ORLANDO – When he was applying for residency, Omar N. Qutub, MD, eagerly arrived at his first interview of the day. But he was quickly thrown off his game.

The interviewer, he said, spent a surprising amount of time asking about his ethnicity and his last name. “I think I spent about 3-5 minutes in the first interview talking about my last name,” said Dr. Qutub, who practices in Portland, Ore., during a session titled “unconscious bias and microaggressions in dermatology” at the ODAC Dermatology, Aesthetic and Surgical Conference. “I really would have rather talked about my research interests.” The interaction threw him off for the rest of the interview process, he said.

The experience is an example of how the field has a ways to go in acquiring cultural competence and in overcoming unconscious biases, said Dr. Qutub. In 2020, a review in Clinics in Dermatology referred to a report that dermatology was the second-least diverse medical specialty, only behind orthopedic surgery, because of its low numbers of residents and faculty from groups underrepresented in medicine.

“We really need to put cultural competency at the forefront in order to do better for our patients,” he said.

Adam Friedman, MD, professor and chair of dermatology and director of the residency program at George Washington University, Washington, who also spoke during the session, said that the process of diversifying the field has to go deeper than the resident interviewing process. “If we just focus on trying to increase the diversity of our applicant pool for residents, it’s too late.”

Nada Elbuluk, MD, associate professor of dermatology at the University of Southern California, Los Angeles, pointed to USC’s Derm RISES initiative, a service program that aims to reach inner-city students through education in the sciences, starting from kindergarten to 12th grade. The program also includes premed undergraduate and medical students, “with the goal of increasing exposure to the sciences, medicine, and dermatology,” according to the USC website. “It’s crucial to begin the process early to get a high yield of students who reach medical school and eventually dermatology, she said, because of the inevitable attrition at each level of the education process.

“It’s incredibly rewarding,” added Dr. Elbuluk, who is also director of the dermatology diversity and inclusion program at USC. “And we get these thank-you letters back from students who [say], ‘I didn’t know I could be a doctor.’ ”

In another presentation, Kavita Mariwalla, MD, who practices in West Islip, N.Y., provided tips on boosting cultural competence during aesthetic consults.

One was to “know your fillers,” she said, noting that fillers have different effects on different skin tones, because of differences in fibroblast content, and fat cells will interact with fillers in different ways across skin tones.

Another is to “understand the shortfall of facial canons,” the idea that you can divide a face into sections that can be viewed and enhanced discretely. This concept was based on a White European model and has to be expanded when considering other ethnicities, Dr. Mariwalla said.

Overgeneralizing categories is another pitfall, she said. “Asian” is a term that covers countries from India to Japan, but within that category are a multitude of notions and nuances about aesthetics, and dermatologists have to be sensitive to all of them.

When meeting with a patient, Dr. Mariwalla said, asking the typical “Where are you from?” is not a helpful question. Instead, she suggested asking: “What is your cultural background? Can you tell me more about what your expectations are?”

“I ask for pictures,” she said. “I want to know what they looked like as a kid. I want to know what their family looks like. And I always hand patients a mirror. Patients will say to me: ‘I want to do what you think.’ It’s not about what I think, because what I see, and what you see in your magnifying mirror, are totally different things.”

After the session ended, a member of the audience, Sharon Stokes, MD, a dermatologist in the Orlando area, provided her view of the presentations, noting that it was an important discussion.

“I think it’s past time in medicine for cultural diversity training and awareness for physicians to understand their patients better and getting to know them – and how to even approach the patient and not to offensively and microaggressively approach the patient,” she said.

Dr. Elbuluk reported relevant relationships with Avita, Incyte, Beiersdorf, and other companies. Dr. Friedman reported financial relationships with Sanova, Pfizer, Novartis and other companies. Dr. Mariwalla reported relevant financial relationships with Abbvie, Sanofi, Regeneron and other companies. Dr. Qutub reported no relevant financial relationships. Dr. Qutub is the ODAC director of equity, diversity, and inclusion.

ORLANDO – When he was applying for residency, Omar N. Qutub, MD, eagerly arrived at his first interview of the day. But he was quickly thrown off his game.

The interviewer, he said, spent a surprising amount of time asking about his ethnicity and his last name. “I think I spent about 3-5 minutes in the first interview talking about my last name,” said Dr. Qutub, who practices in Portland, Ore., during a session titled “unconscious bias and microaggressions in dermatology” at the ODAC Dermatology, Aesthetic and Surgical Conference. “I really would have rather talked about my research interests.” The interaction threw him off for the rest of the interview process, he said.

The experience is an example of how the field has a ways to go in acquiring cultural competence and in overcoming unconscious biases, said Dr. Qutub. In 2020, a review in Clinics in Dermatology referred to a report that dermatology was the second-least diverse medical specialty, only behind orthopedic surgery, because of its low numbers of residents and faculty from groups underrepresented in medicine.

“We really need to put cultural competency at the forefront in order to do better for our patients,” he said.

Adam Friedman, MD, professor and chair of dermatology and director of the residency program at George Washington University, Washington, who also spoke during the session, said that the process of diversifying the field has to go deeper than the resident interviewing process. “If we just focus on trying to increase the diversity of our applicant pool for residents, it’s too late.”

Nada Elbuluk, MD, associate professor of dermatology at the University of Southern California, Los Angeles, pointed to USC’s Derm RISES initiative, a service program that aims to reach inner-city students through education in the sciences, starting from kindergarten to 12th grade. The program also includes premed undergraduate and medical students, “with the goal of increasing exposure to the sciences, medicine, and dermatology,” according to the USC website. “It’s crucial to begin the process early to get a high yield of students who reach medical school and eventually dermatology, she said, because of the inevitable attrition at each level of the education process.

“It’s incredibly rewarding,” added Dr. Elbuluk, who is also director of the dermatology diversity and inclusion program at USC. “And we get these thank-you letters back from students who [say], ‘I didn’t know I could be a doctor.’ ”

In another presentation, Kavita Mariwalla, MD, who practices in West Islip, N.Y., provided tips on boosting cultural competence during aesthetic consults.

One was to “know your fillers,” she said, noting that fillers have different effects on different skin tones, because of differences in fibroblast content, and fat cells will interact with fillers in different ways across skin tones.

Another is to “understand the shortfall of facial canons,” the idea that you can divide a face into sections that can be viewed and enhanced discretely. This concept was based on a White European model and has to be expanded when considering other ethnicities, Dr. Mariwalla said.

Overgeneralizing categories is another pitfall, she said. “Asian” is a term that covers countries from India to Japan, but within that category are a multitude of notions and nuances about aesthetics, and dermatologists have to be sensitive to all of them.

When meeting with a patient, Dr. Mariwalla said, asking the typical “Where are you from?” is not a helpful question. Instead, she suggested asking: “What is your cultural background? Can you tell me more about what your expectations are?”

“I ask for pictures,” she said. “I want to know what they looked like as a kid. I want to know what their family looks like. And I always hand patients a mirror. Patients will say to me: ‘I want to do what you think.’ It’s not about what I think, because what I see, and what you see in your magnifying mirror, are totally different things.”

After the session ended, a member of the audience, Sharon Stokes, MD, a dermatologist in the Orlando area, provided her view of the presentations, noting that it was an important discussion.

“I think it’s past time in medicine for cultural diversity training and awareness for physicians to understand their patients better and getting to know them – and how to even approach the patient and not to offensively and microaggressively approach the patient,” she said.

Dr. Elbuluk reported relevant relationships with Avita, Incyte, Beiersdorf, and other companies. Dr. Friedman reported financial relationships with Sanova, Pfizer, Novartis and other companies. Dr. Mariwalla reported relevant financial relationships with Abbvie, Sanofi, Regeneron and other companies. Dr. Qutub reported no relevant financial relationships. Dr. Qutub is the ODAC director of equity, diversity, and inclusion.

ORLANDO – When he was applying for residency, Omar N. Qutub, MD, eagerly arrived at his first interview of the day. But he was quickly thrown off his game.

The interviewer, he said, spent a surprising amount of time asking about his ethnicity and his last name. “I think I spent about 3-5 minutes in the first interview talking about my last name,” said Dr. Qutub, who practices in Portland, Ore., during a session titled “unconscious bias and microaggressions in dermatology” at the ODAC Dermatology, Aesthetic and Surgical Conference. “I really would have rather talked about my research interests.” The interaction threw him off for the rest of the interview process, he said.

The experience is an example of how the field has a ways to go in acquiring cultural competence and in overcoming unconscious biases, said Dr. Qutub. In 2020, a review in Clinics in Dermatology referred to a report that dermatology was the second-least diverse medical specialty, only behind orthopedic surgery, because of its low numbers of residents and faculty from groups underrepresented in medicine.

“We really need to put cultural competency at the forefront in order to do better for our patients,” he said.

Adam Friedman, MD, professor and chair of dermatology and director of the residency program at George Washington University, Washington, who also spoke during the session, said that the process of diversifying the field has to go deeper than the resident interviewing process. “If we just focus on trying to increase the diversity of our applicant pool for residents, it’s too late.”

Nada Elbuluk, MD, associate professor of dermatology at the University of Southern California, Los Angeles, pointed to USC’s Derm RISES initiative, a service program that aims to reach inner-city students through education in the sciences, starting from kindergarten to 12th grade. The program also includes premed undergraduate and medical students, “with the goal of increasing exposure to the sciences, medicine, and dermatology,” according to the USC website. “It’s crucial to begin the process early to get a high yield of students who reach medical school and eventually dermatology, she said, because of the inevitable attrition at each level of the education process.

“It’s incredibly rewarding,” added Dr. Elbuluk, who is also director of the dermatology diversity and inclusion program at USC. “And we get these thank-you letters back from students who [say], ‘I didn’t know I could be a doctor.’ ”

In another presentation, Kavita Mariwalla, MD, who practices in West Islip, N.Y., provided tips on boosting cultural competence during aesthetic consults.

One was to “know your fillers,” she said, noting that fillers have different effects on different skin tones, because of differences in fibroblast content, and fat cells will interact with fillers in different ways across skin tones.

Another is to “understand the shortfall of facial canons,” the idea that you can divide a face into sections that can be viewed and enhanced discretely. This concept was based on a White European model and has to be expanded when considering other ethnicities, Dr. Mariwalla said.

Overgeneralizing categories is another pitfall, she said. “Asian” is a term that covers countries from India to Japan, but within that category are a multitude of notions and nuances about aesthetics, and dermatologists have to be sensitive to all of them.

When meeting with a patient, Dr. Mariwalla said, asking the typical “Where are you from?” is not a helpful question. Instead, she suggested asking: “What is your cultural background? Can you tell me more about what your expectations are?”

“I ask for pictures,” she said. “I want to know what they looked like as a kid. I want to know what their family looks like. And I always hand patients a mirror. Patients will say to me: ‘I want to do what you think.’ It’s not about what I think, because what I see, and what you see in your magnifying mirror, are totally different things.”

