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Novel drug slows progression of diabetic kidney disease
For patients with diabetic kidney disease, finerenone, an agent from a new class of selective, nonsteroidal mineralocorticoid receptor antagonists, led to significant reductions in combined adverse renal outcomes and in combined adverse cardiovascular outcomes in the pivotal FIDELIO-DKD trial.
And the safety results showed a good level of tolerability. The rate of hyperkalemia was higher with finerenone than with placebo, but the rate of drug discontinuations for elevated potassium was lower than that seen with spironolactone, a steroidal mineralocorticoid receptor antagonist (MRA).
“An ideal drug would cause no hyperkalemia, but the absolute risk we saw is a fraction of what we see with spironolactone in this vulnerable patient population,” said Rajiv Agarwal, MD, from Indiana in Indianapolis, during a press briefing.
After a median follow-up of 2.6 years, finerenone was associated with a 3.4% absolute reduction in the rate of combined adverse renal events, the study’s primary end point, which comprised kidney failure, renal death, and a drop in estimated glomerular filtration rate (eGFR) of at least 40% from baseline. This produced a significant relative risk reduction of 18%, with a number needed to treat of 32 to prevent one of these events, Dr. Agarwal reported at Kidney Week 2020. Findings from the FIDELIO-DKD trial were published simultaneously in the New England Journal of Medicine.
Finerenone was also associated with an absolute 2.4% reduction in the rate of combined adverse cardiovascular events, the study’s “key secondary end point,” which included cardiovascular death, nonfatal MI, nonfatal stroke, and hospitalization for heart failure. This translated into a significant relative risk reduction of 14% and a number needed to treat of 42 to prevent one of these events.
FIDELIO-DKD assessed 5,734 patients with type 2 diabetes and chronic kidney disease from more than 1,000 sites in 48 countries, including the United States, from 2015 to 2018. In the study cohort, average age was slightly more than 65 years, average baseline systolic blood pressure was 138 mm Hg, average duration of diabetes was nearly 17 years, average baseline glycated hemoglobin (A1c) was 7.7%, and fewer than 5% of patients were Black, 25% were Asian, and about 63% were White.
A suggestion of less severe hyperkalemia
Finerenone was well tolerated by the participants, and the findings suggest that it caused less clinically meaningful hyperkalemia than spironolactone, the most established and widely used MRA.
Like all MRA drugs, finerenone led to an increase in serum potassium in all patient subgroups – in this case 0.2 mmol/L – unlike placebo, said Dr. Agarwal.
The overall incidence of hyperkalemia was 16% in the 2,827 evaluable patients in the finerenone group and 8% in the 2,831 evaluable patients in the placebo group. Fewer than 10% of patients in the trial received a potassium-binding agent.
The rate of hyperkalemia leading to treatment discontinuation was higher in the finerenone group than in the placebo group (2.3% vs. 0.9%).
That 2.3% rate is 10 times lower than the 23.0% rate of hyperkalemia-related treatment discontinuation in patients who received spironolactone and no potassium-binding agent, said Dr. Agarwal, citing a previous study he was involved with.
He hypothesized that finerenone might cause less clinically meaningful hyperkalemia because it creates no active metabolites that linger in the body, whereas spironolactone produces active metabolites with a half life of about 1 week.
“The risk for hyperkalemia is clearly increased with finerenone compared with placebo, and in the absence of head-to-head studies, it’s hard to know how it compares with spironolactone or eplerenone [Inspra],” the other agents in the MRA class, said Mikhail N. Kosiborod, MD, from the University of Missouri–Kansas City.
“The rates of hyperkalemia observed in FIDELIO-DKD were overall comparable to what we would expect from eplerenone. But the rate of serious hyperkalemia was quite low with finerenone, which is reassuring,” Dr. Kosiborod said in an interview.
And the adverse-effect profile showed that finerenone “is as safe as you could expect from an MRA,” said Janani Rangaswami, MD, from the Einstein Medical Center in Philadelphia.
The rate of hyperkalemia should be interpreted in the context of the high risk the enrolled patients faced, given that they all had moderate to severe diabetic kidney disease with albuminuria and, in some cases, eGFR rates as low as 25 mL/min per 1.73m2, she explained. In addition, all patients were on maximally tolerated treatment with either an angiotensin-converting–enzyme inhibitor or an angiotensin receptor blocker to inhibit the renin angiotensin system (RAS).
“Considering this background, it’s a very acceptable adverse-event profile,” Dr. Rangaswami said in an interview.
Renal drugs that could work together
More than 99% of patients in FIDELIO-DKD were on an RAS inhibitor, but fewer than 5% were on a sodium glucose cotransporter 2 (SGLT2) inhibitor at baseline, and fewer than 10% started on this drug class during the course of the study.
Despite that, both Dr. Kosiborod and Dr. Rangaswami are enthusiastic about the prospect of using the three drugs in combination to maximize renal and cardiovascular benefits in FIDELIO-DKD–type patients. Recent results from the CREDENCE study of canagliflozin (Invokana) and from the DAPA-CKD study of dapagluflozin (Farxiga) have established SGLT2 inhibitors – at least those two – as key agents for patients with chronic kidney disease.
Dual treatment with an RAS inhibitor and an SGLT2 inhibitor is “clearly established” for patients with diabetic kidney disease, said Dr. Agarwal.
“After CREDENCE, DAPA-CKD, and now FIDELIO-DKD, we need to seriously consider triple therapy as the future of treatment for diabetic kidney disease to prevent both cardiovascular and kidney complications,” said Dr. Kosiborod. The approach will mimic the multidrug therapy that’s now standard for patients with heart failure with reduced ejection fraction (HFrEF). But he cautioned that this triple combination needs further testing.
“Triple therapy will be the standard of care” for patients with diabetic kidney disease, Dr. Rangaswami agreed, but she cautioned that she would not currently expand the target population for finerenone to patients without type 2 diabetes or to patients without the level of albuminuria required for entry into FIDELIO-DKD: at least 30 mg/g of creatinine per day. And patients with HFrEF were excluded from FIDELIO-DKD, so that limitation on finerenone use should remain for the time being, she added.
Dr. Rangaswami said she is optimistic about the potential efficacy of finerenone added to an SGLT2 inhibitor because of the likelihood that the two drug classes work in different but complementary ways. SGLT2 inhibitors seem to exert their renal protective effects largely through hemodynamic effects, whereas it is likely that finerenone exerts its effects largely as an anti-inflammatory and antifibrotic agent, she speculated. The FIDELIO-DKD results appear to rule out any major effect of finerenone on blood pressure lowering because average systolic pressure fell by only about 2 mm Hg in the treatment group.
“The benefits of finerenone for cardiorenal outcomes are substantial and clinically meaningful,” Dr. Kosiborod said. “We cannot assume that other MRAs, such as spironolactone, provide similar benefits,” he cautioned, but the results are “very good news for patients with type 2 diabetes and chronic kidney disease. We now have another effective intervention with a different mechanism of action.”
FIDELIO-DKD was sponsored by Bayer, the company developing finerenone (BAY 94-8862). Dr. Agarwal has been a consultant to and has received honoraria from Bayer and from several other companies. Dr. Kosiborod has been a consultant to Bayer and to AstraZeneca, Boehringer Ingelheim, Jansse, Merck, and Vifor and has received research funding from AstraZeneca and Boehringer Ingelheim. Dr. Rangaswami has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
For patients with diabetic kidney disease, finerenone, an agent from a new class of selective, nonsteroidal mineralocorticoid receptor antagonists, led to significant reductions in combined adverse renal outcomes and in combined adverse cardiovascular outcomes in the pivotal FIDELIO-DKD trial.
And the safety results showed a good level of tolerability. The rate of hyperkalemia was higher with finerenone than with placebo, but the rate of drug discontinuations for elevated potassium was lower than that seen with spironolactone, a steroidal mineralocorticoid receptor antagonist (MRA).
“An ideal drug would cause no hyperkalemia, but the absolute risk we saw is a fraction of what we see with spironolactone in this vulnerable patient population,” said Rajiv Agarwal, MD, from Indiana in Indianapolis, during a press briefing.
After a median follow-up of 2.6 years, finerenone was associated with a 3.4% absolute reduction in the rate of combined adverse renal events, the study’s primary end point, which comprised kidney failure, renal death, and a drop in estimated glomerular filtration rate (eGFR) of at least 40% from baseline. This produced a significant relative risk reduction of 18%, with a number needed to treat of 32 to prevent one of these events, Dr. Agarwal reported at Kidney Week 2020. Findings from the FIDELIO-DKD trial were published simultaneously in the New England Journal of Medicine.
Finerenone was also associated with an absolute 2.4% reduction in the rate of combined adverse cardiovascular events, the study’s “key secondary end point,” which included cardiovascular death, nonfatal MI, nonfatal stroke, and hospitalization for heart failure. This translated into a significant relative risk reduction of 14% and a number needed to treat of 42 to prevent one of these events.
FIDELIO-DKD assessed 5,734 patients with type 2 diabetes and chronic kidney disease from more than 1,000 sites in 48 countries, including the United States, from 2015 to 2018. In the study cohort, average age was slightly more than 65 years, average baseline systolic blood pressure was 138 mm Hg, average duration of diabetes was nearly 17 years, average baseline glycated hemoglobin (A1c) was 7.7%, and fewer than 5% of patients were Black, 25% were Asian, and about 63% were White.
A suggestion of less severe hyperkalemia
Finerenone was well tolerated by the participants, and the findings suggest that it caused less clinically meaningful hyperkalemia than spironolactone, the most established and widely used MRA.
Like all MRA drugs, finerenone led to an increase in serum potassium in all patient subgroups – in this case 0.2 mmol/L – unlike placebo, said Dr. Agarwal.
The overall incidence of hyperkalemia was 16% in the 2,827 evaluable patients in the finerenone group and 8% in the 2,831 evaluable patients in the placebo group. Fewer than 10% of patients in the trial received a potassium-binding agent.
The rate of hyperkalemia leading to treatment discontinuation was higher in the finerenone group than in the placebo group (2.3% vs. 0.9%).
That 2.3% rate is 10 times lower than the 23.0% rate of hyperkalemia-related treatment discontinuation in patients who received spironolactone and no potassium-binding agent, said Dr. Agarwal, citing a previous study he was involved with.
He hypothesized that finerenone might cause less clinically meaningful hyperkalemia because it creates no active metabolites that linger in the body, whereas spironolactone produces active metabolites with a half life of about 1 week.
“The risk for hyperkalemia is clearly increased with finerenone compared with placebo, and in the absence of head-to-head studies, it’s hard to know how it compares with spironolactone or eplerenone [Inspra],” the other agents in the MRA class, said Mikhail N. Kosiborod, MD, from the University of Missouri–Kansas City.
“The rates of hyperkalemia observed in FIDELIO-DKD were overall comparable to what we would expect from eplerenone. But the rate of serious hyperkalemia was quite low with finerenone, which is reassuring,” Dr. Kosiborod said in an interview.
And the adverse-effect profile showed that finerenone “is as safe as you could expect from an MRA,” said Janani Rangaswami, MD, from the Einstein Medical Center in Philadelphia.
The rate of hyperkalemia should be interpreted in the context of the high risk the enrolled patients faced, given that they all had moderate to severe diabetic kidney disease with albuminuria and, in some cases, eGFR rates as low as 25 mL/min per 1.73m2, she explained. In addition, all patients were on maximally tolerated treatment with either an angiotensin-converting–enzyme inhibitor or an angiotensin receptor blocker to inhibit the renin angiotensin system (RAS).
“Considering this background, it’s a very acceptable adverse-event profile,” Dr. Rangaswami said in an interview.
Renal drugs that could work together
More than 99% of patients in FIDELIO-DKD were on an RAS inhibitor, but fewer than 5% were on a sodium glucose cotransporter 2 (SGLT2) inhibitor at baseline, and fewer than 10% started on this drug class during the course of the study.
Despite that, both Dr. Kosiborod and Dr. Rangaswami are enthusiastic about the prospect of using the three drugs in combination to maximize renal and cardiovascular benefits in FIDELIO-DKD–type patients. Recent results from the CREDENCE study of canagliflozin (Invokana) and from the DAPA-CKD study of dapagluflozin (Farxiga) have established SGLT2 inhibitors – at least those two – as key agents for patients with chronic kidney disease.
Dual treatment with an RAS inhibitor and an SGLT2 inhibitor is “clearly established” for patients with diabetic kidney disease, said Dr. Agarwal.
“After CREDENCE, DAPA-CKD, and now FIDELIO-DKD, we need to seriously consider triple therapy as the future of treatment for diabetic kidney disease to prevent both cardiovascular and kidney complications,” said Dr. Kosiborod. The approach will mimic the multidrug therapy that’s now standard for patients with heart failure with reduced ejection fraction (HFrEF). But he cautioned that this triple combination needs further testing.
“Triple therapy will be the standard of care” for patients with diabetic kidney disease, Dr. Rangaswami agreed, but she cautioned that she would not currently expand the target population for finerenone to patients without type 2 diabetes or to patients without the level of albuminuria required for entry into FIDELIO-DKD: at least 30 mg/g of creatinine per day. And patients with HFrEF were excluded from FIDELIO-DKD, so that limitation on finerenone use should remain for the time being, she added.
Dr. Rangaswami said she is optimistic about the potential efficacy of finerenone added to an SGLT2 inhibitor because of the likelihood that the two drug classes work in different but complementary ways. SGLT2 inhibitors seem to exert their renal protective effects largely through hemodynamic effects, whereas it is likely that finerenone exerts its effects largely as an anti-inflammatory and antifibrotic agent, she speculated. The FIDELIO-DKD results appear to rule out any major effect of finerenone on blood pressure lowering because average systolic pressure fell by only about 2 mm Hg in the treatment group.
“The benefits of finerenone for cardiorenal outcomes are substantial and clinically meaningful,” Dr. Kosiborod said. “We cannot assume that other MRAs, such as spironolactone, provide similar benefits,” he cautioned, but the results are “very good news for patients with type 2 diabetes and chronic kidney disease. We now have another effective intervention with a different mechanism of action.”
FIDELIO-DKD was sponsored by Bayer, the company developing finerenone (BAY 94-8862). Dr. Agarwal has been a consultant to and has received honoraria from Bayer and from several other companies. Dr. Kosiborod has been a consultant to Bayer and to AstraZeneca, Boehringer Ingelheim, Jansse, Merck, and Vifor and has received research funding from AstraZeneca and Boehringer Ingelheim. Dr. Rangaswami has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
For patients with diabetic kidney disease, finerenone, an agent from a new class of selective, nonsteroidal mineralocorticoid receptor antagonists, led to significant reductions in combined adverse renal outcomes and in combined adverse cardiovascular outcomes in the pivotal FIDELIO-DKD trial.
And the safety results showed a good level of tolerability. The rate of hyperkalemia was higher with finerenone than with placebo, but the rate of drug discontinuations for elevated potassium was lower than that seen with spironolactone, a steroidal mineralocorticoid receptor antagonist (MRA).
“An ideal drug would cause no hyperkalemia, but the absolute risk we saw is a fraction of what we see with spironolactone in this vulnerable patient population,” said Rajiv Agarwal, MD, from Indiana in Indianapolis, during a press briefing.
After a median follow-up of 2.6 years, finerenone was associated with a 3.4% absolute reduction in the rate of combined adverse renal events, the study’s primary end point, which comprised kidney failure, renal death, and a drop in estimated glomerular filtration rate (eGFR) of at least 40% from baseline. This produced a significant relative risk reduction of 18%, with a number needed to treat of 32 to prevent one of these events, Dr. Agarwal reported at Kidney Week 2020. Findings from the FIDELIO-DKD trial were published simultaneously in the New England Journal of Medicine.
Finerenone was also associated with an absolute 2.4% reduction in the rate of combined adverse cardiovascular events, the study’s “key secondary end point,” which included cardiovascular death, nonfatal MI, nonfatal stroke, and hospitalization for heart failure. This translated into a significant relative risk reduction of 14% and a number needed to treat of 42 to prevent one of these events.
FIDELIO-DKD assessed 5,734 patients with type 2 diabetes and chronic kidney disease from more than 1,000 sites in 48 countries, including the United States, from 2015 to 2018. In the study cohort, average age was slightly more than 65 years, average baseline systolic blood pressure was 138 mm Hg, average duration of diabetes was nearly 17 years, average baseline glycated hemoglobin (A1c) was 7.7%, and fewer than 5% of patients were Black, 25% were Asian, and about 63% were White.
A suggestion of less severe hyperkalemia
Finerenone was well tolerated by the participants, and the findings suggest that it caused less clinically meaningful hyperkalemia than spironolactone, the most established and widely used MRA.
Like all MRA drugs, finerenone led to an increase in serum potassium in all patient subgroups – in this case 0.2 mmol/L – unlike placebo, said Dr. Agarwal.
The overall incidence of hyperkalemia was 16% in the 2,827 evaluable patients in the finerenone group and 8% in the 2,831 evaluable patients in the placebo group. Fewer than 10% of patients in the trial received a potassium-binding agent.
