The Food and Drug Administration has granted accelerated approval to nivolumab for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and posttransplantation brentuximab vedotin.

Approval was based on a 65% objective response rate in 95 patients treated with nivolumab following autologous HSCT and posttransplantation brentuximab vedotin. All patients in the single-arm, multicenter trial had relapsed or refractory cHL and were enrolled regardless of PD-L1 expression status. Patients received a median of 17 doses of nivolumab, the FDA said in a written statement.

The median time to response was 2.1 months (range, 0.7-5.7 months). The estimated median duration of response was 8.7 months.

The FDA also issued a warning for complications of allogeneic HSCT after nivolumab, reporting that transplant-related deaths have occurred. Health care professionals should follow patients closely for early evidence of transplant-related complications, such as hyperacute graft-versus-host disease (GVHD), severe acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions, they said.

The most common adverse reactions in a second single-arm study used to evaluate safety (n = 263) were upper respiratory tract infection, cough, pyrexia, and diarrhea. Other immune-mediated adverse reactions, occurring in 1%-5% of patients, included rash, pneumonitis, hepatitis, hyperthyroidism, and colitis. The most common serious adverse reactions, which were reported in 1%-3% of patients, were pneumonia, pleural effusion, pneumonitis, pyrexia, infusion-related reaction, and rash.

Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and has been previously approved to treat advanced renal cell carcinoma, lung cancer, and melanoma.

[email protected]

On Twitter @NikolaidesLaura

The Food and Drug Administration has granted accelerated approval to nivolumab for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and posttransplantation brentuximab vedotin.

Approval was based on a 65% objective response rate in 95 patients treated with nivolumab following autologous HSCT and posttransplantation brentuximab vedotin. All patients in the single-arm, multicenter trial had relapsed or refractory cHL and were enrolled regardless of PD-L1 expression status. Patients received a median of 17 doses of nivolumab, the FDA said in a written statement.

The median time to response was 2.1 months (range, 0.7-5.7 months). The estimated median duration of response was 8.7 months.

The FDA also issued a warning for complications of allogeneic HSCT after nivolumab, reporting that transplant-related deaths have occurred. Health care professionals should follow patients closely for early evidence of transplant-related complications, such as hyperacute graft-versus-host disease (GVHD), severe acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions, they said.

The most common adverse reactions in a second single-arm study used to evaluate safety (n = 263) were upper respiratory tract infection, cough, pyrexia, and diarrhea. Other immune-mediated adverse reactions, occurring in 1%-5% of patients, included rash, pneumonitis, hepatitis, hyperthyroidism, and colitis. The most common serious adverse reactions, which were reported in 1%-3% of patients, were pneumonia, pleural effusion, pneumonitis, pyrexia, infusion-related reaction, and rash.

Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and has been previously approved to treat advanced renal cell carcinoma, lung cancer, and melanoma.

[email protected]

On Twitter @NikolaidesLaura

The Food and Drug Administration has granted accelerated approval to nivolumab for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and posttransplantation brentuximab vedotin.

Approval was based on a 65% objective response rate in 95 patients treated with nivolumab following autologous HSCT and posttransplantation brentuximab vedotin. All patients in the single-arm, multicenter trial had relapsed or refractory cHL and were enrolled regardless of PD-L1 expression status. Patients received a median of 17 doses of nivolumab, the FDA said in a written statement.

The median time to response was 2.1 months (range, 0.7-5.7 months). The estimated median duration of response was 8.7 months.

The FDA also issued a warning for complications of allogeneic HSCT after nivolumab, reporting that transplant-related deaths have occurred. Health care professionals should follow patients closely for early evidence of transplant-related complications, such as hyperacute graft-versus-host disease (GVHD), severe acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions, they said.

The most common adverse reactions in a second single-arm study used to evaluate safety (n = 263) were upper respiratory tract infection, cough, pyrexia, and diarrhea. Other immune-mediated adverse reactions, occurring in 1%-5% of patients, included rash, pneumonitis, hepatitis, hyperthyroidism, and colitis. The most common serious adverse reactions, which were reported in 1%-3% of patients, were pneumonia, pleural effusion, pneumonitis, pyrexia, infusion-related reaction, and rash.

Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and has been previously approved to treat advanced renal cell carcinoma, lung cancer, and melanoma.

[email protected]

On Twitter @NikolaidesLaura

One of the most valuable things I learned in business school was how to be a better negotiator. Negotiation skills are helpful not only for job contracts, but also for many areas of life. Negotiating with your vendors, employees, health plans, and even spouse or children can be a fruitful experience. Indeed, using good negotiation techniques with your patients can help you optimize the best care with the best service whether in person or virtually.

The three principles I want you to understand are:

1. Negotiate on interests, not positions.

2. Frame or be framed.

3. Win/Win is not only possible; it is the most likely outcome of good negotiating.

Let’s use an example to illustrate each of these: If a patient comes to you asking for Vicodin (hydrocodone and acetaminophen) because you froze actinic keratoses, your first instinct might be to think this patient is a drug seeker and that he is not going to be satisfied unless you give in to his demand. You are a conscientious doctor and never prescribe narcotics for liquid nitrogen treatments. Here, you’ve just locked into a position, and there is no opportunity for negotiation. Instead, take a different approach – consider interests, not positions.

Positions are what you’ve decided. Interests, in contrast, are the reasons why you came to that decision. Think about both your interests and your patient’s interests. The patient wants something to block pain. You want to provide appropriate, safe care. In this instance, ask him why he wants Vicodin; probe about issues that might underlie his request. Keep asking until you feel you understand his interests. This is critical to good negotiation. Then think about your interests. You don’t want your patient to be in pain, and you don’t want to feed a patient’s dependency problem or risk your license for inappropriate drug dispensing.

Second, frame the problem (as you see it) or risk being framed by your patient. Your patient might see you as uncaring and unwilling to help him. You can change this by reframing yourself as the doctor who actually does care. For example, you might say, “I’m concerned about you. Taking Vicodin for this is not normal, and this drug is notorious for leading people into drug dependency. I don’t want to expose you to that risk.” Here, you have taken control of the frame and presented yourself as concerned rather than uncaring.

Third, in almost every negotiation there is an opportunity to expand the pie. That is, each party can offer something that was not in the original discussion but would benefit both. In this instance, you might offer to give the patient samples of a topical treatment for actinic keratoses. The patient, sensing your genuine concern, might offer to bring his mother to you for skin cancer treatment as she, too, is particularly sensitive to pain.

Of course, not all negotiations end in agreement. Sometimes your best option is to reject the request. If your patient is unwilling to compromise, then your best course of action might be to not treat him at all. Before doing so, remember that you will often have a better outcome if you try to reach agreement and that using sound negotiating practice will be a significant advantage. (Please, just don’t tell my wife about this column.)

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter. Write to him at [email protected].

One of the most valuable things I learned in business school was how to be a better negotiator. Negotiation skills are helpful not only for job contracts, but also for many areas of life. Negotiating with your vendors, employees, health plans, and even spouse or children can be a fruitful experience. Indeed, using good negotiation techniques with your patients can help you optimize the best care with the best service whether in person or virtually.

The three principles I want you to understand are:

1. Negotiate on interests, not positions.

2. Frame or be framed.

3. Win/Win is not only possible; it is the most likely outcome of good negotiating.

Let’s use an example to illustrate each of these: If a patient comes to you asking for Vicodin (hydrocodone and acetaminophen) because you froze actinic keratoses, your first instinct might be to think this patient is a drug seeker and that he is not going to be satisfied unless you give in to his demand. You are a conscientious doctor and never prescribe narcotics for liquid nitrogen treatments. Here, you’ve just locked into a position, and there is no opportunity for negotiation. Instead, take a different approach – consider interests, not positions.

Positions are what you’ve decided. Interests, in contrast, are the reasons why you came to that decision. Think about both your interests and your patient’s interests. The patient wants something to block pain. You want to provide appropriate, safe care. In this instance, ask him why he wants Vicodin; probe about issues that might underlie his request. Keep asking until you feel you understand his interests. This is critical to good negotiation. Then think about your interests. You don’t want your patient to be in pain, and you don’t want to feed a patient’s dependency problem or risk your license for inappropriate drug dispensing.

Second, frame the problem (as you see it) or risk being framed by your patient. Your patient might see you as uncaring and unwilling to help him. You can change this by reframing yourself as the doctor who actually does care. For example, you might say, “I’m concerned about you. Taking Vicodin for this is not normal, and this drug is notorious for leading people into drug dependency. I don’t want to expose you to that risk.” Here, you have taken control of the frame and presented yourself as concerned rather than uncaring.

Third, in almost every negotiation there is an opportunity to expand the pie. That is, each party can offer something that was not in the original discussion but would benefit both. In this instance, you might offer to give the patient samples of a topical treatment for actinic keratoses. The patient, sensing your genuine concern, might offer to bring his mother to you for skin cancer treatment as she, too, is particularly sensitive to pain.

Of course, not all negotiations end in agreement. Sometimes your best option is to reject the request. If your patient is unwilling to compromise, then your best course of action might be to not treat him at all. Before doing so, remember that you will often have a better outcome if you try to reach agreement and that using sound negotiating practice will be a significant advantage. (Please, just don’t tell my wife about this column.)

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter. Write to him at [email protected].

One of the most valuable things I learned in business school was how to be a better negotiator. Negotiation skills are helpful not only for job contracts, but also for many areas of life. Negotiating with your vendors, employees, health plans, and even spouse or children can be a fruitful experience. Indeed, using good negotiation techniques with your patients can help you optimize the best care with the best service whether in person or virtually.

The three principles I want you to understand are:

1. Negotiate on interests, not positions.

2. Frame or be framed.

3. Win/Win is not only possible; it is the most likely outcome of good negotiating.

Let’s use an example to illustrate each of these: If a patient comes to you asking for Vicodin (hydrocodone and acetaminophen) because you froze actinic keratoses, your first instinct might be to think this patient is a drug seeker and that he is not going to be satisfied unless you give in to his demand. You are a conscientious doctor and never prescribe narcotics for liquid nitrogen treatments. Here, you’ve just locked into a position, and there is no opportunity for negotiation. Instead, take a different approach – consider interests, not positions.

Positions are what you’ve decided. Interests, in contrast, are the reasons why you came to that decision. Think about both your interests and your patient’s interests. The patient wants something to block pain. You want to provide appropriate, safe care. In this instance, ask him why he wants Vicodin; probe about issues that might underlie his request. Keep asking until you feel you understand his interests. This is critical to good negotiation. Then think about your interests. You don’t want your patient to be in pain, and you don’t want to feed a patient’s dependency problem or risk your license for inappropriate drug dispensing.

Second, frame the problem (as you see it) or risk being framed by your patient. Your patient might see you as uncaring and unwilling to help him. You can change this by reframing yourself as the doctor who actually does care. For example, you might say, “I’m concerned about you. Taking Vicodin for this is not normal, and this drug is notorious for leading people into drug dependency. I don’t want to expose you to that risk.” Here, you have taken control of the frame and presented yourself as concerned rather than uncaring.

Third, in almost every negotiation there is an opportunity to expand the pie. That is, each party can offer something that was not in the original discussion but would benefit both. In this instance, you might offer to give the patient samples of a topical treatment for actinic keratoses. The patient, sensing your genuine concern, might offer to bring his mother to you for skin cancer treatment as she, too, is particularly sensitive to pain.

