FDA confirms complications from intragastric balloons

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Complications from overinflation and acute pancreatitis can create problems for obesity patients treated with intragastric balloons, according to a statement from the Food and Drug Administration. In a letter to health care providers published on February 9, 2017, the FDA warned of the two specific issues that have been the subject of multiple adverse event reports.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License
Overinflation may occur when the fluid-filled intragastric balloon inflates with more fluid or with air after placement in the patient’s stomach. If overinflation occurs, the device will likely need to be removed. Reports to the FDA show that overinflation can occur as early as 9 days following implantation, and symptoms included abdominal distention, severe abdominal pain, breathing problems, and vomiting.

Most of the overinflation reports involved the Orbera Intragastric Balloon System (Apollo Endosurgery) that uses a single balloon, although some reports involved the ReShape Integrated Dual Balloon System (ReShape Medical) that uses two balloons. Neither product mentions overinflation risk in its labeling. “At this moment there is not enough information to determine what is causing the balloon to overinflate,” according to the FDA letter.
 

 
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Complications from overinflation and acute pancreatitis can create problems for obesity patients treated with intragastric balloons, according to a statement from the Food and Drug Administration. In a letter to health care providers published on February 9, 2017, the FDA warned of the two specific issues that have been the subject of multiple adverse event reports.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License
Overinflation may occur when the fluid-filled intragastric balloon inflates with more fluid or with air after placement in the patient’s stomach. If overinflation occurs, the device will likely need to be removed. Reports to the FDA show that overinflation can occur as early as 9 days following implantation, and symptoms included abdominal distention, severe abdominal pain, breathing problems, and vomiting.

Most of the overinflation reports involved the Orbera Intragastric Balloon System (Apollo Endosurgery) that uses a single balloon, although some reports involved the ReShape Integrated Dual Balloon System (ReShape Medical) that uses two balloons. Neither product mentions overinflation risk in its labeling. “At this moment there is not enough information to determine what is causing the balloon to overinflate,” according to the FDA letter.
 

 

 

Complications from overinflation and acute pancreatitis can create problems for obesity patients treated with intragastric balloons, according to a statement from the Food and Drug Administration. In a letter to health care providers published on February 9, 2017, the FDA warned of the two specific issues that have been the subject of multiple adverse event reports.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License
Overinflation may occur when the fluid-filled intragastric balloon inflates with more fluid or with air after placement in the patient’s stomach. If overinflation occurs, the device will likely need to be removed. Reports to the FDA show that overinflation can occur as early as 9 days following implantation, and symptoms included abdominal distention, severe abdominal pain, breathing problems, and vomiting.

Most of the overinflation reports involved the Orbera Intragastric Balloon System (Apollo Endosurgery) that uses a single balloon, although some reports involved the ReShape Integrated Dual Balloon System (ReShape Medical) that uses two balloons. Neither product mentions overinflation risk in its labeling. “At this moment there is not enough information to determine what is causing the balloon to overinflate,” according to the FDA letter.
 

 
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What I wish I knew when I started my internship

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In my first year of residency I faced a steep learning curve. I learned a lot about psychiatry, but I learned so much more about myself. If I had known then what I know now, my internship would have been smoother and more enjoyable.

Be organized. Create systems to remember your patients’ information and your to-do list. I have templates of progress notes, psychiatry assessments, mental status assessments, “rounds sheets” (a sheet listing every patient on my floor, including their diagnoses, laboratories, medications, and other notes). Although my system involves lots of paper, I like it. Make a system that works for you. Go out and have fun. I know you are tired, you haven’t slept, and your apartment is a mess, but you won’t remember that time you went home, did laundry, and went to bed early. You will remember the fun night when you and other interns went out and explored the city.

Unplug from medicine. Nothing is more boring than working for 12 hours, only to go out for drinks with coworkers and talk about work. Although you need to vent, life is more than medicine. Find time for something else. Read a book, play a video game, hang out with people who are not doctors. I started a monthly book club with other women around my age. Make some time for something other than your profession.

Reach out to your senior colleagues. I was so concerned about making a good first impression that I didn’t share my concerns with others. I kept my head low because I always blame myself first when something is wrong.

During an off-service rotation, I was unable to finish my shift because I had food poisoning. To make up for that uncompleted shift, the chief from that service gave me 2 extra night shifts. I found the measure extreme, but thought it was my fault for going home early. A few days later, the Psychiatry Chief Resident approached me, after he had seen my schedule and spoke with the other chief because he found the situation unfair. He was reaching out to me saying, “We’ve got your back.” I realized that it wasn’t always my fault, and I could speak up when there was an issue. I was fortunate to have seniors and chiefs who looked out for me. I always found support, good advice, and respect for my feelings.

 

 

 

If you have questions or concerns, are anxious, or feel something is wrong, approach a senior or the chief. They were in your shoes once and will give you their best advice.

Medicine is different in the United States. As an international medical graduate from Colombia, I panicked on my first day when everyone was talking in acronyms. I did not have a lot of U.S. clinical experience, and back home it’s frowned upon to write full sentences in acronyms. My students helped me get over it. I started my internship in the general medical floor and felt so embarrassed. Then I realized that it didn’t matter because it did not affect how I cared for my patients.

People understand that you are from another country. At the beginning, I used Google to search for everything, and then I realized that my 2 wonderful students didn’t think less of me because I didn’t know what BKA (below knee amputation) means. Do not be ashamed if you don’t know how things work in a different country. You will find people who are willing to help you; you will learn, and it will be a minor thing a year from now.

Keep your support system. It was 3 am in the emergency department, and on my break I went running out to the hallway feeling overwhelmed, tired, and lonely. I called my best friend across the globe.

If you moved away from home for residency, you are surrounded by new faces and far from the people you are comfortable with. Do not lose touch with them because you never know when you might need them the most. I had a hard road getting to where I am now, and many people helped me. You have to be there for them, too; a text message takes 30 seconds, and an e-mail, 1 minute.

Remember, you need to take care of yourself before taking care of others. No matter how much the MD or DO degree makes you feel like a superhero, you are still human.

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Dr. Serrano is a PGY-3 Resident, Department of Psychiatry, Einstein Medical Center, Philadelphia, Pennsylvania.

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Author and Disclosure Information

Dr. Serrano is a PGY-3 Resident, Department of Psychiatry, Einstein Medical Center, Philadelphia, Pennsylvania.

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The author reports no financial relationships with any company whose products are mentioned in this article or with manufacturers of competing products.

 

 

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In my first year of residency I faced a steep learning curve. I learned a lot about psychiatry, but I learned so much more about myself. If I had known then what I know now, my internship would have been smoother and more enjoyable.

Be organized. Create systems to remember your patients’ information and your to-do list. I have templates of progress notes, psychiatry assessments, mental status assessments, “rounds sheets” (a sheet listing every patient on my floor, including their diagnoses, laboratories, medications, and other notes). Although my system involves lots of paper, I like it. Make a system that works for you. Go out and have fun. I know you are tired, you haven’t slept, and your apartment is a mess, but you won’t remember that time you went home, did laundry, and went to bed early. You will remember the fun night when you and other interns went out and explored the city.

Unplug from medicine. Nothing is more boring than working for 12 hours, only to go out for drinks with coworkers and talk about work. Although you need to vent, life is more than medicine. Find time for something else. Read a book, play a video game, hang out with people who are not doctors. I started a monthly book club with other women around my age. Make some time for something other than your profession.

Reach out to your senior colleagues. I was so concerned about making a good first impression that I didn’t share my concerns with others. I kept my head low because I always blame myself first when something is wrong.

During an off-service rotation, I was unable to finish my shift because I had food poisoning. To make up for that uncompleted shift, the chief from that service gave me 2 extra night shifts. I found the measure extreme, but thought it was my fault for going home early. A few days later, the Psychiatry Chief Resident approached me, after he had seen my schedule and spoke with the other chief because he found the situation unfair. He was reaching out to me saying, “We’ve got your back.” I realized that it wasn’t always my fault, and I could speak up when there was an issue. I was fortunate to have seniors and chiefs who looked out for me. I always found support, good advice, and respect for my feelings.

 

 

 

If you have questions or concerns, are anxious, or feel something is wrong, approach a senior or the chief. They were in your shoes once and will give you their best advice.

Medicine is different in the United States. As an international medical graduate from Colombia, I panicked on my first day when everyone was talking in acronyms. I did not have a lot of U.S. clinical experience, and back home it’s frowned upon to write full sentences in acronyms. My students helped me get over it. I started my internship in the general medical floor and felt so embarrassed. Then I realized that it didn’t matter because it did not affect how I cared for my patients.

People understand that you are from another country. At the beginning, I used Google to search for everything, and then I realized that my 2 wonderful students didn’t think less of me because I didn’t know what BKA (below knee amputation) means. Do not be ashamed if you don’t know how things work in a different country. You will find people who are willing to help you; you will learn, and it will be a minor thing a year from now.

Keep your support system. It was 3 am in the emergency department, and on my break I went running out to the hallway feeling overwhelmed, tired, and lonely. I called my best friend across the globe.

If you moved away from home for residency, you are surrounded by new faces and far from the people you are comfortable with. Do not lose touch with them because you never know when you might need them the most. I had a hard road getting to where I am now, and many people helped me. You have to be there for them, too; a text message takes 30 seconds, and an e-mail, 1 minute.

Remember, you need to take care of yourself before taking care of others. No matter how much the MD or DO degree makes you feel like a superhero, you are still human.

 

In my first year of residency I faced a steep learning curve. I learned a lot about psychiatry, but I learned so much more about myself. If I had known then what I know now, my internship would have been smoother and more enjoyable.

Be organized. Create systems to remember your patients’ information and your to-do list. I have templates of progress notes, psychiatry assessments, mental status assessments, “rounds sheets” (a sheet listing every patient on my floor, including their diagnoses, laboratories, medications, and other notes). Although my system involves lots of paper, I like it. Make a system that works for you. Go out and have fun. I know you are tired, you haven’t slept, and your apartment is a mess, but you won’t remember that time you went home, did laundry, and went to bed early. You will remember the fun night when you and other interns went out and explored the city.

Unplug from medicine. Nothing is more boring than working for 12 hours, only to go out for drinks with coworkers and talk about work. Although you need to vent, life is more than medicine. Find time for something else. Read a book, play a video game, hang out with people who are not doctors. I started a monthly book club with other women around my age. Make some time for something other than your profession.

Reach out to your senior colleagues. I was so concerned about making a good first impression that I didn’t share my concerns with others. I kept my head low because I always blame myself first when something is wrong.

During an off-service rotation, I was unable to finish my shift because I had food poisoning. To make up for that uncompleted shift, the chief from that service gave me 2 extra night shifts. I found the measure extreme, but thought it was my fault for going home early. A few days later, the Psychiatry Chief Resident approached me, after he had seen my schedule and spoke with the other chief because he found the situation unfair. He was reaching out to me saying, “We’ve got your back.” I realized that it wasn’t always my fault, and I could speak up when there was an issue. I was fortunate to have seniors and chiefs who looked out for me. I always found support, good advice, and respect for my feelings.

 

 

 

If you have questions or concerns, are anxious, or feel something is wrong, approach a senior or the chief. They were in your shoes once and will give you their best advice.

Medicine is different in the United States. As an international medical graduate from Colombia, I panicked on my first day when everyone was talking in acronyms. I did not have a lot of U.S. clinical experience, and back home it’s frowned upon to write full sentences in acronyms. My students helped me get over it. I started my internship in the general medical floor and felt so embarrassed. Then I realized that it didn’t matter because it did not affect how I cared for my patients.

People understand that you are from another country. At the beginning, I used Google to search for everything, and then I realized that my 2 wonderful students didn’t think less of me because I didn’t know what BKA (below knee amputation) means. Do not be ashamed if you don’t know how things work in a different country. You will find people who are willing to help you; you will learn, and it will be a minor thing a year from now.

Keep your support system. It was 3 am in the emergency department, and on my break I went running out to the hallway feeling overwhelmed, tired, and lonely. I called my best friend across the globe.

If you moved away from home for residency, you are surrounded by new faces and far from the people you are comfortable with. Do not lose touch with them because you never know when you might need them the most. I had a hard road getting to where I am now, and many people helped me. You have to be there for them, too; a text message takes 30 seconds, and an e-mail, 1 minute.

Remember, you need to take care of yourself before taking care of others. No matter how much the MD or DO degree makes you feel like a superhero, you are still human.

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Watch and wait often better than resecting in ground-glass opacities

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Three years of follow-up is adequate for partially solid ground-glass opacity lesions that do not progress, while pure ground-glass opacity lesions that show no progression may require further follow-up care, a study suggests.


The results of the study strengthen the argument for taking a “watch and wait” approach, and raise the question of whether patient outcomes can be improved without more precise diagnostic criteria, said study author Shigei Sawada, MD, PhD, a researcher at the Shikoku Cancer Center in Matsuyama, Japan, and his colleagues. They drew these conclusions from performing a long-term outcome investigation of 226 patients with pure or mixed ground-glass opacity lesions shown by CT imaging to be 3 cm or less in diameter.


Once established that the disease has stabilized in a pure or mixed ground-glass opacity lesion, “the frequency of CT examinations could probably be reduced or ... discontinued,” the investigators wrote. The study is published online in Chest (2017;151[2]:308-15).
Because ground-glass opacities often can remain unchanged for years, reflexively choosing resection can result in a patient’s being overtreated. Meanwhile, the use of increasingly accurate imaging technology likely means detection rates of such lesions will continue to increase, leaving clinicians to wonder about optimal management protocols, particularly since several guidance documents include differing recommendations on the timing of surveillance CTs for patients with stable disease.


The study includes 10-15 years of follow-up data on the 226 patients, registered between 2000 and 2005. Across the study, there were nearly twice as many women as men, all with an average age of 61 years. About a quarter had multiple ground-glass opacities; about a quarter also had partially consolidated lesions. Of the 124 patients who’d had resections, all but one was stage IA. The most prominent histologic subtype was adenocarcinoma in situ in 63 patients, followed by 39 patients with minimally invasive adenocarcinomas, and 19 with lepidic predominant adenocarcinomas. Five patients had papillary-predominant adenocarcinomas.   


Roughly one-quarter of the cohort did not receive follow-up examinations after 68 months, as their lesions either remained stable or were shown to have reduced in size. Another 45 continued to undergo follow-up examinations.


After initial detection of a pure ground-glass opacity, the CT examination schedule was every 3, 6, and 12 months, and then annually. After detection of a mixed ground-glass opacity, a CT examination was given every 3 months for the first year, then reduced to every 6 months thereafter. In patients with stable disease, the individual clinicians determined whether to obtain additional CT follow-up imaging.


A ground-glass lesion was determined to have progressed if the diameter increased, as it did in about a third of patients; or, if there was new or increased consolidation, as there was in about two-thirds of patients. The table of consolidation/tumor ratios (CTR) used included CTR zero, also referred to as a pure ground-glass lesion; CTR 1-25; CTR 26-50; and CTR equal to or greater than 51. When there were multiple lesions, the largest one detected was the target.
All cases of patients with a CTR of more than zero were identified within 3 years, while 13.6% of patients with a CTR of zero required more than 3 years to identify tumor growth. Aggressive cancer was detected in 4% of patients with a CTR of zero and in 70% of those with a CTR greater than 25% (P less than .001). Aggressive cancer was seen in 46% of those with consolidation/tumor ratios that increased during follow-up and in 8% of those whose tumors increased in diameter (P less than .007). After about 10 years of follow-up after resection, 1.6% of cancers recurred.


There were two deaths from lung cancer among the study’s patients. The first, a 54-year-old man, had an acinar-predominant adenocarcinoma, 5 mm in diameter with a consolidation/tumor ratio of 0.75 that increased during follow-up. The recurrence developed in the mediastinal lymph nodes 51 months after resection surgery. The second patient had a papillary-predominant adenocarcinoma appearing as a pure ground-glass opacity 27 mm in diameter. The consolidation/tumor ratio also increased during follow-up, with recurrences in the bone and mediastinal lymph nodes at 30 months post resectioning.


