Subcutaneous or IV trastuzumab? Take your pick

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Thu, 12/15/2022 - 17:43

It’s a toss-up: For patients with early, HER2-positive breast cancer, subcutaneous trastuzumab is comparable in efficacy and safety with intravenous trastuzumab, final results of the phase 3, randomized HannaH trial indicate.

The 6-year event-free survival (EFS) and overall survival (OS) rates were identical for patients randomized either to subcutaneously or intravenously delivered trastuzumab (Herceptin and biosimilars); adverse events rates also were similar, reported Christian Jackisch, MD, PhD, from Sana Klinikum Offenbach, Germany, and his associates.

“Event-free survival and OS results after 6 years of follow-up continue to support the noninferiority of subcutaneous trastuzumab to intravenous trastuzumab observed in the primary analysis. Results for EFS were consistent with those observed in the Neoadjuvant Herceptin [NOAH] trial of intravenous trastuzumab,” the investigators wrote in JAMA Oncology.

The HannaH (Enhanced Treatment With Neoadjuvant Herceptin) trial was designed to show whether subcutaneous trastuzumab was noninferior to intravenous trastuzumab for patients with HER2 (ERBB2)-positive early breast cancer.

Patients received four cycles of neoadjuvant docetaxel, followed by four cycles of combination chemotherapy with fluorouracil, epirubicin, and cyclophosphamide, plus either subcutaneous trastuzumab 600 mg delivered over 5 minutes or IV trastuzumab at a loading dose of 8 mg/kg and maintenance dose of 6 mg/kg every 3 weeks. Patients received an additional 10 cycles of trastuzumab post surgery.

The coprimary endpoints were pathologic complete response, defined as absence of invasive neoplastic cells in the breast (remaining ductal carcinoma in situ was accepted) and serum trough concentration predose on dose cycle 8.

The primary analysis, published in 2012, showed that the subcutaneous formulation has pharmacokinetic, efficacy and safety profiles comparable with those of standard intravenous administration. Subsequent analyses showed similar 3-year EFS rates and safety profiles, Dr. Jackisch and colleagues noted.

The current, final analysis was conducted after a median follow-up of 5.9 years in an intention-to-treat population within the subcutaneous group (294 women), and 6.0 years in the intravenous group (297 women).

The 6-year EFS rate was 65% in each group, and the OS rate was 84% in each group. In both trial arms, 6-year EFS and OS rates were higher for patients with complete pathologic responses than for patients with residual disease.

Adverse events of any grade were reported in 97.6% in the subcutaneous group and 94.6% in the intravenous group. Grade 3 or greater adverse events occurred in 53.2% versus 53.7%, cardiac adverse events in 14.8% versus 14.1%, and serious adverse events in 21.9% versus 15.1%, respectively.

The HannaH trial was sponsored by Hoffman-La Roche. Dr. Jackisch and several coauthors reported receiving grants and personal fees from Hoffmann-La Roche.

SOURCE: Jackisch C et al. JAMA Oncol. 2019 Apr 18. doi: 10.1001/jamaoncol.2019.0339.

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It’s a toss-up: For patients with early, HER2-positive breast cancer, subcutaneous trastuzumab is comparable in efficacy and safety with intravenous trastuzumab, final results of the phase 3, randomized HannaH trial indicate.

The 6-year event-free survival (EFS) and overall survival (OS) rates were identical for patients randomized either to subcutaneously or intravenously delivered trastuzumab (Herceptin and biosimilars); adverse events rates also were similar, reported Christian Jackisch, MD, PhD, from Sana Klinikum Offenbach, Germany, and his associates.

“Event-free survival and OS results after 6 years of follow-up continue to support the noninferiority of subcutaneous trastuzumab to intravenous trastuzumab observed in the primary analysis. Results for EFS were consistent with those observed in the Neoadjuvant Herceptin [NOAH] trial of intravenous trastuzumab,” the investigators wrote in JAMA Oncology.

The HannaH (Enhanced Treatment With Neoadjuvant Herceptin) trial was designed to show whether subcutaneous trastuzumab was noninferior to intravenous trastuzumab for patients with HER2 (ERBB2)-positive early breast cancer.

Patients received four cycles of neoadjuvant docetaxel, followed by four cycles of combination chemotherapy with fluorouracil, epirubicin, and cyclophosphamide, plus either subcutaneous trastuzumab 600 mg delivered over 5 minutes or IV trastuzumab at a loading dose of 8 mg/kg and maintenance dose of 6 mg/kg every 3 weeks. Patients received an additional 10 cycles of trastuzumab post surgery.

The coprimary endpoints were pathologic complete response, defined as absence of invasive neoplastic cells in the breast (remaining ductal carcinoma in situ was accepted) and serum trough concentration predose on dose cycle 8.

The primary analysis, published in 2012, showed that the subcutaneous formulation has pharmacokinetic, efficacy and safety profiles comparable with those of standard intravenous administration. Subsequent analyses showed similar 3-year EFS rates and safety profiles, Dr. Jackisch and colleagues noted.

The current, final analysis was conducted after a median follow-up of 5.9 years in an intention-to-treat population within the subcutaneous group (294 women), and 6.0 years in the intravenous group (297 women).

The 6-year EFS rate was 65% in each group, and the OS rate was 84% in each group. In both trial arms, 6-year EFS and OS rates were higher for patients with complete pathologic responses than for patients with residual disease.

Adverse events of any grade were reported in 97.6% in the subcutaneous group and 94.6% in the intravenous group. Grade 3 or greater adverse events occurred in 53.2% versus 53.7%, cardiac adverse events in 14.8% versus 14.1%, and serious adverse events in 21.9% versus 15.1%, respectively.

The HannaH trial was sponsored by Hoffman-La Roche. Dr. Jackisch and several coauthors reported receiving grants and personal fees from Hoffmann-La Roche.

SOURCE: Jackisch C et al. JAMA Oncol. 2019 Apr 18. doi: 10.1001/jamaoncol.2019.0339.

It’s a toss-up: For patients with early, HER2-positive breast cancer, subcutaneous trastuzumab is comparable in efficacy and safety with intravenous trastuzumab, final results of the phase 3, randomized HannaH trial indicate.

The 6-year event-free survival (EFS) and overall survival (OS) rates were identical for patients randomized either to subcutaneously or intravenously delivered trastuzumab (Herceptin and biosimilars); adverse events rates also were similar, reported Christian Jackisch, MD, PhD, from Sana Klinikum Offenbach, Germany, and his associates.

“Event-free survival and OS results after 6 years of follow-up continue to support the noninferiority of subcutaneous trastuzumab to intravenous trastuzumab observed in the primary analysis. Results for EFS were consistent with those observed in the Neoadjuvant Herceptin [NOAH] trial of intravenous trastuzumab,” the investigators wrote in JAMA Oncology.

The HannaH (Enhanced Treatment With Neoadjuvant Herceptin) trial was designed to show whether subcutaneous trastuzumab was noninferior to intravenous trastuzumab for patients with HER2 (ERBB2)-positive early breast cancer.

Patients received four cycles of neoadjuvant docetaxel, followed by four cycles of combination chemotherapy with fluorouracil, epirubicin, and cyclophosphamide, plus either subcutaneous trastuzumab 600 mg delivered over 5 minutes or IV trastuzumab at a loading dose of 8 mg/kg and maintenance dose of 6 mg/kg every 3 weeks. Patients received an additional 10 cycles of trastuzumab post surgery.

The coprimary endpoints were pathologic complete response, defined as absence of invasive neoplastic cells in the breast (remaining ductal carcinoma in situ was accepted) and serum trough concentration predose on dose cycle 8.

The primary analysis, published in 2012, showed that the subcutaneous formulation has pharmacokinetic, efficacy and safety profiles comparable with those of standard intravenous administration. Subsequent analyses showed similar 3-year EFS rates and safety profiles, Dr. Jackisch and colleagues noted.

The current, final analysis was conducted after a median follow-up of 5.9 years in an intention-to-treat population within the subcutaneous group (294 women), and 6.0 years in the intravenous group (297 women).

The 6-year EFS rate was 65% in each group, and the OS rate was 84% in each group. In both trial arms, 6-year EFS and OS rates were higher for patients with complete pathologic responses than for patients with residual disease.

Adverse events of any grade were reported in 97.6% in the subcutaneous group and 94.6% in the intravenous group. Grade 3 or greater adverse events occurred in 53.2% versus 53.7%, cardiac adverse events in 14.8% versus 14.1%, and serious adverse events in 21.9% versus 15.1%, respectively.

The HannaH trial was sponsored by Hoffman-La Roche. Dr. Jackisch and several coauthors reported receiving grants and personal fees from Hoffmann-La Roche.

SOURCE: Jackisch C et al. JAMA Oncol. 2019 Apr 18. doi: 10.1001/jamaoncol.2019.0339.

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Suicide barriers on the Golden Gate Bridge: Will they save lives?

Article Type
Changed
Fri, 05/17/2019 - 11:47

Ultimately, we need to find better treatments for depression and anxiety

San Francisco entrances people. Photographers capture more images of the Golden Gate Bridge than any other bridge in the world.1 And only the Nanjing Yangtze River Bridge in China surpasses the Golden Gate as a destination for dying by suicide.2 At least 1,700 people reportedly have plunged from the bridge to their deaths since its opening in 1937.3

San Francisco's Golden Gate Bridge
Eloi_Omella/Getty Images

Despite concerted efforts by bridge security, the local mental health community, and a volunteer organization – Bridgewatch Angels – suicides continue at the pace of about 1 every 2 weeks. After more than 60 years of discussion, transportation officials allocated funding and have started building a suicide prevention barrier system on the Golden Gate.

Extrapolating from the success of barriers built on other bridges that were “suicide magnets,” we should be able to assure people that suicide deaths from the Golden Gate will dramatically decrease, and perhaps cease completely.4 Certainly, some in the mental health community think this barrier will save lives. They support this claim by citing research showing that removing highly accessible and lethal means of suicide reduces overall suicide rates, and that suicidal individuals, when thwarted, do not seek alternate modes of death.

I support building the Golden Gate suicide barrier, partly because symbolically, it should deliver a powerful message that we value all human life. But will the barrier save lives? I don’t think it will. As the American Psychiatric Association prepares to gather for its annual meeting in San Francisco, I would like to share my reasoning.
 

What the evidence shows

The most robust evidence that restricting availability of highly lethal and accessible means of suicide reduces overall suicide deaths comes from studies looking at self-poisoning in Asian countries and Great Britain. In many parts of Asia, ingestion of pesticides constitutes a significant proportion of suicide deaths, and several studies have found that, in localities where sales of highly lethal pesticides were restricted, overall suicide deaths decreased.5,6 Conversely, suicide rates increased when more lethal varieties of pesticides became more available. In Great Britain, overall suicide rates decreased when natural gas replaced coal gas for home heating and cooking.7 For decades preceding this change, more Britons had killed themselves by inhaling coal gas than by any other method.

Strong correlations exist between regional levels of gun ownership and suicide rates by shooting,8 but several potentially confounding sociopolitical factors explain some portion of this connection. Stronger evidence of gun availability affecting suicide rates has been demonstrated by decreases in suicide rates after restrictions in gun access in Switzerland,9 Israel,10 and other areas. These studies show correlations – not causality. However, the number of studies, links between increases and decreases in suicide rates with changes in access to guns, absence of changes in suicide rates during the same time periods among ostensibly similar control populations, and lack of other compelling explanations support the argument that restricting access to highly lethal and accessible means of suicide prevents suicide deaths overall.

The installation of suicide barriers on bridges that have been the sites of multiple suicides robustly reduces or even eliminates suicide deaths from those bridges,11 but the effect on overall suicide rates remains less clear. Various studies have found subsequent increases or no changes12-14 in suicide deaths from other bridges or tall buildings in the vicinity after the installation of suicide barriers on a “suicide magnet.” Many of the studies failed to find any impact on overall suicide rates in the regions investigated. Deaths from jumping off tall structures constitute a tiny proportion of total suicide deaths, making it difficult to detect any changes in overall suicide rates. In the United States, suicides by jumping/falling constituted 1%-2% of total suicides over the last several decades.15

If we know that restricting highly lethal and accessible methods of killing reduces suicide deaths, why would I question the value of the Golden Gate suicide barrier in preventing overall suicide deaths? I posit that the Golden Gate Bridge is both less lethal and less accessible than we assume.
 

 

 

Unique aspects of the bridge

The World High Dive Federation recommends keeping dives to less than 20 meters (65.5 feet), with a few exceptions.16 The rail of the Golden Gate Bridge stands 67 meters (220 feet) above the water, and assuming minimal wind resistance, a falling person traverses that distance in about 3.7 seconds and lands with an impact of 130 km/hour (81 miles per hour).17 Only about 1%-2% of those jumping from the Golden Gate survive that fall.18

A 99% likelihood of death sounds pretty lethal; however, death by jumping from the Golden Gate inherently takes place in a public space, with the opportunity for interventions by other people. A more realistic calculation of the lethality would start the instant that someone initiates a sequence of behaviors leading to the intended death. By that criteria, measuring the lethality of the Golden Gate would begin when an individual enters a vehicle or sets off on foot with the plan of going over the railing.

Unless our surveillance-oriented society makes substantially greater advances (which I oppose), we will remain unable to assess suicide lethality by starting at the moment of inception. However, we do have data showing what happens once someone with suicidal intentions walks onto the bridge.

Between 2000 and 2018, observers noted 2,546 people on the Golden Gate who appeared to be considering a suicide attempt, the San Francisco Chronicle has reported. Five hundred sixty-four confirmed suicides occurred. In an additional 71 cases, suicide is presumed but bodies were not recovered. In the 1,911 remaining instances, mental health interventions were made, with individuals taken to local hospitals and psychiatric wards, and released when no longer overtly suicidal. Interventions successfully diverted 75% (1,911/2,546) of those intending to end their own lives, which suggests that the current lethality of the Golden Gate as a means of suicide is only 25%. Even in the bridge’s first half-century, without constant camera monitoring, and a cadre of volunteers and professionals scanning for those attempting suicide, the lethality rate approached about 50%.19

We face even more difficulties measuring accessibility than in determining lethality. The Golden Gate appears to be accessible to almost anyone – drivers have to pay a toll only when traveling from the north, and then only after they have traversed the span. Pedestrians retain unfettered admittance to the east sidewalk (facing San Francisco city and bay) throughout daylight hours. But any determination of accessibility must include how quickly and easily one can make use of an opportunity.

Both entrances to the Golden Gate are embedded in the Golden Gate National Recreational Area, part of the National Park system. The south entrance to the bridge arises from The Presidio, a former military installation that housed about 4,000 people.20 Even fewer people live in the parklands at the north end of the bridge. The Presidio extends far enough so that the closest San Francisco neighborhoods outside of the park are a full 2.2 km (1.36 miles) from the bridge railing. A brisk walk would still require a minimum of about 20 minutes to get to the bridge; it is difficult to arrive at the bridge without a trek.

Researchers define impulsivity, like accessibility, inconsistently – and often imprecisely. Impulsivity, which clearly exists on a spectrum, connotes overvaluing of immediate feelings and thoughts at the expense of longer term goals and aspirations. Some suicide research appears to define impulsivity as the antithesis of planned behavior;21,22 others define it pragmatically as behaviors executed within 5 minutes of a decision,23 and still others contend that “suicidal behavior is rarely if ever impulsive.”24 Furthermore, when we assess impulsivity, we must acknowledge a fundamental difference between “impulsive” shootings and poisonings that are accomplished at home and within seconds or minutes, from “impulsive” Golden Gate Bridge suicide attempts, which require substantial travel and time commitments, and inherently involve the potential for others to intervene.

Those arguing that the bridge suicide barrier will save lives often bring up two additional sets of numbers to back up their assertions. They provide evidence that most of those people who were stopped in their attempts at suicide at the Golden Gate do not go on to commit suicide elsewhere, and that many of those who survived their attempts express regret at having tried to kill themselves. Specifically, 94% of those who were prevented from jumping from the Golden Gate had not committed suicide after a median follow-up of 26 years, according to a follow-up study published a few years ago. On the other hand, those who have made a serious suicide attempt have a substantially increased risk, relative to the general population, of dying from a later attempt,25,26 and the strongest predictor for death by suicide is having made a previous, serious suicide attempt.27

While all of these studies provide important and interesting information regarding suicide, none directly address the question of whether individuals will substitute attempts by other methods if the Golden Gate Bridge were no longer available. Many discussions blur the distinction between how individuals behave after a thwarted Golden Gate suicide attempt and how other people might act if we secured the bridge from any potential future suicide attempts. I hope that the following analogy makes this distinction clearer without trivializing: Imagine that we know that everyone who was interrupted while eating their dinner in a particular restaurant never went back and ate out anywhere, ever again. We could not conclude from this that another individual, who learned that the intended restaurant was indefinitely closed, would never dine out again. Once effective suicide barriers exist on the Golden Gate, this will likely become widely known, thereby greatly reducing the likelihood that any individuals will consider the possibility of jumping from the bridge. But it seems very unlikely that this would vanquish all suicidal impulses from the northern California population.
 

 

 

Lessons from patients

Two former patients of mine ended their lives by suicide from the Golden Gate. P, a solitary and lonely man in his 50s, was referred to me by his neighbor, Q, one of my long-term patients. P had a history of repeated assessments for lifelong depression, with minimal follow-up. I made a treatment plan with P that we hoped would address both his depression and his reluctance to engage with mental health professionals. He did not return for his follow-up appointment and ignored all my attempts to contact him.

P continued to have intermittent contact with Q. A decade after I had evaluated him, P was finally hospitalized for depression. Since P had no local family or friends, he asked Q to pick him up from the hospital at the time of his discharge. P asked Q to drive him to the Golden Gate Bridge, ostensibly to relish his release by partaking of the panoramic view of San Francisco from the bridge. They parked in the lot at the north end of the bridge, where Q stayed with the car at the vista point. The last that anyone saw of P was when Q noticed him walking on the bridge; nobody saw him go over and his body was not recovered.

In contrast to my brief connection with P, I worked with S over the course of 8 years to deal with her very severe attention-deficit/hyperactivity disorder and associated depression, which destroyed jobs and friendships, and estranged her from her family. She moved to Hawaii in hopes of “starting over with less baggage,” but I received a few phone calls over the next few years detailing suicide attempts, including driving her car off a bridge. Floundering in life, she returned to San Francisco and was hospitalized with suicidal ideation. The inpatient team sedated her heavily, ignored her past treatments and diagnoses, and discharged her after several days. Within a day of discharge, S’s sister called to say that S’s body had been recovered from the water below the bridge.

Dr. John Kruse, a psychiatrist who practices in San Francisco
Dr. John Kruse

I don’t think that suicide was inevitable for either P or S, but I also lack any indication that either would be alive today had we installed suicide barriers on the Golden Gate years ago. Unless we eliminate access to guns, cars, trains, poisons, ropes, tall buildings and cliffs, people contemplating suicide will have numerous options at their disposal. We are likely to save lives by continuing to find ways to restrict access to means of death that can be used within seconds and have a high degree of lethality, and we should persist with such efforts. Buying a $5 trigger lock for every gun in California, and spending tens of millions on a public service campaign would cost less and may well save more lives than the Golden Gate suicide barrier. Unfortunately, we still possess very limited knowledge regarding which suicide prevention measures have an “impact on actual deaths or behavior.”28

To increase our efficacy in reducing suicide, we need to find better treatments for depression and anxiety. We also need to identify better ways of targeting those most at risk for suicide,29 improve our delivery of such treatments, and mitigate the social factors that contribute to such misery and unhappiness.

