Megan Brooks

Colonoscopy performed with an artificial intelligence (AI)–based computer-aided detection (CADe) system decreased the adenoma miss rate (AMR) by roughly half, compared with standard colonoscopy without AI assistance in a randomized controlled trial.

“Such reduction is achieved by reducing the error in detecting subtle, small lesions that can be missed by the human eye,” lead investigator Cesare Hassan, MD, PhD, with the gastroenterology unit at Nuovo Regina Margherita Hospital in Rome, Italy, told this news organization.

The study was published online March 15 in Gastroenterology.
 

Tandem colonoscopy study

Investigators behind the study enrolled 230 adults undergoing colorectal cancer screening or surveillance at eight centers in Italy, the United Kingdom, and the United States.

All participants underwent two same-day, back-to-back colonoscopies with or without the GI-Genius (Medtronic) AI deep-learning CADe program in two different arms. In one arm, AI was followed by standard colonoscopy; in the other arm, standard colonoscopy was followed by AI.

The primary outcome of the study was AMR, defined as the number of histologically confirmed lesions detected during the second colonoscopy divided by the total number of lesions detected during both procedures.

Bowel preparation and quality of the examinations were similar for the study groups.

The AMR was significantly lower with AI-assisted colonoscopy first than non-AI first (15.5% vs. 32.4%; adjusted odds ratio, 0.38; 95% confidence interval, 0.23-0.62). This was largely due to a decrease in the miss rate of flat and small lesions in the proximal and distal colon.

Among adenomas less than 10 mm, the AMR with AI first was 16.5%, compared with 33.8% with standard non-AI colonoscopy first (OR, 0.39; 95% CI, 0.25-0.61). The AMR was also significantly lower with AI first for adenomas less than or equal to 5 mm (15.9% vs. 35.8%; OR, 0.34; 95% CI, 0.21-0.55). No differences in AMR were evident for adenomas measuring 6-9 mm or greater than or equal to 10 mm.

With regard to morphology, the miss rate of non-polypoid lesions was significantly lower with AI first (16.8% vs. 45.8%; OR, 0.24; 95% CI, 0.13-0.45), and there was a numerical decrease in the miss rate of polypoid lesions with AI that did not reach statistical significance.

The use of AI was also associated with a statistically significant reduction in the false negative rate (6.8% vs. 29.6%; OR, 0.17; 95% CI, 0.05-0.67).

The authors say their findings offer indirect support to the higher adenoma detection rate demonstrated with this CADe system in two previous randomized controlled trials.
 

More high-quality evidence for AI-assisted colonoscopy

“This is a very well-executed study, and it does show a reduced miss rate with AI during colonoscopy,” Douglas Rex, MD, director of endoscopy at Indiana University Hospital in Indianapolis, said in an interview.

“AI seems destined to contribute importantly to colonoscopy,” added Dr. Rex, who was not involved in the study.

Atsushi Sakuraba, MD, PhD, gastroenterologist with the University of Chicago Medical Center, who also was not involved in the study, said he is not surprised by these latest findings on AI-assisted colonoscopy.

This study and others have provided “high-quality evidence that AI-aided colonoscopy increases the adenoma detection rate and decreases the adenoma miss rate, so I consider that it would soon become standard of care to use AI-aided colonoscopy in clinical practice,” Dr. Sakuraba told this news organization.

Dr. Rex noted that this specific AI program is a “detection program, so-called CADe, but there will be programs for the prediction of histology (CADx) and programs that assess how carefully the colon is being examined by the doctor. All of these show promise for reducing operator dependence, which is very problematic in colonoscopy.”

Dr. Rex emphasized that AI programs are “not a threat to endoscopists, as there is still an enormous skill set required to effectively examine the colon and clear it of neoplasia.”

He cautioned that currently, the cost of the CADe programs is significant but is likely to come down as more vendors get U.S. Food and Drug Administration approval for their programs.

The study was funded by Cosmo Artificial Intelligence-AI. Dr. Hassan has relationships with Medtronic and Fujfilm. Dr. Rex and Dr. Sakuraba have disclosed no relevant financial relationships.

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

This article was updated 3/16/22.

Colonoscopy performed with an artificial intelligence (AI)–based computer-aided detection (CADe) system decreased the adenoma miss rate (AMR) by roughly half, compared with standard colonoscopy without AI assistance in a randomized controlled trial.

“Such reduction is achieved by reducing the error in detecting subtle, small lesions that can be missed by the human eye,” lead investigator Cesare Hassan, MD, PhD, with the gastroenterology unit at Nuovo Regina Margherita Hospital in Rome, Italy, told this news organization.

The study was published online March 15 in Gastroenterology.
 

Tandem colonoscopy study

Investigators behind the study enrolled 230 adults undergoing colorectal cancer screening or surveillance at eight centers in Italy, the United Kingdom, and the United States.

All participants underwent two same-day, back-to-back colonoscopies with or without the GI-Genius (Medtronic) AI deep-learning CADe program in two different arms. In one arm, AI was followed by standard colonoscopy; in the other arm, standard colonoscopy was followed by AI.

The primary outcome of the study was AMR, defined as the number of histologically confirmed lesions detected during the second colonoscopy divided by the total number of lesions detected during both procedures.

Bowel preparation and quality of the examinations were similar for the study groups.

The AMR was significantly lower with AI-assisted colonoscopy first than non-AI first (15.5% vs. 32.4%; adjusted odds ratio, 0.38; 95% confidence interval, 0.23-0.62). This was largely due to a decrease in the miss rate of flat and small lesions in the proximal and distal colon.

Among adenomas less than 10 mm, the AMR with AI first was 16.5%, compared with 33.8% with standard non-AI colonoscopy first (OR, 0.39; 95% CI, 0.25-0.61). The AMR was also significantly lower with AI first for adenomas less than or equal to 5 mm (15.9% vs. 35.8%; OR, 0.34; 95% CI, 0.21-0.55). No differences in AMR were evident for adenomas measuring 6-9 mm or greater than or equal to 10 mm.

With regard to morphology, the miss rate of non-polypoid lesions was significantly lower with AI first (16.8% vs. 45.8%; OR, 0.24; 95% CI, 0.13-0.45), and there was a numerical decrease in the miss rate of polypoid lesions with AI that did not reach statistical significance.

The use of AI was also associated with a statistically significant reduction in the false negative rate (6.8% vs. 29.6%; OR, 0.17; 95% CI, 0.05-0.67).

The authors say their findings offer indirect support to the higher adenoma detection rate demonstrated with this CADe system in two previous randomized controlled trials.
 

More high-quality evidence for AI-assisted colonoscopy

“This is a very well-executed study, and it does show a reduced miss rate with AI during colonoscopy,” Douglas Rex, MD, director of endoscopy at Indiana University Hospital in Indianapolis, said in an interview.

“AI seems destined to contribute importantly to colonoscopy,” added Dr. Rex, who was not involved in the study.

Atsushi Sakuraba, MD, PhD, gastroenterologist with the University of Chicago Medical Center, who also was not involved in the study, said he is not surprised by these latest findings on AI-assisted colonoscopy.

This study and others have provided “high-quality evidence that AI-aided colonoscopy increases the adenoma detection rate and decreases the adenoma miss rate, so I consider that it would soon become standard of care to use AI-aided colonoscopy in clinical practice,” Dr. Sakuraba told this news organization.

Dr. Rex noted that this specific AI program is a “detection program, so-called CADe, but there will be programs for the prediction of histology (CADx) and programs that assess how carefully the colon is being examined by the doctor. All of these show promise for reducing operator dependence, which is very problematic in colonoscopy.”

Dr. Rex emphasized that AI programs are “not a threat to endoscopists, as there is still an enormous skill set required to effectively examine the colon and clear it of neoplasia.”

He cautioned that currently, the cost of the CADe programs is significant but is likely to come down as more vendors get U.S. Food and Drug Administration approval for their programs.

The study was funded by Cosmo Artificial Intelligence-AI. Dr. Hassan has relationships with Medtronic and Fujfilm. Dr. Rex and Dr. Sakuraba have disclosed no relevant financial relationships.

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

This article was updated 3/16/22.

Colonoscopy performed with an artificial intelligence (AI)–based computer-aided detection (CADe) system decreased the adenoma miss rate (AMR) by roughly half, compared with standard colonoscopy without AI assistance in a randomized controlled trial.

“Such reduction is achieved by reducing the error in detecting subtle, small lesions that can be missed by the human eye,” lead investigator Cesare Hassan, MD, PhD, with the gastroenterology unit at Nuovo Regina Margherita Hospital in Rome, Italy, told this news organization.

The study was published online March 15 in Gastroenterology.
 

Tandem colonoscopy study

Investigators behind the study enrolled 230 adults undergoing colorectal cancer screening or surveillance at eight centers in Italy, the United Kingdom, and the United States.

All participants underwent two same-day, back-to-back colonoscopies with or without the GI-Genius (Medtronic) AI deep-learning CADe program in two different arms. In one arm, AI was followed by standard colonoscopy; in the other arm, standard colonoscopy was followed by AI.

The primary outcome of the study was AMR, defined as the number of histologically confirmed lesions detected during the second colonoscopy divided by the total number of lesions detected during both procedures.

Bowel preparation and quality of the examinations were similar for the study groups.

The AMR was significantly lower with AI-assisted colonoscopy first than non-AI first (15.5% vs. 32.4%; adjusted odds ratio, 0.38; 95% confidence interval, 0.23-0.62). This was largely due to a decrease in the miss rate of flat and small lesions in the proximal and distal colon.

Among adenomas less than 10 mm, the AMR with AI first was 16.5%, compared with 33.8% with standard non-AI colonoscopy first (OR, 0.39; 95% CI, 0.25-0.61). The AMR was also significantly lower with AI first for adenomas less than or equal to 5 mm (15.9% vs. 35.8%; OR, 0.34; 95% CI, 0.21-0.55). No differences in AMR were evident for adenomas measuring 6-9 mm or greater than or equal to 10 mm.

With regard to morphology, the miss rate of non-polypoid lesions was significantly lower with AI first (16.8% vs. 45.8%; OR, 0.24; 95% CI, 0.13-0.45), and there was a numerical decrease in the miss rate of polypoid lesions with AI that did not reach statistical significance.

The use of AI was also associated with a statistically significant reduction in the false negative rate (6.8% vs. 29.6%; OR, 0.17; 95% CI, 0.05-0.67).

The authors say their findings offer indirect support to the higher adenoma detection rate demonstrated with this CADe system in two previous randomized controlled trials.
 

More high-quality evidence for AI-assisted colonoscopy

“This is a very well-executed study, and it does show a reduced miss rate with AI during colonoscopy,” Douglas Rex, MD, director of endoscopy at Indiana University Hospital in Indianapolis, said in an interview.

“AI seems destined to contribute importantly to colonoscopy,” added Dr. Rex, who was not involved in the study.

Atsushi Sakuraba, MD, PhD, gastroenterologist with the University of Chicago Medical Center, who also was not involved in the study, said he is not surprised by these latest findings on AI-assisted colonoscopy.

This study and others have provided “high-quality evidence that AI-aided colonoscopy increases the adenoma detection rate and decreases the adenoma miss rate, so I consider that it would soon become standard of care to use AI-aided colonoscopy in clinical practice,” Dr. Sakuraba told this news organization.

