MDedge ObGyn

Death by self-harm through suicide or overdose is a leading cause of death for women in the first year post partum, data indicate. Many of these deaths may be preventable, said Adrienne Griffen, MPP, executive director of the Maternal Mental Health Leadership Alliance.

Ms. Griffen discussed these findings and ways clinicians may be able to help at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

Women “visit a health care provider an average of 25 times during a healthy pregnancy and first year of baby’s life,” she said. “Obstetric and primary care providers who serve pregnant and postpartum women are uniquely positioned to intervene effectively to screen and assess women for mental health disorders.”

To that end, clinicians should discuss mental health “early and often,” Ms. Griffen said.

“Asking about mental health issues and suicide will not cause women to think these thoughts,” she said. “We cannot wait for women to raise their hand and ask for help because by the time they do that, they needed help many weeks ago.”

Obstetric providers can explain to patients that they will check on their mental health every visit, just as they do with their weight and blood pressure, Ms. Griffen said.

For example, a doctor might tell a patient: “Your mental health is just as important as your physical health, and anxiety and depression are the most common complications of pregnancy and childbirth,” Ms. Griffen suggested. “Every time I see you, I’m going to ask you how you are doing, and we’ll do a formal screening assessment periodically over the course of the pregnancy. … Your job is to answer us honestly so that we can connect you with resources as soon as possible to minimize the impact on you and your baby.”

Although the obstetric provider should introduce this topic, a nurse, lactation consultant, or social worker may conduct screenings and help patients who are experiencing distress, she said.

During the past decade, several medical associations have issued new guidance around screening new mothers for anxiety and depression. One recent ACOG committee opinion recommends screening for depression at least once during pregnancy and once post partum, and encourages doctors to initiate medical therapy if possible and provide resources and referrals.

Another committee opinion suggests that doctors should have contact with a patient between 2 and 3 weeks post partum, primarily to assess for mental health.
 

Limited data

In discussing maternal suicide statistics, Ms. Griffen focused on data from Maternal Mortality Review Committees (MMRCs).

Two other sources of data about maternal mortality – the National Vital Statistics System and the Pregnancy Mortality Surveillance System – do not include information about suicide, which may be a reason this cause of death is not discussed more often, Ms. Griffen noted.

MMRCs, on the other hand, include information about suicide and self-harm. About half of the states in the United States have these multidisciplinary committees. Committee members review deaths of all women during pregnancy or within 1 year of pregnancy. Members consider a range of clinical and nonclinical data, including reports from social services and police, to try to understand the circumstances of each death.

A report that examined pregnancy-related deaths using data from 14 U.S. MMRCs between 2008 and 2017 showed that mental health conditions were the leading cause of death for non-Hispanic White women. In all, 34% of pregnancy-related suicide deaths had a documented prior suicide attempt, and the majority of suicides happened in the late postpartum time frame (43-365 days post partum).

Some physicians cite a lack of education, time, reimbursement, or referral resources as barriers to maternal mental health screening and treatment, but there may be useful options available, Ms. Griffen said. Postpartum Support International provides resources for physicians, as well as mothers. The National Curriculum in Reproductive Psychiatry and the Seleni Institute also have educational resources.

Some states have psychiatry access programs, where psychiatrists educate obstetricians, family physicians, and pediatricians about how to assess for and treat maternal mental health issues, Ms. Griffen noted.

Self care, social support, and talk therapy may help patients. “Sometimes medication is needed, but a combination of all of these things … can help women recover from maternal mental health conditions,” Ms. Griffen said.
 

Need to intervene

Although medical societies have emphasized the importance of maternal mental health screening and treatment in recent years, the risk of self-harm has been a concern for obstetricians and gynecologists long before then, said Marc Alan Landsberg, MD, a member of the meeting’s scientific committee who moderated the session.

“We have been talking about this at ACOG for a long time,” Dr. Landsberg said in an interview.

The presentation highlighted why obstetricians, gynecologists, and other doctors who deliver babies and care for women post partum “have got to screen these people,” he said. The finding that 34% of pregnancy-related suicide deaths had a prior suicide attempt indicates that clinicians may be able to identify these patients, Dr. Landsberg said. Suicide and overdose are leading causes of death in the first year post partum and “probably 100% of these are preventable,” he said.

As a first step, screening may be relatively simple. The Edinburgh Postnatal Depression Scale, highlighted during the talk, is an easy and quick tool to use, Dr. Landsberg said. It contains 10 items and assesses for anxiety and depression. It also specifically asks about suicide.

Ms. Griffen and Dr. Landsberg had no conflicts of interest.

jremaly@mdedge.com

Death by self-harm through suicide or overdose is a leading cause of death for women in the first year post partum, data indicate. Many of these deaths may be preventable, said Adrienne Griffen, MPP, executive director of the Maternal Mental Health Leadership Alliance.

Ms. Griffen discussed these findings and ways clinicians may be able to help at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

Women “visit a health care provider an average of 25 times during a healthy pregnancy and first year of baby’s life,” she said. “Obstetric and primary care providers who serve pregnant and postpartum women are uniquely positioned to intervene effectively to screen and assess women for mental health disorders.”

To that end, clinicians should discuss mental health “early and often,” Ms. Griffen said.

“Asking about mental health issues and suicide will not cause women to think these thoughts,” she said. “We cannot wait for women to raise their hand and ask for help because by the time they do that, they needed help many weeks ago.”

Obstetric providers can explain to patients that they will check on their mental health every visit, just as they do with their weight and blood pressure, Ms. Griffen said.

For example, a doctor might tell a patient: “Your mental health is just as important as your physical health, and anxiety and depression are the most common complications of pregnancy and childbirth,” Ms. Griffen suggested. “Every time I see you, I’m going to ask you how you are doing, and we’ll do a formal screening assessment periodically over the course of the pregnancy. … Your job is to answer us honestly so that we can connect you with resources as soon as possible to minimize the impact on you and your baby.”

Although the obstetric provider should introduce this topic, a nurse, lactation consultant, or social worker may conduct screenings and help patients who are experiencing distress, she said.

During the past decade, several medical associations have issued new guidance around screening new mothers for anxiety and depression. One recent ACOG committee opinion recommends screening for depression at least once during pregnancy and once post partum, and encourages doctors to initiate medical therapy if possible and provide resources and referrals.

Another committee opinion suggests that doctors should have contact with a patient between 2 and 3 weeks post partum, primarily to assess for mental health.
 

Limited data

In discussing maternal suicide statistics, Ms. Griffen focused on data from Maternal Mortality Review Committees (MMRCs).

Two other sources of data about maternal mortality – the National Vital Statistics System and the Pregnancy Mortality Surveillance System – do not include information about suicide, which may be a reason this cause of death is not discussed more often, Ms. Griffen noted.

MMRCs, on the other hand, include information about suicide and self-harm. About half of the states in the United States have these multidisciplinary committees. Committee members review deaths of all women during pregnancy or within 1 year of pregnancy. Members consider a range of clinical and nonclinical data, including reports from social services and police, to try to understand the circumstances of each death.

A report that examined pregnancy-related deaths using data from 14 U.S. MMRCs between 2008 and 2017 showed that mental health conditions were the leading cause of death for non-Hispanic White women. In all, 34% of pregnancy-related suicide deaths had a documented prior suicide attempt, and the majority of suicides happened in the late postpartum time frame (43-365 days post partum).

Some physicians cite a lack of education, time, reimbursement, or referral resources as barriers to maternal mental health screening and treatment, but there may be useful options available, Ms. Griffen said. Postpartum Support International provides resources for physicians, as well as mothers. The National Curriculum in Reproductive Psychiatry and the Seleni Institute also have educational resources.

Some states have psychiatry access programs, where psychiatrists educate obstetricians, family physicians, and pediatricians about how to assess for and treat maternal mental health issues, Ms. Griffen noted.

Self care, social support, and talk therapy may help patients. “Sometimes medication is needed, but a combination of all of these things … can help women recover from maternal mental health conditions,” Ms. Griffen said.
 

Need to intervene

Although medical societies have emphasized the importance of maternal mental health screening and treatment in recent years, the risk of self-harm has been a concern for obstetricians and gynecologists long before then, said Marc Alan Landsberg, MD, a member of the meeting’s scientific committee who moderated the session.

“We have been talking about this at ACOG for a long time,” Dr. Landsberg said in an interview.

The presentation highlighted why obstetricians, gynecologists, and other doctors who deliver babies and care for women post partum “have got to screen these people,” he said. The finding that 34% of pregnancy-related suicide deaths had a prior suicide attempt indicates that clinicians may be able to identify these patients, Dr. Landsberg said. Suicide and overdose are leading causes of death in the first year post partum and “probably 100% of these are preventable,” he said.

As a first step, screening may be relatively simple. The Edinburgh Postnatal Depression Scale, highlighted during the talk, is an easy and quick tool to use, Dr. Landsberg said. It contains 10 items and assesses for anxiety and depression. It also specifically asks about suicide.

Ms. Griffen and Dr. Landsberg had no conflicts of interest.

jremaly@mdedge.com

Death by self-harm through suicide or overdose is a leading cause of death for women in the first year post partum, data indicate. Many of these deaths may be preventable, said Adrienne Griffen, MPP, executive director of the Maternal Mental Health Leadership Alliance.

Ms. Griffen discussed these findings and ways clinicians may be able to help at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

Women “visit a health care provider an average of 25 times during a healthy pregnancy and first year of baby’s life,” she said. “Obstetric and primary care providers who serve pregnant and postpartum women are uniquely positioned to intervene effectively to screen and assess women for mental health disorders.”

To that end, clinicians should discuss mental health “early and often,” Ms. Griffen said.

“Asking about mental health issues and suicide will not cause women to think these thoughts,” she said. “We cannot wait for women to raise their hand and ask for help because by the time they do that, they needed help many weeks ago.”

Obstetric providers can explain to patients that they will check on their mental health every visit, just as they do with their weight and blood pressure, Ms. Griffen said.

For example, a doctor might tell a patient: “Your mental health is just as important as your physical health, and anxiety and depression are the most common complications of pregnancy and childbirth,” Ms. Griffen suggested. “Every time I see you, I’m going to ask you how you are doing, and we’ll do a formal screening assessment periodically over the course of the pregnancy. … Your job is to answer us honestly so that we can connect you with resources as soon as possible to minimize the impact on you and your baby.”

Although the obstetric provider should introduce this topic, a nurse, lactation consultant, or social worker may conduct screenings and help patients who are experiencing distress, she said.

During the past decade, several medical associations have issued new guidance around screening new mothers for anxiety and depression. One recent ACOG committee opinion recommends screening for depression at least once during pregnancy and once post partum, and encourages doctors to initiate medical therapy if possible and provide resources and referrals.

Another committee opinion suggests that doctors should have contact with a patient between 2 and 3 weeks post partum, primarily to assess for mental health.
 

Limited data

In discussing maternal suicide statistics, Ms. Griffen focused on data from Maternal Mortality Review Committees (MMRCs).

Two other sources of data about maternal mortality – the National Vital Statistics System and the Pregnancy Mortality Surveillance System – do not include information about suicide, which may be a reason this cause of death is not discussed more often, Ms. Griffen noted.

MMRCs, on the other hand, include information about suicide and self-harm. About half of the states in the United States have these multidisciplinary committees. Committee members review deaths of all women during pregnancy or within 1 year of pregnancy. Members consider a range of clinical and nonclinical data, including reports from social services and police, to try to understand the circumstances of each death.

A report that examined pregnancy-related deaths using data from 14 U.S. MMRCs between 2008 and 2017 showed that mental health conditions were the leading cause of death for non-Hispanic White women. In all, 34% of pregnancy-related suicide deaths had a documented prior suicide attempt, and the majority of suicides happened in the late postpartum time frame (43-365 days post partum).

Some physicians cite a lack of education, time, reimbursement, or referral resources as barriers to maternal mental health screening and treatment, but there may be useful options available, Ms. Griffen said. Postpartum Support International provides resources for physicians, as well as mothers. The National Curriculum in Reproductive Psychiatry and the Seleni Institute also have educational resources.

Some states have psychiatry access programs, where psychiatrists educate obstetricians, family physicians, and pediatricians about how to assess for and treat maternal mental health issues, Ms. Griffen noted.

Self care, social support, and talk therapy may help patients. “Sometimes medication is needed, but a combination of all of these things … can help women recover from maternal mental health conditions,” Ms. Griffen said.
 

Need to intervene

Although medical societies have emphasized the importance of maternal mental health screening and treatment in recent years, the risk of self-harm has been a concern for obstetricians and gynecologists long before then, said Marc Alan Landsberg, MD, a member of the meeting’s scientific committee who moderated the session.

“We have been talking about this at ACOG for a long time,” Dr. Landsberg said in an interview.

The presentation highlighted why obstetricians, gynecologists, and other doctors who deliver babies and care for women post partum “have got to screen these people,” he said. The finding that 34% of pregnancy-related suicide deaths had a prior suicide attempt indicates that clinicians may be able to identify these patients, Dr. Landsberg said. Suicide and overdose are leading causes of death in the first year post partum and “probably 100% of these are preventable,” he said.

As a first step, screening may be relatively simple. The Edinburgh Postnatal Depression Scale, highlighted during the talk, is an easy and quick tool to use, Dr. Landsberg said. It contains 10 items and assesses for anxiety and depression. It also specifically asks about suicide.

Ms. Griffen and Dr. Landsberg had no conflicts of interest.

jremaly@mdedge.com

Improving maternal morbidity and mortality begins prior to conception. Numerous modifiable and nonmodifiable factors—lifestyle behaviors, chronic medical conditions, medications, immunizations, prior pregnancy events—have been shown to improve pregnancy outcomes if they are reviewed, identified, and optimized before conception.

Laying a solid foundation for a healthy pregnancy requires a comprehensive approach to patient counseling. However, the national Pregnancy Risk Assessment Monitoring System (PRAMS; a surveillance program of the Centers for Disease Control and Prevention) data from 2014 show that only about 20% of women receive counseling on at least 5 out of 11 healthy lifestyle behaviors and prevention strategies before pregnancy. The ability to leverage technology-enabled smart device applications can provide clinicians with immediate access to information necessary to address with patients at a preconception visit. Apps built specifically for physicians offer a convenient, thorough, and peer-vetted reference that can increase the efficiency and quality of consultation in a busy practice.

Prepregnancy care app considerations

When applying the ACOG-recommended rubric to evaluate the quality of an app targeted to address preconception counseling, the accuracy and objectivity of the content, as well as the app’s ease of use, are vital characteristics to consider, and these criteria should score 4 out of 4 on the rubric.

Several apps offer suggestions on how to address important components of health, including counseling and intervention strategies and evidence-based recommendations. The most efficacious apps offer embedded references to more detailed resources for use when complexities inevitably arise during consultation. Truly comprehensive prepregnancy care requires clinicians to take a step beyond the review of patients’ medications and comorbidities. It is therefore helpful to implement point-of-care apps that prompt evaluation of the often-overlooked aspects of prepregnancy counseling, including risk of interpersonal violence and infectious diseases, occupational exposures, and immunization status.

Physician-focused prepregnancy apps that provide reminders, prompts, and strategies for addressing a comprehensive set of health components prior to conception can be valuable tools to incorporate into both educational environments and busy practices to address maternal morbidity and mortality. ●

Improving maternal morbidity and mortality begins prior to conception. Numerous modifiable and nonmodifiable factors—lifestyle behaviors, chronic medical conditions, medications, immunizations, prior pregnancy events—have been shown to improve pregnancy outcomes if they are reviewed, identified, and optimized before conception.

Laying a solid foundation for a healthy pregnancy requires a comprehensive approach to patient counseling. However, the national Pregnancy Risk Assessment Monitoring System (PRAMS; a surveillance program of the Centers for Disease Control and Prevention) data from 2014 show that only about 20% of women receive counseling on at least 5 out of 11 healthy lifestyle behaviors and prevention strategies before pregnancy. The ability to leverage technology-enabled smart device applications can provide clinicians with immediate access to information necessary to address with patients at a preconception visit. Apps built specifically for physicians offer a convenient, thorough, and peer-vetted reference that can increase the efficiency and quality of consultation in a busy practice.

Prepregnancy care app considerations

When applying the ACOG-recommended rubric to evaluate the quality of an app targeted to address preconception counseling, the accuracy and objectivity of the content, as well as the app’s ease of use, are vital characteristics to consider, and these criteria should score 4 out of 4 on the rubric.

Several apps offer suggestions on how to address important components of health, including counseling and intervention strategies and evidence-based recommendations. The most efficacious apps offer embedded references to more detailed resources for use when complexities inevitably arise during consultation. Truly comprehensive prepregnancy care requires clinicians to take a step beyond the review of patients’ medications and comorbidities. It is therefore helpful to implement point-of-care apps that prompt evaluation of the often-overlooked aspects of prepregnancy counseling, including risk of interpersonal violence and infectious diseases, occupational exposures, and immunization status.

Physician-focused prepregnancy apps that provide reminders, prompts, and strategies for addressing a comprehensive set of health components prior to conception can be valuable tools to incorporate into both educational environments and busy practices to address maternal morbidity and mortality. ●

Improving maternal morbidity and mortality begins prior to conception. Numerous modifiable and nonmodifiable factors—lifestyle behaviors, chronic medical conditions, medications, immunizations, prior pregnancy events—have been shown to improve pregnancy outcomes if they are reviewed, identified, and optimized before conception.

Laying a solid foundation for a healthy pregnancy requires a comprehensive approach to patient counseling. However, the national Pregnancy Risk Assessment Monitoring System (PRAMS; a surveillance program of the Centers for Disease Control and Prevention) data from 2014 show that only about 20% of women receive counseling on at least 5 out of 11 healthy lifestyle behaviors and prevention strategies before pregnancy. The ability to leverage technology-enabled smart device applications can provide clinicians with immediate access to information necessary to address with patients at a preconception visit. Apps built specifically for physicians offer a convenient, thorough, and peer-vetted reference that can increase the efficiency and quality of consultation in a busy practice.

Prepregnancy care app considerations

When applying the ACOG-recommended rubric to evaluate the quality of an app targeted to address preconception counseling, the accuracy and objectivity of the content, as well as the app’s ease of use, are vital characteristics to consider, and these criteria should score 4 out of 4 on the rubric.

Several apps offer suggestions on how to address important components of health, including counseling and intervention strategies and evidence-based recommendations. The most efficacious apps offer embedded references to more detailed resources for use when complexities inevitably arise during consultation. Truly comprehensive prepregnancy care requires clinicians to take a step beyond the review of patients’ medications and comorbidities. It is therefore helpful to implement point-of-care apps that prompt evaluation of the often-overlooked aspects of prepregnancy counseling, including risk of interpersonal violence and infectious diseases, occupational exposures, and immunization status.

Physician-focused prepregnancy apps that provide reminders, prompts, and strategies for addressing a comprehensive set of health components prior to conception can be valuable tools to incorporate into both educational environments and busy practices to address maternal morbidity and mortality. ●

Personalizing care is at the heart of the American College of Obstetricians and Gynecologists (ACOG) 2020–2021 President Dr. Eva Chalas’ initiative to “Revisit the Visit.” As obstetrician-gynecologists, we care for patients across the entirety of their life. This role gives us the opportunity to form long-term partnerships with women to address important preventive health care measures.