 

 

As a psychiatrist who has lost not only patients but also family members to suicide, I appreciate the hole in the soul these deaths create. I understand the drive to find ways to prevent additional deaths and save future survivors from such grief. But we must design psychiatric interventions that do the maximum good. To be imprecise in the lessons we learn from those who have killed themselves doubles down on the disservice to those lives already lost.

Dr. Kruse is a psychiatrist who practices in San Francisco. Several key details about the patients were changed to protect confidentiality.

References

1. Frommer’s Comprehensive Travel Guide, California. New York: Prentice Hall Travel, 1993.

2. “Chen Si, the ‘Angel of Nanjing,’ has saved more than 330 people from suicide,” by Matt Young, News.com.au. May 14, 2017.

3. “Finding Kyle,” by Lizzie Johnson, San Francisco Chronicle. Feb 8, 2019.

4. Beautrais A. Suicide by jumping. A review of research and prevention strategies. Crisis. 2007 Jan;28 Suppl 1:58-63. Crisis: The J of Crisis Interven Suicide Preven. 2007 Jan. (28)[Suppl1]:58-63.

5. Gunnell D et al. The global distribution of fatal pesticide self-poisoning: Systematic review. BMC Public Health. 2007 Dec. 21;7:357.

6. Vijayakumar L and Satheesh-Babu R. Does ‘no pesticide’ reduce suicides? Int J Soc Psychiatry. 2009 Jul 17;55:401-6.

7. Kreitman N. The coal gas story. United Kingdom suicide rates, 1960-71. Br J Prev Soc Med. 1976 Jun;30(2)86-93.

8. Ajdacic-Gross V et al. Changing times: A longitudinal analysis of international firearm suicide data. Am J Public Health. 2006 Oct;96(10):1752-5.

9. Reisch T et al. Change in suicide rates in Switzerland before and after firearm restriction resulting from the 2003 “Army XXI” reform. Am J Psychiatry. 2013 Sep170(9):977-84.

10. Lubin G et al. Decrease in suicide rates after a change of policy reducing access to firearms in adolescents: A naturalistic epidemiological study. Suicide Life Threat Behav. 2010 Oct;40(5):421-4.

11. Sinyor M and Levitt A. Effect of a barrier at Bloor Street Viaduct on suicide rates in Toronto: Natural experiment BMJ. 2010;341. doi: 1136/bmjc2884.

12. O’Carroll P and Silverman M. Community suicide prevention: The effectiveness of bridge barriers. Suicide Life Threat Behav. 1994 Spring;24(1):89-91; discussion 91-9.

13. Pelletier A. Preventing suicide by jumping: The effect of a bridge safety fence. Inj Prev. 2007 Feb;13(1):57-9.

14. Bennewith O et al. Effect of barriers on the Clifton suspension bridge, England, on local patterns of suicide: Implications for prevention. Br J Psychiatry. 2007 Mar;190:266-7.

15. Harvard T.H. Chan School of Public Health. 2004. “How do people most commonly complete suicide?”

16. “How cliff diving works,” by Heather Kolich, HowStuffWorks.com. Oct 5, 2009.

17. “Bridge design and construction statistics.” Goldengate.org

18. “How did teen survive fall from Golden Gate Bridge?” by Remy Molina, Live Science. Apr 19, 2011.

19. Seiden R. Where are they now? A follow-up study of suicide attempters from the Golden Gate Bridge. Suicide Life Threat Behav. 1978 Winter;8(4):203-16.

20. Presidio demographics. Point2homes.com.

21. Baca-García E et al. A prospective study of the paradoxical relationship between impulsivity and lethality of suicide attempts. J Clin Psychiatry. 2001 Jul;62(7):560-4.

22. Lim M et al. Differences between impulsive and non-impulsive suicide attempts among individuals treated in emergency rooms of South Korea. Psychiatry Investig. 2016 Jul;13(4):389-96.

23. Simon O et al. Characteristics of impulsive suicide attempts and attempters. Suicide Life Threat Behav. 2001;32(1 Suppl):49-59.

24. Anestis M et al. Reconsidering the link between impulsivity and suicidal behavior. Pers Soc Psychol Rev. 2014 Nov;18(4):366-86.

25. Ostamo A et al. Excess mortality of suicide attempters. Psychiatry Psychiatr Epidemiol. 2001 Jan;36(1):29-35.

26. Leon A et al. Statistical issues in the identification of risk factors for suicidal behavior: The application of survival analysis. Psychiatry Res. 1990 Jan;31(1):99-108.

27. Bostwick J et al. Suicide attempt as a risk factor for completed suicide: Even more lethal than we knew. Am J Psychiatry. 2016 Nov 1;173(11):1094-100.

28. Stone D and Crosby A. Suicide prevention. Am J Lifestyle Med. 2014;8(6):404-20.

29. Belsher B et al. Prediction models for suicide attempts and deaths: A systematic review and simulation. JAMA Psychiatry. 2019 Mar 13. doi: 10.1001/jamapsychiatry.2019.0174.

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Ultimately, we need to find better treatments for depression and anxiety

Ultimately, we need to find better treatments for depression and anxiety

San Francisco entrances people. Photographers capture more images of the Golden Gate Bridge than any other bridge in the world.1 And only the Nanjing Yangtze River Bridge in China surpasses the Golden Gate as a destination for dying by suicide.2 At least 1,700 people reportedly have plunged from the bridge to their deaths since its opening in 1937.3

San Francisco's Golden Gate Bridge
Eloi_Omella/Getty Images

Despite concerted efforts by bridge security, the local mental health community, and a volunteer organization – Bridgewatch Angels – suicides continue at the pace of about 1 every 2 weeks. After more than 60 years of discussion, transportation officials allocated funding and have started building a suicide prevention barrier system on the Golden Gate.

Extrapolating from the success of barriers built on other bridges that were “suicide magnets,” we should be able to assure people that suicide deaths from the Golden Gate will dramatically decrease, and perhaps cease completely.4 Certainly, some in the mental health community think this barrier will save lives. They support this claim by citing research showing that removing highly accessible and lethal means of suicide reduces overall suicide rates, and that suicidal individuals, when thwarted, do not seek alternate modes of death.

I support building the Golden Gate suicide barrier, partly because symbolically, it should deliver a powerful message that we value all human life. But will the barrier save lives? I don’t think it will. As the American Psychiatric Association prepares to gather for its annual meeting in San Francisco, I would like to share my reasoning.
 

What the evidence shows

The most robust evidence that restricting availability of highly lethal and accessible means of suicide reduces overall suicide deaths comes from studies looking at self-poisoning in Asian countries and Great Britain. In many parts of Asia, ingestion of pesticides constitutes a significant proportion of suicide deaths, and several studies have found that, in localities where sales of highly lethal pesticides were restricted, overall suicide deaths decreased.5,6 Conversely, suicide rates increased when more lethal varieties of pesticides became more available. In Great Britain, overall suicide rates decreased when natural gas replaced coal gas for home heating and cooking.7 For decades preceding this change, more Britons had killed themselves by inhaling coal gas than by any other method.

Strong correlations exist between regional levels of gun ownership and suicide rates by shooting,8 but several potentially confounding sociopolitical factors explain some portion of this connection. Stronger evidence of gun availability affecting suicide rates has been demonstrated by decreases in suicide rates after restrictions in gun access in Switzerland,9 Israel,10 and other areas. These studies show correlations – not causality. However, the number of studies, links between increases and decreases in suicide rates with changes in access to guns, absence of changes in suicide rates during the same time periods among ostensibly similar control populations, and lack of other compelling explanations support the argument that restricting access to highly lethal and accessible means of suicide prevents suicide deaths overall.

The installation of suicide barriers on bridges that have been the sites of multiple suicides robustly reduces or even eliminates suicide deaths from those bridges,11 but the effect on overall suicide rates remains less clear. Various studies have found subsequent increases or no changes12-14 in suicide deaths from other bridges or tall buildings in the vicinity after the installation of suicide barriers on a “suicide magnet.” Many of the studies failed to find any impact on overall suicide rates in the regions investigated. Deaths from jumping off tall structures constitute a tiny proportion of total suicide deaths, making it difficult to detect any changes in overall suicide rates. In the United States, suicides by jumping/falling constituted 1%-2% of total suicides over the last several decades.15

If we know that restricting highly lethal and accessible methods of killing reduces suicide deaths, why would I question the value of the Golden Gate suicide barrier in preventing overall suicide deaths? I posit that the Golden Gate Bridge is both less lethal and less accessible than we assume.
 

 

 

Unique aspects of the bridge

The World High Dive Federation recommends keeping dives to less than 20 meters (65.5 feet), with a few exceptions.16 The rail of the Golden Gate Bridge stands 67 meters (220 feet) above the water, and assuming minimal wind resistance, a falling person traverses that distance in about 3.7 seconds and lands with an impact of 130 km/hour (81 miles per hour).17 Only about 1%-2% of those jumping from the Golden Gate survive that fall.18

A 99% likelihood of death sounds pretty lethal; however, death by jumping from the Golden Gate inherently takes place in a public space, with the opportunity for interventions by other people. A more realistic calculation of the lethality would start the instant that someone initiates a sequence of behaviors leading to the intended death. By that criteria, measuring the lethality of the Golden Gate would begin when an individual enters a vehicle or sets off on foot with the plan of going over the railing.

Unless our surveillance-oriented society makes substantially greater advances (which I oppose), we will remain unable to assess suicide lethality by starting at the moment of inception. However, we do have data showing what happens once someone with suicidal intentions walks onto the bridge.

Between 2000 and 2018, observers noted 2,546 people on the Golden Gate who appeared to be considering a suicide attempt, the San Francisco Chronicle has reported. Five hundred sixty-four confirmed suicides occurred. In an additional 71 cases, suicide is presumed but bodies were not recovered. In the 1,911 remaining instances, mental health interventions were made, with individuals taken to local hospitals and psychiatric wards, and released when no longer overtly suicidal. Interventions successfully diverted 75% (1,911/2,546) of those intending to end their own lives, which suggests that the current lethality of the Golden Gate as a means of suicide is only 25%. Even in the bridge’s first half-century, without constant camera monitoring, and a cadre of volunteers and professionals scanning for those attempting suicide, the lethality rate approached about 50%.19

We face even more difficulties measuring accessibility than in determining lethality. The Golden Gate appears to be accessible to almost anyone – drivers have to pay a toll only when traveling from the north, and then only after they have traversed the span. Pedestrians retain unfettered admittance to the east sidewalk (facing San Francisco city and bay) throughout daylight hours. But any determination of accessibility must include how quickly and easily one can make use of an opportunity.

Both entrances to the Golden Gate are embedded in the Golden Gate National Recreational Area, part of the National Park system. The south entrance to the bridge arises from The Presidio, a former military installation that housed about 4,000 people.20 Even fewer people live in the parklands at the north end of the bridge. The Presidio extends far enough so that the closest San Francisco neighborhoods outside of the park are a full 2.2 km (1.36 miles) from the bridge railing. A brisk walk would still require a minimum of about 20 minutes to get to the bridge; it is difficult to arrive at the bridge without a trek.

Researchers define impulsivity, like accessibility, inconsistently – and often imprecisely. Impulsivity, which clearly exists on a spectrum, connotes overvaluing of immediate feelings and thoughts at the expense of longer term goals and aspirations. Some suicide research appears to define impulsivity as the antithesis of planned behavior;21,22 others define it pragmatically as behaviors executed within 5 minutes of a decision,23 and still others contend that “suicidal behavior is rarely if ever impulsive.”24 Furthermore, when we assess impulsivity, we must acknowledge a fundamental difference between “impulsive” shootings and poisonings that are accomplished at home and within seconds or minutes, from “impulsive” Golden Gate Bridge suicide attempts, which require substantial travel and time commitments, and inherently involve the potential for others to intervene.

Those arguing that the bridge suicide barrier will save lives often bring up two additional sets of numbers to back up their assertions. They provide evidence that most of those people who were stopped in their attempts at suicide at the Golden Gate do not go on to commit suicide elsewhere, and that many of those who survived their attempts express regret at having tried to kill themselves. Specifically, 94% of those who were prevented from jumping from the Golden Gate had not committed suicide after a median follow-up of 26 years, according to a follow-up study published a few years ago. On the other hand, those who have made a serious suicide attempt have a substantially increased risk, relative to the general population, of dying from a later attempt,25,26 and the strongest predictor for death by suicide is having made a previous, serious suicide attempt.27

While all of these studies provide important and interesting information regarding suicide, none directly address the question of whether individuals will substitute attempts by other methods if the Golden Gate Bridge were no longer available. Many discussions blur the distinction between how individuals behave after a thwarted Golden Gate suicide attempt and how other people might act if we secured the bridge from any potential future suicide attempts. I hope that the following analogy makes this distinction clearer without trivializing: Imagine that we know that everyone who was interrupted while eating their dinner in a particular restaurant never went back and ate out anywhere, ever again. We could not conclude from this that another individual, who learned that the intended restaurant was indefinitely closed, would never dine out again. Once effective suicide barriers exist on the Golden Gate, this will likely become widely known, thereby greatly reducing the likelihood that any individuals will consider the possibility of jumping from the bridge. But it seems very unlikely that this would vanquish all suicidal impulses from the northern California population.
 

 

 

Lessons from patients

Two former patients of mine ended their lives by suicide from the Golden Gate. P, a solitary and lonely man in his 50s, was referred to me by his neighbor, Q, one of my long-term patients. P had a history of repeated assessments for lifelong depression, with minimal follow-up. I made a treatment plan with P that we hoped would address both his depression and his reluctance to engage with mental health professionals. He did not return for his follow-up appointment and ignored all my attempts to contact him.

P continued to have intermittent contact with Q. A decade after I had evaluated him, P was finally hospitalized for depression. Since P had no local family or friends, he asked Q to pick him up from the hospital at the time of his discharge. P asked Q to drive him to the Golden Gate Bridge, ostensibly to relish his release by partaking of the panoramic view of San Francisco from the bridge. They parked in the lot at the north end of the bridge, where Q stayed with the car at the vista point. The last that anyone saw of P was when Q noticed him walking on the bridge; nobody saw him go over and his body was not recovered.

In contrast to my brief connection with P, I worked with S over the course of 8 years to deal with her very severe attention-deficit/hyperactivity disorder and associated depression, which destroyed jobs and friendships, and estranged her from her family. She moved to Hawaii in hopes of “starting over with less baggage,” but I received a few phone calls over the next few years detailing suicide attempts, including driving her car off a bridge. Floundering in life, she returned to San Francisco and was hospitalized with suicidal ideation. The inpatient team sedated her heavily, ignored her past treatments and diagnoses, and discharged her after several days. Within a day of discharge, S’s sister called to say that S’s body had been recovered from the water below the bridge.

Dr. John Kruse, a psychiatrist who practices in San Francisco
Dr. John Kruse

I don’t think that suicide was inevitable for either P or S, but I also lack any indication that either would be alive today had we installed suicide barriers on the Golden Gate years ago. Unless we eliminate access to guns, cars, trains, poisons, ropes, tall buildings and cliffs, people contemplating suicide will have numerous options at their disposal. We are likely to save lives by continuing to find ways to restrict access to means of death that can be used within seconds and have a high degree of lethality, and we should persist with such efforts. Buying a $5 trigger lock for every gun in California, and spending tens of millions on a public service campaign would cost less and may well save more lives than the Golden Gate suicide barrier. Unfortunately, we still possess very limited knowledge regarding which suicide prevention measures have an “impact on actual deaths or behavior.”28

To increase our efficacy in reducing suicide, we need to find better treatments for depression and anxiety. We also need to identify better ways of targeting those most at risk for suicide,29 improve our delivery of such treatments, and mitigate the social factors that contribute to such misery and unhappiness.

 

 

As a psychiatrist who has lost not only patients but also family members to suicide, I appreciate the hole in the soul these deaths create. I understand the drive to find ways to prevent additional deaths and save future survivors from such grief. But we must design psychiatric interventions that do the maximum good. To be imprecise in the lessons we learn from those who have killed themselves doubles down on the disservice to those lives already lost.

Dr. Kruse is a psychiatrist who practices in San Francisco. Several key details about the patients were changed to protect confidentiality.

References

1. Frommer’s Comprehensive Travel Guide, California. New York: Prentice Hall Travel, 1993.

2. “Chen Si, the ‘Angel of Nanjing,’ has saved more than 330 people from suicide,” by Matt Young, News.com.au. May 14, 2017.

3. “Finding Kyle,” by Lizzie Johnson, San Francisco Chronicle. Feb 8, 2019.

4. Beautrais A. Suicide by jumping. A review of research and prevention strategies. Crisis. 2007 Jan;28 Suppl 1:58-63. Crisis: The J of Crisis Interven Suicide Preven. 2007 Jan. (28)[Suppl1]:58-63.

5. Gunnell D et al. The global distribution of fatal pesticide self-poisoning: Systematic review. BMC Public Health. 2007 Dec. 21;7:357.

6. Vijayakumar L and Satheesh-Babu R. Does ‘no pesticide’ reduce suicides? Int J Soc Psychiatry. 2009 Jul 17;55:401-6.

7. Kreitman N. The coal gas story. United Kingdom suicide rates, 1960-71. Br J Prev Soc Med. 1976 Jun;30(2)86-93.

8. Ajdacic-Gross V et al. Changing times: A longitudinal analysis of international firearm suicide data. Am J Public Health. 2006 Oct;96(10):1752-5.

9. Reisch T et al. Change in suicide rates in Switzerland before and after firearm restriction resulting from the 2003 “Army XXI” reform. Am J Psychiatry. 2013 Sep170(9):977-84.

10. Lubin G et al. Decrease in suicide rates after a change of policy reducing access to firearms in adolescents: A naturalistic epidemiological study. Suicide Life Threat Behav. 2010 Oct;40(5):421-4.

11. Sinyor M and Levitt A. Effect of a barrier at Bloor Street Viaduct on suicide rates in Toronto: Natural experiment BMJ. 2010;341. doi: 1136/bmjc2884.

12. O’Carroll P and Silverman M. Community suicide prevention: The effectiveness of bridge barriers. Suicide Life Threat Behav. 1994 Spring;24(1):89-91; discussion 91-9.

13. Pelletier A. Preventing suicide by jumping: The effect of a bridge safety fence. Inj Prev. 2007 Feb;13(1):57-9.

14. Bennewith O et al. Effect of barriers on the Clifton suspension bridge, England, on local patterns of suicide: Implications for prevention. Br J Psychiatry. 2007 Mar;190:266-7.

15. Harvard T.H. Chan School of Public Health. 2004. “How do people most commonly complete suicide?”

16. “How cliff diving works,” by Heather Kolich, HowStuffWorks.com. Oct 5, 2009.

17. “Bridge design and construction statistics.” Goldengate.org

18. “How did teen survive fall from Golden Gate Bridge?” by Remy Molina, Live Science. Apr 19, 2011.

19. Seiden R. Where are they now? A follow-up study of suicide attempters from the Golden Gate Bridge. Suicide Life Threat Behav. 1978 Winter;8(4):203-16.

20. Presidio demographics. Point2homes.com.

21. Baca-García E et al. A prospective study of the paradoxical relationship between impulsivity and lethality of suicide attempts. J Clin Psychiatry. 2001 Jul;62(7):560-4.

22. Lim M et al. Differences between impulsive and non-impulsive suicide attempts among individuals treated in emergency rooms of South Korea. Psychiatry Investig. 2016 Jul;13(4):389-96.

