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Empirical evidence lags behind rise in preadolescents presenting with gender dysphoria
SCOTTSDALE, ARIZ. – The treatment of preadolescents who present with gender questions is often complicated by the absence of evidence-based data on who is most likely to remain gender dysphoric into adulthood and who is not, an expert said at the annual meeting of the American College of Psychiatrists.
“There are some [clinicians] who believe they can predict who will persist and who will not. But they have not published, to my satisfaction, a way to show anyone else how to tell the difference,” said Jack Drescher, MD, a member of the World Health Organization’s (WHO’s) Working Group on the Classification of Sexual Disorders and Sexual Health and clinical professor of psychiatry and behavioral sciences at New York Medical College, Valhalla.
The WHO working group was tasked with categorizing sex and gender diagnoses in the forthcoming International Classification of Diseases (ICD-11). Dr. Drescher said that he and his fellow WHO working group members have identified at least three discrete transgender populations.
“There are persisters, desisters, and those who first develop gender dysphoria in adolescence and adulthood,” he said. “It would be a clinical mistake to think that there is a seamless transition from childhood gender dysphoria into adolescent and adult gender dysphoria.”
Dr. Drescher said that he believes the Dutch model for treating younger children diagnosed with what is interchangeably referred to as gender dysphoria or gender variance demonstrates the greatest sensitivity to how fluid the situation can be for many of these children. The absence of biomarkers for dysphoria that will persist into adulthood and the finding that a minority of prepubescent gender dysphoria diagnoses persist into adolescence inform the Dutch approach.
This approach, which originated at the VU University Medical Center Amsterdam, is based on 2 decades of research and practice. It assumes that it is better not to actively transition a child socially but to remain neutral to the way in which the child expresses gender identity. If children persist into late adolescence in this model, they are assisted in transitioning. If not, they are supported socially as they adjust to their natal gender. Puberty may sometimes have to be suppressed until the time one of the two paths has been decided.
“In my opinion, it is the most conservative approach,” Dr. Drescher said of the Dutch model. “They are the most cognizant of how much we don’t know, and they do a lot of good research.”
An approach originating at the Child and Adolescent Gender Center Clinic, which is affiliated with the University of California, San Francisco, supports a child socially into a cross-gendered role without medical or surgical intervention but also suppresses puberty. This method is based on the presumption of an adult transgender outcome, despite the absence of a way to predict results, said Dr. Drescher, who also cautions about the iatrogenic effects of such a presumption. “It takes a lot of work to socially transition a child in one direction. It would take a lot to transition back in the other direction, and there is no good empirical data as to whether this is entirely a benign process,” he said.
A third method originated in Toronto at the Centre for Addiction and Mental Health. This method actively discourages a child’s atypical gender interests and views transsexualism as an undesirable outcome that can be prevented, despite what Dr. Drescher said is a complete lack of evidence to either support or refute this claim. This method largely has been abandoned, in part since Ontario and five U.S. states and the District of Columbia have passed laws banning efforts to change a minor’s sexual orientation or gender identity. This method does have puberty suppression in children whose gender dysphoria appears to be persisting into adolescence in common with the other two.
Dr. Drescher said puberty suppression has helped decrease the levels of anxiety, depression, and suicidal ideation typically associated with this cohort. Postponing the development of secondary sexual characteristics gives those who ultimately will desist from their dysphoria more time to let it run its course. The Dutch first initiated this procedure 2 decades ago and have shown that any possible future side effects are outweighed by the psychosocial advantages it provides in the present.
The clinical view of gender dysphoria probably will get a jolt in 2018 upon publication of the ICD-11. In an interview, Dr. Drescher said that, if the condition is no longer categorized by the WHO as a mental disorder and is instead called “gender incongruence” in a chapter dedicated to gender and sexuality issues as currently planned, “it is likely the [American Psychiatric Association] will follow suit and remove gender dysphoria from the DSM. However, I don’t know how long that will take,” he said.
In his presentation, Dr. Drescher said that the causes for gender dysphoria remain unknown, as do the ways in which gender identity develops. It is also unclear how biological, psychosocial, and environmental factors affect gender dysphoria. What is clear, he said, is that “we have to rethink our developmental literature.”
Meanwhile, although gender dysphoria affects a relatively small percentage of the population – less than 1% of “nonreferred” children and adolescents, according to the DSM-5 – the number of prepubescent children presenting to gender clinics is on the rise. This increase might be driven more by social forces than by scientific ones. Dr. Drescher made an anecdotal observation during the presentation that more children are presenting to gender clinics already socially transitioned by their parents than there are children in the research literature on persisters and desisters.
Dr. Drescher recalled in the interview that, during the public comment period for the DSM-5, gender dysphoria elicited the third most responses, compared with other diagnoses, despite its rarity as a condition. “Interest in the subject far outweighs its prevalence.”
Gender-related glossary of terms
"There are so many moving parts to our understanding of gender," said Jack Drescher, MD, during a plenary session at the annual meeting of the American College of Psychiatrists. For that reason, "language is very important" when addressing children who might have questions about their gender identity, he said.
To help establish as much clarity as possible when discussing gender in the clinical setting, Dr. Drescher offered the following glossary of terms. These are not listed alphabetically but in a stepwise fashion aimed at leading to a clearer understanding of successive terms.
Sex: The biological attributes of being male or female. This includes sex chromosomes, gonads, sex hormones, and nonambiguous internal and external genitalia.
Gender: The public - and typically the legal - recognition of one's lived role as a boy, girl, man, woman or of other biological factors in combination with psychosocial factors that are seen as contributing to identity development.
Sexual orientation: A person's erotic response tendency or sexual attractions, either directed toward individuals of the same sex (homosexual), the other sex (heterosexual), or both sexes (bisexual).
Gender identity: Often an independent variable from sexual orientation, this refers to how an individual identifies as either male, female, or, in some cases, some other category.
Gender assignment: The natal presentation as either male or female. The historical terms are "biological male" or "biological female"; also occasionally known as "birth assigned male" or "birth assigned female."
Gender atypical: The somatic features or behaviors not statistically typical in individuals with the same assigned gender in a given society or era.
Gender nonconforming: Typically used as an alternative descriptive term for "gender atypical".
Gender dysphoria: The conflict between a person's assigned gender and that person's gender identity and expression; replaced "gender identity disorder" in the DSM-5.
Gender variant: Often used by those who are concerned the term "gender dysphoria" will unnecessarily pathologize a child.
Gender expression: How an individual demonstrates gender to others, including by way of dress, behavior, and appearance. Increasingly, the term is used in antidiscrimination documents.
Desister: Prepubescent children who present with gender dysphoria but who do not become transgender adults.
Persister: This refers to children who present with gender dysphoria and progress to a transgender adulthood.
Gender reassignment: An official - and often legal - change of gender by way of cross-sex endocrine therapy and/or gender reassignment surgery.
Transsexual: An individual who modifies the body via endocrine and/or surgical means to conform with gender identity either partially or completely.
Transwoman: A person, such as Caitlyn Jenner, who transitions from a male sex assignment to become female.
Transman: A person who transitions from a female sex assignment to become male.
Transgender: The "T" in the acronym LGBT; the popular - not scientific - inclusive term for those whose gender identity, gender expression, or behavior does not conform to that which is typically associated with the natal sex assignment.
Cisgender: From the Latin for "on the same side"; used in the transgender community to describe those whose gender identities align with their natal assignment.
Gender beliefs: Used to refer to the implicit, typically binary, cultural views on the "essential" qualities of men and women.
[email protected]
On Twitter @whitneymcknight
SCOTTSDALE, ARIZ. – The treatment of preadolescents who present with gender questions is often complicated by the absence of evidence-based data on who is most likely to remain gender dysphoric into adulthood and who is not, an expert said at the annual meeting of the American College of Psychiatrists.
“There are some [clinicians] who believe they can predict who will persist and who will not. But they have not published, to my satisfaction, a way to show anyone else how to tell the difference,” said Jack Drescher, MD, a member of the World Health Organization’s (WHO’s) Working Group on the Classification of Sexual Disorders and Sexual Health and clinical professor of psychiatry and behavioral sciences at New York Medical College, Valhalla.
The WHO working group was tasked with categorizing sex and gender diagnoses in the forthcoming International Classification of Diseases (ICD-11). Dr. Drescher said that he and his fellow WHO working group members have identified at least three discrete transgender populations.
“There are persisters, desisters, and those who first develop gender dysphoria in adolescence and adulthood,” he said. “It would be a clinical mistake to think that there is a seamless transition from childhood gender dysphoria into adolescent and adult gender dysphoria.”
Dr. Drescher said that he believes the Dutch model for treating younger children diagnosed with what is interchangeably referred to as gender dysphoria or gender variance demonstrates the greatest sensitivity to how fluid the situation can be for many of these children. The absence of biomarkers for dysphoria that will persist into adulthood and the finding that a minority of prepubescent gender dysphoria diagnoses persist into adolescence inform the Dutch approach.
This approach, which originated at the VU University Medical Center Amsterdam, is based on 2 decades of research and practice. It assumes that it is better not to actively transition a child socially but to remain neutral to the way in which the child expresses gender identity. If children persist into late adolescence in this model, they are assisted in transitioning. If not, they are supported socially as they adjust to their natal gender. Puberty may sometimes have to be suppressed until the time one of the two paths has been decided.
“In my opinion, it is the most conservative approach,” Dr. Drescher said of the Dutch model. “They are the most cognizant of how much we don’t know, and they do a lot of good research.”
An approach originating at the Child and Adolescent Gender Center Clinic, which is affiliated with the University of California, San Francisco, supports a child socially into a cross-gendered role without medical or surgical intervention but also suppresses puberty. This method is based on the presumption of an adult transgender outcome, despite the absence of a way to predict results, said Dr. Drescher, who also cautions about the iatrogenic effects of such a presumption. “It takes a lot of work to socially transition a child in one direction. It would take a lot to transition back in the other direction, and there is no good empirical data as to whether this is entirely a benign process,” he said.
A third method originated in Toronto at the Centre for Addiction and Mental Health. This method actively discourages a child’s atypical gender interests and views transsexualism as an undesirable outcome that can be prevented, despite what Dr. Drescher said is a complete lack of evidence to either support or refute this claim. This method largely has been abandoned, in part since Ontario and five U.S. states and the District of Columbia have passed laws banning efforts to change a minor’s sexual orientation or gender identity. This method does have puberty suppression in children whose gender dysphoria appears to be persisting into adolescence in common with the other two.
Dr. Drescher said puberty suppression has helped decrease the levels of anxiety, depression, and suicidal ideation typically associated with this cohort. Postponing the development of secondary sexual characteristics gives those who ultimately will desist from their dysphoria more time to let it run its course. The Dutch first initiated this procedure 2 decades ago and have shown that any possible future side effects are outweighed by the psychosocial advantages it provides in the present.
The clinical view of gender dysphoria probably will get a jolt in 2018 upon publication of the ICD-11. In an interview, Dr. Drescher said that, if the condition is no longer categorized by the WHO as a mental disorder and is instead called “gender incongruence” in a chapter dedicated to gender and sexuality issues as currently planned, “it is likely the [American Psychiatric Association] will follow suit and remove gender dysphoria from the DSM. However, I don’t know how long that will take,” he said.
In his presentation, Dr. Drescher said that the causes for gender dysphoria remain unknown, as do the ways in which gender identity develops. It is also unclear how biological, psychosocial, and environmental factors affect gender dysphoria. What is clear, he said, is that “we have to rethink our developmental literature.”
Meanwhile, although gender dysphoria affects a relatively small percentage of the population – less than 1% of “nonreferred” children and adolescents, according to the DSM-5 – the number of prepubescent children presenting to gender clinics is on the rise. This increase might be driven more by social forces than by scientific ones. Dr. Drescher made an anecdotal observation during the presentation that more children are presenting to gender clinics already socially transitioned by their parents than there are children in the research literature on persisters and desisters.
Dr. Drescher recalled in the interview that, during the public comment period for the DSM-5, gender dysphoria elicited the third most responses, compared with other diagnoses, despite its rarity as a condition. “Interest in the subject far outweighs its prevalence.”
Gender-related glossary of terms
"There are so many moving parts to our understanding of gender," said Jack Drescher, MD, during a plenary session at the annual meeting of the American College of Psychiatrists. For that reason, "language is very important" when addressing children who might have questions about their gender identity, he said.
To help establish as much clarity as possible when discussing gender in the clinical setting, Dr. Drescher offered the following glossary of terms. These are not listed alphabetically but in a stepwise fashion aimed at leading to a clearer understanding of successive terms.
Sex: The biological attributes of being male or female. This includes sex chromosomes, gonads, sex hormones, and nonambiguous internal and external genitalia.
Gender: The public - and typically the legal - recognition of one's lived role as a boy, girl, man, woman or of other biological factors in combination with psychosocial factors that are seen as contributing to identity development.
Sexual orientation: A person's erotic response tendency or sexual attractions, either directed toward individuals of the same sex (homosexual), the other sex (heterosexual), or both sexes (bisexual).
Gender identity: Often an independent variable from sexual orientation, this refers to how an individual identifies as either male, female, or, in some cases, some other category.
Gender assignment: The natal presentation as either male or female. The historical terms are "biological male" or "biological female"; also occasionally known as "birth assigned male" or "birth assigned female."
Gender atypical: The somatic features or behaviors not statistically typical in individuals with the same assigned gender in a given society or era.
Gender nonconforming: Typically used as an alternative descriptive term for "gender atypical".
Gender dysphoria: The conflict between a person's assigned gender and that person's gender identity and expression; replaced "gender identity disorder" in the DSM-5.
Gender variant: Often used by those who are concerned the term "gender dysphoria" will unnecessarily pathologize a child.
Gender expression: How an individual demonstrates gender to others, including by way of dress, behavior, and appearance. Increasingly, the term is used in antidiscrimination documents.
Desister: Prepubescent children who present with gender dysphoria but who do not become transgender adults.
Persister: This refers to children who present with gender dysphoria and progress to a transgender adulthood.
Gender reassignment: An official - and often legal - change of gender by way of cross-sex endocrine therapy and/or gender reassignment surgery.
Transsexual: An individual who modifies the body via endocrine and/or surgical means to conform with gender identity either partially or completely.