Dr. Chalas established a Presidential Task Force that identified 5 areas of preventive health that significantly influence the long-term morbidity of women: obesity, cardiovascular disease, preconception counseling, diabetes, and cancer risk. The annual visit can serve as a particularly impactful point of care to achieve specific preventive care objectives and offer mitigation strategies based on patient-specific risk factors. We are uniquely positioned to identify and initiate the conversation and subsequently manage, treat, and address these critical health areas.

Harnessing modern technology

To adopt these health topics into practice, we need improved, more effective tools both to increase productivity during the office visit and to provide more personalized care. Notably, the widespread adoption of and proliferation of mobile devices—and the medical apps accessible on them—is creating new and innovative ways to improve health and health care delivery. More than 90% of physicians use a smartphone at work, and 62% of smartphone users have used their device to gather health data.¹

In addition, according to a US Food and Drug Administration (FDA) report, in 2017, 325,000 health care applications were available on smartphones; this equates to an expected 3.7 billion mobile health application downloads that year by 1.7 billion smartphone users worldwide.² As of October 2020, 48,000-plus health apps were available on the iOS mobile operating system alone.³

For patients and clinicians, picking the most suitable apps can be challenging in the face of evolving clinical evidence, emerging privacy risks, functionality concerns, and the fact that apps constantly update and change. Many have relied on star rating systems and user reviews in app stores to guide their selection process despite mounting evidence that suggests that such evaluation methods are misleading, not always addressing such important parameters as usability, validity, security, and privacy.^4,5

Approaches for evaluating medical apps

Many app evaluation frameworks have emerged, but none is universally accepted within the health care field.

The American Psychiatric Association’s (APA) App Evaluation Model represents a comprehensive resource to consider when evaluating medical apps. It stratifies numerous variables into 5 levels that form a pyramid. In this model, background information forms the base of this pyramid and includes factors such as business model, credibility, cost, and advertising of the app. The top of the pyramid is comprised of data integration that considers data ownership and therapeutic alliance.⁶ Although this model is beneficial in that it provides a framework, it is not practical for point-of-care purposes as it offers no objective way to rate or score an app for quick and easy comparison.

The privately owned and operated Health On the Net (HON) Foundation is well known for its HONcode, an ethical standard for quality medical information on the internet. It uses 8 principles to certify a health website. However, the HON website itself states that it cannot guarantee the accuracy or completeness of medical information presented by a site.⁷ Although HON certification by a website is a sign of good intention, it is not beneficial to the practicing clinician who is looking to use an app to directly assist in clinical care.

The Agency for Healthcare Research and Quality (AHRQ) is another well-respected body that has delineated essential details to consider when using a health website. The AHRQ identifies features (similar to those of the APA pyramid and HONcode) for users to consider, such as credibility, content, design, and disclosures.⁸ However, this model too lacks a concise user-friendly evaluating system.

Although the FDA plans to apply some regulatory authority to the evaluation of a certain subset of high-risk mobile medical apps, it is not planning to evaluate or regulate many of the medical apps that clinicians use in daily practice. This leaves us, and our patients, to be guided by the principle of caveat emptor, or “let the buyer beware.”

Thus, Dr. Chalas’ Presidential Task Force carefully considered various resources to provide a useful tool that would help obstetrician-gynecologists objectively vet a medical app in practice.

Continue to: The Task Force’s recommended rubric...

The Task Force’s recommended rubric

The rubric shown for evaluating mobile drug information apps was developed by the American Society of Health-System Pharmacists (ASHP). The ASHP rubric takes into account the criteria recognized by the APA pyramid, the HON Foundation, and the AHRQ and incorporates them into a user-friendly tool and scoring system that can be applied as an evaluation checklist.⁹ This tool is meant to aid clinicians in evaluating medical apps, but it ultimately is the user’s decision to determine if an app’s deficiencies should deter its use.

While all of the criteria are relevant and important, it is incumbent on us as medical experts to pay careful attention to the accuracy, authority, objectivity, timeliness, and security of any app we consider incorporating into clinical practice. A low score on these criteria would belie any perceived usefulness or value the app may have.

When applying the rubric to evaluate the quality of an app, we should be mindful of the primary user and which characteristics are more important than others to effect positive changes in health. For example, in addressing obesity, it is the patient who will be interacting with the app. Therefore, it’s important that the app should score, on a 1- to 4-point scale (1 point being major deficiencies, 4 points being no deficiencies), a 4 out of 4 on features like usefulness, functionality, and design. Coveted design features that enhance the user’s experience will appeal to patients and keep them engaged and motivated. However, when addressing a woman’s health with respect to cancer risk, the principal features on which the app should score 4 out of 4 would be authority, objectivity, timeliness, and accuracy.

In the upcoming articles in this series, a member of the Presidential Task Force will reference the ASHP rubric to guide clinicians in choosing apps to address one of the critical health areas with their patients. The author of the piece will highlight key features of an app to consider what would add the most value in incorporating its use in clinical practice.

It would be impossible to evaluate all health care apps even if we focused only on the medical apps relevant to obstetrics and gynecology. There is much value in having a framework for efficiently measuring an app’s benefit in clinical practice. The objective of this article series is to help clinicians Revisit the Visit by providing an effective tool to evaluate a medical app. ●

Personalizing care is at the heart of the American College of Obstetricians and Gynecologists (ACOG) 2020–2021 President Dr. Eva Chalas’ initiative to “Revisit the Visit.” As obstetrician-gynecologists, we care for patients across the entirety of their life. This role gives us the opportunity to form long-term partnerships with women to address important preventive health care measures.

Dr. Chalas established a Presidential Task Force that identified 5 areas of preventive health that significantly influence the long-term morbidity of women: obesity, cardiovascular disease, preconception counseling, diabetes, and cancer risk. The annual visit can serve as a particularly impactful point of care to achieve specific preventive care objectives and offer mitigation strategies based on patient-specific risk factors. We are uniquely positioned to identify and initiate the conversation and subsequently manage, treat, and address these critical health areas.

Harnessing modern technology

To adopt these health topics into practice, we need improved, more effective tools both to increase productivity during the office visit and to provide more personalized care. Notably, the widespread adoption of and proliferation of mobile devices—and the medical apps accessible on them—is creating new and innovative ways to improve health and health care delivery. More than 90% of physicians use a smartphone at work, and 62% of smartphone users have used their device to gather health data.¹

In addition, according to a US Food and Drug Administration (FDA) report, in 2017, 325,000 health care applications were available on smartphones; this equates to an expected 3.7 billion mobile health application downloads that year by 1.7 billion smartphone users worldwide.² As of October 2020, 48,000-plus health apps were available on the iOS mobile operating system alone.³

For patients and clinicians, picking the most suitable apps can be challenging in the face of evolving clinical evidence, emerging privacy risks, functionality concerns, and the fact that apps constantly update and change. Many have relied on star rating systems and user reviews in app stores to guide their selection process despite mounting evidence that suggests that such evaluation methods are misleading, not always addressing such important parameters as usability, validity, security, and privacy.^4,5

Approaches for evaluating medical apps

Many app evaluation frameworks have emerged, but none is universally accepted within the health care field.

The American Psychiatric Association’s (APA) App Evaluation Model represents a comprehensive resource to consider when evaluating medical apps. It stratifies numerous variables into 5 levels that form a pyramid. In this model, background information forms the base of this pyramid and includes factors such as business model, credibility, cost, and advertising of the app. The top of the pyramid is comprised of data integration that considers data ownership and therapeutic alliance.⁶ Although this model is beneficial in that it provides a framework, it is not practical for point-of-care purposes as it offers no objective way to rate or score an app for quick and easy comparison.

The privately owned and operated Health On the Net (HON) Foundation is well known for its HONcode, an ethical standard for quality medical information on the internet. It uses 8 principles to certify a health website. However, the HON website itself states that it cannot guarantee the accuracy or completeness of medical information presented by a site.⁷ Although HON certification by a website is a sign of good intention, it is not beneficial to the practicing clinician who is looking to use an app to directly assist in clinical care.

The Agency for Healthcare Research and Quality (AHRQ) is another well-respected body that has delineated essential details to consider when using a health website. The AHRQ identifies features (similar to those of the APA pyramid and HONcode) for users to consider, such as credibility, content, design, and disclosures.⁸ However, this model too lacks a concise user-friendly evaluating system.

Although the FDA plans to apply some regulatory authority to the evaluation of a certain subset of high-risk mobile medical apps, it is not planning to evaluate or regulate many of the medical apps that clinicians use in daily practice. This leaves us, and our patients, to be guided by the principle of caveat emptor, or “let the buyer beware.”

Thus, Dr. Chalas’ Presidential Task Force carefully considered various resources to provide a useful tool that would help obstetrician-gynecologists objectively vet a medical app in practice.

Continue to: The Task Force’s recommended rubric...

The Task Force’s recommended rubric

The rubric shown for evaluating mobile drug information apps was developed by the American Society of Health-System Pharmacists (ASHP). The ASHP rubric takes into account the criteria recognized by the APA pyramid, the HON Foundation, and the AHRQ and incorporates them into a user-friendly tool and scoring system that can be applied as an evaluation checklist.⁹ This tool is meant to aid clinicians in evaluating medical apps, but it ultimately is the user’s decision to determine if an app’s deficiencies should deter its use.

While all of the criteria are relevant and important, it is incumbent on us as medical experts to pay careful attention to the accuracy, authority, objectivity, timeliness, and security of any app we consider incorporating into clinical practice. A low score on these criteria would belie any perceived usefulness or value the app may have.

When applying the rubric to evaluate the quality of an app, we should be mindful of the primary user and which characteristics are more important than others to effect positive changes in health. For example, in addressing obesity, it is the patient who will be interacting with the app. Therefore, it’s important that the app should score, on a 1- to 4-point scale (1 point being major deficiencies, 4 points being no deficiencies), a 4 out of 4 on features like usefulness, functionality, and design. Coveted design features that enhance the user’s experience will appeal to patients and keep them engaged and motivated. However, when addressing a woman’s health with respect to cancer risk, the principal features on which the app should score 4 out of 4 would be authority, objectivity, timeliness, and accuracy.

In the upcoming articles in this series, a member of the Presidential Task Force will reference the ASHP rubric to guide clinicians in choosing apps to address one of the critical health areas with their patients. The author of the piece will highlight key features of an app to consider what would add the most value in incorporating its use in clinical practice.

It would be impossible to evaluate all health care apps even if we focused only on the medical apps relevant to obstetrics and gynecology. There is much value in having a framework for efficiently measuring an app’s benefit in clinical practice. The objective of this article series is to help clinicians Revisit the Visit by providing an effective tool to evaluate a medical app. ●

Personalizing care is at the heart of the American College of Obstetricians and Gynecologists (ACOG) 2020–2021 President Dr. Eva Chalas’ initiative to “Revisit the Visit.” As obstetrician-gynecologists, we care for patients across the entirety of their life. This role gives us the opportunity to form long-term partnerships with women to address important preventive health care measures.

Dr. Chalas established a Presidential Task Force that identified 5 areas of preventive health that significantly influence the long-term morbidity of women: obesity, cardiovascular disease, preconception counseling, diabetes, and cancer risk. The annual visit can serve as a particularly impactful point of care to achieve specific preventive care objectives and offer mitigation strategies based on patient-specific risk factors. We are uniquely positioned to identify and initiate the conversation and subsequently manage, treat, and address these critical health areas.

Harnessing modern technology

To adopt these health topics into practice, we need improved, more effective tools both to increase productivity during the office visit and to provide more personalized care. Notably, the widespread adoption of and proliferation of mobile devices—and the medical apps accessible on them—is creating new and innovative ways to improve health and health care delivery. More than 90% of physicians use a smartphone at work, and 62% of smartphone users have used their device to gather health data.¹

In addition, according to a US Food and Drug Administration (FDA) report, in 2017, 325,000 health care applications were available on smartphones; this equates to an expected 3.7 billion mobile health application downloads that year by 1.7 billion smartphone users worldwide.² As of October 2020, 48,000-plus health apps were available on the iOS mobile operating system alone.³

For patients and clinicians, picking the most suitable apps can be challenging in the face of evolving clinical evidence, emerging privacy risks, functionality concerns, and the fact that apps constantly update and change. Many have relied on star rating systems and user reviews in app stores to guide their selection process despite mounting evidence that suggests that such evaluation methods are misleading, not always addressing such important parameters as usability, validity, security, and privacy.^4,5

Approaches for evaluating medical apps

Many app evaluation frameworks have emerged, but none is universally accepted within the health care field.

The American Psychiatric Association’s (APA) App Evaluation Model represents a comprehensive resource to consider when evaluating medical apps. It stratifies numerous variables into 5 levels that form a pyramid. In this model, background information forms the base of this pyramid and includes factors such as business model, credibility, cost, and advertising of the app. The top of the pyramid is comprised of data integration that considers data ownership and therapeutic alliance.⁶ Although this model is beneficial in that it provides a framework, it is not practical for point-of-care purposes as it offers no objective way to rate or score an app for quick and easy comparison.

The privately owned and operated Health On the Net (HON) Foundation is well known for its HONcode, an ethical standard for quality medical information on the internet. It uses 8 principles to certify a health website. However, the HON website itself states that it cannot guarantee the accuracy or completeness of medical information presented by a site.⁷ Although HON certification by a website is a sign of good intention, it is not beneficial to the practicing clinician who is looking to use an app to directly assist in clinical care.

The Agency for Healthcare Research and Quality (AHRQ) is another well-respected body that has delineated essential details to consider when using a health website. The AHRQ identifies features (similar to those of the APA pyramid and HONcode) for users to consider, such as credibility, content, design, and disclosures.⁸ However, this model too lacks a concise user-friendly evaluating system.

Although the FDA plans to apply some regulatory authority to the evaluation of a certain subset of high-risk mobile medical apps, it is not planning to evaluate or regulate many of the medical apps that clinicians use in daily practice. This leaves us, and our patients, to be guided by the principle of caveat emptor, or “let the buyer beware.”

Thus, Dr. Chalas’ Presidential Task Force carefully considered various resources to provide a useful tool that would help obstetrician-gynecologists objectively vet a medical app in practice.

Continue to: The Task Force’s recommended rubric...

The Task Force’s recommended rubric

The rubric shown for evaluating mobile drug information apps was developed by the American Society of Health-System Pharmacists (ASHP). The ASHP rubric takes into account the criteria recognized by the APA pyramid, the HON Foundation, and the AHRQ and incorporates them into a user-friendly tool and scoring system that can be applied as an evaluation checklist.⁹ This tool is meant to aid clinicians in evaluating medical apps, but it ultimately is the user’s decision to determine if an app’s deficiencies should deter its use.

While all of the criteria are relevant and important, it is incumbent on us as medical experts to pay careful attention to the accuracy, authority, objectivity, timeliness, and security of any app we consider incorporating into clinical practice. A low score on these criteria would belie any perceived usefulness or value the app may have.

When applying the rubric to evaluate the quality of an app, we should be mindful of the primary user and which characteristics are more important than others to effect positive changes in health. For example, in addressing obesity, it is the patient who will be interacting with the app. Therefore, it’s important that the app should score, on a 1- to 4-point scale (1 point being major deficiencies, 4 points being no deficiencies), a 4 out of 4 on features like usefulness, functionality, and design. Coveted design features that enhance the user’s experience will appeal to patients and keep them engaged and motivated. However, when addressing a woman’s health with respect to cancer risk, the principal features on which the app should score 4 out of 4 would be authority, objectivity, timeliness, and accuracy.

In the upcoming articles in this series, a member of the Presidential Task Force will reference the ASHP rubric to guide clinicians in choosing apps to address one of the critical health areas with their patients. The author of the piece will highlight key features of an app to consider what would add the most value in incorporating its use in clinical practice.

It would be impossible to evaluate all health care apps even if we focused only on the medical apps relevant to obstetrics and gynecology. There is much value in having a framework for efficiently measuring an app’s benefit in clinical practice. The objective of this article series is to help clinicians Revisit the Visit by providing an effective tool to evaluate a medical app. ●

To help ObGyns evaluate mobile apps for use in clinical practice, the American College of Obstetricians and Gynecologists Presidential Task Force of Dr. Eva Chalas recommends a quantitative rubric that was developed by the American Society of Health-System Pharmacists (ASHP) for evaluating drug information apps (TABLE).¹ Criteria are graded on a point scale of 1 to 4, with 1 point indicating major deficiencies and 4 points indicating no deficiencies.

The ASHP used the following criteria in evaluating mobile apps:

• Usefulness: the app’s overall usefulness in a particular practice setting
• Accuracy: overall accuracy of the app should be thoroughly examined
• Authority: it is critical to assess authority or authorship to determine that the developers are reputable, qualified, and authoritative enough to create the medical content in question
• Objectivity: to determine if content is fair, balanced, and unbiased
• Timeliness: given that medical information is continually changing, an app must be evaluated based on the timeliness of its content
• Functionality: how the app downloads, deploys, and operates across devices and software platforms (that is, iOS, Android)
• Design: well-designed apps are generally more user friendly and, therefore, useful. They should require minimal or no training and have easily discernible buttons, a clean and uncluttered format, consistent graphics layout, terminology appropriate for the intended audience, streamlined navigation without extraneous steps/gestures, appropriate-sized text, and sufficient white space to improve readability.
• Security: Many apps collect a wide array of personal and device data. Collected data has the potential for being sold to third parties for marketing and advertising purposes. Apps should disclose their privacy policy and provide an explanation as to why personal data are being collected. If personal identifiable information (PII) is collected, then the app should be encrypted. If protected health information (PHI) is collected, the app must follow compliance with HIPAA/HITECH (Health Insurance Portability and Accountability Act/Health Information Technology for Economic and Clinical Health Act). Additionally, apps should not compromise the security or functionality of the mobile device being used.
• Value: appropriateness of an app's cost. ●

To help ObGyns evaluate mobile apps for use in clinical practice, the American College of Obstetricians and Gynecologists Presidential Task Force of Dr. Eva Chalas recommends a quantitative rubric that was developed by the American Society of Health-System Pharmacists (ASHP) for evaluating drug information apps (TABLE).¹ Criteria are graded on a point scale of 1 to 4, with 1 point indicating major deficiencies and 4 points indicating no deficiencies.