After the session ended, a member of the audience, Sharon Stokes, MD, a dermatologist in the Orlando area, provided her view of the presentations, noting that it was an important discussion.

“I think it’s past time in medicine for cultural diversity training and awareness for physicians to understand their patients better and getting to know them – and how to even approach the patient and not to offensively and microaggressively approach the patient,” she said.

Dr. Elbuluk reported relevant relationships with Avita, Incyte, Beiersdorf, and other companies. Dr. Friedman reported financial relationships with Sanova, Pfizer, Novartis and other companies. Dr. Mariwalla reported relevant financial relationships with Abbvie, Sanofi, Regeneron and other companies. Dr. Qutub reported no relevant financial relationships. Dr. Qutub is the ODAC director of equity, diversity, and inclusion.

In a head-to-head comparison, two commercially available computer-aided diagnosis systems appeared clinically equivalent for the optical diagnosis of small colorectal polyps, according to a research letter published in Gastroenterology.

For the optical diagnosis of diminutive colorectal polyps, the comparable performances of both CAD EYE (Fujifilm Co.) and GI Genius (Medtronic) met cutoff guidelines to implement the cost-saving leave-in-situ and resect-and-discard strategies, wrote Cesare Hassan, MD, PhD, associate professor of gastroenterology at Humanitas University and member of the endoscopy unit at Humanitas Clinical Research Hospital in Milan, and colleagues.

“Screening colonoscopy is effective in reducing colorectal cancer risk but also represents a substantial financial burden,” the authors wrote. “Novel strategies based on artificial intelligence may enable targeted removal only of polyps deemed to be neoplastic, thus reducing patient burden for unnecessary removal of nonneoplastic polyps and reducing costs for histopathology.”

Several computer-aided diagnosis (CADx) systems are commercially available for optical diagnosis of colorectal polyps, the authors wrote. However, each artificial intelligence (AI) system has been trained and validated with different polyp datasets, which may contribute to variability and affect the clinical outcome of optical diagnosis-based strategies.

Dr. Hassan and colleagues conducted a prospective comparison trial at a single center to look at the real-life performances of two CADx systems on optical diagnosis of polyps smaller than 5 mm.

At colonoscopy, the same polyp was visualized by the same endoscopist on two different monitors simultaneously with the respective output from each of the two CADx systems. Pre- and post-CADx human diagnoses were also collected.

Between January 2022 and March 2022, 176 consecutive patients age 40 and older underwent colonoscopy for colorectal cancer screening, polypectomy surveillance, or gastrointestinal symptoms. About 60.8% of participants were men, and the average age was 60.

Among 543 polyps detected and removed, 169 (31.3%) were adenomas, and 373 (68.7%) were nonadenomas. Of those, 325 (59.9%) were rectosigmoid polyps of 5 mm or less in diameter and eligible for analyses in the study. This included 44 adenomas (13.5%) and 281 nonadenomas (86.5%).

The two CADx systems were grouped as CADx-A for CAD EYE and CADx-B for GI Genius. CADx-A provided prediction output for all 325 rectosigmoid polyps of 5 mm or less, whereas CADx-B wasn’t able to provide output for six of the nonadenomas, which were excluded from the analysis.

The negative predictive value (NPV) for rectosigmoid polyps of 5 mm or less was 97% for CADx-A and 97.7% for CADx-B, the authors wrote. The American Society for Gastrointestinal Endoscopy recommends a threshold for optical diagnosis of at least 90%.

In addition, the sensitivity for adenomas was 81.8% for CADx-A and 86.4% for CADx-B. The accuracy of CADx-A was slightly higher, at 93.2%, as compared with 91.5% for CADx-B.

Based on AI prediction alone, 269 of 319 polyps (84.3%) with CADx-A and 260 of 319 polyps (81.5%) with CADx-B would have been classified as nonneoplastic and avoided removal. This corresponded to a specificity of 94.9% for CADx-A and 92.4% for CADx-B, which wasn’t significantly different, the authors wrote. Concordance in histology prediction between the two systems was 94.7%.

Based on the 2020 U.S. Multi-Society Task Force on Colorectal Cancer (USMSTF) guidelines, the agreement with histopathology in surveillance interval assignment was 84.7% for CADx-A and 89.2% for CADx-B. Based on the 2020 European Society of Gastrointestinal Endoscopy (ESGE) guidelines, the agreement was 98.3% for both systems.

For rectosigmoid polyps of 5 mm or less, the NPV of unassisted optical diagnosis was 97.8% for a high-confidence diagnosis, but it wasn’t significantly different from the NPV of CADx-A (96.9%) or CADx-B (97.6%). The NPV of a CADx-assisted optical diagnosis at high confidence was 97.7%, without statistically significant differences as compared with unassisted interpretation.

Based on the 2020 USMSTF and ESGE guidelines, the agreement between unassisted interpretation and histopathology in surveillance interval assignment was 92.6% and 98.9%, respectively. There was total agreement between unassisted interpretation and CADx-assisted interpretation in surveillance interval assignment based on both guidelines.

As in previous findings, unassisted endoscopic diagnosis was on par with CADx-assisted, both in technical accuracy and clinical outcomes. The study authors attributed the lack of additional benefit from CADx to a high performance of unassisted-endoscopist diagnosis, with the 97.8% NPV for rectosigmoid polyps and 90% or greater concordance in postpolypectomy surveillance intervals with histology. In addition, a human endoscopist was the only one to achieve 90% or greater agreement in postpolypectomy surveillance intervals under the U.S. guidelines, mainly due to a very high specificity.

“This confirms the complexity of the human-machine interaction that should not be marginalized in the stand-alone performance of the machine,” the authors wrote.

However, the high accuracy of unassisted endoscopists in the academic center in Italy is unlikely to mirror the real performance in community settings, they added. Future studies should focus on nontertiary centers to show the additional benefit, if any, that CADx provides for leave-in-situ colorectal polyps.

“A high degree of concordance in clinical outcomes was shown when directly comparing in vivo two different systems of CADx,” the authors concluded. “This reassured our confidence in the standardization of performance that may be achieved with the incorporation of AI in clinical practice, irrespective of the availability of multiple systems.”

The study authors declared no funding source for this study. Several authors reported consulting relationships with numerous companies, including Fuji and Medtronic, which make the CAD EYE and GI Genius systems, respectively.

In a head-to-head comparison, two commercially available computer-aided diagnosis systems appeared clinically equivalent for the optical diagnosis of small colorectal polyps, according to a research letter published in Gastroenterology.

For the optical diagnosis of diminutive colorectal polyps, the comparable performances of both CAD EYE (Fujifilm Co.) and GI Genius (Medtronic) met cutoff guidelines to implement the cost-saving leave-in-situ and resect-and-discard strategies, wrote Cesare Hassan, MD, PhD, associate professor of gastroenterology at Humanitas University and member of the endoscopy unit at Humanitas Clinical Research Hospital in Milan, and colleagues.

“Screening colonoscopy is effective in reducing colorectal cancer risk but also represents a substantial financial burden,” the authors wrote. “Novel strategies based on artificial intelligence may enable targeted removal only of polyps deemed to be neoplastic, thus reducing patient burden for unnecessary removal of nonneoplastic polyps and reducing costs for histopathology.”

Several computer-aided diagnosis (CADx) systems are commercially available for optical diagnosis of colorectal polyps, the authors wrote. However, each artificial intelligence (AI) system has been trained and validated with different polyp datasets, which may contribute to variability and affect the clinical outcome of optical diagnosis-based strategies.

Dr. Hassan and colleagues conducted a prospective comparison trial at a single center to look at the real-life performances of two CADx systems on optical diagnosis of polyps smaller than 5 mm.

At colonoscopy, the same polyp was visualized by the same endoscopist on two different monitors simultaneously with the respective output from each of the two CADx systems. Pre- and post-CADx human diagnoses were also collected.

Between January 2022 and March 2022, 176 consecutive patients age 40 and older underwent colonoscopy for colorectal cancer screening, polypectomy surveillance, or gastrointestinal symptoms. About 60.8% of participants were men, and the average age was 60.

Among 543 polyps detected and removed, 169 (31.3%) were adenomas, and 373 (68.7%) were nonadenomas. Of those, 325 (59.9%) were rectosigmoid polyps of 5 mm or less in diameter and eligible for analyses in the study. This included 44 adenomas (13.5%) and 281 nonadenomas (86.5%).

The two CADx systems were grouped as CADx-A for CAD EYE and CADx-B for GI Genius. CADx-A provided prediction output for all 325 rectosigmoid polyps of 5 mm or less, whereas CADx-B wasn’t able to provide output for six of the nonadenomas, which were excluded from the analysis.

The negative predictive value (NPV) for rectosigmoid polyps of 5 mm or less was 97% for CADx-A and 97.7% for CADx-B, the authors wrote. The American Society for Gastrointestinal Endoscopy recommends a threshold for optical diagnosis of at least 90%.

In addition, the sensitivity for adenomas was 81.8% for CADx-A and 86.4% for CADx-B. The accuracy of CADx-A was slightly higher, at 93.2%, as compared with 91.5% for CADx-B.

Based on AI prediction alone, 269 of 319 polyps (84.3%) with CADx-A and 260 of 319 polyps (81.5%) with CADx-B would have been classified as nonneoplastic and avoided removal. This corresponded to a specificity of 94.9% for CADx-A and 92.4% for CADx-B, which wasn’t significantly different, the authors wrote. Concordance in histology prediction between the two systems was 94.7%.

Based on the 2020 U.S. Multi-Society Task Force on Colorectal Cancer (USMSTF) guidelines, the agreement with histopathology in surveillance interval assignment was 84.7% for CADx-A and 89.2% for CADx-B. Based on the 2020 European Society of Gastrointestinal Endoscopy (ESGE) guidelines, the agreement was 98.3% for both systems.

For rectosigmoid polyps of 5 mm or less, the NPV of unassisted optical diagnosis was 97.8% for a high-confidence diagnosis, but it wasn’t significantly different from the NPV of CADx-A (96.9%) or CADx-B (97.6%). The NPV of a CADx-assisted optical diagnosis at high confidence was 97.7%, without statistically significant differences as compared with unassisted interpretation.

Based on the 2020 USMSTF and ESGE guidelines, the agreement between unassisted interpretation and histopathology in surveillance interval assignment was 92.6% and 98.9%, respectively. There was total agreement between unassisted interpretation and CADx-assisted interpretation in surveillance interval assignment based on both guidelines.

As in previous findings, unassisted endoscopic diagnosis was on par with CADx-assisted, both in technical accuracy and clinical outcomes. The study authors attributed the lack of additional benefit from CADx to a high performance of unassisted-endoscopist diagnosis, with the 97.8% NPV for rectosigmoid polyps and 90% or greater concordance in postpolypectomy surveillance intervals with histology. In addition, a human endoscopist was the only one to achieve 90% or greater agreement in postpolypectomy surveillance intervals under the U.S. guidelines, mainly due to a very high specificity.

