Novartis has recalled three lots of 12.5-mg eltrombopag (Promacta) for oral suspension following discovery of possible contamination with peanut flour at a third-party manufacturing site.

Tablets at doses of 12.5 mg, 25 mg, 50 mg, and 75 mg are unaffected by this recall because they are not manufactured in the same facility. The recalled lots of medication were distributed between January and April 2019, but so far, Novartis has not received any reports of adverse events related to the recall.

Oral suspension of eltrombopag is indicated for certain patients with chronic immune thrombocytopenia, hepatitis C–associated thrombocytopenia, and severe aplastic anemia.

More information on the recalled lots and instructions on how to return the product can be found in the full announcement, which is also available through the Food and Drug Administration website.

[email protected]

Novartis has recalled three lots of 12.5-mg eltrombopag (Promacta) for oral suspension following discovery of possible contamination with peanut flour at a third-party manufacturing site.

Tablets at doses of 12.5 mg, 25 mg, 50 mg, and 75 mg are unaffected by this recall because they are not manufactured in the same facility. The recalled lots of medication were distributed between January and April 2019, but so far, Novartis has not received any reports of adverse events related to the recall.

Oral suspension of eltrombopag is indicated for certain patients with chronic immune thrombocytopenia, hepatitis C–associated thrombocytopenia, and severe aplastic anemia.

More information on the recalled lots and instructions on how to return the product can be found in the full announcement, which is also available through the Food and Drug Administration website.

[email protected]

Novartis has recalled three lots of 12.5-mg eltrombopag (Promacta) for oral suspension following discovery of possible contamination with peanut flour at a third-party manufacturing site.

Tablets at doses of 12.5 mg, 25 mg, 50 mg, and 75 mg are unaffected by this recall because they are not manufactured in the same facility. The recalled lots of medication were distributed between January and April 2019, but so far, Novartis has not received any reports of adverse events related to the recall.

Oral suspension of eltrombopag is indicated for certain patients with chronic immune thrombocytopenia, hepatitis C–associated thrombocytopenia, and severe aplastic anemia.

More information on the recalled lots and instructions on how to return the product can be found in the full announcement, which is also available through the Food and Drug Administration website.

[email protected]

LOS ANGELES – In the opinion of Felicia Cosman, MD, the current state of osteoporosis treatment is fraught with clinical challenges.

First, most patients at highest risk for future fractures are not being treated. “In fact, fewer than 25% of patients with new clinical fractures are treated for their underlying disease,” Dr. Cosman, professor of medicine at Columbia University, New York, said at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists (AACE).

“One of the reasons doctors are not treating these patients is that many of them do not have a T-score in the osteoporosis range. There’s a misunderstanding here. A fracture that occurs in people with low bone mass in the setting of minimal trauma – such as a fall from standing height – meets the criteria for the clinical diagnosis of osteoporosis and qualifies a person for being at high risk of more fractures. This is likely because bone weakness or fragility is related not just to quantitative aspects, but also to structural and qualitative aspects that cannot be measured as easily.”

Another problem is that some of the highest-risk patients are those with a vertebral fracture. “However, vertebral fractures are particularly difficult to find and treat because they’re often asymptomatic and we’re not [identifying] these patients,” she said. “Targeted screening [with] spine imaging to find vertebral fractures is probably as important as BMD [bone mineral density] testing.”

To complicate matters, Dr. Cosman said that clinicians and patients “misunderstand the balance between benefits and risks of osteoporosis medications and they don’t consider the risk of not treating the underlying disease. Lastly, there’s little evidence to help guide long-term strategies. Guidelines across medical specialties are incredibly inconsistent. With the exception of guidelines from AACE, the one thing that they’re very consistent about is underrecognizing the value of anabolic therapy for people with severe osteoporosis.”

It is well known that previous bone fracture is the most important risk factor for a future fracture, but the recency of the fracture is also important. In a recent study, researchers followed 377,561 female Medicare beneficiaries with a first fracture for up to 5 years (Osteoporos Int. 2019;30[1]:79-92). They found that at 1 year, the risk of another fracture was 10%. The fracture risk rose to 18% at 2 years, and to 31% at 5 years. “I like to think of this as the osteoporosis emergency,” said Dr. Cosman, co–editor-in-chief of Osteoporosis International. “We need to treat these people right away to prevent more fractures and related disability, morbidity, and mortality.”

According to data from pivotal trials, the anabolic agents teriparatide, abaloparatide, and romosozumab appear to produce more rapid and larger effects against all fractures, compared with even the best antiresorptive agents. “However, comparing across studies can be problematic, because the different populations have varying baseline characteristics and different underlying risk,” Dr. Cosman said. “The protocols and the outcome definitions might be different. It’s better to compare anabolic agents with antiresorptive agents in head-to-head trials, and we now have a few of these.”

Two trials are older studies in which fracture outcomes were not the primary endpoints. One study evaluated a population of patients with glucocorticoid-induced osteoporosis and found that over 18 months, teriparatide reduced vertebral fractures by 90%, compared with alendronate (N Engl J Med. 2007;357[20]:2028-39). The other trial focused on a population of patients with acute, painful vertebral fractures. It found that over 1 year, teriparatide reduced vertebral fractures by 50%, compared with risedronate (Osteoporos Int. 2012;23[8]:2141-50). Two more recent studies compared anabolic and antiresorptive therapies on fracture outcomes as primary endpoints in patients with prevalent fractures. The VERO trial compared teriparatide with risedronate (Lancet. 2018;391[10117]:230-40), and ARCH compared romosozumab with alendronate (N Engl J Med. 2017;377[15]:1417-27).

In VERO, 1,360 patients with a prevalent vertebral fracture were randomized to receive teriparatide or risedronate for 2 years. At 12 months, the proportion of patients with a new vertebral fracture was 3.1% and 6% in the teriparatide and risedronate groups, respectively, a pattern that held true at 24 months (6.4% vs. 12%). The study also showed that the number of nonvertebral fractures was significantly lower in teriparatide-treated patients, compared with those on risedronate. In ARCH, 4,093 postmenopausal women at high risk of fracture were randomized to receive romosozumab or alendronate for 1 year and then followed for a median period of 33 months. At 12 months, the proportion of patients with a new vertebral fracture was 4% and 6.3% in the romosozumab and alendronate groups, respectively, a pattern that held true at 24 months (6.2% vs. 11.9%).

“These trials showed that the antifracture effects are faster and larger with anabolic agents, compared with antiresorptive agents,” Dr. Cosman said. “They also showed that antifracture effects are sustained after transition to antiresorptive therapy.” In ARCH, both nonvertebral and hip fracture incidences were lower in the romosozumab group, compared with the alendronate group.

The trials demonstrated that improving total hip BMD is associated with improved bone strength and resistance to fracture, yet treatment sequence matters. “The greatest BMD gains of the hip are seen when anabolic agents are used first-line, followed by a potent antiresorptive agent,” she said.

Dr. Cosman offered a strategy for patients on potent antiresorptive agents who need anabolic medication. In patients on bisphosphonates, especially with an incident hip fracture or very low hip BMD, consider combination therapy with initiation of teriparatide or abaloparatide, along with an antiresorptive agent. “There are very little data addressing patients on denosumab, but I would suggest perhaps adding teriparatide or abaloparatide in this population, and continuing denosumab,” she said. “That could lead to BMD gain. Switching to romosozumab might also be an option. But, if possible, use an anabolic agent first. The role of anabolic medication for osteoporosis is evolving as evidence continues to suggest superior benefit of anabolic-first regimens for high-risk patients.”

Dr. Cosman disclosed that she has received advising, consulting, and speaking fees from Amgen and Radius. She has received consulting fees from Tarsa and research grants and medication from Amgen.

[email protected]

LOS ANGELES – In the opinion of Felicia Cosman, MD, the current state of osteoporosis treatment is fraught with clinical challenges.

First, most patients at highest risk for future fractures are not being treated. “In fact, fewer than 25% of patients with new clinical fractures are treated for their underlying disease,” Dr. Cosman, professor of medicine at Columbia University, New York, said at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists (AACE).

“One of the reasons doctors are not treating these patients is that many of them do not have a T-score in the osteoporosis range. There’s a misunderstanding here. A fracture that occurs in people with low bone mass in the setting of minimal trauma – such as a fall from standing height – meets the criteria for the clinical diagnosis of osteoporosis and qualifies a person for being at high risk of more fractures. This is likely because bone weakness or fragility is related not just to quantitative aspects, but also to structural and qualitative aspects that cannot be measured as easily.”

Another problem is that some of the highest-risk patients are those with a vertebral fracture. “However, vertebral fractures are particularly difficult to find and treat because they’re often asymptomatic and we’re not [identifying] these patients,” she said. “Targeted screening [with] spine imaging to find vertebral fractures is probably as important as BMD [bone mineral density] testing.”

To complicate matters, Dr. Cosman said that clinicians and patients “misunderstand the balance between benefits and risks of osteoporosis medications and they don’t consider the risk of not treating the underlying disease. Lastly, there’s little evidence to help guide long-term strategies. Guidelines across medical specialties are incredibly inconsistent. With the exception of guidelines from AACE, the one thing that they’re very consistent about is underrecognizing the value of anabolic therapy for people with severe osteoporosis.”

It is well known that previous bone fracture is the most important risk factor for a future fracture, but the recency of the fracture is also important. In a recent study, researchers followed 377,561 female Medicare beneficiaries with a first fracture for up to 5 years (Osteoporos Int. 2019;30[1]:79-92). They found that at 1 year, the risk of another fracture was 10%. The fracture risk rose to 18% at 2 years, and to 31% at 5 years. “I like to think of this as the osteoporosis emergency,” said Dr. Cosman, co–editor-in-chief of Osteoporosis International. “We need to treat these people right away to prevent more fractures and related disability, morbidity, and mortality.”

According to data from pivotal trials, the anabolic agents teriparatide, abaloparatide, and romosozumab appear to produce more rapid and larger effects against all fractures, compared with even the best antiresorptive agents. “However, comparing across studies can be problematic, because the different populations have varying baseline characteristics and different underlying risk,” Dr. Cosman said. “The protocols and the outcome definitions might be different. It’s better to compare anabolic agents with antiresorptive agents in head-to-head trials, and we now have a few of these.”

Two trials are older studies in which fracture outcomes were not the primary endpoints. One study evaluated a population of patients with glucocorticoid-induced osteoporosis and found that over 18 months, teriparatide reduced vertebral fractures by 90%, compared with alendronate (N Engl J Med. 2007;357[20]:2028-39). The other trial focused on a population of patients with acute, painful vertebral fractures. It found that over 1 year, teriparatide reduced vertebral fractures by 50%, compared with risedronate (Osteoporos Int. 2012;23[8]:2141-50). Two more recent studies compared anabolic and antiresorptive therapies on fracture outcomes as primary endpoints in patients with prevalent fractures. The VERO trial compared teriparatide with risedronate (Lancet. 2018;391[10117]:230-40), and ARCH compared romosozumab with alendronate (N Engl J Med. 2017;377[15]:1417-27).

In VERO, 1,360 patients with a prevalent vertebral fracture were randomized to receive teriparatide or risedronate for 2 years. At 12 months, the proportion of patients with a new vertebral fracture was 3.1% and 6% in the teriparatide and risedronate groups, respectively, a pattern that held true at 24 months (6.4% vs. 12%). The study also showed that the number of nonvertebral fractures was significantly lower in teriparatide-treated patients, compared with those on risedronate. In ARCH, 4,093 postmenopausal women at high risk of fracture were randomized to receive romosozumab or alendronate for 1 year and then followed for a median period of 33 months. At 12 months, the proportion of patients with a new vertebral fracture was 4% and 6.3% in the romosozumab and alendronate groups, respectively, a pattern that held true at 24 months (6.2% vs. 11.9%).

“These trials showed that the antifracture effects are faster and larger with anabolic agents, compared with antiresorptive agents,” Dr. Cosman said. “They also showed that antifracture effects are sustained after transition to antiresorptive therapy.” In ARCH, both nonvertebral and hip fracture incidences were lower in the romosozumab group, compared with the alendronate group.

The trials demonstrated that improving total hip BMD is associated with improved bone strength and resistance to fracture, yet treatment sequence matters. “The greatest BMD gains of the hip are seen when anabolic agents are used first-line, followed by a potent antiresorptive agent,” she said.

