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Absorb’s problems will revise coronary scaffold standards
One-year outcome results of the first bioresorbable coronary scaffold on the U.S. and world markets, Absorb, failed to show longer-term problems with the device that only became apparent with 3-year follow-up.
The failure of Absorb to show benefits after 3 years in the ABSORB II trial will probably not dampen enthusiasm for the concept of a bioresorbable coronary scaffold (BRS). The idea of treating coronary stenoses with a stent that disappears after a few years once it has done its job is a powerfully attractive idea, and reports from several early-stage clinical tests of new BRSs during TCT 2016 showed that many next-generation versions of these devices are in very active development.
The surprising ABSORB II results showed more than just a failure of the Absorb BRS to produce 3 years after placement the improved coronary artery vasomotion and reduced late lumen loss that were the two primary efficacy endpoints of the trial.
The results also showed troubling signs of harm from the BRS, including significantly worse late lumen loss, compared with a contemporary drug-eluting metallic stent. In addition, there was a shocking 1%/year rate of late stent thrombosis during both the second and third years following Absorb placement in coronary arteries, the period when the Absorb BRS was in the process of disappearing, and which did not occur in the study’s control patients who received a conventional, metallic drug-eluting stent.
Patrick W. Serruys, MD, lead investigator of ABSORB II, attributed these adverse outcomes to the “highly thrombogenic” proteoglycan material that formed as the Absorb BRS resorbed, and a “structural discontinuity” of the BRS as it resorbed in some patients, resulting in parts of the scaffold remnant sticking out from the coronary artery wall toward the center of the vessel.
These late flaws in the bioresorption process will now need closer scrutiny during future studies of next-generation BRSs, and will surely mean longer follow-up of pivotal trials and a shift from the 1-year follow-up data used by the Food and Drug Administration when it approved the Absorb BRS last July.
“The challenge for the field [of BRS development] is the late results, as we saw in ABSORB II,” commented David J. Cohen, MD, an interventional cardiologist at Saint Luke’s Health System in Kansas City, Mo. The ABSORB II results “will lead to reexamination of the trial design and endpoints for the next generation of BRSs,” Dr. Cohen predicted at the meeting, sponsored by the Cardiovascular Research Foundation.
“It’s not clear that BRS reduces the duration for DAPT,” Dr. Cohen noted, at least for the Absorb device, which is not full resorbed until it’s been in patients for about 3 years.
A striking property of the next-generation BRSs reported at the meeting was their use of thinner struts and faster resorption times. “These iterations hold immense promise for improving late outcomes,” commented Dean J. Kereiakes, MD, an interventional cardiologist at the Christ Hospital in Cincinnati who helped lead the large U.S. clinical trial of the Absorb BRS, ABSORB III.
[email protected]
On Twitter @mitchelzoler
One-year outcome results of the first bioresorbable coronary scaffold on the U.S. and world markets, Absorb, failed to show longer-term problems with the device that only became apparent with 3-year follow-up.
The failure of Absorb to show benefits after 3 years in the ABSORB II trial will probably not dampen enthusiasm for the concept of a bioresorbable coronary scaffold (BRS). The idea of treating coronary stenoses with a stent that disappears after a few years once it has done its job is a powerfully attractive idea, and reports from several early-stage clinical tests of new BRSs during TCT 2016 showed that many next-generation versions of these devices are in very active development.
The surprising ABSORB II results showed more than just a failure of the Absorb BRS to produce 3 years after placement the improved coronary artery vasomotion and reduced late lumen loss that were the two primary efficacy endpoints of the trial.
The results also showed troubling signs of harm from the BRS, including significantly worse late lumen loss, compared with a contemporary drug-eluting metallic stent. In addition, there was a shocking 1%/year rate of late stent thrombosis during both the second and third years following Absorb placement in coronary arteries, the period when the Absorb BRS was in the process of disappearing, and which did not occur in the study’s control patients who received a conventional, metallic drug-eluting stent.
Patrick W. Serruys, MD, lead investigator of ABSORB II, attributed these adverse outcomes to the “highly thrombogenic” proteoglycan material that formed as the Absorb BRS resorbed, and a “structural discontinuity” of the BRS as it resorbed in some patients, resulting in parts of the scaffold remnant sticking out from the coronary artery wall toward the center of the vessel.
These late flaws in the bioresorption process will now need closer scrutiny during future studies of next-generation BRSs, and will surely mean longer follow-up of pivotal trials and a shift from the 1-year follow-up data used by the Food and Drug Administration when it approved the Absorb BRS last July.
“The challenge for the field [of BRS development] is the late results, as we saw in ABSORB II,” commented David J. Cohen, MD, an interventional cardiologist at Saint Luke’s Health System in Kansas City, Mo. The ABSORB II results “will lead to reexamination of the trial design and endpoints for the next generation of BRSs,” Dr. Cohen predicted at the meeting, sponsored by the Cardiovascular Research Foundation.
“It’s not clear that BRS reduces the duration for DAPT,” Dr. Cohen noted, at least for the Absorb device, which is not full resorbed until it’s been in patients for about 3 years.
A striking property of the next-generation BRSs reported at the meeting was their use of thinner struts and faster resorption times. “These iterations hold immense promise for improving late outcomes,” commented Dean J. Kereiakes, MD, an interventional cardiologist at the Christ Hospital in Cincinnati who helped lead the large U.S. clinical trial of the Absorb BRS, ABSORB III.
[email protected]
On Twitter @mitchelzoler
One-year outcome results of the first bioresorbable coronary scaffold on the U.S. and world markets, Absorb, failed to show longer-term problems with the device that only became apparent with 3-year follow-up.
The failure of Absorb to show benefits after 3 years in the ABSORB II trial will probably not dampen enthusiasm for the concept of a bioresorbable coronary scaffold (BRS). The idea of treating coronary stenoses with a stent that disappears after a few years once it has done its job is a powerfully attractive idea, and reports from several early-stage clinical tests of new BRSs during TCT 2016 showed that many next-generation versions of these devices are in very active development.
The surprising ABSORB II results showed more than just a failure of the Absorb BRS to produce 3 years after placement the improved coronary artery vasomotion and reduced late lumen loss that were the two primary efficacy endpoints of the trial.
The results also showed troubling signs of harm from the BRS, including significantly worse late lumen loss, compared with a contemporary drug-eluting metallic stent. In addition, there was a shocking 1%/year rate of late stent thrombosis during both the second and third years following Absorb placement in coronary arteries, the period when the Absorb BRS was in the process of disappearing, and which did not occur in the study’s control patients who received a conventional, metallic drug-eluting stent.
Patrick W. Serruys, MD, lead investigator of ABSORB II, attributed these adverse outcomes to the “highly thrombogenic” proteoglycan material that formed as the Absorb BRS resorbed, and a “structural discontinuity” of the BRS as it resorbed in some patients, resulting in parts of the scaffold remnant sticking out from the coronary artery wall toward the center of the vessel.
These late flaws in the bioresorption process will now need closer scrutiny during future studies of next-generation BRSs, and will surely mean longer follow-up of pivotal trials and a shift from the 1-year follow-up data used by the Food and Drug Administration when it approved the Absorb BRS last July.
“The challenge for the field [of BRS development] is the late results, as we saw in ABSORB II,” commented David J. Cohen, MD, an interventional cardiologist at Saint Luke’s Health System in Kansas City, Mo. The ABSORB II results “will lead to reexamination of the trial design and endpoints for the next generation of BRSs,” Dr. Cohen predicted at the meeting, sponsored by the Cardiovascular Research Foundation.
“It’s not clear that BRS reduces the duration for DAPT,” Dr. Cohen noted, at least for the Absorb device, which is not full resorbed until it’s been in patients for about 3 years.
A striking property of the next-generation BRSs reported at the meeting was their use of thinner struts and faster resorption times. “These iterations hold immense promise for improving late outcomes,” commented Dean J. Kereiakes, MD, an interventional cardiologist at the Christ Hospital in Cincinnati who helped lead the large U.S. clinical trial of the Absorb BRS, ABSORB III.
[email protected]
On Twitter @mitchelzoler
Why is the mental health burden in EDs rising?
The mounting impact of mental illness on patients and the American health care system has been of growing concern, especially in recent years. As such, now more than ever, it is important to understand the mental health burden and investigate the factors contributing to the elevated use of emergency departments to treat patients with psychiatric illness.
In recent years, the overall prevalence of mental illness has not changed drastically. According to the 2014 National Survey of Drug Use and Health, 18.1% of adults indicated having “any mental illness,” a prevalence that had not changed much since 2008.1 It is possible, however, that despite the relative stability in the prevalence of mental illness, the acuity of mental illness may be on the rise. For instance, 4.1% of adults indicated having a “serious mental illness” (SMI) in 2014, a prevalence that was 0.4% higher than that of 2008 and 2009.1 Also, of note, the prevalence of SMI among the 18-to-25-year-old population in 2014 had increased in previous years.1 Meanwhile, 6.6% of adults indicated having experienced a major depressive episode at least once in the preceding 12 months. That prevalence has held relatively steady over recent years.1
Despite the rising need for mental health services, the number of inpatient psychiatric beds has declined. During the 32 years between 1970 and 2002, the United States experienced a staggering nearly 60% decline in the number of inpatient psychiatric beds.4 Moreover, the number of psychiatric beds within the national public sector fell from 50,509 in 2005 to 43,318 in 2010, which is about a 14% decline.5 This decrease translated to a decrease from 17.1 beds/100,000 people in 2005 to 14.1 beds/100,000 in 2010 – both of which fall drastically below the “minimum number of public psychiatric beds deemed necessary for adequate psychiatric services (50/100,000).”5 Similarly, psychiatric practice has been unable to keep up with the increasing population size – the population-adjusted median number of psychiatrists declined 10.2% between 2003 and 2013.6
While inpatient psychiatric beds and psychiatrist availability have declined, the frequency of ED use for mental health reasons has increased. Mental health or substance abuse diagnoses directly accounted for 4.3% of ED visits in 2007 and were associated with 12.5% of ED visits.7 Specifically, there was a 19.3% increase in the rate of nonmaternal treat-and-release ED visits for mental health reasons between 2008-2012.8 Moreover, in a study assessing frequent treat-and-release ED visits among Medicaid patients, investigators found that while most ED visits were for non–mental health purposes, the odds of frequent ED use were higher among patients with either a psychiatric disorder or substance use problem across all levels of overall health complexity.9
What factors have been driving adults to increasingly rely on ED visits for their mental health care? Given the immense complexity of the U.S. mental health delivery system, it is evident that there is no clear-cut explanation. However, several specific factors may have contributed and must be investigated to better our understanding of this public health conundrum. The opioid epidemic, transition out of the correctional system, and coverage changes under the Affordable Care Act are hypotheses that will be examined further in the context of this pressing issue.
References
1. “Behavioral Health Trends in the United States: Results from the 2014 National Survey on Drug Use and Health.”
2. “Increase in Suicide in the United States, 1999-2014.” NCHS Data Brief No. 241, April 2016.
3. Web-Based Injury Statistics Query and Reporting System (WISQARS), Centers for Disease Control and Prevention.
4. National Health Policy Forum Issue Brief (2007 Aug 1;[823]:1-21).
5. “No Room at the Inn: Trends and Consequences of Closing Public Psychiatric Hospitals, 2005-2010,” Arlington, Va.: Treatment Advocacy Center, July 19, 2012.
6. “Population of U.S. Practicing Psychiatrists Declined, 2003-13, Which May Help Explain Poor Access to Mental Health Care,” Health Aff (Millwood). 2016 Jul 1;35[7]:1271-7.
7. “Mental Health and Substance Abuse-Related Emergency Department Visits Among Adults, 2007: Statistical Brief #92,” in Healthcare Cost and Utilization Project Statistical Briefs, (Rockville, Md.: Agency for Healthcare Research and Quality, 2010).
8. “Trends in Potentially Preventable Inpatient Hospital Admissions and Emergency Department Visits, 2015: Statistical Brief #195,” in Healthcare Cost and Utilization Project Statistical Briefs, (Rockville, Md.: Agency for Healthcare Research and Quality).
9. Nurs Res. 2015 Jan-Feb;64[1]3-12.
10. Ann Emerg Med. 2016 Apr;67[4]:525-30.
Ms. Kablanian is a 2nd-year medical student at the George Washington University, Washington, where she is enrolled in the Community and Urban Health Scholarly Concentration Program. Before attending medical school, she earned a master of public health degree in epidemiology from Columbia University, New York. She also holds a bachelor’s degree in biology and French from Scripps College, Claremont, Calif. Her interests include advocating for the urban underserved, contributing to medical curriculum development, and investigating population-level contributors to adverse health outcomes. Dr. Norris is assistant professor in the department of psychiatry & behavioral sciences, and assistant dean of student affairs at the George Washington University. He also is medical director of psychiatric & behavioral sciences at George Washington University Hospital. As part of his commitment to providing mental health care to patients with severe medical illness, Dr. Norris has been a leading voice within the psychiatric community on the value of palliative psychotherapy.
The mounting impact of mental illness on patients and the American health care system has been of growing concern, especially in recent years. As such, now more than ever, it is important to understand the mental health burden and investigate the factors contributing to the elevated use of emergency departments to treat patients with psychiatric illness.