Neither patient was re-biopsied, and both were diagnosed according to CT imaging alone. There were 13 other patient deaths from non–lung cancer related causes.


Given the 3-year timespan necessary to detect tumor growth in all but the CTR zero group, and the study’s size and long-term nature, the investigators concluded that a follow-up period of 3 years for patients with part-solid lesions “should be adequate.”


By contrast, CHEST recommends CT scans be done for at least 3 years in patients with pure ground-glass lesions and between 3 and 5 years in the other CTR groups with nodules measuring 8 mm or less. The National Comprehensive Cancer Network guideline advises low-dose CT scanning until a patient is no longer eligible for definitive treatment.
Dr. Sawada and his colleagues did not use an exact criterion for tumor growth in their study, such as a precise ratio of increase in size or consolidation, in part because at the time of the study the most common form of CT evaluation was visual inspection; they reported that tumors exhibiting growth most commonly increased between 2 and 3 mm in either size or consolidation. “Evaluations based on visual inspections can be imprecise, and different physicians may arrive at different judgments,” the investigators wrote. “However, [the use of] computer-aided diagnosis systems are not yet commonly applied in clinical practice.”
Although imaging should have guided the decision to resect, according to Dr. Sawada and his coauthors, two-thirds of patients in the study were given the procedure even though their lesions were not shown by CT scans to have progressed. This was done either at the patient’s request, or per the clinical judgment of a physician.


Dr. Frank Detterbeck, surgical director, Yale University
Dr. Frank Detterbeck
Although the study “represents a major advance,” according to Frank C. Detterbeck, MD, FCCP, surgical director of thoracic oncology at Yale University, New Haven, Conn., who wrote an editorial accompanying the study, the results should spur the field to get more specific, and question whether a 3-year window was enough. “This seems counterintuitive given the chance of it becoming an invasive cancer,” Dr. Detterbeck wrote, indicating that not rushing to resection should mean more use of CT. “We should just look at what is already in front of our eyes: the radiographic features of [ground-glass nodules] are highly predictive of biological behavior. It will be hard to do better than this.”


Also becoming more specific about changing CTRs would be helpful in developing management protocols, according to Dr. Detterbeck. “In my opinion, we need to start factoring in the rate of change. A gradual 2 mm increase in size over a period of 5 years may not be an appropriate trigger for resection.”


Neither the investigators nor the editorial writer had any relevant disclosures.

 

Body

 

Eric Gartman, MD, FCCP, comments: This study provides further support that the biology of ground-glass and part-solid nodules is different than fully solid nodules – and we should not be in a rush to resect these lesions. While the recommendations are likely to evolve over time as more information becomes available, this conservative approach toward nonsolid nodules is currently adopted in the Lung-RADS guidelines.

Dr. Eric J. Gartman
Dr. Eric J. Gartman
Invasive action on these nodules is based on solid component size and growth, and usually the interval for following them once they have demonstrated early stability is annually. The optimal duration of follow-up is still in question, but ceasing follow-up for all part-solid nodules at 3 years likely is premature given the variable slow progression these nodules exhibit.

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Body

 

Eric Gartman, MD, FCCP, comments: This study provides further support that the biology of ground-glass and part-solid nodules is different than fully solid nodules – and we should not be in a rush to resect these lesions. While the recommendations are likely to evolve over time as more information becomes available, this conservative approach toward nonsolid nodules is currently adopted in the Lung-RADS guidelines.

Dr. Eric J. Gartman
Dr. Eric J. Gartman
Invasive action on these nodules is based on solid component size and growth, and usually the interval for following them once they have demonstrated early stability is annually. The optimal duration of follow-up is still in question, but ceasing follow-up for all part-solid nodules at 3 years likely is premature given the variable slow progression these nodules exhibit.

Body

 

Eric Gartman, MD, FCCP, comments: This study provides further support that the biology of ground-glass and part-solid nodules is different than fully solid nodules – and we should not be in a rush to resect these lesions. While the recommendations are likely to evolve over time as more information becomes available, this conservative approach toward nonsolid nodules is currently adopted in the Lung-RADS guidelines.

Dr. Eric J. Gartman
Dr. Eric J. Gartman
Invasive action on these nodules is based on solid component size and growth, and usually the interval for following them once they have demonstrated early stability is annually. The optimal duration of follow-up is still in question, but ceasing follow-up for all part-solid nodules at 3 years likely is premature given the variable slow progression these nodules exhibit.

 

Three years of follow-up is adequate for partially solid ground-glass opacity lesions that do not progress, while pure ground-glass opacity lesions that show no progression may require further follow-up care, a study suggests.


The results of the study strengthen the argument for taking a “watch and wait” approach, and raise the question of whether patient outcomes can be improved without more precise diagnostic criteria, said study author Shigei Sawada, MD, PhD, a researcher at the Shikoku Cancer Center in Matsuyama, Japan, and his colleagues. They drew these conclusions from performing a long-term outcome investigation of 226 patients with pure or mixed ground-glass opacity lesions shown by CT imaging to be 3 cm or less in diameter.


Once established that the disease has stabilized in a pure or mixed ground-glass opacity lesion, “the frequency of CT examinations could probably be reduced or ... discontinued,” the investigators wrote. The study is published online in Chest (2017;151[2]:308-15).
Because ground-glass opacities often can remain unchanged for years, reflexively choosing resection can result in a patient’s being overtreated. Meanwhile, the use of increasingly accurate imaging technology likely means detection rates of such lesions will continue to increase, leaving clinicians to wonder about optimal management protocols, particularly since several guidance documents include differing recommendations on the timing of surveillance CTs for patients with stable disease.


The study includes 10-15 years of follow-up data on the 226 patients, registered between 2000 and 2005. Across the study, there were nearly twice as many women as men, all with an average age of 61 years. About a quarter had multiple ground-glass opacities; about a quarter also had partially consolidated lesions. Of the 124 patients who’d had resections, all but one was stage IA. The most prominent histologic subtype was adenocarcinoma in situ in 63 patients, followed by 39 patients with minimally invasive adenocarcinomas, and 19 with lepidic predominant adenocarcinomas. Five patients had papillary-predominant adenocarcinomas.   


Roughly one-quarter of the cohort did not receive follow-up examinations after 68 months, as their lesions either remained stable or were shown to have reduced in size. Another 45 continued to undergo follow-up examinations.


After initial detection of a pure ground-glass opacity, the CT examination schedule was every 3, 6, and 12 months, and then annually. After detection of a mixed ground-glass opacity, a CT examination was given every 3 months for the first year, then reduced to every 6 months thereafter. In patients with stable disease, the individual clinicians determined whether to obtain additional CT follow-up imaging.


A ground-glass lesion was determined to have progressed if the diameter increased, as it did in about a third of patients; or, if there was new or increased consolidation, as there was in about two-thirds of patients. The table of consolidation/tumor ratios (CTR) used included CTR zero, also referred to as a pure ground-glass lesion; CTR 1-25; CTR 26-50; and CTR equal to or greater than 51. When there were multiple lesions, the largest one detected was the target.
All cases of patients with a CTR of more than zero were identified within 3 years, while 13.6% of patients with a CTR of zero required more than 3 years to identify tumor growth. Aggressive cancer was detected in 4% of patients with a CTR of zero and in 70% of those with a CTR greater than 25% (P less than .001). Aggressive cancer was seen in 46% of those with consolidation/tumor ratios that increased during follow-up and in 8% of those whose tumors increased in diameter (P less than .007). After about 10 years of follow-up after resection, 1.6% of cancers recurred.


There were two deaths from lung cancer among the study’s patients. The first, a 54-year-old man, had an acinar-predominant adenocarcinoma, 5 mm in diameter with a consolidation/tumor ratio of 0.75 that increased during follow-up. The recurrence developed in the mediastinal lymph nodes 51 months after resection surgery. The second patient had a papillary-predominant adenocarcinoma appearing as a pure ground-glass opacity 27 mm in diameter. The consolidation/tumor ratio also increased during follow-up, with recurrences in the bone and mediastinal lymph nodes at 30 months post resectioning.


Neither patient was re-biopsied, and both were diagnosed according to CT imaging alone. There were 13 other patient deaths from non–lung cancer related causes.


Given the 3-year timespan necessary to detect tumor growth in all but the CTR zero group, and the study’s size and long-term nature, the investigators concluded that a follow-up period of 3 years for patients with part-solid lesions “should be adequate.”


By contrast, CHEST recommends CT scans be done for at least 3 years in patients with pure ground-glass lesions and between 3 and 5 years in the other CTR groups with nodules measuring 8 mm or less. The National Comprehensive Cancer Network guideline advises low-dose CT scanning until a patient is no longer eligible for definitive treatment.
Dr. Sawada and his colleagues did not use an exact criterion for tumor growth in their study, such as a precise ratio of increase in size or consolidation, in part because at the time of the study the most common form of CT evaluation was visual inspection; they reported that tumors exhibiting growth most commonly increased between 2 and 3 mm in either size or consolidation. “Evaluations based on visual inspections can be imprecise, and different physicians may arrive at different judgments,” the investigators wrote. “However, [the use of] computer-aided diagnosis systems are not yet commonly applied in clinical practice.”
Although imaging should have guided the decision to resect, according to Dr. Sawada and his coauthors, two-thirds of patients in the study were given the procedure even though their lesions were not shown by CT scans to have progressed. This was done either at the patient’s request, or per the clinical judgment of a physician.


Dr. Frank Detterbeck, surgical director, Yale University
Dr. Frank Detterbeck
Although the study “represents a major advance,” according to Frank C. Detterbeck, MD, FCCP, surgical director of thoracic oncology at Yale University, New Haven, Conn., who wrote an editorial accompanying the study, the results should spur the field to get more specific, and question whether a 3-year window was enough. “This seems counterintuitive given the chance of it becoming an invasive cancer,” Dr. Detterbeck wrote, indicating that not rushing to resection should mean more use of CT. “We should just look at what is already in front of our eyes: the radiographic features of [ground-glass nodules] are highly predictive of biological behavior. It will be hard to do better than this.”


Also becoming more specific about changing CTRs would be helpful in developing management protocols, according to Dr. Detterbeck. “In my opinion, we need to start factoring in the rate of change. A gradual 2 mm increase in size over a period of 5 years may not be an appropriate trigger for resection.”


Neither the investigators nor the editorial writer had any relevant disclosures.

 

 

Three years of follow-up is adequate for partially solid ground-glass opacity lesions that do not progress, while pure ground-glass opacity lesions that show no progression may require further follow-up care, a study suggests.


The results of the study strengthen the argument for taking a “watch and wait” approach, and raise the question of whether patient outcomes can be improved without more precise diagnostic criteria, said study author Shigei Sawada, MD, PhD, a researcher at the Shikoku Cancer Center in Matsuyama, Japan, and his colleagues. They drew these conclusions from performing a long-term outcome investigation of 226 patients with pure or mixed ground-glass opacity lesions shown by CT imaging to be 3 cm or less in diameter.


Once established that the disease has stabilized in a pure or mixed ground-glass opacity lesion, “the frequency of CT examinations could probably be reduced or ... discontinued,” the investigators wrote. The study is published online in Chest (2017;151[2]:308-15).
Because ground-glass opacities often can remain unchanged for years, reflexively choosing resection can result in a patient’s being overtreated. Meanwhile, the use of increasingly accurate imaging technology likely means detection rates of such lesions will continue to increase, leaving clinicians to wonder about optimal management protocols, particularly since several guidance documents include differing recommendations on the timing of surveillance CTs for patients with stable disease.


The study includes 10-15 years of follow-up data on the 226 patients, registered between 2000 and 2005. Across the study, there were nearly twice as many women as men, all with an average age of 61 years. About a quarter had multiple ground-glass opacities; about a quarter also had partially consolidated lesions. Of the 124 patients who’d had resections, all but one was stage IA. The most prominent histologic subtype was adenocarcinoma in situ in 63 patients, followed by 39 patients with minimally invasive adenocarcinomas, and 19 with lepidic predominant adenocarcinomas. Five patients had papillary-predominant adenocarcinomas.   


Roughly one-quarter of the cohort did not receive follow-up examinations after 68 months, as their lesions either remained stable or were shown to have reduced in size. Another 45 continued to undergo follow-up examinations.


After initial detection of a pure ground-glass opacity, the CT examination schedule was every 3, 6, and 12 months, and then annually. After detection of a mixed ground-glass opacity, a CT examination was given every 3 months for the first year, then reduced to every 6 months thereafter. In patients with stable disease, the individual clinicians determined whether to obtain additional CT follow-up imaging.


A ground-glass lesion was determined to have progressed if the diameter increased, as it did in about a third of patients; or, if there was new or increased consolidation, as there was in about two-thirds of patients. The table of consolidation/tumor ratios (CTR) used included CTR zero, also referred to as a pure ground-glass lesion; CTR 1-25; CTR 26-50; and CTR equal to or greater than 51. When there were multiple lesions, the largest one detected was the target.
All cases of patients with a CTR of more than zero were identified within 3 years, while 13.6% of patients with a CTR of zero required more than 3 years to identify tumor growth. Aggressive cancer was detected in 4% of patients with a CTR of zero and in 70% of those with a CTR greater than 25% (P less than .001). Aggressive cancer was seen in 46% of those with consolidation/tumor ratios that increased during follow-up and in 8% of those whose tumors increased in diameter (P less than .007). After about 10 years of follow-up after resection, 1.6% of cancers recurred.


There were two deaths from lung cancer among the study’s patients. The first, a 54-year-old man, had an acinar-predominant adenocarcinoma, 5 mm in diameter with a consolidation/tumor ratio of 0.75 that increased during follow-up. The recurrence developed in the mediastinal lymph nodes 51 months after resection surgery. The second patient had a papillary-predominant adenocarcinoma appearing as a pure ground-glass opacity 27 mm in diameter. The consolidation/tumor ratio also increased during follow-up, with recurrences in the bone and mediastinal lymph nodes at 30 months post resectioning.


Neither patient was re-biopsied, and both were diagnosed according to CT imaging alone. There were 13 other patient deaths from non–lung cancer related causes.


Given the 3-year timespan necessary to detect tumor growth in all but the CTR zero group, and the study’s size and long-term nature, the investigators concluded that a follow-up period of 3 years for patients with part-solid lesions “should be adequate.”


By contrast, CHEST recommends CT scans be done for at least 3 years in patients with pure ground-glass lesions and between 3 and 5 years in the other CTR groups with nodules measuring 8 mm or less. The National Comprehensive Cancer Network guideline advises low-dose CT scanning until a patient is no longer eligible for definitive treatment.
Dr. Sawada and his colleagues did not use an exact criterion for tumor growth in their study, such as a precise ratio of increase in size or consolidation, in part because at the time of the study the most common form of CT evaluation was visual inspection; they reported that tumors exhibiting growth most commonly increased between 2 and 3 mm in either size or consolidation. “Evaluations based on visual inspections can be imprecise, and different physicians may arrive at different judgments,” the investigators wrote. “However, [the use of] computer-aided diagnosis systems are not yet commonly applied in clinical practice.”
Although imaging should have guided the decision to resect, according to Dr. Sawada and his coauthors, two-thirds of patients in the study were given the procedure even though their lesions were not shown by CT scans to have progressed. This was done either at the patient’s request, or per the clinical judgment of a physician.


Dr. Frank Detterbeck, surgical director, Yale University
Dr. Frank Detterbeck
Although the study “represents a major advance,” according to Frank C. Detterbeck, MD, FCCP, surgical director of thoracic oncology at Yale University, New Haven, Conn., who wrote an editorial accompanying the study, the results should spur the field to get more specific, and question whether a 3-year window was enough. “This seems counterintuitive given the chance of it becoming an invasive cancer,” Dr. Detterbeck wrote, indicating that not rushing to resection should mean more use of CT. “We should just look at what is already in front of our eyes: the radiographic features of [ground-glass nodules] are highly predictive of biological behavior. It will be hard to do better than this.”