Dr. Cosman offered a strategy for patients on potent antiresorptive agents who need anabolic medication. In patients on bisphosphonates, especially with an incident hip fracture or very low hip BMD, consider combination therapy with initiation of teriparatide or abaloparatide, along with an antiresorptive agent. “There are very little data addressing patients on denosumab, but I would suggest perhaps adding teriparatide or abaloparatide in this population, and continuing denosumab,” she said. “That could lead to BMD gain. Switching to romosozumab might also be an option. But, if possible, use an anabolic agent first. The role of anabolic medication for osteoporosis is evolving as evidence continues to suggest superior benefit of anabolic-first regimens for high-risk patients.”

Dr. Cosman disclosed that she has received advising, consulting, and speaking fees from Amgen and Radius. She has received consulting fees from Tarsa and research grants and medication from Amgen.

[email protected]

LOS ANGELES – In the opinion of Felicia Cosman, MD, the current state of osteoporosis treatment is fraught with clinical challenges.

First, most patients at highest risk for future fractures are not being treated. “In fact, fewer than 25% of patients with new clinical fractures are treated for their underlying disease,” Dr. Cosman, professor of medicine at Columbia University, New York, said at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists (AACE).

“One of the reasons doctors are not treating these patients is that many of them do not have a T-score in the osteoporosis range. There’s a misunderstanding here. A fracture that occurs in people with low bone mass in the setting of minimal trauma – such as a fall from standing height – meets the criteria for the clinical diagnosis of osteoporosis and qualifies a person for being at high risk of more fractures. This is likely because bone weakness or fragility is related not just to quantitative aspects, but also to structural and qualitative aspects that cannot be measured as easily.”

Another problem is that some of the highest-risk patients are those with a vertebral fracture. “However, vertebral fractures are particularly difficult to find and treat because they’re often asymptomatic and we’re not [identifying] these patients,” she said. “Targeted screening [with] spine imaging to find vertebral fractures is probably as important as BMD [bone mineral density] testing.”

To complicate matters, Dr. Cosman said that clinicians and patients “misunderstand the balance between benefits and risks of osteoporosis medications and they don’t consider the risk of not treating the underlying disease. Lastly, there’s little evidence to help guide long-term strategies. Guidelines across medical specialties are incredibly inconsistent. With the exception of guidelines from AACE, the one thing that they’re very consistent about is underrecognizing the value of anabolic therapy for people with severe osteoporosis.”

It is well known that previous bone fracture is the most important risk factor for a future fracture, but the recency of the fracture is also important. In a recent study, researchers followed 377,561 female Medicare beneficiaries with a first fracture for up to 5 years (Osteoporos Int. 2019;30[1]:79-92). They found that at 1 year, the risk of another fracture was 10%. The fracture risk rose to 18% at 2 years, and to 31% at 5 years. “I like to think of this as the osteoporosis emergency,” said Dr. Cosman, co–editor-in-chief of Osteoporosis International. “We need to treat these people right away to prevent more fractures and related disability, morbidity, and mortality.”

According to data from pivotal trials, the anabolic agents teriparatide, abaloparatide, and romosozumab appear to produce more rapid and larger effects against all fractures, compared with even the best antiresorptive agents. “However, comparing across studies can be problematic, because the different populations have varying baseline characteristics and different underlying risk,” Dr. Cosman said. “The protocols and the outcome definitions might be different. It’s better to compare anabolic agents with antiresorptive agents in head-to-head trials, and we now have a few of these.”

Two trials are older studies in which fracture outcomes were not the primary endpoints. One study evaluated a population of patients with glucocorticoid-induced osteoporosis and found that over 18 months, teriparatide reduced vertebral fractures by 90%, compared with alendronate (N Engl J Med. 2007;357[20]:2028-39). The other trial focused on a population of patients with acute, painful vertebral fractures. It found that over 1 year, teriparatide reduced vertebral fractures by 50%, compared with risedronate (Osteoporos Int. 2012;23[8]:2141-50). Two more recent studies compared anabolic and antiresorptive therapies on fracture outcomes as primary endpoints in patients with prevalent fractures. The VERO trial compared teriparatide with risedronate (Lancet. 2018;391[10117]:230-40), and ARCH compared romosozumab with alendronate (N Engl J Med. 2017;377[15]:1417-27).

In VERO, 1,360 patients with a prevalent vertebral fracture were randomized to receive teriparatide or risedronate for 2 years. At 12 months, the proportion of patients with a new vertebral fracture was 3.1% and 6% in the teriparatide and risedronate groups, respectively, a pattern that held true at 24 months (6.4% vs. 12%). The study also showed that the number of nonvertebral fractures was significantly lower in teriparatide-treated patients, compared with those on risedronate. In ARCH, 4,093 postmenopausal women at high risk of fracture were randomized to receive romosozumab or alendronate for 1 year and then followed for a median period of 33 months. At 12 months, the proportion of patients with a new vertebral fracture was 4% and 6.3% in the romosozumab and alendronate groups, respectively, a pattern that held true at 24 months (6.2% vs. 11.9%).

“These trials showed that the antifracture effects are faster and larger with anabolic agents, compared with antiresorptive agents,” Dr. Cosman said. “They also showed that antifracture effects are sustained after transition to antiresorptive therapy.” In ARCH, both nonvertebral and hip fracture incidences were lower in the romosozumab group, compared with the alendronate group.

The trials demonstrated that improving total hip BMD is associated with improved bone strength and resistance to fracture, yet treatment sequence matters. “The greatest BMD gains of the hip are seen when anabolic agents are used first-line, followed by a potent antiresorptive agent,” she said.

Dr. Cosman offered a strategy for patients on potent antiresorptive agents who need anabolic medication. In patients on bisphosphonates, especially with an incident hip fracture or very low hip BMD, consider combination therapy with initiation of teriparatide or abaloparatide, along with an antiresorptive agent. “There are very little data addressing patients on denosumab, but I would suggest perhaps adding teriparatide or abaloparatide in this population, and continuing denosumab,” she said. “That could lead to BMD gain. Switching to romosozumab might also be an option. But, if possible, use an anabolic agent first. The role of anabolic medication for osteoporosis is evolving as evidence continues to suggest superior benefit of anabolic-first regimens for high-risk patients.”

Dr. Cosman disclosed that she has received advising, consulting, and speaking fees from Amgen and Radius. She has received consulting fees from Tarsa and research grants and medication from Amgen.

[email protected]

BALTIMORE – A study that examined the quality of data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBASQIP) registry found inconsistencies that may undermine the quality of the registry, which could be misleading for clinicians and investigators who used the data, according to an analysis presented at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons. The researchers recommended ways to improve data-gathering techniques to better identify the nature of these inconsistencies.

“Our original enthusiasm about the availability of data from MBASQIP turned into a cautious optimism about potential usefulness of these data,” Katia Noyes, PhD, of the State University of New York at Buffalo, said in presenting the study. She noted her research team’s analysis of 168,093 cases in the 2015 MBASQIP Participant Use Data File found that 20% of the cases (n = 33,868) had missing or unusable information for at least one key variable, such as age, race, ethnicity, body mass index (BMI) before and after surgery, and American Society of Anesthesiologists classification. Specifically, preoperative and postoperative BMI data were missing or zero in 6.7% of cases (n = 11,211).

The researchers developed a single flat file for patient-level outcomes evaluation using five files (main, BMI, readmission, intervention, and reoperation). They used logic and validity tests that included individual profiles of patient BMI changes over time, individual patient care pathways (chronologic record of patient admission, discharge and procedure history), and correlation tests between pairs of variables associated with the same clinical encounters (emergency intervention vs. procedure type; related admission with intervention vs. planned intervention).

“Weight reduction at the first postoperative visit ranged from –71% to a gain of 132% of preoperative weight,” she said. “We also found inconsistency in the sequence of events. Seven percent of readmissions and 12.5% of postoperative interventions were categorized as planned, which is not a problem, but when you look at the reported reasons for planned procedures, they could not all have been possibly planned before discharge.”

Based on 2015 MBASQIP data, “planned” readmissions and postoperative procedures included admissions for nonspecific abdominal pain, band erosion, slippage or prolapse, bleeding, gastrogastric fistula, incisional hernia, infection and/or fever, pneumonia, and wound infection, among other reasons.

“Our analysis found inconsistent quality of data for key parameters, missing and miscoded values and lack of clarity for coding and definitions,” Dr. Noyes said.

The study made four recommendations to improve the quality of data submitted to MASQIP.

• Use health IT applications to provide automated data checks to validate completeness of submitted data – by utilizing a no-skip pattern for core variables – and accuracy of data– by flagging values outside predefined acceptable ranges.
• Perform data audits for consistency, using multiple variables to conduct logic checks, such as by not allowing “readmission” before discharge for the index admission.
• Give data auditors specific recommendations for definitions of registry variables, standardization of algorithms for abstracting values based on commonly used clinical data systems, such as Allscripts and Epic, and standardized use of diagnostic and procedure codes to link with payers’ reimbursement schedules.
• Provide ongoing education to stakeholders such as researchers and hospital administrators on best data management practices and how to best use the data for quality improvement.

Dr. Noyes had no financial relationships to disclose. Coauthor Steven Schwaitzberg, MD, disclosed consulting arrangements with New View Surgical, AcuityBio, Activ Surgical, Human Extensions, Levita Magnetics, and Arch Therapeutics. Aaron Hoffman, MD, disclosed a consulting arrangement with Ethicon.

SOURCE: Noyes K et al. SAGES 2019, Abstract 21

BALTIMORE – A study that examined the quality of data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBASQIP) registry found inconsistencies that may undermine the quality of the registry, which could be misleading for clinicians and investigators who used the data, according to an analysis presented at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons. The researchers recommended ways to improve data-gathering techniques to better identify the nature of these inconsistencies.

“Our original enthusiasm about the availability of data from MBASQIP turned into a cautious optimism about potential usefulness of these data,” Katia Noyes, PhD, of the State University of New York at Buffalo, said in presenting the study. She noted her research team’s analysis of 168,093 cases in the 2015 MBASQIP Participant Use Data File found that 20% of the cases (n = 33,868) had missing or unusable information for at least one key variable, such as age, race, ethnicity, body mass index (BMI) before and after surgery, and American Society of Anesthesiologists classification. Specifically, preoperative and postoperative BMI data were missing or zero in 6.7% of cases (n = 11,211).

The researchers developed a single flat file for patient-level outcomes evaluation using five files (main, BMI, readmission, intervention, and reoperation). They used logic and validity tests that included individual profiles of patient BMI changes over time, individual patient care pathways (chronologic record of patient admission, discharge and procedure history), and correlation tests between pairs of variables associated with the same clinical encounters (emergency intervention vs. procedure type; related admission with intervention vs. planned intervention).

“Weight reduction at the first postoperative visit ranged from –71% to a gain of 132% of preoperative weight,” she said. “We also found inconsistency in the sequence of events. Seven percent of readmissions and 12.5% of postoperative interventions were categorized as planned, which is not a problem, but when you look at the reported reasons for planned procedures, they could not all have been possibly planned before discharge.”

Based on 2015 MBASQIP data, “planned” readmissions and postoperative procedures included admissions for nonspecific abdominal pain, band erosion, slippage or prolapse, bleeding, gastrogastric fistula, incisional hernia, infection and/or fever, pneumonia, and wound infection, among other reasons.

“Our analysis found inconsistent quality of data for key parameters, missing and miscoded values and lack of clarity for coding and definitions,” Dr. Noyes said.

The study made four recommendations to improve the quality of data submitted to MASQIP.

• Use health IT applications to provide automated data checks to validate completeness of submitted data – by utilizing a no-skip pattern for core variables – and accuracy of data– by flagging values outside predefined acceptable ranges.
• Perform data audits for consistency, using multiple variables to conduct logic checks, such as by not allowing “readmission” before discharge for the index admission.
• Give data auditors specific recommendations for definitions of registry variables, standardization of algorithms for abstracting values based on commonly used clinical data systems, such as Allscripts and Epic, and standardized use of diagnostic and procedure codes to link with payers’ reimbursement schedules.
• Provide ongoing education to stakeholders such as researchers and hospital administrators on best data management practices and how to best use the data for quality improvement.

Dr. Noyes had no financial relationships to disclose. Coauthor Steven Schwaitzberg, MD, disclosed consulting arrangements with New View Surgical, AcuityBio, Activ Surgical, Human Extensions, Levita Magnetics, and Arch Therapeutics. Aaron Hoffman, MD, disclosed a consulting arrangement with Ethicon.