The rate of hyperkalemia leading to treatment discontinuation was higher in the finerenone group than in the placebo group (2.3% vs. 0.9%).
That 2.3% rate is 10 times lower than the 23.0% rate of hyperkalemia-related treatment discontinuation in patients who received spironolactone and no potassium-binding agent, said Dr. Agarwal, citing a previous study he was involved with.
He hypothesized that finerenone might cause less clinically meaningful hyperkalemia because it creates no active metabolites that linger in the body, whereas spironolactone produces active metabolites with a half life of about 1 week.
“The risk for hyperkalemia is clearly increased with finerenone compared with placebo, and in the absence of head-to-head studies, it’s hard to know how it compares with spironolactone or eplerenone [Inspra],” the other agents in the MRA class, said Mikhail N. Kosiborod, MD, from the University of Missouri–Kansas City.
“The rates of hyperkalemia observed in FIDELIO-DKD were overall comparable to what we would expect from eplerenone. But the rate of serious hyperkalemia was quite low with finerenone, which is reassuring,” Dr. Kosiborod said in an interview.
And the adverse-effect profile showed that finerenone “is as safe as you could expect from an MRA,” said Janani Rangaswami, MD, from the Einstein Medical Center in Philadelphia.
The rate of hyperkalemia should be interpreted in the context of the high risk the enrolled patients faced, given that they all had moderate to severe diabetic kidney disease with albuminuria and, in some cases, eGFR rates as low as 25 mL/min per 1.73m2, she explained. In addition, all patients were on maximally tolerated treatment with either an angiotensin-converting–enzyme inhibitor or an angiotensin receptor blocker to inhibit the renin angiotensin system (RAS).
“Considering this background, it’s a very acceptable adverse-event profile,” Dr. Rangaswami said in an interview.
Renal drugs that could work together
More than 99% of patients in FIDELIO-DKD were on an RAS inhibitor, but fewer than 5% were on a sodium glucose cotransporter 2 (SGLT2) inhibitor at baseline, and fewer than 10% started on this drug class during the course of the study.
Despite that, both Dr. Kosiborod and Dr. Rangaswami are enthusiastic about the prospect of using the three drugs in combination to maximize renal and cardiovascular benefits in FIDELIO-DKD–type patients. Recent results from the CREDENCE study of canagliflozin (Invokana) and from the DAPA-CKD study of dapagluflozin (Farxiga) have established SGLT2 inhibitors – at least those two – as key agents for patients with chronic kidney disease.
Dual treatment with an RAS inhibitor and an SGLT2 inhibitor is “clearly established” for patients with diabetic kidney disease, said Dr. Agarwal.
“After CREDENCE, DAPA-CKD, and now FIDELIO-DKD, we need to seriously consider triple therapy as the future of treatment for diabetic kidney disease to prevent both cardiovascular and kidney complications,” said Dr. Kosiborod. The approach will mimic the multidrug therapy that’s now standard for patients with heart failure with reduced ejection fraction (HFrEF). But he cautioned that this triple combination needs further testing.
“Triple therapy will be the standard of care” for patients with diabetic kidney disease, Dr. Rangaswami agreed, but she cautioned that she would not currently expand the target population for finerenone to patients without type 2 diabetes or to patients without the level of albuminuria required for entry into FIDELIO-DKD: at least 30 mg/g of creatinine per day. And patients with HFrEF were excluded from FIDELIO-DKD, so that limitation on finerenone use should remain for the time being, she added.
Dr. Rangaswami said she is optimistic about the potential efficacy of finerenone added to an SGLT2 inhibitor because of the likelihood that the two drug classes work in different but complementary ways. SGLT2 inhibitors seem to exert their renal protective effects largely through hemodynamic effects, whereas it is likely that finerenone exerts its effects largely as an anti-inflammatory and antifibrotic agent, she speculated. The FIDELIO-DKD results appear to rule out any major effect of finerenone on blood pressure lowering because average systolic pressure fell by only about 2 mm Hg in the treatment group.
“The benefits of finerenone for cardiorenal outcomes are substantial and clinically meaningful,” Dr. Kosiborod said. “We cannot assume that other MRAs, such as spironolactone, provide similar benefits,” he cautioned, but the results are “very good news for patients with type 2 diabetes and chronic kidney disease. We now have another effective intervention with a different mechanism of action.”
FIDELIO-DKD was sponsored by Bayer, the company developing finerenone (BAY 94-8862). Dr. Agarwal has been a consultant to and has received honoraria from Bayer and from several other companies. Dr. Kosiborod has been a consultant to Bayer and to AstraZeneca, Boehringer Ingelheim, Jansse, Merck, and Vifor and has received research funding from AstraZeneca and Boehringer Ingelheim. Dr. Rangaswami has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM KIDNEY WEEK
The authority/accountability balance
Evaluating your career trajectory
I have had the pleasure of working on the Society of Hospital Medicine’s signature Leadership Academies since 2010, and I enjoy working with hospital medicine leaders from around the country every year. I started as a hospital medicine leader in 2000 and served during the unprecedented growth of the field when it was “the most rapidly growing specialty in the history of medicine.”
Most businesses dream of having a year of double-digit growth; my department grew an average of 15% annually for more than 10 years. These unique experiences have taught me many lessons and afforded me the opportunity to watch many stars of hospital medicine rise, as well as to learn from several less-scrupulous leaders about the darker side of hospital politics.
One of the lessons I learned the hard way about hospital politics is striking the “Authority/Accountability balance” in your career. I shared this perspective at the SHM annual conference in 2018, at speaking engagements on the West Coast, and with my leadership group at the academies. I am sharing it with you because the feedback I have received has been very positive.
The Authority/Accountability balance is a tool for evaluating your current career trajectory and measuring if it is set up for success or failure. The essence is that your Authority and Accountability need to be balanced for you to be successful in your career, regardless of your station. Everybody from the hospitalist fresh out of residency to the CEO needs to have Authority and Accountability in balance to be successful. And as you use the tool to measure your own potential for success or failure, learn to apply it to those who report to you.
I believe the rising tide lifts all boats and the success of your subordinates, through mentoring and support, will add to your success. There is another, more cynical view of subordinates that can be identified using the Authority/Accountability balance, which I will address.
Authority
In this construct, “Authority” has a much broader meaning than just the ability to tell people what to do. The ability to tell people what to do is important but not sufficient for success in hospital politics.
Financial resources are essential for a successful Authority/Accountability balance – not only the hardware such as computers, telephones, pagers, and so on, but also clerical support, technical support, and analytic support so that you are getting high-quality data on the performance of the members of your hospital medicine group (HMG). These “soft” resources (clerical, technical, and analytical) are often overlooked as needs that HMG leaders must advocate for; I speak with many HMG leaders who remain under-resourced with “soft” assets. However, being appropriately resourced in these areas can be transformational for a group. Hospitalists don’t like doing clerical work, and if you don’t like a menial job assigned to you, you probably won’t do it very well. Having an unlicensed person dedicated to these clerical activities not only will cost less, but will ensure the job is done better.
Reporting structure is critically important, often overlooked, and historically misaligned in HMGs. When hospital medicine was starting in the late 1990s and early 2000s, rapidly growing hospitalist groups were typically led by young, early-career physicians who had chosen hospital medicine as a career. The problem was that they often lacked the seniority and connections at the executive level to advocate for their HMG. All too often the hospitalist group was tucked in under another department or division which, in turn, reported HMG updates and issues to the board of directors and the CEO.
A common reporting structure in the early days was that a senior member of the medical staff, or group, had once worked in the hospital and therefore “understood” the issues and challenges that the hospitalists were facing. It was up to this physician with seniority and connections to advocate for the hospitalists as they saw fit. The problem was that the hospital landscape was, and is, constantly evolving in innumerable ways. These “once removed” reporting structures for HMGs failed to get the required information on the rapidly changing, and evolving, hospitalist landscape to the desks of executives who had the financial and structural control to address the challenges that the hospitalists in the trenches were facing.
Numerous HMGs failed in the early days of hospital medicine because of this type of misaligned reporting structure. This is a lesson that should not be forgotten: Make sure your HMG leader has a seat at the table where executive decisions are made, including but not limited to the board of directors. To be in balance, you have to be “in the room where it happens.”
Accountability
The outcomes that you are responsible for need to be explicit, appropriately resourced with Authority, and clearly spelled out in your job description. Your job description is a document you should know, own, and revisit regularly with whomever you report to, in order to ensure success.
Once you have the Authority side of the equation appropriately resourced, setting outcomes that are a stretch, but still realistic and achievable within the scope of your position, is critical to your success. It is good to think about short-, medium-, and long-term goals, especially if you are in a leadership role. For example, one expectation you will have, regardless of your station, is that you keep up on your email and answer your phone. These are short-term goals that will often be included in your job description. However, taking on a new hospital contract and making sure that it has 24/7 hospitalist coverage, that all the hospitalists are meeting the geometric mean length of stay, and that all the physicians are having 15 encounters per day doesn’t happen immediately. Long-term goals, such as taking on a new hospital contract, are the big-picture stuff that can make or break the career of an HMG leader. Long-term goals also need to be delineated in the job description, along with specific time stamps and the resources you need to accomplish big ticket items – which are spelled out in the Authority side (that is, physician recruiter, secretary, background checks, and so on).
One of the classic misuses of Accountability is the “Fall Guy” scenario. The Fall Guy scenario is often used by cynical hospital and medical group executives to expand their influence while limiting their liability. In the Fall Guy scenario, the executive is surrounded with junior partners who are underpowered with Authority, and then the executive makes decisions for which the junior partners are Accountable. This allows the senior executive to make risky decisions on behalf of the hospital or medical group without the liability of being held accountable when the decision-making process fails. When the risky, and often ill-informed, decision fails, the junior partner who lacked the Authority to make the decision – but held the Accountability for it – becomes the Fall Guy for the failed endeavor. This is a critical outcome that the Authority/Accountability balance can help you avoid, if you use it wisely and properly.
If you find yourself in the Fall Guy position, it is time for a change. The Authority, the Accountability, or both need to change so that they are in better balance. Or your employer needs to change. Changing employers is an outcome worth avoiding, if at all possible. I have scrutinized thousands of resumes in my career, and frequent job changes always wave a red flag to prospective employers. However, changing jobs remains a crucial option if you are being set up for failure when Authority and Accountability are out of balance.
If you are unable to negotiate for the balance that will allow you to be successful with your current group, remember that HMG leaders are a prized commodity and in short supply. Leaving a group that has been your career is hard, but it is better to leave than stay in a position where you are set up for failure as the Fall Guy. Further, the most effective time to expand your Authority is when you are negotiating the terms of a new position. Changing positions is the nuclear option. However, it is better than becoming the Fall Guy, and a change can create opportunities that will accelerate your career and influence, if done right.
When I talk about Authority/Accountability balance, I always counter the Fall Guy with an ignominious historical figure: General George B. McClellan. General McClellan was the commander of the Army of the Potomac during the early years of the American Civil War. General McClellan had the industrial might of the Union north at his beck and call, as well as extraordinary resources for recruiting and retaining soldiers for his army. At every encounter with General Robert E. Lee’s Army of Northern Virginia, General McClellan outnumbered them, sometimes by more than two to one. Yet General McClellan was outfoxed repeatedly for the same reason: He failed to take decisive action.
Every time that McClellan failed, he blamed insufficient resources and told President Lincoln that he needed more troops and more equipment to be successful. In summary, while the Fall Guy scenario needs to be avoided, once you are adequately resourced, success requires taking decisive and strategic action, or you will suffer as did General McClellan. Failing to act when you are appropriately resourced can be just as damaging to your career and credibility as allowing yourself to become the Fall Guy.
Job description
Everybody has somebody that they report to, no matter how high up on the executive ladder they have climbed. Even the CEO must report to the board of directors. And that reporting structure usually involves periodic formal reviews. Your formal review is a good time to go over your job description, note what is relevant, remove what is irrelevant, and add new elements that have evolved in importance since your last review.
Job descriptions take many forms, but they always include a list of qualifications. If you have the job, you have the qualifications, so that is not likely to change. You may become more qualified for a higher-level position, but that is an entirely different discussion. I like to think of a well-written job description as including short-term and long-term goals. Short-term goals are usually the daily stuff that keeps operations running smoothly but garners little attention. Examples would include staying current on your emails, answering your phone, organizing meetings, and regularly attending various committees. Even some of these short-term goals can and will change over time. I always enjoyed quality oversight in my department, but as the department and my responsibilities grew, I realized I couldn’t do everything that I wanted to do. I needed to focus on the things only I could do and delegate those things that could be done by someone else, even though I wanted to continue doing them myself. I created a position for a clinical quality officer, and quality oversight moved off of my job description.
Long-term goals are the aspirational items, such as increasing market share, decreasing readmissions, improving patient satisfaction, and the like. Effective leaders are often focused on these aspirational, long-term goals, but they still must effectively execute their short-term goals. Stephen Covey outlines the dilemma with the “time management matrix” in his seminal work “The 7 Habits of Highly Effective People.” An in-depth discussion is beyond the scope of this article, but the time management matrix places tasks into one of four categories based on urgency and importance, and provides strategies for staying up on short-term goals while continually moving long-term goals forward.If you show up at your review with a list of accomplishments as well as an understanding of how the “time management matrix” affects your responsibilities, your boss will be impressed. It is also worth mentioning that Covey’s first habit is “Proactivity.” He uses the term Proactivity in a much more nuanced form than we typically think of, however. Simply put, Proactivity is the opposite of Reactivity, and it is another invaluable tool for success with those long-term goals that will help you make a name for yourself.
When you show up for your review, be it annual, biannual, or other, be prepared. Not only should you bring your job description and recommendations for how it should be adapted in the changing environment, but also bring examples of your accomplishments since the last review.
I talk with leaders frequently who are hardworking and diligent and hate bragging about their achievements; I get that. At the same time, if you don’t inform your superiors about your successes, there is no guarantee that they will hear about them or understand them in the appropriate context. Bragging about how great you are in the physician’s lounge is annoying; telling your boss about your accomplishments since the last review is critical to maintaining the momentum of past accomplishments. If you are not willing to toot your own horn, there is a very good chance that your horn will remain silent. I don’t think self-promotion comes easily to anyone, and it has to be done with a degree of humility and sensitivity; but it has to be done, so prepare for it.
Look out for yourself and others
We talk about teamwork and collaboration as hospitalists, and SHM is always underscoring the importance of teamwork and highlighting examples of successful teamwork in its many conferences and publications. Most hospital executives are focused on their own careers, however, and many have no reservations about damaging your career (your brand) if they think it will promote theirs. You have to look out for yourself and size up every leadership position you get into.
Physicians can expect their careers to last decades. The average hospital CEO has a tenure of less than 3.5 years, however, and when a new CEO is hired, almost half of chief financial, chief operating, and chief information officers are fired within 9 months. You may be focused on the long-term success of your organization as you plan your career, but many hospital administrators are interested only in short-term gains. It is similar to some members of Congress who are interested only in what they need to do now to win the next election and not in the long-term needs of the country. You should understand this disconnect when dealing with hospital executives, and how you and your credibility can become cannon fodder in their quest for short-term self-preservation.
You have to look out for and take care of yourself as you promote your group. With a better understanding of the Authority/Accountability balance, you have new tools to assess your chances of success and to advocate for yourself so that you and your group can be successful.
Despite my cynicism toward executives in the medical field, I personally advocate for supporting the career development of those around you and advise against furthering your career at the expense of others. Many unscrupulous executives will use this approach, surrounding themselves with Fall Guys, but my experience shows that this is not a sustainable strategy for success. It can lead to short-term gains, but eventually the piper must be paid. Moreover, the most successful medical executives and leaders that I have encountered have been those who genuinely cared about their subordinates, looked out for them, and selflessly promoted their careers.
In the age of social media, tearing others down seems to be the fastest way to get more “likes.” However, I strongly believe that you can’t build up your group, and our profession, just by tearing people down. Lending a helping hand may bring you less attention in the short term, but such action raises your stature, creates loyalty, and leads to sustainable success for the long run.
Dr. McIlraith is the founding chairman of the Hospital Medicine Department at Mercy Medical Group in Sacramento, Calif. He received the SHM Award for Outstanding Service in Hospital Medicine in 2016 and is currently a member of the SHM Practice Management and Awards Committees, as well as the SHM Critical Care Task Force.
Sources
Quinn R. HM Turns 20: A look at the evolution of hospital medicine. The Hospitalist. 2016 August. https://www.the-hospitalist.org/hospitalist/article/121525/hm-turns-20-look-evolution-hospital-medicine
Stephen R. Covey. The 7 Habits of Highly Effective People: Powerful Lessons in Personal Change. Simon & Schuster. 1989.