Transwoman: A person, such as Caitlyn Jenner, who transitions from a male sex assignment to become female.
Transman: A person who transitions from a female sex assignment to become male.
Transgender: The "T" in the acronym LGBT; the popular - not scientific - inclusive term for those whose gender identity, gender expression, or behavior does not conform to that which is typically associated with the natal sex assignment.
Cisgender: From the Latin for "on the same side"; used in the transgender community to describe those whose gender identities align with their natal assignment.
Gender beliefs: Used to refer to the implicit, typically binary, cultural views on the "essential" qualities of men and women.
[email protected]
On Twitter @whitneymcknight
SCOTTSDALE, ARIZ. – The treatment of preadolescents who present with gender questions is often complicated by the absence of evidence-based data on who is most likely to remain gender dysphoric into adulthood and who is not, an expert said at the annual meeting of the American College of Psychiatrists.
“There are some [clinicians] who believe they can predict who will persist and who will not. But they have not published, to my satisfaction, a way to show anyone else how to tell the difference,” said Jack Drescher, MD, a member of the World Health Organization’s (WHO’s) Working Group on the Classification of Sexual Disorders and Sexual Health and clinical professor of psychiatry and behavioral sciences at New York Medical College, Valhalla.
The WHO working group was tasked with categorizing sex and gender diagnoses in the forthcoming International Classification of Diseases (ICD-11). Dr. Drescher said that he and his fellow WHO working group members have identified at least three discrete transgender populations.
“There are persisters, desisters, and those who first develop gender dysphoria in adolescence and adulthood,” he said. “It would be a clinical mistake to think that there is a seamless transition from childhood gender dysphoria into adolescent and adult gender dysphoria.”
Dr. Drescher said that he believes the Dutch model for treating younger children diagnosed with what is interchangeably referred to as gender dysphoria or gender variance demonstrates the greatest sensitivity to how fluid the situation can be for many of these children. The absence of biomarkers for dysphoria that will persist into adulthood and the finding that a minority of prepubescent gender dysphoria diagnoses persist into adolescence inform the Dutch approach.
This approach, which originated at the VU University Medical Center Amsterdam, is based on 2 decades of research and practice. It assumes that it is better not to actively transition a child socially but to remain neutral to the way in which the child expresses gender identity. If children persist into late adolescence in this model, they are assisted in transitioning. If not, they are supported socially as they adjust to their natal gender. Puberty may sometimes have to be suppressed until the time one of the two paths has been decided.
“In my opinion, it is the most conservative approach,” Dr. Drescher said of the Dutch model. “They are the most cognizant of how much we don’t know, and they do a lot of good research.”
An approach originating at the Child and Adolescent Gender Center Clinic, which is affiliated with the University of California, San Francisco, supports a child socially into a cross-gendered role without medical or surgical intervention but also suppresses puberty. This method is based on the presumption of an adult transgender outcome, despite the absence of a way to predict results, said Dr. Drescher, who also cautions about the iatrogenic effects of such a presumption. “It takes a lot of work to socially transition a child in one direction. It would take a lot to transition back in the other direction, and there is no good empirical data as to whether this is entirely a benign process,” he said.
A third method originated in Toronto at the Centre for Addiction and Mental Health. This method actively discourages a child’s atypical gender interests and views transsexualism as an undesirable outcome that can be prevented, despite what Dr. Drescher said is a complete lack of evidence to either support or refute this claim. This method largely has been abandoned, in part since Ontario and five U.S. states and the District of Columbia have passed laws banning efforts to change a minor’s sexual orientation or gender identity. This method does have puberty suppression in children whose gender dysphoria appears to be persisting into adolescence in common with the other two.
Dr. Drescher said puberty suppression has helped decrease the levels of anxiety, depression, and suicidal ideation typically associated with this cohort. Postponing the development of secondary sexual characteristics gives those who ultimately will desist from their dysphoria more time to let it run its course. The Dutch first initiated this procedure 2 decades ago and have shown that any possible future side effects are outweighed by the psychosocial advantages it provides in the present.
The clinical view of gender dysphoria probably will get a jolt in 2018 upon publication of the ICD-11. In an interview, Dr. Drescher said that, if the condition is no longer categorized by the WHO as a mental disorder and is instead called “gender incongruence” in a chapter dedicated to gender and sexuality issues as currently planned, “it is likely the [American Psychiatric Association] will follow suit and remove gender dysphoria from the DSM. However, I don’t know how long that will take,” he said.
In his presentation, Dr. Drescher said that the causes for gender dysphoria remain unknown, as do the ways in which gender identity develops. It is also unclear how biological, psychosocial, and environmental factors affect gender dysphoria. What is clear, he said, is that “we have to rethink our developmental literature.”
Meanwhile, although gender dysphoria affects a relatively small percentage of the population – less than 1% of “nonreferred” children and adolescents, according to the DSM-5 – the number of prepubescent children presenting to gender clinics is on the rise. This increase might be driven more by social forces than by scientific ones. Dr. Drescher made an anecdotal observation during the presentation that more children are presenting to gender clinics already socially transitioned by their parents than there are children in the research literature on persisters and desisters.
Dr. Drescher recalled in the interview that, during the public comment period for the DSM-5, gender dysphoria elicited the third most responses, compared with other diagnoses, despite its rarity as a condition. “Interest in the subject far outweighs its prevalence.”
Gender-related glossary of terms
"There are so many moving parts to our understanding of gender," said Jack Drescher, MD, during a plenary session at the annual meeting of the American College of Psychiatrists. For that reason, "language is very important" when addressing children who might have questions about their gender identity, he said.
To help establish as much clarity as possible when discussing gender in the clinical setting, Dr. Drescher offered the following glossary of terms. These are not listed alphabetically but in a stepwise fashion aimed at leading to a clearer understanding of successive terms.
Sex: The biological attributes of being male or female. This includes sex chromosomes, gonads, sex hormones, and nonambiguous internal and external genitalia.
Gender: The public - and typically the legal - recognition of one's lived role as a boy, girl, man, woman or of other biological factors in combination with psychosocial factors that are seen as contributing to identity development.
Sexual orientation: A person's erotic response tendency or sexual attractions, either directed toward individuals of the same sex (homosexual), the other sex (heterosexual), or both sexes (bisexual).
Gender identity: Often an independent variable from sexual orientation, this refers to how an individual identifies as either male, female, or, in some cases, some other category.
Gender assignment: The natal presentation as either male or female. The historical terms are "biological male" or "biological female"; also occasionally known as "birth assigned male" or "birth assigned female."
Gender atypical: The somatic features or behaviors not statistically typical in individuals with the same assigned gender in a given society or era.
Gender nonconforming: Typically used as an alternative descriptive term for "gender atypical".
Gender dysphoria: The conflict between a person's assigned gender and that person's gender identity and expression; replaced "gender identity disorder" in the DSM-5.
Gender variant: Often used by those who are concerned the term "gender dysphoria" will unnecessarily pathologize a child.
Gender expression: How an individual demonstrates gender to others, including by way of dress, behavior, and appearance. Increasingly, the term is used in antidiscrimination documents.
Desister: Prepubescent children who present with gender dysphoria but who do not become transgender adults.
Persister: This refers to children who present with gender dysphoria and progress to a transgender adulthood.
Gender reassignment: An official - and often legal - change of gender by way of cross-sex endocrine therapy and/or gender reassignment surgery.
Transsexual: An individual who modifies the body via endocrine and/or surgical means to conform with gender identity either partially or completely.
Transwoman: A person, such as Caitlyn Jenner, who transitions from a male sex assignment to become female.
Transman: A person who transitions from a female sex assignment to become male.
Transgender: The "T" in the acronym LGBT; the popular - not scientific - inclusive term for those whose gender identity, gender expression, or behavior does not conform to that which is typically associated with the natal sex assignment.
Cisgender: From the Latin for "on the same side"; used in the transgender community to describe those whose gender identities align with their natal assignment.
Gender beliefs: Used to refer to the implicit, typically binary, cultural views on the "essential" qualities of men and women.
[email protected]
On Twitter @whitneymcknight
EXPERT ANALYSIS AT THE AMERICAN COLLEGE OF PSYCHIATRISTS ANNUAL MEETING
Study boosts surgical left atrial appendage occlusion
WASHINGTON – Surgical left atrial appendage occlusion in older patients with atrial fibrillation already undergoing cardiac surgery was associated with a 38% reduction in thromboembolism and a 15% lower risk of all-cause mortality during the subsequent year in a large observational study.
“Although randomized trial data are needed, our study demonstrates strong support for the benefits of closing the left atrial appendage at the time of cardiac surgery in patients with atrial fibrillation,” Daniel J. Friedman, MD, said at the annual meeting of the American College of Cardiology.
Thirty-seven percent of patients underwent surgical left atrial appendage occlusion (LAAO) at the time of their primary heart operation. They were slightly younger, more often female, in better cardiovascular health, and more likely to have their surgery at an academic medical center than were patients who didn’t have LAAO. Adjustment for all of these factors was made in the statistical analysis.
The primary outcome was rehospitalization for thromboembolism – that is, ischemic stroke, transient ischemic attack, or other systemic arterial embolism – within 1 year. This occurred in 1.6% of the LAAO group and 2.5% of the non-LAAO group, for an unadjusted 37% and an adjusted 38% relative risk reduction, reported Dr. Friedman, a cardiology research fellow at the Duke Clinical Research Institute in Durham, N.C.
Turning to prespecified secondary endpoints, he noted that the all-cause mortality rate at 1 year was 7.0% in the LAAO group and 10.8% in the comparison arm, for a significant adjusted 15% risk reduction in the closure group. The composite endpoint of thromboembolism, hemorrhagic stroke, or death occurred in 8.7% of the LAAO group compared with 13.5% of non-LAAO patients, representing an adjusted 30% reduction in risk.
In an exploratory analysis, Dr. Friedman and his coinvestigators determined that, in patients discharged without oral anticoagulation, LAAO was associated with a 71% reduction in risk of thromboembolism. In contrast, LAAO didn’t significantly affect thromboembolic risk in patients discharged on an oral anticoagulant.
The STS database did not include information on the methods or completeness of LAAO.
Discussant David J. Wilber, MD, urged care in attempting to translate the study findings into clinical practice.
“I must say, given the diversity of surgical occlusion techniques – everything from excision to internal sutures to external clipping and stapling – I’m really a bit surprised to see the relatively strong outcomes, with a very strong signal for reduction in thromboembolism and also an opportunity to decrease mortality. I guess I’d say I’d be a little bit cautious. I’d want to see data assessing the completeness of closure and its success long term before we take this to heart clinically,” said Dr. Wilber, professor of cardiology and pediatrics and codirector of the Cardiovascular Research Institute at Loyola University in Maywood, Ill.
Dr. Friedman shared Dr. Wilber’s reservations about applying these observational data to clinical practice.
“I think what we can say is that this study supports the concept that the left atrial appendage is important as a source of thromboembolism in atrial fibrillation, and that exclusion of the left atrial appendage can be a potentially viable treatment option for patients,” he said. “I think it’s going to be increasingly important to bring this up as a possible treatment option when we’re discussing cardiac surgery with our heart teams – and that means talking to the surgeon, the cardiologist who may be following the patient afterwards, and even the cardiothoracic anesthesiologist who’s going to be manning the transesophageal echo probe and may be able to give us some insight as to the quality of closure before the patient leaves the operating room.”
There is considerable surgical interest in LAAO for stroke prevention in AF in light of the success of the percutaneous Watchman device. However, many cardiothoracic surgeons have refrained from performing the brief occlusion procedure because of what up until now has been a lack of evidence as to safety and efficacy.
Asked if his study findings imply that oral anticoagulation can routinely be stopped after LAAO provided the surgeon believes the appendage has been successfully excluded from the circulation, Dr. Friedman replied that he does not.
Although the left atrial appendage has been implicated as the site of thrombus formation in 90% of thromboembolic events occurring in patients with AF, ligation of the appendage doesn’t address that other 10%. Dr. Friedman said he believes it’s appropriate to await the results of an ongoing prospective randomized trial of LAAO led by investigators at McMaster University in Hamilton, Ont.
Dr. Friedman reported having no financial conflicts regarding his study, funded by the Burroughs Welcome Fund and the Food and Drug Administration.
WASHINGTON – Surgical left atrial appendage occlusion in older patients with atrial fibrillation already undergoing cardiac surgery was associated with a 38% reduction in thromboembolism and a 15% lower risk of all-cause mortality during the subsequent year in a large observational study.
“Although randomized trial data are needed, our study demonstrates strong support for the benefits of closing the left atrial appendage at the time of cardiac surgery in patients with atrial fibrillation,” Daniel J. Friedman, MD, said at the annual meeting of the American College of Cardiology.
Thirty-seven percent of patients underwent surgical left atrial appendage occlusion (LAAO) at the time of their primary heart operation. They were slightly younger, more often female, in better cardiovascular health, and more likely to have their surgery at an academic medical center than were patients who didn’t have LAAO. Adjustment for all of these factors was made in the statistical analysis.
The primary outcome was rehospitalization for thromboembolism – that is, ischemic stroke, transient ischemic attack, or other systemic arterial embolism – within 1 year. This occurred in 1.6% of the LAAO group and 2.5% of the non-LAAO group, for an unadjusted 37% and an adjusted 38% relative risk reduction, reported Dr. Friedman, a cardiology research fellow at the Duke Clinical Research Institute in Durham, N.C.
Turning to prespecified secondary endpoints, he noted that the all-cause mortality rate at 1 year was 7.0% in the LAAO group and 10.8% in the comparison arm, for a significant adjusted 15% risk reduction in the closure group. The composite endpoint of thromboembolism, hemorrhagic stroke, or death occurred in 8.7% of the LAAO group compared with 13.5% of non-LAAO patients, representing an adjusted 30% reduction in risk.
In an exploratory analysis, Dr. Friedman and his coinvestigators determined that, in patients discharged without oral anticoagulation, LAAO was associated with a 71% reduction in risk of thromboembolism. In contrast, LAAO didn’t significantly affect thromboembolic risk in patients discharged on an oral anticoagulant.
The STS database did not include information on the methods or completeness of LAAO.
Discussant David J. Wilber, MD, urged care in attempting to translate the study findings into clinical practice.