In recent years, the overall prevalence of mental illness has not changed drastically. According to the 2014 National Survey of Drug Use and Health, 18.1% of adults indicated having “any mental illness,” a prevalence that had not changed much since 2008.1 It is possible, however, that despite the relative stability in the prevalence of mental illness, the acuity of mental illness may be on the rise. For instance, 4.1% of adults indicated having a “serious mental illness” (SMI) in 2014, a prevalence that was 0.4% higher than that of 2008 and 2009.1 Also, of note, the prevalence of SMI among the 18-to-25-year-old population in 2014 had increased in previous years.1 Meanwhile, 6.6% of adults indicated having experienced a major depressive episode at least once in the preceding 12 months. That prevalence has held relatively steady over recent years.1
Despite the rising need for mental health services, the number of inpatient psychiatric beds has declined. During the 32 years between 1970 and 2002, the United States experienced a staggering nearly 60% decline in the number of inpatient psychiatric beds.4 Moreover, the number of psychiatric beds within the national public sector fell from 50,509 in 2005 to 43,318 in 2010, which is about a 14% decline.5 This decrease translated to a decrease from 17.1 beds/100,000 people in 2005 to 14.1 beds/100,000 in 2010 – both of which fall drastically below the “minimum number of public psychiatric beds deemed necessary for adequate psychiatric services (50/100,000).”5 Similarly, psychiatric practice has been unable to keep up with the increasing population size – the population-adjusted median number of psychiatrists declined 10.2% between 2003 and 2013.6
While inpatient psychiatric beds and psychiatrist availability have declined, the frequency of ED use for mental health reasons has increased. Mental health or substance abuse diagnoses directly accounted for 4.3% of ED visits in 2007 and were associated with 12.5% of ED visits.7 Specifically, there was a 19.3% increase in the rate of nonmaternal treat-and-release ED visits for mental health reasons between 2008-2012.8 Moreover, in a study assessing frequent treat-and-release ED visits among Medicaid patients, investigators found that while most ED visits were for non–mental health purposes, the odds of frequent ED use were higher among patients with either a psychiatric disorder or substance use problem across all levels of overall health complexity.9
What factors have been driving adults to increasingly rely on ED visits for their mental health care? Given the immense complexity of the U.S. mental health delivery system, it is evident that there is no clear-cut explanation. However, several specific factors may have contributed and must be investigated to better our understanding of this public health conundrum. The opioid epidemic, transition out of the correctional system, and coverage changes under the Affordable Care Act are hypotheses that will be examined further in the context of this pressing issue.
References
1. “Behavioral Health Trends in the United States: Results from the 2014 National Survey on Drug Use and Health.”
2. “Increase in Suicide in the United States, 1999-2014.” NCHS Data Brief No. 241, April 2016.
3. Web-Based Injury Statistics Query and Reporting System (WISQARS), Centers for Disease Control and Prevention.
4. National Health Policy Forum Issue Brief (2007 Aug 1;[823]:1-21).
5. “No Room at the Inn: Trends and Consequences of Closing Public Psychiatric Hospitals, 2005-2010,” Arlington, Va.: Treatment Advocacy Center, July 19, 2012.
6. “Population of U.S. Practicing Psychiatrists Declined, 2003-13, Which May Help Explain Poor Access to Mental Health Care,” Health Aff (Millwood). 2016 Jul 1;35[7]:1271-7.
7. “Mental Health and Substance Abuse-Related Emergency Department Visits Among Adults, 2007: Statistical Brief #92,” in Healthcare Cost and Utilization Project Statistical Briefs, (Rockville, Md.: Agency for Healthcare Research and Quality, 2010).
8. “Trends in Potentially Preventable Inpatient Hospital Admissions and Emergency Department Visits, 2015: Statistical Brief #195,” in Healthcare Cost and Utilization Project Statistical Briefs, (Rockville, Md.: Agency for Healthcare Research and Quality).
9. Nurs Res. 2015 Jan-Feb;64[1]3-12.
10. Ann Emerg Med. 2016 Apr;67[4]:525-30.
Ms. Kablanian is a 2nd-year medical student at the George Washington University, Washington, where she is enrolled in the Community and Urban Health Scholarly Concentration Program. Before attending medical school, she earned a master of public health degree in epidemiology from Columbia University, New York. She also holds a bachelor’s degree in biology and French from Scripps College, Claremont, Calif. Her interests include advocating for the urban underserved, contributing to medical curriculum development, and investigating population-level contributors to adverse health outcomes. Dr. Norris is assistant professor in the department of psychiatry & behavioral sciences, and assistant dean of student affairs at the George Washington University. He also is medical director of psychiatric & behavioral sciences at George Washington University Hospital. As part of his commitment to providing mental health care to patients with severe medical illness, Dr. Norris has been a leading voice within the psychiatric community on the value of palliative psychotherapy.
The mounting impact of mental illness on patients and the American health care system has been of growing concern, especially in recent years. As such, now more than ever, it is important to understand the mental health burden and investigate the factors contributing to the elevated use of emergency departments to treat patients with psychiatric illness.
In recent years, the overall prevalence of mental illness has not changed drastically. According to the 2014 National Survey of Drug Use and Health, 18.1% of adults indicated having “any mental illness,” a prevalence that had not changed much since 2008.1 It is possible, however, that despite the relative stability in the prevalence of mental illness, the acuity of mental illness may be on the rise. For instance, 4.1% of adults indicated having a “serious mental illness” (SMI) in 2014, a prevalence that was 0.4% higher than that of 2008 and 2009.1 Also, of note, the prevalence of SMI among the 18-to-25-year-old population in 2014 had increased in previous years.1 Meanwhile, 6.6% of adults indicated having experienced a major depressive episode at least once in the preceding 12 months. That prevalence has held relatively steady over recent years.1
Despite the rising need for mental health services, the number of inpatient psychiatric beds has declined. During the 32 years between 1970 and 2002, the United States experienced a staggering nearly 60% decline in the number of inpatient psychiatric beds.4 Moreover, the number of psychiatric beds within the national public sector fell from 50,509 in 2005 to 43,318 in 2010, which is about a 14% decline.5 This decrease translated to a decrease from 17.1 beds/100,000 people in 2005 to 14.1 beds/100,000 in 2010 – both of which fall drastically below the “minimum number of public psychiatric beds deemed necessary for adequate psychiatric services (50/100,000).”5 Similarly, psychiatric practice has been unable to keep up with the increasing population size – the population-adjusted median number of psychiatrists declined 10.2% between 2003 and 2013.6
While inpatient psychiatric beds and psychiatrist availability have declined, the frequency of ED use for mental health reasons has increased. Mental health or substance abuse diagnoses directly accounted for 4.3% of ED visits in 2007 and were associated with 12.5% of ED visits.7 Specifically, there was a 19.3% increase in the rate of nonmaternal treat-and-release ED visits for mental health reasons between 2008-2012.8 Moreover, in a study assessing frequent treat-and-release ED visits among Medicaid patients, investigators found that while most ED visits were for non–mental health purposes, the odds of frequent ED use were higher among patients with either a psychiatric disorder or substance use problem across all levels of overall health complexity.9
What factors have been driving adults to increasingly rely on ED visits for their mental health care? Given the immense complexity of the U.S. mental health delivery system, it is evident that there is no clear-cut explanation. However, several specific factors may have contributed and must be investigated to better our understanding of this public health conundrum. The opioid epidemic, transition out of the correctional system, and coverage changes under the Affordable Care Act are hypotheses that will be examined further in the context of this pressing issue.
References
1. “Behavioral Health Trends in the United States: Results from the 2014 National Survey on Drug Use and Health.”
2. “Increase in Suicide in the United States, 1999-2014.” NCHS Data Brief No. 241, April 2016.
3. Web-Based Injury Statistics Query and Reporting System (WISQARS), Centers for Disease Control and Prevention.
4. National Health Policy Forum Issue Brief (2007 Aug 1;[823]:1-21).
5. “No Room at the Inn: Trends and Consequences of Closing Public Psychiatric Hospitals, 2005-2010,” Arlington, Va.: Treatment Advocacy Center, July 19, 2012.
6. “Population of U.S. Practicing Psychiatrists Declined, 2003-13, Which May Help Explain Poor Access to Mental Health Care,” Health Aff (Millwood). 2016 Jul 1;35[7]:1271-7.
7. “Mental Health and Substance Abuse-Related Emergency Department Visits Among Adults, 2007: Statistical Brief #92,” in Healthcare Cost and Utilization Project Statistical Briefs, (Rockville, Md.: Agency for Healthcare Research and Quality, 2010).
8. “Trends in Potentially Preventable Inpatient Hospital Admissions and Emergency Department Visits, 2015: Statistical Brief #195,” in Healthcare Cost and Utilization Project Statistical Briefs, (Rockville, Md.: Agency for Healthcare Research and Quality).
9. Nurs Res. 2015 Jan-Feb;64[1]3-12.
10. Ann Emerg Med. 2016 Apr;67[4]:525-30.
Ms. Kablanian is a 2nd-year medical student at the George Washington University, Washington, where she is enrolled in the Community and Urban Health Scholarly Concentration Program. Before attending medical school, she earned a master of public health degree in epidemiology from Columbia University, New York. She also holds a bachelor’s degree in biology and French from Scripps College, Claremont, Calif. Her interests include advocating for the urban underserved, contributing to medical curriculum development, and investigating population-level contributors to adverse health outcomes. Dr. Norris is assistant professor in the department of psychiatry & behavioral sciences, and assistant dean of student affairs at the George Washington University. He also is medical director of psychiatric & behavioral sciences at George Washington University Hospital. As part of his commitment to providing mental health care to patients with severe medical illness, Dr. Norris has been a leading voice within the psychiatric community on the value of palliative psychotherapy.
The voice of the patient in a doctor-centric world
The American health care system has been plagued by poor medical outcomes and an inefficient cost structure for many years.1,2 The primary loser in this game is the patient, the player who bears the brunt of health care expenses, either directly or through taxes, and whose voice has been largely ignored until recently. As with many other service industries, health care delivery represents a highly complex process that is difficult to define or measure. Innovative procedures and state-of-the-art medical therapies have provided effective options that extend or improve life, but at increasing cost.
Further complicating the existing cost-vs.-benefit debate is a relatively new polemic regarding the degree to which patient satisfaction should be a measure of health care quality. How satisfied will a patient be with his or her health care experience? This depends, in large part, on the medical outcome.3
Many public and private organizations use patient satisfaction surveys to measure the performance of health care delivery systems. In many cases, patient satisfaction data are being used to determine insurance payouts, physician compensation, and institutional rankings.5 It may seem logical to adopt pay-for-performance strategies based on patient satisfaction surveys, but there is a fundamental flaw: Survey data are not always accurate.
It is not entirely clear what constitutes a positive or negative health care experience. Much of this depends on the expectations of the consumer.6 Those with low expectations may be delighted with mediocre performance. Those with inflated expectations may be disappointed even when provided excellent customer service.
Surveys are not durable. That is, when performed under distinct environmental conditions or at different times, surveys may not produce the same results when repeated by the same respondent.7 Surveys are easily manipulated by simple changes in wording or punctuation. Some specific encounters may be rated as “unsatisfactory” because of external factors, circumstances beyond the control of the health care provider.
Many health care providers feel that surveys are poor indicators of individual performance. Some critics highlight a paucity of data. A limited number of returned surveys, relative to the total number of encounters, may yield results that are not statistically significant. Increasing the amount of data decreases the risk that a sample set taken from the studied population is the result of sampling error alone. Nonetheless, sampling error is never completely eliminated, and it is not entirely clear to what degree statistical significance should be used to substantiate satisfaction, a subjective measure.
Surveys often provide data in a very small range, making ranking of facilities or providers difficult. For example, national polling services utilize surveys with thousands of respondents and the margin of error often exceeds plus or minus 3%. Data sets with a smaller number of responses have margins of error that are even greater. Even plus or minus 3% is a sizable deviation when considering that health care survey results often are compared and ranked based on a distribution of scores in a narrow response range. In the author’s experience, a 6% difference in survey scores can represent the difference between a ranking of “excellent” and “poor.”
Many patients are disenfranchised by survey methodology. In the most extreme example, deceased or severely disabled patients are unable to provide feedback. Patients transferred to other facilities and those who are lost to follow-up will be missed also. Many patient surveys may not be successfully retrieved from the homeless, the illiterate, minors, or those without phone or e-mail access. Because surveys are voluntarily submitted, the results may skew opinion toward a select group of outspoken customers who may not be representative of the general population.
The use of patient satisfaction surveys, especially when they are linked to employee compensation, may create a system of survey-based value. This is similar to the problem of defensive medicine, where providers perform medicine in a way that reduces legal risk. Aware that patients will be asked to fill out satisfaction surveys, associates may perform in a way that increases patient satisfaction scores at the expense of patient outcomes or the bottom line. Some institutions may inappropriately “cherry-pick” the easy-to-treat patient and transfer medically complex cases elsewhere.
It is not clear how to best measure the quality of a health care experience. With the broad range of patient encounter types and the inherent complexity of collaboration among providers, it is difficult to determine to what degree satisfaction can be attributed to individual providers or specific environmental factors. Patients do not typically interact with a specific provider, but are treated by a service delivery system, which often encompasses multiple players and multiple physical locations. Moreover, it is not always clear when the patient encounter begins and ends.
Despite the criticism of patient satisfaction survey methodology, the patient must ultimately define the value of the health care service offering. This “voice of the customer” approach is a diversion from the antiquated practitioner-centric model. Traditionally, patient appointment times and locations are decided by the availability and convenience of the provider. Many consumers have compensated for this inefficiency by accessing local emergency departments for nonurgent ambulatory care. Nonetheless,EDs often suffer from long waits and higher costs. Facilities designed for urgent, but nonemergent, care have attempted to address convenience issues but these facilities sacrifice continuity and specialization of care. In a truly patient-centric health care model, patients would be provided the care that they need, when and where they need it.
The patient satisfaction survey remains a primary tool for linking patient-centered value to health care reform. Ranking the results among market competitors can provide an incentive for improvement. Health care professionals are competitive by nature and the extrinsic motivation of quality rankings can be beneficial if well controlled. Employers should use caution when using survey data for performance measurement because survey data are subject to a variety of sources of bias or error. Patient survey data should be used to drive improvement, not to punish. Further research on patient survey methodology is needed to elucidate improved methods of bringing the voice of the patient to the forefront of health care reform.