The ASHP used the following criteria in evaluating mobile apps:

• Usefulness: the app’s overall usefulness in a particular practice setting
• Accuracy: overall accuracy of the app should be thoroughly examined
• Authority: it is critical to assess authority or authorship to determine that the developers are reputable, qualified, and authoritative enough to create the medical content in question
• Objectivity: to determine if content is fair, balanced, and unbiased
• Timeliness: given that medical information is continually changing, an app must be evaluated based on the timeliness of its content
• Functionality: how the app downloads, deploys, and operates across devices and software platforms (that is, iOS, Android)
• Design: well-designed apps are generally more user friendly and, therefore, useful. They should require minimal or no training and have easily discernible buttons, a clean and uncluttered format, consistent graphics layout, terminology appropriate for the intended audience, streamlined navigation without extraneous steps/gestures, appropriate-sized text, and sufficient white space to improve readability.
• Security: Many apps collect a wide array of personal and device data. Collected data has the potential for being sold to third parties for marketing and advertising purposes. Apps should disclose their privacy policy and provide an explanation as to why personal data are being collected. If personal identifiable information (PII) is collected, then the app should be encrypted. If protected health information (PHI) is collected, the app must follow compliance with HIPAA/HITECH (Health Insurance Portability and Accountability Act/Health Information Technology for Economic and Clinical Health Act). Additionally, apps should not compromise the security or functionality of the mobile device being used.
• Value: appropriateness of an app's cost. ●

To help ObGyns evaluate mobile apps for use in clinical practice, the American College of Obstetricians and Gynecologists Presidential Task Force of Dr. Eva Chalas recommends a quantitative rubric that was developed by the American Society of Health-System Pharmacists (ASHP) for evaluating drug information apps (TABLE).¹ Criteria are graded on a point scale of 1 to 4, with 1 point indicating major deficiencies and 4 points indicating no deficiencies.

The ASHP used the following criteria in evaluating mobile apps:

• Usefulness: the app’s overall usefulness in a particular practice setting
• Accuracy: overall accuracy of the app should be thoroughly examined
• Authority: it is critical to assess authority or authorship to determine that the developers are reputable, qualified, and authoritative enough to create the medical content in question
• Objectivity: to determine if content is fair, balanced, and unbiased
• Timeliness: given that medical information is continually changing, an app must be evaluated based on the timeliness of its content
• Functionality: how the app downloads, deploys, and operates across devices and software platforms (that is, iOS, Android)
• Design: well-designed apps are generally more user friendly and, therefore, useful. They should require minimal or no training and have easily discernible buttons, a clean and uncluttered format, consistent graphics layout, terminology appropriate for the intended audience, streamlined navigation without extraneous steps/gestures, appropriate-sized text, and sufficient white space to improve readability.
• Security: Many apps collect a wide array of personal and device data. Collected data has the potential for being sold to third parties for marketing and advertising purposes. Apps should disclose their privacy policy and provide an explanation as to why personal data are being collected. If personal identifiable information (PII) is collected, then the app should be encrypted. If protected health information (PHI) is collected, the app must follow compliance with HIPAA/HITECH (Health Insurance Portability and Accountability Act/Health Information Technology for Economic and Clinical Health Act). Additionally, apps should not compromise the security or functionality of the mobile device being used.
• Value: appropriateness of an app's cost. ●

About 2% of asymptomatic college students carried 90% of COVID-19 viral load levels on a Colorado campus last year, new research reveals. Furthermore, the viral loads in these students were as elevated as those seen in hospitalized patients.

“College campuses were one of the few places where people without any symptoms or suspicions of exposure were being screened for the virus. This allowed us to make some powerful comparisons between symptomatic vs healthy carriers of the virus,” senior study author Sara Sawyer, PhD, professor of virology at the University of Colorado, Boulder, said in an interview.

“It turns out, walking around a college campus can be as dangerous as walking through a COVID ward in the hospital, in that you will experience these viral ‘super carriers’ equally in both settings,” she said.

“This is an important study in advancing our understanding of how SARS-CoV-2 is distributed in the population,” Thomas Giordano, MD, MPH, professor and section chief of infectious diseases at Baylor College of Medicine, Houston, said in an interview.

The study “adds to the evidence that viral load is not too tightly correlated with symptoms.” In fact, Dr. Giordano added, “this study suggests viral load is not at all correlated with symptoms.”

Viral load may not be correlated with transmissibility either, said Raphael Viscidi, MD, when asked to comment. “This is not a transmissibility study. They did not show that viral load is the factor related to transmission.”

“It’s true that 2% of the population they studied carried 90% of the virus, but it does not establish any biological importance to that 2%,” added Dr. Viscidi, professor of pediatrics and oncology at Johns Hopkins University, Baltimore,.

The 2% could just be the upper tail end of a normal bell-shaped distribution curve, Dr. Viscidi said, or there could be something biologically unique about that group. But the study does not make that distinction, he said.

The study was published online May 10, 2021, in PNAS, the official journal of the National Academy of Sciences.
 

A similar picture in hospitalized patients

Out of more than 72,500 saliva samples taken during COVID-19 screening at the University of Colorado Boulder between Aug. 27 and Dec. 11, 2020, 1,405 were positive for SARS-CoV-2.

The investigators also compared viral loads from students with those of hospitalized patients based on published data. They found the distribution of viral loads between these groups “indistinguishable.”

“Strikingly, these datasets demonstrate dramatic differences in viral levels between individuals, with a very small minority of the infected individuals harboring the vast majority of the infectious virions,” the researchers wrote. The comparison “really represents two extremes: One group is mostly hospitalized, while the other group represents a mostly young and healthy (but infected) college population.”

“It would be interesting to adjust public health recommendations based on a person’s viral load,” Dr. Giordano said. “One could speculate that a person with a very high viral load could be isolated longer or more thoroughly, while someone with a very low viral load could be minimally isolated.

“This is speculation, and more data are needed to test this concept,” he added. Also, quantitative viral load testing would need to be standardized before it could be used to guide such decision-making
 

Preceding the COVID-19 vaccine era

It should be noted that the research was conducted in fall 2020, before access to COVID-19 immunization.

“The study was performed prior to vaccine availability in a cohort of young people. It adds further data to support prior observations that the majority of infections are spread by a much smaller group of individuals,” David Hirschwerk, MD, said in an interview.

“Now that vaccines are available, I think it is very likely that a repeat study of this type would show diminished transmission from vaccinated people who were infected yet asymptomatic,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in New Hyde Park, N.Y., who was not affiliated with the research.
 

Mechanism still a mystery

“This finding has been in the literature in piecemeal fashion since the beginning of the pandemic,” Dr. Sawyer said. “I just think we were the first to realize the bigger implications of these plots of viral load that we have all been seeing over and over again.”

How a minority of people walk around asymptomatic with a majority of virus remains unanswered. Are there special people who can harbor these extremely high viral loads? Or do many infected individuals experience a short period of time when they carry such elevated levels?

The highest observed viral load in the current study was more than 6 trillion virions per mL. “It is remarkable to consider that this individual was on campus and reported no symptoms at our testing site,” the researchers wrote.

In contrast, the lowest viral load detected was 8 virions per mL.

Although more research is needed, the investigators noted that “a strong implication is that these individuals who are viral ‘super carriers’ may also be ‘superspreaders.’ ”

Some of the study authors have financial ties to companies that offer commercial SARS-CoV-2 testing, including Darwin Biosciences, TUMI Genomics, Faze Medicines, and Arpeggio Biosciences.

A version of this article first appeared on Medscape.com.

About 2% of asymptomatic college students carried 90% of COVID-19 viral load levels on a Colorado campus last year, new research reveals. Furthermore, the viral loads in these students were as elevated as those seen in hospitalized patients.

“College campuses were one of the few places where people without any symptoms or suspicions of exposure were being screened for the virus. This allowed us to make some powerful comparisons between symptomatic vs healthy carriers of the virus,” senior study author Sara Sawyer, PhD, professor of virology at the University of Colorado, Boulder, said in an interview.

“It turns out, walking around a college campus can be as dangerous as walking through a COVID ward in the hospital, in that you will experience these viral ‘super carriers’ equally in both settings,” she said.

“This is an important study in advancing our understanding of how SARS-CoV-2 is distributed in the population,” Thomas Giordano, MD, MPH, professor and section chief of infectious diseases at Baylor College of Medicine, Houston, said in an interview.

The study “adds to the evidence that viral load is not too tightly correlated with symptoms.” In fact, Dr. Giordano added, “this study suggests viral load is not at all correlated with symptoms.”

Viral load may not be correlated with transmissibility either, said Raphael Viscidi, MD, when asked to comment. “This is not a transmissibility study. They did not show that viral load is the factor related to transmission.”

“It’s true that 2% of the population they studied carried 90% of the virus, but it does not establish any biological importance to that 2%,” added Dr. Viscidi, professor of pediatrics and oncology at Johns Hopkins University, Baltimore,.

The 2% could just be the upper tail end of a normal bell-shaped distribution curve, Dr. Viscidi said, or there could be something biologically unique about that group. But the study does not make that distinction, he said.

The study was published online May 10, 2021, in PNAS, the official journal of the National Academy of Sciences.
 

A similar picture in hospitalized patients

Out of more than 72,500 saliva samples taken during COVID-19 screening at the University of Colorado Boulder between Aug. 27 and Dec. 11, 2020, 1,405 were positive for SARS-CoV-2.

The investigators also compared viral loads from students with those of hospitalized patients based on published data. They found the distribution of viral loads between these groups “indistinguishable.”

“Strikingly, these datasets demonstrate dramatic differences in viral levels between individuals, with a very small minority of the infected individuals harboring the vast majority of the infectious virions,” the researchers wrote. The comparison “really represents two extremes: One group is mostly hospitalized, while the other group represents a mostly young and healthy (but infected) college population.”

“It would be interesting to adjust public health recommendations based on a person’s viral load,” Dr. Giordano said. “One could speculate that a person with a very high viral load could be isolated longer or more thoroughly, while someone with a very low viral load could be minimally isolated.

“This is speculation, and more data are needed to test this concept,” he added. Also, quantitative viral load testing would need to be standardized before it could be used to guide such decision-making
 

Preceding the COVID-19 vaccine era

It should be noted that the research was conducted in fall 2020, before access to COVID-19 immunization.

“The study was performed prior to vaccine availability in a cohort of young people. It adds further data to support prior observations that the majority of infections are spread by a much smaller group of individuals,” David Hirschwerk, MD, said in an interview.

“Now that vaccines are available, I think it is very likely that a repeat study of this type would show diminished transmission from vaccinated people who were infected yet asymptomatic,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in New Hyde Park, N.Y., who was not affiliated with the research.
 

Mechanism still a mystery

“This finding has been in the literature in piecemeal fashion since the beginning of the pandemic,” Dr. Sawyer said. “I just think we were the first to realize the bigger implications of these plots of viral load that we have all been seeing over and over again.”

How a minority of people walk around asymptomatic with a majority of virus remains unanswered. Are there special people who can harbor these extremely high viral loads? Or do many infected individuals experience a short period of time when they carry such elevated levels?

The highest observed viral load in the current study was more than 6 trillion virions per mL. “It is remarkable to consider that this individual was on campus and reported no symptoms at our testing site,” the researchers wrote.

In contrast, the lowest viral load detected was 8 virions per mL.

Although more research is needed, the investigators noted that “a strong implication is that these individuals who are viral ‘super carriers’ may also be ‘superspreaders.’ ”

Some of the study authors have financial ties to companies that offer commercial SARS-CoV-2 testing, including Darwin Biosciences, TUMI Genomics, Faze Medicines, and Arpeggio Biosciences.

A version of this article first appeared on Medscape.com.

About 2% of asymptomatic college students carried 90% of COVID-19 viral load levels on a Colorado campus last year, new research reveals. Furthermore, the viral loads in these students were as elevated as those seen in hospitalized patients.

“College campuses were one of the few places where people without any symptoms or suspicions of exposure were being screened for the virus. This allowed us to make some powerful comparisons between symptomatic vs healthy carriers of the virus,” senior study author Sara Sawyer, PhD, professor of virology at the University of Colorado, Boulder, said in an interview.

“It turns out, walking around a college campus can be as dangerous as walking through a COVID ward in the hospital, in that you will experience these viral ‘super carriers’ equally in both settings,” she said.

“This is an important study in advancing our understanding of how SARS-CoV-2 is distributed in the population,” Thomas Giordano, MD, MPH, professor and section chief of infectious diseases at Baylor College of Medicine, Houston, said in an interview.

The study “adds to the evidence that viral load is not too tightly correlated with symptoms.” In fact, Dr. Giordano added, “this study suggests viral load is not at all correlated with symptoms.”

Viral load may not be correlated with transmissibility either, said Raphael Viscidi, MD, when asked to comment. “This is not a transmissibility study. They did not show that viral load is the factor related to transmission.”

“It’s true that 2% of the population they studied carried 90% of the virus, but it does not establish any biological importance to that 2%,” added Dr. Viscidi, professor of pediatrics and oncology at Johns Hopkins University, Baltimore,.

The 2% could just be the upper tail end of a normal bell-shaped distribution curve, Dr. Viscidi said, or there could be something biologically unique about that group. But the study does not make that distinction, he said.

The study was published online May 10, 2021, in PNAS, the official journal of the National Academy of Sciences.
 

A similar picture in hospitalized patients

Out of more than 72,500 saliva samples taken during COVID-19 screening at the University of Colorado Boulder between Aug. 27 and Dec. 11, 2020, 1,405 were positive for SARS-CoV-2.

The investigators also compared viral loads from students with those of hospitalized patients based on published data. They found the distribution of viral loads between these groups “indistinguishable.”

“Strikingly, these datasets demonstrate dramatic differences in viral levels between individuals, with a very small minority of the infected individuals harboring the vast majority of the infectious virions,” the researchers wrote. The comparison “really represents two extremes: One group is mostly hospitalized, while the other group represents a mostly young and healthy (but infected) college population.”

“It would be interesting to adjust public health recommendations based on a person’s viral load,” Dr. Giordano said. “One could speculate that a person with a very high viral load could be isolated longer or more thoroughly, while someone with a very low viral load could be minimally isolated.

“This is speculation, and more data are needed to test this concept,” he added. Also, quantitative viral load testing would need to be standardized before it could be used to guide such decision-making
 

Preceding the COVID-19 vaccine era

It should be noted that the research was conducted in fall 2020, before access to COVID-19 immunization.

“The study was performed prior to vaccine availability in a cohort of young people. It adds further data to support prior observations that the majority of infections are spread by a much smaller group of individuals,” David Hirschwerk, MD, said in an interview.

“Now that vaccines are available, I think it is very likely that a repeat study of this type would show diminished transmission from vaccinated people who were infected yet asymptomatic,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in New Hyde Park, N.Y., who was not affiliated with the research.
 

Mechanism still a mystery

“This finding has been in the literature in piecemeal fashion since the beginning of the pandemic,” Dr. Sawyer said. “I just think we were the first to realize the bigger implications of these plots of viral load that we have all been seeing over and over again.”

How a minority of people walk around asymptomatic with a majority of virus remains unanswered. Are there special people who can harbor these extremely high viral loads? Or do many infected individuals experience a short period of time when they carry such elevated levels?

The highest observed viral load in the current study was more than 6 trillion virions per mL. “It is remarkable to consider that this individual was on campus and reported no symptoms at our testing site,” the researchers wrote.

In contrast, the lowest viral load detected was 8 virions per mL.

Although more research is needed, the investigators noted that “a strong implication is that these individuals who are viral ‘super carriers’ may also be ‘superspreaders.’ ”

Some of the study authors have financial ties to companies that offer commercial SARS-CoV-2 testing, including Darwin Biosciences, TUMI Genomics, Faze Medicines, and Arpeggio Biosciences.

A version of this article first appeared on Medscape.com.

In 2013, a California hospital paid $275,000 to settle claims that it violated the HIPAA privacy rule when it disclosed a patient’s health information in response to a negative online review. More recently, a Texas dental practice paid a substantial fine to the Department of Health & Human Services, which enforces HIPAA, after it responded to unfavorable Yelp reviews with patient names and details of their health conditions, treatment plans, and cost information. In addition to the fine, the practice agreed to 2 years of monitoring by HHS for compliance with HIPAA rules.

Most physicians have had the unpleasant experience of finding a negative online review from a disgruntled patient or family member. Some are justified, many are not; either way, your first impulse will often be to post a response – but that is almost always a bad idea. “Social media is not the place for providers to discuss a patient’s care,” an HHS official said in a statement issued about the dental practice case in 2016. “Doctors and dentists must think carefully about patient privacy before responding to online reviews.”

Any information that could be used to identify a patient is a HIPAA breach. This is true even if the patient has already disclosed information, because doing so does not nullify their HIPAA rights, and HIPAA provides no exceptions for responses. Even acknowledging that the reviewer was in fact your patient could, in some cases, be considered a violation.

Responding to good reviews can get you in trouble too, for the same reasons. In 2016, a physical therapy practice paid a $25,000 fine after it posted patient testimonials, “including full names and full-face photographic images to its website without obtaining valid, HIPAA-compliant authorizations.”

And by the way, most malpractice policies specifically exclude disciplinary fines and settlements from coverage.

All of that said, there are legal and ethical ways to deal with negative reviews. Here are some options:
 

• Ignore them. This is your best choice most of the time. Most negative reviews have minimal impact and simply do not deserve a response; responding may pour fuel on the fire. Besides, an occasional negative review actually lends credibility to a reviewing site and to the positive reviews posted on that site. Polls show that readers are suspicious of sites that contain only rave reviews. They assume such reviews have been “whitewashed” – or just fabricated.
• Solicit more reviews to that site. The more you can obtain, the less impact any complaints will have, since you know the overwhelming majority of your patients are happy with your care and will post a positive review if asked. Solicit them on your website, on social media, or in your email reminders. To be clear, you must encourage reviews from all patients, whether they have had a positive experience or not. If you invite only the satisfied ones, you are “filtering,” which can be perceived as false or deceptive advertising. (Google calls it “review-gating,” and according to their guidelines, if they catch you doing it they will remove all of your reviews.)
• Respond politely. In those rare cases where you feel you must respond, do so without acknowledging that the individual was a patient, or disclosing any information that may be linked to the patient. For example, you can say that you provide excellent and appropriate care, or describe your general policies. Be polite, professional, and sensitive to the patient’s position. Readers tend to respect and sympathize with a doctor who responds in a professional, respectful manner and does not trash the complainant in retaliation.
• Take the discussion offline. Sometimes the person posting the review is just frustrated and wants to be heard. In those cases, consider contacting the patient and offering to discuss their concerns privately. If you cannot resolve your differences, try to get the patient’s written permission to post a response to their review. If they refuse, you can explain that, thereby capturing the moral high ground.

If the review contains false or defamatory content, that’s a different situation entirely; you will probably need to consult your attorney.

Regardless of how you handle negative reviews, be sure to learn from them. Your critics, as the song goes, are not always evil – and not always wrong. Complaints give you a chance to review your office policies and procedures and your own conduct, identify weaknesses, and make changes as necessary. At the very least, the exercise will help you to avoid similar complaints in the future. Don’t let valuable opportunities like that pass you by.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@frontlinemedcom.com.

In 2013, a California hospital paid $275,000 to settle claims that it violated the HIPAA privacy rule when it disclosed a patient’s health information in response to a negative online review. More recently, a Texas dental practice paid a substantial fine to the Department of Health & Human Services, which enforces HIPAA, after it responded to unfavorable Yelp reviews with patient names and details of their health conditions, treatment plans, and cost information. In addition to the fine, the practice agreed to 2 years of monitoring by HHS for compliance with HIPAA rules.