10 Statistics on CEO Turnover, Recruitment. Becker’s Hospital Review. 2020. https://www.beckershospitalreview.com/hospital-management-administration/10-statistics-on-ceo-turnover-recruitment.html
Evaluating your career trajectory
Evaluating your career trajectory
I have had the pleasure of working on the Society of Hospital Medicine’s signature Leadership Academies since 2010, and I enjoy working with hospital medicine leaders from around the country every year. I started as a hospital medicine leader in 2000 and served during the unprecedented growth of the field when it was “the most rapidly growing specialty in the history of medicine.”
Most businesses dream of having a year of double-digit growth; my department grew an average of 15% annually for more than 10 years. These unique experiences have taught me many lessons and afforded me the opportunity to watch many stars of hospital medicine rise, as well as to learn from several less-scrupulous leaders about the darker side of hospital politics.
One of the lessons I learned the hard way about hospital politics is striking the “Authority/Accountability balance” in your career. I shared this perspective at the SHM annual conference in 2018, at speaking engagements on the West Coast, and with my leadership group at the academies. I am sharing it with you because the feedback I have received has been very positive.
The Authority/Accountability balance is a tool for evaluating your current career trajectory and measuring if it is set up for success or failure. The essence is that your Authority and Accountability need to be balanced for you to be successful in your career, regardless of your station. Everybody from the hospitalist fresh out of residency to the CEO needs to have Authority and Accountability in balance to be successful. And as you use the tool to measure your own potential for success or failure, learn to apply it to those who report to you.
I believe the rising tide lifts all boats and the success of your subordinates, through mentoring and support, will add to your success. There is another, more cynical view of subordinates that can be identified using the Authority/Accountability balance, which I will address.
Authority
In this construct, “Authority” has a much broader meaning than just the ability to tell people what to do. The ability to tell people what to do is important but not sufficient for success in hospital politics.
Financial resources are essential for a successful Authority/Accountability balance – not only the hardware such as computers, telephones, pagers, and so on, but also clerical support, technical support, and analytic support so that you are getting high-quality data on the performance of the members of your hospital medicine group (HMG). These “soft” resources (clerical, technical, and analytical) are often overlooked as needs that HMG leaders must advocate for; I speak with many HMG leaders who remain under-resourced with “soft” assets. However, being appropriately resourced in these areas can be transformational for a group. Hospitalists don’t like doing clerical work, and if you don’t like a menial job assigned to you, you probably won’t do it very well. Having an unlicensed person dedicated to these clerical activities not only will cost less, but will ensure the job is done better.
Reporting structure is critically important, often overlooked, and historically misaligned in HMGs. When hospital medicine was starting in the late 1990s and early 2000s, rapidly growing hospitalist groups were typically led by young, early-career physicians who had chosen hospital medicine as a career. The problem was that they often lacked the seniority and connections at the executive level to advocate for their HMG. All too often the hospitalist group was tucked in under another department or division which, in turn, reported HMG updates and issues to the board of directors and the CEO.
A common reporting structure in the early days was that a senior member of the medical staff, or group, had once worked in the hospital and therefore “understood” the issues and challenges that the hospitalists were facing. It was up to this physician with seniority and connections to advocate for the hospitalists as they saw fit. The problem was that the hospital landscape was, and is, constantly evolving in innumerable ways. These “once removed” reporting structures for HMGs failed to get the required information on the rapidly changing, and evolving, hospitalist landscape to the desks of executives who had the financial and structural control to address the challenges that the hospitalists in the trenches were facing.
Numerous HMGs failed in the early days of hospital medicine because of this type of misaligned reporting structure. This is a lesson that should not be forgotten: Make sure your HMG leader has a seat at the table where executive decisions are made, including but not limited to the board of directors. To be in balance, you have to be “in the room where it happens.”
Accountability
The outcomes that you are responsible for need to be explicit, appropriately resourced with Authority, and clearly spelled out in your job description. Your job description is a document you should know, own, and revisit regularly with whomever you report to, in order to ensure success.
Once you have the Authority side of the equation appropriately resourced, setting outcomes that are a stretch, but still realistic and achievable within the scope of your position, is critical to your success. It is good to think about short-, medium-, and long-term goals, especially if you are in a leadership role. For example, one expectation you will have, regardless of your station, is that you keep up on your email and answer your phone. These are short-term goals that will often be included in your job description. However, taking on a new hospital contract and making sure that it has 24/7 hospitalist coverage, that all the hospitalists are meeting the geometric mean length of stay, and that all the physicians are having 15 encounters per day doesn’t happen immediately. Long-term goals, such as taking on a new hospital contract, are the big-picture stuff that can make or break the career of an HMG leader. Long-term goals also need to be delineated in the job description, along with specific time stamps and the resources you need to accomplish big ticket items – which are spelled out in the Authority side (that is, physician recruiter, secretary, background checks, and so on).
One of the classic misuses of Accountability is the “Fall Guy” scenario. The Fall Guy scenario is often used by cynical hospital and medical group executives to expand their influence while limiting their liability. In the Fall Guy scenario, the executive is surrounded with junior partners who are underpowered with Authority, and then the executive makes decisions for which the junior partners are Accountable. This allows the senior executive to make risky decisions on behalf of the hospital or medical group without the liability of being held accountable when the decision-making process fails. When the risky, and often ill-informed, decision fails, the junior partner who lacked the Authority to make the decision – but held the Accountability for it – becomes the Fall Guy for the failed endeavor. This is a critical outcome that the Authority/Accountability balance can help you avoid, if you use it wisely and properly.
If you find yourself in the Fall Guy position, it is time for a change. The Authority, the Accountability, or both need to change so that they are in better balance. Or your employer needs to change. Changing employers is an outcome worth avoiding, if at all possible. I have scrutinized thousands of resumes in my career, and frequent job changes always wave a red flag to prospective employers. However, changing jobs remains a crucial option if you are being set up for failure when Authority and Accountability are out of balance.
If you are unable to negotiate for the balance that will allow you to be successful with your current group, remember that HMG leaders are a prized commodity and in short supply. Leaving a group that has been your career is hard, but it is better to leave than stay in a position where you are set up for failure as the Fall Guy. Further, the most effective time to expand your Authority is when you are negotiating the terms of a new position. Changing positions is the nuclear option. However, it is better than becoming the Fall Guy, and a change can create opportunities that will accelerate your career and influence, if done right.
When I talk about Authority/Accountability balance, I always counter the Fall Guy with an ignominious historical figure: General George B. McClellan. General McClellan was the commander of the Army of the Potomac during the early years of the American Civil War. General McClellan had the industrial might of the Union north at his beck and call, as well as extraordinary resources for recruiting and retaining soldiers for his army. At every encounter with General Robert E. Lee’s Army of Northern Virginia, General McClellan outnumbered them, sometimes by more than two to one. Yet General McClellan was outfoxed repeatedly for the same reason: He failed to take decisive action.
Every time that McClellan failed, he blamed insufficient resources and told President Lincoln that he needed more troops and more equipment to be successful. In summary, while the Fall Guy scenario needs to be avoided, once you are adequately resourced, success requires taking decisive and strategic action, or you will suffer as did General McClellan. Failing to act when you are appropriately resourced can be just as damaging to your career and credibility as allowing yourself to become the Fall Guy.
Job description
Everybody has somebody that they report to, no matter how high up on the executive ladder they have climbed. Even the CEO must report to the board of directors. And that reporting structure usually involves periodic formal reviews. Your formal review is a good time to go over your job description, note what is relevant, remove what is irrelevant, and add new elements that have evolved in importance since your last review.
Job descriptions take many forms, but they always include a list of qualifications. If you have the job, you have the qualifications, so that is not likely to change. You may become more qualified for a higher-level position, but that is an entirely different discussion. I like to think of a well-written job description as including short-term and long-term goals. Short-term goals are usually the daily stuff that keeps operations running smoothly but garners little attention. Examples would include staying current on your emails, answering your phone, organizing meetings, and regularly attending various committees. Even some of these short-term goals can and will change over time. I always enjoyed quality oversight in my department, but as the department and my responsibilities grew, I realized I couldn’t do everything that I wanted to do. I needed to focus on the things only I could do and delegate those things that could be done by someone else, even though I wanted to continue doing them myself. I created a position for a clinical quality officer, and quality oversight moved off of my job description.
Long-term goals are the aspirational items, such as increasing market share, decreasing readmissions, improving patient satisfaction, and the like. Effective leaders are often focused on these aspirational, long-term goals, but they still must effectively execute their short-term goals. Stephen Covey outlines the dilemma with the “time management matrix” in his seminal work “The 7 Habits of Highly Effective People.” An in-depth discussion is beyond the scope of this article, but the time management matrix places tasks into one of four categories based on urgency and importance, and provides strategies for staying up on short-term goals while continually moving long-term goals forward.If you show up at your review with a list of accomplishments as well as an understanding of how the “time management matrix” affects your responsibilities, your boss will be impressed. It is also worth mentioning that Covey’s first habit is “Proactivity.” He uses the term Proactivity in a much more nuanced form than we typically think of, however. Simply put, Proactivity is the opposite of Reactivity, and it is another invaluable tool for success with those long-term goals that will help you make a name for yourself.
When you show up for your review, be it annual, biannual, or other, be prepared. Not only should you bring your job description and recommendations for how it should be adapted in the changing environment, but also bring examples of your accomplishments since the last review.
I talk with leaders frequently who are hardworking and diligent and hate bragging about their achievements; I get that. At the same time, if you don’t inform your superiors about your successes, there is no guarantee that they will hear about them or understand them in the appropriate context. Bragging about how great you are in the physician’s lounge is annoying; telling your boss about your accomplishments since the last review is critical to maintaining the momentum of past accomplishments. If you are not willing to toot your own horn, there is a very good chance that your horn will remain silent. I don’t think self-promotion comes easily to anyone, and it has to be done with a degree of humility and sensitivity; but it has to be done, so prepare for it.
Look out for yourself and others
We talk about teamwork and collaboration as hospitalists, and SHM is always underscoring the importance of teamwork and highlighting examples of successful teamwork in its many conferences and publications. Most hospital executives are focused on their own careers, however, and many have no reservations about damaging your career (your brand) if they think it will promote theirs. You have to look out for yourself and size up every leadership position you get into.
Physicians can expect their careers to last decades. The average hospital CEO has a tenure of less than 3.5 years, however, and when a new CEO is hired, almost half of chief financial, chief operating, and chief information officers are fired within 9 months. You may be focused on the long-term success of your organization as you plan your career, but many hospital administrators are interested only in short-term gains. It is similar to some members of Congress who are interested only in what they need to do now to win the next election and not in the long-term needs of the country. You should understand this disconnect when dealing with hospital executives, and how you and your credibility can become cannon fodder in their quest for short-term self-preservation.
You have to look out for and take care of yourself as you promote your group. With a better understanding of the Authority/Accountability balance, you have new tools to assess your chances of success and to advocate for yourself so that you and your group can be successful.
Despite my cynicism toward executives in the medical field, I personally advocate for supporting the career development of those around you and advise against furthering your career at the expense of others. Many unscrupulous executives will use this approach, surrounding themselves with Fall Guys, but my experience shows that this is not a sustainable strategy for success. It can lead to short-term gains, but eventually the piper must be paid. Moreover, the most successful medical executives and leaders that I have encountered have been those who genuinely cared about their subordinates, looked out for them, and selflessly promoted their careers.
In the age of social media, tearing others down seems to be the fastest way to get more “likes.” However, I strongly believe that you can’t build up your group, and our profession, just by tearing people down. Lending a helping hand may bring you less attention in the short term, but such action raises your stature, creates loyalty, and leads to sustainable success for the long run.
Dr. McIlraith is the founding chairman of the Hospital Medicine Department at Mercy Medical Group in Sacramento, Calif. He received the SHM Award for Outstanding Service in Hospital Medicine in 2016 and is currently a member of the SHM Practice Management and Awards Committees, as well as the SHM Critical Care Task Force.
Sources
Quinn R. HM Turns 20: A look at the evolution of hospital medicine. The Hospitalist. 2016 August. https://www.the-hospitalist.org/hospitalist/article/121525/hm-turns-20-look-evolution-hospital-medicine
Stephen R. Covey. The 7 Habits of Highly Effective People: Powerful Lessons in Personal Change. Simon & Schuster. 1989.
10 Statistics on CEO Turnover, Recruitment. Becker’s Hospital Review. 2020. https://www.beckershospitalreview.com/hospital-management-administration/10-statistics-on-ceo-turnover-recruitment.html
I have had the pleasure of working on the Society of Hospital Medicine’s signature Leadership Academies since 2010, and I enjoy working with hospital medicine leaders from around the country every year. I started as a hospital medicine leader in 2000 and served during the unprecedented growth of the field when it was “the most rapidly growing specialty in the history of medicine.”
Most businesses dream of having a year of double-digit growth; my department grew an average of 15% annually for more than 10 years. These unique experiences have taught me many lessons and afforded me the opportunity to watch many stars of hospital medicine rise, as well as to learn from several less-scrupulous leaders about the darker side of hospital politics.
One of the lessons I learned the hard way about hospital politics is striking the “Authority/Accountability balance” in your career. I shared this perspective at the SHM annual conference in 2018, at speaking engagements on the West Coast, and with my leadership group at the academies. I am sharing it with you because the feedback I have received has been very positive.
The Authority/Accountability balance is a tool for evaluating your current career trajectory and measuring if it is set up for success or failure. The essence is that your Authority and Accountability need to be balanced for you to be successful in your career, regardless of your station. Everybody from the hospitalist fresh out of residency to the CEO needs to have Authority and Accountability in balance to be successful. And as you use the tool to measure your own potential for success or failure, learn to apply it to those who report to you.
I believe the rising tide lifts all boats and the success of your subordinates, through mentoring and support, will add to your success. There is another, more cynical view of subordinates that can be identified using the Authority/Accountability balance, which I will address.
Authority
In this construct, “Authority” has a much broader meaning than just the ability to tell people what to do. The ability to tell people what to do is important but not sufficient for success in hospital politics.
Financial resources are essential for a successful Authority/Accountability balance – not only the hardware such as computers, telephones, pagers, and so on, but also clerical support, technical support, and analytic support so that you are getting high-quality data on the performance of the members of your hospital medicine group (HMG). These “soft” resources (clerical, technical, and analytical) are often overlooked as needs that HMG leaders must advocate for; I speak with many HMG leaders who remain under-resourced with “soft” assets. However, being appropriately resourced in these areas can be transformational for a group. Hospitalists don’t like doing clerical work, and if you don’t like a menial job assigned to you, you probably won’t do it very well. Having an unlicensed person dedicated to these clerical activities not only will cost less, but will ensure the job is done better.
Reporting structure is critically important, often overlooked, and historically misaligned in HMGs. When hospital medicine was starting in the late 1990s and early 2000s, rapidly growing hospitalist groups were typically led by young, early-career physicians who had chosen hospital medicine as a career. The problem was that they often lacked the seniority and connections at the executive level to advocate for their HMG. All too often the hospitalist group was tucked in under another department or division which, in turn, reported HMG updates and issues to the board of directors and the CEO.
A common reporting structure in the early days was that a senior member of the medical staff, or group, had once worked in the hospital and therefore “understood” the issues and challenges that the hospitalists were facing. It was up to this physician with seniority and connections to advocate for the hospitalists as they saw fit. The problem was that the hospital landscape was, and is, constantly evolving in innumerable ways. These “once removed” reporting structures for HMGs failed to get the required information on the rapidly changing, and evolving, hospitalist landscape to the desks of executives who had the financial and structural control to address the challenges that the hospitalists in the trenches were facing.
Numerous HMGs failed in the early days of hospital medicine because of this type of misaligned reporting structure. This is a lesson that should not be forgotten: Make sure your HMG leader has a seat at the table where executive decisions are made, including but not limited to the board of directors. To be in balance, you have to be “in the room where it happens.”
Accountability
The outcomes that you are responsible for need to be explicit, appropriately resourced with Authority, and clearly spelled out in your job description. Your job description is a document you should know, own, and revisit regularly with whomever you report to, in order to ensure success.
Once you have the Authority side of the equation appropriately resourced, setting outcomes that are a stretch, but still realistic and achievable within the scope of your position, is critical to your success. It is good to think about short-, medium-, and long-term goals, especially if you are in a leadership role. For example, one expectation you will have, regardless of your station, is that you keep up on your email and answer your phone. These are short-term goals that will often be included in your job description. However, taking on a new hospital contract and making sure that it has 24/7 hospitalist coverage, that all the hospitalists are meeting the geometric mean length of stay, and that all the physicians are having 15 encounters per day doesn’t happen immediately. Long-term goals, such as taking on a new hospital contract, are the big-picture stuff that can make or break the career of an HMG leader. Long-term goals also need to be delineated in the job description, along with specific time stamps and the resources you need to accomplish big ticket items – which are spelled out in the Authority side (that is, physician recruiter, secretary, background checks, and so on).