“This confirms the complexity of the human-machine interaction that should not be marginalized in the stand-alone performance of the machine,” the authors wrote.

However, the high accuracy of unassisted endoscopists in the academic center in Italy is unlikely to mirror the real performance in community settings, they added. Future studies should focus on nontertiary centers to show the additional benefit, if any, that CADx provides for leave-in-situ colorectal polyps.

“A high degree of concordance in clinical outcomes was shown when directly comparing in vivo two different systems of CADx,” the authors concluded. “This reassured our confidence in the standardization of performance that may be achieved with the incorporation of AI in clinical practice, irrespective of the availability of multiple systems.”

The study authors declared no funding source for this study. Several authors reported consulting relationships with numerous companies, including Fuji and Medtronic, which make the CAD EYE and GI Genius systems, respectively.

In a head-to-head comparison, two commercially available computer-aided diagnosis systems appeared clinically equivalent for the optical diagnosis of small colorectal polyps, according to a research letter published in Gastroenterology.

For the optical diagnosis of diminutive colorectal polyps, the comparable performances of both CAD EYE (Fujifilm Co.) and GI Genius (Medtronic) met cutoff guidelines to implement the cost-saving leave-in-situ and resect-and-discard strategies, wrote Cesare Hassan, MD, PhD, associate professor of gastroenterology at Humanitas University and member of the endoscopy unit at Humanitas Clinical Research Hospital in Milan, and colleagues.

“Screening colonoscopy is effective in reducing colorectal cancer risk but also represents a substantial financial burden,” the authors wrote. “Novel strategies based on artificial intelligence may enable targeted removal only of polyps deemed to be neoplastic, thus reducing patient burden for unnecessary removal of nonneoplastic polyps and reducing costs for histopathology.”

Several computer-aided diagnosis (CADx) systems are commercially available for optical diagnosis of colorectal polyps, the authors wrote. However, each artificial intelligence (AI) system has been trained and validated with different polyp datasets, which may contribute to variability and affect the clinical outcome of optical diagnosis-based strategies.

Dr. Hassan and colleagues conducted a prospective comparison trial at a single center to look at the real-life performances of two CADx systems on optical diagnosis of polyps smaller than 5 mm.

At colonoscopy, the same polyp was visualized by the same endoscopist on two different monitors simultaneously with the respective output from each of the two CADx systems. Pre- and post-CADx human diagnoses were also collected.

Between January 2022 and March 2022, 176 consecutive patients age 40 and older underwent colonoscopy for colorectal cancer screening, polypectomy surveillance, or gastrointestinal symptoms. About 60.8% of participants were men, and the average age was 60.

Among 543 polyps detected and removed, 169 (31.3%) were adenomas, and 373 (68.7%) were nonadenomas. Of those, 325 (59.9%) were rectosigmoid polyps of 5 mm or less in diameter and eligible for analyses in the study. This included 44 adenomas (13.5%) and 281 nonadenomas (86.5%).

The two CADx systems were grouped as CADx-A for CAD EYE and CADx-B for GI Genius. CADx-A provided prediction output for all 325 rectosigmoid polyps of 5 mm or less, whereas CADx-B wasn’t able to provide output for six of the nonadenomas, which were excluded from the analysis.

The negative predictive value (NPV) for rectosigmoid polyps of 5 mm or less was 97% for CADx-A and 97.7% for CADx-B, the authors wrote. The American Society for Gastrointestinal Endoscopy recommends a threshold for optical diagnosis of at least 90%.

In addition, the sensitivity for adenomas was 81.8% for CADx-A and 86.4% for CADx-B. The accuracy of CADx-A was slightly higher, at 93.2%, as compared with 91.5% for CADx-B.

Based on AI prediction alone, 269 of 319 polyps (84.3%) with CADx-A and 260 of 319 polyps (81.5%) with CADx-B would have been classified as nonneoplastic and avoided removal. This corresponded to a specificity of 94.9% for CADx-A and 92.4% for CADx-B, which wasn’t significantly different, the authors wrote. Concordance in histology prediction between the two systems was 94.7%.

Based on the 2020 U.S. Multi-Society Task Force on Colorectal Cancer (USMSTF) guidelines, the agreement with histopathology in surveillance interval assignment was 84.7% for CADx-A and 89.2% for CADx-B. Based on the 2020 European Society of Gastrointestinal Endoscopy (ESGE) guidelines, the agreement was 98.3% for both systems.

For rectosigmoid polyps of 5 mm or less, the NPV of unassisted optical diagnosis was 97.8% for a high-confidence diagnosis, but it wasn’t significantly different from the NPV of CADx-A (96.9%) or CADx-B (97.6%). The NPV of a CADx-assisted optical diagnosis at high confidence was 97.7%, without statistically significant differences as compared with unassisted interpretation.

Based on the 2020 USMSTF and ESGE guidelines, the agreement between unassisted interpretation and histopathology in surveillance interval assignment was 92.6% and 98.9%, respectively. There was total agreement between unassisted interpretation and CADx-assisted interpretation in surveillance interval assignment based on both guidelines.

As in previous findings, unassisted endoscopic diagnosis was on par with CADx-assisted, both in technical accuracy and clinical outcomes. The study authors attributed the lack of additional benefit from CADx to a high performance of unassisted-endoscopist diagnosis, with the 97.8% NPV for rectosigmoid polyps and 90% or greater concordance in postpolypectomy surveillance intervals with histology. In addition, a human endoscopist was the only one to achieve 90% or greater agreement in postpolypectomy surveillance intervals under the U.S. guidelines, mainly due to a very high specificity.

“This confirms the complexity of the human-machine interaction that should not be marginalized in the stand-alone performance of the machine,” the authors wrote.

However, the high accuracy of unassisted endoscopists in the academic center in Italy is unlikely to mirror the real performance in community settings, they added. Future studies should focus on nontertiary centers to show the additional benefit, if any, that CADx provides for leave-in-situ colorectal polyps.

“A high degree of concordance in clinical outcomes was shown when directly comparing in vivo two different systems of CADx,” the authors concluded. “This reassured our confidence in the standardization of performance that may be achieved with the incorporation of AI in clinical practice, irrespective of the availability of multiple systems.”

The study authors declared no funding source for this study. Several authors reported consulting relationships with numerous companies, including Fuji and Medtronic, which make the CAD EYE and GI Genius systems, respectively.

Sustaining even a single head injury has been linked to a significantly increased risk of all-cause mortality in new research.

An analysis of more than 13,000 adult participants in the Atherosclerosis Risk in Communities (ARIC) study showed a dose-response pattern in which one head injury was linked to a 66% increased risk for all-cause mortality, and two or more head injuries were associated with twice the risk in comparison with no head injuries.

These findings underscore the importance of preventing head injuries and of swift clinical intervention once a head injury occurs, lead author Holly Elser, MD, PhD, department of neurology, Hospital of the University of Pennsylvania, Philadelphia, told this news organization.

“Clinicians should counsel patients who are at risk for falls about head injuries and ensure patients are promptly evaluated in the hospital setting if they do have a fall – especially with loss of consciousness or other symptoms, such as headache or dizziness,” Dr. Elser added.

The findings were published online in JAMA Neurology.
 

Consistent evidence

There is “pretty consistent evidence” that mortality rates are increased in the short term after head injury, predominantly among hospitalized patients, Dr. Elser noted.

“But there’s less evidence about the long-term mortality implications of head injuries and less evidence from adults living in the community,” she added.

The analysis included 13,037 participants in the ARIC study, an ongoing study involving adults aged 45-65 years who were recruited from four geographically and racially diverse U.S. communities. The mean age at baseline (1987-1989) was 54 years; 57.7% were women; and 27.9% were Black.

Study participants are followed at routine in-person visits and semiannually via telephone.

Data on head injuries came from hospital diagnostic codes and self-reports. These reports included information on the number of injuries and whether the injury required medical care and involved loss of consciousness.

During the 27-year follow-up, 18.4% of the study sample had at least one head injury. Injuries occurred more frequently among women, which may reflect the predominance of women in the study population, said Dr. Elser.

Overall, about 56% of participants died during the study period. The estimated median amount of survival time after head injury was 4.7 years.

The most common causes of death were neoplasm, cardiovascular disease, and neurologic disorders. Regarding specific neurologic causes of death, the researchers found that 62.2% of deaths were due to neurodegenerative disease among individuals with head injury, vs. 51.4% among those without head injury.

This, said Dr. Elser, raises the possibility of reverse causality. “If you have a neurodegenerative disorder like Alzheimer’s disease dementia or Parkinson’s disease that leads to difficulty walking, you may be more likely to fall and have a head injury. The head injury in turn may lead to increased mortality,” she noted.

However, she stressed that the data on cause-specific mortality are exploratory. “Our research motivates future studies that really examine this time-dependent relationship between neurodegenerative disease and head injuries,” Dr. Elser said.
 

Dose-dependent response

In the unadjusted analysis, the hazard ratio of mortality among individuals with head injury was 2.21 (95% confidence interval, 2.09-2.34) compared with those who did not have head injury.

The association remained significant with adjustment for sociodemographic factors (HR, 1.99; 95% CI, 1.88-2.11) and with additional adjustment for vascular risk factors (HR, 1.92; 95% CI, 1.81-2.03).

The findings also showed a dose-response pattern in the association of head injuries with mortality. Compared with participants who did not have head injury, the HR was 1.66 (95% CI, 1.56-1.77) for those with one head injury and 2.11 (95% CI, 1.89-2.37) for those with two or more head injuries.

“It’s not as though once you’ve had one head injury, you’ve accrued all the damage you possibly can. We see pretty clearly here that recurrent head injury further increased the rate of deaths from all causes,” said Dr. Elser.

Injury severity was determined from hospital diagnostic codes using established algorithms. Results showed that mortality rates were increased with even mild head injury.

Interestingly, the association between head injury and all-cause mortality was weaker among those whose injuries were self-reported. One possibility is that these injuries were less severe, Dr. Elser noted.

“If you have head injury that’s mild enough that you don’t need to go to the hospital, it’s probably going to confer less long-term health risks than one that’s severe enough that you needed to be examined in an acute care setting,” she said.

Results were similar by race and for sex. “Even though there were more women with head injuries, the rate of mortality associated with head injury doesn’t differ from the rate among men,” Dr. Elser reported.

However, the association was stronger among those younger than 54 years at baseline (HR, 2.26) compared with older individuals (HR, 2.0) in the model that adjusted for demographics and lifestyle factors.

This may be explained by the reference group (those without a head injury) – the mortality rate was in general higher for the older participants, said Dr. Elser. It could also be that younger adults are more likely to have severe head injuries from, for example, motor vehicle accidents or violence, she added.