Most physicians have had the unpleasant experience of finding a negative online review from a disgruntled patient or family member. Some are justified, many are not; either way, your first impulse will often be to post a response – but that is almost always a bad idea. “Social media is not the place for providers to discuss a patient’s care,” an HHS official said in a statement issued about the dental practice case in 2016. “Doctors and dentists must think carefully about patient privacy before responding to online reviews.”

Any information that could be used to identify a patient is a HIPAA breach. This is true even if the patient has already disclosed information, because doing so does not nullify their HIPAA rights, and HIPAA provides no exceptions for responses. Even acknowledging that the reviewer was in fact your patient could, in some cases, be considered a violation.

Responding to good reviews can get you in trouble too, for the same reasons. In 2016, a physical therapy practice paid a $25,000 fine after it posted patient testimonials, “including full names and full-face photographic images to its website without obtaining valid, HIPAA-compliant authorizations.”

And by the way, most malpractice policies specifically exclude disciplinary fines and settlements from coverage.

All of that said, there are legal and ethical ways to deal with negative reviews. Here are some options:
 

• Ignore them. This is your best choice most of the time. Most negative reviews have minimal impact and simply do not deserve a response; responding may pour fuel on the fire. Besides, an occasional negative review actually lends credibility to a reviewing site and to the positive reviews posted on that site. Polls show that readers are suspicious of sites that contain only rave reviews. They assume such reviews have been “whitewashed” – or just fabricated.
• Solicit more reviews to that site. The more you can obtain, the less impact any complaints will have, since you know the overwhelming majority of your patients are happy with your care and will post a positive review if asked. Solicit them on your website, on social media, or in your email reminders. To be clear, you must encourage reviews from all patients, whether they have had a positive experience or not. If you invite only the satisfied ones, you are “filtering,” which can be perceived as false or deceptive advertising. (Google calls it “review-gating,” and according to their guidelines, if they catch you doing it they will remove all of your reviews.)
• Respond politely. In those rare cases where you feel you must respond, do so without acknowledging that the individual was a patient, or disclosing any information that may be linked to the patient. For example, you can say that you provide excellent and appropriate care, or describe your general policies. Be polite, professional, and sensitive to the patient’s position. Readers tend to respect and sympathize with a doctor who responds in a professional, respectful manner and does not trash the complainant in retaliation.
• Take the discussion offline. Sometimes the person posting the review is just frustrated and wants to be heard. In those cases, consider contacting the patient and offering to discuss their concerns privately. If you cannot resolve your differences, try to get the patient’s written permission to post a response to their review. If they refuse, you can explain that, thereby capturing the moral high ground.

If the review contains false or defamatory content, that’s a different situation entirely; you will probably need to consult your attorney.

Regardless of how you handle negative reviews, be sure to learn from them. Your critics, as the song goes, are not always evil – and not always wrong. Complaints give you a chance to review your office policies and procedures and your own conduct, identify weaknesses, and make changes as necessary. At the very least, the exercise will help you to avoid similar complaints in the future. Don’t let valuable opportunities like that pass you by.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@frontlinemedcom.com.

In 2013, a California hospital paid $275,000 to settle claims that it violated the HIPAA privacy rule when it disclosed a patient’s health information in response to a negative online review. More recently, a Texas dental practice paid a substantial fine to the Department of Health & Human Services, which enforces HIPAA, after it responded to unfavorable Yelp reviews with patient names and details of their health conditions, treatment plans, and cost information. In addition to the fine, the practice agreed to 2 years of monitoring by HHS for compliance with HIPAA rules.

Most physicians have had the unpleasant experience of finding a negative online review from a disgruntled patient or family member. Some are justified, many are not; either way, your first impulse will often be to post a response – but that is almost always a bad idea. “Social media is not the place for providers to discuss a patient’s care,” an HHS official said in a statement issued about the dental practice case in 2016. “Doctors and dentists must think carefully about patient privacy before responding to online reviews.”

Any information that could be used to identify a patient is a HIPAA breach. This is true even if the patient has already disclosed information, because doing so does not nullify their HIPAA rights, and HIPAA provides no exceptions for responses. Even acknowledging that the reviewer was in fact your patient could, in some cases, be considered a violation.

Responding to good reviews can get you in trouble too, for the same reasons. In 2016, a physical therapy practice paid a $25,000 fine after it posted patient testimonials, “including full names and full-face photographic images to its website without obtaining valid, HIPAA-compliant authorizations.”

And by the way, most malpractice policies specifically exclude disciplinary fines and settlements from coverage.

All of that said, there are legal and ethical ways to deal with negative reviews. Here are some options:
 

• Ignore them. This is your best choice most of the time. Most negative reviews have minimal impact and simply do not deserve a response; responding may pour fuel on the fire. Besides, an occasional negative review actually lends credibility to a reviewing site and to the positive reviews posted on that site. Polls show that readers are suspicious of sites that contain only rave reviews. They assume such reviews have been “whitewashed” – or just fabricated.
• Solicit more reviews to that site. The more you can obtain, the less impact any complaints will have, since you know the overwhelming majority of your patients are happy with your care and will post a positive review if asked. Solicit them on your website, on social media, or in your email reminders. To be clear, you must encourage reviews from all patients, whether they have had a positive experience or not. If you invite only the satisfied ones, you are “filtering,” which can be perceived as false or deceptive advertising. (Google calls it “review-gating,” and according to their guidelines, if they catch you doing it they will remove all of your reviews.)
• Respond politely. In those rare cases where you feel you must respond, do so without acknowledging that the individual was a patient, or disclosing any information that may be linked to the patient. For example, you can say that you provide excellent and appropriate care, or describe your general policies. Be polite, professional, and sensitive to the patient’s position. Readers tend to respect and sympathize with a doctor who responds in a professional, respectful manner and does not trash the complainant in retaliation.
• Take the discussion offline. Sometimes the person posting the review is just frustrated and wants to be heard. In those cases, consider contacting the patient and offering to discuss their concerns privately. If you cannot resolve your differences, try to get the patient’s written permission to post a response to their review. If they refuse, you can explain that, thereby capturing the moral high ground.

If the review contains false or defamatory content, that’s a different situation entirely; you will probably need to consult your attorney.

Regardless of how you handle negative reviews, be sure to learn from them. Your critics, as the song goes, are not always evil – and not always wrong. Complaints give you a chance to review your office policies and procedures and your own conduct, identify weaknesses, and make changes as necessary. At the very least, the exercise will help you to avoid similar complaints in the future. Don’t let valuable opportunities like that pass you by.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@frontlinemedcom.com.

People who are fully vaccinated against COVID-19 are no longer required to wear masks or physically distance, regardless of location or size of the gathering, the CDC announced on May 13.

“Anyone who is fully vaccinated can participate in indoor and outdoor activities, large or small, without wearing a mask or physically distancing,” CDC director Rochelle Walensky, MD, said at a press briefing. “We have all longed for this moment when we can get back to some sense of normalcy.

“This is an exciting and powerful moment,” she added, “It could only happen because of the work from so many who made sure we had the rapid administration of three safe and effective vaccines.”

Dr. Walensky cited three large studies on the effectiveness of COVID-19 vaccines against the original virus and its variants. One study from Israel found the vaccine to be 97% effective against symptomatic infection.

Those who are symptomatic should still wear masks, Dr. Walensky said, and those who are immunocompromised should talk to their doctors for further guidance. The CDC still advises travelers to wear masks while on airplanes or trains.

The COVID-19 death rates are now the lowest they have been since April 2020.

A version of this article first appeared on Medscape.com.

People who are fully vaccinated against COVID-19 are no longer required to wear masks or physically distance, regardless of location or size of the gathering, the CDC announced on May 13.

“Anyone who is fully vaccinated can participate in indoor and outdoor activities, large or small, without wearing a mask or physically distancing,” CDC director Rochelle Walensky, MD, said at a press briefing. “We have all longed for this moment when we can get back to some sense of normalcy.

“This is an exciting and powerful moment,” she added, “It could only happen because of the work from so many who made sure we had the rapid administration of three safe and effective vaccines.”

Dr. Walensky cited three large studies on the effectiveness of COVID-19 vaccines against the original virus and its variants. One study from Israel found the vaccine to be 97% effective against symptomatic infection.

Those who are symptomatic should still wear masks, Dr. Walensky said, and those who are immunocompromised should talk to their doctors for further guidance. The CDC still advises travelers to wear masks while on airplanes or trains.

The COVID-19 death rates are now the lowest they have been since April 2020.

A version of this article first appeared on Medscape.com.

People who are fully vaccinated against COVID-19 are no longer required to wear masks or physically distance, regardless of location or size of the gathering, the CDC announced on May 13.

“Anyone who is fully vaccinated can participate in indoor and outdoor activities, large or small, without wearing a mask or physically distancing,” CDC director Rochelle Walensky, MD, said at a press briefing. “We have all longed for this moment when we can get back to some sense of normalcy.

“This is an exciting and powerful moment,” she added, “It could only happen because of the work from so many who made sure we had the rapid administration of three safe and effective vaccines.”

Dr. Walensky cited three large studies on the effectiveness of COVID-19 vaccines against the original virus and its variants. One study from Israel found the vaccine to be 97% effective against symptomatic infection.

Those who are symptomatic should still wear masks, Dr. Walensky said, and those who are immunocompromised should talk to their doctors for further guidance. The CDC still advises travelers to wear masks while on airplanes or trains.

The COVID-19 death rates are now the lowest they have been since April 2020.

A version of this article first appeared on Medscape.com.

The American Medical Association has released a 3-year strategic plan to counter longstanding health inequities that hurt marginalized communities and to improve the AMA’s own performance in this regard.

The 82-page report, which was created by the association’s Center for Health Equity, argues for both internal changes at the AMA and changes in how the association addresses race-based inequities in general.

The report was released just 2 months after this news organization reported that a podcast hosted by AMA’s top journal was lambasted as racist and out of touch. In the podcast – entitled “Stuctural Racism for Doctors – What Is It?” – one JAMA editor argued that structural racism doesn’t exist. He eventually resigned and the journal’s top editor was placed on administration leave.

The new AMA report’s strategic framework “is driven by the immense need for equity-centered solutions to confront harms produced by systemic racism and other forms of oppression for Black, Latinx, Indigenous, Asian, and other people of color, as well as people who identify as LGBTQ+ and people with disabilities,” the AMA said in a news release. “Its urgency is underscored by ongoing circumstances including inequities exacerbated by the COVID-19 pandemic, ongoing police brutality, and hate crimes targeting Asian, Black, and Brown communities.”

The plan includes five main approaches to addressing inequities in health care and the AMA:

• Implement antiracist equity strategies through AMA practices, programming, policies, and culture.
• Build alliances with marginalized doctors and other stakeholders to elevate the experiences and ideas of historically marginalized and minority health care leaders.
• Strengthen, empower, and equip doctors with the knowledge and tools to dismantle structural and social health inequities.
• Ensure equitable opportunities in innovation.
• Foster truth, racial healing, reconciliation, and transformation for AMA’s past by accounting for how policies and processes excluded, discriminated, and harmed communities.

As the report acknowledges, the AMA has a long history of exclusion of and discrimination against Black physicians, for which the association publicly apologized in 2008. Within the past year, the AMA has reaffirmed its commitment to addressing this legacy and to be proactive on health equity.

Among other things, the association has described racism as a public health crisis, stated that race has nothing to do with biology, said police brutality is a product of structural racism, and called on the federal government to collect and release COVID-19 race/ethnicity data. It also removed the name of AMA founder Nathan Davis, MD, from an annual award and display because of his contribution to explicit racist practices.
 

Equity-centered solutions

The AMA launched its Center for Health Equity in 2019 with a mandate “to embed health equity across the organization.” Aletha Maybank, MD, was named the AMA’s chief health equity officer to lead the center.

In the report that Dr. Maybank helped write, the AMA discusses the consequences of individual and systemic injustice toward minorities. Among these consequences, the report said, is “segregated and inequitable health care systems.”

The “equity-centered solutions” listed in the report include:

• End segregated health care.
• Establish national health care equity and racial justice standards.
• End the use of race-based clinical decision models.
• Eliminate all forms of discrimination, exclusion and oppression in medical and physician education, training, hiring, and promotion.
• Prevent exclusion of and ensure equal representation of Black, Indigenous and Latinx people in medical school admissions as well as medical school and hospital leadership ranks.
• Ensure equity in innovation, including design, development, implementation along with support for equitable innovation opportunities and entrepreneurship.
• Solidify connections and coordination between health care and public health.
• Acknowledge and repair past harms committed by institutions.
•  

Changing medical education

In an exclusive interview, Gerald E. Harmon, MD, president-elect of the AMA, singled out medical education as an area that is ripe for change. “One of the most threatened phenotypes on the planet is the Black male physician,” he said. “Their numbers among medical school applicants continue to drop. We have increasing numbers of women in medical schools – over 50% of trainees are women – and more Black women are entering medical school, but Black men in medical school are an endangered species.

“We’re trying to get the physician workforce to look like the patient workforce.”

Dr. Harmon cited the “pipeline program” at the Morehouse School of Medicine in Atlanta and the AMA’s “doctors back to school” program as examples of efforts to attract minority high school students to health care careers. Much more needs to be done, he added. “We have to put equity and representation into our medical workforce so we can provide better high quality, more reliable care for underrepresented patients.”
 

Putting the AMA’s house in order

In its report, the AMA also makes recommendations about how it can improve equity within its own organization. Over the next 3 years, among other things, the association plans to improve the diversity of leadership at the AMA and its journal, JAMA; train all staff on equity requirements; and develop a plan to recruit more racial and ethnic minorities, LGBTQ+ people, and disabled people.

Dr. Maybank, the AMA’s chief health equity officer, said in an interview that she wouldn’t describe these efforts as affirmative action. “This is beyond affirmative action. It’s about intentional activity and action to ensure equity and justice within the AMA.”

The AMA has to thoroughly examine its own processes and determine “how inequity shows up on a day-to-day basis,” she said. “Whether it’s through hiring, innovation, publishing or communications, everybody needs to know how inequity shows up and how their own mental models can exacerbate inequities. People need tools to challenge themselves and ask themselves critical questions about racism in their processes and what they can do to mitigate those.”

A version of this article first appeared on WebMD.com.

The American Medical Association has released a 3-year strategic plan to counter longstanding health inequities that hurt marginalized communities and to improve the AMA’s own performance in this regard.

The 82-page report, which was created by the association’s Center for Health Equity, argues for both internal changes at the AMA and changes in how the association addresses race-based inequities in general.

The report was released just 2 months after this news organization reported that a podcast hosted by AMA’s top journal was lambasted as racist and out of touch. In the podcast – entitled “Stuctural Racism for Doctors – What Is It?” – one JAMA editor argued that structural racism doesn’t exist. He eventually resigned and the journal’s top editor was placed on administration leave.

The new AMA report’s strategic framework “is driven by the immense need for equity-centered solutions to confront harms produced by systemic racism and other forms of oppression for Black, Latinx, Indigenous, Asian, and other people of color, as well as people who identify as LGBTQ+ and people with disabilities,” the AMA said in a news release. “Its urgency is underscored by ongoing circumstances including inequities exacerbated by the COVID-19 pandemic, ongoing police brutality, and hate crimes targeting Asian, Black, and Brown communities.”

The plan includes five main approaches to addressing inequities in health care and the AMA:

• Implement antiracist equity strategies through AMA practices, programming, policies, and culture.
• Build alliances with marginalized doctors and other stakeholders to elevate the experiences and ideas of historically marginalized and minority health care leaders.
• Strengthen, empower, and equip doctors with the knowledge and tools to dismantle structural and social health inequities.
• Ensure equitable opportunities in innovation.
• Foster truth, racial healing, reconciliation, and transformation for AMA’s past by accounting for how policies and processes excluded, discriminated, and harmed communities.

As the report acknowledges, the AMA has a long history of exclusion of and discrimination against Black physicians, for which the association publicly apologized in 2008. Within the past year, the AMA has reaffirmed its commitment to addressing this legacy and to be proactive on health equity.

Among other things, the association has described racism as a public health crisis, stated that race has nothing to do with biology, said police brutality is a product of structural racism, and called on the federal government to collect and release COVID-19 race/ethnicity data. It also removed the name of AMA founder Nathan Davis, MD, from an annual award and display because of his contribution to explicit racist practices.
 

Equity-centered solutions

The AMA launched its Center for Health Equity in 2019 with a mandate “to embed health equity across the organization.” Aletha Maybank, MD, was named the AMA’s chief health equity officer to lead the center.

In the report that Dr. Maybank helped write, the AMA discusses the consequences of individual and systemic injustice toward minorities. Among these consequences, the report said, is “segregated and inequitable health care systems.”

The “equity-centered solutions” listed in the report include:

• End segregated health care.
• Establish national health care equity and racial justice standards.
• End the use of race-based clinical decision models.
• Eliminate all forms of discrimination, exclusion and oppression in medical and physician education, training, hiring, and promotion.
• Prevent exclusion of and ensure equal representation of Black, Indigenous and Latinx people in medical school admissions as well as medical school and hospital leadership ranks.
• Ensure equity in innovation, including design, development, implementation along with support for equitable innovation opportunities and entrepreneurship.
• Solidify connections and coordination between health care and public health.
• Acknowledge and repair past harms committed by institutions.
•  

Changing medical education

In an exclusive interview, Gerald E. Harmon, MD, president-elect of the AMA, singled out medical education as an area that is ripe for change. “One of the most threatened phenotypes on the planet is the Black male physician,” he said. “Their numbers among medical school applicants continue to drop. We have increasing numbers of women in medical schools – over 50% of trainees are women – and more Black women are entering medical school, but Black men in medical school are an endangered species.

“We’re trying to get the physician workforce to look like the patient workforce.”

Dr. Harmon cited the “pipeline program” at the Morehouse School of Medicine in Atlanta and the AMA’s “doctors back to school” program as examples of efforts to attract minority high school students to health care careers. Much more needs to be done, he added. “We have to put equity and representation into our medical workforce so we can provide better high quality, more reliable care for underrepresented patients.”
 

Putting the AMA’s house in order

In its report, the AMA also makes recommendations about how it can improve equity within its own organization. Over the next 3 years, among other things, the association plans to improve the diversity of leadership at the AMA and its journal, JAMA; train all staff on equity requirements; and develop a plan to recruit more racial and ethnic minorities, LGBTQ+ people, and disabled people.

Dr. Maybank, the AMA’s chief health equity officer, said in an interview that she wouldn’t describe these efforts as affirmative action. “This is beyond affirmative action. It’s about intentional activity and action to ensure equity and justice within the AMA.”

The AMA has to thoroughly examine its own processes and determine “how inequity shows up on a day-to-day basis,” she said. “Whether it’s through hiring, innovation, publishing or communications, everybody needs to know how inequity shows up and how their own mental models can exacerbate inequities. People need tools to challenge themselves and ask themselves critical questions about racism in their processes and what they can do to mitigate those.”

A version of this article first appeared on WebMD.com.

The American Medical Association has released a 3-year strategic plan to counter longstanding health inequities that hurt marginalized communities and to improve the AMA’s own performance in this regard.

The 82-page report, which was created by the association’s Center for Health Equity, argues for both internal changes at the AMA and changes in how the association addresses race-based inequities in general.