“I must say, given the diversity of surgical occlusion techniques – everything from excision to internal sutures to external clipping and stapling – I’m really a bit surprised to see the relatively strong outcomes, with a very strong signal for reduction in thromboembolism and also an opportunity to decrease mortality. I guess I’d say I’d be a little bit cautious. I’d want to see data assessing the completeness of closure and its success long term before we take this to heart clinically,” said Dr. Wilber, professor of cardiology and pediatrics and codirector of the Cardiovascular Research Institute at Loyola University in Maywood, Ill.
Dr. Friedman shared Dr. Wilber’s reservations about applying these observational data to clinical practice.
“I think what we can say is that this study supports the concept that the left atrial appendage is important as a source of thromboembolism in atrial fibrillation, and that exclusion of the left atrial appendage can be a potentially viable treatment option for patients,” he said. “I think it’s going to be increasingly important to bring this up as a possible treatment option when we’re discussing cardiac surgery with our heart teams – and that means talking to the surgeon, the cardiologist who may be following the patient afterwards, and even the cardiothoracic anesthesiologist who’s going to be manning the transesophageal echo probe and may be able to give us some insight as to the quality of closure before the patient leaves the operating room.”
There is considerable surgical interest in LAAO for stroke prevention in AF in light of the success of the percutaneous Watchman device. However, many cardiothoracic surgeons have refrained from performing the brief occlusion procedure because of what up until now has been a lack of evidence as to safety and efficacy.
Asked if his study findings imply that oral anticoagulation can routinely be stopped after LAAO provided the surgeon believes the appendage has been successfully excluded from the circulation, Dr. Friedman replied that he does not.
Although the left atrial appendage has been implicated as the site of thrombus formation in 90% of thromboembolic events occurring in patients with AF, ligation of the appendage doesn’t address that other 10%. Dr. Friedman said he believes it’s appropriate to await the results of an ongoing prospective randomized trial of LAAO led by investigators at McMaster University in Hamilton, Ont.
Dr. Friedman reported having no financial conflicts regarding his study, funded by the Burroughs Welcome Fund and the Food and Drug Administration.
WASHINGTON – Surgical left atrial appendage occlusion in older patients with atrial fibrillation already undergoing cardiac surgery was associated with a 38% reduction in thromboembolism and a 15% lower risk of all-cause mortality during the subsequent year in a large observational study.
“Although randomized trial data are needed, our study demonstrates strong support for the benefits of closing the left atrial appendage at the time of cardiac surgery in patients with atrial fibrillation,” Daniel J. Friedman, MD, said at the annual meeting of the American College of Cardiology.
Thirty-seven percent of patients underwent surgical left atrial appendage occlusion (LAAO) at the time of their primary heart operation. They were slightly younger, more often female, in better cardiovascular health, and more likely to have their surgery at an academic medical center than were patients who didn’t have LAAO. Adjustment for all of these factors was made in the statistical analysis.
The primary outcome was rehospitalization for thromboembolism – that is, ischemic stroke, transient ischemic attack, or other systemic arterial embolism – within 1 year. This occurred in 1.6% of the LAAO group and 2.5% of the non-LAAO group, for an unadjusted 37% and an adjusted 38% relative risk reduction, reported Dr. Friedman, a cardiology research fellow at the Duke Clinical Research Institute in Durham, N.C.
Turning to prespecified secondary endpoints, he noted that the all-cause mortality rate at 1 year was 7.0% in the LAAO group and 10.8% in the comparison arm, for a significant adjusted 15% risk reduction in the closure group. The composite endpoint of thromboembolism, hemorrhagic stroke, or death occurred in 8.7% of the LAAO group compared with 13.5% of non-LAAO patients, representing an adjusted 30% reduction in risk.
In an exploratory analysis, Dr. Friedman and his coinvestigators determined that, in patients discharged without oral anticoagulation, LAAO was associated with a 71% reduction in risk of thromboembolism. In contrast, LAAO didn’t significantly affect thromboembolic risk in patients discharged on an oral anticoagulant.
The STS database did not include information on the methods or completeness of LAAO.
Discussant David J. Wilber, MD, urged care in attempting to translate the study findings into clinical practice.
“I must say, given the diversity of surgical occlusion techniques – everything from excision to internal sutures to external clipping and stapling – I’m really a bit surprised to see the relatively strong outcomes, with a very strong signal for reduction in thromboembolism and also an opportunity to decrease mortality. I guess I’d say I’d be a little bit cautious. I’d want to see data assessing the completeness of closure and its success long term before we take this to heart clinically,” said Dr. Wilber, professor of cardiology and pediatrics and codirector of the Cardiovascular Research Institute at Loyola University in Maywood, Ill.
Dr. Friedman shared Dr. Wilber’s reservations about applying these observational data to clinical practice.
“I think what we can say is that this study supports the concept that the left atrial appendage is important as a source of thromboembolism in atrial fibrillation, and that exclusion of the left atrial appendage can be a potentially viable treatment option for patients,” he said. “I think it’s going to be increasingly important to bring this up as a possible treatment option when we’re discussing cardiac surgery with our heart teams – and that means talking to the surgeon, the cardiologist who may be following the patient afterwards, and even the cardiothoracic anesthesiologist who’s going to be manning the transesophageal echo probe and may be able to give us some insight as to the quality of closure before the patient leaves the operating room.”
There is considerable surgical interest in LAAO for stroke prevention in AF in light of the success of the percutaneous Watchman device. However, many cardiothoracic surgeons have refrained from performing the brief occlusion procedure because of what up until now has been a lack of evidence as to safety and efficacy.
Asked if his study findings imply that oral anticoagulation can routinely be stopped after LAAO provided the surgeon believes the appendage has been successfully excluded from the circulation, Dr. Friedman replied that he does not.
Although the left atrial appendage has been implicated as the site of thrombus formation in 90% of thromboembolic events occurring in patients with AF, ligation of the appendage doesn’t address that other 10%. Dr. Friedman said he believes it’s appropriate to await the results of an ongoing prospective randomized trial of LAAO led by investigators at McMaster University in Hamilton, Ont.
Dr. Friedman reported having no financial conflicts regarding his study, funded by the Burroughs Welcome Fund and the Food and Drug Administration.
At ACC 17
Key clinical point:
Major finding: The ancillary surgical procedure was associated with a 38% reduction in thromboembolism and a 15% lower risk of all-cause mortality at 1 year, compared with no appendage closure.
Data source: A retrospective comparative effectiveness study using the Society of Thoracic Surgeons database of more than 10,000 Medicare recipients with atrial fibrillation who underwent cardiac surgery, 37% of whom underwent surgical left atrial appendage occlusion during their primary operation.
Disclosures: The presenter reported having no financial conflicts. The Burroughs Welcome Fund and the Food and Drug Administration funded the study.
Hospitalists seek tools for more efficient admissions
Moving patients safely and efficiently through the admission process is always a priority for hospitalists. Is there a way to optimize and standardize the process?
“In hopes of improving admission efficiency, while simultaneously increasing quality of care, we decided to use Lean/Six Sigma methodology to streamline our admission process,” says Escher Howard-Williams, MD, lead author of an abstract called “Standardizing the Admission Process Using Lean/Six Sigma One Piece Flow.”1
A basic tenet of the methodology is called “one piece flow” (OPF), the idea that standardized processes are more efficient and less prone to error when completed from start to finish without interruption. In the study, hospitalists committed to performing all patient admissions in OPF, focusing on one patient from initiation of chart review through exam, order entry and documentation, without interruption. Researchers then analyzed times, including time to call back to ED, time at initiation of chart review, time of evaluation of patient, time orders were placed, and time of sign-out note completed, before and after implementation of OPF. They found a substantial reduction in time of the admission process across all time points with OPF.
“When you are trying to improve quality of care in your institution, dissecting the overall work flow will allow you to discover areas that hinder the overall process,” Dr. Howard-Williams says. “Reframing your process to focus on providing excellent quality care will allow you to find workable solutions to improve the quality of care and efficiency in your practice. As part of this process, developing a team with an appropriate variety of members lays the foundation for success.”
Dr. Howard-Williams hopes that the study will inspire others to reflect on their own practices.
“If, during that reflection, they can identify areas that they would like to improve quality, we would encourage them to join us,” she says. “They will have the opportunity to build their personal work flow maps, find choke points and devise a plan for moving forward with new solutions.”
Reference
1. Howard-Williams E, Liles A, Stephens J, lanza-Kaduce K. Standardizing the admission process using Lean/Six Sigma One Piece Flow [abstract]. J Hosp Med. 2016;11(suppl 1). Available at: http://www.shmabstracts.com/abstract/standardizing-the-admission-process-using-lean-six-sigma-one-piece-flow/. Accessed March 7, 2017.
Moving patients safely and efficiently through the admission process is always a priority for hospitalists. Is there a way to optimize and standardize the process?
“In hopes of improving admission efficiency, while simultaneously increasing quality of care, we decided to use Lean/Six Sigma methodology to streamline our admission process,” says Escher Howard-Williams, MD, lead author of an abstract called “Standardizing the Admission Process Using Lean/Six Sigma One Piece Flow.”1
A basic tenet of the methodology is called “one piece flow” (OPF), the idea that standardized processes are more efficient and less prone to error when completed from start to finish without interruption. In the study, hospitalists committed to performing all patient admissions in OPF, focusing on one patient from initiation of chart review through exam, order entry and documentation, without interruption. Researchers then analyzed times, including time to call back to ED, time at initiation of chart review, time of evaluation of patient, time orders were placed, and time of sign-out note completed, before and after implementation of OPF. They found a substantial reduction in time of the admission process across all time points with OPF.
“When you are trying to improve quality of care in your institution, dissecting the overall work flow will allow you to discover areas that hinder the overall process,” Dr. Howard-Williams says. “Reframing your process to focus on providing excellent quality care will allow you to find workable solutions to improve the quality of care and efficiency in your practice. As part of this process, developing a team with an appropriate variety of members lays the foundation for success.”
Dr. Howard-Williams hopes that the study will inspire others to reflect on their own practices.
“If, during that reflection, they can identify areas that they would like to improve quality, we would encourage them to join us,” she says. “They will have the opportunity to build their personal work flow maps, find choke points and devise a plan for moving forward with new solutions.”
Reference
1. Howard-Williams E, Liles A, Stephens J, lanza-Kaduce K. Standardizing the admission process using Lean/Six Sigma One Piece Flow [abstract]. J Hosp Med. 2016;11(suppl 1). Available at: http://www.shmabstracts.com/abstract/standardizing-the-admission-process-using-lean-six-sigma-one-piece-flow/. Accessed March 7, 2017.
Moving patients safely and efficiently through the admission process is always a priority for hospitalists. Is there a way to optimize and standardize the process?
“In hopes of improving admission efficiency, while simultaneously increasing quality of care, we decided to use Lean/Six Sigma methodology to streamline our admission process,” says Escher Howard-Williams, MD, lead author of an abstract called “Standardizing the Admission Process Using Lean/Six Sigma One Piece Flow.”1
A basic tenet of the methodology is called “one piece flow” (OPF), the idea that standardized processes are more efficient and less prone to error when completed from start to finish without interruption. In the study, hospitalists committed to performing all patient admissions in OPF, focusing on one patient from initiation of chart review through exam, order entry and documentation, without interruption. Researchers then analyzed times, including time to call back to ED, time at initiation of chart review, time of evaluation of patient, time orders were placed, and time of sign-out note completed, before and after implementation of OPF. They found a substantial reduction in time of the admission process across all time points with OPF.
“When you are trying to improve quality of care in your institution, dissecting the overall work flow will allow you to discover areas that hinder the overall process,” Dr. Howard-Williams says. “Reframing your process to focus on providing excellent quality care will allow you to find workable solutions to improve the quality of care and efficiency in your practice. As part of this process, developing a team with an appropriate variety of members lays the foundation for success.”
Dr. Howard-Williams hopes that the study will inspire others to reflect on their own practices.
“If, during that reflection, they can identify areas that they would like to improve quality, we would encourage them to join us,” she says. “They will have the opportunity to build their personal work flow maps, find choke points and devise a plan for moving forward with new solutions.”
Reference
1. Howard-Williams E, Liles A, Stephens J, lanza-Kaduce K. Standardizing the admission process using Lean/Six Sigma One Piece Flow [abstract]. J Hosp Med. 2016;11(suppl 1). Available at: http://www.shmabstracts.com/abstract/standardizing-the-admission-process-using-lean-six-sigma-one-piece-flow/. Accessed March 7, 2017.
Using shock index in the ED to predict hospital admission and inpatient mortality
CLINICAL QUESTION: Can shock index (SI) in the ED predict the likelihood for hospital admission and inpatient mortality?
BACKGROUND: SI is defined as heart rate divided by systolic blood pressure. It is postulated to have an inverse relationship to cardiac output. SI has been studied as a prognostic metric of poor outcomes in patients with myocardial infarction, gastrointestinal hemorrhage, sepsis, and trauma. There are no large studies on SI in the general ED population.
SETTING: Academic tertiary care center.
SYNOPSIS: All ED patients over 18 years of age over a 12-month period were included in the study for a total of 58,633 charts. Charts were excluded if the patient presented in cardiac arrest, left prior to full evaluation in the ED, or had an incomplete or absent first set of vital signs. Likelihood ratio (LR) values of greater than 5 and 10 were considered moderate and large increases in the outcomes, respectively. Authors found SI greater than 1.2 had a positive LR of 11.69 for admission to the hospital and a positive LR of 5.82 for inpatient mortality.
This study identified potential thresholds for SI but did not validate them. Whether SI would be a useful tool for triage remains unanswered.
BOTTOM LINE: Initial SI greater than 1.2 at presentation to the ED was associated with increased likelihood of hospital admission and inpatient mortality.
CITATIONS: Balhara KS, Hsieh YH, Hamade B, et al. Clinical metrics in emergency medicine: the shock index and the probability of hospital admission and inpatient mortality. Emerg Med J. 2017 Feb;34(2):89-94.
Dr. Dietsche is a clinical instructor, Division of Hospital Medicine, University of Colorado School of Medicine, Aurora.
CLINICAL QUESTION: Can shock index (SI) in the ED predict the likelihood for hospital admission and inpatient mortality?