Also becoming more specific about changing CTRs would be helpful in developing management protocols, according to Dr. Detterbeck. “In my opinion, we need to start factoring in the rate of change. A gradual 2 mm increase in size over a period of 5 years may not be an appropriate trigger for resection.”


Neither the investigators nor the editorial writer had any relevant disclosures.

 

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Key clinical point: Three-year observation of ground-glass opacities is an appropriate management protocol for patients with a CTR greater than zero, although more may be necessary for those with zero ratio.

Major finding: Of 226 patients with ground-glass opacity lesions 3 cm or less in size, 124 had resection, 57 required no further follow-up, and 45 continue to receive follow-up.

Data source: Long-term study of 226 patients with pure or mixed ground-glass opacities of 3 cm or less given regular CT imaging between 2000 and 2005.

Disclosures: Neither the investigators nor the editorial writer had any relevant disclosures.

Pregnancy medical home reduces hospital visits, overall costs

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Thu, 03/28/2019 - 14:56

 

– Women and their newborns who received care through a pregnancy medical home model used the emergency department less and had fewer inpatient stays, resulting in significant cost savings to a state health insurance plan.

In the single-center, retrospective cohort study, women who had at least one medical home visit had 897 emergency department visits per 1,000 member months, compared with 1,969/1,000 member months for patients who had no medical home visits (P less than .01). Newborns in the medical home group had fewer inpatient days per 1,000 member months as well, compared with non–medical home infants (698 vs. 1,799 days/member month, P less than .01). Inpatient stays for pregnant women receiving medical home care were also reduced (4,279 vs. 2,939 inpatient days, P less than .01).

Jupiterimages/Thinkstock
“The pregnancy medical home model was associated with reduced emergency department utilization and hospital stays, and reduced cost for participating women and their newborns,” said the study’s first author, Anju Suhag, MD, adding that the enhanced access, including after-hours care and 24-hour nurse triage, could potentially avert ED visits.

The pregnancy medical home project was conducted jointly by the Texas Children’s Health Plan and Baylor College of Medicine. The care delivery model, offered from the Baylor Center for Children and Women, gave pregnant women enhanced access, used evidence-based protocols for treatment, and emphasized both quality care and the patient experience, said Dr. Suhag, professor of ob.gyn. at Baylor College of Medicine, Houston.

The pregnancy medical home includes extended hours, walk-in appointments, 24-hour nurse availability for triage, and a laborist model for hospital coverage.

From a payment perspective, the medical home is a fully capitated, full-risk model. “Our center is paid on a monthly basis to provide care to members of our panel,” Dr. Suhag said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The primary outcomes measured by the study were the number of inpatient days and the rate of emergency department usage among pregnancy medical home participants, compared with nonparticipating pregnant women and newborns seen at the Center for Children and Women. Annualized cost savings for the pregnancy medical home model was a secondary outcome measure.

Over a 1-year period, the study examined claims data for pregnant women and newborns who were enrolled in the Texas Children’s Health Plan and were assigned to the pregnancy medical home panel. In total, 27,912 member months (including care for both women and newborns) were examined; of these, about 37% (10,402) were for women and newborns who had at least one medical home visit, and 63% (17,510) of the member months accrued to patients who had no medical home visits. Women and their infants were excluded from the cohort if they received care billed to another health plan.

Participation in the medical home group resulted in lower costs, with annualized estimated emergency department cost savings of $330,161 and $30,739 for pregnant women and newborns, respectively. The reduced number of inpatient days in the medical home group resulted in a total savings of $494,313 for pregnant women and $1,606,392 for newborns in this cohort.

The integrated care model, which used a care coordinator and provided care from multiple specialties at a single site, was likely the key to success, Dr. Suhag said. “With this access, 40% of our pregnant moms were able to access prenatal care in the first trimester, which likely improved outcomes and contributed to the cost savings,” she said.

The control group in the study was made up of individuals who had been randomized to the medical home, but who had chosen care from another provider instead. Because the researchers were relying on health claims data, they were not able to perform a detailed comparison between the two groups, leaving open the possibility that patient characteristics may have accounted for part of the differences in outcomes. Women “could self-select to receive care at the Center for Children and Women,” Dr. Suhag said in an interview. “It is possible that they are different than the women who did not choose care in our clinic.”

A strength of the study, Dr. Suhag said, is that it evaluated outcomes from the medical home model by comparing it to several other medical practices caring for a similar demographic in the same geographic area.

The study was conducted by the Texas Children’s Health Plan and Baylor College of Medicine. Dr. Suhag reported having no other outside sources of funding or conflicts of interest.

Dr. Suhag reported having no outside sources of funding beyond the study’s two sponsoring organizations and no conflicts of interest.

 

 

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– Women and their newborns who received care through a pregnancy medical home model used the emergency department less and had fewer inpatient stays, resulting in significant cost savings to a state health insurance plan.

In the single-center, retrospective cohort study, women who had at least one medical home visit had 897 emergency department visits per 1,000 member months, compared with 1,969/1,000 member months for patients who had no medical home visits (P less than .01). Newborns in the medical home group had fewer inpatient days per 1,000 member months as well, compared with non–medical home infants (698 vs. 1,799 days/member month, P less than .01). Inpatient stays for pregnant women receiving medical home care were also reduced (4,279 vs. 2,939 inpatient days, P less than .01).

Jupiterimages/Thinkstock
“The pregnancy medical home model was associated with reduced emergency department utilization and hospital stays, and reduced cost for participating women and their newborns,” said the study’s first author, Anju Suhag, MD, adding that the enhanced access, including after-hours care and 24-hour nurse triage, could potentially avert ED visits.

The pregnancy medical home project was conducted jointly by the Texas Children’s Health Plan and Baylor College of Medicine. The care delivery model, offered from the Baylor Center for Children and Women, gave pregnant women enhanced access, used evidence-based protocols for treatment, and emphasized both quality care and the patient experience, said Dr. Suhag, professor of ob.gyn. at Baylor College of Medicine, Houston.

The pregnancy medical home includes extended hours, walk-in appointments, 24-hour nurse availability for triage, and a laborist model for hospital coverage.

From a payment perspective, the medical home is a fully capitated, full-risk model. “Our center is paid on a monthly basis to provide care to members of our panel,” Dr. Suhag said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The primary outcomes measured by the study were the number of inpatient days and the rate of emergency department usage among pregnancy medical home participants, compared with nonparticipating pregnant women and newborns seen at the Center for Children and Women. Annualized cost savings for the pregnancy medical home model was a secondary outcome measure.

Over a 1-year period, the study examined claims data for pregnant women and newborns who were enrolled in the Texas Children’s Health Plan and were assigned to the pregnancy medical home panel. In total, 27,912 member months (including care for both women and newborns) were examined; of these, about 37% (10,402) were for women and newborns who had at least one medical home visit, and 63% (17,510) of the member months accrued to patients who had no medical home visits. Women and their infants were excluded from the cohort if they received care billed to another health plan.

Participation in the medical home group resulted in lower costs, with annualized estimated emergency department cost savings of $330,161 and $30,739 for pregnant women and newborns, respectively. The reduced number of inpatient days in the medical home group resulted in a total savings of $494,313 for pregnant women and $1,606,392 for newborns in this cohort.

The integrated care model, which used a care coordinator and provided care from multiple specialties at a single site, was likely the key to success, Dr. Suhag said. “With this access, 40% of our pregnant moms were able to access prenatal care in the first trimester, which likely improved outcomes and contributed to the cost savings,” she said.

The control group in the study was made up of individuals who had been randomized to the medical home, but who had chosen care from another provider instead. Because the researchers were relying on health claims data, they were not able to perform a detailed comparison between the two groups, leaving open the possibility that patient characteristics may have accounted for part of the differences in outcomes. Women “could self-select to receive care at the Center for Children and Women,” Dr. Suhag said in an interview. “It is possible that they are different than the women who did not choose care in our clinic.”

A strength of the study, Dr. Suhag said, is that it evaluated outcomes from the medical home model by comparing it to several other medical practices caring for a similar demographic in the same geographic area.

The study was conducted by the Texas Children’s Health Plan and Baylor College of Medicine. Dr. Suhag reported having no other outside sources of funding or conflicts of interest.

Dr. Suhag reported having no outside sources of funding beyond the study’s two sponsoring organizations and no conflicts of interest.

 

 

 

– Women and their newborns who received care through a pregnancy medical home model used the emergency department less and had fewer inpatient stays, resulting in significant cost savings to a state health insurance plan.

In the single-center, retrospective cohort study, women who had at least one medical home visit had 897 emergency department visits per 1,000 member months, compared with 1,969/1,000 member months for patients who had no medical home visits (P less than .01). Newborns in the medical home group had fewer inpatient days per 1,000 member months as well, compared with non–medical home infants (698 vs. 1,799 days/member month, P less than .01). Inpatient stays for pregnant women receiving medical home care were also reduced (4,279 vs. 2,939 inpatient days, P less than .01).

Jupiterimages/Thinkstock
“The pregnancy medical home model was associated with reduced emergency department utilization and hospital stays, and reduced cost for participating women and their newborns,” said the study’s first author, Anju Suhag, MD, adding that the enhanced access, including after-hours care and 24-hour nurse triage, could potentially avert ED visits.

The pregnancy medical home project was conducted jointly by the Texas Children’s Health Plan and Baylor College of Medicine. The care delivery model, offered from the Baylor Center for Children and Women, gave pregnant women enhanced access, used evidence-based protocols for treatment, and emphasized both quality care and the patient experience, said Dr. Suhag, professor of ob.gyn. at Baylor College of Medicine, Houston.

The pregnancy medical home includes extended hours, walk-in appointments, 24-hour nurse availability for triage, and a laborist model for hospital coverage.

From a payment perspective, the medical home is a fully capitated, full-risk model. “Our center is paid on a monthly basis to provide care to members of our panel,” Dr. Suhag said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

The primary outcomes measured by the study were the number of inpatient days and the rate of emergency department usage among pregnancy medical home participants, compared with nonparticipating pregnant women and newborns seen at the Center for Children and Women. Annualized cost savings for the pregnancy medical home model was a secondary outcome measure.

Over a 1-year period, the study examined claims data for pregnant women and newborns who were enrolled in the Texas Children’s Health Plan and were assigned to the pregnancy medical home panel. In total, 27,912 member months (including care for both women and newborns) were examined; of these, about 37% (10,402) were for women and newborns who had at least one medical home visit, and 63% (17,510) of the member months accrued to patients who had no medical home visits. Women and their infants were excluded from the cohort if they received care billed to another health plan.

Participation in the medical home group resulted in lower costs, with annualized estimated emergency department cost savings of $330,161 and $30,739 for pregnant women and newborns, respectively. The reduced number of inpatient days in the medical home group resulted in a total savings of $494,313 for pregnant women and $1,606,392 for newborns in this cohort.

The integrated care model, which used a care coordinator and provided care from multiple specialties at a single site, was likely the key to success, Dr. Suhag said. “With this access, 40% of our pregnant moms were able to access prenatal care in the first trimester, which likely improved outcomes and contributed to the cost savings,” she said.

The control group in the study was made up of individuals who had been randomized to the medical home, but who had chosen care from another provider instead. Because the researchers were relying on health claims data, they were not able to perform a detailed comparison between the two groups, leaving open the possibility that patient characteristics may have accounted for part of the differences in outcomes. Women “could self-select to receive care at the Center for Children and Women,” Dr. Suhag said in an interview. “It is possible that they are different than the women who did not choose care in our clinic.”

A strength of the study, Dr. Suhag said, is that it evaluated outcomes from the medical home model by comparing it to several other medical practices caring for a similar demographic in the same geographic area.

The study was conducted by the Texas Children’s Health Plan and Baylor College of Medicine. Dr. Suhag reported having no other outside sources of funding or conflicts of interest.

Dr. Suhag reported having no outside sources of funding beyond the study’s two sponsoring organizations and no conflicts of interest.

 

 

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Key clinical point: A pregnancy medical home reduced emergency department use, inpatient days, and costs.

Major finding: Medical home patients had 897 emergency department visits, compared with 1,969 per 1,000 member months for non–medical home patients (P less than .01).

Data source: A retrospective cohort study of 27,912 patient member months comparing pregnancy medical home patients with non–medical home patients.

Disclosures: The study was conducted by the Texas Children’s Health Plan and Baylor College of Medicine. Dr. Suhag reported having no other outside sources of funding or conflicts of interest.

Weekend births linked to higher maternal-fetal mortality

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Fri, 01/18/2019 - 16:33

 

– Weekend deliveries were associated with a significantly increased risk of maternal-fetal morbidity and death, according to a review of all U.S. deliveries over the past decade.

“Maternal morbidity and mortality were increased on weekends, compared to weekdays, and stillbirth and neonatal morbidity were also increased in infants delivered on weekends. Both of these findings occur against a background of lower intrinsic risk among weekend deliveries,” Amirhossein Moaddab, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Kari Oakes/ Frontline Medical News
Dr. Amirhossein Moaddab
“Any system that shows this sort of variation in the most important of all system outcomes is, by definition, badly broken,” senior author Steven L. Clark, MD, said in a press release about the study. “Our data suggest that a part of the overall dismal U.S. obstetric performance may be related to this systems issue.”

Study objectives included measuring both maternal and fetal mortality ratios by the day and month of death or delivery; the study also tracked maternal and neonatal morbidities according to the day of the week the delivery occurred.

Using publicly available data sets (the National Vital Statistics System and the Centers for Disease Control and Prevention WONDER online database), Dr. Moaddab and his colleagues examined all live births and all maternal and fetal deaths in all 50 states and the District of Columbia for the period from 2004 to 2014.

In total, there were 45,036,622 live births, 7,551 maternal deaths, and 275,914 stillbirths during this period.

On weekdays, the maternal mortality rate was 15.3/100,000 live births; the rate rose to 22.8 maternal deaths per 100,000 live births on the weekends (P less than .001). Fetal mortality followed a similar pattern: The weekday fetal mortality rate was 5.85/1,000 live births, compared with 7.21/1,000 live births on the weekends (P less than .001).

A wide range of maternal and fetal morbidities were also more common when deliveries happened on the weekend. For mothers, the adjusted relative risk (aRR) ranged from 1.41 for maternal transfusion to 1.166 for perineal lacerations with Saturday or Sunday deliveries. Unplanned hysterectomy, however, was less likely on the weekend (aRR, 0.810).

Neonatal morbidities with a higher adjusted relative risk included gestational age less than 28 weeks (aRR, 1.481), a 5-minute Apgar score less than 7 (aRR, 1.251), and being placed on a ventilator or admitted to the neonatal intensive care unit (aRRs, 1.219 and 1.199, respectively). The odds of having a chromosomal abnormality were lower for infants delivered on weekends (aRR, 0.864), a result consistent with the increased likelihood of planned delivery for fetuses whose chromosomal status was known, said Dr. Moaddab, a postdoctoral fellow in obstetrics and gynecology at the Baylor College of Medicine, Houston .

Examining maternal characteristics, Dr. Moaddab and his colleagues did find some significant differences between those delivering on weekdays and weekends. However, because the weekend group was healthier overall than the weekday group, these differences were not likely to account for the worse weekend outcomes.

“We were able to control for pregnancy complications, and found that most women with pregnancy complications known to lead to death actually deliver on weekdays, suggesting that the total problem with weekend deliveries is even greater,” said Dr. Clark, professor of ob.gyn. at Baylor College of Medicine.