Of course, not all negotiations end in agreement. Sometimes your best option is to reject the request. If your patient is unwilling to compromise, then your best course of action might be to not treat him at all. Before doing so, remember that you will often have a better outcome if you try to reach agreement and that using sound negotiating practice will be a significant advantage. (Please, just don’t tell my wife about this column.)

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @dermdoc on Twitter. Write to him at [email protected].

WASHINGTON – A 1-week course of tamoxifen significantly reduced unscheduled bleeding in women using an etonogestrel contraceptive implant, compared with placebo.

The selective estrogen reuptake modifier cut bleeding days by half, compared with placebo, and in some women induced at least 1 month of amenorrhea, Dr. Katharine Simmons said at the annual meeting of the American College of Obstetricians and Gynecologists.

There were no real downsides to using the drug, added Dr. Simmons, an ob.gyn. in Atlanta. There were no significant differences in adverse events between the two treatment groups.

The 6-month study randomized 56 women to 10 mg tamoxifen twice daily or placebo for 7 days. Women were instructed to begin treatment on the third day of any period of unscheduled bleeding. They could use the drug once each month, for up to three cycles during the study period. Every day, the women had to complete a short bleeding diary. This was administered by a daily text message, which asked them to rate the strength of any bleeding over the last 24 hours, and whether or not they had taken the study drug on that day.

The women were young (mean age 25 years), and most were white (about 80%). More than 60% were nulliparous. They had been using the implant for a mean of 275 days. Upon randomization, those in the tamoxifen group reported more unscheduled bleeding days than did those in the placebo group (mean 23 vs. 20 per 30 days). Ten women in the tamoxifen group reported bleeding almost every day of the prior month.

Thirty days after taking the study drug, bleeding days were significantly reduced in the tamoxifen group, compared with the placebo group. Four of 28 women taking the drug experienced complete amenorrhea; 9 reported 5 days of bleeding. The tamoxifen group reported a median of 6 bleeding days after treatment, compared with 12 days in the placebo group.

The effect was sustained, Dr. Simmons said, with a median of 30 days before bleeding resumed in the tamoxifen group, compared with 8 days in the placebo group. Women taking the drug reported significantly greater levels of satisfaction than did those taking placebo. They also were less likely to discontinue the treatment (18% vs. 36%).

There were no significant differences in side effects. Headache was the most common, with 12 women in each group reporting it. Mood changes occurred in 7 taking tamoxifen and in 12 women taking placebo. Hot flashes were slightly more common in the tamoxifen group (6 vs. 4). Reports of nausea, weight gain, and fluid retention were similar.

Dr. Simmons conducted the study during her time at Oregon Health & Science University in Portland. She had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

WASHINGTON – A 1-week course of tamoxifen significantly reduced unscheduled bleeding in women using an etonogestrel contraceptive implant, compared with placebo.

The selective estrogen reuptake modifier cut bleeding days by half, compared with placebo, and in some women induced at least 1 month of amenorrhea, Dr. Katharine Simmons said at the annual meeting of the American College of Obstetricians and Gynecologists.

There were no real downsides to using the drug, added Dr. Simmons, an ob.gyn. in Atlanta. There were no significant differences in adverse events between the two treatment groups.

The 6-month study randomized 56 women to 10 mg tamoxifen twice daily or placebo for 7 days. Women were instructed to begin treatment on the third day of any period of unscheduled bleeding. They could use the drug once each month, for up to three cycles during the study period. Every day, the women had to complete a short bleeding diary. This was administered by a daily text message, which asked them to rate the strength of any bleeding over the last 24 hours, and whether or not they had taken the study drug on that day.

The women were young (mean age 25 years), and most were white (about 80%). More than 60% were nulliparous. They had been using the implant for a mean of 275 days. Upon randomization, those in the tamoxifen group reported more unscheduled bleeding days than did those in the placebo group (mean 23 vs. 20 per 30 days). Ten women in the tamoxifen group reported bleeding almost every day of the prior month.

Thirty days after taking the study drug, bleeding days were significantly reduced in the tamoxifen group, compared with the placebo group. Four of 28 women taking the drug experienced complete amenorrhea; 9 reported 5 days of bleeding. The tamoxifen group reported a median of 6 bleeding days after treatment, compared with 12 days in the placebo group.

The effect was sustained, Dr. Simmons said, with a median of 30 days before bleeding resumed in the tamoxifen group, compared with 8 days in the placebo group. Women taking the drug reported significantly greater levels of satisfaction than did those taking placebo. They also were less likely to discontinue the treatment (18% vs. 36%).

There were no significant differences in side effects. Headache was the most common, with 12 women in each group reporting it. Mood changes occurred in 7 taking tamoxifen and in 12 women taking placebo. Hot flashes were slightly more common in the tamoxifen group (6 vs. 4). Reports of nausea, weight gain, and fluid retention were similar.

Dr. Simmons conducted the study during her time at Oregon Health & Science University in Portland. She had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

WASHINGTON – A 1-week course of tamoxifen significantly reduced unscheduled bleeding in women using an etonogestrel contraceptive implant, compared with placebo.

The selective estrogen reuptake modifier cut bleeding days by half, compared with placebo, and in some women induced at least 1 month of amenorrhea, Dr. Katharine Simmons said at the annual meeting of the American College of Obstetricians and Gynecologists.

There were no real downsides to using the drug, added Dr. Simmons, an ob.gyn. in Atlanta. There were no significant differences in adverse events between the two treatment groups.

The 6-month study randomized 56 women to 10 mg tamoxifen twice daily or placebo for 7 days. Women were instructed to begin treatment on the third day of any period of unscheduled bleeding. They could use the drug once each month, for up to three cycles during the study period. Every day, the women had to complete a short bleeding diary. This was administered by a daily text message, which asked them to rate the strength of any bleeding over the last 24 hours, and whether or not they had taken the study drug on that day.

The women were young (mean age 25 years), and most were white (about 80%). More than 60% were nulliparous. They had been using the implant for a mean of 275 days. Upon randomization, those in the tamoxifen group reported more unscheduled bleeding days than did those in the placebo group (mean 23 vs. 20 per 30 days). Ten women in the tamoxifen group reported bleeding almost every day of the prior month.

Thirty days after taking the study drug, bleeding days were significantly reduced in the tamoxifen group, compared with the placebo group. Four of 28 women taking the drug experienced complete amenorrhea; 9 reported 5 days of bleeding. The tamoxifen group reported a median of 6 bleeding days after treatment, compared with 12 days in the placebo group.

The effect was sustained, Dr. Simmons said, with a median of 30 days before bleeding resumed in the tamoxifen group, compared with 8 days in the placebo group. Women taking the drug reported significantly greater levels of satisfaction than did those taking placebo. They also were less likely to discontinue the treatment (18% vs. 36%).

There were no significant differences in side effects. Headache was the most common, with 12 women in each group reporting it. Mood changes occurred in 7 taking tamoxifen and in 12 women taking placebo. Hot flashes were slightly more common in the tamoxifen group (6 vs. 4). Reports of nausea, weight gain, and fluid retention were similar.

Dr. Simmons conducted the study during her time at Oregon Health & Science University in Portland. She had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

George Smith (DOB 2/12/51) is a 65-year-old male patient with a history of hypertension and hyperlipidemia who presents to his local emergency department complaining of worsening dyspnea. He has been suffering with a “chest cold” for the past week, and has also noticed a gradual increase in chest discomfort. The patient is unsure if this is related to exertion or due to his nonproductive cough, but describes the sensation as a “tightness that seems to be getting worse.” The emergency physician is appropriately concerned about a cardiac cause for his symptoms, but is reassured after a check of his electronic health record reveals a recent nuclear treadmill stress test showing normal myocardial perfusion and excellent exercise tolerance, with a low probability of coronary disease.

The only problem is that George Smith never had a stress test. In fact, it’s his twin brother James Smith – also with a birth date of 2/12/51 and a home in the same city – who just had the study done in preparation for surgery. The mix-up in the records began 3 weeks ago, when a tech in the cardiac testing department made an error registering James for his stress test, and now the results of his study have filed into the chart of his twin brother. Fortunately for George, the primary care physician who cares for both brothers happens to be in the emergency department seeing a different patient. He is “curbsided” by the ED doc and recognizes the identification error before the patient is to be discharged home.

This alarming situation – a fictionalized version of a story that happens regularly in hospitals all across the United States – highlights several serious problems with electronic health records. With all of their claimed advantages, EHRs have created a tremendous number of new complications. Some are obvious, such as increased documentation time, connectivity issues, hardware failures, and superfluous “overdocumentation.” But the more troubling issues with electronic records are the ones that are much subtler. Specifically, as the case above highlights, there is the tendency to “lose the forest in the trees” of the EHR, and actually make mistakes that can have devastating consequences. This month we want to cast a light on how electronic tools designed to improve quality and safety actually can compromise them, beginning with the unfortunate reality that …

Modern conveniences can make errors more convenient as well

One of the great advantages of a well-designed electronic record is the ease of locating information when you need it; by entering a few pieces of information such as a last name and date of birth, we can find the needed data in seconds. Unfortunately, this simple and elegant system has exposed a weakness in the people using it: confirmation bias – the idea that we all tend to see what we want to see. This is an adaptive behavior that we all develop to improve efficiency and successfully navigate all of the conscious and subconscious decisions we make throughout the day. Typically, confirmation bias serves to make our lives easier, but in the case above, it didn’t help Mr. Smith; on the contrary, it almost led to disastrous consequences. The error was fortunately recognized by his astute primary care physician, but this case could have ended much differently. The experience should serve as a reminder to us that …

We can easily lose the big picture

The days of hunting for missing patient charts are thankfully long gone, but there are a few critical aspects of paper records that have been lost in the translation to electronic form. One such missing piece was noted by a colleague when first transitioning to an EHR. After a day or two of struggling with the new software, he lamented “I’m missing the big picture!” He had lost the advantage of glancing at a paper chart and instantly recalling the details about his patients that he had compiled over many years of care. For many physicians like him, this may mean reviewing handwritten notes or jottings in the margin of the chart, but sometimes just the appearance of the chart itself is enough to trigger an intellectual or emotional response.

This notion simply doesn’t exist in the world of electronic “charts,” which are all uniform by design. In the quest to simplify workflow and encourage muscle memory, EHR designers have eschewed the intangible experience of holding a yellowing, dog-eared, overflowing patient folder. Instead, physicians now find themselves holding the same PC or tablet as they walk into every patient encounter, left with only a name and date of birth to distinguish one patient from the next. Even worse, the mere definition of a patient chart has moved from a physical construct to a metaphysical one. Charts can be anywhere and everywhere, and can be edited by any end user at virtually any point of care. This opens up almost limitless opportunities for error, and unfortunately …

Errors can last a lifetime

With each episode of care, the charts of the two Mr. Smiths could become more enmeshed, and the histories harder to untangle. (In this case, a passing reference to the stress test results in the ED intern’s history and physical of George Smith may perpetuate the mistake, even though the error has been caught this time.) When mistakes like this are identified, hundreds of collective staff hours can be required to unweave comingled medical records, even when they don’t result in patient harm. It is therefore critical to develop safeguards to prevent them from occurring in the first place, with efforts that include training programs, workflow process improvement, and technology enhancement.

Ultimately, it may be impossible to prevent all documentation errors. However, by focusing on the big picture and considering patient safety first, we can raise awareness of these and other critical issues and develop the tools and training necessary to make mistakes possible to avoid.

