Aesthetic dermatology: What do we know so far about Volbella?

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Aesthetic dermatology: What do we know so far about Volbella?

On May 31, 2016, the Food and Drug Administration approved Juvéderm Volbella XC for use in the lips for lip augmentation and for correction of perioral rhytids, in adults over the age of 21. In the U.S. pivotal clinical trial of 168 patients, Juvederm Volbella XC was found to increase lip fullness and soften the appearance of perioral rhytids in two-thirds through 1 year.

Like its previously approved predecessor Juvéderm Voluma XC, approved for the mid-face/cheek area, Juvéderm Volbella XC is composed of hyaluronic acid (HA) using Vycross technology. Vycross technology blends different molecular weights of hyaluronic acid together, allowing for longer duration of the product. Unlike Juvéderm Voluma XC (20 mg/mL), Juvéderm Volbella XC is a lower-concentration HA (15 mg/mL) and has a lower G prime and cohesivity, allowing more horizontal spread as opposed to a lift, which makes it more appropriate for injection into the lips and superficial perioral lines.1

Dr. Naissan O. Wesley

Juvéderm Volbella XC will not be available for use in the United States until October 2016. However, the product was first approved in Europe in 2011, and subsequently in Latin America, the Middle East, Asia Pacific, and Canada. What has been the experience of our neighboring colleagues?

In a randomized, prospective, 12-month controlled European study of 280 patients comparing Volbella to a nonanimal stabilized hyaluronic acid (NASHA), Volbella was found to be noninferior to NASHA at 3 months.2 Improvements in lip fullness, perioral lines, and oral commissures for Volbella were statistically significant at 6 and 12 months. Acute swelling was also noted to be less.

In a German 62-patient study with primary endpoints of satisfaction with improvement and look and feel of the lips, a high degree of subject satisfaction with aesthetic improvement in the lips, as well as with their natural look and feel, was noted among 83.6% and 75%-93%, respectively.3

In a retrospective chart review of 400 patients in Israel, where Volbella was injected into tear troughs (disclaimer: not approved for tear troughs in the United States) and/or lips, 17 patients (4.25%) developed prolonged inflammatory cutaneous reactions, lasting up to 11 months, which recurred (with an average number of 3.17 episodes) and occurred late (with an average onset of 8.41 weeks after the injection).4 The reactions were treated with antibiotics and hyaluronidase injections. The finding in this published report is higher than the 0.02% of delayed-onset inflammatory reaction previously reported with HA fillers.

Dr. Lily Talakoub

With a full armamentarium of HA and non-HA fillers on the market, we are lucky to have many options to select from to treat aesthetic concerns of patients. For lip and perioral enhancement in the United States, Restylane, Juvéderm, Belotero, and now Volbella are all excellent options. As the dermal filler portfolio available internationally is larger than that in the United States, much can be learned from the experience of our international colleagues.

References

1. Plast Reconstr Surg. 2015 Nov;136(5 Suppl):139S-48S.

2. J Drugs Dermatol. 2015 Dec;14(12):1444-52.

3. J Cosmet Dermatol. 2014 Jun;13(2):125-34.

4. Dermatol Surg. 2016 Jan;42(1):31-7.

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. Dr. Wesley has no disclosures with regard to Volbella; she participated in clinical trials for Juvéderm Voluma. Dr. Talakoub is a national trainer for Juvéderm manufacturer Allergan for all its injectables.

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On May 31, 2016, the Food and Drug Administration approved Juvéderm Volbella XC for use in the lips for lip augmentation and for correction of perioral rhytids, in adults over the age of 21. In the U.S. pivotal clinical trial of 168 patients, Juvederm Volbella XC was found to increase lip fullness and soften the appearance of perioral rhytids in two-thirds through 1 year.

Like its previously approved predecessor Juvéderm Voluma XC, approved for the mid-face/cheek area, Juvéderm Volbella XC is composed of hyaluronic acid (HA) using Vycross technology. Vycross technology blends different molecular weights of hyaluronic acid together, allowing for longer duration of the product. Unlike Juvéderm Voluma XC (20 mg/mL), Juvéderm Volbella XC is a lower-concentration HA (15 mg/mL) and has a lower G prime and cohesivity, allowing more horizontal spread as opposed to a lift, which makes it more appropriate for injection into the lips and superficial perioral lines.1

Dr. Naissan O. Wesley

Juvéderm Volbella XC will not be available for use in the United States until October 2016. However, the product was first approved in Europe in 2011, and subsequently in Latin America, the Middle East, Asia Pacific, and Canada. What has been the experience of our neighboring colleagues?

In a randomized, prospective, 12-month controlled European study of 280 patients comparing Volbella to a nonanimal stabilized hyaluronic acid (NASHA), Volbella was found to be noninferior to NASHA at 3 months.2 Improvements in lip fullness, perioral lines, and oral commissures for Volbella were statistically significant at 6 and 12 months. Acute swelling was also noted to be less.

In a German 62-patient study with primary endpoints of satisfaction with improvement and look and feel of the lips, a high degree of subject satisfaction with aesthetic improvement in the lips, as well as with their natural look and feel, was noted among 83.6% and 75%-93%, respectively.3

In a retrospective chart review of 400 patients in Israel, where Volbella was injected into tear troughs (disclaimer: not approved for tear troughs in the United States) and/or lips, 17 patients (4.25%) developed prolonged inflammatory cutaneous reactions, lasting up to 11 months, which recurred (with an average number of 3.17 episodes) and occurred late (with an average onset of 8.41 weeks after the injection).4 The reactions were treated with antibiotics and hyaluronidase injections. The finding in this published report is higher than the 0.02% of delayed-onset inflammatory reaction previously reported with HA fillers.

Dr. Lily Talakoub

With a full armamentarium of HA and non-HA fillers on the market, we are lucky to have many options to select from to treat aesthetic concerns of patients. For lip and perioral enhancement in the United States, Restylane, Juvéderm, Belotero, and now Volbella are all excellent options. As the dermal filler portfolio available internationally is larger than that in the United States, much can be learned from the experience of our international colleagues.

References

1. Plast Reconstr Surg. 2015 Nov;136(5 Suppl):139S-48S.

2. J Drugs Dermatol. 2015 Dec;14(12):1444-52.

3. J Cosmet Dermatol. 2014 Jun;13(2):125-34.

4. Dermatol Surg. 2016 Jan;42(1):31-7.

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. Dr. Wesley has no disclosures with regard to Volbella; she participated in clinical trials for Juvéderm Voluma. Dr. Talakoub is a national trainer for Juvéderm manufacturer Allergan for all its injectables.

On May 31, 2016, the Food and Drug Administration approved Juvéderm Volbella XC for use in the lips for lip augmentation and for correction of perioral rhytids, in adults over the age of 21. In the U.S. pivotal clinical trial of 168 patients, Juvederm Volbella XC was found to increase lip fullness and soften the appearance of perioral rhytids in two-thirds through 1 year.

Like its previously approved predecessor Juvéderm Voluma XC, approved for the mid-face/cheek area, Juvéderm Volbella XC is composed of hyaluronic acid (HA) using Vycross technology. Vycross technology blends different molecular weights of hyaluronic acid together, allowing for longer duration of the product. Unlike Juvéderm Voluma XC (20 mg/mL), Juvéderm Volbella XC is a lower-concentration HA (15 mg/mL) and has a lower G prime and cohesivity, allowing more horizontal spread as opposed to a lift, which makes it more appropriate for injection into the lips and superficial perioral lines.1

Dr. Naissan O. Wesley

Juvéderm Volbella XC will not be available for use in the United States until October 2016. However, the product was first approved in Europe in 2011, and subsequently in Latin America, the Middle East, Asia Pacific, and Canada. What has been the experience of our neighboring colleagues?

In a randomized, prospective, 12-month controlled European study of 280 patients comparing Volbella to a nonanimal stabilized hyaluronic acid (NASHA), Volbella was found to be noninferior to NASHA at 3 months.2 Improvements in lip fullness, perioral lines, and oral commissures for Volbella were statistically significant at 6 and 12 months. Acute swelling was also noted to be less.

In a German 62-patient study with primary endpoints of satisfaction with improvement and look and feel of the lips, a high degree of subject satisfaction with aesthetic improvement in the lips, as well as with their natural look and feel, was noted among 83.6% and 75%-93%, respectively.3

In a retrospective chart review of 400 patients in Israel, where Volbella was injected into tear troughs (disclaimer: not approved for tear troughs in the United States) and/or lips, 17 patients (4.25%) developed prolonged inflammatory cutaneous reactions, lasting up to 11 months, which recurred (with an average number of 3.17 episodes) and occurred late (with an average onset of 8.41 weeks after the injection).4 The reactions were treated with antibiotics and hyaluronidase injections. The finding in this published report is higher than the 0.02% of delayed-onset inflammatory reaction previously reported with HA fillers.

Dr. Lily Talakoub

With a full armamentarium of HA and non-HA fillers on the market, we are lucky to have many options to select from to treat aesthetic concerns of patients. For lip and perioral enhancement in the United States, Restylane, Juvéderm, Belotero, and now Volbella are all excellent options. As the dermal filler portfolio available internationally is larger than that in the United States, much can be learned from the experience of our international colleagues.

References

1. Plast Reconstr Surg. 2015 Nov;136(5 Suppl):139S-48S.

2. J Drugs Dermatol. 2015 Dec;14(12):1444-52.

3. J Cosmet Dermatol. 2014 Jun;13(2):125-34.

4. Dermatol Surg. 2016 Jan;42(1):31-7.

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. Dr. Wesley has no disclosures with regard to Volbella; she participated in clinical trials for Juvéderm Voluma. Dr. Talakoub is a national trainer for Juvéderm manufacturer Allergan for all its injectables.

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Hepatitis Outlook: August 2016

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If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

A study in Hepatology has provided a preclinical risk assessment paradigm with which to better understand cardiovascular drug-drug interaction risk for hepatitis C–virus infected patients treated with sofosbuvir in combination with other direct acting antivirals and the antiarrhythmic drug amiodarone.

©Zerbor/Thinkstock

A Japanese study found that, although levels of Wisteria floribunda agglutinin-positive Mac-2-binding protein could be a useful indicator of liver fibrosis in patients with hepatitis B or C infection, WFA+-M2BP levels in the two groups significantly differed, even in the same degree of fibrosis.

Interferon-free, guideline-tailored therapy with direct-acting antivirals is highly effective and safe for hepatitis C virus–associated mixed cryoglobulinemia patients, according to a recent study.

Another recent study found that pegylated interferon (PegIFN) intensification in hepatitis B “e” antigen (HBeAg)-positive coinfected patients did not lead to increased clearance rates of HBeAg or hepatitis B surface antigen quantification (qHBsAg), despite faster declines of antigen levels while on PegIFN.

A study in HIV Medicine found that, under real-life conditions, treatment of patients infected with hepatitis C virus and of patients coinfected with HCV/HIV with all-oral direct-acting antiviral combinations led to high and similar rates of sustained virological response 12 weeks after the end of therapy.

Hepatitis B virus coinfection was the most important risk factor for liver fibrosis and cirrhosis in HIV-infected patients, and should be diagnosed early in HIV care to optimize treatment outcomes, a recent study showed.

Immunity persisted 24 months after a single dose of inactivated hepatitis A vaccine and live attenuated hepatitis A vaccine was administered to school-age children, according to a study published in Human Vaccines & Immunotherapeutics.

A hepatitis C treatment scale-up strategy in Rhode Island could reduce cirrhosis cases and liver-related deaths by 78.9% and 72.4%, respectively, by 2030, according to a study in Epidemiology and Infection.

Viral blipping is a frequent event during nucleoside analogue treatment of patients with chronic hepatitis B virus infection, a study found, although it did not lead to any clinically significant outcomes and thus may not require more frequent blood work and patient visits in clinical practice.

A study of liver and spleen stiffness in hepatitis C virus–infected patients – with advanced liver disease and sustained virologic response after interferon-free treatment – found that improvement of liver stiffness may be due to reduced necroinflammation, and to a lesser extent regression of cirrhosis. Improvement was more pronounced between therapy baseline and end of treatment than therapy baseline and 24 weeks after end of treatment.

From 2000 to 2011, 4,346 adults who died in New York City had a report of a hepatitis B virus infection (0.7%), according to a study in Epidemiology and Infection. Of the HBV-infected decedents, 1,074 (25%) were HIV coinfected. Fifty-five percent of HBV monoinfected and 95% of HBV/HIV coinfected decedents died prematurely, the researchers found.

Prison-based hepatitis C virus treatment achieves outcomes similar to those of community-based treatment, according to a study in the Journal of Viral Hepatitis, with those not released or transferred during treatment doing particularly well.

Treatment interventions to curb the hepatitis C virus epidemic among HIV-infected men who have sex with men are effective if high-risk behavior does not increase as it has during the last decade, according to a study in Hepatology.

The results of an international quality control study underline the urgent need to improve methods used to monitor hepatitis Delta virus viremia.

An investigation of a hepatitis E virus genotype 4 outbreak in Zhejiang Province, China, found that the outbreak was most likely caused by contaminated tap water rather than food.

A German study found that short treatment with 8 weeks of sofosbuvir and ledipasvir seems highly effective and safe in well-selected hepatitis C virus mono- and HIV/HCV-coinfected patients in a real-world setting.

A study of historical events fueling the cross-continental spread of hepatitis C virus epidemics said drivers for the epidemic were the advent of intravenous medical therapies and devices, growth in the heroin trade, and population mixing during armed conflicts.

[email protected]

On Twitter @richpizzi

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If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

A study in Hepatology has provided a preclinical risk assessment paradigm with which to better understand cardiovascular drug-drug interaction risk for hepatitis C–virus infected patients treated with sofosbuvir in combination with other direct acting antivirals and the antiarrhythmic drug amiodarone.

©Zerbor/Thinkstock

A Japanese study found that, although levels of Wisteria floribunda agglutinin-positive Mac-2-binding protein could be a useful indicator of liver fibrosis in patients with hepatitis B or C infection, WFA+-M2BP levels in the two groups significantly differed, even in the same degree of fibrosis.

Interferon-free, guideline-tailored therapy with direct-acting antivirals is highly effective and safe for hepatitis C virus–associated mixed cryoglobulinemia patients, according to a recent study.

Another recent study found that pegylated interferon (PegIFN) intensification in hepatitis B “e” antigen (HBeAg)-positive coinfected patients did not lead to increased clearance rates of HBeAg or hepatitis B surface antigen quantification (qHBsAg), despite faster declines of antigen levels while on PegIFN.

A study in HIV Medicine found that, under real-life conditions, treatment of patients infected with hepatitis C virus and of patients coinfected with HCV/HIV with all-oral direct-acting antiviral combinations led to high and similar rates of sustained virological response 12 weeks after the end of therapy.

Hepatitis B virus coinfection was the most important risk factor for liver fibrosis and cirrhosis in HIV-infected patients, and should be diagnosed early in HIV care to optimize treatment outcomes, a recent study showed.

Immunity persisted 24 months after a single dose of inactivated hepatitis A vaccine and live attenuated hepatitis A vaccine was administered to school-age children, according to a study published in Human Vaccines & Immunotherapeutics.

A hepatitis C treatment scale-up strategy in Rhode Island could reduce cirrhosis cases and liver-related deaths by 78.9% and 72.4%, respectively, by 2030, according to a study in Epidemiology and Infection.

Viral blipping is a frequent event during nucleoside analogue treatment of patients with chronic hepatitis B virus infection, a study found, although it did not lead to any clinically significant outcomes and thus may not require more frequent blood work and patient visits in clinical practice.

A study of liver and spleen stiffness in hepatitis C virus–infected patients – with advanced liver disease and sustained virologic response after interferon-free treatment – found that improvement of liver stiffness may be due to reduced necroinflammation, and to a lesser extent regression of cirrhosis. Improvement was more pronounced between therapy baseline and end of treatment than therapy baseline and 24 weeks after end of treatment.

From 2000 to 2011, 4,346 adults who died in New York City had a report of a hepatitis B virus infection (0.7%), according to a study in Epidemiology and Infection. Of the HBV-infected decedents, 1,074 (25%) were HIV coinfected. Fifty-five percent of HBV monoinfected and 95% of HBV/HIV coinfected decedents died prematurely, the researchers found.

Prison-based hepatitis C virus treatment achieves outcomes similar to those of community-based treatment, according to a study in the Journal of Viral Hepatitis, with those not released or transferred during treatment doing particularly well.

Treatment interventions to curb the hepatitis C virus epidemic among HIV-infected men who have sex with men are effective if high-risk behavior does not increase as it has during the last decade, according to a study in Hepatology.

The results of an international quality control study underline the urgent need to improve methods used to monitor hepatitis Delta virus viremia.

An investigation of a hepatitis E virus genotype 4 outbreak in Zhejiang Province, China, found that the outbreak was most likely caused by contaminated tap water rather than food.

A German study found that short treatment with 8 weeks of sofosbuvir and ledipasvir seems highly effective and safe in well-selected hepatitis C virus mono- and HIV/HCV-coinfected patients in a real-world setting.

A study of historical events fueling the cross-continental spread of hepatitis C virus epidemics said drivers for the epidemic were the advent of intravenous medical therapies and devices, growth in the heroin trade, and population mixing during armed conflicts.

[email protected]

On Twitter @richpizzi

If you work on the front lines of medical care treating patients with hepatitis, you may not have time to review all the hepatitis research that enters the medical literature every month. Here’s a quick look at some notable news items and journal articles published over the past month, covering a variety of the major hepatitis viruses.

A study in Hepatology has provided a preclinical risk assessment paradigm with which to better understand cardiovascular drug-drug interaction risk for hepatitis C–virus infected patients treated with sofosbuvir in combination with other direct acting antivirals and the antiarrhythmic drug amiodarone.

©Zerbor/Thinkstock

A Japanese study found that, although levels of Wisteria floribunda agglutinin-positive Mac-2-binding protein could be a useful indicator of liver fibrosis in patients with hepatitis B or C infection, WFA+-M2BP levels in the two groups significantly differed, even in the same degree of fibrosis.

Interferon-free, guideline-tailored therapy with direct-acting antivirals is highly effective and safe for hepatitis C virus–associated mixed cryoglobulinemia patients, according to a recent study.

Another recent study found that pegylated interferon (PegIFN) intensification in hepatitis B “e” antigen (HBeAg)-positive coinfected patients did not lead to increased clearance rates of HBeAg or hepatitis B surface antigen quantification (qHBsAg), despite faster declines of antigen levels while on PegIFN.

A study in HIV Medicine found that, under real-life conditions, treatment of patients infected with hepatitis C virus and of patients coinfected with HCV/HIV with all-oral direct-acting antiviral combinations led to high and similar rates of sustained virological response 12 weeks after the end of therapy.

Hepatitis B virus coinfection was the most important risk factor for liver fibrosis and cirrhosis in HIV-infected patients, and should be diagnosed early in HIV care to optimize treatment outcomes, a recent study showed.

Immunity persisted 24 months after a single dose of inactivated hepatitis A vaccine and live attenuated hepatitis A vaccine was administered to school-age children, according to a study published in Human Vaccines & Immunotherapeutics.

