.
Additional interventions
Metformin alone is not sufficient to mitigate metabolic risk. Providers should address dietary interventions, exercise, and smoking cessation at each visit, and communicate actively with other providers to create a comprehensive treatment plan.
Many atypical antipsychotics, particularly clozapine and olanzapine, are associated with weight gain, insulin resistance, and metabolic syndrome. Metabolic syndrome is associated with type 2 diabetes mellitus (T2DM) and cardiovascular disease, which are among the leading causes of morbidity and mortality in persons with severe mental illness.1
Clinicians should take measures to prevent T2DM and weight gain in individuals taking antipsychotics before these conditions develop. Metformin re-sensitizes the body to insulin and is a first-line treatment for T2DM. Adding metformin when patients start metabolically high-risk antipsychotics or shortly after they begin gaining weight is an evidence-based strategy to prevent metabolic syndrome.
Evaluate the evidence
In randomized controlled trials, metformin was associated with modest weight loss and improvement in metabolic parameters (eg, fasting blood glucose, serum triglycerides, and total cholesterol) in patients with schizophrenia receiving antipsychotics.1,2 Metformin is effective for preventing metabolic syndrome and as a treatment intervention; therefore, it may prove most beneficial early in treatment before weight gain or insulin resistance develop.
Importantly, weight gain and metabolic syndrome are risk factors for cardiovascular disease, but the number needed to treat for metformin to prevent cardiovascular outcomes, such as myocardial infarction, is not known. Also, metformin is not FDA-approved for this indication. Clinicians should discuss with the patient the risks and benefits of prophylactic metformin, and consider his (her) treatment preferences.
Tolerability and adverse effects
Metformin generally is well-tolerated. Gastrointestinal (GI) symptoms, including nausea and vomiting (14%) and diarrhea (7%), are the most common adverse effects.2 Lactic acidosis is rare and is associated with alcohol use disorders and impaired renal, hepatic, or cardiopulmonary function.3 Because metformin is excreted renally, toxicity could occur in patients with impaired renal function.
Before initiating prophylactic metformin, confirm that the patient does not have T2DM (eg, hemoglobin A1c <6.5%). A thorough medical history, including alcohol use and kidney and liver function tests, are needed to reduce the risk of lactic acidosis.3
Dosing
Although metformin has been studied at many dosages,2 we recommend gradual titration to 1,000 mg, twice daily, taken with meals to reduce the risk of GI effects.
Additional interventions
Metformin alone is not sufficient to mitigate metabolic risk. Providers should address dietary interventions, exercise, and smoking cessation at each visit, and communicate actively with other providers to create a comprehensive treatment plan.
1. Jarskog LF, Hamer RF, Catellier DJ, et al; METS Investigators. Metformin for weight loss and metabolic control in overweight patients with schizophrenia and schizoaffective disorder. Am J Psychiatry. 2013;170(9):1032-1040.
2. Zheng W, Li X-B, Tang Y-L, et al. Metformin for weight gain and metabolic abnormalities associated with antipsychotic treatment: meta-analysis of randomized placebo-controlled trials. J Clin Psychopharmacol. 2015;35(5):499-509.
3. Wang M, Tong J-H, Zhu G, et al. Metformin for treatment of antipsychotic-induced weight gain: a randomized, placebo-controlled study. Schizophr Res. 2012;138(1):54-57.
1. Jarskog LF, Hamer RF, Catellier DJ, et al; METS Investigators. Metformin for weight loss and metabolic control in overweight patients with schizophrenia and schizoaffective disorder. Am J Psychiatry. 2013;170(9):1032-1040.
2. Zheng W, Li X-B, Tang Y-L, et al. Metformin for weight gain and metabolic abnormalities associated with antipsychotic treatment: meta-analysis of randomized placebo-controlled trials. J Clin Psychopharmacol. 2015;35(5):499-509.
3. Wang M, Tong J-H, Zhu G, et al. Metformin for treatment of antipsychotic-induced weight gain: a randomized, placebo-controlled study. Schizophr Res. 2012;138(1):54-57.
Fostering surgical innovation: The path forward
Click here to download the PDF.
Key learning objectives
The faculty for this roundtable aim to:
- Explain the process for bringing an innovation to market, including the roles of surgeon inventor, engineer, manufacturer, and industry
- Discuss best practices, based on lessons learned, when pursuing an innovative idea for patient care
- Articulate ways to improve upon the entire development process for new techniques, devices, etc, being brought to the FDA for possible approval and to market for patient use.
Click here to download the PDF.
Key learning objectives
The faculty for this roundtable aim to:
- Explain the process for bringing an innovation to market, including the roles of surgeon inventor, engineer, manufacturer, and industry
- Discuss best practices, based on lessons learned, when pursuing an innovative idea for patient care
- Articulate ways to improve upon the entire development process for new techniques, devices, etc, being brought to the FDA for possible approval and to market for patient use.
Click here to download the PDF.
Key learning objectives
The faculty for this roundtable aim to:
- Explain the process for bringing an innovation to market, including the roles of surgeon inventor, engineer, manufacturer, and industry
- Discuss best practices, based on lessons learned, when pursuing an innovative idea for patient care
- Articulate ways to improve upon the entire development process for new techniques, devices, etc, being brought to the FDA for possible approval and to market for patient use.
Product Update: Kyleena; LapCap2
NEW LNG IUS: GOOD FOR 5 YEARS
FOR MORE INFORMATION, VISIT:
https://hcp.kyleena-us.com/
EASIER LAPAROSCOPIC ACCESS
To use LapCap2, says Life Care, center it over the umbilicus, attach a hose to the suction port, and apply negative pressure. The abdomen immediately rises for Veress needle insertion. Inert gas is then delivered to replace the negative pressure, and the procedure can continue.
FOR MORE INFORMATION, VISIT:
http://www.lcmd.com/products/lapcap2
NEW LNG IUS: GOOD FOR 5 YEARS
FOR MORE INFORMATION, VISIT:
https://hcp.kyleena-us.com/
EASIER LAPAROSCOPIC ACCESS
To use LapCap2, says Life Care, center it over the umbilicus, attach a hose to the suction port, and apply negative pressure. The abdomen immediately rises for Veress needle insertion. Inert gas is then delivered to replace the negative pressure, and the procedure can continue.
FOR MORE INFORMATION, VISIT:
http://www.lcmd.com/products/lapcap2
NEW LNG IUS: GOOD FOR 5 YEARS
FOR MORE INFORMATION, VISIT:
https://hcp.kyleena-us.com/
EASIER LAPAROSCOPIC ACCESS
To use LapCap2, says Life Care, center it over the umbilicus, attach a hose to the suction port, and apply negative pressure. The abdomen immediately rises for Veress needle insertion. Inert gas is then delivered to replace the negative pressure, and the procedure can continue.
FOR MORE INFORMATION, VISIT:
http://www.lcmd.com/products/lapcap2
Do you utilize vasopressin in your difficult cesarean delivery surgeries?
Vasopressin is often used to reduce blood loss in gynecologic surgery. Results of randomized clinical trials indicate that its use reduces blood loss in many gynecologic surgery procedures, including hysterectomy, myomectomy, cervical conization, and second trimester pregnancy termination.1−7 In contrast to the widespread use of dilute vasopressin injection in gynecology surgery, obstetricians in the United States seldom use vasopressin to reduce blood loss in difficult cesarean delivery surgery. Although there is very little direct evidence from clinical trials on the value of vasopressin in obstetric surgery, high-quality evidence from relevant gynecologic surgery and case reports from obstetricians support its use during difficult cesarean delivery surgery.
Biology of oxytocin and vasopressin
Oxytocin and vasopressin are fraternal twin nanopeptides that differ by only two amino acids and are secreted from the posterior pituitary. The human uterus contains both oxytocin and vasopressin receptors; stimulation of either receptor causes uterine contraction. Vasopressin receptor activation also causes vasoconstriction and platelet activation.
Given the similar biochemistry of oxytocin and vasopressin it is not surprising that each hormone is capable of binding to both oxytocin and vasopressin receptors. The affinity of oxytocin for the oxytocin and vasopressin receptors as expressed as an inhibition constant is 6.8 nM and 35 nM, respectively. Vasopressin’s affinity for the oxytocin and vasopressin V1a receptors is 48 nM and 1.4 nM, respectively.8
Administering vasopressin into the uterus will achieve a high concentration of the hormone, which stimulates both the oxytocin and vasopressin receptors, resulting in uterine contraction, vasoconstriction, and platelet activation. Of particular importance to obstetricians is that following a prolonged labor or administration of oxytocin, myometrial oxytocin receptors may be downregulated, but vasopressin receptors may remain functional.9,10
Vasopressin regulates plasma volume, blood pressure, osmolality, and uterine contractility. The vasopressin V1a receptor is present on vascular smooth muscle cells, platelets, and uterine myocytes. Activating this receptor causes vasoconstriction, platelet activation, and uterine contraction.
Vasopressin reduces surgical blood loss in two ways. The first major mechanism is through vasoconstriction.11 Second, in uterine surgery specifically, vasopressin stimulates uterine contraction. The hormone exerts its antidiuretic action through the V2 receptor in the kidney.
Optimal vasopressin dose
In gynecologic surgery, the vasopressin doses utilized to reduce blood loss range from 5 U to 20 U diluted in 20 mL to 200 mL of saline. Randomized trial results indicate that a vasopressin dose of 4 U is effective in reducing blood loss during second trimester pregnancy termination,7 and a dose of 3 U is effective in reducing blood loss during cervical conization.5,6 There is insufficient obstetric literature to determine the optimal dose of vasopressin to reduce blood loss in difficult cesarean delivery sur- gery, but doses similar to those used in gynecologic surgery should be considered.
Possible effects of vasopressin overdosing. In gynecologic surgery, injection of vasopressin has been reported to cause bradycardia, hypotension, myocardial infarction, and cardiovascular collapse.12 Given that multiple vasoactive medications may be given to a patient undergoing a complex cesarean delivery, including oxytocin, methergine, and ephedrine, it is important for the obstetrician to use the lowest effective dose of vasopressin necessary to facilitate control of blood loss. The obstetrician needs to communicate with the anesthesiologist and coordinate the use of dilute vasopressin with other vasoactive medications.
Avoid intravascular injection of vasopressin. I prefer to inject vasopressin in the subserosa of the uterus rather than to inject it in a highly vascular area such as the subendometrium or near the uterine artery and vein.
Vasopressin reduces blood loss during hysterectomy
One randomized trial has reported that the administration of 10 U of vasopressin diluted in saline into the lower uterine segment reduced blood loss at abdominal hysterectomy in nonpregnant women compared with an injection of saline alone (445 mL vs 748 mL of blood loss, respectively).1 There are no clinical trials of the use of vasopressin in cesarean hysterectomy. However, abdominal hysterectomy procedures and cesarean hysterectomy are similar, and vasopressin likely helps to reduce blood loss at cesarean hysterectomy.
Vasopressin reduces blood loss during myomectomy
Authors of 3 small, randomized clinical trials in nonpregnant women have reported that the intramyometrial injection of dilute vasopressin reduces blood loss during myomectomy surgery.2−4 The vasopressin doses in the 3 trials ranged from 5 U of vasopressin in 100 mL of saline to 20 U of vasopressin in 20 mL of saline. A Cochrane meta-analyis of the 3 studies concluded that, at myomectomy, the intramyometrial injection of dilute vasopressin was associated with a significant reduction in blood loss compared with placebo (246 mL vs 483 mL, respectively).13
There are great similarities between myomectomy in the nonpregnant and pregnant uterus. Given the clinical trials data that support the use of vasopressin to reduce blood loss during myomectomy in the nonpregnant uterus, it is likely that vasopressin also would reduce blood loss during myomectomy performed at the time of a cesarean delivery.
At cesarean delivery, elective myomectomy of intramural fibroids is generally not recommended because of the risk of massive blood loss. Clinicians often remove large pedunculated fibroids because this surgery does not usually cause massive bleeding. However, on occasion it may be necessary to perform a myomectomy on intramural myoma(s) in order to close a hysterotomy incision.