The report was released just 2 months after this news organization reported that a podcast hosted by AMA’s top journal was lambasted as racist and out of touch. In the podcast – entitled “Stuctural Racism for Doctors – What Is It?” – one JAMA editor argued that structural racism doesn’t exist. He eventually resigned and the journal’s top editor was placed on administration leave.

The new AMA report’s strategic framework “is driven by the immense need for equity-centered solutions to confront harms produced by systemic racism and other forms of oppression for Black, Latinx, Indigenous, Asian, and other people of color, as well as people who identify as LGBTQ+ and people with disabilities,” the AMA said in a news release. “Its urgency is underscored by ongoing circumstances including inequities exacerbated by the COVID-19 pandemic, ongoing police brutality, and hate crimes targeting Asian, Black, and Brown communities.”

The plan includes five main approaches to addressing inequities in health care and the AMA:

• Implement antiracist equity strategies through AMA practices, programming, policies, and culture.
• Build alliances with marginalized doctors and other stakeholders to elevate the experiences and ideas of historically marginalized and minority health care leaders.
• Strengthen, empower, and equip doctors with the knowledge and tools to dismantle structural and social health inequities.
• Ensure equitable opportunities in innovation.
• Foster truth, racial healing, reconciliation, and transformation for AMA’s past by accounting for how policies and processes excluded, discriminated, and harmed communities.

As the report acknowledges, the AMA has a long history of exclusion of and discrimination against Black physicians, for which the association publicly apologized in 2008. Within the past year, the AMA has reaffirmed its commitment to addressing this legacy and to be proactive on health equity.

Among other things, the association has described racism as a public health crisis, stated that race has nothing to do with biology, said police brutality is a product of structural racism, and called on the federal government to collect and release COVID-19 race/ethnicity data. It also removed the name of AMA founder Nathan Davis, MD, from an annual award and display because of his contribution to explicit racist practices.
 

Equity-centered solutions

The AMA launched its Center for Health Equity in 2019 with a mandate “to embed health equity across the organization.” Aletha Maybank, MD, was named the AMA’s chief health equity officer to lead the center.

In the report that Dr. Maybank helped write, the AMA discusses the consequences of individual and systemic injustice toward minorities. Among these consequences, the report said, is “segregated and inequitable health care systems.”

The “equity-centered solutions” listed in the report include:

• End segregated health care.
• Establish national health care equity and racial justice standards.
• End the use of race-based clinical decision models.
• Eliminate all forms of discrimination, exclusion and oppression in medical and physician education, training, hiring, and promotion.
• Prevent exclusion of and ensure equal representation of Black, Indigenous and Latinx people in medical school admissions as well as medical school and hospital leadership ranks.
• Ensure equity in innovation, including design, development, implementation along with support for equitable innovation opportunities and entrepreneurship.
• Solidify connections and coordination between health care and public health.
• Acknowledge and repair past harms committed by institutions.
•  

Changing medical education

In an exclusive interview, Gerald E. Harmon, MD, president-elect of the AMA, singled out medical education as an area that is ripe for change. “One of the most threatened phenotypes on the planet is the Black male physician,” he said. “Their numbers among medical school applicants continue to drop. We have increasing numbers of women in medical schools – over 50% of trainees are women – and more Black women are entering medical school, but Black men in medical school are an endangered species.

“We’re trying to get the physician workforce to look like the patient workforce.”

Dr. Harmon cited the “pipeline program” at the Morehouse School of Medicine in Atlanta and the AMA’s “doctors back to school” program as examples of efforts to attract minority high school students to health care careers. Much more needs to be done, he added. “We have to put equity and representation into our medical workforce so we can provide better high quality, more reliable care for underrepresented patients.”
 

Putting the AMA’s house in order

In its report, the AMA also makes recommendations about how it can improve equity within its own organization. Over the next 3 years, among other things, the association plans to improve the diversity of leadership at the AMA and its journal, JAMA; train all staff on equity requirements; and develop a plan to recruit more racial and ethnic minorities, LGBTQ+ people, and disabled people.

Dr. Maybank, the AMA’s chief health equity officer, said in an interview that she wouldn’t describe these efforts as affirmative action. “This is beyond affirmative action. It’s about intentional activity and action to ensure equity and justice within the AMA.”

The AMA has to thoroughly examine its own processes and determine “how inequity shows up on a day-to-day basis,” she said. “Whether it’s through hiring, innovation, publishing or communications, everybody needs to know how inequity shows up and how their own mental models can exacerbate inequities. People need tools to challenge themselves and ask themselves critical questions about racism in their processes and what they can do to mitigate those.”

A version of this article first appeared on WebMD.com.

Lower blood sugar with sardines

Brand X Pictures/thinkstock.com

If you’ve ever turned your nose up at someone eating sardines straight from the can, you could be the one missing out on a good way to boost your own health.

New research from Open University of Catalonia (Spain) has found that eating two cans of whole sardines a week can help prevent people from developing type 2 diabetes (T2D). Now you might be thinking: That’s a lot of fish, can’t I just take a supplement pill? Actually, no.

“Nutrients can play an essential role in the prevention and treatment of many different pathologies, but their effect is usually caused by the synergy that exists between them and the food that they are contained in,” study coauthor Diana Rizzolo, PhD, said in a written statement. See, we told you.

In a study of 152 patients with prediabetes, each participant was put on a specific diet to reduce their chances of developing T2D. Among the patients who were not given sardines each week, the proportion considered to be at the highest risk fell from 27% to 22% after 1 year, but for those who did get the sardines, the size of the high-risk group shrank from 37% to just 8%.

Suggesting sardines during checkups could make eating them more widely accepted, Dr. Rizzolo and associates said. Sardines are cheap, easy to find, and also have the benefits of other oily fish, like boosting insulin resistance and increasing good cholesterol.

So why not have a can with a couple of saltine crackers for lunch? Your blood sugar will thank you. Just please avoid indulging on a plane or in your office, where workers are slowly returning – no need to give them another excuse to avoid their cubicle.
 

Come for the torture, stay for the vaccine

MMZ84 from Pixabay

Bran Castle. Home of Dracula and Vlad the Impaler (at least in pop culture’s eyes). A moody Gothic structure atop a hill. You can practically hear the ancient screams of thousands of tortured souls as you wander the grounds and its cursed halls. Naturally, it’s a major tourist destination.

Unfortunately for Romania, the pandemic has rather put a damper on tourism. The restrictions have done their damage, but here’s a quick LOTME theory: Perhaps people don’t want to be reminded of medieval tortures when we’ve got plenty of modern-day ones right now.

The management of Bran Castle has developed a new gimmick to drum up attendance – come to Bran Castle and get your COVID vaccine. Anyone can come and get jabbed with the Pfizer vaccine on all weekends in May, and when they do, they gain free admittance to the castle and the exhibit within, home to 52 medieval torture instruments. “The idea … was to show how people got jabbed 500-600 years ago in Europe,” the castle’s marketing director said.

While it may not be kind of the jabbing ole Vladdy got his name for – fully impaling people on hundreds of wooden stakes while you eat a nice dinner isn’t exactly smiled upon in today’s world – we’re sure he’d approve of this more limited but ultimately beneficial version. Jabbing people while helping them really is the dream.
 

Fuzzy little COVID detectors

temmuzcan/Getty Images

Before we get started, we need a moment to get our deep, movie trailer announcer-type voice ready. Okay, here goes.

“In a world where an organism too tiny to see brings entire economies to a standstill and pits scientists against doofuses, who can humanity turn to for help?”

How about bees? That’s right, we said bees. But not just any bees. Specially trained bees. Specially trained Dutch bees. Bees trained to sniff out our greatest nemesis. No, we’re not talking about Ted Cruz anymore. Let it go, that was just a joke. We’re talking COVID.

We’ll let Wim van der Poel, professor of virology at Wageningen (the Netherlands) University, explain the process: “We collect normal honeybees from a beekeeper, and we put the bees in harnesses.” And you thought their tulips were pretty great – the Dutch are putting harnesses on bees! (Which is much better than our previous story of bees involving a Taiwanese patient.)

The researchers presented the bees with two types of samples: COVID infected and non–COVID infected. The infected samples came with a sugary water reward and the noninfected samples did not, so the bees quickly learned to tell the difference.

The bees, then, could cut the waiting time for test results down to seconds, and at a fraction of the cost, making them an option in countries without a lot of testing infrastructure, the research team suggested.

The plan is not without its flaws, of course, but we’re convinced. More than that, we are true bee-lievers.
 

A little slice of … well, not heaven

risalbudiman006/Pixaby

If you’ve been around for the last 2 decades, you’ve seen your share of Internet trends: Remember the ice bucket challenge? Tide pod eating? We know what you’re thinking: Sigh, what could they be doing now?

Well, people are eating old meat, and before you think about the expired ground beef you got on special from the grocery store yesterday, that’s not quite what we mean. We all know expiration dates are “suggestions,” like yield signs and yellow lights. People are eating rotten, decomposing, borderline moldy meat.

They claim that the meat tastes better. We’re not so sure, but don’t worry, because it gets weirder. Some folks, apparently, are getting high from eating this meat, experiencing a feeling of euphoria. Personally, we think that rotten fumes probably knocked these people out and made them hallucinate.

Singaporean dietitian Naras Lapsys says that eating rotten meat can possibly cause a person to go into another state of consciousness, but it’s not a good thing. We don’t think you have to be a dietitian to know that.

It has not been definitively proven that eating rotting meat makes you high, but it’s definitely proven that this is disgusting … and very dangerous.
 

Lower blood sugar with sardines

Brand X Pictures/thinkstock.com

If you’ve ever turned your nose up at someone eating sardines straight from the can, you could be the one missing out on a good way to boost your own health.

New research from Open University of Catalonia (Spain) has found that eating two cans of whole sardines a week can help prevent people from developing type 2 diabetes (T2D). Now you might be thinking: That’s a lot of fish, can’t I just take a supplement pill? Actually, no.

“Nutrients can play an essential role in the prevention and treatment of many different pathologies, but their effect is usually caused by the synergy that exists between them and the food that they are contained in,” study coauthor Diana Rizzolo, PhD, said in a written statement. See, we told you.

In a study of 152 patients with prediabetes, each participant was put on a specific diet to reduce their chances of developing T2D. Among the patients who were not given sardines each week, the proportion considered to be at the highest risk fell from 27% to 22% after 1 year, but for those who did get the sardines, the size of the high-risk group shrank from 37% to just 8%.

Suggesting sardines during checkups could make eating them more widely accepted, Dr. Rizzolo and associates said. Sardines are cheap, easy to find, and also have the benefits of other oily fish, like boosting insulin resistance and increasing good cholesterol.

So why not have a can with a couple of saltine crackers for lunch? Your blood sugar will thank you. Just please avoid indulging on a plane or in your office, where workers are slowly returning – no need to give them another excuse to avoid their cubicle.
 

Come for the torture, stay for the vaccine

MMZ84 from Pixabay

Bran Castle. Home of Dracula and Vlad the Impaler (at least in pop culture’s eyes). A moody Gothic structure atop a hill. You can practically hear the ancient screams of thousands of tortured souls as you wander the grounds and its cursed halls. Naturally, it’s a major tourist destination.

Unfortunately for Romania, the pandemic has rather put a damper on tourism. The restrictions have done their damage, but here’s a quick LOTME theory: Perhaps people don’t want to be reminded of medieval tortures when we’ve got plenty of modern-day ones right now.

The management of Bran Castle has developed a new gimmick to drum up attendance – come to Bran Castle and get your COVID vaccine. Anyone can come and get jabbed with the Pfizer vaccine on all weekends in May, and when they do, they gain free admittance to the castle and the exhibit within, home to 52 medieval torture instruments. “The idea … was to show how people got jabbed 500-600 years ago in Europe,” the castle’s marketing director said.

While it may not be kind of the jabbing ole Vladdy got his name for – fully impaling people on hundreds of wooden stakes while you eat a nice dinner isn’t exactly smiled upon in today’s world – we’re sure he’d approve of this more limited but ultimately beneficial version. Jabbing people while helping them really is the dream.
 

Fuzzy little COVID detectors

temmuzcan/Getty Images

Before we get started, we need a moment to get our deep, movie trailer announcer-type voice ready. Okay, here goes.

“In a world where an organism too tiny to see brings entire economies to a standstill and pits scientists against doofuses, who can humanity turn to for help?”

How about bees? That’s right, we said bees. But not just any bees. Specially trained bees. Specially trained Dutch bees. Bees trained to sniff out our greatest nemesis. No, we’re not talking about Ted Cruz anymore. Let it go, that was just a joke. We’re talking COVID.

We’ll let Wim van der Poel, professor of virology at Wageningen (the Netherlands) University, explain the process: “We collect normal honeybees from a beekeeper, and we put the bees in harnesses.” And you thought their tulips were pretty great – the Dutch are putting harnesses on bees! (Which is much better than our previous story of bees involving a Taiwanese patient.)

The researchers presented the bees with two types of samples: COVID infected and non–COVID infected. The infected samples came with a sugary water reward and the noninfected samples did not, so the bees quickly learned to tell the difference.

The bees, then, could cut the waiting time for test results down to seconds, and at a fraction of the cost, making them an option in countries without a lot of testing infrastructure, the research team suggested.

The plan is not without its flaws, of course, but we’re convinced. More than that, we are true bee-lievers.
 

A little slice of … well, not heaven

risalbudiman006/Pixaby

If you’ve been around for the last 2 decades, you’ve seen your share of Internet trends: Remember the ice bucket challenge? Tide pod eating? We know what you’re thinking: Sigh, what could they be doing now?

Well, people are eating old meat, and before you think about the expired ground beef you got on special from the grocery store yesterday, that’s not quite what we mean. We all know expiration dates are “suggestions,” like yield signs and yellow lights. People are eating rotten, decomposing, borderline moldy meat.

They claim that the meat tastes better. We’re not so sure, but don’t worry, because it gets weirder. Some folks, apparently, are getting high from eating this meat, experiencing a feeling of euphoria. Personally, we think that rotten fumes probably knocked these people out and made them hallucinate.

Singaporean dietitian Naras Lapsys says that eating rotten meat can possibly cause a person to go into another state of consciousness, but it’s not a good thing. We don’t think you have to be a dietitian to know that.

It has not been definitively proven that eating rotting meat makes you high, but it’s definitely proven that this is disgusting … and very dangerous.
 

Lower blood sugar with sardines

Brand X Pictures/thinkstock.com

If you’ve ever turned your nose up at someone eating sardines straight from the can, you could be the one missing out on a good way to boost your own health.

New research from Open University of Catalonia (Spain) has found that eating two cans of whole sardines a week can help prevent people from developing type 2 diabetes (T2D). Now you might be thinking: That’s a lot of fish, can’t I just take a supplement pill? Actually, no.

“Nutrients can play an essential role in the prevention and treatment of many different pathologies, but their effect is usually caused by the synergy that exists between them and the food that they are contained in,” study coauthor Diana Rizzolo, PhD, said in a written statement. See, we told you.

In a study of 152 patients with prediabetes, each participant was put on a specific diet to reduce their chances of developing T2D. Among the patients who were not given sardines each week, the proportion considered to be at the highest risk fell from 27% to 22% after 1 year, but for those who did get the sardines, the size of the high-risk group shrank from 37% to just 8%.

Suggesting sardines during checkups could make eating them more widely accepted, Dr. Rizzolo and associates said. Sardines are cheap, easy to find, and also have the benefits of other oily fish, like boosting insulin resistance and increasing good cholesterol.

So why not have a can with a couple of saltine crackers for lunch? Your blood sugar will thank you. Just please avoid indulging on a plane or in your office, where workers are slowly returning – no need to give them another excuse to avoid their cubicle.
 

Come for the torture, stay for the vaccine

MMZ84 from Pixabay

Bran Castle. Home of Dracula and Vlad the Impaler (at least in pop culture’s eyes). A moody Gothic structure atop a hill. You can practically hear the ancient screams of thousands of tortured souls as you wander the grounds and its cursed halls. Naturally, it’s a major tourist destination.

Unfortunately for Romania, the pandemic has rather put a damper on tourism. The restrictions have done their damage, but here’s a quick LOTME theory: Perhaps people don’t want to be reminded of medieval tortures when we’ve got plenty of modern-day ones right now.

The management of Bran Castle has developed a new gimmick to drum up attendance – come to Bran Castle and get your COVID vaccine. Anyone can come and get jabbed with the Pfizer vaccine on all weekends in May, and when they do, they gain free admittance to the castle and the exhibit within, home to 52 medieval torture instruments. “The idea … was to show how people got jabbed 500-600 years ago in Europe,” the castle’s marketing director said.

While it may not be kind of the jabbing ole Vladdy got his name for – fully impaling people on hundreds of wooden stakes while you eat a nice dinner isn’t exactly smiled upon in today’s world – we’re sure he’d approve of this more limited but ultimately beneficial version. Jabbing people while helping them really is the dream.
 

Fuzzy little COVID detectors

temmuzcan/Getty Images

Before we get started, we need a moment to get our deep, movie trailer announcer-type voice ready. Okay, here goes.

“In a world where an organism too tiny to see brings entire economies to a standstill and pits scientists against doofuses, who can humanity turn to for help?”

How about bees? That’s right, we said bees. But not just any bees. Specially trained bees. Specially trained Dutch bees. Bees trained to sniff out our greatest nemesis. No, we’re not talking about Ted Cruz anymore. Let it go, that was just a joke. We’re talking COVID.

We’ll let Wim van der Poel, professor of virology at Wageningen (the Netherlands) University, explain the process: “We collect normal honeybees from a beekeeper, and we put the bees in harnesses.” And you thought their tulips were pretty great – the Dutch are putting harnesses on bees! (Which is much better than our previous story of bees involving a Taiwanese patient.)

The researchers presented the bees with two types of samples: COVID infected and non–COVID infected. The infected samples came with a sugary water reward and the noninfected samples did not, so the bees quickly learned to tell the difference.

The bees, then, could cut the waiting time for test results down to seconds, and at a fraction of the cost, making them an option in countries without a lot of testing infrastructure, the research team suggested.

The plan is not without its flaws, of course, but we’re convinced. More than that, we are true bee-lievers.
 

A little slice of … well, not heaven

risalbudiman006/Pixaby

If you’ve been around for the last 2 decades, you’ve seen your share of Internet trends: Remember the ice bucket challenge? Tide pod eating? We know what you’re thinking: Sigh, what could they be doing now?

Well, people are eating old meat, and before you think about the expired ground beef you got on special from the grocery store yesterday, that’s not quite what we mean. We all know expiration dates are “suggestions,” like yield signs and yellow lights. People are eating rotten, decomposing, borderline moldy meat.

They claim that the meat tastes better. We’re not so sure, but don’t worry, because it gets weirder. Some folks, apparently, are getting high from eating this meat, experiencing a feeling of euphoria. Personally, we think that rotten fumes probably knocked these people out and made them hallucinate.

Singaporean dietitian Naras Lapsys says that eating rotten meat can possibly cause a person to go into another state of consciousness, but it’s not a good thing. We don’t think you have to be a dietitian to know that.

It has not been definitively proven that eating rotting meat makes you high, but it’s definitely proven that this is disgusting … and very dangerous.
 