BACKGROUND: SI is defined as heart rate divided by systolic blood pressure. It is postulated to have an inverse relationship to cardiac output. SI has been studied as a prognostic metric of poor outcomes in patients with myocardial infarction, gastrointestinal hemorrhage, sepsis, and trauma. There are no large studies on SI in the general ED population.
SETTING: Academic tertiary care center.
SYNOPSIS: All ED patients over 18 years of age over a 12-month period were included in the study for a total of 58,633 charts. Charts were excluded if the patient presented in cardiac arrest, left prior to full evaluation in the ED, or had an incomplete or absent first set of vital signs. Likelihood ratio (LR) values of greater than 5 and 10 were considered moderate and large increases in the outcomes, respectively. Authors found SI greater than 1.2 had a positive LR of 11.69 for admission to the hospital and a positive LR of 5.82 for inpatient mortality.
This study identified potential thresholds for SI but did not validate them. Whether SI would be a useful tool for triage remains unanswered.
BOTTOM LINE: Initial SI greater than 1.2 at presentation to the ED was associated with increased likelihood of hospital admission and inpatient mortality.
CITATIONS: Balhara KS, Hsieh YH, Hamade B, et al. Clinical metrics in emergency medicine: the shock index and the probability of hospital admission and inpatient mortality. Emerg Med J. 2017 Feb;34(2):89-94.
Dr. Dietsche is a clinical instructor, Division of Hospital Medicine, University of Colorado School of Medicine, Aurora.
CLINICAL QUESTION: Can shock index (SI) in the ED predict the likelihood for hospital admission and inpatient mortality?
BACKGROUND: SI is defined as heart rate divided by systolic blood pressure. It is postulated to have an inverse relationship to cardiac output. SI has been studied as a prognostic metric of poor outcomes in patients with myocardial infarction, gastrointestinal hemorrhage, sepsis, and trauma. There are no large studies on SI in the general ED population.
SETTING: Academic tertiary care center.
SYNOPSIS: All ED patients over 18 years of age over a 12-month period were included in the study for a total of 58,633 charts. Charts were excluded if the patient presented in cardiac arrest, left prior to full evaluation in the ED, or had an incomplete or absent first set of vital signs. Likelihood ratio (LR) values of greater than 5 and 10 were considered moderate and large increases in the outcomes, respectively. Authors found SI greater than 1.2 had a positive LR of 11.69 for admission to the hospital and a positive LR of 5.82 for inpatient mortality.
This study identified potential thresholds for SI but did not validate them. Whether SI would be a useful tool for triage remains unanswered.
BOTTOM LINE: Initial SI greater than 1.2 at presentation to the ED was associated with increased likelihood of hospital admission and inpatient mortality.
CITATIONS: Balhara KS, Hsieh YH, Hamade B, et al. Clinical metrics in emergency medicine: the shock index and the probability of hospital admission and inpatient mortality. Emerg Med J. 2017 Feb;34(2):89-94.
Dr. Dietsche is a clinical instructor, Division of Hospital Medicine, University of Colorado School of Medicine, Aurora.
Gorsuch keeps cards close during nomination hearing
Throughout his marathon confirmation hearing, U.S. Supreme Court nominee Neil Gorsuch remained tight-lipped about how he might rule on major health care issues if confirmed to the country’s highest court, pledging to look at the facts of each case and rule according to the law.
The Senate Committee on the Judiciary wrapped up its nearly week-long questioning of Judge Gorsuch on March 23. Inquiries during the hearing ranged from Judge Gorsuch’s stance on abortion, to his support of religious freedom, to whether he would uphold President Trump’s controversial Executive Order on travel and immigration. Through it all, Judge Gorsuch, who presides over Denver’s 10th Circuit, kept his composure and refused to offer insight into which way he would lean when deciding such hot-button issues.
“If I were to start telling you which are my favorite [Supreme Court] precedents or which are my least favorite precedents, or if I viewed precedents in that fashion, I would be tipping my hand and suggesting to litigants that I’ve already made up my mind about their cases. That’s not a fair judge. I didn’t want that kind of judge when I was a lawyer, and I don’t want to be that kind of judge now.”
During the hearing, the case of Roe v. Wade was brought up repeatedly, and multiple senators from both parties questioned whether Judge Gorsuch would vote to overturn the right to an abortion. Sen. Lindsey Graham, (R-S.C.) discussed recent legislation he supports that would prohibit abortion if the probable postfertilization age of the fetus is 20 weeks or greater.
“We’re one of seven nations that allow wholesale, on demand, unlimited abortion at 20 weeks. I’d like to get out of that club,” Sen. Graham said during the hearing. “I’m just letting everybody know that if this legislation passes, it will be challenged before you and you will have to look at a new theory of how the state can protect the unborn ... Here’s what I think. You will read the briefs, look at the facts, and make a decision, am I fair to conclude that?”
“Senator, I can promise you no more than that, and I guarantee no less than that in every single case that comes before me,” Judge Gorsuch responded.
Sen. Dianne Feinstein (D-Calif.) queried whether Judge Gorsuch considered Roe to be “super precedent.”
“Senator, [the ruling] has been reaffirmed many times,” Judge Gorsuch responded, stressing that all Supreme Court precedent deserves respect and consideration when deciding new challenges.
The judge defended his 10th Circuit decision that found in favor of Hobby Lobby Stores after the company objected to the Affordable Care Act’s contraceptive coverage requirements based on religious grounds. In a separate case, Judge Gorsuch dissented from a ruling not to rehear a challenge by the Little Sisters of the Poor against certain contraceptive coverage provisions.
“Senator, our job there was to apply the statute as best we could understand its purpose as expressed in its text,” Judge Gorsuch said. “And I think every judge who faced that case – everyone – found it a hard case and did their level best and that’s all any judge can promise or guarantee. I respect all of my colleagues who addressed that case.”
The subject of religious freedom also was addressed during questions regarding President Trump’s Executive Order on travel and immigration and whether Judge Gorsuch would uphold the Executive Order if it came before the high court.
“President Trump promised a Muslim ban,” Sen. Patrick J. Leahy (D-Vt.) said during the hearing. “He still has on his website to this day that he’s called for a total and complete shutdown of Muslims entering the United States. And a Republican congressman recently said the best thing the president can do for his Muslim ban is to make sure he has Gorsuch on the Supreme Court.”
Judge Gorsuch called the unnamed congressman’s remark “silly,” adding that the congressman had “no idea” how Judge Gorsuch would rule in any case that comes before him. Sen. Leahy went on to ask Judge Gorsuch whether the president has the authority to block Jews from coming to the country or ban residents of Israel.
“We have a Constitution,” Judge Gorsuch replied. “And it does guarantee free exercise [of religion]. It also guarantees equal protection of the laws and a whole lot else besides, and the Supreme Court has held that due process rights extend even to undocumented persons in this country. I will apply the law faithfully and fearlessly and without regard to persons.”
A vote by the Senate Judiciary Committee is expected April 3 followed by a Senate floor vote later that week. Supreme Court justices require 60 votes for confirmation. Republicans control the Senate 52-48, so eight Democrats are needed to confirm Judge Gorsuch. Senate Minority Leader Charles E. Schumer (D-N.Y.) vowed on March 23 to oppose Judge Gorsuch and asked other Democrats to join him, setting up a potential filibuster against Judge Gorsuch’s confirmation.
[email protected]
On Twitter @legal_med
Throughout his marathon confirmation hearing, U.S. Supreme Court nominee Neil Gorsuch remained tight-lipped about how he might rule on major health care issues if confirmed to the country’s highest court, pledging to look at the facts of each case and rule according to the law.
The Senate Committee on the Judiciary wrapped up its nearly week-long questioning of Judge Gorsuch on March 23. Inquiries during the hearing ranged from Judge Gorsuch’s stance on abortion, to his support of religious freedom, to whether he would uphold President Trump’s controversial Executive Order on travel and immigration. Through it all, Judge Gorsuch, who presides over Denver’s 10th Circuit, kept his composure and refused to offer insight into which way he would lean when deciding such hot-button issues.
“If I were to start telling you which are my favorite [Supreme Court] precedents or which are my least favorite precedents, or if I viewed precedents in that fashion, I would be tipping my hand and suggesting to litigants that I’ve already made up my mind about their cases. That’s not a fair judge. I didn’t want that kind of judge when I was a lawyer, and I don’t want to be that kind of judge now.”
During the hearing, the case of Roe v. Wade was brought up repeatedly, and multiple senators from both parties questioned whether Judge Gorsuch would vote to overturn the right to an abortion. Sen. Lindsey Graham, (R-S.C.) discussed recent legislation he supports that would prohibit abortion if the probable postfertilization age of the fetus is 20 weeks or greater.
“We’re one of seven nations that allow wholesale, on demand, unlimited abortion at 20 weeks. I’d like to get out of that club,” Sen. Graham said during the hearing. “I’m just letting everybody know that if this legislation passes, it will be challenged before you and you will have to look at a new theory of how the state can protect the unborn ... Here’s what I think. You will read the briefs, look at the facts, and make a decision, am I fair to conclude that?”
“Senator, I can promise you no more than that, and I guarantee no less than that in every single case that comes before me,” Judge Gorsuch responded.
Sen. Dianne Feinstein (D-Calif.) queried whether Judge Gorsuch considered Roe to be “super precedent.”
“Senator, [the ruling] has been reaffirmed many times,” Judge Gorsuch responded, stressing that all Supreme Court precedent deserves respect and consideration when deciding new challenges.
The judge defended his 10th Circuit decision that found in favor of Hobby Lobby Stores after the company objected to the Affordable Care Act’s contraceptive coverage requirements based on religious grounds. In a separate case, Judge Gorsuch dissented from a ruling not to rehear a challenge by the Little Sisters of the Poor against certain contraceptive coverage provisions.
“Senator, our job there was to apply the statute as best we could understand its purpose as expressed in its text,” Judge Gorsuch said. “And I think every judge who faced that case – everyone – found it a hard case and did their level best and that’s all any judge can promise or guarantee. I respect all of my colleagues who addressed that case.”
The subject of religious freedom also was addressed during questions regarding President Trump’s Executive Order on travel and immigration and whether Judge Gorsuch would uphold the Executive Order if it came before the high court.
“President Trump promised a Muslim ban,” Sen. Patrick J. Leahy (D-Vt.) said during the hearing. “He still has on his website to this day that he’s called for a total and complete shutdown of Muslims entering the United States. And a Republican congressman recently said the best thing the president can do for his Muslim ban is to make sure he has Gorsuch on the Supreme Court.”
Judge Gorsuch called the unnamed congressman’s remark “silly,” adding that the congressman had “no idea” how Judge Gorsuch would rule in any case that comes before him. Sen. Leahy went on to ask Judge Gorsuch whether the president has the authority to block Jews from coming to the country or ban residents of Israel.
“We have a Constitution,” Judge Gorsuch replied. “And it does guarantee free exercise [of religion]. It also guarantees equal protection of the laws and a whole lot else besides, and the Supreme Court has held that due process rights extend even to undocumented persons in this country. I will apply the law faithfully and fearlessly and without regard to persons.”
A vote by the Senate Judiciary Committee is expected April 3 followed by a Senate floor vote later that week. Supreme Court justices require 60 votes for confirmation. Republicans control the Senate 52-48, so eight Democrats are needed to confirm Judge Gorsuch. Senate Minority Leader Charles E. Schumer (D-N.Y.) vowed on March 23 to oppose Judge Gorsuch and asked other Democrats to join him, setting up a potential filibuster against Judge Gorsuch’s confirmation.
[email protected]
On Twitter @legal_med
Throughout his marathon confirmation hearing, U.S. Supreme Court nominee Neil Gorsuch remained tight-lipped about how he might rule on major health care issues if confirmed to the country’s highest court, pledging to look at the facts of each case and rule according to the law.
The Senate Committee on the Judiciary wrapped up its nearly week-long questioning of Judge Gorsuch on March 23. Inquiries during the hearing ranged from Judge Gorsuch’s stance on abortion, to his support of religious freedom, to whether he would uphold President Trump’s controversial Executive Order on travel and immigration. Through it all, Judge Gorsuch, who presides over Denver’s 10th Circuit, kept his composure and refused to offer insight into which way he would lean when deciding such hot-button issues.
“If I were to start telling you which are my favorite [Supreme Court] precedents or which are my least favorite precedents, or if I viewed precedents in that fashion, I would be tipping my hand and suggesting to litigants that I’ve already made up my mind about their cases. That’s not a fair judge. I didn’t want that kind of judge when I was a lawyer, and I don’t want to be that kind of judge now.”
During the hearing, the case of Roe v. Wade was brought up repeatedly, and multiple senators from both parties questioned whether Judge Gorsuch would vote to overturn the right to an abortion. Sen. Lindsey Graham, (R-S.C.) discussed recent legislation he supports that would prohibit abortion if the probable postfertilization age of the fetus is 20 weeks or greater.
“We’re one of seven nations that allow wholesale, on demand, unlimited abortion at 20 weeks. I’d like to get out of that club,” Sen. Graham said during the hearing. “I’m just letting everybody know that if this legislation passes, it will be challenged before you and you will have to look at a new theory of how the state can protect the unborn ... Here’s what I think. You will read the briefs, look at the facts, and make a decision, am I fair to conclude that?”
“Senator, I can promise you no more than that, and I guarantee no less than that in every single case that comes before me,” Judge Gorsuch responded.
Sen. Dianne Feinstein (D-Calif.) queried whether Judge Gorsuch considered Roe to be “super precedent.”
“Senator, [the ruling] has been reaffirmed many times,” Judge Gorsuch responded, stressing that all Supreme Court precedent deserves respect and consideration when deciding new challenges.
The judge defended his 10th Circuit decision that found in favor of Hobby Lobby Stores after the company objected to the Affordable Care Act’s contraceptive coverage requirements based on religious grounds. In a separate case, Judge Gorsuch dissented from a ruling not to rehear a challenge by the Little Sisters of the Poor against certain contraceptive coverage provisions.
“Senator, our job there was to apply the statute as best we could understand its purpose as expressed in its text,” Judge Gorsuch said. “And I think every judge who faced that case – everyone – found it a hard case and did their level best and that’s all any judge can promise or guarantee. I respect all of my colleagues who addressed that case.”
