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[polldaddy:10359495]

[polldaddy:10359495]

The use of nivolumab is associated with a long-term survival benefit, compared with docetaxel in patients with previously treated advanced non–small cell lung cancer (NSCLC), according to a pooled analysis of four trials.

The survival outcomes comparing the two therapies demonstrates an extended survival advantage for nivolumab up to and past a duration of 4 years.

“We aimed to evaluate the long-term benefit of nivolumab and the effect of response and disease control on subsequent survival,” wrote Scott J. Antonia, MD, PhD, formally of the H. Lee Moffitt Cancer Center in Tampa and now at Duke Cancer Center, Durham, N.C., and colleagues. The findings were published in the Lancet Oncology.

The researchers combined data from four clinical studies (CheckMate 003, 017, 057, and 063) that assessed survival outcomes in patients receiving second-line or later nivolumab therapy. Across the four trials, a total of 664 patients were administered nivolumab.

The CheckMate 057 and 017 phase 3, randomized clinical trials compared docetaxel versus nivolumab in patients with previously treated nonsquamous and squamous NSCLC, respectively.

With respect to safety analyses, Dr. Antonia and colleagues included patients who were administered a minimum of one dose of nivolumab.

Across the four trials, the 4-year overall survival with nivolumab was 14% (11%-17%), including 11% (7%-16%) for patients with under 1% programmed death–ligand 1 expression, and 19% (15%-24%) for patients with a minimum of 1% programmed death–ligand 1 expression.

In CheckMate 057 and 017, the 4-year overall survival with nivolumab was 14% (11%-18%) versus 5% (3%-7%) in patients who received docetaxel.

With respect to safety, analysis of the long-term data did not reveal any novel safety signals.

The researchers acknowledged that a key limitation of the study was the exclusion of patients who were maintained in stable disease or in response at the point of data lock.

As a result, the findings likely minimize the survival advantage seen post–disease progression for nivolumab, compared with docetaxel.

“Additional analyses assessing the effect of various factors on long-term survival with immunotherapy versus chemotherapy are planned,” they wrote.

The study was funded by Bristol-Myers Squibb. The authors reported financial affiliations with AstraZeneca, Boehringer Ingelheim, Cellular Biomedicine Group, FLX Bio, Genentech, Novartis, Regeneron, and several others.

SOURCE: Antonia SJ et al. Lancet Oncol. 2019 Aug 14. doi: 10.1016/S1470-2045(19)30407-3.

The use of nivolumab is associated with a long-term survival benefit, compared with docetaxel in patients with previously treated advanced non–small cell lung cancer (NSCLC), according to a pooled analysis of four trials.

The survival outcomes comparing the two therapies demonstrates an extended survival advantage for nivolumab up to and past a duration of 4 years.

“We aimed to evaluate the long-term benefit of nivolumab and the effect of response and disease control on subsequent survival,” wrote Scott J. Antonia, MD, PhD, formally of the H. Lee Moffitt Cancer Center in Tampa and now at Duke Cancer Center, Durham, N.C., and colleagues. The findings were published in the Lancet Oncology.

The researchers combined data from four clinical studies (CheckMate 003, 017, 057, and 063) that assessed survival outcomes in patients receiving second-line or later nivolumab therapy. Across the four trials, a total of 664 patients were administered nivolumab.

The CheckMate 057 and 017 phase 3, randomized clinical trials compared docetaxel versus nivolumab in patients with previously treated nonsquamous and squamous NSCLC, respectively.

With respect to safety analyses, Dr. Antonia and colleagues included patients who were administered a minimum of one dose of nivolumab.

Across the four trials, the 4-year overall survival with nivolumab was 14% (11%-17%), including 11% (7%-16%) for patients with under 1% programmed death–ligand 1 expression, and 19% (15%-24%) for patients with a minimum of 1% programmed death–ligand 1 expression.

In CheckMate 057 and 017, the 4-year overall survival with nivolumab was 14% (11%-18%) versus 5% (3%-7%) in patients who received docetaxel.

With respect to safety, analysis of the long-term data did not reveal any novel safety signals.

The researchers acknowledged that a key limitation of the study was the exclusion of patients who were maintained in stable disease or in response at the point of data lock.

As a result, the findings likely minimize the survival advantage seen post–disease progression for nivolumab, compared with docetaxel.

“Additional analyses assessing the effect of various factors on long-term survival with immunotherapy versus chemotherapy are planned,” they wrote.

The study was funded by Bristol-Myers Squibb. The authors reported financial affiliations with AstraZeneca, Boehringer Ingelheim, Cellular Biomedicine Group, FLX Bio, Genentech, Novartis, Regeneron, and several others.

SOURCE: Antonia SJ et al. Lancet Oncol. 2019 Aug 14. doi: 10.1016/S1470-2045(19)30407-3.

The use of nivolumab is associated with a long-term survival benefit, compared with docetaxel in patients with previously treated advanced non–small cell lung cancer (NSCLC), according to a pooled analysis of four trials.

The survival outcomes comparing the two therapies demonstrates an extended survival advantage for nivolumab up to and past a duration of 4 years.

“We aimed to evaluate the long-term benefit of nivolumab and the effect of response and disease control on subsequent survival,” wrote Scott J. Antonia, MD, PhD, formally of the H. Lee Moffitt Cancer Center in Tampa and now at Duke Cancer Center, Durham, N.C., and colleagues. The findings were published in the Lancet Oncology.

The researchers combined data from four clinical studies (CheckMate 003, 017, 057, and 063) that assessed survival outcomes in patients receiving second-line or later nivolumab therapy. Across the four trials, a total of 664 patients were administered nivolumab.

The CheckMate 057 and 017 phase 3, randomized clinical trials compared docetaxel versus nivolumab in patients with previously treated nonsquamous and squamous NSCLC, respectively.

With respect to safety analyses, Dr. Antonia and colleagues included patients who were administered a minimum of one dose of nivolumab.

Across the four trials, the 4-year overall survival with nivolumab was 14% (11%-17%), including 11% (7%-16%) for patients with under 1% programmed death–ligand 1 expression, and 19% (15%-24%) for patients with a minimum of 1% programmed death–ligand 1 expression.

In CheckMate 057 and 017, the 4-year overall survival with nivolumab was 14% (11%-18%) versus 5% (3%-7%) in patients who received docetaxel.

With respect to safety, analysis of the long-term data did not reveal any novel safety signals.

The researchers acknowledged that a key limitation of the study was the exclusion of patients who were maintained in stable disease or in response at the point of data lock.

As a result, the findings likely minimize the survival advantage seen post–disease progression for nivolumab, compared with docetaxel.

“Additional analyses assessing the effect of various factors on long-term survival with immunotherapy versus chemotherapy are planned,” they wrote.

The study was funded by Bristol-Myers Squibb. The authors reported financial affiliations with AstraZeneca, Boehringer Ingelheim, Cellular Biomedicine Group, FLX Bio, Genentech, Novartis, Regeneron, and several others.

SOURCE: Antonia SJ et al. Lancet Oncol. 2019 Aug 14. doi: 10.1016/S1470-2045(19)30407-3.

Innovations in care delivery, as previously introduced by Dr. Robert Gabbay, can enhance the patient and physician experience. Providing care via telemedicine can bring joy to work by introducing variety to practice. It also carries the satisfaction of easing access to care for the patient.

Vanderbilt University Medical Center

Broadly speaking, telemedicine can be seen as a tool for delivering care when a hands-on exam is not required. In direct-to-patient telemedicine, the patient can use a personal smartphone, tablet, or computer to connect with a provider in a real-time audio and/or video “visit” from home or work. The engagement can be scheduled or on demand. Although telemedicine is generally associated with the delivery of care to patients in remote or rural locations, it is increasingly being used in urban areas, especially with older patients and those for whom transport or time away from work might be difficult.
 

How the patient benefits

This built-in flexibility is appealing to patients – the easier access and convenience can translate into reduced time away from work or school and possibly a reduction in patient “no-shows.” Patients are more likely to enjoy the benefits of continuity of care with their own providers, rather than seeking independent, consumer-marketed services. In a nationwide survey of 4,345 respondents about attitudes toward telemedicine in primary care, 52% of respondents said they would like to see their own providers via telemedicine, 35% were willing to see a different provider from the same organization, and 15% said they would consider leaving their current provider to see one who offered telemedicine (BMC Health Services Research. 2017;17:784).

In addition, numerous studies have reported on the equivalent clinical outcomes and improved cost-of-care benefits in patients who receive diabetes care through telemedicine. Lui and colleagues looked at patients at the Denver VA Medical Center who were newly diagnosed with diabetes and they compared short-term glycemic control in patients who had telemedicine consultations with patients who had in-person visits. They found that the telemedicine consultations improved short-term glycemic control as effectively as the in-person visits, but with possible added financial benefits for both the patients and the health care system. (J Diabetes Sci Technol. 2016;10[5]:1079-86). Likewise, Fatehi and colleagues have reported that method of consultation – telemedicine or in-person consultation – did not affect concordance of advice between two endocrinologists (Diabetes Technol Ther. 2015;17[10]:717-25).
 

What telemedicine has to offer

There is a range of diabetes care services that can be delivered through telemedicine consultation. When appropriate diagnostic labs have already been performed, newly diagnosed patients can be counseled on their diagnosis and started on therapy. For patients who have already been diagnosed, follow-up and monitoring of therapy adherence and glycemic control can be more convenient and done more routinely, compared with in-person visits, and thus yield better outcomes.

Use of cloud-based services to review data from glucometers, insulin pumps, and continuous glucose monitors allows the clinicians to access the same data they would in the office. Combining this data review with a video visit, rather than looking at the data in isolation, allows for increased patient engagement, shared decision making, and patient counseling.

Other diagnoses that readily fit at-home telemedicine care include gestational diabetes, as these patients need frequent follow-up, and doing some of their visits via telemedicine can reduce their burden of travel. Hypothyroidism follow-ups, with labs completed before the visit, can be very efficient via telemedicine. Internal surveys of direct-to-patient services at my institution demonstrated a high level of patient satisfaction, with 91% of patients indicating they were satisfied overall, and 81% saying that connection with the provider matched that of an in-person visit.
 

Gains for the provider, the care team, and the practice

Endocrinologists can derive benefit from telemedicine engagement with their patients, which could have positive implications for other members of the care team and for the practice as a whole. For the provider, being able to streamline clinical workflows and increase practice efficiency can help reduce personal and workplace-related stress and translate into greater personal satisfaction in one’s work and delivery of better-quality care.

At the practice level, the use of telemedicine presents opportunities for expanding the patient base and perhaps working more flexible hours to better accommodate the personal and professional time demands on providers and their staff. In addition, offering telemedicine as a medium of consultation could be a practice differentiator that could give you a competitive edge. That, along with smaller changes, such as enhancing or even reducing space utilization, could contribute to reduced overheads and a boost in revenue, which would have a positive impact on the practice’s bottom line.
 

Getting started

There is important groundwork to be done before a telemedicine program can get underway. First, bear in mind that there is considerable state-based variation in regulations and insurance coverage, so you need to be sure that you are in compliance with the requirements for your state. If direct-to-patient telemedicine is not widely reimbursed in your state, direct-payment models may be feasible. Providers who accept Medicare payments need to understand restrictions on self-payment for those patients. You may also be able to negotiate with payers to include reimbursement for telemedicine visits in your contracts. Negotiation with payers and direct-pay models may be possible.

Key guidelines. In addition to understanding your state’s regulations around telemedicine, there are specific aspects of practice about which you need to be clear, for example:

• You must be licensed in the state in which your patient is located at the time of their visit.
• Understand any restrictions on prescribing via telemedicine in your state.
• Be aware that Medicare has very specific guidelines and, at this time, does not recognize home as a place of service.
• You must be sure that you use HIPAA-compliant video software.
• If in any doubt, seek guidance from an attorney or your organization’s compliance office.

Infrastructure and outlay. Your infrastructure needs will depend on the specific services that you provide, but in general, you should include a communication platform and video conferencing equipment; sufficient bandwidth and a secure, reliable Internet connection; ready access to sound IT support; and comprehensive staff training at the outset, with subsequent refresher training sessions on a regular basis. Within the practice, you will need to think about adjustments to your existing workflow to accommodate the telemedicine services you plan to offer.

Resources. Two nonprofit groups that offer nonpartisan guidance in telemedicine are the Center for Connected Health Policy and the Regional Telehealth Resource Centers.

Dr. Griffith is assistant professor of medicine and medical director, Ambulatory Telehealth Services, Vanderbilt University Medical Center, in Nashville, Tenn. This article is part of a series based on presentations from the annual meeting of the Endocrine Society in March 2019. Dr. Griffith has no disclosures. Write to her at cenews@mdedge.com.

Innovations in care delivery, as previously introduced by Dr. Robert Gabbay, can enhance the patient and physician experience. Providing care via telemedicine can bring joy to work by introducing variety to practice. It also carries the satisfaction of easing access to care for the patient.

Vanderbilt University Medical Center

Broadly speaking, telemedicine can be seen as a tool for delivering care when a hands-on exam is not required. In direct-to-patient telemedicine, the patient can use a personal smartphone, tablet, or computer to connect with a provider in a real-time audio and/or video “visit” from home or work. The engagement can be scheduled or on demand. Although telemedicine is generally associated with the delivery of care to patients in remote or rural locations, it is increasingly being used in urban areas, especially with older patients and those for whom transport or time away from work might be difficult.
 

How the patient benefits

This built-in flexibility is appealing to patients – the easier access and convenience can translate into reduced time away from work or school and possibly a reduction in patient “no-shows.” Patients are more likely to enjoy the benefits of continuity of care with their own providers, rather than seeking independent, consumer-marketed services. In a nationwide survey of 4,345 respondents about attitudes toward telemedicine in primary care, 52% of respondents said they would like to see their own providers via telemedicine, 35% were willing to see a different provider from the same organization, and 15% said they would consider leaving their current provider to see one who offered telemedicine (BMC Health Services Research. 2017;17:784).

In addition, numerous studies have reported on the equivalent clinical outcomes and improved cost-of-care benefits in patients who receive diabetes care through telemedicine. Lui and colleagues looked at patients at the Denver VA Medical Center who were newly diagnosed with diabetes and they compared short-term glycemic control in patients who had telemedicine consultations with patients who had in-person visits. They found that the telemedicine consultations improved short-term glycemic control as effectively as the in-person visits, but with possible added financial benefits for both the patients and the health care system. (J Diabetes Sci Technol. 2016;10[5]:1079-86). Likewise, Fatehi and colleagues have reported that method of consultation – telemedicine or in-person consultation – did not affect concordance of advice between two endocrinologists (Diabetes Technol Ther. 2015;17[10]:717-25).
 

What telemedicine has to offer

There is a range of diabetes care services that can be delivered through telemedicine consultation. When appropriate diagnostic labs have already been performed, newly diagnosed patients can be counseled on their diagnosis and started on therapy. For patients who have already been diagnosed, follow-up and monitoring of therapy adherence and glycemic control can be more convenient and done more routinely, compared with in-person visits, and thus yield better outcomes.

Use of cloud-based services to review data from glucometers, insulin pumps, and continuous glucose monitors allows the clinicians to access the same data they would in the office. Combining this data review with a video visit, rather than looking at the data in isolation, allows for increased patient engagement, shared decision making, and patient counseling.

Other diagnoses that readily fit at-home telemedicine care include gestational diabetes, as these patients need frequent follow-up, and doing some of their visits via telemedicine can reduce their burden of travel. Hypothyroidism follow-ups, with labs completed before the visit, can be very efficient via telemedicine. Internal surveys of direct-to-patient services at my institution demonstrated a high level of patient satisfaction, with 91% of patients indicating they were satisfied overall, and 81% saying that connection with the provider matched that of an in-person visit.
 