For myomectomy surgery performed at the time of cesarean delivery, many techniques have been utilized to reduce blood loss, including:
- intravenous oxytocin infusion14,15
- injection of oxytocin into the myoma pseudocapsule15
- electrosurgery16−18
- argon beam coagulator19
- uterine tourniquet20
- premyomectomy placement of a uterine U stitch21 or purse string suture22
- O’Leary sutures23,24
- temporary balloon occlusion of pelvic arteries25
- vasopressin injection.26
Given the widespread use of vasopressin injection in gynecologic surgery to reduce blood loss at myomectomy, obstetricians should consider using vasopressin in their cesarean myomectomy surgery.
Use of vasopressin during cesarean delivery for placenta previa may reduce blood loss
Women with a complete placenta previa require a cesarean delivery to safely birth their baby. Cesarean deliveries performed for this indication are associated with an increased risk of hemorrhage. In one case series of 59 patients with placenta previa undergoing cesarean delivery, 4 U of vasopressin diluted in 20 mL of saline was injected into the placental implantation site to reduce blood loss. Among the patients receiving vasopressin in- jection, the blood loss was 1,149 mL. Among 50 women with placenta previa who did not receive vasopressin injection, the blood loss was 1,634 mL.27
Obstetric surgery and vasopressin: The time has come
As obstetricians and gynecologists we constantly strive to improve the effectiveness of our surgical procedures and reduce adverse outcomes, including infection and blood loss. The use of vasopressin is widely accepted in gynecologic surgery as an adjuvant that reduces blood loss. The time has come to expand the use of vasopressin in difficult obstetric surgery.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Okin CR, Guido RS, Meyn LA, Ramanathan S. Vasopressin during abdominal hysterectomy: a randomized controlled trial. Obstet Gynecol. 2001;97:867–872.
- Frederick J, Fletcher H, Simeon D, Mullings A, Hardie M. Intramyometrial vasopressin as a haemostatic agent during myomectomy. Brit J Obstet Gynaecol. 1994;101:435–437.
- Assaf A. Adhesions after laparoscopic myomectomy effect of the technique used. Gynaecol Endosc. 1999;8(4):225–229.
- Zhao F, Jiao Y, Guo Z, Hou R, Wang M. Evaluation of loop ligation of larger myoma pseudocapsule combined with vasopressin on laparoscopic myomectomy. Fertil Steril. 2011;95(2):762–766.
- Sabol ED, Gibson JL, Bowes WA Jr. Vasopressin injection in cervical conization. A double-blind study. Obstet Gynecol. 1971;37(4):596–601.
- Martin-Hirsch PP, Keep SL, Bryant A. Interventions for preventing blood loss during the treatment of cervical intraepithelial neoplasia. Cochrane Database Syst Rev. 2010;(6):CD001421.
- Schulz KE, Grimes DA, Christensen DD. Vasopressin reduces blood loss from second trimester dilatation and evacuation abortion. Lancet. 1985;2(8451):353–356.
- Akerlund M, Bossmar T, Brouard R, et al. Receptor binding of oxytocin and vasopressin antagonists and inhibitory effects in isolated myometrium from preterm and term pregnant women. Br J Obstet Gynaecol. 1999;106(10):1047–1053.
- Akerlund M. Involvement of oxytocin and vasopressin in the pathophysiology of preterm labor and primary dysmenorrhea. Prog Brain Res. 2002;139:359–365.
- Helmer H, Hacki T, Schneeberger C, et al. Oxytocinand vasopressin 1a receptor gene expression in the cycling or pregnant human uterus. Am J Obstet Gynecol. 1998;179(6 pt 1):1572–1578.
- Wing DA, Goharkhay N, Felix JC, Rostamkhani M, Naidu YM, Kovacs BW. Expression of the oxytocin and V1a vasopressin receptors in human myometrium during differing physiological states and following misoprostol administration. Gynecol Obstet Invest. 2006;62(4):181–185.
- Hobo R, Netsu S, Koyasu Y, Tsutsumi O. Bradycardia and cardiac arrest caused by intramyometrial injection of vasopressin during a laparoscopically assisted myomectomy. Obstet Gynecol. 2009;113(2 pt 2):484–486.
- Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014; (8):CD005355.
- Tinelli A, Malvasi A, Mynbaev OA, et al. The surgical outcome of intracapsular cesarean myomectomy. A match control study. J Matern Fetal Neonatal Med. 2014;27(1):66–71.
- Brown D, Fletcher HM, Myrie MO, Reid M. Caesarean myomectomy—a safe procedure. A retrospective case controlled study. J Obstet Gynaecol. 1999;19(2):139–141.
- Kaymak O, Ustunyrt E, Okyay RE, Kalyoncu S, Mollamahmutoglu L. Myomectomy during cesarean section. Int J Gynaecol Obstet. 2005;89(2):90–93.
- Park BJ, Kim YW. Safety of cesarean myomectomy. J Obstet Gynaecol Res. 2009;35(5):906–911.
- Kim YS, Choi SD, Bae DH. Risk factors for complications in patients undergoing myomectomy at the time of cesarean section. J Obstet Gynaecol Res. 2010;36(3):550–554.
- Ortac F, Gungor M, Sonmezer M. Myomectomy during cesarean section. Int J Gynecol Obstet. 1999;67(3):189–190.
- Incebiyik A, Hilali NG, Camuzcuoglu A, Vural M, Camuzcuoglu H. Myomectomy during caesarean: a retrospective evaluation of 6 cases. Arch Gynecol Obstet. 2014;289(3):569–573.
- Cobellis L, Pecori E, Cobellis G. Hemostatic technique for myomectomy during cesarean section. Int J Gynaecol Obstet. 2002;79(3):261–262.
- Lee JH, Cho DH. Myomectomy using purse-string suture during cesarean section. Arch Gynecol Obstet. 2011;283(suppl 1):S35–S37.
- Desai BR, Patted SS, Pujar YV, Sheriqar BY, Das SR, Ruge JC. A novel technique of selective uterine devascularization before myomectomy at the time of cesarean section: a pilot study. Fertil Steril. 2010;94(1):362–364.
- Sapmaz E, Celik H, Altungul A. Bilateral ascending uterine artery ligation vs. tourniquet use for hemostasis in cesarean myomectomy. A comparison. J Reprod Med. 2003;48(12):950–954.
- Sparic R, Malvasi A, Kadija S, Babovic I, Nejkovic L, Tinelli A. Cesarean myomectomy trends and controveries: an appraisal [published online ahead of print July 17, 2016]. J Matern Fetal Neonatal Med. doi:10.1080/14767058.2016.1205024.
- Lin JY, Lee WL, Wang PH, et al. Uterine artery occlusion and myomectomy for treatment of pregnant women with uterine leiomyomas who are undergoing cesarean section. J Obstet Gynaecol Res. 2010;36(2):284–290.
- Kato S, Tanabe A, Kanki K, et al. Local injection of vasopressin reduces the blood loss during cesarean section in placenta previa. J Obstet Gynaecol Res. 2014;40(5):1249–1256.
Vasopressin is often used to reduce blood loss in gynecologic surgery. Results of randomized clinical trials indicate that its use reduces blood loss in many gynecologic surgery procedures, including hysterectomy, myomectomy, cervical conization, and second trimester pregnancy termination.1−7 In contrast to the widespread use of dilute vasopressin injection in gynecology surgery, obstetricians in the United States seldom use vasopressin to reduce blood loss in difficult cesarean delivery surgery. Although there is very little direct evidence from clinical trials on the value of vasopressin in obstetric surgery, high-quality evidence from relevant gynecologic surgery and case reports from obstetricians support its use during difficult cesarean delivery surgery.
Biology of oxytocin and vasopressin
Oxytocin and vasopressin are fraternal twin nanopeptides that differ by only two amino acids and are secreted from the posterior pituitary. The human uterus contains both oxytocin and vasopressin receptors; stimulation of either receptor causes uterine contraction. Vasopressin receptor activation also causes vasoconstriction and platelet activation.
Given the similar biochemistry of oxytocin and vasopressin it is not surprising that each hormone is capable of binding to both oxytocin and vasopressin receptors. The affinity of oxytocin for the oxytocin and vasopressin receptors as expressed as an inhibition constant is 6.8 nM and 35 nM, respectively. Vasopressin’s affinity for the oxytocin and vasopressin V1a receptors is 48 nM and 1.4 nM, respectively.8
Administering vasopressin into the uterus will achieve a high concentration of the hormone, which stimulates both the oxytocin and vasopressin receptors, resulting in uterine contraction, vasoconstriction, and platelet activation. Of particular importance to obstetricians is that following a prolonged labor or administration of oxytocin, myometrial oxytocin receptors may be downregulated, but vasopressin receptors may remain functional.9,10
Vasopressin regulates plasma volume, blood pressure, osmolality, and uterine contractility. The vasopressin V1a receptor is present on vascular smooth muscle cells, platelets, and uterine myocytes. Activating this receptor causes vasoconstriction, platelet activation, and uterine contraction.
Vasopressin reduces surgical blood loss in two ways. The first major mechanism is through vasoconstriction.11 Second, in uterine surgery specifically, vasopressin stimulates uterine contraction. The hormone exerts its antidiuretic action through the V2 receptor in the kidney.
Optimal vasopressin dose
In gynecologic surgery, the vasopressin doses utilized to reduce blood loss range from 5 U to 20 U diluted in 20 mL to 200 mL of saline. Randomized trial results indicate that a vasopressin dose of 4 U is effective in reducing blood loss during second trimester pregnancy termination,7 and a dose of 3 U is effective in reducing blood loss during cervical conization.5,6 There is insufficient obstetric literature to determine the optimal dose of vasopressin to reduce blood loss in difficult cesarean delivery sur- gery, but doses similar to those used in gynecologic surgery should be considered.
Possible effects of vasopressin overdosing. In gynecologic surgery, injection of vasopressin has been reported to cause bradycardia, hypotension, myocardial infarction, and cardiovascular collapse.12 Given that multiple vasoactive medications may be given to a patient undergoing a complex cesarean delivery, including oxytocin, methergine, and ephedrine, it is important for the obstetrician to use the lowest effective dose of vasopressin necessary to facilitate control of blood loss. The obstetrician needs to communicate with the anesthesiologist and coordinate the use of dilute vasopressin with other vasoactive medications.
Avoid intravascular injection of vasopressin. I prefer to inject vasopressin in the subserosa of the uterus rather than to inject it in a highly vascular area such as the subendometrium or near the uterine artery and vein.
Vasopressin reduces blood loss during hysterectomy
One randomized trial has reported that the administration of 10 U of vasopressin diluted in saline into the lower uterine segment reduced blood loss at abdominal hysterectomy in nonpregnant women compared with an injection of saline alone (445 mL vs 748 mL of blood loss, respectively).1 There are no clinical trials of the use of vasopressin in cesarean hysterectomy. However, abdominal hysterectomy procedures and cesarean hysterectomy are similar, and vasopressin likely helps to reduce blood loss at cesarean hysterectomy.
Vasopressin reduces blood loss during myomectomy
Authors of 3 small, randomized clinical trials in nonpregnant women have reported that the intramyometrial injection of dilute vasopressin reduces blood loss during myomectomy surgery.2−4 The vasopressin doses in the 3 trials ranged from 5 U of vasopressin in 100 mL of saline to 20 U of vasopressin in 20 mL of saline. A Cochrane meta-analyis of the 3 studies concluded that, at myomectomy, the intramyometrial injection of dilute vasopressin was associated with a significant reduction in blood loss compared with placebo (246 mL vs 483 mL, respectively).13
There are great similarities between myomectomy in the nonpregnant and pregnant uterus. Given the clinical trials data that support the use of vasopressin to reduce blood loss during myomectomy in the nonpregnant uterus, it is likely that vasopressin also would reduce blood loss during myomectomy performed at the time of a cesarean delivery.
At cesarean delivery, elective myomectomy of intramural fibroids is generally not recommended because of the risk of massive blood loss. Clinicians often remove large pedunculated fibroids because this surgery does not usually cause massive bleeding. However, on occasion it may be necessary to perform a myomectomy on intramural myoma(s) in order to close a hysterotomy incision.