Dr. Rex noted that this specific AI program is a “detection program, so-called CADe, but there will be programs for the prediction of histology (CADx) and programs that assess how carefully the colon is being examined by the doctor. All of these show promise for reducing operator dependence, which is very problematic in colonoscopy.”

Dr. Rex emphasized that AI programs are “not a threat to endoscopists, as there is still an enormous skill set required to effectively examine the colon and clear it of neoplasia.”

He cautioned that currently, the cost of the CADe programs is significant but is likely to come down as more vendors get U.S. Food and Drug Administration approval for their programs.

The study was funded by Cosmo Artificial Intelligence-AI. Dr. Hassan has relationships with Medtronic and Fujfilm. Dr. Rex and Dr. Sakuraba have disclosed no relevant financial relationships.

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

This article was updated 3/16/22.

Green tea extract (GTE) does not appear to protect against colorectal adenoma recurrence, according to a study from Germany.

Preclinical, epidemiologic, and small clinical studies have suggested that GTE and its major active component, epigallocatechin gallate (EGCG), have antineoplastic effects in the colon and rectum.

But the new study found no statistically significant difference in adenoma recurrence in people who took GTE, standardized to 150 mg EGCG, twice daily for 3 years, relative to those who took matching placebo.

However, there was a suggestion of possible benefit in men but not women, which requires further study, Thomas Seufferlein, MD, with Ulm University Hospital, Baden-Württemberg, Germany, and colleagues write.

Their study was published online in The American Journal of Gastroenterology.
 

Largest trial to date

The MIRACLE trial (Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract) included 879 adults aged 50-80 years. Participants had undergone removal of one or more histologically confirmed colorectal adenomas within 6 months prior to recruitment during colonoscopy, and there were no remaining colorectal adenomas.

There were 432 patients in the GTE group and 447 in the placebo group. Baseline characteristics were well balanced between the groups, and overall adherence to the study protocol was good.

After 3 years, adenomas were detected in 55.7% of participants in the placebo group and in 51.1% of those in the GTE group in the modified intention-to-treat population. This absolute difference of 4.6% in favor of GTE was not statistically significant.

The per protocol analysis also did not show a significant effect of GTE on new adenoma formation in the whole study population.

However, a preplanned subgroup analysis revealed a significant difference in the adenoma recurrence rate in favor of GTE in men but not women.

In men, GTE intake was associated with a significant 12.4% relative and 7.5% absolute reduction of metachronous adenomas, they report.

This potential gender-specific difference in chemoprevention “warrants further investigations,” the study team writes.

The safety profile of GTE as taken in this trial was good, with only grade 1/2 elevations in liver enzymes in the GTE group, compared with the placebo group. However, because the follow-up period was limited to 3 years, the long-term safety of GTE cannot be determined.

The researchers write that, to their knowledge, this study is the largest randomized trial to date of the effect of GTE on adenoma recurrence in a colorectal cancer screening population consisting of White patients.
 

Caveats and cautionary notes

Reached for comment, David Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia School of Medicine, Norfolk, noted that “although the study showed no significant differences, the time horizon to show benefit may be longer than the 3-year duration of the study.”

“There are also methodologic issues with the readjustment of the target sample size, which may have led to a type II error, related to underpowering of the sample size,” said Dr. Johnson, who wasn’t involved in the study.

The researchers write that the study initially generated “great interest” and that many centers applied to participate. However, “quite a few” centers did not meet their promised recruitment targets and had to be replaced. Therefore, the statistical analysis plan had to be modified, and the number of participants had to be reduced over the course of the trial, they note.

Dr. Johnson also cautioned that while green tea is a popular drink, “there is strong evidence that green tea extract, found in many herbal and dietary supplements, is among the leading causes listed for drug-induced liver injury, including acute liver failure, urgent liver transplantation, and death.”

The study was fully funded by a grant from German Cancer Aid. The investigators and Dr. Johnson report no relevant financial relationships.

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

Green tea extract (GTE) does not appear to protect against colorectal adenoma recurrence, according to a study from Germany.

Preclinical, epidemiologic, and small clinical studies have suggested that GTE and its major active component, epigallocatechin gallate (EGCG), have antineoplastic effects in the colon and rectum.

But the new study found no statistically significant difference in adenoma recurrence in people who took GTE, standardized to 150 mg EGCG, twice daily for 3 years, relative to those who took matching placebo.

However, there was a suggestion of possible benefit in men but not women, which requires further study, Thomas Seufferlein, MD, with Ulm University Hospital, Baden-Württemberg, Germany, and colleagues write.

Their study was published online in The American Journal of Gastroenterology.
 

Largest trial to date

The MIRACLE trial (Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract) included 879 adults aged 50-80 years. Participants had undergone removal of one or more histologically confirmed colorectal adenomas within 6 months prior to recruitment during colonoscopy, and there were no remaining colorectal adenomas.

There were 432 patients in the GTE group and 447 in the placebo group. Baseline characteristics were well balanced between the groups, and overall adherence to the study protocol was good.

After 3 years, adenomas were detected in 55.7% of participants in the placebo group and in 51.1% of those in the GTE group in the modified intention-to-treat population. This absolute difference of 4.6% in favor of GTE was not statistically significant.

The per protocol analysis also did not show a significant effect of GTE on new adenoma formation in the whole study population.

However, a preplanned subgroup analysis revealed a significant difference in the adenoma recurrence rate in favor of GTE in men but not women.

In men, GTE intake was associated with a significant 12.4% relative and 7.5% absolute reduction of metachronous adenomas, they report.

This potential gender-specific difference in chemoprevention “warrants further investigations,” the study team writes.

The safety profile of GTE as taken in this trial was good, with only grade 1/2 elevations in liver enzymes in the GTE group, compared with the placebo group. However, because the follow-up period was limited to 3 years, the long-term safety of GTE cannot be determined.

The researchers write that, to their knowledge, this study is the largest randomized trial to date of the effect of GTE on adenoma recurrence in a colorectal cancer screening population consisting of White patients.
 

Caveats and cautionary notes

Reached for comment, David Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia School of Medicine, Norfolk, noted that “although the study showed no significant differences, the time horizon to show benefit may be longer than the 3-year duration of the study.”

“There are also methodologic issues with the readjustment of the target sample size, which may have led to a type II error, related to underpowering of the sample size,” said Dr. Johnson, who wasn’t involved in the study.

The researchers write that the study initially generated “great interest” and that many centers applied to participate. However, “quite a few” centers did not meet their promised recruitment targets and had to be replaced. Therefore, the statistical analysis plan had to be modified, and the number of participants had to be reduced over the course of the trial, they note.

Dr. Johnson also cautioned that while green tea is a popular drink, “there is strong evidence that green tea extract, found in many herbal and dietary supplements, is among the leading causes listed for drug-induced liver injury, including acute liver failure, urgent liver transplantation, and death.”

The study was fully funded by a grant from German Cancer Aid. The investigators and Dr. Johnson report no relevant financial relationships.

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

Green tea extract (GTE) does not appear to protect against colorectal adenoma recurrence, according to a study from Germany.

Preclinical, epidemiologic, and small clinical studies have suggested that GTE and its major active component, epigallocatechin gallate (EGCG), have antineoplastic effects in the colon and rectum.

But the new study found no statistically significant difference in adenoma recurrence in people who took GTE, standardized to 150 mg EGCG, twice daily for 3 years, relative to those who took matching placebo.

However, there was a suggestion of possible benefit in men but not women, which requires further study, Thomas Seufferlein, MD, with Ulm University Hospital, Baden-Württemberg, Germany, and colleagues write.

Their study was published online in The American Journal of Gastroenterology.
 

Largest trial to date

The MIRACLE trial (Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract) included 879 adults aged 50-80 years. Participants had undergone removal of one or more histologically confirmed colorectal adenomas within 6 months prior to recruitment during colonoscopy, and there were no remaining colorectal adenomas.

There were 432 patients in the GTE group and 447 in the placebo group. Baseline characteristics were well balanced between the groups, and overall adherence to the study protocol was good.

After 3 years, adenomas were detected in 55.7% of participants in the placebo group and in 51.1% of those in the GTE group in the modified intention-to-treat population. This absolute difference of 4.6% in favor of GTE was not statistically significant.

The per protocol analysis also did not show a significant effect of GTE on new adenoma formation in the whole study population.

However, a preplanned subgroup analysis revealed a significant difference in the adenoma recurrence rate in favor of GTE in men but not women.

In men, GTE intake was associated with a significant 12.4% relative and 7.5% absolute reduction of metachronous adenomas, they report.

This potential gender-specific difference in chemoprevention “warrants further investigations,” the study team writes.

The safety profile of GTE as taken in this trial was good, with only grade 1/2 elevations in liver enzymes in the GTE group, compared with the placebo group. However, because the follow-up period was limited to 3 years, the long-term safety of GTE cannot be determined.

The researchers write that, to their knowledge, this study is the largest randomized trial to date of the effect of GTE on adenoma recurrence in a colorectal cancer screening population consisting of White patients.
 

Caveats and cautionary notes

Reached for comment, David Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia School of Medicine, Norfolk, noted that “although the study showed no significant differences, the time horizon to show benefit may be longer than the 3-year duration of the study.”

“There are also methodologic issues with the readjustment of the target sample size, which may have led to a type II error, related to underpowering of the sample size,” said Dr. Johnson, who wasn’t involved in the study.

The researchers write that the study initially generated “great interest” and that many centers applied to participate. However, “quite a few” centers did not meet their promised recruitment targets and had to be replaced. Therefore, the statistical analysis plan had to be modified, and the number of participants had to be reduced over the course of the trial, they note.

Dr. Johnson also cautioned that while green tea is a popular drink, “there is strong evidence that green tea extract, found in many herbal and dietary supplements, is among the leading causes listed for drug-induced liver injury, including acute liver failure, urgent liver transplantation, and death.”

The study was fully funded by a grant from German Cancer Aid. The investigators and Dr. Johnson report no relevant financial relationships.

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

John Giacomini, MD, has pleaded guilty to one count of abusive sexual contact of a female physician he was supervising, the Department of Justice (DOJ) has announced.

Dr. Giacomini, 73, of Atherton, California, had practiced medicine and cardiology for more than 30 years and served as chief of the cardiology section at the VA Hospital in Palo Alto from 1985 to 2018.

According to the statement from DOJ, starting in the fall of 2017, Dr. Giacomini repeatedly subjected a subordinate doctor to unwanted and unwelcome sexual contact, which included hugging, kissing, and intimate touching while on VA premises.

The victim explicitly told Dr. Giacomini she was not interested in a romantic or sexual relationship with him and forcibly resisted his repeated attempts to kiss her, the statement notes.

The abuse continued, culminating in December 2017 with the incident of abusive sexual contact, the DOJ says.

Afterward, the victim resigned from her position at the VA, citing Dr. Giacomini’s behavior as her principal reason for leaving.

“As a federal employee for well over 30 years, [Dr.] Giacomini was trained throughout his career on the prevention of workplace sexual assault and sexual harassment,” the DOJ says.

“As a supervisor and manager, [Dr.] Giacomini had an obligation to the VA and to his subordinates to prevent workplace sexual harassment and disclose any harassing behavior of which he became aware. He failed to do this,” the DOJ says.

A federal grand jury indicted Dr. Giacomini in March 2020, charging him with one count of abusive sexual contact. Dr. Giacomini has now pleaded guilty to the charge, a felony.

Sentencing is scheduled for July 12. Dr. Giacomini faces a maximum sentence of 2 years in prison, a fine of $250,000, restitution, and supervised release.