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is also a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital and professor of family and community medicine at Temple University, Philadelphia.

George Smith (DOB 2/12/51) is a 65-year-old male patient with a history of hypertension and hyperlipidemia who presents to his local emergency department complaining of worsening dyspnea. He has been suffering with a “chest cold” for the past week, and has also noticed a gradual increase in chest discomfort. The patient is unsure if this is related to exertion or due to his nonproductive cough, but describes the sensation as a “tightness that seems to be getting worse.” The emergency physician is appropriately concerned about a cardiac cause for his symptoms, but is reassured after a check of his electronic health record reveals a recent nuclear treadmill stress test showing normal myocardial perfusion and excellent exercise tolerance, with a low probability of coronary disease.

The only problem is that George Smith never had a stress test. In fact, it’s his twin brother James Smith – also with a birth date of 2/12/51 and a home in the same city – who just had the study done in preparation for surgery. The mix-up in the records began 3 weeks ago, when a tech in the cardiac testing department made an error registering James for his stress test, and now the results of his study have filed into the chart of his twin brother. Fortunately for George, the primary care physician who cares for both brothers happens to be in the emergency department seeing a different patient. He is “curbsided” by the ED doc and recognizes the identification error before the patient is to be discharged home.

This alarming situation – a fictionalized version of a story that happens regularly in hospitals all across the United States – highlights several serious problems with electronic health records. With all of their claimed advantages, EHRs have created a tremendous number of new complications. Some are obvious, such as increased documentation time, connectivity issues, hardware failures, and superfluous “overdocumentation.” But the more troubling issues with electronic records are the ones that are much subtler. Specifically, as the case above highlights, there is the tendency to “lose the forest in the trees” of the EHR, and actually make mistakes that can have devastating consequences. This month we want to cast a light on how electronic tools designed to improve quality and safety actually can compromise them, beginning with the unfortunate reality that …

Modern conveniences can make errors more convenient as well

One of the great advantages of a well-designed electronic record is the ease of locating information when you need it; by entering a few pieces of information such as a last name and date of birth, we can find the needed data in seconds. Unfortunately, this simple and elegant system has exposed a weakness in the people using it: confirmation bias – the idea that we all tend to see what we want to see. This is an adaptive behavior that we all develop to improve efficiency and successfully navigate all of the conscious and subconscious decisions we make throughout the day. Typically, confirmation bias serves to make our lives easier, but in the case above, it didn’t help Mr. Smith; on the contrary, it almost led to disastrous consequences. The error was fortunately recognized by his astute primary care physician, but this case could have ended much differently. The experience should serve as a reminder to us that …

We can easily lose the big picture

The days of hunting for missing patient charts are thankfully long gone, but there are a few critical aspects of paper records that have been lost in the translation to electronic form. One such missing piece was noted by a colleague when first transitioning to an EHR. After a day or two of struggling with the new software, he lamented “I’m missing the big picture!” He had lost the advantage of glancing at a paper chart and instantly recalling the details about his patients that he had compiled over many years of care. For many physicians like him, this may mean reviewing handwritten notes or jottings in the margin of the chart, but sometimes just the appearance of the chart itself is enough to trigger an intellectual or emotional response.

This notion simply doesn’t exist in the world of electronic “charts,” which are all uniform by design. In the quest to simplify workflow and encourage muscle memory, EHR designers have eschewed the intangible experience of holding a yellowing, dog-eared, overflowing patient folder. Instead, physicians now find themselves holding the same PC or tablet as they walk into every patient encounter, left with only a name and date of birth to distinguish one patient from the next. Even worse, the mere definition of a patient chart has moved from a physical construct to a metaphysical one. Charts can be anywhere and everywhere, and can be edited by any end user at virtually any point of care. This opens up almost limitless opportunities for error, and unfortunately …

Errors can last a lifetime

With each episode of care, the charts of the two Mr. Smiths could become more enmeshed, and the histories harder to untangle. (In this case, a passing reference to the stress test results in the ED intern’s history and physical of George Smith may perpetuate the mistake, even though the error has been caught this time.) When mistakes like this are identified, hundreds of collective staff hours can be required to unweave comingled medical records, even when they don’t result in patient harm. It is therefore critical to develop safeguards to prevent them from occurring in the first place, with efforts that include training programs, workflow process improvement, and technology enhancement.

Ultimately, it may be impossible to prevent all documentation errors. However, by focusing on the big picture and considering patient safety first, we can raise awareness of these and other critical issues and develop the tools and training necessary to make mistakes possible to avoid.

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is also a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital and professor of family and community medicine at Temple University, Philadelphia.

George Smith (DOB 2/12/51) is a 65-year-old male patient with a history of hypertension and hyperlipidemia who presents to his local emergency department complaining of worsening dyspnea. He has been suffering with a “chest cold” for the past week, and has also noticed a gradual increase in chest discomfort. The patient is unsure if this is related to exertion or due to his nonproductive cough, but describes the sensation as a “tightness that seems to be getting worse.” The emergency physician is appropriately concerned about a cardiac cause for his symptoms, but is reassured after a check of his electronic health record reveals a recent nuclear treadmill stress test showing normal myocardial perfusion and excellent exercise tolerance, with a low probability of coronary disease.

The only problem is that George Smith never had a stress test. In fact, it’s his twin brother James Smith – also with a birth date of 2/12/51 and a home in the same city – who just had the study done in preparation for surgery. The mix-up in the records began 3 weeks ago, when a tech in the cardiac testing department made an error registering James for his stress test, and now the results of his study have filed into the chart of his twin brother. Fortunately for George, the primary care physician who cares for both brothers happens to be in the emergency department seeing a different patient. He is “curbsided” by the ED doc and recognizes the identification error before the patient is to be discharged home.

This alarming situation – a fictionalized version of a story that happens regularly in hospitals all across the United States – highlights several serious problems with electronic health records. With all of their claimed advantages, EHRs have created a tremendous number of new complications. Some are obvious, such as increased documentation time, connectivity issues, hardware failures, and superfluous “overdocumentation.” But the more troubling issues with electronic records are the ones that are much subtler. Specifically, as the case above highlights, there is the tendency to “lose the forest in the trees” of the EHR, and actually make mistakes that can have devastating consequences. This month we want to cast a light on how electronic tools designed to improve quality and safety actually can compromise them, beginning with the unfortunate reality that …

Modern conveniences can make errors more convenient as well

One of the great advantages of a well-designed electronic record is the ease of locating information when you need it; by entering a few pieces of information such as a last name and date of birth, we can find the needed data in seconds. Unfortunately, this simple and elegant system has exposed a weakness in the people using it: confirmation bias – the idea that we all tend to see what we want to see. This is an adaptive behavior that we all develop to improve efficiency and successfully navigate all of the conscious and subconscious decisions we make throughout the day. Typically, confirmation bias serves to make our lives easier, but in the case above, it didn’t help Mr. Smith; on the contrary, it almost led to disastrous consequences. The error was fortunately recognized by his astute primary care physician, but this case could have ended much differently. The experience should serve as a reminder to us that …

We can easily lose the big picture

The days of hunting for missing patient charts are thankfully long gone, but there are a few critical aspects of paper records that have been lost in the translation to electronic form. One such missing piece was noted by a colleague when first transitioning to an EHR. After a day or two of struggling with the new software, he lamented “I’m missing the big picture!” He had lost the advantage of glancing at a paper chart and instantly recalling the details about his patients that he had compiled over many years of care. For many physicians like him, this may mean reviewing handwritten notes or jottings in the margin of the chart, but sometimes just the appearance of the chart itself is enough to trigger an intellectual or emotional response.

This notion simply doesn’t exist in the world of electronic “charts,” which are all uniform by design. In the quest to simplify workflow and encourage muscle memory, EHR designers have eschewed the intangible experience of holding a yellowing, dog-eared, overflowing patient folder. Instead, physicians now find themselves holding the same PC or tablet as they walk into every patient encounter, left with only a name and date of birth to distinguish one patient from the next. Even worse, the mere definition of a patient chart has moved from a physical construct to a metaphysical one. Charts can be anywhere and everywhere, and can be edited by any end user at virtually any point of care. This opens up almost limitless opportunities for error, and unfortunately …

Errors can last a lifetime

With each episode of care, the charts of the two Mr. Smiths could become more enmeshed, and the histories harder to untangle. (In this case, a passing reference to the stress test results in the ED intern’s history and physical of George Smith may perpetuate the mistake, even though the error has been caught this time.) When mistakes like this are identified, hundreds of collective staff hours can be required to unweave comingled medical records, even when they don’t result in patient harm. It is therefore critical to develop safeguards to prevent them from occurring in the first place, with efforts that include training programs, workflow process improvement, and technology enhancement.

Ultimately, it may be impossible to prevent all documentation errors. However, by focusing on the big picture and considering patient safety first, we can raise awareness of these and other critical issues and develop the tools and training necessary to make mistakes possible to avoid.

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is also a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington (Pa.) Memorial Hospital and professor of family and community medicine at Temple University, Philadelphia.

The recent reclassification of encapsulated follicular variant of papillary thyroid carcinoma (EFVPTC) as noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) – an action taken to better reflect the very low risk of adverse events associated with these tumors – has important clinical and psychological implications for patients.

“Even though physicians know that most thyroid cancers have an excellent prognosis, the impact on a patient of being given a diagnosis of cancer should not be underestimated,” Dr. Peter Angelos, professor of surgery and chief of endocrine surgery at the University of Chicago, said in an interview. “It is, however, critical for doctors and patients to understand that this change from ‘thyroid cancer’ to a ‘benign thyroid nodule,’ is not something that can be determined prior to surgery. Patients will still need thyroid operations to determine if their indeterminate nodules have cancer in them or not.”

The change in nomenclature followed an international, multidisciplinary, retrospective study of patients with thyroid nodules diagnosed as EFVPTC. Such patients are usually treated as having conventional thyroid cancer. The study included 109 patients with noninvasive EFVPTC who were followed for 10-26 years, and 101 with invasive EFVPTC who were followed for 1-18 years. At median follow-up of 13 years, all of the 109 patients with noninvasive EFVPTC were alive, and based on consensus diagnostic criteria developed by an Endocrine Pathology Society working group – a multinational panel of 24 thyroid pathologists – they had no evidence of disease, reported Dr. Yuri E. Nikiforov of the University of Pittsburgh and colleagues (JAMA Oncol. 2016 April 14. doi: 10.1001/jamaoncol.2016.0386).

Most of those patients (67%) were treated only with lobectomy, and none received radioiodine (RAI) treatment.

Of the 101 with invasive EFVPTC, 12 experienced an adverse event, including 5 who developed distant (lung and/or bone) metastases. Two died from the disease, one had a lymph node recurrence, one had persistent disease, and five had detectable serum thyroglobulin and were considered to have indeterminate or biochemically incomplete response to therapy, the investigators said.

Based on the findings in the noninvasive EFVPTC patients, the recommended nomenclature change was adopted to reflect the main morphological features of, and lack of invasion of, the benign tumors as well as their very low risk of adverse outcome. To assist in the diagnosis of NIFTP in routine pathology practice, a simplified three-point diagnostic nuclear scoring scheme based on the six main consensus nuclear features of the tumors was developed and validated; the scoring scheme yielded sensitivity of 98.6%, specificity of 90.1%, and overall classification accuracy of 94.3% for NIFTP.