SOURCE: Noyes K et al. SAGES 2019, Abstract 21

BALTIMORE – A study that examined the quality of data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBASQIP) registry found inconsistencies that may undermine the quality of the registry, which could be misleading for clinicians and investigators who used the data, according to an analysis presented at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons. The researchers recommended ways to improve data-gathering techniques to better identify the nature of these inconsistencies.

“Our original enthusiasm about the availability of data from MBASQIP turned into a cautious optimism about potential usefulness of these data,” Katia Noyes, PhD, of the State University of New York at Buffalo, said in presenting the study. She noted her research team’s analysis of 168,093 cases in the 2015 MBASQIP Participant Use Data File found that 20% of the cases (n = 33,868) had missing or unusable information for at least one key variable, such as age, race, ethnicity, body mass index (BMI) before and after surgery, and American Society of Anesthesiologists classification. Specifically, preoperative and postoperative BMI data were missing or zero in 6.7% of cases (n = 11,211).

The researchers developed a single flat file for patient-level outcomes evaluation using five files (main, BMI, readmission, intervention, and reoperation). They used logic and validity tests that included individual profiles of patient BMI changes over time, individual patient care pathways (chronologic record of patient admission, discharge and procedure history), and correlation tests between pairs of variables associated with the same clinical encounters (emergency intervention vs. procedure type; related admission with intervention vs. planned intervention).

“Weight reduction at the first postoperative visit ranged from –71% to a gain of 132% of preoperative weight,” she said. “We also found inconsistency in the sequence of events. Seven percent of readmissions and 12.5% of postoperative interventions were categorized as planned, which is not a problem, but when you look at the reported reasons for planned procedures, they could not all have been possibly planned before discharge.”

Based on 2015 MBASQIP data, “planned” readmissions and postoperative procedures included admissions for nonspecific abdominal pain, band erosion, slippage or prolapse, bleeding, gastrogastric fistula, incisional hernia, infection and/or fever, pneumonia, and wound infection, among other reasons.

“Our analysis found inconsistent quality of data for key parameters, missing and miscoded values and lack of clarity for coding and definitions,” Dr. Noyes said.

The study made four recommendations to improve the quality of data submitted to MASQIP.

• Use health IT applications to provide automated data checks to validate completeness of submitted data – by utilizing a no-skip pattern for core variables – and accuracy of data– by flagging values outside predefined acceptable ranges.
• Perform data audits for consistency, using multiple variables to conduct logic checks, such as by not allowing “readmission” before discharge for the index admission.
• Give data auditors specific recommendations for definitions of registry variables, standardization of algorithms for abstracting values based on commonly used clinical data systems, such as Allscripts and Epic, and standardized use of diagnostic and procedure codes to link with payers’ reimbursement schedules.
• Provide ongoing education to stakeholders such as researchers and hospital administrators on best data management practices and how to best use the data for quality improvement.

Dr. Noyes had no financial relationships to disclose. Coauthor Steven Schwaitzberg, MD, disclosed consulting arrangements with New View Surgical, AcuityBio, Activ Surgical, Human Extensions, Levita Magnetics, and Arch Therapeutics. Aaron Hoffman, MD, disclosed a consulting arrangement with Ethicon.

SOURCE: Noyes K et al. SAGES 2019, Abstract 21

Comorbid depression significantly increased hospitalization costs, length of stay, and mortality among pediatric patients, according to a study in the Journal of Affective Disorders.

©drpnncpp/thinkstockphotos.com

The investigators led by Mayowa Olusunmade, MD, MPH, of New Jersey Medical School, Newark, found that, compared with those among nondepressed pediatric patients, hospitalization costs were $2,961 higher (P less than .001), length of stay was 0.89 days longer (P less than .001), and odds of death as an outcome while hospitalized was 1.77 times higher (P = .013) among depressed pediatric patients. On the other hand, depressed patients had 0.3 fewer procedures (P less than .001) than nondepressed patients.

This analysis is based on 17,073 pairs of patients with and without depression that were created through one-to-one propensity score matching. The investigators drew these pairs from an estimated 937,971 patients in the Kids’ Inpatient Database for 2012 who were identified as being aged 6 years and older and having any of the 10 of the most common diagnoses other than affective disorders. The investigators then determined which children among those identified had comorbid depression (2.9%) and which did not (97.1%) to create the propensity score–matched pairs.

One limitation in this study is that the mean age was 17.5 years because depression diagnosis is more atypical among younger patients such that adolescents were disproportionately represented.

The study did not receive funding, and the authors declared there are no conflicts of interest.

[email protected]

SOURCE: Olusunmade M et al. J Affect Disord. 2019 Mar 27. doi: 10.1016/j.jad.2019.03.073.

Comorbid depression significantly increased hospitalization costs, length of stay, and mortality among pediatric patients, according to a study in the Journal of Affective Disorders.

©drpnncpp/thinkstockphotos.com

The investigators led by Mayowa Olusunmade, MD, MPH, of New Jersey Medical School, Newark, found that, compared with those among nondepressed pediatric patients, hospitalization costs were $2,961 higher (P less than .001), length of stay was 0.89 days longer (P less than .001), and odds of death as an outcome while hospitalized was 1.77 times higher (P = .013) among depressed pediatric patients. On the other hand, depressed patients had 0.3 fewer procedures (P less than .001) than nondepressed patients.

This analysis is based on 17,073 pairs of patients with and without depression that were created through one-to-one propensity score matching. The investigators drew these pairs from an estimated 937,971 patients in the Kids’ Inpatient Database for 2012 who were identified as being aged 6 years and older and having any of the 10 of the most common diagnoses other than affective disorders. The investigators then determined which children among those identified had comorbid depression (2.9%) and which did not (97.1%) to create the propensity score–matched pairs.

One limitation in this study is that the mean age was 17.5 years because depression diagnosis is more atypical among younger patients such that adolescents were disproportionately represented.

The study did not receive funding, and the authors declared there are no conflicts of interest.

[email protected]

SOURCE: Olusunmade M et al. J Affect Disord. 2019 Mar 27. doi: 10.1016/j.jad.2019.03.073.

Comorbid depression significantly increased hospitalization costs, length of stay, and mortality among pediatric patients, according to a study in the Journal of Affective Disorders.

©drpnncpp/thinkstockphotos.com

The investigators led by Mayowa Olusunmade, MD, MPH, of New Jersey Medical School, Newark, found that, compared with those among nondepressed pediatric patients, hospitalization costs were $2,961 higher (P less than .001), length of stay was 0.89 days longer (P less than .001), and odds of death as an outcome while hospitalized was 1.77 times higher (P = .013) among depressed pediatric patients. On the other hand, depressed patients had 0.3 fewer procedures (P less than .001) than nondepressed patients.

This analysis is based on 17,073 pairs of patients with and without depression that were created through one-to-one propensity score matching. The investigators drew these pairs from an estimated 937,971 patients in the Kids’ Inpatient Database for 2012 who were identified as being aged 6 years and older and having any of the 10 of the most common diagnoses other than affective disorders. The investigators then determined which children among those identified had comorbid depression (2.9%) and which did not (97.1%) to create the propensity score–matched pairs.

One limitation in this study is that the mean age was 17.5 years because depression diagnosis is more atypical among younger patients such that adolescents were disproportionately represented.

The study did not receive funding, and the authors declared there are no conflicts of interest.

[email protected]

SOURCE: Olusunmade M et al. J Affect Disord. 2019 Mar 27. doi: 10.1016/j.jad.2019.03.073.

Women undergoing open descending thoracic aortic aneurysm (DTA) and open thoracoabdominal aortic aneurysm (TAAA) repair are not at greater risk for operative mortality than their male counterparts. However, they are at significantly greater risk for major adverse events and have significantly lower 5-year survival, according to the results of a single institution database review of 738 surgery patients.

From May 1997 to June 2017, there were 462 men (59%) and 321 women (41%) who underwent open repair of DTA or TAAA, according to Leonard N. Girardi, MD, and colleagues from Weill Cornell Medicine, New York, who performed the study published in the Journal of Vascular Surgery. The researchers used logistic regression and Cox regression analyses to assess the effect of sex on perioperative and long-term outcomes.

Demographically, women were significantly older (67.6 years vs. 62.6 years), with a significantly higher incidence of chronic obstructive pulmonary disease (47.0% vs. 35.7%) and a significantly greater percentage of patients with a forced expiratory volume in 1 second less than 50% (28.3% vs 18.2%). Degenerative aneurysms were significantly more common in women (61.7% vs. 41.6%), whereas chronic dissections significantly predominated in men (42.4% vs. 23.1%). Operative mortality was not significantly different between women and men (5.6% vs. 6.2%); however, women were significantly more likely to require a tracheostomy after surgery (10.6% vs. 5.0%).

Logistic regression found that being a woman was an independent risk factor for a composite of major adverse events (odds ratio, 2.68) and need for tracheostomy (OR, 3.73). In addition, women had significantly worse 5-year survival than men undergoing DTA or TAAA repair (59.7% vs. 66.2%, P =.025). There was no difference in overall survival between 1997-2007 and 2008-2017.

“Women and men undergoing TAAA repair have significant and consistent differences in preoperative characteristics. Despite these differences, operative mortality is similar between the two groups. However, women are at significantly increased risk of [major adverse events], especially respiratory failure, because of those differences in risk factors, including age, pulmonary function, and aneurysm etiology,” the researchers concluded.

The authors reported that they had no conflicts of interest.

[email protected]

SOURCE: Girardi LN et al. J Vasc Surg 2019;69:1028-35.

Women undergoing open descending thoracic aortic aneurysm (DTA) and open thoracoabdominal aortic aneurysm (TAAA) repair are not at greater risk for operative mortality than their male counterparts. However, they are at significantly greater risk for major adverse events and have significantly lower 5-year survival, according to the results of a single institution database review of 738 surgery patients.

From May 1997 to June 2017, there were 462 men (59%) and 321 women (41%) who underwent open repair of DTA or TAAA, according to Leonard N. Girardi, MD, and colleagues from Weill Cornell Medicine, New York, who performed the study published in the Journal of Vascular Surgery. The researchers used logistic regression and Cox regression analyses to assess the effect of sex on perioperative and long-term outcomes.

Demographically, women were significantly older (67.6 years vs. 62.6 years), with a significantly higher incidence of chronic obstructive pulmonary disease (47.0% vs. 35.7%) and a significantly greater percentage of patients with a forced expiratory volume in 1 second less than 50% (28.3% vs 18.2%). Degenerative aneurysms were significantly more common in women (61.7% vs. 41.6%), whereas chronic dissections significantly predominated in men (42.4% vs. 23.1%). Operative mortality was not significantly different between women and men (5.6% vs. 6.2%); however, women were significantly more likely to require a tracheostomy after surgery (10.6% vs. 5.0%).

Logistic regression found that being a woman was an independent risk factor for a composite of major adverse events (odds ratio, 2.68) and need for tracheostomy (OR, 3.73). In addition, women had significantly worse 5-year survival than men undergoing DTA or TAAA repair (59.7% vs. 66.2%, P =.025). There was no difference in overall survival between 1997-2007 and 2008-2017.

“Women and men undergoing TAAA repair have significant and consistent differences in preoperative characteristics. Despite these differences, operative mortality is similar between the two groups. However, women are at significantly increased risk of [major adverse events], especially respiratory failure, because of those differences in risk factors, including age, pulmonary function, and aneurysm etiology,” the researchers concluded.

The authors reported that they had no conflicts of interest.

[email protected]

SOURCE: Girardi LN et al. J Vasc Surg 2019;69:1028-35.

Women undergoing open descending thoracic aortic aneurysm (DTA) and open thoracoabdominal aortic aneurysm (TAAA) repair are not at greater risk for operative mortality than their male counterparts. However, they are at significantly greater risk for major adverse events and have significantly lower 5-year survival, according to the results of a single institution database review of 738 surgery patients.

From May 1997 to June 2017, there were 462 men (59%) and 321 women (41%) who underwent open repair of DTA or TAAA, according to Leonard N. Girardi, MD, and colleagues from Weill Cornell Medicine, New York, who performed the study published in the Journal of Vascular Surgery. The researchers used logistic regression and Cox regression analyses to assess the effect of sex on perioperative and long-term outcomes.