Gains for the provider, the care team, and the practice

Endocrinologists can derive benefit from telemedicine engagement with their patients, which could have positive implications for other members of the care team and for the practice as a whole. For the provider, being able to streamline clinical workflows and increase practice efficiency can help reduce personal and workplace-related stress and translate into greater personal satisfaction in one’s work and delivery of better-quality care.

At the practice level, the use of telemedicine presents opportunities for expanding the patient base and perhaps working more flexible hours to better accommodate the personal and professional time demands on providers and their staff. In addition, offering telemedicine as a medium of consultation could be a practice differentiator that could give you a competitive edge. That, along with smaller changes, such as enhancing or even reducing space utilization, could contribute to reduced overheads and a boost in revenue, which would have a positive impact on the practice’s bottom line.
 

Getting started

There is important groundwork to be done before a telemedicine program can get underway. First, bear in mind that there is considerable state-based variation in regulations and insurance coverage, so you need to be sure that you are in compliance with the requirements for your state. If direct-to-patient telemedicine is not widely reimbursed in your state, direct-payment models may be feasible. Providers who accept Medicare payments need to understand restrictions on self-payment for those patients. You may also be able to negotiate with payers to include reimbursement for telemedicine visits in your contracts. Negotiation with payers and direct-pay models may be possible.

Key guidelines. In addition to understanding your state’s regulations around telemedicine, there are specific aspects of practice about which you need to be clear, for example:

• You must be licensed in the state in which your patient is located at the time of their visit.
• Understand any restrictions on prescribing via telemedicine in your state.
• Be aware that Medicare has very specific guidelines and, at this time, does not recognize home as a place of service.
• You must be sure that you use HIPAA-compliant video software.
• If in any doubt, seek guidance from an attorney or your organization’s compliance office.

Infrastructure and outlay. Your infrastructure needs will depend on the specific services that you provide, but in general, you should include a communication platform and video conferencing equipment; sufficient bandwidth and a secure, reliable Internet connection; ready access to sound IT support; and comprehensive staff training at the outset, with subsequent refresher training sessions on a regular basis. Within the practice, you will need to think about adjustments to your existing workflow to accommodate the telemedicine services you plan to offer.

Resources. Two nonprofit groups that offer nonpartisan guidance in telemedicine are the Center for Connected Health Policy and the Regional Telehealth Resource Centers.

Dr. Griffith is assistant professor of medicine and medical director, Ambulatory Telehealth Services, Vanderbilt University Medical Center, in Nashville, Tenn. This article is part of a series based on presentations from the annual meeting of the Endocrine Society in March 2019. Dr. Griffith has no disclosures. Write to her at cenews@mdedge.com.

Innovations in care delivery, as previously introduced by Dr. Robert Gabbay, can enhance the patient and physician experience. Providing care via telemedicine can bring joy to work by introducing variety to practice. It also carries the satisfaction of easing access to care for the patient.

Vanderbilt University Medical Center

Broadly speaking, telemedicine can be seen as a tool for delivering care when a hands-on exam is not required. In direct-to-patient telemedicine, the patient can use a personal smartphone, tablet, or computer to connect with a provider in a real-time audio and/or video “visit” from home or work. The engagement can be scheduled or on demand. Although telemedicine is generally associated with the delivery of care to patients in remote or rural locations, it is increasingly being used in urban areas, especially with older patients and those for whom transport or time away from work might be difficult.
 

How the patient benefits

This built-in flexibility is appealing to patients – the easier access and convenience can translate into reduced time away from work or school and possibly a reduction in patient “no-shows.” Patients are more likely to enjoy the benefits of continuity of care with their own providers, rather than seeking independent, consumer-marketed services. In a nationwide survey of 4,345 respondents about attitudes toward telemedicine in primary care, 52% of respondents said they would like to see their own providers via telemedicine, 35% were willing to see a different provider from the same organization, and 15% said they would consider leaving their current provider to see one who offered telemedicine (BMC Health Services Research. 2017;17:784).

In addition, numerous studies have reported on the equivalent clinical outcomes and improved cost-of-care benefits in patients who receive diabetes care through telemedicine. Lui and colleagues looked at patients at the Denver VA Medical Center who were newly diagnosed with diabetes and they compared short-term glycemic control in patients who had telemedicine consultations with patients who had in-person visits. They found that the telemedicine consultations improved short-term glycemic control as effectively as the in-person visits, but with possible added financial benefits for both the patients and the health care system. (J Diabetes Sci Technol. 2016;10[5]:1079-86). Likewise, Fatehi and colleagues have reported that method of consultation – telemedicine or in-person consultation – did not affect concordance of advice between two endocrinologists (Diabetes Technol Ther. 2015;17[10]:717-25).
 

What telemedicine has to offer

There is a range of diabetes care services that can be delivered through telemedicine consultation. When appropriate diagnostic labs have already been performed, newly diagnosed patients can be counseled on their diagnosis and started on therapy. For patients who have already been diagnosed, follow-up and monitoring of therapy adherence and glycemic control can be more convenient and done more routinely, compared with in-person visits, and thus yield better outcomes.

Use of cloud-based services to review data from glucometers, insulin pumps, and continuous glucose monitors allows the clinicians to access the same data they would in the office. Combining this data review with a video visit, rather than looking at the data in isolation, allows for increased patient engagement, shared decision making, and patient counseling.

Other diagnoses that readily fit at-home telemedicine care include gestational diabetes, as these patients need frequent follow-up, and doing some of their visits via telemedicine can reduce their burden of travel. Hypothyroidism follow-ups, with labs completed before the visit, can be very efficient via telemedicine. Internal surveys of direct-to-patient services at my institution demonstrated a high level of patient satisfaction, with 91% of patients indicating they were satisfied overall, and 81% saying that connection with the provider matched that of an in-person visit.
 

Gains for the provider, the care team, and the practice

Endocrinologists can derive benefit from telemedicine engagement with their patients, which could have positive implications for other members of the care team and for the practice as a whole. For the provider, being able to streamline clinical workflows and increase practice efficiency can help reduce personal and workplace-related stress and translate into greater personal satisfaction in one’s work and delivery of better-quality care.

At the practice level, the use of telemedicine presents opportunities for expanding the patient base and perhaps working more flexible hours to better accommodate the personal and professional time demands on providers and their staff. In addition, offering telemedicine as a medium of consultation could be a practice differentiator that could give you a competitive edge. That, along with smaller changes, such as enhancing or even reducing space utilization, could contribute to reduced overheads and a boost in revenue, which would have a positive impact on the practice’s bottom line.
 

Getting started

There is important groundwork to be done before a telemedicine program can get underway. First, bear in mind that there is considerable state-based variation in regulations and insurance coverage, so you need to be sure that you are in compliance with the requirements for your state. If direct-to-patient telemedicine is not widely reimbursed in your state, direct-payment models may be feasible. Providers who accept Medicare payments need to understand restrictions on self-payment for those patients. You may also be able to negotiate with payers to include reimbursement for telemedicine visits in your contracts. Negotiation with payers and direct-pay models may be possible.

Key guidelines. In addition to understanding your state’s regulations around telemedicine, there are specific aspects of practice about which you need to be clear, for example:

• You must be licensed in the state in which your patient is located at the time of their visit.
• Understand any restrictions on prescribing via telemedicine in your state.
• Be aware that Medicare has very specific guidelines and, at this time, does not recognize home as a place of service.
• You must be sure that you use HIPAA-compliant video software.
• If in any doubt, seek guidance from an attorney or your organization’s compliance office.

Infrastructure and outlay. Your infrastructure needs will depend on the specific services that you provide, but in general, you should include a communication platform and video conferencing equipment; sufficient bandwidth and a secure, reliable Internet connection; ready access to sound IT support; and comprehensive staff training at the outset, with subsequent refresher training sessions on a regular basis. Within the practice, you will need to think about adjustments to your existing workflow to accommodate the telemedicine services you plan to offer.

Resources. Two nonprofit groups that offer nonpartisan guidance in telemedicine are the Center for Connected Health Policy and the Regional Telehealth Resource Centers.

Dr. Griffith is assistant professor of medicine and medical director, Ambulatory Telehealth Services, Vanderbilt University Medical Center, in Nashville, Tenn. This article is part of a series based on presentations from the annual meeting of the Endocrine Society in March 2019. Dr. Griffith has no disclosures. Write to her at cenews@mdedge.com.

There is a national epidemic of physician burnout, and endocrinologists are not immune to it, with 47% reporting significant burnout in a recent survey.¹ As the incidence of physician burnout increases, so does the overall cost to the health system, both in quality of care and financially, and findings from a recent study suggested that patients are becoming aware of burnout among providers and are concerned about its impact on the quality of the care that they are receiving.²

Burnout can be described as a form of extreme work-related stress manifesting as physical and/or emotional exhaustion that can generate a range of psychological ripple effects, such as depression, mood and anxiety disorders, a crippling sense of worthlessness, and a loss of sense of self. Anyone can be affected by burnout, but there seems to be a greater prevalence among women (50% vs 30% for men); younger doctors, especially residents; and providers of color.^3,4

The fallout from burnout affects both our personal and professional lives. In our personal lives, it can translate into broken or strained relationships, alcohol and substance abuse, depression and mood or anxiety disorders, financial difficulties, and suicide (14% have reported thoughts of suicide; 1% have committed suicide). Juggling work and family can be overwhelming, and additional strains, such as caring for a parent or a sick family member, having a child, going through a divorce or a family bereavement, dealing with student debt, and pressure to achieve, can be cumulatively devastating for a hardworking provider.⁵

In the practice, we see burnout translate into an increase in the number of medical errors, diminished quality of care, lower patient satisfaction with care, decreased productivity and professional effort, dissatisfaction among staff, and an increase in physician turnover.⁶ Workplace-specific factors that can contribute to burnout include daily use of health information technology, especially the EHR; workplace inequities; pressures to keep abreast with changes in the specialty; and time management challenges and constraints that go along with the continual pressure to deliver better quality care, for less money, in less time.⁷

Our group wanted to devise innovative, practice-based strategies that would help our colleagues address the burnout crisis. We asked ourselves how – through new, innovative models of care – we could rediscover the joy in our work, and what the steppingstones of “meaningful work” would be. It seemed to us that working as a team and revisiting the care we deliver might be good starting points, and that, if we drilled down further, common themes to address burnout and find joy in work revolve around choice, camaraderie, equity, and cocreating solutions.

Evidence suggests that physicians who spend at least 20% of their professional effort focused on work they find most meaningful have a notably lower risk for burnout.⁸ Each 1% reduction below this threshold increases the risk of burnout, and there is a ceiling effect to the benefit at 20% – for example, spending 50% of your time in the most meaningful area is associated with similar rates of burnout as spending 20% on it.

So how do we to get to that meaningful threshold of 20%? You can begin with identifying your passion, making the business case, speaking to your boss, getting your colleagues’ buy-in, and even looking for grants and other funding if needed. We came up with five ways you might bring more joy to your work by adopting innovative models of diabetes care: the first – implementing a direct-to-patient telemedicine program – has been written by Michelle Griffith, MD, and is featured here. In coming articles, we will take a look at tackling the impediments of clinical inertia, coordinating care through use of a transfer summary, shifting to team-based care, how to use  e-consultations to connect with primary care providers, and devising a business case for these and other innovations.

References

1. Kane L. National Physician Burnout, Depression & Suicide Report 2019. Medscape. Published online Jan 16, 2019.

2. American Society of Health-System Pharmacists. Press release. 2019 Jun 17.

3. Oakes K. Female family physicians come up short in burnout gender divide. Family Practice News. Published online November 27, 2017.

4. Dyrbye L. JAMA Network Open. 2019 Jul 26. doi: 10.1001/jamanetworkopen.2019.7457.

5. Yank V et al. JAMA Intern Med. 2019 Jan 28. doi: 10.1001/jamainternmed.2018.6411.

6 . Panagioti M et al. JAMA Intern Med. 2018;178(10):1317-31.

7. Gardner R et al. J Am Med Inform Assoc. doi: 10.1093/jamia/ocy145.

8. Shanafelt T et al. Am J Med Qual. 2017;32(5):563-5.

Dr. Gabbay is chief medical officer at Joslin Diabetes Center and an associate professor of medicine at Harvard Medical School, both in Boston. This is the introduction to a series of articles based on presentations from the annual meeting of the Endocrine Society in March 2019. Dr. Gabbay reports being an adviser to Lark, Onduo, and HealthReveal. Write to him at cenews@mdedge.com.

There is a national epidemic of physician burnout, and endocrinologists are not immune to it, with 47% reporting significant burnout in a recent survey.¹ As the incidence of physician burnout increases, so does the overall cost to the health system, both in quality of care and financially, and findings from a recent study suggested that patients are becoming aware of burnout among providers and are concerned about its impact on the quality of the care that they are receiving.²

Burnout can be described as a form of extreme work-related stress manifesting as physical and/or emotional exhaustion that can generate a range of psychological ripple effects, such as depression, mood and anxiety disorders, a crippling sense of worthlessness, and a loss of sense of self. Anyone can be affected by burnout, but there seems to be a greater prevalence among women (50% vs 30% for men); younger doctors, especially residents; and providers of color.^3,4

The fallout from burnout affects both our personal and professional lives. In our personal lives, it can translate into broken or strained relationships, alcohol and substance abuse, depression and mood or anxiety disorders, financial difficulties, and suicide (14% have reported thoughts of suicide; 1% have committed suicide). Juggling work and family can be overwhelming, and additional strains, such as caring for a parent or a sick family member, having a child, going through a divorce or a family bereavement, dealing with student debt, and pressure to achieve, can be cumulatively devastating for a hardworking provider.⁵

In the practice, we see burnout translate into an increase in the number of medical errors, diminished quality of care, lower patient satisfaction with care, decreased productivity and professional effort, dissatisfaction among staff, and an increase in physician turnover.⁶ Workplace-specific factors that can contribute to burnout include daily use of health information technology, especially the EHR; workplace inequities; pressures to keep abreast with changes in the specialty; and time management challenges and constraints that go along with the continual pressure to deliver better quality care, for less money, in less time.⁷

Our group wanted to devise innovative, practice-based strategies that would help our colleagues address the burnout crisis. We asked ourselves how – through new, innovative models of care – we could rediscover the joy in our work, and what the steppingstones of “meaningful work” would be. It seemed to us that working as a team and revisiting the care we deliver might be good starting points, and that, if we drilled down further, common themes to address burnout and find joy in work revolve around choice, camaraderie, equity, and cocreating solutions.

Evidence suggests that physicians who spend at least 20% of their professional effort focused on work they find most meaningful have a notably lower risk for burnout.⁸ Each 1% reduction below this threshold increases the risk of burnout, and there is a ceiling effect to the benefit at 20% – for example, spending 50% of your time in the most meaningful area is associated with similar rates of burnout as spending 20% on it.

So how do we to get to that meaningful threshold of 20%? You can begin with identifying your passion, making the business case, speaking to your boss, getting your colleagues’ buy-in, and even looking for grants and other funding if needed. We came up with five ways you might bring more joy to your work by adopting innovative models of diabetes care: the first – implementing a direct-to-patient telemedicine program – has been written by Michelle Griffith, MD, and is featured here. In coming articles, we will take a look at tackling the impediments of clinical inertia, coordinating care through use of a transfer summary, shifting to team-based care, how to use  e-consultations to connect with primary care providers, and devising a business case for these and other innovations.

References

1. Kane L. National Physician Burnout, Depression & Suicide Report 2019. Medscape. Published online Jan 16, 2019.

2. American Society of Health-System Pharmacists. Press release. 2019 Jun 17.

3. Oakes K. Female family physicians come up short in burnout gender divide. Family Practice News. Published online November 27, 2017.

4. Dyrbye L. JAMA Network Open. 2019 Jul 26. doi: 10.1001/jamanetworkopen.2019.7457.

5. Yank V et al. JAMA Intern Med. 2019 Jan 28. doi: 10.1001/jamainternmed.2018.6411.

6 . Panagioti M et al. JAMA Intern Med. 2018;178(10):1317-31.