References
1. N Engl J Med. 2003 Aug 21;349(8):768-75.
2. Centers for Medicare & Medicaid Services. Medicare hospital quality chartbook: Performance report on outcome measures. September 2014.
3. N Engl J Med. 2008 Oct 30;359(18):1921-31.
4. “Better Customer Insight – in Real Time,” by Emma K. Macdonald, Hugh N. Wilson, and Umut Konuş (Harvard Business Review, September 2012).
5. “The Dangers of Linking Pay to Customer Feedback,” by Rob Markey, (Harvard Business Review, Sept. 8, 2011).
6. “Health Care’s Service Fanatics,” by James I. Merlino and Ananth Raman, (Harvard Business Review, May 2013).
7. Trochim, WMK. Research Methods Knowledge Base.
Dr. Davis is a pediatric gastroenterologists at University of Florida Health, Gainesville. He has no financial relationships relevant to this article to disclose.
The American health care system has been plagued by poor medical outcomes and an inefficient cost structure for many years.1,2 The primary loser in this game is the patient, the player who bears the brunt of health care expenses, either directly or through taxes, and whose voice has been largely ignored until recently. As with many other service industries, health care delivery represents a highly complex process that is difficult to define or measure. Innovative procedures and state-of-the-art medical therapies have provided effective options that extend or improve life, but at increasing cost.
Further complicating the existing cost-vs.-benefit debate is a relatively new polemic regarding the degree to which patient satisfaction should be a measure of health care quality. How satisfied will a patient be with his or her health care experience? This depends, in large part, on the medical outcome.3
Many public and private organizations use patient satisfaction surveys to measure the performance of health care delivery systems. In many cases, patient satisfaction data are being used to determine insurance payouts, physician compensation, and institutional rankings.5 It may seem logical to adopt pay-for-performance strategies based on patient satisfaction surveys, but there is a fundamental flaw: Survey data are not always accurate.
It is not entirely clear what constitutes a positive or negative health care experience. Much of this depends on the expectations of the consumer.6 Those with low expectations may be delighted with mediocre performance. Those with inflated expectations may be disappointed even when provided excellent customer service.
Surveys are not durable. That is, when performed under distinct environmental conditions or at different times, surveys may not produce the same results when repeated by the same respondent.7 Surveys are easily manipulated by simple changes in wording or punctuation. Some specific encounters may be rated as “unsatisfactory” because of external factors, circumstances beyond the control of the health care provider.
Many health care providers feel that surveys are poor indicators of individual performance. Some critics highlight a paucity of data. A limited number of returned surveys, relative to the total number of encounters, may yield results that are not statistically significant. Increasing the amount of data decreases the risk that a sample set taken from the studied population is the result of sampling error alone. Nonetheless, sampling error is never completely eliminated, and it is not entirely clear to what degree statistical significance should be used to substantiate satisfaction, a subjective measure.
Surveys often provide data in a very small range, making ranking of facilities or providers difficult. For example, national polling services utilize surveys with thousands of respondents and the margin of error often exceeds plus or minus 3%. Data sets with a smaller number of responses have margins of error that are even greater. Even plus or minus 3% is a sizable deviation when considering that health care survey results often are compared and ranked based on a distribution of scores in a narrow response range. In the author’s experience, a 6% difference in survey scores can represent the difference between a ranking of “excellent” and “poor.”
Many patients are disenfranchised by survey methodology. In the most extreme example, deceased or severely disabled patients are unable to provide feedback. Patients transferred to other facilities and those who are lost to follow-up will be missed also. Many patient surveys may not be successfully retrieved from the homeless, the illiterate, minors, or those without phone or e-mail access. Because surveys are voluntarily submitted, the results may skew opinion toward a select group of outspoken customers who may not be representative of the general population.
The use of patient satisfaction surveys, especially when they are linked to employee compensation, may create a system of survey-based value. This is similar to the problem of defensive medicine, where providers perform medicine in a way that reduces legal risk. Aware that patients will be asked to fill out satisfaction surveys, associates may perform in a way that increases patient satisfaction scores at the expense of patient outcomes or the bottom line. Some institutions may inappropriately “cherry-pick” the easy-to-treat patient and transfer medically complex cases elsewhere.
It is not clear how to best measure the quality of a health care experience. With the broad range of patient encounter types and the inherent complexity of collaboration among providers, it is difficult to determine to what degree satisfaction can be attributed to individual providers or specific environmental factors. Patients do not typically interact with a specific provider, but are treated by a service delivery system, which often encompasses multiple players and multiple physical locations. Moreover, it is not always clear when the patient encounter begins and ends.
Despite the criticism of patient satisfaction survey methodology, the patient must ultimately define the value of the health care service offering. This “voice of the customer” approach is a diversion from the antiquated practitioner-centric model. Traditionally, patient appointment times and locations are decided by the availability and convenience of the provider. Many consumers have compensated for this inefficiency by accessing local emergency departments for nonurgent ambulatory care. Nonetheless,EDs often suffer from long waits and higher costs. Facilities designed for urgent, but nonemergent, care have attempted to address convenience issues but these facilities sacrifice continuity and specialization of care. In a truly patient-centric health care model, patients would be provided the care that they need, when and where they need it.
The patient satisfaction survey remains a primary tool for linking patient-centered value to health care reform. Ranking the results among market competitors can provide an incentive for improvement. Health care professionals are competitive by nature and the extrinsic motivation of quality rankings can be beneficial if well controlled. Employers should use caution when using survey data for performance measurement because survey data are subject to a variety of sources of bias or error. Patient survey data should be used to drive improvement, not to punish. Further research on patient survey methodology is needed to elucidate improved methods of bringing the voice of the patient to the forefront of health care reform.
References
1. N Engl J Med. 2003 Aug 21;349(8):768-75.
2. Centers for Medicare & Medicaid Services. Medicare hospital quality chartbook: Performance report on outcome measures. September 2014.
3. N Engl J Med. 2008 Oct 30;359(18):1921-31.
4. “Better Customer Insight – in Real Time,” by Emma K. Macdonald, Hugh N. Wilson, and Umut Konuş (Harvard Business Review, September 2012).
5. “The Dangers of Linking Pay to Customer Feedback,” by Rob Markey, (Harvard Business Review, Sept. 8, 2011).
6. “Health Care’s Service Fanatics,” by James I. Merlino and Ananth Raman, (Harvard Business Review, May 2013).
7. Trochim, WMK. Research Methods Knowledge Base.
Dr. Davis is a pediatric gastroenterologists at University of Florida Health, Gainesville. He has no financial relationships relevant to this article to disclose.
The American health care system has been plagued by poor medical outcomes and an inefficient cost structure for many years.1,2 The primary loser in this game is the patient, the player who bears the brunt of health care expenses, either directly or through taxes, and whose voice has been largely ignored until recently. As with many other service industries, health care delivery represents a highly complex process that is difficult to define or measure. Innovative procedures and state-of-the-art medical therapies have provided effective options that extend or improve life, but at increasing cost.
Further complicating the existing cost-vs.-benefit debate is a relatively new polemic regarding the degree to which patient satisfaction should be a measure of health care quality. How satisfied will a patient be with his or her health care experience? This depends, in large part, on the medical outcome.3
Many public and private organizations use patient satisfaction surveys to measure the performance of health care delivery systems. In many cases, patient satisfaction data are being used to determine insurance payouts, physician compensation, and institutional rankings.5 It may seem logical to adopt pay-for-performance strategies based on patient satisfaction surveys, but there is a fundamental flaw: Survey data are not always accurate.
It is not entirely clear what constitutes a positive or negative health care experience. Much of this depends on the expectations of the consumer.6 Those with low expectations may be delighted with mediocre performance. Those with inflated expectations may be disappointed even when provided excellent customer service.
Surveys are not durable. That is, when performed under distinct environmental conditions or at different times, surveys may not produce the same results when repeated by the same respondent.7 Surveys are easily manipulated by simple changes in wording or punctuation. Some specific encounters may be rated as “unsatisfactory” because of external factors, circumstances beyond the control of the health care provider.
Many health care providers feel that surveys are poor indicators of individual performance. Some critics highlight a paucity of data. A limited number of returned surveys, relative to the total number of encounters, may yield results that are not statistically significant. Increasing the amount of data decreases the risk that a sample set taken from the studied population is the result of sampling error alone. Nonetheless, sampling error is never completely eliminated, and it is not entirely clear to what degree statistical significance should be used to substantiate satisfaction, a subjective measure.
Surveys often provide data in a very small range, making ranking of facilities or providers difficult. For example, national polling services utilize surveys with thousands of respondents and the margin of error often exceeds plus or minus 3%. Data sets with a smaller number of responses have margins of error that are even greater. Even plus or minus 3% is a sizable deviation when considering that health care survey results often are compared and ranked based on a distribution of scores in a narrow response range. In the author’s experience, a 6% difference in survey scores can represent the difference between a ranking of “excellent” and “poor.”
Many patients are disenfranchised by survey methodology. In the most extreme example, deceased or severely disabled patients are unable to provide feedback. Patients transferred to other facilities and those who are lost to follow-up will be missed also. Many patient surveys may not be successfully retrieved from the homeless, the illiterate, minors, or those without phone or e-mail access. Because surveys are voluntarily submitted, the results may skew opinion toward a select group of outspoken customers who may not be representative of the general population.
The use of patient satisfaction surveys, especially when they are linked to employee compensation, may create a system of survey-based value. This is similar to the problem of defensive medicine, where providers perform medicine in a way that reduces legal risk. Aware that patients will be asked to fill out satisfaction surveys, associates may perform in a way that increases patient satisfaction scores at the expense of patient outcomes or the bottom line. Some institutions may inappropriately “cherry-pick” the easy-to-treat patient and transfer medically complex cases elsewhere.
It is not clear how to best measure the quality of a health care experience. With the broad range of patient encounter types and the inherent complexity of collaboration among providers, it is difficult to determine to what degree satisfaction can be attributed to individual providers or specific environmental factors. Patients do not typically interact with a specific provider, but are treated by a service delivery system, which often encompasses multiple players and multiple physical locations. Moreover, it is not always clear when the patient encounter begins and ends.
Despite the criticism of patient satisfaction survey methodology, the patient must ultimately define the value of the health care service offering. This “voice of the customer” approach is a diversion from the antiquated practitioner-centric model. Traditionally, patient appointment times and locations are decided by the availability and convenience of the provider. Many consumers have compensated for this inefficiency by accessing local emergency departments for nonurgent ambulatory care. Nonetheless,EDs often suffer from long waits and higher costs. Facilities designed for urgent, but nonemergent, care have attempted to address convenience issues but these facilities sacrifice continuity and specialization of care. In a truly patient-centric health care model, patients would be provided the care that they need, when and where they need it.
The patient satisfaction survey remains a primary tool for linking patient-centered value to health care reform. Ranking the results among market competitors can provide an incentive for improvement. Health care professionals are competitive by nature and the extrinsic motivation of quality rankings can be beneficial if well controlled. Employers should use caution when using survey data for performance measurement because survey data are subject to a variety of sources of bias or error. Patient survey data should be used to drive improvement, not to punish. Further research on patient survey methodology is needed to elucidate improved methods of bringing the voice of the patient to the forefront of health care reform.
References
1. N Engl J Med. 2003 Aug 21;349(8):768-75.
2. Centers for Medicare & Medicaid Services. Medicare hospital quality chartbook: Performance report on outcome measures. September 2014.
3. N Engl J Med. 2008 Oct 30;359(18):1921-31.
4. “Better Customer Insight – in Real Time,” by Emma K. Macdonald, Hugh N. Wilson, and Umut Konuş (Harvard Business Review, September 2012).
5. “The Dangers of Linking Pay to Customer Feedback,” by Rob Markey, (Harvard Business Review, Sept. 8, 2011).
6. “Health Care’s Service Fanatics,” by James I. Merlino and Ananth Raman, (Harvard Business Review, May 2013).
7. Trochim, WMK. Research Methods Knowledge Base.
Dr. Davis is a pediatric gastroenterologists at University of Florida Health, Gainesville. He has no financial relationships relevant to this article to disclose.
Back to the Future
Those who cannot remember the past are condemned to repeat it.
—George Santayana (Life of Reason, 1905)
Zero. That’s the number I put on the screen when I start the lecture I give to residents about the future of orthopedics. It represents the number of cases I still do exactly the same way now as I did when I graduated from my residency program. It represents the commitment to lifelong learning that we’ve made as orthopedists. Surgical techniques innovate so rapidly that they often outpace our research, leaving us performing new techniques based solely on industry and key opinion leader recommendation, and not on randomized controlled studies. Sometimes we’re led down the wrong path (remember when the meniscus was thought to be vestigial?) and other times new techniques lead to disappoint
So it seems “everything old is new again.” That’s why this issue of AJO is called The Throwback Issue. In this issue, we revisit ideas whose time has come and gone and now come again.
Our lead article this month focuses on ACL repair. Once abandoned after a landmark paper by Feagin and Curl1 showed poor mid-term results, new and innovative techniques and instrumentation for knee surgery have made this possible. Investigators such as Murray2 and DiFelice3 have done outstanding work showing the feasibility of ACL repair. In this issue we offer a comprehensive review and surgical technique for adding ACL repair to your portfolio of surgical offerings (see pages 408 and 454). Expanded versions of both of these articles are available at amjorthopedics.com.
Our second feature article discusses the reemergence of the ALL, an idea so hot in the public domain that it has been featured as a Jeopardy question. Described originally by Müller4 as the missing link in persistent rotational instability, the ALL might offer the key to improved long-term outcomes for patients undergoing ACL surgery. Read the article on page 418 and learn how to identify which patients are candidates for ALL reconstruction, and a simple surgical technique you can apply to your practice. Scan the provided QR code to watch the accompanying surgical technique video.
The Throwback Issue marks the fifth edition of the “new AJO.” It’s time to let us know how we are doing. Please email us at [email protected] to suggest future themes, articles you’d like to read, or suggestions for improvement.