23. Simon O et al. Characteristics of impulsive suicide attempts and attempters. Suicide Life Threat Behav. 2001;32(1 Suppl):49-59.

24. Anestis M et al. Reconsidering the link between impulsivity and suicidal behavior. Pers Soc Psychol Rev. 2014 Nov;18(4):366-86.

25. Ostamo A et al. Excess mortality of suicide attempters. Psychiatry Psychiatr Epidemiol. 2001 Jan;36(1):29-35.

26. Leon A et al. Statistical issues in the identification of risk factors for suicidal behavior: The application of survival analysis. Psychiatry Res. 1990 Jan;31(1):99-108.

27. Bostwick J et al. Suicide attempt as a risk factor for completed suicide: Even more lethal than we knew. Am J Psychiatry. 2016 Nov 1;173(11):1094-100.

28. Stone D and Crosby A. Suicide prevention. Am J Lifestyle Med. 2014;8(6):404-20.

29. Belsher B et al. Prediction models for suicide attempts and deaths: A systematic review and simulation. JAMA Psychiatry. 2019 Mar 13. doi: 10.1001/jamapsychiatry.2019.0174.

San Francisco entrances people. Photographers capture more images of the Golden Gate Bridge than any other bridge in the world.1 And only the Nanjing Yangtze River Bridge in China surpasses the Golden Gate as a destination for dying by suicide.2 At least 1,700 people reportedly have plunged from the bridge to their deaths since its opening in 1937.3

San Francisco's Golden Gate Bridge
Eloi_Omella/Getty Images

Despite concerted efforts by bridge security, the local mental health community, and a volunteer organization – Bridgewatch Angels – suicides continue at the pace of about 1 every 2 weeks. After more than 60 years of discussion, transportation officials allocated funding and have started building a suicide prevention barrier system on the Golden Gate.

Extrapolating from the success of barriers built on other bridges that were “suicide magnets,” we should be able to assure people that suicide deaths from the Golden Gate will dramatically decrease, and perhaps cease completely.4 Certainly, some in the mental health community think this barrier will save lives. They support this claim by citing research showing that removing highly accessible and lethal means of suicide reduces overall suicide rates, and that suicidal individuals, when thwarted, do not seek alternate modes of death.

I support building the Golden Gate suicide barrier, partly because symbolically, it should deliver a powerful message that we value all human life. But will the barrier save lives? I don’t think it will. As the American Psychiatric Association prepares to gather for its annual meeting in San Francisco, I would like to share my reasoning.
 

What the evidence shows

The most robust evidence that restricting availability of highly lethal and accessible means of suicide reduces overall suicide deaths comes from studies looking at self-poisoning in Asian countries and Great Britain. In many parts of Asia, ingestion of pesticides constitutes a significant proportion of suicide deaths, and several studies have found that, in localities where sales of highly lethal pesticides were restricted, overall suicide deaths decreased.5,6 Conversely, suicide rates increased when more lethal varieties of pesticides became more available. In Great Britain, overall suicide rates decreased when natural gas replaced coal gas for home heating and cooking.7 For decades preceding this change, more Britons had killed themselves by inhaling coal gas than by any other method.

Strong correlations exist between regional levels of gun ownership and suicide rates by shooting,8 but several potentially confounding sociopolitical factors explain some portion of this connection. Stronger evidence of gun availability affecting suicide rates has been demonstrated by decreases in suicide rates after restrictions in gun access in Switzerland,9 Israel,10 and other areas. These studies show correlations – not causality. However, the number of studies, links between increases and decreases in suicide rates with changes in access to guns, absence of changes in suicide rates during the same time periods among ostensibly similar control populations, and lack of other compelling explanations support the argument that restricting access to highly lethal and accessible means of suicide prevents suicide deaths overall.

The installation of suicide barriers on bridges that have been the sites of multiple suicides robustly reduces or even eliminates suicide deaths from those bridges,11 but the effect on overall suicide rates remains less clear. Various studies have found subsequent increases or no changes12-14 in suicide deaths from other bridges or tall buildings in the vicinity after the installation of suicide barriers on a “suicide magnet.” Many of the studies failed to find any impact on overall suicide rates in the regions investigated. Deaths from jumping off tall structures constitute a tiny proportion of total suicide deaths, making it difficult to detect any changes in overall suicide rates. In the United States, suicides by jumping/falling constituted 1%-2% of total suicides over the last several decades.15

If we know that restricting highly lethal and accessible methods of killing reduces suicide deaths, why would I question the value of the Golden Gate suicide barrier in preventing overall suicide deaths? I posit that the Golden Gate Bridge is both less lethal and less accessible than we assume.
 

 

 

Unique aspects of the bridge

The World High Dive Federation recommends keeping dives to less than 20 meters (65.5 feet), with a few exceptions.16 The rail of the Golden Gate Bridge stands 67 meters (220 feet) above the water, and assuming minimal wind resistance, a falling person traverses that distance in about 3.7 seconds and lands with an impact of 130 km/hour (81 miles per hour).17 Only about 1%-2% of those jumping from the Golden Gate survive that fall.18

A 99% likelihood of death sounds pretty lethal; however, death by jumping from the Golden Gate inherently takes place in a public space, with the opportunity for interventions by other people. A more realistic calculation of the lethality would start the instant that someone initiates a sequence of behaviors leading to the intended death. By that criteria, measuring the lethality of the Golden Gate would begin when an individual enters a vehicle or sets off on foot with the plan of going over the railing.

Unless our surveillance-oriented society makes substantially greater advances (which I oppose), we will remain unable to assess suicide lethality by starting at the moment of inception. However, we do have data showing what happens once someone with suicidal intentions walks onto the bridge.

Between 2000 and 2018, observers noted 2,546 people on the Golden Gate who appeared to be considering a suicide attempt, the San Francisco Chronicle has reported. Five hundred sixty-four confirmed suicides occurred. In an additional 71 cases, suicide is presumed but bodies were not recovered. In the 1,911 remaining instances, mental health interventions were made, with individuals taken to local hospitals and psychiatric wards, and released when no longer overtly suicidal. Interventions successfully diverted 75% (1,911/2,546) of those intending to end their own lives, which suggests that the current lethality of the Golden Gate as a means of suicide is only 25%. Even in the bridge’s first half-century, without constant camera monitoring, and a cadre of volunteers and professionals scanning for those attempting suicide, the lethality rate approached about 50%.19

We face even more difficulties measuring accessibility than in determining lethality. The Golden Gate appears to be accessible to almost anyone – drivers have to pay a toll only when traveling from the north, and then only after they have traversed the span. Pedestrians retain unfettered admittance to the east sidewalk (facing San Francisco city and bay) throughout daylight hours. But any determination of accessibility must include how quickly and easily one can make use of an opportunity.

Both entrances to the Golden Gate are embedded in the Golden Gate National Recreational Area, part of the National Park system. The south entrance to the bridge arises from The Presidio, a former military installation that housed about 4,000 people.20 Even fewer people live in the parklands at the north end of the bridge. The Presidio extends far enough so that the closest San Francisco neighborhoods outside of the park are a full 2.2 km (1.36 miles) from the bridge railing. A brisk walk would still require a minimum of about 20 minutes to get to the bridge; it is difficult to arrive at the bridge without a trek.

Researchers define impulsivity, like accessibility, inconsistently – and often imprecisely. Impulsivity, which clearly exists on a spectrum, connotes overvaluing of immediate feelings and thoughts at the expense of longer term goals and aspirations. Some suicide research appears to define impulsivity as the antithesis of planned behavior;21,22 others define it pragmatically as behaviors executed within 5 minutes of a decision,23 and still others contend that “suicidal behavior is rarely if ever impulsive.”24 Furthermore, when we assess impulsivity, we must acknowledge a fundamental difference between “impulsive” shootings and poisonings that are accomplished at home and within seconds or minutes, from “impulsive” Golden Gate Bridge suicide attempts, which require substantial travel and time commitments, and inherently involve the potential for others to intervene.

Those arguing that the bridge suicide barrier will save lives often bring up two additional sets of numbers to back up their assertions. They provide evidence that most of those people who were stopped in their attempts at suicide at the Golden Gate do not go on to commit suicide elsewhere, and that many of those who survived their attempts express regret at having tried to kill themselves. Specifically, 94% of those who were prevented from jumping from the Golden Gate had not committed suicide after a median follow-up of 26 years, according to a follow-up study published a few years ago. On the other hand, those who have made a serious suicide attempt have a substantially increased risk, relative to the general population, of dying from a later attempt,25,26 and the strongest predictor for death by suicide is having made a previous, serious suicide attempt.27

While all of these studies provide important and interesting information regarding suicide, none directly address the question of whether individuals will substitute attempts by other methods if the Golden Gate Bridge were no longer available. Many discussions blur the distinction between how individuals behave after a thwarted Golden Gate suicide attempt and how other people might act if we secured the bridge from any potential future suicide attempts. I hope that the following analogy makes this distinction clearer without trivializing: Imagine that we know that everyone who was interrupted while eating their dinner in a particular restaurant never went back and ate out anywhere, ever again. We could not conclude from this that another individual, who learned that the intended restaurant was indefinitely closed, would never dine out again. Once effective suicide barriers exist on the Golden Gate, this will likely become widely known, thereby greatly reducing the likelihood that any individuals will consider the possibility of jumping from the bridge. But it seems very unlikely that this would vanquish all suicidal impulses from the northern California population.
 

 

 

Lessons from patients

Two former patients of mine ended their lives by suicide from the Golden Gate. P, a solitary and lonely man in his 50s, was referred to me by his neighbor, Q, one of my long-term patients. P had a history of repeated assessments for lifelong depression, with minimal follow-up. I made a treatment plan with P that we hoped would address both his depression and his reluctance to engage with mental health professionals. He did not return for his follow-up appointment and ignored all my attempts to contact him.

P continued to have intermittent contact with Q. A decade after I had evaluated him, P was finally hospitalized for depression. Since P had no local family or friends, he asked Q to pick him up from the hospital at the time of his discharge. P asked Q to drive him to the Golden Gate Bridge, ostensibly to relish his release by partaking of the panoramic view of San Francisco from the bridge. They parked in the lot at the north end of the bridge, where Q stayed with the car at the vista point. The last that anyone saw of P was when Q noticed him walking on the bridge; nobody saw him go over and his body was not recovered.

In contrast to my brief connection with P, I worked with S over the course of 8 years to deal with her very severe attention-deficit/hyperactivity disorder and associated depression, which destroyed jobs and friendships, and estranged her from her family. She moved to Hawaii in hopes of “starting over with less baggage,” but I received a few phone calls over the next few years detailing suicide attempts, including driving her car off a bridge. Floundering in life, she returned to San Francisco and was hospitalized with suicidal ideation. The inpatient team sedated her heavily, ignored her past treatments and diagnoses, and discharged her after several days. Within a day of discharge, S’s sister called to say that S’s body had been recovered from the water below the bridge.

Dr. John Kruse, a psychiatrist who practices in San Francisco
Dr. John Kruse

I don’t think that suicide was inevitable for either P or S, but I also lack any indication that either would be alive today had we installed suicide barriers on the Golden Gate years ago. Unless we eliminate access to guns, cars, trains, poisons, ropes, tall buildings and cliffs, people contemplating suicide will have numerous options at their disposal. We are likely to save lives by continuing to find ways to restrict access to means of death that can be used within seconds and have a high degree of lethality, and we should persist with such efforts. Buying a $5 trigger lock for every gun in California, and spending tens of millions on a public service campaign would cost less and may well save more lives than the Golden Gate suicide barrier. Unfortunately, we still possess very limited knowledge regarding which suicide prevention measures have an “impact on actual deaths or behavior.”28

To increase our efficacy in reducing suicide, we need to find better treatments for depression and anxiety. We also need to identify better ways of targeting those most at risk for suicide,29 improve our delivery of such treatments, and mitigate the social factors that contribute to such misery and unhappiness.

 

 

As a psychiatrist who has lost not only patients but also family members to suicide, I appreciate the hole in the soul these deaths create. I understand the drive to find ways to prevent additional deaths and save future survivors from such grief. But we must design psychiatric interventions that do the maximum good. To be imprecise in the lessons we learn from those who have killed themselves doubles down on the disservice to those lives already lost.

Dr. Kruse is a psychiatrist who practices in San Francisco. Several key details about the patients were changed to protect confidentiality.

References

1. Frommer’s Comprehensive Travel Guide, California. New York: Prentice Hall Travel, 1993.

2. “Chen Si, the ‘Angel of Nanjing,’ has saved more than 330 people from suicide,” by Matt Young, News.com.au. May 14, 2017.

3. “Finding Kyle,” by Lizzie Johnson, San Francisco Chronicle. Feb 8, 2019.

4. Beautrais A. Suicide by jumping. A review of research and prevention strategies. Crisis. 2007 Jan;28 Suppl 1:58-63. Crisis: The J of Crisis Interven Suicide Preven. 2007 Jan. (28)[Suppl1]:58-63.

5. Gunnell D et al. The global distribution of fatal pesticide self-poisoning: Systematic review. BMC Public Health. 2007 Dec. 21;7:357.

6. Vijayakumar L and Satheesh-Babu R. Does ‘no pesticide’ reduce suicides? Int J Soc Psychiatry. 2009 Jul 17;55:401-6.

7. Kreitman N. The coal gas story. United Kingdom suicide rates, 1960-71. Br J Prev Soc Med. 1976 Jun;30(2)86-93.

8. Ajdacic-Gross V et al. Changing times: A longitudinal analysis of international firearm suicide data. Am J Public Health. 2006 Oct;96(10):1752-5.

9. Reisch T et al. Change in suicide rates in Switzerland before and after firearm restriction resulting from the 2003 “Army XXI” reform. Am J Psychiatry. 2013 Sep170(9):977-84.

10. Lubin G et al. Decrease in suicide rates after a change of policy reducing access to firearms in adolescents: A naturalistic epidemiological study. Suicide Life Threat Behav. 2010 Oct;40(5):421-4.

11. Sinyor M and Levitt A. Effect of a barrier at Bloor Street Viaduct on suicide rates in Toronto: Natural experiment BMJ. 2010;341. doi: 1136/bmjc2884.

12. O’Carroll P and Silverman M. Community suicide prevention: The effectiveness of bridge barriers. Suicide Life Threat Behav. 1994 Spring;24(1):89-91; discussion 91-9.

13. Pelletier A. Preventing suicide by jumping: The effect of a bridge safety fence. Inj Prev. 2007 Feb;13(1):57-9.

14. Bennewith O et al. Effect of barriers on the Clifton suspension bridge, England, on local patterns of suicide: Implications for prevention. Br J Psychiatry. 2007 Mar;190:266-7.

15. Harvard T.H. Chan School of Public Health. 2004. “How do people most commonly complete suicide?”

16. “How cliff diving works,” by Heather Kolich, HowStuffWorks.com. Oct 5, 2009.

17. “Bridge design and construction statistics.” Goldengate.org

18. “How did teen survive fall from Golden Gate Bridge?” by Remy Molina, Live Science. Apr 19, 2011.

19. Seiden R. Where are they now? A follow-up study of suicide attempters from the Golden Gate Bridge. Suicide Life Threat Behav. 1978 Winter;8(4):203-16.

20. Presidio demographics. Point2homes.com.

21. Baca-García E et al. A prospective study of the paradoxical relationship between impulsivity and lethality of suicide attempts. J Clin Psychiatry. 2001 Jul;62(7):560-4.

22. Lim M et al. Differences between impulsive and non-impulsive suicide attempts among individuals treated in emergency rooms of South Korea. Psychiatry Investig. 2016 Jul;13(4):389-96.

23. Simon O et al. Characteristics of impulsive suicide attempts and attempters. Suicide Life Threat Behav. 2001;32(1 Suppl):49-59.

24. Anestis M et al. Reconsidering the link between impulsivity and suicidal behavior. Pers Soc Psychol Rev. 2014 Nov;18(4):366-86.

25. Ostamo A et al. Excess mortality of suicide attempters. Psychiatry Psychiatr Epidemiol. 2001 Jan;36(1):29-35.

26. Leon A et al. Statistical issues in the identification of risk factors for suicidal behavior: The application of survival analysis. Psychiatry Res. 1990 Jan;31(1):99-108.

27. Bostwick J et al. Suicide attempt as a risk factor for completed suicide: Even more lethal than we knew. Am J Psychiatry. 2016 Nov 1;173(11):1094-100.

28. Stone D and Crosby A. Suicide prevention. Am J Lifestyle Med. 2014;8(6):404-20.

29. Belsher B et al. Prediction models for suicide attempts and deaths: A systematic review and simulation. JAMA Psychiatry. 2019 Mar 13. doi: 10.1001/jamapsychiatry.2019.0174.

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Monitoring, early intervention key to CAR T safety

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Wed, 01/11/2023 - 15:12

 

– Constant patient monitoring and early intervention with tocilizumab and steroids are essential to the safe delivery of chimeric antigen receptor (CAR) T-cell therapy in patients with non-Hodgkin lymphoma (NHL), according to a leading expert.

Dr. Loretta Nastoupil, clinical researcher at MD Anderson Cancer Center in Houston
Dr. Loretta Nastoupil

As a clinical researcher at MD Anderson Cancer Center in Houston, Loretta Nastoupil, MD has played an active role in the evolution of CAR T-cell therapy, from early trials to ongoing development of treatment protocols. During a presentation at the annual meeting of the British Society for Haematology, Dr. Nastoupil discussed leading topics in CAR T-cell therapy, with an emphasis on safe delivery.

“[Toxicity] is something we don’t talk about as much as we should, partly because this therapy works and it’s really exciting,” Dr. Nastoupil said. “But the toxicity is not something that I minimize, and it’s very challenging. It’s led us to restructure our inpatient services. It’s led to a lot of sleepless nights. These patients can do very, very well, or they can do very, very poorly in terms of toxicity and I think the most important strategy is recognition and early intervention.”

Monitoring

Early recognition depends on close monitoring, Dr. Nastoupil said, which is carried out by highly trained nursing staff who follow therapy-specific decision algorithms.

“We have nurses that are on the front line,” Dr. Nastoupil said. “They’re the most important group. We have staff that round on [patients] daily, but the nurses are there 24 hours a day. We have a flow sheet where they grade cytokine release syndrome and neurotoxicity every 8 hours, or if there is an acute change in symptoms or toxicity, they’ll do it in real time.”

Dr. Nastoupil said that if these toxicities are detected, intervention is occurring sooner than it did with some of the first patients to receive CAR-T cell therapy.

“Initially there was a lot of fear surrounding anything that would abort the CAR-T cell therapy,” Dr. Nastoupil said. “There was concern that if you were trying to mitigate some of the toxicity you might have a negative impact on efficacy ... [W]ith the first iteration of studies, generally we were waiting until grade 3 or higher cytokine release syndrome before initiating either tocilizumab and/or steroids. As the studies evolved, it started to move into grade 2 toxicity that we started using therapy, mostly because we started to see that those patients were still responding.”

At MD Anderson, these earlier interventions have decreased severity of adverse events.

“It’s rare nowadays to have grade 3 or 4 cytokine release syndrome because we are generally introducing abortive therapy at grade 2,” Dr. Nastoupil said, citing increased use of steroids and tocilizumab.

Currently, no consensus exists for managing these events, partly because clinicians are still learning about best management practices.

“There will be a consensus on management,” Dr. Nastoupil said. “I think that’s needed. The problem is, it will probably evolve as we get more experience with managing these patients. I think there’s been a little hesitation to put something out on paper knowing that a year from now that might change.”