For myomectomy surgery performed at the time of cesarean delivery, many techniques have been utilized to reduce blood loss, including:
- intravenous oxytocin infusion14,15
- injection of oxytocin into the myoma pseudocapsule15
- electrosurgery16−18
- argon beam coagulator19
- uterine tourniquet20
- premyomectomy placement of a uterine U stitch21 or purse string suture22
- O’Leary sutures23,24
- temporary balloon occlusion of pelvic arteries25
- vasopressin injection.26
Given the widespread use of vasopressin injection in gynecologic surgery to reduce blood loss at myomectomy, obstetricians should consider using vasopressin in their cesarean myomectomy surgery.
Use of vasopressin during cesarean delivery for placenta previa may reduce blood loss
Women with a complete placenta previa require a cesarean delivery to safely birth their baby. Cesarean deliveries performed for this indication are associated with an increased risk of hemorrhage. In one case series of 59 patients with placenta previa undergoing cesarean delivery, 4 U of vasopressin diluted in 20 mL of saline was injected into the placental implantation site to reduce blood loss. Among the patients receiving vasopressin in- jection, the blood loss was 1,149 mL. Among 50 women with placenta previa who did not receive vasopressin injection, the blood loss was 1,634 mL.27
Obstetric surgery and vasopressin: The time has come
As obstetricians and gynecologists we constantly strive to improve the effectiveness of our surgical procedures and reduce adverse outcomes, including infection and blood loss. The use of vasopressin is widely accepted in gynecologic surgery as an adjuvant that reduces blood loss. The time has come to expand the use of vasopressin in difficult obstetric surgery.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
Vasopressin is often used to reduce blood loss in gynecologic surgery. Results of randomized clinical trials indicate that its use reduces blood loss in many gynecologic surgery procedures, including hysterectomy, myomectomy, cervical conization, and second trimester pregnancy termination.1−7 In contrast to the widespread use of dilute vasopressin injection in gynecology surgery, obstetricians in the United States seldom use vasopressin to reduce blood loss in difficult cesarean delivery surgery. Although there is very little direct evidence from clinical trials on the value of vasopressin in obstetric surgery, high-quality evidence from relevant gynecologic surgery and case reports from obstetricians support its use during difficult cesarean delivery surgery.
Biology of oxytocin and vasopressin
Oxytocin and vasopressin are fraternal twin nanopeptides that differ by only two amino acids and are secreted from the posterior pituitary. The human uterus contains both oxytocin and vasopressin receptors; stimulation of either receptor causes uterine contraction. Vasopressin receptor activation also causes vasoconstriction and platelet activation.
Given the similar biochemistry of oxytocin and vasopressin it is not surprising that each hormone is capable of binding to both oxytocin and vasopressin receptors. The affinity of oxytocin for the oxytocin and vasopressin receptors as expressed as an inhibition constant is 6.8 nM and 35 nM, respectively. Vasopressin’s affinity for the oxytocin and vasopressin V1a receptors is 48 nM and 1.4 nM, respectively.8
Administering vasopressin into the uterus will achieve a high concentration of the hormone, which stimulates both the oxytocin and vasopressin receptors, resulting in uterine contraction, vasoconstriction, and platelet activation. Of particular importance to obstetricians is that following a prolonged labor or administration of oxytocin, myometrial oxytocin receptors may be downregulated, but vasopressin receptors may remain functional.9,10
Vasopressin regulates plasma volume, blood pressure, osmolality, and uterine contractility. The vasopressin V1a receptor is present on vascular smooth muscle cells, platelets, and uterine myocytes. Activating this receptor causes vasoconstriction, platelet activation, and uterine contraction.
Vasopressin reduces surgical blood loss in two ways. The first major mechanism is through vasoconstriction.11 Second, in uterine surgery specifically, vasopressin stimulates uterine contraction. The hormone exerts its antidiuretic action through the V2 receptor in the kidney.
Optimal vasopressin dose
In gynecologic surgery, the vasopressin doses utilized to reduce blood loss range from 5 U to 20 U diluted in 20 mL to 200 mL of saline. Randomized trial results indicate that a vasopressin dose of 4 U is effective in reducing blood loss during second trimester pregnancy termination,7 and a dose of 3 U is effective in reducing blood loss during cervical conization.5,6 There is insufficient obstetric literature to determine the optimal dose of vasopressin to reduce blood loss in difficult cesarean delivery sur- gery, but doses similar to those used in gynecologic surgery should be considered.
Possible effects of vasopressin overdosing. In gynecologic surgery, injection of vasopressin has been reported to cause bradycardia, hypotension, myocardial infarction, and cardiovascular collapse.12 Given that multiple vasoactive medications may be given to a patient undergoing a complex cesarean delivery, including oxytocin, methergine, and ephedrine, it is important for the obstetrician to use the lowest effective dose of vasopressin necessary to facilitate control of blood loss. The obstetrician needs to communicate with the anesthesiologist and coordinate the use of dilute vasopressin with other vasoactive medications.
Avoid intravascular injection of vasopressin. I prefer to inject vasopressin in the subserosa of the uterus rather than to inject it in a highly vascular area such as the subendometrium or near the uterine artery and vein.
Vasopressin reduces blood loss during hysterectomy
One randomized trial has reported that the administration of 10 U of vasopressin diluted in saline into the lower uterine segment reduced blood loss at abdominal hysterectomy in nonpregnant women compared with an injection of saline alone (445 mL vs 748 mL of blood loss, respectively).1 There are no clinical trials of the use of vasopressin in cesarean hysterectomy. However, abdominal hysterectomy procedures and cesarean hysterectomy are similar, and vasopressin likely helps to reduce blood loss at cesarean hysterectomy.
Vasopressin reduces blood loss during myomectomy
Authors of 3 small, randomized clinical trials in nonpregnant women have reported that the intramyometrial injection of dilute vasopressin reduces blood loss during myomectomy surgery.2−4 The vasopressin doses in the 3 trials ranged from 5 U of vasopressin in 100 mL of saline to 20 U of vasopressin in 20 mL of saline. A Cochrane meta-analyis of the 3 studies concluded that, at myomectomy, the intramyometrial injection of dilute vasopressin was associated with a significant reduction in blood loss compared with placebo (246 mL vs 483 mL, respectively).13
There are great similarities between myomectomy in the nonpregnant and pregnant uterus. Given the clinical trials data that support the use of vasopressin to reduce blood loss during myomectomy in the nonpregnant uterus, it is likely that vasopressin also would reduce blood loss during myomectomy performed at the time of a cesarean delivery.
At cesarean delivery, elective myomectomy of intramural fibroids is generally not recommended because of the risk of massive blood loss. Clinicians often remove large pedunculated fibroids because this surgery does not usually cause massive bleeding. However, on occasion it may be necessary to perform a myomectomy on intramural myoma(s) in order to close a hysterotomy incision.
For myomectomy surgery performed at the time of cesarean delivery, many techniques have been utilized to reduce blood loss, including:
- intravenous oxytocin infusion14,15
- injection of oxytocin into the myoma pseudocapsule15
- electrosurgery16−18
- argon beam coagulator19
- uterine tourniquet20
- premyomectomy placement of a uterine U stitch21 or purse string suture22
- O’Leary sutures23,24
- temporary balloon occlusion of pelvic arteries25
- vasopressin injection.26
Given the widespread use of vasopressin injection in gynecologic surgery to reduce blood loss at myomectomy, obstetricians should consider using vasopressin in their cesarean myomectomy surgery.
Use of vasopressin during cesarean delivery for placenta previa may reduce blood loss
Women with a complete placenta previa require a cesarean delivery to safely birth their baby. Cesarean deliveries performed for this indication are associated with an increased risk of hemorrhage. In one case series of 59 patients with placenta previa undergoing cesarean delivery, 4 U of vasopressin diluted in 20 mL of saline was injected into the placental implantation site to reduce blood loss. Among the patients receiving vasopressin in- jection, the blood loss was 1,149 mL. Among 50 women with placenta previa who did not receive vasopressin injection, the blood loss was 1,634 mL.27
Obstetric surgery and vasopressin: The time has come
As obstetricians and gynecologists we constantly strive to improve the effectiveness of our surgical procedures and reduce adverse outcomes, including infection and blood loss. The use of vasopressin is widely accepted in gynecologic surgery as an adjuvant that reduces blood loss. The time has come to expand the use of vasopressin in difficult obstetric surgery.
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Okin CR, Guido RS, Meyn LA, Ramanathan S. Vasopressin during abdominal hysterectomy: a randomized controlled trial. Obstet Gynecol. 2001;97:867–872.
- Frederick J, Fletcher H, Simeon D, Mullings A, Hardie M. Intramyometrial vasopressin as a haemostatic agent during myomectomy. Brit J Obstet Gynaecol. 1994;101:435–437.
- Assaf A. Adhesions after laparoscopic myomectomy effect of the technique used. Gynaecol Endosc. 1999;8(4):225–229.
- Zhao F, Jiao Y, Guo Z, Hou R, Wang M. Evaluation of loop ligation of larger myoma pseudocapsule combined with vasopressin on laparoscopic myomectomy. Fertil Steril. 2011;95(2):762–766.
- Sabol ED, Gibson JL, Bowes WA Jr. Vasopressin injection in cervical conization. A double-blind study. Obstet Gynecol. 1971;37(4):596–601.
- Martin-Hirsch PP, Keep SL, Bryant A. Interventions for preventing blood loss during the treatment of cervical intraepithelial neoplasia. Cochrane Database Syst Rev. 2010;(6):CD001421.
- Schulz KE, Grimes DA, Christensen DD. Vasopressin reduces blood loss from second trimester dilatation and evacuation abortion. Lancet. 1985;2(8451):353–356.
- Akerlund M, Bossmar T, Brouard R, et al. Receptor binding of oxytocin and vasopressin antagonists and inhibitory effects in isolated myometrium from preterm and term pregnant women. Br J Obstet Gynaecol. 1999;106(10):1047–1053.
- Akerlund M. Involvement of oxytocin and vasopressin in the pathophysiology of preterm labor and primary dysmenorrhea. Prog Brain Res. 2002;139:359–365.
- Helmer H, Hacki T, Schneeberger C, et al. Oxytocinand vasopressin 1a receptor gene expression in the cycling or pregnant human uterus. Am J Obstet Gynecol. 1998;179(6 pt 1):1572–1578.
- Wing DA, Goharkhay N, Felix JC, Rostamkhani M, Naidu YM, Kovacs BW. Expression of the oxytocin and V1a vasopressin receptors in human myometrium during differing physiological states and following misoprostol administration. Gynecol Obstet Invest. 2006;62(4):181–185.
- Hobo R, Netsu S, Koyasu Y, Tsutsumi O. Bradycardia and cardiac arrest caused by intramyometrial injection of vasopressin during a laparoscopically assisted myomectomy. Obstet Gynecol. 2009;113(2 pt 2):484–486.
- Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014; (8):CD005355.
- Tinelli A, Malvasi A, Mynbaev OA, et al. The surgical outcome of intracapsular cesarean myomectomy. A match control study. J Matern Fetal Neonatal Med. 2014;27(1):66–71.
- Brown D, Fletcher HM, Myrie MO, Reid M. Caesarean myomectomy—a safe procedure. A retrospective case controlled study. J Obstet Gynaecol. 1999;19(2):139–141.
- Kaymak O, Ustunyrt E, Okyay RE, Kalyoncu S, Mollamahmutoglu L. Myomectomy during cesarean section. Int J Gynaecol Obstet. 2005;89(2):90–93.
- Park BJ, Kim YW. Safety of cesarean myomectomy. J Obstet Gynaecol Res. 2009;35(5):906–911.
- Kim YS, Choi SD, Bae DH. Risk factors for complications in patients undergoing myomectomy at the time of cesarean section. J Obstet Gynaecol Res. 2010;36(3):550–554.
- Ortac F, Gungor M, Sonmezer M. Myomectomy during cesarean section. Int J Gynecol Obstet. 1999;67(3):189–190.