The study involved a review of digitized histologic slides collected at 13 sites in 5 countries. The pathologists who composed the working group conducted the review and consulted in a series of teleconferences and face-to-face meetings to establish the consensus criteria. They measured the frequency of adverse outcomes, including death from disease, distant or locoregional metastases, and structural or biochemical recurrence.

The findings suggest that “clinical management of patients with NIFTP can be deescalated because they are unlikely to benefit from immediate completion thyroidectomy and RAI therapy,” the investigators said.

“Staging would be unnecessary. In addition to eliminating the psychological impact of the diagnosis of cancer, this would reduce complications of total thyroidectomy, risk of secondary tumors following RAI therapy, and the overall cost of health care. Avoidance of RAI treatment alone would save between $5,000 and $8,500 per patient (based on U.S. cost),” they wrote, adding that an estimated 45,000 patients worldwide each year will be affected by this reclassification, resulting in significant reduction in “psychological burden, medical overtreatment and expense, and other clinical consequences associated with a cancer diagnosis.”

Dr. Martha A. Zeiger, professor of surgery at Johns Hopkins University, Baltimore, agreed that the change has important implications for patients.

“With the advent of new nomenclature for encapsulated follicular variant of papillary thyroid cancer, namely that it is now considered a benign tumor, thousands of patients who have carried this original diagnosis of cancer can breathe a sigh of relief. Our new understanding will also decrease the number of patients undergoing more extensive surgery and many can now be treated with a thyroid lobectomy only,” she said in an interview.

One thing the new nomenclature doesn’t do, however, is solve the problem of the suspicious or indeterminate thyroid fine needle aspiration diagnosis, she noted.

“Clouding the landscape even further is the fact that many of our commonly used molecular diagnostics were based on studies in which encapsulated follicular variant of papillary thyroid cancer was considered malignant, and were included in the analysis. Because of this, diagnostic molecular tools will likely now require a renewed scrutiny as to their true efficacy in differentiating benign from malignant tumors,” she said.

Dr. Nikiforov is a consultant for Quest Diagnostics. A coauthor, Dr. Sylvia Asa, is a member of the medical advisory board of Leica Aperio, and another coauthor, Dr. Virginia LiVolsi, is a consultant for Veracyte Inc. The project used a facility supported by the National Cancer Institute, and molecular analysis was supported in part by funds from the University of Pittsburgh Cancer Institute and the University of Pittsburgh Medical Center. The Endocrine Pathology Society working group conference was supported by a grant from CBLPath Inc. Dr. Angelos and Dr. Zeiger reported having no disclosures.

[email protected]

The recent reclassification of encapsulated follicular variant of papillary thyroid carcinoma (EFVPTC) as noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) – an action taken to better reflect the very low risk of adverse events associated with these tumors – has important clinical and psychological implications for patients.

“Even though physicians know that most thyroid cancers have an excellent prognosis, the impact on a patient of being given a diagnosis of cancer should not be underestimated,” Dr. Peter Angelos, professor of surgery and chief of endocrine surgery at the University of Chicago, said in an interview. “It is, however, critical for doctors and patients to understand that this change from ‘thyroid cancer’ to a ‘benign thyroid nodule,’ is not something that can be determined prior to surgery. Patients will still need thyroid operations to determine if their indeterminate nodules have cancer in them or not.”

The change in nomenclature followed an international, multidisciplinary, retrospective study of patients with thyroid nodules diagnosed as EFVPTC. Such patients are usually treated as having conventional thyroid cancer. The study included 109 patients with noninvasive EFVPTC who were followed for 10-26 years, and 101 with invasive EFVPTC who were followed for 1-18 years. At median follow-up of 13 years, all of the 109 patients with noninvasive EFVPTC were alive, and based on consensus diagnostic criteria developed by an Endocrine Pathology Society working group – a multinational panel of 24 thyroid pathologists – they had no evidence of disease, reported Dr. Yuri E. Nikiforov of the University of Pittsburgh and colleagues (JAMA Oncol. 2016 April 14. doi: 10.1001/jamaoncol.2016.0386).

Most of those patients (67%) were treated only with lobectomy, and none received radioiodine (RAI) treatment.

Of the 101 with invasive EFVPTC, 12 experienced an adverse event, including 5 who developed distant (lung and/or bone) metastases. Two died from the disease, one had a lymph node recurrence, one had persistent disease, and five had detectable serum thyroglobulin and were considered to have indeterminate or biochemically incomplete response to therapy, the investigators said.

Based on the findings in the noninvasive EFVPTC patients, the recommended nomenclature change was adopted to reflect the main morphological features of, and lack of invasion of, the benign tumors as well as their very low risk of adverse outcome. To assist in the diagnosis of NIFTP in routine pathology practice, a simplified three-point diagnostic nuclear scoring scheme based on the six main consensus nuclear features of the tumors was developed and validated; the scoring scheme yielded sensitivity of 98.6%, specificity of 90.1%, and overall classification accuracy of 94.3% for NIFTP.

The study involved a review of digitized histologic slides collected at 13 sites in 5 countries. The pathologists who composed the working group conducted the review and consulted in a series of teleconferences and face-to-face meetings to establish the consensus criteria. They measured the frequency of adverse outcomes, including death from disease, distant or locoregional metastases, and structural or biochemical recurrence.

The findings suggest that “clinical management of patients with NIFTP can be deescalated because they are unlikely to benefit from immediate completion thyroidectomy and RAI therapy,” the investigators said.

“Staging would be unnecessary. In addition to eliminating the psychological impact of the diagnosis of cancer, this would reduce complications of total thyroidectomy, risk of secondary tumors following RAI therapy, and the overall cost of health care. Avoidance of RAI treatment alone would save between $5,000 and $8,500 per patient (based on U.S. cost),” they wrote, adding that an estimated 45,000 patients worldwide each year will be affected by this reclassification, resulting in significant reduction in “psychological burden, medical overtreatment and expense, and other clinical consequences associated with a cancer diagnosis.”

Dr. Martha A. Zeiger, professor of surgery at Johns Hopkins University, Baltimore, agreed that the change has important implications for patients.

“With the advent of new nomenclature for encapsulated follicular variant of papillary thyroid cancer, namely that it is now considered a benign tumor, thousands of patients who have carried this original diagnosis of cancer can breathe a sigh of relief. Our new understanding will also decrease the number of patients undergoing more extensive surgery and many can now be treated with a thyroid lobectomy only,” she said in an interview.

One thing the new nomenclature doesn’t do, however, is solve the problem of the suspicious or indeterminate thyroid fine needle aspiration diagnosis, she noted.

“Clouding the landscape even further is the fact that many of our commonly used molecular diagnostics were based on studies in which encapsulated follicular variant of papillary thyroid cancer was considered malignant, and were included in the analysis. Because of this, diagnostic molecular tools will likely now require a renewed scrutiny as to their true efficacy in differentiating benign from malignant tumors,” she said.

Dr. Nikiforov is a consultant for Quest Diagnostics. A coauthor, Dr. Sylvia Asa, is a member of the medical advisory board of Leica Aperio, and another coauthor, Dr. Virginia LiVolsi, is a consultant for Veracyte Inc. The project used a facility supported by the National Cancer Institute, and molecular analysis was supported in part by funds from the University of Pittsburgh Cancer Institute and the University of Pittsburgh Medical Center. The Endocrine Pathology Society working group conference was supported by a grant from CBLPath Inc. Dr. Angelos and Dr. Zeiger reported having no disclosures.

[email protected]

The recent reclassification of encapsulated follicular variant of papillary thyroid carcinoma (EFVPTC) as noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) – an action taken to better reflect the very low risk of adverse events associated with these tumors – has important clinical and psychological implications for patients.

“Even though physicians know that most thyroid cancers have an excellent prognosis, the impact on a patient of being given a diagnosis of cancer should not be underestimated,” Dr. Peter Angelos, professor of surgery and chief of endocrine surgery at the University of Chicago, said in an interview. “It is, however, critical for doctors and patients to understand that this change from ‘thyroid cancer’ to a ‘benign thyroid nodule,’ is not something that can be determined prior to surgery. Patients will still need thyroid operations to determine if their indeterminate nodules have cancer in them or not.”

The change in nomenclature followed an international, multidisciplinary, retrospective study of patients with thyroid nodules diagnosed as EFVPTC. Such patients are usually treated as having conventional thyroid cancer. The study included 109 patients with noninvasive EFVPTC who were followed for 10-26 years, and 101 with invasive EFVPTC who were followed for 1-18 years. At median follow-up of 13 years, all of the 109 patients with noninvasive EFVPTC were alive, and based on consensus diagnostic criteria developed by an Endocrine Pathology Society working group – a multinational panel of 24 thyroid pathologists – they had no evidence of disease, reported Dr. Yuri E. Nikiforov of the University of Pittsburgh and colleagues (JAMA Oncol. 2016 April 14. doi: 10.1001/jamaoncol.2016.0386).

Most of those patients (67%) were treated only with lobectomy, and none received radioiodine (RAI) treatment.

Of the 101 with invasive EFVPTC, 12 experienced an adverse event, including 5 who developed distant (lung and/or bone) metastases. Two died from the disease, one had a lymph node recurrence, one had persistent disease, and five had detectable serum thyroglobulin and were considered to have indeterminate or biochemically incomplete response to therapy, the investigators said.

Based on the findings in the noninvasive EFVPTC patients, the recommended nomenclature change was adopted to reflect the main morphological features of, and lack of invasion of, the benign tumors as well as their very low risk of adverse outcome. To assist in the diagnosis of NIFTP in routine pathology practice, a simplified three-point diagnostic nuclear scoring scheme based on the six main consensus nuclear features of the tumors was developed and validated; the scoring scheme yielded sensitivity of 98.6%, specificity of 90.1%, and overall classification accuracy of 94.3% for NIFTP.

The study involved a review of digitized histologic slides collected at 13 sites in 5 countries. The pathologists who composed the working group conducted the review and consulted in a series of teleconferences and face-to-face meetings to establish the consensus criteria. They measured the frequency of adverse outcomes, including death from disease, distant or locoregional metastases, and structural or biochemical recurrence.

The findings suggest that “clinical management of patients with NIFTP can be deescalated because they are unlikely to benefit from immediate completion thyroidectomy and RAI therapy,” the investigators said.

“Staging would be unnecessary. In addition to eliminating the psychological impact of the diagnosis of cancer, this would reduce complications of total thyroidectomy, risk of secondary tumors following RAI therapy, and the overall cost of health care. Avoidance of RAI treatment alone would save between $5,000 and $8,500 per patient (based on U.S. cost),” they wrote, adding that an estimated 45,000 patients worldwide each year will be affected by this reclassification, resulting in significant reduction in “psychological burden, medical overtreatment and expense, and other clinical consequences associated with a cancer diagnosis.”

Dr. Martha A. Zeiger, professor of surgery at Johns Hopkins University, Baltimore, agreed that the change has important implications for patients.

“With the advent of new nomenclature for encapsulated follicular variant of papillary thyroid cancer, namely that it is now considered a benign tumor, thousands of patients who have carried this original diagnosis of cancer can breathe a sigh of relief. Our new understanding will also decrease the number of patients undergoing more extensive surgery and many can now be treated with a thyroid lobectomy only,” she said in an interview.