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

John Giacomini, MD, has pleaded guilty to one count of abusive sexual contact of a female physician he was supervising, the Department of Justice (DOJ) has announced.

Dr. Giacomini, 73, of Atherton, California, had practiced medicine and cardiology for more than 30 years and served as chief of the cardiology section at the VA Hospital in Palo Alto from 1985 to 2018.

According to the statement from DOJ, starting in the fall of 2017, Dr. Giacomini repeatedly subjected a subordinate doctor to unwanted and unwelcome sexual contact, which included hugging, kissing, and intimate touching while on VA premises.

The victim explicitly told Dr. Giacomini she was not interested in a romantic or sexual relationship with him and forcibly resisted his repeated attempts to kiss her, the statement notes.

The abuse continued, culminating in December 2017 with the incident of abusive sexual contact, the DOJ says.

Afterward, the victim resigned from her position at the VA, citing Dr. Giacomini’s behavior as her principal reason for leaving.

“As a federal employee for well over 30 years, [Dr.] Giacomini was trained throughout his career on the prevention of workplace sexual assault and sexual harassment,” the DOJ says.

“As a supervisor and manager, [Dr.] Giacomini had an obligation to the VA and to his subordinates to prevent workplace sexual harassment and disclose any harassing behavior of which he became aware. He failed to do this,” the DOJ says.

A federal grand jury indicted Dr. Giacomini in March 2020, charging him with one count of abusive sexual contact. Dr. Giacomini has now pleaded guilty to the charge, a felony.

Sentencing is scheduled for July 12. Dr. Giacomini faces a maximum sentence of 2 years in prison, a fine of $250,000, restitution, and supervised release.

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

John Giacomini, MD, has pleaded guilty to one count of abusive sexual contact of a female physician he was supervising, the Department of Justice (DOJ) has announced.

Dr. Giacomini, 73, of Atherton, California, had practiced medicine and cardiology for more than 30 years and served as chief of the cardiology section at the VA Hospital in Palo Alto from 1985 to 2018.

According to the statement from DOJ, starting in the fall of 2017, Dr. Giacomini repeatedly subjected a subordinate doctor to unwanted and unwelcome sexual contact, which included hugging, kissing, and intimate touching while on VA premises.

The victim explicitly told Dr. Giacomini she was not interested in a romantic or sexual relationship with him and forcibly resisted his repeated attempts to kiss her, the statement notes.

The abuse continued, culminating in December 2017 with the incident of abusive sexual contact, the DOJ says.

Afterward, the victim resigned from her position at the VA, citing Dr. Giacomini’s behavior as her principal reason for leaving.

“As a federal employee for well over 30 years, [Dr.] Giacomini was trained throughout his career on the prevention of workplace sexual assault and sexual harassment,” the DOJ says.

“As a supervisor and manager, [Dr.] Giacomini had an obligation to the VA and to his subordinates to prevent workplace sexual harassment and disclose any harassing behavior of which he became aware. He failed to do this,” the DOJ says.

A federal grand jury indicted Dr. Giacomini in March 2020, charging him with one count of abusive sexual contact. Dr. Giacomini has now pleaded guilty to the charge, a felony.

Sentencing is scheduled for July 12. Dr. Giacomini faces a maximum sentence of 2 years in prison, a fine of $250,000, restitution, and supervised release.

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

It’s now known that tinnitus may be an unexpected side effect of SARS-CoV-2 vaccination, and there is an urgent need to understand the precise mechanisms and best treatment for vaccine-associated tinnitus, researchers say.

As of mid-September 2021, 12,247 cases of tinnitus, or ringing in the ears, following COVID-19 vaccination had been reported to the Vaccine Adverse Event Reporting System of the U.S. Centers for Disease Control and Prevention.

“Despite several cases of tinnitus being reported following SARS-CoV-2 vaccination, the precise pathophysiology is still not clear,” write Syed Hassan Ahmed, 3rd-year MBBS student, Dow University of Health Sciences, Karachi, Pakistan, and coauthors.

The researchers review what is known and unknown about SARS-CoV-2 vaccine-associated tinnitus in an article published online Feb. 11 in Annals of Medicine and Surgery.
 

Molecular mimicry?

The researchers say cross-reactivity between anti-spike SARS-CoV-2 antibodies and otologic antigens is one possibility, based on the mechanisms behind other COVID-19 vaccine–induced disorders and the phenomenon of molecular mimicry.

“The heptapeptide resemblance between coronavirus spike glycoprotein and numerous human proteins further supports molecular mimicry as a potential mechanism behind such vaccine-induced disorders,” they write.

Anti-spike antibodies may react with antigens anywhere along the auditory pathway and fuel an inflammatory reaction, they point out.

“Therefore, understanding the phenomenon of cross-reactivity and molecular mimicry may be helpful in postulating potential treatment behind not only tinnitus but also the rare events of vaccination associated hearing loss and other otologic manifestations,” the authors say.

Genetic predispositions and associated conditions may also play a significant role in determining whether an individual develops vaccine-induced tinnitus.

Stress and anxiety following COVID vaccination may also play a role, inasmuch as anxiety-related adverse events following vaccination have been reported. Vaccine-related anxiety as a potential cause of tinnitus developing after vaccination needs to be explored, they write.
 

Jury out on best management

How best to manage COVID vaccine-associated tinnitus also remains unclear, but it starts with a well-established diagnosis, the authors say.

A well-focused and detailed history and examination are essential, with particular emphasis placed on preexisting health conditions, specifically, autoimmune diseases, such as Hashimoto thyroiditis; otologic conditions, such as sensorineural hearing loss; glaucoma; and psychological well-being. According to the review, patients often present with a history of one or more of these disorders.

“However, any such association has not yet been established and requires further investigation to be concluded as potential risk factors for vaccine-induced tinnitus,” they caution.

Routine cranial nerve examination, otoscopy, Weber test, and Rinne test, which are used for tinnitus diagnosis in general, may be helpful for confirmation of vaccine-associated tinnitus.

Owing to the significant association between tinnitus and hearing impairment, audiology should also performed, the authors say.

Although treatments for non–vaccine-induced tinnitus vary significantly, corticosteroids are the top treatment choice for SARS-CoV-2 vaccine-induced tinnitus reported in the literature.

Trials of other drug and nondrug interventions that may uniquely help with vaccine-associated tinnitus are urgently needed, the authors say.

Summing up, the reviewers say, “Although the incidence of COVID-19 vaccine-associated tinnitus is rare, there is an overwhelming need to discern the precise pathophysiology and clinical management as a better understanding of adverse events may help in encountering vaccine hesitancy and hence fostering the COVID-19 global vaccination program.

“Despite the incidence of adverse events, the benefits of the SARS-CoV-2 vaccine in reducing hospitalization and deaths continue to outweigh the rare ramifications,” they conclude.

The research had no specific funding. The authors have disclosed no relevant financial relationships.

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

It’s now known that tinnitus may be an unexpected side effect of SARS-CoV-2 vaccination, and there is an urgent need to understand the precise mechanisms and best treatment for vaccine-associated tinnitus, researchers say.

As of mid-September 2021, 12,247 cases of tinnitus, or ringing in the ears, following COVID-19 vaccination had been reported to the Vaccine Adverse Event Reporting System of the U.S. Centers for Disease Control and Prevention.

“Despite several cases of tinnitus being reported following SARS-CoV-2 vaccination, the precise pathophysiology is still not clear,” write Syed Hassan Ahmed, 3rd-year MBBS student, Dow University of Health Sciences, Karachi, Pakistan, and coauthors.

The researchers review what is known and unknown about SARS-CoV-2 vaccine-associated tinnitus in an article published online Feb. 11 in Annals of Medicine and Surgery.
 

Molecular mimicry?

The researchers say cross-reactivity between anti-spike SARS-CoV-2 antibodies and otologic antigens is one possibility, based on the mechanisms behind other COVID-19 vaccine–induced disorders and the phenomenon of molecular mimicry.

“The heptapeptide resemblance between coronavirus spike glycoprotein and numerous human proteins further supports molecular mimicry as a potential mechanism behind such vaccine-induced disorders,” they write.

Anti-spike antibodies may react with antigens anywhere along the auditory pathway and fuel an inflammatory reaction, they point out.

“Therefore, understanding the phenomenon of cross-reactivity and molecular mimicry may be helpful in postulating potential treatment behind not only tinnitus but also the rare events of vaccination associated hearing loss and other otologic manifestations,” the authors say.

Genetic predispositions and associated conditions may also play a significant role in determining whether an individual develops vaccine-induced tinnitus.

Stress and anxiety following COVID vaccination may also play a role, inasmuch as anxiety-related adverse events following vaccination have been reported. Vaccine-related anxiety as a potential cause of tinnitus developing after vaccination needs to be explored, they write.
 

Jury out on best management

How best to manage COVID vaccine-associated tinnitus also remains unclear, but it starts with a well-established diagnosis, the authors say.

A well-focused and detailed history and examination are essential, with particular emphasis placed on preexisting health conditions, specifically, autoimmune diseases, such as Hashimoto thyroiditis; otologic conditions, such as sensorineural hearing loss; glaucoma; and psychological well-being. According to the review, patients often present with a history of one or more of these disorders.

“However, any such association has not yet been established and requires further investigation to be concluded as potential risk factors for vaccine-induced tinnitus,” they caution.

Routine cranial nerve examination, otoscopy, Weber test, and Rinne test, which are used for tinnitus diagnosis in general, may be helpful for confirmation of vaccine-associated tinnitus.

Owing to the significant association between tinnitus and hearing impairment, audiology should also performed, the authors say.

Although treatments for non–vaccine-induced tinnitus vary significantly, corticosteroids are the top treatment choice for SARS-CoV-2 vaccine-induced tinnitus reported in the literature.

Trials of other drug and nondrug interventions that may uniquely help with vaccine-associated tinnitus are urgently needed, the authors say.

Summing up, the reviewers say, “Although the incidence of COVID-19 vaccine-associated tinnitus is rare, there is an overwhelming need to discern the precise pathophysiology and clinical management as a better understanding of adverse events may help in encountering vaccine hesitancy and hence fostering the COVID-19 global vaccination program.

“Despite the incidence of adverse events, the benefits of the SARS-CoV-2 vaccine in reducing hospitalization and deaths continue to outweigh the rare ramifications,” they conclude.

The research had no specific funding. The authors have disclosed no relevant financial relationships.

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

It’s now known that tinnitus may be an unexpected side effect of SARS-CoV-2 vaccination, and there is an urgent need to understand the precise mechanisms and best treatment for vaccine-associated tinnitus, researchers say.

As of mid-September 2021, 12,247 cases of tinnitus, or ringing in the ears, following COVID-19 vaccination had been reported to the Vaccine Adverse Event Reporting System of the U.S. Centers for Disease Control and Prevention.

“Despite several cases of tinnitus being reported following SARS-CoV-2 vaccination, the precise pathophysiology is still not clear,” write Syed Hassan Ahmed, 3rd-year MBBS student, Dow University of Health Sciences, Karachi, Pakistan, and coauthors.

The researchers review what is known and unknown about SARS-CoV-2 vaccine-associated tinnitus in an article published online Feb. 11 in Annals of Medicine and Surgery.
 

Molecular mimicry?

The researchers say cross-reactivity between anti-spike SARS-CoV-2 antibodies and otologic antigens is one possibility, based on the mechanisms behind other COVID-19 vaccine–induced disorders and the phenomenon of molecular mimicry.

