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Every year, hospitalists across the country receive SHM membership renewal notices in the mail. For the vast majority of them, the decision to renew is an easy one.
For the others, hospitalist Mike Hawkins, MD, FACP, FHM, recommends a tried-and-true approach in the field: Evaluate the risk-to-benefit ratio.
“As they say in medicine, the risk-to-benefit ratio is a no-brainer,” says Dr. Hawkins, the Southeast region medical director for Brentwood, Tenn.-based Cogent Healthcare.
Dr. Hawkins should know about membership benefits; he’s been an SHM member since 1996. In fact, he was one of the first 200 members of SHM’s original incarnation, the National Association of Inpatient Physicians. He joined for the resources that helped his new hospitalist program grow and for the access to people who were doing the same thing he was in his hospital. He also recognized the potential for networking and the sharing of ideas from such industry leaders as Bob Wachter, MD, MHM, and John Nelson, MD, MHM.
Since then, the membership benefits that Dr. Hawkins and more than 10,000 other hospitalists receive have evolved along with their careers and the specialty as a whole.
SHM membership and the HM specialty have become nearly synonymous to most hospitalists. “I can’t imagine a true hospitalist that wouldn’t be an SHM member,” Dr. Hawkins says. “Most of the hospitalists on my teams are members. As a company, we strongly encourage our physicians to be SHM members.”
Membership: The Basics
Hawkins’ enthusiasm for becoming an SHM member is no surprise to Todd Von Deak, MBA, CAE, vice president of operations and general manager for SHM.
“Thousands of hospitalists join SHM for the many tangible benefits like discounts or subscriptions to the Journal of Hospital Medicine and The Hospitalist,” Von Deak says.
As SHM has evolved, so have the benefits it offers to members. The original society publication sent to members was only four pages; today, members receive both The Hospitalist and the Journal of Hospital Medicine, one of the top peer-reviewed journals in healthcare—and the only peer-reviewed journal for HM.
A Hospitalist Voice on Capitol Hill
With the critical role that hospitals play in healthcare reform, members of Congress and others in Washington are eager to hear from experts like hospitalists. In May, members of SHM’s Public Policy Committee took their message directly to members of Congress. Hospitalists engaged in a series of one-on-one meetings with legislators, relating their personal experiences in patient care and QI to the continued public dialogue over healthcare reform.
In early June, SHM past president Scott Flanders, MD, SFHM, along with representatives of Blue Cross Blue Shield Michigan and the American Hospital Association, conducted a briefing with about 50 legislative aides. The briefing was intended to educate members of Congress and their staffs about Project BOOST and the need to reduce unplanned readmissions.
“Hospitalists bring a very important perspective to the policy conversation about improving healthcare in America,” says Eric Siegal, MD, SFHM, an SHM board member and former chair of the Public Policy Committee. “SHM helps to facilitate that conversation.”
Even if they can’t make it to Washington, SHM members can stay on top of the issues affecting them and make their opinions known, Dr. Siegal says. Members can use SHM’s Legislative Action Center in the advocacy section of www.hospitalmedicine.org to learn more about current legislation and activities by the members of Congress in their area. The Legislative Action Center also makes contacting members of Congress easy by supplying contact information and tips for effective outreach.
“This is an important time to be a hospitalist,” Siegal says. “As a unified society, we can influence decisions that will shape healthcare for decades to come.”
The evolution of services to members has helped members establish credibility with their peers. Last year, SHM introduced the Fellow in Hospital Medicine designation to its members. This year, it expanded the fellowship program to include the new Senior Fellow in Hospital Medicine and the Master in Hospital Medicine programs.
“Many of our members are younger than the average physician, and in an emerging specialty,” Von Deak says. “That’s why so many of SHM’s benefits help members to establish themselves within healthcare. Our fellowship program has only been around for two years and we’ve already inducted nearly 1,000 members.”
The products and events—all offered to members at reduced rates—have all grown with SHM and its members. This year’s annual meeting attracted more than 2,500 of the most dedicated hospitalists from around the world.
Eugene Chu, MD, FHM, hospitalist and director of hospital medicine at the Denver Health Medical Center, remembers when he first joined SHM eight years ago. At the time, he says the member discount for the annual meeting was one of the deciding factors. “Financially, it made a lot of sense. The meeting discount and the member fee were close,” he says. “I’m glad it did, as SHM has offered a lot of additional benefits since then.”
Join the Movement
Over time, Dr. Chu found that the discounts for events and products were just the beginning. He now sees value in the energy that SHM brings to its members.
“Being a member brings you into the community of hospitalists,” he says. “It’s hard to quantify, but every time I come back from the spring meeting, I come back really charged up and enthusiastic about where hospital medicine is going.”
Dr. Chu isn’t alone. Many hospitalists become SHM members for financial reasons but end up renewing for the intangibles, Von Deak says.
“As members, they discover a lot more: the ability to network with peers in a growing specialty, a unified voice on critical issues, and, above all, the feeling that they are part of a real movement made up of dedicated professionals just like them,” Von Deak says.
The movement is equal parts human capital and mission. In recent years, SHM members and leadership have created new quality-improvement (QI) programs that have benefited hospitals and patients alike. The Project BOOST (Better Outcomes for Older Adults through Safer Transitions) initiative, for example, is helping more than 60 hospitals improve their discharge processes. Programs like Project BOOST, which was created in 2008, have raised the profiles of both SHM and its members within hospitals and all of healthcare.
SHM members also have ample opportunities for leadership development; like the movement, those opportunities go beyond HM. SHM’s online resource centers and mentored QI programs bring the very best of the specialty to aspiring hospitalist leaders in hospitals across the country.
For Aziz Ansari, DO, an assistant professor in hospital medicine and associate director for Loyola University Medical Center’s hospital medicine practice in Chicago, joining SHM was part of the natural progression in his career. He became an SHM member near the end of his first year as a hospitalist. Since then, Ansari’s appreciation of SHM membership has changed.
“As I progressed into leadership positions in hospital medicine, I found that the society brings credibility to the specialty,” Dr. Ansari explains. “To be established, the society needs members.”
Dr. Ansari can’t imagine not being an active member. “In fact, I haven’t met a nonmember who is as invested in their career and the specialty as SHM’s members are,” he says. TH
Brendon Shank is a freelance writer based in Philadelphia.
Every year, hospitalists across the country receive SHM membership renewal notices in the mail. For the vast majority of them, the decision to renew is an easy one.
For the others, hospitalist Mike Hawkins, MD, FACP, FHM, recommends a tried-and-true approach in the field: Evaluate the risk-to-benefit ratio.
“As they say in medicine, the risk-to-benefit ratio is a no-brainer,” says Dr. Hawkins, the Southeast region medical director for Brentwood, Tenn.-based Cogent Healthcare.
Dr. Hawkins should know about membership benefits; he’s been an SHM member since 1996. In fact, he was one of the first 200 members of SHM’s original incarnation, the National Association of Inpatient Physicians. He joined for the resources that helped his new hospitalist program grow and for the access to people who were doing the same thing he was in his hospital. He also recognized the potential for networking and the sharing of ideas from such industry leaders as Bob Wachter, MD, MHM, and John Nelson, MD, MHM.
Since then, the membership benefits that Dr. Hawkins and more than 10,000 other hospitalists receive have evolved along with their careers and the specialty as a whole.
SHM membership and the HM specialty have become nearly synonymous to most hospitalists. “I can’t imagine a true hospitalist that wouldn’t be an SHM member,” Dr. Hawkins says. “Most of the hospitalists on my teams are members. As a company, we strongly encourage our physicians to be SHM members.”
Membership: The Basics
Hawkins’ enthusiasm for becoming an SHM member is no surprise to Todd Von Deak, MBA, CAE, vice president of operations and general manager for SHM.
“Thousands of hospitalists join SHM for the many tangible benefits like discounts or subscriptions to the Journal of Hospital Medicine and The Hospitalist,” Von Deak says.
As SHM has evolved, so have the benefits it offers to members. The original society publication sent to members was only four pages; today, members receive both The Hospitalist and the Journal of Hospital Medicine, one of the top peer-reviewed journals in healthcare—and the only peer-reviewed journal for HM.
A Hospitalist Voice on Capitol Hill
With the critical role that hospitals play in healthcare reform, members of Congress and others in Washington are eager to hear from experts like hospitalists. In May, members of SHM’s Public Policy Committee took their message directly to members of Congress. Hospitalists engaged in a series of one-on-one meetings with legislators, relating their personal experiences in patient care and QI to the continued public dialogue over healthcare reform.
In early June, SHM past president Scott Flanders, MD, SFHM, along with representatives of Blue Cross Blue Shield Michigan and the American Hospital Association, conducted a briefing with about 50 legislative aides. The briefing was intended to educate members of Congress and their staffs about Project BOOST and the need to reduce unplanned readmissions.
“Hospitalists bring a very important perspective to the policy conversation about improving healthcare in America,” says Eric Siegal, MD, SFHM, an SHM board member and former chair of the Public Policy Committee. “SHM helps to facilitate that conversation.”
Even if they can’t make it to Washington, SHM members can stay on top of the issues affecting them and make their opinions known, Dr. Siegal says. Members can use SHM’s Legislative Action Center in the advocacy section of www.hospitalmedicine.org to learn more about current legislation and activities by the members of Congress in their area. The Legislative Action Center also makes contacting members of Congress easy by supplying contact information and tips for effective outreach.
“This is an important time to be a hospitalist,” Siegal says. “As a unified society, we can influence decisions that will shape healthcare for decades to come.”
The evolution of services to members has helped members establish credibility with their peers. Last year, SHM introduced the Fellow in Hospital Medicine designation to its members. This year, it expanded the fellowship program to include the new Senior Fellow in Hospital Medicine and the Master in Hospital Medicine programs.
“Many of our members are younger than the average physician, and in an emerging specialty,” Von Deak says. “That’s why so many of SHM’s benefits help members to establish themselves within healthcare. Our fellowship program has only been around for two years and we’ve already inducted nearly 1,000 members.”
The products and events—all offered to members at reduced rates—have all grown with SHM and its members. This year’s annual meeting attracted more than 2,500 of the most dedicated hospitalists from around the world.
Eugene Chu, MD, FHM, hospitalist and director of hospital medicine at the Denver Health Medical Center, remembers when he first joined SHM eight years ago. At the time, he says the member discount for the annual meeting was one of the deciding factors. “Financially, it made a lot of sense. The meeting discount and the member fee were close,” he says. “I’m glad it did, as SHM has offered a lot of additional benefits since then.”
Join the Movement
Over time, Dr. Chu found that the discounts for events and products were just the beginning. He now sees value in the energy that SHM brings to its members.
“Being a member brings you into the community of hospitalists,” he says. “It’s hard to quantify, but every time I come back from the spring meeting, I come back really charged up and enthusiastic about where hospital medicine is going.”
Dr. Chu isn’t alone. Many hospitalists become SHM members for financial reasons but end up renewing for the intangibles, Von Deak says.
“As members, they discover a lot more: the ability to network with peers in a growing specialty, a unified voice on critical issues, and, above all, the feeling that they are part of a real movement made up of dedicated professionals just like them,” Von Deak says.
The movement is equal parts human capital and mission. In recent years, SHM members and leadership have created new quality-improvement (QI) programs that have benefited hospitals and patients alike. The Project BOOST (Better Outcomes for Older Adults through Safer Transitions) initiative, for example, is helping more than 60 hospitals improve their discharge processes. Programs like Project BOOST, which was created in 2008, have raised the profiles of both SHM and its members within hospitals and all of healthcare.
SHM members also have ample opportunities for leadership development; like the movement, those opportunities go beyond HM. SHM’s online resource centers and mentored QI programs bring the very best of the specialty to aspiring hospitalist leaders in hospitals across the country.
For Aziz Ansari, DO, an assistant professor in hospital medicine and associate director for Loyola University Medical Center’s hospital medicine practice in Chicago, joining SHM was part of the natural progression in his career. He became an SHM member near the end of his first year as a hospitalist. Since then, Ansari’s appreciation of SHM membership has changed.
“As I progressed into leadership positions in hospital medicine, I found that the society brings credibility to the specialty,” Dr. Ansari explains. “To be established, the society needs members.”
Dr. Ansari can’t imagine not being an active member. “In fact, I haven’t met a nonmember who is as invested in their career and the specialty as SHM’s members are,” he says. TH
Brendon Shank is a freelance writer based in Philadelphia.
Every year, hospitalists across the country receive SHM membership renewal notices in the mail. For the vast majority of them, the decision to renew is an easy one.
For the others, hospitalist Mike Hawkins, MD, FACP, FHM, recommends a tried-and-true approach in the field: Evaluate the risk-to-benefit ratio.
“As they say in medicine, the risk-to-benefit ratio is a no-brainer,” says Dr. Hawkins, the Southeast region medical director for Brentwood, Tenn.-based Cogent Healthcare.
Dr. Hawkins should know about membership benefits; he’s been an SHM member since 1996. In fact, he was one of the first 200 members of SHM’s original incarnation, the National Association of Inpatient Physicians. He joined for the resources that helped his new hospitalist program grow and for the access to people who were doing the same thing he was in his hospital. He also recognized the potential for networking and the sharing of ideas from such industry leaders as Bob Wachter, MD, MHM, and John Nelson, MD, MHM.
Since then, the membership benefits that Dr. Hawkins and more than 10,000 other hospitalists receive have evolved along with their careers and the specialty as a whole.
SHM membership and the HM specialty have become nearly synonymous to most hospitalists. “I can’t imagine a true hospitalist that wouldn’t be an SHM member,” Dr. Hawkins says. “Most of the hospitalists on my teams are members. As a company, we strongly encourage our physicians to be SHM members.”
Membership: The Basics
Hawkins’ enthusiasm for becoming an SHM member is no surprise to Todd Von Deak, MBA, CAE, vice president of operations and general manager for SHM.
“Thousands of hospitalists join SHM for the many tangible benefits like discounts or subscriptions to the Journal of Hospital Medicine and The Hospitalist,” Von Deak says.
As SHM has evolved, so have the benefits it offers to members. The original society publication sent to members was only four pages; today, members receive both The Hospitalist and the Journal of Hospital Medicine, one of the top peer-reviewed journals in healthcare—and the only peer-reviewed journal for HM.
A Hospitalist Voice on Capitol Hill
With the critical role that hospitals play in healthcare reform, members of Congress and others in Washington are eager to hear from experts like hospitalists. In May, members of SHM’s Public Policy Committee took their message directly to members of Congress. Hospitalists engaged in a series of one-on-one meetings with legislators, relating their personal experiences in patient care and QI to the continued public dialogue over healthcare reform.
In early June, SHM past president Scott Flanders, MD, SFHM, along with representatives of Blue Cross Blue Shield Michigan and the American Hospital Association, conducted a briefing with about 50 legislative aides. The briefing was intended to educate members of Congress and their staffs about Project BOOST and the need to reduce unplanned readmissions.
“Hospitalists bring a very important perspective to the policy conversation about improving healthcare in America,” says Eric Siegal, MD, SFHM, an SHM board member and former chair of the Public Policy Committee. “SHM helps to facilitate that conversation.”
Even if they can’t make it to Washington, SHM members can stay on top of the issues affecting them and make their opinions known, Dr. Siegal says. Members can use SHM’s Legislative Action Center in the advocacy section of www.hospitalmedicine.org to learn more about current legislation and activities by the members of Congress in their area. The Legislative Action Center also makes contacting members of Congress easy by supplying contact information and tips for effective outreach.
“This is an important time to be a hospitalist,” Siegal says. “As a unified society, we can influence decisions that will shape healthcare for decades to come.”
The evolution of services to members has helped members establish credibility with their peers. Last year, SHM introduced the Fellow in Hospital Medicine designation to its members. This year, it expanded the fellowship program to include the new Senior Fellow in Hospital Medicine and the Master in Hospital Medicine programs.
“Many of our members are younger than the average physician, and in an emerging specialty,” Von Deak says. “That’s why so many of SHM’s benefits help members to establish themselves within healthcare. Our fellowship program has only been around for two years and we’ve already inducted nearly 1,000 members.”
The products and events—all offered to members at reduced rates—have all grown with SHM and its members. This year’s annual meeting attracted more than 2,500 of the most dedicated hospitalists from around the world.
Eugene Chu, MD, FHM, hospitalist and director of hospital medicine at the Denver Health Medical Center, remembers when he first joined SHM eight years ago. At the time, he says the member discount for the annual meeting was one of the deciding factors. “Financially, it made a lot of sense. The meeting discount and the member fee were close,” he says. “I’m glad it did, as SHM has offered a lot of additional benefits since then.”
Join the Movement
Over time, Dr. Chu found that the discounts for events and products were just the beginning. He now sees value in the energy that SHM brings to its members.
“Being a member brings you into the community of hospitalists,” he says. “It’s hard to quantify, but every time I come back from the spring meeting, I come back really charged up and enthusiastic about where hospital medicine is going.”
Dr. Chu isn’t alone. Many hospitalists become SHM members for financial reasons but end up renewing for the intangibles, Von Deak says.
“As members, they discover a lot more: the ability to network with peers in a growing specialty, a unified voice on critical issues, and, above all, the feeling that they are part of a real movement made up of dedicated professionals just like them,” Von Deak says.
The movement is equal parts human capital and mission. In recent years, SHM members and leadership have created new quality-improvement (QI) programs that have benefited hospitals and patients alike. The Project BOOST (Better Outcomes for Older Adults through Safer Transitions) initiative, for example, is helping more than 60 hospitals improve their discharge processes. Programs like Project BOOST, which was created in 2008, have raised the profiles of both SHM and its members within hospitals and all of healthcare.
SHM members also have ample opportunities for leadership development; like the movement, those opportunities go beyond HM. SHM’s online resource centers and mentored QI programs bring the very best of the specialty to aspiring hospitalist leaders in hospitals across the country.
For Aziz Ansari, DO, an assistant professor in hospital medicine and associate director for Loyola University Medical Center’s hospital medicine practice in Chicago, joining SHM was part of the natural progression in his career. He became an SHM member near the end of his first year as a hospitalist. Since then, Ansari’s appreciation of SHM membership has changed.
“As I progressed into leadership positions in hospital medicine, I found that the society brings credibility to the specialty,” Dr. Ansari explains. “To be established, the society needs members.”
Dr. Ansari can’t imagine not being an active member. “In fact, I haven’t met a nonmember who is as invested in their career and the specialty as SHM’s members are,” he says. TH
Brendon Shank is a freelance writer based in Philadelphia.
In the Literature
In This Edition
Literature at a Glance
A guide to this month’s studies
- Risk factors for iatrogenic pneumothorax
- Residency acceptance and use of pharmaceutical industry funding
- Early cholecystectomy outcomes for gallstone pancreatitis
- Use of microbial DNA in sepsis
- Adding rifampicin to vancomycin in MRSA pneumonia
- Rate and outcomes of culture-negative severe sepsis
- Rates of surgical comanagement in U.S. hospitals
- Probiotics and rates of ventilator-associated pneumonia
Ultrasound Guidance and Operator Experience Decrease Risk of Pneumothorax Following Thoracentesis
Clinical question: How often does pneumothorax happen following thoracentesis, and what factors are associated with increased risk of this complication?
Background: Procedural complications are an important source of adverse events in the hospital. Iatrogenic pneumothorax after thoracentesis results in increased hospital length of stay, morbidity, and mortality. Large variation exists in reported pneumothorax rates, and little is known about procedure- and patient-specific factors associated with development of this complication.
Study design: Systematic review and meta-analysis.
Setting: Review of 24 MEDLINE-indexed studies from January 1966 to April 2009.
Synopsis: A total of 349 pneumothoraces were reported after 6,605 thoracenteses (overall incidence 6.0%). Chest-tube insertion was required in 34.1% of the cases. Risk for pneumothorax was significantly higher when larger needles or catheters were used compared with needles smaller than 20-gauge (odds ratio 2.5, 95% confidence interval [CI], 1.1-6.0) and after therapeutic thoracentesis compared with diagnostic procedures (OR 2.6, 95% CI, 1.8-3.8).
Procedures requiring two or more needle passes did not significantly increase pneumothorax risk (OR 2.5, 95% CI, 0.3-20.1). In contrast, pneumothorax rates were significantly lower when using ultrasound guidance (OR 0.3, 95% CI, 0.2-0.7) and with experienced operators (3.9% vs. 8.5%, P=0.04).
Examining patient risk factors, pneumothorax rates were similar regardless of effusion size and patient gender. Additionally, rates were similar among non-ICU inpatients, ICU inpatients, and outpatients. Data did show a trend toward increased risk of pneumothorax with mechanical ventilation (OR 4.0, 95% CI, 0.95-16.8), although no study directly compared rates in ICU patients with and without mechanical ventilation.
Bottom line: Ultrasound guidance is a modifiable factor that decreases the risk of post-thoracentesis pneumothorax. Pneumothorax rates are lower when performed by experienced clinicians, providing an important opportunity to reduce procedure-related complications by increasing direct trainee supervision.
Citation: Gordon CE, Feller-Kopman D, Balk EM, Smetana GW. Pneumothorax following thoracentesis: a systematic review and meta-analysis. Arch Intern Med. 2010;170(4):332-339.
Pharmaceutical Industry Support Is Common in U.S. Internal-Medicine Residency Programs
Clinical question: What are the current attitudes of program directors regarding pharmaceutical industry support of internal-medicine residency activities? What are the potential associations between program characteristics and acceptance of industry support?
Background: Increasing evidence suggests that interactions with the pharmaceutical industry influence physician attitudes and practices. Recently, the Association of American Medical Colleges (AAMC) proposed that academic medical centers prohibit the acceptance of all gifts and restrict access by pharmaceutical industry representatives.
Study design: Survey of U.S. internal-medicine residency program directors.
Setting: Web-based survey of residency program directors in 388 U.S. internal-medicine residency programs.
Synopsis: Of the 236 program directors responding to the survey, 132 (55.9%) reported accepting some kind of support from the pharmaceutical industry. Support was most commonly provided in the form of food for conferences (90.9%), educational materials (83.3%), office supplies (68.9%), and drug samples (57.6%).
When programs reported accepting pharmaceutical industry support, 67.9% cited a lack of other funding sources as the reason for acceptance. Only 22.7% of programs with a program director who thinks pharmaceutical support is unacceptable actually accepted industry support. The likelihood of accepting support was associated with location in the Southern U.S. and was inversely associated with the three-year rolling American Board of Internal Medicine (ABIM) pass rates (each 1% decrease in the pass rate was associated with a 21% increase in the odds of accepting pharmaceutical industry support).
Bottom line: While most program directors did not find pharmaceutical industry support desirable, more than half reported acceptance of such support, with most citing lack of other funding resources as the reason for acceptance.
Citation: Loertscher LL, Halvorsen AJ, Beasley BW, Holmboe ES, Kolars JC, McDonald FS. Pharmaceutical industry support and residency education: a survey of internal medicine program directors. Arch Intern Med. 2010;170(4):356-362.
Early Cholecystectomy Safely Decreases Hospital Stay in Patients with Mild Gallstone Pancreatitis
Clinical question: Can laparoscopic cholecystectomy performed within 48 hours of admission for mild gallstone pancreatitis reduce hospital length of stay without increasing perioperative complications?
Background: Although there is a clear consensus that patients who present with gallstone pancreatitis should undergo cholecystectomy to prevent recurrence, precise timing of surgery remains controversial.
Study design: Randomized prospective trial.
Setting: Harbor-UCLA Medical Center, a Los Angeles County public teaching hospital and Level I trauma center.
Synopsis: Patients were prospectively randomized to an early group and a control group. Inclusion criteria consisted of adults from the ages of 18 to 100 with mild gallstone pancreatitis and three or fewer Ranson criteria. The primary endpoint was length of hospital stay. The secondary endpoint was a composite of complications, including the need for conversion to open cholecystectomy, readmission within 30 days, bleeding requiring transfusion, bile duct injury, or wound infection.
The study was terminated after 50 patients, as there was a difference in the length of hospital stay with a predefined alpha level of 0.005. Patients in the early group were taken to the operating room at a mean of 35.1 hours after admission, compared with 77.8 hours in the control group. The overall length of hospital stay was shorter in the early group (mean 3.5 days, 95% CI, 2.7-4.3), compared with the control group (mean 5.8, 95% CI, 3.8-7.9). All cholecystectomies were completed laparoscopically, without conversion to open. No statistically significant difference existed in secondary endpoints (P=0.48, OR 1.66, 95% CI, 0.41-6.78).
Bottom line: Laparoscopic cholecystectomy performed within 48 hours of admission, irrespective of normalization of laboratory values or clinical progress, safely decreases the overall length of stay, compared with delaying laparoscopic cholecystectomy until laboratory values and clinical condition normalize.
Citation: Aboulian A, Chan T, Yaghoubian A, et al. Early cholecystectomy safely decreases hospital stay in patients with mild gallstone pancreatitis: a randomized prospective study. Ann Surg. 2010;251(4): 615-619.
Presence of Microbial DNA in Blood Correlates with Disease Severity
Clinical question: Is the presence of microbial DNA in the blood associated with disease severity in severe sepsis, and how does detection of this microbial DNA by polymerase chain reaction (PCR) compare with blood cultures (BC)?
Background: Inadequate antibiotic therapy is a strong and independent predictor of poor outcomes in sepsis. Diagnostic uncertainty regarding the causative micro-organism is compensated for by liberal use of broad-spectrum antibiotics. As a result, resistance to antibiotics is an increasing public-health problem.
Study design: Prospective multicenter controlled observational study.
Setting: Three ICUs in Germany and France.
Synopsis: From 2005 to 2007, 63 patients were enrolled in the control group and 142 patients were enrolled in the sepsis group. In control patients, blood cultures and specimens were drawn daily at a maximum of three days after admission. In the sepsis group, blood samples were obtained on the day severe sepsis was suspected. Consecutive samples for the next two days after study inclusion were taken.
Taking BC as the laboratory comparison method, the sensitivity of PCR to detect culture-positive bacteremia in sepsis was 0.80 with a specificity of 0.77. PCR detected 29 of 41 microorganisms (70.3%) found in the BC. The highest recovery rate was observed for gram-negative bacteria (78.6%), fungi (50.0%), and gram-positive bacteria (47.6%). PCR from septic patients correlated well with markers of host response (IL-6 and PCT) and disease severity (SOFA score), even when the BC remained negative.
The appropriateness of antimicrobial therapy based on culture-based methods was not recorded, so it’s impossible to conclude whether or not the PCR would have contributed to a more effective therapy.
Bottom line: Concordance between BC and PCR is moderate in septic patients. PCR-based pathogen detection correlated with disease severity even if the BC remained negative, suggesting that the presence of microbial DNA in the bloodstream is a clinically significant event.
Citation: Bloos F, Hinder F, Becker K, et al. A multicenter trial to compare blood culture with polymerase chain reaction in severe human sepsis. Intensive Care Med. 2010;36(2):241-247.
Adding Rifampicin to Vancomycin Improves Outcomes in MRSA Pneumonia
Clinical question: Does adding rifampicin to vancomycin improve outcomes in patients with hospital-acquired MRSA pneumonia?
Background: Hospital-acquired MRSA pneumonia has a mortality of more than 20%. Vancomycin penetrates the lung tissue poorly. The value of adding rifampicin, an antibiotic with broad-spectrum coverage and good tissue penetration, was investigated.