Recently, based on the work of the authors mentioned above, I’ve begun offering ACL repair to select patients in my practice. I wouldn’t be able to do this if we as orthopedists weren’t constantly looking to improve, and weren’t willing to revisit old ideas to do it. Our goal at AJO is to present something in every article that can be immediately applied to your practice. Take a look at the articles presented this month, as we go “Back to the Future” to see what discarded ideas from our recent past can be applied to improve outcomes for your patients in the future.
1. Feagin JA Jr, Curl WW. Isolated tear of the anterior cruciate ligament: 5-year follow-up study. Am J Sports Med. 1976;4(3):95-100.
2. Murray MM, Fleming BC. Use of a bioactive scaffold to stimulate anterior cruciate ligament healing also minimizes posttraumatic osteoarthritis after surgery. Am J Sports Med. 2013;41(8):1762-1770.
3. DiFelice GS, Villegas C, Taylor SA. Anterior cruciate ligament preservation: early results of a novel arthroscopic technique for suture anchor primary anterior cruciate ligament repair. Arthroscopy. 2015;31(11):2162-2171.
4. Müller W. The Knee: Form, Function, and Ligament Reconstruction. Berlin: Springer-Verlag, 1983.
Those who cannot remember the past are condemned to repeat it.
—George Santayana (Life of Reason, 1905)
Zero. That’s the number I put on the screen when I start the lecture I give to residents about the future of orthopedics. It represents the number of cases I still do exactly the same way now as I did when I graduated from my residency program. It represents the commitment to lifelong learning that we’ve made as orthopedists. Surgical techniques innovate so rapidly that they often outpace our research, leaving us performing new techniques based solely on industry and key opinion leader recommendation, and not on randomized controlled studies. Sometimes we’re led down the wrong path (remember when the meniscus was thought to be vestigial?) and other times new techniques lead to disappoint
So it seems “everything old is new again.” That’s why this issue of AJO is called The Throwback Issue. In this issue, we revisit ideas whose time has come and gone and now come again.
Our lead article this month focuses on ACL repair. Once abandoned after a landmark paper by Feagin and Curl1 showed poor mid-term results, new and innovative techniques and instrumentation for knee surgery have made this possible. Investigators such as Murray2 and DiFelice3 have done outstanding work showing the feasibility of ACL repair. In this issue we offer a comprehensive review and surgical technique for adding ACL repair to your portfolio of surgical offerings (see pages 408 and 454). Expanded versions of both of these articles are available at amjorthopedics.com.
Our second feature article discusses the reemergence of the ALL, an idea so hot in the public domain that it has been featured as a Jeopardy question. Described originally by Müller4 as the missing link in persistent rotational instability, the ALL might offer the key to improved long-term outcomes for patients undergoing ACL surgery. Read the article on page 418 and learn how to identify which patients are candidates for ALL reconstruction, and a simple surgical technique you can apply to your practice. Scan the provided QR code to watch the accompanying surgical technique video.
The Throwback Issue marks the fifth edition of the “new AJO.” It’s time to let us know how we are doing. Please email us at [email protected] to suggest future themes, articles you’d like to read, or suggestions for improvement.
Recently, based on the work of the authors mentioned above, I’ve begun offering ACL repair to select patients in my practice. I wouldn’t be able to do this if we as orthopedists weren’t constantly looking to improve, and weren’t willing to revisit old ideas to do it. Our goal at AJO is to present something in every article that can be immediately applied to your practice. Take a look at the articles presented this month, as we go “Back to the Future” to see what discarded ideas from our recent past can be applied to improve outcomes for your patients in the future.
Those who cannot remember the past are condemned to repeat it.
—George Santayana (Life of Reason, 1905)
Zero. That’s the number I put on the screen when I start the lecture I give to residents about the future of orthopedics. It represents the number of cases I still do exactly the same way now as I did when I graduated from my residency program. It represents the commitment to lifelong learning that we’ve made as orthopedists. Surgical techniques innovate so rapidly that they often outpace our research, leaving us performing new techniques based solely on industry and key opinion leader recommendation, and not on randomized controlled studies. Sometimes we’re led down the wrong path (remember when the meniscus was thought to be vestigial?) and other times new techniques lead to disappoint
So it seems “everything old is new again.” That’s why this issue of AJO is called The Throwback Issue. In this issue, we revisit ideas whose time has come and gone and now come again.
Our lead article this month focuses on ACL repair. Once abandoned after a landmark paper by Feagin and Curl1 showed poor mid-term results, new and innovative techniques and instrumentation for knee surgery have made this possible. Investigators such as Murray2 and DiFelice3 have done outstanding work showing the feasibility of ACL repair. In this issue we offer a comprehensive review and surgical technique for adding ACL repair to your portfolio of surgical offerings (see pages 408 and 454). Expanded versions of both of these articles are available at amjorthopedics.com.
Our second feature article discusses the reemergence of the ALL, an idea so hot in the public domain that it has been featured as a Jeopardy question. Described originally by Müller4 as the missing link in persistent rotational instability, the ALL might offer the key to improved long-term outcomes for patients undergoing ACL surgery. Read the article on page 418 and learn how to identify which patients are candidates for ALL reconstruction, and a simple surgical technique you can apply to your practice. Scan the provided QR code to watch the accompanying surgical technique video.
The Throwback Issue marks the fifth edition of the “new AJO.” It’s time to let us know how we are doing. Please email us at [email protected] to suggest future themes, articles you’d like to read, or suggestions for improvement.
Recently, based on the work of the authors mentioned above, I’ve begun offering ACL repair to select patients in my practice. I wouldn’t be able to do this if we as orthopedists weren’t constantly looking to improve, and weren’t willing to revisit old ideas to do it. Our goal at AJO is to present something in every article that can be immediately applied to your practice. Take a look at the articles presented this month, as we go “Back to the Future” to see what discarded ideas from our recent past can be applied to improve outcomes for your patients in the future.
1. Feagin JA Jr, Curl WW. Isolated tear of the anterior cruciate ligament: 5-year follow-up study. Am J Sports Med. 1976;4(3):95-100.
2. Murray MM, Fleming BC. Use of a bioactive scaffold to stimulate anterior cruciate ligament healing also minimizes posttraumatic osteoarthritis after surgery. Am J Sports Med. 2013;41(8):1762-1770.
3. DiFelice GS, Villegas C, Taylor SA. Anterior cruciate ligament preservation: early results of a novel arthroscopic technique for suture anchor primary anterior cruciate ligament repair. Arthroscopy. 2015;31(11):2162-2171.
4. Müller W. The Knee: Form, Function, and Ligament Reconstruction. Berlin: Springer-Verlag, 1983.
1. Feagin JA Jr, Curl WW. Isolated tear of the anterior cruciate ligament: 5-year follow-up study. Am J Sports Med. 1976;4(3):95-100.
2. Murray MM, Fleming BC. Use of a bioactive scaffold to stimulate anterior cruciate ligament healing also minimizes posttraumatic osteoarthritis after surgery. Am J Sports Med. 2013;41(8):1762-1770.
3. DiFelice GS, Villegas C, Taylor SA. Anterior cruciate ligament preservation: early results of a novel arthroscopic technique for suture anchor primary anterior cruciate ligament repair. Arthroscopy. 2015;31(11):2162-2171.
4. Müller W. The Knee: Form, Function, and Ligament Reconstruction. Berlin: Springer-Verlag, 1983.
Addiction potential
By nature, my wife and I are risk-averse people. Our investment strategy is just a few baby steps short of hiding our money under the mattress. We have never tried marijuana, though to some extent this is because we were out of college and already married when its popularity surged across this country’s campuses. We do drink alcohol, which was so ubiquitous when we were teenagers that it seemed innocuous.
Given my personality, you can understand why I have trouble understanding why anyone would ever try heroin or any opiate. I realize that many of the young addicts don’t follow the news closely enough to realize the risks. But the epidemic of addiction is so entrenched here in rural Maine that they must have known someone who has died of an overdose.
A recent op-ed piece in the New York Times describes a program that attempts to do just that (“The 4 Traits That Put Kids at Risk for Addiction,” by Maia Szalavitz, Sept. 29, 2016). The program is called Preventure and is the result of some work by Patricia Conrod, a psychiatry professor at the University of Montreal. It has been tried in Britain, Canada, Australia, and the Netherlands with some success in reducing binge drinking. In other studies, it reduced symptoms of depression, panic attacks, and impulsive behavior.
The program begins with testing middle school students and focuses on the traits of hopelessness, sensation-seeking, impulsiveness, and anxiety sensitivity. Hopeless is not a surprising choice given that many of the areas of this country with highest rates of opiate addiction are economically depressed. And it is easy to see why impulsivity and sensation-seeking are related to addiction potential. Anxiety-sensitivity is a less intuitive choice.
With the results of this testing in hand, the program administrators wait several months before approaching the outliers. The next step offers two 90-minute workshops to the entire school with the stated goal of showing how the students can channel their personalities toward success. Although the workshops are advertised as being open to everyone but limited in number of attendees, only the students identified as being at the highest risk are actually selected. It is hoped that this deception will avoid having the participants feel that they have been labeled. However, if a student asks about the selection process, he is given an honest answer. The workshops are targeted to the students’ specific emotional and behavioral vulnerabilities, and teaches cognitive behavioral techniques on how they can be managed.
While I think the deceptive selection process is a clever to wrinkle to avoid labeling, I wonder how long the ruse will survive should the program become more universally adopted. With increased popularity and publicity, every parent and most of the children in a school will realize why the test is being administered and what being selected for the workshop means. There is the threat that being identified as at risk for addiction will become a self-fulfilling prophecy and a trigger for depression.
Preventure sounds like a program worth watching. If larger series and long-term outcomes continue to be favorable, it will remain to be seen whether labeling is a hazard worth worrying about.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at [email protected].
By nature, my wife and I are risk-averse people. Our investment strategy is just a few baby steps short of hiding our money under the mattress. We have never tried marijuana, though to some extent this is because we were out of college and already married when its popularity surged across this country’s campuses. We do drink alcohol, which was so ubiquitous when we were teenagers that it seemed innocuous.
Given my personality, you can understand why I have trouble understanding why anyone would ever try heroin or any opiate. I realize that many of the young addicts don’t follow the news closely enough to realize the risks. But the epidemic of addiction is so entrenched here in rural Maine that they must have known someone who has died of an overdose.
A recent op-ed piece in the New York Times describes a program that attempts to do just that (“The 4 Traits That Put Kids at Risk for Addiction,” by Maia Szalavitz, Sept. 29, 2016). The program is called Preventure and is the result of some work by Patricia Conrod, a psychiatry professor at the University of Montreal. It has been tried in Britain, Canada, Australia, and the Netherlands with some success in reducing binge drinking. In other studies, it reduced symptoms of depression, panic attacks, and impulsive behavior.
The program begins with testing middle school students and focuses on the traits of hopelessness, sensation-seeking, impulsiveness, and anxiety sensitivity. Hopeless is not a surprising choice given that many of the areas of this country with highest rates of opiate addiction are economically depressed. And it is easy to see why impulsivity and sensation-seeking are related to addiction potential. Anxiety-sensitivity is a less intuitive choice.
With the results of this testing in hand, the program administrators wait several months before approaching the outliers. The next step offers two 90-minute workshops to the entire school with the stated goal of showing how the students can channel their personalities toward success. Although the workshops are advertised as being open to everyone but limited in number of attendees, only the students identified as being at the highest risk are actually selected. It is hoped that this deception will avoid having the participants feel that they have been labeled. However, if a student asks about the selection process, he is given an honest answer. The workshops are targeted to the students’ specific emotional and behavioral vulnerabilities, and teaches cognitive behavioral techniques on how they can be managed.
While I think the deceptive selection process is a clever to wrinkle to avoid labeling, I wonder how long the ruse will survive should the program become more universally adopted. With increased popularity and publicity, every parent and most of the children in a school will realize why the test is being administered and what being selected for the workshop means. There is the threat that being identified as at risk for addiction will become a self-fulfilling prophecy and a trigger for depression.
Preventure sounds like a program worth watching. If larger series and long-term outcomes continue to be favorable, it will remain to be seen whether labeling is a hazard worth worrying about.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at [email protected].
By nature, my wife and I are risk-averse people. Our investment strategy is just a few baby steps short of hiding our money under the mattress. We have never tried marijuana, though to some extent this is because we were out of college and already married when its popularity surged across this country’s campuses. We do drink alcohol, which was so ubiquitous when we were teenagers that it seemed innocuous.
Given my personality, you can understand why I have trouble understanding why anyone would ever try heroin or any opiate. I realize that many of the young addicts don’t follow the news closely enough to realize the risks. But the epidemic of addiction is so entrenched here in rural Maine that they must have known someone who has died of an overdose.
A recent op-ed piece in the New York Times describes a program that attempts to do just that (“The 4 Traits That Put Kids at Risk for Addiction,” by Maia Szalavitz, Sept. 29, 2016). The program is called Preventure and is the result of some work by Patricia Conrod, a psychiatry professor at the University of Montreal. It has been tried in Britain, Canada, Australia, and the Netherlands with some success in reducing binge drinking. In other studies, it reduced symptoms of depression, panic attacks, and impulsive behavior.
The program begins with testing middle school students and focuses on the traits of hopelessness, sensation-seeking, impulsiveness, and anxiety sensitivity. Hopeless is not a surprising choice given that many of the areas of this country with highest rates of opiate addiction are economically depressed. And it is easy to see why impulsivity and sensation-seeking are related to addiction potential. Anxiety-sensitivity is a less intuitive choice.
With the results of this testing in hand, the program administrators wait several months before approaching the outliers. The next step offers two 90-minute workshops to the entire school with the stated goal of showing how the students can channel their personalities toward success. Although the workshops are advertised as being open to everyone but limited in number of attendees, only the students identified as being at the highest risk are actually selected. It is hoped that this deception will avoid having the participants feel that they have been labeled. However, if a student asks about the selection process, he is given an honest answer. The workshops are targeted to the students’ specific emotional and behavioral vulnerabilities, and teaches cognitive behavioral techniques on how they can be managed.