- Incebiyik A, Hilali NG, Camuzcuoglu A, Vural M, Camuzcuoglu H. Myomectomy during caesarean: a retrospective evaluation of 6 cases. Arch Gynecol Obstet. 2014;289(3):569–573.
- Cobellis L, Pecori E, Cobellis G. Hemostatic technique for myomectomy during cesarean section. Int J Gynaecol Obstet. 2002;79(3):261–262.
- Lee JH, Cho DH. Myomectomy using purse-string suture during cesarean section. Arch Gynecol Obstet. 2011;283(suppl 1):S35–S37.
- Desai BR, Patted SS, Pujar YV, Sheriqar BY, Das SR, Ruge JC. A novel technique of selective uterine devascularization before myomectomy at the time of cesarean section: a pilot study. Fertil Steril. 2010;94(1):362–364.
- Sapmaz E, Celik H, Altungul A. Bilateral ascending uterine artery ligation vs. tourniquet use for hemostasis in cesarean myomectomy. A comparison. J Reprod Med. 2003;48(12):950–954.
- Sparic R, Malvasi A, Kadija S, Babovic I, Nejkovic L, Tinelli A. Cesarean myomectomy trends and controveries: an appraisal [published online ahead of print July 17, 2016]. J Matern Fetal Neonatal Med. doi:10.1080/14767058.2016.1205024.
- Lin JY, Lee WL, Wang PH, et al. Uterine artery occlusion and myomectomy for treatment of pregnant women with uterine leiomyomas who are undergoing cesarean section. J Obstet Gynaecol Res. 2010;36(2):284–290.
- Kato S, Tanabe A, Kanki K, et al. Local injection of vasopressin reduces the blood loss during cesarean section in placenta previa. J Obstet Gynaecol Res. 2014;40(5):1249–1256.
- Okin CR, Guido RS, Meyn LA, Ramanathan S. Vasopressin during abdominal hysterectomy: a randomized controlled trial. Obstet Gynecol. 2001;97:867–872.
- Frederick J, Fletcher H, Simeon D, Mullings A, Hardie M. Intramyometrial vasopressin as a haemostatic agent during myomectomy. Brit J Obstet Gynaecol. 1994;101:435–437.
- Assaf A. Adhesions after laparoscopic myomectomy effect of the technique used. Gynaecol Endosc. 1999;8(4):225–229.
- Zhao F, Jiao Y, Guo Z, Hou R, Wang M. Evaluation of loop ligation of larger myoma pseudocapsule combined with vasopressin on laparoscopic myomectomy. Fertil Steril. 2011;95(2):762–766.
- Sabol ED, Gibson JL, Bowes WA Jr. Vasopressin injection in cervical conization. A double-blind study. Obstet Gynecol. 1971;37(4):596–601.
- Martin-Hirsch PP, Keep SL, Bryant A. Interventions for preventing blood loss during the treatment of cervical intraepithelial neoplasia. Cochrane Database Syst Rev. 2010;(6):CD001421.
- Schulz KE, Grimes DA, Christensen DD. Vasopressin reduces blood loss from second trimester dilatation and evacuation abortion. Lancet. 1985;2(8451):353–356.
- Akerlund M, Bossmar T, Brouard R, et al. Receptor binding of oxytocin and vasopressin antagonists and inhibitory effects in isolated myometrium from preterm and term pregnant women. Br J Obstet Gynaecol. 1999;106(10):1047–1053.
- Akerlund M. Involvement of oxytocin and vasopressin in the pathophysiology of preterm labor and primary dysmenorrhea. Prog Brain Res. 2002;139:359–365.
- Helmer H, Hacki T, Schneeberger C, et al. Oxytocinand vasopressin 1a receptor gene expression in the cycling or pregnant human uterus. Am J Obstet Gynecol. 1998;179(6 pt 1):1572–1578.
- Wing DA, Goharkhay N, Felix JC, Rostamkhani M, Naidu YM, Kovacs BW. Expression of the oxytocin and V1a vasopressin receptors in human myometrium during differing physiological states and following misoprostol administration. Gynecol Obstet Invest. 2006;62(4):181–185.
- Hobo R, Netsu S, Koyasu Y, Tsutsumi O. Bradycardia and cardiac arrest caused by intramyometrial injection of vasopressin during a laparoscopically assisted myomectomy. Obstet Gynecol. 2009;113(2 pt 2):484–486.
- Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014; (8):CD005355.
- Tinelli A, Malvasi A, Mynbaev OA, et al. The surgical outcome of intracapsular cesarean myomectomy. A match control study. J Matern Fetal Neonatal Med. 2014;27(1):66–71.
- Brown D, Fletcher HM, Myrie MO, Reid M. Caesarean myomectomy—a safe procedure. A retrospective case controlled study. J Obstet Gynaecol. 1999;19(2):139–141.
- Kaymak O, Ustunyrt E, Okyay RE, Kalyoncu S, Mollamahmutoglu L. Myomectomy during cesarean section. Int J Gynaecol Obstet. 2005;89(2):90–93.
- Park BJ, Kim YW. Safety of cesarean myomectomy. J Obstet Gynaecol Res. 2009;35(5):906–911.
- Kim YS, Choi SD, Bae DH. Risk factors for complications in patients undergoing myomectomy at the time of cesarean section. J Obstet Gynaecol Res. 2010;36(3):550–554.
- Ortac F, Gungor M, Sonmezer M. Myomectomy during cesarean section. Int J Gynecol Obstet. 1999;67(3):189–190.
- Incebiyik A, Hilali NG, Camuzcuoglu A, Vural M, Camuzcuoglu H. Myomectomy during caesarean: a retrospective evaluation of 6 cases. Arch Gynecol Obstet. 2014;289(3):569–573.
- Cobellis L, Pecori E, Cobellis G. Hemostatic technique for myomectomy during cesarean section. Int J Gynaecol Obstet. 2002;79(3):261–262.
- Lee JH, Cho DH. Myomectomy using purse-string suture during cesarean section. Arch Gynecol Obstet. 2011;283(suppl 1):S35–S37.
- Desai BR, Patted SS, Pujar YV, Sheriqar BY, Das SR, Ruge JC. A novel technique of selective uterine devascularization before myomectomy at the time of cesarean section: a pilot study. Fertil Steril. 2010;94(1):362–364.
- Sapmaz E, Celik H, Altungul A. Bilateral ascending uterine artery ligation vs. tourniquet use for hemostasis in cesarean myomectomy. A comparison. J Reprod Med. 2003;48(12):950–954.
- Sparic R, Malvasi A, Kadija S, Babovic I, Nejkovic L, Tinelli A. Cesarean myomectomy trends and controveries: an appraisal [published online ahead of print July 17, 2016]. J Matern Fetal Neonatal Med. doi:10.1080/14767058.2016.1205024.
- Lin JY, Lee WL, Wang PH, et al. Uterine artery occlusion and myomectomy for treatment of pregnant women with uterine leiomyomas who are undergoing cesarean section. J Obstet Gynaecol Res. 2010;36(2):284–290.
- Kato S, Tanabe A, Kanki K, et al. Local injection of vasopressin reduces the blood loss during cesarean section in placenta previa. J Obstet Gynaecol Res. 2014;40(5):1249–1256.
PCI noninferior to CABG for certain left main CAD
Percutaneous coronary intervention (PCI) using everolimus-eluting stents was found noninferior to coronary artery bypass grafting (CABG) with respect to the composite end point of death, stroke, or myocardial infarction at 3 years among patients with left main coronary artery disease and low or intermediate anatomical complexity, according to a report presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the New England Journal of Medicine.
The rate of this composite outcome was lower with PCI than with CABG during the first 30 days following the procedure, but higher between day 30 and year 3. In addition, the 3-year rate of revascularization was slightly higher with PCI (23.1% vs 19.1%), but the rate of periprocedural MI and major adverse events was lower (8.1% vs 23.0%).
Taken together, these results “suggest that PCI with everolimus-eluting stents is an acceptable or perhaps preferred alternative to CABG in selected patients with left main CAD who are candidates for either procedure,” said Gregg W. Stone, MD, of Columbia University Medical Center, New York, and his associates in the EXCEL (Evaluation of XIENCE versus CABG for Effectiveness of Left Main Revascularization) trial.
This study was funded by Abbott Vascular, maker of the everolimus-eluting stent (the XIENCE). The company also participated in the design of the trial and in the selection and management of the treatment sites.
Until now, it was generally agreed that most patients with left main CAD would have better outcomes with CABG than with PCI, based on the results of earlier trials comparing the two approaches. But contemporary drug-eluting stents have better safety and efficacy profiles than first-generation stents, and surgical techniques have also improved over time, so a study comparing the current standards of care was warranted, Dr. Stone and his associates said (New Engl J Med. 2016 Oct 31. doi:10.1056/NEJMoa1610227).
They assessed 1,905 patients at 126 medical centers in 17 countries in the open-label noninferiority trial. Participants had left main coronary artery stenosis of 70% or more (estimated visually) or of 50%-70% (estimated by invasive or noninvasive testing) if the stenosis was judged to be hemodynamically significant. The study participants also were required to have low or intermediate anatomical complexity of the involved portion of the coronary artery, as defined by a SYNTAX score of 32 or lower. A total of 948 patients were randomly assigned to PCI and 957 to CABG.
The primary composite end point – the rate of death, stroke, or MI assessed at a median of 3 years of follow-up – was 15.4% with PCI and 14.7% with CABG, a nonsignificant difference (Hazard Ratio, 1.00) that demonstrates the noninferiority of PCI. This rate was consistently noninferior across all subgroups of patients, regardless of age, sex, and the presence or absence of diabetes or chronic kidney disease.
At 30 days, the rate of the composite end point was 4.9% with PCI and 7.9% with CABG, which also demonstrates the noninferiority of PCI. At 3 years, secondary end points including the rate of ischemia-driven revascularization also showed the noninferiority of PCI, as did each of the individual components of the primary composite end point.
The rate of death, stroke, or MI was lower at 30 days with PCI than with CABG, mainly because there were fewer MIs with PCI. But a post-hoc analysis showed that this rate was higher with PCI than with CABG after 30 days.
During follow-up, ischemia-driven revascularization was more common after PCI (12.6%) than after CABG (7.5%). However, symptomatic graft occlusion after CABG (5.4%) was more frequent than definite stent thrombosis after PCI (0.7%).
Periprocedural major adverse events developed in 8.1% of the PCI group and 23.0% of the CABG group, and the difference was attributed mainly to fewer arrhythmias, infections, and blood transfusions in the PCI group. Cardiovascular mortality was similar between the two study groups, though all-cause mortality was higher with PCI due to an excess of fatal infections and malignancies in that group.
The investigators noted several limitations with the EXCEL trial. First, treatment blinding wasn’t possible, so some degree of bias may have resulted.
Second, prerandomization SYNTAX scores estimating the anatomical complexity of the affected vessels weren’t always accurate, and 24% of the patients in this study proved to have complex lesions when their procedures were undertaken. However, the rate of the primary composite end point was the same in this subgroup of patients as in the overall patient population.
Third, long-term medications after PCI differ from those after CABG, and the investigators said further study is needed to determine how these differences may have contributed to patient outcomes. And finally, longer follow-up is needed to assess whether more differences between the two study groups emerge over time. Five-year follow-up of this study population is now under way.
Dr. Stone and his associates reported ties to numerous industry sources.
The well-designed and rigorously conducted EXCEL trial’s take-home message is that most patients with left main CAD can now be managed equally well using either PCI or CABG, provided that their treatment team is as experienced as those participating in the study.
PCI may be favored in some patients because of its greater periprocedural safety, shorter hospital stay, and more rapid recovery. However, the composite rate of death, stroke, or MI after 30 days was higher with PCI (11.5% vs 7.9%). It is reassuring that these study participants will be followed for another 2 years so that longer-term events can be assessed.
Eugene Braunwald, MD, is in the Thrombolysis in Myocardial Infarction Study Group, in the cardiovascular division at Brigham and Women’s Hospital, and in the department of medicine at Harvard Medical School. He reported having no relevant financial disclosures. Dr. Braunwald made these remarks in an editorial accompanying Dr. Stone’s report (New Engl J Med. 2016 Oct 31. doi:10.1056/NEJMe1612570).