Study design: Randomized open-label trial.
Setting: Medical ICU patients at Ulsan College of Medicine, Asan Medical Center, South Korea.
Synopsis: Patients older than 18 years of age with clinical symptoms suggestive of nosocomial pneumonia were randomized to receive vancomycin alone (V) or vancomycin plus rifampicin (VR). Clinicians could add additional antibiotics for gram-negative coverage as needed.
Of the 183 patients screened, 93 met the inclusion criteria and were randomized in a 1:1 ratio. MRSA infection was microbiologically confirmed. Clinical cure rate in VR patients was significantly greater at day 14 compared with the V group (53.7% vs. 31.0%, P=0.047) based on a modified intention-to-treat model. The overall mortality at day 28 did not significantly differ between the groups (22.0% vs. 38.1%, P=0.15), although the 60-day mortality was lower in the VR group (26.8% vs. 50.0%, P=0.042). Mortality from MRSA pneumonia had a trend toward a decrease in the VR group (14.7% vs. 28.6%, P=0.18).
The trial was limited because it was a single-site study and lacked statistical power to assess certain outcomes. Additionally, treatment protocols were not compared with other antimicrobial therapies.
Bottom line: Vancomycin plus rifampicin improves MRSA pneumonia outcomes in ICU patients.
Citation: Jung YJ, Koh Y, Hong SB, et al. Effect of vancomycin plus rifampicin in the treatment of nosocomial MRSA pneumonia. Crit Care Med. 2010;38(1):175-180.
Severe Sepsis Syndromes Are Not Always Caused by Bacteremia
Clinical question: What are the common causes of clinical sepsis?
Background: When sepsis is defined by systemic inflammatory response syndrome (SIRS) criteria, the etiology is not always infectious. Rapid initiation of antimicrobial therapy for infectious SIRS is a priority, but it could result in treating a significant number of patients who are not bacteremic.
Study design: Prospective secondary analysis of a registry of patients created to evaluate an institutional standard-of-care protocol.
Setting: Urban, 850-bed, tertiary-care teaching institution in North Carolina.
Synopsis: ED cases meeting the criteria for severe sepsis underwent a secondary review that looked at the cause of the sepsis. Only 45% of patients identified as having severe sepsis were blood-culture-positive during that episode of care. The culture-positive group was more likely to have central lines, malignancies, or reside in a nursing home.
Of the subgroup of culture-negative patients, 52% had another infectious etiology, most commonly pneumonia. Other “noninfectious mimics,” including inflammatory colitis, myocardial infarction, and pulmonary embolism, were noted in 32% of patients in the subgroup, and the cause was not identified in 16% of the patients.
In-hospital mortality was higher in the culture-positive group than in the culture-negative group (25% vs. 4%, P=0.05). There was no evidence of harm in patients with culture-negative sepsis treated for a systemic infection.
Bottom line: Many patients with a clinical picture of severe sepsis will not have positive blood cultures or an infectious etiology.
Citation: Heffner AC, Horton JM, Marchick MR, Jones AE. Etiology of illness in patients with severe sepsis admitted to the hospital from the emergency department. Clin Infect Dis. 2010;50(6):814-820.
Comanagement of Surgical Inpatients by Hospitalists Is Rapidly Expanding
Clinical question: What is the prevalence and nature of comanagement of surgical patients by medicine physicians?
Background: Comanagement of surgical patients is a common clinical role for hospitalists, but the relationship is not well characterized in the literature in terms of numbers of patients or types of physicians involved in this practice.
Study design: Retrospective cohort.
Setting: Cross-section of hospitals from a Medicare database.
Synopsis: During the study period, 35.2% of patients were comanaged by a medicine physician—23.7% by a generalist and 14% by a subspecialist. Cardiothoracic surgery patients were more likely to be comanaged by a subspecialist, whereas all other patients were more likely to be comanaged by a generalist.
Although subspecialist comanagement actually declined during the study period, overall comanagement increased from 33.3% in 1996 to 40.8% in 2006. This increase is entirely attributable to the increase in comanagement by hospitalists. Most of this growth occurred with orthopedic patients.
Patient factors associated with comanagement include advanced age, emergency admissions, and increasing comorbidities. Teaching hospitals had less comanagement, while midsize, nonteaching, and for-profit hospitals had more comanagement.
Bottom line: Comanagement of surgical patients by medicine physicians is a common and growing clinical relationship. Hospitalists are responsible for increasing numbers of comanaged surgical patients.
Citation: Sharma G, Kuo YF, Freeman J, Zhang DD, Goodwin JS. Comanagement of hospitalized surgical patients by medicine physicians in the United States. Arch Intern Med. 2010;170(4):363-368.
Probiotics Might Decrease Risk of Ventilator-Associated Pneumonia
Clinical question: Does the administration of probiotics decrease the incidence of ventilator-associated pneumonia in critically ill patients?
Background: Ventilator-associated pneumonia (VAP) is a major nosocomial infection in ICUs. Probiotics are thought to decrease colonization and, therefore, infection with serious hospital-acquired pathogens.
Study design: Meta-analysis of five randomized controlled trials.
Setting: ICU patients on mechanical ventilation for at least 24 hours.
Synopsis: Five trials met the inclusion criteria of comparing probiotics to placebo in critically ill patients on mechanical ventilation and reporting the outcome of VAP. Administration of probiotics decreased the incidence of VAP (odds ratio 0.61, 95% CI, 0.41-0.91) and colonization of the respiratory tract with Pseudomonas aeruginosa (OR 0.35, 95% CI, 0.13-0.93).
Length of ICU stay was decreased in the probiotic arm, although this effect was not statistically significant in all analyses. Probiotics had no effect on such outcomes as ICU mortality, in-hospital mortality, or duration of mechanical ventilation.
Bottom line: Probiotics might be an effective strategy to reduce the risk of VAP, even if they do not appear to impact such outcomes as mortality.
Citation: Siempos II, Ntaidou TK, Falagas ME. Impact of the administration of probiotics on the incidence of ventilator-associated pneumonia: a meta-analysis of randomized controlled trials. Crit Care Med. 2010;38(3):954-962. TH
PEDIATRIC HM LITERATURE
By Mark Shen, MD
Renal Ultrasound Identifies Children with High-Grade Vesicoureteral Reflux
Clinical question: What is the diagnostic accuracy of specific renal ultrasound (US) criterion for detection of vesicoureteral reflux (VUR)?
Background: Based on the paradigm that undetected and untreated VUR might lead to long-term complications, voiding cystography traditionally has been recommended for all young children with a first urinary tract infection (UTI). An increasing base of evidence suggests that antibiotic prophylaxis for low-grade VUR might be unnecessary. However, less-invasive methods of screening for high-grade reflux have not yet been identified.
Study design: Secondary analysis of data from a prior prospective study.
Setting: Nephrology department of a French teaching hospital.
Synopsis: One hundred seventeen children (0-16 years) with a UTI were included and underwent renal US and voiding cystography. Patients with a known uropathy or those who had received antibiotics within the past 48 hours were excluded. A generalized linear multilevel model was used to analyze the relationship between standardized renal US criterion and VUR.
Twenty-seven percent of children had VUR and 8% had high-grade VUR (grade ≥3). Pelvic, ureteral, and urinary tract dilatation were significantly associated with high-grade VUR. Ureteral dilatation offered the best combination of standardized criterion, sensitivity (75%), and specificity (88%).
Significant limitations of this study include the use of bag urine cultures and the lack of consensus-based US criterion for ureteral and pelvic dilatation. The authors appropriately caution that these renal US criteria do not identify all children with high-grade VUR and are merely one step toward an intermediate screening strategy for high-grade VUR in order to mitigate adverse effects of universal voiding cystography. Further validation of this work in a clinically representative population will be needed.
Bottom line: Ureteral dilatation accurately identifies children with high-grade VUR.
Citation: Leroy S, Vantalon S, Larakeb A, Ducou-Le-Pointe H, Bensman A. Vesicoureteral reflux in children with urinary tract infection: comparison of diagnostic accuracy of renal US criteria. Radiology. 2010;255(3):890-898.
In This Edition
Literature at a Glance
A guide to this month’s studies
- Risk factors for iatrogenic pneumothorax
- Residency acceptance and use of pharmaceutical industry funding
- Early cholecystectomy outcomes for gallstone pancreatitis
- Use of microbial DNA in sepsis
- Adding rifampicin to vancomycin in MRSA pneumonia
- Rate and outcomes of culture-negative severe sepsis
- Rates of surgical comanagement in U.S. hospitals
- Probiotics and rates of ventilator-associated pneumonia
Ultrasound Guidance and Operator Experience Decrease Risk of Pneumothorax Following Thoracentesis
Clinical question: How often does pneumothorax happen following thoracentesis, and what factors are associated with increased risk of this complication?
Background: Procedural complications are an important source of adverse events in the hospital. Iatrogenic pneumothorax after thoracentesis results in increased hospital length of stay, morbidity, and mortality. Large variation exists in reported pneumothorax rates, and little is known about procedure- and patient-specific factors associated with development of this complication.
Study design: Systematic review and meta-analysis.
Setting: Review of 24 MEDLINE-indexed studies from January 1966 to April 2009.
Synopsis: A total of 349 pneumothoraces were reported after 6,605 thoracenteses (overall incidence 6.0%). Chest-tube insertion was required in 34.1% of the cases. Risk for pneumothorax was significantly higher when larger needles or catheters were used compared with needles smaller than 20-gauge (odds ratio 2.5, 95% confidence interval [CI], 1.1-6.0) and after therapeutic thoracentesis compared with diagnostic procedures (OR 2.6, 95% CI, 1.8-3.8).
Procedures requiring two or more needle passes did not significantly increase pneumothorax risk (OR 2.5, 95% CI, 0.3-20.1). In contrast, pneumothorax rates were significantly lower when using ultrasound guidance (OR 0.3, 95% CI, 0.2-0.7) and with experienced operators (3.9% vs. 8.5%, P=0.04).
Examining patient risk factors, pneumothorax rates were similar regardless of effusion size and patient gender. Additionally, rates were similar among non-ICU inpatients, ICU inpatients, and outpatients. Data did show a trend toward increased risk of pneumothorax with mechanical ventilation (OR 4.0, 95% CI, 0.95-16.8), although no study directly compared rates in ICU patients with and without mechanical ventilation.
Bottom line: Ultrasound guidance is a modifiable factor that decreases the risk of post-thoracentesis pneumothorax. Pneumothorax rates are lower when performed by experienced clinicians, providing an important opportunity to reduce procedure-related complications by increasing direct trainee supervision.
Citation: Gordon CE, Feller-Kopman D, Balk EM, Smetana GW. Pneumothorax following thoracentesis: a systematic review and meta-analysis. Arch Intern Med. 2010;170(4):332-339.
Pharmaceutical Industry Support Is Common in U.S. Internal-Medicine Residency Programs
Clinical question: What are the current attitudes of program directors regarding pharmaceutical industry support of internal-medicine residency activities? What are the potential associations between program characteristics and acceptance of industry support?
Background: Increasing evidence suggests that interactions with the pharmaceutical industry influence physician attitudes and practices. Recently, the Association of American Medical Colleges (AAMC) proposed that academic medical centers prohibit the acceptance of all gifts and restrict access by pharmaceutical industry representatives.
Study design: Survey of U.S. internal-medicine residency program directors.
Setting: Web-based survey of residency program directors in 388 U.S. internal-medicine residency programs.
Synopsis: Of the 236 program directors responding to the survey, 132 (55.9%) reported accepting some kind of support from the pharmaceutical industry. Support was most commonly provided in the form of food for conferences (90.9%), educational materials (83.3%), office supplies (68.9%), and drug samples (57.6%).
When programs reported accepting pharmaceutical industry support, 67.9% cited a lack of other funding sources as the reason for acceptance. Only 22.7% of programs with a program director who thinks pharmaceutical support is unacceptable actually accepted industry support. The likelihood of accepting support was associated with location in the Southern U.S. and was inversely associated with the three-year rolling American Board of Internal Medicine (ABIM) pass rates (each 1% decrease in the pass rate was associated with a 21% increase in the odds of accepting pharmaceutical industry support).
Bottom line: While most program directors did not find pharmaceutical industry support desirable, more than half reported acceptance of such support, with most citing lack of other funding resources as the reason for acceptance.
Citation: Loertscher LL, Halvorsen AJ, Beasley BW, Holmboe ES, Kolars JC, McDonald FS. Pharmaceutical industry support and residency education: a survey of internal medicine program directors. Arch Intern Med. 2010;170(4):356-362.
Early Cholecystectomy Safely Decreases Hospital Stay in Patients with Mild Gallstone Pancreatitis
Clinical question: Can laparoscopic cholecystectomy performed within 48 hours of admission for mild gallstone pancreatitis reduce hospital length of stay without increasing perioperative complications?
Background: Although there is a clear consensus that patients who present with gallstone pancreatitis should undergo cholecystectomy to prevent recurrence, precise timing of surgery remains controversial.
Study design: Randomized prospective trial.
Setting: Harbor-UCLA Medical Center, a Los Angeles County public teaching hospital and Level I trauma center.
Synopsis: Patients were prospectively randomized to an early group and a control group. Inclusion criteria consisted of adults from the ages of 18 to 100 with mild gallstone pancreatitis and three or fewer Ranson criteria. The primary endpoint was length of hospital stay. The secondary endpoint was a composite of complications, including the need for conversion to open cholecystectomy, readmission within 30 days, bleeding requiring transfusion, bile duct injury, or wound infection.
The study was terminated after 50 patients, as there was a difference in the length of hospital stay with a predefined alpha level of 0.005. Patients in the early group were taken to the operating room at a mean of 35.1 hours after admission, compared with 77.8 hours in the control group. The overall length of hospital stay was shorter in the early group (mean 3.5 days, 95% CI, 2.7-4.3), compared with the control group (mean 5.8, 95% CI, 3.8-7.9). All cholecystectomies were completed laparoscopically, without conversion to open. No statistically significant difference existed in secondary endpoints (P=0.48, OR 1.66, 95% CI, 0.41-6.78).
Bottom line: Laparoscopic cholecystectomy performed within 48 hours of admission, irrespective of normalization of laboratory values or clinical progress, safely decreases the overall length of stay, compared with delaying laparoscopic cholecystectomy until laboratory values and clinical condition normalize.
Citation: Aboulian A, Chan T, Yaghoubian A, et al. Early cholecystectomy safely decreases hospital stay in patients with mild gallstone pancreatitis: a randomized prospective study. Ann Surg. 2010;251(4): 615-619.
Presence of Microbial DNA in Blood Correlates with Disease Severity
Clinical question: Is the presence of microbial DNA in the blood associated with disease severity in severe sepsis, and how does detection of this microbial DNA by polymerase chain reaction (PCR) compare with blood cultures (BC)?
Background: Inadequate antibiotic therapy is a strong and independent predictor of poor outcomes in sepsis. Diagnostic uncertainty regarding the causative micro-organism is compensated for by liberal use of broad-spectrum antibiotics. As a result, resistance to antibiotics is an increasing public-health problem.
Study design: Prospective multicenter controlled observational study.
Setting: Three ICUs in Germany and France.
Synopsis: From 2005 to 2007, 63 patients were enrolled in the control group and 142 patients were enrolled in the sepsis group. In control patients, blood cultures and specimens were drawn daily at a maximum of three days after admission. In the sepsis group, blood samples were obtained on the day severe sepsis was suspected. Consecutive samples for the next two days after study inclusion were taken.
Taking BC as the laboratory comparison method, the sensitivity of PCR to detect culture-positive bacteremia in sepsis was 0.80 with a specificity of 0.77. PCR detected 29 of 41 microorganisms (70.3%) found in the BC. The highest recovery rate was observed for gram-negative bacteria (78.6%), fungi (50.0%), and gram-positive bacteria (47.6%). PCR from septic patients correlated well with markers of host response (IL-6 and PCT) and disease severity (SOFA score), even when the BC remained negative.
The appropriateness of antimicrobial therapy based on culture-based methods was not recorded, so it’s impossible to conclude whether or not the PCR would have contributed to a more effective therapy.
Bottom line: Concordance between BC and PCR is moderate in septic patients. PCR-based pathogen detection correlated with disease severity even if the BC remained negative, suggesting that the presence of microbial DNA in the bloodstream is a clinically significant event.
Citation: Bloos F, Hinder F, Becker K, et al. A multicenter trial to compare blood culture with polymerase chain reaction in severe human sepsis. Intensive Care Med. 2010;36(2):241-247.
Adding Rifampicin to Vancomycin Improves Outcomes in MRSA Pneumonia
Clinical question: Does adding rifampicin to vancomycin improve outcomes in patients with hospital-acquired MRSA pneumonia?
Background: Hospital-acquired MRSA pneumonia has a mortality of more than 20%. Vancomycin penetrates the lung tissue poorly. The value of adding rifampicin, an antibiotic with broad-spectrum coverage and good tissue penetration, was investigated.
Study design: Randomized open-label trial.
Setting: Medical ICU patients at Ulsan College of Medicine, Asan Medical Center, South Korea.
Synopsis: Patients older than 18 years of age with clinical symptoms suggestive of nosocomial pneumonia were randomized to receive vancomycin alone (V) or vancomycin plus rifampicin (VR). Clinicians could add additional antibiotics for gram-negative coverage as needed.
Of the 183 patients screened, 93 met the inclusion criteria and were randomized in a 1:1 ratio. MRSA infection was microbiologically confirmed. Clinical cure rate in VR patients was significantly greater at day 14 compared with the V group (53.7% vs. 31.0%, P=0.047) based on a modified intention-to-treat model. The overall mortality at day 28 did not significantly differ between the groups (22.0% vs. 38.1%, P=0.15), although the 60-day mortality was lower in the VR group (26.8% vs. 50.0%, P=0.042). Mortality from MRSA pneumonia had a trend toward a decrease in the VR group (14.7% vs. 28.6%, P=0.18).
The trial was limited because it was a single-site study and lacked statistical power to assess certain outcomes. Additionally, treatment protocols were not compared with other antimicrobial therapies.
Bottom line: Vancomycin plus rifampicin improves MRSA pneumonia outcomes in ICU patients.
Citation: Jung YJ, Koh Y, Hong SB, et al. Effect of vancomycin plus rifampicin in the treatment of nosocomial MRSA pneumonia. Crit Care Med. 2010;38(1):175-180.
Severe Sepsis Syndromes Are Not Always Caused by Bacteremia
Clinical question: What are the common causes of clinical sepsis?
Background: When sepsis is defined by systemic inflammatory response syndrome (SIRS) criteria, the etiology is not always infectious. Rapid initiation of antimicrobial therapy for infectious SIRS is a priority, but it could result in treating a significant number of patients who are not bacteremic.
Study design: Prospective secondary analysis of a registry of patients created to evaluate an institutional standard-of-care protocol.
Setting: Urban, 850-bed, tertiary-care teaching institution in North Carolina.
Synopsis: ED cases meeting the criteria for severe sepsis underwent a secondary review that looked at the cause of the sepsis. Only 45% of patients identified as having severe sepsis were blood-culture-positive during that episode of care. The culture-positive group was more likely to have central lines, malignancies, or reside in a nursing home.
Of the subgroup of culture-negative patients, 52% had another infectious etiology, most commonly pneumonia. Other “noninfectious mimics,” including inflammatory colitis, myocardial infarction, and pulmonary embolism, were noted in 32% of patients in the subgroup, and the cause was not identified in 16% of the patients.
In-hospital mortality was higher in the culture-positive group than in the culture-negative group (25% vs. 4%, P=0.05). There was no evidence of harm in patients with culture-negative sepsis treated for a systemic infection.
Bottom line: Many patients with a clinical picture of severe sepsis will not have positive blood cultures or an infectious etiology.
Citation: Heffner AC, Horton JM, Marchick MR, Jones AE. Etiology of illness in patients with severe sepsis admitted to the hospital from the emergency department. Clin Infect Dis. 2010;50(6):814-820.
Comanagement of Surgical Inpatients by Hospitalists Is Rapidly Expanding
Clinical question: What is the prevalence and nature of comanagement of surgical patients by medicine physicians?
Background: Comanagement of surgical patients is a common clinical role for hospitalists, but the relationship is not well characterized in the literature in terms of numbers of patients or types of physicians involved in this practice.
Study design: Retrospective cohort.
Setting: Cross-section of hospitals from a Medicare database.
Synopsis: During the study period, 35.2% of patients were comanaged by a medicine physician—23.7% by a generalist and 14% by a subspecialist. Cardiothoracic surgery patients were more likely to be comanaged by a subspecialist, whereas all other patients were more likely to be comanaged by a generalist.
Although subspecialist comanagement actually declined during the study period, overall comanagement increased from 33.3% in 1996 to 40.8% in 2006. This increase is entirely attributable to the increase in comanagement by hospitalists. Most of this growth occurred with orthopedic patients.
Patient factors associated with comanagement include advanced age, emergency admissions, and increasing comorbidities. Teaching hospitals had less comanagement, while midsize, nonteaching, and for-profit hospitals had more comanagement.
Bottom line: Comanagement of surgical patients by medicine physicians is a common and growing clinical relationship. Hospitalists are responsible for increasing numbers of comanaged surgical patients.
Citation: Sharma G, Kuo YF, Freeman J, Zhang DD, Goodwin JS. Comanagement of hospitalized surgical patients by medicine physicians in the United States. Arch Intern Med. 2010;170(4):363-368.
Probiotics Might Decrease Risk of Ventilator-Associated Pneumonia
Clinical question: Does the administration of probiotics decrease the incidence of ventilator-associated pneumonia in critically ill patients?
Background: Ventilator-associated pneumonia (VAP) is a major nosocomial infection in ICUs. Probiotics are thought to decrease colonization and, therefore, infection with serious hospital-acquired pathogens.
Study design: Meta-analysis of five randomized controlled trials.
Setting: ICU patients on mechanical ventilation for at least 24 hours.
Synopsis: Five trials met the inclusion criteria of comparing probiotics to placebo in critically ill patients on mechanical ventilation and reporting the outcome of VAP. Administration of probiotics decreased the incidence of VAP (odds ratio 0.61, 95% CI, 0.41-0.91) and colonization of the respiratory tract with Pseudomonas aeruginosa (OR 0.35, 95% CI, 0.13-0.93).
Length of ICU stay was decreased in the probiotic arm, although this effect was not statistically significant in all analyses. Probiotics had no effect on such outcomes as ICU mortality, in-hospital mortality, or duration of mechanical ventilation.
Bottom line: Probiotics might be an effective strategy to reduce the risk of VAP, even if they do not appear to impact such outcomes as mortality.
Citation: Siempos II, Ntaidou TK, Falagas ME. Impact of the administration of probiotics on the incidence of ventilator-associated pneumonia: a meta-analysis of randomized controlled trials. Crit Care Med. 2010;38(3):954-962. TH
PEDIATRIC HM LITERATURE
By Mark Shen, MD
Renal Ultrasound Identifies Children with High-Grade Vesicoureteral Reflux
Clinical question: What is the diagnostic accuracy of specific renal ultrasound (US) criterion for detection of vesicoureteral reflux (VUR)?
Background: Based on the paradigm that undetected and untreated VUR might lead to long-term complications, voiding cystography traditionally has been recommended for all young children with a first urinary tract infection (UTI). An increasing base of evidence suggests that antibiotic prophylaxis for low-grade VUR might be unnecessary. However, less-invasive methods of screening for high-grade reflux have not yet been identified.
Study design: Secondary analysis of data from a prior prospective study.
Setting: Nephrology department of a French teaching hospital.
Synopsis: One hundred seventeen children (0-16 years) with a UTI were included and underwent renal US and voiding cystography. Patients with a known uropathy or those who had received antibiotics within the past 48 hours were excluded. A generalized linear multilevel model was used to analyze the relationship between standardized renal US criterion and VUR.
Twenty-seven percent of children had VUR and 8% had high-grade VUR (grade ≥3). Pelvic, ureteral, and urinary tract dilatation were significantly associated with high-grade VUR. Ureteral dilatation offered the best combination of standardized criterion, sensitivity (75%), and specificity (88%).
Significant limitations of this study include the use of bag urine cultures and the lack of consensus-based US criterion for ureteral and pelvic dilatation. The authors appropriately caution that these renal US criteria do not identify all children with high-grade VUR and are merely one step toward an intermediate screening strategy for high-grade VUR in order to mitigate adverse effects of universal voiding cystography. Further validation of this work in a clinically representative population will be needed.
Bottom line: Ureteral dilatation accurately identifies children with high-grade VUR.
Citation: Leroy S, Vantalon S, Larakeb A, Ducou-Le-Pointe H, Bensman A. Vesicoureteral reflux in children with urinary tract infection: comparison of diagnostic accuracy of renal US criteria. Radiology. 2010;255(3):890-898.
In This Edition
Literature at a Glance
A guide to this month’s studies
- Risk factors for iatrogenic pneumothorax
- Residency acceptance and use of pharmaceutical industry funding
- Early cholecystectomy outcomes for gallstone pancreatitis
- Use of microbial DNA in sepsis
- Adding rifampicin to vancomycin in MRSA pneumonia
- Rate and outcomes of culture-negative severe sepsis
- Rates of surgical comanagement in U.S. hospitals
- Probiotics and rates of ventilator-associated pneumonia
Ultrasound Guidance and Operator Experience Decrease Risk of Pneumothorax Following Thoracentesis
Clinical question: How often does pneumothorax happen following thoracentesis, and what factors are associated with increased risk of this complication?
Background: Procedural complications are an important source of adverse events in the hospital. Iatrogenic pneumothorax after thoracentesis results in increased hospital length of stay, morbidity, and mortality. Large variation exists in reported pneumothorax rates, and little is known about procedure- and patient-specific factors associated with development of this complication.
Study design: Systematic review and meta-analysis.
Setting: Review of 24 MEDLINE-indexed studies from January 1966 to April 2009.
Synopsis: A total of 349 pneumothoraces were reported after 6,605 thoracenteses (overall incidence 6.0%). Chest-tube insertion was required in 34.1% of the cases. Risk for pneumothorax was significantly higher when larger needles or catheters were used compared with needles smaller than 20-gauge (odds ratio 2.5, 95% confidence interval [CI], 1.1-6.0) and after therapeutic thoracentesis compared with diagnostic procedures (OR 2.6, 95% CI, 1.8-3.8).
Procedures requiring two or more needle passes did not significantly increase pneumothorax risk (OR 2.5, 95% CI, 0.3-20.1). In contrast, pneumothorax rates were significantly lower when using ultrasound guidance (OR 0.3, 95% CI, 0.2-0.7) and with experienced operators (3.9% vs. 8.5%, P=0.04).
Examining patient risk factors, pneumothorax rates were similar regardless of effusion size and patient gender. Additionally, rates were similar among non-ICU inpatients, ICU inpatients, and outpatients. Data did show a trend toward increased risk of pneumothorax with mechanical ventilation (OR 4.0, 95% CI, 0.95-16.8), although no study directly compared rates in ICU patients with and without mechanical ventilation.
Bottom line: Ultrasound guidance is a modifiable factor that decreases the risk of post-thoracentesis pneumothorax. Pneumothorax rates are lower when performed by experienced clinicians, providing an important opportunity to reduce procedure-related complications by increasing direct trainee supervision.