A hepatitis C treatment scale-up strategy in Rhode Island could reduce cirrhosis cases and liver-related deaths by 78.9% and 72.4%, respectively, by 2030, according to a study in Epidemiology and Infection.

Viral blipping is a frequent event during nucleoside analogue treatment of patients with chronic hepatitis B virus infection, a study found, although it did not lead to any clinically significant outcomes and thus may not require more frequent blood work and patient visits in clinical practice.

A study of liver and spleen stiffness in hepatitis C virus–infected patients – with advanced liver disease and sustained virologic response after interferon-free treatment – found that improvement of liver stiffness may be due to reduced necroinflammation, and to a lesser extent regression of cirrhosis. Improvement was more pronounced between therapy baseline and end of treatment than therapy baseline and 24 weeks after end of treatment.

From 2000 to 2011, 4,346 adults who died in New York City had a report of a hepatitis B virus infection (0.7%), according to a study in Epidemiology and Infection. Of the HBV-infected decedents, 1,074 (25%) were HIV coinfected. Fifty-five percent of HBV monoinfected and 95% of HBV/HIV coinfected decedents died prematurely, the researchers found.

Prison-based hepatitis C virus treatment achieves outcomes similar to those of community-based treatment, according to a study in the Journal of Viral Hepatitis, with those not released or transferred during treatment doing particularly well.

Treatment interventions to curb the hepatitis C virus epidemic among HIV-infected men who have sex with men are effective if high-risk behavior does not increase as it has during the last decade, according to a study in Hepatology.

The results of an international quality control study underline the urgent need to improve methods used to monitor hepatitis Delta virus viremia.

An investigation of a hepatitis E virus genotype 4 outbreak in Zhejiang Province, China, found that the outbreak was most likely caused by contaminated tap water rather than food.

A German study found that short treatment with 8 weeks of sofosbuvir and ledipasvir seems highly effective and safe in well-selected hepatitis C virus mono- and HIV/HCV-coinfected patients in a real-world setting.

A study of historical events fueling the cross-continental spread of hepatitis C virus epidemics said drivers for the epidemic were the advent of intravenous medical therapies and devices, growth in the heroin trade, and population mixing during armed conflicts.

[email protected]

On Twitter @richpizzi

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It does get better ... with your help: Preventing suicide

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It does get better ... with your help: Preventing suicide

Suicide continues to be a major public health problem in the United States. It is the second leading cause of death in young people aged 10-24 years, according to 2010 injury data from the Centers from Disease Control and Prevention.1 This problem disproportionately affects lesbian, gay, bisexual, and transgender (LGBT) youth. Compared to their heterosexual peers, LGBT youth are four times as likely to attempt suicide.2 In addition, almost 50% of transgender youth have attempted suicide.3

Why are LGBT youth at high risk for suicide? Antigay and antitrans stigma and discrimination against LGBT youth create a very stressful environment. For example, LGBT youth are two times more likely than are heterosexual youth to experience bullying4 because of their sexual orientation, and half of transgender youth have reported bullying because of their gender identity.3 LGBT youth tend to perceive lower levels of parental support than do heterosexual youth.5-8 A combination of harassment from peers and decreased perceived support from families increases the risk for suicide in LGBT youth.

Dr. Gerald Montano

However, there are factors that can reduce this risk. LGBT youth whose parents reject their sexual orientation or gender identity are eight times as likely to be suicidal,3,9 while in contrast, LGBT youth whose parents are more accepting are less likely to be suicidal.10 These studies underscore the importance of social support in reducing the stress from antigay and antitrans discrimination, and therefore, play a role in preventing suicide.

Health care providers are another source of support for LGBT youth. They can play a role in providing education and preventing suicide in this population because many victims of suicide have visited a health care provider before attempting to kill themselves.11 It is important for providers to screen for suicide in their patients. Although there is no lab test for suicidal ideation, suicidal adolescents tend to have certain risk factors. In addition to being LGBT, being bullied, and having a lack of social support, other risk factors are psychiatric illness, a history of being impulsive, alcohol and substance abuse, and most important of all, a previous suicide attempt.12

©ArishaRay/ThinkStock

When screening for suicide risk, always remember that at the beginning of any visit with an adolescent, remind them about confidentiality and its limits (e.g., breaking confidentiality if the patient is suicidal). Although this appears counterintuitive, it actually builds rapport between you and the patient. If you don’t discuss the limits of confidentiality beforehand and have to break it because the patient is suicidal, the patient is less likely to tell you again in the future. Once you suspect suicidal ideation based on the above risk factors, you can ask:

•  Have you thought about ending your own life or would you rather be dead?

•  Have you done something to harm yourself or to end your life?

•  Have you considered ways to end your own life?12

Some clinicians have expressed concern over asking about suicide in their adolescent patients, but doing so does not induce suicidal thoughts.13 If a patient does express any of the above, the clinician must then inquire about other risk factors that increase the individual’s chances of completing suicide. The American Association of Suicidology has listed several warning signs of imminent suicide, which can be remembered with the acronym IS PATH WARM. This stands for Ideation, Substance use, Purposelessness, heightened Anxiety, feeling Trapped, feeling Hopeless, Withdrawal from friends and family, uncontrollable Anger, engaging in Reckless behavior, and dramatic Mood changes.14

If a patient threatens to kill him/herself, has a specific plan to do so, or speaks about death and suicide, then the clinician must act immediately. Although sending a patient to the emergency department is the safest option, it is not the only option. If a good support system is present, and the patient lives in an environment where he or she does not have the means to carry out a suicide (e.g., there are no guns in the home), then the clinician can create a safety plan for the patient. A safety plan is different from a “no suicide contract.” A no suicide contract is a written commitment that the patient does not engage in suicidal behavior. Many experts caution against a no suicide contract because it can create a false sense of security for the clinician and does not address the strategies needed to combat feelings of suicidality.15,16

Usually with a safety plan, the clinician and the patient identify several people the patient can contact if the patient feels suicidal. In addition, the clinician and the patient can discuss ways the patient can cope with his/her feelings or distract himself/herself from suicidal thoughts (e.g., going out for a walk, watching a movie, etc.). Finally, if these methods fail, patients are provided with emergency hotlines or directed to the emergency department. The Suicide Prevention Resource Center has a template of a patient safety plan.

 

 

Finally, clinicians should be proactive in preventing suicide, especially for LGBT youth. Because bullying is a risk factor for suicide, and because LGBT youth are disproportionately affected by bullying, clinicians should advocate for antibullying school policies and advocate for schools to be more LGBT friendly. Clinicians also should speak to the community about suicide, its warning signs, and how to address it. Just like with any disease, prevention is the most effective form of treatment.

As clinicians, we should always be on the lookout for suicide in our young patients, especially LGBT youth. For many LGBT youth, we may be the only source of support. If patients are suicidal, we should work with them to determine how to keep the them safe. We have a powerful voice in the community. We can advocate for making schools safe for LGBT youth and educate the community in suicide prevention. Such a powerful voice proclaiming that it gets better can save a life.

Resources

The Trevor Project: A non-profit organization dedicated to prevent suicide in LGBT Youth (www.thetrevorproject.org)

It Gets Better Project: Another website dedicated to preventing suicide in LGBT youth by promoting the message that life will improve for LGBT teens (www.itgetsbetter.org)

Patient Safety Plan Template from the Suicide Prevention Resource Center (www.sprc.org)

References

1. CDC. NCIPC. Web-based Injury Statistics Query and Reporting System (WISQARS). 2010.

2. MMWR Surveill Summ. 2011 Jun 10;60(7):1-133.

3. Injustice at Every Turn: A Report of the National Transgender Discrimination Survey. (Washington: National Center for Transgender Equality and National Gay and Lesbian Task Force, 2011).

4. J Adolesc Health. 2014 Sep;55(3):432-8.

5. J Youth Adolesc. 2013 Mar;42(3):376-93.

6. J Youth Adolesc. 2010 Oct;39(10):1189-98.

7. School Psychology Review. 2008;37(2):202-16.

8. J Homosex. 2010;57(2):287-309.

9. Pediatrics. 2009 Jan;123(1):346-52.

10. J Child Adolesc Psychiatr Nurs. 2010 Nov;23(4):205-13.

11. Mayo Clin Proc. 2011 Aug;86(8):792-800.

12. Ital J Pediatr. 2015 Jul 7;41:49.

13. Ment Health Fam Med. 2008 Dec;5(4):229-35.

14. Know the Warning Signs of Suicide. American Association of Suicidology.

15. J Psychiatr Ment Health Nurs. 2008 Aug;15(6):512-22.

16. J Amer Acad Psych Law. 1999;27(3):445-50.

Dr. Montano is a physician at Children’s Hospital of Pittsburgh of UPMC and a clinical instructor of pediatrics at the University of Pittsburgh School of Medicine.

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Suicide continues to be a major public health problem in the United States. It is the second leading cause of death in young people aged 10-24 years, according to 2010 injury data from the Centers from Disease Control and Prevention.1 This problem disproportionately affects lesbian, gay, bisexual, and transgender (LGBT) youth. Compared to their heterosexual peers, LGBT youth are four times as likely to attempt suicide.2 In addition, almost 50% of transgender youth have attempted suicide.3

Why are LGBT youth at high risk for suicide? Antigay and antitrans stigma and discrimination against LGBT youth create a very stressful environment. For example, LGBT youth are two times more likely than are heterosexual youth to experience bullying4 because of their sexual orientation, and half of transgender youth have reported bullying because of their gender identity.3 LGBT youth tend to perceive lower levels of parental support than do heterosexual youth.5-8 A combination of harassment from peers and decreased perceived support from families increases the risk for suicide in LGBT youth.

Dr. Gerald Montano

However, there are factors that can reduce this risk. LGBT youth whose parents reject their sexual orientation or gender identity are eight times as likely to be suicidal,3,9 while in contrast, LGBT youth whose parents are more accepting are less likely to be suicidal.10 These studies underscore the importance of social support in reducing the stress from antigay and antitrans discrimination, and therefore, play a role in preventing suicide.

Health care providers are another source of support for LGBT youth. They can play a role in providing education and preventing suicide in this population because many victims of suicide have visited a health care provider before attempting to kill themselves.11 It is important for providers to screen for suicide in their patients. Although there is no lab test for suicidal ideation, suicidal adolescents tend to have certain risk factors. In addition to being LGBT, being bullied, and having a lack of social support, other risk factors are psychiatric illness, a history of being impulsive, alcohol and substance abuse, and most important of all, a previous suicide attempt.12

©ArishaRay/ThinkStock

When screening for suicide risk, always remember that at the beginning of any visit with an adolescent, remind them about confidentiality and its limits (e.g., breaking confidentiality if the patient is suicidal). Although this appears counterintuitive, it actually builds rapport between you and the patient. If you don’t discuss the limits of confidentiality beforehand and have to break it because the patient is suicidal, the patient is less likely to tell you again in the future. Once you suspect suicidal ideation based on the above risk factors, you can ask:

•  Have you thought about ending your own life or would you rather be dead?

•  Have you done something to harm yourself or to end your life?

•  Have you considered ways to end your own life?12

Some clinicians have expressed concern over asking about suicide in their adolescent patients, but doing so does not induce suicidal thoughts.13 If a patient does express any of the above, the clinician must then inquire about other risk factors that increase the individual’s chances of completing suicide. The American Association of Suicidology has listed several warning signs of imminent suicide, which can be remembered with the acronym IS PATH WARM. This stands for Ideation, Substance use, Purposelessness, heightened Anxiety, feeling Trapped, feeling Hopeless, Withdrawal from friends and family, uncontrollable Anger, engaging in Reckless behavior, and dramatic Mood changes.14

If a patient threatens to kill him/herself, has a specific plan to do so, or speaks about death and suicide, then the clinician must act immediately. Although sending a patient to the emergency department is the safest option, it is not the only option. If a good support system is present, and the patient lives in an environment where he or she does not have the means to carry out a suicide (e.g., there are no guns in the home), then the clinician can create a safety plan for the patient. A safety plan is different from a “no suicide contract.” A no suicide contract is a written commitment that the patient does not engage in suicidal behavior. Many experts caution against a no suicide contract because it can create a false sense of security for the clinician and does not address the strategies needed to combat feelings of suicidality.15,16

Usually with a safety plan, the clinician and the patient identify several people the patient can contact if the patient feels suicidal. In addition, the clinician and the patient can discuss ways the patient can cope with his/her feelings or distract himself/herself from suicidal thoughts (e.g., going out for a walk, watching a movie, etc.). Finally, if these methods fail, patients are provided with emergency hotlines or directed to the emergency department. The Suicide Prevention Resource Center has a template of a patient safety plan.

 

 

Finally, clinicians should be proactive in preventing suicide, especially for LGBT youth. Because bullying is a risk factor for suicide, and because LGBT youth are disproportionately affected by bullying, clinicians should advocate for antibullying school policies and advocate for schools to be more LGBT friendly. Clinicians also should speak to the community about suicide, its warning signs, and how to address it. Just like with any disease, prevention is the most effective form of treatment.

As clinicians, we should always be on the lookout for suicide in our young patients, especially LGBT youth. For many LGBT youth, we may be the only source of support. If patients are suicidal, we should work with them to determine how to keep the them safe. We have a powerful voice in the community. We can advocate for making schools safe for LGBT youth and educate the community in suicide prevention. Such a powerful voice proclaiming that it gets better can save a life.

Resources

The Trevor Project: A non-profit organization dedicated to prevent suicide in LGBT Youth (www.thetrevorproject.org)

It Gets Better Project: Another website dedicated to preventing suicide in LGBT youth by promoting the message that life will improve for LGBT teens (www.itgetsbetter.org)

Patient Safety Plan Template from the Suicide Prevention Resource Center (www.sprc.org)

References

1. CDC. NCIPC. Web-based Injury Statistics Query and Reporting System (WISQARS). 2010.

2. MMWR Surveill Summ. 2011 Jun 10;60(7):1-133.

3. Injustice at Every Turn: A Report of the National Transgender Discrimination Survey. (Washington: National Center for Transgender Equality and National Gay and Lesbian Task Force, 2011).

4. J Adolesc Health. 2014 Sep;55(3):432-8.

5. J Youth Adolesc. 2013 Mar;42(3):376-93.

6. J Youth Adolesc. 2010 Oct;39(10):1189-98.

7. School Psychology Review. 2008;37(2):202-16.

8. J Homosex. 2010;57(2):287-309.

9. Pediatrics. 2009 Jan;123(1):346-52.

10. J Child Adolesc Psychiatr Nurs. 2010 Nov;23(4):205-13.

11. Mayo Clin Proc. 2011 Aug;86(8):792-800.

12. Ital J Pediatr. 2015 Jul 7;41:49.

13. Ment Health Fam Med. 2008 Dec;5(4):229-35.

14. Know the Warning Signs of Suicide. American Association of Suicidology.

15. J Psychiatr Ment Health Nurs. 2008 Aug;15(6):512-22.

16. J Amer Acad Psych Law. 1999;27(3):445-50.

Dr. Montano is a physician at Children’s Hospital of Pittsburgh of UPMC and a clinical instructor of pediatrics at the University of Pittsburgh School of Medicine.

Suicide continues to be a major public health problem in the United States. It is the second leading cause of death in young people aged 10-24 years, according to 2010 injury data from the Centers from Disease Control and Prevention.1 This problem disproportionately affects lesbian, gay, bisexual, and transgender (LGBT) youth. Compared to their heterosexual peers, LGBT youth are four times as likely to attempt suicide.2 In addition, almost 50% of transgender youth have attempted suicide.3

Why are LGBT youth at high risk for suicide? Antigay and antitrans stigma and discrimination against LGBT youth create a very stressful environment. For example, LGBT youth are two times more likely than are heterosexual youth to experience bullying4 because of their sexual orientation, and half of transgender youth have reported bullying because of their gender identity.3 LGBT youth tend to perceive lower levels of parental support than do heterosexual youth.5-8 A combination of harassment from peers and decreased perceived support from families increases the risk for suicide in LGBT youth.

Dr. Gerald Montano

However, there are factors that can reduce this risk. LGBT youth whose parents reject their sexual orientation or gender identity are eight times as likely to be suicidal,3,9 while in contrast, LGBT youth whose parents are more accepting are less likely to be suicidal.10 These studies underscore the importance of social support in reducing the stress from antigay and antitrans discrimination, and therefore, play a role in preventing suicide.

Health care providers are another source of support for LGBT youth. They can play a role in providing education and preventing suicide in this population because many victims of suicide have visited a health care provider before attempting to kill themselves.11 It is important for providers to screen for suicide in their patients. Although there is no lab test for suicidal ideation, suicidal adolescents tend to have certain risk factors. In addition to being LGBT, being bullied, and having a lack of social support, other risk factors are psychiatric illness, a history of being impulsive, alcohol and substance abuse, and most important of all, a previous suicide attempt.12

©ArishaRay/ThinkStock

When screening for suicide risk, always remember that at the beginning of any visit with an adolescent, remind them about confidentiality and its limits (e.g., breaking confidentiality if the patient is suicidal). Although this appears counterintuitive, it actually builds rapport between you and the patient. If you don’t discuss the limits of confidentiality beforehand and have to break it because the patient is suicidal, the patient is less likely to tell you again in the future. Once you suspect suicidal ideation based on the above risk factors, you can ask:

•  Have you thought about ending your own life or would you rather be dead?

•  Have you done something to harm yourself or to end your life?

•  Have you considered ways to end your own life?12

Some clinicians have expressed concern over asking about suicide in their adolescent patients, but doing so does not induce suicidal thoughts.13 If a patient does express any of the above, the clinician must then inquire about other risk factors that increase the individual’s chances of completing suicide. The American Association of Suicidology has listed several warning signs of imminent suicide, which can be remembered with the acronym IS PATH WARM. This stands for Ideation, Substance use, Purposelessness, heightened Anxiety, feeling Trapped, feeling Hopeless, Withdrawal from friends and family, uncontrollable Anger, engaging in Reckless behavior, and dramatic Mood changes.14

If a patient threatens to kill him/herself, has a specific plan to do so, or speaks about death and suicide, then the clinician must act immediately. Although sending a patient to the emergency department is the safest option, it is not the only option. If a good support system is present, and the patient lives in an environment where he or she does not have the means to carry out a suicide (e.g., there are no guns in the home), then the clinician can create a safety plan for the patient. A safety plan is different from a “no suicide contract.” A no suicide contract is a written commitment that the patient does not engage in suicidal behavior. Many experts caution against a no suicide contract because it can create a false sense of security for the clinician and does not address the strategies needed to combat feelings of suicidality.15,16

Usually with a safety plan, the clinician and the patient identify several people the patient can contact if the patient feels suicidal. In addition, the clinician and the patient can discuss ways the patient can cope with his/her feelings or distract himself/herself from suicidal thoughts (e.g., going out for a walk, watching a movie, etc.). Finally, if these methods fail, patients are provided with emergency hotlines or directed to the emergency department. The Suicide Prevention Resource Center has a template of a patient safety plan.