For example, women delivering on weekends were less likely to be smokers, have diabetes or gestational diabetes, or have chronic or gestational hypertension; they were also less likely to have had a previous cesarean delivery (all P equal to or less than .0001). They were, however, more likely to be nulliparous and to have eclampsia (P equal to or less than .0001).

Dr. Moaddab said that his group’s examination of monthly variations in maternal and fetal morbidity and mortality showed no sign of the “July phenomenon,” the worsening in outcomes seen in some specialties when new interns take to the wards and clinics.

The “weekend effect,” said Dr. Moaddab, has been documented elsewhere as well. In the United Kingdom, a recent observational study of obstetric outcomes found “increases in the rates of death and other complications for both women and babies born at weekends,” he said (BMJ. 2015;351:h5774).

Though Dr. Moaddab’s descriptive study couldn’t get at underlying causes, he said that there are many possible culprits. These can include the divided physician attention and reduced provider availability that can come with weekend staffing, as well as the possibility that the experience level of both physician and nurse staff drops on weekends. Long work hours that come with call may also contribute, he said.

The study authors reported no outside sources of funding and no conflicts of interest.
 

 

 

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– Weekend deliveries were associated with a significantly increased risk of maternal-fetal morbidity and death, according to a review of all U.S. deliveries over the past decade.

“Maternal morbidity and mortality were increased on weekends, compared to weekdays, and stillbirth and neonatal morbidity were also increased in infants delivered on weekends. Both of these findings occur against a background of lower intrinsic risk among weekend deliveries,” Amirhossein Moaddab, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Kari Oakes/ Frontline Medical News
Dr. Amirhossein Moaddab
“Any system that shows this sort of variation in the most important of all system outcomes is, by definition, badly broken,” senior author Steven L. Clark, MD, said in a press release about the study. “Our data suggest that a part of the overall dismal U.S. obstetric performance may be related to this systems issue.”

Study objectives included measuring both maternal and fetal mortality ratios by the day and month of death or delivery; the study also tracked maternal and neonatal morbidities according to the day of the week the delivery occurred.

Using publicly available data sets (the National Vital Statistics System and the Centers for Disease Control and Prevention WONDER online database), Dr. Moaddab and his colleagues examined all live births and all maternal and fetal deaths in all 50 states and the District of Columbia for the period from 2004 to 2014.

In total, there were 45,036,622 live births, 7,551 maternal deaths, and 275,914 stillbirths during this period.

On weekdays, the maternal mortality rate was 15.3/100,000 live births; the rate rose to 22.8 maternal deaths per 100,000 live births on the weekends (P less than .001). Fetal mortality followed a similar pattern: The weekday fetal mortality rate was 5.85/1,000 live births, compared with 7.21/1,000 live births on the weekends (P less than .001).

A wide range of maternal and fetal morbidities were also more common when deliveries happened on the weekend. For mothers, the adjusted relative risk (aRR) ranged from 1.41 for maternal transfusion to 1.166 for perineal lacerations with Saturday or Sunday deliveries. Unplanned hysterectomy, however, was less likely on the weekend (aRR, 0.810).

Neonatal morbidities with a higher adjusted relative risk included gestational age less than 28 weeks (aRR, 1.481), a 5-minute Apgar score less than 7 (aRR, 1.251), and being placed on a ventilator or admitted to the neonatal intensive care unit (aRRs, 1.219 and 1.199, respectively). The odds of having a chromosomal abnormality were lower for infants delivered on weekends (aRR, 0.864), a result consistent with the increased likelihood of planned delivery for fetuses whose chromosomal status was known, said Dr. Moaddab, a postdoctoral fellow in obstetrics and gynecology at the Baylor College of Medicine, Houston .

Examining maternal characteristics, Dr. Moaddab and his colleagues did find some significant differences between those delivering on weekdays and weekends. However, because the weekend group was healthier overall than the weekday group, these differences were not likely to account for the worse weekend outcomes.

“We were able to control for pregnancy complications, and found that most women with pregnancy complications known to lead to death actually deliver on weekdays, suggesting that the total problem with weekend deliveries is even greater,” said Dr. Clark, professor of ob.gyn. at Baylor College of Medicine.

For example, women delivering on weekends were less likely to be smokers, have diabetes or gestational diabetes, or have chronic or gestational hypertension; they were also less likely to have had a previous cesarean delivery (all P equal to or less than .0001). They were, however, more likely to be nulliparous and to have eclampsia (P equal to or less than .0001).

Dr. Moaddab said that his group’s examination of monthly variations in maternal and fetal morbidity and mortality showed no sign of the “July phenomenon,” the worsening in outcomes seen in some specialties when new interns take to the wards and clinics.

The “weekend effect,” said Dr. Moaddab, has been documented elsewhere as well. In the United Kingdom, a recent observational study of obstetric outcomes found “increases in the rates of death and other complications for both women and babies born at weekends,” he said (BMJ. 2015;351:h5774).

Though Dr. Moaddab’s descriptive study couldn’t get at underlying causes, he said that there are many possible culprits. These can include the divided physician attention and reduced provider availability that can come with weekend staffing, as well as the possibility that the experience level of both physician and nurse staff drops on weekends. Long work hours that come with call may also contribute, he said.

The study authors reported no outside sources of funding and no conflicts of interest.
 

 

 

 

– Weekend deliveries were associated with a significantly increased risk of maternal-fetal morbidity and death, according to a review of all U.S. deliveries over the past decade.

“Maternal morbidity and mortality were increased on weekends, compared to weekdays, and stillbirth and neonatal morbidity were also increased in infants delivered on weekends. Both of these findings occur against a background of lower intrinsic risk among weekend deliveries,” Amirhossein Moaddab, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

Kari Oakes/ Frontline Medical News
Dr. Amirhossein Moaddab
“Any system that shows this sort of variation in the most important of all system outcomes is, by definition, badly broken,” senior author Steven L. Clark, MD, said in a press release about the study. “Our data suggest that a part of the overall dismal U.S. obstetric performance may be related to this systems issue.”

Study objectives included measuring both maternal and fetal mortality ratios by the day and month of death or delivery; the study also tracked maternal and neonatal morbidities according to the day of the week the delivery occurred.

Using publicly available data sets (the National Vital Statistics System and the Centers for Disease Control and Prevention WONDER online database), Dr. Moaddab and his colleagues examined all live births and all maternal and fetal deaths in all 50 states and the District of Columbia for the period from 2004 to 2014.

In total, there were 45,036,622 live births, 7,551 maternal deaths, and 275,914 stillbirths during this period.

On weekdays, the maternal mortality rate was 15.3/100,000 live births; the rate rose to 22.8 maternal deaths per 100,000 live births on the weekends (P less than .001). Fetal mortality followed a similar pattern: The weekday fetal mortality rate was 5.85/1,000 live births, compared with 7.21/1,000 live births on the weekends (P less than .001).

A wide range of maternal and fetal morbidities were also more common when deliveries happened on the weekend. For mothers, the adjusted relative risk (aRR) ranged from 1.41 for maternal transfusion to 1.166 for perineal lacerations with Saturday or Sunday deliveries. Unplanned hysterectomy, however, was less likely on the weekend (aRR, 0.810).

Neonatal morbidities with a higher adjusted relative risk included gestational age less than 28 weeks (aRR, 1.481), a 5-minute Apgar score less than 7 (aRR, 1.251), and being placed on a ventilator or admitted to the neonatal intensive care unit (aRRs, 1.219 and 1.199, respectively). The odds of having a chromosomal abnormality were lower for infants delivered on weekends (aRR, 0.864), a result consistent with the increased likelihood of planned delivery for fetuses whose chromosomal status was known, said Dr. Moaddab, a postdoctoral fellow in obstetrics and gynecology at the Baylor College of Medicine, Houston .

Examining maternal characteristics, Dr. Moaddab and his colleagues did find some significant differences between those delivering on weekdays and weekends. However, because the weekend group was healthier overall than the weekday group, these differences were not likely to account for the worse weekend outcomes.

“We were able to control for pregnancy complications, and found that most women with pregnancy complications known to lead to death actually deliver on weekdays, suggesting that the total problem with weekend deliveries is even greater,” said Dr. Clark, professor of ob.gyn. at Baylor College of Medicine.

For example, women delivering on weekends were less likely to be smokers, have diabetes or gestational diabetes, or have chronic or gestational hypertension; they were also less likely to have had a previous cesarean delivery (all P equal to or less than .0001). They were, however, more likely to be nulliparous and to have eclampsia (P equal to or less than .0001).

Dr. Moaddab said that his group’s examination of monthly variations in maternal and fetal morbidity and mortality showed no sign of the “July phenomenon,” the worsening in outcomes seen in some specialties when new interns take to the wards and clinics.

The “weekend effect,” said Dr. Moaddab, has been documented elsewhere as well. In the United Kingdom, a recent observational study of obstetric outcomes found “increases in the rates of death and other complications for both women and babies born at weekends,” he said (BMJ. 2015;351:h5774).

Though Dr. Moaddab’s descriptive study couldn’t get at underlying causes, he said that there are many possible culprits. These can include the divided physician attention and reduced provider availability that can come with weekend staffing, as well as the possibility that the experience level of both physician and nurse staff drops on weekends. Long work hours that come with call may also contribute, he said.

The study authors reported no outside sources of funding and no conflicts of interest.
 

 

 

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Key clinical point: Weekend deliveries are associated with higher maternal-fetal morbidity and death.

Major finding: On weekends, the maternal death rate was 22.8/100,000 live births, compared with a weekday rate of 15.3/100,000 (P less than .001).

Data source: A retrospective study of U.S. publicly available maternal-fetal data, including 45,036,622 live births, 7,551 maternal deaths, and 275,914 stillbirths from 2004 to 2014.

Disclosures: The study authors reported no outside sources of funding and no conflicts of interest.

Want better patient engagement? Use social media

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– Looking for a better way to reach your patients and guide them to being more engaged in their own health care? Then expand your social media presence.

That was the message Kevin Campbell, MD, a cardiologist at the University of North Carolina, Chapel Hill, told attendees at the annual meeting of the Healthcare Information and Management Systems Society.

Dr. Kevin Campbell


“Social media is where our patients, customers, and consumers, as well as our colleagues are and where we need to be,” Dr. Campbell said.

He called out three specific social media tools – Twitter, Facebook Live, and blogging – as the most effective for physicians. The first two offer a key way to connect with patients and colleagues – the ability to use video.

“The most important thing out in the digital space in terms of engagement is video and the visual,” Dr. Campbell said. “You’ll get 6,000% more engagement with a video-type point of contact. That can be a link from Twitter or it can be a Facebook Live [session] or a YouTube video.”

Video messaging also helps doctors support their peers, Dr. Campbell said.

“We can provide timely information to our colleagues,” he noted. “We have Twitter chats with fellows-in-training … I can talk to fellows who are in Germany about a technique we’re using here and then they can learn more about that technique.”

Secure social media channels also can be used to share thoughts and ideas regarding a clinical query regarding a specific test or imaging result, he said.

“The patient benefits because there are more brains thinking about their problem,” he noted.

Blogging also can be effective for reaching out to patients and colleagues as it provides a way to disseminate information on topics such as new treatments or learning about disease states.

But if the blog is set up to be interactive, doctors can get insights into their patients’ health concerns, Dr. Campbell said.

“I let patients write on my blog and I actually learn a ton about the patient experience,” he said. “I don’t even think of X, Y, and Z situation. I will be more empathetic to this because of what [they] told me.”

The caveat, of course, is that specific, protected information cannot be shared or posted.

“The attorneys will really get upset,” he noted. “So you do not develop a legal duty to that patient. But you can talk about treatments and what’s out there and what’s available. ... There may be a new treatment for leukemia that’s experimental that’s coming out of a university in Philadelphia and I can talk about that treatment.”

Dr. Campbell also said social media can be effective for doctors to promote themselves, pointing to his own career where he serves as a regular commentator on both the national and local levels. Engaging with media outlets can help turn a doctor into a key opinion leader, he said.

“If you say something important, engage about important issues, patients, consumers, industry partners and other leaders in the field are going to engage with you,” he said.

Dr. Campbell reported no conflicts of interest.

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– Looking for a better way to reach your patients and guide them to being more engaged in their own health care? Then expand your social media presence.

That was the message Kevin Campbell, MD, a cardiologist at the University of North Carolina, Chapel Hill, told attendees at the annual meeting of the Healthcare Information and Management Systems Society.

Dr. Kevin Campbell


“Social media is where our patients, customers, and consumers, as well as our colleagues are and where we need to be,” Dr. Campbell said.

He called out three specific social media tools – Twitter, Facebook Live, and blogging – as the most effective for physicians. The first two offer a key way to connect with patients and colleagues – the ability to use video.

“The most important thing out in the digital space in terms of engagement is video and the visual,” Dr. Campbell said. “You’ll get 6,000% more engagement with a video-type point of contact. That can be a link from Twitter or it can be a Facebook Live [session] or a YouTube video.”

Video messaging also helps doctors support their peers, Dr. Campbell said.

“We can provide timely information to our colleagues,” he noted. “We have Twitter chats with fellows-in-training … I can talk to fellows who are in Germany about a technique we’re using here and then they can learn more about that technique.”

Secure social media channels also can be used to share thoughts and ideas regarding a clinical query regarding a specific test or imaging result, he said.

“The patient benefits because there are more brains thinking about their problem,” he noted.

Blogging also can be effective for reaching out to patients and colleagues as it provides a way to disseminate information on topics such as new treatments or learning about disease states.

But if the blog is set up to be interactive, doctors can get insights into their patients’ health concerns, Dr. Campbell said.

“I let patients write on my blog and I actually learn a ton about the patient experience,” he said. “I don’t even think of X, Y, and Z situation. I will be more empathetic to this because of what [they] told me.”

The caveat, of course, is that specific, protected information cannot be shared or posted.

“The attorneys will really get upset,” he noted. “So you do not develop a legal duty to that patient. But you can talk about treatments and what’s out there and what’s available. ... There may be a new treatment for leukemia that’s experimental that’s coming out of a university in Philadelphia and I can talk about that treatment.”

Dr. Campbell also said social media can be effective for doctors to promote themselves, pointing to his own career where he serves as a regular commentator on both the national and local levels. Engaging with media outlets can help turn a doctor into a key opinion leader, he said.

“If you say something important, engage about important issues, patients, consumers, industry partners and other leaders in the field are going to engage with you,” he said.

Dr. Campbell reported no conflicts of interest.

 

– Looking for a better way to reach your patients and guide them to being more engaged in their own health care? Then expand your social media presence.

That was the message Kevin Campbell, MD, a cardiologist at the University of North Carolina, Chapel Hill, told attendees at the annual meeting of the Healthcare Information and Management Systems Society.

Dr. Kevin Campbell


“Social media is where our patients, customers, and consumers, as well as our colleagues are and where we need to be,” Dr. Campbell said.

He called out three specific social media tools – Twitter, Facebook Live, and blogging – as the most effective for physicians. The first two offer a key way to connect with patients and colleagues – the ability to use video.

“The most important thing out in the digital space in terms of engagement is video and the visual,” Dr. Campbell said. “You’ll get 6,000% more engagement with a video-type point of contact. That can be a link from Twitter or it can be a Facebook Live [session] or a YouTube video.”

Video messaging also helps doctors support their peers, Dr. Campbell said.

“We can provide timely information to our colleagues,” he noted. “We have Twitter chats with fellows-in-training … I can talk to fellows who are in Germany about a technique we’re using here and then they can learn more about that technique.”

Secure social media channels also can be used to share thoughts and ideas regarding a clinical query regarding a specific test or imaging result, he said.

“The patient benefits because there are more brains thinking about their problem,” he noted.

Blogging also can be effective for reaching out to patients and colleagues as it provides a way to disseminate information on topics such as new treatments or learning about disease states.

But if the blog is set up to be interactive, doctors can get insights into their patients’ health concerns, Dr. Campbell said.