Citation: Gordon CE, Feller-Kopman D, Balk EM, Smetana GW. Pneumothorax following thoracentesis: a systematic review and meta-analysis. Arch Intern Med. 2010;170(4):332-339.
Pharmaceutical Industry Support Is Common in U.S. Internal-Medicine Residency Programs
Clinical question: What are the current attitudes of program directors regarding pharmaceutical industry support of internal-medicine residency activities? What are the potential associations between program characteristics and acceptance of industry support?
Background: Increasing evidence suggests that interactions with the pharmaceutical industry influence physician attitudes and practices. Recently, the Association of American Medical Colleges (AAMC) proposed that academic medical centers prohibit the acceptance of all gifts and restrict access by pharmaceutical industry representatives.
Study design: Survey of U.S. internal-medicine residency program directors.
Setting: Web-based survey of residency program directors in 388 U.S. internal-medicine residency programs.
Synopsis: Of the 236 program directors responding to the survey, 132 (55.9%) reported accepting some kind of support from the pharmaceutical industry. Support was most commonly provided in the form of food for conferences (90.9%), educational materials (83.3%), office supplies (68.9%), and drug samples (57.6%).
When programs reported accepting pharmaceutical industry support, 67.9% cited a lack of other funding sources as the reason for acceptance. Only 22.7% of programs with a program director who thinks pharmaceutical support is unacceptable actually accepted industry support. The likelihood of accepting support was associated with location in the Southern U.S. and was inversely associated with the three-year rolling American Board of Internal Medicine (ABIM) pass rates (each 1% decrease in the pass rate was associated with a 21% increase in the odds of accepting pharmaceutical industry support).
Bottom line: While most program directors did not find pharmaceutical industry support desirable, more than half reported acceptance of such support, with most citing lack of other funding resources as the reason for acceptance.
Citation: Loertscher LL, Halvorsen AJ, Beasley BW, Holmboe ES, Kolars JC, McDonald FS. Pharmaceutical industry support and residency education: a survey of internal medicine program directors. Arch Intern Med. 2010;170(4):356-362.
Early Cholecystectomy Safely Decreases Hospital Stay in Patients with Mild Gallstone Pancreatitis
Clinical question: Can laparoscopic cholecystectomy performed within 48 hours of admission for mild gallstone pancreatitis reduce hospital length of stay without increasing perioperative complications?
Background: Although there is a clear consensus that patients who present with gallstone pancreatitis should undergo cholecystectomy to prevent recurrence, precise timing of surgery remains controversial.
Study design: Randomized prospective trial.
Setting: Harbor-UCLA Medical Center, a Los Angeles County public teaching hospital and Level I trauma center.
Synopsis: Patients were prospectively randomized to an early group and a control group. Inclusion criteria consisted of adults from the ages of 18 to 100 with mild gallstone pancreatitis and three or fewer Ranson criteria. The primary endpoint was length of hospital stay. The secondary endpoint was a composite of complications, including the need for conversion to open cholecystectomy, readmission within 30 days, bleeding requiring transfusion, bile duct injury, or wound infection.
The study was terminated after 50 patients, as there was a difference in the length of hospital stay with a predefined alpha level of 0.005. Patients in the early group were taken to the operating room at a mean of 35.1 hours after admission, compared with 77.8 hours in the control group. The overall length of hospital stay was shorter in the early group (mean 3.5 days, 95% CI, 2.7-4.3), compared with the control group (mean 5.8, 95% CI, 3.8-7.9). All cholecystectomies were completed laparoscopically, without conversion to open. No statistically significant difference existed in secondary endpoints (P=0.48, OR 1.66, 95% CI, 0.41-6.78).
Bottom line: Laparoscopic cholecystectomy performed within 48 hours of admission, irrespective of normalization of laboratory values or clinical progress, safely decreases the overall length of stay, compared with delaying laparoscopic cholecystectomy until laboratory values and clinical condition normalize.
Citation: Aboulian A, Chan T, Yaghoubian A, et al. Early cholecystectomy safely decreases hospital stay in patients with mild gallstone pancreatitis: a randomized prospective study. Ann Surg. 2010;251(4): 615-619.
Presence of Microbial DNA in Blood Correlates with Disease Severity
Clinical question: Is the presence of microbial DNA in the blood associated with disease severity in severe sepsis, and how does detection of this microbial DNA by polymerase chain reaction (PCR) compare with blood cultures (BC)?
Background: Inadequate antibiotic therapy is a strong and independent predictor of poor outcomes in sepsis. Diagnostic uncertainty regarding the causative micro-organism is compensated for by liberal use of broad-spectrum antibiotics. As a result, resistance to antibiotics is an increasing public-health problem.
Study design: Prospective multicenter controlled observational study.
Setting: Three ICUs in Germany and France.
Synopsis: From 2005 to 2007, 63 patients were enrolled in the control group and 142 patients were enrolled in the sepsis group. In control patients, blood cultures and specimens were drawn daily at a maximum of three days after admission. In the sepsis group, blood samples were obtained on the day severe sepsis was suspected. Consecutive samples for the next two days after study inclusion were taken.
Taking BC as the laboratory comparison method, the sensitivity of PCR to detect culture-positive bacteremia in sepsis was 0.80 with a specificity of 0.77. PCR detected 29 of 41 microorganisms (70.3%) found in the BC. The highest recovery rate was observed for gram-negative bacteria (78.6%), fungi (50.0%), and gram-positive bacteria (47.6%). PCR from septic patients correlated well with markers of host response (IL-6 and PCT) and disease severity (SOFA score), even when the BC remained negative.
The appropriateness of antimicrobial therapy based on culture-based methods was not recorded, so it’s impossible to conclude whether or not the PCR would have contributed to a more effective therapy.
Bottom line: Concordance between BC and PCR is moderate in septic patients. PCR-based pathogen detection correlated with disease severity even if the BC remained negative, suggesting that the presence of microbial DNA in the bloodstream is a clinically significant event.
Citation: Bloos F, Hinder F, Becker K, et al. A multicenter trial to compare blood culture with polymerase chain reaction in severe human sepsis. Intensive Care Med. 2010;36(2):241-247.
Adding Rifampicin to Vancomycin Improves Outcomes in MRSA Pneumonia
Clinical question: Does adding rifampicin to vancomycin improve outcomes in patients with hospital-acquired MRSA pneumonia?
Background: Hospital-acquired MRSA pneumonia has a mortality of more than 20%. Vancomycin penetrates the lung tissue poorly. The value of adding rifampicin, an antibiotic with broad-spectrum coverage and good tissue penetration, was investigated.
Study design: Randomized open-label trial.
Setting: Medical ICU patients at Ulsan College of Medicine, Asan Medical Center, South Korea.
Synopsis: Patients older than 18 years of age with clinical symptoms suggestive of nosocomial pneumonia were randomized to receive vancomycin alone (V) or vancomycin plus rifampicin (VR). Clinicians could add additional antibiotics for gram-negative coverage as needed.
Of the 183 patients screened, 93 met the inclusion criteria and were randomized in a 1:1 ratio. MRSA infection was microbiologically confirmed. Clinical cure rate in VR patients was significantly greater at day 14 compared with the V group (53.7% vs. 31.0%, P=0.047) based on a modified intention-to-treat model. The overall mortality at day 28 did not significantly differ between the groups (22.0% vs. 38.1%, P=0.15), although the 60-day mortality was lower in the VR group (26.8% vs. 50.0%, P=0.042). Mortality from MRSA pneumonia had a trend toward a decrease in the VR group (14.7% vs. 28.6%, P=0.18).
The trial was limited because it was a single-site study and lacked statistical power to assess certain outcomes. Additionally, treatment protocols were not compared with other antimicrobial therapies.
Bottom line: Vancomycin plus rifampicin improves MRSA pneumonia outcomes in ICU patients.
Citation: Jung YJ, Koh Y, Hong SB, et al. Effect of vancomycin plus rifampicin in the treatment of nosocomial MRSA pneumonia. Crit Care Med. 2010;38(1):175-180.
Severe Sepsis Syndromes Are Not Always Caused by Bacteremia
Clinical question: What are the common causes of clinical sepsis?
Background: When sepsis is defined by systemic inflammatory response syndrome (SIRS) criteria, the etiology is not always infectious. Rapid initiation of antimicrobial therapy for infectious SIRS is a priority, but it could result in treating a significant number of patients who are not bacteremic.
Study design: Prospective secondary analysis of a registry of patients created to evaluate an institutional standard-of-care protocol.
Setting: Urban, 850-bed, tertiary-care teaching institution in North Carolina.
Synopsis: ED cases meeting the criteria for severe sepsis underwent a secondary review that looked at the cause of the sepsis. Only 45% of patients identified as having severe sepsis were blood-culture-positive during that episode of care. The culture-positive group was more likely to have central lines, malignancies, or reside in a nursing home.
Of the subgroup of culture-negative patients, 52% had another infectious etiology, most commonly pneumonia. Other “noninfectious mimics,” including inflammatory colitis, myocardial infarction, and pulmonary embolism, were noted in 32% of patients in the subgroup, and the cause was not identified in 16% of the patients.
In-hospital mortality was higher in the culture-positive group than in the culture-negative group (25% vs. 4%, P=0.05). There was no evidence of harm in patients with culture-negative sepsis treated for a systemic infection.
Bottom line: Many patients with a clinical picture of severe sepsis will not have positive blood cultures or an infectious etiology.
Citation: Heffner AC, Horton JM, Marchick MR, Jones AE. Etiology of illness in patients with severe sepsis admitted to the hospital from the emergency department. Clin Infect Dis. 2010;50(6):814-820.
Comanagement of Surgical Inpatients by Hospitalists Is Rapidly Expanding
Clinical question: What is the prevalence and nature of comanagement of surgical patients by medicine physicians?
Background: Comanagement of surgical patients is a common clinical role for hospitalists, but the relationship is not well characterized in the literature in terms of numbers of patients or types of physicians involved in this practice.
Study design: Retrospective cohort.
Setting: Cross-section of hospitals from a Medicare database.
Synopsis: During the study period, 35.2% of patients were comanaged by a medicine physician—23.7% by a generalist and 14% by a subspecialist. Cardiothoracic surgery patients were more likely to be comanaged by a subspecialist, whereas all other patients were more likely to be comanaged by a generalist.
Although subspecialist comanagement actually declined during the study period, overall comanagement increased from 33.3% in 1996 to 40.8% in 2006. This increase is entirely attributable to the increase in comanagement by hospitalists. Most of this growth occurred with orthopedic patients.
Patient factors associated with comanagement include advanced age, emergency admissions, and increasing comorbidities. Teaching hospitals had less comanagement, while midsize, nonteaching, and for-profit hospitals had more comanagement.
Bottom line: Comanagement of surgical patients by medicine physicians is a common and growing clinical relationship. Hospitalists are responsible for increasing numbers of comanaged surgical patients.
Citation: Sharma G, Kuo YF, Freeman J, Zhang DD, Goodwin JS. Comanagement of hospitalized surgical patients by medicine physicians in the United States. Arch Intern Med. 2010;170(4):363-368.
Probiotics Might Decrease Risk of Ventilator-Associated Pneumonia
Clinical question: Does the administration of probiotics decrease the incidence of ventilator-associated pneumonia in critically ill patients?
Background: Ventilator-associated pneumonia (VAP) is a major nosocomial infection in ICUs. Probiotics are thought to decrease colonization and, therefore, infection with serious hospital-acquired pathogens.
Study design: Meta-analysis of five randomized controlled trials.
Setting: ICU patients on mechanical ventilation for at least 24 hours.
Synopsis: Five trials met the inclusion criteria of comparing probiotics to placebo in critically ill patients on mechanical ventilation and reporting the outcome of VAP. Administration of probiotics decreased the incidence of VAP (odds ratio 0.61, 95% CI, 0.41-0.91) and colonization of the respiratory tract with Pseudomonas aeruginosa (OR 0.35, 95% CI, 0.13-0.93).
Length of ICU stay was decreased in the probiotic arm, although this effect was not statistically significant in all analyses. Probiotics had no effect on such outcomes as ICU mortality, in-hospital mortality, or duration of mechanical ventilation.
Bottom line: Probiotics might be an effective strategy to reduce the risk of VAP, even if they do not appear to impact such outcomes as mortality.
Citation: Siempos II, Ntaidou TK, Falagas ME. Impact of the administration of probiotics on the incidence of ventilator-associated pneumonia: a meta-analysis of randomized controlled trials. Crit Care Med. 2010;38(3):954-962. TH
PEDIATRIC HM LITERATURE
By Mark Shen, MD
Renal Ultrasound Identifies Children with High-Grade Vesicoureteral Reflux
Clinical question: What is the diagnostic accuracy of specific renal ultrasound (US) criterion for detection of vesicoureteral reflux (VUR)?
Background: Based on the paradigm that undetected and untreated VUR might lead to long-term complications, voiding cystography traditionally has been recommended for all young children with a first urinary tract infection (UTI). An increasing base of evidence suggests that antibiotic prophylaxis for low-grade VUR might be unnecessary. However, less-invasive methods of screening for high-grade reflux have not yet been identified.
Study design: Secondary analysis of data from a prior prospective study.
Setting: Nephrology department of a French teaching hospital.
Synopsis: One hundred seventeen children (0-16 years) with a UTI were included and underwent renal US and voiding cystography. Patients with a known uropathy or those who had received antibiotics within the past 48 hours were excluded. A generalized linear multilevel model was used to analyze the relationship between standardized renal US criterion and VUR.
Twenty-seven percent of children had VUR and 8% had high-grade VUR (grade ≥3). Pelvic, ureteral, and urinary tract dilatation were significantly associated with high-grade VUR. Ureteral dilatation offered the best combination of standardized criterion, sensitivity (75%), and specificity (88%).
Significant limitations of this study include the use of bag urine cultures and the lack of consensus-based US criterion for ureteral and pelvic dilatation. The authors appropriately caution that these renal US criteria do not identify all children with high-grade VUR and are merely one step toward an intermediate screening strategy for high-grade VUR in order to mitigate adverse effects of universal voiding cystography. Further validation of this work in a clinically representative population will be needed.
Bottom line: Ureteral dilatation accurately identifies children with high-grade VUR.
Citation: Leroy S, Vantalon S, Larakeb A, Ducou-Le-Pointe H, Bensman A. Vesicoureteral reflux in children with urinary tract infection: comparison of diagnostic accuracy of renal US criteria. Radiology. 2010;255(3):890-898.
Market Watch
New Drugs, Indications, Dosage Forms, and Approvals
- Hydromorphone extended-release tablets (Exalgo) have been approved by the FDA as a once-daily treatment for managing moderate to severe pain in opioid-tolerant patients needing continuous opioid analgesia for an extended period of time.1 This formulation uses the OROS osmotic delivery system to control the release rate. It is a CII controlled substance and is accompanied by a comprehensive Risk Evaluation and Mitigation Strategy (REMS) to ensure that the medication’s benefits outweigh its risks.
- IMGN910 has received orphan drug status for treating Merkel cell carcinoma, a skin cancer that usually occurs on the head or neck.2 It is in early-stage clinical trials.
- Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA as a once-weekly immunoglobulin replacement therapy for patients with primary immunodeficiency.3 It’s the first 20% subcutaneous immunoglobulin to receive FDA approval. This high-concentration product is stabilized with L-proline, a naturally occurring amino acid, which allows it to be stored at room temperature (up to 25°C [77°F]). Some adverse reactions include injection site bruising, pain, cysts, eczema, irritation, headache, cough, diarrhea, and fatigue.4
- Velaglucerase alfa for injection (VPRIV) has been approved by the FDA to treat adults and children with the rare genetic disorder Gaucher disease.5 Patients with Gaucher disease have a deficiency of the glucocerebrosidase enzyme. This enzyme prevents lipids from building up in the liver, spleen, bone marrow, and nervous system, which prevents them from working properly. VPRIV, a long-term replacement therapy, is approved for Type 1 Gaucher disease, the most common form, and is an alternative to imiglucerase (Cerezyme), which is in short supply. The most common reactions seen in clinical trials were allergic reactions, headache, dizziness, abdominal and back pain, nausea, fatigue/weakness, fever, and prolonged activated partial thromboplastin time.
Pipeline
- Betrixaban is a once-daily oral anticoagulant in Phase 2 clinical studies.6 Compared with warfarin in the EXPLORE-Xa study, betrixaban decreased the bleeding incidence in patients with nonvalvular atrial fibrillation or atrial flutter who had at least one stroke risk factor. The major and clinically relevant nonmajor bleeding episodes occurred less frequently in betrixaban-treated patients.
- Dabigatran etexilate is an oral anticoagulant in Phase 3 clinical trials.7 At the recent American College of Cardiology meeting in Ingelheim, Germany, dabigatran demonstrated consistent stroke prevention in patients with atrial fibrillation. It also reduced the number of strokes in patients with atrial fibrillation, compared with warfarin therapy. Additionally, dabigatran etexilate 110 mg and 150 mg twice daily was associated with a lower rate of major bleeding compared with warfarin in atrial fibrillation patients at low risk of stroke.
- Fentanyl sublingual spray (SL Spray) is in Phase 3 clinical trials to treat breakthrough pain in cancer patients. Sublingual administration of this product showed rapid, effective pain relief within five minutes.8
- Ketamine intranasal (Ereska) is a nonopioid NMDA receptor antagonist analgesic, which is undergoing Phase 3 clinical trials for managing moderate to severe acute pain.9 Studies have shown rapid, statistically significant relief of moderate to severe acute postoperative pain following dental surgery, following a variety of major orthopedic surgical procedures, and in cancer breakthrough pain.
- Lu AA21004 and Lu AA24530 are undergoing Phase 3 clinical trials for treating major depressive disorder (MDD).10 Lu AA21004 is a 5-HT3, 5-HT7 and 5-HT1B receptor antagonist, 5HT1A receptor agonist, and 5-HT transporter inhibitor. To date, it has shown a low propensity for drug-drug interactions and is extensively metabolized in the liver. Lu AA24530 has shown activity as a multimodal enhancer with reuptake inhibition at monoamine transporters, and having 5-HT3 and 5-HT2c receptor antagonist activity.
- Lurasidone is an atypical antipsychotic with high affinity and antagonist effects at the dopamine D2, serotonin 5-HT2, and serotonin 5-HT7 receptors.11 It is a partial agonist at serotonin 5HT1A receptor. The NDA was filed for this agent Dec. 30, 2009.
- Mipomersen, an apo-B synthesis inhibitor, is in Phase 3 clinical trials for treating patients with homozygous familial hypercholesterolemia (HoFM).12 This agent is proposed to reduce LDL-C by preventing the development of atherogenic lipids. In a study published in Lancet, mipomersen reduced LDL-C levels by an average of more than 100 mg/dL in HoFM patients.13
- Oxycodone/niacin (Acurox), an abuse deterrent formulation for this popular opioid, has been rejected by the FDA.14 According to the FDA and its review committee, the rejection was due to the “flushing” from the niacin, which was deemed ineffective as an abuse deterrent. In addition, the FDA said the “flushing” could be overcome by food intake or administration with over-the-counter pain relievers.
- Vilanterol/fluticasone is a combination of the inhaled corticosteroid fluticasone and the long-acting beta-agonist (LABA) vilanterol.15 It is in Phase 3 clinical trials for treating asthma. TH
Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.
References
- FDA approves Exaglo (hydromorphone HCl) extended-release tablets. Drugs.com website. Available at: www.drugs.com/newdrugs/fda-approves-exaglo-hydromorphone-hcl-extended-release-2033.html?printable=1. Accessed April 27, 2010.
- ImmunoGen’s skin cancer drug gets orphan drug status. Reuters website. Available at: www.reuters.com/article/idUSSGE6270L720100308. Accessed April 27, 2010.
- CSL Behring receives FDA approval of Hizentra, first 20 percent subcutaneous immunoglobulin therapy. Drugs.com website. Available at: www.drugs.com/newdrugs/csl-behring-receives-fda-approval-hizentra-first-20-percent-subcutaneous-immunoglobulin-therapy-2037.html. Accessed April 27, 2010.
- Petrochko C. FDA okays 20% skin-injection immunodeficiency treatment. MedPage Today website. Available at: www.medpagetoday.com/tbprint.cfm?tbid=18858. Accessed April 27, 2010.
- Gansz Bobo E. FDA approves therapy to treat Gaucher disease. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm202288.htm. Accessed April 27, 2010.
- Portola Pharmaceuticals and Merck announce that Phase 2 study showed investigational factor Xa inhibitor, betrixaban, reduced incidence of bleeding compared to warfarin in patients with atrial fibrillation. Merck website. Available at: www.merck.com/newsroom/news-release-archive/research-and-development/2010_0315.html. Accessed April 27, 2010.
- Dabigatran etexilate shows greater reductions than warfarin in stroke in patients with atrial fibrillation across all stroke risk groups. Beohringer Ingelheim website. Available at: www.boehringer-ingelheim.com/news/news_releases/press_releases/2010/15_march_2010.html. Accessed April 27, 2010.
- INSYS Therapeutics, Inc. Announces Positive Phase III Efficacy Trial Results for Fentanyl Sublingual Spray. INSYS Therapeutics website. Available at: www.insysrx.com/news.htm. Accessed April 27, 2010.
- Third party reexamination of Javelin Pharmaceuticals’ Phase III trial data for Ereska (intranasal ketamine) yields statistically significant primary endpoint. Javelin website. Available at: ir.javelinpharmaceuticals.com/releasedetail.cfm?ReleaseID=444353. Accessed April 27, 2010.
- Lundbeck and Takeda finalise plans to initiate phase III pivotal clinical trials with Lu AA21004 and Lu AA24530. Takeda Pharmaceutical Company Limited website. Available at: www.takeda.com/press/article_35859.html. Accessed April 27, 2010.
- Dainippon Sumitomo Pharma America announces FDA acceptance of lurasidone new drug application for treatment of schizophrenia. PR Newswire website. Available at: www.prnewswire.com/news-releases/dainippon-sumitomo-pharma-america-announces-fda-acceptance-of-lurasidone-new-drug-application-for-treatment-of-schizophrenia-87265597.html. Accessed April 27, 2010.
- Mipomersen Phase 3 study in HoFH featured in The Lancet. Business Wire website. Available at: www.businesswire.com/portal/site/home/email/alert/?ndmViewId=news_view&newsLang=en&newsId=20100315005928. Accessed April 27, 2010.
- Raal FJ, Santos RD, Blom DJ, et al. Mipomersen, an apolipoprotein B synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;375(9719):998-1006.
- US FDA panel rejects King, Acura painkiller. Reuters website. Available at: www.reuters.com/assets/print?aid=USN2223552220100422. Accessed April 27, 2010.
- Dennis M. GlaxoSmithKline begins late-stage clinical programme for asthma drug Relovair. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=E256469FBD8F4A2F80C5DD3E844CC1E1&logRowId=356423. Accessed April 27, 2010.
New Drugs, Indications, Dosage Forms, and Approvals
- Hydromorphone extended-release tablets (Exalgo) have been approved by the FDA as a once-daily treatment for managing moderate to severe pain in opioid-tolerant patients needing continuous opioid analgesia for an extended period of time.1 This formulation uses the OROS osmotic delivery system to control the release rate. It is a CII controlled substance and is accompanied by a comprehensive Risk Evaluation and Mitigation Strategy (REMS) to ensure that the medication’s benefits outweigh its risks.
- IMGN910 has received orphan drug status for treating Merkel cell carcinoma, a skin cancer that usually occurs on the head or neck.2 It is in early-stage clinical trials.
- Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA as a once-weekly immunoglobulin replacement therapy for patients with primary immunodeficiency.3 It’s the first 20% subcutaneous immunoglobulin to receive FDA approval. This high-concentration product is stabilized with L-proline, a naturally occurring amino acid, which allows it to be stored at room temperature (up to 25°C [77°F]). Some adverse reactions include injection site bruising, pain, cysts, eczema, irritation, headache, cough, diarrhea, and fatigue.4
- Velaglucerase alfa for injection (VPRIV) has been approved by the FDA to treat adults and children with the rare genetic disorder Gaucher disease.5 Patients with Gaucher disease have a deficiency of the glucocerebrosidase enzyme. This enzyme prevents lipids from building up in the liver, spleen, bone marrow, and nervous system, which prevents them from working properly. VPRIV, a long-term replacement therapy, is approved for Type 1 Gaucher disease, the most common form, and is an alternative to imiglucerase (Cerezyme), which is in short supply. The most common reactions seen in clinical trials were allergic reactions, headache, dizziness, abdominal and back pain, nausea, fatigue/weakness, fever, and prolonged activated partial thromboplastin time.
Pipeline
- Betrixaban is a once-daily oral anticoagulant in Phase 2 clinical studies.6 Compared with warfarin in the EXPLORE-Xa study, betrixaban decreased the bleeding incidence in patients with nonvalvular atrial fibrillation or atrial flutter who had at least one stroke risk factor. The major and clinically relevant nonmajor bleeding episodes occurred less frequently in betrixaban-treated patients.
- Dabigatran etexilate is an oral anticoagulant in Phase 3 clinical trials.7 At the recent American College of Cardiology meeting in Ingelheim, Germany, dabigatran demonstrated consistent stroke prevention in patients with atrial fibrillation. It also reduced the number of strokes in patients with atrial fibrillation, compared with warfarin therapy. Additionally, dabigatran etexilate 110 mg and 150 mg twice daily was associated with a lower rate of major bleeding compared with warfarin in atrial fibrillation patients at low risk of stroke.
- Fentanyl sublingual spray (SL Spray) is in Phase 3 clinical trials to treat breakthrough pain in cancer patients. Sublingual administration of this product showed rapid, effective pain relief within five minutes.8
- Ketamine intranasal (Ereska) is a nonopioid NMDA receptor antagonist analgesic, which is undergoing Phase 3 clinical trials for managing moderate to severe acute pain.9 Studies have shown rapid, statistically significant relief of moderate to severe acute postoperative pain following dental surgery, following a variety of major orthopedic surgical procedures, and in cancer breakthrough pain.
- Lu AA21004 and Lu AA24530 are undergoing Phase 3 clinical trials for treating major depressive disorder (MDD).10 Lu AA21004 is a 5-HT3, 5-HT7 and 5-HT1B receptor antagonist, 5HT1A receptor agonist, and 5-HT transporter inhibitor. To date, it has shown a low propensity for drug-drug interactions and is extensively metabolized in the liver. Lu AA24530 has shown activity as a multimodal enhancer with reuptake inhibition at monoamine transporters, and having 5-HT3 and 5-HT2c receptor antagonist activity.
- Lurasidone is an atypical antipsychotic with high affinity and antagonist effects at the dopamine D2, serotonin 5-HT2, and serotonin 5-HT7 receptors.11 It is a partial agonist at serotonin 5HT1A receptor. The NDA was filed for this agent Dec. 30, 2009.
- Mipomersen, an apo-B synthesis inhibitor, is in Phase 3 clinical trials for treating patients with homozygous familial hypercholesterolemia (HoFM).12 This agent is proposed to reduce LDL-C by preventing the development of atherogenic lipids. In a study published in Lancet, mipomersen reduced LDL-C levels by an average of more than 100 mg/dL in HoFM patients.13
- Oxycodone/niacin (Acurox), an abuse deterrent formulation for this popular opioid, has been rejected by the FDA.14 According to the FDA and its review committee, the rejection was due to the “flushing” from the niacin, which was deemed ineffective as an abuse deterrent. In addition, the FDA said the “flushing” could be overcome by food intake or administration with over-the-counter pain relievers.