 

 

Grading toxicity

In contrast, Dr. Nastoupil said that a consensus has been reached for grading acute toxicity. Of note, fever is now considered an essential element of cytokine release syndrome.

“The first thing we see [with cytokine release syndrome] is fever, generally speaking,” Dr. Nastoupil said. “That will prompt a workup for infection because these patients are going to be neutropenic. And we initiate broad spectrum antimicrobials.”

She said that some patients treated with CAR T-cell therapy have had disseminated fungal infections, so clinicians need to be on the lookout for septic shock.

To assess neurotoxicity, the team at MD Anderson uses an objective scoring system, called “CARTOX.” This helps maintain consistency when facing broadly different neurological presentations.



“There’s such a wide ranging spectrum of patients that are undergoing neurotoxicity you can’t expect someone, even myself, to be consistent when you are trying to tease out how serious it is,” Dr. Nastoupil said.

With CARTOX, nurses can easily score patients and call clinicians with results. Still, this doesn’t eliminate difficulties inherent to managing neurotoxicity, particularly when it is severe.

“I’d say one of the areas that is still very challenging is when [patients with neurotoxicity] are no longer responding,” Dr. Nastoupil said. “You have to be very mindful of seizure activity. We’ve had a couple of patients with status [epilepticus]. You don’t see seizure activity physically, but when you do an EEG, you pick it up.”

Dr. Nastoupil added that most centers are now giving patients prophylactic levetiracetam (Keppra) to lower seizure risk.

Choosing therapy

When selecting between the two therapies currently approved by the Food and Drug Administration – tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta) – based on safety, Dr. Nastoupil said that rates of cytokine release syndrome appear similar, but neurotoxicity rates may differ.

“Cytokine release syndrome in my opinion is probably more similar than different in terms of grade 3 or higher because tocilizumab and steroids work quite well in aborting those toxicities,” Dr. Nastoupil said. “But neurotoxicity still sticks out in my mind as the most striking difference, where with axicabtagene you see more grade 3 or higher neurotoxicity, though very, very few deaths as a result of this. But it’s very challenging in terms of management.”

According to Dr. Nastoupil, comparisons between CAR T-cell therapies have been complicated by differences in clinical trial methodologies. However, she offered a general conclusion regarding efficacy.

“[W]hat I’ll tell you, at the end of the day, is [that existing CAR T-cell therapies] all seem to sort of settle out around 30%-40% in terms of durable responses,” Dr. Nastoupil said.

Dr. Nastoupil concluded her presentation with an overview and look to the future.

“I do think [CAR T-cell therapy] is transformative, particularly for our chemo refractory patients,” she said. “There is nothing else like it. The problem right now is that it is only durable in 40% of patients. So can we be better at selecting out patients that are more likely to respond? Does introducing this in earlier lines of therapy increase that fraction of patients that are potentially cured?”

Considering these questions, she said: “We need more patients. We need more data. We need longer follow-up to understand the nuances of this therapy.”

Dr. Nastoupil previously reported financial relationships with Celgene, Genentech, Gilead, Merck, Novartis, Spectrum, and TG Therapeutics.

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– Constant patient monitoring and early intervention with tocilizumab and steroids are essential to the safe delivery of chimeric antigen receptor (CAR) T-cell therapy in patients with non-Hodgkin lymphoma (NHL), according to a leading expert.

Dr. Loretta Nastoupil, clinical researcher at MD Anderson Cancer Center in Houston
Dr. Loretta Nastoupil

As a clinical researcher at MD Anderson Cancer Center in Houston, Loretta Nastoupil, MD has played an active role in the evolution of CAR T-cell therapy, from early trials to ongoing development of treatment protocols. During a presentation at the annual meeting of the British Society for Haematology, Dr. Nastoupil discussed leading topics in CAR T-cell therapy, with an emphasis on safe delivery.

“[Toxicity] is something we don’t talk about as much as we should, partly because this therapy works and it’s really exciting,” Dr. Nastoupil said. “But the toxicity is not something that I minimize, and it’s very challenging. It’s led us to restructure our inpatient services. It’s led to a lot of sleepless nights. These patients can do very, very well, or they can do very, very poorly in terms of toxicity and I think the most important strategy is recognition and early intervention.”

Monitoring

Early recognition depends on close monitoring, Dr. Nastoupil said, which is carried out by highly trained nursing staff who follow therapy-specific decision algorithms.

“We have nurses that are on the front line,” Dr. Nastoupil said. “They’re the most important group. We have staff that round on [patients] daily, but the nurses are there 24 hours a day. We have a flow sheet where they grade cytokine release syndrome and neurotoxicity every 8 hours, or if there is an acute change in symptoms or toxicity, they’ll do it in real time.”

Dr. Nastoupil said that if these toxicities are detected, intervention is occurring sooner than it did with some of the first patients to receive CAR-T cell therapy.

“Initially there was a lot of fear surrounding anything that would abort the CAR-T cell therapy,” Dr. Nastoupil said. “There was concern that if you were trying to mitigate some of the toxicity you might have a negative impact on efficacy ... [W]ith the first iteration of studies, generally we were waiting until grade 3 or higher cytokine release syndrome before initiating either tocilizumab and/or steroids. As the studies evolved, it started to move into grade 2 toxicity that we started using therapy, mostly because we started to see that those patients were still responding.”

At MD Anderson, these earlier interventions have decreased severity of adverse events.

“It’s rare nowadays to have grade 3 or 4 cytokine release syndrome because we are generally introducing abortive therapy at grade 2,” Dr. Nastoupil said, citing increased use of steroids and tocilizumab.

Currently, no consensus exists for managing these events, partly because clinicians are still learning about best management practices.

“There will be a consensus on management,” Dr. Nastoupil said. “I think that’s needed. The problem is, it will probably evolve as we get more experience with managing these patients. I think there’s been a little hesitation to put something out on paper knowing that a year from now that might change.”

 

 

Grading toxicity

In contrast, Dr. Nastoupil said that a consensus has been reached for grading acute toxicity. Of note, fever is now considered an essential element of cytokine release syndrome.

“The first thing we see [with cytokine release syndrome] is fever, generally speaking,” Dr. Nastoupil said. “That will prompt a workup for infection because these patients are going to be neutropenic. And we initiate broad spectrum antimicrobials.”

She said that some patients treated with CAR T-cell therapy have had disseminated fungal infections, so clinicians need to be on the lookout for septic shock.

To assess neurotoxicity, the team at MD Anderson uses an objective scoring system, called “CARTOX.” This helps maintain consistency when facing broadly different neurological presentations.



“There’s such a wide ranging spectrum of patients that are undergoing neurotoxicity you can’t expect someone, even myself, to be consistent when you are trying to tease out how serious it is,” Dr. Nastoupil said.

With CARTOX, nurses can easily score patients and call clinicians with results. Still, this doesn’t eliminate difficulties inherent to managing neurotoxicity, particularly when it is severe.

“I’d say one of the areas that is still very challenging is when [patients with neurotoxicity] are no longer responding,” Dr. Nastoupil said. “You have to be very mindful of seizure activity. We’ve had a couple of patients with status [epilepticus]. You don’t see seizure activity physically, but when you do an EEG, you pick it up.”

Dr. Nastoupil added that most centers are now giving patients prophylactic levetiracetam (Keppra) to lower seizure risk.

Choosing therapy

When selecting between the two therapies currently approved by the Food and Drug Administration – tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta) – based on safety, Dr. Nastoupil said that rates of cytokine release syndrome appear similar, but neurotoxicity rates may differ.

“Cytokine release syndrome in my opinion is probably more similar than different in terms of grade 3 or higher because tocilizumab and steroids work quite well in aborting those toxicities,” Dr. Nastoupil said. “But neurotoxicity still sticks out in my mind as the most striking difference, where with axicabtagene you see more grade 3 or higher neurotoxicity, though very, very few deaths as a result of this. But it’s very challenging in terms of management.”

According to Dr. Nastoupil, comparisons between CAR T-cell therapies have been complicated by differences in clinical trial methodologies. However, she offered a general conclusion regarding efficacy.

“[W]hat I’ll tell you, at the end of the day, is [that existing CAR T-cell therapies] all seem to sort of settle out around 30%-40% in terms of durable responses,” Dr. Nastoupil said.

Dr. Nastoupil concluded her presentation with an overview and look to the future.

“I do think [CAR T-cell therapy] is transformative, particularly for our chemo refractory patients,” she said. “There is nothing else like it. The problem right now is that it is only durable in 40% of patients. So can we be better at selecting out patients that are more likely to respond? Does introducing this in earlier lines of therapy increase that fraction of patients that are potentially cured?”

Considering these questions, she said: “We need more patients. We need more data. We need longer follow-up to understand the nuances of this therapy.”

Dr. Nastoupil previously reported financial relationships with Celgene, Genentech, Gilead, Merck, Novartis, Spectrum, and TG Therapeutics.

 

– Constant patient monitoring and early intervention with tocilizumab and steroids are essential to the safe delivery of chimeric antigen receptor (CAR) T-cell therapy in patients with non-Hodgkin lymphoma (NHL), according to a leading expert.

Dr. Loretta Nastoupil, clinical researcher at MD Anderson Cancer Center in Houston
Dr. Loretta Nastoupil

As a clinical researcher at MD Anderson Cancer Center in Houston, Loretta Nastoupil, MD has played an active role in the evolution of CAR T-cell therapy, from early trials to ongoing development of treatment protocols. During a presentation at the annual meeting of the British Society for Haematology, Dr. Nastoupil discussed leading topics in CAR T-cell therapy, with an emphasis on safe delivery.

“[Toxicity] is something we don’t talk about as much as we should, partly because this therapy works and it’s really exciting,” Dr. Nastoupil said. “But the toxicity is not something that I minimize, and it’s very challenging. It’s led us to restructure our inpatient services. It’s led to a lot of sleepless nights. These patients can do very, very well, or they can do very, very poorly in terms of toxicity and I think the most important strategy is recognition and early intervention.”

Monitoring

Early recognition depends on close monitoring, Dr. Nastoupil said, which is carried out by highly trained nursing staff who follow therapy-specific decision algorithms.

“We have nurses that are on the front line,” Dr. Nastoupil said. “They’re the most important group. We have staff that round on [patients] daily, but the nurses are there 24 hours a day. We have a flow sheet where they grade cytokine release syndrome and neurotoxicity every 8 hours, or if there is an acute change in symptoms or toxicity, they’ll do it in real time.”

Dr. Nastoupil said that if these toxicities are detected, intervention is occurring sooner than it did with some of the first patients to receive CAR-T cell therapy.

“Initially there was a lot of fear surrounding anything that would abort the CAR-T cell therapy,” Dr. Nastoupil said. “There was concern that if you were trying to mitigate some of the toxicity you might have a negative impact on efficacy ... [W]ith the first iteration of studies, generally we were waiting until grade 3 or higher cytokine release syndrome before initiating either tocilizumab and/or steroids. As the studies evolved, it started to move into grade 2 toxicity that we started using therapy, mostly because we started to see that those patients were still responding.”

At MD Anderson, these earlier interventions have decreased severity of adverse events.

“It’s rare nowadays to have grade 3 or 4 cytokine release syndrome because we are generally introducing abortive therapy at grade 2,” Dr. Nastoupil said, citing increased use of steroids and tocilizumab.

Currently, no consensus exists for managing these events, partly because clinicians are still learning about best management practices.

“There will be a consensus on management,” Dr. Nastoupil said. “I think that’s needed. The problem is, it will probably evolve as we get more experience with managing these patients. I think there’s been a little hesitation to put something out on paper knowing that a year from now that might change.”

 

 

Grading toxicity

In contrast, Dr. Nastoupil said that a consensus has been reached for grading acute toxicity. Of note, fever is now considered an essential element of cytokine release syndrome.

“The first thing we see [with cytokine release syndrome] is fever, generally speaking,” Dr. Nastoupil said. “That will prompt a workup for infection because these patients are going to be neutropenic. And we initiate broad spectrum antimicrobials.”

She said that some patients treated with CAR T-cell therapy have had disseminated fungal infections, so clinicians need to be on the lookout for septic shock.

To assess neurotoxicity, the team at MD Anderson uses an objective scoring system, called “CARTOX.” This helps maintain consistency when facing broadly different neurological presentations.



“There’s such a wide ranging spectrum of patients that are undergoing neurotoxicity you can’t expect someone, even myself, to be consistent when you are trying to tease out how serious it is,” Dr. Nastoupil said.

With CARTOX, nurses can easily score patients and call clinicians with results. Still, this doesn’t eliminate difficulties inherent to managing neurotoxicity, particularly when it is severe.

“I’d say one of the areas that is still very challenging is when [patients with neurotoxicity] are no longer responding,” Dr. Nastoupil said. “You have to be very mindful of seizure activity. We’ve had a couple of patients with status [epilepticus]. You don’t see seizure activity physically, but when you do an EEG, you pick it up.”

Dr. Nastoupil added that most centers are now giving patients prophylactic levetiracetam (Keppra) to lower seizure risk.

Choosing therapy

When selecting between the two therapies currently approved by the Food and Drug Administration – tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta) – based on safety, Dr. Nastoupil said that rates of cytokine release syndrome appear similar, but neurotoxicity rates may differ.

“Cytokine release syndrome in my opinion is probably more similar than different in terms of grade 3 or higher because tocilizumab and steroids work quite well in aborting those toxicities,” Dr. Nastoupil said. “But neurotoxicity still sticks out in my mind as the most striking difference, where with axicabtagene you see more grade 3 or higher neurotoxicity, though very, very few deaths as a result of this. But it’s very challenging in terms of management.”

According to Dr. Nastoupil, comparisons between CAR T-cell therapies have been complicated by differences in clinical trial methodologies. However, she offered a general conclusion regarding efficacy.

“[W]hat I’ll tell you, at the end of the day, is [that existing CAR T-cell therapies] all seem to sort of settle out around 30%-40% in terms of durable responses,” Dr. Nastoupil said.

Dr. Nastoupil concluded her presentation with an overview and look to the future.

“I do think [CAR T-cell therapy] is transformative, particularly for our chemo refractory patients,” she said. “There is nothing else like it. The problem right now is that it is only durable in 40% of patients. So can we be better at selecting out patients that are more likely to respond? Does introducing this in earlier lines of therapy increase that fraction of patients that are potentially cured?”

Considering these questions, she said: “We need more patients. We need more data. We need longer follow-up to understand the nuances of this therapy.”

Dr. Nastoupil previously reported financial relationships with Celgene, Genentech, Gilead, Merck, Novartis, Spectrum, and TG Therapeutics.

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Top 10 things physician advisors want hospitalists to know

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The practice of hospital medicine is rapidly changing. Higher-acuity patients are being admitted to hospitals already struggling with capacity, and hospitalists are being instructed to pay attention to length of stay, improve their documentation and billing, and participate in initiatives to improve hospital throughput, all while delivering high-quality patient care.

Dr. Sarguni Singh, University of Colorado at Denver, Aurora
Dr. Sarguni Singh

As hospitalists and SHM members who are also physician advisors, we have a unique understanding of these pressures. In this article, we answer common questions we receive from hospitalists regarding utilization management, care coordination, clinical documentation, and CMS regulations.
 

Why do physician advisors exist, and what do they do?

A physician advisor is hired by the hospital to act as a liaison between the hospital administration, clinical staff, and support personnel in order to ensure regulatory compliance, advise physicians on medical necessity, and assist hospital leadership in meeting overall organizational goals related to the efficient utilization of health care services.1

Given their deep knowledge of hospital systems and processes, and ability to collaborate and teach, hospitalists are well-positioned to serve in this capacity. Our primary goal as physician advisors is to help physicians continue to focus on the parts of medicine they enjoy – clinical care, education, quality improvement, research etc. – by helping to demystify complex regulatory requirements and by creating streamlined processes to make following these requirements easier.
 

Why does this matter?

We understand that regulatory and hospital systems issues such as patient class determination, appropriate clinical documentation, and hospital throughput and capacity management can feel tedious, and sometimes overwhelming, to busy hospitalists. While it is easy to attribute these problems solely to hospitals’ desire for increased revenue, these issues directly impact the quality of care we provide to their patients.

Dr. Hemali Patel, University of Colorado at Denver, Aurora
Dr. Hemali Patel

In addition, our entire financial system is predicated on appropriate health care resource utilization, financial reimbursement, demonstration of medical acuity, and our impact on the care of a patient. Thus, our ability to advocate for our patients and for ourselves is directly connected with this endeavor. Developing a working knowledge of regulatory and systems issues allows hospitalists to be more engaged in leadership and negotiations and allows us to advocate for resources we deem most important.
 

Why are clinical documentation integrity teams so important?

Accurately and specifically describing how sick your patients are helps ensure that hospitals are reimbursed appropriately, coded data is accurate for research purposes, quality metrics are attributed correctly, and patients receive the correct diagnoses.

Clarification of documentation and/or addressing “clinical validity” of a given diagnosis (e.g., acute hypoxic respiratory failure requires both hypoxia and respiratory distress) may support an increase or result in a decrease in hospital reimbursement. For example, if the reason for a patient’s admission is renal failure, renal failure with true acute hypoxic respiratory failure will be reimbursed at a rate 40% higher than renal failure without the documentation of other conditions that reflect how ill the patient really is. The patient with acute hypoxic respiratory failure (or other major comorbid condition) is genuinely sicker, thus requiring more time (length of stay) and resources (deserved higher reimbursement).
 

 

 

What is the two-midnight rule, and why does it matter?

In October of 2013, the Centers for Medicare & Medicaid Services initiated the two-midnight rule, which states a Medicare patient can be an “inpatient” class if the admitting provider determines that 1) the patient requires medically necessary care which cannot be provided outside the hospital and 2) the patient is expected to stay at least 2 midnights in the hospital.

Dr. Debra Anoff, University of Colorado at Denver, Aurora
Dr. Debra Anoff

If, at the time of admission, an admitting provider thinks it is likely that the patient may be discharged prior to 2 midnights, then outpatient care with “observation” designation is appropriate. Incorrect patient class assignment may result in significant adverse consequences for hospitals, including improper patient billing, decreased hospital reimbursement, substantial risk for external auditing, violation of Medicare conditions of participation, and even loss of accreditation.
 

Who can I talk to if I have a question about a patient’s class? What should I do if I disagree with the class assigned to my patient?

The Utilization Management team typically consists of nurses and physician advisors specifically trained in UM. This team functions as a liaison between providers and payers (particularly Medicare and Medicaid) regarding medical necessity, appropriateness of care received, and efficiency of health care services.

When it comes to discussions about patient class, start by learning more about why the determination was made. The most common reason for patient class disagreements is simply that the documentation does not reflect the severity of illness or accurately reflect the care the patient is receiving. Your documentation should communicate that your patient needs services that only the hospital can provide, and/or they need monitoring that must be done in the hospital to meet the medical necessity criteria that CMS requires for a patient to be “inpatient” class.

If you disagree with a determination provided by the UM nurse and/or physician advisor, then the case will be presented to the hospital UM committee for further review. Two physicians from the UM committee must review the case and provide their own determinations of patient status, and whichever admission determination has two votes is the one that is appropriate.
 

How do I talk to patients about class determinations?

As media coverage continues about the two-midnight rule and the impact this has on patients, providers should expect more questions about class determination from their patients.

An AARP Bulletin article from 2012 advised patients to “ask [their] own doctor whether observation status is justified … and if not ask him or her to call the hospital to explain the medical reasons why they should be admitted as inpatient.”2 Patients should be informed that providers understand the implications of patient class determinations and are making these decisions as outlined by CMS.