One thing the new nomenclature doesn’t do, however, is solve the problem of the suspicious or indeterminate thyroid fine needle aspiration diagnosis, she noted.

“Clouding the landscape even further is the fact that many of our commonly used molecular diagnostics were based on studies in which encapsulated follicular variant of papillary thyroid cancer was considered malignant, and were included in the analysis. Because of this, diagnostic molecular tools will likely now require a renewed scrutiny as to their true efficacy in differentiating benign from malignant tumors,” she said.

Dr. Nikiforov is a consultant for Quest Diagnostics. A coauthor, Dr. Sylvia Asa, is a member of the medical advisory board of Leica Aperio, and another coauthor, Dr. Virginia LiVolsi, is a consultant for Veracyte Inc. The project used a facility supported by the National Cancer Institute, and molecular analysis was supported in part by funds from the University of Pittsburgh Cancer Institute and the University of Pittsburgh Medical Center. The Endocrine Pathology Society working group conference was supported by a grant from CBLPath Inc. Dr. Angelos and Dr. Zeiger reported having no disclosures.

[email protected]

The measure of a country’s greatness, Mahatma Gandhi said, should be based on how well it cares for its most vulnerable. Recently, I had the opportunity to work with members of a vulnerable population: men and women who have a mental illness and languish in jails and prisons around the country. My experience was eye-opening and heartbreaking.

Widespread incarceration of the mentally ill in a developed country such as the United States should be a national embarrassment. But this tragedy, which has reached an epidemic level, has been effectively shut out of the national conversation.

The problem has grown, and is enormous
By the estimate of the U.S. Department of Justice, more than one-half of people incarcerated in the United States are mentally ill and approximately 20% suffer from a serious mental illness.^1,2 In fact, there are now 3 times as many mentally ill people in jail and prison as there are occupying psychiatric beds in hospitals.³ These numbers represent a considerable increase over the past 6 decades, and can be attributed to 2 major factors:

• A program of deinstitutionalization set in motion by the federal government in the 1950s called for shuttering of state psychiatric facilities around the country. This was a period of renewed national discourse on civil rights; for many people, the practice of institutionalization was considered a violation of civil rights. (Coincidentally, chlorpromazine was introduced about this time, and many experts believed that the drug would revolutionize outpatient management of psychiatric disorders.)
• More recently, heavy criminal penalties have been attached to convictions for possession and distribution of illegal substances—part of the government’s “war on drugs.”

As a consequence of these programs and policies, the United States has come full circle—routinely incarcerating the mentally ill as it did in the early 19th century, before reforms were initiated in response to the lobbying efforts of activist Dorothea Dix and her contemporaries.

My distressing, eye-opening experience
The time I spent with the incarcerated mentally ill was limited to a 6-month period at a county jail during residency. Yet the contrast between services provided to this population and those that are available to people in the community was immediately evident—and stark. The sheer number of adults in jails and prisons who require mental health care is such that the ratio of patients to psychiatrists, psychologists, and other mental health clinicians is shockingly skewed.

It does not take years of experience to figure out that a brief interview with an 18-year-old who is being jailed for the first time, has never seen a psychiatrist, and suffers panic attacks (or hallucinations, or suicidal thoughts) is a less-than-ideal clinical situation. Making that situation even more hazardous is that inmates have a high risk of suicide, particularly in the first 24 to 48 hours of incarceration.⁴

Other ethical issues arose during my stint in the correctional system: My patients frequently would be charged with prison-rule violations (there is evidence that mentally ill inmates are more likely to be charged with such violations²); on many such occasions, they would be placed in solitary confinement (“the hole”), a practice the United Nations has called “cruel, inhuman, and degrading: for the mentally ill⁵ and that, in turn, exacerbates the inmate’s psychiatric illness.^6-11

Last, there are restrictions on the types of formulations of medications that can be prescribed, involuntary treatment, and other critical aspects of care that make the experience of providing care in this system frustrating for mental health providers.

Are there solutions?
One way to tackle this crisis might be to insert more psychiatrists and psychologists into the correctional system. A more sensible approach, however, would be to tackle the root cause and divert the mentally ill away from incarceration and into treatment—moving from a model of retribution and incapacitation to one of rehabilitation. For example:

• Several counties nationwide have adopted diversion programs that include so-called mental health courts and drug courts, with encouraging results¹²
• Police departments are establishing Crisis Intervention Teams
• Assisted outpatient treatment programs are growing in popularity.

Far more needs to be done, however. In the absence of a national debate on the problem of the incarcerated mentally ill, there is real risk that this population will continue to be ignored and that our mental health care infrastructure will remain inadequate for meeting their need for services.

The measure of a country’s greatness, Mahatma Gandhi said, should be based on how well it cares for its most vulnerable. Recently, I had the opportunity to work with members of a vulnerable population: men and women who have a mental illness and languish in jails and prisons around the country. My experience was eye-opening and heartbreaking.

Widespread incarceration of the mentally ill in a developed country such as the United States should be a national embarrassment. But this tragedy, which has reached an epidemic level, has been effectively shut out of the national conversation.

The problem has grown, and is enormous
By the estimate of the U.S. Department of Justice, more than one-half of people incarcerated in the United States are mentally ill and approximately 20% suffer from a serious mental illness.^1,2 In fact, there are now 3 times as many mentally ill people in jail and prison as there are occupying psychiatric beds in hospitals.³ These numbers represent a considerable increase over the past 6 decades, and can be attributed to 2 major factors:

• A program of deinstitutionalization set in motion by the federal government in the 1950s called for shuttering of state psychiatric facilities around the country. This was a period of renewed national discourse on civil rights; for many people, the practice of institutionalization was considered a violation of civil rights. (Coincidentally, chlorpromazine was introduced about this time, and many experts believed that the drug would revolutionize outpatient management of psychiatric disorders.)
• More recently, heavy criminal penalties have been attached to convictions for possession and distribution of illegal substances—part of the government’s “war on drugs.”

As a consequence of these programs and policies, the United States has come full circle—routinely incarcerating the mentally ill as it did in the early 19th century, before reforms were initiated in response to the lobbying efforts of activist Dorothea Dix and her contemporaries.

My distressing, eye-opening experience
The time I spent with the incarcerated mentally ill was limited to a 6-month period at a county jail during residency. Yet the contrast between services provided to this population and those that are available to people in the community was immediately evident—and stark. The sheer number of adults in jails and prisons who require mental health care is such that the ratio of patients to psychiatrists, psychologists, and other mental health clinicians is shockingly skewed.

It does not take years of experience to figure out that a brief interview with an 18-year-old who is being jailed for the first time, has never seen a psychiatrist, and suffers panic attacks (or hallucinations, or suicidal thoughts) is a less-than-ideal clinical situation. Making that situation even more hazardous is that inmates have a high risk of suicide, particularly in the first 24 to 48 hours of incarceration.⁴

Other ethical issues arose during my stint in the correctional system: My patients frequently would be charged with prison-rule violations (there is evidence that mentally ill inmates are more likely to be charged with such violations²); on many such occasions, they would be placed in solitary confinement (“the hole”), a practice the United Nations has called “cruel, inhuman, and degrading: for the mentally ill⁵ and that, in turn, exacerbates the inmate’s psychiatric illness.^6-11

Last, there are restrictions on the types of formulations of medications that can be prescribed, involuntary treatment, and other critical aspects of care that make the experience of providing care in this system frustrating for mental health providers.

Are there solutions?
One way to tackle this crisis might be to insert more psychiatrists and psychologists into the correctional system. A more sensible approach, however, would be to tackle the root cause and divert the mentally ill away from incarceration and into treatment—moving from a model of retribution and incapacitation to one of rehabilitation. For example:

• Several counties nationwide have adopted diversion programs that include so-called mental health courts and drug courts, with encouraging results¹²
• Police departments are establishing Crisis Intervention Teams
• Assisted outpatient treatment programs are growing in popularity.

Far more needs to be done, however. In the absence of a national debate on the problem of the incarcerated mentally ill, there is real risk that this population will continue to be ignored and that our mental health care infrastructure will remain inadequate for meeting their need for services.

The measure of a country’s greatness, Mahatma Gandhi said, should be based on how well it cares for its most vulnerable. Recently, I had the opportunity to work with members of a vulnerable population: men and women who have a mental illness and languish in jails and prisons around the country. My experience was eye-opening and heartbreaking.

Widespread incarceration of the mentally ill in a developed country such as the United States should be a national embarrassment. But this tragedy, which has reached an epidemic level, has been effectively shut out of the national conversation.

The problem has grown, and is enormous
By the estimate of the U.S. Department of Justice, more than one-half of people incarcerated in the United States are mentally ill and approximately 20% suffer from a serious mental illness.^1,2 In fact, there are now 3 times as many mentally ill people in jail and prison as there are occupying psychiatric beds in hospitals.³ These numbers represent a considerable increase over the past 6 decades, and can be attributed to 2 major factors:

• A program of deinstitutionalization set in motion by the federal government in the 1950s called for shuttering of state psychiatric facilities around the country. This was a period of renewed national discourse on civil rights; for many people, the practice of institutionalization was considered a violation of civil rights. (Coincidentally, chlorpromazine was introduced about this time, and many experts believed that the drug would revolutionize outpatient management of psychiatric disorders.)
• More recently, heavy criminal penalties have been attached to convictions for possession and distribution of illegal substances—part of the government’s “war on drugs.”

As a consequence of these programs and policies, the United States has come full circle—routinely incarcerating the mentally ill as it did in the early 19th century, before reforms were initiated in response to the lobbying efforts of activist Dorothea Dix and her contemporaries.

My distressing, eye-opening experience
The time I spent with the incarcerated mentally ill was limited to a 6-month period at a county jail during residency. Yet the contrast between services provided to this population and those that are available to people in the community was immediately evident—and stark. The sheer number of adults in jails and prisons who require mental health care is such that the ratio of patients to psychiatrists, psychologists, and other mental health clinicians is shockingly skewed.

It does not take years of experience to figure out that a brief interview with an 18-year-old who is being jailed for the first time, has never seen a psychiatrist, and suffers panic attacks (or hallucinations, or suicidal thoughts) is a less-than-ideal clinical situation. Making that situation even more hazardous is that inmates have a high risk of suicide, particularly in the first 24 to 48 hours of incarceration.⁴

Other ethical issues arose during my stint in the correctional system: My patients frequently would be charged with prison-rule violations (there is evidence that mentally ill inmates are more likely to be charged with such violations²); on many such occasions, they would be placed in solitary confinement (“the hole”), a practice the United Nations has called “cruel, inhuman, and degrading: for the mentally ill⁵ and that, in turn, exacerbates the inmate’s psychiatric illness.^6-11

Last, there are restrictions on the types of formulations of medications that can be prescribed, involuntary treatment, and other critical aspects of care that make the experience of providing care in this system frustrating for mental health providers.

Are there solutions?
One way to tackle this crisis might be to insert more psychiatrists and psychologists into the correctional system. A more sensible approach, however, would be to tackle the root cause and divert the mentally ill away from incarceration and into treatment—moving from a model of retribution and incapacitation to one of rehabilitation. For example:

• Several counties nationwide have adopted diversion programs that include so-called mental health courts and drug courts, with encouraging results¹²
• Police departments are establishing Crisis Intervention Teams
• Assisted outpatient treatment programs are growing in popularity.

Far more needs to be done, however. In the absence of a national debate on the problem of the incarcerated mentally ill, there is real risk that this population will continue to be ignored and that our mental health care infrastructure will remain inadequate for meeting their need for services.