- Vilanterol/fluticasone is a combination of the inhaled corticosteroid fluticasone and the long-acting beta-agonist (LABA) vilanterol.15 It is in Phase 3 clinical trials for treating asthma. TH
Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.
References
- FDA approves Exaglo (hydromorphone HCl) extended-release tablets. Drugs.com website. Available at: www.drugs.com/newdrugs/fda-approves-exaglo-hydromorphone-hcl-extended-release-2033.html?printable=1. Accessed April 27, 2010.
- ImmunoGen’s skin cancer drug gets orphan drug status. Reuters website. Available at: www.reuters.com/article/idUSSGE6270L720100308. Accessed April 27, 2010.
- CSL Behring receives FDA approval of Hizentra, first 20 percent subcutaneous immunoglobulin therapy. Drugs.com website. Available at: www.drugs.com/newdrugs/csl-behring-receives-fda-approval-hizentra-first-20-percent-subcutaneous-immunoglobulin-therapy-2037.html. Accessed April 27, 2010.
- Petrochko C. FDA okays 20% skin-injection immunodeficiency treatment. MedPage Today website. Available at: www.medpagetoday.com/tbprint.cfm?tbid=18858. Accessed April 27, 2010.
- Gansz Bobo E. FDA approves therapy to treat Gaucher disease. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm202288.htm. Accessed April 27, 2010.
- Portola Pharmaceuticals and Merck announce that Phase 2 study showed investigational factor Xa inhibitor, betrixaban, reduced incidence of bleeding compared to warfarin in patients with atrial fibrillation. Merck website. Available at: www.merck.com/newsroom/news-release-archive/research-and-development/2010_0315.html. Accessed April 27, 2010.
- Dabigatran etexilate shows greater reductions than warfarin in stroke in patients with atrial fibrillation across all stroke risk groups. Beohringer Ingelheim website. Available at: www.boehringer-ingelheim.com/news/news_releases/press_releases/2010/15_march_2010.html. Accessed April 27, 2010.
- INSYS Therapeutics, Inc. Announces Positive Phase III Efficacy Trial Results for Fentanyl Sublingual Spray. INSYS Therapeutics website. Available at: www.insysrx.com/news.htm. Accessed April 27, 2010.
- Third party reexamination of Javelin Pharmaceuticals’ Phase III trial data for Ereska (intranasal ketamine) yields statistically significant primary endpoint. Javelin website. Available at: ir.javelinpharmaceuticals.com/releasedetail.cfm?ReleaseID=444353. Accessed April 27, 2010.
- Lundbeck and Takeda finalise plans to initiate phase III pivotal clinical trials with Lu AA21004 and Lu AA24530. Takeda Pharmaceutical Company Limited website. Available at: www.takeda.com/press/article_35859.html. Accessed April 27, 2010.
- Dainippon Sumitomo Pharma America announces FDA acceptance of lurasidone new drug application for treatment of schizophrenia. PR Newswire website. Available at: www.prnewswire.com/news-releases/dainippon-sumitomo-pharma-america-announces-fda-acceptance-of-lurasidone-new-drug-application-for-treatment-of-schizophrenia-87265597.html. Accessed April 27, 2010.
- Mipomersen Phase 3 study in HoFH featured in The Lancet. Business Wire website. Available at: www.businesswire.com/portal/site/home/email/alert/?ndmViewId=news_view&newsLang=en&newsId=20100315005928. Accessed April 27, 2010.
- Raal FJ, Santos RD, Blom DJ, et al. Mipomersen, an apolipoprotein B synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;375(9719):998-1006.
- US FDA panel rejects King, Acura painkiller. Reuters website. Available at: www.reuters.com/assets/print?aid=USN2223552220100422. Accessed April 27, 2010.
- Dennis M. GlaxoSmithKline begins late-stage clinical programme for asthma drug Relovair. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=E256469FBD8F4A2F80C5DD3E844CC1E1&logRowId=356423. Accessed April 27, 2010.
New Drugs, Indications, Dosage Forms, and Approvals
- Hydromorphone extended-release tablets (Exalgo) have been approved by the FDA as a once-daily treatment for managing moderate to severe pain in opioid-tolerant patients needing continuous opioid analgesia for an extended period of time.1 This formulation uses the OROS osmotic delivery system to control the release rate. It is a CII controlled substance and is accompanied by a comprehensive Risk Evaluation and Mitigation Strategy (REMS) to ensure that the medication’s benefits outweigh its risks.
- IMGN910 has received orphan drug status for treating Merkel cell carcinoma, a skin cancer that usually occurs on the head or neck.2 It is in early-stage clinical trials.
- Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA as a once-weekly immunoglobulin replacement therapy for patients with primary immunodeficiency.3 It’s the first 20% subcutaneous immunoglobulin to receive FDA approval. This high-concentration product is stabilized with L-proline, a naturally occurring amino acid, which allows it to be stored at room temperature (up to 25°C [77°F]). Some adverse reactions include injection site bruising, pain, cysts, eczema, irritation, headache, cough, diarrhea, and fatigue.4
- Velaglucerase alfa for injection (VPRIV) has been approved by the FDA to treat adults and children with the rare genetic disorder Gaucher disease.5 Patients with Gaucher disease have a deficiency of the glucocerebrosidase enzyme. This enzyme prevents lipids from building up in the liver, spleen, bone marrow, and nervous system, which prevents them from working properly. VPRIV, a long-term replacement therapy, is approved for Type 1 Gaucher disease, the most common form, and is an alternative to imiglucerase (Cerezyme), which is in short supply. The most common reactions seen in clinical trials were allergic reactions, headache, dizziness, abdominal and back pain, nausea, fatigue/weakness, fever, and prolonged activated partial thromboplastin time.
Pipeline
- Betrixaban is a once-daily oral anticoagulant in Phase 2 clinical studies.6 Compared with warfarin in the EXPLORE-Xa study, betrixaban decreased the bleeding incidence in patients with nonvalvular atrial fibrillation or atrial flutter who had at least one stroke risk factor. The major and clinically relevant nonmajor bleeding episodes occurred less frequently in betrixaban-treated patients.
- Dabigatran etexilate is an oral anticoagulant in Phase 3 clinical trials.7 At the recent American College of Cardiology meeting in Ingelheim, Germany, dabigatran demonstrated consistent stroke prevention in patients with atrial fibrillation. It also reduced the number of strokes in patients with atrial fibrillation, compared with warfarin therapy. Additionally, dabigatran etexilate 110 mg and 150 mg twice daily was associated with a lower rate of major bleeding compared with warfarin in atrial fibrillation patients at low risk of stroke.
- Fentanyl sublingual spray (SL Spray) is in Phase 3 clinical trials to treat breakthrough pain in cancer patients. Sublingual administration of this product showed rapid, effective pain relief within five minutes.8
- Ketamine intranasal (Ereska) is a nonopioid NMDA receptor antagonist analgesic, which is undergoing Phase 3 clinical trials for managing moderate to severe acute pain.9 Studies have shown rapid, statistically significant relief of moderate to severe acute postoperative pain following dental surgery, following a variety of major orthopedic surgical procedures, and in cancer breakthrough pain.
- Lu AA21004 and Lu AA24530 are undergoing Phase 3 clinical trials for treating major depressive disorder (MDD).10 Lu AA21004 is a 5-HT3, 5-HT7 and 5-HT1B receptor antagonist, 5HT1A receptor agonist, and 5-HT transporter inhibitor. To date, it has shown a low propensity for drug-drug interactions and is extensively metabolized in the liver. Lu AA24530 has shown activity as a multimodal enhancer with reuptake inhibition at monoamine transporters, and having 5-HT3 and 5-HT2c receptor antagonist activity.
- Lurasidone is an atypical antipsychotic with high affinity and antagonist effects at the dopamine D2, serotonin 5-HT2, and serotonin 5-HT7 receptors.11 It is a partial agonist at serotonin 5HT1A receptor. The NDA was filed for this agent Dec. 30, 2009.
- Mipomersen, an apo-B synthesis inhibitor, is in Phase 3 clinical trials for treating patients with homozygous familial hypercholesterolemia (HoFM).12 This agent is proposed to reduce LDL-C by preventing the development of atherogenic lipids. In a study published in Lancet, mipomersen reduced LDL-C levels by an average of more than 100 mg/dL in HoFM patients.13
- Oxycodone/niacin (Acurox), an abuse deterrent formulation for this popular opioid, has been rejected by the FDA.14 According to the FDA and its review committee, the rejection was due to the “flushing” from the niacin, which was deemed ineffective as an abuse deterrent. In addition, the FDA said the “flushing” could be overcome by food intake or administration with over-the-counter pain relievers.
- Vilanterol/fluticasone is a combination of the inhaled corticosteroid fluticasone and the long-acting beta-agonist (LABA) vilanterol.15 It is in Phase 3 clinical trials for treating asthma. TH
Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.
References
- FDA approves Exaglo (hydromorphone HCl) extended-release tablets. Drugs.com website. Available at: www.drugs.com/newdrugs/fda-approves-exaglo-hydromorphone-hcl-extended-release-2033.html?printable=1. Accessed April 27, 2010.
- ImmunoGen’s skin cancer drug gets orphan drug status. Reuters website. Available at: www.reuters.com/article/idUSSGE6270L720100308. Accessed April 27, 2010.
- CSL Behring receives FDA approval of Hizentra, first 20 percent subcutaneous immunoglobulin therapy. Drugs.com website. Available at: www.drugs.com/newdrugs/csl-behring-receives-fda-approval-hizentra-first-20-percent-subcutaneous-immunoglobulin-therapy-2037.html. Accessed April 27, 2010.
- Petrochko C. FDA okays 20% skin-injection immunodeficiency treatment. MedPage Today website. Available at: www.medpagetoday.com/tbprint.cfm?tbid=18858. Accessed April 27, 2010.
- Gansz Bobo E. FDA approves therapy to treat Gaucher disease. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm202288.htm. Accessed April 27, 2010.
- Portola Pharmaceuticals and Merck announce that Phase 2 study showed investigational factor Xa inhibitor, betrixaban, reduced incidence of bleeding compared to warfarin in patients with atrial fibrillation. Merck website. Available at: www.merck.com/newsroom/news-release-archive/research-and-development/2010_0315.html. Accessed April 27, 2010.
- Dabigatran etexilate shows greater reductions than warfarin in stroke in patients with atrial fibrillation across all stroke risk groups. Beohringer Ingelheim website. Available at: www.boehringer-ingelheim.com/news/news_releases/press_releases/2010/15_march_2010.html. Accessed April 27, 2010.
- INSYS Therapeutics, Inc. Announces Positive Phase III Efficacy Trial Results for Fentanyl Sublingual Spray. INSYS Therapeutics website. Available at: www.insysrx.com/news.htm. Accessed April 27, 2010.
- Third party reexamination of Javelin Pharmaceuticals’ Phase III trial data for Ereska (intranasal ketamine) yields statistically significant primary endpoint. Javelin website. Available at: ir.javelinpharmaceuticals.com/releasedetail.cfm?ReleaseID=444353. Accessed April 27, 2010.
- Lundbeck and Takeda finalise plans to initiate phase III pivotal clinical trials with Lu AA21004 and Lu AA24530. Takeda Pharmaceutical Company Limited website. Available at: www.takeda.com/press/article_35859.html. Accessed April 27, 2010.
- Dainippon Sumitomo Pharma America announces FDA acceptance of lurasidone new drug application for treatment of schizophrenia. PR Newswire website. Available at: www.prnewswire.com/news-releases/dainippon-sumitomo-pharma-america-announces-fda-acceptance-of-lurasidone-new-drug-application-for-treatment-of-schizophrenia-87265597.html. Accessed April 27, 2010.
- Mipomersen Phase 3 study in HoFH featured in The Lancet. Business Wire website. Available at: www.businesswire.com/portal/site/home/email/alert/?ndmViewId=news_view&newsLang=en&newsId=20100315005928. Accessed April 27, 2010.
- Raal FJ, Santos RD, Blom DJ, et al. Mipomersen, an apolipoprotein B synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;375(9719):998-1006.
- US FDA panel rejects King, Acura painkiller. Reuters website. Available at: www.reuters.com/assets/print?aid=USN2223552220100422. Accessed April 27, 2010.
- Dennis M. GlaxoSmithKline begins late-stage clinical programme for asthma drug Relovair. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=E256469FBD8F4A2F80C5DD3E844CC1E1&logRowId=356423. Accessed April 27, 2010.
How Should Hypertensive Emergencies Be Managed?
Case
A 57-year-old male with hypertension and end-stage renal disease is brought into the ED by his family for evaluation of headache, nausea, blurry vision, and confusion. Blood pressure is 235/130 mmHg. He is somnolent but arousable and oriented only to person; the remainder of his neurologic exam is nonfocal. A fundoscopic exam shows retinal hemorrhages, exudates, and papilledema. How should this patient be managed?
Overview
Hypertension (HTN) is a medical problem that affects an estimated 1 in 3 adults in the U.S. and more than 1 billion people worldwide. The Joint National Committee (JNC) 7 Report defines hypertensive emergency as severe hypertension with evidence of impending or progressive end-organ dysfunction.1 Systolic blood pressure (SBP) in these settings often is >180 mm Hg with diastolic blood pressure (DBP) >120 mm Hg. The JNC 7 Report defines hypertensive urgency as severe HTN without acute end-organ dysfunction. Whereas hypertensive urgencies can be treated with oral antihypertensive agents with close outpatient follow-up, hypertensive emergencies require immediate BP reduction to halt the progression of end-organ damage.
Severe HTN causes shear stress and endothelial injury, leading to activation of the coagulation cascade, fibrinoid necrosis, and tissue ischemia.2 Due to adaptive vascular changes, pre-existing hypertension lowers the probability of a hypertensive emergency developing at a particular BP. The rate of BP rise, rather than the absolute level, determines most end-organ damage.3 In previously normotensive patients, end-organ damage can occur at BPs >160/100 mm Hg; however, organ dysfunction is uncommon in chronically hypertensive individuals, unless BP >220/120 mm Hg.
Clinical manifestations of hypertensive emergency depend on the target organs involved (see Figure 1, right). When a patient presents with severe hypertension, a focused evaluation should attempt to identify the presence of end-organ damage. If present, these patients should be admitted to an ICU for close monitoring, and administration of parenteral antihypertensive agents should be started. (Online Exclusive: View a chart of “Parenteral Antihypertensive Agents Used in Hypertensive Emergencies”)
Review of the Data
General principles: The initial therapeutic goal in most hypertensive emergencies is to reduce the mean arterial pressure (MAP) by no more than 25% within the first hour. Precipitous or excessive decreases in BP might worsen renal, cerebral, or coronary ischemia. Due to pressure natriuresis, patients with primary malignant hypertension might be volume-depleted. Restoration of intravascular volume with intravenous (IV) saline can prevent precipitous falls in BP when antihypertensive agents are started.
After the patient stabilizes, the BP can be lowered about 10% per hour to 160/100-110 mm Hg. A gradual reduction to the patient’s baseline BP is targeted over the ensuing 24 to 48 hours. Once there is stable BP control and end-organ damage has ceased, patients can be transitioned to oral therapy.
No large clinical trials have investigated optimal drug therapy in patients with hypertensive emergencies. The choice of pharmacologic agent should be individualized based on drug properties, patient comorbidities, and the end-organ(s) involved.
Selected pharmacologic agents: Sodium nitroprusside (SNP) is a short-acting, potent arterial and venous dilator that has been used extensively in the treatment of hypertensive emergencies. Despite its familiarity, there are several important limitations to its use. SNP can increase intracranial pressure (ICP), worsen myocardial ischemia through coronary steal, and is associated with cyanide and/or thiocyanate toxicity. Although used broadly across many types of hypertensive emergencies, SNP should be considered a first-line agent in acute left ventricular (LV) failure and, when combined with beta-blockers, in acute aortic dissection.
Labetalol is an alpha-1 and nonselective beta-blocker that reduces systemic vascular resistance while preserving cerebral, renal, and coronary blood flow. It is considered a first-line agent in most hypertensive emergencies, with the exception of acute LV failure.
Esmolol is a short-acting, selective beta-blocker that decreases heart rate, myocardial contractility, and cardiac output.
Nicardipine is a second-generation dihydropyridine calcium channel blocker. Although it has a longer duration of action, excess hypotension has not been seen in clinical trials comparing it with SNP.4 Nicardipine is used safely in such hypertensive emergencies as hypertensive encephalopathy, cerebral vascular accidents, and postoperatively.
Fenoldopam creates vasodilation by acting on peripheral dopamine type 1 receptors. It improves creatinine clearance and urine output, and is most useful in acute kidney injury.5 It is a well-tolerated and highly effective agent for use in most hypertensive crises, although is expensive and has limited hard outcome data.
Nitroglycerin is a potent venodilator that is used as an adjunct to other anti-hypertensives in the treatment of acute coronary syndromes and acute pulmonary edema.
Immediate-release nifedipine and clonidine are not recommended; they are long-acting and poorly titratable, with unpredictable hypotensive effects.
Hydralazine may be used in LV failure and in pregnancy.
Specific emergencies: Aortic dissection is the most rapidly fatal complication of severe HTN. Untreated, approximately 80% of patients with acute type-A dissections die within two weeks.6 In this specific setting, SBP should be decreased as rapidly as possible to <110 mm Hg in order to halt propagation of the dissection prior to surgery. Therapy should aim to reduce the shear stress on the aortic wall by decreasing both BP and heart rate. This can be accomplished with a combination of esmolol and SNP. Nicardipine and fenoldopam are effective alternatives to SNP. Labetalol is a good single-agent option, provided adequate heart rate suppression is achieved.
LV failure and acute pulmonary edema are associated with high systemic vascular resistance and activation of the Renin Angiotensin Aldosterone (RAAS) system. First-line therapy should consist of arterial vasodilators (e.g., SNP, nicardipine, fenoldopam) in combination with a loop diuretic. Nitroglycerin can be used as an adjunct to reduce LV preload.
In hypertensive encephalopathy, blood pressure exceeds the cerebral autoregulatory threshold, leading to breakthrough vasodilation and the development of cerebral edema. Characteristic symptoms include the insidious onset of headache, nausea, vomiting, and nonlocalizing neurologic signs (e.g., lethargy, confusion, seizures). It is important to exclude stroke, as treatment strategies differ. SNP is used widely in the treatment of hypertensive encephalopathy; it may increase ICP and should be used with caution. Nicardipine and labetalol are effective alternatives with favorable cerebral hemodynamic profiles.
Malignant HTN is characterized by neuroretinopathy: cotton wool spots, flame hemorrhages, and papilledema. Encephalopathy and other evidence of end-organ dysfunction might not be present, although renal disease is common. Preferred drugs are SNP and labetalol, although fenoldopam has been used successfully.
Appropriate BP management following acute ischemic stroke remains controversial. Elevated BP often is a protective physiologic response to maintain cerebral perfusion. The American Heart Association (AHA) recommends initiating IV antihypertensive therapy for thrombolysis candidates when SBP >185 or DBP >110 mm Hg. For those who are not thrombolysis candidates, the recommended threshold for initiating IV antihypertensives is SBP >220 or DBP >120 mm Hg.7 The goal is to lower the BP by 15% to 25% within the first 24 hours. These goals are less aggressive than in patients with hypertensive encephalopathy without stroke.
Spontaneous intracerebral hemorrhage causes a rise in ICP with reflex systemic hypertension. Although a correlation between HTN and hematoma expansion exists, there is no evidence that shows lowering BP is protective. Two clinical trials are evaluating the effects of BP reduction to specified target levels.8 Pending those results, the AHA recommends BP reduction for patients with SBP >200 or MAP >150 mm Hg, or for patients with SBP >180 or MAP >130 mm Hg and evidence of elevated ICP.7 In both ischemic and hemorrhagic stroke, nicardipine and labetalol are appropriate first-line agents.
Most sympathetic crises are related to the recreational use of sympathomimetic drugs, pheochromocytoma, abrupt antihypertensive withdrawal, or concurrent ingestion of monoamine-oxidase inhibitors and tyramine-containing foods. Selective beta-blockers can increase BP and worsen HTN through unopposed alpha effects.
Although labetalol traditionally has been considered the ideal agent—due to its alpha and beta antagonism—studies have failed to support its use in this clinical setting.9 Phentolamine, nicardipine, and fenoldopam are reasonable selections.
Hypertension is common in the early postoperative period following cardiothoracic, vascular, head and neck, and neurosurgical procedures. No consensus exists regarding the treatment of noncardiac surgery patients, but treatment is recommended for BP >140/90 or MAP >105 mmHg in cardiac surgery patients. Nicardipine, clevidipine, and esmolol are proven agents. All three have been shown more effective than SNP in maintaining target BP, and each is associated with less BP variability.10
In patients with pregnancy-induced hypertension, initial therapy for preeclampsia includes magnesium sulfate for seizure prophylaxis and BP control until delivery of the fetus can be safely undertaken. The FDA does not recommend any specific antihypertensive agents; however, ACE inhibitors and SNP are contraindicated. Although hydralazine is used extensively in this setting, a meta-analysis showed increased risk of maternal hypotension, Cesarean section, placental abruptions, and low Apgar scores.11 Labetalol and nicardipine appear to be safe and effective in pregnant hypertensive patients.
Back to the Case
This case represents a classic presentation of malignant hypertension with hypertensive encephalopathy, which is reversible with timely and appropriate management. The patient’s MAP is approximately 165 mmHg, well above the upper threshold of cerebral vascular autoregulation in most patients with chronic hypertension. A brain MRI should be obtained to definitively rule out stroke, as management goals would be considerably different.
If the scan is negative, treatment should be initiated immediately with a goal of reducing the MAP by no more than 25% within the first hour. Nicardipine or labetalol would be appropriate therapeutic choices, administered in an ICU with close hemodynamic monitoring.
Given the patient’s end-stage renal disease and evidence of intracranial hypertension, SNP would be a suboptimal choice. Over hours two through six, BP could be lowered gradually to 160/100, then to his baseline BP over the ensuing 24 to 48 hours, monitoring closely for signs of neurologic deterioration. Once BP is stable and there is no evidence of worsening end-organ damage, he can be safely transitioned to oral agents.
Bottom Line
The therapeutic goal in hypertensive emergencies is to immediately and safely lower BP to halt end-organ damage. Drug selection should be individualized. TH
Dr. Shanahan is a hospitalist and assistant professor at the Denver VA Medical Center. Dr. Linas is professor of medicine in the division of renal diseases and hypertension at the University of Colorado Denver School of Medicine. Dr. Anderson is associate professor and chief of the hospital medicine section at the Denver VA Medical Center.
References
- Lenfant C, Chobanian AV, Jones DW, Roccella EJ. Seventh report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7): resetting the hypertension sails. Hypertension. 2003;41(6):1178-1179.
- Ault MJ, Ellrodt AG. Pathophysiological events leading to the end-organ effects of acute hypertension. Am J Emerg Med. 1985;3(6 Suppl):10-15.
- Vaughan CJ, Delanty N. Hypertensive emergencies. Lancet. 2000;356(9227):411-417.
- Neutel JM, Smith DH, Wallin D, et al. A comparison of intravenous nicardipine and sodium nitroprusside in the immediate treatment of severe hypertension. Am J Hypertens. 1994;7(7 Pt 1):623-628.
- Shusterman NH, Elliott WJ, White WB. Fenoldopam, but not nitroprusside, improves renal function in severely hypertensive patients with impaired renal function. Am J Med. 1993;95(2):161-168.
- Khan IA, Nair CK. Clinical, diagnostic, and management perspectives of aortic dissection. Chest. 2002;122(1):311-328.
- Adams HP Jr., del Zoppo G, Alberts MJ, et al. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Circulation. 2007;115(20):e478-534.
- Qureshi AI. Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH): rationale and design. Neurocrit Care. 2007;6(1):56-66.
- Marik PE, Varon J. Hypertensive crises: challenges and management. Chest. 2007;131(6):1949-1962.
- Aronson S, Dyke CM, Stierer KA, et al. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008;107(4):1110-1121.
- Magee LA, Cham C, Waterman EJ, Ohlsson A, von Dadelszen P. Hydralazine for treatment of severe hypertension in pregnancy: meta-analysis. BMJ. 2003;327(7421):955-960.
- Aggarwal M, Khan IA. Hypertensive crisis: hypertensive emergencies and urgencies. Cardiol Clin. 2006; 24(1):135-146.
- Rhoney D, Peacock WF. Intravenous therapy for hypertensive emergencies, part 1. Am J Health Syst Pharm. 2009;66(15):1343-1352.
- Rhoney D, Peacock WF. Intravenous therapy for hypertensive emergencies, part 2. Am J Health Syst Pharm. 2009;66(16):1448-1457.
- Varon J. Treatment of acute severe hypertension: current and newer agents. Drugs. 2008;68(3):283-297.
Case
A 57-year-old male with hypertension and end-stage renal disease is brought into the ED by his family for evaluation of headache, nausea, blurry vision, and confusion. Blood pressure is 235/130 mmHg. He is somnolent but arousable and oriented only to person; the remainder of his neurologic exam is nonfocal. A fundoscopic exam shows retinal hemorrhages, exudates, and papilledema. How should this patient be managed?
Overview
Hypertension (HTN) is a medical problem that affects an estimated 1 in 3 adults in the U.S. and more than 1 billion people worldwide. The Joint National Committee (JNC) 7 Report defines hypertensive emergency as severe hypertension with evidence of impending or progressive end-organ dysfunction.1 Systolic blood pressure (SBP) in these settings often is >180 mm Hg with diastolic blood pressure (DBP) >120 mm Hg. The JNC 7 Report defines hypertensive urgency as severe HTN without acute end-organ dysfunction. Whereas hypertensive urgencies can be treated with oral antihypertensive agents with close outpatient follow-up, hypertensive emergencies require immediate BP reduction to halt the progression of end-organ damage.
Severe HTN causes shear stress and endothelial injury, leading to activation of the coagulation cascade, fibrinoid necrosis, and tissue ischemia.2 Due to adaptive vascular changes, pre-existing hypertension lowers the probability of a hypertensive emergency developing at a particular BP. The rate of BP rise, rather than the absolute level, determines most end-organ damage.3 In previously normotensive patients, end-organ damage can occur at BPs >160/100 mm Hg; however, organ dysfunction is uncommon in chronically hypertensive individuals, unless BP >220/120 mm Hg.
Clinical manifestations of hypertensive emergency depend on the target organs involved (see Figure 1, right). When a patient presents with severe hypertension, a focused evaluation should attempt to identify the presence of end-organ damage. If present, these patients should be admitted to an ICU for close monitoring, and administration of parenteral antihypertensive agents should be started. (Online Exclusive: View a chart of “Parenteral Antihypertensive Agents Used in Hypertensive Emergencies”)
Review of the Data
General principles: The initial therapeutic goal in most hypertensive emergencies is to reduce the mean arterial pressure (MAP) by no more than 25% within the first hour. Precipitous or excessive decreases in BP might worsen renal, cerebral, or coronary ischemia. Due to pressure natriuresis, patients with primary malignant hypertension might be volume-depleted. Restoration of intravascular volume with intravenous (IV) saline can prevent precipitous falls in BP when antihypertensive agents are started.