These new findings underscore the importance of public health measures, such as seatbelt laws, to reduce head injuries, the investigators note.

They add that clinicians with patients at risk for head injuries may recommend steps to lessen the risk of falls, such as having access to durable medical equipment, and ensuring driver safety.
 

Shorter life span

Commenting for this news organization, Frank Conidi, MD, director of the Florida Center for Headache and Sports Neurology in Port St. Lucie and past president of the Florida Society of Neurology, said the large number of participants “adds validity” to the finding that individuals with head injury are likely to have a shorter life span than those who do not suffer head trauma – and that this “was not purely by chance or from other causes.”

However, patients may not have accurately reported head injuries, in which case the rate of injury in the self-report subgroup would not reflect the actual incidence, noted Dr. Conidi, who was not involved with the research.

“In my practice, most patients have little knowledge as to the signs and symptoms of concussion and traumatic brain injury. Most think there needs to be some form of loss of consciousness to have a head injury, which is of course not true,” he said.

Dr. Conidi added that the finding of a higher incidence of death from neurodegenerative disorders supports the generally accepted consensus view that about 30% of patients with traumatic brain injury experience progression of symptoms and are at risk for early dementia.

The ARIC study is supported by the National Heart, Lung, and Blood Institute. Dr. Elser and Dr. Conidi have reported no relevant financial relationships.

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

Sustaining even a single head injury has been linked to a significantly increased risk of all-cause mortality in new research.

An analysis of more than 13,000 adult participants in the Atherosclerosis Risk in Communities (ARIC) study showed a dose-response pattern in which one head injury was linked to a 66% increased risk for all-cause mortality, and two or more head injuries were associated with twice the risk in comparison with no head injuries.

These findings underscore the importance of preventing head injuries and of swift clinical intervention once a head injury occurs, lead author Holly Elser, MD, PhD, department of neurology, Hospital of the University of Pennsylvania, Philadelphia, told this news organization.

“Clinicians should counsel patients who are at risk for falls about head injuries and ensure patients are promptly evaluated in the hospital setting if they do have a fall – especially with loss of consciousness or other symptoms, such as headache or dizziness,” Dr. Elser added.

The findings were published online in JAMA Neurology.
 

Consistent evidence

There is “pretty consistent evidence” that mortality rates are increased in the short term after head injury, predominantly among hospitalized patients, Dr. Elser noted.

“But there’s less evidence about the long-term mortality implications of head injuries and less evidence from adults living in the community,” she added.

The analysis included 13,037 participants in the ARIC study, an ongoing study involving adults aged 45-65 years who were recruited from four geographically and racially diverse U.S. communities. The mean age at baseline (1987-1989) was 54 years; 57.7% were women; and 27.9% were Black.

Study participants are followed at routine in-person visits and semiannually via telephone.

Data on head injuries came from hospital diagnostic codes and self-reports. These reports included information on the number of injuries and whether the injury required medical care and involved loss of consciousness.

During the 27-year follow-up, 18.4% of the study sample had at least one head injury. Injuries occurred more frequently among women, which may reflect the predominance of women in the study population, said Dr. Elser.

Overall, about 56% of participants died during the study period. The estimated median amount of survival time after head injury was 4.7 years.

The most common causes of death were neoplasm, cardiovascular disease, and neurologic disorders. Regarding specific neurologic causes of death, the researchers found that 62.2% of deaths were due to neurodegenerative disease among individuals with head injury, vs. 51.4% among those without head injury.

This, said Dr. Elser, raises the possibility of reverse causality. “If you have a neurodegenerative disorder like Alzheimer’s disease dementia or Parkinson’s disease that leads to difficulty walking, you may be more likely to fall and have a head injury. The head injury in turn may lead to increased mortality,” she noted.

However, she stressed that the data on cause-specific mortality are exploratory. “Our research motivates future studies that really examine this time-dependent relationship between neurodegenerative disease and head injuries,” Dr. Elser said.
 

Dose-dependent response

In the unadjusted analysis, the hazard ratio of mortality among individuals with head injury was 2.21 (95% confidence interval, 2.09-2.34) compared with those who did not have head injury.

The association remained significant with adjustment for sociodemographic factors (HR, 1.99; 95% CI, 1.88-2.11) and with additional adjustment for vascular risk factors (HR, 1.92; 95% CI, 1.81-2.03).

The findings also showed a dose-response pattern in the association of head injuries with mortality. Compared with participants who did not have head injury, the HR was 1.66 (95% CI, 1.56-1.77) for those with one head injury and 2.11 (95% CI, 1.89-2.37) for those with two or more head injuries.

“It’s not as though once you’ve had one head injury, you’ve accrued all the damage you possibly can. We see pretty clearly here that recurrent head injury further increased the rate of deaths from all causes,” said Dr. Elser.

Injury severity was determined from hospital diagnostic codes using established algorithms. Results showed that mortality rates were increased with even mild head injury.

Interestingly, the association between head injury and all-cause mortality was weaker among those whose injuries were self-reported. One possibility is that these injuries were less severe, Dr. Elser noted.

“If you have head injury that’s mild enough that you don’t need to go to the hospital, it’s probably going to confer less long-term health risks than one that’s severe enough that you needed to be examined in an acute care setting,” she said.

Results were similar by race and for sex. “Even though there were more women with head injuries, the rate of mortality associated with head injury doesn’t differ from the rate among men,” Dr. Elser reported.

However, the association was stronger among those younger than 54 years at baseline (HR, 2.26) compared with older individuals (HR, 2.0) in the model that adjusted for demographics and lifestyle factors.

This may be explained by the reference group (those without a head injury) – the mortality rate was in general higher for the older participants, said Dr. Elser. It could also be that younger adults are more likely to have severe head injuries from, for example, motor vehicle accidents or violence, she added.

These new findings underscore the importance of public health measures, such as seatbelt laws, to reduce head injuries, the investigators note.

They add that clinicians with patients at risk for head injuries may recommend steps to lessen the risk of falls, such as having access to durable medical equipment, and ensuring driver safety.
 

Shorter life span

Commenting for this news organization, Frank Conidi, MD, director of the Florida Center for Headache and Sports Neurology in Port St. Lucie and past president of the Florida Society of Neurology, said the large number of participants “adds validity” to the finding that individuals with head injury are likely to have a shorter life span than those who do not suffer head trauma – and that this “was not purely by chance or from other causes.”

However, patients may not have accurately reported head injuries, in which case the rate of injury in the self-report subgroup would not reflect the actual incidence, noted Dr. Conidi, who was not involved with the research.

“In my practice, most patients have little knowledge as to the signs and symptoms of concussion and traumatic brain injury. Most think there needs to be some form of loss of consciousness to have a head injury, which is of course not true,” he said.

Dr. Conidi added that the finding of a higher incidence of death from neurodegenerative disorders supports the generally accepted consensus view that about 30% of patients with traumatic brain injury experience progression of symptoms and are at risk for early dementia.

The ARIC study is supported by the National Heart, Lung, and Blood Institute. Dr. Elser and Dr. Conidi have reported no relevant financial relationships.

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

Sustaining even a single head injury has been linked to a significantly increased risk of all-cause mortality in new research.

An analysis of more than 13,000 adult participants in the Atherosclerosis Risk in Communities (ARIC) study showed a dose-response pattern in which one head injury was linked to a 66% increased risk for all-cause mortality, and two or more head injuries were associated with twice the risk in comparison with no head injuries.

These findings underscore the importance of preventing head injuries and of swift clinical intervention once a head injury occurs, lead author Holly Elser, MD, PhD, department of neurology, Hospital of the University of Pennsylvania, Philadelphia, told this news organization.

“Clinicians should counsel patients who are at risk for falls about head injuries and ensure patients are promptly evaluated in the hospital setting if they do have a fall – especially with loss of consciousness or other symptoms, such as headache or dizziness,” Dr. Elser added.

The findings were published online in JAMA Neurology.
 

Consistent evidence

There is “pretty consistent evidence” that mortality rates are increased in the short term after head injury, predominantly among hospitalized patients, Dr. Elser noted.

“But there’s less evidence about the long-term mortality implications of head injuries and less evidence from adults living in the community,” she added.

The analysis included 13,037 participants in the ARIC study, an ongoing study involving adults aged 45-65 years who were recruited from four geographically and racially diverse U.S. communities. The mean age at baseline (1987-1989) was 54 years; 57.7% were women; and 27.9% were Black.

Study participants are followed at routine in-person visits and semiannually via telephone.

Data on head injuries came from hospital diagnostic codes and self-reports. These reports included information on the number of injuries and whether the injury required medical care and involved loss of consciousness.

During the 27-year follow-up, 18.4% of the study sample had at least one head injury. Injuries occurred more frequently among women, which may reflect the predominance of women in the study population, said Dr. Elser.

Overall, about 56% of participants died during the study period. The estimated median amount of survival time after head injury was 4.7 years.

The most common causes of death were neoplasm, cardiovascular disease, and neurologic disorders. Regarding specific neurologic causes of death, the researchers found that 62.2% of deaths were due to neurodegenerative disease among individuals with head injury, vs. 51.4% among those without head injury.

This, said Dr. Elser, raises the possibility of reverse causality. “If you have a neurodegenerative disorder like Alzheimer’s disease dementia or Parkinson’s disease that leads to difficulty walking, you may be more likely to fall and have a head injury. The head injury in turn may lead to increased mortality,” she noted.

However, she stressed that the data on cause-specific mortality are exploratory. “Our research motivates future studies that really examine this time-dependent relationship between neurodegenerative disease and head injuries,” Dr. Elser said.
 

Dose-dependent response

In the unadjusted analysis, the hazard ratio of mortality among individuals with head injury was 2.21 (95% confidence interval, 2.09-2.34) compared with those who did not have head injury.

The association remained significant with adjustment for sociodemographic factors (HR, 1.99; 95% CI, 1.88-2.11) and with additional adjustment for vascular risk factors (HR, 1.92; 95% CI, 1.81-2.03).

The findings also showed a dose-response pattern in the association of head injuries with mortality. Compared with participants who did not have head injury, the HR was 1.66 (95% CI, 1.56-1.77) for those with one head injury and 2.11 (95% CI, 1.89-2.37) for those with two or more head injuries.

“It’s not as though once you’ve had one head injury, you’ve accrued all the damage you possibly can. We see pretty clearly here that recurrent head injury further increased the rate of deaths from all causes,” said Dr. Elser.

Injury severity was determined from hospital diagnostic codes using established algorithms. Results showed that mortality rates were increased with even mild head injury.

Interestingly, the association between head injury and all-cause mortality was weaker among those whose injuries were self-reported. One possibility is that these injuries were less severe, Dr. Elser noted.

“If you have head injury that’s mild enough that you don’t need to go to the hospital, it’s probably going to confer less long-term health risks than one that’s severe enough that you needed to be examined in an acute care setting,” she said.