 

 

Finally, clinicians should be proactive in preventing suicide, especially for LGBT youth. Because bullying is a risk factor for suicide, and because LGBT youth are disproportionately affected by bullying, clinicians should advocate for antibullying school policies and advocate for schools to be more LGBT friendly. Clinicians also should speak to the community about suicide, its warning signs, and how to address it. Just like with any disease, prevention is the most effective form of treatment.

As clinicians, we should always be on the lookout for suicide in our young patients, especially LGBT youth. For many LGBT youth, we may be the only source of support. If patients are suicidal, we should work with them to determine how to keep the them safe. We have a powerful voice in the community. We can advocate for making schools safe for LGBT youth and educate the community in suicide prevention. Such a powerful voice proclaiming that it gets better can save a life.

Resources

The Trevor Project: A non-profit organization dedicated to prevent suicide in LGBT Youth (www.thetrevorproject.org)

It Gets Better Project: Another website dedicated to preventing suicide in LGBT youth by promoting the message that life will improve for LGBT teens (www.itgetsbetter.org)

Patient Safety Plan Template from the Suicide Prevention Resource Center (www.sprc.org)

References

1. CDC. NCIPC. Web-based Injury Statistics Query and Reporting System (WISQARS). 2010.

2. MMWR Surveill Summ. 2011 Jun 10;60(7):1-133.

3. Injustice at Every Turn: A Report of the National Transgender Discrimination Survey. (Washington: National Center for Transgender Equality and National Gay and Lesbian Task Force, 2011).

4. J Adolesc Health. 2014 Sep;55(3):432-8.

5. J Youth Adolesc. 2013 Mar;42(3):376-93.

6. J Youth Adolesc. 2010 Oct;39(10):1189-98.

7. School Psychology Review. 2008;37(2):202-16.

8. J Homosex. 2010;57(2):287-309.

9. Pediatrics. 2009 Jan;123(1):346-52.

10. J Child Adolesc Psychiatr Nurs. 2010 Nov;23(4):205-13.

11. Mayo Clin Proc. 2011 Aug;86(8):792-800.

12. Ital J Pediatr. 2015 Jul 7;41:49.

13. Ment Health Fam Med. 2008 Dec;5(4):229-35.

14. Know the Warning Signs of Suicide. American Association of Suicidology.

15. J Psychiatr Ment Health Nurs. 2008 Aug;15(6):512-22.

16. J Amer Acad Psych Law. 1999;27(3):445-50.

Dr. Montano is a physician at Children’s Hospital of Pittsburgh of UPMC and a clinical instructor of pediatrics at the University of Pittsburgh School of Medicine.

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(This column is the second in a three-part series.)

Question: A penicillin-allergic patient died from massive hemolysis after receiving the antibiotic ceftriaxone (Rocephin). The plaintiff alleged that the defendant was grossly negligent in administering the drug and subsequently refusing to treat or to readmit the decedent.

If this case is referred to the state’s medical board, which of the following statements is best?

A. The outcome depends on the jurisdiction.

B. Substandard medical care is not part of professional misconduct, which is what a medical board is supposed to look at.

C. Disciplinary action requires a simple showing of ordinary negligence.

D. Disciplinary action requires more than one act of ordinary negligence.

E. Disciplinary action requires proof of gross negligence.

Answer: A. Under the Medical Practice Act, each state authorizes its medical board to issue licenses and regulate physician practice. Professional misconduct is about unprofessional behavior, and covers both ethical breach and substandard care.

Dr. S.Y. Tan

Medical boards do not typically adjudicate single acts of ordinary negligence, leaving them instead to the tort system and civil lawsuits. However, grossly culpable misconduct – even in a single instance – or a recurring pattern of ordinary negligence can come under medical board review. And it is common practice for boards to use malpractice data as a tool to trigger further investigations, such as a certain number of malpractice settlements over a given span of time.

States vary somewhat over when to investigate a complaint of alleged substandard practice. In California, the term “unprofessional conduct” is codified under section 2234 of the California Business and Professions Code, and the errant doctor is subject to disciplinary sanction if there is gross negligence, repeated negligent acts (defined as two or more negligent acts or omissions), or incompetence.

In Hawaii, the disciplinary law is set up under Hawaii Revised Statutes section 453-8, which lists 15 situations of wrongdoing. In the malpractice category, Hawaii’s law uses the terms hazardous misconduct, hazardous negligence, incompetence, or multiple instances of negligence.

The state of New York defines professional misconduct by reference to a comprehensive list of 49 categories under section 6530, which include gross incompetence or gross negligence on a single occasion, or negligence or incompetence on more than one occasion.

However, Maryland is an example of a jurisdiction that does not require gross or repeated negligence; the state considers any failure to meet the appropriate medical standards as professional misconduct.1

But what constitutes gross negligence?

The vast majority of medical malpractice lawsuits allege ordinary, not gross negligence. Ordinary negligence is a well-defined legal term, as illustrated in Prosser’s Textbook on Torts: “The formula under which this usually is put to the jury is that the doctor must have and use the knowledge, skill, and care ordinarily possessed and employed by members of the profession in good standing.”2

In contrast, there is no universal definition for the term gross negligence. Everyone recognizes it denotes a greater degree of culpability than ordinary negligence, but how much greater?

According to the California Supreme Court, gross negligence may be said to be “the want of even scant care or an extreme departure from the ordinary standard of conduct.”3 The law in Texas stipulates: “Gross negligence means more than momentary thoughtlessness, inadvertence, or error of judgment. It means an entire want of care as to establish that the act or omission was the result of actual, conscious indifference to the rights, safety, and welfare of the person affected.”4

Examples in case law of gross negligence (or where punitive damages were awarded, which usually signify egregious conduct) include a doctor’s wanton failure to provide follow-up care for a child who developed fever and gangrenous toes following foot surgery,5 the prescription of an excessive number of birth control pills (more than 1,000 pills within a time period when less than 200 were sufficient) with resulting liver complications,6 and leaving behind a 6.5-inch clamp in a surgical incision.7

On the other hand, a Connecticut court (which decided the case in the hypothetical above) ruled that, under the facts, the defendant’s conduct did not meet the high threshold of egregiousness that defines gross negligence.8

As in any malpractice lawsuit, a medical board investigation involves determining whether the accused physician has met the standard of care in his or her specialty, and boards usually look to expert community physicians to articulate that requisite standard.

Compared with a civil lawsuit, a disciplinary hearing has the physician at a disadvantage. Medical board complaints are easier to file; the complaining party does not need an attorney; impartial expert witnesses are the responsibility of the board, not the complainant; and no patient injury needs to be shown.

 

 

Furthermore, a settlement is rarely reached or negotiated, and penalties are potentially far more serious, such as public posting of an adverse decision and restriction or actual loss of licensure.

Reputational loss also is arguably more devastating with board censure, because an adverse action taken by a medical board indicates a violation of the Medical Practice Act. In contrast, malpractice settlements or verdicts are regularly viewed as unreliable measures of a physician’s competence.

Still, two features work in favor of the doctor facing a board hearing. First, the misconduct typically has to be recurrent or grossly negligent, rather than an isolated case of carelessness. And second, some boards (only a small minority) require evidentiary proof of fault to be “clear and convincing,” instead of the familiar “more probable than not” standard that is used in a civil negligence suit. This makes it theoretically harder to reach a finding of culpability against the doctor.

References

1. Md. Code Ann. Health Occ. section 14-404.

2. Prosser and Keeton on Torts, 5th ed., 1984.

3. Van Meter v. Bent Construction Co., 297 P.2d 644 (Cal. 1956).

4. Texas Civil Practice & Remedies Code section 41.001(7).

5. Dempsey v. Phelps, 700 So.2d 1340 (Ala. 1997).

6. Jackson v. Taylor, 912 F.2d 795 (5th Cir. 1990).

7. Fox v. Oklahoma Memorial Hospital, 774 P.2d 459 (Ok. 1989).

8. Boone v. William W. Backus Hospital, 864 A.2d 1 (Conn. 2005).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

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(This column is the second in a three-part series.)

Question: A penicillin-allergic patient died from massive hemolysis after receiving the antibiotic ceftriaxone (Rocephin). The plaintiff alleged that the defendant was grossly negligent in administering the drug and subsequently refusing to treat or to readmit the decedent.

If this case is referred to the state’s medical board, which of the following statements is best?

A. The outcome depends on the jurisdiction.

B. Substandard medical care is not part of professional misconduct, which is what a medical board is supposed to look at.

C. Disciplinary action requires a simple showing of ordinary negligence.

D. Disciplinary action requires more than one act of ordinary negligence.

E. Disciplinary action requires proof of gross negligence.

Answer: A. Under the Medical Practice Act, each state authorizes its medical board to issue licenses and regulate physician practice. Professional misconduct is about unprofessional behavior, and covers both ethical breach and substandard care.

Dr. S.Y. Tan

Medical boards do not typically adjudicate single acts of ordinary negligence, leaving them instead to the tort system and civil lawsuits. However, grossly culpable misconduct – even in a single instance – or a recurring pattern of ordinary negligence can come under medical board review. And it is common practice for boards to use malpractice data as a tool to trigger further investigations, such as a certain number of malpractice settlements over a given span of time.

States vary somewhat over when to investigate a complaint of alleged substandard practice. In California, the term “unprofessional conduct” is codified under section 2234 of the California Business and Professions Code, and the errant doctor is subject to disciplinary sanction if there is gross negligence, repeated negligent acts (defined as two or more negligent acts or omissions), or incompetence.

In Hawaii, the disciplinary law is set up under Hawaii Revised Statutes section 453-8, which lists 15 situations of wrongdoing. In the malpractice category, Hawaii’s law uses the terms hazardous misconduct, hazardous negligence, incompetence, or multiple instances of negligence.

The state of New York defines professional misconduct by reference to a comprehensive list of 49 categories under section 6530, which include gross incompetence or gross negligence on a single occasion, or negligence or incompetence on more than one occasion.

However, Maryland is an example of a jurisdiction that does not require gross or repeated negligence; the state considers any failure to meet the appropriate medical standards as professional misconduct.1

But what constitutes gross negligence?

The vast majority of medical malpractice lawsuits allege ordinary, not gross negligence. Ordinary negligence is a well-defined legal term, as illustrated in Prosser’s Textbook on Torts: “The formula under which this usually is put to the jury is that the doctor must have and use the knowledge, skill, and care ordinarily possessed and employed by members of the profession in good standing.”2

In contrast, there is no universal definition for the term gross negligence. Everyone recognizes it denotes a greater degree of culpability than ordinary negligence, but how much greater?

According to the California Supreme Court, gross negligence may be said to be “the want of even scant care or an extreme departure from the ordinary standard of conduct.”3 The law in Texas stipulates: “Gross negligence means more than momentary thoughtlessness, inadvertence, or error of judgment. It means an entire want of care as to establish that the act or omission was the result of actual, conscious indifference to the rights, safety, and welfare of the person affected.”4

Examples in case law of gross negligence (or where punitive damages were awarded, which usually signify egregious conduct) include a doctor’s wanton failure to provide follow-up care for a child who developed fever and gangrenous toes following foot surgery,5 the prescription of an excessive number of birth control pills (more than 1,000 pills within a time period when less than 200 were sufficient) with resulting liver complications,6 and leaving behind a 6.5-inch clamp in a surgical incision.7

On the other hand, a Connecticut court (which decided the case in the hypothetical above) ruled that, under the facts, the defendant’s conduct did not meet the high threshold of egregiousness that defines gross negligence.8

As in any malpractice lawsuit, a medical board investigation involves determining whether the accused physician has met the standard of care in his or her specialty, and boards usually look to expert community physicians to articulate that requisite standard.

Compared with a civil lawsuit, a disciplinary hearing has the physician at a disadvantage. Medical board complaints are easier to file; the complaining party does not need an attorney; impartial expert witnesses are the responsibility of the board, not the complainant; and no patient injury needs to be shown.

 

 

Furthermore, a settlement is rarely reached or negotiated, and penalties are potentially far more serious, such as public posting of an adverse decision and restriction or actual loss of licensure.

Reputational loss also is arguably more devastating with board censure, because an adverse action taken by a medical board indicates a violation of the Medical Practice Act. In contrast, malpractice settlements or verdicts are regularly viewed as unreliable measures of a physician’s competence.

Still, two features work in favor of the doctor facing a board hearing. First, the misconduct typically has to be recurrent or grossly negligent, rather than an isolated case of carelessness. And second, some boards (only a small minority) require evidentiary proof of fault to be “clear and convincing,” instead of the familiar “more probable than not” standard that is used in a civil negligence suit. This makes it theoretically harder to reach a finding of culpability against the doctor.

References

1. Md. Code Ann. Health Occ. section 14-404.

2. Prosser and Keeton on Torts, 5th ed., 1984.

3. Van Meter v. Bent Construction Co., 297 P.2d 644 (Cal. 1956).

4. Texas Civil Practice & Remedies Code section 41.001(7).

5. Dempsey v. Phelps, 700 So.2d 1340 (Ala. 1997).

6. Jackson v. Taylor, 912 F.2d 795 (5th Cir. 1990).

7. Fox v. Oklahoma Memorial Hospital, 774 P.2d 459 (Ok. 1989).

8. Boone v. William W. Backus Hospital, 864 A.2d 1 (Conn. 2005).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

(This column is the second in a three-part series.)

Question: A penicillin-allergic patient died from massive hemolysis after receiving the antibiotic ceftriaxone (Rocephin). The plaintiff alleged that the defendant was grossly negligent in administering the drug and subsequently refusing to treat or to readmit the decedent.

If this case is referred to the state’s medical board, which of the following statements is best?

A. The outcome depends on the jurisdiction.

B. Substandard medical care is not part of professional misconduct, which is what a medical board is supposed to look at.

C. Disciplinary action requires a simple showing of ordinary negligence.

D. Disciplinary action requires more than one act of ordinary negligence.

E. Disciplinary action requires proof of gross negligence.

Answer: A. Under the Medical Practice Act, each state authorizes its medical board to issue licenses and regulate physician practice. Professional misconduct is about unprofessional behavior, and covers both ethical breach and substandard care.

Dr. S.Y. Tan

Medical boards do not typically adjudicate single acts of ordinary negligence, leaving them instead to the tort system and civil lawsuits. However, grossly culpable misconduct – even in a single instance – or a recurring pattern of ordinary negligence can come under medical board review. And it is common practice for boards to use malpractice data as a tool to trigger further investigations, such as a certain number of malpractice settlements over a given span of time.

States vary somewhat over when to investigate a complaint of alleged substandard practice. In California, the term “unprofessional conduct” is codified under section 2234 of the California Business and Professions Code, and the errant doctor is subject to disciplinary sanction if there is gross negligence, repeated negligent acts (defined as two or more negligent acts or omissions), or incompetence.

In Hawaii, the disciplinary law is set up under Hawaii Revised Statutes section 453-8, which lists 15 situations of wrongdoing. In the malpractice category, Hawaii’s law uses the terms hazardous misconduct, hazardous negligence, incompetence, or multiple instances of negligence.

The state of New York defines professional misconduct by reference to a comprehensive list of 49 categories under section 6530, which include gross incompetence or gross negligence on a single occasion, or negligence or incompetence on more than one occasion.

However, Maryland is an example of a jurisdiction that does not require gross or repeated negligence; the state considers any failure to meet the appropriate medical standards as professional misconduct.1

But what constitutes gross negligence?

The vast majority of medical malpractice lawsuits allege ordinary, not gross negligence. Ordinary negligence is a well-defined legal term, as illustrated in Prosser’s Textbook on Torts: “The formula under which this usually is put to the jury is that the doctor must have and use the knowledge, skill, and care ordinarily possessed and employed by members of the profession in good standing.”2

In contrast, there is no universal definition for the term gross negligence. Everyone recognizes it denotes a greater degree of culpability than ordinary negligence, but how much greater?

According to the California Supreme Court, gross negligence may be said to be “the want of even scant care or an extreme departure from the ordinary standard of conduct.”3 The law in Texas stipulates: “Gross negligence means more than momentary thoughtlessness, inadvertence, or error of judgment. It means an entire want of care as to establish that the act or omission was the result of actual, conscious indifference to the rights, safety, and welfare of the person affected.”4

Examples in case law of gross negligence (or where punitive damages were awarded, which usually signify egregious conduct) include a doctor’s wanton failure to provide follow-up care for a child who developed fever and gangrenous toes following foot surgery,5 the prescription of an excessive number of birth control pills (more than 1,000 pills within a time period when less than 200 were sufficient) with resulting liver complications,6 and leaving behind a 6.5-inch clamp in a surgical incision.7

On the other hand, a Connecticut court (which decided the case in the hypothetical above) ruled that, under the facts, the defendant’s conduct did not meet the high threshold of egregiousness that defines gross negligence.8

As in any malpractice lawsuit, a medical board investigation involves determining whether the accused physician has met the standard of care in his or her specialty, and boards usually look to expert community physicians to articulate that requisite standard.

Compared with a civil lawsuit, a disciplinary hearing has the physician at a disadvantage. Medical board complaints are easier to file; the complaining party does not need an attorney; impartial expert witnesses are the responsibility of the board, not the complainant; and no patient injury needs to be shown.

 

 

Furthermore, a settlement is rarely reached or negotiated, and penalties are potentially far more serious, such as public posting of an adverse decision and restriction or actual loss of licensure.

Reputational loss also is arguably more devastating with board censure, because an adverse action taken by a medical board indicates a violation of the Medical Practice Act. In contrast, malpractice settlements or verdicts are regularly viewed as unreliable measures of a physician’s competence.

Still, two features work in favor of the doctor facing a board hearing. First, the misconduct typically has to be recurrent or grossly negligent, rather than an isolated case of carelessness. And second, some boards (only a small minority) require evidentiary proof of fault to be “clear and convincing,” instead of the familiar “more probable than not” standard that is used in a civil negligence suit. This makes it theoretically harder to reach a finding of culpability against the doctor.

References

1. Md. Code Ann. Health Occ. section 14-404.

2. Prosser and Keeton on Torts, 5th ed., 1984.

3. Van Meter v. Bent Construction Co., 297 P.2d 644 (Cal. 1956).

4. Texas Civil Practice & Remedies Code section 41.001(7).

5. Dempsey v. Phelps, 700 So.2d 1340 (Ala. 1997).

6. Jackson v. Taylor, 912 F.2d 795 (5th Cir. 1990).

7. Fox v. Oklahoma Memorial Hospital, 774 P.2d 459 (Ok. 1989).

8. Boone v. William W. Backus Hospital, 864 A.2d 1 (Conn. 2005).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

References

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A quarter of hypertensive Medicare enrollees are nonadherent

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Over 26% of Medicare part D enrollees aged 65 years and over are not taking their antihypertensive drugs properly, according to a report published online Sept. 13 in MMWR.

An analysis of 2014 data showed that 4.9 million hypertensive Medicare patients were taking an incorrect dose of their medication or were not taking it at all, reported Matthew Ritchey, DPT of the Centers for Disease Control and Prevention’s division for heart disease and stroke prevention, and his associates (MMWR. 2016 Sep 13:65).