After the patient stabilizes, the BP can be lowered about 10% per hour to 160/100-110 mm Hg. A gradual reduction to the patient’s baseline BP is targeted over the ensuing 24 to 48 hours. Once there is stable BP control and end-organ damage has ceased, patients can be transitioned to oral therapy.
No large clinical trials have investigated optimal drug therapy in patients with hypertensive emergencies. The choice of pharmacologic agent should be individualized based on drug properties, patient comorbidities, and the end-organ(s) involved.
Selected pharmacologic agents: Sodium nitroprusside (SNP) is a short-acting, potent arterial and venous dilator that has been used extensively in the treatment of hypertensive emergencies. Despite its familiarity, there are several important limitations to its use. SNP can increase intracranial pressure (ICP), worsen myocardial ischemia through coronary steal, and is associated with cyanide and/or thiocyanate toxicity. Although used broadly across many types of hypertensive emergencies, SNP should be considered a first-line agent in acute left ventricular (LV) failure and, when combined with beta-blockers, in acute aortic dissection.
Labetalol is an alpha-1 and nonselective beta-blocker that reduces systemic vascular resistance while preserving cerebral, renal, and coronary blood flow. It is considered a first-line agent in most hypertensive emergencies, with the exception of acute LV failure.
Esmolol is a short-acting, selective beta-blocker that decreases heart rate, myocardial contractility, and cardiac output.
Nicardipine is a second-generation dihydropyridine calcium channel blocker. Although it has a longer duration of action, excess hypotension has not been seen in clinical trials comparing it with SNP.4 Nicardipine is used safely in such hypertensive emergencies as hypertensive encephalopathy, cerebral vascular accidents, and postoperatively.
Fenoldopam creates vasodilation by acting on peripheral dopamine type 1 receptors. It improves creatinine clearance and urine output, and is most useful in acute kidney injury.5 It is a well-tolerated and highly effective agent for use in most hypertensive crises, although is expensive and has limited hard outcome data.
Nitroglycerin is a potent venodilator that is used as an adjunct to other anti-hypertensives in the treatment of acute coronary syndromes and acute pulmonary edema.
Immediate-release nifedipine and clonidine are not recommended; they are long-acting and poorly titratable, with unpredictable hypotensive effects.
Hydralazine may be used in LV failure and in pregnancy.
Specific emergencies: Aortic dissection is the most rapidly fatal complication of severe HTN. Untreated, approximately 80% of patients with acute type-A dissections die within two weeks.6 In this specific setting, SBP should be decreased as rapidly as possible to <110 mm Hg in order to halt propagation of the dissection prior to surgery. Therapy should aim to reduce the shear stress on the aortic wall by decreasing both BP and heart rate. This can be accomplished with a combination of esmolol and SNP. Nicardipine and fenoldopam are effective alternatives to SNP. Labetalol is a good single-agent option, provided adequate heart rate suppression is achieved.
LV failure and acute pulmonary edema are associated with high systemic vascular resistance and activation of the Renin Angiotensin Aldosterone (RAAS) system. First-line therapy should consist of arterial vasodilators (e.g., SNP, nicardipine, fenoldopam) in combination with a loop diuretic. Nitroglycerin can be used as an adjunct to reduce LV preload.
In hypertensive encephalopathy, blood pressure exceeds the cerebral autoregulatory threshold, leading to breakthrough vasodilation and the development of cerebral edema. Characteristic symptoms include the insidious onset of headache, nausea, vomiting, and nonlocalizing neurologic signs (e.g., lethargy, confusion, seizures). It is important to exclude stroke, as treatment strategies differ. SNP is used widely in the treatment of hypertensive encephalopathy; it may increase ICP and should be used with caution. Nicardipine and labetalol are effective alternatives with favorable cerebral hemodynamic profiles.
Malignant HTN is characterized by neuroretinopathy: cotton wool spots, flame hemorrhages, and papilledema. Encephalopathy and other evidence of end-organ dysfunction might not be present, although renal disease is common. Preferred drugs are SNP and labetalol, although fenoldopam has been used successfully.
Appropriate BP management following acute ischemic stroke remains controversial. Elevated BP often is a protective physiologic response to maintain cerebral perfusion. The American Heart Association (AHA) recommends initiating IV antihypertensive therapy for thrombolysis candidates when SBP >185 or DBP >110 mm Hg. For those who are not thrombolysis candidates, the recommended threshold for initiating IV antihypertensives is SBP >220 or DBP >120 mm Hg.7 The goal is to lower the BP by 15% to 25% within the first 24 hours. These goals are less aggressive than in patients with hypertensive encephalopathy without stroke.
Spontaneous intracerebral hemorrhage causes a rise in ICP with reflex systemic hypertension. Although a correlation between HTN and hematoma expansion exists, there is no evidence that shows lowering BP is protective. Two clinical trials are evaluating the effects of BP reduction to specified target levels.8 Pending those results, the AHA recommends BP reduction for patients with SBP >200 or MAP >150 mm Hg, or for patients with SBP >180 or MAP >130 mm Hg and evidence of elevated ICP.7 In both ischemic and hemorrhagic stroke, nicardipine and labetalol are appropriate first-line agents.
Most sympathetic crises are related to the recreational use of sympathomimetic drugs, pheochromocytoma, abrupt antihypertensive withdrawal, or concurrent ingestion of monoamine-oxidase inhibitors and tyramine-containing foods. Selective beta-blockers can increase BP and worsen HTN through unopposed alpha effects.
Although labetalol traditionally has been considered the ideal agent—due to its alpha and beta antagonism—studies have failed to support its use in this clinical setting.9 Phentolamine, nicardipine, and fenoldopam are reasonable selections.
Hypertension is common in the early postoperative period following cardiothoracic, vascular, head and neck, and neurosurgical procedures. No consensus exists regarding the treatment of noncardiac surgery patients, but treatment is recommended for BP >140/90 or MAP >105 mmHg in cardiac surgery patients. Nicardipine, clevidipine, and esmolol are proven agents. All three have been shown more effective than SNP in maintaining target BP, and each is associated with less BP variability.10
In patients with pregnancy-induced hypertension, initial therapy for preeclampsia includes magnesium sulfate for seizure prophylaxis and BP control until delivery of the fetus can be safely undertaken. The FDA does not recommend any specific antihypertensive agents; however, ACE inhibitors and SNP are contraindicated. Although hydralazine is used extensively in this setting, a meta-analysis showed increased risk of maternal hypotension, Cesarean section, placental abruptions, and low Apgar scores.11 Labetalol and nicardipine appear to be safe and effective in pregnant hypertensive patients.
Back to the Case
This case represents a classic presentation of malignant hypertension with hypertensive encephalopathy, which is reversible with timely and appropriate management. The patient’s MAP is approximately 165 mmHg, well above the upper threshold of cerebral vascular autoregulation in most patients with chronic hypertension. A brain MRI should be obtained to definitively rule out stroke, as management goals would be considerably different.
If the scan is negative, treatment should be initiated immediately with a goal of reducing the MAP by no more than 25% within the first hour. Nicardipine or labetalol would be appropriate therapeutic choices, administered in an ICU with close hemodynamic monitoring.
Given the patient’s end-stage renal disease and evidence of intracranial hypertension, SNP would be a suboptimal choice. Over hours two through six, BP could be lowered gradually to 160/100, then to his baseline BP over the ensuing 24 to 48 hours, monitoring closely for signs of neurologic deterioration. Once BP is stable and there is no evidence of worsening end-organ damage, he can be safely transitioned to oral agents.
Bottom Line
The therapeutic goal in hypertensive emergencies is to immediately and safely lower BP to halt end-organ damage. Drug selection should be individualized. TH
Dr. Shanahan is a hospitalist and assistant professor at the Denver VA Medical Center. Dr. Linas is professor of medicine in the division of renal diseases and hypertension at the University of Colorado Denver School of Medicine. Dr. Anderson is associate professor and chief of the hospital medicine section at the Denver VA Medical Center.
References
- Lenfant C, Chobanian AV, Jones DW, Roccella EJ. Seventh report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7): resetting the hypertension sails. Hypertension. 2003;41(6):1178-1179.
- Ault MJ, Ellrodt AG. Pathophysiological events leading to the end-organ effects of acute hypertension. Am J Emerg Med. 1985;3(6 Suppl):10-15.
- Vaughan CJ, Delanty N. Hypertensive emergencies. Lancet. 2000;356(9227):411-417.
- Neutel JM, Smith DH, Wallin D, et al. A comparison of intravenous nicardipine and sodium nitroprusside in the immediate treatment of severe hypertension. Am J Hypertens. 1994;7(7 Pt 1):623-628.
- Shusterman NH, Elliott WJ, White WB. Fenoldopam, but not nitroprusside, improves renal function in severely hypertensive patients with impaired renal function. Am J Med. 1993;95(2):161-168.
- Khan IA, Nair CK. Clinical, diagnostic, and management perspectives of aortic dissection. Chest. 2002;122(1):311-328.
- Adams HP Jr., del Zoppo G, Alberts MJ, et al. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Circulation. 2007;115(20):e478-534.
- Qureshi AI. Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH): rationale and design. Neurocrit Care. 2007;6(1):56-66.
- Marik PE, Varon J. Hypertensive crises: challenges and management. Chest. 2007;131(6):1949-1962.
- Aronson S, Dyke CM, Stierer KA, et al. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008;107(4):1110-1121.
- Magee LA, Cham C, Waterman EJ, Ohlsson A, von Dadelszen P. Hydralazine for treatment of severe hypertension in pregnancy: meta-analysis. BMJ. 2003;327(7421):955-960.
- Aggarwal M, Khan IA. Hypertensive crisis: hypertensive emergencies and urgencies. Cardiol Clin. 2006; 24(1):135-146.
- Rhoney D, Peacock WF. Intravenous therapy for hypertensive emergencies, part 1. Am J Health Syst Pharm. 2009;66(15):1343-1352.
- Rhoney D, Peacock WF. Intravenous therapy for hypertensive emergencies, part 2. Am J Health Syst Pharm. 2009;66(16):1448-1457.
- Varon J. Treatment of acute severe hypertension: current and newer agents. Drugs. 2008;68(3):283-297.
Case
A 57-year-old male with hypertension and end-stage renal disease is brought into the ED by his family for evaluation of headache, nausea, blurry vision, and confusion. Blood pressure is 235/130 mmHg. He is somnolent but arousable and oriented only to person; the remainder of his neurologic exam is nonfocal. A fundoscopic exam shows retinal hemorrhages, exudates, and papilledema. How should this patient be managed?
Overview
Hypertension (HTN) is a medical problem that affects an estimated 1 in 3 adults in the U.S. and more than 1 billion people worldwide. The Joint National Committee (JNC) 7 Report defines hypertensive emergency as severe hypertension with evidence of impending or progressive end-organ dysfunction.1 Systolic blood pressure (SBP) in these settings often is >180 mm Hg with diastolic blood pressure (DBP) >120 mm Hg. The JNC 7 Report defines hypertensive urgency as severe HTN without acute end-organ dysfunction. Whereas hypertensive urgencies can be treated with oral antihypertensive agents with close outpatient follow-up, hypertensive emergencies require immediate BP reduction to halt the progression of end-organ damage.
Severe HTN causes shear stress and endothelial injury, leading to activation of the coagulation cascade, fibrinoid necrosis, and tissue ischemia.2 Due to adaptive vascular changes, pre-existing hypertension lowers the probability of a hypertensive emergency developing at a particular BP. The rate of BP rise, rather than the absolute level, determines most end-organ damage.3 In previously normotensive patients, end-organ damage can occur at BPs >160/100 mm Hg; however, organ dysfunction is uncommon in chronically hypertensive individuals, unless BP >220/120 mm Hg.
Clinical manifestations of hypertensive emergency depend on the target organs involved (see Figure 1, right). When a patient presents with severe hypertension, a focused evaluation should attempt to identify the presence of end-organ damage. If present, these patients should be admitted to an ICU for close monitoring, and administration of parenteral antihypertensive agents should be started. (Online Exclusive: View a chart of “Parenteral Antihypertensive Agents Used in Hypertensive Emergencies”)
Review of the Data
General principles: The initial therapeutic goal in most hypertensive emergencies is to reduce the mean arterial pressure (MAP) by no more than 25% within the first hour. Precipitous or excessive decreases in BP might worsen renal, cerebral, or coronary ischemia. Due to pressure natriuresis, patients with primary malignant hypertension might be volume-depleted. Restoration of intravascular volume with intravenous (IV) saline can prevent precipitous falls in BP when antihypertensive agents are started.
After the patient stabilizes, the BP can be lowered about 10% per hour to 160/100-110 mm Hg. A gradual reduction to the patient’s baseline BP is targeted over the ensuing 24 to 48 hours. Once there is stable BP control and end-organ damage has ceased, patients can be transitioned to oral therapy.
No large clinical trials have investigated optimal drug therapy in patients with hypertensive emergencies. The choice of pharmacologic agent should be individualized based on drug properties, patient comorbidities, and the end-organ(s) involved.
Selected pharmacologic agents: Sodium nitroprusside (SNP) is a short-acting, potent arterial and venous dilator that has been used extensively in the treatment of hypertensive emergencies. Despite its familiarity, there are several important limitations to its use. SNP can increase intracranial pressure (ICP), worsen myocardial ischemia through coronary steal, and is associated with cyanide and/or thiocyanate toxicity. Although used broadly across many types of hypertensive emergencies, SNP should be considered a first-line agent in acute left ventricular (LV) failure and, when combined with beta-blockers, in acute aortic dissection.
Labetalol is an alpha-1 and nonselective beta-blocker that reduces systemic vascular resistance while preserving cerebral, renal, and coronary blood flow. It is considered a first-line agent in most hypertensive emergencies, with the exception of acute LV failure.
Esmolol is a short-acting, selective beta-blocker that decreases heart rate, myocardial contractility, and cardiac output.
Nicardipine is a second-generation dihydropyridine calcium channel blocker. Although it has a longer duration of action, excess hypotension has not been seen in clinical trials comparing it with SNP.4 Nicardipine is used safely in such hypertensive emergencies as hypertensive encephalopathy, cerebral vascular accidents, and postoperatively.
Fenoldopam creates vasodilation by acting on peripheral dopamine type 1 receptors. It improves creatinine clearance and urine output, and is most useful in acute kidney injury.5 It is a well-tolerated and highly effective agent for use in most hypertensive crises, although is expensive and has limited hard outcome data.
Nitroglycerin is a potent venodilator that is used as an adjunct to other anti-hypertensives in the treatment of acute coronary syndromes and acute pulmonary edema.
Immediate-release nifedipine and clonidine are not recommended; they are long-acting and poorly titratable, with unpredictable hypotensive effects.
Hydralazine may be used in LV failure and in pregnancy.
Specific emergencies: Aortic dissection is the most rapidly fatal complication of severe HTN. Untreated, approximately 80% of patients with acute type-A dissections die within two weeks.6 In this specific setting, SBP should be decreased as rapidly as possible to <110 mm Hg in order to halt propagation of the dissection prior to surgery. Therapy should aim to reduce the shear stress on the aortic wall by decreasing both BP and heart rate. This can be accomplished with a combination of esmolol and SNP. Nicardipine and fenoldopam are effective alternatives to SNP. Labetalol is a good single-agent option, provided adequate heart rate suppression is achieved.
LV failure and acute pulmonary edema are associated with high systemic vascular resistance and activation of the Renin Angiotensin Aldosterone (RAAS) system. First-line therapy should consist of arterial vasodilators (e.g., SNP, nicardipine, fenoldopam) in combination with a loop diuretic. Nitroglycerin can be used as an adjunct to reduce LV preload.
In hypertensive encephalopathy, blood pressure exceeds the cerebral autoregulatory threshold, leading to breakthrough vasodilation and the development of cerebral edema. Characteristic symptoms include the insidious onset of headache, nausea, vomiting, and nonlocalizing neurologic signs (e.g., lethargy, confusion, seizures). It is important to exclude stroke, as treatment strategies differ. SNP is used widely in the treatment of hypertensive encephalopathy; it may increase ICP and should be used with caution. Nicardipine and labetalol are effective alternatives with favorable cerebral hemodynamic profiles.
Malignant HTN is characterized by neuroretinopathy: cotton wool spots, flame hemorrhages, and papilledema. Encephalopathy and other evidence of end-organ dysfunction might not be present, although renal disease is common. Preferred drugs are SNP and labetalol, although fenoldopam has been used successfully.
Appropriate BP management following acute ischemic stroke remains controversial. Elevated BP often is a protective physiologic response to maintain cerebral perfusion. The American Heart Association (AHA) recommends initiating IV antihypertensive therapy for thrombolysis candidates when SBP >185 or DBP >110 mm Hg. For those who are not thrombolysis candidates, the recommended threshold for initiating IV antihypertensives is SBP >220 or DBP >120 mm Hg.7 The goal is to lower the BP by 15% to 25% within the first 24 hours. These goals are less aggressive than in patients with hypertensive encephalopathy without stroke.
Spontaneous intracerebral hemorrhage causes a rise in ICP with reflex systemic hypertension. Although a correlation between HTN and hematoma expansion exists, there is no evidence that shows lowering BP is protective. Two clinical trials are evaluating the effects of BP reduction to specified target levels.8 Pending those results, the AHA recommends BP reduction for patients with SBP >200 or MAP >150 mm Hg, or for patients with SBP >180 or MAP >130 mm Hg and evidence of elevated ICP.7 In both ischemic and hemorrhagic stroke, nicardipine and labetalol are appropriate first-line agents.
Most sympathetic crises are related to the recreational use of sympathomimetic drugs, pheochromocytoma, abrupt antihypertensive withdrawal, or concurrent ingestion of monoamine-oxidase inhibitors and tyramine-containing foods. Selective beta-blockers can increase BP and worsen HTN through unopposed alpha effects.
Although labetalol traditionally has been considered the ideal agent—due to its alpha and beta antagonism—studies have failed to support its use in this clinical setting.9 Phentolamine, nicardipine, and fenoldopam are reasonable selections.
Hypertension is common in the early postoperative period following cardiothoracic, vascular, head and neck, and neurosurgical procedures. No consensus exists regarding the treatment of noncardiac surgery patients, but treatment is recommended for BP >140/90 or MAP >105 mmHg in cardiac surgery patients. Nicardipine, clevidipine, and esmolol are proven agents. All three have been shown more effective than SNP in maintaining target BP, and each is associated with less BP variability.10
In patients with pregnancy-induced hypertension, initial therapy for preeclampsia includes magnesium sulfate for seizure prophylaxis and BP control until delivery of the fetus can be safely undertaken. The FDA does not recommend any specific antihypertensive agents; however, ACE inhibitors and SNP are contraindicated. Although hydralazine is used extensively in this setting, a meta-analysis showed increased risk of maternal hypotension, Cesarean section, placental abruptions, and low Apgar scores.11 Labetalol and nicardipine appear to be safe and effective in pregnant hypertensive patients.
Back to the Case
This case represents a classic presentation of malignant hypertension with hypertensive encephalopathy, which is reversible with timely and appropriate management. The patient’s MAP is approximately 165 mmHg, well above the upper threshold of cerebral vascular autoregulation in most patients with chronic hypertension. A brain MRI should be obtained to definitively rule out stroke, as management goals would be considerably different.
If the scan is negative, treatment should be initiated immediately with a goal of reducing the MAP by no more than 25% within the first hour. Nicardipine or labetalol would be appropriate therapeutic choices, administered in an ICU with close hemodynamic monitoring.
Given the patient’s end-stage renal disease and evidence of intracranial hypertension, SNP would be a suboptimal choice. Over hours two through six, BP could be lowered gradually to 160/100, then to his baseline BP over the ensuing 24 to 48 hours, monitoring closely for signs of neurologic deterioration. Once BP is stable and there is no evidence of worsening end-organ damage, he can be safely transitioned to oral agents.
Bottom Line
The therapeutic goal in hypertensive emergencies is to immediately and safely lower BP to halt end-organ damage. Drug selection should be individualized. TH
Dr. Shanahan is a hospitalist and assistant professor at the Denver VA Medical Center. Dr. Linas is professor of medicine in the division of renal diseases and hypertension at the University of Colorado Denver School of Medicine. Dr. Anderson is associate professor and chief of the hospital medicine section at the Denver VA Medical Center.
References
- Lenfant C, Chobanian AV, Jones DW, Roccella EJ. Seventh report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7): resetting the hypertension sails. Hypertension. 2003;41(6):1178-1179.
- Ault MJ, Ellrodt AG. Pathophysiological events leading to the end-organ effects of acute hypertension. Am J Emerg Med. 1985;3(6 Suppl):10-15.
- Vaughan CJ, Delanty N. Hypertensive emergencies. Lancet. 2000;356(9227):411-417.
- Neutel JM, Smith DH, Wallin D, et al. A comparison of intravenous nicardipine and sodium nitroprusside in the immediate treatment of severe hypertension. Am J Hypertens. 1994;7(7 Pt 1):623-628.
- Shusterman NH, Elliott WJ, White WB. Fenoldopam, but not nitroprusside, improves renal function in severely hypertensive patients with impaired renal function. Am J Med. 1993;95(2):161-168.
- Khan IA, Nair CK. Clinical, diagnostic, and management perspectives of aortic dissection. Chest. 2002;122(1):311-328.
- Adams HP Jr., del Zoppo G, Alberts MJ, et al. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Circulation. 2007;115(20):e478-534.
- Qureshi AI. Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH): rationale and design. Neurocrit Care. 2007;6(1):56-66.
- Marik PE, Varon J. Hypertensive crises: challenges and management. Chest. 2007;131(6):1949-1962.
- Aronson S, Dyke CM, Stierer KA, et al. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008;107(4):1110-1121.
- Magee LA, Cham C, Waterman EJ, Ohlsson A, von Dadelszen P. Hydralazine for treatment of severe hypertension in pregnancy: meta-analysis. BMJ. 2003;327(7421):955-960.
- Aggarwal M, Khan IA. Hypertensive crisis: hypertensive emergencies and urgencies. Cardiol Clin. 2006; 24(1):135-146.
- Rhoney D, Peacock WF. Intravenous therapy for hypertensive emergencies, part 1. Am J Health Syst Pharm. 2009;66(15):1343-1352.
- Rhoney D, Peacock WF. Intravenous therapy for hypertensive emergencies, part 2. Am J Health Syst Pharm. 2009;66(16):1448-1457.
- Varon J. Treatment of acute severe hypertension: current and newer agents. Drugs. 2008;68(3):283-297.
Raise the ‘Red Flags’
To no one’s surprise, federal legislation doesn’t always do what its architects originally intended. A bill designed to protect consumers from identify theft can instead leave small hospitalist practices and other healthcare businesses in the lurch over whether they must meet stringent antitheft requirements intended for credit-card companies and banks. A bill designed to add millions of patients to the ranks of the insured could instead subtract millions of dollars from the reimbursements hospitals and doctors receive from private insurers.
—Jon Leibowitz, chairman, Federal Trade Commission
So What’s to Be Done?
An effort to correct one of these lingering headaches—known as the “Red Flags Rule”—is again on the table, though not everyone’s convinced it might finally be fixed seven years after it was first enacted. The rule, folded into the Fair and Accurate Credit Transactions Act of 2003, required the Federal Trade Commission (FTC) and other government agencies to come up with specific measures that “creditors” and “financial institutions” would have to design and implement to counter the growing risk of identity theft.
As intended, these measures would help businesses “identify, detect, and respond” to anything that might suggest identity theft. In other words, they could throw up red flags to warn of illegal activity.
But five years later, as the act’s Nov. 1, 2008, enforcement date was approaching, no one seemed to know exactly which businesses should be considered “creditors.” The act’s vague wording, in fact, created widespread fear that a measure designed principally for banks and credit-card companies would also apply to small accounting, legal, and healthcare practices, saddling them with cumbersome and expensive vetting protocols.
Thus began a series of requests by federal legislators that the FTC delay enforcement until the confusion could be sorted out. After three delays, including the latest pushback from June 1 through the end of this year, the commission’s patience is wearing thin. FTC Chairman Jon Leibowitz has been clear about the agency’s frustration over the extensions in lieu of a permanent resolution.
“Congress needs to fix the unintended consequences of the legislation establishing the Red Flags Rule—and to fix this problem quickly,” he said in a May 28 release. “As an agency, we’re charged with enforcing the law, and endless extensions delay enforcement.”
The not-so-subtle jab at Congressional inaction was aimed at one chamber in particular. Bill HR3763, which adds clarifying language to the rule and specifically excludes accounting, legal, and medical practices with 20 or fewer employees, sailed through the House of Representatives last October by a vote of 400-0. And then it promptly hit a giant sandbar in the form of the Senate. On May 25, Sen. John Thune (R-S.D.) and Sen. Mark Begich (D-Alaska) attempted a relaunch with their introduction of S3416, a near carbon copy of the House bill.
The measure is hardly a fait accompli, given the Senate’s recent track record, but a spokesman for Sen. Thune said the senator’s office is expecting a resolution before the FTC’s latest extension expires. Citing the commission’s decision to delay enforcement soon after the Senate bill’s introduction, he said, “We interpret that as an indication that they want to give Congress time to act, so we’re very optimistic that something will happen this year.”
Of course, the enforcement delay also might have something to do with the joint lawsuit filed May 21 by the American Medical Association, American Osteopathic Association, and the Medical Society of the District of Columbia. In their complaint, the three medical associations charged that the FTC’s application of the rule to physicians is “arbitrary, capricious, and contrary to the law.”
It’s now up to the Senate to decide whether that suit will become moot. TH
Bryn Nelson is a freelance medical writer based in Seattle.
To no one’s surprise, federal legislation doesn’t always do what its architects originally intended. A bill designed to protect consumers from identify theft can instead leave small hospitalist practices and other healthcare businesses in the lurch over whether they must meet stringent antitheft requirements intended for credit-card companies and banks. A bill designed to add millions of patients to the ranks of the insured could instead subtract millions of dollars from the reimbursements hospitals and doctors receive from private insurers.
—Jon Leibowitz, chairman, Federal Trade Commission
So What’s to Be Done?
An effort to correct one of these lingering headaches—known as the “Red Flags Rule”—is again on the table, though not everyone’s convinced it might finally be fixed seven years after it was first enacted. The rule, folded into the Fair and Accurate Credit Transactions Act of 2003, required the Federal Trade Commission (FTC) and other government agencies to come up with specific measures that “creditors” and “financial institutions” would have to design and implement to counter the growing risk of identity theft.
As intended, these measures would help businesses “identify, detect, and respond” to anything that might suggest identity theft. In other words, they could throw up red flags to warn of illegal activity.
But five years later, as the act’s Nov. 1, 2008, enforcement date was approaching, no one seemed to know exactly which businesses should be considered “creditors.” The act’s vague wording, in fact, created widespread fear that a measure designed principally for banks and credit-card companies would also apply to small accounting, legal, and healthcare practices, saddling them with cumbersome and expensive vetting protocols.
Thus began a series of requests by federal legislators that the FTC delay enforcement until the confusion could be sorted out. After three delays, including the latest pushback from June 1 through the end of this year, the commission’s patience is wearing thin. FTC Chairman Jon Leibowitz has been clear about the agency’s frustration over the extensions in lieu of a permanent resolution.