CASE Mixed CP diagnosed at age 6 months

After learning that the statute of limitations was to run out in the near future, the parents of a 17-year-old with cerebral palsy (CP) initiated a lawsuit. At the time of her pregnancy, the mother (G2P2002) was age 39 and first sought prenatal care at 14 weeks.

Her past medical history was largely noncontributory to her current pregnancy, except for that she had hypothyroidism that was being treated with levothyroxine. She also had a history of asthma, but had had no acute episodes for years. During the course of the pregnancy there was evidence of polyhydramnios; her initial thyroid studies were abnormal (thyroid-stimulating hormone levels, 7.1 mIU/L), in part due to lack of adherence with prescribed medications. She was noted to have elevated blood pressure (BP) 150/100 mm Hg but no proteinuria, with BP monitoring during her last trimester.

The patient went into labor at 40 3/7 weeks, after spontaneous rupture of membranes. In labor and delivery she was placed on a monitor, and irregular contractions were noted. The initial vaginal examination was noted as 1-cm cervical dilation, 90% effaced, and station zero. The obstetrician evaluated the patient and ordered Pitocin augmentation. The next vaginal exam several hours later noted 3-cm dilation and 100% effacement. The Pitocin was continued. Several early decelerations, moderate variability, and better contraction pattern was noted. Eight hours into the Pitocin, there were repetitive late decelerations; the obstetrician was not notified. The nursing staff proceeded with vaginal examination, and the patient was fully dilated at station +1. Again, the doctor was not informed of the patient’s status. At 10 hours post-Pitocin initiation, the patient felt the urge to push. The obstetrician was notified, and he promptly arrived to the unit and patient’s bedside. His decision was to use forceps for the delivery, feeling this would be the most expedient way to proceed, although cesarean delivery (CD) was a definite consideration. Forceps were applied, and as the nursing staff noted,” the doctor really had to pull to deliver the head.” A male baby, 8 lb 8 oz, was delivered. A second-degree tear was noted and easily repaired following delivery of the placenta. Apgar scores were 5 and 7 at 1 and 5 minutes after birth, respectively.

The patient’s postpartum course was uneventful. The patient and baby were discharged on the third day postpartum.

As the child was evaluated by the pediatrician, the mother noted at 6 months that the child’s head lagged behind when he was picked up. He appeared stiff at times and floppy at other times according to the parents. As the child progressed he had problems with hand-to-mouth coordination, and when he would crawl he seemed to “scoot his butt,” as they stated.

The child was tested and a diagnosis of mixed cerebral palsy was made, implying a combination of spastic CP and dyskinetic CP. He is wheelchair bound. The parents filed a lawsuit against the obstetrician and the hospital, focused on hypoxic-ischemic encephalopathy (HIE) due to labor and delivery management being below the standard of care. They claimed that the obstetrician should have been informed by the hospital staff during the course of labor, and the obstetrician should have been more proactive in monitoring the deteriorating circumstances. This included performing a CD based on “the Category III fetal heart tracing.”

At trial, the plaintiff expert argued that failure of nursing staff to properly communicate with the obstetrician led to mismanagement. Furthermore, the obstetrician used poor judgement (ie, below the standard of care) in not performing a CD. The defense expert argued that, overall, the fetal heart tracing was Category II, and the events occurred in utero, in part reflected by the mother having polyhydramnios and hypothyroidism that was not well controlled due to lack of adherence with prescribed medications. The child in his wheelchair was brought into the courtroom. The trial went on for more than 1 week, and the jury deliberated for several hours. (Note: This case is a composite of several different events and claims.) strong="">

Continue to: WHAT’S THE VERDICT?

WHAT’S THE VERDICT?

The jury returns a verdict for the defense.

Should anything have been done differently in this trial?

Medical considerations

Cerebral palsy is a neurodevelopmental disorder affecting 1 in 500 children.¹ Other prevalence data (from a European study) indicate an incidence of 1.3–1.9 cases per 1,000 livebirths.¹ The controversy continues with respect to the disorder’s etiology, especially when the infant’s magnetic resonance imaging (MRI) does not identify specific pathology. The finger is then pointed at HIE and thus the fault of the obstetrician and labor and delivery staff. In reality, HIE accounts for less than 10% of all cases of CP.² Overall, CP is a condition focused on progressive motor impairments, many times associated with specific MRI findings.³ In addition, “MRI-negative” CP is a more vague diagnosis as discussed among neurologists.

The International Consensus Definition of CP is “a group of permanent disorders of the development of movement and posture, causing activity limitations, that are attributed to nonprogressive disturbances that occurred in the developing fetal or infant brain.”⁴ The International Cerebral Palsy Genomics Consortium have provided a consensus statement that defines CP based upon clinical type as opposed to etiology.⁵ Many times, however, ascribing an HIE cause to CP is “barking up the wrong tree,” in that we now know there are clear cut genetic causes of CP, and etiology attributed to perinatal causes, in reality, are genetic in up to 80% of cases.³ Types of CP are addressed in FIGURE 1. Overall, the pathophysiology of the disorder remains unknown. Some affected children have intellectual disabilities, as well as visual, hearing, and/or speech impairment.

DNA sequencing

The DNA story continues to unfold with the concept that DNA variants alter susceptibility to environmental influences. These insults are, for example, thrombosis or hemorrhage, all of which affect motor function.¹ Duplications or deletions of portions of a chromosome, related to copy number variants (CNVs) as well as advances in human-genome sequencing, can identify a single gene mutation leading to CP.¹ Microdeletions, microduplications, and single nucleotide variants (SNVs) are to be included in genetic-related problems causing CP.³

A number of candidate genes have been considered and include “de novo heterozygous mutations in known Online Mendelian Inheritance (OMIM).” TIBA1A and SCN8A genes are highly associated with CP.⁸ Genetic assessment, as it evolves and more recently with the advent of exome sequencing, appears to provide a new and unprecedented level of understanding of CP. Specifically, exome sequencing provides a diagnostic tool with which to identify the prevalence of pathogenic and pathogenic variants (the latter encompassing genomic variants) with CP.⁹ A retrospective study assessed a cohort of patients with CP and noted that 32.7% of the pediatric-aged patients who underwent exome sequencing had pathogenic and pathogenic variants in the sequencing.⁹ Thus, we have a tool to identify underlying genetic pathogenesis with CP. This theoretically can change the outcome of lawsuits initiated for CP that ascribe an HIE etiology. Clinicians need to stay tuned as the genetic repertoire continues to unfold.

Continue to: Legal considerations...

Legal considerations

Although CP is not a common event, it has been a major factor in the total malpractice payments for ObGyns, neonatologists, and related medical disciplines. That is because the per-event liability can be staggering. Some law firms provide a “checklist” for plaintiffs early on in assessing a potential case (FIGURE 2).¹⁰

The financial risks and incentives

To understand what the current settlements and verdicts are in birth-related CP cases, a search of Lexis files revealed the reported outcomes of cases in 2019 and 2020 (FIGURE 3). Taking into account that the pandemic limited legal activity, 23 unduplicated cases were described with a reported settlement or verdict. Four cases resulted in verdicts for the injured patients, with the mean of these awards substantially higher than the settlements ($88.3 million vs $11.1 million, respectively).

These numbers are a glimpse at some of the very high settlements and verdicts that are common in CP cases. Notably, these are not a random sample of CP cases, but only those with the amount of the verdict or settlement reported. Potentially tried cases that may have been simply abandoned or dismissed are not reported. Furthermore, most settlements include confidentiality clauses, which may preclude the release of the financial value of the settlement. Cases in which the defense won (for example, a jury verdict in favor of the physician) are not included.

The high monetary awards in some CP cases are indirectly backed by Google search results for “cerebral palsy and liability” or “cerebral palsy and malpractice.” A very large number of results for law firms seeking clients with CP injuries is produced. Some of the websites note that only 10% (or 20% on some sites) of CP cases are caused by medical negligence, offering a “free legal case review” and a phone number for callers to “ask a legal question.” In the fine print one site notes that, “if you request any information you may receive a phone call or email from a partner law firm.”¹¹ US physicians may be interested to note that a recent study of CP-based malpractice cases in China found that, although nearly 90% of the claims resulted in compensation, the mean damage award was $73,500.¹² This was compared with a mean actual loss to the family of $128,200.

The interest by law firms in CP cases may be generated in part by the opportunity to assist a settlement or judgement that may be in the tens of millions of dollars. It is financially sensible to take a substantial risk on a contingency fee in a CP case compared with many other malpractice areas or claims where the likely damages are much lower. In addition, the vast majority of the damages in CP cases are for economic damages (cost of care and treatment and lost earning capacity), not noneconomic damages (pain and suffering). Therefore, the cap on noneconomic damages available in many states would not reduce the damages by a significant percentage.

CP cases are a significant part of the malpractice costs for ObGyns. Nearly one-third of obstetric claims are for neurologic injuries, including CP.^13,14 These cases are often very complex and difficult, meaning that, in addition to the payments to the injured, there are considerable litigation costs associated with defending the cases. Perhaps as much as 60% of malpractice costs in obstetrics are in some way related to CP claims.^15,16

Continue to: Negligence...

Negligence

Malpractice cases require not only damages (which clearly there are with CP) but also negligence and causation. (A more complete discussion of the elements of professional liability are included in a recent “What’s the Verdict?” column within OBG Management.)¹⁷ CP cases are somewhat unusual in that, frequently, both negligence and causation are bitterly disputed. In a CP case, even where negligence is obvious (and it usually is not), causation may not be obvious and is likely to become a key to the defense of a very big case.

Several areas of negligence are common in CP related to delivery, including failure to monitor properly or ignoring, or not responding to, fetal heart rate (FHR) monitoring.^18,19 For FHR monitoring, the claim is that problems can lead to asphyxia, resulting in HIE. Electronic fetal monitoring (EFM) has been an especially contentious matter. On one hand, the evidence of its efficacy is doubtful, but it has remained a standard practice, and it is often a centerpiece of delivery.²⁰ Attorney Thomas Sartwelle has been prolific in suggesting that it not only has created legal problems for physicians but also results in unnecessary cesarean deliveries (CDs), which carry attendant risks for mother and infant.²¹ (It should be noted that other attorneys have expressed quite different views.²²) He has argued that experts relying on EFM should be excluded from testifying because the technology is not based on sufficient science to meet the standard criteria used to determine the admissibility of expert witness (the Daubert standard).²³ This argument is a difficult one so long as EFM is standard practice. Other claims of negligence include improper use of instruments at delivery, resulting in physical damage to the baby’s head, neck, or shoulders or internal hemorrhage. In addition, failure to deal with neonatal infection may be the basis for negligence.²⁴

Causation

The question of whether or not the negligence (no matter how bad it was) caused the CP still needs to be addressed. Because a number of factors may cause CP, it has often been difficult to determine for any individual what the cause, or contributing causes, were. This fact would ordinarily work to the advantage of defendant-physicians and hospitals because the plaintiff in a malpractice case must prove by a preponderance of the evidence that the defendant’s negligence caused the CP. “Caused” is a term of art in the law; at the most basic level it means that the harm would not have occurred (or would have been less severe) but for the negligence.

In most CP cases the real cause is unknowable. It is, therefore, important to understand the difference between the certainty required in negligence cases and the certainty required in scientific studies (eg, 95% confidence). Negligence and causation in civil cases (including malpractice) must only be demonstrated by a preponderance of the evidence, which means “more likely than not.” For recovery in malpractice cases, states may require only that negligence be a “substantial factor.”

The theory that this lack of knowledge means that the plaintiff cannot prove causation, however, does not always hold.²⁵ The following is what a jury might see: a child who will have a lifetime of medical, social, and financial burdens. Clear negligent practice by the physician coupled with severe injury can create considerable sympathy for the family. Then there are experts on both sides claiming that it is reasonably certain, in their opinions, that the injury was/was not caused by the negligence of the physician and health care team. The plaintiff’s witnesses will start eliminating other causes of CP in a form of differential diagnosis, stating that the remaining possibilities of causation clearly point to malpractice as the cause of CP. At some point, the elimination of alternative explanations for CP makes malpractice more likely than not to be a substantial factor in causing CP. On the other hand, the defense witnesses will stress that CP occurs most often without any negligence, and that, in this case, there are remaining, perhaps unknown, possible causes that are more likely than malpractice.

In this trial mix, it is not unthinkable that a jury or judge might find the plaintiff’s opinions more appealing. As a practical matter, and contrary to the technical rules, the burden of proof can seem to shift. The defendant clinician may, in effect, have to prove that the CP was caused by something other than the clinician’s negligence.

The role of insurance in award amounts

One reason that malpractice insurance companies settle CP cases for millions of dollars is that they face the possibility of judgements in the tens of millions. We saw even more than $100 million, in the 2019-2020 CP cases reported above. Another risk for malpractice insurance companies is that, if they do not settle, they may have liability beyond the policy limits. (Policy limits are the maximum an insurance policy is obligated to pay for any occurrence, or the total for all claims for the time covered by the premium.) For example, assume a malpractice policy has a $5 million policy limit covering Dr. Defendant, who has been sued for CP resulting from malpractice. There was apparently negligence during delivery in monitoring the fetus, but on the issue of causation the best estimate is that there is a 75% probability a jury would find no causal link between the negligence and the CP. If there is liability, damages would likely range from $5 to $25 million. Assume that the plaintiff has signaled it would settle for the policy limits ($5 million). Based purely on the odds and the policy limits, the insurance company should go to trial as opposed to settling for $5 million. That is because the physician personally (as opposed to the insurance company) is responsible for that part of a verdict that exceeds $5 million.

To prevent just such abuse (or bad faith), in most states, if the insurance company declines to settle the case for $5 million, it may become liable for the excess verdict above the policy limits. One reason that the cases that result in a verdict on damages—the 4 cases reported above for 2019‒2020—are interesting is that they help establish the risk of failing to settle a CP case.

Genetic understanding of causation

Given the importance of defendant-clinicians to be able to find a cause other than negligence to explain CP, the recent research of Moreno-De-Luca and colleagues may be especially meaningful.⁹ Using exome sequencing, the researchers found that 32.7% of pediatric-aged CP patients had pathogenic variance in the sequencing. In theory, this might mean that for about one-third of the CP plaintiffs, there may be genomic (rather than malpractice) explanations for CP, which might ultimately result in fewer cases of CP.

As significant as these findings are, caution is warranted. As the authors note, “this was an observational study and a causal relationship between detected gene variants and phenotypes in participants was not definitively established.”⁹ Until the causal relationship is established, it is not clear how much influence such a study would have in CP malpractice cases. Another caveat is that, at most, the genetic variants accounted for less than a third of CP cases studied, leaving many cases in which the cause remains unknown. In those cases in which a genomic association was not found, the case may be stronger for the “malpractice was the cause” claim. The follow-up research will likely shed light on some of these issues. Of course, if the genetic research demonstrates that in some proportion of cases there are genetic factors that contribute to the probability of CP, then the search will be for other triggering elements, which could possibly include poor care (that might well be a substantial factor for malpractice). Therefore, the preliminary genetic research likely represents only a part of the CP puzzle in malpractice cases.

Continue to: Why the opening case outcome was for the defense...

Why the opening case outcome was for the defense

Juries, of course, do not write opinions, so the basis for the jury’s decision in the example case is somewhat speculative. It seems most likely that causation had not been established. That is, the plaintiff-patient did not demonstrate that any malpractice was the likely, or substantial contributing, cause of the CP. The case illustrates several important issues.

Statute of limitations. This issue is common in CP cases because the condition may not be diagnosed for some time after birth. The statute of limitations can vary by state for medical malpractice cases “from 2 years to 22 years.”²⁶ Many states begin with a 2-year statute but extend it if the injury or harm is not discovered. The extension is sometimes referred to as a statute of repose because, after that time, there is no extension even if the harm is discovered only later. In some states the statute does not run until the plaintiff is at or near the time of majority (usually age 18).²⁷

Establishing negligence. The information provided about the presented case is mixed on the question of negligence, both regarding the hospital (through its nursing staff) for not properly contacting the obstetrician over the 10 hours, or the physician for inadequate monitoring. In addition, the reference to “really had to pull to deliver the head” may be the basis for claiming excessive, and potentially harmful use of force, which may have caused injury. In addition, the question remains whether the combination of these factors, including the Category III fetal heart tracing, made a cesarean delivery the appropriate standard of care.

Addressing causation. Assuming negligence, there is still a question of causation. It is far from clear that what the clinician did, or did not do, in terms of monitoring caused the CP injury. There is, however, no alternative causation that appeared in the case record, and this may be because of dueling expert witnesses.

The plaintiff sued both the obstetrician and the hospital, which is common among CP cases. While the legal interest of the two parties are aligned in some areas (causation), they may be in conflict in others (the failure of the hospital staff to keep the obstetrician informed). These potential conflicts are not for the clinicians to try to work out on their own. There is the potential for their actions to be misunderstood. When such a case is filed or threatened, the obstetrician should immediately discuss these matters with their attorney. In malpractice cases, malpractice insurance companies often select the attorneys who are experienced in such conflicts. If clinicians are not entirely comfortable that the appointed attorney is representing their interest and preserving a relationship with the hospital or other institution, however, they may engage their own legal counsel to protect their interests.

Practical considerations for avoiding malpractice claims

Good practices for avoiding malpractice claims apply with special force as it relates to CP.^28,29

Uphold practice standards and good patient records. The causation element of these legal cases will remain problematic in the foreseeable future. But causation does not matter if negligent practice is not demonstrated. Therefore, maintaining best practices and continuous efforts at quality assurance and following all relevant professional practice guidelines is a good start. More than good intentions, it is essential that policies are implemented and reviewed. Among the areas of ongoing concern is the failure to monitor patients sufficiently. The long period of labor—where perhaps no physician is present for many hours—can introduce problems, as laypersons may have the impression that medical personnel were not on top of the situation.

Maintaining excellent records is also key for clinicians. The more complete the record, the fewer opportunities there are for faulty memories of parties and caregivers to fill in the gaps (especially when causation is so difficult to establish). Under absolutely no circumstances should records be changed or modified to eliminate damaging or an otherwise unfortunate notation. Few things are as harmful to credibility as discovered record tampering.

Inform patients of what is to come. Expectations are an important part of patient satisfaction. While not unduly frightening pregnant patients or eliminating reassurance, the informed consent process and patient counseling should be opportunities to avoid unreasonable expectations.

Stay alert to early genetic counseling, which is becoming increasingly available and important. Maintaining currency with what early testing can be done will become a critical part of ObGyn practice. For CP cases, in the near future, genetic testing may become part of determining causation. In the longer term, it will be part of counseling women and couples in deciding whether to have children, or potentially to end a pregnancy.

Expect the unexpected, and plan for it. Sometimes things just go wrong—there is a bad outcome, mistakes are made, patients are upset. It is important that any practice or institution have a clear plan for when such things happen. Some organizations have used apologies when appropriate,³⁰ others have more complex plans for dealing with bad outcomes.³¹ Implement developed plans when they are needed. Individual practitioners also should consult with their attorney, who is familiar with their practice and who can help them maintain adherence to legal requirements and good legal problem prevention. ●

CASE Mixed CP diagnosed at age 6 months

After learning that the statute of limitations was to run out in the near future, the parents of a 17-year-old with cerebral palsy (CP) initiated a lawsuit. At the time of her pregnancy, the mother (G2P2002) was age 39 and first sought prenatal care at 14 weeks.