While I think the deceptive selection process is a clever to wrinkle to avoid labeling, I wonder how long the ruse will survive should the program become more universally adopted. With increased popularity and publicity, every parent and most of the children in a school will realize why the test is being administered and what being selected for the workshop means. There is the threat that being identified as at risk for addiction will become a self-fulfilling prophecy and a trigger for depression.
Preventure sounds like a program worth watching. If larger series and long-term outcomes continue to be favorable, it will remain to be seen whether labeling is a hazard worth worrying about.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at [email protected].
Is physician-assisted suicide compatible with the Hippocratic Oath?
Do we stand by our Hippocratic Oath when providing physician-assisted suicide?
Physician-assisted suicide (PAS) is a form of euthanasia in which a physician provides the patient with the pertinent information, and, in certain cases, a prescription for the necessary lethal drugs, so that the individual can willingly and successfully terminate his or her own life. The justification for PAS is the compassionate relief of intractable human suffering. Euthanasia and PAS are accepted practices in European countries such as the Netherlands, Belgium, and Luxembourg.
Such patients are mentally incapable of making the difficult decision to end their life and therefore should require a psychiatric evaluation to include counseling prior to making a decision to engage in PAS. For patients with mental illness, PAS is even more problematic than for terminally ill patients, because patients may lack the capacity to make rational and responsible decisions. Indeed, there are sizable loopholes where our medical system lacks safeguards and similarly lacks the requirements for a thorough, pre-PAS mental health examination, family notifications, and consultations, and for the minimally necessary legal pressure required to ensure patient cooperation.
Critical role of mental health workers
Although PAS has been legalized in those five U.S. states, its support and cases have stalled in recent years, indicating serious ethical concerns, mostly because of multileveled challenges of combating and delineating cultural stereotypes, quantifying mental capacity, gauging quality of life, and deciding where to situate psychiatrists in the PAS decision.
The psychiatrist’s role is being debated. In the United States, opponents take issue with current PAS-legal state’s legislation regarding psychiatric evaluations. For example, Oregon stipulates a psychiatrist referral only in cases where a physician other than a psychiatrist believes the patient’s judgment is impaired. It’s agreed that psychiatrists have the best skill set to assess a patient’s perceptions. Other PAS-legal states require a psychiatrist or psychologist assessment before making the decision. Unfortunately, though, physicians have rarely referred these patients to psychiatrists before offering PAS as an option.
PAS opponents target standards by which concepts like “quality of life” or “contributing member of society” are judged – specifically, that “unbearable suffering” and its ramifications are ill defined – people whose lives are deemed “not worth living” (including the terminally ill) would be susceptible to “sympathetic death” via PAS that might result from PAS legalization. Opponents also argue that recognizing a suicide “right” contradicts that a significant number of suicide attempters have mental illness and need help. They say that legalizing PAS would enable mentally incapacitated people to commit the irreversible act based on their distorted perceptions without providing them the expected assistance from their profession.1
The use of euthanasia or PAS gradually is trending from physically terminally ill patients toward psychiatrically complex patients. There are cases in which euthanasia or PAS was requested by psychiatric patients who had chronic psychiatric, medical, and psychosocial histories rather than purely physical ailment histories. In one study, Scott Y. H. Kim, MD, PhD, and his associates reviewed cases in the Netherlands in which either euthanasia or PAS for psychiatric disorders was deployed. The granted PAS requests appeared to involve physician judgment without psychiatric input.
The study reviewed 66 cases: 55% of patients had chronic severe conditions with extensive histories of attempted suicides and psychiatric hospitalizations, demonstrating that the granted euthanasia and PAS requests had involved extensive evaluations. However, 11% of cases had no independent psychiatric input, and 24% involved disagreement among the physicians.2 PAS proponents and opponents support the involvement and expertise of psychiatrists in all of this.
Psychiatrists have long contended that suicide attempts are often a “cry for help,” not an earnest act to end one’s life. Legalizing PAS tells suicidal individuals that society does not care whether they live or die – a truly un-Hippocratic stance. The stereotypes tossed around in the PAS debate, which could mean life or death, need to be unpacked with specific criteria attached, rather than preconceptions.
Autonomy of patients and implications of PAS
In the PAS debate, there are serious life concerns exhibited by terminally ill/psychiatrically ill patients over losing their autonomy and becoming a burden to their families and caregivers. Stereotypes must be deconstructed, yes, but such patients generally have been considered to be rendered, by the sum effect of their illnesses, mentally incapable of making the decision to end their lives. Addressing this order of patient life concerns generally has been the realm of social workers, psychologists, and, in the most desirable cases, psychiatrists. Therefore, even in keeping with established practice, some form of competent psychiatric evaluation should be required before considering PAS as a viable option.
The call for this requirement is backed up by a study, which reported that 47% of patients who had considered or committed suicide previously were diagnosed with psychiatric disorders, and 15% had undiagnosed psychiatric disorders.3 Also, inventories of thwarted suicide attempters reveal that most lack the conviction to end their lives, and this obverse phenomenon is backed by a study that revealed that 75% of 96 suicidal patients were found to be ambivalent in their intent to end their lives. Suicide attempters simply may be trying to communicate with people in their lives in order to test their love and care.4 This indicates that those who attempt suicide are predominantly psychiatrically ill and prone to distorted perceptions, impaired judgment, frustration, escapism, and manipulative guilt.
Suicide is abhorrent to most human beings’ sensibilities, because humanity has an innate will to live.5 It is wrong to offer patients life-ending options when they might rejuvenate or ease into death naturally. With the debilitated or elderly, PAS could violate their human rights. If the attitude that they are a burden to society persists, then a certain segment of society might be tempted to avoid their intergenerational obligations to elders, particularly those elders presenting with concurrent mental illnesses. PAS would additionally fuel that problem. This would represent a profound injustice and gross violation of human dignity, while also serving as a denial of basic human rights, particularly the right to life and care.6
Conclusion
The complex physical, psychological, and social challenges associated with PAS and the difficulty in enforcing its laws necessitate more adept alternatives. Instead of conditionally legalizing suicide, we should ease patient suffering with compassion and calibrated treatment.6,7
Terminally ill patients often suffer from depression, affecting their rationality. Adequate counseling, medical care, and psychological care should be the response to terminally ill patients considering suicide. If society accepts that ending a life is a reasonable response to human suffering that could otherwise be treated or reversed, then those with the most serious psychiatric conditions are destined to become more vulnerable. Therefore, physicians and psychiatrists should instead work harder to help patients recover, rather than participating in their quest for death.
Simplistic legal and regulatory oversight is insufficient, because the questions evoked by PAS are complicated by life, death, and ethics. Further research is needed to look into the mechanisms and morality of how psychiatrists and other physicians will make judgments and recommendations that are vital elements in developing regulatory oversight on PAS. Finally, future studies should look at which practices have been successful and which might be deemed unethical.
References
1. Clin Med (Lond). 2010 Aug;109(4):323-5.
2. JAMA Psychiatry. 2016;73(4):362-8.
3. “The Final Months: A Study of the Lives of 134 Persons Who Committed Suicide,” New York: Oxford University Press, 1981.
4. “Why We Shouldn’t Legalize Assisting Suicide, Part I.” Department of Medical Ethics, National Right to Life Committee.
5. “Working with Suicidal Individuals: A Guide to Providing Understanding, Assessment and Support,” Philadelphia: Jessica Kingsley Publishers, 2010.
6. “Always Care, Never Kill: How Physician-Assisted Suicide Endangers the Weak, Corrupts Medicine, Compromises the Family, and Violates Human Dignity and Equality,” Washington: The Heritage Foundation, 2015.
7. Ann Intern Med. 2012 Jan 3;156(1 Pt 2):73-104.
Dr. Ahmed is a 2nd-year resident in the psychiatry & behavioral sciences department at the Nassau University Medical Center, New York. Over the last 3 years, he has published and presented papers at national and international forums. His interests include public social psychiatry, health care policy, health disparities, mental health stigma, and undiagnosed and overdiagnosed psychiatric illnesses in children. Dr. Ahmed is a member of the American Psychiatric Association, the American Society of Clinical Psychopharmacology, and the American Association for Social Psychiatry.
Do we stand by our Hippocratic Oath when providing physician-assisted suicide?
Physician-assisted suicide (PAS) is a form of euthanasia in which a physician provides the patient with the pertinent information, and, in certain cases, a prescription for the necessary lethal drugs, so that the individual can willingly and successfully terminate his or her own life. The justification for PAS is the compassionate relief of intractable human suffering. Euthanasia and PAS are accepted practices in European countries such as the Netherlands, Belgium, and Luxembourg.
Such patients are mentally incapable of making the difficult decision to end their life and therefore should require a psychiatric evaluation to include counseling prior to making a decision to engage in PAS. For patients with mental illness, PAS is even more problematic than for terminally ill patients, because patients may lack the capacity to make rational and responsible decisions. Indeed, there are sizable loopholes where our medical system lacks safeguards and similarly lacks the requirements for a thorough, pre-PAS mental health examination, family notifications, and consultations, and for the minimally necessary legal pressure required to ensure patient cooperation.
Critical role of mental health workers
Although PAS has been legalized in those five U.S. states, its support and cases have stalled in recent years, indicating serious ethical concerns, mostly because of multileveled challenges of combating and delineating cultural stereotypes, quantifying mental capacity, gauging quality of life, and deciding where to situate psychiatrists in the PAS decision.
The psychiatrist’s role is being debated. In the United States, opponents take issue with current PAS-legal state’s legislation regarding psychiatric evaluations. For example, Oregon stipulates a psychiatrist referral only in cases where a physician other than a psychiatrist believes the patient’s judgment is impaired. It’s agreed that psychiatrists have the best skill set to assess a patient’s perceptions. Other PAS-legal states require a psychiatrist or psychologist assessment before making the decision. Unfortunately, though, physicians have rarely referred these patients to psychiatrists before offering PAS as an option.
PAS opponents target standards by which concepts like “quality of life” or “contributing member of society” are judged – specifically, that “unbearable suffering” and its ramifications are ill defined – people whose lives are deemed “not worth living” (including the terminally ill) would be susceptible to “sympathetic death” via PAS that might result from PAS legalization. Opponents also argue that recognizing a suicide “right” contradicts that a significant number of suicide attempters have mental illness and need help. They say that legalizing PAS would enable mentally incapacitated people to commit the irreversible act based on their distorted perceptions without providing them the expected assistance from their profession.1
The use of euthanasia or PAS gradually is trending from physically terminally ill patients toward psychiatrically complex patients. There are cases in which euthanasia or PAS was requested by psychiatric patients who had chronic psychiatric, medical, and psychosocial histories rather than purely physical ailment histories. In one study, Scott Y. H. Kim, MD, PhD, and his associates reviewed cases in the Netherlands in which either euthanasia or PAS for psychiatric disorders was deployed. The granted PAS requests appeared to involve physician judgment without psychiatric input.
The study reviewed 66 cases: 55% of patients had chronic severe conditions with extensive histories of attempted suicides and psychiatric hospitalizations, demonstrating that the granted euthanasia and PAS requests had involved extensive evaluations. However, 11% of cases had no independent psychiatric input, and 24% involved disagreement among the physicians.2 PAS proponents and opponents support the involvement and expertise of psychiatrists in all of this.
Psychiatrists have long contended that suicide attempts are often a “cry for help,” not an earnest act to end one’s life. Legalizing PAS tells suicidal individuals that society does not care whether they live or die – a truly un-Hippocratic stance. The stereotypes tossed around in the PAS debate, which could mean life or death, need to be unpacked with specific criteria attached, rather than preconceptions.
Autonomy of patients and implications of PAS
In the PAS debate, there are serious life concerns exhibited by terminally ill/psychiatrically ill patients over losing their autonomy and becoming a burden to their families and caregivers. Stereotypes must be deconstructed, yes, but such patients generally have been considered to be rendered, by the sum effect of their illnesses, mentally incapable of making the decision to end their lives. Addressing this order of patient life concerns generally has been the realm of social workers, psychologists, and, in the most desirable cases, psychiatrists. Therefore, even in keeping with established practice, some form of competent psychiatric evaluation should be required before considering PAS as a viable option.
The call for this requirement is backed up by a study, which reported that 47% of patients who had considered or committed suicide previously were diagnosed with psychiatric disorders, and 15% had undiagnosed psychiatric disorders.3 Also, inventories of thwarted suicide attempters reveal that most lack the conviction to end their lives, and this obverse phenomenon is backed by a study that revealed that 75% of 96 suicidal patients were found to be ambivalent in their intent to end their lives. Suicide attempters simply may be trying to communicate with people in their lives in order to test their love and care.4 This indicates that those who attempt suicide are predominantly psychiatrically ill and prone to distorted perceptions, impaired judgment, frustration, escapism, and manipulative guilt.
Suicide is abhorrent to most human beings’ sensibilities, because humanity has an innate will to live.5 It is wrong to offer patients life-ending options when they might rejuvenate or ease into death naturally. With the debilitated or elderly, PAS could violate their human rights. If the attitude that they are a burden to society persists, then a certain segment of society might be tempted to avoid their intergenerational obligations to elders, particularly those elders presenting with concurrent mental illnesses. PAS would additionally fuel that problem. This would represent a profound injustice and gross violation of human dignity, while also serving as a denial of basic human rights, particularly the right to life and care.6
Conclusion
The complex physical, psychological, and social challenges associated with PAS and the difficulty in enforcing its laws necessitate more adept alternatives. Instead of conditionally legalizing suicide, we should ease patient suffering with compassion and calibrated treatment.6,7
Terminally ill patients often suffer from depression, affecting their rationality. Adequate counseling, medical care, and psychological care should be the response to terminally ill patients considering suicide. If society accepts that ending a life is a reasonable response to human suffering that could otherwise be treated or reversed, then those with the most serious psychiatric conditions are destined to become more vulnerable. Therefore, physicians and psychiatrists should instead work harder to help patients recover, rather than participating in their quest for death.