Results were similar by race and for sex. “Even though there were more women with head injuries, the rate of mortality associated with head injury doesn’t differ from the rate among men,” Dr. Elser reported.

However, the association was stronger among those younger than 54 years at baseline (HR, 2.26) compared with older individuals (HR, 2.0) in the model that adjusted for demographics and lifestyle factors.

This may be explained by the reference group (those without a head injury) – the mortality rate was in general higher for the older participants, said Dr. Elser. It could also be that younger adults are more likely to have severe head injuries from, for example, motor vehicle accidents or violence, she added.

These new findings underscore the importance of public health measures, such as seatbelt laws, to reduce head injuries, the investigators note.

They add that clinicians with patients at risk for head injuries may recommend steps to lessen the risk of falls, such as having access to durable medical equipment, and ensuring driver safety.
 

Shorter life span

Commenting for this news organization, Frank Conidi, MD, director of the Florida Center for Headache and Sports Neurology in Port St. Lucie and past president of the Florida Society of Neurology, said the large number of participants “adds validity” to the finding that individuals with head injury are likely to have a shorter life span than those who do not suffer head trauma – and that this “was not purely by chance or from other causes.”

However, patients may not have accurately reported head injuries, in which case the rate of injury in the self-report subgroup would not reflect the actual incidence, noted Dr. Conidi, who was not involved with the research.

“In my practice, most patients have little knowledge as to the signs and symptoms of concussion and traumatic brain injury. Most think there needs to be some form of loss of consciousness to have a head injury, which is of course not true,” he said.

Dr. Conidi added that the finding of a higher incidence of death from neurodegenerative disorders supports the generally accepted consensus view that about 30% of patients with traumatic brain injury experience progression of symptoms and are at risk for early dementia.

The ARIC study is supported by the National Heart, Lung, and Blood Institute. Dr. Elser and Dr. Conidi have reported no relevant financial relationships.

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

Almost 36% of students and faculty at George Washington University with a history of COVID-19 reported symptoms consistent with long COVID in a new study.

With a median age of 23 years, the study is unique for evaluating mostly healthy, young adults and for its rare look at long COVID in a university community. 

The more symptoms during a bout with COVID, the greater the risk for long COVID, the researchers found. That lines up with previous studies. Also, the more vaccinations and booster shots against SARS-CoV-2, the virus that causes COVID, the lower the long COVID risk.

Women were more likely than men to be affected. Current or prior smoking, seeking medical care for COVID, and receiving antibody treatment also were linked to higher chances for developing long COVID. 

Lead author Megan Landry, DrPH, MPH, and colleagues were already assessing students, staff, and faculty at George Washington University, Washington, who tested positive for COVID. Then they started seeing symptoms that lasted 28 days or more after their 10-day isolation period. 

“We were starting to recognize that individuals ... were still having symptoms longer than the typical isolation period,” said Dr. Landry. So they developed a questionnaire to figure out the how long these symptoms last and how many people are affected by them. 

The list of potential symptoms was long and included trouble thinking, fatigue, loss of smell or taste, shortness of breath, and more. 

The study was published online in Emerging Infectious Diseases. Results are based on records and responses from 1,388 students, faculty, and staff from July 2021 to March 2022.

People had a median of four long COVID symptoms, about 63% were women, and 56% were non-Hispanic White. About three-quarters were students and the remainder were faculty and staff. 

The finding that 36% of people with a history of COVID reported long COVID symptoms did not surprise Dr. Landry.

“Based on the literature that’s currently out there, it ranges from a 10% to an 80% prevalence of long COVID,” she said. “We kind of figured that we would fall somewhere in there.”

In contrast, that figure seemed high to Eric Topol, MD.

“That’s really high,” said Dr. Topol, founder and director of the Scripps Research Translational Institute in La Jolla, Calif. He added most studies estimate that about 10% of people with a history of acute infection develop long COVID. 

Even at 10%, which could be an underestimate, that’s a lot of affected people globally. 

“At least 65 million individuals around the world have long COVID, based on a conservative estimated incidence of 10% of infected people and more than 651 million documented COVID-19 cases worldwide; the number is likely much higher due to many undocumented cases,” Dr. Topol and colleagues wrote in a long COVID review article published in Nature Reviews Microbiology.

Research continues

“Long COVID is still evolving and we continue to learn more about it every day,” Landry said. “It’s just so new and there are still a lot of unknowns. That’s why it’s important to get this information out.” 

People with long COVID often have a hard time with occupational, educational, social, or personal activities, compared with before COVID, with effects that can last for more than 6 months, the authors noted. 

“I think across the board, universities in general need to consider the possibility of folks on their campuses are having symptoms of long COVID,” Dr. Landry said.

Moving forward, Dr. Landry and colleagues would like to continue investigating long COVID. For example, in the current study, they did not ask about severity of symptoms or how the symptoms affected daily functioning. 

“I would like to continue this and dive deeper into how disruptive their symptoms of long COVID are to their everyday studying, teaching, or their activities to keeping a university running,” Dr. Landry said.

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

Almost 36% of students and faculty at George Washington University with a history of COVID-19 reported symptoms consistent with long COVID in a new study.

With a median age of 23 years, the study is unique for evaluating mostly healthy, young adults and for its rare look at long COVID in a university community. 

The more symptoms during a bout with COVID, the greater the risk for long COVID, the researchers found. That lines up with previous studies. Also, the more vaccinations and booster shots against SARS-CoV-2, the virus that causes COVID, the lower the long COVID risk.

Women were more likely than men to be affected. Current or prior smoking, seeking medical care for COVID, and receiving antibody treatment also were linked to higher chances for developing long COVID. 

Lead author Megan Landry, DrPH, MPH, and colleagues were already assessing students, staff, and faculty at George Washington University, Washington, who tested positive for COVID. Then they started seeing symptoms that lasted 28 days or more after their 10-day isolation period. 

“We were starting to recognize that individuals ... were still having symptoms longer than the typical isolation period,” said Dr. Landry. So they developed a questionnaire to figure out the how long these symptoms last and how many people are affected by them. 

The list of potential symptoms was long and included trouble thinking, fatigue, loss of smell or taste, shortness of breath, and more. 

The study was published online in Emerging Infectious Diseases. Results are based on records and responses from 1,388 students, faculty, and staff from July 2021 to March 2022.

People had a median of four long COVID symptoms, about 63% were women, and 56% were non-Hispanic White. About three-quarters were students and the remainder were faculty and staff. 

The finding that 36% of people with a history of COVID reported long COVID symptoms did not surprise Dr. Landry.

“Based on the literature that’s currently out there, it ranges from a 10% to an 80% prevalence of long COVID,” she said. “We kind of figured that we would fall somewhere in there.”

In contrast, that figure seemed high to Eric Topol, MD.

“That’s really high,” said Dr. Topol, founder and director of the Scripps Research Translational Institute in La Jolla, Calif. He added most studies estimate that about 10% of people with a history of acute infection develop long COVID. 

Even at 10%, which could be an underestimate, that’s a lot of affected people globally. 

“At least 65 million individuals around the world have long COVID, based on a conservative estimated incidence of 10% of infected people and more than 651 million documented COVID-19 cases worldwide; the number is likely much higher due to many undocumented cases,” Dr. Topol and colleagues wrote in a long COVID review article published in Nature Reviews Microbiology.

Research continues

“Long COVID is still evolving and we continue to learn more about it every day,” Landry said. “It’s just so new and there are still a lot of unknowns. That’s why it’s important to get this information out.” 

People with long COVID often have a hard time with occupational, educational, social, or personal activities, compared with before COVID, with effects that can last for more than 6 months, the authors noted. 

“I think across the board, universities in general need to consider the possibility of folks on their campuses are having symptoms of long COVID,” Dr. Landry said.

Moving forward, Dr. Landry and colleagues would like to continue investigating long COVID. For example, in the current study, they did not ask about severity of symptoms or how the symptoms affected daily functioning. 

“I would like to continue this and dive deeper into how disruptive their symptoms of long COVID are to their everyday studying, teaching, or their activities to keeping a university running,” Dr. Landry said.

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

Almost 36% of students and faculty at George Washington University with a history of COVID-19 reported symptoms consistent with long COVID in a new study.

With a median age of 23 years, the study is unique for evaluating mostly healthy, young adults and for its rare look at long COVID in a university community. 

The more symptoms during a bout with COVID, the greater the risk for long COVID, the researchers found. That lines up with previous studies. Also, the more vaccinations and booster shots against SARS-CoV-2, the virus that causes COVID, the lower the long COVID risk.

Women were more likely than men to be affected. Current or prior smoking, seeking medical care for COVID, and receiving antibody treatment also were linked to higher chances for developing long COVID. 

Lead author Megan Landry, DrPH, MPH, and colleagues were already assessing students, staff, and faculty at George Washington University, Washington, who tested positive for COVID. Then they started seeing symptoms that lasted 28 days or more after their 10-day isolation period. 

“We were starting to recognize that individuals ... were still having symptoms longer than the typical isolation period,” said Dr. Landry. So they developed a questionnaire to figure out the how long these symptoms last and how many people are affected by them. 

The list of potential symptoms was long and included trouble thinking, fatigue, loss of smell or taste, shortness of breath, and more. 

The study was published online in Emerging Infectious Diseases. Results are based on records and responses from 1,388 students, faculty, and staff from July 2021 to March 2022.

People had a median of four long COVID symptoms, about 63% were women, and 56% were non-Hispanic White. About three-quarters were students and the remainder were faculty and staff. 

The finding that 36% of people with a history of COVID reported long COVID symptoms did not surprise Dr. Landry.

“Based on the literature that’s currently out there, it ranges from a 10% to an 80% prevalence of long COVID,” she said. “We kind of figured that we would fall somewhere in there.”

In contrast, that figure seemed high to Eric Topol, MD.

“That’s really high,” said Dr. Topol, founder and director of the Scripps Research Translational Institute in La Jolla, Calif. He added most studies estimate that about 10% of people with a history of acute infection develop long COVID. 

Even at 10%, which could be an underestimate, that’s a lot of affected people globally. 

“At least 65 million individuals around the world have long COVID, based on a conservative estimated incidence of 10% of infected people and more than 651 million documented COVID-19 cases worldwide; the number is likely much higher due to many undocumented cases,” Dr. Topol and colleagues wrote in a long COVID review article published in Nature Reviews Microbiology.

Research continues

“Long COVID is still evolving and we continue to learn more about it every day,” Landry said. “It’s just so new and there are still a lot of unknowns. That’s why it’s important to get this information out.” 

People with long COVID often have a hard time with occupational, educational, social, or personal activities, compared with before COVID, with effects that can last for more than 6 months, the authors noted. 

“I think across the board, universities in general need to consider the possibility of folks on their campuses are having symptoms of long COVID,” Dr. Landry said.