The well-designed and rigorously conducted EXCEL trial’s take-home message is that most patients with left main CAD can now be managed equally well using either PCI or CABG, provided that their treatment team is as experienced as those participating in the study.
PCI may be favored in some patients because of its greater periprocedural safety, shorter hospital stay, and more rapid recovery. However, the composite rate of death, stroke, or MI after 30 days was higher with PCI (11.5% vs 7.9%). It is reassuring that these study participants will be followed for another 2 years so that longer-term events can be assessed.
Eugene Braunwald, MD, is in the Thrombolysis in Myocardial Infarction Study Group, in the cardiovascular division at Brigham and Women’s Hospital, and in the department of medicine at Harvard Medical School. He reported having no relevant financial disclosures. Dr. Braunwald made these remarks in an editorial accompanying Dr. Stone’s report (New Engl J Med. 2016 Oct 31. doi:10.1056/NEJMe1612570).
The well-designed and rigorously conducted EXCEL trial’s take-home message is that most patients with left main CAD can now be managed equally well using either PCI or CABG, provided that their treatment team is as experienced as those participating in the study.
PCI may be favored in some patients because of its greater periprocedural safety, shorter hospital stay, and more rapid recovery. However, the composite rate of death, stroke, or MI after 30 days was higher with PCI (11.5% vs 7.9%). It is reassuring that these study participants will be followed for another 2 years so that longer-term events can be assessed.
Eugene Braunwald, MD, is in the Thrombolysis in Myocardial Infarction Study Group, in the cardiovascular division at Brigham and Women’s Hospital, and in the department of medicine at Harvard Medical School. He reported having no relevant financial disclosures. Dr. Braunwald made these remarks in an editorial accompanying Dr. Stone’s report (New Engl J Med. 2016 Oct 31. doi:10.1056/NEJMe1612570).
Percutaneous coronary intervention (PCI) using everolimus-eluting stents was found noninferior to coronary artery bypass grafting (CABG) with respect to the composite end point of death, stroke, or myocardial infarction at 3 years among patients with left main coronary artery disease and low or intermediate anatomical complexity, according to a report presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the New England Journal of Medicine.
The rate of this composite outcome was lower with PCI than with CABG during the first 30 days following the procedure, but higher between day 30 and year 3. In addition, the 3-year rate of revascularization was slightly higher with PCI (23.1% vs 19.1%), but the rate of periprocedural MI and major adverse events was lower (8.1% vs 23.0%).
Taken together, these results “suggest that PCI with everolimus-eluting stents is an acceptable or perhaps preferred alternative to CABG in selected patients with left main CAD who are candidates for either procedure,” said Gregg W. Stone, MD, of Columbia University Medical Center, New York, and his associates in the EXCEL (Evaluation of XIENCE versus CABG for Effectiveness of Left Main Revascularization) trial.
This study was funded by Abbott Vascular, maker of the everolimus-eluting stent (the XIENCE). The company also participated in the design of the trial and in the selection and management of the treatment sites.
Until now, it was generally agreed that most patients with left main CAD would have better outcomes with CABG than with PCI, based on the results of earlier trials comparing the two approaches. But contemporary drug-eluting stents have better safety and efficacy profiles than first-generation stents, and surgical techniques have also improved over time, so a study comparing the current standards of care was warranted, Dr. Stone and his associates said (New Engl J Med. 2016 Oct 31. doi:10.1056/NEJMoa1610227).
They assessed 1,905 patients at 126 medical centers in 17 countries in the open-label noninferiority trial. Participants had left main coronary artery stenosis of 70% or more (estimated visually) or of 50%-70% (estimated by invasive or noninvasive testing) if the stenosis was judged to be hemodynamically significant. The study participants also were required to have low or intermediate anatomical complexity of the involved portion of the coronary artery, as defined by a SYNTAX score of 32 or lower. A total of 948 patients were randomly assigned to PCI and 957 to CABG.
The primary composite end point – the rate of death, stroke, or MI assessed at a median of 3 years of follow-up – was 15.4% with PCI and 14.7% with CABG, a nonsignificant difference (Hazard Ratio, 1.00) that demonstrates the noninferiority of PCI. This rate was consistently noninferior across all subgroups of patients, regardless of age, sex, and the presence or absence of diabetes or chronic kidney disease.
At 30 days, the rate of the composite end point was 4.9% with PCI and 7.9% with CABG, which also demonstrates the noninferiority of PCI. At 3 years, secondary end points including the rate of ischemia-driven revascularization also showed the noninferiority of PCI, as did each of the individual components of the primary composite end point.
The rate of death, stroke, or MI was lower at 30 days with PCI than with CABG, mainly because there were fewer MIs with PCI. But a post-hoc analysis showed that this rate was higher with PCI than with CABG after 30 days.
During follow-up, ischemia-driven revascularization was more common after PCI (12.6%) than after CABG (7.5%). However, symptomatic graft occlusion after CABG (5.4%) was more frequent than definite stent thrombosis after PCI (0.7%).
Periprocedural major adverse events developed in 8.1% of the PCI group and 23.0% of the CABG group, and the difference was attributed mainly to fewer arrhythmias, infections, and blood transfusions in the PCI group. Cardiovascular mortality was similar between the two study groups, though all-cause mortality was higher with PCI due to an excess of fatal infections and malignancies in that group.
The investigators noted several limitations with the EXCEL trial. First, treatment blinding wasn’t possible, so some degree of bias may have resulted.
Second, prerandomization SYNTAX scores estimating the anatomical complexity of the affected vessels weren’t always accurate, and 24% of the patients in this study proved to have complex lesions when their procedures were undertaken. However, the rate of the primary composite end point was the same in this subgroup of patients as in the overall patient population.
Third, long-term medications after PCI differ from those after CABG, and the investigators said further study is needed to determine how these differences may have contributed to patient outcomes. And finally, longer follow-up is needed to assess whether more differences between the two study groups emerge over time. Five-year follow-up of this study population is now under way.
Dr. Stone and his associates reported ties to numerous industry sources.
Percutaneous coronary intervention (PCI) using everolimus-eluting stents was found noninferior to coronary artery bypass grafting (CABG) with respect to the composite end point of death, stroke, or myocardial infarction at 3 years among patients with left main coronary artery disease and low or intermediate anatomical complexity, according to a report presented at the Transcatheter Cardiovascular Therapeutics annual meeting and published simultaneously in the New England Journal of Medicine.
The rate of this composite outcome was lower with PCI than with CABG during the first 30 days following the procedure, but higher between day 30 and year 3. In addition, the 3-year rate of revascularization was slightly higher with PCI (23.1% vs 19.1%), but the rate of periprocedural MI and major adverse events was lower (8.1% vs 23.0%).
Taken together, these results “suggest that PCI with everolimus-eluting stents is an acceptable or perhaps preferred alternative to CABG in selected patients with left main CAD who are candidates for either procedure,” said Gregg W. Stone, MD, of Columbia University Medical Center, New York, and his associates in the EXCEL (Evaluation of XIENCE versus CABG for Effectiveness of Left Main Revascularization) trial.
This study was funded by Abbott Vascular, maker of the everolimus-eluting stent (the XIENCE). The company also participated in the design of the trial and in the selection and management of the treatment sites.
Until now, it was generally agreed that most patients with left main CAD would have better outcomes with CABG than with PCI, based on the results of earlier trials comparing the two approaches. But contemporary drug-eluting stents have better safety and efficacy profiles than first-generation stents, and surgical techniques have also improved over time, so a study comparing the current standards of care was warranted, Dr. Stone and his associates said (New Engl J Med. 2016 Oct 31. doi:10.1056/NEJMoa1610227).
They assessed 1,905 patients at 126 medical centers in 17 countries in the open-label noninferiority trial. Participants had left main coronary artery stenosis of 70% or more (estimated visually) or of 50%-70% (estimated by invasive or noninvasive testing) if the stenosis was judged to be hemodynamically significant. The study participants also were required to have low or intermediate anatomical complexity of the involved portion of the coronary artery, as defined by a SYNTAX score of 32 or lower. A total of 948 patients were randomly assigned to PCI and 957 to CABG.
The primary composite end point – the rate of death, stroke, or MI assessed at a median of 3 years of follow-up – was 15.4% with PCI and 14.7% with CABG, a nonsignificant difference (Hazard Ratio, 1.00) that demonstrates the noninferiority of PCI. This rate was consistently noninferior across all subgroups of patients, regardless of age, sex, and the presence or absence of diabetes or chronic kidney disease.
At 30 days, the rate of the composite end point was 4.9% with PCI and 7.9% with CABG, which also demonstrates the noninferiority of PCI. At 3 years, secondary end points including the rate of ischemia-driven revascularization also showed the noninferiority of PCI, as did each of the individual components of the primary composite end point.
The rate of death, stroke, or MI was lower at 30 days with PCI than with CABG, mainly because there were fewer MIs with PCI. But a post-hoc analysis showed that this rate was higher with PCI than with CABG after 30 days.
During follow-up, ischemia-driven revascularization was more common after PCI (12.6%) than after CABG (7.5%). However, symptomatic graft occlusion after CABG (5.4%) was more frequent than definite stent thrombosis after PCI (0.7%).
Periprocedural major adverse events developed in 8.1% of the PCI group and 23.0% of the CABG group, and the difference was attributed mainly to fewer arrhythmias, infections, and blood transfusions in the PCI group. Cardiovascular mortality was similar between the two study groups, though all-cause mortality was higher with PCI due to an excess of fatal infections and malignancies in that group.
The investigators noted several limitations with the EXCEL trial. First, treatment blinding wasn’t possible, so some degree of bias may have resulted.
Second, prerandomization SYNTAX scores estimating the anatomical complexity of the affected vessels weren’t always accurate, and 24% of the patients in this study proved to have complex lesions when their procedures were undertaken. However, the rate of the primary composite end point was the same in this subgroup of patients as in the overall patient population.
Third, long-term medications after PCI differ from those after CABG, and the investigators said further study is needed to determine how these differences may have contributed to patient outcomes. And finally, longer follow-up is needed to assess whether more differences between the two study groups emerge over time. Five-year follow-up of this study population is now under way.
Dr. Stone and his associates reported ties to numerous industry sources.
Key clinical point: PCI was found noninferior to CABG regarding the composite end point of death, stroke, or myocardial infarction in certain patients with left main CAD.
Major finding: The primary composite end point – the rate of death, stroke, or MI assessed at a median of 3 years of follow-up – was 15.4% with PCI and 14.7% with CABG, a nonsignificant difference (HR, 1.00) that demonstrates the noninferiority of PCI.
Data source: An international open-label randomized trial involving 1,905 patients followed for 3 years.
Disclosures: The EXCEL trial was funded by Abbott Vascular, maker of the everolimus-eluting stent used in this study. The company participated in the design of the trial and in selection and management of the treatment sites, but was not involved in managing or analyzing the data or writing the manuscript. Dr. Stone and his associates reported ties to numerous industry sources.
Why Aren’t Doctors Following Guidelines?
One recent paper in Clinical Pediatrics, for example, chronicled low adherence to the 2011 National Heart, Lung, and Blood Institute lipid screening guidelines in primary-care settings.1 Another cautioned providers to “mind the (implementation) gap” in venous thromboembolism prevention guidelines for medical inpatients.2 A third found that lower adherence to guidelines issued by the American College of Cardiology/American Heart Association for acute coronary syndrome patients was significantly associated with higher bleeding and mortality rates.3
Both clinical trials and real-world studies have demonstrated that when guidelines are applied, patients do better, says William Lewis, MD, professor of medicine at Case Western Reserve University and director of the Heart & Vascular Center at MetroHealth in Cleveland. So why aren’t they followed more consistently?
Experts in both HM and other disciplines cite multiple obstacles. Lack of evidence, conflicting evidence, or lack of awareness about evidence can all conspire against the main goal of helping providers deliver consistent high-value care, says Christopher Moriates, MD, assistant clinical professor in the Division of Hospital Medicine at the University of California, San Francisco.