“The heptapeptide resemblance between coronavirus spike glycoprotein and numerous human proteins further supports molecular mimicry as a potential mechanism behind such vaccine-induced disorders,” they write.

Anti-spike antibodies may react with antigens anywhere along the auditory pathway and fuel an inflammatory reaction, they point out.

“Therefore, understanding the phenomenon of cross-reactivity and molecular mimicry may be helpful in postulating potential treatment behind not only tinnitus but also the rare events of vaccination associated hearing loss and other otologic manifestations,” the authors say.

Genetic predispositions and associated conditions may also play a significant role in determining whether an individual develops vaccine-induced tinnitus.

Stress and anxiety following COVID vaccination may also play a role, inasmuch as anxiety-related adverse events following vaccination have been reported. Vaccine-related anxiety as a potential cause of tinnitus developing after vaccination needs to be explored, they write.
 

Jury out on best management

How best to manage COVID vaccine-associated tinnitus also remains unclear, but it starts with a well-established diagnosis, the authors say.

A well-focused and detailed history and examination are essential, with particular emphasis placed on preexisting health conditions, specifically, autoimmune diseases, such as Hashimoto thyroiditis; otologic conditions, such as sensorineural hearing loss; glaucoma; and psychological well-being. According to the review, patients often present with a history of one or more of these disorders.

“However, any such association has not yet been established and requires further investigation to be concluded as potential risk factors for vaccine-induced tinnitus,” they caution.

Routine cranial nerve examination, otoscopy, Weber test, and Rinne test, which are used for tinnitus diagnosis in general, may be helpful for confirmation of vaccine-associated tinnitus.

Owing to the significant association between tinnitus and hearing impairment, audiology should also performed, the authors say.

Although treatments for non–vaccine-induced tinnitus vary significantly, corticosteroids are the top treatment choice for SARS-CoV-2 vaccine-induced tinnitus reported in the literature.

Trials of other drug and nondrug interventions that may uniquely help with vaccine-associated tinnitus are urgently needed, the authors say.

Summing up, the reviewers say, “Although the incidence of COVID-19 vaccine-associated tinnitus is rare, there is an overwhelming need to discern the precise pathophysiology and clinical management as a better understanding of adverse events may help in encountering vaccine hesitancy and hence fostering the COVID-19 global vaccination program.

“Despite the incidence of adverse events, the benefits of the SARS-CoV-2 vaccine in reducing hospitalization and deaths continue to outweigh the rare ramifications,” they conclude.

The research had no specific funding. The authors have disclosed no relevant financial relationships.

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

Adults with a congenital heart defect (CHD) are at increased risk for serious illness and death when hospitalized with COVID-19, making vaccination and other preventive measures even important in this population, say researchers with the Centers for Disease Control and Prevention.

“We found that hospitalized patients with heart defects are up to twice as likely to have critical outcomes of COVID-19 illness (admission to the intensive care unit, use of a ventilator to help with breathing, or death) compared to hospitalized COVID-19 patients without heart defects,” Karrie Downing, MPH, epidemiologist, with the CDC’s National Center on Birth Defects and Developmental Disabilities, said in an interview.

“Additionally, we learned that people with hearts defects who were older or who also had other conditions like heart failure, pulmonary hypertension, Down syndrome, diabetes, or obesity were the most likely to have critical COVID-19 illness, but children and adults with heart defects without these other conditions were still at increased risk,” Ms. Downing said.

The message for health care providers is clear: “Encourage your patients with heart defects to get vaccinated and discuss with your patients the need for other preventive measures to avoid infection that may progress to severe COVID-19 illness,” Ms. Downing added.

The study was published online March 7, 2022, in Circulation.

The researchers analyzed data on 235,638 patients hospitalized with COVID-19 between March 2020 and January 2021, including 421 (0.2%) with CHD. Most CHD patients were older than 30 years (73%) and 61% were men, with 55% non-Hispanic white, 19% Hispanic and 16% non-Hispanic Black.

Overall, 68% of CHD patients had at least one comorbidity, as did 59% of patients without CHD.

Rates of ICU admission were higher in the CHD group (54% vs. 43%), as were rates of invasive mechanical ventilation (24% vs. 15%) and in-hospital death (11% vs. 7%).

After accounting for patient characteristics, ICU admission, invasive mechanical ventilation and death were more prevalent among COVID-19 patients with rather than without CHD, with adjusted prevalence ratios of 1.4, 1.8 and 2.0, respectively.

When stratified by high-risk characteristics, prevalence estimates for ICU admission, invasive mechanical ventilation and death remained higher among patients with COVID-19 and CHD across nearly all strata, including younger age groups and those without heart failure, pulmonary hypertension, Down syndrome, diabetes, or obesity, the researchers reported.

Ms. Downing said more work is needed to identify why the clinical course of COVID-19 disease results in admission to the ICU, the need for a ventilator, or death for some hospitalized patients with CHD and not for others.

“There could be a number of social, environmental, economic, medical, and genetic factors playing a role. But staying up to date with COVID-19 vaccines and following preventive measures for COVID-19 are effective ways to reduce the risk of severe illness from COVID-19,” Ms. Downing said.

The study had no specific funding. The authors reported no relevant disclosures.

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

Adults with a congenital heart defect (CHD) are at increased risk for serious illness and death when hospitalized with COVID-19, making vaccination and other preventive measures even important in this population, say researchers with the Centers for Disease Control and Prevention.

“We found that hospitalized patients with heart defects are up to twice as likely to have critical outcomes of COVID-19 illness (admission to the intensive care unit, use of a ventilator to help with breathing, or death) compared to hospitalized COVID-19 patients without heart defects,” Karrie Downing, MPH, epidemiologist, with the CDC’s National Center on Birth Defects and Developmental Disabilities, said in an interview.

“Additionally, we learned that people with hearts defects who were older or who also had other conditions like heart failure, pulmonary hypertension, Down syndrome, diabetes, or obesity were the most likely to have critical COVID-19 illness, but children and adults with heart defects without these other conditions were still at increased risk,” Ms. Downing said.

The message for health care providers is clear: “Encourage your patients with heart defects to get vaccinated and discuss with your patients the need for other preventive measures to avoid infection that may progress to severe COVID-19 illness,” Ms. Downing added.

The study was published online March 7, 2022, in Circulation.

The researchers analyzed data on 235,638 patients hospitalized with COVID-19 between March 2020 and January 2021, including 421 (0.2%) with CHD. Most CHD patients were older than 30 years (73%) and 61% were men, with 55% non-Hispanic white, 19% Hispanic and 16% non-Hispanic Black.

Overall, 68% of CHD patients had at least one comorbidity, as did 59% of patients without CHD.

Rates of ICU admission were higher in the CHD group (54% vs. 43%), as were rates of invasive mechanical ventilation (24% vs. 15%) and in-hospital death (11% vs. 7%).

After accounting for patient characteristics, ICU admission, invasive mechanical ventilation and death were more prevalent among COVID-19 patients with rather than without CHD, with adjusted prevalence ratios of 1.4, 1.8 and 2.0, respectively.

When stratified by high-risk characteristics, prevalence estimates for ICU admission, invasive mechanical ventilation and death remained higher among patients with COVID-19 and CHD across nearly all strata, including younger age groups and those without heart failure, pulmonary hypertension, Down syndrome, diabetes, or obesity, the researchers reported.

Ms. Downing said more work is needed to identify why the clinical course of COVID-19 disease results in admission to the ICU, the need for a ventilator, or death for some hospitalized patients with CHD and not for others.

“There could be a number of social, environmental, economic, medical, and genetic factors playing a role. But staying up to date with COVID-19 vaccines and following preventive measures for COVID-19 are effective ways to reduce the risk of severe illness from COVID-19,” Ms. Downing said.

The study had no specific funding. The authors reported no relevant disclosures.

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

Adults with a congenital heart defect (CHD) are at increased risk for serious illness and death when hospitalized with COVID-19, making vaccination and other preventive measures even important in this population, say researchers with the Centers for Disease Control and Prevention.

“We found that hospitalized patients with heart defects are up to twice as likely to have critical outcomes of COVID-19 illness (admission to the intensive care unit, use of a ventilator to help with breathing, or death) compared to hospitalized COVID-19 patients without heart defects,” Karrie Downing, MPH, epidemiologist, with the CDC’s National Center on Birth Defects and Developmental Disabilities, said in an interview.

“Additionally, we learned that people with hearts defects who were older or who also had other conditions like heart failure, pulmonary hypertension, Down syndrome, diabetes, or obesity were the most likely to have critical COVID-19 illness, but children and adults with heart defects without these other conditions were still at increased risk,” Ms. Downing said.

The message for health care providers is clear: “Encourage your patients with heart defects to get vaccinated and discuss with your patients the need for other preventive measures to avoid infection that may progress to severe COVID-19 illness,” Ms. Downing added.

The study was published online March 7, 2022, in Circulation.

The researchers analyzed data on 235,638 patients hospitalized with COVID-19 between March 2020 and January 2021, including 421 (0.2%) with CHD. Most CHD patients were older than 30 years (73%) and 61% were men, with 55% non-Hispanic white, 19% Hispanic and 16% non-Hispanic Black.

Overall, 68% of CHD patients had at least one comorbidity, as did 59% of patients without CHD.

Rates of ICU admission were higher in the CHD group (54% vs. 43%), as were rates of invasive mechanical ventilation (24% vs. 15%) and in-hospital death (11% vs. 7%).

After accounting for patient characteristics, ICU admission, invasive mechanical ventilation and death were more prevalent among COVID-19 patients with rather than without CHD, with adjusted prevalence ratios of 1.4, 1.8 and 2.0, respectively.

When stratified by high-risk characteristics, prevalence estimates for ICU admission, invasive mechanical ventilation and death remained higher among patients with COVID-19 and CHD across nearly all strata, including younger age groups and those without heart failure, pulmonary hypertension, Down syndrome, diabetes, or obesity, the researchers reported.

Ms. Downing said more work is needed to identify why the clinical course of COVID-19 disease results in admission to the ICU, the need for a ventilator, or death for some hospitalized patients with CHD and not for others.

“There could be a number of social, environmental, economic, medical, and genetic factors playing a role. But staying up to date with COVID-19 vaccines and following preventive measures for COVID-19 are effective ways to reduce the risk of severe illness from COVID-19,” Ms. Downing said.

The study had no specific funding. The authors reported no relevant disclosures.

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

Heavy drinking during early adulthood may raise the risk for alcohol-related cancers, even after drinking stops or decreases in middle age, according to a new study from Australia.

Although alcohol is a known risk factor for cancer, people generally do not expect their heavy drinking in early adulthood to affect their cancer risk many years later, lead author Harindra Jayasekara, MBBS, MD, PhD, with Cancer Council Victoria and University of Melbourne, said in an interview. But in this analysis, “we found evidence consistent with early initiation and chronic progression of carcinogenesis linked to alcohol and its toxic metabolites.”

Courtesy Debora Cartagena, USCDCP

Impact on cancer risk

For men, relative to lifetime abstention, heavy drinking trajectories were associated with an increased risk for alcohol-related cancer overall.

The strongest associations were for the early decreasing heavy trajectory (hazard ratio, 1.75) and the late decreasing heavy trajectory (HR, 1.94), with the increasing heavy trajectory not far behind (HR, 1.45).

The strength of these associations did not change appreciably in analyses excluding current smokers at baseline.