We recommend informing patients that the decision about whether a patient is “inpatient” or “outpatient with observation” class is complex and involves taking into consideration a patient’s medical history, the severity of their current medical condition, need for diagnostic testing, and degree of health resource utilization, as well as a provider’s medical opinion of the risk of an adverse event occurring.
 

 

 

Is it true that observation patients receive higher hospital bills?

It is a common misperception that a designation of “observation” class means that a patient’s medical bill will be higher than “inpatient” class. In 2016, CMS changed the way observation class patients are billed so that, in most scenarios, patients do not receive a higher hospital bill when placed in “observation” class.

How do I approach a denial from a payer?

Commercial payers review all hospitalizations for medical necessity and appropriateness of care received during a patient’s hospitalization. If you receive notice that all or part of your patient’s hospital stay was denied coverage, you have the option of discussing the case with the medical director of the insurance company – this is called a peer-to-peer discussion.

Dr. Sarah Stella, University of Colorado at Denver, Aurora
Dr. Sarah Stella

We recommend reviewing the patient’s case and your documentation of the care you provided prior to the peer to peer, especially since these denials may come weeks to months after you have cared for the patient. Begin your conversation by learning why the insurance company denied coverage of the stay and then provide an accurate portrayal of the acuity of illness of the patient, and the resources your hospital used in caring for them. Consider consulting with your hospital’s physician advisor for other high-yield tips.
 

How can care management help with ‘nonmedical’ hospitalizations?

Care managers are your allies for all patients, especially those with complex discharge needs. Often patients admitted for “nonmedical” reasons do not have the ability to discharge to a skilled nursing facility, long-term care facility, or home due to lack of insurance coverage or resources and/or assistance. Care managers can help you creatively problem solve and coordinate care. Physician advisors are your allies in helping create system-level interventions that might avert some of these “nonmedical” admissions. Consider involving both care managers and physician advisors early in the admission to help navigate social complexities.

How can hospitalists get involved?

According to CMS, the decision on “whether patients will require further treatment as hospital inpatients or if they are able to be discharged from the hospital … can typically be made in less than 48 hours, usually in less than 24 hours.”3 In reality, this is not black and white. The “2 midnights” has brought a host of new challenges for hospitals, hospitalists, and patients to navigate. The Society of Hospital Medicine released an Observation White Paper in 2017 challenging the status quo and proposing comprehensive observation reform.4

We encourage hospital medicine providers to more routinely engage with their institutional physician advisors and consider joining the SHM Public Policy Committee to become more involved in advocacy, and/or consider becoming a physician advisor.
 

Dr. Singh is physician advisor for Utilization & CM in the division of hospital medicine at the University of Colorado at Denver, Aurora. Dr. Patel is a hospitalist and assistant professor of medicine at the university. Dr. Anoff is director of clinical operations and director of nights for the Hospital Medicine Group at the University of Colorado at Denver. Dr. Stella is a hospitalist at Denver Health and Hospital Authority and an associate professor of medicine at the university.

References

1. What is a physician advisor? 2017 Oct 9.

2. Barry P. Medicare: Inpatient or outpatient. AARP Bulletin. 2012 Oct.

3. Goldberg TH. The long-term and post-acute care continuum. WV Med J. 2014 Nov-Dec;10(6):24-30.

4. Society of Hospital Medicine Public Policy Committee. The hospital observation care problem. Perspectives and solutions from the Society of Hospital Medicine. 2017 Sep.

Publications
Topics
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The practice of hospital medicine is rapidly changing. Higher-acuity patients are being admitted to hospitals already struggling with capacity, and hospitalists are being instructed to pay attention to length of stay, improve their documentation and billing, and participate in initiatives to improve hospital throughput, all while delivering high-quality patient care.

Dr. Sarguni Singh, University of Colorado at Denver, Aurora
Dr. Sarguni Singh

As hospitalists and SHM members who are also physician advisors, we have a unique understanding of these pressures. In this article, we answer common questions we receive from hospitalists regarding utilization management, care coordination, clinical documentation, and CMS regulations.
 

Why do physician advisors exist, and what do they do?

A physician advisor is hired by the hospital to act as a liaison between the hospital administration, clinical staff, and support personnel in order to ensure regulatory compliance, advise physicians on medical necessity, and assist hospital leadership in meeting overall organizational goals related to the efficient utilization of health care services.1

Given their deep knowledge of hospital systems and processes, and ability to collaborate and teach, hospitalists are well-positioned to serve in this capacity. Our primary goal as physician advisors is to help physicians continue to focus on the parts of medicine they enjoy – clinical care, education, quality improvement, research etc. – by helping to demystify complex regulatory requirements and by creating streamlined processes to make following these requirements easier.
 

Why does this matter?

We understand that regulatory and hospital systems issues such as patient class determination, appropriate clinical documentation, and hospital throughput and capacity management can feel tedious, and sometimes overwhelming, to busy hospitalists. While it is easy to attribute these problems solely to hospitals’ desire for increased revenue, these issues directly impact the quality of care we provide to their patients.

Dr. Hemali Patel, University of Colorado at Denver, Aurora
Dr. Hemali Patel

In addition, our entire financial system is predicated on appropriate health care resource utilization, financial reimbursement, demonstration of medical acuity, and our impact on the care of a patient. Thus, our ability to advocate for our patients and for ourselves is directly connected with this endeavor. Developing a working knowledge of regulatory and systems issues allows hospitalists to be more engaged in leadership and negotiations and allows us to advocate for resources we deem most important.
 

Why are clinical documentation integrity teams so important?

Accurately and specifically describing how sick your patients are helps ensure that hospitals are reimbursed appropriately, coded data is accurate for research purposes, quality metrics are attributed correctly, and patients receive the correct diagnoses.

Clarification of documentation and/or addressing “clinical validity” of a given diagnosis (e.g., acute hypoxic respiratory failure requires both hypoxia and respiratory distress) may support an increase or result in a decrease in hospital reimbursement. For example, if the reason for a patient’s admission is renal failure, renal failure with true acute hypoxic respiratory failure will be reimbursed at a rate 40% higher than renal failure without the documentation of other conditions that reflect how ill the patient really is. The patient with acute hypoxic respiratory failure (or other major comorbid condition) is genuinely sicker, thus requiring more time (length of stay) and resources (deserved higher reimbursement).
 

 

 

What is the two-midnight rule, and why does it matter?

In October of 2013, the Centers for Medicare & Medicaid Services initiated the two-midnight rule, which states a Medicare patient can be an “inpatient” class if the admitting provider determines that 1) the patient requires medically necessary care which cannot be provided outside the hospital and 2) the patient is expected to stay at least 2 midnights in the hospital.

Dr. Debra Anoff, University of Colorado at Denver, Aurora
Dr. Debra Anoff

If, at the time of admission, an admitting provider thinks it is likely that the patient may be discharged prior to 2 midnights, then outpatient care with “observation” designation is appropriate. Incorrect patient class assignment may result in significant adverse consequences for hospitals, including improper patient billing, decreased hospital reimbursement, substantial risk for external auditing, violation of Medicare conditions of participation, and even loss of accreditation.
 

Who can I talk to if I have a question about a patient’s class? What should I do if I disagree with the class assigned to my patient?

The Utilization Management team typically consists of nurses and physician advisors specifically trained in UM. This team functions as a liaison between providers and payers (particularly Medicare and Medicaid) regarding medical necessity, appropriateness of care received, and efficiency of health care services.

When it comes to discussions about patient class, start by learning more about why the determination was made. The most common reason for patient class disagreements is simply that the documentation does not reflect the severity of illness or accurately reflect the care the patient is receiving. Your documentation should communicate that your patient needs services that only the hospital can provide, and/or they need monitoring that must be done in the hospital to meet the medical necessity criteria that CMS requires for a patient to be “inpatient” class.

If you disagree with a determination provided by the UM nurse and/or physician advisor, then the case will be presented to the hospital UM committee for further review. Two physicians from the UM committee must review the case and provide their own determinations of patient status, and whichever admission determination has two votes is the one that is appropriate.
 

How do I talk to patients about class determinations?

As media coverage continues about the two-midnight rule and the impact this has on patients, providers should expect more questions about class determination from their patients.

An AARP Bulletin article from 2012 advised patients to “ask [their] own doctor whether observation status is justified … and if not ask him or her to call the hospital to explain the medical reasons why they should be admitted as inpatient.”2 Patients should be informed that providers understand the implications of patient class determinations and are making these decisions as outlined by CMS.

We recommend informing patients that the decision about whether a patient is “inpatient” or “outpatient with observation” class is complex and involves taking into consideration a patient’s medical history, the severity of their current medical condition, need for diagnostic testing, and degree of health resource utilization, as well as a provider’s medical opinion of the risk of an adverse event occurring.
 

 

 

Is it true that observation patients receive higher hospital bills?

It is a common misperception that a designation of “observation” class means that a patient’s medical bill will be higher than “inpatient” class. In 2016, CMS changed the way observation class patients are billed so that, in most scenarios, patients do not receive a higher hospital bill when placed in “observation” class.

How do I approach a denial from a payer?

Commercial payers review all hospitalizations for medical necessity and appropriateness of care received during a patient’s hospitalization. If you receive notice that all or part of your patient’s hospital stay was denied coverage, you have the option of discussing the case with the medical director of the insurance company – this is called a peer-to-peer discussion.

Dr. Sarah Stella, University of Colorado at Denver, Aurora
Dr. Sarah Stella

We recommend reviewing the patient’s case and your documentation of the care you provided prior to the peer to peer, especially since these denials may come weeks to months after you have cared for the patient. Begin your conversation by learning why the insurance company denied coverage of the stay and then provide an accurate portrayal of the acuity of illness of the patient, and the resources your hospital used in caring for them. Consider consulting with your hospital’s physician advisor for other high-yield tips.
 

How can care management help with ‘nonmedical’ hospitalizations?

Care managers are your allies for all patients, especially those with complex discharge needs. Often patients admitted for “nonmedical” reasons do not have the ability to discharge to a skilled nursing facility, long-term care facility, or home due to lack of insurance coverage or resources and/or assistance. Care managers can help you creatively problem solve and coordinate care. Physician advisors are your allies in helping create system-level interventions that might avert some of these “nonmedical” admissions. Consider involving both care managers and physician advisors early in the admission to help navigate social complexities.

How can hospitalists get involved?

According to CMS, the decision on “whether patients will require further treatment as hospital inpatients or if they are able to be discharged from the hospital … can typically be made in less than 48 hours, usually in less than 24 hours.”3 In reality, this is not black and white. The “2 midnights” has brought a host of new challenges for hospitals, hospitalists, and patients to navigate. The Society of Hospital Medicine released an Observation White Paper in 2017 challenging the status quo and proposing comprehensive observation reform.4

We encourage hospital medicine providers to more routinely engage with their institutional physician advisors and consider joining the SHM Public Policy Committee to become more involved in advocacy, and/or consider becoming a physician advisor.
 

Dr. Singh is physician advisor for Utilization & CM in the division of hospital medicine at the University of Colorado at Denver, Aurora. Dr. Patel is a hospitalist and assistant professor of medicine at the university. Dr. Anoff is director of clinical operations and director of nights for the Hospital Medicine Group at the University of Colorado at Denver. Dr. Stella is a hospitalist at Denver Health and Hospital Authority and an associate professor of medicine at the university.

References

1. What is a physician advisor? 2017 Oct 9.

2. Barry P. Medicare: Inpatient or outpatient. AARP Bulletin. 2012 Oct.

3. Goldberg TH. The long-term and post-acute care continuum. WV Med J. 2014 Nov-Dec;10(6):24-30.

4. Society of Hospital Medicine Public Policy Committee. The hospital observation care problem. Perspectives and solutions from the Society of Hospital Medicine. 2017 Sep.

The practice of hospital medicine is rapidly changing. Higher-acuity patients are being admitted to hospitals already struggling with capacity, and hospitalists are being instructed to pay attention to length of stay, improve their documentation and billing, and participate in initiatives to improve hospital throughput, all while delivering high-quality patient care.

Dr. Sarguni Singh, University of Colorado at Denver, Aurora
Dr. Sarguni Singh

As hospitalists and SHM members who are also physician advisors, we have a unique understanding of these pressures. In this article, we answer common questions we receive from hospitalists regarding utilization management, care coordination, clinical documentation, and CMS regulations.
 

Why do physician advisors exist, and what do they do?

A physician advisor is hired by the hospital to act as a liaison between the hospital administration, clinical staff, and support personnel in order to ensure regulatory compliance, advise physicians on medical necessity, and assist hospital leadership in meeting overall organizational goals related to the efficient utilization of health care services.1

Given their deep knowledge of hospital systems and processes, and ability to collaborate and teach, hospitalists are well-positioned to serve in this capacity. Our primary goal as physician advisors is to help physicians continue to focus on the parts of medicine they enjoy – clinical care, education, quality improvement, research etc. – by helping to demystify complex regulatory requirements and by creating streamlined processes to make following these requirements easier.
 

Why does this matter?

We understand that regulatory and hospital systems issues such as patient class determination, appropriate clinical documentation, and hospital throughput and capacity management can feel tedious, and sometimes overwhelming, to busy hospitalists. While it is easy to attribute these problems solely to hospitals’ desire for increased revenue, these issues directly impact the quality of care we provide to their patients.

Dr. Hemali Patel, University of Colorado at Denver, Aurora
Dr. Hemali Patel

In addition, our entire financial system is predicated on appropriate health care resource utilization, financial reimbursement, demonstration of medical acuity, and our impact on the care of a patient. Thus, our ability to advocate for our patients and for ourselves is directly connected with this endeavor. Developing a working knowledge of regulatory and systems issues allows hospitalists to be more engaged in leadership and negotiations and allows us to advocate for resources we deem most important.
 

Why are clinical documentation integrity teams so important?

Accurately and specifically describing how sick your patients are helps ensure that hospitals are reimbursed appropriately, coded data is accurate for research purposes, quality metrics are attributed correctly, and patients receive the correct diagnoses.

Clarification of documentation and/or addressing “clinical validity” of a given diagnosis (e.g., acute hypoxic respiratory failure requires both hypoxia and respiratory distress) may support an increase or result in a decrease in hospital reimbursement. For example, if the reason for a patient’s admission is renal failure, renal failure with true acute hypoxic respiratory failure will be reimbursed at a rate 40% higher than renal failure without the documentation of other conditions that reflect how ill the patient really is. The patient with acute hypoxic respiratory failure (or other major comorbid condition) is genuinely sicker, thus requiring more time (length of stay) and resources (deserved higher reimbursement).
 

 

 

What is the two-midnight rule, and why does it matter?

In October of 2013, the Centers for Medicare & Medicaid Services initiated the two-midnight rule, which states a Medicare patient can be an “inpatient” class if the admitting provider determines that 1) the patient requires medically necessary care which cannot be provided outside the hospital and 2) the patient is expected to stay at least 2 midnights in the hospital.

Dr. Debra Anoff, University of Colorado at Denver, Aurora
Dr. Debra Anoff

If, at the time of admission, an admitting provider thinks it is likely that the patient may be discharged prior to 2 midnights, then outpatient care with “observation” designation is appropriate. Incorrect patient class assignment may result in significant adverse consequences for hospitals, including improper patient billing, decreased hospital reimbursement, substantial risk for external auditing, violation of Medicare conditions of participation, and even loss of accreditation.
 

Who can I talk to if I have a question about a patient’s class? What should I do if I disagree with the class assigned to my patient?

The Utilization Management team typically consists of nurses and physician advisors specifically trained in UM. This team functions as a liaison between providers and payers (particularly Medicare and Medicaid) regarding medical necessity, appropriateness of care received, and efficiency of health care services.

When it comes to discussions about patient class, start by learning more about why the determination was made. The most common reason for patient class disagreements is simply that the documentation does not reflect the severity of illness or accurately reflect the care the patient is receiving. Your documentation should communicate that your patient needs services that only the hospital can provide, and/or they need monitoring that must be done in the hospital to meet the medical necessity criteria that CMS requires for a patient to be “inpatient” class.

If you disagree with a determination provided by the UM nurse and/or physician advisor, then the case will be presented to the hospital UM committee for further review. Two physicians from the UM committee must review the case and provide their own determinations of patient status, and whichever admission determination has two votes is the one that is appropriate.
 

How do I talk to patients about class determinations?

As media coverage continues about the two-midnight rule and the impact this has on patients, providers should expect more questions about class determination from their patients.

An AARP Bulletin article from 2012 advised patients to “ask [their] own doctor whether observation status is justified … and if not ask him or her to call the hospital to explain the medical reasons why they should be admitted as inpatient.”2 Patients should be informed that providers understand the implications of patient class determinations and are making these decisions as outlined by CMS.

We recommend informing patients that the decision about whether a patient is “inpatient” or “outpatient with observation” class is complex and involves taking into consideration a patient’s medical history, the severity of their current medical condition, need for diagnostic testing, and degree of health resource utilization, as well as a provider’s medical opinion of the risk of an adverse event occurring.
 

 

 

Is it true that observation patients receive higher hospital bills?

It is a common misperception that a designation of “observation” class means that a patient’s medical bill will be higher than “inpatient” class. In 2016, CMS changed the way observation class patients are billed so that, in most scenarios, patients do not receive a higher hospital bill when placed in “observation” class.

How do I approach a denial from a payer?

Commercial payers review all hospitalizations for medical necessity and appropriateness of care received during a patient’s hospitalization. If you receive notice that all or part of your patient’s hospital stay was denied coverage, you have the option of discussing the case with the medical director of the insurance company – this is called a peer-to-peer discussion.

Dr. Sarah Stella, University of Colorado at Denver, Aurora
Dr. Sarah Stella

We recommend reviewing the patient’s case and your documentation of the care you provided prior to the peer to peer, especially since these denials may come weeks to months after you have cared for the patient. Begin your conversation by learning why the insurance company denied coverage of the stay and then provide an accurate portrayal of the acuity of illness of the patient, and the resources your hospital used in caring for them. Consider consulting with your hospital’s physician advisor for other high-yield tips.
 

How can care management help with ‘nonmedical’ hospitalizations?

Care managers are your allies for all patients, especially those with complex discharge needs. Often patients admitted for “nonmedical” reasons do not have the ability to discharge to a skilled nursing facility, long-term care facility, or home due to lack of insurance coverage or resources and/or assistance. Care managers can help you creatively problem solve and coordinate care. Physician advisors are your allies in helping create system-level interventions that might avert some of these “nonmedical” admissions. Consider involving both care managers and physician advisors early in the admission to help navigate social complexities.

How can hospitalists get involved?

According to CMS, the decision on “whether patients will require further treatment as hospital inpatients or if they are able to be discharged from the hospital … can typically be made in less than 48 hours, usually in less than 24 hours.”3 In reality, this is not black and white. The “2 midnights” has brought a host of new challenges for hospitals, hospitalists, and patients to navigate. The Society of Hospital Medicine released an Observation White Paper in 2017 challenging the status quo and proposing comprehensive observation reform.4

We encourage hospital medicine providers to more routinely engage with their institutional physician advisors and consider joining the SHM Public Policy Committee to become more involved in advocacy, and/or consider becoming a physician advisor.
 

Dr. Singh is physician advisor for Utilization & CM in the division of hospital medicine at the University of Colorado at Denver, Aurora. Dr. Patel is a hospitalist and assistant professor of medicine at the university. Dr. Anoff is director of clinical operations and director of nights for the Hospital Medicine Group at the University of Colorado at Denver. Dr. Stella is a hospitalist at Denver Health and Hospital Authority and an associate professor of medicine at the university.