“I let patients write on my blog and I actually learn a ton about the patient experience,” he said. “I don’t even think of X, Y, and Z situation. I will be more empathetic to this because of what [they] told me.”

The caveat, of course, is that specific, protected information cannot be shared or posted.

“The attorneys will really get upset,” he noted. “So you do not develop a legal duty to that patient. But you can talk about treatments and what’s out there and what’s available. ... There may be a new treatment for leukemia that’s experimental that’s coming out of a university in Philadelphia and I can talk about that treatment.”

Dr. Campbell also said social media can be effective for doctors to promote themselves, pointing to his own career where he serves as a regular commentator on both the national and local levels. Engaging with media outlets can help turn a doctor into a key opinion leader, he said.

“If you say something important, engage about important issues, patients, consumers, industry partners and other leaders in the field are going to engage with you,” he said.

Dr. Campbell reported no conflicts of interest.

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Precision and Accuracy of Identification of Anatomical Surface Landmarks by 30 Expert Hip Arthroscopists

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Precision and Accuracy of Identification of Anatomical Surface Landmarks by 30 Expert Hip Arthroscopists

Take-Home Points

  • Surface landmarks are routinely used for physical examination and surgical technique.
  • Common surface landmarks used in establishing arthroscopic portals may be more difficult to accurately identify than previously thought.
  • The greater trochanter was the surface landmark most precisely identified by expert examiners.
  • Ultrasound examination identified landmarks varied from landmarks identified by palpation alone.

Anatomical surface landmarks about the hip and lower abdomen are often referenced when placing arthroscopic portals and office-based injections.1-3 However, the degree to which these landmarks can be reproducibly identified using only visual inspection and palpation is unknown.

Safe access to the hip joint and surrounding structures during hip arthroscopy has been a focus in the orthopedic literature. Authors have described anatomical relationships of recommended portals to neurovascular and other anatomical structures.4-6 This information has been reported in millimeters to centimeters of safety based on cadaver dissection studies.4-7We conducted a study to assess expert hip arthroscopists’ ability to identify, using only physical examination techniques, the anatomical structures used for reference when creating safe starting points for arthroscopic access. We hypothesized that variance in examiner-identified points would exceed safe distances from neurovascular structures for the most commonly used hip arthroscopic portals. The volunteer in this study provided written informed consent for print and electronic publication of this article.

Methods

In this study, we prospectively assessed 30 expert hip arthroscopic surgeons’ ability to identify commonly referenced surface landmarks on the adult male hip, using only inspection and manual palpation. Surgeons were defined as experts on the basis of their status as hip arthroscopy instructors at the Orthopaedic Learning Center (Rosemont, IL) for the Arthroscopy Association of North America and industry-sponsored hip arthroscopy education faculty (Arthrex). Five surface landmarks were selected for their relevance to publications on safe portal placement2-5: anterior superior iliac spine (ASIS), tip of greater trochanter (GT), rectus origin (RO), superficial inguinal ring (SIR), and psoas tendon (PT).

A healthy adult male volunteer was placed supine on an examination table and exposed distally from the mid abdomen, with the perineum and the genital area covered bikini-style. An expert musculoskeletal ultrasonographer used a handheld musculoskeletal ultrasound transducer (Sonosite) to identify the 5 landmarks. Short- and long-axis images of each structure were obtained. The examiner applied a round (1 cm in diameter), uniquely colored adhesive label to the skin over each location. A professional photographer using a Canon digital camera and fixed mounts made precise overhead and lateral images. The positional integrity and scale of these images were confirmed with referral to constant anatomical skin features. Images were archived for analysis (Figure 1A).

After the ultrasonographer’s labels were removed, each of the 30 expert hip arthroscopic surgeons identified the structures by static physical examination (inspection and palpation only) and applied the same colored labels to the skin.

Figure 1.
The volunteer was not allowed to communicate about label placement with examiners but was encouraged to report any safety-related concerns. The photographer made the same digital photographs of the labels for each examiner as for the ultrasonographer (Figure 1B).

Imaging software (Adobe Photoshop Creative Suite 5.1) was used to superimpose the digital images of the examiner labels on those of the ultrasound-verified anatomical labels (Figure 1C). Measurements were then taken with digital calipers to determine average distance from ultrasound label; accuracy within 10 mm of verified ultrasound label; true average location (TAL) determined by 95% confidence interval (CI); and interobserver variability calculated by 95% prediction interval, which determined the probability of where an additional examiner data point would lie.

In the second arm of the study, examiner data were compared with previously published data on arthroscopic portal safety.
Figure 2.
Distances from surface landmarks have been used to create common arthroscopy portals.2-4 The risk of neurovascular injury resulting from errors in identifying surface landmarks for creating portals was calculated using the direction and distance of the examiner TAL and the nearest published direction and distance of the nearest neurovascular structure. Increased risk of injury resulting from inaccurate identification of surface landmarks was surmised if the TAL of the anatomical structure fell outside the safe distance and direction to the nearest neurovascular structure for each of 4 common portals: anterolateral portal (ALP), anterior portal (AP), posterolateral portal (PLP), and mid-anterior portal (MAP).

Results

Average absolute distance from examiner labels to ultrasonographer labels was 31 mm for ASIS, 24 mm for GT, 26 mm for RO, 19 mm for SIR, and 35 mm for PT (Figure 2).

 

 

Of the 30 surgeons, 1 (3%) came within 10 mm of the ultrasound for ASIS, 1 (3%) for GT, 4 (13%) for RO, 5 (17%) for SIR, and 1 (3%) for PT (Table 1).

Table 1.


TAL as determined by CI was 16 mm medial and 29 mm inferior for ASIS; 8 mm anterior and 22 mm superior for GT; 10 mm medial and 25 mm inferior for RO; 5 mm lateral and 5 mm inferior for SIR; and 28 mm medial and 16 mm inferior for PT (Figure 3, Table 2). Interobserver variability determined by prediction interval had a range of 18 mm medial to lateral × 36 mm proximal to distal for ASIS; 33 mm anterior to posterior × 48 mm superior to inferior for GT; 41 mm medial to distal × 54 mm proximal to distal for RO; 51 mm medial to lateral × 74 mm proximal to distal for SIR; and 49 mm medial to distal × 61 mm proximal to distal for PT.
Figure 3.
Table 2.


Given the difference between examiner data (direction and distance from ultrasound labels) and published data (distance to significant neurovascular structures), inaccurate identification of surface landmarks has the potential to lead to AP and MAP damage (Table 3). The examiner GT and ASIS surface landmarks used for AP overlapped directly with the safe distances for the lateral femoral cutaneous nerve and the terminal branch of the lateral circumflex femoral artery.
Table 3.

Discussion

Others have investigated examiners’ use of palpation, compared with ultrasound, to identify common shoulder and knee structures.8-10 In a 2011 systematic review, Gilliland and colleagues11 confirmed that accuracy was improved with use of ultrasound (vs palpation) for injections in the shoulder, hip, knee, wrist, and ankle. Given the scarcity of data in this setting, we conducted the present study to assess the precision and accuracy of expert arthroscopists in identifying common surface landmarks. We hypothesized that physical examination and ultrasound examination would differ significantly in precisely and accurately identifying these landmarks.

Working with a standard awake volunteer, our test group of examiners was consistently inaccurate when they accepted ultrasonographer-placed labels as the ideal. Precision within the group, however, trended toward close agreement; examiners consistently placed labels in the same direction and approximate magnitude away from ultrasonographer labels. This suggests that a discrepancy between the ultrasonographic surface structure definitions taught to ultrasonographers and the manually identified definitions taught to surgeons for arthroscopy (training bias) can generate differences in landmark identification.

Given reported low rates of complications in the creation of standard surface anatomy portals, more data is needed to correlate whether safe distance guidelines best apply to the points identified by hip experts or the points identified by ultrasonographers. In a 2013 systematic review, Harris and colleagues8 found a 7.5% overall complication rate, with temporary neuropraxia 1 of the 2 most common complications. Whether adding ultrasound to physical examination for the creation of some or all portals will reduce the incidence of these problems is unknown. Regardless of the anatomical area referenced by experts for portal creation, the tight grouping of examiner marks in our study supports a consensus regarding the location of the landmarks studied.

In our study of the use of surface anatomical landmarks for the creation of portals, we analyzed 4 previously described locations: ALP, AP, PLP, and MAP. ALP, AP, and PLP directly reference at least 1 surface anatomical structure; AP references 2 anatomical structures (ASIS, GT); and MAP indirectly references ASIS and GT and directly references ALP and AP. In cadaveric and radiographic studies, 7 neurovascular structures have been described in proximity to ALP, AP, MAP, and PLP: superior gluteal nerve, sciatic nerve, femoral nerve, lateral femoral cutaneous nerve, lateral circumflex femoral artery, and medial circumflex femoral artery.5,6 Our results showed that use of surface anatomy in AP and MAP creation most likely places structures at risk, given the overlap of examiner CIs and the previously published cadaveric5,6 and radiographic7 data.

Hua and colleagues12 confirmed the feasibility of using ultrasound for the creation of hip arthroscopy portals. More data is needed to assess how the standard palpation-and-fluoroscopy method described by Byrd3 compares with an ultrasound-guided technique in safety and cost. However, data from our study should not be used to justify a demand for ultrasound during arthroscopy portal establishment, as limitations do not permit such a recommendation.

With diagnostic injection remaining a mainstay of differential diagnosis and treatment about the hip,1 the data presented here suggest a potential for ultrasound in enhancing outcomes. There is evidence supporting the role of image guidance in improving palpation accuracy in the area of the biceps tendon in the forearm.10 Potentially, identification and treatment of specific extra-articular structures surrounding the hip could be made safer with more routine use of ultrasound.

 

 

Limitations

This study had several limitations. The surgeons were limited to palpation and static examination of a body in its natural state. Hip arthroscopic portals typically are created under traction and after a standard perineal post is placed for hip arthroscopy. In addition, in an awake injection setting, the clinician may receive patient feedback in the form of limb movement or speech. To what degree palpation or ultrasound will be affected in these scenarios is unknown.

Another limitation is the lack of serial examination by each examiner—intrarater variability could not be gauged. In addition, with only 1 ultrasonographic examination performed, there is the potential that adding ultrasonographic examinations, or having an examiner perform serial physical examinations, could better define the precision of each component. Given the practical limitations of our volunteer’s time and the schedules of 30 expert arthroscopists, we kept the chosen study design for its single setting.

Conclusion

Visual inspection and manual palpation are standard means of identifying common surface anatomical landmarks for the creation of arthroscopy portals and the placement of injections. Our study results showed variance in landmark identification between expert examiners and an ultrasonographer. The degree of variance exceeded established neurovascular safe zones, particularly for AP and MAP. This new evidence calls for further investigation into the best, safest means of performing hip arthroscopic techniques and injection-based interventions.

Am J Orthop. 2017;46(1):E65-E70. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

References

1. Byrd JW, Potts EA, Allison RK, Jones KS. Ultrasound-guided hip injections: a comparative study with fluoroscopy-guided injections. Arthroscopy. 2014;30(1):42-46.

2. Dienst M, Seil R, Kohn DM. Safe arthroscopic access to the central compartment of the hip. Arthroscopy. 2005;21(12):1510-1514.

3. Byrd JW. Hip arthroscopy, the supine approach: technique and anatomy of the intraarticular and peripheral compartments. Tech Orthop. 2005;20(1):17-31.

4. Bond JL, Knutson ZA, Ebert A, Guanche CA. The 23-point arthroscopic examination of the hip: basic setup, portal placement, and surgical technique. Arthroscopy. 2009;25(4):416-429.

5. Roberson WJ, Kelly BT. The safe zone for hip arthroscopy: a cadaveric assessment of central, peripheral, and lateral compartment portal placement. Arthroscopy. 2008;24(9):1019-1026.

6. Byrd JW, Pappas JN, Pedley MJ. Hip arthroscopy: an anatomic study of portal placement and relationship to the extra-articular structures. Arthroscopy. 1995;11(4):418-423.

7. Watson JN, Bohnenkamp F, El-Bitar Y, Moretti V, Domb BG. Variability in locations of hip neurovascular structures and their proximity to hip arthroscopic portals. Arthroscopy. 2014;30(4):462-467.

8. Harris JD, McCormick FM, Abrams GD, et al. Complications and reoperations during and after hip arthroscopy: a systematic review of 92 studies and more than 6,000 patients. Arthroscopy. 2013;29(3):589-595.

9. Jacobson JA, Bedi A, Sekiya JK, Blankenbaker DG. Evaluation of the painful athletic hip: imaging options and imaging-guided injections. AJR Am J Roentgenol. 2012;199(3):516-524.

10. Gazzillo GP, Finnoff JT, Hall MM, Sayeed YA, Smith J. Accuracy of palpating the long head of the biceps tendon: an ultrasonographic study. PM R. 2011;3(11):1035-1040.

11. Gilliland CA, Salazar LD, Borchers JR. Ultrasound versus anatomic guidance for intra-articular and periarticular injection: a systematic review. Phys Sportsmed. 2011;39(3):121-131.

12. Hua Y, Yang Y, Chen S, et al. Ultrasound-guided establishment of hip arthroscopy portals. Arthroscopy. 2009;25(12):1491-1495.

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Take-Home Points

  • Surface landmarks are routinely used for physical examination and surgical technique.
  • Common surface landmarks used in establishing arthroscopic portals may be more difficult to accurately identify than previously thought.
  • The greater trochanter was the surface landmark most precisely identified by expert examiners.
  • Ultrasound examination identified landmarks varied from landmarks identified by palpation alone.

Anatomical surface landmarks about the hip and lower abdomen are often referenced when placing arthroscopic portals and office-based injections.1-3 However, the degree to which these landmarks can be reproducibly identified using only visual inspection and palpation is unknown.

Safe access to the hip joint and surrounding structures during hip arthroscopy has been a focus in the orthopedic literature. Authors have described anatomical relationships of recommended portals to neurovascular and other anatomical structures.4-6 This information has been reported in millimeters to centimeters of safety based on cadaver dissection studies.4-7We conducted a study to assess expert hip arthroscopists’ ability to identify, using only physical examination techniques, the anatomical structures used for reference when creating safe starting points for arthroscopic access. We hypothesized that variance in examiner-identified points would exceed safe distances from neurovascular structures for the most commonly used hip arthroscopic portals. The volunteer in this study provided written informed consent for print and electronic publication of this article.

Methods

In this study, we prospectively assessed 30 expert hip arthroscopic surgeons’ ability to identify commonly referenced surface landmarks on the adult male hip, using only inspection and manual palpation. Surgeons were defined as experts on the basis of their status as hip arthroscopy instructors at the Orthopaedic Learning Center (Rosemont, IL) for the Arthroscopy Association of North America and industry-sponsored hip arthroscopy education faculty (Arthrex). Five surface landmarks were selected for their relevance to publications on safe portal placement2-5: anterior superior iliac spine (ASIS), tip of greater trochanter (GT), rectus origin (RO), superficial inguinal ring (SIR), and psoas tendon (PT).

A healthy adult male volunteer was placed supine on an examination table and exposed distally from the mid abdomen, with the perineum and the genital area covered bikini-style. An expert musculoskeletal ultrasonographer used a handheld musculoskeletal ultrasound transducer (Sonosite) to identify the 5 landmarks. Short- and long-axis images of each structure were obtained. The examiner applied a round (1 cm in diameter), uniquely colored adhesive label to the skin over each location. A professional photographer using a Canon digital camera and fixed mounts made precise overhead and lateral images. The positional integrity and scale of these images were confirmed with referral to constant anatomical skin features. Images were archived for analysis (Figure 1A).

After the ultrasonographer’s labels were removed, each of the 30 expert hip arthroscopic surgeons identified the structures by static physical examination (inspection and palpation only) and applied the same colored labels to the skin.