“In our day-to-day lives as hospitalists, for the vast majority probably of what we do there’s no clear guideline or there’s a guideline that doesn’t necessarily apply to the patient standing in front of me,” he says.
Even when a guideline is clear and relevant, other doctors say inadequate dissemination and implementation can still derail quality improvement efforts.
“A lot of what we do as physicians is what we learned in residency, and to incorporate the new data is difficult,” says Leonard Feldman, MD, SFHM, a hospitalist and associate professor of internal medicine and pediatrics at Johns Hopkins School of Medicine in Baltimore.
Dr. Feldman believes many doctors have yet to integrate recently revised hypertension and cholesterol guidelines into their practice, for example. Some guidelines have proven more complex or controversial, limiting their adoption.
“I know I struggle to keep up with all of the guidelines, and I’m in a big academic center where people are talking about them all the time, and I’m working with residents who are talking about them all the time,” Dr. Feldman says.
Despite the remaining gaps, however, many researchers agree that momentum has built steadily over the past two decades toward a more systematic approach to creating solid evidence-based guidelines and integrating them into real-world decision making.
Emphasis on Evidence and Transparency
The term “evidence-based medicine” was coined in 1990 by Gordon Guyatt, MD, MSc, FRCPC, distinguished professor of medicine and clinical epidemiology at McMaster University in Hamilton, Ontario. It’s played an active role in formulating guidelines for multiple organizations. The guideline-writing process, Dr. Guyatt says, once consisted of little more than self-selected clinicians sitting around a table.
“It used to be that a bunch of experts got together and decided and made the recommendations with very little in the way of a systematic process and certainly not evidence based,” he says.
Cincinnati Children’s Hospital Medical Center was among the pioneers pushing for a more systematic approach; the hospital began working on its own guidelines in 1995 and published the first of many the following year.
“We started evidence-based guidelines when the docs were still saying, ‘This is cookbook medicine. I don’t know if I want to do this or not,’” says Wendy Gerhardt, MSN, director of evidence-based decision making in the James M. Anderson Center for Health Systems Excellence at Cincinnati Children’s.
Some doctors also argued that clinical guidelines would stifle innovation, cramp their individual style, or intrude on their relationships with patients. Despite some lingering misgivings among clinicians, however, the process has gained considerable support. In 2000, an organization called the GRADE Working Group (Grading of Recommendations, Assessment, Development and Evaluation) began developing a new approach to raise the quality of evidence and strength of recommendations.
The group’s work led to a 2004 article in BMJ, and the journal subsequently published a six-part series about GRADE for clinicians.4 More recently, the Journal of Clinical Epidemiology also delved into the issue with a 15-part series detailing the GRADE methodology.5 Together, Dr. Guyatt says, the articles have become a go-to guide for guidelines and have helped solidify the focus on evidence.
Cincinnati Children’s and other institutions also have developed tools, and the Institute of Medicine has published guideline-writing standards.
“So it’s easier than it’s ever been to know whether or not you have a decent guideline in your hand,” Gerhardt says.
Likewise, medical organizations are more clearly explaining how they came up with different kinds of guidelines. Evidence-based and consensus guidelines aren’t necessarily mutually exclusive, though consensus building is often used in the absence of high-quality evidence. Some organizations have limited the pool of evidence for guidelines to randomized controlled trial data.
“Unfortunately, for us in the real world, we actually have to make decisions even when there’s not enough data,” Dr. Feldman says.
Sometimes, the best available evidence may be observational studies, and some committees still try to reach a consensus based on that evidence and on the panelists’ professional opinions.
Dr. Guyatt agrees that it’s “absolutely not” true that evidence-based guidelines require randomized controlled trials. “What you need for any recommendation is a thorough review and summary of the best available evidence,” he says.
As part of each final document, Cincinnati Children’s details how it created the guideline, when the literature searches occurred, how the committee reached a consensus, and which panelists participated in the deliberations. The information, Gerhardt says, allows anyone else to “make some sensible decisions about whether or not it’s a guideline you want to use.”
Guideline-crafting institutions are also focusing more on the proper makeup of their panels. In general, Dr. Guyatt says, a panel with more than 10 people can be unwieldy. Guidelines that include many specific recommendations, however, may require multiple subsections, each with its own committee.
Dr. Guyatt is careful to note that, like many other experts, he has multiple potential conflicts of interest, such as working on the anti-thrombotic guidelines issued by the American College of Chest Physicians. Committees, he says, have become increasingly aware of how properly handling conflicts (financial or otherwise) can be critical in building and maintaining trust among clinicians and patients. One technique is to ensure that a diversity of opinions is reflected among a committee whose experts have various conflicts. If one expert’s company makes drug A, for example, then the committee also includes experts involved with drugs B or C. As an alternative, some committees have explicitly barred anyone with a conflict of interest from participating at all.
But experts often provide crucial input, Dr. Guyatt says, and several committees have adopted variations of a middle-ground approach. In an approach that he favors, all guideline-formulating panelists are conflict-free but begin their work by meeting with a separate group of experts who may have some conflicts but can help point out the main issues. The panelists then deliberate and write a draft of the recommendations, after which they meet again with the experts to receive feedback before finalizing the draft.
In a related approach, experts sit on the panel and discuss the evidence, but those with conflicts recuse themselves before the group votes on any recommendations. Delineating between discussions of the evidence and discussions of recommendations can be tricky, though, increasing the risk that a conflict of interest may influence the outcome. Even so, Dr. Guyatt says the model is still preferable to other alternatives.
Getting the Word Out
Once guidelines have been crafted and vetted, how can hospitalists get up to speed on them? Dr. Feldman’s favorite go-to source is Guideline.gov, a national guideline clearinghouse that he calls one of the best compendiums of available information. Especially helpful, he adds, are details such as how the guidelines were created.
To help maximize his time, he also uses tools like NEJM Journal Watch, which sends daily emails on noteworthy articles and weekend roundups of the most important studies.
“It is a way of at least trying to keep up with what’s going on,” he says. Similarly, he adds, ACP Journal Club provides summaries of important new articles, The Hospitalist can help highlight important guidelines that affect HM, and CME meetings or online modules like SHMconsults.com can help doctors keep pace.
For the past decade, Dr. Guyatt has worked with another popular tool, a guideline-disseminating service called UpToDate. Many alternatives exist, such as DynaMed Plus.
“I think you just need to pick away,” Dr. Feldman says. “You need to decide that as a physician, as a lifelong learner, that you are going to do something that is going to keep you up-to-date. There are many ways of doing it. You just have to decide what you’re going to do and commit to it.”
Researchers are helping out by studying how to present new guidelines in ways that engage doctors and improve patient outcomes. Another trend is to make guidelines routinely accessible not only in electronic medical records but also on tablets and smartphones. Lisa Shieh, MD, PhD, FHM, a hospitalist and clinical professor of medicine at Stanford University Medical Center, has studied how best-practice alerts, or BPAs, impact adherence to guidelines covering the appropriate use of blood products. Dr. Shieh, who splits her time between quality improvement and hospital medicine, says getting new information and guidelines into clinicians’ hands can be a logistical challenge.
“At Stanford, we had a huge official campaign around the guidelines, and that did make some impact, but it wasn’t huge in improving appropriate blood use,” she says. When the medial center set up a BPA through the electronic medical record system, however, both overall and inappropriate blood use declined significantly. In fact, the percentage of providers ordering blood products for patients with a hemoglobin count above 8 g/dL dropped from 60% to 25%.6
One difference maker, Dr. Shieh says, was providing education at the moment a doctor actually ordered blood. To avoid alert fatigue, the “smart BPA” fires only if a doctor tries to order blood and the patient’s hemoglobin is greater than 7 or 8 g/dL, depending on the diagnosis. If the doctor still wants to transfuse, the system requests a clinical indication for the exception.
Despite the clear improvement in appropriate use, the team wanted to understand why 25% of providers were still ordering blood products for patients with a hemoglobin count greater than 8 despite the triggered BPA and whether additional interventions could yield further improvements. Through their study, the researchers documented several reasons for the continued ordering. In some cases, the system failed to properly document actual or potential bleeding as an indicator. In other cases, the ordering reflected a lack of consensus on the guidelines in fields like hematology and oncology.
One of the most intriguing reasons, though, was that residents often did the ordering at the behest of an attending who might have never seen the BPA.
“It’s not actually reaching the audience making the decision; it might be reaching the audience that’s just carrying out the order,” Dr. Shieh says.
The insight, she says, may provide an opportunity to talk with attending physicians who may not have completely bought into the guidelines and to involve the entire team in the decision-making process.
Hospitalists, she says, can play a vital role in guideline development and implementation, especially for strategies that include BPAs.
“I think they’re the perfect group to help use this technology wisely because they are at the front lines taking care of patients so they’ll know the best workflow of when these alerts fire and maybe which ones happen the most often,” Dr. Shieh says. “I think this is a fantastic opportunity to get more hospitalists involved in designing these alerts and collaborating with the IT folks.”
Even with widespread buy-in from providers, guidelines may not reach their full potential without a careful consideration of patients’ values and concerns. Experts say joint deliberations and discussions are especially important for guidelines that are complicated, controversial, or carrying potential risks that must be weighed against the benefits.
Some of the conversations are easy, with well-defined risks and benefits and clear patient preferences, but others must traverse vast tracts of gray area. Fortunately, Dr. Feldman says, more tools also are becoming available for this kind of shared decision making. Some use pictorial representations to help patients understand the potential outcomes of alternative courses of action or inaction.
“Sometimes, that pictorial representation is worth the 1,000 words that we wouldn’t be able to adequately describe otherwise,” he says.
Similarly, Cincinnati Children’s has developed tools to help to ease the shared decision-making process.
“We look where there’s equivocal evidence or no evidence and have developed tools that help the clinician have that conversation with the family and then have them informed enough that they can actually weigh in on what they want,” Gerhardt says. One end product is a card or trifold pamphlet that might help parents understand the benefits and side effects of alternate strategies.
“Typically, in medicine, we’re used to telling people what needs to be done,” she says. “So shared decision making is kind of a different thing for clinicians to engage in.” TH
Bryn Nelson, PhD, is a freelance writer in Seattle.
References
- Valle CW, Binns HJ, Quadri-Sheriff M, Benuck I, Patel A. Physicians’ lack of adherence to National Heart, Lung, and Blood Institute guidelines for pediatric lipid screening. Clin Pediatr. 2015;54(12):1200-1205.
- Maynard G, Jenkins IH, Merli GJ. Venous thromboembolism prevention guidelines for medical inpatients: mind the (implementation) gap. J Hosp Med. 2013;8(10):582-588.
- Mehta RH, Chen AY, Alexander KP, Ohman EM, Roe MT, Peterson ED. Doing the right things and doing them the right way: association between hospital guideline adherence, dosing safety, and outcomes among patients with acute coronary syndrome. Circulation. 2015;131(11):980-987.
- GRADE Working Group. Grading quality of evidence and strength of recommendations. BMJ. 2004;328:1490
- Andrews JC, Schünemann HJ, Oxman AD, et al. GRADE guidelines: 15. Going from evidence to recommendation—determinants of a recommendation’s direction and strength. J Clin Epidemiol. 2013;66(7):726-735.
- 6. Chen JH, Fang DZ, Tim Goodnough L, Evans KH, Lee Porter M, Shieh L. Why providers transfuse blood products outside recommended guidelines in spite of integrated electronic best practice alerts. J Hosp Med. 2015;10(1):1-7.
One recent paper in Clinical Pediatrics, for example, chronicled low adherence to the 2011 National Heart, Lung, and Blood Institute lipid screening guidelines in primary-care settings.1 Another cautioned providers to “mind the (implementation) gap” in venous thromboembolism prevention guidelines for medical inpatients.2 A third found that lower adherence to guidelines issued by the American College of Cardiology/American Heart Association for acute coronary syndrome patients was significantly associated with higher bleeding and mortality rates.3
Both clinical trials and real-world studies have demonstrated that when guidelines are applied, patients do better, says William Lewis, MD, professor of medicine at Case Western Reserve University and director of the Heart & Vascular Center at MetroHealth in Cleveland. So why aren’t they followed more consistently?