Moving forward, Dr. Landry and colleagues would like to continue investigating long COVID. For example, in the current study, they did not ask about severity of symptoms or how the symptoms affected daily functioning. 

“I would like to continue this and dive deeper into how disruptive their symptoms of long COVID are to their everyday studying, teaching, or their activities to keeping a university running,” Dr. Landry said.

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

A noninvasive test for liver disease may be a useful, low-cost screening tool to select asymptomatic candidates for a detailed examination of heart failure with preserved ejection fraction (HFpEF), say authors of a report published in Gastro Hep Advances.

The fibrosis-4 (FIB-4) index was a significant predictor of high HFpEF risk, wrote Chisato Okamoto, MD, of the department of medical biochemistry at Osaka University Graduate School of Medicine and the National Cerebral and Cardiovascular Center in Japan, and colleagues.

“Recognition of heart failure with preserved ejection fraction at an early stage in mass screening is desirable, but difficult to achieve,” the authors wrote. “The FIB-4 index is calculated using only four parameters that are routinely evaluated in general health check-up programs.”

HFpEF is an emerging disease in recent years with a poor prognosis, they wrote. Early diagnosis can be challenging for several reasons, particularly because HFpEF patients are often asymptomatic until late in the disease process and have normal left ventricular filling pressures at rest. By using a tool to select probable cases from subclinical participants in a health check-up program, clinicians can refer patients for a diastolic stress test, which is considered the gold standard for diagnosing HFpEF.

Previous studies have found that the FIB-4 index, a noninvasive tool to estimate liver stiffness and fibrosis, is associated with a higher risk of major adverse cardiovascular events (MACE) in patients with HFpEF. In addition, patients with nonalcoholic fatty liver disease (NAFLD) have a twofold higher prevalence of HFpEF than the general population.

Dr. Okamoto and colleagues examined the association between the FIB-4 index and HFpEF risk based on the Heart Failure Association’s diagnostic algorithm for HFpEF in patients with breathlessness (HFA-PEFF). The researchers looked at the prognostic impact of the FIB-4 index in 710 patients who participated in a health check-up program in the rural community of Arita-cho, Japan, between 2006 and 2007. They excluded participants with a history of cardiovascular disease or reduced left ventricular systolic function (LVEF < 50%). Researchers calculated the FIB-4 index and HFA-PEFF score for all participants.

First, using the HFA-PEFF scores, the researchers sorted participants into five groups by HFpEF risk: 215 (30%) with zero points, 100 (14%) with 1 point, 171 (24%) with 2 points, 163 (23%) with 3 points, and 61 (9%) with 4-6 points. Participants in the high-risk group (scores 4-6) were older, mostly men, and had higher blood pressure, alcohol intake, hypertension, dyslipidemia, and liver disease. The higher the HFpEF risk group, the higher the rates of all-cause mortality, hospitalization for heart failure, and MACE.

Overall, the FIB-4 index was correlated with the HFpEF risk groups and showed a stepwise increase across the groups, with .94 for the low-risk group, 1.45 for the intermediate-risk group, and 1.99 for the high-risk group, the authors wrote. The FIB-4 index also correlated with markers associated with components of the HFA-PEFF scoring system.

Using multivariate logistic regression analysis, the FIB-4 index was associated with a high HFpEF risk, and an increase in FIB-4 was associated with increased odds of high HFpEF risk. The association remained significant across four separate models that accounted for risk factors associated with lifestyle-related diseases, blood parameters associated with liver disease, and chronic conditions such as hypertension, dyslipidemia, diabetes mellitus, and liver disease.

In additional area under the curve (AUC) analyses, the FIB-4 index was a significant predictor of high HFpEF risk. At cutoff values typically used for advanced liver fibrosis in NAFLD, a FIB-4 cutoff of 1.3 or less had a sensitivity of 85.2%, while a FIB-4 cutoff of 2.67 or higher had a specificity of 94.8%. At alternate cutoff values typically used for patients with HIV/hepatitis C virus infection, a FIB-4 cutoff of less than 1.45 had a sensitivity of 75.4%, while a FIB-4 cutoff of greater than 3.25 had a specificity of 98%.

Using cutoffs of 1.3 and 2.67, a higher FIB-4 was associated with higher rates of clinical events and MACE, as well as a higher HFpEF risk. Using the alternate cutoffs of 1.45 and 3.25, prognostic stratification of clinical events and MACE was also possible.

When all variables were included in the multivariate model, the FIB-4 index remained a significant prognostic predictor. The FIB-4 index stratified clinical prognosis was also an independent predictor of all-cause mortality and hospitalization for heart failure.

Although additional studies are needed to reveal the interaction between liver and heart function, the study authors wrote, the findings provide valuable insights that can help discover the cardiohepatic interaction to reduce the development of HFpEF.

“Since it can be easily, quickly, and inexpensively measured, routine or repeated measurements of the FIB-4 index could help in selecting preferred candidates for detailed examination of HFpEF risk, which may improve clinical outcomes by diagnosing HFpEF at an early stage,” they wrote.

The study was supported by grants from the Osaka Medical Research Foundation for Intractable Disease, the Japan Arteriosclerosis Prevention Fund, the Japan Society for the Promotion of Science, and the Japan Heart Foundation. The authors disclosed no conflicts.

A noninvasive test for liver disease may be a useful, low-cost screening tool to select asymptomatic candidates for a detailed examination of heart failure with preserved ejection fraction (HFpEF), say authors of a report published in Gastro Hep Advances.

The fibrosis-4 (FIB-4) index was a significant predictor of high HFpEF risk, wrote Chisato Okamoto, MD, of the department of medical biochemistry at Osaka University Graduate School of Medicine and the National Cerebral and Cardiovascular Center in Japan, and colleagues.

“Recognition of heart failure with preserved ejection fraction at an early stage in mass screening is desirable, but difficult to achieve,” the authors wrote. “The FIB-4 index is calculated using only four parameters that are routinely evaluated in general health check-up programs.”

HFpEF is an emerging disease in recent years with a poor prognosis, they wrote. Early diagnosis can be challenging for several reasons, particularly because HFpEF patients are often asymptomatic until late in the disease process and have normal left ventricular filling pressures at rest. By using a tool to select probable cases from subclinical participants in a health check-up program, clinicians can refer patients for a diastolic stress test, which is considered the gold standard for diagnosing HFpEF.

Previous studies have found that the FIB-4 index, a noninvasive tool to estimate liver stiffness and fibrosis, is associated with a higher risk of major adverse cardiovascular events (MACE) in patients with HFpEF. In addition, patients with nonalcoholic fatty liver disease (NAFLD) have a twofold higher prevalence of HFpEF than the general population.

Dr. Okamoto and colleagues examined the association between the FIB-4 index and HFpEF risk based on the Heart Failure Association’s diagnostic algorithm for HFpEF in patients with breathlessness (HFA-PEFF). The researchers looked at the prognostic impact of the FIB-4 index in 710 patients who participated in a health check-up program in the rural community of Arita-cho, Japan, between 2006 and 2007. They excluded participants with a history of cardiovascular disease or reduced left ventricular systolic function (LVEF < 50%). Researchers calculated the FIB-4 index and HFA-PEFF score for all participants.

First, using the HFA-PEFF scores, the researchers sorted participants into five groups by HFpEF risk: 215 (30%) with zero points, 100 (14%) with 1 point, 171 (24%) with 2 points, 163 (23%) with 3 points, and 61 (9%) with 4-6 points. Participants in the high-risk group (scores 4-6) were older, mostly men, and had higher blood pressure, alcohol intake, hypertension, dyslipidemia, and liver disease. The higher the HFpEF risk group, the higher the rates of all-cause mortality, hospitalization for heart failure, and MACE.

Overall, the FIB-4 index was correlated with the HFpEF risk groups and showed a stepwise increase across the groups, with .94 for the low-risk group, 1.45 for the intermediate-risk group, and 1.99 for the high-risk group, the authors wrote. The FIB-4 index also correlated with markers associated with components of the HFA-PEFF scoring system.

Using multivariate logistic regression analysis, the FIB-4 index was associated with a high HFpEF risk, and an increase in FIB-4 was associated with increased odds of high HFpEF risk. The association remained significant across four separate models that accounted for risk factors associated with lifestyle-related diseases, blood parameters associated with liver disease, and chronic conditions such as hypertension, dyslipidemia, diabetes mellitus, and liver disease.

In additional area under the curve (AUC) analyses, the FIB-4 index was a significant predictor of high HFpEF risk. At cutoff values typically used for advanced liver fibrosis in NAFLD, a FIB-4 cutoff of 1.3 or less had a sensitivity of 85.2%, while a FIB-4 cutoff of 2.67 or higher had a specificity of 94.8%. At alternate cutoff values typically used for patients with HIV/hepatitis C virus infection, a FIB-4 cutoff of less than 1.45 had a sensitivity of 75.4%, while a FIB-4 cutoff of greater than 3.25 had a specificity of 98%.

Using cutoffs of 1.3 and 2.67, a higher FIB-4 was associated with higher rates of clinical events and MACE, as well as a higher HFpEF risk. Using the alternate cutoffs of 1.45 and 3.25, prognostic stratification of clinical events and MACE was also possible.

When all variables were included in the multivariate model, the FIB-4 index remained a significant prognostic predictor. The FIB-4 index stratified clinical prognosis was also an independent predictor of all-cause mortality and hospitalization for heart failure.

Although additional studies are needed to reveal the interaction between liver and heart function, the study authors wrote, the findings provide valuable insights that can help discover the cardiohepatic interaction to reduce the development of HFpEF.

“Since it can be easily, quickly, and inexpensively measured, routine or repeated measurements of the FIB-4 index could help in selecting preferred candidates for detailed examination of HFpEF risk, which may improve clinical outcomes by diagnosing HFpEF at an early stage,” they wrote.

The study was supported by grants from the Osaka Medical Research Foundation for Intractable Disease, the Japan Arteriosclerosis Prevention Fund, the Japan Society for the Promotion of Science, and the Japan Heart Foundation. The authors disclosed no conflicts.

A noninvasive test for liver disease may be a useful, low-cost screening tool to select asymptomatic candidates for a detailed examination of heart failure with preserved ejection fraction (HFpEF), say authors of a report published in Gastro Hep Advances.

The fibrosis-4 (FIB-4) index was a significant predictor of high HFpEF risk, wrote Chisato Okamoto, MD, of the department of medical biochemistry at Osaka University Graduate School of Medicine and the National Cerebral and Cardiovascular Center in Japan, and colleagues.

“Recognition of heart failure with preserved ejection fraction at an early stage in mass screening is desirable, but difficult to achieve,” the authors wrote. “The FIB-4 index is calculated using only four parameters that are routinely evaluated in general health check-up programs.”