Nonadherence rates varied considerably by race and ethnicity, with American Indians/Alaska Natives the highest at 39%, followed by blacks at 36%, Hispanics at 34%, Asian/Pacific Islanders at 26%, and white non-Hispanics at 24%, the investigators noted.

The analysis included 18.5 million part D beneficiaries who filled two or more antihypertensive prescriptions in the same therapeutic class on different dates within a period of more than 90 days in 2014.

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Over 26% of Medicare part D enrollees aged 65 years and over are not taking their antihypertensive drugs properly, according to a report published online Sept. 13 in MMWR.

An analysis of 2014 data showed that 4.9 million hypertensive Medicare patients were taking an incorrect dose of their medication or were not taking it at all, reported Matthew Ritchey, DPT of the Centers for Disease Control and Prevention’s division for heart disease and stroke prevention, and his associates (MMWR. 2016 Sep 13:65).

Nonadherence rates varied considerably by race and ethnicity, with American Indians/Alaska Natives the highest at 39%, followed by blacks at 36%, Hispanics at 34%, Asian/Pacific Islanders at 26%, and white non-Hispanics at 24%, the investigators noted.

The analysis included 18.5 million part D beneficiaries who filled two or more antihypertensive prescriptions in the same therapeutic class on different dates within a period of more than 90 days in 2014.

[email protected]

Over 26% of Medicare part D enrollees aged 65 years and over are not taking their antihypertensive drugs properly, according to a report published online Sept. 13 in MMWR.

An analysis of 2014 data showed that 4.9 million hypertensive Medicare patients were taking an incorrect dose of their medication or were not taking it at all, reported Matthew Ritchey, DPT of the Centers for Disease Control and Prevention’s division for heart disease and stroke prevention, and his associates (MMWR. 2016 Sep 13:65).

Nonadherence rates varied considerably by race and ethnicity, with American Indians/Alaska Natives the highest at 39%, followed by blacks at 36%, Hispanics at 34%, Asian/Pacific Islanders at 26%, and white non-Hispanics at 24%, the investigators noted.

The analysis included 18.5 million part D beneficiaries who filled two or more antihypertensive prescriptions in the same therapeutic class on different dates within a period of more than 90 days in 2014.

[email protected]

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Quality or convenience: Pick one

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A 35-year-old male with a 5-year-history of a changing mole on his back sends a picture of the lesion to a telemedicine website for advice. The photo reveals a black nodule. The clinician replies, advising the patient that the lesion is benign.

To most dermatologists, the above scenario would occur only in a bizarre nightmare, never in real life. In real life, if the words “black” and “nodule” are used to describe a lesion, they are followed by the verb “biopsy.” Most dermatologists would recognize this as a high-risk growth and recommend additional investigation.

 

Dr. Jeffrey Benabio

Unfortunately, a recent study of direct-to-consumer (DTC) telemedicine in JAMA Dermatology showed that 21% of the time, the patient was wrongfully reassured that a lesion was benign (JAMA Dermatol. 2016;152[7]:768-75). The study examined how 16 DTC telemedicine websites and apps handled six standardized dermatology cases designed to test the quality of the services. While some provided good care, others missed important diagnoses such as syphilis, eczema herpeticum, and melanoma. If these cases had been actual patients, the consequences for such mistakes could have been dire.

“The services failed to ask simple, relevant questions of patients about their symptoms, leading them to repeatedly miss important diagnoses,” Jack Resneck Jr., MD, a dermatologist at the University of California, San Francisco, and lead author of the study, told the Wall Street Journal.

The study is timely, as telemedicine is accelerating explosively. The low cost of connectivity, viable business models, and changing consumer behaviors are fueling its rocket growth. Startups in digital health and telemedicine have raised over $700 million already this year, indicating that there is more fuel to be burned and more money to be made.

DTC telemedicine describes the model when a patient sends photos directly to a clinician without a prior history with that provider. A teleconsultation, in contrast, is an interaction between two doctors. In DTC, the episode of care is usually isolated from the patient’s record, and the information is not transferred to the primary care physician. Patients pay a fee, which can range from $1.59 to $250.

Advocates of DTC cite its low cost and extraordinary convenience as arguments for its adoption. However, these disconnected visits are notable exceptions to the current trend toward better care coordination and information sharing among providers.

Quality is also a concern. Although consumers were often promised answers from board-certified physicians, the JAMA Dermatology study was unable to verify this in many cases. The researchers also found that nondermatologists, physician extenders, and physicians practicing in India were often the providers, facts that were not obvious to users.

Worse, the study found both the quality of the diagnoses and the recommendations were poor. All the providers missed the cases of syphilis and most missed eczema herpeticum. Risks of prescription medications were not disclosed two-thirds of the time. Worse yet, three services mistakenly advised that a nodular melanoma did not need further treatment. Had these been real patients, such wrongful recommendations could have resulted in deaths.

In an effort to ensure safety and reliability for consumers, the American Telemedicine Association has begun credentialing telemedicine providers. Such credentials are not required, however, and consumers are likely to be unaware of which providers have or have not met this standard. The American Academy of Dermatology addresses DTC teledermatology in its position statement, updated in 2016: “Dermatologists providing direct-to-patient teledermatology must make every effort to collect accurate, complete, and quality clinical information. When appropriate, the dermatologist may wish to contact the primary care providers or other specialists to obtain additional corroborating information.”

Currently, patients remain on their own in choosing telemedicine and other digital health services: caveat emptor. Do they want quality and convenient care? For now, it seems, they must pick only one.

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego. He is @Dermdoc on Twitter. Write to him at [email protected].

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A 35-year-old male with a 5-year-history of a changing mole on his back sends a picture of the lesion to a telemedicine website for advice. The photo reveals a black nodule. The clinician replies, advising the patient that the lesion is benign.

To most dermatologists, the above scenario would occur only in a bizarre nightmare, never in real life. In real life, if the words “black” and “nodule” are used to describe a lesion, they are followed by the verb “biopsy.” Most dermatologists would recognize this as a high-risk growth and recommend additional investigation.

 

Dr. Jeffrey Benabio

Unfortunately, a recent study of direct-to-consumer (DTC) telemedicine in JAMA Dermatology showed that 21% of the time, the patient was wrongfully reassured that a lesion was benign (JAMA Dermatol. 2016;152[7]:768-75). The study examined how 16 DTC telemedicine websites and apps handled six standardized dermatology cases designed to test the quality of the services. While some provided good care, others missed important diagnoses such as syphilis, eczema herpeticum, and melanoma. If these cases had been actual patients, the consequences for such mistakes could have been dire.

“The services failed to ask simple, relevant questions of patients about their symptoms, leading them to repeatedly miss important diagnoses,” Jack Resneck Jr., MD, a dermatologist at the University of California, San Francisco, and lead author of the study, told the Wall Street Journal.

The study is timely, as telemedicine is accelerating explosively. The low cost of connectivity, viable business models, and changing consumer behaviors are fueling its rocket growth. Startups in digital health and telemedicine have raised over $700 million already this year, indicating that there is more fuel to be burned and more money to be made.

DTC telemedicine describes the model when a patient sends photos directly to a clinician without a prior history with that provider. A teleconsultation, in contrast, is an interaction between two doctors. In DTC, the episode of care is usually isolated from the patient’s record, and the information is not transferred to the primary care physician. Patients pay a fee, which can range from $1.59 to $250.

Advocates of DTC cite its low cost and extraordinary convenience as arguments for its adoption. However, these disconnected visits are notable exceptions to the current trend toward better care coordination and information sharing among providers.

Quality is also a concern. Although consumers were often promised answers from board-certified physicians, the JAMA Dermatology study was unable to verify this in many cases. The researchers also found that nondermatologists, physician extenders, and physicians practicing in India were often the providers, facts that were not obvious to users.

Worse, the study found both the quality of the diagnoses and the recommendations were poor. All the providers missed the cases of syphilis and most missed eczema herpeticum. Risks of prescription medications were not disclosed two-thirds of the time. Worse yet, three services mistakenly advised that a nodular melanoma did not need further treatment. Had these been real patients, such wrongful recommendations could have resulted in deaths.

In an effort to ensure safety and reliability for consumers, the American Telemedicine Association has begun credentialing telemedicine providers. Such credentials are not required, however, and consumers are likely to be unaware of which providers have or have not met this standard. The American Academy of Dermatology addresses DTC teledermatology in its position statement, updated in 2016: “Dermatologists providing direct-to-patient teledermatology must make every effort to collect accurate, complete, and quality clinical information. When appropriate, the dermatologist may wish to contact the primary care providers or other specialists to obtain additional corroborating information.”

Currently, patients remain on their own in choosing telemedicine and other digital health services: caveat emptor. Do they want quality and convenient care? For now, it seems, they must pick only one.

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego. He is @Dermdoc on Twitter. Write to him at [email protected].

A 35-year-old male with a 5-year-history of a changing mole on his back sends a picture of the lesion to a telemedicine website for advice. The photo reveals a black nodule. The clinician replies, advising the patient that the lesion is benign.

To most dermatologists, the above scenario would occur only in a bizarre nightmare, never in real life. In real life, if the words “black” and “nodule” are used to describe a lesion, they are followed by the verb “biopsy.” Most dermatologists would recognize this as a high-risk growth and recommend additional investigation.

 

Dr. Jeffrey Benabio

Unfortunately, a recent study of direct-to-consumer (DTC) telemedicine in JAMA Dermatology showed that 21% of the time, the patient was wrongfully reassured that a lesion was benign (JAMA Dermatol. 2016;152[7]:768-75). The study examined how 16 DTC telemedicine websites and apps handled six standardized dermatology cases designed to test the quality of the services. While some provided good care, others missed important diagnoses such as syphilis, eczema herpeticum, and melanoma. If these cases had been actual patients, the consequences for such mistakes could have been dire.

“The services failed to ask simple, relevant questions of patients about their symptoms, leading them to repeatedly miss important diagnoses,” Jack Resneck Jr., MD, a dermatologist at the University of California, San Francisco, and lead author of the study, told the Wall Street Journal.

The study is timely, as telemedicine is accelerating explosively. The low cost of connectivity, viable business models, and changing consumer behaviors are fueling its rocket growth. Startups in digital health and telemedicine have raised over $700 million already this year, indicating that there is more fuel to be burned and more money to be made.

DTC telemedicine describes the model when a patient sends photos directly to a clinician without a prior history with that provider. A teleconsultation, in contrast, is an interaction between two doctors. In DTC, the episode of care is usually isolated from the patient’s record, and the information is not transferred to the primary care physician. Patients pay a fee, which can range from $1.59 to $250.

Advocates of DTC cite its low cost and extraordinary convenience as arguments for its adoption. However, these disconnected visits are notable exceptions to the current trend toward better care coordination and information sharing among providers.

Quality is also a concern. Although consumers were often promised answers from board-certified physicians, the JAMA Dermatology study was unable to verify this in many cases. The researchers also found that nondermatologists, physician extenders, and physicians practicing in India were often the providers, facts that were not obvious to users.

Worse, the study found both the quality of the diagnoses and the recommendations were poor. All the providers missed the cases of syphilis and most missed eczema herpeticum. Risks of prescription medications were not disclosed two-thirds of the time. Worse yet, three services mistakenly advised that a nodular melanoma did not need further treatment. Had these been real patients, such wrongful recommendations could have resulted in deaths.

In an effort to ensure safety and reliability for consumers, the American Telemedicine Association has begun credentialing telemedicine providers. Such credentials are not required, however, and consumers are likely to be unaware of which providers have or have not met this standard. The American Academy of Dermatology addresses DTC teledermatology in its position statement, updated in 2016: “Dermatologists providing direct-to-patient teledermatology must make every effort to collect accurate, complete, and quality clinical information. When appropriate, the dermatologist may wish to contact the primary care providers or other specialists to obtain additional corroborating information.”

Currently, patients remain on their own in choosing telemedicine and other digital health services: caveat emptor. Do they want quality and convenient care? For now, it seems, they must pick only one.

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego. He is @Dermdoc on Twitter. Write to him at [email protected].

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Four factors raise risk of post-TAVR endocarditis

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Four factors – younger patient age, male sex, diabetes, and moderate to severe residual aortic regurgitation – are associated with a significantly increased risk of infective endocarditis after transcatheter aortic valve replacement, according to a report published online Sept. 13 in JAMA.

Until now, data pertaining to endocarditis following TAVR “have been limited to case reports and relatively small series with limited follow-up,” said Ander Regueiro, MD, of Laval University, Quebec City, and his associates.

They performed a retrospective analysis of data in a large international registry of TAVR cases to better characterize post-TAVR endocarditis.

Dr. Regueiro and his colleagues focused on 20,006 TAVR procedures done at 47 medical centers in Europe, North America, and South America during a 10-year period. The median time to symptom onset was 5.3 months after the procedure.

Infective endocarditis was definitively diagnosed in 250 of these cases. This incidence is similar to that reported for endocarditis following surgical aortic valve replacement, indicating that TAVR is no less predisposing to endocarditis despite being a less invasive approach.

The mean age of patients who developed post-TAVR endocarditis was 78.9 years, compared with 81.8 years for those who did not (HR, 0.97). The reason for this association is unclear, but it is possible that younger patients chosen for TAVR because of their prohibitive surgical risk carry a higher burden of comorbidity than do older patients. Similarly, 62% of endocarditis cases arose in men (HR, 1.69), and sex differences in comorbid conditions may explain the higher risk among men.

More patients who developed endocarditis had diabetes (41.7%), compared with those who did not develop endocarditis (30%), for an HR of 1.52. And patients who had moderate to severe residual aortic regurgitation after TAVR also were at much higher risk for endocarditis than were those who did not (HR, 2.05), the investigators noted (JAMA. 2016 Sep 13;316[10]:1083-92).

In contrast, factors that were not associated with endocarditis risk included chronic pulmonary disease, type of valve (self-expandable or balloon-expandable), and setting of the procedure (catheterization lab vs. operating room).

The bacteria that most commonly caused infective endocarditis were Enterococci species (24.6% of cases), Staphylococcus aureus (23.8%), and coagulase-negative staphylococci (16.8%). This should be taken into consideration when selecting antibiotics for prophylaxis before TAVR and when choosing empirical antibiotics for treatment while waiting for blood culture results, wrote Dr. Regueiro and his associates.

“This information may help clinicians identify patients at higher risk [for endocarditis] and aid in implementing appropriate preventive measures,” they noted.

This study was supported by a grant from the Alfonso Martin Escudero Foundation. Dr. Regueiro reported having no relevant financial disclosures; his associates reported ties to numerous industry sources.

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Four factors – younger patient age, male sex, diabetes, and moderate to severe residual aortic regurgitation – are associated with a significantly increased risk of infective endocarditis after transcatheter aortic valve replacement, according to a report published online Sept. 13 in JAMA.

Until now, data pertaining to endocarditis following TAVR “have been limited to case reports and relatively small series with limited follow-up,” said Ander Regueiro, MD, of Laval University, Quebec City, and his associates.

They performed a retrospective analysis of data in a large international registry of TAVR cases to better characterize post-TAVR endocarditis.

Dr. Regueiro and his colleagues focused on 20,006 TAVR procedures done at 47 medical centers in Europe, North America, and South America during a 10-year period. The median time to symptom onset was 5.3 months after the procedure.

Infective endocarditis was definitively diagnosed in 250 of these cases. This incidence is similar to that reported for endocarditis following surgical aortic valve replacement, indicating that TAVR is no less predisposing to endocarditis despite being a less invasive approach.

The mean age of patients who developed post-TAVR endocarditis was 78.9 years, compared with 81.8 years for those who did not (HR, 0.97). The reason for this association is unclear, but it is possible that younger patients chosen for TAVR because of their prohibitive surgical risk carry a higher burden of comorbidity than do older patients. Similarly, 62% of endocarditis cases arose in men (HR, 1.69), and sex differences in comorbid conditions may explain the higher risk among men.

More patients who developed endocarditis had diabetes (41.7%), compared with those who did not develop endocarditis (30%), for an HR of 1.52. And patients who had moderate to severe residual aortic regurgitation after TAVR also were at much higher risk for endocarditis than were those who did not (HR, 2.05), the investigators noted (JAMA. 2016 Sep 13;316[10]:1083-92).

In contrast, factors that were not associated with endocarditis risk included chronic pulmonary disease, type of valve (self-expandable or balloon-expandable), and setting of the procedure (catheterization lab vs. operating room).

The bacteria that most commonly caused infective endocarditis were Enterococci species (24.6% of cases), Staphylococcus aureus (23.8%), and coagulase-negative staphylococci (16.8%). This should be taken into consideration when selecting antibiotics for prophylaxis before TAVR and when choosing empirical antibiotics for treatment while waiting for blood culture results, wrote Dr. Regueiro and his associates.

“This information may help clinicians identify patients at higher risk [for endocarditis] and aid in implementing appropriate preventive measures,” they noted.

This study was supported by a grant from the Alfonso Martin Escudero Foundation. Dr. Regueiro reported having no relevant financial disclosures; his associates reported ties to numerous industry sources.

Four factors – younger patient age, male sex, diabetes, and moderate to severe residual aortic regurgitation – are associated with a significantly increased risk of infective endocarditis after transcatheter aortic valve replacement, according to a report published online Sept. 13 in JAMA.

Until now, data pertaining to endocarditis following TAVR “have been limited to case reports and relatively small series with limited follow-up,” said Ander Regueiro, MD, of Laval University, Quebec City, and his associates.

They performed a retrospective analysis of data in a large international registry of TAVR cases to better characterize post-TAVR endocarditis.

Dr. Regueiro and his colleagues focused on 20,006 TAVR procedures done at 47 medical centers in Europe, North America, and South America during a 10-year period. The median time to symptom onset was 5.3 months after the procedure.

Infective endocarditis was definitively diagnosed in 250 of these cases. This incidence is similar to that reported for endocarditis following surgical aortic valve replacement, indicating that TAVR is no less predisposing to endocarditis despite being a less invasive approach.

The mean age of patients who developed post-TAVR endocarditis was 78.9 years, compared with 81.8 years for those who did not (HR, 0.97). The reason for this association is unclear, but it is possible that younger patients chosen for TAVR because of their prohibitive surgical risk carry a higher burden of comorbidity than do older patients. Similarly, 62% of endocarditis cases arose in men (HR, 1.69), and sex differences in comorbid conditions may explain the higher risk among men.

More patients who developed endocarditis had diabetes (41.7%), compared with those who did not develop endocarditis (30%), for an HR of 1.52. And patients who had moderate to severe residual aortic regurgitation after TAVR also were at much higher risk for endocarditis than were those who did not (HR, 2.05), the investigators noted (JAMA. 2016 Sep 13;316[10]:1083-92).

In contrast, factors that were not associated with endocarditis risk included chronic pulmonary disease, type of valve (self-expandable or balloon-expandable), and setting of the procedure (catheterization lab vs. operating room).

The bacteria that most commonly caused infective endocarditis were Enterococci species (24.6% of cases), Staphylococcus aureus (23.8%), and coagulase-negative staphylococci (16.8%). This should be taken into consideration when selecting antibiotics for prophylaxis before TAVR and when choosing empirical antibiotics for treatment while waiting for blood culture results, wrote Dr. Regueiro and his associates.