One of the classic misuses of Accountability is the “Fall Guy” scenario. The Fall Guy scenario is often used by cynical hospital and medical group executives to expand their influence while limiting their liability. In the Fall Guy scenario, the executive is surrounded with junior partners who are underpowered with Authority, and then the executive makes decisions for which the junior partners are Accountable. This allows the senior executive to make risky decisions on behalf of the hospital or medical group without the liability of being held accountable when the decision-making process fails. When the risky, and often ill-informed, decision fails, the junior partner who lacked the Authority to make the decision – but held the Accountability for it – becomes the Fall Guy for the failed endeavor. This is a critical outcome that the Authority/Accountability balance can help you avoid, if you use it wisely and properly.
If you find yourself in the Fall Guy position, it is time for a change. The Authority, the Accountability, or both need to change so that they are in better balance. Or your employer needs to change. Changing employers is an outcome worth avoiding, if at all possible. I have scrutinized thousands of resumes in my career, and frequent job changes always wave a red flag to prospective employers. However, changing jobs remains a crucial option if you are being set up for failure when Authority and Accountability are out of balance.
If you are unable to negotiate for the balance that will allow you to be successful with your current group, remember that HMG leaders are a prized commodity and in short supply. Leaving a group that has been your career is hard, but it is better to leave than stay in a position where you are set up for failure as the Fall Guy. Further, the most effective time to expand your Authority is when you are negotiating the terms of a new position. Changing positions is the nuclear option. However, it is better than becoming the Fall Guy, and a change can create opportunities that will accelerate your career and influence, if done right.
When I talk about Authority/Accountability balance, I always counter the Fall Guy with an ignominious historical figure: General George B. McClellan. General McClellan was the commander of the Army of the Potomac during the early years of the American Civil War. General McClellan had the industrial might of the Union north at his beck and call, as well as extraordinary resources for recruiting and retaining soldiers for his army. At every encounter with General Robert E. Lee’s Army of Northern Virginia, General McClellan outnumbered them, sometimes by more than two to one. Yet General McClellan was outfoxed repeatedly for the same reason: He failed to take decisive action.
Every time that McClellan failed, he blamed insufficient resources and told President Lincoln that he needed more troops and more equipment to be successful. In summary, while the Fall Guy scenario needs to be avoided, once you are adequately resourced, success requires taking decisive and strategic action, or you will suffer as did General McClellan. Failing to act when you are appropriately resourced can be just as damaging to your career and credibility as allowing yourself to become the Fall Guy.
Job description
Everybody has somebody that they report to, no matter how high up on the executive ladder they have climbed. Even the CEO must report to the board of directors. And that reporting structure usually involves periodic formal reviews. Your formal review is a good time to go over your job description, note what is relevant, remove what is irrelevant, and add new elements that have evolved in importance since your last review.
Job descriptions take many forms, but they always include a list of qualifications. If you have the job, you have the qualifications, so that is not likely to change. You may become more qualified for a higher-level position, but that is an entirely different discussion. I like to think of a well-written job description as including short-term and long-term goals. Short-term goals are usually the daily stuff that keeps operations running smoothly but garners little attention. Examples would include staying current on your emails, answering your phone, organizing meetings, and regularly attending various committees. Even some of these short-term goals can and will change over time. I always enjoyed quality oversight in my department, but as the department and my responsibilities grew, I realized I couldn’t do everything that I wanted to do. I needed to focus on the things only I could do and delegate those things that could be done by someone else, even though I wanted to continue doing them myself. I created a position for a clinical quality officer, and quality oversight moved off of my job description.
Long-term goals are the aspirational items, such as increasing market share, decreasing readmissions, improving patient satisfaction, and the like. Effective leaders are often focused on these aspirational, long-term goals, but they still must effectively execute their short-term goals. Stephen Covey outlines the dilemma with the “time management matrix” in his seminal work “The 7 Habits of Highly Effective People.” An in-depth discussion is beyond the scope of this article, but the time management matrix places tasks into one of four categories based on urgency and importance, and provides strategies for staying up on short-term goals while continually moving long-term goals forward.If you show up at your review with a list of accomplishments as well as an understanding of how the “time management matrix” affects your responsibilities, your boss will be impressed. It is also worth mentioning that Covey’s first habit is “Proactivity.” He uses the term Proactivity in a much more nuanced form than we typically think of, however. Simply put, Proactivity is the opposite of Reactivity, and it is another invaluable tool for success with those long-term goals that will help you make a name for yourself.
When you show up for your review, be it annual, biannual, or other, be prepared. Not only should you bring your job description and recommendations for how it should be adapted in the changing environment, but also bring examples of your accomplishments since the last review.
I talk with leaders frequently who are hardworking and diligent and hate bragging about their achievements; I get that. At the same time, if you don’t inform your superiors about your successes, there is no guarantee that they will hear about them or understand them in the appropriate context. Bragging about how great you are in the physician’s lounge is annoying; telling your boss about your accomplishments since the last review is critical to maintaining the momentum of past accomplishments. If you are not willing to toot your own horn, there is a very good chance that your horn will remain silent. I don’t think self-promotion comes easily to anyone, and it has to be done with a degree of humility and sensitivity; but it has to be done, so prepare for it.
Look out for yourself and others
We talk about teamwork and collaboration as hospitalists, and SHM is always underscoring the importance of teamwork and highlighting examples of successful teamwork in its many conferences and publications. Most hospital executives are focused on their own careers, however, and many have no reservations about damaging your career (your brand) if they think it will promote theirs. You have to look out for yourself and size up every leadership position you get into.
Physicians can expect their careers to last decades. The average hospital CEO has a tenure of less than 3.5 years, however, and when a new CEO is hired, almost half of chief financial, chief operating, and chief information officers are fired within 9 months. You may be focused on the long-term success of your organization as you plan your career, but many hospital administrators are interested only in short-term gains. It is similar to some members of Congress who are interested only in what they need to do now to win the next election and not in the long-term needs of the country. You should understand this disconnect when dealing with hospital executives, and how you and your credibility can become cannon fodder in their quest for short-term self-preservation.
You have to look out for and take care of yourself as you promote your group. With a better understanding of the Authority/Accountability balance, you have new tools to assess your chances of success and to advocate for yourself so that you and your group can be successful.
Despite my cynicism toward executives in the medical field, I personally advocate for supporting the career development of those around you and advise against furthering your career at the expense of others. Many unscrupulous executives will use this approach, surrounding themselves with Fall Guys, but my experience shows that this is not a sustainable strategy for success. It can lead to short-term gains, but eventually the piper must be paid. Moreover, the most successful medical executives and leaders that I have encountered have been those who genuinely cared about their subordinates, looked out for them, and selflessly promoted their careers.
In the age of social media, tearing others down seems to be the fastest way to get more “likes.” However, I strongly believe that you can’t build up your group, and our profession, just by tearing people down. Lending a helping hand may bring you less attention in the short term, but such action raises your stature, creates loyalty, and leads to sustainable success for the long run.
Dr. McIlraith is the founding chairman of the Hospital Medicine Department at Mercy Medical Group in Sacramento, Calif. He received the SHM Award for Outstanding Service in Hospital Medicine in 2016 and is currently a member of the SHM Practice Management and Awards Committees, as well as the SHM Critical Care Task Force.
Sources
Quinn R. HM Turns 20: A look at the evolution of hospital medicine. The Hospitalist. 2016 August. https://www.the-hospitalist.org/hospitalist/article/121525/hm-turns-20-look-evolution-hospital-medicine
Stephen R. Covey. The 7 Habits of Highly Effective People: Powerful Lessons in Personal Change. Simon & Schuster. 1989.
10 Statistics on CEO Turnover, Recruitment. Becker’s Hospital Review. 2020. https://www.beckershospitalreview.com/hospital-management-administration/10-statistics-on-ceo-turnover-recruitment.html
Brain imaging reveals a neural basis for partisan politics
The differences between politically left- and right-leaning individuals may have neural underpinnings, results from a new brain imaging study suggest.
Investigators found that despite watching the same videos related to immigration policy, neural responses differed between liberals and conservatives.
“This divergence was strongest when the videos used language that highlighted threat, morality, and emotions, suggesting that certain words are more likely to drive polarized response,” lead researcher Yuan Chang Leong, PhD, a postdoctoral scholar in cognitive neuroscience at the University of California, Berkeley, told Medscape Medical News.
“The results suggest a neural basis for partisan biases in interpreting political messages, the effects these biases have on attitude change, and the type of language most likely to drive biased interpretations,” Leong added.
The study was published online Oct. 20 in Proceedings of the National Academy of Sciences.
Hardwired to disagree?
The researchers combined fMRI with semantic content analysis to investigate neural mechanisms that underlie the biased processing of political content.
They scanned 38 middle-aged men and women with liberal- or conservative-leaning immigration attitudes while the participants watched short news clips, campaign ads, and public speeches related to various immigration policies.
These policies included those that led to the United States–Mexico border wall, Deferred Action for Childhood Arrivals (DACA) protections for undocumented immigrants, the ban on refugees from majority-Muslim countries coming to the United States, and the cutting of federal funding to sanctuary cities.
After each video, participants rated on a scale of 1 to 5 how much they agreed with the general message of the video, the credibility of the information presented, and the extent to which the video made them likely to change their position and to support the policy in question.
The study revealed evidence of “neural polarization” – activity in the brain that diverges between people who hold liberal vs. conservative political views, the researchers reported.
Neural polarization was observed in the dorsomedial prefrontal cortex (DMPFC), a brain region associated with the interpretation of narrative content.
Neural polarization in this region intensified during moments in the videos that included risk-related and moral-emotional language, highlighting content features most likely to drive divergent interpretations between conservatives and liberals, they noted.
For a given individual, the closer that brain activity resembled that of the “average conservative” or “average liberal,” the more likely the person was to adopt that group’s position after watching the videos.
“We know that partisans respond differently to the same information. So in that sense, it’s not surprising to find that their brains respond differently as well,” Leong told Medscape Medical News.
“What we weren’t sure about was where in the brain we would find these differences, how neural differences were related to attitude change, and what type of content would be most likely to be associated with these differences,” he said.
Importantly, said Leong, these differences do not imply that people are hardwired to disagree. Rather, individual experiences and the media that is consumed likely contribute to neural polarization.
“ – for example, by framing messages to appeal to the core values of the respective voter,” he said.
Brain stimulation to alter political perception?
Reached for comment, Shaheen Lakhan, MD, PhD, neurologist in Newton, Mass., and executive director, Global Neuroscience Initiative Foundation, said the research “puts us one step closer to identifying how our brains interpret political information.”
The study, Lakhan noted, implicates a specific brain structure, the DMPFC, which is the “lens” in which information that gets into our brain is “viewed and acted on.”
“I trust that there will be plenty more work using a similar fMRI approach to tease out scenarios outside of immigration policy, as used in this study. Down the line, brain signatures through fMRI may be able to tell an individual’s political bent, and perhaps technologies like transcranial magnetic stimulation may be able to modulate our perceptions of political content, Shaheen said.
The research was supported by a grant from the Army Research Office. Leong and Lakhan have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
The differences between politically left- and right-leaning individuals may have neural underpinnings, results from a new brain imaging study suggest.
Investigators found that despite watching the same videos related to immigration policy, neural responses differed between liberals and conservatives.
“This divergence was strongest when the videos used language that highlighted threat, morality, and emotions, suggesting that certain words are more likely to drive polarized response,” lead researcher Yuan Chang Leong, PhD, a postdoctoral scholar in cognitive neuroscience at the University of California, Berkeley, told Medscape Medical News.
“The results suggest a neural basis for partisan biases in interpreting political messages, the effects these biases have on attitude change, and the type of language most likely to drive biased interpretations,” Leong added.
The study was published online Oct. 20 in Proceedings of the National Academy of Sciences.
Hardwired to disagree?
The researchers combined fMRI with semantic content analysis to investigate neural mechanisms that underlie the biased processing of political content.
They scanned 38 middle-aged men and women with liberal- or conservative-leaning immigration attitudes while the participants watched short news clips, campaign ads, and public speeches related to various immigration policies.
These policies included those that led to the United States–Mexico border wall, Deferred Action for Childhood Arrivals (DACA) protections for undocumented immigrants, the ban on refugees from majority-Muslim countries coming to the United States, and the cutting of federal funding to sanctuary cities.
After each video, participants rated on a scale of 1 to 5 how much they agreed with the general message of the video, the credibility of the information presented, and the extent to which the video made them likely to change their position and to support the policy in question.
The study revealed evidence of “neural polarization” – activity in the brain that diverges between people who hold liberal vs. conservative political views, the researchers reported.
Neural polarization was observed in the dorsomedial prefrontal cortex (DMPFC), a brain region associated with the interpretation of narrative content.
Neural polarization in this region intensified during moments in the videos that included risk-related and moral-emotional language, highlighting content features most likely to drive divergent interpretations between conservatives and liberals, they noted.
For a given individual, the closer that brain activity resembled that of the “average conservative” or “average liberal,” the more likely the person was to adopt that group’s position after watching the videos.
“We know that partisans respond differently to the same information. So in that sense, it’s not surprising to find that their brains respond differently as well,” Leong told Medscape Medical News.
“What we weren’t sure about was where in the brain we would find these differences, how neural differences were related to attitude change, and what type of content would be most likely to be associated with these differences,” he said.
Importantly, said Leong, these differences do not imply that people are hardwired to disagree. Rather, individual experiences and the media that is consumed likely contribute to neural polarization.
“ – for example, by framing messages to appeal to the core values of the respective voter,” he said.
Brain stimulation to alter political perception?
Reached for comment, Shaheen Lakhan, MD, PhD, neurologist in Newton, Mass., and executive director, Global Neuroscience Initiative Foundation, said the research “puts us one step closer to identifying how our brains interpret political information.”
The study, Lakhan noted, implicates a specific brain structure, the DMPFC, which is the “lens” in which information that gets into our brain is “viewed and acted on.”
“I trust that there will be plenty more work using a similar fMRI approach to tease out scenarios outside of immigration policy, as used in this study. Down the line, brain signatures through fMRI may be able to tell an individual’s political bent, and perhaps technologies like transcranial magnetic stimulation may be able to modulate our perceptions of political content, Shaheen said.
The research was supported by a grant from the Army Research Office. Leong and Lakhan have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
The differences between politically left- and right-leaning individuals may have neural underpinnings, results from a new brain imaging study suggest.
Investigators found that despite watching the same videos related to immigration policy, neural responses differed between liberals and conservatives.
“This divergence was strongest when the videos used language that highlighted threat, morality, and emotions, suggesting that certain words are more likely to drive polarized response,” lead researcher Yuan Chang Leong, PhD, a postdoctoral scholar in cognitive neuroscience at the University of California, Berkeley, told Medscape Medical News.
“The results suggest a neural basis for partisan biases in interpreting political messages, the effects these biases have on attitude change, and the type of language most likely to drive biased interpretations,” Leong added.
The study was published online Oct. 20 in Proceedings of the National Academy of Sciences.
Hardwired to disagree?
The researchers combined fMRI with semantic content analysis to investigate neural mechanisms that underlie the biased processing of political content.
They scanned 38 middle-aged men and women with liberal- or conservative-leaning immigration attitudes while the participants watched short news clips, campaign ads, and public speeches related to various immigration policies.
These policies included those that led to the United States–Mexico border wall, Deferred Action for Childhood Arrivals (DACA) protections for undocumented immigrants, the ban on refugees from majority-Muslim countries coming to the United States, and the cutting of federal funding to sanctuary cities.
After each video, participants rated on a scale of 1 to 5 how much they agreed with the general message of the video, the credibility of the information presented, and the extent to which the video made them likely to change their position and to support the policy in question.
The study revealed evidence of “neural polarization” – activity in the brain that diverges between people who hold liberal vs. conservative political views, the researchers reported.
Neural polarization was observed in the dorsomedial prefrontal cortex (DMPFC), a brain region associated with the interpretation of narrative content.
Neural polarization in this region intensified during moments in the videos that included risk-related and moral-emotional language, highlighting content features most likely to drive divergent interpretations between conservatives and liberals, they noted.
For a given individual, the closer that brain activity resembled that of the “average conservative” or “average liberal,” the more likely the person was to adopt that group’s position after watching the videos.
“We know that partisans respond differently to the same information. So in that sense, it’s not surprising to find that their brains respond differently as well,” Leong told Medscape Medical News.
“What we weren’t sure about was where in the brain we would find these differences, how neural differences were related to attitude change, and what type of content would be most likely to be associated with these differences,” he said.
Importantly, said Leong, these differences do not imply that people are hardwired to disagree. Rather, individual experiences and the media that is consumed likely contribute to neural polarization.
“ – for example, by framing messages to appeal to the core values of the respective voter,” he said.
Brain stimulation to alter political perception?
Reached for comment, Shaheen Lakhan, MD, PhD, neurologist in Newton, Mass., and executive director, Global Neuroscience Initiative Foundation, said the research “puts us one step closer to identifying how our brains interpret political information.”
The study, Lakhan noted, implicates a specific brain structure, the DMPFC, which is the “lens” in which information that gets into our brain is “viewed and acted on.”