Demographically, women were significantly older (67.6 years vs. 62.6 years), with a significantly higher incidence of chronic obstructive pulmonary disease (47.0% vs. 35.7%) and a significantly greater percentage of patients with a forced expiratory volume in 1 second less than 50% (28.3% vs 18.2%). Degenerative aneurysms were significantly more common in women (61.7% vs. 41.6%), whereas chronic dissections significantly predominated in men (42.4% vs. 23.1%). Operative mortality was not significantly different between women and men (5.6% vs. 6.2%); however, women were significantly more likely to require a tracheostomy after surgery (10.6% vs. 5.0%).

Logistic regression found that being a woman was an independent risk factor for a composite of major adverse events (odds ratio, 2.68) and need for tracheostomy (OR, 3.73). In addition, women had significantly worse 5-year survival than men undergoing DTA or TAAA repair (59.7% vs. 66.2%, P =.025). There was no difference in overall survival between 1997-2007 and 2008-2017.

“Women and men undergoing TAAA repair have significant and consistent differences in preoperative characteristics. Despite these differences, operative mortality is similar between the two groups. However, women are at significantly increased risk of [major adverse events], especially respiratory failure, because of those differences in risk factors, including age, pulmonary function, and aneurysm etiology,” the researchers concluded.

The authors reported that they had no conflicts of interest.

[email protected]

SOURCE: Girardi LN et al. J Vasc Surg 2019;69:1028-35.

NEW ORLEANS – In a survey of pediatric hematologists, quality of life was the most frequently cited reason for starting second-line therapy in children with immune thrombocytopenia.

Jennifer Smith/MDedge News

Quality of life (QOL) was an indication for second-line treatment in nearly three-quarters of patients studied, and it ranked among the top three indications – along with bleeding frequency and bleeding severity – for treatment in more than half of patients.

Kristin A. Shimano, MD, of the department of pediatrics at the University of California, San Francisco, presented these results at the annual meeting of the American Society of Pediatric Hematology/Oncology.

Dr. Shimano and colleagues surveyed hematologists treating children in the ICON1 study (Am J Hematol. 2019 Apr 3. doi: 10.1002/ajh.25479).

The study enrolled 120 children receiving second-line immune thrombocytopenia (ITP) treatment at 21 centers. The median age at enrollment was 11.7 years (range, 1.2-17.8 years). About half of patients (53%) had chronic ITP, 31% had persistent ITP, and 16% had newly diagnosed ITP. The median number of prior treatments was three (range, zero to eight).

At study entry, the hematologists were asked to provide reasons that patients required second-line treatment. The list of 12 possible reasons included patient or parent QOL; bleeding severity; bleeding frequency; severity of thrombocytopenia; chronicity of ITP; high baseline activity level; involvement in sports; patient age; distance from medical center; and parent, patient, or physician anxiety. The hematologists were asked to choose all reasons that applied and to rank the top three reasons.

QOL was chosen as a reason to treat in 73% of patients (n = 88). QOL was among the top three reasons in 57% of patients (n = 68) and was the most important reason in 27% of patients (n = 32).

The severity and frequency of bleeding were ranked among the top three indications as well. Bleeding severity was a top indication in 29% of cases (n = 35), and bleeding frequency was a top indication in 40% of cases (n = 48).

Reasons for starting second-line treatment varied depending on patients’ phase of disease.

Bleeding severity was significantly more likely to be an indication for treatment among patients who had newly diagnosed or persistent ITP (69%), rather than chronic ITP (31%; P = .0025). Bleeding frequency was also significantly more likely to be an indication among patients with newly diagnosed or persistent ITP (63% vs. 37%; P = .0054).

Conversely, QOL was significantly more likely to be an indication for patients with chronic ITP (65%) rather than newly diagnosed or persistent ITP (35%, P = .0056). Sports participation was a more likely indication among patients with chronic ITP as well (75% vs. 26%, P = .017).

Indications for treatment also varied according to baseline platelet counts. For example, QOL was an indication for treatment in 42% of patients with baseline platelet counts less than 10 x 10⁹/L and 78% of patients with platelet counts of 20 x 10⁹/L or greater. So the higher the baseline platelet count, the more likely QOL was an indication for treatment (P = .006).

On the other hand, the importance hematologists placed on QOL did not appear to correlate with actual health-related QOL as assessed by the Kids ITP Tool. There was no difference reported in baseline health-related QOL, according to the tool, in children for whom QOL was ranked versus unranked by hematologists.

This finding suggests physicians may not be adequately assessing the impact of ITP on QOL, Dr. Shimano said.

“Better clinical measures of the impact of ITP on patient quality of life are needed to assess both need for treatment and treatment response,” she said. “Understanding the effects of individual second-line treatments on quality of life is critical for this patient population in order to best tailor therapy for each patient.”

Dr. Shimano reported involvement in an investigator-initiated trial for eltrombopag in children with ITP. The study, which has not yet opened, is funded by Novartis.

[email protected]

SOURCE: Shimano KA et al. ASPHO 2019, Abstract 2012.

NEW ORLEANS – In a survey of pediatric hematologists, quality of life was the most frequently cited reason for starting second-line therapy in children with immune thrombocytopenia.

Jennifer Smith/MDedge News

Quality of life (QOL) was an indication for second-line treatment in nearly three-quarters of patients studied, and it ranked among the top three indications – along with bleeding frequency and bleeding severity – for treatment in more than half of patients.

Kristin A. Shimano, MD, of the department of pediatrics at the University of California, San Francisco, presented these results at the annual meeting of the American Society of Pediatric Hematology/Oncology.

Dr. Shimano and colleagues surveyed hematologists treating children in the ICON1 study (Am J Hematol. 2019 Apr 3. doi: 10.1002/ajh.25479).

The study enrolled 120 children receiving second-line immune thrombocytopenia (ITP) treatment at 21 centers. The median age at enrollment was 11.7 years (range, 1.2-17.8 years). About half of patients (53%) had chronic ITP, 31% had persistent ITP, and 16% had newly diagnosed ITP. The median number of prior treatments was three (range, zero to eight).

At study entry, the hematologists were asked to provide reasons that patients required second-line treatment. The list of 12 possible reasons included patient or parent QOL; bleeding severity; bleeding frequency; severity of thrombocytopenia; chronicity of ITP; high baseline activity level; involvement in sports; patient age; distance from medical center; and parent, patient, or physician anxiety. The hematologists were asked to choose all reasons that applied and to rank the top three reasons.

QOL was chosen as a reason to treat in 73% of patients (n = 88). QOL was among the top three reasons in 57% of patients (n = 68) and was the most important reason in 27% of patients (n = 32).

The severity and frequency of bleeding were ranked among the top three indications as well. Bleeding severity was a top indication in 29% of cases (n = 35), and bleeding frequency was a top indication in 40% of cases (n = 48).

Reasons for starting second-line treatment varied depending on patients’ phase of disease.

Bleeding severity was significantly more likely to be an indication for treatment among patients who had newly diagnosed or persistent ITP (69%), rather than chronic ITP (31%; P = .0025). Bleeding frequency was also significantly more likely to be an indication among patients with newly diagnosed or persistent ITP (63% vs. 37%; P = .0054).

Conversely, QOL was significantly more likely to be an indication for patients with chronic ITP (65%) rather than newly diagnosed or persistent ITP (35%, P = .0056). Sports participation was a more likely indication among patients with chronic ITP as well (75% vs. 26%, P = .017).

Indications for treatment also varied according to baseline platelet counts. For example, QOL was an indication for treatment in 42% of patients with baseline platelet counts less than 10 x 10⁹/L and 78% of patients with platelet counts of 20 x 10⁹/L or greater. So the higher the baseline platelet count, the more likely QOL was an indication for treatment (P = .006).

On the other hand, the importance hematologists placed on QOL did not appear to correlate with actual health-related QOL as assessed by the Kids ITP Tool. There was no difference reported in baseline health-related QOL, according to the tool, in children for whom QOL was ranked versus unranked by hematologists.

This finding suggests physicians may not be adequately assessing the impact of ITP on QOL, Dr. Shimano said.

“Better clinical measures of the impact of ITP on patient quality of life are needed to assess both need for treatment and treatment response,” she said. “Understanding the effects of individual second-line treatments on quality of life is critical for this patient population in order to best tailor therapy for each patient.”

Dr. Shimano reported involvement in an investigator-initiated trial for eltrombopag in children with ITP. The study, which has not yet opened, is funded by Novartis.

[email protected]

SOURCE: Shimano KA et al. ASPHO 2019, Abstract 2012.

NEW ORLEANS – In a survey of pediatric hematologists, quality of life was the most frequently cited reason for starting second-line therapy in children with immune thrombocytopenia.

Jennifer Smith/MDedge News

Quality of life (QOL) was an indication for second-line treatment in nearly three-quarters of patients studied, and it ranked among the top three indications – along with bleeding frequency and bleeding severity – for treatment in more than half of patients.

Kristin A. Shimano, MD, of the department of pediatrics at the University of California, San Francisco, presented these results at the annual meeting of the American Society of Pediatric Hematology/Oncology.

Dr. Shimano and colleagues surveyed hematologists treating children in the ICON1 study (Am J Hematol. 2019 Apr 3. doi: 10.1002/ajh.25479).

The study enrolled 120 children receiving second-line immune thrombocytopenia (ITP) treatment at 21 centers. The median age at enrollment was 11.7 years (range, 1.2-17.8 years). About half of patients (53%) had chronic ITP, 31% had persistent ITP, and 16% had newly diagnosed ITP. The median number of prior treatments was three (range, zero to eight).

At study entry, the hematologists were asked to provide reasons that patients required second-line treatment. The list of 12 possible reasons included patient or parent QOL; bleeding severity; bleeding frequency; severity of thrombocytopenia; chronicity of ITP; high baseline activity level; involvement in sports; patient age; distance from medical center; and parent, patient, or physician anxiety. The hematologists were asked to choose all reasons that applied and to rank the top three reasons.

QOL was chosen as a reason to treat in 73% of patients (n = 88). QOL was among the top three reasons in 57% of patients (n = 68) and was the most important reason in 27% of patients (n = 32).

The severity and frequency of bleeding were ranked among the top three indications as well. Bleeding severity was a top indication in 29% of cases (n = 35), and bleeding frequency was a top indication in 40% of cases (n = 48).

Reasons for starting second-line treatment varied depending on patients’ phase of disease.

Bleeding severity was significantly more likely to be an indication for treatment among patients who had newly diagnosed or persistent ITP (69%), rather than chronic ITP (31%; P = .0025). Bleeding frequency was also significantly more likely to be an indication among patients with newly diagnosed or persistent ITP (63% vs. 37%; P = .0054).

Conversely, QOL was significantly more likely to be an indication for patients with chronic ITP (65%) rather than newly diagnosed or persistent ITP (35%, P = .0056). Sports participation was a more likely indication among patients with chronic ITP as well (75% vs. 26%, P = .017).

Indications for treatment also varied according to baseline platelet counts. For example, QOL was an indication for treatment in 42% of patients with baseline platelet counts less than 10 x 10⁹/L and 78% of patients with platelet counts of 20 x 10⁹/L or greater. So the higher the baseline platelet count, the more likely QOL was an indication for treatment (P = .006).

On the other hand, the importance hematologists placed on QOL did not appear to correlate with actual health-related QOL as assessed by the Kids ITP Tool. There was no difference reported in baseline health-related QOL, according to the tool, in children for whom QOL was ranked versus unranked by hematologists.

This finding suggests physicians may not be adequately assessing the impact of ITP on QOL, Dr. Shimano said.

“Better clinical measures of the impact of ITP on patient quality of life are needed to assess both need for treatment and treatment response,” she said. “Understanding the effects of individual second-line treatments on quality of life is critical for this patient population in order to best tailor therapy for each patient.”

Dr. Shimano reported involvement in an investigator-initiated trial for eltrombopag in children with ITP. The study, which has not yet opened, is funded by Novartis.

[email protected]

SOURCE: Shimano KA et al. ASPHO 2019, Abstract 2012.

SAN FRANCISCO – As a tool for the screening and diagnosis of diseases in the gastrointestinal (GI) tract, artificial intelligence (AI) is advancing rapidly, according to a review of this technology presented at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Much of the focus of the update was on screening colonoscopy, but the same principles are relevant and being pursued for other GI conditions, such as dysplasia screening in patients with Barrett’s esophagus and the assessment of mucosal healing in inflammatory bowel disease, according to Michael F. Byrne, MD, a clinical professor in the division of gastroenterology at Vancouver General Hospital.