7. Gardner R et al. J Am Med Inform Assoc. doi: 10.1093/jamia/ocy145.

8. Shanafelt T et al. Am J Med Qual. 2017;32(5):563-5.

Dr. Gabbay is chief medical officer at Joslin Diabetes Center and an associate professor of medicine at Harvard Medical School, both in Boston. This is the introduction to a series of articles based on presentations from the annual meeting of the Endocrine Society in March 2019. Dr. Gabbay reports being an adviser to Lark, Onduo, and HealthReveal. Write to him at cenews@mdedge.com.

There is a national epidemic of physician burnout, and endocrinologists are not immune to it, with 47% reporting significant burnout in a recent survey.¹ As the incidence of physician burnout increases, so does the overall cost to the health system, both in quality of care and financially, and findings from a recent study suggested that patients are becoming aware of burnout among providers and are concerned about its impact on the quality of the care that they are receiving.²

Burnout can be described as a form of extreme work-related stress manifesting as physical and/or emotional exhaustion that can generate a range of psychological ripple effects, such as depression, mood and anxiety disorders, a crippling sense of worthlessness, and a loss of sense of self. Anyone can be affected by burnout, but there seems to be a greater prevalence among women (50% vs 30% for men); younger doctors, especially residents; and providers of color.^3,4

The fallout from burnout affects both our personal and professional lives. In our personal lives, it can translate into broken or strained relationships, alcohol and substance abuse, depression and mood or anxiety disorders, financial difficulties, and suicide (14% have reported thoughts of suicide; 1% have committed suicide). Juggling work and family can be overwhelming, and additional strains, such as caring for a parent or a sick family member, having a child, going through a divorce or a family bereavement, dealing with student debt, and pressure to achieve, can be cumulatively devastating for a hardworking provider.⁵

In the practice, we see burnout translate into an increase in the number of medical errors, diminished quality of care, lower patient satisfaction with care, decreased productivity and professional effort, dissatisfaction among staff, and an increase in physician turnover.⁶ Workplace-specific factors that can contribute to burnout include daily use of health information technology, especially the EHR; workplace inequities; pressures to keep abreast with changes in the specialty; and time management challenges and constraints that go along with the continual pressure to deliver better quality care, for less money, in less time.⁷

Our group wanted to devise innovative, practice-based strategies that would help our colleagues address the burnout crisis. We asked ourselves how – through new, innovative models of care – we could rediscover the joy in our work, and what the steppingstones of “meaningful work” would be. It seemed to us that working as a team and revisiting the care we deliver might be good starting points, and that, if we drilled down further, common themes to address burnout and find joy in work revolve around choice, camaraderie, equity, and cocreating solutions.

Evidence suggests that physicians who spend at least 20% of their professional effort focused on work they find most meaningful have a notably lower risk for burnout.⁸ Each 1% reduction below this threshold increases the risk of burnout, and there is a ceiling effect to the benefit at 20% – for example, spending 50% of your time in the most meaningful area is associated with similar rates of burnout as spending 20% on it.

So how do we to get to that meaningful threshold of 20%? You can begin with identifying your passion, making the business case, speaking to your boss, getting your colleagues’ buy-in, and even looking for grants and other funding if needed. We came up with five ways you might bring more joy to your work by adopting innovative models of diabetes care: the first – implementing a direct-to-patient telemedicine program – has been written by Michelle Griffith, MD, and is featured here. In coming articles, we will take a look at tackling the impediments of clinical inertia, coordinating care through use of a transfer summary, shifting to team-based care, how to use  e-consultations to connect with primary care providers, and devising a business case for these and other innovations.

References

1. Kane L. National Physician Burnout, Depression & Suicide Report 2019. Medscape. Published online Jan 16, 2019.

2. American Society of Health-System Pharmacists. Press release. 2019 Jun 17.

3. Oakes K. Female family physicians come up short in burnout gender divide. Family Practice News. Published online November 27, 2017.

4. Dyrbye L. JAMA Network Open. 2019 Jul 26. doi: 10.1001/jamanetworkopen.2019.7457.

5. Yank V et al. JAMA Intern Med. 2019 Jan 28. doi: 10.1001/jamainternmed.2018.6411.

6 . Panagioti M et al. JAMA Intern Med. 2018;178(10):1317-31.

7. Gardner R et al. J Am Med Inform Assoc. doi: 10.1093/jamia/ocy145.

8. Shanafelt T et al. Am J Med Qual. 2017;32(5):563-5.

Dr. Gabbay is chief medical officer at Joslin Diabetes Center and an associate professor of medicine at Harvard Medical School, both in Boston. This is the introduction to a series of articles based on presentations from the annual meeting of the Endocrine Society in March 2019. Dr. Gabbay reports being an adviser to Lark, Onduo, and HealthReveal. Write to him at cenews@mdedge.com.

In a sampling of 300 individuals with a mean age of 41 years and nearly 16 self-reported headache days per month over the past 6 months, respondents agreed that they were willing to trade some degree of efficacy for less severe adverse events—namely weight gain and memory problems—and that they were even willing to pay more for these tradeoffs in some cases. On average, respondents were willing to pay:

• $84 more (95% confidence interval [CI], $64‐$103) per month to avoid a 10% weight gain
• $59 more (95% CI, $42‐$76) per month to avoid memory problems
• $35 more (95% CI, $20‐$51) per month to avoid a 5% weight gain, and
• $32 (95% CI, $18‐$46) per month to avoid thinking problems.

Within the pool, 81% of respondents confirmed that they had taken a prescription medicine to prevent migraine in the past 6 months.

I think the broad message of this study is important: migraine is not just about migraine or headache days per month. This should not come as news to anyone with more than a passing interest in this condition. As an epidemiological study, it is useful to understand how migraine patients, as a group, view the relative value of cost, side effects, etc. For clinicians, the value of this study is to remind us of the complexity we need to consider when prescribing a migraine treatment. Issues of co-morbidity, economic resources, type of work or daily activities, and most bothersome symptom all play into the decision process, and it is critical to have the patient expressly involved in this process. It is not just about migraine days. It never has been.

Implicit in this article is the reality that we now have a wide variety of pharmacologic and device options for treating migraine. In the past, this was not the case. There is no clear winner among the preventives in terms of headache or migraine days per month. Rather, as the article suggests, we now have the option of selecting our preventives based on a cost-benefit analysis. Because of the near parity in terms of efficacy, the choices are often based on accessibility, financial burden, delivery system, and side effect profile. Properly presented, this can be an empowering experience for the patient. Choices may involve the need for trialing one or more treatments before gaining access to a preferred treatment, or the willingness to risk the chance of an untoward side effect against the promise of a more convivial dosing regimen. This collaborative decision-making process helps center the locus of control with the patient and secure a healthy relationship between the provider and patient.

It should also be remembered that the promise of a given side effect profile is based on the observation in trials and does not reflect the probability of a given outcome in a single patient. Neither does the side effect profile generated in a controlled trial necessarily reflect the side effect profile in any given individual. Too often we fail to stress this to patients and a 1% risk becomes an unavoidable consequence or a promise of smooth sailing. Time spent educating patients (and providers) with regard to the interpretation of efficacy and risk data, is time well spent.

Dr. Cowan is a Higgins Professor of Neurology, Chief of the Division of Headache Medicine and the Department of Neurology and Neurosciences, and Director of the Center for Headache and Facial Pain, at Stanford University School of Medicine.

In a sampling of 300 individuals with a mean age of 41 years and nearly 16 self-reported headache days per month over the past 6 months, respondents agreed that they were willing to trade some degree of efficacy for less severe adverse events—namely weight gain and memory problems—and that they were even willing to pay more for these tradeoffs in some cases. On average, respondents were willing to pay:

• $84 more (95% confidence interval [CI], $64‐$103) per month to avoid a 10% weight gain
• $59 more (95% CI, $42‐$76) per month to avoid memory problems
• $35 more (95% CI, $20‐$51) per month to avoid a 5% weight gain, and
• $32 (95% CI, $18‐$46) per month to avoid thinking problems.

Within the pool, 81% of respondents confirmed that they had taken a prescription medicine to prevent migraine in the past 6 months.

I think the broad message of this study is important: migraine is not just about migraine or headache days per month. This should not come as news to anyone with more than a passing interest in this condition. As an epidemiological study, it is useful to understand how migraine patients, as a group, view the relative value of cost, side effects, etc. For clinicians, the value of this study is to remind us of the complexity we need to consider when prescribing a migraine treatment. Issues of co-morbidity, economic resources, type of work or daily activities, and most bothersome symptom all play into the decision process, and it is critical to have the patient expressly involved in this process. It is not just about migraine days. It never has been.

Implicit in this article is the reality that we now have a wide variety of pharmacologic and device options for treating migraine. In the past, this was not the case. There is no clear winner among the preventives in terms of headache or migraine days per month. Rather, as the article suggests, we now have the option of selecting our preventives based on a cost-benefit analysis. Because of the near parity in terms of efficacy, the choices are often based on accessibility, financial burden, delivery system, and side effect profile. Properly presented, this can be an empowering experience for the patient. Choices may involve the need for trialing one or more treatments before gaining access to a preferred treatment, or the willingness to risk the chance of an untoward side effect against the promise of a more convivial dosing regimen. This collaborative decision-making process helps center the locus of control with the patient and secure a healthy relationship between the provider and patient.

It should also be remembered that the promise of a given side effect profile is based on the observation in trials and does not reflect the probability of a given outcome in a single patient. Neither does the side effect profile generated in a controlled trial necessarily reflect the side effect profile in any given individual. Too often we fail to stress this to patients and a 1% risk becomes an unavoidable consequence or a promise of smooth sailing. Time spent educating patients (and providers) with regard to the interpretation of efficacy and risk data, is time well spent.

Dr. Cowan is a Higgins Professor of Neurology, Chief of the Division of Headache Medicine and the Department of Neurology and Neurosciences, and Director of the Center for Headache and Facial Pain, at Stanford University School of Medicine.

In a sampling of 300 individuals with a mean age of 41 years and nearly 16 self-reported headache days per month over the past 6 months, respondents agreed that they were willing to trade some degree of efficacy for less severe adverse events—namely weight gain and memory problems—and that they were even willing to pay more for these tradeoffs in some cases. On average, respondents were willing to pay:

• $84 more (95% confidence interval [CI], $64‐$103) per month to avoid a 10% weight gain
• $59 more (95% CI, $42‐$76) per month to avoid memory problems
• $35 more (95% CI, $20‐$51) per month to avoid a 5% weight gain, and
• $32 (95% CI, $18‐$46) per month to avoid thinking problems.

Within the pool, 81% of respondents confirmed that they had taken a prescription medicine to prevent migraine in the past 6 months.

I think the broad message of this study is important: migraine is not just about migraine or headache days per month. This should not come as news to anyone with more than a passing interest in this condition. As an epidemiological study, it is useful to understand how migraine patients, as a group, view the relative value of cost, side effects, etc. For clinicians, the value of this study is to remind us of the complexity we need to consider when prescribing a migraine treatment. Issues of co-morbidity, economic resources, type of work or daily activities, and most bothersome symptom all play into the decision process, and it is critical to have the patient expressly involved in this process. It is not just about migraine days. It never has been.

Implicit in this article is the reality that we now have a wide variety of pharmacologic and device options for treating migraine. In the past, this was not the case. There is no clear winner among the preventives in terms of headache or migraine days per month. Rather, as the article suggests, we now have the option of selecting our preventives based on a cost-benefit analysis. Because of the near parity in terms of efficacy, the choices are often based on accessibility, financial burden, delivery system, and side effect profile. Properly presented, this can be an empowering experience for the patient. Choices may involve the need for trialing one or more treatments before gaining access to a preferred treatment, or the willingness to risk the chance of an untoward side effect against the promise of a more convivial dosing regimen. This collaborative decision-making process helps center the locus of control with the patient and secure a healthy relationship between the provider and patient.

It should also be remembered that the promise of a given side effect profile is based on the observation in trials and does not reflect the probability of a given outcome in a single patient. Neither does the side effect profile generated in a controlled trial necessarily reflect the side effect profile in any given individual. Too often we fail to stress this to patients and a 1% risk becomes an unavoidable consequence or a promise of smooth sailing. Time spent educating patients (and providers) with regard to the interpretation of efficacy and risk data, is time well spent.

Dr. Cowan is a Higgins Professor of Neurology, Chief of the Division of Headache Medicine and the Department of Neurology and Neurosciences, and Director of the Center for Headache and Facial Pain, at Stanford University School of Medicine.

Many readers may be aware of large payments made by such companies as Johnson & Johnson to compensate women with a history of ovarian cancer who have claimed that perineal application of talc played a causative role in their cancer development. This column serves to review the purported role of perineal talc use in the development of ovarian cancer, and explore some of the pitfalls of observational science.

ThitareeSarmkasat/iStock/Getty Images Plus

Talc, a hydrated magnesium silicate, is the softest mineral on earth, and has been sold as a personal hygiene product for many decades. Perineal application of talc to sanitary pads, perineal skin, undergarments, and diapers has been a common practice to decrease friction, moisture build-up, and as a deodorant. Talc is chemically similar, although not identical, to asbestos and is geologically located in close proximity to the known carcinogen. In the 1970s, there were concerns raised regarding the possible contamination of cosmetic-grade talc with asbestos, which led to the development of asbestos-free forms of the substance. Given that a strong causal relationship had been established between asbestos exposure and lung and pleural cancers, there was concern that exposure to perineal talc might increase cancer risk.

In the 1980s, an association between perineal talc exposure and ovarian cancer was observed in a case-control study.¹ Since that time, multiple other observational studies, predominately case-control studies, have observed an increased ovarian cancer risk among users of perineal talc including the findings of a meta-analysis which estimated a 24%-39% increased risk for ovarian cancer among users.² Does this establish a causal relationship? For the purposes of legal cases, these associations are adequate. However, science demands a different standard when determining cause and effect.

It is not unusual to rely on observational studies to establish a causal relationship between exposure and disease when it is unethical to randomize subjects in a clinical trial to exposure of the potential harmful agent. This was the necessary methodology behind establishing that smoking causes lung cancer. Several factors must be present when relying on observational studies to establish plausible causation including an observable biologic mechanism, dose-effect response, temporal relationship, consistent effect observed in multiple study populations, and statistical strength of response. These elements should be present in a consistent and powerful enough way to balance the pitfalls of observational studies, namely biases.

A particularly problematic bias is one of recall bias, which plagues case-control studies. Case-control studies are a popular tool to measure a relationship between an exposure and a rare disease, because they are more feasible than the prospective, observational cohort studies that require very large study populations observed over very long periods of time to capture enough events of interest (in this case, cases of ovarian cancer). In case-control studies, researchers identify a cohort of patients with the outcome of interest (ovarian cancer) and compare this population to a control group of similar demographic features. They then survey directly or indirectly (through medical records) for the exposure of interest (perineal talc use).