Experts in both HM and other disciplines cite multiple obstacles. Lack of evidence, conflicting evidence, or lack of awareness about evidence can all conspire against the main goal of helping providers deliver consistent high-value care, says Christopher Moriates, MD, assistant clinical professor in the Division of Hospital Medicine at the University of California, San Francisco.
“In our day-to-day lives as hospitalists, for the vast majority probably of what we do there’s no clear guideline or there’s a guideline that doesn’t necessarily apply to the patient standing in front of me,” he says.
Even when a guideline is clear and relevant, other doctors say inadequate dissemination and implementation can still derail quality improvement efforts.
“A lot of what we do as physicians is what we learned in residency, and to incorporate the new data is difficult,” says Leonard Feldman, MD, SFHM, a hospitalist and associate professor of internal medicine and pediatrics at Johns Hopkins School of Medicine in Baltimore.
Dr. Feldman believes many doctors have yet to integrate recently revised hypertension and cholesterol guidelines into their practice, for example. Some guidelines have proven more complex or controversial, limiting their adoption.
“I know I struggle to keep up with all of the guidelines, and I’m in a big academic center where people are talking about them all the time, and I’m working with residents who are talking about them all the time,” Dr. Feldman says.
Despite the remaining gaps, however, many researchers agree that momentum has built steadily over the past two decades toward a more systematic approach to creating solid evidence-based guidelines and integrating them into real-world decision making.
Emphasis on Evidence and Transparency
The term “evidence-based medicine” was coined in 1990 by Gordon Guyatt, MD, MSc, FRCPC, distinguished professor of medicine and clinical epidemiology at McMaster University in Hamilton, Ontario. It’s played an active role in formulating guidelines for multiple organizations. The guideline-writing process, Dr. Guyatt says, once consisted of little more than self-selected clinicians sitting around a table.
“It used to be that a bunch of experts got together and decided and made the recommendations with very little in the way of a systematic process and certainly not evidence based,” he says.
Cincinnati Children’s Hospital Medical Center was among the pioneers pushing for a more systematic approach; the hospital began working on its own guidelines in 1995 and published the first of many the following year.
“We started evidence-based guidelines when the docs were still saying, ‘This is cookbook medicine. I don’t know if I want to do this or not,’” says Wendy Gerhardt, MSN, director of evidence-based decision making in the James M. Anderson Center for Health Systems Excellence at Cincinnati Children’s.
Some doctors also argued that clinical guidelines would stifle innovation, cramp their individual style, or intrude on their relationships with patients. Despite some lingering misgivings among clinicians, however, the process has gained considerable support. In 2000, an organization called the GRADE Working Group (Grading of Recommendations, Assessment, Development and Evaluation) began developing a new approach to raise the quality of evidence and strength of recommendations.
The group’s work led to a 2004 article in BMJ, and the journal subsequently published a six-part series about GRADE for clinicians.4 More recently, the Journal of Clinical Epidemiology also delved into the issue with a 15-part series detailing the GRADE methodology.5 Together, Dr. Guyatt says, the articles have become a go-to guide for guidelines and have helped solidify the focus on evidence.
Cincinnati Children’s and other institutions also have developed tools, and the Institute of Medicine has published guideline-writing standards.
“So it’s easier than it’s ever been to know whether or not you have a decent guideline in your hand,” Gerhardt says.
Likewise, medical organizations are more clearly explaining how they came up with different kinds of guidelines. Evidence-based and consensus guidelines aren’t necessarily mutually exclusive, though consensus building is often used in the absence of high-quality evidence. Some organizations have limited the pool of evidence for guidelines to randomized controlled trial data.
“Unfortunately, for us in the real world, we actually have to make decisions even when there’s not enough data,” Dr. Feldman says.
Sometimes, the best available evidence may be observational studies, and some committees still try to reach a consensus based on that evidence and on the panelists’ professional opinions.
Dr. Guyatt agrees that it’s “absolutely not” true that evidence-based guidelines require randomized controlled trials. “What you need for any recommendation is a thorough review and summary of the best available evidence,” he says.
As part of each final document, Cincinnati Children’s details how it created the guideline, when the literature searches occurred, how the committee reached a consensus, and which panelists participated in the deliberations. The information, Gerhardt says, allows anyone else to “make some sensible decisions about whether or not it’s a guideline you want to use.”
Guideline-crafting institutions are also focusing more on the proper makeup of their panels. In general, Dr. Guyatt says, a panel with more than 10 people can be unwieldy. Guidelines that include many specific recommendations, however, may require multiple subsections, each with its own committee.
Dr. Guyatt is careful to note that, like many other experts, he has multiple potential conflicts of interest, such as working on the anti-thrombotic guidelines issued by the American College of Chest Physicians. Committees, he says, have become increasingly aware of how properly handling conflicts (financial or otherwise) can be critical in building and maintaining trust among clinicians and patients. One technique is to ensure that a diversity of opinions is reflected among a committee whose experts have various conflicts. If one expert’s company makes drug A, for example, then the committee also includes experts involved with drugs B or C. As an alternative, some committees have explicitly barred anyone with a conflict of interest from participating at all.
But experts often provide crucial input, Dr. Guyatt says, and several committees have adopted variations of a middle-ground approach. In an approach that he favors, all guideline-formulating panelists are conflict-free but begin their work by meeting with a separate group of experts who may have some conflicts but can help point out the main issues. The panelists then deliberate and write a draft of the recommendations, after which they meet again with the experts to receive feedback before finalizing the draft.
In a related approach, experts sit on the panel and discuss the evidence, but those with conflicts recuse themselves before the group votes on any recommendations. Delineating between discussions of the evidence and discussions of recommendations can be tricky, though, increasing the risk that a conflict of interest may influence the outcome. Even so, Dr. Guyatt says the model is still preferable to other alternatives.
Getting the Word Out
Once guidelines have been crafted and vetted, how can hospitalists get up to speed on them? Dr. Feldman’s favorite go-to source is Guideline.gov, a national guideline clearinghouse that he calls one of the best compendiums of available information. Especially helpful, he adds, are details such as how the guidelines were created.
To help maximize his time, he also uses tools like NEJM Journal Watch, which sends daily emails on noteworthy articles and weekend roundups of the most important studies.
“It is a way of at least trying to keep up with what’s going on,” he says. Similarly, he adds, ACP Journal Club provides summaries of important new articles, The Hospitalist can help highlight important guidelines that affect HM, and CME meetings or online modules like SHMconsults.com can help doctors keep pace.
For the past decade, Dr. Guyatt has worked with another popular tool, a guideline-disseminating service called UpToDate. Many alternatives exist, such as DynaMed Plus.
“I think you just need to pick away,” Dr. Feldman says. “You need to decide that as a physician, as a lifelong learner, that you are going to do something that is going to keep you up-to-date. There are many ways of doing it. You just have to decide what you’re going to do and commit to it.”
Researchers are helping out by studying how to present new guidelines in ways that engage doctors and improve patient outcomes. Another trend is to make guidelines routinely accessible not only in electronic medical records but also on tablets and smartphones. Lisa Shieh, MD, PhD, FHM, a hospitalist and clinical professor of medicine at Stanford University Medical Center, has studied how best-practice alerts, or BPAs, impact adherence to guidelines covering the appropriate use of blood products. Dr. Shieh, who splits her time between quality improvement and hospital medicine, says getting new information and guidelines into clinicians’ hands can be a logistical challenge.
“At Stanford, we had a huge official campaign around the guidelines, and that did make some impact, but it wasn’t huge in improving appropriate blood use,” she says. When the medial center set up a BPA through the electronic medical record system, however, both overall and inappropriate blood use declined significantly. In fact, the percentage of providers ordering blood products for patients with a hemoglobin count above 8 g/dL dropped from 60% to 25%.6
One difference maker, Dr. Shieh says, was providing education at the moment a doctor actually ordered blood. To avoid alert fatigue, the “smart BPA” fires only if a doctor tries to order blood and the patient’s hemoglobin is greater than 7 or 8 g/dL, depending on the diagnosis. If the doctor still wants to transfuse, the system requests a clinical indication for the exception.
Despite the clear improvement in appropriate use, the team wanted to understand why 25% of providers were still ordering blood products for patients with a hemoglobin count greater than 8 despite the triggered BPA and whether additional interventions could yield further improvements. Through their study, the researchers documented several reasons for the continued ordering. In some cases, the system failed to properly document actual or potential bleeding as an indicator. In other cases, the ordering reflected a lack of consensus on the guidelines in fields like hematology and oncology.
One of the most intriguing reasons, though, was that residents often did the ordering at the behest of an attending who might have never seen the BPA.
“It’s not actually reaching the audience making the decision; it might be reaching the audience that’s just carrying out the order,” Dr. Shieh says.
The insight, she says, may provide an opportunity to talk with attending physicians who may not have completely bought into the guidelines and to involve the entire team in the decision-making process.
Hospitalists, she says, can play a vital role in guideline development and implementation, especially for strategies that include BPAs.
“I think they’re the perfect group to help use this technology wisely because they are at the front lines taking care of patients so they’ll know the best workflow of when these alerts fire and maybe which ones happen the most often,” Dr. Shieh says. “I think this is a fantastic opportunity to get more hospitalists involved in designing these alerts and collaborating with the IT folks.”
Even with widespread buy-in from providers, guidelines may not reach their full potential without a careful consideration of patients’ values and concerns. Experts say joint deliberations and discussions are especially important for guidelines that are complicated, controversial, or carrying potential risks that must be weighed against the benefits.
Some of the conversations are easy, with well-defined risks and benefits and clear patient preferences, but others must traverse vast tracts of gray area. Fortunately, Dr. Feldman says, more tools also are becoming available for this kind of shared decision making. Some use pictorial representations to help patients understand the potential outcomes of alternative courses of action or inaction.
“Sometimes, that pictorial representation is worth the 1,000 words that we wouldn’t be able to adequately describe otherwise,” he says.
Similarly, Cincinnati Children’s has developed tools to help to ease the shared decision-making process.
“We look where there’s equivocal evidence or no evidence and have developed tools that help the clinician have that conversation with the family and then have them informed enough that they can actually weigh in on what they want,” Gerhardt says. One end product is a card or trifold pamphlet that might help parents understand the benefits and side effects of alternate strategies.
“Typically, in medicine, we’re used to telling people what needs to be done,” she says. “So shared decision making is kind of a different thing for clinicians to engage in.” TH
Bryn Nelson, PhD, is a freelance writer in Seattle.
References
- Valle CW, Binns HJ, Quadri-Sheriff M, Benuck I, Patel A. Physicians’ lack of adherence to National Heart, Lung, and Blood Institute guidelines for pediatric lipid screening. Clin Pediatr. 2015;54(12):1200-1205.
- Maynard G, Jenkins IH, Merli GJ. Venous thromboembolism prevention guidelines for medical inpatients: mind the (implementation) gap. J Hosp Med. 2013;8(10):582-588.
- Mehta RH, Chen AY, Alexander KP, Ohman EM, Roe MT, Peterson ED. Doing the right things and doing them the right way: association between hospital guideline adherence, dosing safety, and outcomes among patients with acute coronary syndrome. Circulation. 2015;131(11):980-987.
- GRADE Working Group. Grading quality of evidence and strength of recommendations. BMJ. 2004;328:1490
- Andrews JC, Schünemann HJ, Oxman AD, et al. GRADE guidelines: 15. Going from evidence to recommendation—determinants of a recommendation’s direction and strength. J Clin Epidemiol. 2013;66(7):726-735.
- 6. Chen JH, Fang DZ, Tim Goodnough L, Evans KH, Lee Porter M, Shieh L. Why providers transfuse blood products outside recommended guidelines in spite of integrated electronic best practice alerts. J Hosp Med. 2015;10(1):1-7.
One recent paper in Clinical Pediatrics, for example, chronicled low adherence to the 2011 National Heart, Lung, and Blood Institute lipid screening guidelines in primary-care settings.1 Another cautioned providers to “mind the (implementation) gap” in venous thromboembolism prevention guidelines for medical inpatients.2 A third found that lower adherence to guidelines issued by the American College of Cardiology/American Heart Association for acute coronary syndrome patients was significantly associated with higher bleeding and mortality rates.3
Both clinical trials and real-world studies have demonstrated that when guidelines are applied, patients do better, says William Lewis, MD, professor of medicine at Case Western Reserve University and director of the Heart & Vascular Center at MetroHealth in Cleveland. So why aren’t they followed more consistently?