Among men, the early decreasing heavy and late decreasing heavy intake trajectories were similarly associated with an increased risk for colorectal cancer (HR, 1.56 for early, and HR, 1.74 for late). The corresponding HR for the increasing heavy trajectory was 1.36.

For women, compared with lifetime abstention, the alcohol intake trajectory classified as increasing moderate (30-59 g/day) was associated with a greater risk for alcohol-related cancer overall (HR, 1.25). The strength of this association weakened slightly when current smokers were excluded.

Compared with lifetime abstention, the increasing moderate trajectory in women was similarly associated with an increased risk for breast cancer (HR, 1.30) and colorectal cancer (HR, 1.23).

The 2018 World Cancer Research Fund and American Institute for Cancer Research global cancer prevention recommendation on alcohol is to “avoid any alcohol,” study investigator Julie Bassett, PhD, MSc, with Cancer Council Victoria, said in an interview. “As much as it is important to limit alcohol intake during middle age to prevent cancer, we have shown that limiting intake during early adulthood is also important.”
 

‘Striking’ findings

Reached for comment, Timothy Brennan, MD, MPH, chief of clinical services at the Addiction Institute of Mount Sinai in New York, said it is “striking” that heavy drinking in early adulthood led to an increased risk for alcohol-related cancers, even among people who drank much less in middle age.

“We’ve known for decades that alcohol is not harmless, but this data adds to the growing body of literature regarding the significant dangers of heavy drinking during early adulthood,” said Dr. Brennan, who wasn’t involved in the study.

Dr. Brennan cautioned, however, that the authors studied alcohol-related cancers, and “there are likely many other [cancer] risk factors that were not analyzed in this dataset.”

Nevertheless, this evidence helps counter the “troubling narrative” that “it is somehow normal and safe to drink excessively in young adulthood.”

“It is most certainly not safe,” Dr. Brennan told this news organization . “We see in this study that drinking excessively in young adulthood can raise the risk of cancer much later in life.”

The study had no commercial funding. Dr. Bassett, Dr. Jayasekara, and Dr. Brennan have disclosed no relevant financial relationships.

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

Heavy drinking during early adulthood may raise the risk for alcohol-related cancers, even after drinking stops or decreases in middle age, according to a new study from Australia.

Although alcohol is a known risk factor for cancer, people generally do not expect their heavy drinking in early adulthood to affect their cancer risk many years later, lead author Harindra Jayasekara, MBBS, MD, PhD, with Cancer Council Victoria and University of Melbourne, said in an interview. But in this analysis, “we found evidence consistent with early initiation and chronic progression of carcinogenesis linked to alcohol and its toxic metabolites.”

Courtesy Debora Cartagena, USCDCP

Impact on cancer risk

For men, relative to lifetime abstention, heavy drinking trajectories were associated with an increased risk for alcohol-related cancer overall.

The strongest associations were for the early decreasing heavy trajectory (hazard ratio, 1.75) and the late decreasing heavy trajectory (HR, 1.94), with the increasing heavy trajectory not far behind (HR, 1.45).

The strength of these associations did not change appreciably in analyses excluding current smokers at baseline.

Among men, the early decreasing heavy and late decreasing heavy intake trajectories were similarly associated with an increased risk for colorectal cancer (HR, 1.56 for early, and HR, 1.74 for late). The corresponding HR for the increasing heavy trajectory was 1.36.

For women, compared with lifetime abstention, the alcohol intake trajectory classified as increasing moderate (30-59 g/day) was associated with a greater risk for alcohol-related cancer overall (HR, 1.25). The strength of this association weakened slightly when current smokers were excluded.

Compared with lifetime abstention, the increasing moderate trajectory in women was similarly associated with an increased risk for breast cancer (HR, 1.30) and colorectal cancer (HR, 1.23).

The 2018 World Cancer Research Fund and American Institute for Cancer Research global cancer prevention recommendation on alcohol is to “avoid any alcohol,” study investigator Julie Bassett, PhD, MSc, with Cancer Council Victoria, said in an interview. “As much as it is important to limit alcohol intake during middle age to prevent cancer, we have shown that limiting intake during early adulthood is also important.”
 

‘Striking’ findings

Reached for comment, Timothy Brennan, MD, MPH, chief of clinical services at the Addiction Institute of Mount Sinai in New York, said it is “striking” that heavy drinking in early adulthood led to an increased risk for alcohol-related cancers, even among people who drank much less in middle age.

“We’ve known for decades that alcohol is not harmless, but this data adds to the growing body of literature regarding the significant dangers of heavy drinking during early adulthood,” said Dr. Brennan, who wasn’t involved in the study.

Dr. Brennan cautioned, however, that the authors studied alcohol-related cancers, and “there are likely many other [cancer] risk factors that were not analyzed in this dataset.”

Nevertheless, this evidence helps counter the “troubling narrative” that “it is somehow normal and safe to drink excessively in young adulthood.”

“It is most certainly not safe,” Dr. Brennan told this news organization . “We see in this study that drinking excessively in young adulthood can raise the risk of cancer much later in life.”

The study had no commercial funding. Dr. Bassett, Dr. Jayasekara, and Dr. Brennan have disclosed no relevant financial relationships.

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

Heavy drinking during early adulthood may raise the risk for alcohol-related cancers, even after drinking stops or decreases in middle age, according to a new study from Australia.

Although alcohol is a known risk factor for cancer, people generally do not expect their heavy drinking in early adulthood to affect their cancer risk many years later, lead author Harindra Jayasekara, MBBS, MD, PhD, with Cancer Council Victoria and University of Melbourne, said in an interview. But in this analysis, “we found evidence consistent with early initiation and chronic progression of carcinogenesis linked to alcohol and its toxic metabolites.”

Courtesy Debora Cartagena, USCDCP

Impact on cancer risk

For men, relative to lifetime abstention, heavy drinking trajectories were associated with an increased risk for alcohol-related cancer overall.

The strongest associations were for the early decreasing heavy trajectory (hazard ratio, 1.75) and the late decreasing heavy trajectory (HR, 1.94), with the increasing heavy trajectory not far behind (HR, 1.45).

The strength of these associations did not change appreciably in analyses excluding current smokers at baseline.

Among men, the early decreasing heavy and late decreasing heavy intake trajectories were similarly associated with an increased risk for colorectal cancer (HR, 1.56 for early, and HR, 1.74 for late). The corresponding HR for the increasing heavy trajectory was 1.36.

For women, compared with lifetime abstention, the alcohol intake trajectory classified as increasing moderate (30-59 g/day) was associated with a greater risk for alcohol-related cancer overall (HR, 1.25). The strength of this association weakened slightly when current smokers were excluded.

Compared with lifetime abstention, the increasing moderate trajectory in women was similarly associated with an increased risk for breast cancer (HR, 1.30) and colorectal cancer (HR, 1.23).

The 2018 World Cancer Research Fund and American Institute for Cancer Research global cancer prevention recommendation on alcohol is to “avoid any alcohol,” study investigator Julie Bassett, PhD, MSc, with Cancer Council Victoria, said in an interview. “As much as it is important to limit alcohol intake during middle age to prevent cancer, we have shown that limiting intake during early adulthood is also important.”
 

‘Striking’ findings

Reached for comment, Timothy Brennan, MD, MPH, chief of clinical services at the Addiction Institute of Mount Sinai in New York, said it is “striking” that heavy drinking in early adulthood led to an increased risk for alcohol-related cancers, even among people who drank much less in middle age.

“We’ve known for decades that alcohol is not harmless, but this data adds to the growing body of literature regarding the significant dangers of heavy drinking during early adulthood,” said Dr. Brennan, who wasn’t involved in the study.

Dr. Brennan cautioned, however, that the authors studied alcohol-related cancers, and “there are likely many other [cancer] risk factors that were not analyzed in this dataset.”

Nevertheless, this evidence helps counter the “troubling narrative” that “it is somehow normal and safe to drink excessively in young adulthood.”

“It is most certainly not safe,” Dr. Brennan told this news organization . “We see in this study that drinking excessively in young adulthood can raise the risk of cancer much later in life.”

The study had no commercial funding. Dr. Bassett, Dr. Jayasekara, and Dr. Brennan have disclosed no relevant financial relationships.

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

David Bennett Sr, the 57-year-old patient with terminal heart disease who became the first person to receive a genetically modified pig heart, has died. He passed away March 8, according to a statement from the University of Maryland Medical Center (UMMC), Baltimore, where the transplant was performed.

Mr. Bennett received the transplant on January 7 and lived for 2 months following the surgery.   

Although not providing the exact cause of his death, UMMC said Mr. Bennett’s condition began deteriorating several days before his death.

When it became clear that he would not recover, he was given compassionate palliative care and was able to communicate with his family during his final hours.

“We are devastated by the loss of Mr. Bennett. He proved to be a brave and noble patient who fought all the way to the end. We extend our sincerest condolences to his family,” Bartley P. Griffith, MD, who performed the transplant, said in the statement.

“We are grateful to Mr. Bennett for his unique and historic role in helping to contribute to a vast array of knowledge to the field of xenotransplantation,” added Muhammad M. Mohiuddin, MD, director of the cardiac xenotransplantation program at University of Maryland School of Medicine.

Before receiving the genetically modified pig heart, Mr. Bennett had required mechanical circulatory support to stay alive but was rejected for standard heart transplantation at UMMC and other centers. He was ineligible for an implanted ventricular assist device due to ventricular arrhythmias.

Following surgery, the transplanted pig heart performed well for several weeks without any signs of rejection. The patient was able to spend time with his family and participate in physical therapy to help regain strength.

“This organ transplant demonstrated for the first time that a genetically modified animal heart can function like a human heart without immediate rejection by the body,” UMMC said in a statement issued 3 days after the surgery.

Thanks to Mr. Bennett, “we have gained invaluable insights learning that the genetically modified pig heart can function well within the human body while the immune system is adequately suppressed,” said Dr. Mohiuddin. “We remain optimistic and plan on continuing our work in future clinical trials.”

The patient’s son, David Bennett Jr, said the family is “profoundly grateful for the life-extending opportunity” provided to his father by the “stellar team” at the University of Maryland School of Medicine and the University of Maryland Medical Center.

“We were able to spend some precious weeks together while he recovered from the transplant surgery, weeks we would not have had without this miraculous effort,” he said.

“We also hope that what was learned from his surgery will benefit future patients and hopefully, one day, end the organ shortage that costs so many lives each year,” he added.

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

David Bennett Sr, the 57-year-old patient with terminal heart disease who became the first person to receive a genetically modified pig heart, has died. He passed away March 8, according to a statement from the University of Maryland Medical Center (UMMC), Baltimore, where the transplant was performed.

Mr. Bennett received the transplant on January 7 and lived for 2 months following the surgery.   

Although not providing the exact cause of his death, UMMC said Mr. Bennett’s condition began deteriorating several days before his death.

When it became clear that he would not recover, he was given compassionate palliative care and was able to communicate with his family during his final hours.

“We are devastated by the loss of Mr. Bennett. He proved to be a brave and noble patient who fought all the way to the end. We extend our sincerest condolences to his family,” Bartley P. Griffith, MD, who performed the transplant, said in the statement.

“We are grateful to Mr. Bennett for his unique and historic role in helping to contribute to a vast array of knowledge to the field of xenotransplantation,” added Muhammad M. Mohiuddin, MD, director of the cardiac xenotransplantation program at University of Maryland School of Medicine.