Recall bias occurs when subjects who have the disease are more likely to have memory of exposure than do control subjects because of the natural instincts individuals have toward attribution. This is emphasized when there is public commentary, justified or not, about the potential risks of that exposure. Given the significant publicity that these lawsuits have had with companies that produced cosmetic talc, it is plausible that ovarian cancer survivors are more likely to remember and negatively attribute their talc exposure to their cancer than are subjects without cancer. Additionally, their memory of volume and duration of exposure generally is enhanced by the same pressures. The potential for this bias is eliminated in prospective, cohort observational studies such as the Women’s Health Initiative Observational Study which, among 61,576 women, half of whom reported perineal talc exposure, did not measure a difference in the development of ovarian cancers during their 12 years of mean follow-up.³

Given these inherent biases, how do studies examining the relationship between talc exposure and ovarian cancer stand up? The biologic mechanism of talc carcinogenesis is largely theoretical. As mentioned earlier, prior to the 1970s, there was some observed contamination of talc with asbestos likely caused by the geologic proximity of these minerals. Asbestos is a known carcinogen, and therefore possibly could be harmful if a contaminant of talc. However, it is not known if this level of contamination was enough to be achieve ovarian carcinogenesis. Most theories of talc carcinogenesis are based on foreign body inflammatory reaction via talc particle ascent through the genital tract. This is proposed to induce an inflammatory release of prostaglandins and cytokines, which could cause a mutagenic effect promoting carcinogenesis. The foreign body inflammatory mechanism is further supported by the observation of a decreased incidence of ovarian cancer after hysterectomy or tubal ligation.⁴ However, inconsistently, a protective effect of NSAIDs has not been observed in ovarian cancer.⁵

A recent meta-analysis, which reviewed 27 of the largest, best-quality observational studies, identified a dose-effect response with an increased risk for ovarian cancer with greater than 3,600 lifetime applications, compared with less than 3,600 applications.² The observed association between perineal talc exposure and increased risk of ovarian cancer appears to be consistent across a number of observational studies, including both case-control studies and prospective cohort studies (although somewhat mitigated in the latter). Additionally, there appears to be consistency in the finding that the risk is present for the epithelial subtypes of serous and endometrioid, but not mucinous or clear cell cancer. However, when considering the magnitude of effect, this remains somewhat small (odds ratio, 1.31; 95% confidence interval, 1.24-1.39) when compared with other better established carcinogenic relationships such as smoking and lung cancer where the hazard ratio is 12.12 (95% CI, 6.94-21.17).^2,6

If talc does not cause ovarian cancer, why would this association be observed at all? One explanation could be that talc use is a confounder for the true causative mechanism. A theoretical example of this would be if the genital microbiome (a subject we have reviewed previously in this column) was the true culprit. If a particular microbiome profile promotes both oncogenic change in the ovary while also causing vaginal discharge and odor, it might increase the likelihood that perineal talc use is reported in the history of these cancer patients. This is purely speculative, but it always is important to consider the potential for confounding variables when utilizing observational studies to attribute cause and effect.

Therefore, there is a consistently observed association between perineal talc application and ovarian cancer, however, the relationship does not appear to be strong enough, associated with a proven carcinogenic mechanism, or free from interfering recall bias such to definitively state that perineal talc exposure causes ovarian cancer. Given these findings, it is reasonable to recommend patients avoid the use of perineal talc application until further definitive safety evidence is provided. In the meantime, it should be noted that even though talc-containing products are not commercially labeled as carcinogens, many pharmaceutical and cosmetic companies have replaced the mineral talc with corn starch in their powders.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She had no relevant financial disclosures. Email her at obnews@mdedge.com.

References

1. Cancer. 1982 Jul 15;50(2):372-6.

2. Epidemiology. 2018 Jan;29(1):41-9.

3. J Natl Cancer Inst. 2014 Sep 10;106(9). pii: dju208.

4. Am J Epidemiol. 1991 Aug 15;134(4):362-9.

5. Int J Cancer. 2008 Jan 1;122(1):170-6.

6. J Natl Cancer Inst. 2018 Nov 1;110(11):1201-7.

Many readers may be aware of large payments made by such companies as Johnson & Johnson to compensate women with a history of ovarian cancer who have claimed that perineal application of talc played a causative role in their cancer development. This column serves to review the purported role of perineal talc use in the development of ovarian cancer, and explore some of the pitfalls of observational science.

ThitareeSarmkasat/iStock/Getty Images Plus

Talc, a hydrated magnesium silicate, is the softest mineral on earth, and has been sold as a personal hygiene product for many decades. Perineal application of talc to sanitary pads, perineal skin, undergarments, and diapers has been a common practice to decrease friction, moisture build-up, and as a deodorant. Talc is chemically similar, although not identical, to asbestos and is geologically located in close proximity to the known carcinogen. In the 1970s, there were concerns raised regarding the possible contamination of cosmetic-grade talc with asbestos, which led to the development of asbestos-free forms of the substance. Given that a strong causal relationship had been established between asbestos exposure and lung and pleural cancers, there was concern that exposure to perineal talc might increase cancer risk.

In the 1980s, an association between perineal talc exposure and ovarian cancer was observed in a case-control study.¹ Since that time, multiple other observational studies, predominately case-control studies, have observed an increased ovarian cancer risk among users of perineal talc including the findings of a meta-analysis which estimated a 24%-39% increased risk for ovarian cancer among users.² Does this establish a causal relationship? For the purposes of legal cases, these associations are adequate. However, science demands a different standard when determining cause and effect.

It is not unusual to rely on observational studies to establish a causal relationship between exposure and disease when it is unethical to randomize subjects in a clinical trial to exposure of the potential harmful agent. This was the necessary methodology behind establishing that smoking causes lung cancer. Several factors must be present when relying on observational studies to establish plausible causation including an observable biologic mechanism, dose-effect response, temporal relationship, consistent effect observed in multiple study populations, and statistical strength of response. These elements should be present in a consistent and powerful enough way to balance the pitfalls of observational studies, namely biases.

A particularly problematic bias is one of recall bias, which plagues case-control studies. Case-control studies are a popular tool to measure a relationship between an exposure and a rare disease, because they are more feasible than the prospective, observational cohort studies that require very large study populations observed over very long periods of time to capture enough events of interest (in this case, cases of ovarian cancer). In case-control studies, researchers identify a cohort of patients with the outcome of interest (ovarian cancer) and compare this population to a control group of similar demographic features. They then survey directly or indirectly (through medical records) for the exposure of interest (perineal talc use).

Recall bias occurs when subjects who have the disease are more likely to have memory of exposure than do control subjects because of the natural instincts individuals have toward attribution. This is emphasized when there is public commentary, justified or not, about the potential risks of that exposure. Given the significant publicity that these lawsuits have had with companies that produced cosmetic talc, it is plausible that ovarian cancer survivors are more likely to remember and negatively attribute their talc exposure to their cancer than are subjects without cancer. Additionally, their memory of volume and duration of exposure generally is enhanced by the same pressures. The potential for this bias is eliminated in prospective, cohort observational studies such as the Women’s Health Initiative Observational Study which, among 61,576 women, half of whom reported perineal talc exposure, did not measure a difference in the development of ovarian cancers during their 12 years of mean follow-up.³

Given these inherent biases, how do studies examining the relationship between talc exposure and ovarian cancer stand up? The biologic mechanism of talc carcinogenesis is largely theoretical. As mentioned earlier, prior to the 1970s, there was some observed contamination of talc with asbestos likely caused by the geologic proximity of these minerals. Asbestos is a known carcinogen, and therefore possibly could be harmful if a contaminant of talc. However, it is not known if this level of contamination was enough to be achieve ovarian carcinogenesis. Most theories of talc carcinogenesis are based on foreign body inflammatory reaction via talc particle ascent through the genital tract. This is proposed to induce an inflammatory release of prostaglandins and cytokines, which could cause a mutagenic effect promoting carcinogenesis. The foreign body inflammatory mechanism is further supported by the observation of a decreased incidence of ovarian cancer after hysterectomy or tubal ligation.⁴ However, inconsistently, a protective effect of NSAIDs has not been observed in ovarian cancer.⁵

A recent meta-analysis, which reviewed 27 of the largest, best-quality observational studies, identified a dose-effect response with an increased risk for ovarian cancer with greater than 3,600 lifetime applications, compared with less than 3,600 applications.² The observed association between perineal talc exposure and increased risk of ovarian cancer appears to be consistent across a number of observational studies, including both case-control studies and prospective cohort studies (although somewhat mitigated in the latter). Additionally, there appears to be consistency in the finding that the risk is present for the epithelial subtypes of serous and endometrioid, but not mucinous or clear cell cancer. However, when considering the magnitude of effect, this remains somewhat small (odds ratio, 1.31; 95% confidence interval, 1.24-1.39) when compared with other better established carcinogenic relationships such as smoking and lung cancer where the hazard ratio is 12.12 (95% CI, 6.94-21.17).^2,6

If talc does not cause ovarian cancer, why would this association be observed at all? One explanation could be that talc use is a confounder for the true causative mechanism. A theoretical example of this would be if the genital microbiome (a subject we have reviewed previously in this column) was the true culprit. If a particular microbiome profile promotes both oncogenic change in the ovary while also causing vaginal discharge and odor, it might increase the likelihood that perineal talc use is reported in the history of these cancer patients. This is purely speculative, but it always is important to consider the potential for confounding variables when utilizing observational studies to attribute cause and effect.

Therefore, there is a consistently observed association between perineal talc application and ovarian cancer, however, the relationship does not appear to be strong enough, associated with a proven carcinogenic mechanism, or free from interfering recall bias such to definitively state that perineal talc exposure causes ovarian cancer. Given these findings, it is reasonable to recommend patients avoid the use of perineal talc application until further definitive safety evidence is provided. In the meantime, it should be noted that even though talc-containing products are not commercially labeled as carcinogens, many pharmaceutical and cosmetic companies have replaced the mineral talc with corn starch in their powders.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She had no relevant financial disclosures. Email her at obnews@mdedge.com.

References

1. Cancer. 1982 Jul 15;50(2):372-6.

2. Epidemiology. 2018 Jan;29(1):41-9.

3. J Natl Cancer Inst. 2014 Sep 10;106(9). pii: dju208.

4. Am J Epidemiol. 1991 Aug 15;134(4):362-9.

5. Int J Cancer. 2008 Jan 1;122(1):170-6.

6. J Natl Cancer Inst. 2018 Nov 1;110(11):1201-7.

Many readers may be aware of large payments made by such companies as Johnson & Johnson to compensate women with a history of ovarian cancer who have claimed that perineal application of talc played a causative role in their cancer development. This column serves to review the purported role of perineal talc use in the development of ovarian cancer, and explore some of the pitfalls of observational science.

ThitareeSarmkasat/iStock/Getty Images Plus

Talc, a hydrated magnesium silicate, is the softest mineral on earth, and has been sold as a personal hygiene product for many decades. Perineal application of talc to sanitary pads, perineal skin, undergarments, and diapers has been a common practice to decrease friction, moisture build-up, and as a deodorant. Talc is chemically similar, although not identical, to asbestos and is geologically located in close proximity to the known carcinogen. In the 1970s, there were concerns raised regarding the possible contamination of cosmetic-grade talc with asbestos, which led to the development of asbestos-free forms of the substance. Given that a strong causal relationship had been established between asbestos exposure and lung and pleural cancers, there was concern that exposure to perineal talc might increase cancer risk.

In the 1980s, an association between perineal talc exposure and ovarian cancer was observed in a case-control study.¹ Since that time, multiple other observational studies, predominately case-control studies, have observed an increased ovarian cancer risk among users of perineal talc including the findings of a meta-analysis which estimated a 24%-39% increased risk for ovarian cancer among users.² Does this establish a causal relationship? For the purposes of legal cases, these associations are adequate. However, science demands a different standard when determining cause and effect.

It is not unusual to rely on observational studies to establish a causal relationship between exposure and disease when it is unethical to randomize subjects in a clinical trial to exposure of the potential harmful agent. This was the necessary methodology behind establishing that smoking causes lung cancer. Several factors must be present when relying on observational studies to establish plausible causation including an observable biologic mechanism, dose-effect response, temporal relationship, consistent effect observed in multiple study populations, and statistical strength of response. These elements should be present in a consistent and powerful enough way to balance the pitfalls of observational studies, namely biases.

A particularly problematic bias is one of recall bias, which plagues case-control studies. Case-control studies are a popular tool to measure a relationship between an exposure and a rare disease, because they are more feasible than the prospective, observational cohort studies that require very large study populations observed over very long periods of time to capture enough events of interest (in this case, cases of ovarian cancer). In case-control studies, researchers identify a cohort of patients with the outcome of interest (ovarian cancer) and compare this population to a control group of similar demographic features. They then survey directly or indirectly (through medical records) for the exposure of interest (perineal talc use).

Recall bias occurs when subjects who have the disease are more likely to have memory of exposure than do control subjects because of the natural instincts individuals have toward attribution. This is emphasized when there is public commentary, justified or not, about the potential risks of that exposure. Given the significant publicity that these lawsuits have had with companies that produced cosmetic talc, it is plausible that ovarian cancer survivors are more likely to remember and negatively attribute their talc exposure to their cancer than are subjects without cancer. Additionally, their memory of volume and duration of exposure generally is enhanced by the same pressures. The potential for this bias is eliminated in prospective, cohort observational studies such as the Women’s Health Initiative Observational Study which, among 61,576 women, half of whom reported perineal talc exposure, did not measure a difference in the development of ovarian cancers during their 12 years of mean follow-up.³

Given these inherent biases, how do studies examining the relationship between talc exposure and ovarian cancer stand up? The biologic mechanism of talc carcinogenesis is largely theoretical. As mentioned earlier, prior to the 1970s, there was some observed contamination of talc with asbestos likely caused by the geologic proximity of these minerals. Asbestos is a known carcinogen, and therefore possibly could be harmful if a contaminant of talc. However, it is not known if this level of contamination was enough to be achieve ovarian carcinogenesis. Most theories of talc carcinogenesis are based on foreign body inflammatory reaction via talc particle ascent through the genital tract. This is proposed to induce an inflammatory release of prostaglandins and cytokines, which could cause a mutagenic effect promoting carcinogenesis. The foreign body inflammatory mechanism is further supported by the observation of a decreased incidence of ovarian cancer after hysterectomy or tubal ligation.⁴ However, inconsistently, a protective effect of NSAIDs has not been observed in ovarian cancer.⁵

A recent meta-analysis, which reviewed 27 of the largest, best-quality observational studies, identified a dose-effect response with an increased risk for ovarian cancer with greater than 3,600 lifetime applications, compared with less than 3,600 applications.² The observed association between perineal talc exposure and increased risk of ovarian cancer appears to be consistent across a number of observational studies, including both case-control studies and prospective cohort studies (although somewhat mitigated in the latter). Additionally, there appears to be consistency in the finding that the risk is present for the epithelial subtypes of serous and endometrioid, but not mucinous or clear cell cancer. However, when considering the magnitude of effect, this remains somewhat small (odds ratio, 1.31; 95% confidence interval, 1.24-1.39) when compared with other better established carcinogenic relationships such as smoking and lung cancer where the hazard ratio is 12.12 (95% CI, 6.94-21.17).^2,6

If talc does not cause ovarian cancer, why would this association be observed at all? One explanation could be that talc use is a confounder for the true causative mechanism. A theoretical example of this would be if the genital microbiome (a subject we have reviewed previously in this column) was the true culprit. If a particular microbiome profile promotes both oncogenic change in the ovary while also causing vaginal discharge and odor, it might increase the likelihood that perineal talc use is reported in the history of these cancer patients. This is purely speculative, but it always is important to consider the potential for confounding variables when utilizing observational studies to attribute cause and effect.

Therefore, there is a consistently observed association between perineal talc application and ovarian cancer, however, the relationship does not appear to be strong enough, associated with a proven carcinogenic mechanism, or free from interfering recall bias such to definitively state that perineal talc exposure causes ovarian cancer. Given these findings, it is reasonable to recommend patients avoid the use of perineal talc application until further definitive safety evidence is provided. In the meantime, it should be noted that even though talc-containing products are not commercially labeled as carcinogens, many pharmaceutical and cosmetic companies have replaced the mineral talc with corn starch in their powders.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She had no relevant financial disclosures. Email her at obnews@mdedge.com.

References

1. Cancer. 1982 Jul 15;50(2):372-6.

2. Epidemiology. 2018 Jan;29(1):41-9.

3. J Natl Cancer Inst. 2014 Sep 10;106(9). pii: dju208.

4. Am J Epidemiol. 1991 Aug 15;134(4):362-9.

5. Int J Cancer. 2008 Jan 1;122(1):170-6.

6. J Natl Cancer Inst. 2018 Nov 1;110(11):1201-7.

Clinical Psychiatry News is pleased to announce the addition of two new Editorial Advisory Board members.