Experts in both HM and other disciplines cite multiple obstacles. Lack of evidence, conflicting evidence, or lack of awareness about evidence can all conspire against the main goal of helping providers deliver consistent high-value care, says Christopher Moriates, MD, assistant clinical professor in the Division of Hospital Medicine at the University of California, San Francisco.
“In our day-to-day lives as hospitalists, for the vast majority probably of what we do there’s no clear guideline or there’s a guideline that doesn’t necessarily apply to the patient standing in front of me,” he says.
Even when a guideline is clear and relevant, other doctors say inadequate dissemination and implementation can still derail quality improvement efforts.
“A lot of what we do as physicians is what we learned in residency, and to incorporate the new data is difficult,” says Leonard Feldman, MD, SFHM, a hospitalist and associate professor of internal medicine and pediatrics at Johns Hopkins School of Medicine in Baltimore.
Dr. Feldman believes many doctors have yet to integrate recently revised hypertension and cholesterol guidelines into their practice, for example. Some guidelines have proven more complex or controversial, limiting their adoption.
“I know I struggle to keep up with all of the guidelines, and I’m in a big academic center where people are talking about them all the time, and I’m working with residents who are talking about them all the time,” Dr. Feldman says.
Despite the remaining gaps, however, many researchers agree that momentum has built steadily over the past two decades toward a more systematic approach to creating solid evidence-based guidelines and integrating them into real-world decision making.
Emphasis on Evidence and Transparency
The term “evidence-based medicine” was coined in 1990 by Gordon Guyatt, MD, MSc, FRCPC, distinguished professor of medicine and clinical epidemiology at McMaster University in Hamilton, Ontario. It’s played an active role in formulating guidelines for multiple organizations. The guideline-writing process, Dr. Guyatt says, once consisted of little more than self-selected clinicians sitting around a table.
“It used to be that a bunch of experts got together and decided and made the recommendations with very little in the way of a systematic process and certainly not evidence based,” he says.
Cincinnati Children’s Hospital Medical Center was among the pioneers pushing for a more systematic approach; the hospital began working on its own guidelines in 1995 and published the first of many the following year.
“We started evidence-based guidelines when the docs were still saying, ‘This is cookbook medicine. I don’t know if I want to do this or not,’” says Wendy Gerhardt, MSN, director of evidence-based decision making in the James M. Anderson Center for Health Systems Excellence at Cincinnati Children’s.
Some doctors also argued that clinical guidelines would stifle innovation, cramp their individual style, or intrude on their relationships with patients. Despite some lingering misgivings among clinicians, however, the process has gained considerable support. In 2000, an organization called the GRADE Working Group (Grading of Recommendations, Assessment, Development and Evaluation) began developing a new approach to raise the quality of evidence and strength of recommendations.
The group’s work led to a 2004 article in BMJ, and the journal subsequently published a six-part series about GRADE for clinicians.4 More recently, the Journal of Clinical Epidemiology also delved into the issue with a 15-part series detailing the GRADE methodology.5 Together, Dr. Guyatt says, the articles have become a go-to guide for guidelines and have helped solidify the focus on evidence.
Cincinnati Children’s and other institutions also have developed tools, and the Institute of Medicine has published guideline-writing standards.
“So it’s easier than it’s ever been to know whether or not you have a decent guideline in your hand,” Gerhardt says.
Likewise, medical organizations are more clearly explaining how they came up with different kinds of guidelines. Evidence-based and consensus guidelines aren’t necessarily mutually exclusive, though consensus building is often used in the absence of high-quality evidence. Some organizations have limited the pool of evidence for guidelines to randomized controlled trial data.
“Unfortunately, for us in the real world, we actually have to make decisions even when there’s not enough data,” Dr. Feldman says.
Sometimes, the best available evidence may be observational studies, and some committees still try to reach a consensus based on that evidence and on the panelists’ professional opinions.
Dr. Guyatt agrees that it’s “absolutely not” true that evidence-based guidelines require randomized controlled trials. “What you need for any recommendation is a thorough review and summary of the best available evidence,” he says.
As part of each final document, Cincinnati Children’s details how it created the guideline, when the literature searches occurred, how the committee reached a consensus, and which panelists participated in the deliberations. The information, Gerhardt says, allows anyone else to “make some sensible decisions about whether or not it’s a guideline you want to use.”
Guideline-crafting institutions are also focusing more on the proper makeup of their panels. In general, Dr. Guyatt says, a panel with more than 10 people can be unwieldy. Guidelines that include many specific recommendations, however, may require multiple subsections, each with its own committee.
Dr. Guyatt is careful to note that, like many other experts, he has multiple potential conflicts of interest, such as working on the anti-thrombotic guidelines issued by the American College of Chest Physicians. Committees, he says, have become increasingly aware of how properly handling conflicts (financial or otherwise) can be critical in building and maintaining trust among clinicians and patients. One technique is to ensure that a diversity of opinions is reflected among a committee whose experts have various conflicts. If one expert’s company makes drug A, for example, then the committee also includes experts involved with drugs B or C. As an alternative, some committees have explicitly barred anyone with a conflict of interest from participating at all.
But experts often provide crucial input, Dr. Guyatt says, and several committees have adopted variations of a middle-ground approach. In an approach that he favors, all guideline-formulating panelists are conflict-free but begin their work by meeting with a separate group of experts who may have some conflicts but can help point out the main issues. The panelists then deliberate and write a draft of the recommendations, after which they meet again with the experts to receive feedback before finalizing the draft.
In a related approach, experts sit on the panel and discuss the evidence, but those with conflicts recuse themselves before the group votes on any recommendations. Delineating between discussions of the evidence and discussions of recommendations can be tricky, though, increasing the risk that a conflict of interest may influence the outcome. Even so, Dr. Guyatt says the model is still preferable to other alternatives.
Getting the Word Out
Once guidelines have been crafted and vetted, how can hospitalists get up to speed on them? Dr. Feldman’s favorite go-to source is Guideline.gov, a national guideline clearinghouse that he calls one of the best compendiums of available information. Especially helpful, he adds, are details such as how the guidelines were created.
To help maximize his time, he also uses tools like NEJM Journal Watch, which sends daily emails on noteworthy articles and weekend roundups of the most important studies.
“It is a way of at least trying to keep up with what’s going on,” he says. Similarly, he adds, ACP Journal Club provides summaries of important new articles, The Hospitalist can help highlight important guidelines that affect HM, and CME meetings or online modules like SHMconsults.com can help doctors keep pace.
For the past decade, Dr. Guyatt has worked with another popular tool, a guideline-disseminating service called UpToDate. Many alternatives exist, such as DynaMed Plus.
“I think you just need to pick away,” Dr. Feldman says. “You need to decide that as a physician, as a lifelong learner, that you are going to do something that is going to keep you up-to-date. There are many ways of doing it. You just have to decide what you’re going to do and commit to it.”
Researchers are helping out by studying how to present new guidelines in ways that engage doctors and improve patient outcomes. Another trend is to make guidelines routinely accessible not only in electronic medical records but also on tablets and smartphones. Lisa Shieh, MD, PhD, FHM, a hospitalist and clinical professor of medicine at Stanford University Medical Center, has studied how best-practice alerts, or BPAs, impact adherence to guidelines covering the appropriate use of blood products. Dr. Shieh, who splits her time between quality improvement and hospital medicine, says getting new information and guidelines into clinicians’ hands can be a logistical challenge.
“At Stanford, we had a huge official campaign around the guidelines, and that did make some impact, but it wasn’t huge in improving appropriate blood use,” she says. When the medial center set up a BPA through the electronic medical record system, however, both overall and inappropriate blood use declined significantly. In fact, the percentage of providers ordering blood products for patients with a hemoglobin count above 8 g/dL dropped from 60% to 25%.6
One difference maker, Dr. Shieh says, was providing education at the moment a doctor actually ordered blood. To avoid alert fatigue, the “smart BPA” fires only if a doctor tries to order blood and the patient’s hemoglobin is greater than 7 or 8 g/dL, depending on the diagnosis. If the doctor still wants to transfuse, the system requests a clinical indication for the exception.
Despite the clear improvement in appropriate use, the team wanted to understand why 25% of providers were still ordering blood products for patients with a hemoglobin count greater than 8 despite the triggered BPA and whether additional interventions could yield further improvements. Through their study, the researchers documented several reasons for the continued ordering. In some cases, the system failed to properly document actual or potential bleeding as an indicator. In other cases, the ordering reflected a lack of consensus on the guidelines in fields like hematology and oncology.
One of the most intriguing reasons, though, was that residents often did the ordering at the behest of an attending who might have never seen the BPA.
“It’s not actually reaching the audience making the decision; it might be reaching the audience that’s just carrying out the order,” Dr. Shieh says.
The insight, she says, may provide an opportunity to talk with attending physicians who may not have completely bought into the guidelines and to involve the entire team in the decision-making process.
Hospitalists, she says, can play a vital role in guideline development and implementation, especially for strategies that include BPAs.
“I think they’re the perfect group to help use this technology wisely because they are at the front lines taking care of patients so they’ll know the best workflow of when these alerts fire and maybe which ones happen the most often,” Dr. Shieh says. “I think this is a fantastic opportunity to get more hospitalists involved in designing these alerts and collaborating with the IT folks.”
Even with widespread buy-in from providers, guidelines may not reach their full potential without a careful consideration of patients’ values and concerns. Experts say joint deliberations and discussions are especially important for guidelines that are complicated, controversial, or carrying potential risks that must be weighed against the benefits.
Some of the conversations are easy, with well-defined risks and benefits and clear patient preferences, but others must traverse vast tracts of gray area. Fortunately, Dr. Feldman says, more tools also are becoming available for this kind of shared decision making. Some use pictorial representations to help patients understand the potential outcomes of alternative courses of action or inaction.
“Sometimes, that pictorial representation is worth the 1,000 words that we wouldn’t be able to adequately describe otherwise,” he says.
Similarly, Cincinnati Children’s has developed tools to help to ease the shared decision-making process.
“We look where there’s equivocal evidence or no evidence and have developed tools that help the clinician have that conversation with the family and then have them informed enough that they can actually weigh in on what they want,” Gerhardt says. One end product is a card or trifold pamphlet that might help parents understand the benefits and side effects of alternate strategies.
“Typically, in medicine, we’re used to telling people what needs to be done,” she says. “So shared decision making is kind of a different thing for clinicians to engage in.” TH
Bryn Nelson, PhD, is a freelance writer in Seattle.
References
- Valle CW, Binns HJ, Quadri-Sheriff M, Benuck I, Patel A. Physicians’ lack of adherence to National Heart, Lung, and Blood Institute guidelines for pediatric lipid screening. Clin Pediatr. 2015;54(12):1200-1205.
- Maynard G, Jenkins IH, Merli GJ. Venous thromboembolism prevention guidelines for medical inpatients: mind the (implementation) gap. J Hosp Med. 2013;8(10):582-588.
- Mehta RH, Chen AY, Alexander KP, Ohman EM, Roe MT, Peterson ED. Doing the right things and doing them the right way: association between hospital guideline adherence, dosing safety, and outcomes among patients with acute coronary syndrome. Circulation. 2015;131(11):980-987.
- GRADE Working Group. Grading quality of evidence and strength of recommendations. BMJ. 2004;328:1490
- Andrews JC, Schünemann HJ, Oxman AD, et al. GRADE guidelines: 15. Going from evidence to recommendation—determinants of a recommendation’s direction and strength. J Clin Epidemiol. 2013;66(7):726-735.
- 6. Chen JH, Fang DZ, Tim Goodnough L, Evans KH, Lee Porter M, Shieh L. Why providers transfuse blood products outside recommended guidelines in spite of integrated electronic best practice alerts. J Hosp Med. 2015;10(1):1-7.