References

1. What is a physician advisor? 2017 Oct 9.

2. Barry P. Medicare: Inpatient or outpatient. AARP Bulletin. 2012 Oct.

3. Goldberg TH. The long-term and post-acute care continuum. WV Med J. 2014 Nov-Dec;10(6):24-30.

4. Society of Hospital Medicine Public Policy Committee. The hospital observation care problem. Perspectives and solutions from the Society of Hospital Medicine. 2017 Sep.

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New vascular 0 + 5 training programs yield fewer PAD cases

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The new vascular surgery training protocol may not reflect what is currently occurring in practice for peripheral artery occlusive disease, and may warrant further investigation, according to a study performed by John Phair, MD, and his colleagues.

© danr13/iStockphoto

“Peripheral arterial occlusive disease constitutes a substantial portion of clinical practice in vascular surgery and, as such, trainees must graduate with proficiency in endovascular and open procedures to become capable vascular surgeons,” they stated, but the new paradigm does not appear to be reflecting that reality.

The researchers compared case volume for 0 + 5 integrated vascular surgery residents (IVSR) in the chief and junior years with their 5 + 2 fellowship counterparts (VSF) for the treatment of peripheral arterial occlusive disease. An aggregate of 887 residents and fellows from 137 programs were identified. From 2012 to 2018, VSFs performed significantly more total peripheral procedures than IVSR surgeon chiefs in the treatment of peripheral arterial occlusive disease, with VSFs consistently performing 1.7-fold (P less than .001) and 1.6-fold (P less than .001) more total peripheral cases than their integrated vascular surgery residents chief and junior counterparts, respectively. When stratified by anatomic location, VSFs were found to have performed more peripheral arterial procedures in the aortoiliac, femoropopliteal, and infrapopliteal arteries, compared with IVSR chiefs, and they also performed more total peripheral procedures than IVSR surgeon juniors, the authors reported online in the journal Surgery (2019 E-pub; doi/10.1016/j.surg.2019.02.021).

“Although both training paradigms offer operative experiences that meet criteria for graduation, it seems that VSFs currently perform more endovascular and open cases than their IVSR counterparts for peripheral arterial occlusive disease during the final phase of training. These findings may be contradictory to current thinking regarding the vascular surgery training paradigms,” the researchers concluded.

There were no disclosures reported.

SOURCE: Phari J et al. Surgery 2019 E-pub; doi/10.1016/j.surg.2019.02.021).

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The new vascular surgery training protocol may not reflect what is currently occurring in practice for peripheral artery occlusive disease, and may warrant further investigation, according to a study performed by John Phair, MD, and his colleagues.

© danr13/iStockphoto

“Peripheral arterial occlusive disease constitutes a substantial portion of clinical practice in vascular surgery and, as such, trainees must graduate with proficiency in endovascular and open procedures to become capable vascular surgeons,” they stated, but the new paradigm does not appear to be reflecting that reality.

The researchers compared case volume for 0 + 5 integrated vascular surgery residents (IVSR) in the chief and junior years with their 5 + 2 fellowship counterparts (VSF) for the treatment of peripheral arterial occlusive disease. An aggregate of 887 residents and fellows from 137 programs were identified. From 2012 to 2018, VSFs performed significantly more total peripheral procedures than IVSR surgeon chiefs in the treatment of peripheral arterial occlusive disease, with VSFs consistently performing 1.7-fold (P less than .001) and 1.6-fold (P less than .001) more total peripheral cases than their integrated vascular surgery residents chief and junior counterparts, respectively. When stratified by anatomic location, VSFs were found to have performed more peripheral arterial procedures in the aortoiliac, femoropopliteal, and infrapopliteal arteries, compared with IVSR chiefs, and they also performed more total peripheral procedures than IVSR surgeon juniors, the authors reported online in the journal Surgery (2019 E-pub; doi/10.1016/j.surg.2019.02.021).

“Although both training paradigms offer operative experiences that meet criteria for graduation, it seems that VSFs currently perform more endovascular and open cases than their IVSR counterparts for peripheral arterial occlusive disease during the final phase of training. These findings may be contradictory to current thinking regarding the vascular surgery training paradigms,” the researchers concluded.

There were no disclosures reported.

SOURCE: Phari J et al. Surgery 2019 E-pub; doi/10.1016/j.surg.2019.02.021).

 

The new vascular surgery training protocol may not reflect what is currently occurring in practice for peripheral artery occlusive disease, and may warrant further investigation, according to a study performed by John Phair, MD, and his colleagues.

© danr13/iStockphoto

“Peripheral arterial occlusive disease constitutes a substantial portion of clinical practice in vascular surgery and, as such, trainees must graduate with proficiency in endovascular and open procedures to become capable vascular surgeons,” they stated, but the new paradigm does not appear to be reflecting that reality.

The researchers compared case volume for 0 + 5 integrated vascular surgery residents (IVSR) in the chief and junior years with their 5 + 2 fellowship counterparts (VSF) for the treatment of peripheral arterial occlusive disease. An aggregate of 887 residents and fellows from 137 programs were identified. From 2012 to 2018, VSFs performed significantly more total peripheral procedures than IVSR surgeon chiefs in the treatment of peripheral arterial occlusive disease, with VSFs consistently performing 1.7-fold (P less than .001) and 1.6-fold (P less than .001) more total peripheral cases than their integrated vascular surgery residents chief and junior counterparts, respectively. When stratified by anatomic location, VSFs were found to have performed more peripheral arterial procedures in the aortoiliac, femoropopliteal, and infrapopliteal arteries, compared with IVSR chiefs, and they also performed more total peripheral procedures than IVSR surgeon juniors, the authors reported online in the journal Surgery (2019 E-pub; doi/10.1016/j.surg.2019.02.021).

“Although both training paradigms offer operative experiences that meet criteria for graduation, it seems that VSFs currently perform more endovascular and open cases than their IVSR counterparts for peripheral arterial occlusive disease during the final phase of training. These findings may be contradictory to current thinking regarding the vascular surgery training paradigms,” the researchers concluded.

There were no disclosures reported.

SOURCE: Phari J et al. Surgery 2019 E-pub; doi/10.1016/j.surg.2019.02.021).

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For more information about upcoming events and award deadlines, please visit http://agau.gastro.org and http://www.gastro.org/research-funding.



May 18-21, 2019

Digestive Disease Week® (DDW) 2018 – San Diego, CA

DDW is the world’s leading educational forum for academicians, clinicians, researchers, students, and trainees working in gastroenterology, hepatology, GI endoscopy, gastrointestinal surgery, and related fields. Whether you work in patient care, research, education or administration, the DDW program offers something for you. DDW is cosponsored by AGA, AASLD, ASGE, and SSAT.


AGA Trainee and Early Career GI Sessions at DDW 2019
Join your colleagues at special sessions to meet the unique needs of physicians who are new to the field. Participants will learn about all aspects of starting a career in clinical practice or research, have the opportunity to network with mentors and peers, and review board material.

  • May 18, 8:15 a.m.–5:30 p.m.; May 19, 8:30 a.m.–12:35 p.m.
    2019 AGA Postgraduate Course
    The AGA Institute’s flagship live educational offering and premier CME activity, the AGA Postgraduate Course, is a one-and-a-half-day multitopic course covering recent clinical advances that affect how care is delivered. This live CME activity is eligible for Maintenance of Certification (MOC) points. Saturday afternoon’s case-based breakout sessions incorporate new learning-style formats for greater audience-speaker engagement. AGA member trainees and early career GIs receive discounted pricing for this cour
  • May 19, 2–3 p.m.
    AGA Networking Hour
    This event is open to all DDW trainee and early career GI attendees and provides a casual atmosphere to network with peers. You can also meet the AGA Trainee & Early Career Committee, participate in an advocacy initiative, and learn more about all that AGA has to offer for fellows and early career GIs. This networking event will take place in the DDW Trainee and Early Career Lounge, Sails Pavilion (San Diego Convention Center). Light refreshments will be served.
  • May 20, 10–11:30 a.m.
    Introduction to GI Practice: A Trainee Boot Camp
    Trainees and early-career GIs interested in or going into private practice should attend this symposium for key tips and insights from experts for a successful career. Learn about the business of private practice GI, how to start and grow your practice, and most importantly, how to find the perfect fit for you. A “must-not-miss ‘insider tips’ session.” This activity has been approved for 1.5 AMA PRA Category 1 Credits™.
  • May 20, 1:30–5:30 p.m.
    AGA Board Review Course
    This session, designed around content from the newly released DDSEP® 9, serves as a primer for third-year fellows preparing for the board exam as well as a review course for others wanting to test their knowledge. Attendees will be provided with real-time feedback on their readiness to take the board exams and will also receive exclusive access to discounts on DDSEP to further prepare. This live CME activity is eligible for MOC points. This activity has been approved for 4 AMA PRA Category 1 Credits.
  • May 20, 2-3:30 p.m.
    Advancing Clinical Practice: GI Fellow-Directed Quality-Improvement Projects
    This trainee-focused session will showcase selected abstracts from GI fellows based on quality improvement with a state-of-the-art lecture. Attendees will learn about practical examples of successful quality-improvement projects for integration into their day-to-day work lives. This session also will provide guidance on how to develop a quality-improvement project and will target a specific need in the GI training program curriculum of addressing the development of quality-improvement requirements within training programs. This activity has been approved for 1.5 AMA PRA Category 1 Credits™.
  • May 20, 4-5:30 p.m.
    GI in the Digital Age
    Social media is becoming a major part of our daily activities at both the social and professional levels. The session will provide attendees with a comprehensive review on the use of social media to build personal brand, interact with other colleagues and with patients. Experts presenting in the session also will discuss tips improve efficiency and safety when working with electronic health records (EHRs). This activity has been approved for 1.5 AMA PRA Category 1 Credits™.

May 18, 2019, 6-8 p.m.
Digestive Health Physicians Association® and The New Gastroenterologist Networking Reception

After a full day of DDW sessions, join the Digestive Health Physicians Association (DHPA) and AGA’s The New Gastroenterologist to relax and network with independent GI physicians from across the nation. This event will take place in the Elevation Room at the Hilton San Diego Bayfront.

May 18-21, 2019, 7:30 a.m.–6 p.m.
Trainee and Early Career Lounge

This space is dedicated to trainee and young GI attendees. Come meet and network with peers from around the world over a cup of coffee. Information will be available from each of the sponsoring societies, in addition to trainee-specific programming tips at DDW.

May 21, 2019, 8-9:30 a.m.
2019 AGA Academy of Educators Plenary Session: Achieving Competence Through Learner-Engaged Teaching Methods

Join your peers to improve your teaching skills with systems and strategies from expert faculty leaders. This session is held in conjunction with DDW 2019. A portion of time will also be dedicated to endoscopy education tools and presentations from the 2018 academy grants recipients.

 

 

UPCOMING EVENTS

May 15, 2019
Coding and Reimbursement Solutions by McVey Associates Inc.

Improve the efficiency and performance of your practice by staying current on the latest reimbursement, coding and compliance changes.
Harrisburg, PA

May 15-16; June 19-20; September 18-19; October 9-10, 2019
Two-Day, In-Depth Coding and Billing Seminar

Become a certified GI coder with a two-day, in-depth training course provided by McVey Associates Inc.
San Diego, CA (May 15-16); Nashville, TN (June 19-20); Atlanta, GA (Sept. 18-19); Las Vegas, NV (Oct. 9-10)

Aug. 9-10, 2019
2019 Freston Conference: Food at the Intersection of Gut Health and Disease

GI clinicians and allied health professionals are increasingly focused on how nutrients influence GI physiology and how diet can promote sound gut health. In response to this growing body of knowledge, the 2019 James W. Freston Conference: Food at the Intersection of Gut Health and Disease, will examine how nutrition management therapies can combat GI disorders such as irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), and celiac disease and how diet supports improvement across the care continuum.
Chicago

Aug. 9-11, 2019
2019 Principles of GI for the NP and PA

The Principles of Gastroenterology for the Nurse Practitioner and Physician Assistant (NPPA) is the medical industry’s premiere course guiding and enabling nurse practitioners and physician assistants in the intricacies of identifying, treating, and managing GI disorders. Designed and taught by expert clinicians and advanced practice providers, NPPA provides the latest insights, knowledge, and research on how to improve GI patient care. Attendees will leave with stronger diagnostic and therapeutic skills, a more robust professional network, and an enhanced value for their practices.
Chicago
 

 

 

AWARDS APPLICATION DEADLINES

AGA-Gastric Cancer Foundation Ben Feinstein Memorial Research Scholar Award in Gastric Cancer
This award provides $100,000 per year for 3 years (total $300,000) to early career faculty (i.e., investigator, instructor, research associate, or equivalent) working toward an independent career in gastric cancer research. Research involving precancerous lesions will be considered if relevance to gastric cancer is explicitly outlined.
Application opens: June 3, 2019

Publications
Sections

 

For more information about upcoming events and award deadlines, please visit http://agau.gastro.org and http://www.gastro.org/research-funding.



May 18-21, 2019

Digestive Disease Week® (DDW) 2018 – San Diego, CA

DDW is the world’s leading educational forum for academicians, clinicians, researchers, students, and trainees working in gastroenterology, hepatology, GI endoscopy, gastrointestinal surgery, and related fields. Whether you work in patient care, research, education or administration, the DDW program offers something for you. DDW is cosponsored by AGA, AASLD, ASGE, and SSAT.


AGA Trainee and Early Career GI Sessions at DDW 2019
Join your colleagues at special sessions to meet the unique needs of physicians who are new to the field. Participants will learn about all aspects of starting a career in clinical practice or research, have the opportunity to network with mentors and peers, and review board material.

  • May 18, 8:15 a.m.–5:30 p.m.; May 19, 8:30 a.m.–12:35 p.m.
    2019 AGA Postgraduate Course
    The AGA Institute’s flagship live educational offering and premier CME activity, the AGA Postgraduate Course, is a one-and-a-half-day multitopic course covering recent clinical advances that affect how care is delivered. This live CME activity is eligible for Maintenance of Certification (MOC) points. Saturday afternoon’s case-based breakout sessions incorporate new learning-style formats for greater audience-speaker engagement. AGA member trainees and early career GIs receive discounted pricing for this cour
  • May 19, 2–3 p.m.
    AGA Networking Hour
    This event is open to all DDW trainee and early career GI attendees and provides a casual atmosphere to network with peers. You can also meet the AGA Trainee & Early Career Committee, participate in an advocacy initiative, and learn more about all that AGA has to offer for fellows and early career GIs. This networking event will take place in the DDW Trainee and Early Career Lounge, Sails Pavilion (San Diego Convention Center). Light refreshments will be served.
  • May 20, 10–11:30 a.m.
    Introduction to GI Practice: A Trainee Boot Camp
    Trainees and early-career GIs interested in or going into private practice should attend this symposium for key tips and insights from experts for a successful career. Learn about the business of private practice GI, how to start and grow your practice, and most importantly, how to find the perfect fit for you. A “must-not-miss ‘insider tips’ session.” This activity has been approved for 1.5 AMA PRA Category 1 Credits™.
  • May 20, 1:30–5:30 p.m.
    AGA Board Review Course
    This session, designed around content from the newly released DDSEP® 9, serves as a primer for third-year fellows preparing for the board exam as well as a review course for others wanting to test their knowledge. Attendees will be provided with real-time feedback on their readiness to take the board exams and will also receive exclusive access to discounts on DDSEP to further prepare. This live CME activity is eligible for MOC points. This activity has been approved for 4 AMA PRA Category 1 Credits.
  • May 20, 2-3:30 p.m.
    Advancing Clinical Practice: GI Fellow-Directed Quality-Improvement Projects
    This trainee-focused session will showcase selected abstracts from GI fellows based on quality improvement with a state-of-the-art lecture. Attendees will learn about practical examples of successful quality-improvement projects for integration into their day-to-day work lives. This session also will provide guidance on how to develop a quality-improvement project and will target a specific need in the GI training program curriculum of addressing the development of quality-improvement requirements within training programs. This activity has been approved for 1.5 AMA PRA Category 1 Credits™.
  • May 20, 4-5:30 p.m.
    GI in the Digital Age
    Social media is becoming a major part of our daily activities at both the social and professional levels. The session will provide attendees with a comprehensive review on the use of social media to build personal brand, interact with other colleagues and with patients. Experts presenting in the session also will discuss tips improve efficiency and safety when working with electronic health records (EHRs). This activity has been approved for 1.5 AMA PRA Category 1 Credits™.

May 18, 2019, 6-8 p.m.
Digestive Health Physicians Association® and The New Gastroenterologist Networking Reception

After a full day of DDW sessions, join the Digestive Health Physicians Association (DHPA) and AGA’s The New Gastroenterologist to relax and network with independent GI physicians from across the nation. This event will take place in the Elevation Room at the Hilton San Diego Bayfront.

May 18-21, 2019, 7:30 a.m.–6 p.m.
Trainee and Early Career Lounge

This space is dedicated to trainee and young GI attendees. Come meet and network with peers from around the world over a cup of coffee. Information will be available from each of the sponsoring societies, in addition to trainee-specific programming tips at DDW.

May 21, 2019, 8-9:30 a.m.
2019 AGA Academy of Educators Plenary Session: Achieving Competence Through Learner-Engaged Teaching Methods

Join your peers to improve your teaching skills with systems and strategies from expert faculty leaders. This session is held in conjunction with DDW 2019. A portion of time will also be dedicated to endoscopy education tools and presentations from the 2018 academy grants recipients.

 

 

UPCOMING EVENTS

May 15, 2019
Coding and Reimbursement Solutions by McVey Associates Inc.

Improve the efficiency and performance of your practice by staying current on the latest reimbursement, coding and compliance changes.
Harrisburg, PA

May 15-16; June 19-20; September 18-19; October 9-10, 2019
Two-Day, In-Depth Coding and Billing Seminar

Become a certified GI coder with a two-day, in-depth training course provided by McVey Associates Inc.
San Diego, CA (May 15-16); Nashville, TN (June 19-20); Atlanta, GA (Sept. 18-19); Las Vegas, NV (Oct. 9-10)

Aug. 9-10, 2019
2019 Freston Conference: Food at the Intersection of Gut Health and Disease

GI clinicians and allied health professionals are increasingly focused on how nutrients influence GI physiology and how diet can promote sound gut health. In response to this growing body of knowledge, the 2019 James W. Freston Conference: Food at the Intersection of Gut Health and Disease, will examine how nutrition management therapies can combat GI disorders such as irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), and celiac disease and how diet supports improvement across the care continuum.
Chicago

Aug. 9-11, 2019
2019 Principles of GI for the NP and PA

The Principles of Gastroenterology for the Nurse Practitioner and Physician Assistant (NPPA) is the medical industry’s premiere course guiding and enabling nurse practitioners and physician assistants in the intricacies of identifying, treating, and managing GI disorders. Designed and taught by expert clinicians and advanced practice providers, NPPA provides the latest insights, knowledge, and research on how to improve GI patient care. Attendees will leave with stronger diagnostic and therapeutic skills, a more robust professional network, and an enhanced value for their practices.
Chicago
 

 

 

AWARDS APPLICATION DEADLINES

AGA-Gastric Cancer Foundation Ben Feinstein Memorial Research Scholar Award in Gastric Cancer
This award provides $100,000 per year for 3 years (total $300,000) to early career faculty (i.e., investigator, instructor, research associate, or equivalent) working toward an independent career in gastric cancer research. Research involving precancerous lesions will be considered if relevance to gastric cancer is explicitly outlined.
Application opens: June 3, 2019

 

For more information about upcoming events and award deadlines, please visit http://agau.gastro.org and http://www.gastro.org/research-funding.