“I trust that there will be plenty more work using a similar fMRI approach to tease out scenarios outside of immigration policy, as used in this study. Down the line, brain signatures through fMRI may be able to tell an individual’s political bent, and perhaps technologies like transcranial magnetic stimulation may be able to modulate our perceptions of political content, Shaheen said.
The research was supported by a grant from the Army Research Office. Leong and Lakhan have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Red, Swollen, Tender Ear
The Diagnosis: Relapsing Polychondritis
Due to suspicion of relapsing polychondritis (RP), we also performed an audiometric evaluation, which demonstrated bilateral sensorineural hearing loss. Echocardiography highlighted mild to moderate mitralic and tricuspidal insufficiency without hemodynamic impairment (ejection fraction, 50%). Corticosteroid therapy was started (prednisone 0.5 mg/kg/d). After 7 days of treatment, inflammation was remarkably reduced, and the patient no longer reported pain.
Relapsing polychondritis is a rare noninfective condition characterized by focal inflammatory destruction of ear cartilage, followed by fibroblastic regeneration. It often is associated with ocular inflammation, including conjunctivitis, scleritis, and episcleritis; cochlear or vestibular lesions; and seronegative nonerosive inflammatory arthritis.1 Clinical examination of the affected area shows swelling, redness, and tenderness of the ear, which could lead to a misdiagnosis of cellulitis. A typical and useful differentiating sign is the sparing of the noncartilaginous parts of the ear lobule. If not promptly diagnosed and treated, the destructive process can cause thinning of the cartilage, leading to deformities of the external ear.
The differential diagnosis includes erysipelas, which presents as a rapidly appearing inflammatory patch with sharply defined borders, accompanied by regional lymphadenopathy or skin streaking as well as fever. Sweet syndrome usually presents with tender erythematous or violaceous skin papules, plaques, or nodules, frequently with a pseudovesicular appearance; patients generally present with a classic fever and peripheral neutrophilia.2 The localized cutaneous form of leishmaniasis usually appears with a papule that generally develops into an ulcerative nodular lesion. Our patient did not have a history of exposure to topical substances that could point to photocontact dermatitis.
Dion et al3 proposed 3 distinct clinical phenotypes of RP: (1) patients with concomitant myelodysplastic syndrome or other hematologic malignancy (<10% of patients), mostly older men with a poor prognosis; (2) patients with tracheobronchial involvement (approximately 25% of patients); and (3) patients who do not have hematologic or tracheobronchial involvement (approximately 65% of patients) with a good prognosis.
Two sets of diagnostic criteria have been proposed. The criteria from McAdam et al4 required the presence of 3 or more of the following clinical features: bilateral auricular chondritis, nonerosive seronegative inflammatory polyarthritis, nasal chondritis, ocular inflammation (eg, conjunctivitis, keratitis, scleritis/episcleritis, uveitis), respiratory tract chondritis (laryngeal and/or tracheal cartilages), and cochlear and/or vestibular dysfunction (eg, neurosensory hearing loss, tinnitus, vertigo). These criteria were modified by Damiani and Levine.5 According to the latter, all patients were required to have one of the following: at least 4 of the McAdam et al4 diagnostic criteria; 1 or more of the clinical findings included in the McAdam et al4 criteria with histologic features suggestive for RP; or chondritis at 2 or more separate anatomic locations with a response to glucocorticoids and/or dapsone.
No laboratory findings are specific for RP, and nonspecific indicators of inflammation--elevated erythrocyte sedimentation rate and C-reactive protein--often are present.
The cause of RP is unknown. Familial clustering has not been observed. Terao et al6 found that HLA-DRB1*1602, -DQB1*0502, and -B*6701, in linkage disequilibrium with each other, are associated with susceptibility to RP.
There is no universal consensus about treatment, but a course of steroids leads to the resolution of the acute phase. Maintenance treatment can include dapsone, azathioprine, methotrexate, cyclophosphamide, and cyclosporine.7,8 Some studies have described the successful use of anti-tumor necrosis factor α inhibitors and rituximab.9,10
- Borgia F, Giuffrida R, Guarneri F, et al. Relapsing polychondritis: an updated review. Biomedicines. 2018;6:84.
- Rednic S, Damian L, Talarico R, et al. Relapsing polychondritis: state of the art on clinical practice guidelines. RMD Open. 2018:4(suppl 1)e000788.
- Dion J, Costedoat-Chalumeau N, Sène D, et al. Relapsing polychondritis can be characterized by three different clinical phenotypes: analysis of a recent series of 142 patients. Arthritis Rheumatol. 2016;68:2992-3001.
- McAdam LP, O'Hanlan MA, Bluestone R, et al. Relapsing polychondritis: prospective study of 23 patients and a review of the literature. Medicine (Baltimore). 1976;55:193.
- Damiani JM, Levine HL. Relapsing polychondritis--report of ten cases. Laryngoscope. 1979;89:929-946.
- Terao C, Yoshifuji H, Yamano Y, et al. Genotyping of relapsing polychondritis identified novel susceptibility HLA alleles and distinct genetic characteristics from other rheumatic diseases. Rheumatology (Oxford). 2016;55:1686.016-82
- Goldenberg G, Sangueza OP, Jorizzo JL. Successful treatment of relapsing polychondritis with mycophenolate mofetil. J Dermatolog Treat. 2006;17:158-159.
- Handler RP. Leflunomide for relapsing polychondritis: successful longterm treatment. J Rheumatol. 2006;33:1916; author reply 1916-1917.
- Carter JD. Treatment of relapsing polychondritis with a TNF antagonist. J Rheumatol. 2005;32:1413.
- Leroux G, Costedoat-Chalumeau N, Brihaye B, et al. Treatment of relapsing polychondritis with rituximab: a retrospective study of nine patients. Arthritis Rheum. 2009;61:577-582.
The Diagnosis: Relapsing Polychondritis
Due to suspicion of relapsing polychondritis (RP), we also performed an audiometric evaluation, which demonstrated bilateral sensorineural hearing loss. Echocardiography highlighted mild to moderate mitralic and tricuspidal insufficiency without hemodynamic impairment (ejection fraction, 50%). Corticosteroid therapy was started (prednisone 0.5 mg/kg/d). After 7 days of treatment, inflammation was remarkably reduced, and the patient no longer reported pain.
Relapsing polychondritis is a rare noninfective condition characterized by focal inflammatory destruction of ear cartilage, followed by fibroblastic regeneration. It often is associated with ocular inflammation, including conjunctivitis, scleritis, and episcleritis; cochlear or vestibular lesions; and seronegative nonerosive inflammatory arthritis.1 Clinical examination of the affected area shows swelling, redness, and tenderness of the ear, which could lead to a misdiagnosis of cellulitis. A typical and useful differentiating sign is the sparing of the noncartilaginous parts of the ear lobule. If not promptly diagnosed and treated, the destructive process can cause thinning of the cartilage, leading to deformities of the external ear.
The differential diagnosis includes erysipelas, which presents as a rapidly appearing inflammatory patch with sharply defined borders, accompanied by regional lymphadenopathy or skin streaking as well as fever. Sweet syndrome usually presents with tender erythematous or violaceous skin papules, plaques, or nodules, frequently with a pseudovesicular appearance; patients generally present with a classic fever and peripheral neutrophilia.2 The localized cutaneous form of leishmaniasis usually appears with a papule that generally develops into an ulcerative nodular lesion. Our patient did not have a history of exposure to topical substances that could point to photocontact dermatitis.
Dion et al3 proposed 3 distinct clinical phenotypes of RP: (1) patients with concomitant myelodysplastic syndrome or other hematologic malignancy (<10% of patients), mostly older men with a poor prognosis; (2) patients with tracheobronchial involvement (approximately 25% of patients); and (3) patients who do not have hematologic or tracheobronchial involvement (approximately 65% of patients) with a good prognosis.
Two sets of diagnostic criteria have been proposed. The criteria from McAdam et al4 required the presence of 3 or more of the following clinical features: bilateral auricular chondritis, nonerosive seronegative inflammatory polyarthritis, nasal chondritis, ocular inflammation (eg, conjunctivitis, keratitis, scleritis/episcleritis, uveitis), respiratory tract chondritis (laryngeal and/or tracheal cartilages), and cochlear and/or vestibular dysfunction (eg, neurosensory hearing loss, tinnitus, vertigo). These criteria were modified by Damiani and Levine.5 According to the latter, all patients were required to have one of the following: at least 4 of the McAdam et al4 diagnostic criteria; 1 or more of the clinical findings included in the McAdam et al4 criteria with histologic features suggestive for RP; or chondritis at 2 or more separate anatomic locations with a response to glucocorticoids and/or dapsone.
No laboratory findings are specific for RP, and nonspecific indicators of inflammation--elevated erythrocyte sedimentation rate and C-reactive protein--often are present.
The cause of RP is unknown. Familial clustering has not been observed. Terao et al6 found that HLA-DRB1*1602, -DQB1*0502, and -B*6701, in linkage disequilibrium with each other, are associated with susceptibility to RP.
There is no universal consensus about treatment, but a course of steroids leads to the resolution of the acute phase. Maintenance treatment can include dapsone, azathioprine, methotrexate, cyclophosphamide, and cyclosporine.7,8 Some studies have described the successful use of anti-tumor necrosis factor α inhibitors and rituximab.9,10
The Diagnosis: Relapsing Polychondritis
Due to suspicion of relapsing polychondritis (RP), we also performed an audiometric evaluation, which demonstrated bilateral sensorineural hearing loss. Echocardiography highlighted mild to moderate mitralic and tricuspidal insufficiency without hemodynamic impairment (ejection fraction, 50%). Corticosteroid therapy was started (prednisone 0.5 mg/kg/d). After 7 days of treatment, inflammation was remarkably reduced, and the patient no longer reported pain.
Relapsing polychondritis is a rare noninfective condition characterized by focal inflammatory destruction of ear cartilage, followed by fibroblastic regeneration. It often is associated with ocular inflammation, including conjunctivitis, scleritis, and episcleritis; cochlear or vestibular lesions; and seronegative nonerosive inflammatory arthritis.1 Clinical examination of the affected area shows swelling, redness, and tenderness of the ear, which could lead to a misdiagnosis of cellulitis. A typical and useful differentiating sign is the sparing of the noncartilaginous parts of the ear lobule. If not promptly diagnosed and treated, the destructive process can cause thinning of the cartilage, leading to deformities of the external ear.
The differential diagnosis includes erysipelas, which presents as a rapidly appearing inflammatory patch with sharply defined borders, accompanied by regional lymphadenopathy or skin streaking as well as fever. Sweet syndrome usually presents with tender erythematous or violaceous skin papules, plaques, or nodules, frequently with a pseudovesicular appearance; patients generally present with a classic fever and peripheral neutrophilia.2 The localized cutaneous form of leishmaniasis usually appears with a papule that generally develops into an ulcerative nodular lesion. Our patient did not have a history of exposure to topical substances that could point to photocontact dermatitis.
Dion et al3 proposed 3 distinct clinical phenotypes of RP: (1) patients with concomitant myelodysplastic syndrome or other hematologic malignancy (<10% of patients), mostly older men with a poor prognosis; (2) patients with tracheobronchial involvement (approximately 25% of patients); and (3) patients who do not have hematologic or tracheobronchial involvement (approximately 65% of patients) with a good prognosis.
Two sets of diagnostic criteria have been proposed. The criteria from McAdam et al4 required the presence of 3 or more of the following clinical features: bilateral auricular chondritis, nonerosive seronegative inflammatory polyarthritis, nasal chondritis, ocular inflammation (eg, conjunctivitis, keratitis, scleritis/episcleritis, uveitis), respiratory tract chondritis (laryngeal and/or tracheal cartilages), and cochlear and/or vestibular dysfunction (eg, neurosensory hearing loss, tinnitus, vertigo). These criteria were modified by Damiani and Levine.5 According to the latter, all patients were required to have one of the following: at least 4 of the McAdam et al4 diagnostic criteria; 1 or more of the clinical findings included in the McAdam et al4 criteria with histologic features suggestive for RP; or chondritis at 2 or more separate anatomic locations with a response to glucocorticoids and/or dapsone.
No laboratory findings are specific for RP, and nonspecific indicators of inflammation--elevated erythrocyte sedimentation rate and C-reactive protein--often are present.
The cause of RP is unknown. Familial clustering has not been observed. Terao et al6 found that HLA-DRB1*1602, -DQB1*0502, and -B*6701, in linkage disequilibrium with each other, are associated with susceptibility to RP.
There is no universal consensus about treatment, but a course of steroids leads to the resolution of the acute phase. Maintenance treatment can include dapsone, azathioprine, methotrexate, cyclophosphamide, and cyclosporine.7,8 Some studies have described the successful use of anti-tumor necrosis factor α inhibitors and rituximab.9,10
- Borgia F, Giuffrida R, Guarneri F, et al. Relapsing polychondritis: an updated review. Biomedicines. 2018;6:84.
- Rednic S, Damian L, Talarico R, et al. Relapsing polychondritis: state of the art on clinical practice guidelines. RMD Open. 2018:4(suppl 1)e000788.
- Dion J, Costedoat-Chalumeau N, Sène D, et al. Relapsing polychondritis can be characterized by three different clinical phenotypes: analysis of a recent series of 142 patients. Arthritis Rheumatol. 2016;68:2992-3001.
- McAdam LP, O'Hanlan MA, Bluestone R, et al. Relapsing polychondritis: prospective study of 23 patients and a review of the literature. Medicine (Baltimore). 1976;55:193.
- Damiani JM, Levine HL. Relapsing polychondritis--report of ten cases. Laryngoscope. 1979;89:929-946.
- Terao C, Yoshifuji H, Yamano Y, et al. Genotyping of relapsing polychondritis identified novel susceptibility HLA alleles and distinct genetic characteristics from other rheumatic diseases. Rheumatology (Oxford). 2016;55:1686.016-82
- Goldenberg G, Sangueza OP, Jorizzo JL. Successful treatment of relapsing polychondritis with mycophenolate mofetil. J Dermatolog Treat. 2006;17:158-159.
- Handler RP. Leflunomide for relapsing polychondritis: successful longterm treatment. J Rheumatol. 2006;33:1916; author reply 1916-1917.
- Carter JD. Treatment of relapsing polychondritis with a TNF antagonist. J Rheumatol. 2005;32:1413.
- Leroux G, Costedoat-Chalumeau N, Brihaye B, et al. Treatment of relapsing polychondritis with rituximab: a retrospective study of nine patients. Arthritis Rheum. 2009;61:577-582.
- Borgia F, Giuffrida R, Guarneri F, et al. Relapsing polychondritis: an updated review. Biomedicines. 2018;6:84.
- Rednic S, Damian L, Talarico R, et al. Relapsing polychondritis: state of the art on clinical practice guidelines. RMD Open. 2018:4(suppl 1)e000788.
- Dion J, Costedoat-Chalumeau N, Sène D, et al. Relapsing polychondritis can be characterized by three different clinical phenotypes: analysis of a recent series of 142 patients. Arthritis Rheumatol. 2016;68:2992-3001.
- McAdam LP, O'Hanlan MA, Bluestone R, et al. Relapsing polychondritis: prospective study of 23 patients and a review of the literature. Medicine (Baltimore). 1976;55:193.
- Damiani JM, Levine HL. Relapsing polychondritis--report of ten cases. Laryngoscope. 1979;89:929-946.
- Terao C, Yoshifuji H, Yamano Y, et al. Genotyping of relapsing polychondritis identified novel susceptibility HLA alleles and distinct genetic characteristics from other rheumatic diseases. Rheumatology (Oxford). 2016;55:1686.016-82
- Goldenberg G, Sangueza OP, Jorizzo JL. Successful treatment of relapsing polychondritis with mycophenolate mofetil. J Dermatolog Treat. 2006;17:158-159.
- Handler RP. Leflunomide for relapsing polychondritis: successful longterm treatment. J Rheumatol. 2006;33:1916; author reply 1916-1917.
- Carter JD. Treatment of relapsing polychondritis with a TNF antagonist. J Rheumatol. 2005;32:1413.
- Leroux G, Costedoat-Chalumeau N, Brihaye B, et al. Treatment of relapsing polychondritis with rituximab: a retrospective study of nine patients. Arthritis Rheum. 2009;61:577-582.
A 67-year-old woman presented with severe pain of the left external ear. She explained that similar episodes had occurred 2 years prior and affected the right ear and the nose. Her general practitioner prescribed topical and systemic antibiotic treatment, but there was no improvement. The patient also reported diffuse small joint pain without any radiologic sign of erosive arthritis. Physical examination revealed a red swollen external ear that was tender to the touch from the helix to the antitragus; conversely, the earlobe did not present any sign of inflammation. Redness of the left eye also was noticed, and a slit-lamp examination confirmed our suspect of scleritis. Results from routine blood tests, including an autoimmune panel, were within reference range, except for a nonspecific increase of inflammatory markers (erythrocyte sedimentation rate, 43 mm/h [reference range, 0–20 mm/h]; C-reactive protein, 5.65 mg/L [reference range, 0.08–3.1 mg/L]).