Pooja Lakshmin, MD, is a board-certified psychiatrist specializing in women’s mental health and perinatal psychiatry, and a clinical assistant professor of psychiatry at the George Washington University, Washington. She maintains a private practice in Washington and is a clinical supervisor in the university’s Five Trimesters Perinatal Psychiatry Clinic. She is passionate about empowering women through psychoeducation and advocacy. She takes an integrative approach to psychiatry and frequently writes about topics related to women’s mental health, maternal mental health, and self-care.

Steven Starks, MD, a geriatric psychiatrist, is a congressional fellow at the Health and Aging Policy Fellows Program in Washington. Dr. Starks, a representative to American Psychiatric Association assembly for the APA Caucus of Black Psychiatrists, is keenly interested in understanding the cultural and social effects of geriatric mental health conditions on the lives of patients and families. Previously, Dr. Starks served as an assistant professor in the Baylor College of Medicine Menninger department of psychiatry and behavioral sciences, and in the department of neurology, Houston. He also was a faculty member at Baylor’s Alzheimer’s Disease and Memory Disorder Center.

Clinical Psychiatry News is pleased to announce the addition of two new Editorial Advisory Board members.

Pooja Lakshmin, MD, is a board-certified psychiatrist specializing in women’s mental health and perinatal psychiatry, and a clinical assistant professor of psychiatry at the George Washington University, Washington. She maintains a private practice in Washington and is a clinical supervisor in the university’s Five Trimesters Perinatal Psychiatry Clinic. She is passionate about empowering women through psychoeducation and advocacy. She takes an integrative approach to psychiatry and frequently writes about topics related to women’s mental health, maternal mental health, and self-care.

Steven Starks, MD, a geriatric psychiatrist, is a congressional fellow at the Health and Aging Policy Fellows Program in Washington. Dr. Starks, a representative to American Psychiatric Association assembly for the APA Caucus of Black Psychiatrists, is keenly interested in understanding the cultural and social effects of geriatric mental health conditions on the lives of patients and families. Previously, Dr. Starks served as an assistant professor in the Baylor College of Medicine Menninger department of psychiatry and behavioral sciences, and in the department of neurology, Houston. He also was a faculty member at Baylor’s Alzheimer’s Disease and Memory Disorder Center.

Clinical Psychiatry News is pleased to announce the addition of two new Editorial Advisory Board members.

Pooja Lakshmin, MD, is a board-certified psychiatrist specializing in women’s mental health and perinatal psychiatry, and a clinical assistant professor of psychiatry at the George Washington University, Washington. She maintains a private practice in Washington and is a clinical supervisor in the university’s Five Trimesters Perinatal Psychiatry Clinic. She is passionate about empowering women through psychoeducation and advocacy. She takes an integrative approach to psychiatry and frequently writes about topics related to women’s mental health, maternal mental health, and self-care.

Steven Starks, MD, a geriatric psychiatrist, is a congressional fellow at the Health and Aging Policy Fellows Program in Washington. Dr. Starks, a representative to American Psychiatric Association assembly for the APA Caucus of Black Psychiatrists, is keenly interested in understanding the cultural and social effects of geriatric mental health conditions on the lives of patients and families. Previously, Dr. Starks served as an assistant professor in the Baylor College of Medicine Menninger department of psychiatry and behavioral sciences, and in the department of neurology, Houston. He also was a faculty member at Baylor’s Alzheimer’s Disease and Memory Disorder Center.

A 39-year-old woman presented to an Arkansas cardiologist on February 12, 2010, with complaints of chest pain. The physician conducted an ankle-brachial index (ABI) test to measure the blood pressure in her lower extremity and interpreted it as less than 0.9%. He then ordered an echocardiogram to gauge the patient’s ejection fraction and interpreted the reading at 25%. Both measurements were below the normal average, which prompted the cardiologist to diagnose peripheral vascular disease and congestive heart failure.

The patient was eventually prescribed a course of cardiac medication and monitored over the ensuing months. On April 15, the cardiologist conducted a nuclear stress test; the computer-generated measurement of her ejection fraction was 50%, which the physician adjusted to 42%. In May, the patient underwent cardiac catheterization, which showed no lesions or blockages in the vessels. In the following months, the patient’s medication dosages were increased. On September 27, the cardiologist conducted another echocardiogram, which he read as 30%, and reaffirmed his diagnosis of congestive heart failure.

The physician continued to monitor the patient. On November 11, after being diagnosed with congestive heart failure, the patient was admitted to the hospital, where the cardiologist implanted an automated implantable cardioverter defibrillator (AICD).

On May 18, 2011, while running with her 2 daughters and a friend, the patient suddenly collapsed and experienced electrical currents coursing through her body (5 times). She was driven to a hospital, where it was determined that she did not go into cardiac arrest (which she suspected) but rather her defibrillator malfunctioned. The defibrillator was recalibrated to a higher setting, and she experienced no further issues.

In the ensuing years, the patient continued to follow up with her cardiologist. She eventually filed a lawsuit claiming that he had misdiagnosed congestive heart failure and unnecessarily implanted the AICD. Her experts in cardiology and cardiac electrophysiology testified that the defendant’s readings of the February 2010 ABI and echocardiogram results were incorrect; the ABIs were in fact .128 and .138 and the ejection fractions were 50% to 55% percent—in both instances, normal results. Furthermore, the September 2010 echocardiogram and another taken in February 2011, which showed little change from the first echocardiogram, were also normal, according to the experts.

The experts also opined that American College of Cardiology/American Heart Association guidelines state that a patient’s ejection fraction has to be less than 35% before a defibrillator is placed. Both experts concluded that the plaintiff did not have congestive heart failure and was therefore not a candidate for an AICD. The cardiac electrophysiology expert stated that to be a candidate, a patient must have an enlarged left ventricle—which plaintiff did not have. Moreover, none of the plaintiff’s physical findings were ever consistent with congestive heart failure: She did not have fluid in her lungs, as examinations always revealed clear lungs without congestion; there was no distention in her jugular veins; she did not experience sleep apnea; she did not lose consciousness; and she only experienced fatigue with exertion. The cardiology expert further faulted the defendant for failing to adjust the patient’s medication dosages to optimize her cardiac repair.

The defense maintained that the defendant’s treatment of the patient met the standard of care. According to the defense, the defendant’s judgment and interpretation of the patient’s ABI and echocardiogram results were medically sound and the defibrillator was necessary.

Continue to: VERDICT

VERDICT

After a 4-day trial and 3 hours of deliberation, the jury found that the defendant was liable and his actions were a factual cause of injury to plaintiff, who was awarded $1.75 million in damages.

COMMENTARY

In this case, the defendant cardiologist placed an AICD (also known as an implantable cardioverter defibrillator, or ICD). There was no allegation that the placement itself was negligent; rather, the claimed negligence was the decision to place it. But the plaintiff’s damages arise from the device’s malfunction—not the cardiologist’s decision to place it.

This case brings up an interesting issue of causation. As most of us know, medical malpractice plaintiffs must show (1) duty, (2) breach, (3) causation, and (4) harm. In law, there are 2 ways to think of causation: “but for” causation and “proximate” causation.

So-called “but for” causation is based on whether any causal relationship exists between an action and an outcome. For example, a drunk driver veers off the highway, through the breakdown lane, and strikes a tree, catching his car on fire. One minute later, a driver in the high-speed lane is captivated by the flaming vehicle, rubbernecks, fails to pay attention to traffic, and rear-ends the vehicle in front of him—injuring the driver of that car. Using “but for” causation, the drunk driver striking the tree “caused” the accident. If that had never happened, the second driver would never have been distracted, and if the driver wasn’t distracted, the second accident would not have occurred.

By contrast, “proximate” causation entails the immediate cause, which is foreseeable. Black’s Law defines proximate cause as “The result of a direct action and cause of loss to property that sets in motion a chain of events that is unbroken and causes damage, injury and destruction with no other interference” (emphasis added).¹ Using a proximate causation analysis, the second driver’s negligent failure to pay attention to the road would be the proximate cause of the second crash.

Continue to: Generally, causation analysis...

Generally, causation analysis is limited to proximate cause on the basis that harm is reasonably foreseeable. A famous example is the case of Palsgraf v. Long Island Railroad.²

Mrs. Palsgraf was standing on a train platform. A man carrying an ordinary-looking package rushed to board a moving train, with help from 2 railroad employees (1 in the car and 1 on the platform). As the ­employees pushed and pulled the man aboard, the package fell onto the tracks. Unbeknownst to everyone but the package’s owner, it contained fireworks—which exploded when the rear wheels of the train ran over the package. The explosion caused a large standing scale to fall over and land on Mrs. Palsgraf, injuring her. This is what law professors live for.

Mrs. Palsgraf sued the railroad, arguing that if the employees had not negligently pushed and pulled the man, the package would not have fallen and would not have exploded, and the scale never would have fallen on her. Mrs. Palsgraf won her trial and won her first appeal. In a famous decision by a famous judge, the win was overturned on the basis that Mrs. Palsgraf’s injuries “were not a reasonably foreseeable consequence of any possible negligence by the railroad.” This case set a foundation of American law regarding reasonable foreseeability, both in terms of identifiable plaintiffs and expected danger.

What does a railroad accident have to do with medical malpractice? In the case described here, we had an arguably negligent medical decision to place the defibrillator. Then we had a malfunction of the device, which caused the plaintiff injury. Was it reasonably foreseeable that the device would malfunction and cause harm—and should the physician be on the hook for that?

Unlike the unforeseeable risk of knocking a simple package to the ground—which unexpectedly turned out to contain fireworks—the risk of device malfunction would be foreseeable. Why? Beyond the usual surgical risks of bleeding and infection, an ICD’s leads can dislodge, the device can fail, and devices can shock inappropriately (with younger patients at increased risk for inappropriate shocks).^3,4 These risks are known, and it is highly likely the defendant cardiologist disclosed them on the consent form he asked the plaintiff to sign. The defense could not credibly argue that device malfunction was an unforeseeable risk. The malpractice here was the decision to place the ICD—and because placement wasn’t warranted in this patient, neither were the risks.

Continue to: This brings us to...

This brings us to the first malpractice trap: If you practice in a setting where a procedure is routinely offered, and that treatment has a billable cost, be cautious. Your decision-making can be made to appear driven by a profit motive. The lay public (including jurors) is suspicious of profit motive in medicine—a concept most clinicians find alien and repugnant.

Back in 2009, while outlining his rationale for the Affordable Care Act, President Obama made several statements that earned him swift rebuke from physician groups; I include them here not to incite political rants but to demonstrate the keen suspicion the public has for profit motives in clinical decision-making. On one occasion, he said, “Right now, doctors a lot of times are forced to make decisions based on the fee payment schedule. ... The doctor may look at the reimbursement system and say to himself, ‘You know what? I make a lot more money if I take this kid’s tonsils out.’”⁵ In another statement, while acknowledging that primary care providers offering preventive diabetes care make “a pittance,” Obama added, “But if that same [patient] ends up getting their foot amputated, that’s $30,000, $40,000, $50,000 immediately the surgeon is reimbursed.”⁶

For most clinicians, the idea of deciding on a course of treatment because it will be lucrative is an alien concept. Good clinicians base treatment on the accepted medical standard, and cost factors are a distant consideration if one at all.

However, if your practice involves a procedure or intervention that is a particularly lucrative billable event, do your part to play mental “devil’s advocate” and ensure that patients are genuinely in need of the treatment.

In some rare, bad (and usually highly publicized) cases, a procedure will be overused in a patently fraudulent way, which we all recognize is unethical and illegal. However, in other instances, a procedure may be overused because it is familiar and available. We’ve all heard the adage, “If all you have is a hammer, everything looks like a nail.” This “cute” expression holds some truth about the risk for cognitive bias based on the over-reliance on a familiar remedy.⁷ This particularly involves specialty practices that perform certain procedures frequently.

Continue to: In this case...

In this case, the plaintiff’s nuclear stress test showed an ejection fraction of 50%, which the defendant decreased to 42%. That is substantially different than the first ejection fraction of 25% and the second of 30% in a 39-year-old patient without any clinical signs of congestive heart failure. Did the defendant’s ability to offer an ICD color his appraisal of the patient’s cardiac function?

In closing arguments to the jury, the plaintiff’s attorney probably argued “this defendant behaved as if every human heart could be improved with a battery and wires.” Examine your practice to be sure you aren’t seeing nails where they don’t exist—because tomorrow, they will be the nails in the coffin of your career.

One thing missing from this case summary—but available via court records—is that the plaintiff claimed she had wanted a second opinion but was told she couldn’t have one: “I wanted a second opinion. And when I called [the defendant’s] office and asked ‘Could I have a second opinion,’ his nurse answered the phone and said that if I did get a second opinion, then I couldn’t come back.”⁸

There are a few aspects to discuss here, one of which is the second malpractice trap: viewing second opinions as an enemy. Most clinicians realize they are actually your friend. However, some providers are threatened by second opinions. It is as if they roll out of bed in the morning and consult the mirror to ask, “Who is the top cardiologist of them all?” and need the validation of that voice saying, “You, Dr. Smith—why of course, you!”

To that I say, forget the mirror, you egotistical so-and-so. Snow White will help protect you, your career, and most importantly, your patient. Allow the second opinion. In fact, integrate an expectation of the them into your practice style, to disarm any feelings of awkwardness, confrontation, or defensiveness. Think of the benefits: If Snow White validates your opinion, you have much stronger case that a course of treatment was indicated. Conversely, if Snow White arrives at a different opinion, she may have seen something you did not, and/or it may also relieve pressure from the patient to take an action with which you were only borderline comfortable.

Continue to: In cases I've worked on...

In cases I’ve worked on, I’ve seen some excellent surgeons who require a second opinion as a precondition to operating. This is particularly helpful when patient expectations are uncertain or there is a track record of unsuccessful interventions (eg, chronic back pain with multiple failed surgeries). Furthermore, a second opinion shows diligence, humility, and concern for the patient. It also gives you backup. As Top Gun taught us, there is no need to be a “maverick” when you can have a wingman.

As far as the alleged comment by the cardiologist’s nurse: We don’t know for certain if this actually happened—but if it did, it was unwarranted and foolish. Any jury would hear this and conclude the defendant (1) was an ass, (2) had something to hide, or (3) was guarding a profit source. Any way you slice it, this is bad for the patient and ultimately bad for the defendant. Make room in your practice for second opinions.

There was a legal fight regarding the admissibility of what the nurse had said. The defense filed a motion to prevent the plaintiff from telling the jury about the nurse’s statement, on the basis that the nurse’s statement was inadmissible hearsay. The court denied the motion, ruling that the cardiologist’s nurse was his agent and her words could be properly brought before the jury. The court found that the plaintiff relied on that statement in determining whether to have the ICD placed or obtain a second opinion.

This raises an interesting malpractice awareness point: If you are sued for malpractice, anything you had said to a patient, the patient’s family, or your coworkers will be admissible in court as a “party admission,” classified as either nonhearsay or a hearsay exception (assuming the statement was not made as part of a bona fide peer review, in which case it will likely be subject to peer review privilege). As seen in this case, this also applies to people acting as agents on your behalf. Be cautious of what you say and how you say it—and what your practice’s representatives are saying as well.

Interestingly, the jury found for the plaintiff in the amount of $1.75 million, but they declined to award punitive damages, which are designed to punish defendants rather than compensate the plaintiff. In Arkansas, the standard for punitive damages is tough; the plaintiff must “prove by clear and convincing evidence that the defendant knew or ought to have known, that their conduct would naturally and probably result in injury or damage and that they continued the conduct with malice or in reckless disregard of the consequences from which malice may be inferred.”⁹ A similar standard exists in most states. Because there were no punitive damages, we can infer the jury did not think the defendant implanted the ICD (for profit) knowing it wasn’t indicated.