“Congress needs to fix the unintended consequences of the legislation establishing the Red Flags Rule—and to fix this problem quickly,” he said in a May 28 release. “As an agency, we’re charged with enforcing the law, and endless extensions delay enforcement.”
The not-so-subtle jab at Congressional inaction was aimed at one chamber in particular. Bill HR3763, which adds clarifying language to the rule and specifically excludes accounting, legal, and medical practices with 20 or fewer employees, sailed through the House of Representatives last October by a vote of 400-0. And then it promptly hit a giant sandbar in the form of the Senate. On May 25, Sen. John Thune (R-S.D.) and Sen. Mark Begich (D-Alaska) attempted a relaunch with their introduction of S3416, a near carbon copy of the House bill.
The measure is hardly a fait accompli, given the Senate’s recent track record, but a spokesman for Sen. Thune said the senator’s office is expecting a resolution before the FTC’s latest extension expires. Citing the commission’s decision to delay enforcement soon after the Senate bill’s introduction, he said, “We interpret that as an indication that they want to give Congress time to act, so we’re very optimistic that something will happen this year.”
Of course, the enforcement delay also might have something to do with the joint lawsuit filed May 21 by the American Medical Association, American Osteopathic Association, and the Medical Society of the District of Columbia. In their complaint, the three medical associations charged that the FTC’s application of the rule to physicians is “arbitrary, capricious, and contrary to the law.”
It’s now up to the Senate to decide whether that suit will become moot. TH
Bryn Nelson is a freelance medical writer based in Seattle.
To no one’s surprise, federal legislation doesn’t always do what its architects originally intended. A bill designed to protect consumers from identify theft can instead leave small hospitalist practices and other healthcare businesses in the lurch over whether they must meet stringent antitheft requirements intended for credit-card companies and banks. A bill designed to add millions of patients to the ranks of the insured could instead subtract millions of dollars from the reimbursements hospitals and doctors receive from private insurers.
—Jon Leibowitz, chairman, Federal Trade Commission
So What’s to Be Done?
An effort to correct one of these lingering headaches—known as the “Red Flags Rule”—is again on the table, though not everyone’s convinced it might finally be fixed seven years after it was first enacted. The rule, folded into the Fair and Accurate Credit Transactions Act of 2003, required the Federal Trade Commission (FTC) and other government agencies to come up with specific measures that “creditors” and “financial institutions” would have to design and implement to counter the growing risk of identity theft.
As intended, these measures would help businesses “identify, detect, and respond” to anything that might suggest identity theft. In other words, they could throw up red flags to warn of illegal activity.
But five years later, as the act’s Nov. 1, 2008, enforcement date was approaching, no one seemed to know exactly which businesses should be considered “creditors.” The act’s vague wording, in fact, created widespread fear that a measure designed principally for banks and credit-card companies would also apply to small accounting, legal, and healthcare practices, saddling them with cumbersome and expensive vetting protocols.
Thus began a series of requests by federal legislators that the FTC delay enforcement until the confusion could be sorted out. After three delays, including the latest pushback from June 1 through the end of this year, the commission’s patience is wearing thin. FTC Chairman Jon Leibowitz has been clear about the agency’s frustration over the extensions in lieu of a permanent resolution.
“Congress needs to fix the unintended consequences of the legislation establishing the Red Flags Rule—and to fix this problem quickly,” he said in a May 28 release. “As an agency, we’re charged with enforcing the law, and endless extensions delay enforcement.”
The not-so-subtle jab at Congressional inaction was aimed at one chamber in particular. Bill HR3763, which adds clarifying language to the rule and specifically excludes accounting, legal, and medical practices with 20 or fewer employees, sailed through the House of Representatives last October by a vote of 400-0. And then it promptly hit a giant sandbar in the form of the Senate. On May 25, Sen. John Thune (R-S.D.) and Sen. Mark Begich (D-Alaska) attempted a relaunch with their introduction of S3416, a near carbon copy of the House bill.
The measure is hardly a fait accompli, given the Senate’s recent track record, but a spokesman for Sen. Thune said the senator’s office is expecting a resolution before the FTC’s latest extension expires. Citing the commission’s decision to delay enforcement soon after the Senate bill’s introduction, he said, “We interpret that as an indication that they want to give Congress time to act, so we’re very optimistic that something will happen this year.”
Of course, the enforcement delay also might have something to do with the joint lawsuit filed May 21 by the American Medical Association, American Osteopathic Association, and the Medical Society of the District of Columbia. In their complaint, the three medical associations charged that the FTC’s application of the rule to physicians is “arbitrary, capricious, and contrary to the law.”
It’s now up to the Senate to decide whether that suit will become moot. TH
Bryn Nelson is a freelance medical writer based in Seattle.
Patients First
Rachel George, MD, MBA, FHM, CPE, acknowledges she found her calling through a fluke. After completing an internal-medicine residency in Chicago in 2002, she knew she wanted to stay in the region. She hadn’t decided much else.
“I was not excited about private practice, and I had thought about a cardiology fellowship,” Dr. George recalls. “I was trying to figure out what I wanted to do when I grew up, so to speak.”
She found a job as the lone hospitalist with OSF Medical Group in Rockford, Ill. Despite knowing she’d see “a ridiculous number of patients”—up to 30 per day on weekends—she liked it enough to sign on. “I decided I’d give it a chance for six months or a year while I figured out what I was really going to do,” she says.
Before long, she realized she already was doing it.
“I absolutely loved it,” says Dr. George, one of six new Team Hospitalist members who joined our reader advisory group in April. She now oversees five hospitalist programs in three states as regional medical director and vice president of operations for Brentwood, Tenn.-based Cogent Healthcare. “It was perfect. It was the niche I was looking for.”
Question: What did you enjoy so much about being a hospitalist?
Answer: The acuity of care, the instant gratification of fixing someone and sending them on their way, the intensity in the hospital, not feeling like I was being pulled in 15 different directions like you are in primary-care practice—all the good things about being a hospitalist.
Q: Within a year of joining OSF, you became medical director of its hospitalist service and oversaw its expansion. Did you always envision yourself moving into a leadership role?
A: When I started, I probably would have said my ultimate goal was to get my MBA and think about hospital administration. That was the 10-year plan, or maybe even the 15- or 20-year plan. But when people at the hospital began talking about expanding the [HM] program, I got thrust into the [medical director] role. By that point, I was hooked.
Q: Within three years, you grew the service from one physician to nine. How did you approach expansion?
A: The goal was sustainable growth—growth without sacrificing quality of patient care. When PCPs approached me about taking over their patient population, I’d say we’d take them on as we hired more people. I didn’t want to take off more than we could chew, and I didn’t want to have ridiculous turnover. That wouldn’t do anybody any good.
Q: You joined Cogent in 2006. What prompted the move?
A: I knew Cogent through SHM, and it was too good of an opportunity to pass up. The chance to expand my management responsibilities also was very appealing.
Q: What do you see as the biggest advantage of Cogent’s model?
A: I was part of an in-house program, and I think they’re great in a lot of ways. What they can’t do is economies of scale. There are certain things you can’t do just because it doesn’t make sense financially.
Q: Can you give an example?
A: The classic example I’ll give is discharge summaries in less than 24 hours. [At OSF], I did everything short of getting on my hands and knees and begging them to transcribe discharge summaries in less than 24 hours. They wouldn’t, and I understand why. It was a financial decision.
Cogent, from its inception, said this is too important and we’re going to make sure PCPs get information at discharge. Those types of economies of scale are very difficult to do in a small program, if you’re trying to do it yourself.
Q: What do you consider your biggest professional reward?
A: Seeing a really high-functioning HM team that I’ve helped make that way.
Q: What are the essential elements of such a team?
A: It’s the culture, that patient-first attitude. If everyone understands getting high-quality care to the patient is the most important thing, and we’re all working together to make sure that happens, everything else—core measure performance, decreasing the length of stay—will follow.
Q: What is your biggest challenge?
A: Trying to revamp broken programs.
Q: How do you begin that process?
A: Once the wrong attitude, wrong vision, and wrong culture have set in, we have to decide “How do we improve this?” It’s very difficult. You can’t just close the service and stop seeing patients until you’ve done what you need to do. It’s like trying to fix an airplane in midair.
Q: Despite an already full plate, you continue to see patients. Why?
A: I do it for myself. I don’t want to quit patient care. I enjoy talking to my patients, figuring out what’s wrong, and trying to help them.
Q: You attended the SHM Leadership Academy and have since facilitated academy sessions. What do you see as its benefit?
A: Hospital medicine is a business, whether we like to accept it or not. It’s important for physicians to understand the business drivers, not only for our own practice but for the hospital as well. The academy gives a great overview of the fundamentals of those business drivers.
Q: Would you recommend it for a physician who doesn’t intend to move into a leadership position?
A: I would. It’s valuable for anyone committed to hospital medicine. It helps them understand how their leaders are thinking and why they’re thinking the way they are.
Q: You are former chair of SHM’s Women in Hospital Medicine Task Force, and you pride yourself on balancing life and work. Is HM conducive to that balance?
A: It absolutely can be. Women sometimes think they have to be all things to all people all the time. It’s really about figuring out what your priorities are. I have two young kids and spending time with them is a bigger priority to me than cooking and cleaning. I’d rather live with a messy house and dishes in the sink than not spend time with them.
As a hospitalist, you have that flexibility, too. Most HM programs would love to have a stable, part-time physician. You can do that if you want, or you can be a nocturnist so you can be home with your kids during the day. You are in control of your own life. Understanding that is important, and you can make your choices accordingly.
Q: How do you think HM fares regarding the inclusion of women?
A: There isn’t as much of a good-old-boys’ club as opposed to other fields, which is really refreshing. Women are very well represented on boards and committees. What strikes me is the percentage of women hospitalist leaders is significantly lower.
Q: Why do you think that is?
A: I haven’t wrapped my mind around whether that’s because they aren’t interested because of the choices they made in their lives—which is perfectly fine—or if it’s a lack of opportunity. I do think some women choose not to have a leadership role because their priorities are different, and that’s wonderful. But I wonder if there are cases when women are being passed over for those positions for men instead. The percentages are something we need to keep an eye on so we can better understand why that’s happening. TH
Mark Leiser is a freelance writer in New Jersey.
Rachel George, MD, MBA, FHM, CPE, acknowledges she found her calling through a fluke. After completing an internal-medicine residency in Chicago in 2002, she knew she wanted to stay in the region. She hadn’t decided much else.
“I was not excited about private practice, and I had thought about a cardiology fellowship,” Dr. George recalls. “I was trying to figure out what I wanted to do when I grew up, so to speak.”
She found a job as the lone hospitalist with OSF Medical Group in Rockford, Ill. Despite knowing she’d see “a ridiculous number of patients”—up to 30 per day on weekends—she liked it enough to sign on. “I decided I’d give it a chance for six months or a year while I figured out what I was really going to do,” she says.
Before long, she realized she already was doing it.
“I absolutely loved it,” says Dr. George, one of six new Team Hospitalist members who joined our reader advisory group in April. She now oversees five hospitalist programs in three states as regional medical director and vice president of operations for Brentwood, Tenn.-based Cogent Healthcare. “It was perfect. It was the niche I was looking for.”
Question: What did you enjoy so much about being a hospitalist?
Answer: The acuity of care, the instant gratification of fixing someone and sending them on their way, the intensity in the hospital, not feeling like I was being pulled in 15 different directions like you are in primary-care practice—all the good things about being a hospitalist.
Q: Within a year of joining OSF, you became medical director of its hospitalist service and oversaw its expansion. Did you always envision yourself moving into a leadership role?
A: When I started, I probably would have said my ultimate goal was to get my MBA and think about hospital administration. That was the 10-year plan, or maybe even the 15- or 20-year plan. But when people at the hospital began talking about expanding the [HM] program, I got thrust into the [medical director] role. By that point, I was hooked.
Q: Within three years, you grew the service from one physician to nine. How did you approach expansion?
A: The goal was sustainable growth—growth without sacrificing quality of patient care. When PCPs approached me about taking over their patient population, I’d say we’d take them on as we hired more people. I didn’t want to take off more than we could chew, and I didn’t want to have ridiculous turnover. That wouldn’t do anybody any good.
Q: You joined Cogent in 2006. What prompted the move?
A: I knew Cogent through SHM, and it was too good of an opportunity to pass up. The chance to expand my management responsibilities also was very appealing.
Q: What do you see as the biggest advantage of Cogent’s model?
A: I was part of an in-house program, and I think they’re great in a lot of ways. What they can’t do is economies of scale. There are certain things you can’t do just because it doesn’t make sense financially.
Q: Can you give an example?
A: The classic example I’ll give is discharge summaries in less than 24 hours. [At OSF], I did everything short of getting on my hands and knees and begging them to transcribe discharge summaries in less than 24 hours. They wouldn’t, and I understand why. It was a financial decision.
Cogent, from its inception, said this is too important and we’re going to make sure PCPs get information at discharge. Those types of economies of scale are very difficult to do in a small program, if you’re trying to do it yourself.
Q: What do you consider your biggest professional reward?
A: Seeing a really high-functioning HM team that I’ve helped make that way.
Q: What are the essential elements of such a team?
A: It’s the culture, that patient-first attitude. If everyone understands getting high-quality care to the patient is the most important thing, and we’re all working together to make sure that happens, everything else—core measure performance, decreasing the length of stay—will follow.
Q: What is your biggest challenge?
A: Trying to revamp broken programs.
Q: How do you begin that process?
A: Once the wrong attitude, wrong vision, and wrong culture have set in, we have to decide “How do we improve this?” It’s very difficult. You can’t just close the service and stop seeing patients until you’ve done what you need to do. It’s like trying to fix an airplane in midair.
Q: Despite an already full plate, you continue to see patients. Why?
A: I do it for myself. I don’t want to quit patient care. I enjoy talking to my patients, figuring out what’s wrong, and trying to help them.
Q: You attended the SHM Leadership Academy and have since facilitated academy sessions. What do you see as its benefit?
A: Hospital medicine is a business, whether we like to accept it or not. It’s important for physicians to understand the business drivers, not only for our own practice but for the hospital as well. The academy gives a great overview of the fundamentals of those business drivers.
Q: Would you recommend it for a physician who doesn’t intend to move into a leadership position?
A: I would. It’s valuable for anyone committed to hospital medicine. It helps them understand how their leaders are thinking and why they’re thinking the way they are.
Q: You are former chair of SHM’s Women in Hospital Medicine Task Force, and you pride yourself on balancing life and work. Is HM conducive to that balance?
A: It absolutely can be. Women sometimes think they have to be all things to all people all the time. It’s really about figuring out what your priorities are. I have two young kids and spending time with them is a bigger priority to me than cooking and cleaning. I’d rather live with a messy house and dishes in the sink than not spend time with them.
As a hospitalist, you have that flexibility, too. Most HM programs would love to have a stable, part-time physician. You can do that if you want, or you can be a nocturnist so you can be home with your kids during the day. You are in control of your own life. Understanding that is important, and you can make your choices accordingly.
Q: How do you think HM fares regarding the inclusion of women?
A: There isn’t as much of a good-old-boys’ club as opposed to other fields, which is really refreshing. Women are very well represented on boards and committees. What strikes me is the percentage of women hospitalist leaders is significantly lower.
Q: Why do you think that is?
A: I haven’t wrapped my mind around whether that’s because they aren’t interested because of the choices they made in their lives—which is perfectly fine—or if it’s a lack of opportunity. I do think some women choose not to have a leadership role because their priorities are different, and that’s wonderful. But I wonder if there are cases when women are being passed over for those positions for men instead. The percentages are something we need to keep an eye on so we can better understand why that’s happening. TH
Mark Leiser is a freelance writer in New Jersey.
Rachel George, MD, MBA, FHM, CPE, acknowledges she found her calling through a fluke. After completing an internal-medicine residency in Chicago in 2002, she knew she wanted to stay in the region. She hadn’t decided much else.
“I was not excited about private practice, and I had thought about a cardiology fellowship,” Dr. George recalls. “I was trying to figure out what I wanted to do when I grew up, so to speak.”
She found a job as the lone hospitalist with OSF Medical Group in Rockford, Ill. Despite knowing she’d see “a ridiculous number of patients”—up to 30 per day on weekends—she liked it enough to sign on. “I decided I’d give it a chance for six months or a year while I figured out what I was really going to do,” she says.
Before long, she realized she already was doing it.
“I absolutely loved it,” says Dr. George, one of six new Team Hospitalist members who joined our reader advisory group in April. She now oversees five hospitalist programs in three states as regional medical director and vice president of operations for Brentwood, Tenn.-based Cogent Healthcare. “It was perfect. It was the niche I was looking for.”
Question: What did you enjoy so much about being a hospitalist?
Answer: The acuity of care, the instant gratification of fixing someone and sending them on their way, the intensity in the hospital, not feeling like I was being pulled in 15 different directions like you are in primary-care practice—all the good things about being a hospitalist.
Q: Within a year of joining OSF, you became medical director of its hospitalist service and oversaw its expansion. Did you always envision yourself moving into a leadership role?
A: When I started, I probably would have said my ultimate goal was to get my MBA and think about hospital administration. That was the 10-year plan, or maybe even the 15- or 20-year plan. But when people at the hospital began talking about expanding the [HM] program, I got thrust into the [medical director] role. By that point, I was hooked.
Q: Within three years, you grew the service from one physician to nine. How did you approach expansion?
A: The goal was sustainable growth—growth without sacrificing quality of patient care. When PCPs approached me about taking over their patient population, I’d say we’d take them on as we hired more people. I didn’t want to take off more than we could chew, and I didn’t want to have ridiculous turnover. That wouldn’t do anybody any good.
Q: You joined Cogent in 2006. What prompted the move?
A: I knew Cogent through SHM, and it was too good of an opportunity to pass up. The chance to expand my management responsibilities also was very appealing.
Q: What do you see as the biggest advantage of Cogent’s model?
A: I was part of an in-house program, and I think they’re great in a lot of ways. What they can’t do is economies of scale. There are certain things you can’t do just because it doesn’t make sense financially.
Q: Can you give an example?
A: The classic example I’ll give is discharge summaries in less than 24 hours. [At OSF], I did everything short of getting on my hands and knees and begging them to transcribe discharge summaries in less than 24 hours. They wouldn’t, and I understand why. It was a financial decision.
Cogent, from its inception, said this is too important and we’re going to make sure PCPs get information at discharge. Those types of economies of scale are very difficult to do in a small program, if you’re trying to do it yourself.
Q: What do you consider your biggest professional reward?
A: Seeing a really high-functioning HM team that I’ve helped make that way.
Q: What are the essential elements of such a team?
A: It’s the culture, that patient-first attitude. If everyone understands getting high-quality care to the patient is the most important thing, and we’re all working together to make sure that happens, everything else—core measure performance, decreasing the length of stay—will follow.
Q: What is your biggest challenge?
A: Trying to revamp broken programs.
Q: How do you begin that process?
A: Once the wrong attitude, wrong vision, and wrong culture have set in, we have to decide “How do we improve this?” It’s very difficult. You can’t just close the service and stop seeing patients until you’ve done what you need to do. It’s like trying to fix an airplane in midair.
Q: Despite an already full plate, you continue to see patients. Why?
A: I do it for myself. I don’t want to quit patient care. I enjoy talking to my patients, figuring out what’s wrong, and trying to help them.
Q: You attended the SHM Leadership Academy and have since facilitated academy sessions. What do you see as its benefit?
A: Hospital medicine is a business, whether we like to accept it or not. It’s important for physicians to understand the business drivers, not only for our own practice but for the hospital as well. The academy gives a great overview of the fundamentals of those business drivers.
Q: Would you recommend it for a physician who doesn’t intend to move into a leadership position?
A: I would. It’s valuable for anyone committed to hospital medicine. It helps them understand how their leaders are thinking and why they’re thinking the way they are.
Q: You are former chair of SHM’s Women in Hospital Medicine Task Force, and you pride yourself on balancing life and work. Is HM conducive to that balance?
A: It absolutely can be. Women sometimes think they have to be all things to all people all the time. It’s really about figuring out what your priorities are. I have two young kids and spending time with them is a bigger priority to me than cooking and cleaning. I’d rather live with a messy house and dishes in the sink than not spend time with them.
As a hospitalist, you have that flexibility, too. Most HM programs would love to have a stable, part-time physician. You can do that if you want, or you can be a nocturnist so you can be home with your kids during the day. You are in control of your own life. Understanding that is important, and you can make your choices accordingly.
Q: How do you think HM fares regarding the inclusion of women?
A: There isn’t as much of a good-old-boys’ club as opposed to other fields, which is really refreshing. Women are very well represented on boards and committees. What strikes me is the percentage of women hospitalist leaders is significantly lower.
Q: Why do you think that is?
A: I haven’t wrapped my mind around whether that’s because they aren’t interested because of the choices they made in their lives—which is perfectly fine—or if it’s a lack of opportunity. I do think some women choose not to have a leadership role because their priorities are different, and that’s wonderful. But I wonder if there are cases when women are being passed over for those positions for men instead. The percentages are something we need to keep an eye on so we can better understand why that’s happening. TH
Mark Leiser is a freelance writer in New Jersey.
Mentorship Matters
As you begin the next phase in your career, whether starting residency, a fellowship, or a new faculty position, it’s likely you have dozens of questions. How do I survive the rigors of residency? What do I need to make the most of my fellowship? What do I need to do to become more efficient in my clinical productivity? How do I succeed in academics? There are many more questions we could add to this list.
While some lessons in life are learned through trial and error, it rarely is the best way. This is especially true when considering your professional future. An essential first step at any phase in your career is finding yourself a mentor. There are many benefits to having someone help you navigate through many of the challenges you will face. A mentor’s experience is invaluable in avoiding potential pitfalls that set many physicians back in their careers, and in giving you the best opportunity to succeed as you begin your desired path.
This might seem like a new idea, but the concept of mentoring has been around for centuries. All of us have been mentored at some point in our lives; you probably just haven’t realized it. It could have been a parent, coach, guidance counselor, or teacher. Mentorship is a mutually beneficial relationship that applies to many areas of life, including your career development in medicine.
Finding a mentor is easier said than done. Many physicians are not sure where to begin. How do you choose? Where do you start? These are common questions, among many others. Some institutions assign mentors for this very reason. However, this is not always an ideal solution, as the mentor/mentee relationship might not be a perfect match.
Here are some ideas to help get you started in your mentor search:
1) Know Thyself: As you begin your search, start by reflecting on yourself. What do you need? What are your current skills? What are your career aspirations? This initial step of introspection is essential in becoming more aware of your own mentoring needs. The more specific you can be in defining your needs and goals, the better equipped you will be to seek out someone who can help guide you on the path to achieve them.
2) Know What to Look for: Having established what you are looking for as a mentee, it is important to consider what makes for a good mentor. A good mentor is experienced, successful, and has the proper skill sets, but also should have the following basic qualities:
- A willingness to mentor. They should want to invest in you and be interested in your career success;
- A commitment to the mentoring relationship. They will spend the time, energy, and resources necessary to help you achieve your goals;
- Availability. They must not be too busy with other responsibilities or other mentees;
- Good communications skills. They need to be a sounding board, and provide honest and constructive advice that is specific to your needs; and
- Professionalism. You should trust them to maintain confidentiality.
3) Start the Search: Now that you understand your needs and the desired qualities in a mentor, start thinking about potential options. You might already have someone in mind based on his or her success or reputation as a mentor. However, by asking around, you might also find other, lesser-known mentors that might be an even better fit for you in the long run.
Don’t limit yourself to your current institution. You might find that the mentors you are looking for are at other institutions. These opportunities are usually found through networking, either through local channels or through regional/national meetings. Although these kinds of mentorship relationships are more difficult to initiate and maintain, the opportunity to collaborate among members at various institutions can end up being more fruitful in the long term.
4) Meet and Greet: After assembling a short list of potential mentors, schedule a meeting with each of them. This may be cumbersome at first, but it is essential in finding out if this is someone you can see working with and learning from over the next few months or years. Finding this natural “fit” is what helps make for a lasting relationship.
At the same time, think of the meetings as interviews for a “position,” which is important to your future. This is the time for communicating your intentions, for making mutual expectations clear, and refining them further. Keep your professional goals in mind, as this will help in narrowing down your list.
5) One Size Does Not Fit All: As you consider potential mentors, keep in mind that it is OK to branch out. You might have many areas (research, education, quality improvement, work-life balance, leadership, clinical productivity, etc.) of interest that need mentoring. One mentor is unlikely to be able to meet all of your needs. This is where developing a core group of mentors could be helpful, each providing their unique insight.
Once you find a good mentor, remember to value their time and respect their expectations for you as a mentee. You are to be as committed to the partnership as you expect them to be. As you develop this mentorship, you will realize that it can become more than a professional relationship—it also can become a lasting alliance that strengthens with time. TH
Dr. LaBrin is an academic hospitalist at Vanderbilt University School of Medicine in Nashville, Tenn.
As you begin the next phase in your career, whether starting residency, a fellowship, or a new faculty position, it’s likely you have dozens of questions. How do I survive the rigors of residency? What do I need to make the most of my fellowship? What do I need to do to become more efficient in my clinical productivity? How do I succeed in academics? There are many more questions we could add to this list.
While some lessons in life are learned through trial and error, it rarely is the best way. This is especially true when considering your professional future. An essential first step at any phase in your career is finding yourself a mentor. There are many benefits to having someone help you navigate through many of the challenges you will face. A mentor’s experience is invaluable in avoiding potential pitfalls that set many physicians back in their careers, and in giving you the best opportunity to succeed as you begin your desired path.
This might seem like a new idea, but the concept of mentoring has been around for centuries. All of us have been mentored at some point in our lives; you probably just haven’t realized it. It could have been a parent, coach, guidance counselor, or teacher. Mentorship is a mutually beneficial relationship that applies to many areas of life, including your career development in medicine.
Finding a mentor is easier said than done. Many physicians are not sure where to begin. How do you choose? Where do you start? These are common questions, among many others. Some institutions assign mentors for this very reason. However, this is not always an ideal solution, as the mentor/mentee relationship might not be a perfect match.
Here are some ideas to help get you started in your mentor search:
1) Know Thyself: As you begin your search, start by reflecting on yourself. What do you need? What are your current skills? What are your career aspirations? This initial step of introspection is essential in becoming more aware of your own mentoring needs. The more specific you can be in defining your needs and goals, the better equipped you will be to seek out someone who can help guide you on the path to achieve them.
2) Know What to Look for: Having established what you are looking for as a mentee, it is important to consider what makes for a good mentor. A good mentor is experienced, successful, and has the proper skill sets, but also should have the following basic qualities:
- A willingness to mentor. They should want to invest in you and be interested in your career success;
- A commitment to the mentoring relationship. They will spend the time, energy, and resources necessary to help you achieve your goals;
- Availability. They must not be too busy with other responsibilities or other mentees;
- Good communications skills. They need to be a sounding board, and provide honest and constructive advice that is specific to your needs; and
- Professionalism. You should trust them to maintain confidentiality.
3) Start the Search: Now that you understand your needs and the desired qualities in a mentor, start thinking about potential options. You might already have someone in mind based on his or her success or reputation as a mentor. However, by asking around, you might also find other, lesser-known mentors that might be an even better fit for you in the long run.