Men do not know as much about skin cancer prevention and detection techniques as women, according to a recent survey conducted by the American Academy of Dermatology (AAD). This lack of knowledge may delay or prevent early diagnosis and treatment of melanoma and other nonmelanoma skin cancers in this patient population.

The survey results showed that only 56% of men versus 76% of women know there is no such thing as a healthy tan, and only 54% of men versus 70% of women know that getting a base tan is not a healthy way to protect skin from the sun. Furthermore, only 56% of men surveyed were aware that skin cancer could occur on areas of the skin not typically exposed to the sun compared to 65% of women.

“While our survey results indicate that men don’t know as much about skin cancer prevention and detection as women, men over 50 have a higher risk of developing melanoma, so it’s especially important for them to be vigilant about protecting and monitoring their skin,” said AAD President Abel Torres, MD, JD.

More resources on the diagnosis and treatment of melanoma.

May is skin cancer awareness month and the AAD is encouraging patients to make sure their skin is “Looking Good in 2016” by using sun protection and regularly examining skin for signs of skin cancer. The campaign features a public service announcement encouraging men to check their skin for signs of skin cancer and find a partner to help. The AAD also released a new infographic with tips on performing a skin cancer self-examination that dermatologists can share with patients to promote early detection of skin cancer.

More resources on nonmelanoma skin cancers. 

Dermatologist intervention in catching skin cancers when they are easier to treat also is key. At the 74th Annual Meeting of the American Academy of Dermatology in Washington, DC, Dr. Orit Markowitz discussed noninvasive imaging tools that can help dermatologists diagnose skin cancers earlier. She noted that even when a lesion looks very small, tools such as dermoscopy can reveal features that indicate it already has depth and therefore may progress to a more serious malignancy. Early detection is particularly crucial in cases of rare aggressive tumors such as amelanotic melanoma. “If something is very pink clinically and then suddenly has pigmentation dermoscopically, you really have to be considering biopsying that lesion because you may be looking at an early amelanotic melanoma,” Dr. Markowitz explained. By the time the lesion develops more obvious clinical features suggesting malignancy, the tumor progression may be far more advanced.

Men do not know as much about skin cancer prevention and detection techniques as women, according to a recent survey conducted by the American Academy of Dermatology (AAD). This lack of knowledge may delay or prevent early diagnosis and treatment of melanoma and other nonmelanoma skin cancers in this patient population.

The survey results showed that only 56% of men versus 76% of women know there is no such thing as a healthy tan, and only 54% of men versus 70% of women know that getting a base tan is not a healthy way to protect skin from the sun. Furthermore, only 56% of men surveyed were aware that skin cancer could occur on areas of the skin not typically exposed to the sun compared to 65% of women.

“While our survey results indicate that men don’t know as much about skin cancer prevention and detection as women, men over 50 have a higher risk of developing melanoma, so it’s especially important for them to be vigilant about protecting and monitoring their skin,” said AAD President Abel Torres, MD, JD.

More resources on the diagnosis and treatment of melanoma.

May is skin cancer awareness month and the AAD is encouraging patients to make sure their skin is “Looking Good in 2016” by using sun protection and regularly examining skin for signs of skin cancer. The campaign features a public service announcement encouraging men to check their skin for signs of skin cancer and find a partner to help. The AAD also released a new infographic with tips on performing a skin cancer self-examination that dermatologists can share with patients to promote early detection of skin cancer.

More resources on nonmelanoma skin cancers. 

Dermatologist intervention in catching skin cancers when they are easier to treat also is key. At the 74th Annual Meeting of the American Academy of Dermatology in Washington, DC, Dr. Orit Markowitz discussed noninvasive imaging tools that can help dermatologists diagnose skin cancers earlier. She noted that even when a lesion looks very small, tools such as dermoscopy can reveal features that indicate it already has depth and therefore may progress to a more serious malignancy. Early detection is particularly crucial in cases of rare aggressive tumors such as amelanotic melanoma. “If something is very pink clinically and then suddenly has pigmentation dermoscopically, you really have to be considering biopsying that lesion because you may be looking at an early amelanotic melanoma,” Dr. Markowitz explained. By the time the lesion develops more obvious clinical features suggesting malignancy, the tumor progression may be far more advanced.

Men do not know as much about skin cancer prevention and detection techniques as women, according to a recent survey conducted by the American Academy of Dermatology (AAD). This lack of knowledge may delay or prevent early diagnosis and treatment of melanoma and other nonmelanoma skin cancers in this patient population.

The survey results showed that only 56% of men versus 76% of women know there is no such thing as a healthy tan, and only 54% of men versus 70% of women know that getting a base tan is not a healthy way to protect skin from the sun. Furthermore, only 56% of men surveyed were aware that skin cancer could occur on areas of the skin not typically exposed to the sun compared to 65% of women.

“While our survey results indicate that men don’t know as much about skin cancer prevention and detection as women, men over 50 have a higher risk of developing melanoma, so it’s especially important for them to be vigilant about protecting and monitoring their skin,” said AAD President Abel Torres, MD, JD.

More resources on the diagnosis and treatment of melanoma.

May is skin cancer awareness month and the AAD is encouraging patients to make sure their skin is “Looking Good in 2016” by using sun protection and regularly examining skin for signs of skin cancer. The campaign features a public service announcement encouraging men to check their skin for signs of skin cancer and find a partner to help. The AAD also released a new infographic with tips on performing a skin cancer self-examination that dermatologists can share with patients to promote early detection of skin cancer.

More resources on nonmelanoma skin cancers. 

Dermatologist intervention in catching skin cancers when they are easier to treat also is key. At the 74th Annual Meeting of the American Academy of Dermatology in Washington, DC, Dr. Orit Markowitz discussed noninvasive imaging tools that can help dermatologists diagnose skin cancers earlier. She noted that even when a lesion looks very small, tools such as dermoscopy can reveal features that indicate it already has depth and therefore may progress to a more serious malignancy. Early detection is particularly crucial in cases of rare aggressive tumors such as amelanotic melanoma. “If something is very pink clinically and then suddenly has pigmentation dermoscopically, you really have to be considering biopsying that lesion because you may be looking at an early amelanotic melanoma,” Dr. Markowitz explained. By the time the lesion develops more obvious clinical features suggesting malignancy, the tumor progression may be far more advanced.

Question: An injured patient alleges that her eye doctor was negligent in failing to adhere to national treatment guidelines and in not using modern medical equipment. The encounter took place in a rural setting, with the nearest hospital 100 miles away.

In her malpractice lawsuit, which of the following choices is incorrect?

A. One of the doctor’s defenses may be the locality rule.

B. The plaintiff’s strongest argument is that community standards should parallel national standards for a specialist doctor such as an ophthalmologist.

C. Her expert witness must be a practicing ophthalmologist from the area.

D. The expert must be familiar with the local standards but does not have to practice there.

E. It all depends on what the state statute says, because the locality rule is not uniform settled law.

Answer: C. In traditional medical tort law, courts would rely on the standard of the particular locale where the tortious act took place, the so-called locality rule. This was based on the belief that different standards of care were applicable in different areas of the country, e.g., urban vs. rural. The rule can be traced to Small v. Howard,¹ an 1880 Massachusetts opinion, which was subsequently overruled in 1968.

Factors favoring the trend away from a local standard toward a national standard include conformity in medical school and residency curricula, and prescribed board certification requirements. Internet access and telemedicine have further propagated this uniformity. Finally, two additional facets of modern medicine – continuing medical education and published clinical practice guidelines – are at odds with a rule geared toward local standards.

One argument against the locality rule is that undue reliance on an outdated mode of practice will perpetuate substandard care. In an older New York malpractice case where a newborn became blind, the pediatrician cited local custom to defend the prolonged use of oxygen to treat preterm infants, despite evidence that this practice might have serious consequences. However, the court of appeals held that the pediatrician’s superior knowledge of the increased risk of hyperoxygenation should have enabled him to use his best judgment instead of relying on the indefensible local custom.

Under a strict version of the locality rule, otherwise qualified expert witnesses may be excluded if they are not practitioners in the locale in question. Still, some courts may allow out-of-state experts to offer their opinions. This has been especially helpful to plaintiffs who are far less likely to be able to secure willing local experts, given the reluctance of many physicians to testify against a fellow doctor in their community.

Take Tennessee as an example. It once excluded the expert testimony of an orthopedic surgeon from Johnson City because the expert witness testified about the national standard and did not have actual knowledge of the standard of care in Nashville, the community where the alleged malpractice occurred.

The Tennessee Court of Appeals later ruled that expert witnesses had to have “personal” or “firsthand knowledge” of the community standard of care, and that interviewing other physicians in the area did not suffice. It subsequently clarified that an expert witness need not actually practice in the same or similar locale, and that professional contact with physicians from comparable communities, such as through referrals, would be acceptable.

Two well-known cases touching on the locality rule bear summarizing: In Swink v. Weintraub,² Mrs. Swink bled into her pericardium during repair of a defective pacemaker electric lead. She died as a result, and her family pursued a wrongful death action, alleging negligence including delayed pericardiocentesis and surgical intervention.

The jury returned a verdict for the plaintiff, awarding damages in the amount of $1,047,732.20. On appeal, the defendants argued that North Carolina’s locality rule extended to all aspects of a negligence action, and that the trial court erred in admitting expert opinions without regard to whether those opinions reflected the “same or similar community” standard of care.

But the court of appeals disagreed, emphasizing that compliance with the “same or similar community” standard does not necessarily exonerate a defendant from an allegation of medical negligence. The court said liability can be established if the defendant did not exercise his “best judgment” in the treatment of the patient or if the defendant failed to use “reasonable care and diligence” in his efforts to render medical assistance.

In McClure v. Inova Medical Group, a Virginia jury found that a family practice resident had failed to meet the Virginia community standard of care when he did not order the prostate-specific antigen (PSA) test in a 53-year-old patient who was subsequently diagnosed with prostate cancer. The doctor had discussed the risks and benefits of PSA testing, but the patient declined taking the test. Jurors sided with the plaintiff’s argument that according to the local or statewide standard, Virginia doctors simply ordered the test as a matter of routine for men older than 50 years without necessarily discussing risks and benefits. The court awarded $1 million to the patient.³

Although the majority of jurisdictions have abandoned the locality rule, several continue to adhere to either a strict or modified version.⁴ Examples are Arizona, Idaho, New York, Tennessee, Virginia, and Washington. A modified rule exists in Louisiana, which holds general practitioners to a community standard and specialists to a national standard.

Finally, many authors have recommended a narrowly constructed rule based not on geographic boundaries, but on the availability of local resources. Courts would then look at the totality of circumstances, but remember that there is always the duty to refer or transfer to an available specialist/facility – and that the failure to do so may form the basis of liability.

As one physician put it: Location should not come into play with respect to the knowledge or skill of the treating physician; and even if a physician may not have the facilities to perform an emergency cesarean section, he or she should still know when it’s called for.

References

1. Small v. Howard, 128 Mass 131 (1880).

2. Swink v. Weintraub, 672 S.E.2d 53 (N.C. Court of Appeals 2009).

3. JAMA. 2004 Jan 7;291(1):15-6.

4. JAMA. 2007 Jun 20;297(23):2633-7.

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

Question: An injured patient alleges that her eye doctor was negligent in failing to adhere to national treatment guidelines and in not using modern medical equipment. The encounter took place in a rural setting, with the nearest hospital 100 miles away.