Figure 1.
The volunteer was not allowed to communicate about label placement with examiners but was encouraged to report any safety-related concerns. The photographer made the same digital photographs of the labels for each examiner as for the ultrasonographer (Figure 1B).

Imaging software (Adobe Photoshop Creative Suite 5.1) was used to superimpose the digital images of the examiner labels on those of the ultrasound-verified anatomical labels (Figure 1C). Measurements were then taken with digital calipers to determine average distance from ultrasound label; accuracy within 10 mm of verified ultrasound label; true average location (TAL) determined by 95% confidence interval (CI); and interobserver variability calculated by 95% prediction interval, which determined the probability of where an additional examiner data point would lie.

In the second arm of the study, examiner data were compared with previously published data on arthroscopic portal safety.
Figure 2.
Distances from surface landmarks have been used to create common arthroscopy portals.2-4 The risk of neurovascular injury resulting from errors in identifying surface landmarks for creating portals was calculated using the direction and distance of the examiner TAL and the nearest published direction and distance of the nearest neurovascular structure. Increased risk of injury resulting from inaccurate identification of surface landmarks was surmised if the TAL of the anatomical structure fell outside the safe distance and direction to the nearest neurovascular structure for each of 4 common portals: anterolateral portal (ALP), anterior portal (AP), posterolateral portal (PLP), and mid-anterior portal (MAP).

Results

Average absolute distance from examiner labels to ultrasonographer labels was 31 mm for ASIS, 24 mm for GT, 26 mm for RO, 19 mm for SIR, and 35 mm for PT (Figure 2).

 

 

Of the 30 surgeons, 1 (3%) came within 10 mm of the ultrasound for ASIS, 1 (3%) for GT, 4 (13%) for RO, 5 (17%) for SIR, and 1 (3%) for PT (Table 1).

Table 1.


TAL as determined by CI was 16 mm medial and 29 mm inferior for ASIS; 8 mm anterior and 22 mm superior for GT; 10 mm medial and 25 mm inferior for RO; 5 mm lateral and 5 mm inferior for SIR; and 28 mm medial and 16 mm inferior for PT (Figure 3, Table 2). Interobserver variability determined by prediction interval had a range of 18 mm medial to lateral × 36 mm proximal to distal for ASIS; 33 mm anterior to posterior × 48 mm superior to inferior for GT; 41 mm medial to distal × 54 mm proximal to distal for RO; 51 mm medial to lateral × 74 mm proximal to distal for SIR; and 49 mm medial to distal × 61 mm proximal to distal for PT.
Figure 3.
Table 2.


Given the difference between examiner data (direction and distance from ultrasound labels) and published data (distance to significant neurovascular structures), inaccurate identification of surface landmarks has the potential to lead to AP and MAP damage (Table 3). The examiner GT and ASIS surface landmarks used for AP overlapped directly with the safe distances for the lateral femoral cutaneous nerve and the terminal branch of the lateral circumflex femoral artery.
Table 3.

Discussion

Others have investigated examiners’ use of palpation, compared with ultrasound, to identify common shoulder and knee structures.8-10 In a 2011 systematic review, Gilliland and colleagues11 confirmed that accuracy was improved with use of ultrasound (vs palpation) for injections in the shoulder, hip, knee, wrist, and ankle. Given the scarcity of data in this setting, we conducted the present study to assess the precision and accuracy of expert arthroscopists in identifying common surface landmarks. We hypothesized that physical examination and ultrasound examination would differ significantly in precisely and accurately identifying these landmarks.

Working with a standard awake volunteer, our test group of examiners was consistently inaccurate when they accepted ultrasonographer-placed labels as the ideal. Precision within the group, however, trended toward close agreement; examiners consistently placed labels in the same direction and approximate magnitude away from ultrasonographer labels. This suggests that a discrepancy between the ultrasonographic surface structure definitions taught to ultrasonographers and the manually identified definitions taught to surgeons for arthroscopy (training bias) can generate differences in landmark identification.

Given reported low rates of complications in the creation of standard surface anatomy portals, more data is needed to correlate whether safe distance guidelines best apply to the points identified by hip experts or the points identified by ultrasonographers. In a 2013 systematic review, Harris and colleagues8 found a 7.5% overall complication rate, with temporary neuropraxia 1 of the 2 most common complications. Whether adding ultrasound to physical examination for the creation of some or all portals will reduce the incidence of these problems is unknown. Regardless of the anatomical area referenced by experts for portal creation, the tight grouping of examiner marks in our study supports a consensus regarding the location of the landmarks studied.

In our study of the use of surface anatomical landmarks for the creation of portals, we analyzed 4 previously described locations: ALP, AP, PLP, and MAP. ALP, AP, and PLP directly reference at least 1 surface anatomical structure; AP references 2 anatomical structures (ASIS, GT); and MAP indirectly references ASIS and GT and directly references ALP and AP. In cadaveric and radiographic studies, 7 neurovascular structures have been described in proximity to ALP, AP, MAP, and PLP: superior gluteal nerve, sciatic nerve, femoral nerve, lateral femoral cutaneous nerve, lateral circumflex femoral artery, and medial circumflex femoral artery.5,6 Our results showed that use of surface anatomy in AP and MAP creation most likely places structures at risk, given the overlap of examiner CIs and the previously published cadaveric5,6 and radiographic7 data.

Hua and colleagues12 confirmed the feasibility of using ultrasound for the creation of hip arthroscopy portals. More data is needed to assess how the standard palpation-and-fluoroscopy method described by Byrd3 compares with an ultrasound-guided technique in safety and cost. However, data from our study should not be used to justify a demand for ultrasound during arthroscopy portal establishment, as limitations do not permit such a recommendation.

With diagnostic injection remaining a mainstay of differential diagnosis and treatment about the hip,1 the data presented here suggest a potential for ultrasound in enhancing outcomes. There is evidence supporting the role of image guidance in improving palpation accuracy in the area of the biceps tendon in the forearm.10 Potentially, identification and treatment of specific extra-articular structures surrounding the hip could be made safer with more routine use of ultrasound.

 

 

Limitations

This study had several limitations. The surgeons were limited to palpation and static examination of a body in its natural state. Hip arthroscopic portals typically are created under traction and after a standard perineal post is placed for hip arthroscopy. In addition, in an awake injection setting, the clinician may receive patient feedback in the form of limb movement or speech. To what degree palpation or ultrasound will be affected in these scenarios is unknown.

Another limitation is the lack of serial examination by each examiner—intrarater variability could not be gauged. In addition, with only 1 ultrasonographic examination performed, there is the potential that adding ultrasonographic examinations, or having an examiner perform serial physical examinations, could better define the precision of each component. Given the practical limitations of our volunteer’s time and the schedules of 30 expert arthroscopists, we kept the chosen study design for its single setting.

Conclusion

Visual inspection and manual palpation are standard means of identifying common surface anatomical landmarks for the creation of arthroscopy portals and the placement of injections. Our study results showed variance in landmark identification between expert examiners and an ultrasonographer. The degree of variance exceeded established neurovascular safe zones, particularly for AP and MAP. This new evidence calls for further investigation into the best, safest means of performing hip arthroscopic techniques and injection-based interventions.

Am J Orthop. 2017;46(1):E65-E70. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

Take-Home Points

  • Surface landmarks are routinely used for physical examination and surgical technique.
  • Common surface landmarks used in establishing arthroscopic portals may be more difficult to accurately identify than previously thought.
  • The greater trochanter was the surface landmark most precisely identified by expert examiners.
  • Ultrasound examination identified landmarks varied from landmarks identified by palpation alone.

Anatomical surface landmarks about the hip and lower abdomen are often referenced when placing arthroscopic portals and office-based injections.1-3 However, the degree to which these landmarks can be reproducibly identified using only visual inspection and palpation is unknown.

Safe access to the hip joint and surrounding structures during hip arthroscopy has been a focus in the orthopedic literature. Authors have described anatomical relationships of recommended portals to neurovascular and other anatomical structures.4-6 This information has been reported in millimeters to centimeters of safety based on cadaver dissection studies.4-7We conducted a study to assess expert hip arthroscopists’ ability to identify, using only physical examination techniques, the anatomical structures used for reference when creating safe starting points for arthroscopic access. We hypothesized that variance in examiner-identified points would exceed safe distances from neurovascular structures for the most commonly used hip arthroscopic portals. The volunteer in this study provided written informed consent for print and electronic publication of this article.

Methods

In this study, we prospectively assessed 30 expert hip arthroscopic surgeons’ ability to identify commonly referenced surface landmarks on the adult male hip, using only inspection and manual palpation. Surgeons were defined as experts on the basis of their status as hip arthroscopy instructors at the Orthopaedic Learning Center (Rosemont, IL) for the Arthroscopy Association of North America and industry-sponsored hip arthroscopy education faculty (Arthrex). Five surface landmarks were selected for their relevance to publications on safe portal placement2-5: anterior superior iliac spine (ASIS), tip of greater trochanter (GT), rectus origin (RO), superficial inguinal ring (SIR), and psoas tendon (PT).

A healthy adult male volunteer was placed supine on an examination table and exposed distally from the mid abdomen, with the perineum and the genital area covered bikini-style. An expert musculoskeletal ultrasonographer used a handheld musculoskeletal ultrasound transducer (Sonosite) to identify the 5 landmarks. Short- and long-axis images of each structure were obtained. The examiner applied a round (1 cm in diameter), uniquely colored adhesive label to the skin over each location. A professional photographer using a Canon digital camera and fixed mounts made precise overhead and lateral images. The positional integrity and scale of these images were confirmed with referral to constant anatomical skin features. Images were archived for analysis (Figure 1A).

After the ultrasonographer’s labels were removed, each of the 30 expert hip arthroscopic surgeons identified the structures by static physical examination (inspection and palpation only) and applied the same colored labels to the skin.

Figure 1.
The volunteer was not allowed to communicate about label placement with examiners but was encouraged to report any safety-related concerns. The photographer made the same digital photographs of the labels for each examiner as for the ultrasonographer (Figure 1B).

Imaging software (Adobe Photoshop Creative Suite 5.1) was used to superimpose the digital images of the examiner labels on those of the ultrasound-verified anatomical labels (Figure 1C). Measurements were then taken with digital calipers to determine average distance from ultrasound label; accuracy within 10 mm of verified ultrasound label; true average location (TAL) determined by 95% confidence interval (CI); and interobserver variability calculated by 95% prediction interval, which determined the probability of where an additional examiner data point would lie.

In the second arm of the study, examiner data were compared with previously published data on arthroscopic portal safety.
Figure 2.
Distances from surface landmarks have been used to create common arthroscopy portals.2-4 The risk of neurovascular injury resulting from errors in identifying surface landmarks for creating portals was calculated using the direction and distance of the examiner TAL and the nearest published direction and distance of the nearest neurovascular structure. Increased risk of injury resulting from inaccurate identification of surface landmarks was surmised if the TAL of the anatomical structure fell outside the safe distance and direction to the nearest neurovascular structure for each of 4 common portals: anterolateral portal (ALP), anterior portal (AP), posterolateral portal (PLP), and mid-anterior portal (MAP).

Results

Average absolute distance from examiner labels to ultrasonographer labels was 31 mm for ASIS, 24 mm for GT, 26 mm for RO, 19 mm for SIR, and 35 mm for PT (Figure 2).

 

 

Of the 30 surgeons, 1 (3%) came within 10 mm of the ultrasound for ASIS, 1 (3%) for GT, 4 (13%) for RO, 5 (17%) for SIR, and 1 (3%) for PT (Table 1).

Table 1.


TAL as determined by CI was 16 mm medial and 29 mm inferior for ASIS; 8 mm anterior and 22 mm superior for GT; 10 mm medial and 25 mm inferior for RO; 5 mm lateral and 5 mm inferior for SIR; and 28 mm medial and 16 mm inferior for PT (Figure 3, Table 2). Interobserver variability determined by prediction interval had a range of 18 mm medial to lateral × 36 mm proximal to distal for ASIS; 33 mm anterior to posterior × 48 mm superior to inferior for GT; 41 mm medial to distal × 54 mm proximal to distal for RO; 51 mm medial to lateral × 74 mm proximal to distal for SIR; and 49 mm medial to distal × 61 mm proximal to distal for PT.
Figure 3.
Table 2.


Given the difference between examiner data (direction and distance from ultrasound labels) and published data (distance to significant neurovascular structures), inaccurate identification of surface landmarks has the potential to lead to AP and MAP damage (Table 3). The examiner GT and ASIS surface landmarks used for AP overlapped directly with the safe distances for the lateral femoral cutaneous nerve and the terminal branch of the lateral circumflex femoral artery.
Table 3.

Discussion

Others have investigated examiners’ use of palpation, compared with ultrasound, to identify common shoulder and knee structures.8-10 In a 2011 systematic review, Gilliland and colleagues11 confirmed that accuracy was improved with use of ultrasound (vs palpation) for injections in the shoulder, hip, knee, wrist, and ankle. Given the scarcity of data in this setting, we conducted the present study to assess the precision and accuracy of expert arthroscopists in identifying common surface landmarks. We hypothesized that physical examination and ultrasound examination would differ significantly in precisely and accurately identifying these landmarks.

Working with a standard awake volunteer, our test group of examiners was consistently inaccurate when they accepted ultrasonographer-placed labels as the ideal. Precision within the group, however, trended toward close agreement; examiners consistently placed labels in the same direction and approximate magnitude away from ultrasonographer labels. This suggests that a discrepancy between the ultrasonographic surface structure definitions taught to ultrasonographers and the manually identified definitions taught to surgeons for arthroscopy (training bias) can generate differences in landmark identification.

Given reported low rates of complications in the creation of standard surface anatomy portals, more data is needed to correlate whether safe distance guidelines best apply to the points identified by hip experts or the points identified by ultrasonographers. In a 2013 systematic review, Harris and colleagues8 found a 7.5% overall complication rate, with temporary neuropraxia 1 of the 2 most common complications. Whether adding ultrasound to physical examination for the creation of some or all portals will reduce the incidence of these problems is unknown. Regardless of the anatomical area referenced by experts for portal creation, the tight grouping of examiner marks in our study supports a consensus regarding the location of the landmarks studied.

In our study of the use of surface anatomical landmarks for the creation of portals, we analyzed 4 previously described locations: ALP, AP, PLP, and MAP. ALP, AP, and PLP directly reference at least 1 surface anatomical structure; AP references 2 anatomical structures (ASIS, GT); and MAP indirectly references ASIS and GT and directly references ALP and AP. In cadaveric and radiographic studies, 7 neurovascular structures have been described in proximity to ALP, AP, MAP, and PLP: superior gluteal nerve, sciatic nerve, femoral nerve, lateral femoral cutaneous nerve, lateral circumflex femoral artery, and medial circumflex femoral artery.5,6 Our results showed that use of surface anatomy in AP and MAP creation most likely places structures at risk, given the overlap of examiner CIs and the previously published cadaveric5,6 and radiographic7 data.

Hua and colleagues12 confirmed the feasibility of using ultrasound for the creation of hip arthroscopy portals. More data is needed to assess how the standard palpation-and-fluoroscopy method described by Byrd3 compares with an ultrasound-guided technique in safety and cost. However, data from our study should not be used to justify a demand for ultrasound during arthroscopy portal establishment, as limitations do not permit such a recommendation.

With diagnostic injection remaining a mainstay of differential diagnosis and treatment about the hip,1 the data presented here suggest a potential for ultrasound in enhancing outcomes. There is evidence supporting the role of image guidance in improving palpation accuracy in the area of the biceps tendon in the forearm.10 Potentially, identification and treatment of specific extra-articular structures surrounding the hip could be made safer with more routine use of ultrasound.

 

 

Limitations

This study had several limitations. The surgeons were limited to palpation and static examination of a body in its natural state. Hip arthroscopic portals typically are created under traction and after a standard perineal post is placed for hip arthroscopy. In addition, in an awake injection setting, the clinician may receive patient feedback in the form of limb movement or speech. To what degree palpation or ultrasound will be affected in these scenarios is unknown.