“There are many technologies [to improve screening and diagnosis of GI diseases], but I believe these will struggle if they do not also have some kind of built-in machine intelligence,” Dr. Byrne said. In addition to his practice in gastroenterology, Dr. Byrne is CEO of Satis Operations and founder of AI4GI, a commercial joint venture focused on clinical applications of AI in colon polyp disease.

In this context, AI is being built on the principle of deep learning, which employs neural networks or a set of algorithms that permits a computer to recognize patterns when “trained” with data. In the machine learning process, the computer can use a large number of features in the task of discrimination.

This might suggest that AI could, in turn, train physicians to recognize the same features, but this underestimates the complexity and sophistication of machine learning, according to Dr. Byrne. The current status of machine learning for screening colonoscopy underscores this point.

“A computer can consider a thousand features when evaluating a polyp, which is way beyond what we can do,” Dr. Byrne said. Even with advances to improve visualization in screening colonoscopy, such as improved resolution and better lighting, the reason that AI is expected to prevail is that “the human eye is just not accurate enough.”

Many groups have developed advanced machine learning systems for screening colonoscopy. Dr. Byrne reviewed some of the early work done in Japan and that performed with a system in development by his group. In a study with the AI4GI model, published recently in Gut (2019;68:94-100), greater than 94% accuracy was achieved in distinguishing adenomas from hyperplastic polyps using histopathology as a gold standard.

Because of the ability of machine learning to see what the human eye cannot, Dr. Byrne predicts that AI-centric classification will replace current polyp classification systems, which could offer categories that are more clinically useful and reliable.

However, the work in screening colonoscopy is just the beginning, according to Dr. Byrne. “The opportunity of machine learning goes way beyond polyps.”

Recognizing dysplasia associated with Barrett’s esophagus has parallels with identifying adenomatous polyps in screening colonoscopy, but Dr. Byrne also discussed machine learning as an “optical biopsy” for evaluating the mucosa of patients with IBD. No longer a screening approach, the characterization of IBD tissue could help with therapeutic decisions.

With an AI approach to optical biopsy, “there is a great opportunity to assign an inflammatory burden in IBD,” he suggested, explaining how evidence of disease activity could guide escalation or de-escalation of treatment within the context of the treat-to-target approach to prolonging remission.

Overall, there is abundant evidence that “optical biopsy is feasible,” Dr. Byrne said. He indicated that clinical applications are approaching quickly. While he acknowledged that the technology “will need a human in the loop” as it enters clinical practice initially, he believes that this technology will play a significant role in GI practice because of the clear limitations of the human eye in assessing endoscopic images of GI tissue.

SAN FRANCISCO – As a tool for the screening and diagnosis of diseases in the gastrointestinal (GI) tract, artificial intelligence (AI) is advancing rapidly, according to a review of this technology presented at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Much of the focus of the update was on screening colonoscopy, but the same principles are relevant and being pursued for other GI conditions, such as dysplasia screening in patients with Barrett’s esophagus and the assessment of mucosal healing in inflammatory bowel disease, according to Michael F. Byrne, MD, a clinical professor in the division of gastroenterology at Vancouver General Hospital.

“There are many technologies [to improve screening and diagnosis of GI diseases], but I believe these will struggle if they do not also have some kind of built-in machine intelligence,” Dr. Byrne said. In addition to his practice in gastroenterology, Dr. Byrne is CEO of Satis Operations and founder of AI4GI, a commercial joint venture focused on clinical applications of AI in colon polyp disease.

In this context, AI is being built on the principle of deep learning, which employs neural networks or a set of algorithms that permits a computer to recognize patterns when “trained” with data. In the machine learning process, the computer can use a large number of features in the task of discrimination.

This might suggest that AI could, in turn, train physicians to recognize the same features, but this underestimates the complexity and sophistication of machine learning, according to Dr. Byrne. The current status of machine learning for screening colonoscopy underscores this point.

“A computer can consider a thousand features when evaluating a polyp, which is way beyond what we can do,” Dr. Byrne said. Even with advances to improve visualization in screening colonoscopy, such as improved resolution and better lighting, the reason that AI is expected to prevail is that “the human eye is just not accurate enough.”

Many groups have developed advanced machine learning systems for screening colonoscopy. Dr. Byrne reviewed some of the early work done in Japan and that performed with a system in development by his group. In a study with the AI4GI model, published recently in Gut (2019;68:94-100), greater than 94% accuracy was achieved in distinguishing adenomas from hyperplastic polyps using histopathology as a gold standard.

Because of the ability of machine learning to see what the human eye cannot, Dr. Byrne predicts that AI-centric classification will replace current polyp classification systems, which could offer categories that are more clinically useful and reliable.

However, the work in screening colonoscopy is just the beginning, according to Dr. Byrne. “The opportunity of machine learning goes way beyond polyps.”

Recognizing dysplasia associated with Barrett’s esophagus has parallels with identifying adenomatous polyps in screening colonoscopy, but Dr. Byrne also discussed machine learning as an “optical biopsy” for evaluating the mucosa of patients with IBD. No longer a screening approach, the characterization of IBD tissue could help with therapeutic decisions.

With an AI approach to optical biopsy, “there is a great opportunity to assign an inflammatory burden in IBD,” he suggested, explaining how evidence of disease activity could guide escalation or de-escalation of treatment within the context of the treat-to-target approach to prolonging remission.

Overall, there is abundant evidence that “optical biopsy is feasible,” Dr. Byrne said. He indicated that clinical applications are approaching quickly. While he acknowledged that the technology “will need a human in the loop” as it enters clinical practice initially, he believes that this technology will play a significant role in GI practice because of the clear limitations of the human eye in assessing endoscopic images of GI tissue.

SAN FRANCISCO – As a tool for the screening and diagnosis of diseases in the gastrointestinal (GI) tract, artificial intelligence (AI) is advancing rapidly, according to a review of this technology presented at the 2019 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

Much of the focus of the update was on screening colonoscopy, but the same principles are relevant and being pursued for other GI conditions, such as dysplasia screening in patients with Barrett’s esophagus and the assessment of mucosal healing in inflammatory bowel disease, according to Michael F. Byrne, MD, a clinical professor in the division of gastroenterology at Vancouver General Hospital.

“There are many technologies [to improve screening and diagnosis of GI diseases], but I believe these will struggle if they do not also have some kind of built-in machine intelligence,” Dr. Byrne said. In addition to his practice in gastroenterology, Dr. Byrne is CEO of Satis Operations and founder of AI4GI, a commercial joint venture focused on clinical applications of AI in colon polyp disease.

In this context, AI is being built on the principle of deep learning, which employs neural networks or a set of algorithms that permits a computer to recognize patterns when “trained” with data. In the machine learning process, the computer can use a large number of features in the task of discrimination.

This might suggest that AI could, in turn, train physicians to recognize the same features, but this underestimates the complexity and sophistication of machine learning, according to Dr. Byrne. The current status of machine learning for screening colonoscopy underscores this point.

“A computer can consider a thousand features when evaluating a polyp, which is way beyond what we can do,” Dr. Byrne said. Even with advances to improve visualization in screening colonoscopy, such as improved resolution and better lighting, the reason that AI is expected to prevail is that “the human eye is just not accurate enough.”

Many groups have developed advanced machine learning systems for screening colonoscopy. Dr. Byrne reviewed some of the early work done in Japan and that performed with a system in development by his group. In a study with the AI4GI model, published recently in Gut (2019;68:94-100), greater than 94% accuracy was achieved in distinguishing adenomas from hyperplastic polyps using histopathology as a gold standard.

Because of the ability of machine learning to see what the human eye cannot, Dr. Byrne predicts that AI-centric classification will replace current polyp classification systems, which could offer categories that are more clinically useful and reliable.

However, the work in screening colonoscopy is just the beginning, according to Dr. Byrne. “The opportunity of machine learning goes way beyond polyps.”

Recognizing dysplasia associated with Barrett’s esophagus has parallels with identifying adenomatous polyps in screening colonoscopy, but Dr. Byrne also discussed machine learning as an “optical biopsy” for evaluating the mucosa of patients with IBD. No longer a screening approach, the characterization of IBD tissue could help with therapeutic decisions.

With an AI approach to optical biopsy, “there is a great opportunity to assign an inflammatory burden in IBD,” he suggested, explaining how evidence of disease activity could guide escalation or de-escalation of treatment within the context of the treat-to-target approach to prolonging remission.

Overall, there is abundant evidence that “optical biopsy is feasible,” Dr. Byrne said. He indicated that clinical applications are approaching quickly. While he acknowledged that the technology “will need a human in the loop” as it enters clinical practice initially, he believes that this technology will play a significant role in GI practice because of the clear limitations of the human eye in assessing endoscopic images of GI tissue.

LOS ANGELES – Recent research, a new test, and upcoming guidelines are providing insight into the diagnosis of adult growth hormone deficiency and the importance of treatment, Kevin C.J. Yuen, MD, FRCP(UK), FACE, told colleagues at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists (AACE).

“The data show that growth hormone replacement is safe and may improve survival,” said Dr Yuen, professor of medicine and medical director at Barrow Neurological Institute Pituitary Center in Phoenix.

Dr. Yuen is chair of the AACE’s growth hormone task force and coauthored both the 2009 and soon-to-be-published 2019 AACE guidelines for the treatment of adult growth hormone deficiency (AGHD).

Updated AGHD guidelines were needed for a variety of reasons, including a greater awareness of the benefits of hormone replacement in these patients and new developments in areas such as testing, he said. The guidelines also are also necessary because of the skepticism about the cost and benefits of AGHD therapy, concerns about the safety of long-term therapy, and the misuse of treatment in certain patients, he added.

On the treatment front, Dr. Yuen said it has become more clear over recent years that patients with AGHD benefit from hormone replacement. Findings from two studies have linked treatment to improvements in exercise capacity (Clin Endocrinol [Oxf]. 2016;85[4]:660-8) and patient quality of life (Eur J Endocrinol. 2017;176:99-109). “Even just after 6 months there’s an improvement in aerobic power,” he said.

And, he continued, other findings have suggested that treatment could lower mortality in men and reduce the number of deaths from malignant neoplasms in all patients (Eur J Endocrinol. 2017;176[1]:67-75).

However, Dr. Yuen cautioned that the confirmation of a survival benefit from hormone replacement will be speculative as long as there are no prospective data available.

He offered five tips about diagnosing and treating AGHD:

First, be aware that a number of conditions other than AGHD can cause low levels of insulin-like growth factor 1, including malnutrition, diabetes, untreated hypothyroidism, liver disease, and kidney failure.

Second, follow recommended algorithms for testing adult patients and transition those pediatric patients who seem to be at risk of having the condition. (Those moving from pediatric to adult care are known as transition patients.) The algorithms suggest that three diagnostic tests can be helpful, depending on the situation: the macimorelin test, the insulin tolerance test, and the glucagon stimulation test.

In 2017, the Food and Drug Administration approved the macimorelin (Macrilen) test, which requires the administration of an oral medication before a blood test. Dr. Yuen cited a phase 3 study that demonstrated that the test was “highly reproducible” and has a “good safety profile” (J Clin Endocrinol Metab. 2018;103[8]:3083-93). Dr. Yuen believes the test will become the preferred alternative to the insulin tolerance test.

Third, transition patients require special care as they move from pediatric care. “The handover is still very challenging,” Dr. Yuen said. “There’s still much to be done to improve the quality of treatment for these patients.” Challenges during the transition can include the patient’s reluctance to continue taking hormones in adulthood, he said. “Encourage pediatricians to start educating patients from early on that they’ll need to remain on hormones,” he advised, and help patients take accountability for their health in areas such as self-injection.

Patients may suffer from “injection fatigue,” they may be concerned about the side effects of the therapy, and/or they may be overwhelmed by the cost of care, he said. They may not understand how to manage their care and lack insight into the consequences of treatment cessation.

He advised endocrinologists to monitor transition patients who aren’t growth-hormone deficient because their status may change in the future.