In her malpractice lawsuit, which of the following choices is incorrect?

A. One of the doctor’s defenses may be the locality rule.

B. The plaintiff’s strongest argument is that community standards should parallel national standards for a specialist doctor such as an ophthalmologist.

C. Her expert witness must be a practicing ophthalmologist from the area.

D. The expert must be familiar with the local standards but does not have to practice there.

E. It all depends on what the state statute says, because the locality rule is not uniform settled law.

Answer: C. In traditional medical tort law, courts would rely on the standard of the particular locale where the tortious act took place, the so-called locality rule. This was based on the belief that different standards of care were applicable in different areas of the country, e.g., urban vs. rural. The rule can be traced to Small v. Howard,¹ an 1880 Massachusetts opinion, which was subsequently overruled in 1968.

Factors favoring the trend away from a local standard toward a national standard include conformity in medical school and residency curricula, and prescribed board certification requirements. Internet access and telemedicine have further propagated this uniformity. Finally, two additional facets of modern medicine – continuing medical education and published clinical practice guidelines – are at odds with a rule geared toward local standards.

One argument against the locality rule is that undue reliance on an outdated mode of practice will perpetuate substandard care. In an older New York malpractice case where a newborn became blind, the pediatrician cited local custom to defend the prolonged use of oxygen to treat preterm infants, despite evidence that this practice might have serious consequences. However, the court of appeals held that the pediatrician’s superior knowledge of the increased risk of hyperoxygenation should have enabled him to use his best judgment instead of relying on the indefensible local custom.

Under a strict version of the locality rule, otherwise qualified expert witnesses may be excluded if they are not practitioners in the locale in question. Still, some courts may allow out-of-state experts to offer their opinions. This has been especially helpful to plaintiffs who are far less likely to be able to secure willing local experts, given the reluctance of many physicians to testify against a fellow doctor in their community.

Take Tennessee as an example. It once excluded the expert testimony of an orthopedic surgeon from Johnson City because the expert witness testified about the national standard and did not have actual knowledge of the standard of care in Nashville, the community where the alleged malpractice occurred.

The Tennessee Court of Appeals later ruled that expert witnesses had to have “personal” or “firsthand knowledge” of the community standard of care, and that interviewing other physicians in the area did not suffice. It subsequently clarified that an expert witness need not actually practice in the same or similar locale, and that professional contact with physicians from comparable communities, such as through referrals, would be acceptable.

Two well-known cases touching on the locality rule bear summarizing: In Swink v. Weintraub,² Mrs. Swink bled into her pericardium during repair of a defective pacemaker electric lead. She died as a result, and her family pursued a wrongful death action, alleging negligence including delayed pericardiocentesis and surgical intervention.

The jury returned a verdict for the plaintiff, awarding damages in the amount of $1,047,732.20. On appeal, the defendants argued that North Carolina’s locality rule extended to all aspects of a negligence action, and that the trial court erred in admitting expert opinions without regard to whether those opinions reflected the “same or similar community” standard of care.

But the court of appeals disagreed, emphasizing that compliance with the “same or similar community” standard does not necessarily exonerate a defendant from an allegation of medical negligence. The court said liability can be established if the defendant did not exercise his “best judgment” in the treatment of the patient or if the defendant failed to use “reasonable care and diligence” in his efforts to render medical assistance.

In McClure v. Inova Medical Group, a Virginia jury found that a family practice resident had failed to meet the Virginia community standard of care when he did not order the prostate-specific antigen (PSA) test in a 53-year-old patient who was subsequently diagnosed with prostate cancer. The doctor had discussed the risks and benefits of PSA testing, but the patient declined taking the test. Jurors sided with the plaintiff’s argument that according to the local or statewide standard, Virginia doctors simply ordered the test as a matter of routine for men older than 50 years without necessarily discussing risks and benefits. The court awarded $1 million to the patient.³

Although the majority of jurisdictions have abandoned the locality rule, several continue to adhere to either a strict or modified version.⁴ Examples are Arizona, Idaho, New York, Tennessee, Virginia, and Washington. A modified rule exists in Louisiana, which holds general practitioners to a community standard and specialists to a national standard.

Finally, many authors have recommended a narrowly constructed rule based not on geographic boundaries, but on the availability of local resources. Courts would then look at the totality of circumstances, but remember that there is always the duty to refer or transfer to an available specialist/facility – and that the failure to do so may form the basis of liability.

As one physician put it: Location should not come into play with respect to the knowledge or skill of the treating physician; and even if a physician may not have the facilities to perform an emergency cesarean section, he or she should still know when it’s called for.

References

1. Small v. Howard, 128 Mass 131 (1880).

2. Swink v. Weintraub, 672 S.E.2d 53 (N.C. Court of Appeals 2009).

3. JAMA. 2004 Jan 7;291(1):15-6.

4. JAMA. 2007 Jun 20;297(23):2633-7.

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

Question: An injured patient alleges that her eye doctor was negligent in failing to adhere to national treatment guidelines and in not using modern medical equipment. The encounter took place in a rural setting, with the nearest hospital 100 miles away.

In her malpractice lawsuit, which of the following choices is incorrect?

A. One of the doctor’s defenses may be the locality rule.

B. The plaintiff’s strongest argument is that community standards should parallel national standards for a specialist doctor such as an ophthalmologist.

C. Her expert witness must be a practicing ophthalmologist from the area.

D. The expert must be familiar with the local standards but does not have to practice there.

E. It all depends on what the state statute says, because the locality rule is not uniform settled law.

Answer: C. In traditional medical tort law, courts would rely on the standard of the particular locale where the tortious act took place, the so-called locality rule. This was based on the belief that different standards of care were applicable in different areas of the country, e.g., urban vs. rural. The rule can be traced to Small v. Howard,¹ an 1880 Massachusetts opinion, which was subsequently overruled in 1968.

Factors favoring the trend away from a local standard toward a national standard include conformity in medical school and residency curricula, and prescribed board certification requirements. Internet access and telemedicine have further propagated this uniformity. Finally, two additional facets of modern medicine – continuing medical education and published clinical practice guidelines – are at odds with a rule geared toward local standards.

One argument against the locality rule is that undue reliance on an outdated mode of practice will perpetuate substandard care. In an older New York malpractice case where a newborn became blind, the pediatrician cited local custom to defend the prolonged use of oxygen to treat preterm infants, despite evidence that this practice might have serious consequences. However, the court of appeals held that the pediatrician’s superior knowledge of the increased risk of hyperoxygenation should have enabled him to use his best judgment instead of relying on the indefensible local custom.

Under a strict version of the locality rule, otherwise qualified expert witnesses may be excluded if they are not practitioners in the locale in question. Still, some courts may allow out-of-state experts to offer their opinions. This has been especially helpful to plaintiffs who are far less likely to be able to secure willing local experts, given the reluctance of many physicians to testify against a fellow doctor in their community.

Take Tennessee as an example. It once excluded the expert testimony of an orthopedic surgeon from Johnson City because the expert witness testified about the national standard and did not have actual knowledge of the standard of care in Nashville, the community where the alleged malpractice occurred.

The Tennessee Court of Appeals later ruled that expert witnesses had to have “personal” or “firsthand knowledge” of the community standard of care, and that interviewing other physicians in the area did not suffice. It subsequently clarified that an expert witness need not actually practice in the same or similar locale, and that professional contact with physicians from comparable communities, such as through referrals, would be acceptable.

Two well-known cases touching on the locality rule bear summarizing: In Swink v. Weintraub,² Mrs. Swink bled into her pericardium during repair of a defective pacemaker electric lead. She died as a result, and her family pursued a wrongful death action, alleging negligence including delayed pericardiocentesis and surgical intervention.

The jury returned a verdict for the plaintiff, awarding damages in the amount of $1,047,732.20. On appeal, the defendants argued that North Carolina’s locality rule extended to all aspects of a negligence action, and that the trial court erred in admitting expert opinions without regard to whether those opinions reflected the “same or similar community” standard of care.

But the court of appeals disagreed, emphasizing that compliance with the “same or similar community” standard does not necessarily exonerate a defendant from an allegation of medical negligence. The court said liability can be established if the defendant did not exercise his “best judgment” in the treatment of the patient or if the defendant failed to use “reasonable care and diligence” in his efforts to render medical assistance.

In McClure v. Inova Medical Group, a Virginia jury found that a family practice resident had failed to meet the Virginia community standard of care when he did not order the prostate-specific antigen (PSA) test in a 53-year-old patient who was subsequently diagnosed with prostate cancer. The doctor had discussed the risks and benefits of PSA testing, but the patient declined taking the test. Jurors sided with the plaintiff’s argument that according to the local or statewide standard, Virginia doctors simply ordered the test as a matter of routine for men older than 50 years without necessarily discussing risks and benefits. The court awarded $1 million to the patient.³

Although the majority of jurisdictions have abandoned the locality rule, several continue to adhere to either a strict or modified version.⁴ Examples are Arizona, Idaho, New York, Tennessee, Virginia, and Washington. A modified rule exists in Louisiana, which holds general practitioners to a community standard and specialists to a national standard.

Finally, many authors have recommended a narrowly constructed rule based not on geographic boundaries, but on the availability of local resources. Courts would then look at the totality of circumstances, but remember that there is always the duty to refer or transfer to an available specialist/facility – and that the failure to do so may form the basis of liability.

As one physician put it: Location should not come into play with respect to the knowledge or skill of the treating physician; and even if a physician may not have the facilities to perform an emergency cesarean section, he or she should still know when it’s called for.

References

1. Small v. Howard, 128 Mass 131 (1880).

2. Swink v. Weintraub, 672 S.E.2d 53 (N.C. Court of Appeals 2009).

3. JAMA. 2004 Jan 7;291(1):15-6.

4. JAMA. 2007 Jun 20;297(23):2633-7.

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

The use of lung ultrasound, both alone and in combination with clinical and microbiologic data, can improve the early diagnosis of ventilator-associated pneumonia (VAP), according to the results of a study published in Chest.

The early diagnosis of VAP is challenging, and leaves intensivists with two options. The first is waiting for positive results from patients’ specimens, which delays treatment and increases mortality risk. The other is to administer antibiotics to all patients suspected of having VAP, which may be inappropriate and can lead to the development of multiresistant bacteria. “A pressing need therefore exists for reliable diagnostic tools to diagnose VAP early so that antibiotics can be promptly initiated, avoiding two extreme approaches,” wrote Dr. Silvia Mongodi of the Fondazione IRCCS Policlinico San Matteo in Pavia, Italy, and her colleagues.

Based on the results of previous research, the investigators hypothesized that lung ultrasound (LUS) could be used to diagnose VAP early and help to avoid treatment delays or mistakes. To test this hypothesis, the diagnostic performance of LUS alone and in combination with clinical and microbiologic data was evaluated prospectively in 99 patients with suspected VAP in ICUs at Saint Joseph Hospital (Paris), Fondazione IRCCS Policlinico San Matteo, and Centre Hospitalier de l’Université de Montréal (Chest. 2016 Apr;149[4]:969-80. doi: 10.1016/j.chest.2015.12.012).