Continue to: IN SUMMARY

IN SUMMARY

Consider foreseeable risks of practice interventions; be sure your practice is not on “autopilot,” recommending a common procedure or intervention too frequently. Don’t be threatened by second opinions; welcome them. And watch your words—­as they say on every police procedural you’ve ever watched, they can be used against you.

A 39-year-old woman presented to an Arkansas cardiologist on February 12, 2010, with complaints of chest pain. The physician conducted an ankle-brachial index (ABI) test to measure the blood pressure in her lower extremity and interpreted it as less than 0.9%. He then ordered an echocardiogram to gauge the patient’s ejection fraction and interpreted the reading at 25%. Both measurements were below the normal average, which prompted the cardiologist to diagnose peripheral vascular disease and congestive heart failure.

The patient was eventually prescribed a course of cardiac medication and monitored over the ensuing months. On April 15, the cardiologist conducted a nuclear stress test; the computer-generated measurement of her ejection fraction was 50%, which the physician adjusted to 42%. In May, the patient underwent cardiac catheterization, which showed no lesions or blockages in the vessels. In the following months, the patient’s medication dosages were increased. On September 27, the cardiologist conducted another echocardiogram, which he read as 30%, and reaffirmed his diagnosis of congestive heart failure.

The physician continued to monitor the patient. On November 11, after being diagnosed with congestive heart failure, the patient was admitted to the hospital, where the cardiologist implanted an automated implantable cardioverter defibrillator (AICD).

On May 18, 2011, while running with her 2 daughters and a friend, the patient suddenly collapsed and experienced electrical currents coursing through her body (5 times). She was driven to a hospital, where it was determined that she did not go into cardiac arrest (which she suspected) but rather her defibrillator malfunctioned. The defibrillator was recalibrated to a higher setting, and she experienced no further issues.

In the ensuing years, the patient continued to follow up with her cardiologist. She eventually filed a lawsuit claiming that he had misdiagnosed congestive heart failure and unnecessarily implanted the AICD. Her experts in cardiology and cardiac electrophysiology testified that the defendant’s readings of the February 2010 ABI and echocardiogram results were incorrect; the ABIs were in fact .128 and .138 and the ejection fractions were 50% to 55% percent—in both instances, normal results. Furthermore, the September 2010 echocardiogram and another taken in February 2011, which showed little change from the first echocardiogram, were also normal, according to the experts.

The experts also opined that American College of Cardiology/American Heart Association guidelines state that a patient’s ejection fraction has to be less than 35% before a defibrillator is placed. Both experts concluded that the plaintiff did not have congestive heart failure and was therefore not a candidate for an AICD. The cardiac electrophysiology expert stated that to be a candidate, a patient must have an enlarged left ventricle—which plaintiff did not have. Moreover, none of the plaintiff’s physical findings were ever consistent with congestive heart failure: She did not have fluid in her lungs, as examinations always revealed clear lungs without congestion; there was no distention in her jugular veins; she did not experience sleep apnea; she did not lose consciousness; and she only experienced fatigue with exertion. The cardiology expert further faulted the defendant for failing to adjust the patient’s medication dosages to optimize her cardiac repair.

The defense maintained that the defendant’s treatment of the patient met the standard of care. According to the defense, the defendant’s judgment and interpretation of the patient’s ABI and echocardiogram results were medically sound and the defibrillator was necessary.

Continue to: VERDICT

VERDICT

After a 4-day trial and 3 hours of deliberation, the jury found that the defendant was liable and his actions were a factual cause of injury to plaintiff, who was awarded $1.75 million in damages.

COMMENTARY

In this case, the defendant cardiologist placed an AICD (also known as an implantable cardioverter defibrillator, or ICD). There was no allegation that the placement itself was negligent; rather, the claimed negligence was the decision to place it. But the plaintiff’s damages arise from the device’s malfunction—not the cardiologist’s decision to place it.

This case brings up an interesting issue of causation. As most of us know, medical malpractice plaintiffs must show (1) duty, (2) breach, (3) causation, and (4) harm. In law, there are 2 ways to think of causation: “but for” causation and “proximate” causation.

So-called “but for” causation is based on whether any causal relationship exists between an action and an outcome. For example, a drunk driver veers off the highway, through the breakdown lane, and strikes a tree, catching his car on fire. One minute later, a driver in the high-speed lane is captivated by the flaming vehicle, rubbernecks, fails to pay attention to traffic, and rear-ends the vehicle in front of him—injuring the driver of that car. Using “but for” causation, the drunk driver striking the tree “caused” the accident. If that had never happened, the second driver would never have been distracted, and if the driver wasn’t distracted, the second accident would not have occurred.

By contrast, “proximate” causation entails the immediate cause, which is foreseeable. Black’s Law defines proximate cause as “The result of a direct action and cause of loss to property that sets in motion a chain of events that is unbroken and causes damage, injury and destruction with no other interference” (emphasis added).¹ Using a proximate causation analysis, the second driver’s negligent failure to pay attention to the road would be the proximate cause of the second crash.

Continue to: Generally, causation analysis...

Generally, causation analysis is limited to proximate cause on the basis that harm is reasonably foreseeable. A famous example is the case of Palsgraf v. Long Island Railroad.²

Mrs. Palsgraf was standing on a train platform. A man carrying an ordinary-looking package rushed to board a moving train, with help from 2 railroad employees (1 in the car and 1 on the platform). As the ­employees pushed and pulled the man aboard, the package fell onto the tracks. Unbeknownst to everyone but the package’s owner, it contained fireworks—which exploded when the rear wheels of the train ran over the package. The explosion caused a large standing scale to fall over and land on Mrs. Palsgraf, injuring her. This is what law professors live for.

Mrs. Palsgraf sued the railroad, arguing that if the employees had not negligently pushed and pulled the man, the package would not have fallen and would not have exploded, and the scale never would have fallen on her. Mrs. Palsgraf won her trial and won her first appeal. In a famous decision by a famous judge, the win was overturned on the basis that Mrs. Palsgraf’s injuries “were not a reasonably foreseeable consequence of any possible negligence by the railroad.” This case set a foundation of American law regarding reasonable foreseeability, both in terms of identifiable plaintiffs and expected danger.

What does a railroad accident have to do with medical malpractice? In the case described here, we had an arguably negligent medical decision to place the defibrillator. Then we had a malfunction of the device, which caused the plaintiff injury. Was it reasonably foreseeable that the device would malfunction and cause harm—and should the physician be on the hook for that?

Unlike the unforeseeable risk of knocking a simple package to the ground—which unexpectedly turned out to contain fireworks—the risk of device malfunction would be foreseeable. Why? Beyond the usual surgical risks of bleeding and infection, an ICD’s leads can dislodge, the device can fail, and devices can shock inappropriately (with younger patients at increased risk for inappropriate shocks).^3,4 These risks are known, and it is highly likely the defendant cardiologist disclosed them on the consent form he asked the plaintiff to sign. The defense could not credibly argue that device malfunction was an unforeseeable risk. The malpractice here was the decision to place the ICD—and because placement wasn’t warranted in this patient, neither were the risks.

Continue to: This brings us to...

This brings us to the first malpractice trap: If you practice in a setting where a procedure is routinely offered, and that treatment has a billable cost, be cautious. Your decision-making can be made to appear driven by a profit motive. The lay public (including jurors) is suspicious of profit motive in medicine—a concept most clinicians find alien and repugnant.

Back in 2009, while outlining his rationale for the Affordable Care Act, President Obama made several statements that earned him swift rebuke from physician groups; I include them here not to incite political rants but to demonstrate the keen suspicion the public has for profit motives in clinical decision-making. On one occasion, he said, “Right now, doctors a lot of times are forced to make decisions based on the fee payment schedule. ... The doctor may look at the reimbursement system and say to himself, ‘You know what? I make a lot more money if I take this kid’s tonsils out.’”⁵ In another statement, while acknowledging that primary care providers offering preventive diabetes care make “a pittance,” Obama added, “But if that same [patient] ends up getting their foot amputated, that’s $30,000, $40,000, $50,000 immediately the surgeon is reimbursed.”⁶

For most clinicians, the idea of deciding on a course of treatment because it will be lucrative is an alien concept. Good clinicians base treatment on the accepted medical standard, and cost factors are a distant consideration if one at all.

However, if your practice involves a procedure or intervention that is a particularly lucrative billable event, do your part to play mental “devil’s advocate” and ensure that patients are genuinely in need of the treatment.

In some rare, bad (and usually highly publicized) cases, a procedure will be overused in a patently fraudulent way, which we all recognize is unethical and illegal. However, in other instances, a procedure may be overused because it is familiar and available. We’ve all heard the adage, “If all you have is a hammer, everything looks like a nail.” This “cute” expression holds some truth about the risk for cognitive bias based on the over-reliance on a familiar remedy.⁷ This particularly involves specialty practices that perform certain procedures frequently.

Continue to: In this case...

In this case, the plaintiff’s nuclear stress test showed an ejection fraction of 50%, which the defendant decreased to 42%. That is substantially different than the first ejection fraction of 25% and the second of 30% in a 39-year-old patient without any clinical signs of congestive heart failure. Did the defendant’s ability to offer an ICD color his appraisal of the patient’s cardiac function?

In closing arguments to the jury, the plaintiff’s attorney probably argued “this defendant behaved as if every human heart could be improved with a battery and wires.” Examine your practice to be sure you aren’t seeing nails where they don’t exist—because tomorrow, they will be the nails in the coffin of your career.

One thing missing from this case summary—but available via court records—is that the plaintiff claimed she had wanted a second opinion but was told she couldn’t have one: “I wanted a second opinion. And when I called [the defendant’s] office and asked ‘Could I have a second opinion,’ his nurse answered the phone and said that if I did get a second opinion, then I couldn’t come back.”⁸

There are a few aspects to discuss here, one of which is the second malpractice trap: viewing second opinions as an enemy. Most clinicians realize they are actually your friend. However, some providers are threatened by second opinions. It is as if they roll out of bed in the morning and consult the mirror to ask, “Who is the top cardiologist of them all?” and need the validation of that voice saying, “You, Dr. Smith—why of course, you!”

To that I say, forget the mirror, you egotistical so-and-so. Snow White will help protect you, your career, and most importantly, your patient. Allow the second opinion. In fact, integrate an expectation of the them into your practice style, to disarm any feelings of awkwardness, confrontation, or defensiveness. Think of the benefits: If Snow White validates your opinion, you have much stronger case that a course of treatment was indicated. Conversely, if Snow White arrives at a different opinion, she may have seen something you did not, and/or it may also relieve pressure from the patient to take an action with which you were only borderline comfortable.

Continue to: In cases I've worked on...

In cases I’ve worked on, I’ve seen some excellent surgeons who require a second opinion as a precondition to operating. This is particularly helpful when patient expectations are uncertain or there is a track record of unsuccessful interventions (eg, chronic back pain with multiple failed surgeries). Furthermore, a second opinion shows diligence, humility, and concern for the patient. It also gives you backup. As Top Gun taught us, there is no need to be a “maverick” when you can have a wingman.

As far as the alleged comment by the cardiologist’s nurse: We don’t know for certain if this actually happened—but if it did, it was unwarranted and foolish. Any jury would hear this and conclude the defendant (1) was an ass, (2) had something to hide, or (3) was guarding a profit source. Any way you slice it, this is bad for the patient and ultimately bad for the defendant. Make room in your practice for second opinions.

There was a legal fight regarding the admissibility of what the nurse had said. The defense filed a motion to prevent the plaintiff from telling the jury about the nurse’s statement, on the basis that the nurse’s statement was inadmissible hearsay. The court denied the motion, ruling that the cardiologist’s nurse was his agent and her words could be properly brought before the jury. The court found that the plaintiff relied on that statement in determining whether to have the ICD placed or obtain a second opinion.

This raises an interesting malpractice awareness point: If you are sued for malpractice, anything you had said to a patient, the patient’s family, or your coworkers will be admissible in court as a “party admission,” classified as either nonhearsay or a hearsay exception (assuming the statement was not made as part of a bona fide peer review, in which case it will likely be subject to peer review privilege). As seen in this case, this also applies to people acting as agents on your behalf. Be cautious of what you say and how you say it—and what your practice’s representatives are saying as well.

Interestingly, the jury found for the plaintiff in the amount of $1.75 million, but they declined to award punitive damages, which are designed to punish defendants rather than compensate the plaintiff. In Arkansas, the standard for punitive damages is tough; the plaintiff must “prove by clear and convincing evidence that the defendant knew or ought to have known, that their conduct would naturally and probably result in injury or damage and that they continued the conduct with malice or in reckless disregard of the consequences from which malice may be inferred.”⁹ A similar standard exists in most states. Because there were no punitive damages, we can infer the jury did not think the defendant implanted the ICD (for profit) knowing it wasn’t indicated.

Continue to: IN SUMMARY

IN SUMMARY

Consider foreseeable risks of practice interventions; be sure your practice is not on “autopilot,” recommending a common procedure or intervention too frequently. Don’t be threatened by second opinions; welcome them. And watch your words—­as they say on every police procedural you’ve ever watched, they can be used against you.

A 39-year-old woman presented to an Arkansas cardiologist on February 12, 2010, with complaints of chest pain. The physician conducted an ankle-brachial index (ABI) test to measure the blood pressure in her lower extremity and interpreted it as less than 0.9%. He then ordered an echocardiogram to gauge the patient’s ejection fraction and interpreted the reading at 25%. Both measurements were below the normal average, which prompted the cardiologist to diagnose peripheral vascular disease and congestive heart failure.

The patient was eventually prescribed a course of cardiac medication and monitored over the ensuing months. On April 15, the cardiologist conducted a nuclear stress test; the computer-generated measurement of her ejection fraction was 50%, which the physician adjusted to 42%. In May, the patient underwent cardiac catheterization, which showed no lesions or blockages in the vessels. In the following months, the patient’s medication dosages were increased. On September 27, the cardiologist conducted another echocardiogram, which he read as 30%, and reaffirmed his diagnosis of congestive heart failure.

The physician continued to monitor the patient. On November 11, after being diagnosed with congestive heart failure, the patient was admitted to the hospital, where the cardiologist implanted an automated implantable cardioverter defibrillator (AICD).

On May 18, 2011, while running with her 2 daughters and a friend, the patient suddenly collapsed and experienced electrical currents coursing through her body (5 times). She was driven to a hospital, where it was determined that she did not go into cardiac arrest (which she suspected) but rather her defibrillator malfunctioned. The defibrillator was recalibrated to a higher setting, and she experienced no further issues.

In the ensuing years, the patient continued to follow up with her cardiologist. She eventually filed a lawsuit claiming that he had misdiagnosed congestive heart failure and unnecessarily implanted the AICD. Her experts in cardiology and cardiac electrophysiology testified that the defendant’s readings of the February 2010 ABI and echocardiogram results were incorrect; the ABIs were in fact .128 and .138 and the ejection fractions were 50% to 55% percent—in both instances, normal results. Furthermore, the September 2010 echocardiogram and another taken in February 2011, which showed little change from the first echocardiogram, were also normal, according to the experts.

The experts also opined that American College of Cardiology/American Heart Association guidelines state that a patient’s ejection fraction has to be less than 35% before a defibrillator is placed. Both experts concluded that the plaintiff did not have congestive heart failure and was therefore not a candidate for an AICD. The cardiac electrophysiology expert stated that to be a candidate, a patient must have an enlarged left ventricle—which plaintiff did not have. Moreover, none of the plaintiff’s physical findings were ever consistent with congestive heart failure: She did not have fluid in her lungs, as examinations always revealed clear lungs without congestion; there was no distention in her jugular veins; she did not experience sleep apnea; she did not lose consciousness; and she only experienced fatigue with exertion. The cardiology expert further faulted the defendant for failing to adjust the patient’s medication dosages to optimize her cardiac repair.

The defense maintained that the defendant’s treatment of the patient met the standard of care. According to the defense, the defendant’s judgment and interpretation of the patient’s ABI and echocardiogram results were medically sound and the defibrillator was necessary.