Before receiving the genetically modified pig heart, Mr. Bennett had required mechanical circulatory support to stay alive but was rejected for standard heart transplantation at UMMC and other centers. He was ineligible for an implanted ventricular assist device due to ventricular arrhythmias.

Following surgery, the transplanted pig heart performed well for several weeks without any signs of rejection. The patient was able to spend time with his family and participate in physical therapy to help regain strength.

“This organ transplant demonstrated for the first time that a genetically modified animal heart can function like a human heart without immediate rejection by the body,” UMMC said in a statement issued 3 days after the surgery.

Thanks to Mr. Bennett, “we have gained invaluable insights learning that the genetically modified pig heart can function well within the human body while the immune system is adequately suppressed,” said Dr. Mohiuddin. “We remain optimistic and plan on continuing our work in future clinical trials.”

The patient’s son, David Bennett Jr, said the family is “profoundly grateful for the life-extending opportunity” provided to his father by the “stellar team” at the University of Maryland School of Medicine and the University of Maryland Medical Center.

“We were able to spend some precious weeks together while he recovered from the transplant surgery, weeks we would not have had without this miraculous effort,” he said.

“We also hope that what was learned from his surgery will benefit future patients and hopefully, one day, end the organ shortage that costs so many lives each year,” he added.

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

David Bennett Sr, the 57-year-old patient with terminal heart disease who became the first person to receive a genetically modified pig heart, has died. He passed away March 8, according to a statement from the University of Maryland Medical Center (UMMC), Baltimore, where the transplant was performed.

Mr. Bennett received the transplant on January 7 and lived for 2 months following the surgery.   

Although not providing the exact cause of his death, UMMC said Mr. Bennett’s condition began deteriorating several days before his death.

When it became clear that he would not recover, he was given compassionate palliative care and was able to communicate with his family during his final hours.

“We are devastated by the loss of Mr. Bennett. He proved to be a brave and noble patient who fought all the way to the end. We extend our sincerest condolences to his family,” Bartley P. Griffith, MD, who performed the transplant, said in the statement.

“We are grateful to Mr. Bennett for his unique and historic role in helping to contribute to a vast array of knowledge to the field of xenotransplantation,” added Muhammad M. Mohiuddin, MD, director of the cardiac xenotransplantation program at University of Maryland School of Medicine.

Before receiving the genetically modified pig heart, Mr. Bennett had required mechanical circulatory support to stay alive but was rejected for standard heart transplantation at UMMC and other centers. He was ineligible for an implanted ventricular assist device due to ventricular arrhythmias.

Following surgery, the transplanted pig heart performed well for several weeks without any signs of rejection. The patient was able to spend time with his family and participate in physical therapy to help regain strength.

“This organ transplant demonstrated for the first time that a genetically modified animal heart can function like a human heart without immediate rejection by the body,” UMMC said in a statement issued 3 days after the surgery.

Thanks to Mr. Bennett, “we have gained invaluable insights learning that the genetically modified pig heart can function well within the human body while the immune system is adequately suppressed,” said Dr. Mohiuddin. “We remain optimistic and plan on continuing our work in future clinical trials.”

The patient’s son, David Bennett Jr, said the family is “profoundly grateful for the life-extending opportunity” provided to his father by the “stellar team” at the University of Maryland School of Medicine and the University of Maryland Medical Center.

“We were able to spend some precious weeks together while he recovered from the transplant surgery, weeks we would not have had without this miraculous effort,” he said.

“We also hope that what was learned from his surgery will benefit future patients and hopefully, one day, end the organ shortage that costs so many lives each year,” he added.

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

A new meta-analysis provides more evidence that taller people may be more likely than their shorter peers to develop colorectal cancer (CRC) or colon polyps.

“There are well-known modifiable dietary associations for colorectal cancer, such as processed red meats and smoking, but guidelines currently are fixated on family history, and height is clinically neglected when it comes to risk screening,” study investigator Gerard Mullin, MD, with Johns Hopkins University, Baltimore, said in a news release. This large study “builds on evidence that taller height is an overlooked risk factor and should be considered when evaluating and recommending patients for colorectal cancer screenings.”

The study was published online March 1 in Cancer Epidemiology, Biomarkers & Prevention.
 

The evidence: Height and cancer risk

Height has been actively studied as a potential nonmodifiable risk factor for a range of cancers, including CRC.

In one large prospective study of postmenopausal women, researchers found a modest but statistically significant positive association between height and risk for any cancer and for melanoma, multiple myeloma, and cancers of the thyroid, ovary, colorectum, and endometrium. 

A separate study found that tall men, especially those who are long-legged, may be at increased risk for prostate cancer, including high-grade tumors, relative to men of more modest stature.

However, the study authors point out, past studies have also produced mixed results, used inconsistent measures of height, and failed to include the risk of adenomas.  

In the current meta-analysis, the investigators included 47 international, observational studies involving 280,644 adults with CRC and 14,139 cases of colorectal adenoma.

Because the definition of tallness differs around the world, the researchers compared the highest versus the lowest height percentile of various study groups. The findings were adjusted for demographic, socioeconomic, behavioral, and other known risk factors for CRC.

Overall, the investigators found that the tallest individuals within the highest percentile of height had a 24% higher risk of developing CRC compared to the shortest individuals within the lowest percentile (hazard ratio [HR], 1.24; P < .001).

In addition, they found that every 10-cm increase (about 4 inches) in height was associated with a 14% increased risk of developing CRC (HR, 1.14; P < .001) and a 6% increased likelihood of adenomas (odds ratio [OR], 1.06; P = .03).

In the United States, the average height for men is 5 feet, 9 inches, and for women it is 5 feet, 4 inches, which means men who are 6 feet, 1 inch and women who are 5 feet, 8 inches or taller have a 14% increased risk of CRC and a 6% increased risk of adenomas, the researchers explained.

According to co–first author Elinor Zhou, MD, also with Johns Hopkins University, a potential explanation for this link “is that adult height correlates with body organ size. More active proliferation in organs of taller people could increase the possibility of mutations leading to malignant transformation.”

The study authors said more research is needed to identify particular subgroups of tall people at risk for CRC.

“For instance, tall athletes and individuals with inherited tallness, such as those with Marfan syndrome, could be screened earlier and the impact of height further explored,” Dr. Zhou said.

Plus, Dr. Zhou added, more studies are needed to “definitively say at what height you would need earlier colorectal cancer screening.”

The current study was supported by grants from Bloomberg Philanthropies, intramural funds, and the Johns Hopkins Cancer Center Support Grant. The authors declared no conflicts of interest.

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

A new meta-analysis provides more evidence that taller people may be more likely than their shorter peers to develop colorectal cancer (CRC) or colon polyps.

“There are well-known modifiable dietary associations for colorectal cancer, such as processed red meats and smoking, but guidelines currently are fixated on family history, and height is clinically neglected when it comes to risk screening,” study investigator Gerard Mullin, MD, with Johns Hopkins University, Baltimore, said in a news release. This large study “builds on evidence that taller height is an overlooked risk factor and should be considered when evaluating and recommending patients for colorectal cancer screenings.”

The study was published online March 1 in Cancer Epidemiology, Biomarkers & Prevention.
 

The evidence: Height and cancer risk

Height has been actively studied as a potential nonmodifiable risk factor for a range of cancers, including CRC.

In one large prospective study of postmenopausal women, researchers found a modest but statistically significant positive association between height and risk for any cancer and for melanoma, multiple myeloma, and cancers of the thyroid, ovary, colorectum, and endometrium. 

A separate study found that tall men, especially those who are long-legged, may be at increased risk for prostate cancer, including high-grade tumors, relative to men of more modest stature.

However, the study authors point out, past studies have also produced mixed results, used inconsistent measures of height, and failed to include the risk of adenomas.  

In the current meta-analysis, the investigators included 47 international, observational studies involving 280,644 adults with CRC and 14,139 cases of colorectal adenoma.

Because the definition of tallness differs around the world, the researchers compared the highest versus the lowest height percentile of various study groups. The findings were adjusted for demographic, socioeconomic, behavioral, and other known risk factors for CRC.

Overall, the investigators found that the tallest individuals within the highest percentile of height had a 24% higher risk of developing CRC compared to the shortest individuals within the lowest percentile (hazard ratio [HR], 1.24; P < .001).

In addition, they found that every 10-cm increase (about 4 inches) in height was associated with a 14% increased risk of developing CRC (HR, 1.14; P < .001) and a 6% increased likelihood of adenomas (odds ratio [OR], 1.06; P = .03).

In the United States, the average height for men is 5 feet, 9 inches, and for women it is 5 feet, 4 inches, which means men who are 6 feet, 1 inch and women who are 5 feet, 8 inches or taller have a 14% increased risk of CRC and a 6% increased risk of adenomas, the researchers explained.

According to co–first author Elinor Zhou, MD, also with Johns Hopkins University, a potential explanation for this link “is that adult height correlates with body organ size. More active proliferation in organs of taller people could increase the possibility of mutations leading to malignant transformation.”

The study authors said more research is needed to identify particular subgroups of tall people at risk for CRC.

“For instance, tall athletes and individuals with inherited tallness, such as those with Marfan syndrome, could be screened earlier and the impact of height further explored,” Dr. Zhou said.

Plus, Dr. Zhou added, more studies are needed to “definitively say at what height you would need earlier colorectal cancer screening.”

The current study was supported by grants from Bloomberg Philanthropies, intramural funds, and the Johns Hopkins Cancer Center Support Grant. The authors declared no conflicts of interest.

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

A new meta-analysis provides more evidence that taller people may be more likely than their shorter peers to develop colorectal cancer (CRC) or colon polyps.

“There are well-known modifiable dietary associations for colorectal cancer, such as processed red meats and smoking, but guidelines currently are fixated on family history, and height is clinically neglected when it comes to risk screening,” study investigator Gerard Mullin, MD, with Johns Hopkins University, Baltimore, said in a news release. This large study “builds on evidence that taller height is an overlooked risk factor and should be considered when evaluating and recommending patients for colorectal cancer screenings.”

The study was published online March 1 in Cancer Epidemiology, Biomarkers & Prevention.
 

The evidence: Height and cancer risk

Height has been actively studied as a potential nonmodifiable risk factor for a range of cancers, including CRC.

In one large prospective study of postmenopausal women, researchers found a modest but statistically significant positive association between height and risk for any cancer and for melanoma, multiple myeloma, and cancers of the thyroid, ovary, colorectum, and endometrium. 

A separate study found that tall men, especially those who are long-legged, may be at increased risk for prostate cancer, including high-grade tumors, relative to men of more modest stature.

However, the study authors point out, past studies have also produced mixed results, used inconsistent measures of height, and failed to include the risk of adenomas.  

In the current meta-analysis, the investigators included 47 international, observational studies involving 280,644 adults with CRC and 14,139 cases of colorectal adenoma.

Because the definition of tallness differs around the world, the researchers compared the highest versus the lowest height percentile of various study groups. The findings were adjusted for demographic, socioeconomic, behavioral, and other known risk factors for CRC.

Overall, the investigators found that the tallest individuals within the highest percentile of height had a 24% higher risk of developing CRC compared to the shortest individuals within the lowest percentile (hazard ratio [HR], 1.24; P < .001).

In addition, they found that every 10-cm increase (about 4 inches) in height was associated with a 14% increased risk of developing CRC (HR, 1.14; P < .001) and a 6% increased likelihood of adenomas (odds ratio [OR], 1.06; P = .03).