TDF preferred in PrEP for Blacks and women, studies indicate
Although the efficacy of two pre-exposure prophylaxis (PrEP) regimens containing differing prodrug formulations of tenofovir are virtually identical, the balance between benefit and risk tips in favor of the combination using the older formulation, tenofovir disoproxil fumarate (TDF), a pharmacology researcher said.
An analysis of the pharmacologic profiles of TDF plus emtricitabine (FTC; Truvada and generic) with tenofovir alafenamide (TAF) plus FTC (Descovy) shows that the risk of decreased bone mineral density and renal toxicity with TDF are significantly lower than those of weight gain and related metabolic and cardiovascular problems associated with the newer tenofovir formulation TAF, according to pharmacology research fellow Andrew Hill, MD, PhD, from the University of Liverpool (England).
“I think when we’re comparing these two drugs overall, we have a clear benefit/risk, and we need to take both of these potential toxicities seriously, “ he said in an online presentation during IDWeek 2020, an annual scientific meeting on infectious diseases held virtually this year.
“But in my view, treating women – Black women – with TAF/FTC is a bad thing,” he continued. “I think it’s going lead to more harm, more myocardial infarctions, more cases of diabetes, and potentially more adverse birth outcomes, and I think that is a risk that is not worth taking, given that the apparent benefit in terms of bone mineral density and renal markers is a hypothesis at best, and is not translated into hard clinical endpoints.”
Adverse event profiles
Dr. Hill compared the side effect profiles of the two agents when used both in antiretroviral therapy (ART) in combination the integrase inhibitor dolutegravir (DTG; Tivicay), and in PrEP.
World Health Organization guidelines for first-line ART recommend the use of TDF/FTC/DTG, reserving TAF plus lamivudine (3TC) and DTG for use in special circumstances only, Dr. Hill noted.
He pointed to a pooled analysis of data from eight randomized, controlled trials of treatment-naive people living with HIV who started on ART from 2003 to 2015. The authors found that demographic factors associated with weight gain included lower CD4 cell counter, higher levels of HIV type 1 RNA, no injection drug use, female sex, and Black race.
They also found that, among nucleoside/nucleotide reverse transcriptase inhibitors, TAF was associated with more weight gain than TDF, abacavir, or zidovudine.
“This pattern is seen consistently across studies both of pre-exposure prophylaxis or treatment comparing tenofovir with either TAF or other nucleoside analogs,” he said.
The greater weight gain with TAF versus TDF was seen in both treatment trials and in the DISCOVER PrEP trial.
In addition, in a crossover trial conducted in Germany, patients who switched from TDF to TAF had an approximately 2 kg increase in body weight.
TAF has also been associated with higher grade 3 or 4 glucose and LDL cholesterol than TDF in clinical trials for the treatment of hepatitis B infections, and with higher LDL cholesterol and total cholesterol levels as well as diabetes in patients treated with the drugs in combination in the EMERALD HIV trial.
Clinical trials also tend to underestimate the real-world population of persons at highest risk for adverse events from TAF, Dr. Hill said, noting that the percentage of Black women in phase 3 trials for dolutegravir was 9%, compared with 42% among persons infected with HIV worldwide. The respective percentages for Black men are 16% versus 30%. These differences are similar across clinical trial programs for other ART agents.
“Generally, it’s women and Black people who seem to be at greatest risk for safety issues,” he said.
In the ADVANCE trial comparing TAF/FTC/DTG with TDF/FTC/DTG and a control arm of TDF, FTC and efavirenz, the mean change in weight among men after 3 years on the TAF-based regimen was a gain of 7.2 kg (15.9 lbs), compared with 5.5 kg (12 lbs) with TDF, and 2.6 kg (5.7 lbs) with the efavirenz-containing regimen.
In women enrolled in the same trial, the respective mean weight gains were 12.3 kg (27 lbs), 7.4 kg (16.3 lbs), and 5.5 kg (12 lbs).
“All of our analyses so far have shown that the weight continues to go up. We’re actually seeing people doubling in their body weight. We’ve seen some women come into clinic and their doctors don’t even recognize them because they’ve put on so much weight,” he said.
In women, most of the gain in weight occurs as limb or trunk fat, with a predominance of visceral fat.
People taking TAF in the trial were also at significantly greater risk for developing the metabolic syndrome, and at week 96, 27% of women on TAF/FTC/DTG had treatment-emergent obesity, compared with 17% for those on TDF/FTC/DTG and 11% for those on TDF/FTC/EFV. In men, the respective 96-week rates of treatment-emergent obesity were 7%, 3%, and 2%.
Clinical obesity itself is a risk factor for obstetric complications and birth outcomes, Alzheimer’s disease, type 2 diabetes, cardiovascular disease, hypertension and cancer, and an average 4-year reduction in life expectancy, Dr. Hill said. “I think it’s actually very unlikely that the [World Health Organization] guidelines will now change and allow the widespread use of TAF/FTC in combination with integrase inhibitors worldwide given these potential implications.”
Modern times
The bad rap that TDF gets for its alleged effects on bone mineral density and kidneys comes from studies where the drug was given in a boosted regimen that can amplify tenofovir toxicities, Dr. Hill said.
He noted that data from Gilead Sciences shows through 7 years of therapy in previously ART-naive patients, the combination of TDF/3TC/EFV showed sustained durable efficacy, no discontinuations to renal adverse effects, and no evidence of clinically relevant bone effects.
“I think we need to be very careful when we look at tenofovir and TAF. We need to look at the more modern way that these drugs are used, which is not with pharmacokinetic boosters anymore, and in that situation the toxicity profile of tenofovir/3TC – the original TDF – is very favorable,” he said.
Robert Goldstein, MD, PhD, an infectious disease specialist and medical director of the transgender health program at Massachusetts General Hospital in Boston, who comoderated the session where Dr. Hill presented his data, said that his clinical experience mirrors the pharmacokinetic findings.
“I certainly have strong feelings about the use of TDF in pre-exposure prophylaxis,” he said in an interview. “TDF is an effective and safe formulation of tenofovir to be used in pre-exposure prophylaxis, and one that we have more experience with. It’s the formulation of tenofovir that I use for all of my patients who are on pre-exposure prophylaxis, and I think it is the most cost-effective.’
No funding source was reported. Andrew Hill consults for Tibotec on clinical trial programs for darunavir, etravirine, and rilpivirine. Dr. Goldstein reported having no relevant disclosures.
Although the efficacy of two pre-exposure prophylaxis (PrEP) regimens containing differing prodrug formulations of tenofovir are virtually identical, the balance between benefit and risk tips in favor of the combination using the older formulation, tenofovir disoproxil fumarate (TDF), a pharmacology researcher said.
An analysis of the pharmacologic profiles of TDF plus emtricitabine (FTC; Truvada and generic) with tenofovir alafenamide (TAF) plus FTC (Descovy) shows that the risk of decreased bone mineral density and renal toxicity with TDF are significantly lower than those of weight gain and related metabolic and cardiovascular problems associated with the newer tenofovir formulation TAF, according to pharmacology research fellow Andrew Hill, MD, PhD, from the University of Liverpool (England).
“I think when we’re comparing these two drugs overall, we have a clear benefit/risk, and we need to take both of these potential toxicities seriously, “ he said in an online presentation during IDWeek 2020, an annual scientific meeting on infectious diseases held virtually this year.
“But in my view, treating women – Black women – with TAF/FTC is a bad thing,” he continued. “I think it’s going lead to more harm, more myocardial infarctions, more cases of diabetes, and potentially more adverse birth outcomes, and I think that is a risk that is not worth taking, given that the apparent benefit in terms of bone mineral density and renal markers is a hypothesis at best, and is not translated into hard clinical endpoints.”
Adverse event profiles
Dr. Hill compared the side effect profiles of the two agents when used both in antiretroviral therapy (ART) in combination the integrase inhibitor dolutegravir (DTG; Tivicay), and in PrEP.
World Health Organization guidelines for first-line ART recommend the use of TDF/FTC/DTG, reserving TAF plus lamivudine (3TC) and DTG for use in special circumstances only, Dr. Hill noted.
He pointed to a pooled analysis of data from eight randomized, controlled trials of treatment-naive people living with HIV who started on ART from 2003 to 2015. The authors found that demographic factors associated with weight gain included lower CD4 cell counter, higher levels of HIV type 1 RNA, no injection drug use, female sex, and Black race.
They also found that, among nucleoside/nucleotide reverse transcriptase inhibitors, TAF was associated with more weight gain than TDF, abacavir, or zidovudine.
“This pattern is seen consistently across studies both of pre-exposure prophylaxis or treatment comparing tenofovir with either TAF or other nucleoside analogs,” he said.
The greater weight gain with TAF versus TDF was seen in both treatment trials and in the DISCOVER PrEP trial.
In addition, in a crossover trial conducted in Germany, patients who switched from TDF to TAF had an approximately 2 kg increase in body weight.
TAF has also been associated with higher grade 3 or 4 glucose and LDL cholesterol than TDF in clinical trials for the treatment of hepatitis B infections, and with higher LDL cholesterol and total cholesterol levels as well as diabetes in patients treated with the drugs in combination in the EMERALD HIV trial.
Clinical trials also tend to underestimate the real-world population of persons at highest risk for adverse events from TAF, Dr. Hill said, noting that the percentage of Black women in phase 3 trials for dolutegravir was 9%, compared with 42% among persons infected with HIV worldwide. The respective percentages for Black men are 16% versus 30%. These differences are similar across clinical trial programs for other ART agents.
“Generally, it’s women and Black people who seem to be at greatest risk for safety issues,” he said.
In the ADVANCE trial comparing TAF/FTC/DTG with TDF/FTC/DTG and a control arm of TDF, FTC and efavirenz, the mean change in weight among men after 3 years on the TAF-based regimen was a gain of 7.2 kg (15.9 lbs), compared with 5.5 kg (12 lbs) with TDF, and 2.6 kg (5.7 lbs) with the efavirenz-containing regimen.
In women enrolled in the same trial, the respective mean weight gains were 12.3 kg (27 lbs), 7.4 kg (16.3 lbs), and 5.5 kg (12 lbs).
“All of our analyses so far have shown that the weight continues to go up. We’re actually seeing people doubling in their body weight. We’ve seen some women come into clinic and their doctors don’t even recognize them because they’ve put on so much weight,” he said.
In women, most of the gain in weight occurs as limb or trunk fat, with a predominance of visceral fat.
People taking TAF in the trial were also at significantly greater risk for developing the metabolic syndrome, and at week 96, 27% of women on TAF/FTC/DTG had treatment-emergent obesity, compared with 17% for those on TDF/FTC/DTG and 11% for those on TDF/FTC/EFV. In men, the respective 96-week rates of treatment-emergent obesity were 7%, 3%, and 2%.
Clinical obesity itself is a risk factor for obstetric complications and birth outcomes, Alzheimer’s disease, type 2 diabetes, cardiovascular disease, hypertension and cancer, and an average 4-year reduction in life expectancy, Dr. Hill said. “I think it’s actually very unlikely that the [World Health Organization] guidelines will now change and allow the widespread use of TAF/FTC in combination with integrase inhibitors worldwide given these potential implications.”
Modern times
The bad rap that TDF gets for its alleged effects on bone mineral density and kidneys comes from studies where the drug was given in a boosted regimen that can amplify tenofovir toxicities, Dr. Hill said.
He noted that data from Gilead Sciences shows through 7 years of therapy in previously ART-naive patients, the combination of TDF/3TC/EFV showed sustained durable efficacy, no discontinuations to renal adverse effects, and no evidence of clinically relevant bone effects.
“I think we need to be very careful when we look at tenofovir and TAF. We need to look at the more modern way that these drugs are used, which is not with pharmacokinetic boosters anymore, and in that situation the toxicity profile of tenofovir/3TC – the original TDF – is very favorable,” he said.
Robert Goldstein, MD, PhD, an infectious disease specialist and medical director of the transgender health program at Massachusetts General Hospital in Boston, who comoderated the session where Dr. Hill presented his data, said that his clinical experience mirrors the pharmacokinetic findings.
“I certainly have strong feelings about the use of TDF in pre-exposure prophylaxis,” he said in an interview. “TDF is an effective and safe formulation of tenofovir to be used in pre-exposure prophylaxis, and one that we have more experience with. It’s the formulation of tenofovir that I use for all of my patients who are on pre-exposure prophylaxis, and I think it is the most cost-effective.’
No funding source was reported. Andrew Hill consults for Tibotec on clinical trial programs for darunavir, etravirine, and rilpivirine. Dr. Goldstein reported having no relevant disclosures.
Although the efficacy of two pre-exposure prophylaxis (PrEP) regimens containing differing prodrug formulations of tenofovir are virtually identical, the balance between benefit and risk tips in favor of the combination using the older formulation, tenofovir disoproxil fumarate (TDF), a pharmacology researcher said.
An analysis of the pharmacologic profiles of TDF plus emtricitabine (FTC; Truvada and generic) with tenofovir alafenamide (TAF) plus FTC (Descovy) shows that the risk of decreased bone mineral density and renal toxicity with TDF are significantly lower than those of weight gain and related metabolic and cardiovascular problems associated with the newer tenofovir formulation TAF, according to pharmacology research fellow Andrew Hill, MD, PhD, from the University of Liverpool (England).
“I think when we’re comparing these two drugs overall, we have a clear benefit/risk, and we need to take both of these potential toxicities seriously, “ he said in an online presentation during IDWeek 2020, an annual scientific meeting on infectious diseases held virtually this year.
“But in my view, treating women – Black women – with TAF/FTC is a bad thing,” he continued. “I think it’s going lead to more harm, more myocardial infarctions, more cases of diabetes, and potentially more adverse birth outcomes, and I think that is a risk that is not worth taking, given that the apparent benefit in terms of bone mineral density and renal markers is a hypothesis at best, and is not translated into hard clinical endpoints.”
Adverse event profiles
Dr. Hill compared the side effect profiles of the two agents when used both in antiretroviral therapy (ART) in combination the integrase inhibitor dolutegravir (DTG; Tivicay), and in PrEP.
World Health Organization guidelines for first-line ART recommend the use of TDF/FTC/DTG, reserving TAF plus lamivudine (3TC) and DTG for use in special circumstances only, Dr. Hill noted.
He pointed to a pooled analysis of data from eight randomized, controlled trials of treatment-naive people living with HIV who started on ART from 2003 to 2015. The authors found that demographic factors associated with weight gain included lower CD4 cell counter, higher levels of HIV type 1 RNA, no injection drug use, female sex, and Black race.
They also found that, among nucleoside/nucleotide reverse transcriptase inhibitors, TAF was associated with more weight gain than TDF, abacavir, or zidovudine.
“This pattern is seen consistently across studies both of pre-exposure prophylaxis or treatment comparing tenofovir with either TAF or other nucleoside analogs,” he said.
The greater weight gain with TAF versus TDF was seen in both treatment trials and in the DISCOVER PrEP trial.
In addition, in a crossover trial conducted in Germany, patients who switched from TDF to TAF had an approximately 2 kg increase in body weight.
TAF has also been associated with higher grade 3 or 4 glucose and LDL cholesterol than TDF in clinical trials for the treatment of hepatitis B infections, and with higher LDL cholesterol and total cholesterol levels as well as diabetes in patients treated with the drugs in combination in the EMERALD HIV trial.
Clinical trials also tend to underestimate the real-world population of persons at highest risk for adverse events from TAF, Dr. Hill said, noting that the percentage of Black women in phase 3 trials for dolutegravir was 9%, compared with 42% among persons infected with HIV worldwide. The respective percentages for Black men are 16% versus 30%. These differences are similar across clinical trial programs for other ART agents.
“Generally, it’s women and Black people who seem to be at greatest risk for safety issues,” he said.
In the ADVANCE trial comparing TAF/FTC/DTG with TDF/FTC/DTG and a control arm of TDF, FTC and efavirenz, the mean change in weight among men after 3 years on the TAF-based regimen was a gain of 7.2 kg (15.9 lbs), compared with 5.5 kg (12 lbs) with TDF, and 2.6 kg (5.7 lbs) with the efavirenz-containing regimen.
In women enrolled in the same trial, the respective mean weight gains were 12.3 kg (27 lbs), 7.4 kg (16.3 lbs), and 5.5 kg (12 lbs).
“All of our analyses so far have shown that the weight continues to go up. We’re actually seeing people doubling in their body weight. We’ve seen some women come into clinic and their doctors don’t even recognize them because they’ve put on so much weight,” he said.
In women, most of the gain in weight occurs as limb or trunk fat, with a predominance of visceral fat.
People taking TAF in the trial were also at significantly greater risk for developing the metabolic syndrome, and at week 96, 27% of women on TAF/FTC/DTG had treatment-emergent obesity, compared with 17% for those on TDF/FTC/DTG and 11% for those on TDF/FTC/EFV. In men, the respective 96-week rates of treatment-emergent obesity were 7%, 3%, and 2%.