Continue to: VERDICT

VERDICT

After a 4-day trial and 3 hours of deliberation, the jury found that the defendant was liable and his actions were a factual cause of injury to plaintiff, who was awarded $1.75 million in damages.

COMMENTARY

In this case, the defendant cardiologist placed an AICD (also known as an implantable cardioverter defibrillator, or ICD). There was no allegation that the placement itself was negligent; rather, the claimed negligence was the decision to place it. But the plaintiff’s damages arise from the device’s malfunction—not the cardiologist’s decision to place it.

This case brings up an interesting issue of causation. As most of us know, medical malpractice plaintiffs must show (1) duty, (2) breach, (3) causation, and (4) harm. In law, there are 2 ways to think of causation: “but for” causation and “proximate” causation.

So-called “but for” causation is based on whether any causal relationship exists between an action and an outcome. For example, a drunk driver veers off the highway, through the breakdown lane, and strikes a tree, catching his car on fire. One minute later, a driver in the high-speed lane is captivated by the flaming vehicle, rubbernecks, fails to pay attention to traffic, and rear-ends the vehicle in front of him—injuring the driver of that car. Using “but for” causation, the drunk driver striking the tree “caused” the accident. If that had never happened, the second driver would never have been distracted, and if the driver wasn’t distracted, the second accident would not have occurred.

By contrast, “proximate” causation entails the immediate cause, which is foreseeable. Black’s Law defines proximate cause as “The result of a direct action and cause of loss to property that sets in motion a chain of events that is unbroken and causes damage, injury and destruction with no other interference” (emphasis added).¹ Using a proximate causation analysis, the second driver’s negligent failure to pay attention to the road would be the proximate cause of the second crash.

Continue to: Generally, causation analysis...

Generally, causation analysis is limited to proximate cause on the basis that harm is reasonably foreseeable. A famous example is the case of Palsgraf v. Long Island Railroad.²

Mrs. Palsgraf was standing on a train platform. A man carrying an ordinary-looking package rushed to board a moving train, with help from 2 railroad employees (1 in the car and 1 on the platform). As the ­employees pushed and pulled the man aboard, the package fell onto the tracks. Unbeknownst to everyone but the package’s owner, it contained fireworks—which exploded when the rear wheels of the train ran over the package. The explosion caused a large standing scale to fall over and land on Mrs. Palsgraf, injuring her. This is what law professors live for.

Mrs. Palsgraf sued the railroad, arguing that if the employees had not negligently pushed and pulled the man, the package would not have fallen and would not have exploded, and the scale never would have fallen on her. Mrs. Palsgraf won her trial and won her first appeal. In a famous decision by a famous judge, the win was overturned on the basis that Mrs. Palsgraf’s injuries “were not a reasonably foreseeable consequence of any possible negligence by the railroad.” This case set a foundation of American law regarding reasonable foreseeability, both in terms of identifiable plaintiffs and expected danger.

What does a railroad accident have to do with medical malpractice? In the case described here, we had an arguably negligent medical decision to place the defibrillator. Then we had a malfunction of the device, which caused the plaintiff injury. Was it reasonably foreseeable that the device would malfunction and cause harm—and should the physician be on the hook for that?

Unlike the unforeseeable risk of knocking a simple package to the ground—which unexpectedly turned out to contain fireworks—the risk of device malfunction would be foreseeable. Why? Beyond the usual surgical risks of bleeding and infection, an ICD’s leads can dislodge, the device can fail, and devices can shock inappropriately (with younger patients at increased risk for inappropriate shocks).^3,4 These risks are known, and it is highly likely the defendant cardiologist disclosed them on the consent form he asked the plaintiff to sign. The defense could not credibly argue that device malfunction was an unforeseeable risk. The malpractice here was the decision to place the ICD—and because placement wasn’t warranted in this patient, neither were the risks.

Continue to: This brings us to...

This brings us to the first malpractice trap: If you practice in a setting where a procedure is routinely offered, and that treatment has a billable cost, be cautious. Your decision-making can be made to appear driven by a profit motive. The lay public (including jurors) is suspicious of profit motive in medicine—a concept most clinicians find alien and repugnant.

Back in 2009, while outlining his rationale for the Affordable Care Act, President Obama made several statements that earned him swift rebuke from physician groups; I include them here not to incite political rants but to demonstrate the keen suspicion the public has for profit motives in clinical decision-making. On one occasion, he said, “Right now, doctors a lot of times are forced to make decisions based on the fee payment schedule. ... The doctor may look at the reimbursement system and say to himself, ‘You know what? I make a lot more money if I take this kid’s tonsils out.’”⁵ In another statement, while acknowledging that primary care providers offering preventive diabetes care make “a pittance,” Obama added, “But if that same [patient] ends up getting their foot amputated, that’s $30,000, $40,000, $50,000 immediately the surgeon is reimbursed.”⁶

For most clinicians, the idea of deciding on a course of treatment because it will be lucrative is an alien concept. Good clinicians base treatment on the accepted medical standard, and cost factors are a distant consideration if one at all.

However, if your practice involves a procedure or intervention that is a particularly lucrative billable event, do your part to play mental “devil’s advocate” and ensure that patients are genuinely in need of the treatment.

In some rare, bad (and usually highly publicized) cases, a procedure will be overused in a patently fraudulent way, which we all recognize is unethical and illegal. However, in other instances, a procedure may be overused because it is familiar and available. We’ve all heard the adage, “If all you have is a hammer, everything looks like a nail.” This “cute” expression holds some truth about the risk for cognitive bias based on the over-reliance on a familiar remedy.⁷ This particularly involves specialty practices that perform certain procedures frequently.

Continue to: In this case...

In this case, the plaintiff’s nuclear stress test showed an ejection fraction of 50%, which the defendant decreased to 42%. That is substantially different than the first ejection fraction of 25% and the second of 30% in a 39-year-old patient without any clinical signs of congestive heart failure. Did the defendant’s ability to offer an ICD color his appraisal of the patient’s cardiac function?

In closing arguments to the jury, the plaintiff’s attorney probably argued “this defendant behaved as if every human heart could be improved with a battery and wires.” Examine your practice to be sure you aren’t seeing nails where they don’t exist—because tomorrow, they will be the nails in the coffin of your career.

One thing missing from this case summary—but available via court records—is that the plaintiff claimed she had wanted a second opinion but was told she couldn’t have one: “I wanted a second opinion. And when I called [the defendant’s] office and asked ‘Could I have a second opinion,’ his nurse answered the phone and said that if I did get a second opinion, then I couldn’t come back.”⁸

There are a few aspects to discuss here, one of which is the second malpractice trap: viewing second opinions as an enemy. Most clinicians realize they are actually your friend. However, some providers are threatened by second opinions. It is as if they roll out of bed in the morning and consult the mirror to ask, “Who is the top cardiologist of them all?” and need the validation of that voice saying, “You, Dr. Smith—why of course, you!”

To that I say, forget the mirror, you egotistical so-and-so. Snow White will help protect you, your career, and most importantly, your patient. Allow the second opinion. In fact, integrate an expectation of the them into your practice style, to disarm any feelings of awkwardness, confrontation, or defensiveness. Think of the benefits: If Snow White validates your opinion, you have much stronger case that a course of treatment was indicated. Conversely, if Snow White arrives at a different opinion, she may have seen something you did not, and/or it may also relieve pressure from the patient to take an action with which you were only borderline comfortable.

Continue to: In cases I've worked on...

In cases I’ve worked on, I’ve seen some excellent surgeons who require a second opinion as a precondition to operating. This is particularly helpful when patient expectations are uncertain or there is a track record of unsuccessful interventions (eg, chronic back pain with multiple failed surgeries). Furthermore, a second opinion shows diligence, humility, and concern for the patient. It also gives you backup. As Top Gun taught us, there is no need to be a “maverick” when you can have a wingman.

As far as the alleged comment by the cardiologist’s nurse: We don’t know for certain if this actually happened—but if it did, it was unwarranted and foolish. Any jury would hear this and conclude the defendant (1) was an ass, (2) had something to hide, or (3) was guarding a profit source. Any way you slice it, this is bad for the patient and ultimately bad for the defendant. Make room in your practice for second opinions.

There was a legal fight regarding the admissibility of what the nurse had said. The defense filed a motion to prevent the plaintiff from telling the jury about the nurse’s statement, on the basis that the nurse’s statement was inadmissible hearsay. The court denied the motion, ruling that the cardiologist’s nurse was his agent and her words could be properly brought before the jury. The court found that the plaintiff relied on that statement in determining whether to have the ICD placed or obtain a second opinion.

This raises an interesting malpractice awareness point: If you are sued for malpractice, anything you had said to a patient, the patient’s family, or your coworkers will be admissible in court as a “party admission,” classified as either nonhearsay or a hearsay exception (assuming the statement was not made as part of a bona fide peer review, in which case it will likely be subject to peer review privilege). As seen in this case, this also applies to people acting as agents on your behalf. Be cautious of what you say and how you say it—and what your practice’s representatives are saying as well.

Interestingly, the jury found for the plaintiff in the amount of $1.75 million, but they declined to award punitive damages, which are designed to punish defendants rather than compensate the plaintiff. In Arkansas, the standard for punitive damages is tough; the plaintiff must “prove by clear and convincing evidence that the defendant knew or ought to have known, that their conduct would naturally and probably result in injury or damage and that they continued the conduct with malice or in reckless disregard of the consequences from which malice may be inferred.”⁹ A similar standard exists in most states. Because there were no punitive damages, we can infer the jury did not think the defendant implanted the ICD (for profit) knowing it wasn’t indicated.

Continue to: IN SUMMARY

IN SUMMARY

Consider foreseeable risks of practice interventions; be sure your practice is not on “autopilot,” recommending a common procedure or intervention too frequently. Don’t be threatened by second opinions; welcome them. And watch your words—­as they say on every police procedural you’ve ever watched, they can be used against you.

Patients at very high risk of adverse cardiovascular outcomes derive substantial benefit from proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition, according to results of two analyses from the ODYSSEY OUTCOMES trial.

In one prespecified analysis, the PCSK9 inhibitor alirocumab was linked to improved cardiovascular outcomes in patients with prior coronary artery bypass grafting (CABG), while in the other, researchers wrote that alirocumab showed a “large absolute benefit” in patients with polyvascular disease, which they defined as the presence of concomitant peripheral artery disease, cerebrovascular disease, or both.

These reports on alirocumab outcomes in patients with prior CABG and polyvascular disease appear in the Journal of the American College of Cardiology.

Prior CABG and polyvascular disease were both associated with markedly elevated risks of major adverse coronary events (MACE) and death, investigators wrote in the reports.

The ODYSSEY OUTCOMES trial included 18,924 patients with recent acute coronary syndrome (ACS) and high atherogenic lipoproteins despite intensive statin treatment. The primary outcome was MACE, comprising a composite of coronary heart disease death, nonfatal MI, ischemic stroke, or unstable angina requiring hospitalization. During a median 2.8 years of follow-up, this outcome occurred in 9.5% of the overall population randomized to alirocumab and 11.1% of those on placebo, for a statistically significant and clinically meaningful 15% relative risk reduction.

Polyvascular disease

In the trial population, 1,405 patients had polyvascular disease in at least two beds, including a coronary artery, plus either peripheral artery or cerebrovascular, while 149 had polyvascular disease in all three beds. The remainder, including 17,370 patients, were classified as having monovascular disease.

The incidences of MACE for placebo-treated patients with monovascular disease, two-bed polyvascular disease, and three-bed polyvascular disease were 10.0%, 22.2%, and 39.7%, respectively. Alirocumab treatment resulted in an absolute risk reduction for MACE of 1.4%, 1.9%, and 13.0%, for those respective groups (P = .0006).

Similarly, the incidence of the secondary endpoint of death for placebo-treated patients was 3.5%, 10.0%, and 21.8%, and the ARR with alirocumab was 0.4%, 1.3%, and 16.2% (P = .002), according to their reported data.

These results suggest that patients with polyvascular disease are an “easily identifiable subgroup” of ACS patients with a high absolute risk of MACE and death, according to the investigators, led by J. Wouter Jukema, MD, PhD, of Leiden (the Netherlands) University Medical Center.

“The large absolute benefit of PCSK9 inhibition with alirocumab, when added to high-intensity statin therapy, is a potential benefit for this group of patients,” Dr. Jukema and coauthors wrote.

Prior CABG

Of the ODYSSEY OUTCOMES patients, 1,025 had an index CABG after ACS, 1,003 had CABG before ACS, and the remaining 16,896 had no such procedure.

Hazard ratios for both MACE and death in all CABG categories were consistent with the overall results of ODYSSEY OUTCOMES, the investigators wrote. Specifically, alirocumab reduced MACE and death in the overall study, with HRs of 0.85 for both endpoints.

The ARRs in MACE with alirocumab were 1.3% for no CABG, 0.9% for index CABG, and 6.4% for prior CABG (P = .0007), while ARRs in death with the treatment were 0.4%, 0.5%, and 3.6% (P = .03) for those categories, respectively. In this analysis, the investigators calculated the number needed to treat to prevent one primary or secondary endpoint over the median 2.8 years of follow-up. The numbers needed to treat were 16 for prior CABG, 111 for index, and 77 for no prior CABG.

“Although the relative benefit of alirocumab versus placebo is consistent regardless of prior CABG status, those with prior CABG achieve substantially greater absolute risk reduction and consequently lower number needed to treat,” wrote the authors of the analysis, led by Shaun G. Goodman, MD, MSc, of St. Michael’s Hospital, Toronto.

Funding for the ODYSSEY OUTCOMES trial and its subanalyses was provided by Sanofi and Regeneron. Authors of the analyses reported disclosures related to Sanofi, Regeneron, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and others.

SOURCES: Goodman SG et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.07.015; Jukema JW et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.03.013.

Patients at very high risk of adverse cardiovascular outcomes derive substantial benefit from proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition, according to results of two analyses from the ODYSSEY OUTCOMES trial.

In one prespecified analysis, the PCSK9 inhibitor alirocumab was linked to improved cardiovascular outcomes in patients with prior coronary artery bypass grafting (CABG), while in the other, researchers wrote that alirocumab showed a “large absolute benefit” in patients with polyvascular disease, which they defined as the presence of concomitant peripheral artery disease, cerebrovascular disease, or both.

These reports on alirocumab outcomes in patients with prior CABG and polyvascular disease appear in the Journal of the American College of Cardiology.

Prior CABG and polyvascular disease were both associated with markedly elevated risks of major adverse coronary events (MACE) and death, investigators wrote in the reports.

The ODYSSEY OUTCOMES trial included 18,924 patients with recent acute coronary syndrome (ACS) and high atherogenic lipoproteins despite intensive statin treatment. The primary outcome was MACE, comprising a composite of coronary heart disease death, nonfatal MI, ischemic stroke, or unstable angina requiring hospitalization. During a median 2.8 years of follow-up, this outcome occurred in 9.5% of the overall population randomized to alirocumab and 11.1% of those on placebo, for a statistically significant and clinically meaningful 15% relative risk reduction.

Polyvascular disease

In the trial population, 1,405 patients had polyvascular disease in at least two beds, including a coronary artery, plus either peripheral artery or cerebrovascular, while 149 had polyvascular disease in all three beds. The remainder, including 17,370 patients, were classified as having monovascular disease.

The incidences of MACE for placebo-treated patients with monovascular disease, two-bed polyvascular disease, and three-bed polyvascular disease were 10.0%, 22.2%, and 39.7%, respectively. Alirocumab treatment resulted in an absolute risk reduction for MACE of 1.4%, 1.9%, and 13.0%, for those respective groups (P = .0006).

Similarly, the incidence of the secondary endpoint of death for placebo-treated patients was 3.5%, 10.0%, and 21.8%, and the ARR with alirocumab was 0.4%, 1.3%, and 16.2% (P = .002), according to their reported data.