May 18-21, 2019

Digestive Disease Week® (DDW) 2018 – San Diego, CA

DDW is the world’s leading educational forum for academicians, clinicians, researchers, students, and trainees working in gastroenterology, hepatology, GI endoscopy, gastrointestinal surgery, and related fields. Whether you work in patient care, research, education or administration, the DDW program offers something for you. DDW is cosponsored by AGA, AASLD, ASGE, and SSAT.


AGA Trainee and Early Career GI Sessions at DDW 2019
Join your colleagues at special sessions to meet the unique needs of physicians who are new to the field. Participants will learn about all aspects of starting a career in clinical practice or research, have the opportunity to network with mentors and peers, and review board material.

  • May 18, 8:15 a.m.–5:30 p.m.; May 19, 8:30 a.m.–12:35 p.m.
    2019 AGA Postgraduate Course
    The AGA Institute’s flagship live educational offering and premier CME activity, the AGA Postgraduate Course, is a one-and-a-half-day multitopic course covering recent clinical advances that affect how care is delivered. This live CME activity is eligible for Maintenance of Certification (MOC) points. Saturday afternoon’s case-based breakout sessions incorporate new learning-style formats for greater audience-speaker engagement. AGA member trainees and early career GIs receive discounted pricing for this cour
  • May 19, 2–3 p.m.
    AGA Networking Hour
    This event is open to all DDW trainee and early career GI attendees and provides a casual atmosphere to network with peers. You can also meet the AGA Trainee & Early Career Committee, participate in an advocacy initiative, and learn more about all that AGA has to offer for fellows and early career GIs. This networking event will take place in the DDW Trainee and Early Career Lounge, Sails Pavilion (San Diego Convention Center). Light refreshments will be served.
  • May 20, 10–11:30 a.m.
    Introduction to GI Practice: A Trainee Boot Camp
    Trainees and early-career GIs interested in or going into private practice should attend this symposium for key tips and insights from experts for a successful career. Learn about the business of private practice GI, how to start and grow your practice, and most importantly, how to find the perfect fit for you. A “must-not-miss ‘insider tips’ session.” This activity has been approved for 1.5 AMA PRA Category 1 Credits™.
  • May 20, 1:30–5:30 p.m.
    AGA Board Review Course
    This session, designed around content from the newly released DDSEP® 9, serves as a primer for third-year fellows preparing for the board exam as well as a review course for others wanting to test their knowledge. Attendees will be provided with real-time feedback on their readiness to take the board exams and will also receive exclusive access to discounts on DDSEP to further prepare. This live CME activity is eligible for MOC points. This activity has been approved for 4 AMA PRA Category 1 Credits.
  • May 20, 2-3:30 p.m.
    Advancing Clinical Practice: GI Fellow-Directed Quality-Improvement Projects
    This trainee-focused session will showcase selected abstracts from GI fellows based on quality improvement with a state-of-the-art lecture. Attendees will learn about practical examples of successful quality-improvement projects for integration into their day-to-day work lives. This session also will provide guidance on how to develop a quality-improvement project and will target a specific need in the GI training program curriculum of addressing the development of quality-improvement requirements within training programs. This activity has been approved for 1.5 AMA PRA Category 1 Credits™.
  • May 20, 4-5:30 p.m.
    GI in the Digital Age
    Social media is becoming a major part of our daily activities at both the social and professional levels. The session will provide attendees with a comprehensive review on the use of social media to build personal brand, interact with other colleagues and with patients. Experts presenting in the session also will discuss tips improve efficiency and safety when working with electronic health records (EHRs). This activity has been approved for 1.5 AMA PRA Category 1 Credits™.

May 18, 2019, 6-8 p.m.
Digestive Health Physicians Association® and The New Gastroenterologist Networking Reception

After a full day of DDW sessions, join the Digestive Health Physicians Association (DHPA) and AGA’s The New Gastroenterologist to relax and network with independent GI physicians from across the nation. This event will take place in the Elevation Room at the Hilton San Diego Bayfront.

May 18-21, 2019, 7:30 a.m.–6 p.m.
Trainee and Early Career Lounge

This space is dedicated to trainee and young GI attendees. Come meet and network with peers from around the world over a cup of coffee. Information will be available from each of the sponsoring societies, in addition to trainee-specific programming tips at DDW.

May 21, 2019, 8-9:30 a.m.
2019 AGA Academy of Educators Plenary Session: Achieving Competence Through Learner-Engaged Teaching Methods

Join your peers to improve your teaching skills with systems and strategies from expert faculty leaders. This session is held in conjunction with DDW 2019. A portion of time will also be dedicated to endoscopy education tools and presentations from the 2018 academy grants recipients.

 

 

UPCOMING EVENTS

May 15, 2019
Coding and Reimbursement Solutions by McVey Associates Inc.

Improve the efficiency and performance of your practice by staying current on the latest reimbursement, coding and compliance changes.
Harrisburg, PA

May 15-16; June 19-20; September 18-19; October 9-10, 2019
Two-Day, In-Depth Coding and Billing Seminar

Become a certified GI coder with a two-day, in-depth training course provided by McVey Associates Inc.
San Diego, CA (May 15-16); Nashville, TN (June 19-20); Atlanta, GA (Sept. 18-19); Las Vegas, NV (Oct. 9-10)

Aug. 9-10, 2019
2019 Freston Conference: Food at the Intersection of Gut Health and Disease

GI clinicians and allied health professionals are increasingly focused on how nutrients influence GI physiology and how diet can promote sound gut health. In response to this growing body of knowledge, the 2019 James W. Freston Conference: Food at the Intersection of Gut Health and Disease, will examine how nutrition management therapies can combat GI disorders such as irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), and celiac disease and how diet supports improvement across the care continuum.
Chicago

Aug. 9-11, 2019
2019 Principles of GI for the NP and PA

The Principles of Gastroenterology for the Nurse Practitioner and Physician Assistant (NPPA) is the medical industry’s premiere course guiding and enabling nurse practitioners and physician assistants in the intricacies of identifying, treating, and managing GI disorders. Designed and taught by expert clinicians and advanced practice providers, NPPA provides the latest insights, knowledge, and research on how to improve GI patient care. Attendees will leave with stronger diagnostic and therapeutic skills, a more robust professional network, and an enhanced value for their practices.
Chicago
 

 

 

AWARDS APPLICATION DEADLINES

AGA-Gastric Cancer Foundation Ben Feinstein Memorial Research Scholar Award in Gastric Cancer
This award provides $100,000 per year for 3 years (total $300,000) to early career faculty (i.e., investigator, instructor, research associate, or equivalent) working toward an independent career in gastric cancer research. Research involving precancerous lesions will be considered if relevance to gastric cancer is explicitly outlined.
Application opens: June 3, 2019

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Complementary medicine use common among patients on TKIs

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Changed
Wed, 04/24/2019 - 15:32

– Many patients receiving tyrosine kinase inhibitors (TKIs) are taking complementary therapies or eating foods that interfere with TKI metabolism, based on results of a British survey of patients with chronic myeloid leukemia.

Grapefruit
©Ls9907/Thinkstockphotos.com

About one out of three patients with chronic myeloid leukemia (CML) reported taking complementary medicines, according to lead author David Sparksman, MD, of Norfolk and Norwich (England) University Hospital, and his colleagues.

Only a minority of patients were aware of the potential for dietary interactions with TKIs. However, even knowing the potential risk, about a quarter of patients still didn’t exclude these foods from their diets.

“These worrying results are unlikely to be confined to patients with CML,” the investigators wrote in an abstract presented at the annual meeting of the British Society for Haematology. “TKIs are used in the treatment of many other haematological malignancies.”

Because TKIs are metabolized by cytochrome P450 enzymes, inhibition of these enzymes by complementary therapies and foods may alter metabolism, and therefore, safety and efficacy of TKIs, according to the investigators.

“Use of complementary medicines and belief in their effectiveness is common,” the investigators wrote. “In a recent YouGov poll, 51% of those asked believed herbal medicine to be an effective treatment for illness.”

To investigate the prevalence of these beliefs and practices in a subset of cancer patients, the investigators identified 78 patients with CML undergoing follow-up at Norfolk and Norwich University Hospital. The median age of patients was 60 years. Eleven patients were excluded because they were not receiving a TKI and 6 patients declined to participate, leaving 61 patients in the final survey group.

Of these respondents, 41% had considered taking a complementary therapy and 34% were actively doing so. Further questioning revealed that about half of the patients taking a complementary medicine (52%) were taking a drug with known potential to interact with their TKI. Of these 11 patients, 5 were taking a complementary drug that would reduce serum concentrations of their TKI, potentially making it less effective. Conversely, six patients were taking a complementary drug that would increase serum concentrations, potentially increasing the risk of TKI side effects.

About 39% of respondents were aware of possible dietary interactions with TKIs, such as grapefruit. “Surprisingly,” the investigators said, 25% of patients with this knowledge still included such foods in their diet.

Dietary questioning revealed that among the patients who were unaware of food interactions, 67% were consuming foods that interact with TKIs.

Considering these results, the investigators offered some advice on patient communication and management.

“The use of complementary medicine should be discussed with all patients when starting TKIs and written information given to patients should highlight the potential dangers posed by substances which many patients currently regard as harmless,” thy wrote. “Since most patients will remain on treatment for many years, re-discussion about food and drug interactions should take place periodically to remind them of the potential risks.”

The investigators reported having no conflicts of interest.

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– Many patients receiving tyrosine kinase inhibitors (TKIs) are taking complementary therapies or eating foods that interfere with TKI metabolism, based on results of a British survey of patients with chronic myeloid leukemia.

Grapefruit
©Ls9907/Thinkstockphotos.com

About one out of three patients with chronic myeloid leukemia (CML) reported taking complementary medicines, according to lead author David Sparksman, MD, of Norfolk and Norwich (England) University Hospital, and his colleagues.

Only a minority of patients were aware of the potential for dietary interactions with TKIs. However, even knowing the potential risk, about a quarter of patients still didn’t exclude these foods from their diets.

“These worrying results are unlikely to be confined to patients with CML,” the investigators wrote in an abstract presented at the annual meeting of the British Society for Haematology. “TKIs are used in the treatment of many other haematological malignancies.”

Because TKIs are metabolized by cytochrome P450 enzymes, inhibition of these enzymes by complementary therapies and foods may alter metabolism, and therefore, safety and efficacy of TKIs, according to the investigators.

“Use of complementary medicines and belief in their effectiveness is common,” the investigators wrote. “In a recent YouGov poll, 51% of those asked believed herbal medicine to be an effective treatment for illness.”

To investigate the prevalence of these beliefs and practices in a subset of cancer patients, the investigators identified 78 patients with CML undergoing follow-up at Norfolk and Norwich University Hospital. The median age of patients was 60 years. Eleven patients were excluded because they were not receiving a TKI and 6 patients declined to participate, leaving 61 patients in the final survey group.

Of these respondents, 41% had considered taking a complementary therapy and 34% were actively doing so. Further questioning revealed that about half of the patients taking a complementary medicine (52%) were taking a drug with known potential to interact with their TKI. Of these 11 patients, 5 were taking a complementary drug that would reduce serum concentrations of their TKI, potentially making it less effective. Conversely, six patients were taking a complementary drug that would increase serum concentrations, potentially increasing the risk of TKI side effects.

About 39% of respondents were aware of possible dietary interactions with TKIs, such as grapefruit. “Surprisingly,” the investigators said, 25% of patients with this knowledge still included such foods in their diet.

Dietary questioning revealed that among the patients who were unaware of food interactions, 67% were consuming foods that interact with TKIs.

Considering these results, the investigators offered some advice on patient communication and management.

“The use of complementary medicine should be discussed with all patients when starting TKIs and written information given to patients should highlight the potential dangers posed by substances which many patients currently regard as harmless,” thy wrote. “Since most patients will remain on treatment for many years, re-discussion about food and drug interactions should take place periodically to remind them of the potential risks.”

The investigators reported having no conflicts of interest.

– Many patients receiving tyrosine kinase inhibitors (TKIs) are taking complementary therapies or eating foods that interfere with TKI metabolism, based on results of a British survey of patients with chronic myeloid leukemia.

Grapefruit
©Ls9907/Thinkstockphotos.com

About one out of three patients with chronic myeloid leukemia (CML) reported taking complementary medicines, according to lead author David Sparksman, MD, of Norfolk and Norwich (England) University Hospital, and his colleagues.

Only a minority of patients were aware of the potential for dietary interactions with TKIs. However, even knowing the potential risk, about a quarter of patients still didn’t exclude these foods from their diets.

“These worrying results are unlikely to be confined to patients with CML,” the investigators wrote in an abstract presented at the annual meeting of the British Society for Haematology. “TKIs are used in the treatment of many other haematological malignancies.”

Because TKIs are metabolized by cytochrome P450 enzymes, inhibition of these enzymes by complementary therapies and foods may alter metabolism, and therefore, safety and efficacy of TKIs, according to the investigators.

“Use of complementary medicines and belief in their effectiveness is common,” the investigators wrote. “In a recent YouGov poll, 51% of those asked believed herbal medicine to be an effective treatment for illness.”

To investigate the prevalence of these beliefs and practices in a subset of cancer patients, the investigators identified 78 patients with CML undergoing follow-up at Norfolk and Norwich University Hospital. The median age of patients was 60 years. Eleven patients were excluded because they were not receiving a TKI and 6 patients declined to participate, leaving 61 patients in the final survey group.

Of these respondents, 41% had considered taking a complementary therapy and 34% were actively doing so. Further questioning revealed that about half of the patients taking a complementary medicine (52%) were taking a drug with known potential to interact with their TKI. Of these 11 patients, 5 were taking a complementary drug that would reduce serum concentrations of their TKI, potentially making it less effective. Conversely, six patients were taking a complementary drug that would increase serum concentrations, potentially increasing the risk of TKI side effects.

About 39% of respondents were aware of possible dietary interactions with TKIs, such as grapefruit. “Surprisingly,” the investigators said, 25% of patients with this knowledge still included such foods in their diet.

Dietary questioning revealed that among the patients who were unaware of food interactions, 67% were consuming foods that interact with TKIs.

Considering these results, the investigators offered some advice on patient communication and management.

“The use of complementary medicine should be discussed with all patients when starting TKIs and written information given to patients should highlight the potential dangers posed by substances which many patients currently regard as harmless,” thy wrote. “Since most patients will remain on treatment for many years, re-discussion about food and drug interactions should take place periodically to remind them of the potential risks.”

The investigators reported having no conflicts of interest.

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In pain treatment, racial bias common among physician trainees

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Wed, 04/24/2019 - 15:33

 

– More than 40% of white physician trainees demonstrated racial bias in medical decision making about treatment of low back pain, as did 31% of nonwhite trainees. However, just 6% of white residents and fellows, and 10% of the nonwhite residents and fellows, reported that patient race had factored into their treatment decisions in a virtual patient task.

The 444 medical residents and fellows who participated viewed video vignettes presenting 12 virtual patients who presented with low back pain, wrote Alexis Grant of Indiana University–Purdue University Indianapolis and her colleagues. In a poster presentation at the scientific meeting of the American Pain Society, Ms. Grant, a doctoral student in clinical psychology, and her collaborators explained that participants agreed to view a series of 12 videos of virtual patients.

The videos presented male and female virtual patients who were black or white and who had jobs associated with low or high socioeconomic status (SES). Information in text vignettes accompanying the videos included occupation, pain etiology, physical exam findings, and pain intensity by self-report.

After viewing the videos and reading the vignettes, participating clinicians were asked to use a 0-100 visual analog scale to report their likelihood of referring patients to a pain specialist or to physical therapy and of recommending opioid or nonopioid analgesia.

“Next, they rated the degree to which they considered different sources of patient information when making treatment decision,” Ms. Grant and her coauthors wrote. Statistical analysis “examined the extent to which providers demonstrated statistically reliable treatment differences across patient race and SES.” These findings were compared with how clinicians reported they used patient race and SES in decision making.

Demonstrated race-based decision making occurred for 41% of white and 31% of nonwhite clinicians. About two-thirds of providers (67.3%) were white, and of the remainder, 26.3% were Asian, 4.4% were classified as “other,” and 2.1% were black. The respondents were aged a mean 29.7 years, and were 42.3% female.

In addition, Ms. Grant and her coauthors estimated provider SES by asking about parental SES, dividing respondents into low (less than $38,000), medium ($38,000-$75,000), and high (greater than $75,000) SES categories.

Demonstrated bias based on socioeconomic status was common, and similar across levels of provider SES, at 41%, 43%, and 38% for low, medium, and high SES residents and fellows, respectively. However, the disconnect between reported and demonstrated bias that was seen with race was not seen with SES bias, with 43%-48% of providers in each SES group reporting that they had factored patient SES into their treatment decision making.

“These results suggest that providers have low awareness of making different pain treatment decisions” for black patients, compared with decision making for white patients, Ms. Grant and her colleagues wrote. “Decision-making awareness did not substantially differ across provider race or SES.” She and her collaborators called for more research into whether raising awareness about demonstrated racial bias in decision making can improve both racial and socioeconomic gaps in pain care.

The authors reported funding from the National Institutes of Health. They reported no conflicts of interest.

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– More than 40% of white physician trainees demonstrated racial bias in medical decision making about treatment of low back pain, as did 31% of nonwhite trainees. However, just 6% of white residents and fellows, and 10% of the nonwhite residents and fellows, reported that patient race had factored into their treatment decisions in a virtual patient task.

The 444 medical residents and fellows who participated viewed video vignettes presenting 12 virtual patients who presented with low back pain, wrote Alexis Grant of Indiana University–Purdue University Indianapolis and her colleagues. In a poster presentation at the scientific meeting of the American Pain Society, Ms. Grant, a doctoral student in clinical psychology, and her collaborators explained that participants agreed to view a series of 12 videos of virtual patients.

The videos presented male and female virtual patients who were black or white and who had jobs associated with low or high socioeconomic status (SES). Information in text vignettes accompanying the videos included occupation, pain etiology, physical exam findings, and pain intensity by self-report.

After viewing the videos and reading the vignettes, participating clinicians were asked to use a 0-100 visual analog scale to report their likelihood of referring patients to a pain specialist or to physical therapy and of recommending opioid or nonopioid analgesia.

“Next, they rated the degree to which they considered different sources of patient information when making treatment decision,” Ms. Grant and her coauthors wrote. Statistical analysis “examined the extent to which providers demonstrated statistically reliable treatment differences across patient race and SES.” These findings were compared with how clinicians reported they used patient race and SES in decision making.

Demonstrated race-based decision making occurred for 41% of white and 31% of nonwhite clinicians. About two-thirds of providers (67.3%) were white, and of the remainder, 26.3% were Asian, 4.4% were classified as “other,” and 2.1% were black. The respondents were aged a mean 29.7 years, and were 42.3% female.

In addition, Ms. Grant and her coauthors estimated provider SES by asking about parental SES, dividing respondents into low (less than $38,000), medium ($38,000-$75,000), and high (greater than $75,000) SES categories.

Demonstrated bias based on socioeconomic status was common, and similar across levels of provider SES, at 41%, 43%, and 38% for low, medium, and high SES residents and fellows, respectively. However, the disconnect between reported and demonstrated bias that was seen with race was not seen with SES bias, with 43%-48% of providers in each SES group reporting that they had factored patient SES into their treatment decision making.