The subject of religious freedom also was addressed during questions regarding President Trump’s Executive Order on travel and immigration and whether Judge Gorsuch would uphold the Executive Order if it came before the high court.
“President Trump promised a Muslim ban,” Sen. Patrick J. Leahy (D-Vt.) said during the hearing. “He still has on his website to this day that he’s called for a total and complete shutdown of Muslims entering the United States. And a Republican congressman recently said the best thing the president can do for his Muslim ban is to make sure he has Gorsuch on the Supreme Court.”
Judge Gorsuch called the unnamed congressman’s remark “silly,” adding that the congressman had “no idea” how Judge Gorsuch would rule in any case that comes before him. Sen. Leahy went on to ask Judge Gorsuch whether the president has the authority to block Jews from coming to the country or ban residents of Israel.
“We have a Constitution,” Judge Gorsuch replied. “And it does guarantee free exercise [of religion]. It also guarantees equal protection of the laws and a whole lot else besides, and the Supreme Court has held that due process rights extend even to undocumented persons in this country. I will apply the law faithfully and fearlessly and without regard to persons.”
A vote by the Senate Judiciary Committee is expected April 3 followed by a Senate floor vote later that week. Supreme Court justices require 60 votes for confirmation. Republicans control the Senate 52-48, so eight Democrats are needed to confirm Judge Gorsuch. Senate Minority Leader Charles E. Schumer (D-N.Y.) vowed on March 23 to oppose Judge Gorsuch and asked other Democrats to join him, setting up a potential filibuster against Judge Gorsuch’s confirmation.
[email protected]
On Twitter @legal_med
Enlisting social networks for better health outcomes
As a hospitalist, you typically have little, if any, contact with patients outside the hospital and, at most, you’ll only spend a couple of hours a year in front of any particular patient. The vast majority of the determinants of your patients’ health occur when you’re not there.
In a commentary in the New England Journal of Medicine entitled “Engineering Social Incentives for Health,” lead author David A. Asch, MD, MBA, addresses that issue.1
“The motivation for the piece is that the people who are in a position to influence a patient’s health are their friends and family, and yet so much of how we have structured health care is between a clinician and a patient,” he says. “We often fail to engage the people in patients’ everyday lives, who can be quite willing partners in improving health care. There are all sorts of things they can do to help patients with hard-to-control diabetes or ... heart failure, or anything that might have put them in the hospital in the first place.”
The column describes a ladder of social engineering strategies, from very simple to complex. One example on the simple end might be to help a patient remember a daily medication by having him place the medication bottle where his partner can see him taking – or not taking – it. (The alternative is that medications are taken in a private place, such in the bathroom, where no one might be watching over the routine to keep the patient on track.)
Moving up the ladder, a hospitalist might help set up a network of other patients with heart failure, so that they can help each other in a kind of peer mentorship.
“These peer-to-peer connections might require Web-based platforms or social support groups, so that kind of activity is a lot more complicated, but the general theme is: Can hospitalists think about ways to constructively engage the social networks that already surround patients, so they don’t need to invoke the health system to do it?”
It’s long been known that people with more social support do better: People who are married do better; people who have more friends do better. “Up until now, it’s just been an observation,” Dr. Asch says. “I think we’re at a point where we could begin to prescribe social support in the way we might prescribe a diuretic. I’d like to try it out at least. I think that’s the call to action.”
Reference
1. Asch D, Rosin R. Engineering social incentives for health. NEJM. 2016;375:2511-2513.
As a hospitalist, you typically have little, if any, contact with patients outside the hospital and, at most, you’ll only spend a couple of hours a year in front of any particular patient. The vast majority of the determinants of your patients’ health occur when you’re not there.
In a commentary in the New England Journal of Medicine entitled “Engineering Social Incentives for Health,” lead author David A. Asch, MD, MBA, addresses that issue.1
“The motivation for the piece is that the people who are in a position to influence a patient’s health are their friends and family, and yet so much of how we have structured health care is between a clinician and a patient,” he says. “We often fail to engage the people in patients’ everyday lives, who can be quite willing partners in improving health care. There are all sorts of things they can do to help patients with hard-to-control diabetes or ... heart failure, or anything that might have put them in the hospital in the first place.”
The column describes a ladder of social engineering strategies, from very simple to complex. One example on the simple end might be to help a patient remember a daily medication by having him place the medication bottle where his partner can see him taking – or not taking – it. (The alternative is that medications are taken in a private place, such in the bathroom, where no one might be watching over the routine to keep the patient on track.)
Moving up the ladder, a hospitalist might help set up a network of other patients with heart failure, so that they can help each other in a kind of peer mentorship.
“These peer-to-peer connections might require Web-based platforms or social support groups, so that kind of activity is a lot more complicated, but the general theme is: Can hospitalists think about ways to constructively engage the social networks that already surround patients, so they don’t need to invoke the health system to do it?”
It’s long been known that people with more social support do better: People who are married do better; people who have more friends do better. “Up until now, it’s just been an observation,” Dr. Asch says. “I think we’re at a point where we could begin to prescribe social support in the way we might prescribe a diuretic. I’d like to try it out at least. I think that’s the call to action.”
Reference
1. Asch D, Rosin R. Engineering social incentives for health. NEJM. 2016;375:2511-2513.
As a hospitalist, you typically have little, if any, contact with patients outside the hospital and, at most, you’ll only spend a couple of hours a year in front of any particular patient. The vast majority of the determinants of your patients’ health occur when you’re not there.
In a commentary in the New England Journal of Medicine entitled “Engineering Social Incentives for Health,” lead author David A. Asch, MD, MBA, addresses that issue.1
“The motivation for the piece is that the people who are in a position to influence a patient’s health are their friends and family, and yet so much of how we have structured health care is between a clinician and a patient,” he says. “We often fail to engage the people in patients’ everyday lives, who can be quite willing partners in improving health care. There are all sorts of things they can do to help patients with hard-to-control diabetes or ... heart failure, or anything that might have put them in the hospital in the first place.”
The column describes a ladder of social engineering strategies, from very simple to complex. One example on the simple end might be to help a patient remember a daily medication by having him place the medication bottle where his partner can see him taking – or not taking – it. (The alternative is that medications are taken in a private place, such in the bathroom, where no one might be watching over the routine to keep the patient on track.)
Moving up the ladder, a hospitalist might help set up a network of other patients with heart failure, so that they can help each other in a kind of peer mentorship.
“These peer-to-peer connections might require Web-based platforms or social support groups, so that kind of activity is a lot more complicated, but the general theme is: Can hospitalists think about ways to constructively engage the social networks that already surround patients, so they don’t need to invoke the health system to do it?”
It’s long been known that people with more social support do better: People who are married do better; people who have more friends do better. “Up until now, it’s just been an observation,” Dr. Asch says. “I think we’re at a point where we could begin to prescribe social support in the way we might prescribe a diuretic. I’d like to try it out at least. I think that’s the call to action.”
Reference
1. Asch D, Rosin R. Engineering social incentives for health. NEJM. 2016;375:2511-2513.
Effect of Plate in Close Proximity to Empty External-Fixation Pin Site on Long-Bone Torsional Strength
Take-Home Points
- The location of a bicortical defect in proximity to a tibia plate does not appear to affect the torsional stiffness or torsional failure strength of the bone.
- External fixator pin placement should be based on considerations other than the potential for creating a distal stress riser after definitive fracture management.
A stress riser in cortical bone may be considered any abrupt change in the contour or consistency of the hollow structure, such as a surface defect, that not only weakens the bone but concentrates stresses at that transition point.1 A cortical defect that is 20% of the bone diameter is associated with a 34% decrease in torsional strength, thus representing a “stress riser.”2 High-energy and complex tibia fractures are often provisionally stabilized with external fixation that gives the soft tissues time to recover before definitive fracture fixation. Pin diameter for a medium-size tibia external fixator typically is 5.0 mm, resulting in a 10-mm defect in bicortical placement. Therefore, any tibia with a diameter of <50 mm is at risk for a stress riser fracture.
Although it had been established that sizable cortical defects can decrease the torsional strength of long bone,2 the effect of a plate in close proximity to a defect secondary to an empty external-fixator pin site on torsional strength has not been determined. We conducted a study to evaluate this effect. The null hypothesis was there would be no difference in tibia torsional strength attributable to varying the proximity of a tibia midshaft plate to a 5.0-mm bicortical defect.
Methods
Forty fourth-generation, medium-size left composite tibias (Pacific Research Laboratories) were divided into 8 groups of 5 bones (Figure 1). 
Torsion testing to failure was performed for all specimens in a manner similar to that described by Gardner and colleagues.3 Impression molds for the composite tibia constructed from polymethylmethacrylate encased the superior and distal ends, leaving 25.5 cm of exposed midshaft. This allowed the composites to be rigidly clamped into a materials testing system (858 Mini-Bionix; MTS) equipped with a 100.0-Nm torsional load cell (Figure 2).
Results
Graphical results for torsional stiffness are presented in Figure 3. R2 for all stiffness calculations was >0.99. 
Discussion
Many tibia fractures require provisional stabilization with an external fixator that spans the knee, because of the high-energy nature of the injury or other, higher-priority polytrauma concerns. When the patient or injury is suitable for definitive fixation, the external fixator typically is removed in favor of internal fixation with a plate and screws. Depending on the nature and location of the fracture and the subsequent plate, the empty cortical pin-site defects, often lying at varying distances from the distal end of the plate, can potentially serve as stress risers for fracture.4
Other studies have evaluated long-bone cortical defects biomechanically1,2,4 and clinically,5-7 and multiple studies have been conducted on the effects of plates on long-bone strength for fracture stabilization.8-13 The present study evaluated the torsional strength of long bones in the presence of a bicortical defect and the proximity of the defect to a plate. There were no differences in stiffness or failure load between any of the groups of plated and unplated fourth-generation composite tibias tested to failure in torsion with varying distal bicortical defects. Hypothetically, one would expect the torsional stiffness of these specimens to increase with the mere addition of a metallic diaphyseal plate. However, this study demonstrated that the addition of a plate did not affect the torsional stiffness or strength of the tibias. Clinically, it is common practice to place external fixator pins as far as possible outside the planned incision site for definitive fracture fixation. Thus, we also hypothesized that the presence of a bicortical pin-site defect and its proximity to the plate would alter the torsional strength of the tibia specimens, and that the distal pin-site defect’s location farthest from the plate would exhibit greater strength, but this did not occur. Although other studies have shown that the presence of bicortical defects decreases the strength of long bones, we were unable to quantify this decrease because the 2 intact groups of composites, plated and unplated, survived failure testing.
This study had several limitations, first being the use of composite tibias as opposed to human cadaver bone. Although fourth-generation composite bone models have been validated as a suitable and accurate biomechanical substitute for cadaver specimens,14 anatomical variations in cadaver tibias may transfer forces differently through plates, screws, and distal pin sites. In order to test plated specimens against the unplated controls, we did not simulate a mid-shaft fracture in any of the tibias. The pin-site defects were intended to reflect the mechanical effects of bicortical defects immediately after pin removal and in the absence of any degree of bone healing. Finally, this study focused on pin-site defects that were distal to a midshaft plate and that may not represent the effects of bicortical pin-site defects proximal to the plate.
Given the results of this biomechanical study in composite tibias, varying the proximity of a bicortical defect to a plate does not affect the torsional stiffness or torsional failure strength of the bone. Placement of an intended bicortical defect should be based on considerations other than the potential for creating a distal stress riser after definitive fracture management.
Am J Orthop. 2017;46(2):E108-E111. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.
1. Brooks DB, Burstein AH, Frankel VH. The biomechanics of torsional fractures. The stress concentration effect of a drill hole. J Bone Joint Surg Am. 1970;52(3):507-514.
2. Edgerton BC, An KN, Morrey BF. Torsional strength reduction due to cortical defects in bone. J Orthop Res. 1990;8(6):851-855.
3. Gardner MP, Chong AC, Pollock AG, Wooley PH. Mechanical evaluation of large-size fourth-generation composite femur and tibia models. Ann Biomed Eng. 2010;38(3):613-620.
4. Wysocki RW, Sheinkop MB, Virkus WW, Della Valle CJ. Femoral fracture through a previous pin site after computer-assisted total knee arthroplasty. J Arthroplasty. 2008;23(3):462-465.
5. Burstein AH, Currey J, Frankel VH, Heiple KG, Lunseth P, Vessely JC. Bone strength. The effect of screw holes. J Bone Joint Surg Am. 1972;54(6):1143-1156.
6. Clark CR, Morgan C, Sonstegard DA, Matthews LS. The effect of biopsy-hole shape and size on bone strength. J Bone Joint Surg Am. 1977;59(2):213-217.
7. Evans PE, Thomas WG. Tibial fracture through a traction-pin site. A report of two cases. J Bone Joint Surg Am. 1984;66(9):1475-1476.
8. Stoffel K, Dieter U, Stachowiak G, Gächter A, Kuster MS. Biomechanical testing of the LCP—how can stability in locked internal fixators be controlled? Injury. 2003;34(suppl 2):B11-B19.
9. Klaue K, Fengels I, Perren SM. Long-term effects of plate osteosynthesis: comparison of four different plates. Injury. 2000;31(suppl 2):B51-B62.
10. Uhthoff HK, Poitras P, Backman DS. Internal plate fixation of fractures: short history and recent developments. J Orthop Sci. 2006;11(2):118-126.
11. Takemoto RC, Sugi MT, Kummer F, Koval KJ, Egol KA. The effects of locked and unlocked neutralization plates on load bearing of fractures fixed with a lag screw. J Orthop Trauma. 2012;26(9):519-522.
12. Wagner M. General principles for the clinical use of the LCP. Injury. 2003;34(suppl 2):B31-B42.
13. Strauss EJ, Schwarzkopf R, Kummer F, Egol KA. The current status of locked plating: the good, the bad, and the ugly. J Orthop Trauma. 2008;22(7):479-486.
14. Elfar J, Menorca RM, Reed JD, Stanbury S. Composite bone models in orthopaedic surgery research and education. J Am Acad Orthop Surg. 2014;22(2):111-120.
Take-Home Points
- The location of a bicortical defect in proximity to a tibia plate does not appear to affect the torsional stiffness or torsional failure strength of the bone.
- External fixator pin placement should be based on considerations other than the potential for creating a distal stress riser after definitive fracture management.