These results suggest that patients with polyvascular disease are an “easily identifiable subgroup” of ACS patients with a high absolute risk of MACE and death, according to the investigators, led by J. Wouter Jukema, MD, PhD, of Leiden (the Netherlands) University Medical Center.

“The large absolute benefit of PCSK9 inhibition with alirocumab, when added to high-intensity statin therapy, is a potential benefit for this group of patients,” Dr. Jukema and coauthors wrote.

Prior CABG

Of the ODYSSEY OUTCOMES patients, 1,025 had an index CABG after ACS, 1,003 had CABG before ACS, and the remaining 16,896 had no such procedure.

Hazard ratios for both MACE and death in all CABG categories were consistent with the overall results of ODYSSEY OUTCOMES, the investigators wrote. Specifically, alirocumab reduced MACE and death in the overall study, with HRs of 0.85 for both endpoints.

The ARRs in MACE with alirocumab were 1.3% for no CABG, 0.9% for index CABG, and 6.4% for prior CABG (P = .0007), while ARRs in death with the treatment were 0.4%, 0.5%, and 3.6% (P = .03) for those categories, respectively. In this analysis, the investigators calculated the number needed to treat to prevent one primary or secondary endpoint over the median 2.8 years of follow-up. The numbers needed to treat were 16 for prior CABG, 111 for index, and 77 for no prior CABG.

“Although the relative benefit of alirocumab versus placebo is consistent regardless of prior CABG status, those with prior CABG achieve substantially greater absolute risk reduction and consequently lower number needed to treat,” wrote the authors of the analysis, led by Shaun G. Goodman, MD, MSc, of St. Michael’s Hospital, Toronto.

Funding for the ODYSSEY OUTCOMES trial and its subanalyses was provided by Sanofi and Regeneron. Authors of the analyses reported disclosures related to Sanofi, Regeneron, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and others.

SOURCES: Goodman SG et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.07.015; Jukema JW et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.03.013.

Patients at very high risk of adverse cardiovascular outcomes derive substantial benefit from proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition, according to results of two analyses from the ODYSSEY OUTCOMES trial.

In one prespecified analysis, the PCSK9 inhibitor alirocumab was linked to improved cardiovascular outcomes in patients with prior coronary artery bypass grafting (CABG), while in the other, researchers wrote that alirocumab showed a “large absolute benefit” in patients with polyvascular disease, which they defined as the presence of concomitant peripheral artery disease, cerebrovascular disease, or both.

These reports on alirocumab outcomes in patients with prior CABG and polyvascular disease appear in the Journal of the American College of Cardiology.

Prior CABG and polyvascular disease were both associated with markedly elevated risks of major adverse coronary events (MACE) and death, investigators wrote in the reports.

The ODYSSEY OUTCOMES trial included 18,924 patients with recent acute coronary syndrome (ACS) and high atherogenic lipoproteins despite intensive statin treatment. The primary outcome was MACE, comprising a composite of coronary heart disease death, nonfatal MI, ischemic stroke, or unstable angina requiring hospitalization. During a median 2.8 years of follow-up, this outcome occurred in 9.5% of the overall population randomized to alirocumab and 11.1% of those on placebo, for a statistically significant and clinically meaningful 15% relative risk reduction.

Polyvascular disease

In the trial population, 1,405 patients had polyvascular disease in at least two beds, including a coronary artery, plus either peripheral artery or cerebrovascular, while 149 had polyvascular disease in all three beds. The remainder, including 17,370 patients, were classified as having monovascular disease.

The incidences of MACE for placebo-treated patients with monovascular disease, two-bed polyvascular disease, and three-bed polyvascular disease were 10.0%, 22.2%, and 39.7%, respectively. Alirocumab treatment resulted in an absolute risk reduction for MACE of 1.4%, 1.9%, and 13.0%, for those respective groups (P = .0006).

Similarly, the incidence of the secondary endpoint of death for placebo-treated patients was 3.5%, 10.0%, and 21.8%, and the ARR with alirocumab was 0.4%, 1.3%, and 16.2% (P = .002), according to their reported data.

These results suggest that patients with polyvascular disease are an “easily identifiable subgroup” of ACS patients with a high absolute risk of MACE and death, according to the investigators, led by J. Wouter Jukema, MD, PhD, of Leiden (the Netherlands) University Medical Center.

“The large absolute benefit of PCSK9 inhibition with alirocumab, when added to high-intensity statin therapy, is a potential benefit for this group of patients,” Dr. Jukema and coauthors wrote.

Prior CABG

Of the ODYSSEY OUTCOMES patients, 1,025 had an index CABG after ACS, 1,003 had CABG before ACS, and the remaining 16,896 had no such procedure.

Hazard ratios for both MACE and death in all CABG categories were consistent with the overall results of ODYSSEY OUTCOMES, the investigators wrote. Specifically, alirocumab reduced MACE and death in the overall study, with HRs of 0.85 for both endpoints.

The ARRs in MACE with alirocumab were 1.3% for no CABG, 0.9% for index CABG, and 6.4% for prior CABG (P = .0007), while ARRs in death with the treatment were 0.4%, 0.5%, and 3.6% (P = .03) for those categories, respectively. In this analysis, the investigators calculated the number needed to treat to prevent one primary or secondary endpoint over the median 2.8 years of follow-up. The numbers needed to treat were 16 for prior CABG, 111 for index, and 77 for no prior CABG.

“Although the relative benefit of alirocumab versus placebo is consistent regardless of prior CABG status, those with prior CABG achieve substantially greater absolute risk reduction and consequently lower number needed to treat,” wrote the authors of the analysis, led by Shaun G. Goodman, MD, MSc, of St. Michael’s Hospital, Toronto.

Funding for the ODYSSEY OUTCOMES trial and its subanalyses was provided by Sanofi and Regeneron. Authors of the analyses reported disclosures related to Sanofi, Regeneron, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and others.

SOURCES: Goodman SG et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.07.015; Jukema JW et al. J Am Coll Cardiol. 2019 Aug 26. doi: 10.1016/j.jacc.2019.03.013.

SEATTLE – Rady Children’s Hospital in San Diego has been doing continuous positive airway pressure for infants with bronchiolitis on the general pediatrics floors safely and with no problems for nearly 20 years, according to a presentation at Pediatric Hospital Medicine.

It’s newsworthy because “very, very few” hospitals do bronchiolitis continuous positive airway pressure (CPAP) outside of the ICU. “The perception is that there are complications, and you might miss kids that are really sick if you keep them on the floor.” However, “we have been doing it safely for so long that no one thinks twice about it,” said Christiane Lenzen, MD, a pediatric hospitalist at Rady and an assistant clinical professor of pediatrics at the University of California, San Diego.

It doesn’t matter if children have congenital heart disease, chronic lung disease, or other problems, she said, “if they are stable enough for the floor, we will see if it’s okay.”

Rady’s hand was forced on the issue because it has a large catchment area but limited ICU beds, so for practical reasons and within certain limits, CPAP moved to the floors. One of Dr. Lenzen’s colleagues noted that, as long as there’s nurse and respiratory leadership buy in, “it’s actually quite easy to pull off in a very safe manner.”

Rady has a significant advantage over community hospitals and other places considering the approach, because it has onsite pediatric ICU services for when things head south. Over the past 3 or so years, 52% of the children the pediatric hospital medicine service started on CPAP (168/324) had to be transferred to the ICU; 17% were ultimately intubated.

Many of those transfers were caused by comorbidities, not CPAP failure, but other times children needed greater respiratory support; in general, the floor CPAP limit is 6 cm H₂O and a fraction of inspired oxygen of 50%. Also, sometimes children needed to be sedated for CPAP, which isn’t done on the floor.

With the 52% transfer rate, “I would worry about patients who are sick enough to need CPAP staying” in a hospital without quick access to ICU services, Dr. Lenzen said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Even so, among 324 children who at least initially were treated with CPAP on the floor – out of 2,424 admitted to the pediatric hospital medicine service with bronchiolitis – there hasn’t been a single pneumothorax, aspiration event, or CPAP equipment–related injury, she said.

CPAP on the floor has several benefits. ICU resources are conserved, patient handoffs and the work of transfers into and out of the ICU are avoided, families don’t have to get used to a new treatment team, and infants aren’t subjected to the jarring ICU environment.

For it to work, though, staff “really need to be on top of this,” and “it needs to be very tightly controlled” with order sets and other measures, the presenters said. There’s regular training at Rady for nurses, respiratory therapists, and hospitalists on CPAP equipment, airway management, monitoring, troubleshooting, and other essentials.

Almost all children on the pediatric floors have a trial of high-flow nasal cannula with an upper limit of 8 L/min. If the Respiratory Assessment Score hasn’t improved in an hour, CPAP is considered. If a child is admitted with a score above 10 and they seem to be worsening, they go straight to CPAP.

Children alternate between nasal prongs and nasal masks to prevent pressure necrosis, and are kept nil per os while on CPAP. They are on continual pulse oximetry and cardiorespiratory monitoring. Vital signs and respiratory scores are checked frequently, more so for children who are struggling.

The patient-to-nurse ratio drops from the usual 4:1 to 3:1 when a child goes on CPAP, and to 2:1 if necessary. Traveling nurses aren’t allowed to take CPAP cases.

The presenters didn’t report any disclosures.

This article was updated 8/27/19.

aotto@mdedge.com

SEATTLE – Rady Children’s Hospital in San Diego has been doing continuous positive airway pressure for infants with bronchiolitis on the general pediatrics floors safely and with no problems for nearly 20 years, according to a presentation at Pediatric Hospital Medicine.

It’s newsworthy because “very, very few” hospitals do bronchiolitis continuous positive airway pressure (CPAP) outside of the ICU. “The perception is that there are complications, and you might miss kids that are really sick if you keep them on the floor.” However, “we have been doing it safely for so long that no one thinks twice about it,” said Christiane Lenzen, MD, a pediatric hospitalist at Rady and an assistant clinical professor of pediatrics at the University of California, San Diego.

It doesn’t matter if children have congenital heart disease, chronic lung disease, or other problems, she said, “if they are stable enough for the floor, we will see if it’s okay.”

Rady’s hand was forced on the issue because it has a large catchment area but limited ICU beds, so for practical reasons and within certain limits, CPAP moved to the floors. One of Dr. Lenzen’s colleagues noted that, as long as there’s nurse and respiratory leadership buy in, “it’s actually quite easy to pull off in a very safe manner.”

Rady has a significant advantage over community hospitals and other places considering the approach, because it has onsite pediatric ICU services for when things head south. Over the past 3 or so years, 52% of the children the pediatric hospital medicine service started on CPAP (168/324) had to be transferred to the ICU; 17% were ultimately intubated.

Many of those transfers were caused by comorbidities, not CPAP failure, but other times children needed greater respiratory support; in general, the floor CPAP limit is 6 cm H₂O and a fraction of inspired oxygen of 50%. Also, sometimes children needed to be sedated for CPAP, which isn’t done on the floor.

With the 52% transfer rate, “I would worry about patients who are sick enough to need CPAP staying” in a hospital without quick access to ICU services, Dr. Lenzen said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Even so, among 324 children who at least initially were treated with CPAP on the floor – out of 2,424 admitted to the pediatric hospital medicine service with bronchiolitis – there hasn’t been a single pneumothorax, aspiration event, or CPAP equipment–related injury, she said.

CPAP on the floor has several benefits. ICU resources are conserved, patient handoffs and the work of transfers into and out of the ICU are avoided, families don’t have to get used to a new treatment team, and infants aren’t subjected to the jarring ICU environment.

For it to work, though, staff “really need to be on top of this,” and “it needs to be very tightly controlled” with order sets and other measures, the presenters said. There’s regular training at Rady for nurses, respiratory therapists, and hospitalists on CPAP equipment, airway management, monitoring, troubleshooting, and other essentials.

Almost all children on the pediatric floors have a trial of high-flow nasal cannula with an upper limit of 8 L/min. If the Respiratory Assessment Score hasn’t improved in an hour, CPAP is considered. If a child is admitted with a score above 10 and they seem to be worsening, they go straight to CPAP.

Children alternate between nasal prongs and nasal masks to prevent pressure necrosis, and are kept nil per os while on CPAP. They are on continual pulse oximetry and cardiorespiratory monitoring. Vital signs and respiratory scores are checked frequently, more so for children who are struggling.

The patient-to-nurse ratio drops from the usual 4:1 to 3:1 when a child goes on CPAP, and to 2:1 if necessary. Traveling nurses aren’t allowed to take CPAP cases.

The presenters didn’t report any disclosures.

This article was updated 8/27/19.

aotto@mdedge.com

SEATTLE – Rady Children’s Hospital in San Diego has been doing continuous positive airway pressure for infants with bronchiolitis on the general pediatrics floors safely and with no problems for nearly 20 years, according to a presentation at Pediatric Hospital Medicine.

It’s newsworthy because “very, very few” hospitals do bronchiolitis continuous positive airway pressure (CPAP) outside of the ICU. “The perception is that there are complications, and you might miss kids that are really sick if you keep them on the floor.” However, “we have been doing it safely for so long that no one thinks twice about it,” said Christiane Lenzen, MD, a pediatric hospitalist at Rady and an assistant clinical professor of pediatrics at the University of California, San Diego.

It doesn’t matter if children have congenital heart disease, chronic lung disease, or other problems, she said, “if they are stable enough for the floor, we will see if it’s okay.”

Rady’s hand was forced on the issue because it has a large catchment area but limited ICU beds, so for practical reasons and within certain limits, CPAP moved to the floors. One of Dr. Lenzen’s colleagues noted that, as long as there’s nurse and respiratory leadership buy in, “it’s actually quite easy to pull off in a very safe manner.”

Rady has a significant advantage over community hospitals and other places considering the approach, because it has onsite pediatric ICU services for when things head south. Over the past 3 or so years, 52% of the children the pediatric hospital medicine service started on CPAP (168/324) had to be transferred to the ICU; 17% were ultimately intubated.

Many of those transfers were caused by comorbidities, not CPAP failure, but other times children needed greater respiratory support; in general, the floor CPAP limit is 6 cm H₂O and a fraction of inspired oxygen of 50%. Also, sometimes children needed to be sedated for CPAP, which isn’t done on the floor.

With the 52% transfer rate, “I would worry about patients who are sick enough to need CPAP staying” in a hospital without quick access to ICU services, Dr. Lenzen said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Even so, among 324 children who at least initially were treated with CPAP on the floor – out of 2,424 admitted to the pediatric hospital medicine service with bronchiolitis – there hasn’t been a single pneumothorax, aspiration event, or CPAP equipment–related injury, she said.

CPAP on the floor has several benefits. ICU resources are conserved, patient handoffs and the work of transfers into and out of the ICU are avoided, families don’t have to get used to a new treatment team, and infants aren’t subjected to the jarring ICU environment.

For it to work, though, staff “really need to be on top of this,” and “it needs to be very tightly controlled” with order sets and other measures, the presenters said. There’s regular training at Rady for nurses, respiratory therapists, and hospitalists on CPAP equipment, airway management, monitoring, troubleshooting, and other essentials.

Almost all children on the pediatric floors have a trial of high-flow nasal cannula with an upper limit of 8 L/min. If the Respiratory Assessment Score hasn’t improved in an hour, CPAP is considered. If a child is admitted with a score above 10 and they seem to be worsening, they go straight to CPAP.

Children alternate between nasal prongs and nasal masks to prevent pressure necrosis, and are kept nil per os while on CPAP. They are on continual pulse oximetry and cardiorespiratory monitoring. Vital signs and respiratory scores are checked frequently, more so for children who are struggling.

The patient-to-nurse ratio drops from the usual 4:1 to 3:1 when a child goes on CPAP, and to 2:1 if necessary. Traveling nurses aren’t allowed to take CPAP cases.

The presenters didn’t report any disclosures.

This article was updated 8/27/19.

aotto@mdedge.com