HFpEF is an emerging disease in recent years with a poor prognosis, they wrote. Early diagnosis can be challenging for several reasons, particularly because HFpEF patients are often asymptomatic until late in the disease process and have normal left ventricular filling pressures at rest. By using a tool to select probable cases from subclinical participants in a health check-up program, clinicians can refer patients for a diastolic stress test, which is considered the gold standard for diagnosing HFpEF.

Previous studies have found that the FIB-4 index, a noninvasive tool to estimate liver stiffness and fibrosis, is associated with a higher risk of major adverse cardiovascular events (MACE) in patients with HFpEF. In addition, patients with nonalcoholic fatty liver disease (NAFLD) have a twofold higher prevalence of HFpEF than the general population.

Dr. Okamoto and colleagues examined the association between the FIB-4 index and HFpEF risk based on the Heart Failure Association’s diagnostic algorithm for HFpEF in patients with breathlessness (HFA-PEFF). The researchers looked at the prognostic impact of the FIB-4 index in 710 patients who participated in a health check-up program in the rural community of Arita-cho, Japan, between 2006 and 2007. They excluded participants with a history of cardiovascular disease or reduced left ventricular systolic function (LVEF < 50%). Researchers calculated the FIB-4 index and HFA-PEFF score for all participants.

First, using the HFA-PEFF scores, the researchers sorted participants into five groups by HFpEF risk: 215 (30%) with zero points, 100 (14%) with 1 point, 171 (24%) with 2 points, 163 (23%) with 3 points, and 61 (9%) with 4-6 points. Participants in the high-risk group (scores 4-6) were older, mostly men, and had higher blood pressure, alcohol intake, hypertension, dyslipidemia, and liver disease. The higher the HFpEF risk group, the higher the rates of all-cause mortality, hospitalization for heart failure, and MACE.

Overall, the FIB-4 index was correlated with the HFpEF risk groups and showed a stepwise increase across the groups, with .94 for the low-risk group, 1.45 for the intermediate-risk group, and 1.99 for the high-risk group, the authors wrote. The FIB-4 index also correlated with markers associated with components of the HFA-PEFF scoring system.

Using multivariate logistic regression analysis, the FIB-4 index was associated with a high HFpEF risk, and an increase in FIB-4 was associated with increased odds of high HFpEF risk. The association remained significant across four separate models that accounted for risk factors associated with lifestyle-related diseases, blood parameters associated with liver disease, and chronic conditions such as hypertension, dyslipidemia, diabetes mellitus, and liver disease.

In additional area under the curve (AUC) analyses, the FIB-4 index was a significant predictor of high HFpEF risk. At cutoff values typically used for advanced liver fibrosis in NAFLD, a FIB-4 cutoff of 1.3 or less had a sensitivity of 85.2%, while a FIB-4 cutoff of 2.67 or higher had a specificity of 94.8%. At alternate cutoff values typically used for patients with HIV/hepatitis C virus infection, a FIB-4 cutoff of less than 1.45 had a sensitivity of 75.4%, while a FIB-4 cutoff of greater than 3.25 had a specificity of 98%.

Using cutoffs of 1.3 and 2.67, a higher FIB-4 was associated with higher rates of clinical events and MACE, as well as a higher HFpEF risk. Using the alternate cutoffs of 1.45 and 3.25, prognostic stratification of clinical events and MACE was also possible.

When all variables were included in the multivariate model, the FIB-4 index remained a significant prognostic predictor. The FIB-4 index stratified clinical prognosis was also an independent predictor of all-cause mortality and hospitalization for heart failure.

Although additional studies are needed to reveal the interaction between liver and heart function, the study authors wrote, the findings provide valuable insights that can help discover the cardiohepatic interaction to reduce the development of HFpEF.

“Since it can be easily, quickly, and inexpensively measured, routine or repeated measurements of the FIB-4 index could help in selecting preferred candidates for detailed examination of HFpEF risk, which may improve clinical outcomes by diagnosing HFpEF at an early stage,” they wrote.

The study was supported by grants from the Osaka Medical Research Foundation for Intractable Disease, the Japan Arteriosclerosis Prevention Fund, the Japan Society for the Promotion of Science, and the Japan Heart Foundation. The authors disclosed no conflicts.

Newly released figures showing a rise in the number of men with advanced prostate cancer have laid bare long-simmering resentment among patient advocates who feel the nation’s leading cancer group has largely ignored their concerns for years.

The American Cancer Society on Jan. 13 revealed what it called “alarming” news about prostate cancer: After 2 decades of decline, the number of men diagnosed with the disease in the United States rose by 15% from 2014 to 2019.

“Most concerning,” according to the group’s CEO Karen Knudsen, PhD, MBA, is that the increase is being driven by diagnoses of advanced disease.

“Since 2011, the diagnosis of advanced-stage (regional- or distant-stage) prostate cancer has increased by 4%-5% annually and the proportion of men diagnosed with distant-stage disease has doubled,” said Dr. Knudsen at a press conference concerning the figures. “These findings underscore the importance of understanding and reducing this trend.”

The increase, which works out to be an additional 99,000 cases of prostate cancer, did not take the ACS by surprise; the group has been predicting a jump in diagnoses of the disease, which is the most common cancer in men after skin cancer, and the second most common cause of cancer death for that group.

The ACS announced a new action plan, “Improving Mortality from Prostate Cancer Together” – or IMPACT – to address the rise, especially in Black men, and to curb the increasing rate of advanced, difficult-to-treat cases.

“We must address these shifts in prostate cancer, especially in the Black community, since the incidence of prostate cancer in Black men is 70% higher than in White men and prostate cancer mortality rates in Black men are approximately two to four times higher than those in every other racial and ethnic group,” William Dahut, MD, PhD, chief scientific officer for the ACS, said at the press conference.

A study published in JAMA Network Open challenged that claim, finding that, after controlling for socioeconomic factors, race does not appear to be a significant predictor of mortality for prostate cancer.

Dr. Dahut said in an interview that IMPACT “is still [in the] early days for this initiative and more details will be coming out soon.”

Charles Ryan, MD, CEO of the Prostate Cancer Foundation, the world’s largest prostate cancer research charity, called IMPACT “extremely important work. Highlighting the disparities can only serve to benefit all men with prostate cancer, especially Black men.”
 

Bold action ... or passivity?

Overall cancer mortality has dropped 33% since 1991, averting an estimated 3.8 million deaths, according to ACS. But the story for prostate cancer is different.

The society and advocates had warned as recently as 2 years ago that prostate cancer was poised to rise again, especially advanced cases that may be too late to treat.

Leaders in the prostate cancer advocacy community praised the ACS plan for IMPACT, but some expressed frustration over what they said was ACS’ passivity in the face of long-anticipated increases in cases of the disease.

“I think prostate cancer was not high on their agenda,” said Rick Davis, founder of AnCan, which offers several support groups for patients with prostate cancer.  “It’s good to see ACS get back into the prostate cancer game.”

Mr. Davis and patient advocate Darryl Mitteldorf, LCSW, founder of Malecare, another prostate support organization, said ACS dropped patient services for prostate cancer patients a decade ago and has not been a vocal supporter of screening for levels of prostate-specific antigen (PSA) to detect prostate cancer early.

“Early detection is supposed to be their goal,” Mr. Davis said.

In 2012, the U.S. Preventive Services Task Force recommended against PSA screening, giving it a D-rating. The move prompted attacks on the task force from most advocates and many urologists.

Following this criticism, the task force recommended shared decision-making between patient and doctor, while giving PSA screening a C-rating. Now, the ACS recommends men in general at age 50 discuss prostate cancer screening with their doctor and that Black men do the same at age 45.

Mr. Mitteldorf said ACS “owes prostate cancer patients an explanation and analysis of its response to the USPTF’s downgrade of PSA testing and how that response might be related to death and instance rates.”

Mr. Mitteldorf added that male patients lost key support from ACS when the group dismantled its Man to Man group for prostate cancer patients and its Brother to Brother group for Blacks in particular.

Dr. Dahut said Man to Man “sunsetted” and was turned over to any local organization that chose to offer it. He said longtime staff didn’t have “a lot of information about [the demise of] Brother to Brother.”

For Mr. Davis, those smaller cuts add up to a much larger insult.

“Today, in 2023, ACS continues to poke a finger in the eyes of prostate cancer patients,” he said. “Since 2010, they have not given us any respect. ACS dumped its support.”

He pointed to the group’s funding priorities, noting that outlays for prostate cancer have consistently lagged behind those for breast cancer.

The ACS spent $25.3 million on breast cancer research and $6.7 million for prostate cancer in 2018, and in 2023 will designate $126.5 for breast cancer research and $43.9 million for prostate cancer.

ACS has earmarked $62 million this year for lung cancer programs and $61 million for colorectal cancer.

“Parity between breast cancer and prostate cancer would be a good start in sizing the IMPACT program,” Mr. Davis said. “After all, breast cancer and prostate cancer are hardly different in numbers today.”

Dr. Dahut denied any gender bias in research funding. He said the group makes funding decisions “based on finding the most impactful science regardless of tumor type. Our mission includes funding every cancer, every day; thus, we generally do not go into our funding cycle with any set-asides for a particular cancer.”

Mr. Davis also said the ACS data suggest the growing number of prostate cancer cases is even worse than the group has said. Although the society cites a 3% annual increase in prostate cancer diagnoses from 2014 to 2019, since 2019 the annual increase is a much more dramatic 16%. Meanwhile, the number of new cases of the disease is projected to rise from 175,000 per year in 2019 to 288,000 this year.

Dr. Dahut said the society used the 2014-2019 time frame for technical reasons, separating confirmed cases in the earlier period from estimated cases in recent years.

“We discourage comparing projected cases over time because these cases are model-based and subject to fluctuations,” Dr. Dahut said.

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

Newly released figures showing a rise in the number of men with advanced prostate cancer have laid bare long-simmering resentment among patient advocates who feel the nation’s leading cancer group has largely ignored their concerns for years.

The American Cancer Society on Jan. 13 revealed what it called “alarming” news about prostate cancer: After 2 decades of decline, the number of men diagnosed with the disease in the United States rose by 15% from 2014 to 2019.

“Most concerning,” according to the group’s CEO Karen Knudsen, PhD, MBA, is that the increase is being driven by diagnoses of advanced disease.

“Since 2011, the diagnosis of advanced-stage (regional- or distant-stage) prostate cancer has increased by 4%-5% annually and the proportion of men diagnosed with distant-stage disease has doubled,” said Dr. Knudsen at a press conference concerning the figures. “These findings underscore the importance of understanding and reducing this trend.”

The increase, which works out to be an additional 99,000 cases of prostate cancer, did not take the ACS by surprise; the group has been predicting a jump in diagnoses of the disease, which is the most common cancer in men after skin cancer, and the second most common cause of cancer death for that group.