Clinical obesity itself is a risk factor for obstetric complications and birth outcomes, Alzheimer’s disease, type 2 diabetes, cardiovascular disease, hypertension and cancer, and an average 4-year reduction in life expectancy, Dr. Hill said. “I think it’s actually very unlikely that the [World Health Organization] guidelines will now change and allow the widespread use of TAF/FTC in combination with integrase inhibitors worldwide given these potential implications.”
Modern times
The bad rap that TDF gets for its alleged effects on bone mineral density and kidneys comes from studies where the drug was given in a boosted regimen that can amplify tenofovir toxicities, Dr. Hill said.
He noted that data from Gilead Sciences shows through 7 years of therapy in previously ART-naive patients, the combination of TDF/3TC/EFV showed sustained durable efficacy, no discontinuations to renal adverse effects, and no evidence of clinically relevant bone effects.
“I think we need to be very careful when we look at tenofovir and TAF. We need to look at the more modern way that these drugs are used, which is not with pharmacokinetic boosters anymore, and in that situation the toxicity profile of tenofovir/3TC – the original TDF – is very favorable,” he said.
Robert Goldstein, MD, PhD, an infectious disease specialist and medical director of the transgender health program at Massachusetts General Hospital in Boston, who comoderated the session where Dr. Hill presented his data, said that his clinical experience mirrors the pharmacokinetic findings.
“I certainly have strong feelings about the use of TDF in pre-exposure prophylaxis,” he said in an interview. “TDF is an effective and safe formulation of tenofovir to be used in pre-exposure prophylaxis, and one that we have more experience with. It’s the formulation of tenofovir that I use for all of my patients who are on pre-exposure prophylaxis, and I think it is the most cost-effective.’
No funding source was reported. Andrew Hill consults for Tibotec on clinical trial programs for darunavir, etravirine, and rilpivirine. Dr. Goldstein reported having no relevant disclosures.
FROM IDWEEK 2020
When recommending photoprotection in dark skin, consider cosmesis
The according to a review of racial differences in the approach to photoprotection, presented at the virtual Skin of Color Update 2020.
“Using photoprotection is not second nature to people of color,” said Amy McMichael, MD, chair, department of dermatology, Wake Forest University, Winston-Salem, N.C. “It is important to understand the complexity of perception in photoprotection patients with skin of color,” she added.
One obstacle is appearance. For instance, some products appear chalky on dark skin.
“Consider cosmesis,” advised Dr. McMichael. As an alternative to oxybenzone and other organic sunscreen filters, she specifically recommended inorganic sunscreens with tint. Currently, zinc oxide and titanium dioxide are the only Food and Drug Administration–approved inorganic filters, she noted. The nanoparticle formulations are less than 100 nm in size. Tinted products blocking visible light of different shades have been developed for individuals of all Fitzpatrick skin types.
Many patients with dark skin will need convincing that sun protection offers benefits and does not impose significant risks. In one survey cited by Dr. McMichael, Blacks reported the lowest level of sunscreen use when compared with Whites, Asians, or Latinos. While the increased melanin content in the skin of people of color does provide natural photoprotection, it does not fully eliminate the many adverse consequences of excess sun exposure.
“Photoprotection is essential to minimize acute and chronic effects of exposure to UV light that includes erythema, pigment darkening, photoaging, and photocarcinogenesis,” Dr. McMichael noted.
Among Black people who do employ sun protection, a large proportion do so to reduce the risk or prevent exacerbation of dyschromias such as vitiligo, melasma, and postinflammatory hyperpigmentation, according to Dr. McMichael. However, there appears to be inadequate use of sunscreens even for these concerns.
According to a study she cited, dermatologists prescribed sunscreens to Black patients in only 1.8% of office visits. Yet, 5% of all dermatologist consultations by Black patients are made to address a dyschromia. After acne, generalized forms of dermatitis, seborrheic dermatitis, and atopic dermatitis, dyschromias are the fifth most common reason for Blacks to consult a dermatologist.
“We cannot know from the data what the provider was seeing, but we can see that sunscreens are not the first medication that providers are reaching for,” Dr. McMichael said.
There are some concerns about the use of sunscreen that can be dispelled. The risk of vitamin D deficiency is one. Dr. McMichael, citing National Health and Nutrition Examination Survey data, said there appears to be a low risk in Whites and essentially no risk in Blacks.
The potential for sunscreens to induce frontal fibrosing alopecia (FFA) is another concern, but Dr. McMichael sees several problems with the surveys that have associated sunscreens with FFA, including recall bias, temporal ambiguity regarding sunscreen exposure and FFA onset, and cases of FFA in areas of the world where sunscreen is not used.
For sunscreens and FFA, “there is no direct evidence of causation,” she said. For concerned patients, she does acknowledge that there are data supporting an association, but she explains that this “connection is very loose at best.”
When encouraging sun protection, Dr. McMichael discusses alternatives to sunscreens, including hats and clothing that are photoprotective, wrap-around sunglasses, and sun avoidance. For patients with dyschromias, it makes particular sense to employ multiple sun protection strategies, but Dr. McMichael suggested that everybody, including individuals with skin of color, should be considering how to reduce excess sun exposure. She indicated that messages should to be tailored for the Black population.
“It is important to understand the complexity of the perception in photoprotection in patients with skin of color,” she said. Success with increasing uptake of sunscreens in patients with darker skin might depend on allaying fears and directing patients to agents that are cosmetically acceptable.
Others have delivered the same or related messages in the past. Natasha Buchanan Lunsford, PhD, a researcher in the Division of Cancer Prevention and Control at the Centers for Disease Control and Prevention, led a study on perceptions about skin cancer among Blacks and Hispanics.
“Most participants perceived themselves to be at low skin cancer risk due to their darker skin tone,” reported Dr. Lundsford and her coinvestigators, a finding based on data collected from 18 focus groups with Black and Hispanic participants aged 18 through 44 years.
In this study, Hispanics reported sun protection behavior more often than Blacks, but the minority of both groups used sunscreen or other sun avoidance measures routinely. For those who did use sunscreens, skin darkening and photoaging, rather than prevention of skin cancer, was the most common motivation to do so.
One problem is that “while general skin cancer prevention messaging exists, tailored and culturally sensitive messaging is limited,” Dr. Lundsford and coauthors wrote.
Dr. McMichael has financial relationships with multiple pharmaceutical companies, including those that make skin care products.
The according to a review of racial differences in the approach to photoprotection, presented at the virtual Skin of Color Update 2020.
“Using photoprotection is not second nature to people of color,” said Amy McMichael, MD, chair, department of dermatology, Wake Forest University, Winston-Salem, N.C. “It is important to understand the complexity of perception in photoprotection patients with skin of color,” she added.
One obstacle is appearance. For instance, some products appear chalky on dark skin.
“Consider cosmesis,” advised Dr. McMichael. As an alternative to oxybenzone and other organic sunscreen filters, she specifically recommended inorganic sunscreens with tint. Currently, zinc oxide and titanium dioxide are the only Food and Drug Administration–approved inorganic filters, she noted. The nanoparticle formulations are less than 100 nm in size. Tinted products blocking visible light of different shades have been developed for individuals of all Fitzpatrick skin types.
Many patients with dark skin will need convincing that sun protection offers benefits and does not impose significant risks. In one survey cited by Dr. McMichael, Blacks reported the lowest level of sunscreen use when compared with Whites, Asians, or Latinos. While the increased melanin content in the skin of people of color does provide natural photoprotection, it does not fully eliminate the many adverse consequences of excess sun exposure.
“Photoprotection is essential to minimize acute and chronic effects of exposure to UV light that includes erythema, pigment darkening, photoaging, and photocarcinogenesis,” Dr. McMichael noted.
Among Black people who do employ sun protection, a large proportion do so to reduce the risk or prevent exacerbation of dyschromias such as vitiligo, melasma, and postinflammatory hyperpigmentation, according to Dr. McMichael. However, there appears to be inadequate use of sunscreens even for these concerns.
According to a study she cited, dermatologists prescribed sunscreens to Black patients in only 1.8% of office visits. Yet, 5% of all dermatologist consultations by Black patients are made to address a dyschromia. After acne, generalized forms of dermatitis, seborrheic dermatitis, and atopic dermatitis, dyschromias are the fifth most common reason for Blacks to consult a dermatologist.
“We cannot know from the data what the provider was seeing, but we can see that sunscreens are not the first medication that providers are reaching for,” Dr. McMichael said.
There are some concerns about the use of sunscreen that can be dispelled. The risk of vitamin D deficiency is one. Dr. McMichael, citing National Health and Nutrition Examination Survey data, said there appears to be a low risk in Whites and essentially no risk in Blacks.
The potential for sunscreens to induce frontal fibrosing alopecia (FFA) is another concern, but Dr. McMichael sees several problems with the surveys that have associated sunscreens with FFA, including recall bias, temporal ambiguity regarding sunscreen exposure and FFA onset, and cases of FFA in areas of the world where sunscreen is not used.
For sunscreens and FFA, “there is no direct evidence of causation,” she said. For concerned patients, she does acknowledge that there are data supporting an association, but she explains that this “connection is very loose at best.”
When encouraging sun protection, Dr. McMichael discusses alternatives to sunscreens, including hats and clothing that are photoprotective, wrap-around sunglasses, and sun avoidance. For patients with dyschromias, it makes particular sense to employ multiple sun protection strategies, but Dr. McMichael suggested that everybody, including individuals with skin of color, should be considering how to reduce excess sun exposure. She indicated that messages should to be tailored for the Black population.
“It is important to understand the complexity of the perception in photoprotection in patients with skin of color,” she said. Success with increasing uptake of sunscreens in patients with darker skin might depend on allaying fears and directing patients to agents that are cosmetically acceptable.
Others have delivered the same or related messages in the past. Natasha Buchanan Lunsford, PhD, a researcher in the Division of Cancer Prevention and Control at the Centers for Disease Control and Prevention, led a study on perceptions about skin cancer among Blacks and Hispanics.
“Most participants perceived themselves to be at low skin cancer risk due to their darker skin tone,” reported Dr. Lundsford and her coinvestigators, a finding based on data collected from 18 focus groups with Black and Hispanic participants aged 18 through 44 years.
In this study, Hispanics reported sun protection behavior more often than Blacks, but the minority of both groups used sunscreen or other sun avoidance measures routinely. For those who did use sunscreens, skin darkening and photoaging, rather than prevention of skin cancer, was the most common motivation to do so.
One problem is that “while general skin cancer prevention messaging exists, tailored and culturally sensitive messaging is limited,” Dr. Lundsford and coauthors wrote.
Dr. McMichael has financial relationships with multiple pharmaceutical companies, including those that make skin care products.
The according to a review of racial differences in the approach to photoprotection, presented at the virtual Skin of Color Update 2020.
“Using photoprotection is not second nature to people of color,” said Amy McMichael, MD, chair, department of dermatology, Wake Forest University, Winston-Salem, N.C. “It is important to understand the complexity of perception in photoprotection patients with skin of color,” she added.
One obstacle is appearance. For instance, some products appear chalky on dark skin.
“Consider cosmesis,” advised Dr. McMichael. As an alternative to oxybenzone and other organic sunscreen filters, she specifically recommended inorganic sunscreens with tint. Currently, zinc oxide and titanium dioxide are the only Food and Drug Administration–approved inorganic filters, she noted. The nanoparticle formulations are less than 100 nm in size. Tinted products blocking visible light of different shades have been developed for individuals of all Fitzpatrick skin types.
Many patients with dark skin will need convincing that sun protection offers benefits and does not impose significant risks. In one survey cited by Dr. McMichael, Blacks reported the lowest level of sunscreen use when compared with Whites, Asians, or Latinos. While the increased melanin content in the skin of people of color does provide natural photoprotection, it does not fully eliminate the many adverse consequences of excess sun exposure.
“Photoprotection is essential to minimize acute and chronic effects of exposure to UV light that includes erythema, pigment darkening, photoaging, and photocarcinogenesis,” Dr. McMichael noted.
Among Black people who do employ sun protection, a large proportion do so to reduce the risk or prevent exacerbation of dyschromias such as vitiligo, melasma, and postinflammatory hyperpigmentation, according to Dr. McMichael. However, there appears to be inadequate use of sunscreens even for these concerns.
According to a study she cited, dermatologists prescribed sunscreens to Black patients in only 1.8% of office visits. Yet, 5% of all dermatologist consultations by Black patients are made to address a dyschromia. After acne, generalized forms of dermatitis, seborrheic dermatitis, and atopic dermatitis, dyschromias are the fifth most common reason for Blacks to consult a dermatologist.
“We cannot know from the data what the provider was seeing, but we can see that sunscreens are not the first medication that providers are reaching for,” Dr. McMichael said.
There are some concerns about the use of sunscreen that can be dispelled. The risk of vitamin D deficiency is one. Dr. McMichael, citing National Health and Nutrition Examination Survey data, said there appears to be a low risk in Whites and essentially no risk in Blacks.
The potential for sunscreens to induce frontal fibrosing alopecia (FFA) is another concern, but Dr. McMichael sees several problems with the surveys that have associated sunscreens with FFA, including recall bias, temporal ambiguity regarding sunscreen exposure and FFA onset, and cases of FFA in areas of the world where sunscreen is not used.
For sunscreens and FFA, “there is no direct evidence of causation,” she said. For concerned patients, she does acknowledge that there are data supporting an association, but she explains that this “connection is very loose at best.”
When encouraging sun protection, Dr. McMichael discusses alternatives to sunscreens, including hats and clothing that are photoprotective, wrap-around sunglasses, and sun avoidance. For patients with dyschromias, it makes particular sense to employ multiple sun protection strategies, but Dr. McMichael suggested that everybody, including individuals with skin of color, should be considering how to reduce excess sun exposure. She indicated that messages should to be tailored for the Black population.
“It is important to understand the complexity of the perception in photoprotection in patients with skin of color,” she said. Success with increasing uptake of sunscreens in patients with darker skin might depend on allaying fears and directing patients to agents that are cosmetically acceptable.
Others have delivered the same or related messages in the past. Natasha Buchanan Lunsford, PhD, a researcher in the Division of Cancer Prevention and Control at the Centers for Disease Control and Prevention, led a study on perceptions about skin cancer among Blacks and Hispanics.
“Most participants perceived themselves to be at low skin cancer risk due to their darker skin tone,” reported Dr. Lundsford and her coinvestigators, a finding based on data collected from 18 focus groups with Black and Hispanic participants aged 18 through 44 years.
In this study, Hispanics reported sun protection behavior more often than Blacks, but the minority of both groups used sunscreen or other sun avoidance measures routinely. For those who did use sunscreens, skin darkening and photoaging, rather than prevention of skin cancer, was the most common motivation to do so.
One problem is that “while general skin cancer prevention messaging exists, tailored and culturally sensitive messaging is limited,” Dr. Lundsford and coauthors wrote.
Dr. McMichael has financial relationships with multiple pharmaceutical companies, including those that make skin care products.
FROM SOC 2020
September 2020 - Quick Quiz Question 2
Q2: Correct answer: D
Rationale
Episodic hepatic encephalopathy is usually precipitant induced in over 80% of cases and precipitants include dehydration, infections, over diuresis, gastrointestinal bleeding, constipation, and the use of narcotics and sedatives. The key is to identify and treat the precipitant. A diagnostic workup to rule out other disorders that can alter brain function and mimic hepatic encephalopathy should also be performed.
Reference
Viltstrup H et al. Hepatic encephalopathy in chronic liver disease: 2014 Practice Guideline by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver. Hepatology. 2014;60(2):715-35.
Q2: Correct answer: D
Rationale
Episodic hepatic encephalopathy is usually precipitant induced in over 80% of cases and precipitants include dehydration, infections, over diuresis, gastrointestinal bleeding, constipation, and the use of narcotics and sedatives. The key is to identify and treat the precipitant. A diagnostic workup to rule out other disorders that can alter brain function and mimic hepatic encephalopathy should also be performed.
Reference
Viltstrup H et al. Hepatic encephalopathy in chronic liver disease: 2014 Practice Guideline by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver. Hepatology. 2014;60(2):715-35.
Q2: Correct answer: D
Rationale
Episodic hepatic encephalopathy is usually precipitant induced in over 80% of cases and precipitants include dehydration, infections, over diuresis, gastrointestinal bleeding, constipation, and the use of narcotics and sedatives. The key is to identify and treat the precipitant. A diagnostic workup to rule out other disorders that can alter brain function and mimic hepatic encephalopathy should also be performed.
Reference
Viltstrup H et al. Hepatic encephalopathy in chronic liver disease: 2014 Practice Guideline by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver. Hepatology. 2014;60(2):715-35.