Simplistic legal and regulatory oversight is insufficient, because the questions evoked by PAS are complicated by life, death, and ethics. Further research is needed to look into the mechanisms and morality of how psychiatrists and other physicians will make judgments and recommendations that are vital elements in developing regulatory oversight on PAS. Finally, future studies should look at which practices have been successful and which might be deemed unethical.
References
1. Clin Med (Lond). 2010 Aug;109(4):323-5.
2. JAMA Psychiatry. 2016;73(4):362-8.
3. “The Final Months: A Study of the Lives of 134 Persons Who Committed Suicide,” New York: Oxford University Press, 1981.
4. “Why We Shouldn’t Legalize Assisting Suicide, Part I.” Department of Medical Ethics, National Right to Life Committee.
5. “Working with Suicidal Individuals: A Guide to Providing Understanding, Assessment and Support,” Philadelphia: Jessica Kingsley Publishers, 2010.
6. “Always Care, Never Kill: How Physician-Assisted Suicide Endangers the Weak, Corrupts Medicine, Compromises the Family, and Violates Human Dignity and Equality,” Washington: The Heritage Foundation, 2015.
7. Ann Intern Med. 2012 Jan 3;156(1 Pt 2):73-104.
Dr. Ahmed is a 2nd-year resident in the psychiatry & behavioral sciences department at the Nassau University Medical Center, New York. Over the last 3 years, he has published and presented papers at national and international forums. His interests include public social psychiatry, health care policy, health disparities, mental health stigma, and undiagnosed and overdiagnosed psychiatric illnesses in children. Dr. Ahmed is a member of the American Psychiatric Association, the American Society of Clinical Psychopharmacology, and the American Association for Social Psychiatry.
Do we stand by our Hippocratic Oath when providing physician-assisted suicide?
Physician-assisted suicide (PAS) is a form of euthanasia in which a physician provides the patient with the pertinent information, and, in certain cases, a prescription for the necessary lethal drugs, so that the individual can willingly and successfully terminate his or her own life. The justification for PAS is the compassionate relief of intractable human suffering. Euthanasia and PAS are accepted practices in European countries such as the Netherlands, Belgium, and Luxembourg.
Such patients are mentally incapable of making the difficult decision to end their life and therefore should require a psychiatric evaluation to include counseling prior to making a decision to engage in PAS. For patients with mental illness, PAS is even more problematic than for terminally ill patients, because patients may lack the capacity to make rational and responsible decisions. Indeed, there are sizable loopholes where our medical system lacks safeguards and similarly lacks the requirements for a thorough, pre-PAS mental health examination, family notifications, and consultations, and for the minimally necessary legal pressure required to ensure patient cooperation.
Critical role of mental health workers
Although PAS has been legalized in those five U.S. states, its support and cases have stalled in recent years, indicating serious ethical concerns, mostly because of multileveled challenges of combating and delineating cultural stereotypes, quantifying mental capacity, gauging quality of life, and deciding where to situate psychiatrists in the PAS decision.
The psychiatrist’s role is being debated. In the United States, opponents take issue with current PAS-legal state’s legislation regarding psychiatric evaluations. For example, Oregon stipulates a psychiatrist referral only in cases where a physician other than a psychiatrist believes the patient’s judgment is impaired. It’s agreed that psychiatrists have the best skill set to assess a patient’s perceptions. Other PAS-legal states require a psychiatrist or psychologist assessment before making the decision. Unfortunately, though, physicians have rarely referred these patients to psychiatrists before offering PAS as an option.
PAS opponents target standards by which concepts like “quality of life” or “contributing member of society” are judged – specifically, that “unbearable suffering” and its ramifications are ill defined – people whose lives are deemed “not worth living” (including the terminally ill) would be susceptible to “sympathetic death” via PAS that might result from PAS legalization. Opponents also argue that recognizing a suicide “right” contradicts that a significant number of suicide attempters have mental illness and need help. They say that legalizing PAS would enable mentally incapacitated people to commit the irreversible act based on their distorted perceptions without providing them the expected assistance from their profession.1
The use of euthanasia or PAS gradually is trending from physically terminally ill patients toward psychiatrically complex patients. There are cases in which euthanasia or PAS was requested by psychiatric patients who had chronic psychiatric, medical, and psychosocial histories rather than purely physical ailment histories. In one study, Scott Y. H. Kim, MD, PhD, and his associates reviewed cases in the Netherlands in which either euthanasia or PAS for psychiatric disorders was deployed. The granted PAS requests appeared to involve physician judgment without psychiatric input.
The study reviewed 66 cases: 55% of patients had chronic severe conditions with extensive histories of attempted suicides and psychiatric hospitalizations, demonstrating that the granted euthanasia and PAS requests had involved extensive evaluations. However, 11% of cases had no independent psychiatric input, and 24% involved disagreement among the physicians.2 PAS proponents and opponents support the involvement and expertise of psychiatrists in all of this.
Psychiatrists have long contended that suicide attempts are often a “cry for help,” not an earnest act to end one’s life. Legalizing PAS tells suicidal individuals that society does not care whether they live or die – a truly un-Hippocratic stance. The stereotypes tossed around in the PAS debate, which could mean life or death, need to be unpacked with specific criteria attached, rather than preconceptions.
Autonomy of patients and implications of PAS
In the PAS debate, there are serious life concerns exhibited by terminally ill/psychiatrically ill patients over losing their autonomy and becoming a burden to their families and caregivers. Stereotypes must be deconstructed, yes, but such patients generally have been considered to be rendered, by the sum effect of their illnesses, mentally incapable of making the decision to end their lives. Addressing this order of patient life concerns generally has been the realm of social workers, psychologists, and, in the most desirable cases, psychiatrists. Therefore, even in keeping with established practice, some form of competent psychiatric evaluation should be required before considering PAS as a viable option.
The call for this requirement is backed up by a study, which reported that 47% of patients who had considered or committed suicide previously were diagnosed with psychiatric disorders, and 15% had undiagnosed psychiatric disorders.3 Also, inventories of thwarted suicide attempters reveal that most lack the conviction to end their lives, and this obverse phenomenon is backed by a study that revealed that 75% of 96 suicidal patients were found to be ambivalent in their intent to end their lives. Suicide attempters simply may be trying to communicate with people in their lives in order to test their love and care.4 This indicates that those who attempt suicide are predominantly psychiatrically ill and prone to distorted perceptions, impaired judgment, frustration, escapism, and manipulative guilt.
Suicide is abhorrent to most human beings’ sensibilities, because humanity has an innate will to live.5 It is wrong to offer patients life-ending options when they might rejuvenate or ease into death naturally. With the debilitated or elderly, PAS could violate their human rights. If the attitude that they are a burden to society persists, then a certain segment of society might be tempted to avoid their intergenerational obligations to elders, particularly those elders presenting with concurrent mental illnesses. PAS would additionally fuel that problem. This would represent a profound injustice and gross violation of human dignity, while also serving as a denial of basic human rights, particularly the right to life and care.6
Conclusion
The complex physical, psychological, and social challenges associated with PAS and the difficulty in enforcing its laws necessitate more adept alternatives. Instead of conditionally legalizing suicide, we should ease patient suffering with compassion and calibrated treatment.6,7
Terminally ill patients often suffer from depression, affecting their rationality. Adequate counseling, medical care, and psychological care should be the response to terminally ill patients considering suicide. If society accepts that ending a life is a reasonable response to human suffering that could otherwise be treated or reversed, then those with the most serious psychiatric conditions are destined to become more vulnerable. Therefore, physicians and psychiatrists should instead work harder to help patients recover, rather than participating in their quest for death.
Simplistic legal and regulatory oversight is insufficient, because the questions evoked by PAS are complicated by life, death, and ethics. Further research is needed to look into the mechanisms and morality of how psychiatrists and other physicians will make judgments and recommendations that are vital elements in developing regulatory oversight on PAS. Finally, future studies should look at which practices have been successful and which might be deemed unethical.
References
1. Clin Med (Lond). 2010 Aug;109(4):323-5.
2. JAMA Psychiatry. 2016;73(4):362-8.
3. “The Final Months: A Study of the Lives of 134 Persons Who Committed Suicide,” New York: Oxford University Press, 1981.
4. “Why We Shouldn’t Legalize Assisting Suicide, Part I.” Department of Medical Ethics, National Right to Life Committee.
5. “Working with Suicidal Individuals: A Guide to Providing Understanding, Assessment and Support,” Philadelphia: Jessica Kingsley Publishers, 2010.
6. “Always Care, Never Kill: How Physician-Assisted Suicide Endangers the Weak, Corrupts Medicine, Compromises the Family, and Violates Human Dignity and Equality,” Washington: The Heritage Foundation, 2015.
7. Ann Intern Med. 2012 Jan 3;156(1 Pt 2):73-104.
Dr. Ahmed is a 2nd-year resident in the psychiatry & behavioral sciences department at the Nassau University Medical Center, New York. Over the last 3 years, he has published and presented papers at national and international forums. His interests include public social psychiatry, health care policy, health disparities, mental health stigma, and undiagnosed and overdiagnosed psychiatric illnesses in children. Dr. Ahmed is a member of the American Psychiatric Association, the American Society of Clinical Psychopharmacology, and the American Association for Social Psychiatry.
FDA addresses unmet need in drug development guidance for female sexual dysfunction
On Oct. 25, 2016, the Food and Drug Administration issued a draft guidance document titled “Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment.” The document outlines FDA’s current thinking about how best to design phase III trials for drugs to treat these problems. The purpose of this guidance is to provide pharmaceutical companies with a road map of what the FDA recommends should be addressed in clinical trials designed for new drug approval.
The FDA makes it clear that this guidance is only a “recommendation,” reflecting the agency’s current thinking on this important issue, and is not a requirement (unless specific regulatory or statutory requirements are cited). That may well be, but this puts me in mind of my graduate school days when my advisor used to tell me that his suggestions for my dissertation were only “recommendations.” I knew, of course, that to ignore these recommendations was folly.
Specifically, I would like to highlight several remarkable advances in this document. First, the guidance document acknowledges that there is a medical need for drugs to treat women with sexual dysfunction. Second, the guidance supports retaining the disorders of Hypoactive Sexual Desire Disorder (HSDD) and Female Sexual Arousal Disorder (FSAD) from the DSM-IV as treatment indications. Further, the guidance recognizes that the DSM-5 revisions of female sexual disorders, in this case, Female Sexual Interest and/or Arousal Disorder (FSIAD) “have not been universally accepted the scientific community.”
With regard to clinical trial design, I commend the FDA for removing Satisfying Sexual Events (SSEs) as a “required” primary endpoint and for allowing sponsors more flexibility to choose primary endpoints that will better align regulatory standards with the definition and key symptoms of HSDD (as well as FSAD and FSIAD). These endpoints include validated patient-reported outcome instruments that assess the symptoms of low desire (or arousal) and sexually related distress.
On the negative side, the guidance also reflects some carryover myths that are not in keeping with evidence or expert opinion. Specifically, the FDA cautions against the use of the Female Sexual Function Index desire (FSFI-D) subdomain as a primary endpoint in its current form. The FSFI-D has excellent construct and content validity. Furthermore, the guidance cautions against using a long recall period – 28 days/4 weeks – reflecting the FDA’s concern that women’s recall over that period of time will be inaccurate. They strongly recommend a 24-hour recall period.
Although it is certainly appropriate to evaluate on-demand treatments using more immediate and specific time frames, longer recall of desire is still appropriate as well. Longer recall periods provide a more accurate assessment of desire, which is best understood as state as of mind. A 24-hour recall (e.g., daily log of desire) is more akin to assessing one’s current hunger, whereas a 28-day look-back reflects one’s overall appetite, a concept more similar to desire.
And finally, although the FDA supports inclusion of postmenopausal women as a target population, it would be best if they not divide women into “groups” based on menopausal status unless hormonal status is relevant. This could further marginalize postmenopausal women and delay access to treatments for this population.
Once finalized, this draft guidance should serve its stated purpose to enhance discussion among FDA, pharmaceutical companies, academics, and the public.
Dr. Kingsberg is chief of the division of behavioral medicine in the department of obstetrics and gynecology at MacDonald Women’s Hospital, part of the University Hospitals Cleveland Medical Center, Ohio. She is also a professor in the departments of reproductive biology and psychiatry at Case Western Reserve University, Cleveland. Dr. Kingsberg reported being a consultant or member of the scientific advisory board for Acerus, AMAG, Bayer, Emotional Brain, Endoceutics, NovoNordisk, Palatin, Pfizer, Shionogi, Sprout, TherapeuticsMD, Sermonix, Strategic Science & Technologies, and Valeant. Valeant is the manufacturer of the HSDD drug flibanserin.
On Oct. 25, 2016, the Food and Drug Administration issued a draft guidance document titled “Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment.” The document outlines FDA’s current thinking about how best to design phase III trials for drugs to treat these problems. The purpose of this guidance is to provide pharmaceutical companies with a road map of what the FDA recommends should be addressed in clinical trials designed for new drug approval.
The FDA makes it clear that this guidance is only a “recommendation,” reflecting the agency’s current thinking on this important issue, and is not a requirement (unless specific regulatory or statutory requirements are cited). That may well be, but this puts me in mind of my graduate school days when my advisor used to tell me that his suggestions for my dissertation were only “recommendations.” I knew, of course, that to ignore these recommendations was folly.