“This information may help clinicians identify patients at higher risk [for endocarditis] and aid in implementing appropriate preventive measures,” they noted.

This study was supported by a grant from the Alfonso Martin Escudero Foundation. Dr. Regueiro reported having no relevant financial disclosures; his associates reported ties to numerous industry sources.

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Key clinical point: Four factors raise the risk that patients undergoing transcatheter aortic valve replacement will develop infective endocarditis.

Major finding: The mean age of patients who developed post-TAVR endocarditis was 78.9 years, compared with 81.8 years for those who didn’t (HR, 0.97).

Data source: A retrospective analysis of data in an international registry involving 20,006 patients who underwent TAVR at 47 medical centers during a 10-year period.

Disclosures: This study was supported by a grant from the Alfonso Martin Escudero Foundation. Dr. Regueiro reported having no relevant financial disclosures; his associates reported ties to numerous industry sources.

Is It All in the Eye of the Beholder? Comparing Pulmonologists’ and Radiologists’ Performance

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Experienced pulmonologists and radiologists were equally accurate in diagnosing malignant lung nodules and lung masses seen on low-dose computed tomography scans.

Lung cancer remains a leading cause of cancer-related deaths, and screening with low-dose computed tomography (LDCT) has the potential to decrease the mortality rate of patients by 20%.1 Most major cancer societies have issued lung cancer screening recommendations. For example, the National Comprehensive Cancer Network recommends annual LDCT scans for high-risk patients (those at moderate or low risk need not be screened). High-risk patients are aged between 55 and 74 years (the U.S. Preventive Services Task Force upper age limit is 80 years) and have a smoking history of ≥ 30 pack-years, or if no longer smoking, a quit date within the past 15 years. Although length of screening needed is unclear, it is advised that patients have annual LDCT scans until they have been smoke free for 15 years, develop limited life expectancy, or are no longer eligible for definitive treatment for lung cancer. A strong antismoking commitment and a multidisciplinary approach are of paramount importance.2,3

Fleischner Society criteria are the most established guidelines for risk-stratifying pulmonary nodules (Table 1). Nodules are stratified by size and change in size over a 2-year period. There is interest in evaluating change in volume as well, but techniques are still emerging and have not been universally adopted.4,5

Lung nodule screening likely will require significant involvement of radiologists and pulmonologists in the workup of patients with positive screens. Radiologists have demonstrated a fair amount of interobserver agreement with respect to diagnosis, but there are no data comparing pulmonologists with other pulmonologists or with radiologists.6-8 In addition, although health care professionals have access to validated models for predicting risk of malignancy, there is evidence they do not use them.9,10 This study was conducted to determine whether pulmonologists and radiologists experienced in thoracic abnormalities are consistent in accurately diagnosing malignant lung nodules and masses noted on CT scans.

 

Methods

After obtaining institutional review board approval for this study, the authors evaluated all the lung nodule or lung mass referrals that had been made to the University of Arkansas for Medical Sciences (UAMS) and Central Arkansas Veterans Healthcare System (CAVHS) interventional pulmonary clinics between March 2009 and March 2013. Of the 1,512 referrals made, 250 were randomly selected for noncontrasted CT image review and data collection. Each CT image was de-identified and then reviewed by a pulmonologist and a radiologist. The study used 4 reviewers—2 board-certified pulmonologists and 2 board-certified radiologists—all with > 3 years of experience. Both radiologists were thoracic specialists, and no residents or fellows participated. For each case, reviewers were given a brief patient history outlining smoking and other malignancies. Data collected included age, sex, race, exposure to cigarette smoking, and the gold standard of final diagnosis (FD).

In each case, a pulmonologist and a radiologist reviewed the patient’s CT images from the first visit. Reviewers were asked to determine and document the single most likely diagnosis. Diagnoses were grouped into primary lung cancer, metastatic disease, lymphoma, infectious/inflammatory etiology, benign neoplasm, and other (eg, sarcoma). A lesion with a diagnostic biopsy and stability at 2 years was deemed benign. A lesion that was culture-positive or responded rapidly to antibacterial or antifungal therapy was deemed infectious/inflammatory. Lesions were grouped by size: group 1 (≤ 10 mm), group 2 (11-30 mm), group 3 (31-50 mm), group 4 (≥ 51 mm).

Statistical Analyses

Student t tests were used to compare means. Concordance of the pulmonary reviewers and FD was assessed with the κ coefficient. The concordance was also evaluated between the radiology reviewers and FD. These statistical analyses were performed with SAS Version 9.4 (SAS Institute). P values were interpreted using the sliding-scale approach of Mendenhall and colleagues: P < .01 (highly significant); .01 < P < .05 (statistically significant); .05 < P < .10 (trending toward significance); P > .10 (not significant).11

Results

Of the 250 patients selected for the study, 111 had the pertinent data available, along with a follow-up appointment > 2 years afterward at the center. The patients included 40 women and 71 men; 79 white patients, 29 black patients, and 3 patients of other races. Mean age was 58 years (range, 21-93 years).

Risk factors for malignancy were older age, larger lesion, and history of smoking. The malignancy rates for women and men were almost identical (53% and 54%, respectively), and the difference was not statistically significant (P = .40).

Diagnosis

Table 2 outlines the distribution of the reviewers’ diagnoses and the distribution of FD. Primary lung cancer was the dominant suspected diagnosis and accounted for 61%, 65%, and 54% of the cases reviewed by the pulmonologist, the radiologist, and FD, respectively. Metastatic disease was a distant second dominant diagnosis (17%, 15%, and 15%, respectively). There was no statistical difference between the reviews of the pulmonologist and radiologist, and the FD (P > .05).

 

 

Table 3 lists the κ results for the strength of agreement between pulmonologist and radiologist. Agreement for primary lung cancer was very good: 0.94 (95% confidence interval [CI], 0.89-0.99). With respect to group 1, agreement was perfect: 1.0 (95% CI, 1.000-1.000). Benign neoplasm had the weakest agreement. There was no statistical difference between pulmonologist and radiologist determinations across size-based groups.Agreement between pulmonologist and FD was almost perfect. The major discrepancy between the sets of reviewers remained benign neoplasm and infectious/inflammatory etiology.

Of the 111 study patients, 68 (61%) and 72 (65%) were suspected of having primary lung cancer by pulmonologist and radiologist, respectively. However, only 60 (54%) actually had primary lung cancer; the differences were not statistically significant (P = .27 and .1, respectively). No cases were reclassified as primary lung cancer on final pathology.

Infectious/inflammatory etiologies did not always have positive cultures. Those with positive cultures included Streptococcus (S) viridans, Rhodococcus equi, Blastomyces dermatitidis, S constellatus, S anginosus, S intermedius, and Histoplasma capsulatum. Benign neoplasms included radiation injuries, benign fibrous tumor of the pleura, and hamartoma.

Pulmonologists and radiologists had identical high sensitivities for primary lung cancer: 1.0 (95% CI, 0.94-1.00). Specificities were 0.84 (95% CI, 0.77-0.84) for pulmonologists and 0.77(95% CI, 0.69-0.77) for radiologists, and the difference was not statistically significant (P = .28) (Table 4).

Discussion

Computed tomography scans are performed to evaluate a variety of diseases. An estimated 7 million CT scans are performed in the U.S. annually.6,12 As the National Lung Screening Trial recommendations are followed more routinely, almost 9 million peoplecould become candidates, adding to the already large number of CTscans to be evaluated.13

Radiologists would understandably read most of these patients’ scans. However, patients referred to tertiary-care centers usually bring CT images with them; even scans performed at UAMS and CAVHS centers may not be read by a radiologist in time for an appointment. The result is that the clinic pulmonologist often must base decisions on a CT reading, but without the assistance of high-fidelity computer programs or a high-definition scan.5 These limitations indicate why it is important to know whether assessment by a pulmonologist compares favorably with assessment by a radiologist and with the eventual diagnosis.

The malignancy rate in the referred population is not insignificant. Halbert and colleagues found a 25% malignancy rate in their study,12 and the present study had an overall malignancy rate of 54%. The difference may be attributed to the possibility that the patients may have been prescreened prior to referral.

The reviewers overestimated the presence of malignant disease, though not to a level of statistical significance. About 88% of cases evaluated by a pulmonologist and 83% of cases evaluated by a radiologist were confirmed to be malignant. The reviewers’ sensitivity was perfect for all diagnoses except benign neoplasms, likely because these cases were classified malignant, thus increasing sensitivity but decreasing specificity.

This dynamic is important to understand, as it allows for a very high negative predictive value, which has real implications for resource management at VA hospitals, including CAVHS facility, where almost every CT scan with an abnormality is referred for pulmonologist consultation. In these cases, the radiologist not only lists the likely suspicion but includes a recommendation for follow-up or further workup based on Fleischner Society guidelines.4,14 The patient should be informed of findings as soon as the radiologist reads the CT scan, and a plan should be made on the basis of the recommendation. The patient should not have to unnecessarily wait—a potential source of anxiety—to see another specialist who would probably make the same recommendation.

Applying this study’s findings could improve workflow and the timing of CT scans. A patient should not be referred to a pulmonologist unless specifically recommended by a radiologist, thus decreasing the scheduling burden on the specialty clinic and allowing for appropriate patients to be scheduled at reasonable intervals. In addition, having only 1 person in charge of ordering CT scans could reduce the chance of duplicating orders and performing CT scans at inappropriate times.

Most important, these results should lead to more detailed physician–patient discussions about radiologic findings, hopefully alleviating any patient anxiety. A patient who still wants to see a specialist may, but with less stress that can accompany being told that there is “something abnormal” on the imaging and that the patient needs to see a lung doctor.

Limitations

This study had a few weaknesses. It was a small trial, and its data were collected retrospectively. In addition, generalizing its results may be difficult, as its reviewers had less than 5 years of training, and reviewers with more experience likely would be more accurate and have a higher rate of agreement.

 

 

Results could have been skewed by the study’s unusually large number of patients with malignant disease. Had the study been conducted with a larger population (patients at primary care offices), accuracy and agreement might have been lower.

Conclusion

This study answered its 2 questions. Although it is universally accepted that pulmonologists can review patients’ scans, to the authors’ knowledge this is the first study that asked, “Are pulmonologists as good as radiologists in reading CT scans?” The answer is yes. Also asked was, “Do pulmonologists’ and radiologists’ diagnoses predict the final path?” The reviewers’ were very accurate except in the case of benign neoplasms.

Experienced pulmonologists and radiologists are consistent in accurately diagnosing malignant lung nodules and lung masses noted on CT scans.

References

1. National Lung Screening Trial Research Team, Aberle DR, Adams AM, Berg CD, et al. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011;365(5):395-409.

2. Wood DE. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Lung Cancer Screening. Thorac Surg Clin. 2015;25(2):185-197.

3. Humphrey LL, Deffebach M, Pappas M, et al. Screening for lung cancer with low-dose computed tomography: a systematic review to update the US Preventive Services task force recommendation. Ann Intern Med. 2013;159(6):411-420.

4. Naidich DP, Bankier AA, MacMahon H, et al. Recommendations for the management of subsolid pulmonary nodules detected at CT: a statement from the Fleischner Society. Radiology. 2013;266(1):304-317.

5. Mehta HJ, Ravenel JG, Shaftman SR, et al. The utility of nodule volume in the context of malignancy prediction for small pulmonary nodules. Chest. 2014;145(3):464-472.

6. Gierada DS, Pilgram TK, Ford M, et al. Lung cancer: interobserver agreement on interpretation of pulmonary findings at low-dose CT screening. Radiology. 2008;246(1):265-272.

7. McCarville MB, Lederman HM, Santana VM, et al. Distinguishing benign from malignant pulmonary nodules with helical chest CT in children with malignant solid tumors. Radiology. 2006;239(2):514-520.

8. Bogot NR, Kazerooni EA, Kelly AM, Quint LE, Desjardins B, Nan B. Interobserver and intraobserver variability in the assessment of pulmonary nodule size on CT using film and computer display methods. Acad Radiol. 2005;12(8):948-956.

9. Schultz EM, Sanders GD, Trotter PR, et al. Validation of two models to estimate the probability of malignancy in patients with solitary pulmonary nodules. Thorax. 2008;63(4):335-341.

10. Tanner NT, Aggarwal J, Gould MK, et al. Management of pulmonary nodules by community pulmonologists: a multicenter observational study. Chest. 2015;148(6):1405-1414.

11. Mendenhall W, Beaver RJ, Beaver BM. Introduction to Probability and Statistics. 13th ed. Belmont, CA: Brooks/Cole, Cengage Learning; 2009.

12. Halbert CL, Madtes DK, Vaughan AE, et al. Expression of human alpha1-antitrypsin in mice and dogs following AAV6 vector-mediated gene transfer to the lungs. Mol Ther. 2010;18(6):1165-1172.

13. Ma J, Ward EM, Smith R, Jemal A. Annual number of lung cancer deaths potentially avertable by screening in the United States. Cancer. 2013;119(7):1381-1385.

14. MacMahon H, Austin JH, Gamsu G, et al; Fleischner Society. Guidelines for management of small pulmonary nodules detected on CT scans: a statement from the Fleischner Society. Radiology. 2005;237(2):395-400.

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The authors report no actual or potential conflicts of interest with regard to this article.

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The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

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Dr. Hammond is a clinical assistant professor in the department of pharmacology, and Dr. Meena is an assistant professor in the department of internal medicine, both at the University of Arkansas for Medical Sciences in Little Rock. Dr. Meena also is a physician at Central Arkansas Veterans Healthcare System in Little Rock.

Author disclosures

The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Author and Disclosure Information

Dr. Hammond is a clinical assistant professor in the department of pharmacology, and Dr. Meena is an assistant professor in the department of internal medicine, both at the University of Arkansas for Medical Sciences in Little Rock. Dr. Meena also is a physician at Central Arkansas Veterans Healthcare System in Little Rock.

Author disclosures

The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

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Related Articles
Experienced pulmonologists and radiologists were equally accurate in diagnosing malignant lung nodules and lung masses seen on low-dose computed tomography scans.
Experienced pulmonologists and radiologists were equally accurate in diagnosing malignant lung nodules and lung masses seen on low-dose computed tomography scans.

Lung cancer remains a leading cause of cancer-related deaths, and screening with low-dose computed tomography (LDCT) has the potential to decrease the mortality rate of patients by 20%.1 Most major cancer societies have issued lung cancer screening recommendations. For example, the National Comprehensive Cancer Network recommends annual LDCT scans for high-risk patients (those at moderate or low risk need not be screened). High-risk patients are aged between 55 and 74 years (the U.S. Preventive Services Task Force upper age limit is 80 years) and have a smoking history of ≥ 30 pack-years, or if no longer smoking, a quit date within the past 15 years. Although length of screening needed is unclear, it is advised that patients have annual LDCT scans until they have been smoke free for 15 years, develop limited life expectancy, or are no longer eligible for definitive treatment for lung cancer. A strong antismoking commitment and a multidisciplinary approach are of paramount importance.2,3

Fleischner Society criteria are the most established guidelines for risk-stratifying pulmonary nodules (Table 1). Nodules are stratified by size and change in size over a 2-year period. There is interest in evaluating change in volume as well, but techniques are still emerging and have not been universally adopted.4,5

Lung nodule screening likely will require significant involvement of radiologists and pulmonologists in the workup of patients with positive screens. Radiologists have demonstrated a fair amount of interobserver agreement with respect to diagnosis, but there are no data comparing pulmonologists with other pulmonologists or with radiologists.6-8 In addition, although health care professionals have access to validated models for predicting risk of malignancy, there is evidence they do not use them.9,10 This study was conducted to determine whether pulmonologists and radiologists experienced in thoracic abnormalities are consistent in accurately diagnosing malignant lung nodules and masses noted on CT scans.

 

Methods

After obtaining institutional review board approval for this study, the authors evaluated all the lung nodule or lung mass referrals that had been made to the University of Arkansas for Medical Sciences (UAMS) and Central Arkansas Veterans Healthcare System (CAVHS) interventional pulmonary clinics between March 2009 and March 2013. Of the 1,512 referrals made, 250 were randomly selected for noncontrasted CT image review and data collection. Each CT image was de-identified and then reviewed by a pulmonologist and a radiologist. The study used 4 reviewers—2 board-certified pulmonologists and 2 board-certified radiologists—all with > 3 years of experience. Both radiologists were thoracic specialists, and no residents or fellows participated. For each case, reviewers were given a brief patient history outlining smoking and other malignancies. Data collected included age, sex, race, exposure to cigarette smoking, and the gold standard of final diagnosis (FD).

In each case, a pulmonologist and a radiologist reviewed the patient’s CT images from the first visit. Reviewers were asked to determine and document the single most likely diagnosis. Diagnoses were grouped into primary lung cancer, metastatic disease, lymphoma, infectious/inflammatory etiology, benign neoplasm, and other (eg, sarcoma). A lesion with a diagnostic biopsy and stability at 2 years was deemed benign. A lesion that was culture-positive or responded rapidly to antibacterial or antifungal therapy was deemed infectious/inflammatory. Lesions were grouped by size: group 1 (≤ 10 mm), group 2 (11-30 mm), group 3 (31-50 mm), group 4 (≥ 51 mm).

Statistical Analyses

Student t tests were used to compare means. Concordance of the pulmonary reviewers and FD was assessed with the κ coefficient. The concordance was also evaluated between the radiology reviewers and FD. These statistical analyses were performed with SAS Version 9.4 (SAS Institute). P values were interpreted using the sliding-scale approach of Mendenhall and colleagues: P < .01 (highly significant); .01 < P < .05 (statistically significant); .05 < P < .10 (trending toward significance); P > .10 (not significant).11

Results

Of the 250 patients selected for the study, 111 had the pertinent data available, along with a follow-up appointment > 2 years afterward at the center. The patients included 40 women and 71 men; 79 white patients, 29 black patients, and 3 patients of other races. Mean age was 58 years (range, 21-93 years).

Risk factors for malignancy were older age, larger lesion, and history of smoking. The malignancy rates for women and men were almost identical (53% and 54%, respectively), and the difference was not statistically significant (P = .40).

Diagnosis

Table 2 outlines the distribution of the reviewers’ diagnoses and the distribution of FD. Primary lung cancer was the dominant suspected diagnosis and accounted for 61%, 65%, and 54% of the cases reviewed by the pulmonologist, the radiologist, and FD, respectively. Metastatic disease was a distant second dominant diagnosis (17%, 15%, and 15%, respectively). There was no statistical difference between the reviews of the pulmonologist and radiologist, and the FD (P > .05).

 

 

Table 3 lists the κ results for the strength of agreement between pulmonologist and radiologist. Agreement for primary lung cancer was very good: 0.94 (95% confidence interval [CI], 0.89-0.99). With respect to group 1, agreement was perfect: 1.0 (95% CI, 1.000-1.000). Benign neoplasm had the weakest agreement. There was no statistical difference between pulmonologist and radiologist determinations across size-based groups.Agreement between pulmonologist and FD was almost perfect. The major discrepancy between the sets of reviewers remained benign neoplasm and infectious/inflammatory etiology.