Don’t limit yourself to your current institution. You might find that the mentors you are looking for are at other institutions. These opportunities are usually found through networking, either through local channels or through regional/national meetings. Although these kinds of mentorship relationships are more difficult to initiate and maintain, the opportunity to collaborate among members at various institutions can end up being more fruitful in the long term.
4) Meet and Greet: After assembling a short list of potential mentors, schedule a meeting with each of them. This may be cumbersome at first, but it is essential in finding out if this is someone you can see working with and learning from over the next few months or years. Finding this natural “fit” is what helps make for a lasting relationship.
At the same time, think of the meetings as interviews for a “position,” which is important to your future. This is the time for communicating your intentions, for making mutual expectations clear, and refining them further. Keep your professional goals in mind, as this will help in narrowing down your list.
5) One Size Does Not Fit All: As you consider potential mentors, keep in mind that it is OK to branch out. You might have many areas (research, education, quality improvement, work-life balance, leadership, clinical productivity, etc.) of interest that need mentoring. One mentor is unlikely to be able to meet all of your needs. This is where developing a core group of mentors could be helpful, each providing their unique insight.
Once you find a good mentor, remember to value their time and respect their expectations for you as a mentee. You are to be as committed to the partnership as you expect them to be. As you develop this mentorship, you will realize that it can become more than a professional relationship—it also can become a lasting alliance that strengthens with time. TH
Dr. LaBrin is an academic hospitalist at Vanderbilt University School of Medicine in Nashville, Tenn.
As you begin the next phase in your career, whether starting residency, a fellowship, or a new faculty position, it’s likely you have dozens of questions. How do I survive the rigors of residency? What do I need to make the most of my fellowship? What do I need to do to become more efficient in my clinical productivity? How do I succeed in academics? There are many more questions we could add to this list.
While some lessons in life are learned through trial and error, it rarely is the best way. This is especially true when considering your professional future. An essential first step at any phase in your career is finding yourself a mentor. There are many benefits to having someone help you navigate through many of the challenges you will face. A mentor’s experience is invaluable in avoiding potential pitfalls that set many physicians back in their careers, and in giving you the best opportunity to succeed as you begin your desired path.
This might seem like a new idea, but the concept of mentoring has been around for centuries. All of us have been mentored at some point in our lives; you probably just haven’t realized it. It could have been a parent, coach, guidance counselor, or teacher. Mentorship is a mutually beneficial relationship that applies to many areas of life, including your career development in medicine.
Finding a mentor is easier said than done. Many physicians are not sure where to begin. How do you choose? Where do you start? These are common questions, among many others. Some institutions assign mentors for this very reason. However, this is not always an ideal solution, as the mentor/mentee relationship might not be a perfect match.
Here are some ideas to help get you started in your mentor search:
1) Know Thyself: As you begin your search, start by reflecting on yourself. What do you need? What are your current skills? What are your career aspirations? This initial step of introspection is essential in becoming more aware of your own mentoring needs. The more specific you can be in defining your needs and goals, the better equipped you will be to seek out someone who can help guide you on the path to achieve them.
2) Know What to Look for: Having established what you are looking for as a mentee, it is important to consider what makes for a good mentor. A good mentor is experienced, successful, and has the proper skill sets, but also should have the following basic qualities:
- A willingness to mentor. They should want to invest in you and be interested in your career success;
- A commitment to the mentoring relationship. They will spend the time, energy, and resources necessary to help you achieve your goals;
- Availability. They must not be too busy with other responsibilities or other mentees;
- Good communications skills. They need to be a sounding board, and provide honest and constructive advice that is specific to your needs; and
- Professionalism. You should trust them to maintain confidentiality.
3) Start the Search: Now that you understand your needs and the desired qualities in a mentor, start thinking about potential options. You might already have someone in mind based on his or her success or reputation as a mentor. However, by asking around, you might also find other, lesser-known mentors that might be an even better fit for you in the long run.
Don’t limit yourself to your current institution. You might find that the mentors you are looking for are at other institutions. These opportunities are usually found through networking, either through local channels or through regional/national meetings. Although these kinds of mentorship relationships are more difficult to initiate and maintain, the opportunity to collaborate among members at various institutions can end up being more fruitful in the long term.
4) Meet and Greet: After assembling a short list of potential mentors, schedule a meeting with each of them. This may be cumbersome at first, but it is essential in finding out if this is someone you can see working with and learning from over the next few months or years. Finding this natural “fit” is what helps make for a lasting relationship.
At the same time, think of the meetings as interviews for a “position,” which is important to your future. This is the time for communicating your intentions, for making mutual expectations clear, and refining them further. Keep your professional goals in mind, as this will help in narrowing down your list.
5) One Size Does Not Fit All: As you consider potential mentors, keep in mind that it is OK to branch out. You might have many areas (research, education, quality improvement, work-life balance, leadership, clinical productivity, etc.) of interest that need mentoring. One mentor is unlikely to be able to meet all of your needs. This is where developing a core group of mentors could be helpful, each providing their unique insight.
Once you find a good mentor, remember to value their time and respect their expectations for you as a mentee. You are to be as committed to the partnership as you expect them to be. As you develop this mentorship, you will realize that it can become more than a professional relationship—it also can become a lasting alliance that strengthens with time. TH
Dr. LaBrin is an academic hospitalist at Vanderbilt University School of Medicine in Nashville, Tenn.
Radical vs. Sensible
Hospital medicine had grown rapidly and provided the platform for change in our nation’s hospitals long before there was any meaningful healthcare legislation in Washington. With President Obama’s appointment of an innovator—Don Berwick—to head the Centers for Medicare and Medicaid Services (CMS), there is increased opportunity to ramp up revisions, large and small, to provide the incentives and the impetus to create a healthcare system for the 21st century.
With that in mind, I thought I’d offer a few ideas that Don could institute on Day 1, which could start us in the right direction, or throw us all into chaos, depending on how it plays out. While most of my attention is directed to the Medicare population, all of these ideas would be equally applicable to the commercially insured population.
Advanced Directives
We all know that too few people in this country have taken the opportunity to discuss with their families and their personal physicians how they want their care managed at critical junctures, whether it comes on suddenly with an accident or with aging. The suggestion that Medicare would pay for an office visit with your doctor to discuss this imploded with the news media’s fanning of the “death panel” flames first stoked by Sarah Palin, which sidetracked all rational discussion.
Besides setting up people for unwarranted and unwanted assaults and protracted misery, mismanaging the end stages of life leads to an enormous misallocation of physicians’ focus at a time when we all need to be mindful stewards of our limited healthcare resources.
It is acceptable if, after careful consideration, anyone chooses to not have any advanced directive, but it should be a cognitive directed choice, not just a failure to engage.
Therefore, I am proposing that Medicare offer an incentive (e.g., waiving co-payments or deductibles) to have all Medicare beneficiaries complete an advanced directive annually, or sign a form indicating they were offered an advanced directive and declined to have one invoked. In addition, Medicare could set up a system that would allow physicians (or facilities) who would manage the patient’s healthcare to have access to the conditions of the advance directives. The forms could be attached to individual Medicare profiles, possibly on the Web, in addition to being held by a patient’s PCP or medical home, if they have one.
Personal Health Records
Most people in this country can access most of the information about their personal financial status in real time from any computer in the world. Less than 10% of Americans can retrieve meaningful personal medical information. This is in spite of the prevalence of Web-based personal health record (PHR) software from Microsoft, Revolution Health, and other software vendors, along with Kaiser Permanente and a handful of insurance companies.
PHRs allow for an initial baseline set of data to be recorded and updated as new tests, diagnoses, and medications are employed. It allows for a composite knowledge of what has been tried in the past and what is being utilized in the present. This can be under patients’ control, but it would allow for appropriate access at times of acute need (e.g., an ED visit or a hospital admission).
Too often, patients with a long-term relationship with a local PCP present to the hospital and all of the healthcare professionals are forced to make critical decisions in the first few hours with insufficient or inaccurate information. This leads to needless repetition of tests or inability to compare current data with previous data (wouldn’t it be nice to have the last EKG or labs?), or in retrying a treatment regimen that hasn’t worked in the past.
And if you are in another city or if you don’t have a local physician with all of your old records, the information gap is far worse.
Once again, we could incentivize patients to have an up-to-date PHR with reduced premiums, or lower deductibles or copayments. We could look for ways to incentivize PCPs and hospitals to help patients build and maintain their PHR. We could make it a matter of course that a patient’s PHR would be updated at each intersection with healthcare information (e.g., the pharmacy or the lab or each office visit).
Physician Accountability
Somehow, we have evolved into a fragmented health system. We need to repair the disconnect between patients and physicians. The professional pact between the patient and their primary physician needs to be in place until the patient and the “next” physician agree to the handoff of responsibility. As hospitalists, we see this at both ends of the continuum. Patients shouldn’t just be “sent” to the ED or the hospital, especially not when they are acutely ill. Their personal physician, their medical home, should “arrange” for an orderly transfer of care. This would involve a transfer of information (possibly facilitated by an updated PHR), but as much by the assurance that the accepting physician or institution is prepared for the handoff, acknowledges this to the PCP, and that the patient understands the handoff has taken place.
In the same way, patients would not be just “sent out” from the hospital. The treating physician (it could be the hospitalist, but also the surgeon or cardiologist) would remain the doctor of record—the first resource for patients’ question and issues—until another “receiving” physician has accepted the handoff, acknowledges this role, and the patient agrees.
We could rapidly shift this process by allowing the patient to decide when the hospitalization has ended. We could change the system overnight by making one of the conditions for payment for a hospitalization (to the physicians and the hospital) that the patient has signed off that indeed the hospitalization has ended.
This might include a discussion of chronic medications to continue, acute therapies to complete, understanding by the patient of where and when to receive follow-up testing and evaluation, and a clear understanding of which physician is now accountable for future issues and questions as patients travel from acute illness to normal function.
There certainly are economic and societal issues. Not everyone has a PCP or can pay for their outpatient care, and this could be a full-employment plan for liability attorneys, but in the end I am confident medical professionals would create the linkages that would minimize the deep white space patients find themselves in once they are wheeled to the front door of their hospitals.
Creatively Complete the Hospitalization
In a perfect world, everyone would have a functional, robust medical home to return to after an acute hospitalization. Unfortunately, a patient-centered medical home (PCMH) is much more of a hope than a reality for most Americans. While we are working to create a better “horizontal” hospitalization, there are clear gaps in the vertical-care world.
If we are going to be responsible for bundled care that encompasses pre-admit and post-discharge care (e.g., 30 days after discharge), then we must beef up our outpatient capabilities.
Hopefully in the long run, this can be supplied by a reinvigorated and reinvented medical home, but it is still a long way off. If payment and accountability continue to blur just when the hospitalization ends, then hospitals (and hospitalists) and Medicare and insurers will need to be creative in how and who will manage the patient. We’ll need to solve the issues around patients who are no longer sick enough to require a hospital bed but clearly are not back to their steady state.
This ties in with the accountability gap that vexes our patients every day. Very likely, hospitalists will have to assume a role in managing the patients after hospital discharge. This might take the form of a few follow-up visits and continued support systems via the Web and telephone. It will probably require a new class of hospitalist—the ambulist or the subacutist—supported by dedicated ancillary staff and systems.
Once again, Medicare and insurers can drive to a better system of post-acute care by supplying incentives: a more robust discharge payment or rewarding successful completion of a hospitalization, possibly by bundled payment incentives. In addition, there could be clear standards set that would define when this is done well with associated rewards.
I know some of these ideas are radical and make us uncomfortable. They seem to assign more responsibilities to an already overburdened profession. To be successful, these innovations require an active participation and accountability of our patients. We as the providers of healthcare cannot do this alone. It also requires the evolution of the hospital as an institution from just the healthcare provider for the acutely ill, horizontal patient, but as more a part of a continuum from acute illness to return to function. And it cries out for a robust, capable, outpatient partner in a medical home or accountable care organization (ACO) that is equally dedicated, incentivized, and accountable.
We won’t get there tomorrow, even if Dr. Berwick reads this and acts on all of the ideas on his first day at CMS.
But if we don’t get started, we know we definitely won’t get there at any time in our future. TH
Dr. Wellikson is CEO of SHM.
Hospital medicine had grown rapidly and provided the platform for change in our nation’s hospitals long before there was any meaningful healthcare legislation in Washington. With President Obama’s appointment of an innovator—Don Berwick—to head the Centers for Medicare and Medicaid Services (CMS), there is increased opportunity to ramp up revisions, large and small, to provide the incentives and the impetus to create a healthcare system for the 21st century.
With that in mind, I thought I’d offer a few ideas that Don could institute on Day 1, which could start us in the right direction, or throw us all into chaos, depending on how it plays out. While most of my attention is directed to the Medicare population, all of these ideas would be equally applicable to the commercially insured population.
Advanced Directives
We all know that too few people in this country have taken the opportunity to discuss with their families and their personal physicians how they want their care managed at critical junctures, whether it comes on suddenly with an accident or with aging. The suggestion that Medicare would pay for an office visit with your doctor to discuss this imploded with the news media’s fanning of the “death panel” flames first stoked by Sarah Palin, which sidetracked all rational discussion.
Besides setting up people for unwarranted and unwanted assaults and protracted misery, mismanaging the end stages of life leads to an enormous misallocation of physicians’ focus at a time when we all need to be mindful stewards of our limited healthcare resources.
It is acceptable if, after careful consideration, anyone chooses to not have any advanced directive, but it should be a cognitive directed choice, not just a failure to engage.
Therefore, I am proposing that Medicare offer an incentive (e.g., waiving co-payments or deductibles) to have all Medicare beneficiaries complete an advanced directive annually, or sign a form indicating they were offered an advanced directive and declined to have one invoked. In addition, Medicare could set up a system that would allow physicians (or facilities) who would manage the patient’s healthcare to have access to the conditions of the advance directives. The forms could be attached to individual Medicare profiles, possibly on the Web, in addition to being held by a patient’s PCP or medical home, if they have one.
Personal Health Records
Most people in this country can access most of the information about their personal financial status in real time from any computer in the world. Less than 10% of Americans can retrieve meaningful personal medical information. This is in spite of the prevalence of Web-based personal health record (PHR) software from Microsoft, Revolution Health, and other software vendors, along with Kaiser Permanente and a handful of insurance companies.
PHRs allow for an initial baseline set of data to be recorded and updated as new tests, diagnoses, and medications are employed. It allows for a composite knowledge of what has been tried in the past and what is being utilized in the present. This can be under patients’ control, but it would allow for appropriate access at times of acute need (e.g., an ED visit or a hospital admission).
Too often, patients with a long-term relationship with a local PCP present to the hospital and all of the healthcare professionals are forced to make critical decisions in the first few hours with insufficient or inaccurate information. This leads to needless repetition of tests or inability to compare current data with previous data (wouldn’t it be nice to have the last EKG or labs?), or in retrying a treatment regimen that hasn’t worked in the past.
And if you are in another city or if you don’t have a local physician with all of your old records, the information gap is far worse.
Once again, we could incentivize patients to have an up-to-date PHR with reduced premiums, or lower deductibles or copayments. We could look for ways to incentivize PCPs and hospitals to help patients build and maintain their PHR. We could make it a matter of course that a patient’s PHR would be updated at each intersection with healthcare information (e.g., the pharmacy or the lab or each office visit).
Physician Accountability
Somehow, we have evolved into a fragmented health system. We need to repair the disconnect between patients and physicians. The professional pact between the patient and their primary physician needs to be in place until the patient and the “next” physician agree to the handoff of responsibility. As hospitalists, we see this at both ends of the continuum. Patients shouldn’t just be “sent” to the ED or the hospital, especially not when they are acutely ill. Their personal physician, their medical home, should “arrange” for an orderly transfer of care. This would involve a transfer of information (possibly facilitated by an updated PHR), but as much by the assurance that the accepting physician or institution is prepared for the handoff, acknowledges this to the PCP, and that the patient understands the handoff has taken place.
In the same way, patients would not be just “sent out” from the hospital. The treating physician (it could be the hospitalist, but also the surgeon or cardiologist) would remain the doctor of record—the first resource for patients’ question and issues—until another “receiving” physician has accepted the handoff, acknowledges this role, and the patient agrees.
We could rapidly shift this process by allowing the patient to decide when the hospitalization has ended. We could change the system overnight by making one of the conditions for payment for a hospitalization (to the physicians and the hospital) that the patient has signed off that indeed the hospitalization has ended.
This might include a discussion of chronic medications to continue, acute therapies to complete, understanding by the patient of where and when to receive follow-up testing and evaluation, and a clear understanding of which physician is now accountable for future issues and questions as patients travel from acute illness to normal function.
There certainly are economic and societal issues. Not everyone has a PCP or can pay for their outpatient care, and this could be a full-employment plan for liability attorneys, but in the end I am confident medical professionals would create the linkages that would minimize the deep white space patients find themselves in once they are wheeled to the front door of their hospitals.
Creatively Complete the Hospitalization
In a perfect world, everyone would have a functional, robust medical home to return to after an acute hospitalization. Unfortunately, a patient-centered medical home (PCMH) is much more of a hope than a reality for most Americans. While we are working to create a better “horizontal” hospitalization, there are clear gaps in the vertical-care world.
If we are going to be responsible for bundled care that encompasses pre-admit and post-discharge care (e.g., 30 days after discharge), then we must beef up our outpatient capabilities.
Hopefully in the long run, this can be supplied by a reinvigorated and reinvented medical home, but it is still a long way off. If payment and accountability continue to blur just when the hospitalization ends, then hospitals (and hospitalists) and Medicare and insurers will need to be creative in how and who will manage the patient. We’ll need to solve the issues around patients who are no longer sick enough to require a hospital bed but clearly are not back to their steady state.
This ties in with the accountability gap that vexes our patients every day. Very likely, hospitalists will have to assume a role in managing the patients after hospital discharge. This might take the form of a few follow-up visits and continued support systems via the Web and telephone. It will probably require a new class of hospitalist—the ambulist or the subacutist—supported by dedicated ancillary staff and systems.
Once again, Medicare and insurers can drive to a better system of post-acute care by supplying incentives: a more robust discharge payment or rewarding successful completion of a hospitalization, possibly by bundled payment incentives. In addition, there could be clear standards set that would define when this is done well with associated rewards.
I know some of these ideas are radical and make us uncomfortable. They seem to assign more responsibilities to an already overburdened profession. To be successful, these innovations require an active participation and accountability of our patients. We as the providers of healthcare cannot do this alone. It also requires the evolution of the hospital as an institution from just the healthcare provider for the acutely ill, horizontal patient, but as more a part of a continuum from acute illness to return to function. And it cries out for a robust, capable, outpatient partner in a medical home or accountable care organization (ACO) that is equally dedicated, incentivized, and accountable.
We won’t get there tomorrow, even if Dr. Berwick reads this and acts on all of the ideas on his first day at CMS.
But if we don’t get started, we know we definitely won’t get there at any time in our future. TH
Dr. Wellikson is CEO of SHM.
Hospital medicine had grown rapidly and provided the platform for change in our nation’s hospitals long before there was any meaningful healthcare legislation in Washington. With President Obama’s appointment of an innovator—Don Berwick—to head the Centers for Medicare and Medicaid Services (CMS), there is increased opportunity to ramp up revisions, large and small, to provide the incentives and the impetus to create a healthcare system for the 21st century.
With that in mind, I thought I’d offer a few ideas that Don could institute on Day 1, which could start us in the right direction, or throw us all into chaos, depending on how it plays out. While most of my attention is directed to the Medicare population, all of these ideas would be equally applicable to the commercially insured population.
Advanced Directives
We all know that too few people in this country have taken the opportunity to discuss with their families and their personal physicians how they want their care managed at critical junctures, whether it comes on suddenly with an accident or with aging. The suggestion that Medicare would pay for an office visit with your doctor to discuss this imploded with the news media’s fanning of the “death panel” flames first stoked by Sarah Palin, which sidetracked all rational discussion.
Besides setting up people for unwarranted and unwanted assaults and protracted misery, mismanaging the end stages of life leads to an enormous misallocation of physicians’ focus at a time when we all need to be mindful stewards of our limited healthcare resources.
It is acceptable if, after careful consideration, anyone chooses to not have any advanced directive, but it should be a cognitive directed choice, not just a failure to engage.
Therefore, I am proposing that Medicare offer an incentive (e.g., waiving co-payments or deductibles) to have all Medicare beneficiaries complete an advanced directive annually, or sign a form indicating they were offered an advanced directive and declined to have one invoked. In addition, Medicare could set up a system that would allow physicians (or facilities) who would manage the patient’s healthcare to have access to the conditions of the advance directives. The forms could be attached to individual Medicare profiles, possibly on the Web, in addition to being held by a patient’s PCP or medical home, if they have one.
Personal Health Records
Most people in this country can access most of the information about their personal financial status in real time from any computer in the world. Less than 10% of Americans can retrieve meaningful personal medical information. This is in spite of the prevalence of Web-based personal health record (PHR) software from Microsoft, Revolution Health, and other software vendors, along with Kaiser Permanente and a handful of insurance companies.
PHRs allow for an initial baseline set of data to be recorded and updated as new tests, diagnoses, and medications are employed. It allows for a composite knowledge of what has been tried in the past and what is being utilized in the present. This can be under patients’ control, but it would allow for appropriate access at times of acute need (e.g., an ED visit or a hospital admission).
Too often, patients with a long-term relationship with a local PCP present to the hospital and all of the healthcare professionals are forced to make critical decisions in the first few hours with insufficient or inaccurate information. This leads to needless repetition of tests or inability to compare current data with previous data (wouldn’t it be nice to have the last EKG or labs?), or in retrying a treatment regimen that hasn’t worked in the past.
And if you are in another city or if you don’t have a local physician with all of your old records, the information gap is far worse.
Once again, we could incentivize patients to have an up-to-date PHR with reduced premiums, or lower deductibles or copayments. We could look for ways to incentivize PCPs and hospitals to help patients build and maintain their PHR. We could make it a matter of course that a patient’s PHR would be updated at each intersection with healthcare information (e.g., the pharmacy or the lab or each office visit).
Physician Accountability
Somehow, we have evolved into a fragmented health system. We need to repair the disconnect between patients and physicians. The professional pact between the patient and their primary physician needs to be in place until the patient and the “next” physician agree to the handoff of responsibility. As hospitalists, we see this at both ends of the continuum. Patients shouldn’t just be “sent” to the ED or the hospital, especially not when they are acutely ill. Their personal physician, their medical home, should “arrange” for an orderly transfer of care. This would involve a transfer of information (possibly facilitated by an updated PHR), but as much by the assurance that the accepting physician or institution is prepared for the handoff, acknowledges this to the PCP, and that the patient understands the handoff has taken place.
In the same way, patients would not be just “sent out” from the hospital. The treating physician (it could be the hospitalist, but also the surgeon or cardiologist) would remain the doctor of record—the first resource for patients’ question and issues—until another “receiving” physician has accepted the handoff, acknowledges this role, and the patient agrees.
We could rapidly shift this process by allowing the patient to decide when the hospitalization has ended. We could change the system overnight by making one of the conditions for payment for a hospitalization (to the physicians and the hospital) that the patient has signed off that indeed the hospitalization has ended.
This might include a discussion of chronic medications to continue, acute therapies to complete, understanding by the patient of where and when to receive follow-up testing and evaluation, and a clear understanding of which physician is now accountable for future issues and questions as patients travel from acute illness to normal function.
There certainly are economic and societal issues. Not everyone has a PCP or can pay for their outpatient care, and this could be a full-employment plan for liability attorneys, but in the end I am confident medical professionals would create the linkages that would minimize the deep white space patients find themselves in once they are wheeled to the front door of their hospitals.
Creatively Complete the Hospitalization
In a perfect world, everyone would have a functional, robust medical home to return to after an acute hospitalization. Unfortunately, a patient-centered medical home (PCMH) is much more of a hope than a reality for most Americans. While we are working to create a better “horizontal” hospitalization, there are clear gaps in the vertical-care world.
If we are going to be responsible for bundled care that encompasses pre-admit and post-discharge care (e.g., 30 days after discharge), then we must beef up our outpatient capabilities.
Hopefully in the long run, this can be supplied by a reinvigorated and reinvented medical home, but it is still a long way off. If payment and accountability continue to blur just when the hospitalization ends, then hospitals (and hospitalists) and Medicare and insurers will need to be creative in how and who will manage the patient. We’ll need to solve the issues around patients who are no longer sick enough to require a hospital bed but clearly are not back to their steady state.
This ties in with the accountability gap that vexes our patients every day. Very likely, hospitalists will have to assume a role in managing the patients after hospital discharge. This might take the form of a few follow-up visits and continued support systems via the Web and telephone. It will probably require a new class of hospitalist—the ambulist or the subacutist—supported by dedicated ancillary staff and systems.
Once again, Medicare and insurers can drive to a better system of post-acute care by supplying incentives: a more robust discharge payment or rewarding successful completion of a hospitalization, possibly by bundled payment incentives. In addition, there could be clear standards set that would define when this is done well with associated rewards.
I know some of these ideas are radical and make us uncomfortable. They seem to assign more responsibilities to an already overburdened profession. To be successful, these innovations require an active participation and accountability of our patients. We as the providers of healthcare cannot do this alone. It also requires the evolution of the hospital as an institution from just the healthcare provider for the acutely ill, horizontal patient, but as more a part of a continuum from acute illness to return to function. And it cries out for a robust, capable, outpatient partner in a medical home or accountable care organization (ACO) that is equally dedicated, incentivized, and accountable.
We won’t get there tomorrow, even if Dr. Berwick reads this and acts on all of the ideas on his first day at CMS.
But if we don’t get started, we know we definitely won’t get there at any time in our future. TH
Dr. Wellikson is CEO of SHM.
Rise of the Napturnist
The best sleep I ever got was in the winter of 1996. I remember it vividly. It was effortless, natural, blissful. I had swiftly slipped through the early phases of non-REM sleep, skillfully side-stepping alpha and theta waves, leaving myoclonic jerks in my wake. There was a brief hypnagogic dream involving sun-swept landscapes, playful butterflies, and a field of rhythmically blowing lavender that waved me further along on my slumbering voyage. And then, magically, I was basking in the pillowy splendor of stage 4 sleep, delta waves soothingly serenading me into hibernation.
I had found the celebrated state of suspended sensory and motor activity characterized by unconsciousness and loss of voluntary muscle movement.1 I was asleep.
I was an intern, had just worked 36 continuous hours, and was driving a car.
ACGME Outlines Resident Duty-Hours Changes
I was reminded of this incident on June 23, when I reviewed the freshly minted recommendations from the Accreditation Council for Graduate Medical Education (ACGME) task force regarding duty hours.2 This proposal follows on ACGME’s 2003 report, which enacted such national resident duty-hour standards as the 80-hour work week, the maximum 24-hour shift (plus six hours for administrative time), and the requirement for 10 hours off between shifts.
Like the 2003 report, which has played a large role in the rise of academic HM, the 2010 recommendations have major implications for academic hospitalists and our community brethren who will receive our residency graduates. As such, the reaction within the hospitalist community was immediate. Within minutes of ACGME’s notification, I was inundated with e-mail from colleagues both locally and nationally. Everyone was struggling with the repercussions. Was this good for resident education, a boon or bust for HM, a death knell for teaching hospitals?
So What’s in There?