Fourth, start treatment in adults with recommended doses of growth hormone. For those younger than 30 years, use 0.4-0.5 mg/day (higher for transition patients); for those aged between 30 and 60 years, use 0.2-0.3 mg/day; and for those who are older than 60 years, use 0.1-0.2 mg/day. Doses should be adjusted to 0.1-0.2 mg/day in patients with diabetes, obesity, and/or previous gestational diabetes.

Fifth, treat patients with growth hormone indefinitely if benefits are seen, but consider stopping treatment after a year if there doesn’t seem to be a benefit, Dr. Yuen advised. Follow up at 6 months, he recommended.

Dr. Yuen disclosed receiving research grants from and consulting for Pfizer, Novo Nordisk, and Aeterna Zentaris. He has also consulted for Strongbridge.

LOS ANGELES – Recent research, a new test, and upcoming guidelines are providing insight into the diagnosis of adult growth hormone deficiency and the importance of treatment, Kevin C.J. Yuen, MD, FRCP(UK), FACE, told colleagues at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists (AACE).

“The data show that growth hormone replacement is safe and may improve survival,” said Dr Yuen, professor of medicine and medical director at Barrow Neurological Institute Pituitary Center in Phoenix.

Dr. Yuen is chair of the AACE’s growth hormone task force and coauthored both the 2009 and soon-to-be-published 2019 AACE guidelines for the treatment of adult growth hormone deficiency (AGHD).

Updated AGHD guidelines were needed for a variety of reasons, including a greater awareness of the benefits of hormone replacement in these patients and new developments in areas such as testing, he said. The guidelines also are also necessary because of the skepticism about the cost and benefits of AGHD therapy, concerns about the safety of long-term therapy, and the misuse of treatment in certain patients, he added.

On the treatment front, Dr. Yuen said it has become more clear over recent years that patients with AGHD benefit from hormone replacement. Findings from two studies have linked treatment to improvements in exercise capacity (Clin Endocrinol [Oxf]. 2016;85[4]:660-8) and patient quality of life (Eur J Endocrinol. 2017;176:99-109). “Even just after 6 months there’s an improvement in aerobic power,” he said.

And, he continued, other findings have suggested that treatment could lower mortality in men and reduce the number of deaths from malignant neoplasms in all patients (Eur J Endocrinol. 2017;176[1]:67-75).

However, Dr. Yuen cautioned that the confirmation of a survival benefit from hormone replacement will be speculative as long as there are no prospective data available.

He offered five tips about diagnosing and treating AGHD:

First, be aware that a number of conditions other than AGHD can cause low levels of insulin-like growth factor 1, including malnutrition, diabetes, untreated hypothyroidism, liver disease, and kidney failure.

Second, follow recommended algorithms for testing adult patients and transition those pediatric patients who seem to be at risk of having the condition. (Those moving from pediatric to adult care are known as transition patients.) The algorithms suggest that three diagnostic tests can be helpful, depending on the situation: the macimorelin test, the insulin tolerance test, and the glucagon stimulation test.

In 2017, the Food and Drug Administration approved the macimorelin (Macrilen) test, which requires the administration of an oral medication before a blood test. Dr. Yuen cited a phase 3 study that demonstrated that the test was “highly reproducible” and has a “good safety profile” (J Clin Endocrinol Metab. 2018;103[8]:3083-93). Dr. Yuen believes the test will become the preferred alternative to the insulin tolerance test.

Third, transition patients require special care as they move from pediatric care. “The handover is still very challenging,” Dr. Yuen said. “There’s still much to be done to improve the quality of treatment for these patients.” Challenges during the transition can include the patient’s reluctance to continue taking hormones in adulthood, he said. “Encourage pediatricians to start educating patients from early on that they’ll need to remain on hormones,” he advised, and help patients take accountability for their health in areas such as self-injection.

Patients may suffer from “injection fatigue,” they may be concerned about the side effects of the therapy, and/or they may be overwhelmed by the cost of care, he said. They may not understand how to manage their care and lack insight into the consequences of treatment cessation.

He advised endocrinologists to monitor transition patients who aren’t growth-hormone deficient because their status may change in the future.

Fourth, start treatment in adults with recommended doses of growth hormone. For those younger than 30 years, use 0.4-0.5 mg/day (higher for transition patients); for those aged between 30 and 60 years, use 0.2-0.3 mg/day; and for those who are older than 60 years, use 0.1-0.2 mg/day. Doses should be adjusted to 0.1-0.2 mg/day in patients with diabetes, obesity, and/or previous gestational diabetes.

Fifth, treat patients with growth hormone indefinitely if benefits are seen, but consider stopping treatment after a year if there doesn’t seem to be a benefit, Dr. Yuen advised. Follow up at 6 months, he recommended.

Dr. Yuen disclosed receiving research grants from and consulting for Pfizer, Novo Nordisk, and Aeterna Zentaris. He has also consulted for Strongbridge.

LOS ANGELES – Recent research, a new test, and upcoming guidelines are providing insight into the diagnosis of adult growth hormone deficiency and the importance of treatment, Kevin C.J. Yuen, MD, FRCP(UK), FACE, told colleagues at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists (AACE).

“The data show that growth hormone replacement is safe and may improve survival,” said Dr Yuen, professor of medicine and medical director at Barrow Neurological Institute Pituitary Center in Phoenix.

Dr. Yuen is chair of the AACE’s growth hormone task force and coauthored both the 2009 and soon-to-be-published 2019 AACE guidelines for the treatment of adult growth hormone deficiency (AGHD).

Updated AGHD guidelines were needed for a variety of reasons, including a greater awareness of the benefits of hormone replacement in these patients and new developments in areas such as testing, he said. The guidelines also are also necessary because of the skepticism about the cost and benefits of AGHD therapy, concerns about the safety of long-term therapy, and the misuse of treatment in certain patients, he added.

On the treatment front, Dr. Yuen said it has become more clear over recent years that patients with AGHD benefit from hormone replacement. Findings from two studies have linked treatment to improvements in exercise capacity (Clin Endocrinol [Oxf]. 2016;85[4]:660-8) and patient quality of life (Eur J Endocrinol. 2017;176:99-109). “Even just after 6 months there’s an improvement in aerobic power,” he said.

And, he continued, other findings have suggested that treatment could lower mortality in men and reduce the number of deaths from malignant neoplasms in all patients (Eur J Endocrinol. 2017;176[1]:67-75).

However, Dr. Yuen cautioned that the confirmation of a survival benefit from hormone replacement will be speculative as long as there are no prospective data available.

He offered five tips about diagnosing and treating AGHD:

First, be aware that a number of conditions other than AGHD can cause low levels of insulin-like growth factor 1, including malnutrition, diabetes, untreated hypothyroidism, liver disease, and kidney failure.

Second, follow recommended algorithms for testing adult patients and transition those pediatric patients who seem to be at risk of having the condition. (Those moving from pediatric to adult care are known as transition patients.) The algorithms suggest that three diagnostic tests can be helpful, depending on the situation: the macimorelin test, the insulin tolerance test, and the glucagon stimulation test.

In 2017, the Food and Drug Administration approved the macimorelin (Macrilen) test, which requires the administration of an oral medication before a blood test. Dr. Yuen cited a phase 3 study that demonstrated that the test was “highly reproducible” and has a “good safety profile” (J Clin Endocrinol Metab. 2018;103[8]:3083-93). Dr. Yuen believes the test will become the preferred alternative to the insulin tolerance test.

Third, transition patients require special care as they move from pediatric care. “The handover is still very challenging,” Dr. Yuen said. “There’s still much to be done to improve the quality of treatment for these patients.” Challenges during the transition can include the patient’s reluctance to continue taking hormones in adulthood, he said. “Encourage pediatricians to start educating patients from early on that they’ll need to remain on hormones,” he advised, and help patients take accountability for their health in areas such as self-injection.

Patients may suffer from “injection fatigue,” they may be concerned about the side effects of the therapy, and/or they may be overwhelmed by the cost of care, he said. They may not understand how to manage their care and lack insight into the consequences of treatment cessation.

He advised endocrinologists to monitor transition patients who aren’t growth-hormone deficient because their status may change in the future.

Fourth, start treatment in adults with recommended doses of growth hormone. For those younger than 30 years, use 0.4-0.5 mg/day (higher for transition patients); for those aged between 30 and 60 years, use 0.2-0.3 mg/day; and for those who are older than 60 years, use 0.1-0.2 mg/day. Doses should be adjusted to 0.1-0.2 mg/day in patients with diabetes, obesity, and/or previous gestational diabetes.

Fifth, treat patients with growth hormone indefinitely if benefits are seen, but consider stopping treatment after a year if there doesn’t seem to be a benefit, Dr. Yuen advised. Follow up at 6 months, he recommended.

Dr. Yuen disclosed receiving research grants from and consulting for Pfizer, Novo Nordisk, and Aeterna Zentaris. He has also consulted for Strongbridge.

BALTIMORE – An analysis of malpractice claims paid for hernia operations found that breach of informed consent was a reason for more than 15% of cases, and intraoperative damage to surrounding structures was the leading reason for such lawsuits, according to research presented at the annual meeting of the American Gastrointestinal and Endoscopic Surgeons.

The purpose of the study was to identify leading causes of litigation for hernia repair as the volume of hernia repairs in the United States increases with a trend toward minimally invasive and robotic surgery, said Asad Choudhry, MBBS, of the State University of New York, Syracuse.“In terms of the hernia itself, inguinal hernia operations were found to be the most common hernia procedure that led to pursuance of litigation, and laparoscopy was the most common type of procedure rather than open in terms of patients pursuing litigation.”

The study sampled the WestLawNext legal database for medical malpractice abdominal wall procedures, and evaluated 430 cases of abdominopelvic wall hernias that fit the study criteria – inguinal, femoral, ventral, umbilical, parastomal, spigelian, obturator, epigastric, incisional, paraumbilical, and pantaloon hernias, Dr. Choudhry said. Hiatal, diaphragmatic, sciatic, gluteal, and lumbar hernias were excluded. He noted that abdominal wall hernia have been reported to be the second most common abdominopelvic procedure performed in the United States after C-section, with more than 1 million procedures done annually (Surg Clin N Am. 2003;83:1045-51).

While most malpractice hernia cases were decided in favor of the defendant surgeon, settlements and cases with a jury verdict in favor of the plaintiff were costly. Dr. Choudhry cited awards of $6.8 million, $12 million, and $3 million in specific hernia cases.

“In terms of the type of repair itself, elective operations were more common, and mesh was used in approximately 27% of cases in which there was a defendant verdict and 18% of cases in which there was a plaintiff verdict,” he said.

For inguinal hernia, 61% of cases were decided for the defendant surgeon. With regards to type of procedure, laparoscopic surgery resulted in defendant verdicts in 31% of cases versus 23% for the plaintiff, and open operations resulted in a ruling favoring the defendant surgeon in 26% versus 15% for the plaintiff. (The remainder were lap-converted-to-open operations, with 2% for the defendant and 1% for the plaintiff.)

Mortality was a key determinant of verdict, Dr. Choudhry added. “Cases with no mortality were more likely of having an outcome in favor of the defendant surgeon.”

The researchers also looked at litigation arising from the phase of care – before, during, or after surgery. “In the preoperative time setting, delay or failure to diagnose or manage a hernia was the leading cause of malpractice,” Dr. Choudhry said. “These cases were mainly emergent patients presenting to the emergency department where the intervention was not performed in a timely manner and leading to some form of complication.”

In the intraoperative period, damage to surrounding structures was by far the leading cause of malpractice, but incomplete procedure or improper surgical technique and use of improper surgical materials also were significant causes in this period. Postoperatively, failure to timely detect and/or repair a surgical complication was the most common cause of litigation. “However, it’s important to note that persistent pain, such as nerve entrapment syndrome, is also noted in the postoperative time period as a cause of litigation,” he added.

The study also evaluated injury severity in the context of a claim outcome. “Most claims where there was an insignificant or minor injury were decided for the defendant surgeon,” Dr. Choudhry said. “But as you start moving higher on the injury scale toward death, these cases were more likely to favor the plaintiff, and that’s correlative because patients tend to sue more when there’s a more significant complication, such as when there’s a death of a family member.” In cases involving death, 41% resulted in a verdict for the defendant surgery, 35% in a plaintiff verdict, and 23% in a settlement, whereas in cases involving insignificant temporary injury, 90% were ruled for the defendant surgeon, with none going to settlement.