Her past medical history was largely noncontributory to her current pregnancy, except for that she had hypothyroidism that was being treated with levothyroxine. She also had a history of asthma, but had had no acute episodes for years. During the course of the pregnancy there was evidence of polyhydramnios; her initial thyroid studies were abnormal (thyroid-stimulating hormone levels, 7.1 mIU/L), in part due to lack of adherence with prescribed medications. She was noted to have elevated blood pressure (BP) 150/100 mm Hg but no proteinuria, with BP monitoring during her last trimester.

The patient went into labor at 40 3/7 weeks, after spontaneous rupture of membranes. In labor and delivery she was placed on a monitor, and irregular contractions were noted. The initial vaginal examination was noted as 1-cm cervical dilation, 90% effaced, and station zero. The obstetrician evaluated the patient and ordered Pitocin augmentation. The next vaginal exam several hours later noted 3-cm dilation and 100% effacement. The Pitocin was continued. Several early decelerations, moderate variability, and better contraction pattern was noted. Eight hours into the Pitocin, there were repetitive late decelerations; the obstetrician was not notified. The nursing staff proceeded with vaginal examination, and the patient was fully dilated at station +1. Again, the doctor was not informed of the patient’s status. At 10 hours post-Pitocin initiation, the patient felt the urge to push. The obstetrician was notified, and he promptly arrived to the unit and patient’s bedside. His decision was to use forceps for the delivery, feeling this would be the most expedient way to proceed, although cesarean delivery (CD) was a definite consideration. Forceps were applied, and as the nursing staff noted,” the doctor really had to pull to deliver the head.” A male baby, 8 lb 8 oz, was delivered. A second-degree tear was noted and easily repaired following delivery of the placenta. Apgar scores were 5 and 7 at 1 and 5 minutes after birth, respectively.

The patient’s postpartum course was uneventful. The patient and baby were discharged on the third day postpartum.

As the child was evaluated by the pediatrician, the mother noted at 6 months that the child’s head lagged behind when he was picked up. He appeared stiff at times and floppy at other times according to the parents. As the child progressed he had problems with hand-to-mouth coordination, and when he would crawl he seemed to “scoot his butt,” as they stated.

The child was tested and a diagnosis of mixed cerebral palsy was made, implying a combination of spastic CP and dyskinetic CP. He is wheelchair bound. The parents filed a lawsuit against the obstetrician and the hospital, focused on hypoxic-ischemic encephalopathy (HIE) due to labor and delivery management being below the standard of care. They claimed that the obstetrician should have been informed by the hospital staff during the course of labor, and the obstetrician should have been more proactive in monitoring the deteriorating circumstances. This included performing a CD based on “the Category III fetal heart tracing.”

At trial, the plaintiff expert argued that failure of nursing staff to properly communicate with the obstetrician led to mismanagement. Furthermore, the obstetrician used poor judgement (ie, below the standard of care) in not performing a CD. The defense expert argued that, overall, the fetal heart tracing was Category II, and the events occurred in utero, in part reflected by the mother having polyhydramnios and hypothyroidism that was not well controlled due to lack of adherence with prescribed medications. The child in his wheelchair was brought into the courtroom. The trial went on for more than 1 week, and the jury deliberated for several hours. (Note: This case is a composite of several different events and claims.) strong="">

Continue to: WHAT’S THE VERDICT?

WHAT’S THE VERDICT?

The jury returns a verdict for the defense.

Should anything have been done differently in this trial?

Medical considerations

Cerebral palsy is a neurodevelopmental disorder affecting 1 in 500 children.¹ Other prevalence data (from a European study) indicate an incidence of 1.3–1.9 cases per 1,000 livebirths.¹ The controversy continues with respect to the disorder’s etiology, especially when the infant’s magnetic resonance imaging (MRI) does not identify specific pathology. The finger is then pointed at HIE and thus the fault of the obstetrician and labor and delivery staff. In reality, HIE accounts for less than 10% of all cases of CP.² Overall, CP is a condition focused on progressive motor impairments, many times associated with specific MRI findings.³ In addition, “MRI-negative” CP is a more vague diagnosis as discussed among neurologists.

The International Consensus Definition of CP is “a group of permanent disorders of the development of movement and posture, causing activity limitations, that are attributed to nonprogressive disturbances that occurred in the developing fetal or infant brain.”⁴ The International Cerebral Palsy Genomics Consortium have provided a consensus statement that defines CP based upon clinical type as opposed to etiology.⁵ Many times, however, ascribing an HIE cause to CP is “barking up the wrong tree,” in that we now know there are clear cut genetic causes of CP, and etiology attributed to perinatal causes, in reality, are genetic in up to 80% of cases.³ Types of CP are addressed in FIGURE 1. Overall, the pathophysiology of the disorder remains unknown. Some affected children have intellectual disabilities, as well as visual, hearing, and/or speech impairment.

DNA sequencing

The DNA story continues to unfold with the concept that DNA variants alter susceptibility to environmental influences. These insults are, for example, thrombosis or hemorrhage, all of which affect motor function.¹ Duplications or deletions of portions of a chromosome, related to copy number variants (CNVs) as well as advances in human-genome sequencing, can identify a single gene mutation leading to CP.¹ Microdeletions, microduplications, and single nucleotide variants (SNVs) are to be included in genetic-related problems causing CP.³

A number of candidate genes have been considered and include “de novo heterozygous mutations in known Online Mendelian Inheritance (OMIM).” TIBA1A and SCN8A genes are highly associated with CP.⁸ Genetic assessment, as it evolves and more recently with the advent of exome sequencing, appears to provide a new and unprecedented level of understanding of CP. Specifically, exome sequencing provides a diagnostic tool with which to identify the prevalence of pathogenic and pathogenic variants (the latter encompassing genomic variants) with CP.⁹ A retrospective study assessed a cohort of patients with CP and noted that 32.7% of the pediatric-aged patients who underwent exome sequencing had pathogenic and pathogenic variants in the sequencing.⁹ Thus, we have a tool to identify underlying genetic pathogenesis with CP. This theoretically can change the outcome of lawsuits initiated for CP that ascribe an HIE etiology. Clinicians need to stay tuned as the genetic repertoire continues to unfold.

Continue to: Legal considerations...

Legal considerations

Although CP is not a common event, it has been a major factor in the total malpractice payments for ObGyns, neonatologists, and related medical disciplines. That is because the per-event liability can be staggering. Some law firms provide a “checklist” for plaintiffs early on in assessing a potential case (FIGURE 2).¹⁰

The financial risks and incentives

To understand what the current settlements and verdicts are in birth-related CP cases, a search of Lexis files revealed the reported outcomes of cases in 2019 and 2020 (FIGURE 3). Taking into account that the pandemic limited legal activity, 23 unduplicated cases were described with a reported settlement or verdict. Four cases resulted in verdicts for the injured patients, with the mean of these awards substantially higher than the settlements ($88.3 million vs $11.1 million, respectively).

These numbers are a glimpse at some of the very high settlements and verdicts that are common in CP cases. Notably, these are not a random sample of CP cases, but only those with the amount of the verdict or settlement reported. Potentially tried cases that may have been simply abandoned or dismissed are not reported. Furthermore, most settlements include confidentiality clauses, which may preclude the release of the financial value of the settlement. Cases in which the defense won (for example, a jury verdict in favor of the physician) are not included.

The high monetary awards in some CP cases are indirectly backed by Google search results for “cerebral palsy and liability” or “cerebral palsy and malpractice.” A very large number of results for law firms seeking clients with CP injuries is produced. Some of the websites note that only 10% (or 20% on some sites) of CP cases are caused by medical negligence, offering a “free legal case review” and a phone number for callers to “ask a legal question.” In the fine print one site notes that, “if you request any information you may receive a phone call or email from a partner law firm.”¹¹ US physicians may be interested to note that a recent study of CP-based malpractice cases in China found that, although nearly 90% of the claims resulted in compensation, the mean damage award was $73,500.¹² This was compared with a mean actual loss to the family of $128,200.

The interest by law firms in CP cases may be generated in part by the opportunity to assist a settlement or judgement that may be in the tens of millions of dollars. It is financially sensible to take a substantial risk on a contingency fee in a CP case compared with many other malpractice areas or claims where the likely damages are much lower. In addition, the vast majority of the damages in CP cases are for economic damages (cost of care and treatment and lost earning capacity), not noneconomic damages (pain and suffering). Therefore, the cap on noneconomic damages available in many states would not reduce the damages by a significant percentage.

CP cases are a significant part of the malpractice costs for ObGyns. Nearly one-third of obstetric claims are for neurologic injuries, including CP.^13,14 These cases are often very complex and difficult, meaning that, in addition to the payments to the injured, there are considerable litigation costs associated with defending the cases. Perhaps as much as 60% of malpractice costs in obstetrics are in some way related to CP claims.^15,16

Continue to: Negligence...

Negligence

Malpractice cases require not only damages (which clearly there are with CP) but also negligence and causation. (A more complete discussion of the elements of professional liability are included in a recent “What’s the Verdict?” column within OBG Management.)¹⁷ CP cases are somewhat unusual in that, frequently, both negligence and causation are bitterly disputed. In a CP case, even where negligence is obvious (and it usually is not), causation may not be obvious and is likely to become a key to the defense of a very big case.

Several areas of negligence are common in CP related to delivery, including failure to monitor properly or ignoring, or not responding to, fetal heart rate (FHR) monitoring.^18,19 For FHR monitoring, the claim is that problems can lead to asphyxia, resulting in HIE. Electronic fetal monitoring (EFM) has been an especially contentious matter. On one hand, the evidence of its efficacy is doubtful, but it has remained a standard practice, and it is often a centerpiece of delivery.²⁰ Attorney Thomas Sartwelle has been prolific in suggesting that it not only has created legal problems for physicians but also results in unnecessary cesarean deliveries (CDs), which carry attendant risks for mother and infant.²¹ (It should be noted that other attorneys have expressed quite different views.²²) He has argued that experts relying on EFM should be excluded from testifying because the technology is not based on sufficient science to meet the standard criteria used to determine the admissibility of expert witness (the Daubert standard).²³ This argument is a difficult one so long as EFM is standard practice. Other claims of negligence include improper use of instruments at delivery, resulting in physical damage to the baby’s head, neck, or shoulders or internal hemorrhage. In addition, failure to deal with neonatal infection may be the basis for negligence.²⁴

Causation

The question of whether or not the negligence (no matter how bad it was) caused the CP still needs to be addressed. Because a number of factors may cause CP, it has often been difficult to determine for any individual what the cause, or contributing causes, were. This fact would ordinarily work to the advantage of defendant-physicians and hospitals because the plaintiff in a malpractice case must prove by a preponderance of the evidence that the defendant’s negligence caused the CP. “Caused” is a term of art in the law; at the most basic level it means that the harm would not have occurred (or would have been less severe) but for the negligence.

In most CP cases the real cause is unknowable. It is, therefore, important to understand the difference between the certainty required in negligence cases and the certainty required in scientific studies (eg, 95% confidence). Negligence and causation in civil cases (including malpractice) must only be demonstrated by a preponderance of the evidence, which means “more likely than not.” For recovery in malpractice cases, states may require only that negligence be a “substantial factor.”

The theory that this lack of knowledge means that the plaintiff cannot prove causation, however, does not always hold.²⁵ The following is what a jury might see: a child who will have a lifetime of medical, social, and financial burdens. Clear negligent practice by the physician coupled with severe injury can create considerable sympathy for the family. Then there are experts on both sides claiming that it is reasonably certain, in their opinions, that the injury was/was not caused by the negligence of the physician and health care team. The plaintiff’s witnesses will start eliminating other causes of CP in a form of differential diagnosis, stating that the remaining possibilities of causation clearly point to malpractice as the cause of CP. At some point, the elimination of alternative explanations for CP makes malpractice more likely than not to be a substantial factor in causing CP. On the other hand, the defense witnesses will stress that CP occurs most often without any negligence, and that, in this case, there are remaining, perhaps unknown, possible causes that are more likely than malpractice.

In this trial mix, it is not unthinkable that a jury or judge might find the plaintiff’s opinions more appealing. As a practical matter, and contrary to the technical rules, the burden of proof can seem to shift. The defendant clinician may, in effect, have to prove that the CP was caused by something other than the clinician’s negligence.

The role of insurance in award amounts

One reason that malpractice insurance companies settle CP cases for millions of dollars is that they face the possibility of judgements in the tens of millions. We saw even more than $100 million, in the 2019-2020 CP cases reported above. Another risk for malpractice insurance companies is that, if they do not settle, they may have liability beyond the policy limits. (Policy limits are the maximum an insurance policy is obligated to pay for any occurrence, or the total for all claims for the time covered by the premium.) For example, assume a malpractice policy has a $5 million policy limit covering Dr. Defendant, who has been sued for CP resulting from malpractice. There was apparently negligence during delivery in monitoring the fetus, but on the issue of causation the best estimate is that there is a 75% probability a jury would find no causal link between the negligence and the CP. If there is liability, damages would likely range from $5 to $25 million. Assume that the plaintiff has signaled it would settle for the policy limits ($5 million). Based purely on the odds and the policy limits, the insurance company should go to trial as opposed to settling for $5 million. That is because the physician personally (as opposed to the insurance company) is responsible for that part of a verdict that exceeds $5 million.

To prevent just such abuse (or bad faith), in most states, if the insurance company declines to settle the case for $5 million, it may become liable for the excess verdict above the policy limits. One reason that the cases that result in a verdict on damages—the 4 cases reported above for 2019‒2020—are interesting is that they help establish the risk of failing to settle a CP case.

Genetic understanding of causation

Given the importance of defendant-clinicians to be able to find a cause other than negligence to explain CP, the recent research of Moreno-De-Luca and colleagues may be especially meaningful.⁹ Using exome sequencing, the researchers found that 32.7% of pediatric-aged CP patients had pathogenic variance in the sequencing. In theory, this might mean that for about one-third of the CP plaintiffs, there may be genomic (rather than malpractice) explanations for CP, which might ultimately result in fewer cases of CP.

As significant as these findings are, caution is warranted. As the authors note, “this was an observational study and a causal relationship between detected gene variants and phenotypes in participants was not definitively established.”⁹ Until the causal relationship is established, it is not clear how much influence such a study would have in CP malpractice cases. Another caveat is that, at most, the genetic variants accounted for less than a third of CP cases studied, leaving many cases in which the cause remains unknown. In those cases in which a genomic association was not found, the case may be stronger for the “malpractice was the cause” claim. The follow-up research will likely shed light on some of these issues. Of course, if the genetic research demonstrates that in some proportion of cases there are genetic factors that contribute to the probability of CP, then the search will be for other triggering elements, which could possibly include poor care (that might well be a substantial factor for malpractice). Therefore, the preliminary genetic research likely represents only a part of the CP puzzle in malpractice cases.

Continue to: Why the opening case outcome was for the defense...

Why the opening case outcome was for the defense

Juries, of course, do not write opinions, so the basis for the jury’s decision in the example case is somewhat speculative. It seems most likely that causation had not been established. That is, the plaintiff-patient did not demonstrate that any malpractice was the likely, or substantial contributing, cause of the CP. The case illustrates several important issues.

Statute of limitations. This issue is common in CP cases because the condition may not be diagnosed for some time after birth. The statute of limitations can vary by state for medical malpractice cases “from 2 years to 22 years.”²⁶ Many states begin with a 2-year statute but extend it if the injury or harm is not discovered. The extension is sometimes referred to as a statute of repose because, after that time, there is no extension even if the harm is discovered only later. In some states the statute does not run until the plaintiff is at or near the time of majority (usually age 18).²⁷

Establishing negligence. The information provided about the presented case is mixed on the question of negligence, both regarding the hospital (through its nursing staff) for not properly contacting the obstetrician over the 10 hours, or the physician for inadequate monitoring. In addition, the reference to “really had to pull to deliver the head” may be the basis for claiming excessive, and potentially harmful use of force, which may have caused injury. In addition, the question remains whether the combination of these factors, including the Category III fetal heart tracing, made a cesarean delivery the appropriate standard of care.

Addressing causation. Assuming negligence, there is still a question of causation. It is far from clear that what the clinician did, or did not do, in terms of monitoring caused the CP injury. There is, however, no alternative causation that appeared in the case record, and this may be because of dueling expert witnesses.

The plaintiff sued both the obstetrician and the hospital, which is common among CP cases. While the legal interest of the two parties are aligned in some areas (causation), they may be in conflict in others (the failure of the hospital staff to keep the obstetrician informed). These potential conflicts are not for the clinicians to try to work out on their own. There is the potential for their actions to be misunderstood. When such a case is filed or threatened, the obstetrician should immediately discuss these matters with their attorney. In malpractice cases, malpractice insurance companies often select the attorneys who are experienced in such conflicts. If clinicians are not entirely comfortable that the appointed attorney is representing their interest and preserving a relationship with the hospital or other institution, however, they may engage their own legal counsel to protect their interests.

Practical considerations for avoiding malpractice claims

Good practices for avoiding malpractice claims apply with special force as it relates to CP.^28,29

Uphold practice standards and good patient records. The causation element of these legal cases will remain problematic in the foreseeable future. But causation does not matter if negligent practice is not demonstrated. Therefore, maintaining best practices and continuous efforts at quality assurance and following all relevant professional practice guidelines is a good start. More than good intentions, it is essential that policies are implemented and reviewed. Among the areas of ongoing concern is the failure to monitor patients sufficiently. The long period of labor—where perhaps no physician is present for many hours—can introduce problems, as laypersons may have the impression that medical personnel were not on top of the situation.

Maintaining excellent records is also key for clinicians. The more complete the record, the fewer opportunities there are for faulty memories of parties and caregivers to fill in the gaps (especially when causation is so difficult to establish). Under absolutely no circumstances should records be changed or modified to eliminate damaging or an otherwise unfortunate notation. Few things are as harmful to credibility as discovered record tampering.

Inform patients of what is to come. Expectations are an important part of patient satisfaction. While not unduly frightening pregnant patients or eliminating reassurance, the informed consent process and patient counseling should be opportunities to avoid unreasonable expectations.

Stay alert to early genetic counseling, which is becoming increasingly available and important. Maintaining currency with what early testing can be done will become a critical part of ObGyn practice. For CP cases, in the near future, genetic testing may become part of determining causation. In the longer term, it will be part of counseling women and couples in deciding whether to have children, or potentially to end a pregnancy.

Expect the unexpected, and plan for it. Sometimes things just go wrong—there is a bad outcome, mistakes are made, patients are upset. It is important that any practice or institution have a clear plan for when such things happen. Some organizations have used apologies when appropriate,³⁰ others have more complex plans for dealing with bad outcomes.³¹ Implement developed plans when they are needed. Individual practitioners also should consult with their attorney, who is familiar with their practice and who can help them maintain adherence to legal requirements and good legal problem prevention. ●

CASE Mixed CP diagnosed at age 6 months

After learning that the statute of limitations was to run out in the near future, the parents of a 17-year-old with cerebral palsy (CP) initiated a lawsuit. At the time of her pregnancy, the mother (G2P2002) was age 39 and first sought prenatal care at 14 weeks.