A stress riser in cortical bone may be considered any abrupt change in the contour or consistency of the hollow structure, such as a surface defect, that not only weakens the bone but concentrates stresses at that transition point.1 A cortical defect that is 20% of the bone diameter is associated with a 34% decrease in torsional strength, thus representing a “stress riser.”2 High-energy and complex tibia fractures are often provisionally stabilized with external fixation that gives the soft tissues time to recover before definitive fracture fixation. Pin diameter for a medium-size tibia external fixator typically is 5.0 mm, resulting in a 10-mm defect in bicortical placement. Therefore, any tibia with a diameter of <50 mm is at risk for a stress riser fracture.
Although it had been established that sizable cortical defects can decrease the torsional strength of long bone,2 the effect of a plate in close proximity to a defect secondary to an empty external-fixator pin site on torsional strength has not been determined. We conducted a study to evaluate this effect. The null hypothesis was there would be no difference in tibia torsional strength attributable to varying the proximity of a tibia midshaft plate to a 5.0-mm bicortical defect.
Methods
Forty fourth-generation, medium-size left composite tibias (Pacific Research Laboratories) were divided into 8 groups of 5 bones (Figure 1).
Torsion testing to failure was performed for all specimens in a manner similar to that described by Gardner and colleagues.3 Impression molds for the composite tibia constructed from polymethylmethacrylate encased the superior and distal ends, leaving 25.5 cm of exposed midshaft. This allowed the composites to be rigidly clamped into a materials testing system (858 Mini-Bionix; MTS) equipped with a 100.0-Nm torsional load cell (Figure 2).
Results
Graphical results for torsional stiffness are presented in Figure 3. R2 for all stiffness calculations was >0.99.
Discussion
Many tibia fractures require provisional stabilization with an external fixator that spans the knee, because of the high-energy nature of the injury or other, higher-priority polytrauma concerns. When the patient or injury is suitable for definitive fixation, the external fixator typically is removed in favor of internal fixation with a plate and screws. Depending on the nature and location of the fracture and the subsequent plate, the empty cortical pin-site defects, often lying at varying distances from the distal end of the plate, can potentially serve as stress risers for fracture.4
Other studies have evaluated long-bone cortical defects biomechanically1,2,4 and clinically,5-7 and multiple studies have been conducted on the effects of plates on long-bone strength for fracture stabilization.8-13 The present study evaluated the torsional strength of long bones in the presence of a bicortical defect and the proximity of the defect to a plate. There were no differences in stiffness or failure load between any of the groups of plated and unplated fourth-generation composite tibias tested to failure in torsion with varying distal bicortical defects. Hypothetically, one would expect the torsional stiffness of these specimens to increase with the mere addition of a metallic diaphyseal plate. However, this study demonstrated that the addition of a plate did not affect the torsional stiffness or strength of the tibias. Clinically, it is common practice to place external fixator pins as far as possible outside the planned incision site for definitive fracture fixation. Thus, we also hypothesized that the presence of a bicortical pin-site defect and its proximity to the plate would alter the torsional strength of the tibia specimens, and that the distal pin-site defect’s location farthest from the plate would exhibit greater strength, but this did not occur. Although other studies have shown that the presence of bicortical defects decreases the strength of long bones, we were unable to quantify this decrease because the 2 intact groups of composites, plated and unplated, survived failure testing.
This study had several limitations, first being the use of composite tibias as opposed to human cadaver bone. Although fourth-generation composite bone models have been validated as a suitable and accurate biomechanical substitute for cadaver specimens,14 anatomical variations in cadaver tibias may transfer forces differently through plates, screws, and distal pin sites. In order to test plated specimens against the unplated controls, we did not simulate a mid-shaft fracture in any of the tibias. The pin-site defects were intended to reflect the mechanical effects of bicortical defects immediately after pin removal and in the absence of any degree of bone healing. Finally, this study focused on pin-site defects that were distal to a midshaft plate and that may not represent the effects of bicortical pin-site defects proximal to the plate.
Given the results of this biomechanical study in composite tibias, varying the proximity of a bicortical defect to a plate does not affect the torsional stiffness or torsional failure strength of the bone. Placement of an intended bicortical defect should be based on considerations other than the potential for creating a distal stress riser after definitive fracture management.
Am J Orthop. 2017;46(2):E108-E111. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.
Take-Home Points
- The location of a bicortical defect in proximity to a tibia plate does not appear to affect the torsional stiffness or torsional failure strength of the bone.
- External fixator pin placement should be based on considerations other than the potential for creating a distal stress riser after definitive fracture management.
A stress riser in cortical bone may be considered any abrupt change in the contour or consistency of the hollow structure, such as a surface defect, that not only weakens the bone but concentrates stresses at that transition point.1 A cortical defect that is 20% of the bone diameter is associated with a 34% decrease in torsional strength, thus representing a “stress riser.”2 High-energy and complex tibia fractures are often provisionally stabilized with external fixation that gives the soft tissues time to recover before definitive fracture fixation. Pin diameter for a medium-size tibia external fixator typically is 5.0 mm, resulting in a 10-mm defect in bicortical placement. Therefore, any tibia with a diameter of <50 mm is at risk for a stress riser fracture.
Although it had been established that sizable cortical defects can decrease the torsional strength of long bone,2 the effect of a plate in close proximity to a defect secondary to an empty external-fixator pin site on torsional strength has not been determined. We conducted a study to evaluate this effect. The null hypothesis was there would be no difference in tibia torsional strength attributable to varying the proximity of a tibia midshaft plate to a 5.0-mm bicortical defect.
Methods
Forty fourth-generation, medium-size left composite tibias (Pacific Research Laboratories) were divided into 8 groups of 5 bones (Figure 1).
Torsion testing to failure was performed for all specimens in a manner similar to that described by Gardner and colleagues.3 Impression molds for the composite tibia constructed from polymethylmethacrylate encased the superior and distal ends, leaving 25.5 cm of exposed midshaft. This allowed the composites to be rigidly clamped into a materials testing system (858 Mini-Bionix; MTS) equipped with a 100.0-Nm torsional load cell (Figure 2).
Results
Graphical results for torsional stiffness are presented in Figure 3. R2 for all stiffness calculations was >0.99.
Discussion
Many tibia fractures require provisional stabilization with an external fixator that spans the knee, because of the high-energy nature of the injury or other, higher-priority polytrauma concerns. When the patient or injury is suitable for definitive fixation, the external fixator typically is removed in favor of internal fixation with a plate and screws. Depending on the nature and location of the fracture and the subsequent plate, the empty cortical pin-site defects, often lying at varying distances from the distal end of the plate, can potentially serve as stress risers for fracture.4
Other studies have evaluated long-bone cortical defects biomechanically1,2,4 and clinically,5-7 and multiple studies have been conducted on the effects of plates on long-bone strength for fracture stabilization.8-13 The present study evaluated the torsional strength of long bones in the presence of a bicortical defect and the proximity of the defect to a plate. There were no differences in stiffness or failure load between any of the groups of plated and unplated fourth-generation composite tibias tested to failure in torsion with varying distal bicortical defects. Hypothetically, one would expect the torsional stiffness of these specimens to increase with the mere addition of a metallic diaphyseal plate. However, this study demonstrated that the addition of a plate did not affect the torsional stiffness or strength of the tibias. Clinically, it is common practice to place external fixator pins as far as possible outside the planned incision site for definitive fracture fixation. Thus, we also hypothesized that the presence of a bicortical pin-site defect and its proximity to the plate would alter the torsional strength of the tibia specimens, and that the distal pin-site defect’s location farthest from the plate would exhibit greater strength, but this did not occur. Although other studies have shown that the presence of bicortical defects decreases the strength of long bones, we were unable to quantify this decrease because the 2 intact groups of composites, plated and unplated, survived failure testing.
This study had several limitations, first being the use of composite tibias as opposed to human cadaver bone. Although fourth-generation composite bone models have been validated as a suitable and accurate biomechanical substitute for cadaver specimens,14 anatomical variations in cadaver tibias may transfer forces differently through plates, screws, and distal pin sites. In order to test plated specimens against the unplated controls, we did not simulate a mid-shaft fracture in any of the tibias. The pin-site defects were intended to reflect the mechanical effects of bicortical defects immediately after pin removal and in the absence of any degree of bone healing. Finally, this study focused on pin-site defects that were distal to a midshaft plate and that may not represent the effects of bicortical pin-site defects proximal to the plate.
Given the results of this biomechanical study in composite tibias, varying the proximity of a bicortical defect to a plate does not affect the torsional stiffness or torsional failure strength of the bone. Placement of an intended bicortical defect should be based on considerations other than the potential for creating a distal stress riser after definitive fracture management.
Am J Orthop. 2017;46(2):E108-E111. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.
1. Brooks DB, Burstein AH, Frankel VH. The biomechanics of torsional fractures. The stress concentration effect of a drill hole. J Bone Joint Surg Am. 1970;52(3):507-514.
2. Edgerton BC, An KN, Morrey BF. Torsional strength reduction due to cortical defects in bone. J Orthop Res. 1990;8(6):851-855.
3. Gardner MP, Chong AC, Pollock AG, Wooley PH. Mechanical evaluation of large-size fourth-generation composite femur and tibia models. Ann Biomed Eng. 2010;38(3):613-620.
4. Wysocki RW, Sheinkop MB, Virkus WW, Della Valle CJ. Femoral fracture through a previous pin site after computer-assisted total knee arthroplasty. J Arthroplasty. 2008;23(3):462-465.
5. Burstein AH, Currey J, Frankel VH, Heiple KG, Lunseth P, Vessely JC. Bone strength. The effect of screw holes. J Bone Joint Surg Am. 1972;54(6):1143-1156.
6. Clark CR, Morgan C, Sonstegard DA, Matthews LS. The effect of biopsy-hole shape and size on bone strength. J Bone Joint Surg Am. 1977;59(2):213-217.
7. Evans PE, Thomas WG. Tibial fracture through a traction-pin site. A report of two cases. J Bone Joint Surg Am. 1984;66(9):1475-1476.
8. Stoffel K, Dieter U, Stachowiak G, Gächter A, Kuster MS. Biomechanical testing of the LCP—how can stability in locked internal fixators be controlled? Injury. 2003;34(suppl 2):B11-B19.
9. Klaue K, Fengels I, Perren SM. Long-term effects of plate osteosynthesis: comparison of four different plates. Injury. 2000;31(suppl 2):B51-B62.
10. Uhthoff HK, Poitras P, Backman DS. Internal plate fixation of fractures: short history and recent developments. J Orthop Sci. 2006;11(2):118-126.
11. Takemoto RC, Sugi MT, Kummer F, Koval KJ, Egol KA. The effects of locked and unlocked neutralization plates on load bearing of fractures fixed with a lag screw. J Orthop Trauma. 2012;26(9):519-522.
12. Wagner M. General principles for the clinical use of the LCP. Injury. 2003;34(suppl 2):B31-B42.
13. Strauss EJ, Schwarzkopf R, Kummer F, Egol KA. The current status of locked plating: the good, the bad, and the ugly. J Orthop Trauma. 2008;22(7):479-486.
14. Elfar J, Menorca RM, Reed JD, Stanbury S. Composite bone models in orthopaedic surgery research and education. J Am Acad Orthop Surg. 2014;22(2):111-120.
1. Brooks DB, Burstein AH, Frankel VH. The biomechanics of torsional fractures. The stress concentration effect of a drill hole. J Bone Joint Surg Am. 1970;52(3):507-514.
2. Edgerton BC, An KN, Morrey BF. Torsional strength reduction due to cortical defects in bone. J Orthop Res. 1990;8(6):851-855.
3. Gardner MP, Chong AC, Pollock AG, Wooley PH. Mechanical evaluation of large-size fourth-generation composite femur and tibia models. Ann Biomed Eng. 2010;38(3):613-620.
4. Wysocki RW, Sheinkop MB, Virkus WW, Della Valle CJ. Femoral fracture through a previous pin site after computer-assisted total knee arthroplasty. J Arthroplasty. 2008;23(3):462-465.
5. Burstein AH, Currey J, Frankel VH, Heiple KG, Lunseth P, Vessely JC. Bone strength. The effect of screw holes. J Bone Joint Surg Am. 1972;54(6):1143-1156.
6. Clark CR, Morgan C, Sonstegard DA, Matthews LS. The effect of biopsy-hole shape and size on bone strength. J Bone Joint Surg Am. 1977;59(2):213-217.
7. Evans PE, Thomas WG. Tibial fracture through a traction-pin site. A report of two cases. J Bone Joint Surg Am. 1984;66(9):1475-1476.
8. Stoffel K, Dieter U, Stachowiak G, Gächter A, Kuster MS. Biomechanical testing of the LCP—how can stability in locked internal fixators be controlled? Injury. 2003;34(suppl 2):B11-B19.
9. Klaue K, Fengels I, Perren SM. Long-term effects of plate osteosynthesis: comparison of four different plates. Injury. 2000;31(suppl 2):B51-B62.
10. Uhthoff HK, Poitras P, Backman DS. Internal plate fixation of fractures: short history and recent developments. J Orthop Sci. 2006;11(2):118-126.
11. Takemoto RC, Sugi MT, Kummer F, Koval KJ, Egol KA. The effects of locked and unlocked neutralization plates on load bearing of fractures fixed with a lag screw. J Orthop Trauma. 2012;26(9):519-522.
12. Wagner M. General principles for the clinical use of the LCP. Injury. 2003;34(suppl 2):B31-B42.
13. Strauss EJ, Schwarzkopf R, Kummer F, Egol KA. The current status of locked plating: the good, the bad, and the ugly. J Orthop Trauma. 2008;22(7):479-486.
14. Elfar J, Menorca RM, Reed JD, Stanbury S. Composite bone models in orthopaedic surgery research and education. J Am Acad Orthop Surg. 2014;22(2):111-120.
Onstep hernia repair decreased postop pain during sexual activity
The Onstep technique for inguinal hernia repair is associated with a lower incidence of postoperative pain during sexual activity than the Lichtenstein surgical technique, according to a paper published online in Surgery.
This study was a part of the Onli trial, the objective of which was to evaluate chronic pain and sexual dysfunction after inguinal hernia repair involving mesh fixation with sutures (Lichtenstein), compared with no mesh fixation (Onstep). The investigators reported the findings of a large study: 20.8% of inguinal repair patients experienced pain during sexual activity 1.4-1.7 years after their operation (Pain. 2006;122:258-63).