“These results suggest that providers have low awareness of making different pain treatment decisions” for black patients, compared with decision making for white patients, Ms. Grant and her colleagues wrote. “Decision-making awareness did not substantially differ across provider race or SES.” She and her collaborators called for more research into whether raising awareness about demonstrated racial bias in decision making can improve both racial and socioeconomic gaps in pain care.

The authors reported funding from the National Institutes of Health. They reported no conflicts of interest.

 

– More than 40% of white physician trainees demonstrated racial bias in medical decision making about treatment of low back pain, as did 31% of nonwhite trainees. However, just 6% of white residents and fellows, and 10% of the nonwhite residents and fellows, reported that patient race had factored into their treatment decisions in a virtual patient task.

The 444 medical residents and fellows who participated viewed video vignettes presenting 12 virtual patients who presented with low back pain, wrote Alexis Grant of Indiana University–Purdue University Indianapolis and her colleagues. In a poster presentation at the scientific meeting of the American Pain Society, Ms. Grant, a doctoral student in clinical psychology, and her collaborators explained that participants agreed to view a series of 12 videos of virtual patients.

The videos presented male and female virtual patients who were black or white and who had jobs associated with low or high socioeconomic status (SES). Information in text vignettes accompanying the videos included occupation, pain etiology, physical exam findings, and pain intensity by self-report.

After viewing the videos and reading the vignettes, participating clinicians were asked to use a 0-100 visual analog scale to report their likelihood of referring patients to a pain specialist or to physical therapy and of recommending opioid or nonopioid analgesia.

“Next, they rated the degree to which they considered different sources of patient information when making treatment decision,” Ms. Grant and her coauthors wrote. Statistical analysis “examined the extent to which providers demonstrated statistically reliable treatment differences across patient race and SES.” These findings were compared with how clinicians reported they used patient race and SES in decision making.

Demonstrated race-based decision making occurred for 41% of white and 31% of nonwhite clinicians. About two-thirds of providers (67.3%) were white, and of the remainder, 26.3% were Asian, 4.4% were classified as “other,” and 2.1% were black. The respondents were aged a mean 29.7 years, and were 42.3% female.

In addition, Ms. Grant and her coauthors estimated provider SES by asking about parental SES, dividing respondents into low (less than $38,000), medium ($38,000-$75,000), and high (greater than $75,000) SES categories.

Demonstrated bias based on socioeconomic status was common, and similar across levels of provider SES, at 41%, 43%, and 38% for low, medium, and high SES residents and fellows, respectively. However, the disconnect between reported and demonstrated bias that was seen with race was not seen with SES bias, with 43%-48% of providers in each SES group reporting that they had factored patient SES into their treatment decision making.

“These results suggest that providers have low awareness of making different pain treatment decisions” for black patients, compared with decision making for white patients, Ms. Grant and her colleagues wrote. “Decision-making awareness did not substantially differ across provider race or SES.” She and her collaborators called for more research into whether raising awareness about demonstrated racial bias in decision making can improve both racial and socioeconomic gaps in pain care.

The authors reported funding from the National Institutes of Health. They reported no conflicts of interest.

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Misleading information, reimbursement among the barriers to teledermatology progress

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Changed
Wed, 04/24/2019 - 11:48

Smartphone applications that provide advice to people about their skin lesions may provide misleading information that could result in not seeking care from a dermatologist, Suephy C. Chen, MD, said at the annual meeting of the American Academy of Dermatology.

Dr. Suephy Chen of Emory
Jeff Craven/MDedge News
Dr. Suephy Chen

Even with disclaimers, there are people who want a “quick and easy answer,” and these apps can provide misleading information that “can lead them down a wrong diagnostic pathway,” said Dr. Chen, professor of dermatology and director of the teledermatology service at Emory University, Atlanta. Users not only include lower income or uninsured patients, but busy, high-powered executives.

Apps focused on photo storage are used to help patients track lesions for changes, with some apps dedicated to total body mole mapping. However, while these apps may empower patients to perform regular self skin checks, there is a question of whether they are HIPAA secure, Dr. Chen said. Another issue is that the many different app choices on the market may make it difficult for providers to keep up with which app a particular patient is using, she added. “If you have 10 different patients coming in with 10 different apps, it’s going to be really hard for you to learn all of those and be able to manipulate that easily, especially in the 15-minute slot.”

Smartphone and tablet apps that offer reminders to perform monthly skin checks or apply sunscreen when outdoors are plentiful. Dr. Chen noted that, while the efficacy of these apps are not known, they are similar to less high-tech technology like alarms or calendar reminders. “[They] are really kind of neat and fun. It’s kind of boring to just get a reminder, and you tune it out if you get a reminder on your calendars, so this may be a new way to help people,” she said.


Wearables also track users’ sun exposure, and range from a UV sensor on the thumb that measures sun exposure over a period of months to clip-on wearables and temporary tattoos that tell users when to apply or reapply sunscreen. Some devices allow entry of an individual’s Fitzpatrick skin type and can detect temperature and humidity, she noted.

Risk-calculating apps use images taken from smartphone cameras to determine the risk of melanoma, using algorithms that consider color and pattern recognition, but these apps are not as accurate as dermatologists, she said. In a study published in 2013, the app that sent images directly to a dermatologist was the most effective, compared with apps that relied on an automated algorithm to analyze the images (JAMA Dermatol. 2013 Apr;149[4]:422-6).

One of the conclusions the authors made was that feedback was slow for the one that required the image be sent to a dermatologist. “As opposed to just a minute and spitting out the result, it took 24 hours. My argument is 24 hours is still a lot faster than if you tried to call and get an appointment with a dermatologist,” Dr. Chen commented.

One step above teledermatology is teledermoscopy, or using a mobile, smartphone-attached device to send images to a dermatologist over a secure cloud service for review. “Most of us would agree that it would just take too long to do a live video with a patient,” Dr. Chen pointed out. “They may as well just come in anyway. It’ll take you 40 minutes to be able to take a look at that mole on the video, but to do it in a store-and-forward format can be quite efficient.”

However, she noted that one barrier to entry for teledermoscopy is defining the type of service, such as whether apps will offer provider-to-provider or patient-to-provider services. “That is fraught with its own details and issues, especially with photo quality.”


Another barrier, reimbursement from Centers for Medicare & Medicaid Services for teledermatology, is “the real sticking point,” Dr. Chen continued. Under a 2019 CMS Final Rule, telemedicine is only covered if the patient is already established within the practice, and reimbursement for Healthcare Common Procedure Coding System codes G2010 and G2012 relating to telemedicine ranges between $12 and $14.

Based on her back-of-the-envelope calculation, she added, “I would have to see 180 patients in a half-day session by this method in order to generate my salary, and that would just be impossible.”

Dr. Chen said that teledermatology is the “way of the future” and hopes the CMS Final Rule is reconsidered so the technology can be used to help solve some of the growing issues in the dermatology field. “There’s no way we can meet the demands of an increasingly aging population by an in-person brick and mortar sort of paradigm,” she said, noting that, even in an urban setting, it can be difficult to see a dermatologist.

Dr. Chen reports relationships with BioPharmX, Dermecular Therapeutics, Leo Pharma, Phoenix Tissue Repair, Trevi Therapeutics, and Unilever.

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Smartphone applications that provide advice to people about their skin lesions may provide misleading information that could result in not seeking care from a dermatologist, Suephy C. Chen, MD, said at the annual meeting of the American Academy of Dermatology.

Dr. Suephy Chen of Emory
Jeff Craven/MDedge News
Dr. Suephy Chen

Even with disclaimers, there are people who want a “quick and easy answer,” and these apps can provide misleading information that “can lead them down a wrong diagnostic pathway,” said Dr. Chen, professor of dermatology and director of the teledermatology service at Emory University, Atlanta. Users not only include lower income or uninsured patients, but busy, high-powered executives.

Apps focused on photo storage are used to help patients track lesions for changes, with some apps dedicated to total body mole mapping. However, while these apps may empower patients to perform regular self skin checks, there is a question of whether they are HIPAA secure, Dr. Chen said. Another issue is that the many different app choices on the market may make it difficult for providers to keep up with which app a particular patient is using, she added. “If you have 10 different patients coming in with 10 different apps, it’s going to be really hard for you to learn all of those and be able to manipulate that easily, especially in the 15-minute slot.”

Smartphone and tablet apps that offer reminders to perform monthly skin checks or apply sunscreen when outdoors are plentiful. Dr. Chen noted that, while the efficacy of these apps are not known, they are similar to less high-tech technology like alarms or calendar reminders. “[They] are really kind of neat and fun. It’s kind of boring to just get a reminder, and you tune it out if you get a reminder on your calendars, so this may be a new way to help people,” she said.


Wearables also track users’ sun exposure, and range from a UV sensor on the thumb that measures sun exposure over a period of months to clip-on wearables and temporary tattoos that tell users when to apply or reapply sunscreen. Some devices allow entry of an individual’s Fitzpatrick skin type and can detect temperature and humidity, she noted.

Risk-calculating apps use images taken from smartphone cameras to determine the risk of melanoma, using algorithms that consider color and pattern recognition, but these apps are not as accurate as dermatologists, she said. In a study published in 2013, the app that sent images directly to a dermatologist was the most effective, compared with apps that relied on an automated algorithm to analyze the images (JAMA Dermatol. 2013 Apr;149[4]:422-6).

One of the conclusions the authors made was that feedback was slow for the one that required the image be sent to a dermatologist. “As opposed to just a minute and spitting out the result, it took 24 hours. My argument is 24 hours is still a lot faster than if you tried to call and get an appointment with a dermatologist,” Dr. Chen commented.

One step above teledermatology is teledermoscopy, or using a mobile, smartphone-attached device to send images to a dermatologist over a secure cloud service for review. “Most of us would agree that it would just take too long to do a live video with a patient,” Dr. Chen pointed out. “They may as well just come in anyway. It’ll take you 40 minutes to be able to take a look at that mole on the video, but to do it in a store-and-forward format can be quite efficient.”

However, she noted that one barrier to entry for teledermoscopy is defining the type of service, such as whether apps will offer provider-to-provider or patient-to-provider services. “That is fraught with its own details and issues, especially with photo quality.”


Another barrier, reimbursement from Centers for Medicare & Medicaid Services for teledermatology, is “the real sticking point,” Dr. Chen continued. Under a 2019 CMS Final Rule, telemedicine is only covered if the patient is already established within the practice, and reimbursement for Healthcare Common Procedure Coding System codes G2010 and G2012 relating to telemedicine ranges between $12 and $14.

Based on her back-of-the-envelope calculation, she added, “I would have to see 180 patients in a half-day session by this method in order to generate my salary, and that would just be impossible.”

Dr. Chen said that teledermatology is the “way of the future” and hopes the CMS Final Rule is reconsidered so the technology can be used to help solve some of the growing issues in the dermatology field. “There’s no way we can meet the demands of an increasingly aging population by an in-person brick and mortar sort of paradigm,” she said, noting that, even in an urban setting, it can be difficult to see a dermatologist.

Dr. Chen reports relationships with BioPharmX, Dermecular Therapeutics, Leo Pharma, Phoenix Tissue Repair, Trevi Therapeutics, and Unilever.

Smartphone applications that provide advice to people about their skin lesions may provide misleading information that could result in not seeking care from a dermatologist, Suephy C. Chen, MD, said at the annual meeting of the American Academy of Dermatology.

Dr. Suephy Chen of Emory
Jeff Craven/MDedge News
Dr. Suephy Chen

Even with disclaimers, there are people who want a “quick and easy answer,” and these apps can provide misleading information that “can lead them down a wrong diagnostic pathway,” said Dr. Chen, professor of dermatology and director of the teledermatology service at Emory University, Atlanta. Users not only include lower income or uninsured patients, but busy, high-powered executives.

Apps focused on photo storage are used to help patients track lesions for changes, with some apps dedicated to total body mole mapping. However, while these apps may empower patients to perform regular self skin checks, there is a question of whether they are HIPAA secure, Dr. Chen said. Another issue is that the many different app choices on the market may make it difficult for providers to keep up with which app a particular patient is using, she added. “If you have 10 different patients coming in with 10 different apps, it’s going to be really hard for you to learn all of those and be able to manipulate that easily, especially in the 15-minute slot.”

Smartphone and tablet apps that offer reminders to perform monthly skin checks or apply sunscreen when outdoors are plentiful. Dr. Chen noted that, while the efficacy of these apps are not known, they are similar to less high-tech technology like alarms or calendar reminders. “[They] are really kind of neat and fun. It’s kind of boring to just get a reminder, and you tune it out if you get a reminder on your calendars, so this may be a new way to help people,” she said.


Wearables also track users’ sun exposure, and range from a UV sensor on the thumb that measures sun exposure over a period of months to clip-on wearables and temporary tattoos that tell users when to apply or reapply sunscreen. Some devices allow entry of an individual’s Fitzpatrick skin type and can detect temperature and humidity, she noted.

Risk-calculating apps use images taken from smartphone cameras to determine the risk of melanoma, using algorithms that consider color and pattern recognition, but these apps are not as accurate as dermatologists, she said. In a study published in 2013, the app that sent images directly to a dermatologist was the most effective, compared with apps that relied on an automated algorithm to analyze the images (JAMA Dermatol. 2013 Apr;149[4]:422-6).

One of the conclusions the authors made was that feedback was slow for the one that required the image be sent to a dermatologist. “As opposed to just a minute and spitting out the result, it took 24 hours. My argument is 24 hours is still a lot faster than if you tried to call and get an appointment with a dermatologist,” Dr. Chen commented.

One step above teledermatology is teledermoscopy, or using a mobile, smartphone-attached device to send images to a dermatologist over a secure cloud service for review. “Most of us would agree that it would just take too long to do a live video with a patient,” Dr. Chen pointed out. “They may as well just come in anyway. It’ll take you 40 minutes to be able to take a look at that mole on the video, but to do it in a store-and-forward format can be quite efficient.”

However, she noted that one barrier to entry for teledermoscopy is defining the type of service, such as whether apps will offer provider-to-provider or patient-to-provider services. “That is fraught with its own details and issues, especially with photo quality.”


Another barrier, reimbursement from Centers for Medicare & Medicaid Services for teledermatology, is “the real sticking point,” Dr. Chen continued. Under a 2019 CMS Final Rule, telemedicine is only covered if the patient is already established within the practice, and reimbursement for Healthcare Common Procedure Coding System codes G2010 and G2012 relating to telemedicine ranges between $12 and $14.

Based on her back-of-the-envelope calculation, she added, “I would have to see 180 patients in a half-day session by this method in order to generate my salary, and that would just be impossible.”

Dr. Chen said that teledermatology is the “way of the future” and hopes the CMS Final Rule is reconsidered so the technology can be used to help solve some of the growing issues in the dermatology field. “There’s no way we can meet the demands of an increasingly aging population by an in-person brick and mortar sort of paradigm,” she said, noting that, even in an urban setting, it can be difficult to see a dermatologist.

Dr. Chen reports relationships with BioPharmX, Dermecular Therapeutics, Leo Pharma, Phoenix Tissue Repair, Trevi Therapeutics, and Unilever.

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EXPERT ANALYSIS FROM AAD 2019

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Ask patients, not devices, about impact of PAD

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Wed, 04/24/2019 - 15:34

The ankle-brachial index (ABI) is a poor indicator of patient-centered and clinician-based evaluations of functional status in patients with intermittent claudication, according to the results of PORTRAIT, a prospective observational study of patients with newly diagnosed or an exacerbation of nonlimb-threatening peripheral arterial disease (PAD).

PORTRAIT studied 1,251 patients with intermittent claudication enrolled at 16 sites. Researchers studied the correlation of ABI values and Rutherford symptom classification with PAD-specific health status as measured by the Peripheral Artery Questionnaire (PAQ).

ABI values were categorized as mild (greater than 0.80), moderate (0.40-0.79), and severe (less than 0.40). Spearman rank correlation coefficients were calculated between raw ABI values and PAQ scores and between the Rutherford classification and PAQ scores.

ABI explained only 0.1%-2.1% of the variation in PAQ scores and the Rutherford classification had stronger but still modest associations with PAQ scores, according to the researchers.

“This large study of IC patients found that the PAQ offers a unique and complementary

measure of disease burden that is not captured by physiologic or clinician-observed classifications. The findings from this study highlight the clinical complexity of PAD

and the difficulty in using common hemodynamic and symptom measures to classify the impact of this disease on patients’ health status,” the researchers concluded.

Several authors reported serving as consultant for and/or receiving grants from various device and pharmaceutical companies involved with PAD. The senior author. owns the copyright to the Peripheral Artery Questionnaire that formed the basis for the study.

SOURCE: Johnston A et al. J Vasc Surg. 2018;69(3):906-12.

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The ankle-brachial index (ABI) is a poor indicator of patient-centered and clinician-based evaluations of functional status in patients with intermittent claudication, according to the results of PORTRAIT, a prospective observational study of patients with newly diagnosed or an exacerbation of nonlimb-threatening peripheral arterial disease (PAD).

PORTRAIT studied 1,251 patients with intermittent claudication enrolled at 16 sites. Researchers studied the correlation of ABI values and Rutherford symptom classification with PAD-specific health status as measured by the Peripheral Artery Questionnaire (PAQ).

ABI values were categorized as mild (greater than 0.80), moderate (0.40-0.79), and severe (less than 0.40). Spearman rank correlation coefficients were calculated between raw ABI values and PAQ scores and between the Rutherford classification and PAQ scores.

ABI explained only 0.1%-2.1% of the variation in PAQ scores and the Rutherford classification had stronger but still modest associations with PAQ scores, according to the researchers.

“This large study of IC patients found that the PAQ offers a unique and complementary

measure of disease burden that is not captured by physiologic or clinician-observed classifications. The findings from this study highlight the clinical complexity of PAD

and the difficulty in using common hemodynamic and symptom measures to classify the impact of this disease on patients’ health status,” the researchers concluded.

Several authors reported serving as consultant for and/or receiving grants from various device and pharmaceutical companies involved with PAD. The senior author. owns the copyright to the Peripheral Artery Questionnaire that formed the basis for the study.

SOURCE: Johnston A et al. J Vasc Surg. 2018;69(3):906-12.

The ankle-brachial index (ABI) is a poor indicator of patient-centered and clinician-based evaluations of functional status in patients with intermittent claudication, according to the results of PORTRAIT, a prospective observational study of patients with newly diagnosed or an exacerbation of nonlimb-threatening peripheral arterial disease (PAD).

PORTRAIT studied 1,251 patients with intermittent claudication enrolled at 16 sites. Researchers studied the correlation of ABI values and Rutherford symptom classification with PAD-specific health status as measured by the Peripheral Artery Questionnaire (PAQ).

ABI values were categorized as mild (greater than 0.80), moderate (0.40-0.79), and severe (less than 0.40). Spearman rank correlation coefficients were calculated between raw ABI values and PAQ scores and between the Rutherford classification and PAQ scores.

ABI explained only 0.1%-2.1% of the variation in PAQ scores and the Rutherford classification had stronger but still modest associations with PAQ scores, according to the researchers.

“This large study of IC patients found that the PAQ offers a unique and complementary

measure of disease burden that is not captured by physiologic or clinician-observed classifications. The findings from this study highlight the clinical complexity of PAD

and the difficulty in using common hemodynamic and symptom measures to classify the impact of this disease on patients’ health status,” the researchers concluded.

Several authors reported serving as consultant for and/or receiving grants from various device and pharmaceutical companies involved with PAD. The senior author. owns the copyright to the Peripheral Artery Questionnaire that formed the basis for the study.

SOURCE: Johnston A et al. J Vasc Surg. 2018;69(3):906-12.

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FROM THE JOURNAL OF VASCULAR SURGERY

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