Her past medical history was largely noncontributory to her current pregnancy, except for that she had hypothyroidism that was being treated with levothyroxine. She also had a history of asthma, but had had no acute episodes for years. During the course of the pregnancy there was evidence of polyhydramnios; her initial thyroid studies were abnormal (thyroid-stimulating hormone levels, 7.1 mIU/L), in part due to lack of adherence with prescribed medications. She was noted to have elevated blood pressure (BP) 150/100 mm Hg but no proteinuria, with BP monitoring during her last trimester.

The patient went into labor at 40 3/7 weeks, after spontaneous rupture of membranes. In labor and delivery she was placed on a monitor, and irregular contractions were noted. The initial vaginal examination was noted as 1-cm cervical dilation, 90% effaced, and station zero. The obstetrician evaluated the patient and ordered Pitocin augmentation. The next vaginal exam several hours later noted 3-cm dilation and 100% effacement. The Pitocin was continued. Several early decelerations, moderate variability, and better contraction pattern was noted. Eight hours into the Pitocin, there were repetitive late decelerations; the obstetrician was not notified. The nursing staff proceeded with vaginal examination, and the patient was fully dilated at station +1. Again, the doctor was not informed of the patient’s status. At 10 hours post-Pitocin initiation, the patient felt the urge to push. The obstetrician was notified, and he promptly arrived to the unit and patient’s bedside. His decision was to use forceps for the delivery, feeling this would be the most expedient way to proceed, although cesarean delivery (CD) was a definite consideration. Forceps were applied, and as the nursing staff noted,” the doctor really had to pull to deliver the head.” A male baby, 8 lb 8 oz, was delivered. A second-degree tear was noted and easily repaired following delivery of the placenta. Apgar scores were 5 and 7 at 1 and 5 minutes after birth, respectively.

The patient’s postpartum course was uneventful. The patient and baby were discharged on the third day postpartum.

As the child was evaluated by the pediatrician, the mother noted at 6 months that the child’s head lagged behind when he was picked up. He appeared stiff at times and floppy at other times according to the parents. As the child progressed he had problems with hand-to-mouth coordination, and when he would crawl he seemed to “scoot his butt,” as they stated.

The child was tested and a diagnosis of mixed cerebral palsy was made, implying a combination of spastic CP and dyskinetic CP. He is wheelchair bound. The parents filed a lawsuit against the obstetrician and the hospital, focused on hypoxic-ischemic encephalopathy (HIE) due to labor and delivery management being below the standard of care. They claimed that the obstetrician should have been informed by the hospital staff during the course of labor, and the obstetrician should have been more proactive in monitoring the deteriorating circumstances. This included performing a CD based on “the Category III fetal heart tracing.”

At trial, the plaintiff expert argued that failure of nursing staff to properly communicate with the obstetrician led to mismanagement. Furthermore, the obstetrician used poor judgement (ie, below the standard of care) in not performing a CD. The defense expert argued that, overall, the fetal heart tracing was Category II, and the events occurred in utero, in part reflected by the mother having polyhydramnios and hypothyroidism that was not well controlled due to lack of adherence with prescribed medications. The child in his wheelchair was brought into the courtroom. The trial went on for more than 1 week, and the jury deliberated for several hours. (Note: This case is a composite of several different events and claims.) strong="">

Continue to: WHAT’S THE VERDICT?

WHAT’S THE VERDICT?

The jury returns a verdict for the defense.

Should anything have been done differently in this trial?

Medical considerations

Cerebral palsy is a neurodevelopmental disorder affecting 1 in 500 children.¹ Other prevalence data (from a European study) indicate an incidence of 1.3–1.9 cases per 1,000 livebirths.¹ The controversy continues with respect to the disorder’s etiology, especially when the infant’s magnetic resonance imaging (MRI) does not identify specific pathology. The finger is then pointed at HIE and thus the fault of the obstetrician and labor and delivery staff. In reality, HIE accounts for less than 10% of all cases of CP.² Overall, CP is a condition focused on progressive motor impairments, many times associated with specific MRI findings.³ In addition, “MRI-negative” CP is a more vague diagnosis as discussed among neurologists.

The International Consensus Definition of CP is “a group of permanent disorders of the development of movement and posture, causing activity limitations, that are attributed to nonprogressive disturbances that occurred in the developing fetal or infant brain.”⁴ The International Cerebral Palsy Genomics Consortium have provided a consensus statement that defines CP based upon clinical type as opposed to etiology.⁵ Many times, however, ascribing an HIE cause to CP is “barking up the wrong tree,” in that we now know there are clear cut genetic causes of CP, and etiology attributed to perinatal causes, in reality, are genetic in up to 80% of cases.³ Types of CP are addressed in FIGURE 1. Overall, the pathophysiology of the disorder remains unknown. Some affected children have intellectual disabilities, as well as visual, hearing, and/or speech impairment.

DNA sequencing

The DNA story continues to unfold with the concept that DNA variants alter susceptibility to environmental influences. These insults are, for example, thrombosis or hemorrhage, all of which affect motor function.¹ Duplications or deletions of portions of a chromosome, related to copy number variants (CNVs) as well as advances in human-genome sequencing, can identify a single gene mutation leading to CP.¹ Microdeletions, microduplications, and single nucleotide variants (SNVs) are to be included in genetic-related problems causing CP.³

A number of candidate genes have been considered and include “de novo heterozygous mutations in known Online Mendelian Inheritance (OMIM).” TIBA1A and SCN8A genes are highly associated with CP.⁸ Genetic assessment, as it evolves and more recently with the advent of exome sequencing, appears to provide a new and unprecedented level of understanding of CP. Specifically, exome sequencing provides a diagnostic tool with which to identify the prevalence of pathogenic and pathogenic variants (the latter encompassing genomic variants) with CP.⁹ A retrospective study assessed a cohort of patients with CP and noted that 32.7% of the pediatric-aged patients who underwent exome sequencing had pathogenic and pathogenic variants in the sequencing.⁹ Thus, we have a tool to identify underlying genetic pathogenesis with CP. This theoretically can change the outcome of lawsuits initiated for CP that ascribe an HIE etiology. Clinicians need to stay tuned as the genetic repertoire continues to unfold.

Continue to: Legal considerations...

Legal considerations

Although CP is not a common event, it has been a major factor in the total malpractice payments for ObGyns, neonatologists, and related medical disciplines. That is because the per-event liability can be staggering. Some law firms provide a “checklist” for plaintiffs early on in assessing a potential case (FIGURE 2).¹⁰

The financial risks and incentives

To understand what the current settlements and verdicts are in birth-related CP cases, a search of Lexis files revealed the reported outcomes of cases in 2019 and 2020 (FIGURE 3). Taking into account that the pandemic limited legal activity, 23 unduplicated cases were described with a reported settlement or verdict. Four cases resulted in verdicts for the injured patients, with the mean of these awards substantially higher than the settlements ($88.3 million vs $11.1 million, respectively).

These numbers are a glimpse at some of the very high settlements and verdicts that are common in CP cases. Notably, these are not a random sample of CP cases, but only those with the amount of the verdict or settlement reported. Potentially tried cases that may have been simply abandoned or dismissed are not reported. Furthermore, most settlements include confidentiality clauses, which may preclude the release of the financial value of the settlement. Cases in which the defense won (for example, a jury verdict in favor of the physician) are not included.

The high monetary awards in some CP cases are indirectly backed by Google search results for “cerebral palsy and liability” or “cerebral palsy and malpractice.” A very large number of results for law firms seeking clients with CP injuries is produced. Some of the websites note that only 10% (or 20% on some sites) of CP cases are caused by medical negligence, offering a “free legal case review” and a phone number for callers to “ask a legal question.” In the fine print one site notes that, “if you request any information you may receive a phone call or email from a partner law firm.”¹¹ US physicians may be interested to note that a recent study of CP-based malpractice cases in China found that, although nearly 90% of the claims resulted in compensation, the mean damage award was $73,500.¹² This was compared with a mean actual loss to the family of $128,200.

The interest by law firms in CP cases may be generated in part by the opportunity to assist a settlement or judgement that may be in the tens of millions of dollars. It is financially sensible to take a substantial risk on a contingency fee in a CP case compared with many other malpractice areas or claims where the likely damages are much lower. In addition, the vast majority of the damages in CP cases are for economic damages (cost of care and treatment and lost earning capacity), not noneconomic damages (pain and suffering). Therefore, the cap on noneconomic damages available in many states would not reduce the damages by a significant percentage.

CP cases are a significant part of the malpractice costs for ObGyns. Nearly one-third of obstetric claims are for neurologic injuries, including CP.^13,14 These cases are often very complex and difficult, meaning that, in addition to the payments to the injured, there are considerable litigation costs associated with defending the cases. Perhaps as much as 60% of malpractice costs in obstetrics are in some way related to CP claims.^15,16

Continue to: Negligence...

Negligence

Malpractice cases require not only damages (which clearly there are with CP) but also negligence and causation. (A more complete discussion of the elements of professional liability are included in a recent “What’s the Verdict?” column within OBG Management.)¹⁷ CP cases are somewhat unusual in that, frequently, both negligence and causation are bitterly disputed. In a CP case, even where negligence is obvious (and it usually is not), causation may not be obvious and is likely to become a key to the defense of a very big case.

Several areas of negligence are common in CP related to delivery, including failure to monitor properly or ignoring, or not responding to, fetal heart rate (FHR) monitoring.^18,19 For FHR monitoring, the claim is that problems can lead to asphyxia, resulting in HIE. Electronic fetal monitoring (EFM) has been an especially contentious matter. On one hand, the evidence of its efficacy is doubtful, but it has remained a standard practice, and it is often a centerpiece of delivery.²⁰ Attorney Thomas Sartwelle has been prolific in suggesting that it not only has created legal problems for physicians but also results in unnecessary cesarean deliveries (CDs), which carry attendant risks for mother and infant.²¹ (It should be noted that other attorneys have expressed quite different views.²²) He has argued that experts relying on EFM should be excluded from testifying because the technology is not based on sufficient science to meet the standard criteria used to determine the admissibility of expert witness (the Daubert standard).²³ This argument is a difficult one so long as EFM is standard practice. Other claims of negligence include improper use of instruments at delivery, resulting in physical damage to the baby’s head, neck, or shoulders or internal hemorrhage. In addition, failure to deal with neonatal infection may be the basis for negligence.²⁴

Causation

The question of whether or not the negligence (no matter how bad it was) caused the CP still needs to be addressed. Because a number of factors may cause CP, it has often been difficult to determine for any individual what the cause, or contributing causes, were. This fact would ordinarily work to the advantage of defendant-physicians and hospitals because the plaintiff in a malpractice case must prove by a preponderance of the evidence that the defendant’s negligence caused the CP. “Caused” is a term of art in the law; at the most basic level it means that the harm would not have occurred (or would have been less severe) but for the negligence.

In most CP cases the real cause is unknowable. It is, therefore, important to understand the difference between the certainty required in negligence cases and the certainty required in scientific studies (eg, 95% confidence). Negligence and causation in civil cases (including malpractice) must only be demonstrated by a preponderance of the evidence, which means “more likely than not.” For recovery in malpractice cases, states may require only that negligence be a “substantial factor.”

The theory that this lack of knowledge means that the plaintiff cannot prove causation, however, does not always hold.²⁵ The following is what a jury might see: a child who will have a lifetime of medical, social, and financial burdens. Clear negligent practice by the physician coupled with severe injury can create considerable sympathy for the family. Then there are experts on both sides claiming that it is reasonably certain, in their opinions, that the injury was/was not caused by the negligence of the physician and health care team. The plaintiff’s witnesses will start eliminating other causes of CP in a form of differential diagnosis, stating that the remaining possibilities of causation clearly point to malpractice as the cause of CP. At some point, the elimination of alternative explanations for CP makes malpractice more likely than not to be a substantial factor in causing CP. On the other hand, the defense witnesses will stress that CP occurs most often without any negligence, and that, in this case, there are remaining, perhaps unknown, possible causes that are more likely than malpractice.

In this trial mix, it is not unthinkable that a jury or judge might find the plaintiff’s opinions more appealing. As a practical matter, and contrary to the technical rules, the burden of proof can seem to shift. The defendant clinician may, in effect, have to prove that the CP was caused by something other than the clinician’s negligence.

The role of insurance in award amounts

One reason that malpractice insurance companies settle CP cases for millions of dollars is that they face the possibility of judgements in the tens of millions. We saw even more than $100 million, in the 2019-2020 CP cases reported above. Another risk for malpractice insurance companies is that, if they do not settle, they may have liability beyond the policy limits. (Policy limits are the maximum an insurance policy is obligated to pay for any occurrence, or the total for all claims for the time covered by the premium.) For example, assume a malpractice policy has a $5 million policy limit covering Dr. Defendant, who has been sued for CP resulting from malpractice. There was apparently negligence during delivery in monitoring the fetus, but on the issue of causation the best estimate is that there is a 75% probability a jury would find no causal link between the negligence and the CP. If there is liability, damages would likely range from $5 to $25 million. Assume that the plaintiff has signaled it would settle for the policy limits ($5 million). Based purely on the odds and the policy limits, the insurance company should go to trial as opposed to settling for $5 million. That is because the physician personally (as opposed to the insurance company) is responsible for that part of a verdict that exceeds $5 million.

To prevent just such abuse (or bad faith), in most states, if the insurance company declines to settle the case for $5 million, it may become liable for the excess verdict above the policy limits. One reason that the cases that result in a verdict on damages—the 4 cases reported above for 2019‒2020—are interesting is that they help establish the risk of failing to settle a CP case.

Genetic understanding of causation

Given the importance of defendant-clinicians to be able to find a cause other than negligence to explain CP, the recent research of Moreno-De-Luca and colleagues may be especially meaningful.⁹ Using exome sequencing, the researchers found that 32.7% of pediatric-aged CP patients had pathogenic variance in the sequencing. In theory, this might mean that for about one-third of the CP plaintiffs, there may be genomic (rather than malpractice) explanations for CP, which might ultimately result in fewer cases of CP.

As significant as these findings are, caution is warranted. As the authors note, “this was an observational study and a causal relationship between detected gene variants and phenotypes in participants was not definitively established.”⁹ Until the causal relationship is established, it is not clear how much influence such a study would have in CP malpractice cases. Another caveat is that, at most, the genetic variants accounted for less than a third of CP cases studied, leaving many cases in which the cause remains unknown. In those cases in which a genomic association was not found, the case may be stronger for the “malpractice was the cause” claim. The follow-up research will likely shed light on some of these issues. Of course, if the genetic research demonstrates that in some proportion of cases there are genetic factors that contribute to the probability of CP, then the search will be for other triggering elements, which could possibly include poor care (that might well be a substantial factor for malpractice). Therefore, the preliminary genetic research likely represents only a part of the CP puzzle in malpractice cases.

Continue to: Why the opening case outcome was for the defense...

Why the opening case outcome was for the defense

Juries, of course, do not write opinions, so the basis for the jury’s decision in the example case is somewhat speculative. It seems most likely that causation had not been established. That is, the plaintiff-patient did not demonstrate that any malpractice was the likely, or substantial contributing, cause of the CP. The case illustrates several important issues.

Statute of limitations. This issue is common in CP cases because the condition may not be diagnosed for some time after birth. The statute of limitations can vary by state for medical malpractice cases “from 2 years to 22 years.”²⁶ Many states begin with a 2-year statute but extend it if the injury or harm is not discovered. The extension is sometimes referred to as a statute of repose because, after that time, there is no extension even if the harm is discovered only later. In some states the statute does not run until the plaintiff is at or near the time of majority (usually age 18).²⁷

Establishing negligence. The information provided about the presented case is mixed on the question of negligence, both regarding the hospital (through its nursing staff) for not properly contacting the obstetrician over the 10 hours, or the physician for inadequate monitoring. In addition, the reference to “really had to pull to deliver the head” may be the basis for claiming excessive, and potentially harmful use of force, which may have caused injury. In addition, the question remains whether the combination of these factors, including the Category III fetal heart tracing, made a cesarean delivery the appropriate standard of care.

Addressing causation. Assuming negligence, there is still a question of causation. It is far from clear that what the clinician did, or did not do, in terms of monitoring caused the CP injury. There is, however, no alternative causation that appeared in the case record, and this may be because of dueling expert witnesses.

The plaintiff sued both the obstetrician and the hospital, which is common among CP cases. While the legal interest of the two parties are aligned in some areas (causation), they may be in conflict in others (the failure of the hospital staff to keep the obstetrician informed). These potential conflicts are not for the clinicians to try to work out on their own. There is the potential for their actions to be misunderstood. When such a case is filed or threatened, the obstetrician should immediately discuss these matters with their attorney. In malpractice cases, malpractice insurance companies often select the attorneys who are experienced in such conflicts. If clinicians are not entirely comfortable that the appointed attorney is representing their interest and preserving a relationship with the hospital or other institution, however, they may engage their own legal counsel to protect their interests.

Practical considerations for avoiding malpractice claims

Good practices for avoiding malpractice claims apply with special force as it relates to CP.^28,29

Uphold practice standards and good patient records. The causation element of these legal cases will remain problematic in the foreseeable future. But causation does not matter if negligent practice is not demonstrated. Therefore, maintaining best practices and continuous efforts at quality assurance and following all relevant professional practice guidelines is a good start. More than good intentions, it is essential that policies are implemented and reviewed. Among the areas of ongoing concern is the failure to monitor patients sufficiently. The long period of labor—where perhaps no physician is present for many hours—can introduce problems, as laypersons may have the impression that medical personnel were not on top of the situation.

Maintaining excellent records is also key for clinicians. The more complete the record, the fewer opportunities there are for faulty memories of parties and caregivers to fill in the gaps (especially when causation is so difficult to establish). Under absolutely no circumstances should records be changed or modified to eliminate damaging or an otherwise unfortunate notation. Few things are as harmful to credibility as discovered record tampering.

Inform patients of what is to come. Expectations are an important part of patient satisfaction. While not unduly frightening pregnant patients or eliminating reassurance, the informed consent process and patient counseling should be opportunities to avoid unreasonable expectations.

Stay alert to early genetic counseling, which is becoming increasingly available and important. Maintaining currency with what early testing can be done will become a critical part of ObGyn practice. For CP cases, in the near future, genetic testing may become part of determining causation. In the longer term, it will be part of counseling women and couples in deciding whether to have children, or potentially to end a pregnancy.

Expect the unexpected, and plan for it. Sometimes things just go wrong—there is a bad outcome, mistakes are made, patients are upset. It is important that any practice or institution have a clear plan for when such things happen. Some organizations have used apologies when appropriate,³⁰ others have more complex plans for dealing with bad outcomes.³¹ Implement developed plans when they are needed. Individual practitioners also should consult with their attorney, who is familiar with their practice and who can help them maintain adherence to legal requirements and good legal problem prevention. ●