This hotly anticipated report focuses its energy on four key elements of what the ACGME has morphed from “duty hours” into the resident “work environment”: resident supervision, handoffs of patient care, use of systems to enhance patient safety, and the effects of sleep on performance. Much of this is not really controversial and likely good for both residents and HM—an emphasis on systems-based practice, transitions of care, and expectations around communication.
The most discussed and controversial changes regard the move toward supervision and work hours that are customized to trainees’ levels. Unlike in the past, when the intern bore the brunt of the hours and patient duties, this proposal emphasizes graded supervision and duty-hour expectations. Practically, this means first-year residents will require closer supervision (whether by a resident or an attending has yet to be delineated) than more senior residents. Likewise, although all residents can only work a maximum of 80 hours averaged over four weeks (no change from 2003), the maximum shift length for interns will be limited to 16 hours. Upper-level residents will be limited to no more than 24 consecutive hours with an additional four hours for administrative work, but it is “strongly suggested” that residents working longer than 16 hours be provided with opportunities for “strategic napping.”
Read the Tea Leaves
I think these recommendations are rational and reasonable. To be sure, when these go into effect on July 1, 2011, they will have a tremendous impact on my residency program, my hospital, and my hospitalist faculty. My program, like most, likely will move toward a shift system of patient care, instead of overnight call. My hospital likely will have to expend millions of dollars annually to back-fill the work that residents would have done. My hospitalist group likely will have to expand our nonresident coverage both during the day and at night, inducing one of my partners to query, “Does this mean we’ll have to hire napturnists to cover the residents’ strategic nap time?”
It’s easy to deride these work environment changes, especially if we see the world through the uphill-in-the-snow-both-ways lenses most of us use to recollect (fondly?) our residency days. Yes, the field of medicine is losing a rite of passage many of us endured, and I too retrospectively feel the nostalgic tug of the long shifts, the seemingly insurmountable avalanche of admissions, and the autonomy in resident decision-making that made my training so valuable. But are we really against ensuring that residents are properly supervised, handoffs are more standardized, and systems are in place to protect the safety of our patients?
Sleep = Safety
The push behind limiting the maximum duration of work to 16 and 24 hours for interns and residents, respectively, stems from the growing body of literature regarding the detrimental effects of the fatigue and sleep deprivation that comes with long shifts. Not so shockingly, the data show that residents are sleepy. When administered the Epworth Sleepiness Score, residents appear sleepier than sleep apneic patients and nearly as sleepy as narcoleptics.3,4 In fact, they are so sleepy they often don’t even recognize when they are sleeping. One study showed that nearly half the time that anesthesia residents were asleep, they were unaware that they were actually sleeping.5
Further data suggest that residents who sleep less than five hours per night are twice as likely to be sued, and significantly more likely to report adverse events and errors in patient care.6 When comparing traditional, every-third-night call and 24- to 30-hour shifts with 16-hour shifts, the former staffing model is associated with 36% more serious errors than the latter.
Furthermore, there is a five-fold increase in the rate of serious diagnostic errors in the residents in the longer-shift group.7 And to finish where I began, residents who worked shifts that lasted more than 24 hours are more than twice as likely to crash their cars as those working less than 24-hour shifts. In fact, every additional extended-duration shift per month increases the chances of a car crash while commuting by 16%.8
So ask yourself this: If you were designing, from scratch, residency training today, would you really design a system similar to what we had 10 years ago? Like the one we have now? Would you ask residents, many just months out of medical school, to admit a dozen or more patients a day, stay awake for more than 30 hours, and care for the sickest, most frail patients without the assistance of more senior physicians?
The field of medicine is at a crossroads, and it faces many questions, not the least of which is how best to train our future physicians. The ACGME has published its proposal and given the public, including you, until Aug. 9 to voice your comments. These are big issues to ponder.
Maybe you should sleep on it. TH
Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program.
References
- Sleep. Wikipedia website. Available at: http://en.wikipedia.org/wiki/Sleep. Accessed July 10, 2010.
- Nasca TJ, Day SH, Amis S. The new recommendations on duty hours from the ACGME task force. New England Journal of Medicine website. Available at: content.nejm.org/cgi/content/full/NEJMsb1005800. Accessed July 2, 2010.
- Mustafa M, Erokwu N, Ebose I, Strohl K. Sleep problems and the risk for sleep disorders in an outpatient veteran population. Sleep & Breathing. 2005;9:57-63.
- Papp KK, Stoller EP, Sage P, et al. The effects of sleep loss and fatigue on resident-physicians: a multi-institutional, mixed-method study. Acad Med. 2005; 79:394-406.
- Howard SK, Gaba DM, Rosekind MR, Zaracone VP. The risks and implications of excessive daytime sleepiness in resident physicians. Acad Med. 2002; 77:1019-1025.
- Baldwin DC, Daugherty SR. Sleep deprivation and fatigue in residency training: results of a national survey of 1st- and 2nd-year residents. Sleep. 2004;27:371-372.
- Landrigan CP, Rothschild JM, Cronin JW, et al. Effect of reducing interns’ work hours on serious medical errors in intensive care units. N Engl J Med. 2004;18:1838-1848.
- Barger LK, Cade BE, Ayas NT, et al. Extended work shifts and the risk of motor vehicle crashes among interns. N Engl J Med. 2005;352:125-134.
The best sleep I ever got was in the winter of 1996. I remember it vividly. It was effortless, natural, blissful. I had swiftly slipped through the early phases of non-REM sleep, skillfully side-stepping alpha and theta waves, leaving myoclonic jerks in my wake. There was a brief hypnagogic dream involving sun-swept landscapes, playful butterflies, and a field of rhythmically blowing lavender that waved me further along on my slumbering voyage. And then, magically, I was basking in the pillowy splendor of stage 4 sleep, delta waves soothingly serenading me into hibernation.
I had found the celebrated state of suspended sensory and motor activity characterized by unconsciousness and loss of voluntary muscle movement.1 I was asleep.
I was an intern, had just worked 36 continuous hours, and was driving a car.
ACGME Outlines Resident Duty-Hours Changes
I was reminded of this incident on June 23, when I reviewed the freshly minted recommendations from the Accreditation Council for Graduate Medical Education (ACGME) task force regarding duty hours.2 This proposal follows on ACGME’s 2003 report, which enacted such national resident duty-hour standards as the 80-hour work week, the maximum 24-hour shift (plus six hours for administrative time), and the requirement for 10 hours off between shifts.
Like the 2003 report, which has played a large role in the rise of academic HM, the 2010 recommendations have major implications for academic hospitalists and our community brethren who will receive our residency graduates. As such, the reaction within the hospitalist community was immediate. Within minutes of ACGME’s notification, I was inundated with e-mail from colleagues both locally and nationally. Everyone was struggling with the repercussions. Was this good for resident education, a boon or bust for HM, a death knell for teaching hospitals?
So What’s in There?
This hotly anticipated report focuses its energy on four key elements of what the ACGME has morphed from “duty hours” into the resident “work environment”: resident supervision, handoffs of patient care, use of systems to enhance patient safety, and the effects of sleep on performance. Much of this is not really controversial and likely good for both residents and HM—an emphasis on systems-based practice, transitions of care, and expectations around communication.
The most discussed and controversial changes regard the move toward supervision and work hours that are customized to trainees’ levels. Unlike in the past, when the intern bore the brunt of the hours and patient duties, this proposal emphasizes graded supervision and duty-hour expectations. Practically, this means first-year residents will require closer supervision (whether by a resident or an attending has yet to be delineated) than more senior residents. Likewise, although all residents can only work a maximum of 80 hours averaged over four weeks (no change from 2003), the maximum shift length for interns will be limited to 16 hours. Upper-level residents will be limited to no more than 24 consecutive hours with an additional four hours for administrative work, but it is “strongly suggested” that residents working longer than 16 hours be provided with opportunities for “strategic napping.”
Read the Tea Leaves
I think these recommendations are rational and reasonable. To be sure, when these go into effect on July 1, 2011, they will have a tremendous impact on my residency program, my hospital, and my hospitalist faculty. My program, like most, likely will move toward a shift system of patient care, instead of overnight call. My hospital likely will have to expend millions of dollars annually to back-fill the work that residents would have done. My hospitalist group likely will have to expand our nonresident coverage both during the day and at night, inducing one of my partners to query, “Does this mean we’ll have to hire napturnists to cover the residents’ strategic nap time?”
It’s easy to deride these work environment changes, especially if we see the world through the uphill-in-the-snow-both-ways lenses most of us use to recollect (fondly?) our residency days. Yes, the field of medicine is losing a rite of passage many of us endured, and I too retrospectively feel the nostalgic tug of the long shifts, the seemingly insurmountable avalanche of admissions, and the autonomy in resident decision-making that made my training so valuable. But are we really against ensuring that residents are properly supervised, handoffs are more standardized, and systems are in place to protect the safety of our patients?
Sleep = Safety
The push behind limiting the maximum duration of work to 16 and 24 hours for interns and residents, respectively, stems from the growing body of literature regarding the detrimental effects of the fatigue and sleep deprivation that comes with long shifts. Not so shockingly, the data show that residents are sleepy. When administered the Epworth Sleepiness Score, residents appear sleepier than sleep apneic patients and nearly as sleepy as narcoleptics.3,4 In fact, they are so sleepy they often don’t even recognize when they are sleeping. One study showed that nearly half the time that anesthesia residents were asleep, they were unaware that they were actually sleeping.5
Further data suggest that residents who sleep less than five hours per night are twice as likely to be sued, and significantly more likely to report adverse events and errors in patient care.6 When comparing traditional, every-third-night call and 24- to 30-hour shifts with 16-hour shifts, the former staffing model is associated with 36% more serious errors than the latter.
Furthermore, there is a five-fold increase in the rate of serious diagnostic errors in the residents in the longer-shift group.7 And to finish where I began, residents who worked shifts that lasted more than 24 hours are more than twice as likely to crash their cars as those working less than 24-hour shifts. In fact, every additional extended-duration shift per month increases the chances of a car crash while commuting by 16%.8
So ask yourself this: If you were designing, from scratch, residency training today, would you really design a system similar to what we had 10 years ago? Like the one we have now? Would you ask residents, many just months out of medical school, to admit a dozen or more patients a day, stay awake for more than 30 hours, and care for the sickest, most frail patients without the assistance of more senior physicians?
The field of medicine is at a crossroads, and it faces many questions, not the least of which is how best to train our future physicians. The ACGME has published its proposal and given the public, including you, until Aug. 9 to voice your comments. These are big issues to ponder.
Maybe you should sleep on it. TH
Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program.
References
- Sleep. Wikipedia website. Available at: http://en.wikipedia.org/wiki/Sleep. Accessed July 10, 2010.
- Nasca TJ, Day SH, Amis S. The new recommendations on duty hours from the ACGME task force. New England Journal of Medicine website. Available at: content.nejm.org/cgi/content/full/NEJMsb1005800. Accessed July 2, 2010.
- Mustafa M, Erokwu N, Ebose I, Strohl K. Sleep problems and the risk for sleep disorders in an outpatient veteran population. Sleep & Breathing. 2005;9:57-63.
- Papp KK, Stoller EP, Sage P, et al. The effects of sleep loss and fatigue on resident-physicians: a multi-institutional, mixed-method study. Acad Med. 2005; 79:394-406.
- Howard SK, Gaba DM, Rosekind MR, Zaracone VP. The risks and implications of excessive daytime sleepiness in resident physicians. Acad Med. 2002; 77:1019-1025.
- Baldwin DC, Daugherty SR. Sleep deprivation and fatigue in residency training: results of a national survey of 1st- and 2nd-year residents. Sleep. 2004;27:371-372.
- Landrigan CP, Rothschild JM, Cronin JW, et al. Effect of reducing interns’ work hours on serious medical errors in intensive care units. N Engl J Med. 2004;18:1838-1848.
- Barger LK, Cade BE, Ayas NT, et al. Extended work shifts and the risk of motor vehicle crashes among interns. N Engl J Med. 2005;352:125-134.
The best sleep I ever got was in the winter of 1996. I remember it vividly. It was effortless, natural, blissful. I had swiftly slipped through the early phases of non-REM sleep, skillfully side-stepping alpha and theta waves, leaving myoclonic jerks in my wake. There was a brief hypnagogic dream involving sun-swept landscapes, playful butterflies, and a field of rhythmically blowing lavender that waved me further along on my slumbering voyage. And then, magically, I was basking in the pillowy splendor of stage 4 sleep, delta waves soothingly serenading me into hibernation.
I had found the celebrated state of suspended sensory and motor activity characterized by unconsciousness and loss of voluntary muscle movement.1 I was asleep.
I was an intern, had just worked 36 continuous hours, and was driving a car.
ACGME Outlines Resident Duty-Hours Changes
I was reminded of this incident on June 23, when I reviewed the freshly minted recommendations from the Accreditation Council for Graduate Medical Education (ACGME) task force regarding duty hours.2 This proposal follows on ACGME’s 2003 report, which enacted such national resident duty-hour standards as the 80-hour work week, the maximum 24-hour shift (plus six hours for administrative time), and the requirement for 10 hours off between shifts.
Like the 2003 report, which has played a large role in the rise of academic HM, the 2010 recommendations have major implications for academic hospitalists and our community brethren who will receive our residency graduates. As such, the reaction within the hospitalist community was immediate. Within minutes of ACGME’s notification, I was inundated with e-mail from colleagues both locally and nationally. Everyone was struggling with the repercussions. Was this good for resident education, a boon or bust for HM, a death knell for teaching hospitals?
So What’s in There?
This hotly anticipated report focuses its energy on four key elements of what the ACGME has morphed from “duty hours” into the resident “work environment”: resident supervision, handoffs of patient care, use of systems to enhance patient safety, and the effects of sleep on performance. Much of this is not really controversial and likely good for both residents and HM—an emphasis on systems-based practice, transitions of care, and expectations around communication.
The most discussed and controversial changes regard the move toward supervision and work hours that are customized to trainees’ levels. Unlike in the past, when the intern bore the brunt of the hours and patient duties, this proposal emphasizes graded supervision and duty-hour expectations. Practically, this means first-year residents will require closer supervision (whether by a resident or an attending has yet to be delineated) than more senior residents. Likewise, although all residents can only work a maximum of 80 hours averaged over four weeks (no change from 2003), the maximum shift length for interns will be limited to 16 hours. Upper-level residents will be limited to no more than 24 consecutive hours with an additional four hours for administrative work, but it is “strongly suggested” that residents working longer than 16 hours be provided with opportunities for “strategic napping.”
Read the Tea Leaves
I think these recommendations are rational and reasonable. To be sure, when these go into effect on July 1, 2011, they will have a tremendous impact on my residency program, my hospital, and my hospitalist faculty. My program, like most, likely will move toward a shift system of patient care, instead of overnight call. My hospital likely will have to expend millions of dollars annually to back-fill the work that residents would have done. My hospitalist group likely will have to expand our nonresident coverage both during the day and at night, inducing one of my partners to query, “Does this mean we’ll have to hire napturnists to cover the residents’ strategic nap time?”
It’s easy to deride these work environment changes, especially if we see the world through the uphill-in-the-snow-both-ways lenses most of us use to recollect (fondly?) our residency days. Yes, the field of medicine is losing a rite of passage many of us endured, and I too retrospectively feel the nostalgic tug of the long shifts, the seemingly insurmountable avalanche of admissions, and the autonomy in resident decision-making that made my training so valuable. But are we really against ensuring that residents are properly supervised, handoffs are more standardized, and systems are in place to protect the safety of our patients?
Sleep = Safety
The push behind limiting the maximum duration of work to 16 and 24 hours for interns and residents, respectively, stems from the growing body of literature regarding the detrimental effects of the fatigue and sleep deprivation that comes with long shifts. Not so shockingly, the data show that residents are sleepy. When administered the Epworth Sleepiness Score, residents appear sleepier than sleep apneic patients and nearly as sleepy as narcoleptics.3,4 In fact, they are so sleepy they often don’t even recognize when they are sleeping. One study showed that nearly half the time that anesthesia residents were asleep, they were unaware that they were actually sleeping.5
Further data suggest that residents who sleep less than five hours per night are twice as likely to be sued, and significantly more likely to report adverse events and errors in patient care.6 When comparing traditional, every-third-night call and 24- to 30-hour shifts with 16-hour shifts, the former staffing model is associated with 36% more serious errors than the latter.
Furthermore, there is a five-fold increase in the rate of serious diagnostic errors in the residents in the longer-shift group.7 And to finish where I began, residents who worked shifts that lasted more than 24 hours are more than twice as likely to crash their cars as those working less than 24-hour shifts. In fact, every additional extended-duration shift per month increases the chances of a car crash while commuting by 16%.8
So ask yourself this: If you were designing, from scratch, residency training today, would you really design a system similar to what we had 10 years ago? Like the one we have now? Would you ask residents, many just months out of medical school, to admit a dozen or more patients a day, stay awake for more than 30 hours, and care for the sickest, most frail patients without the assistance of more senior physicians?
The field of medicine is at a crossroads, and it faces many questions, not the least of which is how best to train our future physicians. The ACGME has published its proposal and given the public, including you, until Aug. 9 to voice your comments. These are big issues to ponder.
Maybe you should sleep on it. TH
Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program.
References
- Sleep. Wikipedia website. Available at: http://en.wikipedia.org/wiki/Sleep. Accessed July 10, 2010.
- Nasca TJ, Day SH, Amis S. The new recommendations on duty hours from the ACGME task force. New England Journal of Medicine website. Available at: content.nejm.org/cgi/content/full/NEJMsb1005800. Accessed July 2, 2010.
- Mustafa M, Erokwu N, Ebose I, Strohl K. Sleep problems and the risk for sleep disorders in an outpatient veteran population. Sleep & Breathing. 2005;9:57-63.
- Papp KK, Stoller EP, Sage P, et al. The effects of sleep loss and fatigue on resident-physicians: a multi-institutional, mixed-method study. Acad Med. 2005; 79:394-406.
- Howard SK, Gaba DM, Rosekind MR, Zaracone VP. The risks and implications of excessive daytime sleepiness in resident physicians. Acad Med. 2002; 77:1019-1025.
- Baldwin DC, Daugherty SR. Sleep deprivation and fatigue in residency training: results of a national survey of 1st- and 2nd-year residents. Sleep. 2004;27:371-372.
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ONLINE EXCLUSIVE: Palliative Care Documentation Key to Core Measures
A growing number of publicly reported hospital quality initiatives include severity-adjusted hospital mortality rates. Although individual hospitalists are unlikely to be rated based on their patients’ mortality, this is an important component of how hospitals are evaluated—and thus a natural target for the hospital’s quality-improvement (QI) efforts and for hospitalists’ participation in them.
The challenge is that some hospital-connected deaths are unavoidable, predictable, and even appropriate when care plans focused on maximizing comfort and quality of life replace medical efforts to stave off death. Referring seriously ill patients to the hospital’s palliative-care service or to a community hospice can influence a hospital’s mortality rate, but not always in the same ways.
Where hospice care and palliative care fit in hospital mortality rates, how they are defined and counted, and how predictable deaths are either included or excluded from hospitals’ risk-adjusted mortality tallies vary between the reporting programs, according to J. Brian Cassel, PhD, senior analyst at Virginia Commonwealth University (VCU), a presenter at the National Hospice and Palliative Care Organization’s Management and Leadership Conference in April 2010 in Washington, D.C.
“Hospitals are naturally concerned about mortality rates because they want to be seen as quality health providers,” Dr. Cassel says. “How hospital mortality rates are determined can be quite complex,” with varied data sources and various methods of adjusting for severity and balancing mortality with other quality metrics. Dr. Cassel says he began digging into mortality data when concerns were raised that VCU’s acute-palliative-care unit might be causing the medical center’s overall mortality rates to spike. His research found that the unit’s operation was probably neutral relative to VCU’s overall mortality rates.
Typically, the risk-adjusted mortality rate is for selected diagnoses but counts deaths from all causes, either during the index hospitalization or within 30 days of that admission, Dr. Cassel says. Three examples of QI programs that use mortality data: CMS’ Hospital Compare, which publicly reports data on patient satisfaction and hospital processes and outcomes, including mortality; U.S. News & World Report’s “Best Hospitals” list, for which one-third of total scores are derived from its mortality index; and HealthGrades, a Golden, Colo.-based company that ranks hospitals and other health providers within a region, one condition or procedure at a time.
An ICD-9 billing code, V66.7 for “palliative care encounter,” can flag the involvement of palliative-care consultants on a hospital case, although this code often goes unused and should be among the top nine listed diagnoses in order to turn up in most quality calculations. Palliative-care consultants can help promote the use and higher positioning of this code in hospital billing, along with more complete documentation of comorbidities and symptoms. It also is possible that involving hospice and palliative-care teams with seriously ill patients earlier in their disease progression could help manage their care in community settings, avoiding hospitalizations when death is likely in the next few months.
Some hospitals might choose to refer patients thought to be close to death to contracted hospice programs—and some hospice and palliative-care advocates are using the rates as conversation starters with hospital administrators. Dr. Cassel’s advice for those advocates: Know which quality-measurement systems the hospital’s leadership follows, where adjusted mortality rates fit in those systems, and how hospice and palliative care affect them.
Regardless of mortality metrics, Dr. Cassell says, a clinician’s primary responsibility is to provide the best possible care to patients and families, reflecting their values, hopes, and treatment goals.
A growing number of publicly reported hospital quality initiatives include severity-adjusted hospital mortality rates. Although individual hospitalists are unlikely to be rated based on their patients’ mortality, this is an important component of how hospitals are evaluated—and thus a natural target for the hospital’s quality-improvement (QI) efforts and for hospitalists’ participation in them.
The challenge is that some hospital-connected deaths are unavoidable, predictable, and even appropriate when care plans focused on maximizing comfort and quality of life replace medical efforts to stave off death. Referring seriously ill patients to the hospital’s palliative-care service or to a community hospice can influence a hospital’s mortality rate, but not always in the same ways.
Where hospice care and palliative care fit in hospital mortality rates, how they are defined and counted, and how predictable deaths are either included or excluded from hospitals’ risk-adjusted mortality tallies vary between the reporting programs, according to J. Brian Cassel, PhD, senior analyst at Virginia Commonwealth University (VCU), a presenter at the National Hospice and Palliative Care Organization’s Management and Leadership Conference in April 2010 in Washington, D.C.
“Hospitals are naturally concerned about mortality rates because they want to be seen as quality health providers,” Dr. Cassel says. “How hospital mortality rates are determined can be quite complex,” with varied data sources and various methods of adjusting for severity and balancing mortality with other quality metrics. Dr. Cassel says he began digging into mortality data when concerns were raised that VCU’s acute-palliative-care unit might be causing the medical center’s overall mortality rates to spike. His research found that the unit’s operation was probably neutral relative to VCU’s overall mortality rates.
Typically, the risk-adjusted mortality rate is for selected diagnoses but counts deaths from all causes, either during the index hospitalization or within 30 days of that admission, Dr. Cassel says. Three examples of QI programs that use mortality data: CMS’ Hospital Compare, which publicly reports data on patient satisfaction and hospital processes and outcomes, including mortality; U.S. News & World Report’s “Best Hospitals” list, for which one-third of total scores are derived from its mortality index; and HealthGrades, a Golden, Colo.-based company that ranks hospitals and other health providers within a region, one condition or procedure at a time.
An ICD-9 billing code, V66.7 for “palliative care encounter,” can flag the involvement of palliative-care consultants on a hospital case, although this code often goes unused and should be among the top nine listed diagnoses in order to turn up in most quality calculations. Palliative-care consultants can help promote the use and higher positioning of this code in hospital billing, along with more complete documentation of comorbidities and symptoms. It also is possible that involving hospice and palliative-care teams with seriously ill patients earlier in their disease progression could help manage their care in community settings, avoiding hospitalizations when death is likely in the next few months.
Some hospitals might choose to refer patients thought to be close to death to contracted hospice programs—and some hospice and palliative-care advocates are using the rates as conversation starters with hospital administrators. Dr. Cassel’s advice for those advocates: Know which quality-measurement systems the hospital’s leadership follows, where adjusted mortality rates fit in those systems, and how hospice and palliative care affect them.
Regardless of mortality metrics, Dr. Cassell says, a clinician’s primary responsibility is to provide the best possible care to patients and families, reflecting their values, hopes, and treatment goals.
A growing number of publicly reported hospital quality initiatives include severity-adjusted hospital mortality rates. Although individual hospitalists are unlikely to be rated based on their patients’ mortality, this is an important component of how hospitals are evaluated—and thus a natural target for the hospital’s quality-improvement (QI) efforts and for hospitalists’ participation in them.
The challenge is that some hospital-connected deaths are unavoidable, predictable, and even appropriate when care plans focused on maximizing comfort and quality of life replace medical efforts to stave off death. Referring seriously ill patients to the hospital’s palliative-care service or to a community hospice can influence a hospital’s mortality rate, but not always in the same ways.
Where hospice care and palliative care fit in hospital mortality rates, how they are defined and counted, and how predictable deaths are either included or excluded from hospitals’ risk-adjusted mortality tallies vary between the reporting programs, according to J. Brian Cassel, PhD, senior analyst at Virginia Commonwealth University (VCU), a presenter at the National Hospice and Palliative Care Organization’s Management and Leadership Conference in April 2010 in Washington, D.C.
“Hospitals are naturally concerned about mortality rates because they want to be seen as quality health providers,” Dr. Cassel says. “How hospital mortality rates are determined can be quite complex,” with varied data sources and various methods of adjusting for severity and balancing mortality with other quality metrics. Dr. Cassel says he began digging into mortality data when concerns were raised that VCU’s acute-palliative-care unit might be causing the medical center’s overall mortality rates to spike. His research found that the unit’s operation was probably neutral relative to VCU’s overall mortality rates.
Typically, the risk-adjusted mortality rate is for selected diagnoses but counts deaths from all causes, either during the index hospitalization or within 30 days of that admission, Dr. Cassel says. Three examples of QI programs that use mortality data: CMS’ Hospital Compare, which publicly reports data on patient satisfaction and hospital processes and outcomes, including mortality; U.S. News & World Report’s “Best Hospitals” list, for which one-third of total scores are derived from its mortality index; and HealthGrades, a Golden, Colo.-based company that ranks hospitals and other health providers within a region, one condition or procedure at a time.
An ICD-9 billing code, V66.7 for “palliative care encounter,” can flag the involvement of palliative-care consultants on a hospital case, although this code often goes unused and should be among the top nine listed diagnoses in order to turn up in most quality calculations. Palliative-care consultants can help promote the use and higher positioning of this code in hospital billing, along with more complete documentation of comorbidities and symptoms. It also is possible that involving hospice and palliative-care teams with seriously ill patients earlier in their disease progression could help manage their care in community settings, avoiding hospitalizations when death is likely in the next few months.
Some hospitals might choose to refer patients thought to be close to death to contracted hospice programs—and some hospice and palliative-care advocates are using the rates as conversation starters with hospital administrators. Dr. Cassel’s advice for those advocates: Know which quality-measurement systems the hospital’s leadership follows, where adjusted mortality rates fit in those systems, and how hospice and palliative care affect them.
Regardless of mortality metrics, Dr. Cassell says, a clinician’s primary responsibility is to provide the best possible care to patients and families, reflecting their values, hopes, and treatment goals.