In the United States, the average height for men is 5 feet, 9 inches, and for women it is 5 feet, 4 inches, which means men who are 6 feet, 1 inch and women who are 5 feet, 8 inches or taller have a 14% increased risk of CRC and a 6% increased risk of adenomas, the researchers explained.

According to co–first author Elinor Zhou, MD, also with Johns Hopkins University, a potential explanation for this link “is that adult height correlates with body organ size. More active proliferation in organs of taller people could increase the possibility of mutations leading to malignant transformation.”

The study authors said more research is needed to identify particular subgroups of tall people at risk for CRC.

“For instance, tall athletes and individuals with inherited tallness, such as those with Marfan syndrome, could be screened earlier and the impact of height further explored,” Dr. Zhou said.

Plus, Dr. Zhou added, more studies are needed to “definitively say at what height you would need earlier colorectal cancer screening.”

The current study was supported by grants from Bloomberg Philanthropies, intramural funds, and the Johns Hopkins Cancer Center Support Grant. The authors declared no conflicts of interest.

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

A prescription, digital therapeutic shows measurable brain changes that correlate with improved attention control in children with attention-deficit/hyperactivity disorder (ADHD).

Investigators found children who used the video game-based therapy (EndeavorRx) experienced increased brain activity related to attention function, as measured by EEG, which correlated with improvements in objective behavioral measures of attention.

Courtesy University of California, San Francisco

“While the previous multicenter trials show attention improvement for children using EndeavorRx, this is the first study to look at the brain activity in children with a primary concern of ADHD,” principal investigator Elysa Marco, MD, clinical executive for neurodevelopmental medicine at Cortica Healthcare, San Rafael, Calif., said in news release.

“It is exciting to see measurable improvement on the EEGs that correlates with the behavioral benefits,” said Dr. Marco.

The study was recently published online in PLOS ONE. 
 

Measurable changes

As previously reported by this news organization, the Food and Drug Administration approved EndeavorRx in June 2020 as a prescription video game–based therapeutic device for children aged 8-12 years with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue.

“The device is intended for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder,” the FDA said upon approval.

In the current unblinded, single-arm study, the researchers assessed 25 children (aged 8-12 years) with a confirmed diagnosis of ADHD on neural, behavioral, and clinical metrics of attention before and after a 4-week at-home intervention.

Participants were instructed to use EndeavorRx for about 25 minutes a day at least 5 days a week for 4 weeks, as recommended by the FDA.

“EndeavorRx enhanced midline frontal theta (MFT) activity, suggesting that patients who used EndeavorRx for 4 weeks showed changes in measurable brain function,” Anil S. Jina, MD, chief medical officer of Akili Interactive, told this news organization. Dr. Jina was not involved with the study.

There was also a correlation between MFT activity and attention functioning, “suggesting that children who experienced the largest gains in MFT activity as measured by EEG also showed the greatest improvements in computerized performance tests designed to measure attention,” Dr. Jina said.

In addition, parents reported significantly fewer inattention symptoms in children after EndeavorRx treatment, as measured by the Vanderbilt ADHD Diagnostic Rating Scale.
 

‘Not just another video game’

EndeavorRx has been evaluated in five clinical studies involving more than 600 children with ADHD, including the STARS-ADHD trial, a prospective, randomized, controlled study published in The Lancet Digital Health.

The STARS-ADHD trial randomly allocated 348 children to either EndeavorRx treatment or a controlled intervention, which was a word game.

The researchers reported statistically significant improvements in attentional functioning in the EndeavorRx group as rated by test of variables of attention.

“This is not just another video game,” STARS-ADHD trialist Scott H. Kollins, PhD, MS, a clinical psychologist at Duke Health’s ADHD Clinic in Durham, N.C., who helped developed it, previously told this news organization.   

The tool’s adaptive algorithms adjust and monitor task difficulty based on performance, using a video game format and rewards to engage users, he explained. EndeavorRx is a challenge to play by design.

“The treatment was programmed into the gameplay experience and designed to challenge a child’s attentional control during gameplay, requiring focus and flexibility to manage tasks at the same time,” Dr. Jina said in an interview.

“Unlike a video game that is designed only for entertainment purposes, to drive efficacy, EndeavorRx is designed to be challenging and can therefore sometimes feel repetitive, and frustrating to some children,” Dr. Jina said.

Commenting on the study, Stephen Faraone, PhD, distinguished professor of psychiatry and vice chair of research, department of psychiatry, State University of New York, Syracuse, said this study “supports the idea that EndeavorRx improves a neural measure of attention.

“The limitation is that we don’t know if this translates into clinically relevant outcomes,” cautioned Dr. Faraone, who was not associated with the current study.

“The main caveat about EndeavorRx is that it was cleared by the FDA for improving a computer-based measure of inattention, not inattentive symptoms as reported by the parents of children with ADHD,” he noted.

Several authors have disclosed financial relationships with Akili Interactive Labs, which funded the study. Dr. Faraone was an investigator on the STARS-ADHD trial.

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

A prescription, digital therapeutic shows measurable brain changes that correlate with improved attention control in children with attention-deficit/hyperactivity disorder (ADHD).

Investigators found children who used the video game-based therapy (EndeavorRx) experienced increased brain activity related to attention function, as measured by EEG, which correlated with improvements in objective behavioral measures of attention.

Courtesy University of California, San Francisco

“While the previous multicenter trials show attention improvement for children using EndeavorRx, this is the first study to look at the brain activity in children with a primary concern of ADHD,” principal investigator Elysa Marco, MD, clinical executive for neurodevelopmental medicine at Cortica Healthcare, San Rafael, Calif., said in news release.

“It is exciting to see measurable improvement on the EEGs that correlates with the behavioral benefits,” said Dr. Marco.

The study was recently published online in PLOS ONE. 
 

Measurable changes

As previously reported by this news organization, the Food and Drug Administration approved EndeavorRx in June 2020 as a prescription video game–based therapeutic device for children aged 8-12 years with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue.

“The device is intended for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder,” the FDA said upon approval.

In the current unblinded, single-arm study, the researchers assessed 25 children (aged 8-12 years) with a confirmed diagnosis of ADHD on neural, behavioral, and clinical metrics of attention before and after a 4-week at-home intervention.

Participants were instructed to use EndeavorRx for about 25 minutes a day at least 5 days a week for 4 weeks, as recommended by the FDA.

“EndeavorRx enhanced midline frontal theta (MFT) activity, suggesting that patients who used EndeavorRx for 4 weeks showed changes in measurable brain function,” Anil S. Jina, MD, chief medical officer of Akili Interactive, told this news organization. Dr. Jina was not involved with the study.

There was also a correlation between MFT activity and attention functioning, “suggesting that children who experienced the largest gains in MFT activity as measured by EEG also showed the greatest improvements in computerized performance tests designed to measure attention,” Dr. Jina said.

In addition, parents reported significantly fewer inattention symptoms in children after EndeavorRx treatment, as measured by the Vanderbilt ADHD Diagnostic Rating Scale.
 

‘Not just another video game’

EndeavorRx has been evaluated in five clinical studies involving more than 600 children with ADHD, including the STARS-ADHD trial, a prospective, randomized, controlled study published in The Lancet Digital Health.

The STARS-ADHD trial randomly allocated 348 children to either EndeavorRx treatment or a controlled intervention, which was a word game.

The researchers reported statistically significant improvements in attentional functioning in the EndeavorRx group as rated by test of variables of attention.

“This is not just another video game,” STARS-ADHD trialist Scott H. Kollins, PhD, MS, a clinical psychologist at Duke Health’s ADHD Clinic in Durham, N.C., who helped developed it, previously told this news organization.   

The tool’s adaptive algorithms adjust and monitor task difficulty based on performance, using a video game format and rewards to engage users, he explained. EndeavorRx is a challenge to play by design.

“The treatment was programmed into the gameplay experience and designed to challenge a child’s attentional control during gameplay, requiring focus and flexibility to manage tasks at the same time,” Dr. Jina said in an interview.

“Unlike a video game that is designed only for entertainment purposes, to drive efficacy, EndeavorRx is designed to be challenging and can therefore sometimes feel repetitive, and frustrating to some children,” Dr. Jina said.

Commenting on the study, Stephen Faraone, PhD, distinguished professor of psychiatry and vice chair of research, department of psychiatry, State University of New York, Syracuse, said this study “supports the idea that EndeavorRx improves a neural measure of attention.

“The limitation is that we don’t know if this translates into clinically relevant outcomes,” cautioned Dr. Faraone, who was not associated with the current study.

“The main caveat about EndeavorRx is that it was cleared by the FDA for improving a computer-based measure of inattention, not inattentive symptoms as reported by the parents of children with ADHD,” he noted.

Several authors have disclosed financial relationships with Akili Interactive Labs, which funded the study. Dr. Faraone was an investigator on the STARS-ADHD trial.

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

A prescription, digital therapeutic shows measurable brain changes that correlate with improved attention control in children with attention-deficit/hyperactivity disorder (ADHD).

Investigators found children who used the video game-based therapy (EndeavorRx) experienced increased brain activity related to attention function, as measured by EEG, which correlated with improvements in objective behavioral measures of attention.

Courtesy University of California, San Francisco

“While the previous multicenter trials show attention improvement for children using EndeavorRx, this is the first study to look at the brain activity in children with a primary concern of ADHD,” principal investigator Elysa Marco, MD, clinical executive for neurodevelopmental medicine at Cortica Healthcare, San Rafael, Calif., said in news release.

“It is exciting to see measurable improvement on the EEGs that correlates with the behavioral benefits,” said Dr. Marco.

The study was recently published online in PLOS ONE. 
 

Measurable changes

As previously reported by this news organization, the Food and Drug Administration approved EndeavorRx in June 2020 as a prescription video game–based therapeutic device for children aged 8-12 years with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue.

“The device is intended for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder,” the FDA said upon approval.

In the current unblinded, single-arm study, the researchers assessed 25 children (aged 8-12 years) with a confirmed diagnosis of ADHD on neural, behavioral, and clinical metrics of attention before and after a 4-week at-home intervention.

Participants were instructed to use EndeavorRx for about 25 minutes a day at least 5 days a week for 4 weeks, as recommended by the FDA.

“EndeavorRx enhanced midline frontal theta (MFT) activity, suggesting that patients who used EndeavorRx for 4 weeks showed changes in measurable brain function,” Anil S. Jina, MD, chief medical officer of Akili Interactive, told this news organization. Dr. Jina was not involved with the study.

There was also a correlation between MFT activity and attention functioning, “suggesting that children who experienced the largest gains in MFT activity as measured by EEG also showed the greatest improvements in computerized performance tests designed to measure attention,” Dr. Jina said.

In addition, parents reported significantly fewer inattention symptoms in children after EndeavorRx treatment, as measured by the Vanderbilt ADHD Diagnostic Rating Scale.
 

‘Not just another video game’

EndeavorRx has been evaluated in five clinical studies involving more than 600 children with ADHD, including the STARS-ADHD trial, a prospective, randomized, controlled study published in The Lancet Digital Health.

The STARS-ADHD trial randomly allocated 348 children to either EndeavorRx treatment or a controlled intervention, which was a word game.

The researchers reported statistically significant improvements in attentional functioning in the EndeavorRx group as rated by test of variables of attention.

“This is not just another video game,” STARS-ADHD trialist Scott H. Kollins, PhD, MS, a clinical psychologist at Duke Health’s ADHD Clinic in Durham, N.C., who helped developed it, previously told this news organization.   