Of the 111 study patients, 68 (61%) and 72 (65%) were suspected of having primary lung cancer by pulmonologist and radiologist, respectively. However, only 60 (54%) actually had primary lung cancer; the differences were not statistically significant (P = .27 and .1, respectively). No cases were reclassified as primary lung cancer on final pathology.

Infectious/inflammatory etiologies did not always have positive cultures. Those with positive cultures included Streptococcus (S) viridans, Rhodococcus equi, Blastomyces dermatitidis, S constellatus, S anginosus, S intermedius, and Histoplasma capsulatum. Benign neoplasms included radiation injuries, benign fibrous tumor of the pleura, and hamartoma.

Pulmonologists and radiologists had identical high sensitivities for primary lung cancer: 1.0 (95% CI, 0.94-1.00). Specificities were 0.84 (95% CI, 0.77-0.84) for pulmonologists and 0.77(95% CI, 0.69-0.77) for radiologists, and the difference was not statistically significant (P = .28) (Table 4).

Discussion

Computed tomography scans are performed to evaluate a variety of diseases. An estimated 7 million CT scans are performed in the U.S. annually.6,12 As the National Lung Screening Trial recommendations are followed more routinely, almost 9 million peoplecould become candidates, adding to the already large number of CTscans to be evaluated.13

Radiologists would understandably read most of these patients’ scans. However, patients referred to tertiary-care centers usually bring CT images with them; even scans performed at UAMS and CAVHS centers may not be read by a radiologist in time for an appointment. The result is that the clinic pulmonologist often must base decisions on a CT reading, but without the assistance of high-fidelity computer programs or a high-definition scan.5 These limitations indicate why it is important to know whether assessment by a pulmonologist compares favorably with assessment by a radiologist and with the eventual diagnosis.

The malignancy rate in the referred population is not insignificant. Halbert and colleagues found a 25% malignancy rate in their study,12 and the present study had an overall malignancy rate of 54%. The difference may be attributed to the possibility that the patients may have been prescreened prior to referral.

The reviewers overestimated the presence of malignant disease, though not to a level of statistical significance. About 88% of cases evaluated by a pulmonologist and 83% of cases evaluated by a radiologist were confirmed to be malignant. The reviewers’ sensitivity was perfect for all diagnoses except benign neoplasms, likely because these cases were classified malignant, thus increasing sensitivity but decreasing specificity.

This dynamic is important to understand, as it allows for a very high negative predictive value, which has real implications for resource management at VA hospitals, including CAVHS facility, where almost every CT scan with an abnormality is referred for pulmonologist consultation. In these cases, the radiologist not only lists the likely suspicion but includes a recommendation for follow-up or further workup based on Fleischner Society guidelines.4,14 The patient should be informed of findings as soon as the radiologist reads the CT scan, and a plan should be made on the basis of the recommendation. The patient should not have to unnecessarily wait—a potential source of anxiety—to see another specialist who would probably make the same recommendation.

Applying this study’s findings could improve workflow and the timing of CT scans. A patient should not be referred to a pulmonologist unless specifically recommended by a radiologist, thus decreasing the scheduling burden on the specialty clinic and allowing for appropriate patients to be scheduled at reasonable intervals. In addition, having only 1 person in charge of ordering CT scans could reduce the chance of duplicating orders and performing CT scans at inappropriate times.

Most important, these results should lead to more detailed physician–patient discussions about radiologic findings, hopefully alleviating any patient anxiety. A patient who still wants to see a specialist may, but with less stress that can accompany being told that there is “something abnormal” on the imaging and that the patient needs to see a lung doctor.

Limitations

This study had a few weaknesses. It was a small trial, and its data were collected retrospectively. In addition, generalizing its results may be difficult, as its reviewers had less than 5 years of training, and reviewers with more experience likely would be more accurate and have a higher rate of agreement.

 

 

Results could have been skewed by the study’s unusually large number of patients with malignant disease. Had the study been conducted with a larger population (patients at primary care offices), accuracy and agreement might have been lower.

Conclusion

This study answered its 2 questions. Although it is universally accepted that pulmonologists can review patients’ scans, to the authors’ knowledge this is the first study that asked, “Are pulmonologists as good as radiologists in reading CT scans?” The answer is yes. Also asked was, “Do pulmonologists’ and radiologists’ diagnoses predict the final path?” The reviewers’ were very accurate except in the case of benign neoplasms.

Experienced pulmonologists and radiologists are consistent in accurately diagnosing malignant lung nodules and lung masses noted on CT scans.

Lung cancer remains a leading cause of cancer-related deaths, and screening with low-dose computed tomography (LDCT) has the potential to decrease the mortality rate of patients by 20%.1 Most major cancer societies have issued lung cancer screening recommendations. For example, the National Comprehensive Cancer Network recommends annual LDCT scans for high-risk patients (those at moderate or low risk need not be screened). High-risk patients are aged between 55 and 74 years (the U.S. Preventive Services Task Force upper age limit is 80 years) and have a smoking history of ≥ 30 pack-years, or if no longer smoking, a quit date within the past 15 years. Although length of screening needed is unclear, it is advised that patients have annual LDCT scans until they have been smoke free for 15 years, develop limited life expectancy, or are no longer eligible for definitive treatment for lung cancer. A strong antismoking commitment and a multidisciplinary approach are of paramount importance.2,3

Fleischner Society criteria are the most established guidelines for risk-stratifying pulmonary nodules (Table 1). Nodules are stratified by size and change in size over a 2-year period. There is interest in evaluating change in volume as well, but techniques are still emerging and have not been universally adopted.4,5

Lung nodule screening likely will require significant involvement of radiologists and pulmonologists in the workup of patients with positive screens. Radiologists have demonstrated a fair amount of interobserver agreement with respect to diagnosis, but there are no data comparing pulmonologists with other pulmonologists or with radiologists.6-8 In addition, although health care professionals have access to validated models for predicting risk of malignancy, there is evidence they do not use them.9,10 This study was conducted to determine whether pulmonologists and radiologists experienced in thoracic abnormalities are consistent in accurately diagnosing malignant lung nodules and masses noted on CT scans.

 

Methods

After obtaining institutional review board approval for this study, the authors evaluated all the lung nodule or lung mass referrals that had been made to the University of Arkansas for Medical Sciences (UAMS) and Central Arkansas Veterans Healthcare System (CAVHS) interventional pulmonary clinics between March 2009 and March 2013. Of the 1,512 referrals made, 250 were randomly selected for noncontrasted CT image review and data collection. Each CT image was de-identified and then reviewed by a pulmonologist and a radiologist. The study used 4 reviewers—2 board-certified pulmonologists and 2 board-certified radiologists—all with > 3 years of experience. Both radiologists were thoracic specialists, and no residents or fellows participated. For each case, reviewers were given a brief patient history outlining smoking and other malignancies. Data collected included age, sex, race, exposure to cigarette smoking, and the gold standard of final diagnosis (FD).

In each case, a pulmonologist and a radiologist reviewed the patient’s CT images from the first visit. Reviewers were asked to determine and document the single most likely diagnosis. Diagnoses were grouped into primary lung cancer, metastatic disease, lymphoma, infectious/inflammatory etiology, benign neoplasm, and other (eg, sarcoma). A lesion with a diagnostic biopsy and stability at 2 years was deemed benign. A lesion that was culture-positive or responded rapidly to antibacterial or antifungal therapy was deemed infectious/inflammatory. Lesions were grouped by size: group 1 (≤ 10 mm), group 2 (11-30 mm), group 3 (31-50 mm), group 4 (≥ 51 mm).

Statistical Analyses

Student t tests were used to compare means. Concordance of the pulmonary reviewers and FD was assessed with the κ coefficient. The concordance was also evaluated between the radiology reviewers and FD. These statistical analyses were performed with SAS Version 9.4 (SAS Institute). P values were interpreted using the sliding-scale approach of Mendenhall and colleagues: P < .01 (highly significant); .01 < P < .05 (statistically significant); .05 < P < .10 (trending toward significance); P > .10 (not significant).11

Results

Of the 250 patients selected for the study, 111 had the pertinent data available, along with a follow-up appointment > 2 years afterward at the center. The patients included 40 women and 71 men; 79 white patients, 29 black patients, and 3 patients of other races. Mean age was 58 years (range, 21-93 years).

Risk factors for malignancy were older age, larger lesion, and history of smoking. The malignancy rates for women and men were almost identical (53% and 54%, respectively), and the difference was not statistically significant (P = .40).

Diagnosis

Table 2 outlines the distribution of the reviewers’ diagnoses and the distribution of FD. Primary lung cancer was the dominant suspected diagnosis and accounted for 61%, 65%, and 54% of the cases reviewed by the pulmonologist, the radiologist, and FD, respectively. Metastatic disease was a distant second dominant diagnosis (17%, 15%, and 15%, respectively). There was no statistical difference between the reviews of the pulmonologist and radiologist, and the FD (P > .05).

 

 

Table 3 lists the κ results for the strength of agreement between pulmonologist and radiologist. Agreement for primary lung cancer was very good: 0.94 (95% confidence interval [CI], 0.89-0.99). With respect to group 1, agreement was perfect: 1.0 (95% CI, 1.000-1.000). Benign neoplasm had the weakest agreement. There was no statistical difference between pulmonologist and radiologist determinations across size-based groups.Agreement between pulmonologist and FD was almost perfect. The major discrepancy between the sets of reviewers remained benign neoplasm and infectious/inflammatory etiology.

Of the 111 study patients, 68 (61%) and 72 (65%) were suspected of having primary lung cancer by pulmonologist and radiologist, respectively. However, only 60 (54%) actually had primary lung cancer; the differences were not statistically significant (P = .27 and .1, respectively). No cases were reclassified as primary lung cancer on final pathology.

Infectious/inflammatory etiologies did not always have positive cultures. Those with positive cultures included Streptococcus (S) viridans, Rhodococcus equi, Blastomyces dermatitidis, S constellatus, S anginosus, S intermedius, and Histoplasma capsulatum. Benign neoplasms included radiation injuries, benign fibrous tumor of the pleura, and hamartoma.

Pulmonologists and radiologists had identical high sensitivities for primary lung cancer: 1.0 (95% CI, 0.94-1.00). Specificities were 0.84 (95% CI, 0.77-0.84) for pulmonologists and 0.77(95% CI, 0.69-0.77) for radiologists, and the difference was not statistically significant (P = .28) (Table 4).

Discussion

Computed tomography scans are performed to evaluate a variety of diseases. An estimated 7 million CT scans are performed in the U.S. annually.6,12 As the National Lung Screening Trial recommendations are followed more routinely, almost 9 million peoplecould become candidates, adding to the already large number of CTscans to be evaluated.13

Radiologists would understandably read most of these patients’ scans. However, patients referred to tertiary-care centers usually bring CT images with them; even scans performed at UAMS and CAVHS centers may not be read by a radiologist in time for an appointment. The result is that the clinic pulmonologist often must base decisions on a CT reading, but without the assistance of high-fidelity computer programs or a high-definition scan.5 These limitations indicate why it is important to know whether assessment by a pulmonologist compares favorably with assessment by a radiologist and with the eventual diagnosis.

The malignancy rate in the referred population is not insignificant. Halbert and colleagues found a 25% malignancy rate in their study,12 and the present study had an overall malignancy rate of 54%. The difference may be attributed to the possibility that the patients may have been prescreened prior to referral.

The reviewers overestimated the presence of malignant disease, though not to a level of statistical significance. About 88% of cases evaluated by a pulmonologist and 83% of cases evaluated by a radiologist were confirmed to be malignant. The reviewers’ sensitivity was perfect for all diagnoses except benign neoplasms, likely because these cases were classified malignant, thus increasing sensitivity but decreasing specificity.

This dynamic is important to understand, as it allows for a very high negative predictive value, which has real implications for resource management at VA hospitals, including CAVHS facility, where almost every CT scan with an abnormality is referred for pulmonologist consultation. In these cases, the radiologist not only lists the likely suspicion but includes a recommendation for follow-up or further workup based on Fleischner Society guidelines.4,14 The patient should be informed of findings as soon as the radiologist reads the CT scan, and a plan should be made on the basis of the recommendation. The patient should not have to unnecessarily wait—a potential source of anxiety—to see another specialist who would probably make the same recommendation.

Applying this study’s findings could improve workflow and the timing of CT scans. A patient should not be referred to a pulmonologist unless specifically recommended by a radiologist, thus decreasing the scheduling burden on the specialty clinic and allowing for appropriate patients to be scheduled at reasonable intervals. In addition, having only 1 person in charge of ordering CT scans could reduce the chance of duplicating orders and performing CT scans at inappropriate times.

Most important, these results should lead to more detailed physician–patient discussions about radiologic findings, hopefully alleviating any patient anxiety. A patient who still wants to see a specialist may, but with less stress that can accompany being told that there is “something abnormal” on the imaging and that the patient needs to see a lung doctor.

Limitations

This study had a few weaknesses. It was a small trial, and its data were collected retrospectively. In addition, generalizing its results may be difficult, as its reviewers had less than 5 years of training, and reviewers with more experience likely would be more accurate and have a higher rate of agreement.

 

 

Results could have been skewed by the study’s unusually large number of patients with malignant disease. Had the study been conducted with a larger population (patients at primary care offices), accuracy and agreement might have been lower.

Conclusion

This study answered its 2 questions. Although it is universally accepted that pulmonologists can review patients’ scans, to the authors’ knowledge this is the first study that asked, “Are pulmonologists as good as radiologists in reading CT scans?” The answer is yes. Also asked was, “Do pulmonologists’ and radiologists’ diagnoses predict the final path?” The reviewers’ were very accurate except in the case of benign neoplasms.

Experienced pulmonologists and radiologists are consistent in accurately diagnosing malignant lung nodules and lung masses noted on CT scans.

References

1. National Lung Screening Trial Research Team, Aberle DR, Adams AM, Berg CD, et al. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011;365(5):395-409.

2. Wood DE. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Lung Cancer Screening. Thorac Surg Clin. 2015;25(2):185-197.

3. Humphrey LL, Deffebach M, Pappas M, et al. Screening for lung cancer with low-dose computed tomography: a systematic review to update the US Preventive Services task force recommendation. Ann Intern Med. 2013;159(6):411-420.

4. Naidich DP, Bankier AA, MacMahon H, et al. Recommendations for the management of subsolid pulmonary nodules detected at CT: a statement from the Fleischner Society. Radiology. 2013;266(1):304-317.

5. Mehta HJ, Ravenel JG, Shaftman SR, et al. The utility of nodule volume in the context of malignancy prediction for small pulmonary nodules. Chest. 2014;145(3):464-472.

6. Gierada DS, Pilgram TK, Ford M, et al. Lung cancer: interobserver agreement on interpretation of pulmonary findings at low-dose CT screening. Radiology. 2008;246(1):265-272.

7. McCarville MB, Lederman HM, Santana VM, et al. Distinguishing benign from malignant pulmonary nodules with helical chest CT in children with malignant solid tumors. Radiology. 2006;239(2):514-520.

8. Bogot NR, Kazerooni EA, Kelly AM, Quint LE, Desjardins B, Nan B. Interobserver and intraobserver variability in the assessment of pulmonary nodule size on CT using film and computer display methods. Acad Radiol. 2005;12(8):948-956.

9. Schultz EM, Sanders GD, Trotter PR, et al. Validation of two models to estimate the probability of malignancy in patients with solitary pulmonary nodules. Thorax. 2008;63(4):335-341.

10. Tanner NT, Aggarwal J, Gould MK, et al. Management of pulmonary nodules by community pulmonologists: a multicenter observational study. Chest. 2015;148(6):1405-1414.

11. Mendenhall W, Beaver RJ, Beaver BM. Introduction to Probability and Statistics. 13th ed. Belmont, CA: Brooks/Cole, Cengage Learning; 2009.

12. Halbert CL, Madtes DK, Vaughan AE, et al. Expression of human alpha1-antitrypsin in mice and dogs following AAV6 vector-mediated gene transfer to the lungs. Mol Ther. 2010;18(6):1165-1172.

13. Ma J, Ward EM, Smith R, Jemal A. Annual number of lung cancer deaths potentially avertable by screening in the United States. Cancer. 2013;119(7):1381-1385.

14. MacMahon H, Austin JH, Gamsu G, et al; Fleischner Society. Guidelines for management of small pulmonary nodules detected on CT scans: a statement from the Fleischner Society. Radiology. 2005;237(2):395-400.

References

1. National Lung Screening Trial Research Team, Aberle DR, Adams AM, Berg CD, et al. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011;365(5):395-409.

2. Wood DE. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Lung Cancer Screening. Thorac Surg Clin. 2015;25(2):185-197.

3. Humphrey LL, Deffebach M, Pappas M, et al. Screening for lung cancer with low-dose computed tomography: a systematic review to update the US Preventive Services task force recommendation. Ann Intern Med. 2013;159(6):411-420.

4. Naidich DP, Bankier AA, MacMahon H, et al. Recommendations for the management of subsolid pulmonary nodules detected at CT: a statement from the Fleischner Society. Radiology. 2013;266(1):304-317.

5. Mehta HJ, Ravenel JG, Shaftman SR, et al. The utility of nodule volume in the context of malignancy prediction for small pulmonary nodules. Chest. 2014;145(3):464-472.

6. Gierada DS, Pilgram TK, Ford M, et al. Lung cancer: interobserver agreement on interpretation of pulmonary findings at low-dose CT screening. Radiology. 2008;246(1):265-272.

7. McCarville MB, Lederman HM, Santana VM, et al. Distinguishing benign from malignant pulmonary nodules with helical chest CT in children with malignant solid tumors. Radiology. 2006;239(2):514-520.

8. Bogot NR, Kazerooni EA, Kelly AM, Quint LE, Desjardins B, Nan B. Interobserver and intraobserver variability in the assessment of pulmonary nodule size on CT using film and computer display methods. Acad Radiol. 2005;12(8):948-956.

9. Schultz EM, Sanders GD, Trotter PR, et al. Validation of two models to estimate the probability of malignancy in patients with solitary pulmonary nodules. Thorax. 2008;63(4):335-341.

10. Tanner NT, Aggarwal J, Gould MK, et al. Management of pulmonary nodules by community pulmonologists: a multicenter observational study. Chest. 2015;148(6):1405-1414.

11. Mendenhall W, Beaver RJ, Beaver BM. Introduction to Probability and Statistics. 13th ed. Belmont, CA: Brooks/Cole, Cengage Learning; 2009.

12. Halbert CL, Madtes DK, Vaughan AE, et al. Expression of human alpha1-antitrypsin in mice and dogs following AAV6 vector-mediated gene transfer to the lungs. Mol Ther. 2010;18(6):1165-1172.

13. Ma J, Ward EM, Smith R, Jemal A. Annual number of lung cancer deaths potentially avertable by screening in the United States. Cancer. 2013;119(7):1381-1385.