The study results showed that subpleural consolidations and dynamic linear/arborescent air bronchograms were the principal LUS signs of VAP, and that the presence of both in the same individual made the diagnosis highly specific (88%), with a high positive predictive value (86%) and a positive likelihood ratio of 2.9. Furthermore, the addition of data from either of two different endotracheal aspirate assessment techniques (EAgram [direct Gram stain examination] or EAquant [direct Gram stain culture]) to the data from the principal LUS signs showed 97% specificity with each technique and positive likelihood ratios of 6.6 and 7.1, respectively, Dr. Mongodi and her associates reported.

Dr. Mongodi and her colleagues said that their results were encouraging but would need to be validated in larger clinical trials.

No funding was received for this study. The authors reported no conflicts of interest.

The use of lung ultrasound, both alone and in combination with clinical and microbiologic data, can improve the early diagnosis of ventilator-associated pneumonia (VAP), according to the results of a study published in Chest.

The early diagnosis of VAP is challenging, and leaves intensivists with two options. The first is waiting for positive results from patients’ specimens, which delays treatment and increases mortality risk. The other is to administer antibiotics to all patients suspected of having VAP, which may be inappropriate and can lead to the development of multiresistant bacteria. “A pressing need therefore exists for reliable diagnostic tools to diagnose VAP early so that antibiotics can be promptly initiated, avoiding two extreme approaches,” wrote Dr. Silvia Mongodi of the Fondazione IRCCS Policlinico San Matteo in Pavia, Italy, and her colleagues.

Based on the results of previous research, the investigators hypothesized that lung ultrasound (LUS) could be used to diagnose VAP early and help to avoid treatment delays or mistakes. To test this hypothesis, the diagnostic performance of LUS alone and in combination with clinical and microbiologic data was evaluated prospectively in 99 patients with suspected VAP in ICUs at Saint Joseph Hospital (Paris), Fondazione IRCCS Policlinico San Matteo, and Centre Hospitalier de l’Université de Montréal (Chest. 2016 Apr;149[4]:969-80. doi: 10.1016/j.chest.2015.12.012).

The study results showed that subpleural consolidations and dynamic linear/arborescent air bronchograms were the principal LUS signs of VAP, and that the presence of both in the same individual made the diagnosis highly specific (88%), with a high positive predictive value (86%) and a positive likelihood ratio of 2.9. Furthermore, the addition of data from either of two different endotracheal aspirate assessment techniques (EAgram [direct Gram stain examination] or EAquant [direct Gram stain culture]) to the data from the principal LUS signs showed 97% specificity with each technique and positive likelihood ratios of 6.6 and 7.1, respectively, Dr. Mongodi and her associates reported.

Dr. Mongodi and her colleagues said that their results were encouraging but would need to be validated in larger clinical trials.

No funding was received for this study. The authors reported no conflicts of interest.

The use of lung ultrasound, both alone and in combination with clinical and microbiologic data, can improve the early diagnosis of ventilator-associated pneumonia (VAP), according to the results of a study published in Chest.

The early diagnosis of VAP is challenging, and leaves intensivists with two options. The first is waiting for positive results from patients’ specimens, which delays treatment and increases mortality risk. The other is to administer antibiotics to all patients suspected of having VAP, which may be inappropriate and can lead to the development of multiresistant bacteria. “A pressing need therefore exists for reliable diagnostic tools to diagnose VAP early so that antibiotics can be promptly initiated, avoiding two extreme approaches,” wrote Dr. Silvia Mongodi of the Fondazione IRCCS Policlinico San Matteo in Pavia, Italy, and her colleagues.

Based on the results of previous research, the investigators hypothesized that lung ultrasound (LUS) could be used to diagnose VAP early and help to avoid treatment delays or mistakes. To test this hypothesis, the diagnostic performance of LUS alone and in combination with clinical and microbiologic data was evaluated prospectively in 99 patients with suspected VAP in ICUs at Saint Joseph Hospital (Paris), Fondazione IRCCS Policlinico San Matteo, and Centre Hospitalier de l’Université de Montréal (Chest. 2016 Apr;149[4]:969-80. doi: 10.1016/j.chest.2015.12.012).

The study results showed that subpleural consolidations and dynamic linear/arborescent air bronchograms were the principal LUS signs of VAP, and that the presence of both in the same individual made the diagnosis highly specific (88%), with a high positive predictive value (86%) and a positive likelihood ratio of 2.9. Furthermore, the addition of data from either of two different endotracheal aspirate assessment techniques (EAgram [direct Gram stain examination] or EAquant [direct Gram stain culture]) to the data from the principal LUS signs showed 97% specificity with each technique and positive likelihood ratios of 6.6 and 7.1, respectively, Dr. Mongodi and her associates reported.

Dr. Mongodi and her colleagues said that their results were encouraging but would need to be validated in larger clinical trials.

No funding was received for this study. The authors reported no conflicts of interest.

WASHINGTON – It will be up to the lower courts to decide how to work out religious exemptions under the Affordable Care Act’s contraception mandate, following the Supreme Court’s decision to remand Zubik v. Burwell back to the U.S. Court of Appeals for the 3rd, 5th, 10th, and District of Columbia Circuits.

In an unusual move, on May 16 the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and has remanded the case back to the four appeals courts that had originally ruled on the issue.

At issue in the case is the implementation of the Affordable Care Act’s contraception mandate and specifically how nonprofit religious employers can opt out of directly paying for their employees’ contraception. The federal government had created a workaround that required employers to submit a form stating that they have religious objections, but the plaintiffs asserted that the process itself was a violation of their religious freedom.

In March, the high court asked all parties in the case to submit additional briefs outlining how contraception could be provided without requiring notice on the part of the employers. After reviewing the briefs, the Supreme Court justices concluded that “such an option is feasible.”

“Given the gravity of the dispute and the substantial clarification and refinement in the positions of the parties, the parties on remand should be afforded an opportunity to arrive at an approach going forward that accommodates petitioners’ religious exercise while at the same time ensuring that women covered by petitioners’ health plans ‘receive full and equal health coverage, including contraceptive coverage,’ ” the justices wrote in the decision. “We anticipate that the Courts of Appeals will allow the parties sufficient time to resolve any outstanding issues between them.”

The Supreme Court made no decision about the merits of Zubik v. Burwell.

Dr. Sara Imershein, a clinical professor at George Washington University and an ob.gyn. at Planned Parenthood in Washington, said the decision was a disappointment because it requires the courts to sort out a workaround to the contraception mandate when the government has already put one in place. Dr. Imershein, who is a reproductive rights advocate, commented on the news in a video interview while attending the annual meeting of the American College of Obstetricians and Gynecologists.

Dr. Mark S. DeFrancesco, ACOG president, expressed the college’s disappointment in the Supreme Court’s decision.

“ACOG strongly believes that contraception is an essential part of women’s preventive care, and that any accommodation to employers’ beliefs must not impose barriers to women’s ability to access contraception,” Dr. DeFrancesco said in a statement. “We encourage the lower courts to adopt a solution that ensures that coverage is provided seamlessly ‘through petitioner’s insurance companies.’”

[email protected]

On Twitter @maryellenny

WASHINGTON – It will be up to the lower courts to decide how to work out religious exemptions under the Affordable Care Act’s contraception mandate, following the Supreme Court’s decision to remand Zubik v. Burwell back to the U.S. Court of Appeals for the 3rd, 5th, 10th, and District of Columbia Circuits.

In an unusual move, on May 16 the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and has remanded the case back to the four appeals courts that had originally ruled on the issue.

At issue in the case is the implementation of the Affordable Care Act’s contraception mandate and specifically how nonprofit religious employers can opt out of directly paying for their employees’ contraception. The federal government had created a workaround that required employers to submit a form stating that they have religious objections, but the plaintiffs asserted that the process itself was a violation of their religious freedom.

In March, the high court asked all parties in the case to submit additional briefs outlining how contraception could be provided without requiring notice on the part of the employers. After reviewing the briefs, the Supreme Court justices concluded that “such an option is feasible.”

“Given the gravity of the dispute and the substantial clarification and refinement in the positions of the parties, the parties on remand should be afforded an opportunity to arrive at an approach going forward that accommodates petitioners’ religious exercise while at the same time ensuring that women covered by petitioners’ health plans ‘receive full and equal health coverage, including contraceptive coverage,’ ” the justices wrote in the decision. “We anticipate that the Courts of Appeals will allow the parties sufficient time to resolve any outstanding issues between them.”

The Supreme Court made no decision about the merits of Zubik v. Burwell.

Dr. Sara Imershein, a clinical professor at George Washington University and an ob.gyn. at Planned Parenthood in Washington, said the decision was a disappointment because it requires the courts to sort out a workaround to the contraception mandate when the government has already put one in place. Dr. Imershein, who is a reproductive rights advocate, commented on the news in a video interview while attending the annual meeting of the American College of Obstetricians and Gynecologists.

Dr. Mark S. DeFrancesco, ACOG president, expressed the college’s disappointment in the Supreme Court’s decision.

“ACOG strongly believes that contraception is an essential part of women’s preventive care, and that any accommodation to employers’ beliefs must not impose barriers to women’s ability to access contraception,” Dr. DeFrancesco said in a statement. “We encourage the lower courts to adopt a solution that ensures that coverage is provided seamlessly ‘through petitioner’s insurance companies.’”

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On Twitter @maryellenny

WASHINGTON – It will be up to the lower courts to decide how to work out religious exemptions under the Affordable Care Act’s contraception mandate, following the Supreme Court’s decision to remand Zubik v. Burwell back to the U.S. Court of Appeals for the 3rd, 5th, 10th, and District of Columbia Circuits.

In an unusual move, on May 16 the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and has remanded the case back to the four appeals courts that had originally ruled on the issue.

At issue in the case is the implementation of the Affordable Care Act’s contraception mandate and specifically how nonprofit religious employers can opt out of directly paying for their employees’ contraception. The federal government had created a workaround that required employers to submit a form stating that they have religious objections, but the plaintiffs asserted that the process itself was a violation of their religious freedom.

In March, the high court asked all parties in the case to submit additional briefs outlining how contraception could be provided without requiring notice on the part of the employers. After reviewing the briefs, the Supreme Court justices concluded that “such an option is feasible.”

“Given the gravity of the dispute and the substantial clarification and refinement in the positions of the parties, the parties on remand should be afforded an opportunity to arrive at an approach going forward that accommodates petitioners’ religious exercise while at the same time ensuring that women covered by petitioners’ health plans ‘receive full and equal health coverage, including contraceptive coverage,’ ” the justices wrote in the decision. “We anticipate that the Courts of Appeals will allow the parties sufficient time to resolve any outstanding issues between them.”

The Supreme Court made no decision about the merits of Zubik v. Burwell.

Dr. Sara Imershein, a clinical professor at George Washington University and an ob.gyn. at Planned Parenthood in Washington, said the decision was a disappointment because it requires the courts to sort out a workaround to the contraception mandate when the government has already put one in place. Dr. Imershein, who is a reproductive rights advocate, commented on the news in a video interview while attending the annual meeting of the American College of Obstetricians and Gynecologists.

Dr. Mark S. DeFrancesco, ACOG president, expressed the college’s disappointment in the Supreme Court’s decision.

“ACOG strongly believes that contraception is an essential part of women’s preventive care, and that any accommodation to employers’ beliefs must not impose barriers to women’s ability to access contraception,” Dr. DeFrancesco said in a statement. “We encourage the lower courts to adopt a solution that ensures that coverage is provided seamlessly ‘through petitioner’s insurance companies.’”

[email protected]

On Twitter @maryellenny