“The Onstep technique could be considered when surgeons and patients are discussing the optimal technique for repair of an inguinal hernia,” wrote Kristoffer Andresen, MD, of the University of Copenhagen, and his coauthors. “If the patient has pain during sexual activity as part of the complaint from the hernia, the Onstep technique seems to have a greater chance of removing this pain and alleviating the complaints.”
Among the 17 patients in the Onstep group who experienced postoperative pain during sexual activity, 8 had experienced preoperative pain during sexual activity and 7 had not. In the Lichtenstein group, 14 of the 30 patients who experienced postoperative pain had experienced preoperative pain, 14 had not. The remaining patients in both groups reported not having sexual activity before surgery or declined to answer.
The Lichtenstein technique was associated with new pain in 14 of the 70 patients (20%) while 7 of the 74 patients (9%) in the Onstep group reported new pain after surgery.
“For patients who experienced pain during sexual activity preoperatively, the Onstep technique removed the pain during sexual activity in the majority of patients while still resulting in few new cases,” the authors wrote.
Among the Lichtenstein group, 20 patients experienced pain from the surgical scar, compared with 7 patients in the Onstep group.
When asked about the degree of impairment of sexual function because of the postoperative pain, four patients in the Lichtenstein group said they had moderate to severe impairment, but none in the Onstep group reported that level of impairment.
Commenting on the possible mechanisms that might result in pain during sexual activity after hernia repair, the authors noted that mesh has been found to shrink from a mass around the vas deferens after a Lichtenstein repair. Previous studies have also found sutures around the iliohypogastric and the ilioinguinal nerves, which could also result in some pain.
“Because the mesh in the Onstep technique is not fixed with sutures, the risk of capturing nerves during the fixation of mesh is nonexistent,” they wrote. “There could, however, still be a risk of scar tissue and mesh shrinkage.”
PolySoft mesh (Bard Davol) was used for the Lichtenstein group and SoftMesh (Bard Davol) was used for the Onstep group.
In the 6 months’ follow-up period, two patients in the Lichtenstein group and one patient in the Onstep group experienced a recurrence of their hernia.
Three authors reported personal fees and travel grants from private industry – including Bard Medical – outside the submitted work. No other conflicts of interest were declared.
The Onstep technique for inguinal hernia repair is associated with a lower incidence of postoperative pain during sexual activity than the Lichtenstein surgical technique, according to a paper published online in Surgery.
This study was a part of the Onli trial, the objective of which was to evaluate chronic pain and sexual dysfunction after inguinal hernia repair involving mesh fixation with sutures (Lichtenstein), compared with no mesh fixation (Onstep). The investigators reported the findings of a large study: 20.8% of inguinal repair patients experienced pain during sexual activity 1.4-1.7 years after their operation (Pain. 2006;122:258-63).
“The Onstep technique could be considered when surgeons and patients are discussing the optimal technique for repair of an inguinal hernia,” wrote Kristoffer Andresen, MD, of the University of Copenhagen, and his coauthors. “If the patient has pain during sexual activity as part of the complaint from the hernia, the Onstep technique seems to have a greater chance of removing this pain and alleviating the complaints.”
Among the 17 patients in the Onstep group who experienced postoperative pain during sexual activity, 8 had experienced preoperative pain during sexual activity and 7 had not. In the Lichtenstein group, 14 of the 30 patients who experienced postoperative pain had experienced preoperative pain, 14 had not. The remaining patients in both groups reported not having sexual activity before surgery or declined to answer.
The Lichtenstein technique was associated with new pain in 14 of the 70 patients (20%) while 7 of the 74 patients (9%) in the Onstep group reported new pain after surgery.
“For patients who experienced pain during sexual activity preoperatively, the Onstep technique removed the pain during sexual activity in the majority of patients while still resulting in few new cases,” the authors wrote.
Among the Lichtenstein group, 20 patients experienced pain from the surgical scar, compared with 7 patients in the Onstep group.
When asked about the degree of impairment of sexual function because of the postoperative pain, four patients in the Lichtenstein group said they had moderate to severe impairment, but none in the Onstep group reported that level of impairment.
Commenting on the possible mechanisms that might result in pain during sexual activity after hernia repair, the authors noted that mesh has been found to shrink from a mass around the vas deferens after a Lichtenstein repair. Previous studies have also found sutures around the iliohypogastric and the ilioinguinal nerves, which could also result in some pain.
“Because the mesh in the Onstep technique is not fixed with sutures, the risk of capturing nerves during the fixation of mesh is nonexistent,” they wrote. “There could, however, still be a risk of scar tissue and mesh shrinkage.”
PolySoft mesh (Bard Davol) was used for the Lichtenstein group and SoftMesh (Bard Davol) was used for the Onstep group.
In the 6 months’ follow-up period, two patients in the Lichtenstein group and one patient in the Onstep group experienced a recurrence of their hernia.
Three authors reported personal fees and travel grants from private industry – including Bard Medical – outside the submitted work. No other conflicts of interest were declared.
The Onstep technique for inguinal hernia repair is associated with a lower incidence of postoperative pain during sexual activity than the Lichtenstein surgical technique, according to a paper published online in Surgery.
This study was a part of the Onli trial, the objective of which was to evaluate chronic pain and sexual dysfunction after inguinal hernia repair involving mesh fixation with sutures (Lichtenstein), compared with no mesh fixation (Onstep). The investigators reported the findings of a large study: 20.8% of inguinal repair patients experienced pain during sexual activity 1.4-1.7 years after their operation (Pain. 2006;122:258-63).
“The Onstep technique could be considered when surgeons and patients are discussing the optimal technique for repair of an inguinal hernia,” wrote Kristoffer Andresen, MD, of the University of Copenhagen, and his coauthors. “If the patient has pain during sexual activity as part of the complaint from the hernia, the Onstep technique seems to have a greater chance of removing this pain and alleviating the complaints.”
Among the 17 patients in the Onstep group who experienced postoperative pain during sexual activity, 8 had experienced preoperative pain during sexual activity and 7 had not. In the Lichtenstein group, 14 of the 30 patients who experienced postoperative pain had experienced preoperative pain, 14 had not. The remaining patients in both groups reported not having sexual activity before surgery or declined to answer.
The Lichtenstein technique was associated with new pain in 14 of the 70 patients (20%) while 7 of the 74 patients (9%) in the Onstep group reported new pain after surgery.
“For patients who experienced pain during sexual activity preoperatively, the Onstep technique removed the pain during sexual activity in the majority of patients while still resulting in few new cases,” the authors wrote.
Among the Lichtenstein group, 20 patients experienced pain from the surgical scar, compared with 7 patients in the Onstep group.
When asked about the degree of impairment of sexual function because of the postoperative pain, four patients in the Lichtenstein group said they had moderate to severe impairment, but none in the Onstep group reported that level of impairment.
Commenting on the possible mechanisms that might result in pain during sexual activity after hernia repair, the authors noted that mesh has been found to shrink from a mass around the vas deferens after a Lichtenstein repair. Previous studies have also found sutures around the iliohypogastric and the ilioinguinal nerves, which could also result in some pain.
“Because the mesh in the Onstep technique is not fixed with sutures, the risk of capturing nerves during the fixation of mesh is nonexistent,” they wrote. “There could, however, still be a risk of scar tissue and mesh shrinkage.”
PolySoft mesh (Bard Davol) was used for the Lichtenstein group and SoftMesh (Bard Davol) was used for the Onstep group.
In the 6 months’ follow-up period, two patients in the Lichtenstein group and one patient in the Onstep group experienced a recurrence of their hernia.
Three authors reported personal fees and travel grants from private industry – including Bard Medical – outside the submitted work. No other conflicts of interest were declared.
FROM SURGERY
Key clinical point: The Onstep technique for inguinal hernia repair is associated with a lower incidence of pain during sexual activity than the Lichtenstein technique.
Major finding: The Lichtenstein technique was associated with new pain in 14 of the 70 patients (20%) while 7 of the 74 patients (9%) in the Onstep group reported new pain after surgery.
Data source: A randomized trial in 259 patients undergoing inguinal hernia repair.
Disclosures: Three authors reported personal fees and travel grants from private industry – including Bard Medical – outside the submitted work. No other conflicts of interest were declared.
OpenNotes: Patient engagement with low physician hassle
ORLANDO – Early evidence suggests that OpenNotes is helping to engage patients and improve health outcomes while not creating undue burden for physicians.
A 2010 pilot project at Beth Israel Deaconess Medical Center in Boston, Geisinger Health System in Pennsylvania, and Harborview Medical Center in Seattle tested OpenNotes, a program that allows patients to see the entirety of a physician’s notes within their medical record and not just a summarized version.
Homer Chin, MD, of the department of medical informatics and outcomes research at Oregon Health & Science University, Portland, an associate with the OpenNotes Program, and physician champion for the Northwest OpenNotes Consortium, noted that a survey of the 105 primary care physicians participating in the pilot revealed they were apprehensive when they heard their visit notes would be completely available to patients.
Prior to the launch of the pilot, 24% of physicians expected significantly longer visits because of the availability of OpenNotes, 42% said they expected to spend more time addressing patient questions outside of visits, and 39% said they expected to spend more time writing/editing/dictating notes, Dr. Chin said at the annual meeting of the Healthcare Information and Management Systems Society.
Their concerns never quite materialized.
According to a survey of the participating physicians after the yearlong pilot, only 2% reported visits took significantly longer, 3% said they spent more time addressing patient questions outside of visits, and 11% said they spent more time writing/editing/dictating notes.
With regard to writing notes, “what we are finding is that most physicians are saying they are changing the way they write the note a little bit, but it is not taking more time,” Dr. Chin said. “They are just watching for certain terms and writing them in a different way, but it is not necessarily taking more time.”
More than 70% of patients who participated in the trial reported they are taking better care of themselves, more than 77% said they have a better understanding of their medical condition, more than 69% said they are better prepared for visits and more than 60% said they are more adherent to their prescription medication regimens.
Importantly, 85% said the availability of OpenNotes would affect their future choice of providers.
Dr. Chin also discussed the results of a survey of patients using OpenNotes in the Virginia Commonwealth University Health System in Richmond, noting that of roughly 420 respondents, 70% said their contact with their providers did not change, with nearly 20% saying they were contacting their provider less. Just over 40% said that reading their notes made them less worried about something health related, while a little more than 50% said there was no change. Nearly 85% said they thought seeing the notes helped them take better care of themselves. Nearly 90% of patients said that they understood some or all of their doctors’ notes.
It has been incredibly valuable “when the patients use the portal to prepare themselves for the visit with the provider,” Mr. Kravitz said. “They will review their case. They’ll look at past x-rays or reports, any kind of information, the results for laboratory and anything else, but they will message their provider. They are very heavy into messaging. It’s secure messaging within the portal and any type of questions, especially after they’ve had an appointment, they’ve thought of something they didn’t think about in the appointment, they have the opportunity to message back to the provider’s office.”
Geisinger saw 620,000 encounter reviews in OpenNotes out of 2 million patient visits in its last fiscal year, with virtually no complaints about the information in the OpenNotes.
Dr. Chin stressed that the implemented OpenNotes needs to be driven by physicians.
“I would emphasize that this has to be a clinician operational leader supported effort, and not an IT effort, so that when clinicians complain, you can point them to their department head, the chief medical officer, and not the IT people,” he said. “You’ve got to have good communication to providers. Our advice is to start with one department. You might do a pilot for a very short period of time, but there is enough evidence now to really implement it throughout the organization. We encourage people not to allow individual providers to opt out on their own, to make their own decision to opt out, to do it as an organizational effort.”
Michael Day, chief information officer of Ascension Health and Columbia St. Mary’s Health System of Milwaukee, offered the same advice.
“You’ve got to have leadership commitment up front,” Mr. Day said. “This really has to have good, strong physician leadership. The key executive in charge of all of this was the president of our medical group which drove a lot of the change with a lot of support from other areas.”
He noted that at his organization there was “a lot of physician grumbling” when OpenNotes was announced. However, there has been “relatively no impact. I think they’ve all agreed that this has made care better. We’ve also seen an actual improvement in the quality of the documentation.”
None of the presenters reported any conflicts of interest.
ORLANDO – Early evidence suggests that OpenNotes is helping to engage patients and improve health outcomes while not creating undue burden for physicians.
A 2010 pilot project at Beth Israel Deaconess Medical Center in Boston, Geisinger Health System in Pennsylvania, and Harborview Medical Center in Seattle tested OpenNotes, a program that allows patients to see the entirety of a physician’s notes within their medical record and not just a summarized version.
Homer Chin, MD, of the department of medical informatics and outcomes research at Oregon Health & Science University, Portland, an associate with the OpenNotes Program, and physician champion for the Northwest OpenNotes Consortium, noted that a survey of the 105 primary care physicians participating in the pilot revealed they were apprehensive when they heard their visit notes would be completely available to patients.
Prior to the launch of the pilot, 24% of physicians expected significantly longer visits because of the availability of OpenNotes, 42% said they expected to spend more time addressing patient questions outside of visits, and 39% said they expected to spend more time writing/editing/dictating notes, Dr. Chin said at the annual meeting of the Healthcare Information and Management Systems Society.
Their concerns never quite materialized.
According to a survey of the participating physicians after the yearlong pilot, only 2% reported visits took significantly longer, 3% said they spent more time addressing patient questions outside of visits, and 11% said they spent more time writing/editing/dictating notes.
With regard to writing notes, “what we are finding is that most physicians are saying they are changing the way they write the note a little bit, but it is not taking more time,” Dr. Chin said. “They are just watching for certain terms and writing them in a different way, but it is not necessarily taking more time.”
More than 70% of patients who participated in the trial reported they are taking better care of themselves, more than 77% said they have a better understanding of their medical condition, more than 69% said they are better prepared for visits and more than 60% said they are more adherent to their prescription medication regimens.
Importantly, 85% said the availability of OpenNotes would affect their future choice of providers.