Q2. A 62-year-old man with hepatitis C cirrhosis is admitted with altered mental status. He had a recent dental procedure and was given pain medication and a short course of antibiotics. He is taking only spironolactone 50 mg for small ascites. The patient is alert but not oriented to place and time. He has evidence of asterixis. His mucous membranes are dry and he has no evidence of ascites on exam. His labs include WBC 4.7 x 103/mm3, AST 45 U/L, ALT 40 U/L, total bilirubin of 2.5 mg/dL, albumin of 3.7 g/dL, sodium 142 mEq/L, and a creatinine of 0.5 mg/dL.
September 2020 - Quick Quiz Question 1
Q1: Correct answer: B
Rationale
A serum ceruloplasmin less than 5 mg/L and a 24-hour urine copper excretion greater than 100 mcg/24 hours are both highly suggestive of Wilson's disease, a disorder of copper metabolism caused by a mutation in a P-type ATP-ase that mediates the excretion of copper into the bile. Treatment of Wilson's disease consists of copper chelation therapy. Commonly used therapies include D-penicillamine, trientine, and zinc. Patients on therapy should have 24-hour urine copper determination every 6-12 months. Patients on maintenance trientine or D-penicillamine should have urine copper excretion of 200-500 mcg/24 hours. Patients on zinc therapy should have much lower copper excretion, in the range of 75 mcg/24 hours.
References
1. European Association for the Study of the Liver. EASL clinical practice guidelines: Wilson's disease. J Hepatol. 2012;56:671-85.
2. Roberts EA, Schilsky ML. Diagnosis and treatment of Wilson disease: An update. Hepatology. 2008;47:2089-111.
Q1: Correct answer: B
Rationale
A serum ceruloplasmin less than 5 mg/L and a 24-hour urine copper excretion greater than 100 mcg/24 hours are both highly suggestive of Wilson's disease, a disorder of copper metabolism caused by a mutation in a P-type ATP-ase that mediates the excretion of copper into the bile. Treatment of Wilson's disease consists of copper chelation therapy. Commonly used therapies include D-penicillamine, trientine, and zinc. Patients on therapy should have 24-hour urine copper determination every 6-12 months. Patients on maintenance trientine or D-penicillamine should have urine copper excretion of 200-500 mcg/24 hours. Patients on zinc therapy should have much lower copper excretion, in the range of 75 mcg/24 hours.
References
1. European Association for the Study of the Liver. EASL clinical practice guidelines: Wilson's disease. J Hepatol. 2012;56:671-85.
2. Roberts EA, Schilsky ML. Diagnosis and treatment of Wilson disease: An update. Hepatology. 2008;47:2089-111.
Q1: Correct answer: B
Rationale
A serum ceruloplasmin less than 5 mg/L and a 24-hour urine copper excretion greater than 100 mcg/24 hours are both highly suggestive of Wilson's disease, a disorder of copper metabolism caused by a mutation in a P-type ATP-ase that mediates the excretion of copper into the bile. Treatment of Wilson's disease consists of copper chelation therapy. Commonly used therapies include D-penicillamine, trientine, and zinc. Patients on therapy should have 24-hour urine copper determination every 6-12 months. Patients on maintenance trientine or D-penicillamine should have urine copper excretion of 200-500 mcg/24 hours. Patients on zinc therapy should have much lower copper excretion, in the range of 75 mcg/24 hours.
References
1. European Association for the Study of the Liver. EASL clinical practice guidelines: Wilson's disease. J Hepatol. 2012;56:671-85.
2. Roberts EA, Schilsky ML. Diagnosis and treatment of Wilson disease: An update. Hepatology. 2008;47:2089-111.
Q1. A 19-year-old male with elevated liver enzymes is found to have a serum ceruloplasmin of 3 mg/L, and a urine copper excretion of 210 mcg/24 hours. He is started on trientine to treat his illness.
Dr. Anique K. Forrester joins editorial advisory board of Clinical Psychiatry News
Clinical Psychiatry News is pleased to announce that Anique K. Forrester, MD, has joined its editorial advisory board.
Dr. Forrester, who is board certified in the subspecialty of psychosomatic medicine (consultation-liaison psychiatry), holds numerous leadership positions at the University of Maryland, Baltimore. She is director of the consultation-liaison psychiatry fellowship at the university and serves as director of education for the C-L psychiatry PGY-2 rotation. Dr. Forrester, an assistant professor, also serves as chair of the department of psychiatry’s diversity committee and is the coordinator of the cultural psychiatry resident course.
Dr. Forrester completed her psychiatry residency training as well as psychosomatic medicine fellowship training at Sidney Kimmel Medical College, Philadelphia. She is a diplomate of the American Board of Psychiatry and Neurology. In addition, Dr. Forrester is a member of the Academy of Consultation-Liaison Psychiatry. She is a graduate of Howard University, Washington.
Her research interests include perinatal psychiatry, psycho-oncology, and cultural competence in medicine.
Welcome aboard, Dr. Forrester!
Clinical Psychiatry News is pleased to announce that Anique K. Forrester, MD, has joined its editorial advisory board.
Dr. Forrester, who is board certified in the subspecialty of psychosomatic medicine (consultation-liaison psychiatry), holds numerous leadership positions at the University of Maryland, Baltimore. She is director of the consultation-liaison psychiatry fellowship at the university and serves as director of education for the C-L psychiatry PGY-2 rotation. Dr. Forrester, an assistant professor, also serves as chair of the department of psychiatry’s diversity committee and is the coordinator of the cultural psychiatry resident course.
Dr. Forrester completed her psychiatry residency training as well as psychosomatic medicine fellowship training at Sidney Kimmel Medical College, Philadelphia. She is a diplomate of the American Board of Psychiatry and Neurology. In addition, Dr. Forrester is a member of the Academy of Consultation-Liaison Psychiatry. She is a graduate of Howard University, Washington.
Her research interests include perinatal psychiatry, psycho-oncology, and cultural competence in medicine.
Welcome aboard, Dr. Forrester!
Clinical Psychiatry News is pleased to announce that Anique K. Forrester, MD, has joined its editorial advisory board.
Dr. Forrester, who is board certified in the subspecialty of psychosomatic medicine (consultation-liaison psychiatry), holds numerous leadership positions at the University of Maryland, Baltimore. She is director of the consultation-liaison psychiatry fellowship at the university and serves as director of education for the C-L psychiatry PGY-2 rotation. Dr. Forrester, an assistant professor, also serves as chair of the department of psychiatry’s diversity committee and is the coordinator of the cultural psychiatry resident course.
Dr. Forrester completed her psychiatry residency training as well as psychosomatic medicine fellowship training at Sidney Kimmel Medical College, Philadelphia. She is a diplomate of the American Board of Psychiatry and Neurology. In addition, Dr. Forrester is a member of the Academy of Consultation-Liaison Psychiatry. She is a graduate of Howard University, Washington.
Her research interests include perinatal psychiatry, psycho-oncology, and cultural competence in medicine.
Welcome aboard, Dr. Forrester!
Red hair in women linked to elevated CRP levels in Nurses’ Health Study
Red-haired women were significantly more likely than were women with nonred hair to have elevated levels of C-reactive protein that may increase risk for cardiovascular conditions, according to data from nearly 9,000 women participating in the Nurses’ Health Study.
“Positive associations between red hair and cardiovascular disease and cancer in women, but not men, have been reported,” wrote Rebecca I. Hartman, MD, of Brigham and Women’s Hospital, Harvard Medical School, Boston, and colleagues.
In a study published in the Journal of Investigative Dermatology, they reviewed data from the Nurses’ Health Study, a 1976 cohort study of 121,700 women registered nurses in the United States. They analyzed blood specimens from 8,994 women that were collected between 1989 and 1990. Participants’ natural hair color was determined by asking them their natural hair color at age 21 years, with choices of red, blonde, light brown, dark brown, or black. Overall, dark brown/black hair was the most common color (45%) and 390 of the women (4.3%) had red hair.
The average CRP levels were significantly higher for women with red hair (3.7 mg/L), compared with those with blonde (3.3 mg/L), light brown (3.0 mg/mL), or dark brown/black (3.2 mg/L).
Using the CRP levels for red-haired women as a reference, women with blond, light brown, and dark brown/black hair averaged significantly lower CRP levels than those of red-haired women in an age-adjusted model (–15.2%, –18/1%, and –14.2%, respectively) and in a multivariate analysis (–12.7%, –14.1%, and –10.9%, respectively).
Non-red-haired women had significantly lower odds of high CRP levels compared with red-haired women, with odds ratios of 0.62, 0.60, and 0.67 for women with blonde, light brown, and dark brown/black hair, respectively, in multivariate analysis, the researchers found.
The study was limited by several factors including the use of self-reports for hair color and the relative homogeneity of the Nurses’ Health Study, which has a population of mostly white, female health professionals, the researchers noted.
However, the findings of significantly increased CRP levels “could potentially explain a prior report of increased risks of cardiovascular disease and cancer in red-haired women,” they said. “Although, we observed similar associations in the NHS between red hair and cardiovascular disease and cancer, they were not statistically significant,” they added.
Additional studies are needed to validate and examine the clinical significance of the results, they concluded.
“Elevated CRP levels, a marker of inflammation, have been associated with increased risk for several diseases, including colon cancer and heart disease,” lead author Dr. Hartman said in an interview. “Another study suggested red-haired women have elevated risks of cardiovascular disease and cancer. We wanted to see if different levels of inflammation in red-haired women could possibly explain these findings.”
She said she was not surprised by the findings, “as they were in line with our hypothesis.” In addition, “animal studies suggest that the gene most responsible for red hair, MC1R, may be linked to inflammation,” she said.
While red-haired women were found to have higher CRP levels in the study, “the underlying mechanism and clinical significance remain unknown,” and more research is needed, Dr. Hartman emphasized. “First, our findings need to be validated in women and also examined in men. If our findings are validated, future studies should examine the mechanism of CRP elevation in red-haired women, and whether these women have elevated risks of colon cancer and heart disease,” she said.
“If red-haired women do have increased levels of inflammation, and as a result have elevated risks of colon cancer and heart disease, then future interventions can focus on enhanced screening and possibly chemoprevention in this population,” she added.
The study was supported by the National Institutes of Health. Lead author Dr. Hartman was supported by an American Skin Association Research Grant.
SOURCE: Hartman RI et al. J Invest Dermatol. 2020 Oct 12. doi: 10.1016/j.jid.2020.09.015.
Red-haired women were significantly more likely than were women with nonred hair to have elevated levels of C-reactive protein that may increase risk for cardiovascular conditions, according to data from nearly 9,000 women participating in the Nurses’ Health Study.
“Positive associations between red hair and cardiovascular disease and cancer in women, but not men, have been reported,” wrote Rebecca I. Hartman, MD, of Brigham and Women’s Hospital, Harvard Medical School, Boston, and colleagues.
In a study published in the Journal of Investigative Dermatology, they reviewed data from the Nurses’ Health Study, a 1976 cohort study of 121,700 women registered nurses in the United States. They analyzed blood specimens from 8,994 women that were collected between 1989 and 1990. Participants’ natural hair color was determined by asking them their natural hair color at age 21 years, with choices of red, blonde, light brown, dark brown, or black. Overall, dark brown/black hair was the most common color (45%) and 390 of the women (4.3%) had red hair.
The average CRP levels were significantly higher for women with red hair (3.7 mg/L), compared with those with blonde (3.3 mg/L), light brown (3.0 mg/mL), or dark brown/black (3.2 mg/L).
Using the CRP levels for red-haired women as a reference, women with blond, light brown, and dark brown/black hair averaged significantly lower CRP levels than those of red-haired women in an age-adjusted model (–15.2%, –18/1%, and –14.2%, respectively) and in a multivariate analysis (–12.7%, –14.1%, and –10.9%, respectively).
Non-red-haired women had significantly lower odds of high CRP levels compared with red-haired women, with odds ratios of 0.62, 0.60, and 0.67 for women with blonde, light brown, and dark brown/black hair, respectively, in multivariate analysis, the researchers found.
The study was limited by several factors including the use of self-reports for hair color and the relative homogeneity of the Nurses’ Health Study, which has a population of mostly white, female health professionals, the researchers noted.
However, the findings of significantly increased CRP levels “could potentially explain a prior report of increased risks of cardiovascular disease and cancer in red-haired women,” they said. “Although, we observed similar associations in the NHS between red hair and cardiovascular disease and cancer, they were not statistically significant,” they added.
Additional studies are needed to validate and examine the clinical significance of the results, they concluded.
“Elevated CRP levels, a marker of inflammation, have been associated with increased risk for several diseases, including colon cancer and heart disease,” lead author Dr. Hartman said in an interview. “Another study suggested red-haired women have elevated risks of cardiovascular disease and cancer. We wanted to see if different levels of inflammation in red-haired women could possibly explain these findings.”
She said she was not surprised by the findings, “as they were in line with our hypothesis.” In addition, “animal studies suggest that the gene most responsible for red hair, MC1R, may be linked to inflammation,” she said.
While red-haired women were found to have higher CRP levels in the study, “the underlying mechanism and clinical significance remain unknown,” and more research is needed, Dr. Hartman emphasized. “First, our findings need to be validated in women and also examined in men. If our findings are validated, future studies should examine the mechanism of CRP elevation in red-haired women, and whether these women have elevated risks of colon cancer and heart disease,” she said.
“If red-haired women do have increased levels of inflammation, and as a result have elevated risks of colon cancer and heart disease, then future interventions can focus on enhanced screening and possibly chemoprevention in this population,” she added.
The study was supported by the National Institutes of Health. Lead author Dr. Hartman was supported by an American Skin Association Research Grant.
SOURCE: Hartman RI et al. J Invest Dermatol. 2020 Oct 12. doi: 10.1016/j.jid.2020.09.015.
Red-haired women were significantly more likely than were women with nonred hair to have elevated levels of C-reactive protein that may increase risk for cardiovascular conditions, according to data from nearly 9,000 women participating in the Nurses’ Health Study.
“Positive associations between red hair and cardiovascular disease and cancer in women, but not men, have been reported,” wrote Rebecca I. Hartman, MD, of Brigham and Women’s Hospital, Harvard Medical School, Boston, and colleagues.
In a study published in the Journal of Investigative Dermatology, they reviewed data from the Nurses’ Health Study, a 1976 cohort study of 121,700 women registered nurses in the United States. They analyzed blood specimens from 8,994 women that were collected between 1989 and 1990. Participants’ natural hair color was determined by asking them their natural hair color at age 21 years, with choices of red, blonde, light brown, dark brown, or black. Overall, dark brown/black hair was the most common color (45%) and 390 of the women (4.3%) had red hair.
The average CRP levels were significantly higher for women with red hair (3.7 mg/L), compared with those with blonde (3.3 mg/L), light brown (3.0 mg/mL), or dark brown/black (3.2 mg/L).
Using the CRP levels for red-haired women as a reference, women with blond, light brown, and dark brown/black hair averaged significantly lower CRP levels than those of red-haired women in an age-adjusted model (–15.2%, –18/1%, and –14.2%, respectively) and in a multivariate analysis (–12.7%, –14.1%, and –10.9%, respectively).
Non-red-haired women had significantly lower odds of high CRP levels compared with red-haired women, with odds ratios of 0.62, 0.60, and 0.67 for women with blonde, light brown, and dark brown/black hair, respectively, in multivariate analysis, the researchers found.
The study was limited by several factors including the use of self-reports for hair color and the relative homogeneity of the Nurses’ Health Study, which has a population of mostly white, female health professionals, the researchers noted.
However, the findings of significantly increased CRP levels “could potentially explain a prior report of increased risks of cardiovascular disease and cancer in red-haired women,” they said. “Although, we observed similar associations in the NHS between red hair and cardiovascular disease and cancer, they were not statistically significant,” they added.
Additional studies are needed to validate and examine the clinical significance of the results, they concluded.
“Elevated CRP levels, a marker of inflammation, have been associated with increased risk for several diseases, including colon cancer and heart disease,” lead author Dr. Hartman said in an interview. “Another study suggested red-haired women have elevated risks of cardiovascular disease and cancer. We wanted to see if different levels of inflammation in red-haired women could possibly explain these findings.”
She said she was not surprised by the findings, “as they were in line with our hypothesis.” In addition, “animal studies suggest that the gene most responsible for red hair, MC1R, may be linked to inflammation,” she said.
While red-haired women were found to have higher CRP levels in the study, “the underlying mechanism and clinical significance remain unknown,” and more research is needed, Dr. Hartman emphasized. “First, our findings need to be validated in women and also examined in men. If our findings are validated, future studies should examine the mechanism of CRP elevation in red-haired women, and whether these women have elevated risks of colon cancer and heart disease,” she said.
“If red-haired women do have increased levels of inflammation, and as a result have elevated risks of colon cancer and heart disease, then future interventions can focus on enhanced screening and possibly chemoprevention in this population,” she added.
The study was supported by the National Institutes of Health. Lead author Dr. Hartman was supported by an American Skin Association Research Grant.
SOURCE: Hartman RI et al. J Invest Dermatol. 2020 Oct 12. doi: 10.1016/j.jid.2020.09.015.
FROM THE JOURNAL OF INVESTIGATIVE DERMATOLOGY