The tool’s adaptive algorithms adjust and monitor task difficulty based on performance, using a video game format and rewards to engage users, he explained. EndeavorRx is a challenge to play by design.

“The treatment was programmed into the gameplay experience and designed to challenge a child’s attentional control during gameplay, requiring focus and flexibility to manage tasks at the same time,” Dr. Jina said in an interview.

“Unlike a video game that is designed only for entertainment purposes, to drive efficacy, EndeavorRx is designed to be challenging and can therefore sometimes feel repetitive, and frustrating to some children,” Dr. Jina said.

Commenting on the study, Stephen Faraone, PhD, distinguished professor of psychiatry and vice chair of research, department of psychiatry, State University of New York, Syracuse, said this study “supports the idea that EndeavorRx improves a neural measure of attention.

“The limitation is that we don’t know if this translates into clinically relevant outcomes,” cautioned Dr. Faraone, who was not associated with the current study.

“The main caveat about EndeavorRx is that it was cleared by the FDA for improving a computer-based measure of inattention, not inattentive symptoms as reported by the parents of children with ADHD,” he noted.

Several authors have disclosed financial relationships with Akili Interactive Labs, which funded the study. Dr. Faraone was an investigator on the STARS-ADHD trial.

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

Earlier menopause appears to be associated with a higher risk of dementia, and earlier onset of dementia, compared with menopause at normal age or later, according to a large study.

“Being aware of this increased risk can help women practice strategies to prevent dementia and to work with their physicians to closely monitor their cognitive status as they age,” study investigator Wenting Hao, MD, with Shandong University, Jinan, China, says in a news release.

The findings were presented in an e-poster March 1 at the Epidemiology, Prevention, Lifestyle & Cardiometabolic Health (EPI|Lifestyle) 2022 conference sponsored by the American Heart Association.
 

UK Biobank data

Dr. Hao and colleagues examined health data for 153,291 women who were 60 years old on average when they became participants in the UK Biobank.

Age at menopause was categorized as premature (younger than age 40), early (40 to 44 years), reference (45 to 51), 52 to 55 years, and 55+ years.

Compared with women who entered menopause around age 50 years (reference), women who experienced premature menopause were 35% more likely to develop some type of dementia later in life (hazard ratio, 1.35; 95% confidence interval, 1.22 to 1.91).

Women with early menopause were also more likely to develop early-onset dementia, that is, before age 65 (HR, 1.31; 95% confidence interval, 1.07 to 1.72).

Women who entered menopause later (at age 52+) had dementia risk similar to women who entered menopause at the average age of 50 to 51 years.

The results were adjusted for relevant cofactors, including age at last exam, race, educational level, cigarette and alcohol use, body mass index, cardiovascular disease, diabetes, income, and leisure and physical activities.

Blame it on estrogen?

Reduced estrogen levels may be a factor in the possible connection between early menopause and dementia, Dr. Hao and her colleagues say.

Estradiol plays a key role in a range of neurological functions, so the reduction of endogenous estrogen at menopause may aggravate brain changes related to neurodegenerative disease and speed up progression of dementia, they explain.

“We know that the lack of estrogen over the long term enhances oxidative stress, which may increase brain aging and lead to cognitive impairment,” Dr. Hao adds.

Limitations of the study include reliance on self-reported information about age at menopause onset.

Also, the researchers did not evaluate dementia rates in women who had a naturally occurring early menopause separate from the women with surgery-induced menopause, which may affect the results.

Finally, the data used for this study included mostly White women living in the U.K. and may not generalize to other populations.
 

Supportive evidence, critical area of research

The U.K. study supports results of a previously reported Kaiser Permanente study, which showed women who entered menopause at age 45 or younger were at 28% greater dementia risk, compared with women who experienced menopause after age 45.

Reached for comment, Heather Snyder, PhD, Alzheimer’s Association vice president of medical and scientific relations, noted that nearly two-thirds of Americans with Alzheimer’s are women.

“We know Alzheimer’s and other dementias impact a greater number of women than men, but we don’t know why,” she told this news organization.

“Lifelong differences in women may affect their risk or affect what is contributing to their underlying biology of the disease, and we need more research to better understand what may be these contributing factors,” said Dr. Snyder.

“Reproductive history is one critical area being studied. The physical and hormonal changes that occur during menopause – as well as other hormonal changes throughout life – are considerable, and it’s important to understand what impact, if any, these changes may have on the brain,” Dr. Snyder added.

“The potential link between reproduction history and brain health is intriguing, but much more research in this area is needed to understand these links,” she said.

The study was funded by the Start-up Foundation for Scientific Research at Shandong University. Dr. Hao and Dr. Snyder have disclosed no relevant financial relationships.

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

Earlier menopause appears to be associated with a higher risk of dementia, and earlier onset of dementia, compared with menopause at normal age or later, according to a large study.

“Being aware of this increased risk can help women practice strategies to prevent dementia and to work with their physicians to closely monitor their cognitive status as they age,” study investigator Wenting Hao, MD, with Shandong University, Jinan, China, says in a news release.

The findings were presented in an e-poster March 1 at the Epidemiology, Prevention, Lifestyle & Cardiometabolic Health (EPI|Lifestyle) 2022 conference sponsored by the American Heart Association.
 

UK Biobank data

Dr. Hao and colleagues examined health data for 153,291 women who were 60 years old on average when they became participants in the UK Biobank.

Age at menopause was categorized as premature (younger than age 40), early (40 to 44 years), reference (45 to 51), 52 to 55 years, and 55+ years.

Compared with women who entered menopause around age 50 years (reference), women who experienced premature menopause were 35% more likely to develop some type of dementia later in life (hazard ratio, 1.35; 95% confidence interval, 1.22 to 1.91).

Women with early menopause were also more likely to develop early-onset dementia, that is, before age 65 (HR, 1.31; 95% confidence interval, 1.07 to 1.72).

Women who entered menopause later (at age 52+) had dementia risk similar to women who entered menopause at the average age of 50 to 51 years.

The results were adjusted for relevant cofactors, including age at last exam, race, educational level, cigarette and alcohol use, body mass index, cardiovascular disease, diabetes, income, and leisure and physical activities.

Blame it on estrogen?

Reduced estrogen levels may be a factor in the possible connection between early menopause and dementia, Dr. Hao and her colleagues say.

Estradiol plays a key role in a range of neurological functions, so the reduction of endogenous estrogen at menopause may aggravate brain changes related to neurodegenerative disease and speed up progression of dementia, they explain.

“We know that the lack of estrogen over the long term enhances oxidative stress, which may increase brain aging and lead to cognitive impairment,” Dr. Hao adds.

Limitations of the study include reliance on self-reported information about age at menopause onset.

Also, the researchers did not evaluate dementia rates in women who had a naturally occurring early menopause separate from the women with surgery-induced menopause, which may affect the results.

Finally, the data used for this study included mostly White women living in the U.K. and may not generalize to other populations.
 

Supportive evidence, critical area of research

The U.K. study supports results of a previously reported Kaiser Permanente study, which showed women who entered menopause at age 45 or younger were at 28% greater dementia risk, compared with women who experienced menopause after age 45.

Reached for comment, Heather Snyder, PhD, Alzheimer’s Association vice president of medical and scientific relations, noted that nearly two-thirds of Americans with Alzheimer’s are women.

“We know Alzheimer’s and other dementias impact a greater number of women than men, but we don’t know why,” she told this news organization.

“Lifelong differences in women may affect their risk or affect what is contributing to their underlying biology of the disease, and we need more research to better understand what may be these contributing factors,” said Dr. Snyder.

“Reproductive history is one critical area being studied. The physical and hormonal changes that occur during menopause – as well as other hormonal changes throughout life – are considerable, and it’s important to understand what impact, if any, these changes may have on the brain,” Dr. Snyder added.

“The potential link between reproduction history and brain health is intriguing, but much more research in this area is needed to understand these links,” she said.

The study was funded by the Start-up Foundation for Scientific Research at Shandong University. Dr. Hao and Dr. Snyder have disclosed no relevant financial relationships.

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

Earlier menopause appears to be associated with a higher risk of dementia, and earlier onset of dementia, compared with menopause at normal age or later, according to a large study.

“Being aware of this increased risk can help women practice strategies to prevent dementia and to work with their physicians to closely monitor their cognitive status as they age,” study investigator Wenting Hao, MD, with Shandong University, Jinan, China, says in a news release.

The findings were presented in an e-poster March 1 at the Epidemiology, Prevention, Lifestyle & Cardiometabolic Health (EPI|Lifestyle) 2022 conference sponsored by the American Heart Association.
 

UK Biobank data

Dr. Hao and colleagues examined health data for 153,291 women who were 60 years old on average when they became participants in the UK Biobank.

Age at menopause was categorized as premature (younger than age 40), early (40 to 44 years), reference (45 to 51), 52 to 55 years, and 55+ years.

Compared with women who entered menopause around age 50 years (reference), women who experienced premature menopause were 35% more likely to develop some type of dementia later in life (hazard ratio, 1.35; 95% confidence interval, 1.22 to 1.91).

Women with early menopause were also more likely to develop early-onset dementia, that is, before age 65 (HR, 1.31; 95% confidence interval, 1.07 to 1.72).

Women who entered menopause later (at age 52+) had dementia risk similar to women who entered menopause at the average age of 50 to 51 years.

The results were adjusted for relevant cofactors, including age at last exam, race, educational level, cigarette and alcohol use, body mass index, cardiovascular disease, diabetes, income, and leisure and physical activities.

Blame it on estrogen?

Reduced estrogen levels may be a factor in the possible connection between early menopause and dementia, Dr. Hao and her colleagues say.

Estradiol plays a key role in a range of neurological functions, so the reduction of endogenous estrogen at menopause may aggravate brain changes related to neurodegenerative disease and speed up progression of dementia, they explain.

“We know that the lack of estrogen over the long term enhances oxidative stress, which may increase brain aging and lead to cognitive impairment,” Dr. Hao adds.

Limitations of the study include reliance on self-reported information about age at menopause onset.

Also, the researchers did not evaluate dementia rates in women who had a naturally occurring early menopause separate from the women with surgery-induced menopause, which may affect the results.

Finally, the data used for this study included mostly White women living in the U.K. and may not generalize to other populations.
 

Supportive evidence, critical area of research

The U.K. study supports results of a previously reported Kaiser Permanente study, which showed women who entered menopause at age 45 or younger were at 28% greater dementia risk, compared with women who experienced menopause after age 45.

Reached for comment, Heather Snyder, PhD, Alzheimer’s Association vice president of medical and scientific relations, noted that nearly two-thirds of Americans with Alzheimer’s are women.

“We know Alzheimer’s and other dementias impact a greater number of women than men, but we don’t know why,” she told this news organization.

“Lifelong differences in women may affect their risk or affect what is contributing to their underlying biology of the disease, and we need more research to better understand what may be these contributing factors,” said Dr. Snyder.

“Reproductive history is one critical area being studied. The physical and hormonal changes that occur during menopause – as well as other hormonal changes throughout life – are considerable, and it’s important to understand what impact, if any, these changes may have on the brain,” Dr. Snyder added.

“The potential link between reproduction history and brain health is intriguing, but much more research in this area is needed to understand these links,” she said.

The study was funded by the Start-up Foundation for Scientific Research at Shandong University. Dr. Hao and Dr. Snyder have disclosed no relevant financial relationships.

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