Dr. Chin also discussed the results of a survey of patients using OpenNotes in the Virginia Commonwealth University Health System in Richmond, noting that of roughly 420 respondents, 70% said their contact with their providers did not change, with nearly 20% saying they were contacting their provider less. Just over 40% said that reading their notes made them less worried about something health related, while a little more than 50% said there was no change. Nearly 85% said they thought seeing the notes helped them take better care of themselves. Nearly 90% of patients said that they understood some or all of their doctors’ notes.
It has been incredibly valuable “when the patients use the portal to prepare themselves for the visit with the provider,” Mr. Kravitz said. “They will review their case. They’ll look at past x-rays or reports, any kind of information, the results for laboratory and anything else, but they will message their provider. They are very heavy into messaging. It’s secure messaging within the portal and any type of questions, especially after they’ve had an appointment, they’ve thought of something they didn’t think about in the appointment, they have the opportunity to message back to the provider’s office.”
Geisinger saw 620,000 encounter reviews in OpenNotes out of 2 million patient visits in its last fiscal year, with virtually no complaints about the information in the OpenNotes.
Dr. Chin stressed that the implemented OpenNotes needs to be driven by physicians.
“I would emphasize that this has to be a clinician operational leader supported effort, and not an IT effort, so that when clinicians complain, you can point them to their department head, the chief medical officer, and not the IT people,” he said. “You’ve got to have good communication to providers. Our advice is to start with one department. You might do a pilot for a very short period of time, but there is enough evidence now to really implement it throughout the organization. We encourage people not to allow individual providers to opt out on their own, to make their own decision to opt out, to do it as an organizational effort.”
Michael Day, chief information officer of Ascension Health and Columbia St. Mary’s Health System of Milwaukee, offered the same advice.
“You’ve got to have leadership commitment up front,” Mr. Day said. “This really has to have good, strong physician leadership. The key executive in charge of all of this was the president of our medical group which drove a lot of the change with a lot of support from other areas.”
He noted that at his organization there was “a lot of physician grumbling” when OpenNotes was announced. However, there has been “relatively no impact. I think they’ve all agreed that this has made care better. We’ve also seen an actual improvement in the quality of the documentation.”
None of the presenters reported any conflicts of interest.
ORLANDO – Early evidence suggests that OpenNotes is helping to engage patients and improve health outcomes while not creating undue burden for physicians.
A 2010 pilot project at Beth Israel Deaconess Medical Center in Boston, Geisinger Health System in Pennsylvania, and Harborview Medical Center in Seattle tested OpenNotes, a program that allows patients to see the entirety of a physician’s notes within their medical record and not just a summarized version.
Homer Chin, MD, of the department of medical informatics and outcomes research at Oregon Health & Science University, Portland, an associate with the OpenNotes Program, and physician champion for the Northwest OpenNotes Consortium, noted that a survey of the 105 primary care physicians participating in the pilot revealed they were apprehensive when they heard their visit notes would be completely available to patients.
Prior to the launch of the pilot, 24% of physicians expected significantly longer visits because of the availability of OpenNotes, 42% said they expected to spend more time addressing patient questions outside of visits, and 39% said they expected to spend more time writing/editing/dictating notes, Dr. Chin said at the annual meeting of the Healthcare Information and Management Systems Society.
Their concerns never quite materialized.
According to a survey of the participating physicians after the yearlong pilot, only 2% reported visits took significantly longer, 3% said they spent more time addressing patient questions outside of visits, and 11% said they spent more time writing/editing/dictating notes.
With regard to writing notes, “what we are finding is that most physicians are saying they are changing the way they write the note a little bit, but it is not taking more time,” Dr. Chin said. “They are just watching for certain terms and writing them in a different way, but it is not necessarily taking more time.”
More than 70% of patients who participated in the trial reported they are taking better care of themselves, more than 77% said they have a better understanding of their medical condition, more than 69% said they are better prepared for visits and more than 60% said they are more adherent to their prescription medication regimens.
Importantly, 85% said the availability of OpenNotes would affect their future choice of providers.
Dr. Chin also discussed the results of a survey of patients using OpenNotes in the Virginia Commonwealth University Health System in Richmond, noting that of roughly 420 respondents, 70% said their contact with their providers did not change, with nearly 20% saying they were contacting their provider less. Just over 40% said that reading their notes made them less worried about something health related, while a little more than 50% said there was no change. Nearly 85% said they thought seeing the notes helped them take better care of themselves. Nearly 90% of patients said that they understood some or all of their doctors’ notes.
It has been incredibly valuable “when the patients use the portal to prepare themselves for the visit with the provider,” Mr. Kravitz said. “They will review their case. They’ll look at past x-rays or reports, any kind of information, the results for laboratory and anything else, but they will message their provider. They are very heavy into messaging. It’s secure messaging within the portal and any type of questions, especially after they’ve had an appointment, they’ve thought of something they didn’t think about in the appointment, they have the opportunity to message back to the provider’s office.”
Geisinger saw 620,000 encounter reviews in OpenNotes out of 2 million patient visits in its last fiscal year, with virtually no complaints about the information in the OpenNotes.
Dr. Chin stressed that the implemented OpenNotes needs to be driven by physicians.
“I would emphasize that this has to be a clinician operational leader supported effort, and not an IT effort, so that when clinicians complain, you can point them to their department head, the chief medical officer, and not the IT people,” he said. “You’ve got to have good communication to providers. Our advice is to start with one department. You might do a pilot for a very short period of time, but there is enough evidence now to really implement it throughout the organization. We encourage people not to allow individual providers to opt out on their own, to make their own decision to opt out, to do it as an organizational effort.”
Michael Day, chief information officer of Ascension Health and Columbia St. Mary’s Health System of Milwaukee, offered the same advice.
“You’ve got to have leadership commitment up front,” Mr. Day said. “This really has to have good, strong physician leadership. The key executive in charge of all of this was the president of our medical group which drove a lot of the change with a lot of support from other areas.”
He noted that at his organization there was “a lot of physician grumbling” when OpenNotes was announced. However, there has been “relatively no impact. I think they’ve all agreed that this has made care better. We’ve also seen an actual improvement in the quality of the documentation.”
None of the presenters reported any conflicts of interest.
AT HIMSS 2017
VIDEO: Pain and impaired QOL persist after open endometrial cancer surgery
NATIONAL HARBOR, MD. – Patient-reported outcomes from a prospective cohort study of minimally invasive versus open surgery for women with endometrial cancer showed that the disability from open surgery persisted for longer than had previously been recognized. Further, for a subset of patients, impairment in sexual functioning was significant, and persistent, regardless of the type of surgery.
At 3 weeks after surgery, patients who had open surgery had greater pain as measured by the Brief Pain Inventory (minimally important difference greater than 1, P = .0004). By 3 months post surgery, responses on the Functional Assessment of Cancer Therapy–General were still significantly lower for the open-surgery group, compared with the minimally invasive group (P = .0011).
Although patients’ pain and overall state of health were better at 3 weeks post surgery, regardless of whether women had open, laparoscopic, or robotic surgery, the reduced overall quality of life experienced by patients who had open surgery persisted.
“What was a bit different from other studies … is that we found that this is maintained even at 3 months, and it was clinically and statistically different,” Sarah Ferguson, MD, said in a video interview at the annual meeting of the Society of Gynecologic Oncology. “So that was really, I think, an interesting finding, that this doesn’t just impact the very short term. Three months is a fairly long time after a primary surgery, and [it’s] important for women to know this.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Patients in the eight-center study had histologically confirmed clinical stage I or II endometrial cancer. The open-surgery arm of the study involved 106 patients, and 414 had minimally invasive surgery (168 laparascopic, 246 robotic).
The robotic and laparoscopic arms showed no statistically significant differences for any patient-reported outcome, even after adjusting for potentially confounding variables, said Dr. Ferguson of Princess Margaret Cancer Centre at the University of Toronto. Accordingly, investigators compared both minimally invasive arms grouped together against open surgery.
Overall, about 80% of patients completed the quality-of-life questionnaires. The response rate for the sexual-functioning questionnaires, however, was much lower, ranging from about a quarter to a half of the participants.
When Dr. Ferguson and her colleagues examined the characteristics of the patients who did complete the sexual-functioning questionnaires, they found that these women were more likely to be younger, partnered, premenopausal and sexually active at the time of diagnosis. Both of the surgical groups “met the clinical cutoff for sexual dysfunction” on the Female Sexual Function Index questionnaire, she said.
For the sexual function questionnaires, differences between the open and minimally invasive groups were not significant at any time point throughout the 26 weeks that patients were studied. “Though it’s a small population, I think these results are important,” said Dr. Ferguson. “These variables may be helpful for us to target patients in our practice, or in future studies, who require intervention.”
Though the study was not randomized, Dr. Ferguson said that the baseline characteristics were similar between groups, and the investigators’ intention-to-treat analysis used a statistical model that adjusted for many potential confounding variables.
Dr. Ferguson reported having no conflicts of interest.
[email protected]
On Twitter @karioakes
NATIONAL HARBOR, MD. – Patient-reported outcomes from a prospective cohort study of minimally invasive versus open surgery for women with endometrial cancer showed that the disability from open surgery persisted for longer than had previously been recognized. Further, for a subset of patients, impairment in sexual functioning was significant, and persistent, regardless of the type of surgery.
At 3 weeks after surgery, patients who had open surgery had greater pain as measured by the Brief Pain Inventory (minimally important difference greater than 1, P = .0004). By 3 months post surgery, responses on the Functional Assessment of Cancer Therapy–General were still significantly lower for the open-surgery group, compared with the minimally invasive group (P = .0011).
Although patients’ pain and overall state of health were better at 3 weeks post surgery, regardless of whether women had open, laparoscopic, or robotic surgery, the reduced overall quality of life experienced by patients who had open surgery persisted.
“What was a bit different from other studies … is that we found that this is maintained even at 3 months, and it was clinically and statistically different,” Sarah Ferguson, MD, said in a video interview at the annual meeting of the Society of Gynecologic Oncology. “So that was really, I think, an interesting finding, that this doesn’t just impact the very short term. Three months is a fairly long time after a primary surgery, and [it’s] important for women to know this.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Patients in the eight-center study had histologically confirmed clinical stage I or II endometrial cancer. The open-surgery arm of the study involved 106 patients, and 414 had minimally invasive surgery (168 laparascopic, 246 robotic).
The robotic and laparoscopic arms showed no statistically significant differences for any patient-reported outcome, even after adjusting for potentially confounding variables, said Dr. Ferguson of Princess Margaret Cancer Centre at the University of Toronto. Accordingly, investigators compared both minimally invasive arms grouped together against open surgery.
Overall, about 80% of patients completed the quality-of-life questionnaires. The response rate for the sexual-functioning questionnaires, however, was much lower, ranging from about a quarter to a half of the participants.
When Dr. Ferguson and her colleagues examined the characteristics of the patients who did complete the sexual-functioning questionnaires, they found that these women were more likely to be younger, partnered, premenopausal and sexually active at the time of diagnosis. Both of the surgical groups “met the clinical cutoff for sexual dysfunction” on the Female Sexual Function Index questionnaire, she said.
For the sexual function questionnaires, differences between the open and minimally invasive groups were not significant at any time point throughout the 26 weeks that patients were studied. “Though it’s a small population, I think these results are important,” said Dr. Ferguson. “These variables may be helpful for us to target patients in our practice, or in future studies, who require intervention.”
Though the study was not randomized, Dr. Ferguson said that the baseline characteristics were similar between groups, and the investigators’ intention-to-treat analysis used a statistical model that adjusted for many potential confounding variables.
Dr. Ferguson reported having no conflicts of interest.
[email protected]
On Twitter @karioakes
NATIONAL HARBOR, MD. – Patient-reported outcomes from a prospective cohort study of minimally invasive versus open surgery for women with endometrial cancer showed that the disability from open surgery persisted for longer than had previously been recognized. Further, for a subset of patients, impairment in sexual functioning was significant, and persistent, regardless of the type of surgery.
At 3 weeks after surgery, patients who had open surgery had greater pain as measured by the Brief Pain Inventory (minimally important difference greater than 1, P = .0004). By 3 months post surgery, responses on the Functional Assessment of Cancer Therapy–General were still significantly lower for the open-surgery group, compared with the minimally invasive group (P = .0011).
Although patients’ pain and overall state of health were better at 3 weeks post surgery, regardless of whether women had open, laparoscopic, or robotic surgery, the reduced overall quality of life experienced by patients who had open surgery persisted.
“What was a bit different from other studies … is that we found that this is maintained even at 3 months, and it was clinically and statistically different,” Sarah Ferguson, MD, said in a video interview at the annual meeting of the Society of Gynecologic Oncology. “So that was really, I think, an interesting finding, that this doesn’t just impact the very short term. Three months is a fairly long time after a primary surgery, and [it’s] important for women to know this.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Patients in the eight-center study had histologically confirmed clinical stage I or II endometrial cancer. The open-surgery arm of the study involved 106 patients, and 414 had minimally invasive surgery (168 laparascopic, 246 robotic).
The robotic and laparoscopic arms showed no statistically significant differences for any patient-reported outcome, even after adjusting for potentially confounding variables, said Dr. Ferguson of Princess Margaret Cancer Centre at the University of Toronto. Accordingly, investigators compared both minimally invasive arms grouped together against open surgery.
Overall, about 80% of patients completed the quality-of-life questionnaires. The response rate for the sexual-functioning questionnaires, however, was much lower, ranging from about a quarter to a half of the participants.
When Dr. Ferguson and her colleagues examined the characteristics of the patients who did complete the sexual-functioning questionnaires, they found that these women were more likely to be younger, partnered, premenopausal and sexually active at the time of diagnosis. Both of the surgical groups “met the clinical cutoff for sexual dysfunction” on the Female Sexual Function Index questionnaire, she said.
For the sexual function questionnaires, differences between the open and minimally invasive groups were not significant at any time point throughout the 26 weeks that patients were studied. “Though it’s a small population, I think these results are important,” said Dr. Ferguson. “These variables may be helpful for us to target patients in our practice, or in future studies, who require intervention.”
Though the study was not randomized, Dr. Ferguson said that the baseline characteristics were similar between groups, and the investigators’ intention-to-treat analysis used a statistical model that adjusted for many potential confounding variables.
Dr. Ferguson reported having no conflicts of interest.
[email protected]
On Twitter @karioakes
AT THE ANNUAL MEETING ON WOMEN'S CANCER