The research also found another mitigating factor in malpractice lawsuits: the number of lawyers in a state. “We noted that specific states such as California, New York, Texas, and Florida were bound to have a higher number of lawsuits per population, and this was correlative with the number of lawyers practicing within that state,” Dr. Choudhry said. New York led the nation with 46 cases, followed by California with 42, Florida with 27 ,and Texas and Pennsylvania with 17 each.

Session moderator Heather Logghe, MD, of Jefferson Medical College, Philadelphia, questioned Dr. Choudhry on how surgeons can improve their informed consent process to protect against potential litigation.

“The most important thing we can do is document and explain the risk, benefits, and alternatives, and use an inclusive informed consent that will allow the patients to have a complete understanding of the procedure that is to be done and the complications that may result,” he said. This process needs to be tailored to individual hospital systems. “This may allow for better documentation, and it may not decrease the number of malpractice lawsuits but it may decrease the outcomes not in favor of physicians.”

The researchers also identified trends in the broader context of medical malpractice. Citing data from the National Practitioner Data Bank, Dr. Choudhry noted that malpractice payouts have been increasing since 2012 after a steady 9-year decline. In addition, general surgeons are at greater risk than all but two other types of specialists – neurosurgeons and thoracic-cardiovascular surgeons (N Engl J Med. 2011;365:629-36). “Fifteen percent of general surgeons will be facing malpractice claims annually across the United States. Physicians in high-legal-risk specialties, such as the surgical specialties, are 99% likely to face a claim over their careers.”

The next step for the researchers is to use malpractice insurance data to study medical liability on a larger scale and identify methods physicians can use to improve patient care and mitigate risk, Dr. Choudhry said.

Dr. Choudhry had no relevant financial relationships to disclose.

SOURCE: Choudhry A et al. SAGES 2109, Abstract S104.

BALTIMORE – An analysis of malpractice claims paid for hernia operations found that breach of informed consent was a reason for more than 15% of cases, and intraoperative damage to surrounding structures was the leading reason for such lawsuits, according to research presented at the annual meeting of the American Gastrointestinal and Endoscopic Surgeons.

The purpose of the study was to identify leading causes of litigation for hernia repair as the volume of hernia repairs in the United States increases with a trend toward minimally invasive and robotic surgery, said Asad Choudhry, MBBS, of the State University of New York, Syracuse.“In terms of the hernia itself, inguinal hernia operations were found to be the most common hernia procedure that led to pursuance of litigation, and laparoscopy was the most common type of procedure rather than open in terms of patients pursuing litigation.”

The study sampled the WestLawNext legal database for medical malpractice abdominal wall procedures, and evaluated 430 cases of abdominopelvic wall hernias that fit the study criteria – inguinal, femoral, ventral, umbilical, parastomal, spigelian, obturator, epigastric, incisional, paraumbilical, and pantaloon hernias, Dr. Choudhry said. Hiatal, diaphragmatic, sciatic, gluteal, and lumbar hernias were excluded. He noted that abdominal wall hernia have been reported to be the second most common abdominopelvic procedure performed in the United States after C-section, with more than 1 million procedures done annually (Surg Clin N Am. 2003;83:1045-51).

While most malpractice hernia cases were decided in favor of the defendant surgeon, settlements and cases with a jury verdict in favor of the plaintiff were costly. Dr. Choudhry cited awards of $6.8 million, $12 million, and $3 million in specific hernia cases.

“In terms of the type of repair itself, elective operations were more common, and mesh was used in approximately 27% of cases in which there was a defendant verdict and 18% of cases in which there was a plaintiff verdict,” he said.

For inguinal hernia, 61% of cases were decided for the defendant surgeon. With regards to type of procedure, laparoscopic surgery resulted in defendant verdicts in 31% of cases versus 23% for the plaintiff, and open operations resulted in a ruling favoring the defendant surgeon in 26% versus 15% for the plaintiff. (The remainder were lap-converted-to-open operations, with 2% for the defendant and 1% for the plaintiff.)

Mortality was a key determinant of verdict, Dr. Choudhry added. “Cases with no mortality were more likely of having an outcome in favor of the defendant surgeon.”

The researchers also looked at litigation arising from the phase of care – before, during, or after surgery. “In the preoperative time setting, delay or failure to diagnose or manage a hernia was the leading cause of malpractice,” Dr. Choudhry said. “These cases were mainly emergent patients presenting to the emergency department where the intervention was not performed in a timely manner and leading to some form of complication.”

In the intraoperative period, damage to surrounding structures was by far the leading cause of malpractice, but incomplete procedure or improper surgical technique and use of improper surgical materials also were significant causes in this period. Postoperatively, failure to timely detect and/or repair a surgical complication was the most common cause of litigation. “However, it’s important to note that persistent pain, such as nerve entrapment syndrome, is also noted in the postoperative time period as a cause of litigation,” he added.

The study also evaluated injury severity in the context of a claim outcome. “Most claims where there was an insignificant or minor injury were decided for the defendant surgeon,” Dr. Choudhry said. “But as you start moving higher on the injury scale toward death, these cases were more likely to favor the plaintiff, and that’s correlative because patients tend to sue more when there’s a more significant complication, such as when there’s a death of a family member.” In cases involving death, 41% resulted in a verdict for the defendant surgery, 35% in a plaintiff verdict, and 23% in a settlement, whereas in cases involving insignificant temporary injury, 90% were ruled for the defendant surgeon, with none going to settlement.

The research also found another mitigating factor in malpractice lawsuits: the number of lawyers in a state. “We noted that specific states such as California, New York, Texas, and Florida were bound to have a higher number of lawsuits per population, and this was correlative with the number of lawyers practicing within that state,” Dr. Choudhry said. New York led the nation with 46 cases, followed by California with 42, Florida with 27 ,and Texas and Pennsylvania with 17 each.

Session moderator Heather Logghe, MD, of Jefferson Medical College, Philadelphia, questioned Dr. Choudhry on how surgeons can improve their informed consent process to protect against potential litigation.

“The most important thing we can do is document and explain the risk, benefits, and alternatives, and use an inclusive informed consent that will allow the patients to have a complete understanding of the procedure that is to be done and the complications that may result,” he said. This process needs to be tailored to individual hospital systems. “This may allow for better documentation, and it may not decrease the number of malpractice lawsuits but it may decrease the outcomes not in favor of physicians.”

The researchers also identified trends in the broader context of medical malpractice. Citing data from the National Practitioner Data Bank, Dr. Choudhry noted that malpractice payouts have been increasing since 2012 after a steady 9-year decline. In addition, general surgeons are at greater risk than all but two other types of specialists – neurosurgeons and thoracic-cardiovascular surgeons (N Engl J Med. 2011;365:629-36). “Fifteen percent of general surgeons will be facing malpractice claims annually across the United States. Physicians in high-legal-risk specialties, such as the surgical specialties, are 99% likely to face a claim over their careers.”

The next step for the researchers is to use malpractice insurance data to study medical liability on a larger scale and identify methods physicians can use to improve patient care and mitigate risk, Dr. Choudhry said.

Dr. Choudhry had no relevant financial relationships to disclose.

SOURCE: Choudhry A et al. SAGES 2109, Abstract S104.

BALTIMORE – An analysis of malpractice claims paid for hernia operations found that breach of informed consent was a reason for more than 15% of cases, and intraoperative damage to surrounding structures was the leading reason for such lawsuits, according to research presented at the annual meeting of the American Gastrointestinal and Endoscopic Surgeons.

The purpose of the study was to identify leading causes of litigation for hernia repair as the volume of hernia repairs in the United States increases with a trend toward minimally invasive and robotic surgery, said Asad Choudhry, MBBS, of the State University of New York, Syracuse.“In terms of the hernia itself, inguinal hernia operations were found to be the most common hernia procedure that led to pursuance of litigation, and laparoscopy was the most common type of procedure rather than open in terms of patients pursuing litigation.”

The study sampled the WestLawNext legal database for medical malpractice abdominal wall procedures, and evaluated 430 cases of abdominopelvic wall hernias that fit the study criteria – inguinal, femoral, ventral, umbilical, parastomal, spigelian, obturator, epigastric, incisional, paraumbilical, and pantaloon hernias, Dr. Choudhry said. Hiatal, diaphragmatic, sciatic, gluteal, and lumbar hernias were excluded. He noted that abdominal wall hernia have been reported to be the second most common abdominopelvic procedure performed in the United States after C-section, with more than 1 million procedures done annually (Surg Clin N Am. 2003;83:1045-51).

While most malpractice hernia cases were decided in favor of the defendant surgeon, settlements and cases with a jury verdict in favor of the plaintiff were costly. Dr. Choudhry cited awards of $6.8 million, $12 million, and $3 million in specific hernia cases.

“In terms of the type of repair itself, elective operations were more common, and mesh was used in approximately 27% of cases in which there was a defendant verdict and 18% of cases in which there was a plaintiff verdict,” he said.

For inguinal hernia, 61% of cases were decided for the defendant surgeon. With regards to type of procedure, laparoscopic surgery resulted in defendant verdicts in 31% of cases versus 23% for the plaintiff, and open operations resulted in a ruling favoring the defendant surgeon in 26% versus 15% for the plaintiff. (The remainder were lap-converted-to-open operations, with 2% for the defendant and 1% for the plaintiff.)

Mortality was a key determinant of verdict, Dr. Choudhry added. “Cases with no mortality were more likely of having an outcome in favor of the defendant surgeon.”

The researchers also looked at litigation arising from the phase of care – before, during, or after surgery. “In the preoperative time setting, delay or failure to diagnose or manage a hernia was the leading cause of malpractice,” Dr. Choudhry said. “These cases were mainly emergent patients presenting to the emergency department where the intervention was not performed in a timely manner and leading to some form of complication.”

In the intraoperative period, damage to surrounding structures was by far the leading cause of malpractice, but incomplete procedure or improper surgical technique and use of improper surgical materials also were significant causes in this period. Postoperatively, failure to timely detect and/or repair a surgical complication was the most common cause of litigation. “However, it’s important to note that persistent pain, such as nerve entrapment syndrome, is also noted in the postoperative time period as a cause of litigation,” he added.

The study also evaluated injury severity in the context of a claim outcome. “Most claims where there was an insignificant or minor injury were decided for the defendant surgeon,” Dr. Choudhry said. “But as you start moving higher on the injury scale toward death, these cases were more likely to favor the plaintiff, and that’s correlative because patients tend to sue more when there’s a more significant complication, such as when there’s a death of a family member.” In cases involving death, 41% resulted in a verdict for the defendant surgery, 35% in a plaintiff verdict, and 23% in a settlement, whereas in cases involving insignificant temporary injury, 90% were ruled for the defendant surgeon, with none going to settlement.

The research also found another mitigating factor in malpractice lawsuits: the number of lawyers in a state. “We noted that specific states such as California, New York, Texas, and Florida were bound to have a higher number of lawsuits per population, and this was correlative with the number of lawyers practicing within that state,” Dr. Choudhry said. New York led the nation with 46 cases, followed by California with 42, Florida with 27 ,and Texas and Pennsylvania with 17 each.

Session moderator Heather Logghe, MD, of Jefferson Medical College, Philadelphia, questioned Dr. Choudhry on how surgeons can improve their informed consent process to protect against potential litigation.

“The most important thing we can do is document and explain the risk, benefits, and alternatives, and use an inclusive informed consent that will allow the patients to have a complete understanding of the procedure that is to be done and the complications that may result,” he said. This process needs to be tailored to individual hospital systems. “This may allow for better documentation, and it may not decrease the number of malpractice lawsuits but it may decrease the outcomes not in favor of physicians.”

The researchers also identified trends in the broader context of medical malpractice. Citing data from the National Practitioner Data Bank, Dr. Choudhry noted that malpractice payouts have been increasing since 2012 after a steady 9-year decline. In addition, general surgeons are at greater risk than all but two other types of specialists – neurosurgeons and thoracic-cardiovascular surgeons (N Engl J Med. 2011;365:629-36). “Fifteen percent of general surgeons will be facing malpractice claims annually across the United States. Physicians in high-legal-risk specialties, such as the surgical specialties, are 99% likely to face a claim over their careers.”

The next step for the researchers is to use malpractice insurance data to study medical liability on a larger scale and identify methods physicians can use to improve patient care and mitigate risk, Dr. Choudhry said.

Dr. Choudhry had no relevant financial relationships to disclose.

SOURCE: Choudhry A et al. SAGES 2109, Abstract S104.