Another limitation is the lack of serial examination by each examiner—intrarater variability could not be gauged. In addition, with only 1 ultrasonographic examination performed, there is the potential that adding ultrasonographic examinations, or having an examiner perform serial physical examinations, could better define the precision of each component. Given the practical limitations of our volunteer’s time and the schedules of 30 expert arthroscopists, we kept the chosen study design for its single setting.

Conclusion

Visual inspection and manual palpation are standard means of identifying common surface anatomical landmarks for the creation of arthroscopy portals and the placement of injections. Our study results showed variance in landmark identification between expert examiners and an ultrasonographer. The degree of variance exceeded established neurovascular safe zones, particularly for AP and MAP. This new evidence calls for further investigation into the best, safest means of performing hip arthroscopic techniques and injection-based interventions.

Am J Orthop. 2017;46(1):E65-E70. Copyright Frontline Medical Communications Inc. 2017. All rights reserved.

References

1. Byrd JW, Potts EA, Allison RK, Jones KS. Ultrasound-guided hip injections: a comparative study with fluoroscopy-guided injections. Arthroscopy. 2014;30(1):42-46.

2. Dienst M, Seil R, Kohn DM. Safe arthroscopic access to the central compartment of the hip. Arthroscopy. 2005;21(12):1510-1514.

3. Byrd JW. Hip arthroscopy, the supine approach: technique and anatomy of the intraarticular and peripheral compartments. Tech Orthop. 2005;20(1):17-31.

4. Bond JL, Knutson ZA, Ebert A, Guanche CA. The 23-point arthroscopic examination of the hip: basic setup, portal placement, and surgical technique. Arthroscopy. 2009;25(4):416-429.

5. Roberson WJ, Kelly BT. The safe zone for hip arthroscopy: a cadaveric assessment of central, peripheral, and lateral compartment portal placement. Arthroscopy. 2008;24(9):1019-1026.

6. Byrd JW, Pappas JN, Pedley MJ. Hip arthroscopy: an anatomic study of portal placement and relationship to the extra-articular structures. Arthroscopy. 1995;11(4):418-423.

7. Watson JN, Bohnenkamp F, El-Bitar Y, Moretti V, Domb BG. Variability in locations of hip neurovascular structures and their proximity to hip arthroscopic portals. Arthroscopy. 2014;30(4):462-467.

8. Harris JD, McCormick FM, Abrams GD, et al. Complications and reoperations during and after hip arthroscopy: a systematic review of 92 studies and more than 6,000 patients. Arthroscopy. 2013;29(3):589-595.

9. Jacobson JA, Bedi A, Sekiya JK, Blankenbaker DG. Evaluation of the painful athletic hip: imaging options and imaging-guided injections. AJR Am J Roentgenol. 2012;199(3):516-524.

10. Gazzillo GP, Finnoff JT, Hall MM, Sayeed YA, Smith J. Accuracy of palpating the long head of the biceps tendon: an ultrasonographic study. PM R. 2011;3(11):1035-1040.

11. Gilliland CA, Salazar LD, Borchers JR. Ultrasound versus anatomic guidance for intra-articular and periarticular injection: a systematic review. Phys Sportsmed. 2011;39(3):121-131.

12. Hua Y, Yang Y, Chen S, et al. Ultrasound-guided establishment of hip arthroscopy portals. Arthroscopy. 2009;25(12):1491-1495.

References

1. Byrd JW, Potts EA, Allison RK, Jones KS. Ultrasound-guided hip injections: a comparative study with fluoroscopy-guided injections. Arthroscopy. 2014;30(1):42-46.

2. Dienst M, Seil R, Kohn DM. Safe arthroscopic access to the central compartment of the hip. Arthroscopy. 2005;21(12):1510-1514.

3. Byrd JW. Hip arthroscopy, the supine approach: technique and anatomy of the intraarticular and peripheral compartments. Tech Orthop. 2005;20(1):17-31.

4. Bond JL, Knutson ZA, Ebert A, Guanche CA. The 23-point arthroscopic examination of the hip: basic setup, portal placement, and surgical technique. Arthroscopy. 2009;25(4):416-429.

5. Roberson WJ, Kelly BT. The safe zone for hip arthroscopy: a cadaveric assessment of central, peripheral, and lateral compartment portal placement. Arthroscopy. 2008;24(9):1019-1026.

6. Byrd JW, Pappas JN, Pedley MJ. Hip arthroscopy: an anatomic study of portal placement and relationship to the extra-articular structures. Arthroscopy. 1995;11(4):418-423.

7. Watson JN, Bohnenkamp F, El-Bitar Y, Moretti V, Domb BG. Variability in locations of hip neurovascular structures and their proximity to hip arthroscopic portals. Arthroscopy. 2014;30(4):462-467.

8. Harris JD, McCormick FM, Abrams GD, et al. Complications and reoperations during and after hip arthroscopy: a systematic review of 92 studies and more than 6,000 patients. Arthroscopy. 2013;29(3):589-595.

9. Jacobson JA, Bedi A, Sekiya JK, Blankenbaker DG. Evaluation of the painful athletic hip: imaging options and imaging-guided injections. AJR Am J Roentgenol. 2012;199(3):516-524.

10. Gazzillo GP, Finnoff JT, Hall MM, Sayeed YA, Smith J. Accuracy of palpating the long head of the biceps tendon: an ultrasonographic study. PM R. 2011;3(11):1035-1040.

11. Gilliland CA, Salazar LD, Borchers JR. Ultrasound versus anatomic guidance for intra-articular and periarticular injection: a systematic review. Phys Sportsmed. 2011;39(3):121-131.

12. Hua Y, Yang Y, Chen S, et al. Ultrasound-guided establishment of hip arthroscopy portals. Arthroscopy. 2009;25(12):1491-1495.

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Gluten-free diets related to high levels of arsenic, mercury

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Individuals who adopt a gluten-free diet are putting themselves at risk for uncommonly high levels of arsenic and mercury, according to the findings of a recent study published in Epidemiology.

 

“Despite [less than] 1% of Americans having diagnosed celiac disease, an estimated 25% of American consumers reported consuming gluten-free food in 2015, a 67% increase from 2013,” wrote the authors of the study, led by Maria Argos, PhD, of the University of Illinois at Chicago. “Despite such a dramatic shift in the diet of many Americans, little is known about how gluten-free diets might affect exposure to toxic metals found in certain foods,” they noted.

Dr. Argos and her colleagues analyzed data collected from the National Health and Nutrition Examination Survey (NHANES), which included self-reported questionnaires in which subjects indicated what type of diet they were on, if any. Data on those who indicated that they followed a gluten-free diet were analyzed to determine if their urinary and blood biomarkers indicated any exposure to toxic metals. A total of 7,471 subjects from the NHANES were included in the analysis.

“We accounted for the complex sampling design of NHANES [by] using Taylor series linearization and sampling weights, per the NHANES analytic guidelines, to ensure unbiased and nationally representative estimates,” the authors explained.

Dima_sidelnikov/Thinkstock

A total of 73 subjects identified themselves as following a gluten-free diet. Within this group, the mean total arsenic level in urine was found to be 12.1 mcg/L, compared to 7.8 mcg/L for the other 7,398 subjects. Levels of dimethylarsinic acid averaged 5.3 mcg/L for those who were gluten-free, but only 3.7 for everyone else, while cadmium and lead levels were also slightly higher for gluten-free individuals: 0.18 mcg/L vs. 0.16 mcg/L, and 0.40 mcg/L vs. 0.37 mcg/L, respectively.

Blood analyses showed that total mercury levels were also substantially higher in the gluten-free group, at a mean of 1.3 mcg/L compared to 0.8 mcg/L. While cadmium levels were the same between the two – both showed a mean level of 0.29 mcg/L – lead measured 1.1 mcg/dL and inorganic mercury measured 0.30 mcg/L, compared to 0.96 mcg/L and 0.28 mcg/L in everyone else, respectively.

Geometric mean ratios showed that total arsenic, total arsenic 1, and total mercury levels had the largest disparity between the two groups. Total arsenic registered a 1.5 (95% CI, 1.2-2.0), total mercury a 1.7 (95% CI, 1.1-2.4), and total arsenic 1 a 1.9 (95% CI 1.3-2.6), meaning the gluten-free group had nearly double the risk for higher levels than those on other diets.

“These findings may have important health implications since the health effects of low-level arsenic and mercury exposure from food sources are uncertain but may increase the risk for cancer and other chronic diseases,” Dr. Argos and her coauthors concluded, adding that “future studies are needed to more fully examine exposure to toxic metals from consuming gluten-free foods.”

The study was funded by a grant from the National Institutes of Health. Dr. Argos and her coauthors did not report any relevant financial disclosures.

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Individuals who adopt a gluten-free diet are putting themselves at risk for uncommonly high levels of arsenic and mercury, according to the findings of a recent study published in Epidemiology.

 

“Despite [less than] 1% of Americans having diagnosed celiac disease, an estimated 25% of American consumers reported consuming gluten-free food in 2015, a 67% increase from 2013,” wrote the authors of the study, led by Maria Argos, PhD, of the University of Illinois at Chicago. “Despite such a dramatic shift in the diet of many Americans, little is known about how gluten-free diets might affect exposure to toxic metals found in certain foods,” they noted.

Dr. Argos and her colleagues analyzed data collected from the National Health and Nutrition Examination Survey (NHANES), which included self-reported questionnaires in which subjects indicated what type of diet they were on, if any. Data on those who indicated that they followed a gluten-free diet were analyzed to determine if their urinary and blood biomarkers indicated any exposure to toxic metals. A total of 7,471 subjects from the NHANES were included in the analysis.

“We accounted for the complex sampling design of NHANES [by] using Taylor series linearization and sampling weights, per the NHANES analytic guidelines, to ensure unbiased and nationally representative estimates,” the authors explained.

Dima_sidelnikov/Thinkstock

A total of 73 subjects identified themselves as following a gluten-free diet. Within this group, the mean total arsenic level in urine was found to be 12.1 mcg/L, compared to 7.8 mcg/L for the other 7,398 subjects. Levels of dimethylarsinic acid averaged 5.3 mcg/L for those who were gluten-free, but only 3.7 for everyone else, while cadmium and lead levels were also slightly higher for gluten-free individuals: 0.18 mcg/L vs. 0.16 mcg/L, and 0.40 mcg/L vs. 0.37 mcg/L, respectively.

Blood analyses showed that total mercury levels were also substantially higher in the gluten-free group, at a mean of 1.3 mcg/L compared to 0.8 mcg/L. While cadmium levels were the same between the two – both showed a mean level of 0.29 mcg/L – lead measured 1.1 mcg/dL and inorganic mercury measured 0.30 mcg/L, compared to 0.96 mcg/L and 0.28 mcg/L in everyone else, respectively.

Geometric mean ratios showed that total arsenic, total arsenic 1, and total mercury levels had the largest disparity between the two groups. Total arsenic registered a 1.5 (95% CI, 1.2-2.0), total mercury a 1.7 (95% CI, 1.1-2.4), and total arsenic 1 a 1.9 (95% CI 1.3-2.6), meaning the gluten-free group had nearly double the risk for higher levels than those on other diets.

“These findings may have important health implications since the health effects of low-level arsenic and mercury exposure from food sources are uncertain but may increase the risk for cancer and other chronic diseases,” Dr. Argos and her coauthors concluded, adding that “future studies are needed to more fully examine exposure to toxic metals from consuming gluten-free foods.”

The study was funded by a grant from the National Institutes of Health. Dr. Argos and her coauthors did not report any relevant financial disclosures.

Individuals who adopt a gluten-free diet are putting themselves at risk for uncommonly high levels of arsenic and mercury, according to the findings of a recent study published in Epidemiology.

 

“Despite [less than] 1% of Americans having diagnosed celiac disease, an estimated 25% of American consumers reported consuming gluten-free food in 2015, a 67% increase from 2013,” wrote the authors of the study, led by Maria Argos, PhD, of the University of Illinois at Chicago. “Despite such a dramatic shift in the diet of many Americans, little is known about how gluten-free diets might affect exposure to toxic metals found in certain foods,” they noted.

Dr. Argos and her colleagues analyzed data collected from the National Health and Nutrition Examination Survey (NHANES), which included self-reported questionnaires in which subjects indicated what type of diet they were on, if any. Data on those who indicated that they followed a gluten-free diet were analyzed to determine if their urinary and blood biomarkers indicated any exposure to toxic metals. A total of 7,471 subjects from the NHANES were included in the analysis.

“We accounted for the complex sampling design of NHANES [by] using Taylor series linearization and sampling weights, per the NHANES analytic guidelines, to ensure unbiased and nationally representative estimates,” the authors explained.

Dima_sidelnikov/Thinkstock

A total of 73 subjects identified themselves as following a gluten-free diet. Within this group, the mean total arsenic level in urine was found to be 12.1 mcg/L, compared to 7.8 mcg/L for the other 7,398 subjects. Levels of dimethylarsinic acid averaged 5.3 mcg/L for those who were gluten-free, but only 3.7 for everyone else, while cadmium and lead levels were also slightly higher for gluten-free individuals: 0.18 mcg/L vs. 0.16 mcg/L, and 0.40 mcg/L vs. 0.37 mcg/L, respectively.

Blood analyses showed that total mercury levels were also substantially higher in the gluten-free group, at a mean of 1.3 mcg/L compared to 0.8 mcg/L. While cadmium levels were the same between the two – both showed a mean level of 0.29 mcg/L – lead measured 1.1 mcg/dL and inorganic mercury measured 0.30 mcg/L, compared to 0.96 mcg/L and 0.28 mcg/L in everyone else, respectively.

Geometric mean ratios showed that total arsenic, total arsenic 1, and total mercury levels had the largest disparity between the two groups. Total arsenic registered a 1.5 (95% CI, 1.2-2.0), total mercury a 1.7 (95% CI, 1.1-2.4), and total arsenic 1 a 1.9 (95% CI 1.3-2.6), meaning the gluten-free group had nearly double the risk for higher levels than those on other diets.

“These findings may have important health implications since the health effects of low-level arsenic and mercury exposure from food sources are uncertain but may increase the risk for cancer and other chronic diseases,” Dr. Argos and her coauthors concluded, adding that “future studies are needed to more fully examine exposure to toxic metals from consuming gluten-free foods.”

The study was funded by a grant from the National Institutes of Health. Dr. Argos and her coauthors did not report any relevant financial disclosures.

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Key clinical point: Gluten-free diets in individuals were related to elevated levels of arsenic and mercury.

Major finding: Total arsenic and mercury levels were higher in those that self-reported being on gluten-free diet than in those who weren’t: 12.1 mcg/L vs. 7.8 mcg/L for arsenic and 1.3 mcg/L vs. 0.8 mcg/L for mercury.

Data source: Retrospective analysis of data from the National Health and Nutrition Examination Survey during 2009-2014.

Disclosures: The National Institutes of Health funded the study. The authors had no relevant financial disclosures.

Cooperation must overcome polarization

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Each profession has its own core set of knowledge, skills, and values. For physicians, the core set of knowledge is anatomy, pathophysiology, and pharmacology. Skills include taking a history, the physical exam, and surgical procedures. The core values traditionally have been compassion and altruism. For modern medical practice, I urge adding cooperation as a core value. Medical school and the apprenticeship of residency are designed to teach, role model, foster, develop, and groom these core competencies.

Getting into medical school is highly competitive. Medical training uses methods that are very different than those used to train elite Olympic and professional athletes. Some competitiveness persists in medical school, but in general the faculty emphasizes cooperation rather than competition. The metric is not whether one student or resident is better than another. Gold and silver medals are not awarded. It is about whether each physician-to-be has passed the milestones needed to practice medicine.