Specifically, I would like to highlight several remarkable advances in this document. First, the guidance document acknowledges that there is a medical need for drugs to treat women with sexual dysfunction. Second, the guidance supports retaining the disorders of Hypoactive Sexual Desire Disorder (HSDD) and Female Sexual Arousal Disorder (FSAD) from the DSM-IV as treatment indications. Further, the guidance recognizes that the DSM-5 revisions of female sexual disorders, in this case, Female Sexual Interest and/or Arousal Disorder (FSIAD) “have not been universally accepted the scientific community.”
With regard to clinical trial design, I commend the FDA for removing Satisfying Sexual Events (SSEs) as a “required” primary endpoint and for allowing sponsors more flexibility to choose primary endpoints that will better align regulatory standards with the definition and key symptoms of HSDD (as well as FSAD and FSIAD). These endpoints include validated patient-reported outcome instruments that assess the symptoms of low desire (or arousal) and sexually related distress.
On the negative side, the guidance also reflects some carryover myths that are not in keeping with evidence or expert opinion. Specifically, the FDA cautions against the use of the Female Sexual Function Index desire (FSFI-D) subdomain as a primary endpoint in its current form. The FSFI-D has excellent construct and content validity. Furthermore, the guidance cautions against using a long recall period – 28 days/4 weeks – reflecting the FDA’s concern that women’s recall over that period of time will be inaccurate. They strongly recommend a 24-hour recall period.
Although it is certainly appropriate to evaluate on-demand treatments using more immediate and specific time frames, longer recall of desire is still appropriate as well. Longer recall periods provide a more accurate assessment of desire, which is best understood as state as of mind. A 24-hour recall (e.g., daily log of desire) is more akin to assessing one’s current hunger, whereas a 28-day look-back reflects one’s overall appetite, a concept more similar to desire.
And finally, although the FDA supports inclusion of postmenopausal women as a target population, it would be best if they not divide women into “groups” based on menopausal status unless hormonal status is relevant. This could further marginalize postmenopausal women and delay access to treatments for this population.
Once finalized, this draft guidance should serve its stated purpose to enhance discussion among FDA, pharmaceutical companies, academics, and the public.
Dr. Kingsberg is chief of the division of behavioral medicine in the department of obstetrics and gynecology at MacDonald Women’s Hospital, part of the University Hospitals Cleveland Medical Center, Ohio. She is also a professor in the departments of reproductive biology and psychiatry at Case Western Reserve University, Cleveland. Dr. Kingsberg reported being a consultant or member of the scientific advisory board for Acerus, AMAG, Bayer, Emotional Brain, Endoceutics, NovoNordisk, Palatin, Pfizer, Shionogi, Sprout, TherapeuticsMD, Sermonix, Strategic Science & Technologies, and Valeant. Valeant is the manufacturer of the HSDD drug flibanserin.
On Oct. 25, 2016, the Food and Drug Administration issued a draft guidance document titled “Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment.” The document outlines FDA’s current thinking about how best to design phase III trials for drugs to treat these problems. The purpose of this guidance is to provide pharmaceutical companies with a road map of what the FDA recommends should be addressed in clinical trials designed for new drug approval.
The FDA makes it clear that this guidance is only a “recommendation,” reflecting the agency’s current thinking on this important issue, and is not a requirement (unless specific regulatory or statutory requirements are cited). That may well be, but this puts me in mind of my graduate school days when my advisor used to tell me that his suggestions for my dissertation were only “recommendations.” I knew, of course, that to ignore these recommendations was folly.
Specifically, I would like to highlight several remarkable advances in this document. First, the guidance document acknowledges that there is a medical need for drugs to treat women with sexual dysfunction. Second, the guidance supports retaining the disorders of Hypoactive Sexual Desire Disorder (HSDD) and Female Sexual Arousal Disorder (FSAD) from the DSM-IV as treatment indications. Further, the guidance recognizes that the DSM-5 revisions of female sexual disorders, in this case, Female Sexual Interest and/or Arousal Disorder (FSIAD) “have not been universally accepted the scientific community.”
With regard to clinical trial design, I commend the FDA for removing Satisfying Sexual Events (SSEs) as a “required” primary endpoint and for allowing sponsors more flexibility to choose primary endpoints that will better align regulatory standards with the definition and key symptoms of HSDD (as well as FSAD and FSIAD). These endpoints include validated patient-reported outcome instruments that assess the symptoms of low desire (or arousal) and sexually related distress.
On the negative side, the guidance also reflects some carryover myths that are not in keeping with evidence or expert opinion. Specifically, the FDA cautions against the use of the Female Sexual Function Index desire (FSFI-D) subdomain as a primary endpoint in its current form. The FSFI-D has excellent construct and content validity. Furthermore, the guidance cautions against using a long recall period – 28 days/4 weeks – reflecting the FDA’s concern that women’s recall over that period of time will be inaccurate. They strongly recommend a 24-hour recall period.
Although it is certainly appropriate to evaluate on-demand treatments using more immediate and specific time frames, longer recall of desire is still appropriate as well. Longer recall periods provide a more accurate assessment of desire, which is best understood as state as of mind. A 24-hour recall (e.g., daily log of desire) is more akin to assessing one’s current hunger, whereas a 28-day look-back reflects one’s overall appetite, a concept more similar to desire.
And finally, although the FDA supports inclusion of postmenopausal women as a target population, it would be best if they not divide women into “groups” based on menopausal status unless hormonal status is relevant. This could further marginalize postmenopausal women and delay access to treatments for this population.
Once finalized, this draft guidance should serve its stated purpose to enhance discussion among FDA, pharmaceutical companies, academics, and the public.
Dr. Kingsberg is chief of the division of behavioral medicine in the department of obstetrics and gynecology at MacDonald Women’s Hospital, part of the University Hospitals Cleveland Medical Center, Ohio. She is also a professor in the departments of reproductive biology and psychiatry at Case Western Reserve University, Cleveland. Dr. Kingsberg reported being a consultant or member of the scientific advisory board for Acerus, AMAG, Bayer, Emotional Brain, Endoceutics, NovoNordisk, Palatin, Pfizer, Shionogi, Sprout, TherapeuticsMD, Sermonix, Strategic Science & Technologies, and Valeant. Valeant is the manufacturer of the HSDD drug flibanserin.
Bertrand M. Bell, MD: An Iconoclast Who Became an Icon
Bertrand M. Bell, MD, Distinguished University Professor Emeritus at Albert Einstein College of Medicine, died at the age of 86 in his Manhattan home on October 4, 2016. For decades, Dr Bell was the Director of Ambulatory Care, which included the ED at Einstein’s teaching hospital, the Bronx Municipal (Jacobi) Hospital Center. But, as Dr Bell was aware for the last 25 years of his life, he would always be remembered for a committee he chaired the year he was on sabbatical from Einstein and Jacobi in 1987.
After the death of 18-year-old Libby Zion from a dangerous drug interaction, the New York State Commissioner of Health asked Dr Bell to chair an ad hoc committee to investigate the care of hospitalized patients by residents and to make recommendations regarding medication ordering and administration, the use of patient restraints, attending supervision, and resident work hours. The “Bell Commission,” as it came to be known, recommended that residents not be allowed to work more than 80 hours a week or more than 24 consecutive hours, and that attending physicians be present in the hospital 24/7. These recommendations were made part of the New York State Health Code in 1989 and adopted nationwide by the Accreditation Council for Graduate Medical Education in 1993.
The Bell Commission changes in resident work hours were not enthusiastically received by all, with most of the criticism centering on a perceived lack of continuity in resident education resulting from the shortened work hours. Largely ignored, however, was the committee’s call for 24/7 attending supervision, which would have provided both continuity in patient care and enhanced resident education and experiences. Dr Bell was outspoken in defending his committee’s recommendations and his views on the inadequacies of graduate medical education (GME), occasionally infuriating those who disagreed with him.
Ironically, though the formal name of the Bell Commission was the “Ad Hoc Advisory Committee on Emergency Services,” the recommendations did not address prehospital care issues and probably affected emergency medicine (EM) residents less than they did residents from other specialties. Both the work-hour rules and mandated attending presence had already been implemented by many EM residency training programs from the time EM became a specialty in 1979, and were required of all EM programs by the end of the 1980s. (See “’My Patient’—More Than Ever,” Emerg Med. 2013;45[4]:1.)
Yet, Bert Bell may have had as profound an effect on the birth and survival of academic EM on the East Coast as did his committee’s recommendations on GME nationwide. Together with his ED Director, Sheldon Jacobson, MD, Bert secured for Einstein/Jacobi the first federally funded paramedic training program in New York State in 1974, followed a year later by the first EM residency in New York State, and one of the earliest in the nation. Bert also hired and trained nurse practitioners and physician assistants to care for patients in the ED and clinics, realizing their potential and the value of their contributions to patient care, years before others did.
The group of emergency physicians that Bert and Shelly assembled at Einstein/Jacobi in the 1970s included John Gallagher, Peter Moyer, Mark Henry, Gregg Husk, Paul Gennis, a young Wallace Carter, me, and several other EM pionee
At Dr Bell’s funeral on October 7, the rabbi alluded to a description of the prophet Elijah, in describing Bert as a “holy troublemaker.” Bert Bell was a larger-than-life iconoclast whose name became an icon for graduate medical education reforms and whose patient care values will survive in future generations of physicians.
Bertrand M. Bell, MD, Distinguished University Professor Emeritus at Albert Einstein College of Medicine, died at the age of 86 in his Manhattan home on October 4, 2016. For decades, Dr Bell was the Director of Ambulatory Care, which included the ED at Einstein’s teaching hospital, the Bronx Municipal (Jacobi) Hospital Center. But, as Dr Bell was aware for the last 25 years of his life, he would always be remembered for a committee he chaired the year he was on sabbatical from Einstein and Jacobi in 1987.
After the death of 18-year-old Libby Zion from a dangerous drug interaction, the New York State Commissioner of Health asked Dr Bell to chair an ad hoc committee to investigate the care of hospitalized patients by residents and to make recommendations regarding medication ordering and administration, the use of patient restraints, attending supervision, and resident work hours. The “Bell Commission,” as it came to be known, recommended that residents not be allowed to work more than 80 hours a week or more than 24 consecutive hours, and that attending physicians be present in the hospital 24/7. These recommendations were made part of the New York State Health Code in 1989 and adopted nationwide by the Accreditation Council for Graduate Medical Education in 1993.
The Bell Commission changes in resident work hours were not enthusiastically received by all, with most of the criticism centering on a perceived lack of continuity in resident education resulting from the shortened work hours. Largely ignored, however, was the committee’s call for 24/7 attending supervision, which would have provided both continuity in patient care and enhanced resident education and experiences. Dr Bell was outspoken in defending his committee’s recommendations and his views on the inadequacies of graduate medical education (GME), occasionally infuriating those who disagreed with him.
Ironically, though the formal name of the Bell Commission was the “Ad Hoc Advisory Committee on Emergency Services,” the recommendations did not address prehospital care issues and probably affected emergency medicine (EM) residents less than they did residents from other specialties. Both the work-hour rules and mandated attending presence had already been implemented by many EM residency training programs from the time EM became a specialty in 1979, and were required of all EM programs by the end of the 1980s. (See “’My Patient’—More Than Ever,” Emerg Med. 2013;45[4]:1.)
Yet, Bert Bell may have had as profound an effect on the birth and survival of academic EM on the East Coast as did his committee’s recommendations on GME nationwide. Together with his ED Director, Sheldon Jacobson, MD, Bert secured for Einstein/Jacobi the first federally funded paramedic training program in New York State in 1974, followed a year later by the first EM residency in New York State, and one of the earliest in the nation. Bert also hired and trained nurse practitioners and physician assistants to care for patients in the ED and clinics, realizing their potential and the value of their contributions to patient care, years before others did.
The group of emergency physicians that Bert and Shelly assembled at Einstein/Jacobi in the 1970s included John Gallagher, Peter Moyer, Mark Henry, Gregg Husk, Paul Gennis, a young Wallace Carter, me, and several other EM pionee
At Dr Bell’s funeral on October 7, the rabbi alluded to a description of the prophet Elijah, in describing Bert as a “holy troublemaker.” Bert Bell was a larger-than-life iconoclast whose name became an icon for graduate medical education reforms and whose patient care values will survive in future generations of physicians.
Bertrand M. Bell, MD, Distinguished University Professor Emeritus at Albert Einstein College of Medicine, died at the age of 86 in his Manhattan home on October 4, 2016. For decades, Dr Bell was the Director of Ambulatory Care, which included the ED at Einstein’s teaching hospital, the Bronx Municipal (Jacobi) Hospital Center. But, as Dr Bell was aware for the last 25 years of his life, he would always be remembered for a committee he chaired the year he was on sabbatical from Einstein and Jacobi in 1987.
After the death of 18-year-old Libby Zion from a dangerous drug interaction, the New York State Commissioner of Health asked Dr Bell to chair an ad hoc committee to investigate the care of hospitalized patients by residents and to make recommendations regarding medication ordering and administration, the use of patient restraints, attending supervision, and resident work hours. The “Bell Commission,” as it came to be known, recommended that residents not be allowed to work more than 80 hours a week or more than 24 consecutive hours, and that attending physicians be present in the hospital 24/7. These recommendations were made part of the New York State Health Code in 1989 and adopted nationwide by the Accreditation Council for Graduate Medical Education in 1993.
The Bell Commission changes in resident work hours were not enthusiastically received by all, with most of the criticism centering on a perceived lack of continuity in resident education resulting from the shortened work hours. Largely ignored, however, was the committee’s call for 24/7 attending supervision, which would have provided both continuity in patient care and enhanced resident education and experiences. Dr Bell was outspoken in defending his committee’s recommendations and his views on the inadequacies of graduate medical education (GME), occasionally infuriating those who disagreed with him.
Ironically, though the formal name of the Bell Commission was the “Ad Hoc Advisory Committee on Emergency Services,” the recommendations did not address prehospital care issues and probably affected emergency medicine (EM) residents less than they did residents from other specialties. Both the work-hour rules and mandated attending presence had already been implemented by many EM residency training programs from the time EM became a specialty in 1979, and were required of all EM programs by the end of the 1980s. (See “’My Patient’—More Than Ever,” Emerg Med. 2013;45[4]:1.)