Patients with intrahepatic cholestasis of pregnancy (ICP) were nearly six times more likely to have a diagnosis of nonalcoholic fatty liver disease (NAFLD) than were controls, results from a retrospective, single-center study demonstrated.

“If this connection is confirmed with future studies, intrahepatic cholestasis of pregnancy may prove a novel model through which to investigate bile acid metabolism in patients with fatty liver disease,” one of the study authors, Tatyana Kushner, MD, MSCE, said during a media briefing in advance of the annual Digestive Disease Week. “This could have implications for future management of fatty liver disease. Additionally, these findings suggest that ICP patients should be seen by a liver specialist because they may go on to develop chronic liver disease or may already have already existing underlying liver disease.”

ICP is characterized by a build-up of bile acids during pregnancy and is associated with an increased risk of negative fetal outcomes and fetal death if left untreated, said Dr. Kushner, of the division of liver diseases at the Icahn School of Medicine at Mount Sinai, New York. The most notable symptom during pregnancy is severe pruritus. In what is believed to be the first study of its kind, Dr. Kushner and colleagues set out to evaluate the association between ICP and NAFLD and associated metabolic risk factors, including obesity, dyslipidemia, hypertension, and diabetes. Between January and December of 2017, they drew from the electronic medical records of a New York City health system to identify 149 pregnancies complicated by ICP and compared them to a control group of 200 pregnancies without an ICP diagnosis. The researchers used Pearson’s chi-square or Fisher’s exact test and Wilcoxon rank-sum tests to evaluate association of ICP with categorical variables and continuous variables, respectively, and unadjusted odds ratios to compare the ICP and control groups for clinically significant outcomes.

The median age of the study population was 30 years, their mean body mass index was 27.5 kg/m², and there was a higher proportion of Hispanic women in the ICP group, compared with the control group (75% vs. 62%, respectively). Dr. Kushner and colleagues found that Hispanic women were nearly twice as likely to be diagnosed with ICP than non-Hispanic women (OR, 1.90; 95% confidence interval, 1.87-3.03). However, patients in both the ICP and control groups were similar for median age (OR, 1.02; 95% CI, 0.99-1.06), nulliparity (OR, 0.79; 95% CI, 0.48-1.30), and prevalence of hepatitis C (OR, 1.35; 95% CI, 0.08-21.67). The two groups were also similar for certain metabolic risk factors, including prevalence of obesity (OR, 1.01; 95% CI, 0.62-1.61), hypertension (OR, 0.69; 95% CI, 0.31-1.52), hemoglobin A_1c greater than 5.5% (OR, 0.80; 95% CI, 0.34-1.9), and total cholesterol above 200 mg/dL (OR, 4.15; 95% CI, 0.83-20.84). Median bile acid levels were 30.6 micromoles (interquartile range, 11.6, 32.7) in the ICP group.

Compared with patients in the control group, those in the ICP group had higher median levels of alanine aminotransferase (ALT) (32 vs. 16 U/L; P less than .0001), alkaline phosphatase (181 vs. 128 U/L; P less than .0001), and total bilirubin (0.5 vs. 0.35 mg/dL; P less than .0001). ICP patients were also more likely than their counterparts to have ALT levels above 50 U/L (two times the upper limit of normal; OR, 3.22; 95% CI, 1.48-7.03), a history of biliary disease (OR, 3.29; 95% CI, 1.39-7.80), and to have evidence of steatosis on liver imaging (OR, 4.69; 95% CI, 1.68-13.12). When the researchers evaluated a diagnosis of NAFLD based on ICD-10 codes or evidence of steatosis on liver imaging, ICP patients were significantly more likely to have a diagnosis of NAFLD than controls (OR, 5.7; 95% CI, 2.08-15.65).

“We recommend additional research to look at differences in NAFLD progression in women who had NAFLD and were later diagnosed with ICP, compared to women with NAFLD who did not go on to develop ICP, because that may be a reflection of the role that bile acid metabolism plays in these particular patients,” Dr. Kushner said.

Digestive Disease Week is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).  

The study’s primary author was Erica Monrose, MD. The researchers reported having no financial disclosures.

[email protected]

SOURCE: Monrose E et al. DDW 2019, Abstract Sa1562.

Patients with intrahepatic cholestasis of pregnancy (ICP) were nearly six times more likely to have a diagnosis of nonalcoholic fatty liver disease (NAFLD) than were controls, results from a retrospective, single-center study demonstrated.

“If this connection is confirmed with future studies, intrahepatic cholestasis of pregnancy may prove a novel model through which to investigate bile acid metabolism in patients with fatty liver disease,” one of the study authors, Tatyana Kushner, MD, MSCE, said during a media briefing in advance of the annual Digestive Disease Week. “This could have implications for future management of fatty liver disease. Additionally, these findings suggest that ICP patients should be seen by a liver specialist because they may go on to develop chronic liver disease or may already have already existing underlying liver disease.”

ICP is characterized by a build-up of bile acids during pregnancy and is associated with an increased risk of negative fetal outcomes and fetal death if left untreated, said Dr. Kushner, of the division of liver diseases at the Icahn School of Medicine at Mount Sinai, New York. The most notable symptom during pregnancy is severe pruritus. In what is believed to be the first study of its kind, Dr. Kushner and colleagues set out to evaluate the association between ICP and NAFLD and associated metabolic risk factors, including obesity, dyslipidemia, hypertension, and diabetes. Between January and December of 2017, they drew from the electronic medical records of a New York City health system to identify 149 pregnancies complicated by ICP and compared them to a control group of 200 pregnancies without an ICP diagnosis. The researchers used Pearson’s chi-square or Fisher’s exact test and Wilcoxon rank-sum tests to evaluate association of ICP with categorical variables and continuous variables, respectively, and unadjusted odds ratios to compare the ICP and control groups for clinically significant outcomes.

The median age of the study population was 30 years, their mean body mass index was 27.5 kg/m², and there was a higher proportion of Hispanic women in the ICP group, compared with the control group (75% vs. 62%, respectively). Dr. Kushner and colleagues found that Hispanic women were nearly twice as likely to be diagnosed with ICP than non-Hispanic women (OR, 1.90; 95% confidence interval, 1.87-3.03). However, patients in both the ICP and control groups were similar for median age (OR, 1.02; 95% CI, 0.99-1.06), nulliparity (OR, 0.79; 95% CI, 0.48-1.30), and prevalence of hepatitis C (OR, 1.35; 95% CI, 0.08-21.67). The two groups were also similar for certain metabolic risk factors, including prevalence of obesity (OR, 1.01; 95% CI, 0.62-1.61), hypertension (OR, 0.69; 95% CI, 0.31-1.52), hemoglobin A_1c greater than 5.5% (OR, 0.80; 95% CI, 0.34-1.9), and total cholesterol above 200 mg/dL (OR, 4.15; 95% CI, 0.83-20.84). Median bile acid levels were 30.6 micromoles (interquartile range, 11.6, 32.7) in the ICP group.

Compared with patients in the control group, those in the ICP group had higher median levels of alanine aminotransferase (ALT) (32 vs. 16 U/L; P less than .0001), alkaline phosphatase (181 vs. 128 U/L; P less than .0001), and total bilirubin (0.5 vs. 0.35 mg/dL; P less than .0001). ICP patients were also more likely than their counterparts to have ALT levels above 50 U/L (two times the upper limit of normal; OR, 3.22; 95% CI, 1.48-7.03), a history of biliary disease (OR, 3.29; 95% CI, 1.39-7.80), and to have evidence of steatosis on liver imaging (OR, 4.69; 95% CI, 1.68-13.12). When the researchers evaluated a diagnosis of NAFLD based on ICD-10 codes or evidence of steatosis on liver imaging, ICP patients were significantly more likely to have a diagnosis of NAFLD than controls (OR, 5.7; 95% CI, 2.08-15.65).

“We recommend additional research to look at differences in NAFLD progression in women who had NAFLD and were later diagnosed with ICP, compared to women with NAFLD who did not go on to develop ICP, because that may be a reflection of the role that bile acid metabolism plays in these particular patients,” Dr. Kushner said.

Digestive Disease Week is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).  

The study’s primary author was Erica Monrose, MD. The researchers reported having no financial disclosures.

[email protected]

SOURCE: Monrose E et al. DDW 2019, Abstract Sa1562.

Patients with intrahepatic cholestasis of pregnancy (ICP) were nearly six times more likely to have a diagnosis of nonalcoholic fatty liver disease (NAFLD) than were controls, results from a retrospective, single-center study demonstrated.

“If this connection is confirmed with future studies, intrahepatic cholestasis of pregnancy may prove a novel model through which to investigate bile acid metabolism in patients with fatty liver disease,” one of the study authors, Tatyana Kushner, MD, MSCE, said during a media briefing in advance of the annual Digestive Disease Week. “This could have implications for future management of fatty liver disease. Additionally, these findings suggest that ICP patients should be seen by a liver specialist because they may go on to develop chronic liver disease or may already have already existing underlying liver disease.”

ICP is characterized by a build-up of bile acids during pregnancy and is associated with an increased risk of negative fetal outcomes and fetal death if left untreated, said Dr. Kushner, of the division of liver diseases at the Icahn School of Medicine at Mount Sinai, New York. The most notable symptom during pregnancy is severe pruritus. In what is believed to be the first study of its kind, Dr. Kushner and colleagues set out to evaluate the association between ICP and NAFLD and associated metabolic risk factors, including obesity, dyslipidemia, hypertension, and diabetes. Between January and December of 2017, they drew from the electronic medical records of a New York City health system to identify 149 pregnancies complicated by ICP and compared them to a control group of 200 pregnancies without an ICP diagnosis. The researchers used Pearson’s chi-square or Fisher’s exact test and Wilcoxon rank-sum tests to evaluate association of ICP with categorical variables and continuous variables, respectively, and unadjusted odds ratios to compare the ICP and control groups for clinically significant outcomes.

The median age of the study population was 30 years, their mean body mass index was 27.5 kg/m², and there was a higher proportion of Hispanic women in the ICP group, compared with the control group (75% vs. 62%, respectively). Dr. Kushner and colleagues found that Hispanic women were nearly twice as likely to be diagnosed with ICP than non-Hispanic women (OR, 1.90; 95% confidence interval, 1.87-3.03). However, patients in both the ICP and control groups were similar for median age (OR, 1.02; 95% CI, 0.99-1.06), nulliparity (OR, 0.79; 95% CI, 0.48-1.30), and prevalence of hepatitis C (OR, 1.35; 95% CI, 0.08-21.67). The two groups were also similar for certain metabolic risk factors, including prevalence of obesity (OR, 1.01; 95% CI, 0.62-1.61), hypertension (OR, 0.69; 95% CI, 0.31-1.52), hemoglobin A_1c greater than 5.5% (OR, 0.80; 95% CI, 0.34-1.9), and total cholesterol above 200 mg/dL (OR, 4.15; 95% CI, 0.83-20.84). Median bile acid levels were 30.6 micromoles (interquartile range, 11.6, 32.7) in the ICP group.

Compared with patients in the control group, those in the ICP group had higher median levels of alanine aminotransferase (ALT) (32 vs. 16 U/L; P less than .0001), alkaline phosphatase (181 vs. 128 U/L; P less than .0001), and total bilirubin (0.5 vs. 0.35 mg/dL; P less than .0001). ICP patients were also more likely than their counterparts to have ALT levels above 50 U/L (two times the upper limit of normal; OR, 3.22; 95% CI, 1.48-7.03), a history of biliary disease (OR, 3.29; 95% CI, 1.39-7.80), and to have evidence of steatosis on liver imaging (OR, 4.69; 95% CI, 1.68-13.12). When the researchers evaluated a diagnosis of NAFLD based on ICD-10 codes or evidence of steatosis on liver imaging, ICP patients were significantly more likely to have a diagnosis of NAFLD than controls (OR, 5.7; 95% CI, 2.08-15.65).

“We recommend additional research to look at differences in NAFLD progression in women who had NAFLD and were later diagnosed with ICP, compared to women with NAFLD who did not go on to develop ICP, because that may be a reflection of the role that bile acid metabolism plays in these particular patients,” Dr. Kushner said.

Digestive Disease Week is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).  

The study’s primary author was Erica Monrose, MD. The researchers reported having no financial disclosures.

[email protected]

SOURCE: Monrose E et al. DDW 2019, Abstract Sa1562.