Dr. Kevin T. Powell
The medical profession has a key fiduciary value that puts the patient’s well-being first. The provision of modern medicine requires the coordination of multiple specialties. Anything that impedes their cooperation is a potential threat to optimal health care for our patients. As a hospitalist, I often describe my function as patching together a quilt of different subspecialty knowledge and skills in order to cover the entire health care needs of my patient. I don’t have the luxury of choosing only Republican or Democratic cardiologists. I have worked with colleagues who are Muslim, Jewish, and young earth creationists. Political and religious affiliations are not important. Competence, compassion, sound medical science, critical thinking, and communication skills are crucial.

But American health care is threatened by the continued polarization of our government and our society. For years both Cleveland Clinic and Dana Farber have held annual fundraising events at Mar-a-Lago. In February 2017, because of that location’s association with President Trump, some people associated with the organizations advocated boycotting those important fund-raisers. These past few months, it seems every action and every purchase has become a political statement. One restaurant mentioned immigrants on its receipt. The action went viral and caused other people to advocate boycotting the restaurant or not tipping the wait staff (“The new political battleground: Your restaurant receipt,” The Washington Post, by Maura Judkis, Feb. 14, 2017).

Secondary boycotts are an ethical quandary. In labor disputes, organized unions can go on strike. In the 1970s, Japanese cars were not welcome in the employee parking lot of a Ford assembly plant. People do vote with their pocketbook. But in labor disputes, there are legal restrictions on secondary boycotts against other companies. People do need to get along with their neighbors and so do businesses. Politics is the art of encouraging cooperation on one project amongst people who disagree about the goals of many other proposed projects. The Preamble to the United States Constitution enumerates the benefits of cooperation.

In any large-scale human endeavor, conflicts arise that may limit cooperation. Accommodating conscientious objection is the safety valve that permits cooperation when dealing with contested government endeavors such as war, abortion, and physician-assisted suicide. It is meant as a last ditch effort to maintain cohesion of both societal and individual moral integrity. But if every proposed action is met with votes divided along party lines, conscientious objection loses its moral high ground.

Judge Neil Gorsuch, the nominee for the U.S. Supreme Court, has a record of supporting religious freedom in Yellowbear v. Lambert (10th Cir. 2014). He would likely support conscientious objection in relation to assisted dying by physicians, contrary to the arguments made recently by bioethicists Julian Savulescu and Udo Schuklenk. In related news, the liberty of physicians to address gun safety was affirmed when a Florida appeals court upheld the overturning of the state’s Privacy of Firearm Owners Act.

Summing up a tumultuous month of medical ethics, I leave you with the words of Voltaire: “Cherish those who seek the truth but beware of those who find it.”
 

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].

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Each profession has its own core set of knowledge, skills, and values. For physicians, the core set of knowledge is anatomy, pathophysiology, and pharmacology. Skills include taking a history, the physical exam, and surgical procedures. The core values traditionally have been compassion and altruism. For modern medical practice, I urge adding cooperation as a core value. Medical school and the apprenticeship of residency are designed to teach, role model, foster, develop, and groom these core competencies.

Getting into medical school is highly competitive. Medical training uses methods that are very different than those used to train elite Olympic and professional athletes. Some competitiveness persists in medical school, but in general the faculty emphasizes cooperation rather than competition. The metric is not whether one student or resident is better than another. Gold and silver medals are not awarded. It is about whether each physician-to-be has passed the milestones needed to practice medicine.

Dr. Kevin T. Powell
The medical profession has a key fiduciary value that puts the patient’s well-being first. The provision of modern medicine requires the coordination of multiple specialties. Anything that impedes their cooperation is a potential threat to optimal health care for our patients. As a hospitalist, I often describe my function as patching together a quilt of different subspecialty knowledge and skills in order to cover the entire health care needs of my patient. I don’t have the luxury of choosing only Republican or Democratic cardiologists. I have worked with colleagues who are Muslim, Jewish, and young earth creationists. Political and religious affiliations are not important. Competence, compassion, sound medical science, critical thinking, and communication skills are crucial.

But American health care is threatened by the continued polarization of our government and our society. For years both Cleveland Clinic and Dana Farber have held annual fundraising events at Mar-a-Lago. In February 2017, because of that location’s association with President Trump, some people associated with the organizations advocated boycotting those important fund-raisers. These past few months, it seems every action and every purchase has become a political statement. One restaurant mentioned immigrants on its receipt. The action went viral and caused other people to advocate boycotting the restaurant or not tipping the wait staff (“The new political battleground: Your restaurant receipt,” The Washington Post, by Maura Judkis, Feb. 14, 2017).

Secondary boycotts are an ethical quandary. In labor disputes, organized unions can go on strike. In the 1970s, Japanese cars were not welcome in the employee parking lot of a Ford assembly plant. People do vote with their pocketbook. But in labor disputes, there are legal restrictions on secondary boycotts against other companies. People do need to get along with their neighbors and so do businesses. Politics is the art of encouraging cooperation on one project amongst people who disagree about the goals of many other proposed projects. The Preamble to the United States Constitution enumerates the benefits of cooperation.

In any large-scale human endeavor, conflicts arise that may limit cooperation. Accommodating conscientious objection is the safety valve that permits cooperation when dealing with contested government endeavors such as war, abortion, and physician-assisted suicide. It is meant as a last ditch effort to maintain cohesion of both societal and individual moral integrity. But if every proposed action is met with votes divided along party lines, conscientious objection loses its moral high ground.

Judge Neil Gorsuch, the nominee for the U.S. Supreme Court, has a record of supporting religious freedom in Yellowbear v. Lambert (10th Cir. 2014). He would likely support conscientious objection in relation to assisted dying by physicians, contrary to the arguments made recently by bioethicists Julian Savulescu and Udo Schuklenk. In related news, the liberty of physicians to address gun safety was affirmed when a Florida appeals court upheld the overturning of the state’s Privacy of Firearm Owners Act.

Summing up a tumultuous month of medical ethics, I leave you with the words of Voltaire: “Cherish those who seek the truth but beware of those who find it.”
 

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].


Each profession has its own core set of knowledge, skills, and values. For physicians, the core set of knowledge is anatomy, pathophysiology, and pharmacology. Skills include taking a history, the physical exam, and surgical procedures. The core values traditionally have been compassion and altruism. For modern medical practice, I urge adding cooperation as a core value. Medical school and the apprenticeship of residency are designed to teach, role model, foster, develop, and groom these core competencies.

Getting into medical school is highly competitive. Medical training uses methods that are very different than those used to train elite Olympic and professional athletes. Some competitiveness persists in medical school, but in general the faculty emphasizes cooperation rather than competition. The metric is not whether one student or resident is better than another. Gold and silver medals are not awarded. It is about whether each physician-to-be has passed the milestones needed to practice medicine.

Dr. Kevin T. Powell
The medical profession has a key fiduciary value that puts the patient’s well-being first. The provision of modern medicine requires the coordination of multiple specialties. Anything that impedes their cooperation is a potential threat to optimal health care for our patients. As a hospitalist, I often describe my function as patching together a quilt of different subspecialty knowledge and skills in order to cover the entire health care needs of my patient. I don’t have the luxury of choosing only Republican or Democratic cardiologists. I have worked with colleagues who are Muslim, Jewish, and young earth creationists. Political and religious affiliations are not important. Competence, compassion, sound medical science, critical thinking, and communication skills are crucial.

But American health care is threatened by the continued polarization of our government and our society. For years both Cleveland Clinic and Dana Farber have held annual fundraising events at Mar-a-Lago. In February 2017, because of that location’s association with President Trump, some people associated with the organizations advocated boycotting those important fund-raisers. These past few months, it seems every action and every purchase has become a political statement. One restaurant mentioned immigrants on its receipt. The action went viral and caused other people to advocate boycotting the restaurant or not tipping the wait staff (“The new political battleground: Your restaurant receipt,” The Washington Post, by Maura Judkis, Feb. 14, 2017).

Secondary boycotts are an ethical quandary. In labor disputes, organized unions can go on strike. In the 1970s, Japanese cars were not welcome in the employee parking lot of a Ford assembly plant. People do vote with their pocketbook. But in labor disputes, there are legal restrictions on secondary boycotts against other companies. People do need to get along with their neighbors and so do businesses. Politics is the art of encouraging cooperation on one project amongst people who disagree about the goals of many other proposed projects. The Preamble to the United States Constitution enumerates the benefits of cooperation.

In any large-scale human endeavor, conflicts arise that may limit cooperation. Accommodating conscientious objection is the safety valve that permits cooperation when dealing with contested government endeavors such as war, abortion, and physician-assisted suicide. It is meant as a last ditch effort to maintain cohesion of both societal and individual moral integrity. But if every proposed action is met with votes divided along party lines, conscientious objection loses its moral high ground.

Judge Neil Gorsuch, the nominee for the U.S. Supreme Court, has a record of supporting religious freedom in Yellowbear v. Lambert (10th Cir. 2014). He would likely support conscientious objection in relation to assisted dying by physicians, contrary to the arguments made recently by bioethicists Julian Savulescu and Udo Schuklenk. In related news, the liberty of physicians to address gun safety was affirmed when a Florida appeals court upheld the overturning of the state’s Privacy of Firearm Owners Act.

Summing up a tumultuous month of medical ethics, I leave you with the words of Voltaire: “Cherish those who seek the truth but beware of those who find it.”
 

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].

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DoD Rolls Out EHR Genesis at Fairchild Air Force Base

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New electronic health record system is built to foster teamwork and increase patient access to medical records.

After years of preparation, a new electronic health record (EHR) system is now live at Fairchild Air Force Base in Washington. According to DoD officials, the system remains on schedule for the next step in the rollout later this year and the eventual completion in 2022. “This is just the first step in implementing what will be the largest integrated inpatient and outpatient electronic health record in the United States,” said VADM Raquel Bono, director of the Defense Health Agency.

Home to the 92nd Medical Group, Fairchild has a number of outpatient clinics and a pharmacy. According to Col Margaret Carey, the 92nd Medical Group commander, Genesis is being used by all the medical personnel at Fairchild.

For many years, the VA and DoD discussed possibly developing a single EHR across both systems before rejecting the idea for being too costly and complicated. Instead the 2 agencies looked to make their systems interoperable and to improve data sharing across the systems. The 2 agencies developed the Joint Legacy Viewer system to improve data sharing. The Joint Legacy Viewer is a clinical application that provides an integrated, read-only display of health data from DoD, VA, private sector partners, and the current military medical record system in a common data viewer.

The DoD originally awarded the $4.3 billion contract to Leidos in 2014 to develop Genesis, but the system was delayed to address cyber-security concerns. The concerns also caused DoD to reduce a larger rollout to focus initially on Fairchild.

“I can report firsthand from the command center that everything is going as expected,” reported Stacy Cummings, program executive officer for Defense Healthcare Management Systems. “Initial feedback from [health care] providers is positive.”

According to Dr. Paul Cordts, director, functional champion for the MHS at the Defense Health Agency, the biggest change that Genesis will bring is offering open medical notes to patients to “empower our patients to know what medical data are in the medical records and to use that data to improve their health and their health care over time.” Patients will be able to access data through a patient portal.

“This EHR is built to enable a team approach to providing health services to patients,” said U.S. Air Force Surgeon General Lt Gen Mark Ediger, MD. “In medicine today we really leverage a number of different skill sets on a health care team… That’s why in the Air Force we are piloting the addition of a health coaching capability here at Fairchild to leverage capabilities that are in MHS, so that health coaches can interact with patients between visits to work on things like tobacco cessation and weight loss, exercise plans and things of that nature.”

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New electronic health record system is built to foster teamwork and increase patient access to medical records.
New electronic health record system is built to foster teamwork and increase patient access to medical records.

After years of preparation, a new electronic health record (EHR) system is now live at Fairchild Air Force Base in Washington. According to DoD officials, the system remains on schedule for the next step in the rollout later this year and the eventual completion in 2022. “This is just the first step in implementing what will be the largest integrated inpatient and outpatient electronic health record in the United States,” said VADM Raquel Bono, director of the Defense Health Agency.

Home to the 92nd Medical Group, Fairchild has a number of outpatient clinics and a pharmacy. According to Col Margaret Carey, the 92nd Medical Group commander, Genesis is being used by all the medical personnel at Fairchild.

For many years, the VA and DoD discussed possibly developing a single EHR across both systems before rejecting the idea for being too costly and complicated. Instead the 2 agencies looked to make their systems interoperable and to improve data sharing across the systems. The 2 agencies developed the Joint Legacy Viewer system to improve data sharing. The Joint Legacy Viewer is a clinical application that provides an integrated, read-only display of health data from DoD, VA, private sector partners, and the current military medical record system in a common data viewer.

The DoD originally awarded the $4.3 billion contract to Leidos in 2014 to develop Genesis, but the system was delayed to address cyber-security concerns. The concerns also caused DoD to reduce a larger rollout to focus initially on Fairchild.

“I can report firsthand from the command center that everything is going as expected,” reported Stacy Cummings, program executive officer for Defense Healthcare Management Systems. “Initial feedback from [health care] providers is positive.”

According to Dr. Paul Cordts, director, functional champion for the MHS at the Defense Health Agency, the biggest change that Genesis will bring is offering open medical notes to patients to “empower our patients to know what medical data are in the medical records and to use that data to improve their health and their health care over time.” Patients will be able to access data through a patient portal.

“This EHR is built to enable a team approach to providing health services to patients,” said U.S. Air Force Surgeon General Lt Gen Mark Ediger, MD. “In medicine today we really leverage a number of different skill sets on a health care team… That’s why in the Air Force we are piloting the addition of a health coaching capability here at Fairchild to leverage capabilities that are in MHS, so that health coaches can interact with patients between visits to work on things like tobacco cessation and weight loss, exercise plans and things of that nature.”

After years of preparation, a new electronic health record (EHR) system is now live at Fairchild Air Force Base in Washington. According to DoD officials, the system remains on schedule for the next step in the rollout later this year and the eventual completion in 2022. “This is just the first step in implementing what will be the largest integrated inpatient and outpatient electronic health record in the United States,” said VADM Raquel Bono, director of the Defense Health Agency.

Home to the 92nd Medical Group, Fairchild has a number of outpatient clinics and a pharmacy. According to Col Margaret Carey, the 92nd Medical Group commander, Genesis is being used by all the medical personnel at Fairchild.

For many years, the VA and DoD discussed possibly developing a single EHR across both systems before rejecting the idea for being too costly and complicated. Instead the 2 agencies looked to make their systems interoperable and to improve data sharing across the systems. The 2 agencies developed the Joint Legacy Viewer system to improve data sharing. The Joint Legacy Viewer is a clinical application that provides an integrated, read-only display of health data from DoD, VA, private sector partners, and the current military medical record system in a common data viewer.

The DoD originally awarded the $4.3 billion contract to Leidos in 2014 to develop Genesis, but the system was delayed to address cyber-security concerns. The concerns also caused DoD to reduce a larger rollout to focus initially on Fairchild.

“I can report firsthand from the command center that everything is going as expected,” reported Stacy Cummings, program executive officer for Defense Healthcare Management Systems. “Initial feedback from [health care] providers is positive.”

According to Dr. Paul Cordts, director, functional champion for the MHS at the Defense Health Agency, the biggest change that Genesis will bring is offering open medical notes to patients to “empower our patients to know what medical data are in the medical records and to use that data to improve their health and their health care over time.” Patients will be able to access data through a patient portal.

“This EHR is built to enable a team approach to providing health services to patients,” said U.S. Air Force Surgeon General Lt Gen Mark Ediger, MD. “In medicine today we really leverage a number of different skill sets on a health care team… That’s why in the Air Force we are piloting the addition of a health coaching capability here at Fairchild to leverage capabilities that are in MHS, so that health coaches can interact with patients between visits to work on things like tobacco cessation and weight loss, exercise plans and things of that nature.”

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