Yet, Bert Bell may have had as profound an effect on the birth and survival of academic EM on the East Coast as did his committee’s recommendations on GME nationwide. Together with his ED Director, Sheldon Jacobson, MD, Bert secured for Einstein/Jacobi the first federally funded paramedic training program in New York State in 1974, followed a year later by the first EM residency in New York State, and one of the earliest in the nation. Bert also hired and trained nurse practitioners and physician assistants to care for patients in the ED and clinics, realizing their potential and the value of their contributions to patient care, years before others did.
The group of emergency physicians that Bert and Shelly assembled at Einstein/Jacobi in the 1970s included John Gallagher, Peter Moyer, Mark Henry, Gregg Husk, Paul Gennis, a young Wallace Carter, me, and several other EM pionee
At Dr Bell’s funeral on October 7, the rabbi alluded to a description of the prophet Elijah, in describing Bert as a “holy troublemaker.” Bert Bell was a larger-than-life iconoclast whose name became an icon for graduate medical education reforms and whose patient care values will survive in future generations of physicians.
Roommates
The American Academy of Pediatrics has recently released a new policy for parents on safe sleep practices that in addition to the previous warnings about bed sharing and positioning includes the recommendation that an infant sleep in the same room as her parent for at least the first 6 months (Pediatrics. 2016 Oct;138[5]:e20162938). Apparently what prompted this new set of recommendations is the observation that deaths from sudden unexpected infant deaths (SUIDS) and sudden infant deaths (SIDS) has plateaued since the dramatic decline we witnessed in the 1990s following the Back-to-Sleep campaign.
Although the policy statement refers to “new research” that has become available since the last policy statement was released in 2011, I have had trouble finding convincing evidence in the references I reviewed to support the room sharing recommendation. In some studies, room sharing was the cultural norm, making it difficult to establish a control group. In one of the most frequently cited papers from New Zealand, the authors could not sort out the effects of prone sleeping and sleeping alone, and wonder whether both factors may be affecting risk “through a common mechanism” (Lancet. 1996 Jan 6;347[8993]:7-12).
For some, parents attempting to follow this recommendation may not be without its negative consequences. Sleeping like a baby is not the same as sleeping quietly. Infants often breathe in a pattern that includes long, anxiety-provoking pauses. The implication of this policy recommendation is that parents can prevent crib death by being more vigilant at night. Do we have enough evidence that this is indeed the case?
Most parents are already anxious, and none of them are getting enough sleep. I can envision that trying to follow this recommendation could aggravate both conditions for some parents. Sleep-deprived parents often are not as capable parents as they could be. And they certainly aren’t as happy as they could be. Postpartum depression compounded by sleep deprivation continues to be an underreported and inadequately managed condition that can have negative effects for the health of the child.
For some parents, room sharing is something they gravitate toward naturally, and it can help them deal with the anxiety of new parenthood. They may sleep better with their infant close by. But for others, the better solution to their own sleep deprivation lies in sleep training, a strategy that is very difficult, if not impossible, for parents who are sharing their bedroom with their infant.
As the authors of one of the most frequently quoted papers that supports room sharing have written, “the traditional habit of labeling one sleep arrangement as being superior to another without awareness of the family context is not only wrong but potentially harmful” (Paediatric Resp Review. 2005, Jun;6[2]:134-52).
I think the academy has gone too far or at least moved prematurely with its room sharing recommendation. For some families, room sharing is a better arrangement, for others it is not. It may well be that the plateau in crib deaths is telling us that we have reached the limits of our abilities to effect any further decline with our recommendations about sleep environments. But more research needs to be done.
On a more positive note, the new recommendation may force parents to reevaluate their habit of having a television in their bedroom. Will it be baby or TV in the bedroom? Unfortunately, I fear too many will opt to have both.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at [email protected].
The American Academy of Pediatrics has recently released a new policy for parents on safe sleep practices that in addition to the previous warnings about bed sharing and positioning includes the recommendation that an infant sleep in the same room as her parent for at least the first 6 months (Pediatrics. 2016 Oct;138[5]:e20162938). Apparently what prompted this new set of recommendations is the observation that deaths from sudden unexpected infant deaths (SUIDS) and sudden infant deaths (SIDS) has plateaued since the dramatic decline we witnessed in the 1990s following the Back-to-Sleep campaign.
Although the policy statement refers to “new research” that has become available since the last policy statement was released in 2011, I have had trouble finding convincing evidence in the references I reviewed to support the room sharing recommendation. In some studies, room sharing was the cultural norm, making it difficult to establish a control group. In one of the most frequently cited papers from New Zealand, the authors could not sort out the effects of prone sleeping and sleeping alone, and wonder whether both factors may be affecting risk “through a common mechanism” (Lancet. 1996 Jan 6;347[8993]:7-12).
For some, parents attempting to follow this recommendation may not be without its negative consequences. Sleeping like a baby is not the same as sleeping quietly. Infants often breathe in a pattern that includes long, anxiety-provoking pauses. The implication of this policy recommendation is that parents can prevent crib death by being more vigilant at night. Do we have enough evidence that this is indeed the case?
Most parents are already anxious, and none of them are getting enough sleep. I can envision that trying to follow this recommendation could aggravate both conditions for some parents. Sleep-deprived parents often are not as capable parents as they could be. And they certainly aren’t as happy as they could be. Postpartum depression compounded by sleep deprivation continues to be an underreported and inadequately managed condition that can have negative effects for the health of the child.
For some parents, room sharing is something they gravitate toward naturally, and it can help them deal with the anxiety of new parenthood. They may sleep better with their infant close by. But for others, the better solution to their own sleep deprivation lies in sleep training, a strategy that is very difficult, if not impossible, for parents who are sharing their bedroom with their infant.
As the authors of one of the most frequently quoted papers that supports room sharing have written, “the traditional habit of labeling one sleep arrangement as being superior to another without awareness of the family context is not only wrong but potentially harmful” (Paediatric Resp Review. 2005, Jun;6[2]:134-52).
I think the academy has gone too far or at least moved prematurely with its room sharing recommendation. For some families, room sharing is a better arrangement, for others it is not. It may well be that the plateau in crib deaths is telling us that we have reached the limits of our abilities to effect any further decline with our recommendations about sleep environments. But more research needs to be done.
On a more positive note, the new recommendation may force parents to reevaluate their habit of having a television in their bedroom. Will it be baby or TV in the bedroom? Unfortunately, I fear too many will opt to have both.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at [email protected].
The American Academy of Pediatrics has recently released a new policy for parents on safe sleep practices that in addition to the previous warnings about bed sharing and positioning includes the recommendation that an infant sleep in the same room as her parent for at least the first 6 months (Pediatrics. 2016 Oct;138[5]:e20162938). Apparently what prompted this new set of recommendations is the observation that deaths from sudden unexpected infant deaths (SUIDS) and sudden infant deaths (SIDS) has plateaued since the dramatic decline we witnessed in the 1990s following the Back-to-Sleep campaign.
Although the policy statement refers to “new research” that has become available since the last policy statement was released in 2011, I have had trouble finding convincing evidence in the references I reviewed to support the room sharing recommendation. In some studies, room sharing was the cultural norm, making it difficult to establish a control group. In one of the most frequently cited papers from New Zealand, the authors could not sort out the effects of prone sleeping and sleeping alone, and wonder whether both factors may be affecting risk “through a common mechanism” (Lancet. 1996 Jan 6;347[8993]:7-12).
For some, parents attempting to follow this recommendation may not be without its negative consequences. Sleeping like a baby is not the same as sleeping quietly. Infants often breathe in a pattern that includes long, anxiety-provoking pauses. The implication of this policy recommendation is that parents can prevent crib death by being more vigilant at night. Do we have enough evidence that this is indeed the case?
Most parents are already anxious, and none of them are getting enough sleep. I can envision that trying to follow this recommendation could aggravate both conditions for some parents. Sleep-deprived parents often are not as capable parents as they could be. And they certainly aren’t as happy as they could be. Postpartum depression compounded by sleep deprivation continues to be an underreported and inadequately managed condition that can have negative effects for the health of the child.
For some parents, room sharing is something they gravitate toward naturally, and it can help them deal with the anxiety of new parenthood. They may sleep better with their infant close by. But for others, the better solution to their own sleep deprivation lies in sleep training, a strategy that is very difficult, if not impossible, for parents who are sharing their bedroom with their infant.
As the authors of one of the most frequently quoted papers that supports room sharing have written, “the traditional habit of labeling one sleep arrangement as being superior to another without awareness of the family context is not only wrong but potentially harmful” (Paediatric Resp Review. 2005, Jun;6[2]:134-52).
I think the academy has gone too far or at least moved prematurely with its room sharing recommendation. For some families, room sharing is a better arrangement, for others it is not. It may well be that the plateau in crib deaths is telling us that we have reached the limits of our abilities to effect any further decline with our recommendations about sleep environments. But more research needs to be done.
On a more positive note, the new recommendation may force parents to reevaluate their habit of having a television in their bedroom. Will it be baby or TV in the bedroom? Unfortunately, I fear too many will opt to have both.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.” Email him at [email protected].
COMMENTARY—Study Reaffirms FDA Findings
The study by Dr. Kesselheim and his colleagues is one of several recently aimed at reviewing the overall safety of generic drug switching. The FDA sponsored three clinical bioequivalence studies to determine the adequacy of average bioequivalence studies for ensuring safe conversion between different antiseizure products for patients with epilepsy. Taken together, these studies confirm that most patients can safely switch between generic formulations, even between tablets differing in appearance.
So why do patients and open series report seizures associated with formulation changes? Probably several things are happening:
• Patients want to find a reason for the near-random pattern of their seizures. Threshold cortical epileptogenic activity triggers seizures in near-random patterns, and their timing might be influenced by triggers such as missing doses, stress, and hormonal changes.
• Patients’ views of illness and treatments might influence their reporting of seizures and drug effects. This search for seizure explanations can even extend to pets with seizures.
• There is temporal variability in individual drug absorption and elimination. Food has a major effect on absorption of antiseizure medications and maximum concentration; this effect is particularly common with modified-release formulations. A small subgroup of patients in the FDA’s clinical bioequivalence studies had variability in concentrations during reexposure to the same product.
• A small group of patients may be outside the 90% confidence interval bioequivalence acceptance range and may experience product switching effects.
—Gregory L. Krauss, MD
Professor of Neurology
Johns Hopkins University, Baltimore
—Michael D. Privitera, MD
Professor of Neurology
University of Cincinnati
This commentary was adapted from Krauss GL, Privitera M. More data on the safety of generic substitution: yes, the blue tablet is OK? Neurology. 2016 Sep 28 [Epub ahead of print].
The study by Dr. Kesselheim and his colleagues is one of several recently aimed at reviewing the overall safety of generic drug switching. The FDA sponsored three clinical bioequivalence studies to determine the adequacy of average bioequivalence studies for ensuring safe conversion between different antiseizure products for patients with epilepsy. Taken together, these studies confirm that most patients can safely switch between generic formulations, even between tablets differing in appearance.
So why do patients and open series report seizures associated with formulation changes? Probably several things are happening:
• Patients want to find a reason for the near-random pattern of their seizures. Threshold cortical epileptogenic activity triggers seizures in near-random patterns, and their timing might be influenced by triggers such as missing doses, stress, and hormonal changes.
• Patients’ views of illness and treatments might influence their reporting of seizures and drug effects. This search for seizure explanations can even extend to pets with seizures.
• There is temporal variability in individual drug absorption and elimination. Food has a major effect on absorption of antiseizure medications and maximum concentration; this effect is particularly common with modified-release formulations. A small subgroup of patients in the FDA’s clinical bioequivalence studies had variability in concentrations during reexposure to the same product.
• A small group of patients may be outside the 90% confidence interval bioequivalence acceptance range and may experience product switching effects.
—Gregory L. Krauss, MD
Professor of Neurology
Johns Hopkins University, Baltimore
—Michael D. Privitera, MD
Professor of Neurology
University of Cincinnati
This commentary was adapted from Krauss GL, Privitera M. More data on the safety of generic substitution: yes, the blue tablet is OK? Neurology. 2016 Sep 28 [Epub ahead of print].
The study by Dr. Kesselheim and his colleagues is one of several recently aimed at reviewing the overall safety of generic drug switching. The FDA sponsored three clinical bioequivalence studies to determine the adequacy of average bioequivalence studies for ensuring safe conversion between different antiseizure products for patients with epilepsy. Taken together, these studies confirm that most patients can safely switch between generic formulations, even between tablets differing in appearance.
So why do patients and open series report seizures associated with formulation changes? Probably several things are happening:
• Patients want to find a reason for the near-random pattern of their seizures. Threshold cortical epileptogenic activity triggers seizures in near-random patterns, and their timing might be influenced by triggers such as missing doses, stress, and hormonal changes.
• Patients’ views of illness and treatments might influence their reporting of seizures and drug effects. This search for seizure explanations can even extend to pets with seizures.
• There is temporal variability in individual drug absorption and elimination. Food has a major effect on absorption of antiseizure medications and maximum concentration; this effect is particularly common with modified-release formulations. A small subgroup of patients in the FDA’s clinical bioequivalence studies had variability in concentrations during reexposure to the same product.
• A small group of patients may be outside the 90% confidence interval bioequivalence acceptance range and may experience product switching effects.
—Gregory L. Krauss, MD
Professor of Neurology
Johns Hopkins University, Baltimore
—Michael D. Privitera, MD
Professor of Neurology
University of Cincinnati
This commentary was adapted from Krauss GL, Privitera M. More data on the safety of generic substitution: yes, the blue tablet is OK? Neurology. 2016 Sep 28 [Epub ahead of print].