14. MacMahon H, Austin JH, Gamsu G, et al; Fleischner Society. Guidelines for management of small pulmonary nodules detected on CT scans: a statement from the Fleischner Society. Radiology. 2005;237(2):395-400.

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Who’s the Best Candidate for Endovascular Treatment?

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Researchers find a better way to determine the need for endovascular surgery with new scanning technology.

Patients who have had ischemic strokes often receive endovascular treatment along with tissue plasminogen activator (T-PA) to break up clots in the brain, but bleeding is a serious risk. T-PA has a distinct window of effectiveness, but less is known about endovascular treatment. A new imaging method may help resolve that by identifying stroke patients who are not likely to benefit from endovascular surgery.

Related: Percutaneous Endovascular Treatment of Subclavian Steal Syndrome

Researchers from the National Institute of Neurological Disorders and Stroke, Bethesda, MD; Stanford University, Palo Alto, CA; University of Melbourne, Australia, collected brain scans from more than 100 patients before they underwent endovascular therapy, within 12 hours of the stroke. Using a new method of image processing, the researchers got detailed measurements on just how much a stroke disrupts the blood-brain barrier and combined those measurements with findings from the DEFUSE-2 study (Diffusion and Perfusion Imaging Evaluation for Understanding Stroke Evolution).

They found that large degrees of blood-brain barrier disruption were associated with severe bleeding following endovascular surgery. Extensive breakdown of the blood-brain barrier was associated with parenchymal hematoma, which 24 of the 100 patients in the study experienced. The study also showed a link between the location of blood-brain barrier damage and posttreatment bleeding.

Related: Standard vs Intensive Emergency Stroke Treatment

“The biggest impact of this research is that information from MRI scans routinely collected at a number of research hospitals and stroke centers can inform treating physicians on the risk of bleeding,” said one of the study authors, Richard Leigh, MD, a scientist with the National Institute of Neurological Disorders and Stroke.

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Researchers find a better way to determine the need for endovascular surgery with new scanning technology.
Researchers find a better way to determine the need for endovascular surgery with new scanning technology.

Patients who have had ischemic strokes often receive endovascular treatment along with tissue plasminogen activator (T-PA) to break up clots in the brain, but bleeding is a serious risk. T-PA has a distinct window of effectiveness, but less is known about endovascular treatment. A new imaging method may help resolve that by identifying stroke patients who are not likely to benefit from endovascular surgery.

Related: Percutaneous Endovascular Treatment of Subclavian Steal Syndrome

Researchers from the National Institute of Neurological Disorders and Stroke, Bethesda, MD; Stanford University, Palo Alto, CA; University of Melbourne, Australia, collected brain scans from more than 100 patients before they underwent endovascular therapy, within 12 hours of the stroke. Using a new method of image processing, the researchers got detailed measurements on just how much a stroke disrupts the blood-brain barrier and combined those measurements with findings from the DEFUSE-2 study (Diffusion and Perfusion Imaging Evaluation for Understanding Stroke Evolution).

They found that large degrees of blood-brain barrier disruption were associated with severe bleeding following endovascular surgery. Extensive breakdown of the blood-brain barrier was associated with parenchymal hematoma, which 24 of the 100 patients in the study experienced. The study also showed a link between the location of blood-brain barrier damage and posttreatment bleeding.

Related: Standard vs Intensive Emergency Stroke Treatment

“The biggest impact of this research is that information from MRI scans routinely collected at a number of research hospitals and stroke centers can inform treating physicians on the risk of bleeding,” said one of the study authors, Richard Leigh, MD, a scientist with the National Institute of Neurological Disorders and Stroke.

Patients who have had ischemic strokes often receive endovascular treatment along with tissue plasminogen activator (T-PA) to break up clots in the brain, but bleeding is a serious risk. T-PA has a distinct window of effectiveness, but less is known about endovascular treatment. A new imaging method may help resolve that by identifying stroke patients who are not likely to benefit from endovascular surgery.

Related: Percutaneous Endovascular Treatment of Subclavian Steal Syndrome

Researchers from the National Institute of Neurological Disorders and Stroke, Bethesda, MD; Stanford University, Palo Alto, CA; University of Melbourne, Australia, collected brain scans from more than 100 patients before they underwent endovascular therapy, within 12 hours of the stroke. Using a new method of image processing, the researchers got detailed measurements on just how much a stroke disrupts the blood-brain barrier and combined those measurements with findings from the DEFUSE-2 study (Diffusion and Perfusion Imaging Evaluation for Understanding Stroke Evolution).

They found that large degrees of blood-brain barrier disruption were associated with severe bleeding following endovascular surgery. Extensive breakdown of the blood-brain barrier was associated with parenchymal hematoma, which 24 of the 100 patients in the study experienced. The study also showed a link between the location of blood-brain barrier damage and posttreatment bleeding.

Related: Standard vs Intensive Emergency Stroke Treatment

“The biggest impact of this research is that information from MRI scans routinely collected at a number of research hospitals and stroke centers can inform treating physicians on the risk of bleeding,” said one of the study authors, Richard Leigh, MD, a scientist with the National Institute of Neurological Disorders and Stroke.

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The State of Hospital Medicine Is Strong

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The State of Hospital Medicine Is Strong

Editor's Note: Listen to Dr. Smith share more of his views on the State of Hospital Medicine report.

2016 is the “Year of the Hospitalist,” a sobriquet meant as a proud nod to the specialty’s maturation as a fixture in hospitals across the country. Hospital medicine is no longer the new kid on the block as it has assumed care for the vast majority of hospitalized patients nationwide.

One could understand then if the ever-rising salaries hospitalists have commanded for 20 years might have finally plateaued, particularly as tightening budgets have C-suite administrators looking to trim costs.

Think again.

Median compensation for adult hospitalists rose 10% to $278,746 from 2013 to 2015, according to data from the Medical Group Management Association (MGMA). The compensation data from MGMA are wrapped into the 2016 State of Hospital Medicine Report (SoHM), which published this month. That double-digit increase continues the steady climb of hospitalist pay, which is up 30% since 2010.

“Growth suggests that there is still a huge demand,” says Leslie Flores, MHA, a partner in Nelson Flores Hospital Medicine Consultants and a member of SHM’s Practice Analysis Committee. “The demand for hospitalists still exceeds the supply, and so recruiting hospitalists, particularly to nonurban areas, is really challenging and is requiring more money.”

The SoHM is a biennial partnership between SHM and MGMA that provides HM group leaders and rank-and-file hospitalists a litany of benchmarks for salaries, workloads, and everything that informs those two topics. Call it the specialty’s empirical roadmap.

“Often, compensation information relative to staffing information is proprietary, so hospitalists are in a position where they are dependent upon their hospital stakeholders to have access to this information, but they are also the same stakeholders with whom they negotiate their contracts,” says G. Randy Smith, MD, MS, FRCP(Edin), SFHM, an assistant professor in the Division of Hospital Medicine at Northwestern University Feinberg School of Medicine in Chicago and a member of SHM’s Practice Analysis Committee. “The State of Hospital Medicine report by SHM provides an opportunity for hospitalists to have an independent view of the compensation and workforce distribution factors that can impact negotiations with their hospital stakeholders. It’s a very powerful tool.”

Compensation Data

Rachel Lovins, MD, SFHM, CPE, voraciously reads every SoHM report because she uses its keynote compensation data to benchmark what she should pay her staff.

“I make a promise to my group,” says Dr. Lovins, chief of hospital medicine and vice chair of the Department of Medicine at Middlesex Hospital in Middletown, Conn. “I promise them that we will always be at or above what is standard for our areas. So for me, I have to look every time.”

Promises like that are getting more expensive to keep.

Hospitalists in the East region earn a median compensation of $245,977, up 3.1% from the $238,676 figure reported in 2014. But the East, where the bulk of the country’s population lives and where competition for hospitalists is typically lessened, is by far the lowest-paid region.

Hospitalists in the South continue to earn the most, with a median compensation of $301,833, up a whopping 16.9% from $258,020 from 2013. Hospitalists in the West earned a median of $275,658 (up 10.3% from $249,894), while Midwestern hospitalists saw a median compensation of $285,213 (up 8.9% from $261,868).

In addition to year-over-year growth, HM is also seeing outsized growth as compared with family medicine physicians, according to MGMA data. From 2011 to 2015, family medicine hospitalists saw an average compensation increase of 4.7%, bringing the average salary to $285,213. During the same period, family medicine physicians who are not hospitalists and don’t practice obstetrics saw an average annual compensation increase of only 3%, bringing the average salary to $230,456.

 

 

“The hospitalist can save the hospital considerable amounts of money because of their ability to better manage the patient and improve the quality of care at the same time,” says David Gans, MSHA, FACMPE, MGMA’s senior fellow of industry affairs. “Hospitals, they have recognized that, and therefore, there is considerable competition for recruiting and retaining hospitalists.”

To that end, 96.3% of HM groups (HMGs) received financial support in addition to their professional fee revenue. That’s up from 89% of HMGs that relied last year on their host hospitals. The median support is $157,535 per full-time employee (FTE), up just 1%. Correspondingly, SoHM reported 8.5% of HMGs received enough income from professional fee revenue to cover expenses, up from 6% two years ago.

Industry watchers predicted that, in two years, fee revenue would have to rise to offset hospitals’ inability to pay. The early returns seem to show that bearing out.

“We’re pretty close to that breaking point,” Flores says. “When we go around the country and do consulting work, we are hearing many more hospital leaders telling us, ‘We’re concerned about how much money this program is costing us, and we are getting to the point where we can’t afford it.’”

Productivity Stalls

While compensation continues to climb, productivity flattened out in this year’s report.

Median relative value units (RVUs) dipped slightly from the figure reported in 2014, to 4,252 from 4,297. But the tally is still ahead of 2012’s total of 4,159. Median collection-to-work RVUs also ticked down from 2014’s tally, to $50.29 from $51.50 in 2013.

Flores largely attributes the falling metrics of productivity to the evolution of HMGs that have standardized their scheduling to the point that most HMGs now offer vacation time.

“So the number of groups that are working 182 days is fewer, and we see a lot more groups that are working something like 168 days or 172 days,” she says. “And if a hospitalist works fewer shifts, even if they see the same number of patients per shift, they’re going to generate less productivity over the course of the year, so that’s part of it.”

Andrew White, MD, SFHM, director of the HM service at the University of Washington Medical Center in Seattle, says the report’s value is in avoiding a myopic approach to how HMGs operate. For example, RVUs are an important metric of productivity, but not all shifts should be expected to produce the same.

For example, it’d be valuable to use the report to see how hard your nocturnists are working compared with other sites, says Dr. White, also a member of the Practice Analysis Committee.

“The fundamental issue with working at night is that not everybody wants to do it, and so you have to recognize that it’s a pain to do and you have to either pay those people more, have them work less, or acknowledge that they’re going to be less productive,” he says. “We use the survey to assess all three of those things and then can work with our nocturnists to reach an agreement about a fair approach to their job structure that’s actually informed by national benchmarks. That process has helped us to pick, for example, how many nights per year they should work or what their salaries should look like compared to the day hospitalists.”

Dr. White says that because the report is comprehensive and includes broad participation, he’s able to use it as a benchmark to make hiring and service structure decisions.

“It also helps me to keep abreast of some trends that may be occurring in the broader workplace that we aren’t participating in but maybe should be or should be thinking about,” he says.

 

 

The report’s subsections are also critical for comparing one HMG to others, Dr. White says.

“Obviously, there is the aggregate data there to look at the average program,” he says. “But really as a hospitalist group leader, you want to know what are other programs like mine doing, and it allows you to drill down into that data.”

Survey Limitations

Any hospitalist worth their weight in scrubs knows that any medical study is only as good as its limitations. And while SoHM is a trove of valuable data information, Flores always cautions against taking data points as gospel.

“People should understand what the numbers are telling us, what goes into those numbers, and take them not with a grain of salt but take them for what they are,” she says.

For example, Flores says, look at productivity metrics per shift. Day shifts have traditionally driven that figure, and those shifts are typically busy. But night shifts have fewer patients and less productivity.

“So as more and more hospitals get 24-hour in-house coverage and have doctors working low-productivity night shifts, that [productivity] number might fall,” she says.

That sort of nuanced analysis of productivity can’t be found anywhere else, says Dr. Lovins.

These are “data that we don’t normally get from our administration,” she says, “information on things like staffing and patient loads, and how much more the director makes than the people that work for the director, and how much more nighttime people make than daytime people make. There is no other way for me to get that information, and it’s very important to make sure that our program is fair.”

Aside from fair, the data points are essential talking points as HMGs negotiate contracts and other arrangements with their administrators.

“It’s a reference point so that everybody feels like we’re using data from a national source that everyone can agree upon as fair,” says Dr. White.

In Dr. White’s case, he doesn’t have many local academic programs to benchmark against. And comparing to private, for-profit hospitals isn’t the proverbial apples-to-apples comparison. Having vetted regional and national figures for comparison is incredibly valuable, particularly since he doesn’t have to compile the data.

“If I had to go call all those group leaders and figure out what they were doing, it would be pretty exhausting,” he says.

Alternative Payment Models

Dr. Smith says that one area where the report will become even more valuable over the next few years is addressing alternative payment models (APMs). In particular, HM leaders say they’re excited about being drivers in one of the largest APMs: the Bundled Payments for Care Improvement (BCPI) initiative. In short, the program covers 48 defined episodes of care, including medical and surgical, that could begin three days prior to admission and stretch 30, 60, or 90 days post-discharge.

Dr. Smith thinks it’s still a bit too early to see from the report how APMs have affected compensation.

“We’re still relatively in the early days of bundled-payment models, so in that regard, the State of Hospital Medicine Report still represents very much a starting point with regard to where hospital medicine groups will find themselves as they start to encounter challenges,” he says.

Perhaps more important, Gans doesn’t expect that the maturation of APMs will result in decreased compensation for hospitalists.

“In a hospital environment where the hospital is being reimbursed a set amount for a complete hospital admission and follow-up care and potential readmissions, that is an episodic payment already,” he says. “Consequently, the incentive is there today to better manage the patient and to attain the care coordination and care management necessary for that patient to be discharged and not readmitted.”

 

 

In fact, the SHM/MGMA data tell him that the basic economic theory of supply and demand continues to drive hospitalist compensation even 20 years after the field was given its name. He says rising compensation, even as more practices look to hire nurse practitioners or physician assistants as less expensive alternatives, shows no sign of letting up.

“I think demand will continue to be there,” Gans adds. “There may be in the long run some lessening of demand for hospitalists, but I don’t see that for years.”


Richard Quinn is a freelance writer in New Jersey.

Is Burnout a Problem?

Image Credit: Shuttershock.com

Burnout has become a major concern across the healthcare spectrum, particularly in cognitive fields such as hospital medicine where physicians can work long days or weeks with little sleep and a lot of pressure.

But despite hospitalists branching into multiple new arenas over the past decade (surgical co-management and informatics, to name a few), burnout has never registered as a significant problem in SHM’s reports. In fact, the 2016 State of Hospital Medicine Report finds that the median turnover rate for physicians “only continues to decline year after year.”

The biennial report found a turnover rate of 6.9% for responding physicians who serve adults only. That’s down from 8% in 2014 and 14% in 2010.

Turnover rate, however, may not be the best measure of burnout levels, one hospitalist admits.

“It could be tempting to think that a decrease in turnover rates would equal to decreased burnout—it might also be that individuals could get so burnt out everywhere that they no longer see that leaving one hospital medicine group for another is a viable cure,” says G. Randy Smith, MD, MS, FRCP(Edin), SFHM, an assistant professor in the Division of Hospital Medicine at Northwestern University Feinberg School of Medicine in Chicago and a member of SHM’s Practice Analysis Committee.

Dr. Smith says SHM is actively trying to address burnout outside of the SoHM but that additional questions added to the report in future years could help home in on the phenomenon.

“There are other ways that burnout can manifest,” he adds. “There is concern that it can manifest in decreased patient satisfaction, in more sick leave, diagnostic error, and decreased ability to teach effectively in academic institutions. … Burnout can still very much remain an issue for a hospitalist group even if they see that their turnover rates are level relative to a regional or national average.”

Richard Quinn

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Editor's Note: Listen to Dr. Smith share more of his views on the State of Hospital Medicine report.

2016 is the “Year of the Hospitalist,” a sobriquet meant as a proud nod to the specialty’s maturation as a fixture in hospitals across the country. Hospital medicine is no longer the new kid on the block as it has assumed care for the vast majority of hospitalized patients nationwide.

One could understand then if the ever-rising salaries hospitalists have commanded for 20 years might have finally plateaued, particularly as tightening budgets have C-suite administrators looking to trim costs.

Think again.

Median compensation for adult hospitalists rose 10% to $278,746 from 2013 to 2015, according to data from the Medical Group Management Association (MGMA). The compensation data from MGMA are wrapped into the 2016 State of Hospital Medicine Report (SoHM), which published this month. That double-digit increase continues the steady climb of hospitalist pay, which is up 30% since 2010.

“Growth suggests that there is still a huge demand,” says Leslie Flores, MHA, a partner in Nelson Flores Hospital Medicine Consultants and a member of SHM’s Practice Analysis Committee. “The demand for hospitalists still exceeds the supply, and so recruiting hospitalists, particularly to nonurban areas, is really challenging and is requiring more money.”

The SoHM is a biennial partnership between SHM and MGMA that provides HM group leaders and rank-and-file hospitalists a litany of benchmarks for salaries, workloads, and everything that informs those two topics. Call it the specialty’s empirical roadmap.

“Often, compensation information relative to staffing information is proprietary, so hospitalists are in a position where they are dependent upon their hospital stakeholders to have access to this information, but they are also the same stakeholders with whom they negotiate their contracts,” says G. Randy Smith, MD, MS, FRCP(Edin), SFHM, an assistant professor in the Division of Hospital Medicine at Northwestern University Feinberg School of Medicine in Chicago and a member of SHM’s Practice Analysis Committee. “The State of Hospital Medicine report by SHM provides an opportunity for hospitalists to have an independent view of the compensation and workforce distribution factors that can impact negotiations with their hospital stakeholders. It’s a very powerful tool.”

Compensation Data

Rachel Lovins, MD, SFHM, CPE, voraciously reads every SoHM report because she uses its keynote compensation data to benchmark what she should pay her staff.

“I make a promise to my group,” says Dr. Lovins, chief of hospital medicine and vice chair of the Department of Medicine at Middlesex Hospital in Middletown, Conn. “I promise them that we will always be at or above what is standard for our areas. So for me, I have to look every time.”

Promises like that are getting more expensive to keep.

Hospitalists in the East region earn a median compensation of $245,977, up 3.1% from the $238,676 figure reported in 2014. But the East, where the bulk of the country’s population lives and where competition for hospitalists is typically lessened, is by far the lowest-paid region.

Hospitalists in the South continue to earn the most, with a median compensation of $301,833, up a whopping 16.9% from $258,020 from 2013. Hospitalists in the West earned a median of $275,658 (up 10.3% from $249,894), while Midwestern hospitalists saw a median compensation of $285,213 (up 8.9% from $261,868).

In addition to year-over-year growth, HM is also seeing outsized growth as compared with family medicine physicians, according to MGMA data. From 2011 to 2015, family medicine hospitalists saw an average compensation increase of 4.7%, bringing the average salary to $285,213. During the same period, family medicine physicians who are not hospitalists and don’t practice obstetrics saw an average annual compensation increase of only 3%, bringing the average salary to $230,456.

 

 

“The hospitalist can save the hospital considerable amounts of money because of their ability to better manage the patient and improve the quality of care at the same time,” says David Gans, MSHA, FACMPE, MGMA’s senior fellow of industry affairs. “Hospitals, they have recognized that, and therefore, there is considerable competition for recruiting and retaining hospitalists.”

To that end, 96.3% of HM groups (HMGs) received financial support in addition to their professional fee revenue. That’s up from 89% of HMGs that relied last year on their host hospitals. The median support is $157,535 per full-time employee (FTE), up just 1%. Correspondingly, SoHM reported 8.5% of HMGs received enough income from professional fee revenue to cover expenses, up from 6% two years ago.

Industry watchers predicted that, in two years, fee revenue would have to rise to offset hospitals’ inability to pay. The early returns seem to show that bearing out.

“We’re pretty close to that breaking point,” Flores says. “When we go around the country and do consulting work, we are hearing many more hospital leaders telling us, ‘We’re concerned about how much money this program is costing us, and we are getting to the point where we can’t afford it.’”

Productivity Stalls

While compensation continues to climb, productivity flattened out in this year’s report.

Median relative value units (RVUs) dipped slightly from the figure reported in 2014, to 4,252 from 4,297. But the tally is still ahead of 2012’s total of 4,159. Median collection-to-work RVUs also ticked down from 2014’s tally, to $50.29 from $51.50 in 2013.

Flores largely attributes the falling metrics of productivity to the evolution of HMGs that have standardized their scheduling to the point that most HMGs now offer vacation time.

“So the number of groups that are working 182 days is fewer, and we see a lot more groups that are working something like 168 days or 172 days,” she says. “And if a hospitalist works fewer shifts, even if they see the same number of patients per shift, they’re going to generate less productivity over the course of the year, so that’s part of it.”

Andrew White, MD, SFHM, director of the HM service at the University of Washington Medical Center in Seattle, says the report’s value is in avoiding a myopic approach to how HMGs operate. For example, RVUs are an important metric of productivity, but not all shifts should be expected to produce the same.

For example, it’d be valuable to use the report to see how hard your nocturnists are working compared with other sites, says Dr. White, also a member of the Practice Analysis Committee.

“The fundamental issue with working at night is that not everybody wants to do it, and so you have to recognize that it’s a pain to do and you have to either pay those people more, have them work less, or acknowledge that they’re going to be less productive,” he says. “We use the survey to assess all three of those things and then can work with our nocturnists to reach an agreement about a fair approach to their job structure that’s actually informed by national benchmarks. That process has helped us to pick, for example, how many nights per year they should work or what their salaries should look like compared to the day hospitalists.”

Dr. White says that because the report is comprehensive and includes broad participation, he’s able to use it as a benchmark to make hiring and service structure decisions.

“It also helps me to keep abreast of some trends that may be occurring in the broader workplace that we aren’t participating in but maybe should be or should be thinking about,” he says.

 

 

The report’s subsections are also critical for comparing one HMG to others, Dr. White says.

“Obviously, there is the aggregate data there to look at the average program,” he says. “But really as a hospitalist group leader, you want to know what are other programs like mine doing, and it allows you to drill down into that data.”

Survey Limitations

Any hospitalist worth their weight in scrubs knows that any medical study is only as good as its limitations. And while SoHM is a trove of valuable data information, Flores always cautions against taking data points as gospel.

“People should understand what the numbers are telling us, what goes into those numbers, and take them not with a grain of salt but take them for what they are,” she says.

For example, Flores says, look at productivity metrics per shift. Day shifts have traditionally driven that figure, and those shifts are typically busy. But night shifts have fewer patients and less productivity.

“So as more and more hospitals get 24-hour in-house coverage and have doctors working low-productivity night shifts, that [productivity] number might fall,” she says.

That sort of nuanced analysis of productivity can’t be found anywhere else, says Dr. Lovins.

These are “data that we don’t normally get from our administration,” she says, “information on things like staffing and patient loads, and how much more the director makes than the people that work for the director, and how much more nighttime people make than daytime people make. There is no other way for me to get that information, and it’s very important to make sure that our program is fair.”

Aside from fair, the data points are essential talking points as HMGs negotiate contracts and other arrangements with their administrators.

“It’s a reference point so that everybody feels like we’re using data from a national source that everyone can agree upon as fair,” says Dr. White.

In Dr. White’s case, he doesn’t have many local academic programs to benchmark against. And comparing to private, for-profit hospitals isn’t the proverbial apples-to-apples comparison. Having vetted regional and national figures for comparison is incredibly valuable, particularly since he doesn’t have to compile the data.

“If I had to go call all those group leaders and figure out what they were doing, it would be pretty exhausting,” he says.

Alternative Payment Models

Dr. Smith says that one area where the report will become even more valuable over the next few years is addressing alternative payment models (APMs). In particular, HM leaders say they’re excited about being drivers in one of the largest APMs: the Bundled Payments for Care Improvement (BCPI) initiative. In short, the program covers 48 defined episodes of care, including medical and surgical, that could begin three days prior to admission and stretch 30, 60, or 90 days post-discharge.

Dr. Smith thinks it’s still a bit too early to see from the report how APMs have affected compensation.

“We’re still relatively in the early days of bundled-payment models, so in that regard, the State of Hospital Medicine Report still represents very much a starting point with regard to where hospital medicine groups will find themselves as they start to encounter challenges,” he says.

Perhaps more important, Gans doesn’t expect that the maturation of APMs will result in decreased compensation for hospitalists.

“In a hospital environment where the hospital is being reimbursed a set amount for a complete hospital admission and follow-up care and potential readmissions, that is an episodic payment already,” he says. “Consequently, the incentive is there today to better manage the patient and to attain the care coordination and care management necessary for that patient to be discharged and not readmitted.”

 

 

In fact, the SHM/MGMA data tell him that the basic economic theory of supply and demand continues to drive hospitalist compensation even 20 years after the field was given its name. He says rising compensation, even as more practices look to hire nurse practitioners or physician assistants as less expensive alternatives, shows no sign of letting up.

“I think demand will continue to be there,” Gans adds. “There may be in the long run some lessening of demand for hospitalists, but I don’t see that for years.”


Richard Quinn is a freelance writer in New Jersey.

Is Burnout a Problem?

Image Credit: Shuttershock.com

Burnout has become a major concern across the healthcare spectrum, particularly in cognitive fields such as hospital medicine where physicians can work long days or weeks with little sleep and a lot of pressure.

But despite hospitalists branching into multiple new arenas over the past decade (surgical co-management and informatics, to name a few), burnout has never registered as a significant problem in SHM’s reports. In fact, the 2016 State of Hospital Medicine Report finds that the median turnover rate for physicians “only continues to decline year after year.”

The biennial report found a turnover rate of 6.9% for responding physicians who serve adults only. That’s down from 8% in 2014 and 14% in 2010.

Turnover rate, however, may not be the best measure of burnout levels, one hospitalist admits.

“It could be tempting to think that a decrease in turnover rates would equal to decreased burnout—it might also be that individuals could get so burnt out everywhere that they no longer see that leaving one hospital medicine group for another is a viable cure,” says G. Randy Smith, MD, MS, FRCP(Edin), SFHM, an assistant professor in the Division of Hospital Medicine at Northwestern University Feinberg School of Medicine in Chicago and a member of SHM’s Practice Analysis Committee.

Dr. Smith says SHM is actively trying to address burnout outside of the SoHM but that additional questions added to the report in future years could help home in on the phenomenon.

“There are other ways that burnout can manifest,” he adds. “There is concern that it can manifest in decreased patient satisfaction, in more sick leave, diagnostic error, and decreased ability to teach effectively in academic institutions. … Burnout can still very much remain an issue for a hospitalist group even if they see that their turnover rates are level relative to a regional or national average.”

Richard Quinn

Editor's Note: Listen to Dr. Smith share more of his views on the State of Hospital Medicine report.

2016 is the “Year of the Hospitalist,” a sobriquet meant as a proud nod to the specialty’s maturation as a fixture in hospitals across the country. Hospital medicine is no longer the new kid on the block as it has assumed care for the vast majority of hospitalized patients nationwide.

One could understand then if the ever-rising salaries hospitalists have commanded for 20 years might have finally plateaued, particularly as tightening budgets have C-suite administrators looking to trim costs.

Think again.

Median compensation for adult hospitalists rose 10% to $278,746 from 2013 to 2015, according to data from the Medical Group Management Association (MGMA). The compensation data from MGMA are wrapped into the 2016 State of Hospital Medicine Report (SoHM), which published this month. That double-digit increase continues the steady climb of hospitalist pay, which is up 30% since 2010.

“Growth suggests that there is still a huge demand,” says Leslie Flores, MHA, a partner in Nelson Flores Hospital Medicine Consultants and a member of SHM’s Practice Analysis Committee. “The demand for hospitalists still exceeds the supply, and so recruiting hospitalists, particularly to nonurban areas, is really challenging and is requiring more money.”

The SoHM is a biennial partnership between SHM and MGMA that provides HM group leaders and rank-and-file hospitalists a litany of benchmarks for salaries, workloads, and everything that informs those two topics. Call it the specialty’s empirical roadmap.

“Often, compensation information relative to staffing information is proprietary, so hospitalists are in a position where they are dependent upon their hospital stakeholders to have access to this information, but they are also the same stakeholders with whom they negotiate their contracts,” says G. Randy Smith, MD, MS, FRCP(Edin), SFHM, an assistant professor in the Division of Hospital Medicine at Northwestern University Feinberg School of Medicine in Chicago and a member of SHM’s Practice Analysis Committee. “The State of Hospital Medicine report by SHM provides an opportunity for hospitalists to have an independent view of the compensation and workforce distribution factors that can impact negotiations with their hospital stakeholders. It’s a very powerful tool.”

Compensation Data

Rachel Lovins, MD, SFHM, CPE, voraciously reads every SoHM report because she uses its keynote compensation data to benchmark what she should pay her staff.

“I make a promise to my group,” says Dr. Lovins, chief of hospital medicine and vice chair of the Department of Medicine at Middlesex Hospital in Middletown, Conn. “I promise them that we will always be at or above what is standard for our areas. So for me, I have to look every time.”

Promises like that are getting more expensive to keep.

Hospitalists in the East region earn a median compensation of $245,977, up 3.1% from the $238,676 figure reported in 2014. But the East, where the bulk of the country’s population lives and where competition for hospitalists is typically lessened, is by far the lowest-paid region.

Hospitalists in the South continue to earn the most, with a median compensation of $301,833, up a whopping 16.9% from $258,020 from 2013. Hospitalists in the West earned a median of $275,658 (up 10.3% from $249,894), while Midwestern hospitalists saw a median compensation of $285,213 (up 8.9% from $261,868).

In addition to year-over-year growth, HM is also seeing outsized growth as compared with family medicine physicians, according to MGMA data. From 2011 to 2015, family medicine hospitalists saw an average compensation increase of 4.7%, bringing the average salary to $285,213. During the same period, family medicine physicians who are not hospitalists and don’t practice obstetrics saw an average annual compensation increase of only 3%, bringing the average salary to $230,456.

 

 

“The hospitalist can save the hospital considerable amounts of money because of their ability to better manage the patient and improve the quality of care at the same time,” says David Gans, MSHA, FACMPE, MGMA’s senior fellow of industry affairs. “Hospitals, they have recognized that, and therefore, there is considerable competition for recruiting and retaining hospitalists.”

To that end, 96.3% of HM groups (HMGs) received financial support in addition to their professional fee revenue. That’s up from 89% of HMGs that relied last year on their host hospitals. The median support is $157,535 per full-time employee (FTE), up just 1%. Correspondingly, SoHM reported 8.5% of HMGs received enough income from professional fee revenue to cover expenses, up from 6% two years ago.

Industry watchers predicted that, in two years, fee revenue would have to rise to offset hospitals’ inability to pay. The early returns seem to show that bearing out.

“We’re pretty close to that breaking point,” Flores says. “When we go around the country and do consulting work, we are hearing many more hospital leaders telling us, ‘We’re concerned about how much money this program is costing us, and we are getting to the point where we can’t afford it.’”

Productivity Stalls

While compensation continues to climb, productivity flattened out in this year’s report.

Median relative value units (RVUs) dipped slightly from the figure reported in 2014, to 4,252 from 4,297. But the tally is still ahead of 2012’s total of 4,159. Median collection-to-work RVUs also ticked down from 2014’s tally, to $50.29 from $51.50 in 2013.

Flores largely attributes the falling metrics of productivity to the evolution of HMGs that have standardized their scheduling to the point that most HMGs now offer vacation time.

“So the number of groups that are working 182 days is fewer, and we see a lot more groups that are working something like 168 days or 172 days,” she says. “And if a hospitalist works fewer shifts, even if they see the same number of patients per shift, they’re going to generate less productivity over the course of the year, so that’s part of it.”

Andrew White, MD, SFHM, director of the HM service at the University of Washington Medical Center in Seattle, says the report’s value is in avoiding a myopic approach to how HMGs operate. For example, RVUs are an important metric of productivity, but not all shifts should be expected to produce the same.

For example, it’d be valuable to use the report to see how hard your nocturnists are working compared with other sites, says Dr. White, also a member of the Practice Analysis Committee.

“The fundamental issue with working at night is that not everybody wants to do it, and so you have to recognize that it’s a pain to do and you have to either pay those people more, have them work less, or acknowledge that they’re going to be less productive,” he says. “We use the survey to assess all three of those things and then can work with our nocturnists to reach an agreement about a fair approach to their job structure that’s actually informed by national benchmarks. That process has helped us to pick, for example, how many nights per year they should work or what their salaries should look like compared to the day hospitalists.”

Dr. White says that because the report is comprehensive and includes broad participation, he’s able to use it as a benchmark to make hiring and service structure decisions.

“It also helps me to keep abreast of some trends that may be occurring in the broader workplace that we aren’t participating in but maybe should be or should be thinking about,” he says.

 

 

The report’s subsections are also critical for comparing one HMG to others, Dr. White says.

“Obviously, there is the aggregate data there to look at the average program,” he says. “But really as a hospitalist group leader, you want to know what are other programs like mine doing, and it allows you to drill down into that data.”

Survey Limitations

Any hospitalist worth their weight in scrubs knows that any medical study is only as good as its limitations. And while SoHM is a trove of valuable data information, Flores always cautions against taking data points as gospel.

“People should understand what the numbers are telling us, what goes into those numbers, and take them not with a grain of salt but take them for what they are,” she says.

For example, Flores says, look at productivity metrics per shift. Day shifts have traditionally driven that figure, and those shifts are typically busy. But night shifts have fewer patients and less productivity.

“So as more and more hospitals get 24-hour in-house coverage and have doctors working low-productivity night shifts, that [productivity] number might fall,” she says.

That sort of nuanced analysis of productivity can’t be found anywhere else, says Dr. Lovins.

These are “data that we don’t normally get from our administration,” she says, “information on things like staffing and patient loads, and how much more the director makes than the people that work for the director, and how much more nighttime people make than daytime people make. There is no other way for me to get that information, and it’s very important to make sure that our program is fair.”

Aside from fair, the data points are essential talking points as HMGs negotiate contracts and other arrangements with their administrators.

“It’s a reference point so that everybody feels like we’re using data from a national source that everyone can agree upon as fair,” says Dr. White.

In Dr. White’s case, he doesn’t have many local academic programs to benchmark against. And comparing to private, for-profit hospitals isn’t the proverbial apples-to-apples comparison. Having vetted regional and national figures for comparison is incredibly valuable, particularly since he doesn’t have to compile the data.

“If I had to go call all those group leaders and figure out what they were doing, it would be pretty exhausting,” he says.

Alternative Payment Models

Dr. Smith says that one area where the report will become even more valuable over the next few years is addressing alternative payment models (APMs). In particular, HM leaders say they’re excited about being drivers in one of the largest APMs: the Bundled Payments for Care Improvement (BCPI) initiative. In short, the program covers 48 defined episodes of care, including medical and surgical, that could begin three days prior to admission and stretch 30, 60, or 90 days post-discharge.

Dr. Smith thinks it’s still a bit too early to see from the report how APMs have affected compensation.

“We’re still relatively in the early days of bundled-payment models, so in that regard, the State of Hospital Medicine Report still represents very much a starting point with regard to where hospital medicine groups will find themselves as they start to encounter challenges,” he says.

Perhaps more important, Gans doesn’t expect that the maturation of APMs will result in decreased compensation for hospitalists.

“In a hospital environment where the hospital is being reimbursed a set amount for a complete hospital admission and follow-up care and potential readmissions, that is an episodic payment already,” he says. “Consequently, the incentive is there today to better manage the patient and to attain the care coordination and care management necessary for that patient to be discharged and not readmitted.”

 

 

In fact, the SHM/MGMA data tell him that the basic economic theory of supply and demand continues to drive hospitalist compensation even 20 years after the field was given its name. He says rising compensation, even as more practices look to hire nurse practitioners or physician assistants as less expensive alternatives, shows no sign of letting up.

“I think demand will continue to be there,” Gans adds. “There may be in the long run some lessening of demand for hospitalists, but I don’t see that for years.”


Richard Quinn is a freelance writer in New Jersey.

Is Burnout a Problem?

Image Credit: Shuttershock.com

Burnout has become a major concern across the healthcare spectrum, particularly in cognitive fields such as hospital medicine where physicians can work long days or weeks with little sleep and a lot of pressure.

But despite hospitalists branching into multiple new arenas over the past decade (surgical co-management and informatics, to name a few), burnout has never registered as a significant problem in SHM’s reports. In fact, the 2016 State of Hospital Medicine Report finds that the median turnover rate for physicians “only continues to decline year after year.”

The biennial report found a turnover rate of 6.9% for responding physicians who serve adults only. That’s down from 8% in 2014 and 14% in 2010.

Turnover rate, however, may not be the best measure of burnout levels, one hospitalist admits.

“It could be tempting to think that a decrease in turnover rates would equal to decreased burnout—it might also be that individuals could get so burnt out everywhere that they no longer see that leaving one hospital medicine group for another is a viable cure,” says G. Randy Smith, MD, MS, FRCP(Edin), SFHM, an assistant professor in the Division of Hospital Medicine at Northwestern University Feinberg School of Medicine in Chicago and a member of SHM’s Practice Analysis Committee.

Dr. Smith says SHM is actively trying to address burnout outside of the SoHM but that additional questions added to the report in future years could help home in on the phenomenon.

“There are other ways that burnout can manifest,” he adds. “There is concern that it can manifest in decreased patient satisfaction, in more sick leave, diagnostic error, and decreased ability to teach effectively in academic institutions. … Burnout can still very much remain an issue for a hospitalist group even if they see that their turnover rates are level relative to a regional or national average.”

Richard Quinn

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