The ACS announced a new action plan, “Improving Mortality from Prostate Cancer Together” – or IMPACT – to address the rise, especially in Black men, and to curb the increasing rate of advanced, difficult-to-treat cases.

“We must address these shifts in prostate cancer, especially in the Black community, since the incidence of prostate cancer in Black men is 70% higher than in White men and prostate cancer mortality rates in Black men are approximately two to four times higher than those in every other racial and ethnic group,” William Dahut, MD, PhD, chief scientific officer for the ACS, said at the press conference.

A study published in JAMA Network Open challenged that claim, finding that, after controlling for socioeconomic factors, race does not appear to be a significant predictor of mortality for prostate cancer.

Dr. Dahut said in an interview that IMPACT “is still [in the] early days for this initiative and more details will be coming out soon.”

Charles Ryan, MD, CEO of the Prostate Cancer Foundation, the world’s largest prostate cancer research charity, called IMPACT “extremely important work. Highlighting the disparities can only serve to benefit all men with prostate cancer, especially Black men.”
 

Bold action ... or passivity?

Overall cancer mortality has dropped 33% since 1991, averting an estimated 3.8 million deaths, according to ACS. But the story for prostate cancer is different.

The society and advocates had warned as recently as 2 years ago that prostate cancer was poised to rise again, especially advanced cases that may be too late to treat.

Leaders in the prostate cancer advocacy community praised the ACS plan for IMPACT, but some expressed frustration over what they said was ACS’ passivity in the face of long-anticipated increases in cases of the disease.

“I think prostate cancer was not high on their agenda,” said Rick Davis, founder of AnCan, which offers several support groups for patients with prostate cancer.  “It’s good to see ACS get back into the prostate cancer game.”

Mr. Davis and patient advocate Darryl Mitteldorf, LCSW, founder of Malecare, another prostate support organization, said ACS dropped patient services for prostate cancer patients a decade ago and has not been a vocal supporter of screening for levels of prostate-specific antigen (PSA) to detect prostate cancer early.

“Early detection is supposed to be their goal,” Mr. Davis said.

In 2012, the U.S. Preventive Services Task Force recommended against PSA screening, giving it a D-rating. The move prompted attacks on the task force from most advocates and many urologists.

Following this criticism, the task force recommended shared decision-making between patient and doctor, while giving PSA screening a C-rating. Now, the ACS recommends men in general at age 50 discuss prostate cancer screening with their doctor and that Black men do the same at age 45.

Mr. Mitteldorf said ACS “owes prostate cancer patients an explanation and analysis of its response to the USPTF’s downgrade of PSA testing and how that response might be related to death and instance rates.”

Mr. Mitteldorf added that male patients lost key support from ACS when the group dismantled its Man to Man group for prostate cancer patients and its Brother to Brother group for Blacks in particular.

Dr. Dahut said Man to Man “sunsetted” and was turned over to any local organization that chose to offer it. He said longtime staff didn’t have “a lot of information about [the demise of] Brother to Brother.”

For Mr. Davis, those smaller cuts add up to a much larger insult.

“Today, in 2023, ACS continues to poke a finger in the eyes of prostate cancer patients,” he said. “Since 2010, they have not given us any respect. ACS dumped its support.”

He pointed to the group’s funding priorities, noting that outlays for prostate cancer have consistently lagged behind those for breast cancer.

The ACS spent $25.3 million on breast cancer research and $6.7 million for prostate cancer in 2018, and in 2023 will designate $126.5 for breast cancer research and $43.9 million for prostate cancer.

ACS has earmarked $62 million this year for lung cancer programs and $61 million for colorectal cancer.

“Parity between breast cancer and prostate cancer would be a good start in sizing the IMPACT program,” Mr. Davis said. “After all, breast cancer and prostate cancer are hardly different in numbers today.”

Dr. Dahut denied any gender bias in research funding. He said the group makes funding decisions “based on finding the most impactful science regardless of tumor type. Our mission includes funding every cancer, every day; thus, we generally do not go into our funding cycle with any set-asides for a particular cancer.”

Mr. Davis also said the ACS data suggest the growing number of prostate cancer cases is even worse than the group has said. Although the society cites a 3% annual increase in prostate cancer diagnoses from 2014 to 2019, since 2019 the annual increase is a much more dramatic 16%. Meanwhile, the number of new cases of the disease is projected to rise from 175,000 per year in 2019 to 288,000 this year.

Dr. Dahut said the society used the 2014-2019 time frame for technical reasons, separating confirmed cases in the earlier period from estimated cases in recent years.

“We discourage comparing projected cases over time because these cases are model-based and subject to fluctuations,” Dr. Dahut said.

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

Newly released figures showing a rise in the number of men with advanced prostate cancer have laid bare long-simmering resentment among patient advocates who feel the nation’s leading cancer group has largely ignored their concerns for years.

The American Cancer Society on Jan. 13 revealed what it called “alarming” news about prostate cancer: After 2 decades of decline, the number of men diagnosed with the disease in the United States rose by 15% from 2014 to 2019.

“Most concerning,” according to the group’s CEO Karen Knudsen, PhD, MBA, is that the increase is being driven by diagnoses of advanced disease.

“Since 2011, the diagnosis of advanced-stage (regional- or distant-stage) prostate cancer has increased by 4%-5% annually and the proportion of men diagnosed with distant-stage disease has doubled,” said Dr. Knudsen at a press conference concerning the figures. “These findings underscore the importance of understanding and reducing this trend.”

The increase, which works out to be an additional 99,000 cases of prostate cancer, did not take the ACS by surprise; the group has been predicting a jump in diagnoses of the disease, which is the most common cancer in men after skin cancer, and the second most common cause of cancer death for that group.

The ACS announced a new action plan, “Improving Mortality from Prostate Cancer Together” – or IMPACT – to address the rise, especially in Black men, and to curb the increasing rate of advanced, difficult-to-treat cases.

“We must address these shifts in prostate cancer, especially in the Black community, since the incidence of prostate cancer in Black men is 70% higher than in White men and prostate cancer mortality rates in Black men are approximately two to four times higher than those in every other racial and ethnic group,” William Dahut, MD, PhD, chief scientific officer for the ACS, said at the press conference.

A study published in JAMA Network Open challenged that claim, finding that, after controlling for socioeconomic factors, race does not appear to be a significant predictor of mortality for prostate cancer.

Dr. Dahut said in an interview that IMPACT “is still [in the] early days for this initiative and more details will be coming out soon.”

Charles Ryan, MD, CEO of the Prostate Cancer Foundation, the world’s largest prostate cancer research charity, called IMPACT “extremely important work. Highlighting the disparities can only serve to benefit all men with prostate cancer, especially Black men.”
 

Bold action ... or passivity?

Overall cancer mortality has dropped 33% since 1991, averting an estimated 3.8 million deaths, according to ACS. But the story for prostate cancer is different.

The society and advocates had warned as recently as 2 years ago that prostate cancer was poised to rise again, especially advanced cases that may be too late to treat.

Leaders in the prostate cancer advocacy community praised the ACS plan for IMPACT, but some expressed frustration over what they said was ACS’ passivity in the face of long-anticipated increases in cases of the disease.

“I think prostate cancer was not high on their agenda,” said Rick Davis, founder of AnCan, which offers several support groups for patients with prostate cancer.  “It’s good to see ACS get back into the prostate cancer game.”

Mr. Davis and patient advocate Darryl Mitteldorf, LCSW, founder of Malecare, another prostate support organization, said ACS dropped patient services for prostate cancer patients a decade ago and has not been a vocal supporter of screening for levels of prostate-specific antigen (PSA) to detect prostate cancer early.

“Early detection is supposed to be their goal,” Mr. Davis said.

In 2012, the U.S. Preventive Services Task Force recommended against PSA screening, giving it a D-rating. The move prompted attacks on the task force from most advocates and many urologists.

Following this criticism, the task force recommended shared decision-making between patient and doctor, while giving PSA screening a C-rating. Now, the ACS recommends men in general at age 50 discuss prostate cancer screening with their doctor and that Black men do the same at age 45.

Mr. Mitteldorf said ACS “owes prostate cancer patients an explanation and analysis of its response to the USPTF’s downgrade of PSA testing and how that response might be related to death and instance rates.”

Mr. Mitteldorf added that male patients lost key support from ACS when the group dismantled its Man to Man group for prostate cancer patients and its Brother to Brother group for Blacks in particular.

Dr. Dahut said Man to Man “sunsetted” and was turned over to any local organization that chose to offer it. He said longtime staff didn’t have “a lot of information about [the demise of] Brother to Brother.”

For Mr. Davis, those smaller cuts add up to a much larger insult.

“Today, in 2023, ACS continues to poke a finger in the eyes of prostate cancer patients,” he said. “Since 2010, they have not given us any respect. ACS dumped its support.”

He pointed to the group’s funding priorities, noting that outlays for prostate cancer have consistently lagged behind those for breast cancer.

The ACS spent $25.3 million on breast cancer research and $6.7 million for prostate cancer in 2018, and in 2023 will designate $126.5 for breast cancer research and $43.9 million for prostate cancer.

ACS has earmarked $62 million this year for lung cancer programs and $61 million for colorectal cancer.

“Parity between breast cancer and prostate cancer would be a good start in sizing the IMPACT program,” Mr. Davis said. “After all, breast cancer and prostate cancer are hardly different in numbers today.”

Dr. Dahut denied any gender bias in research funding. He said the group makes funding decisions “based on finding the most impactful science regardless of tumor type. Our mission includes funding every cancer, every day; thus, we generally do not go into our funding cycle with any set-asides for a particular cancer.”

Mr. Davis also said the ACS data suggest the growing number of prostate cancer cases is even worse than the group has said. Although the society cites a 3% annual increase in prostate cancer diagnoses from 2014 to 2019, since 2019 the annual increase is a much more dramatic 16%. Meanwhile, the number of new cases of the disease is projected to rise from 175,000 per year in 2019 to 288,000 this year.

Dr. Dahut said the society used the 2014-2019 time frame for technical reasons, separating confirmed cases in the earlier period from estimated cases in recent years.

“We discourage comparing projected cases over time because these cases are model-based and subject to fluctuations,” Dr. Dahut said.

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

Appropriate assessment of MSK symptoms and signs by dermatologists may lead to more appropriate referral to rheumatologists. MSUS is being increasingly explored for early identification of PsA. A handheld, chip-based ultrasound device (HHUD) is a novel promising instrument that can be easily implemented in clinical practice. In a prospective study including 140 patients with psoriasis who presented to dermatologists with arthralgia. Grobelski and colleagues screened for PsA using medical history, CE, and the German Psoriasis Arthritis Diagnostic PsA screening questionnaire (GEPARD) paired with MSUS examination of up to three painful joints by trained dermatologists. Nineteen patients (13.6%) were diagnosed with PsA by rheumatologists. Interestingly, in 45 of the 46 patients the preliminary diagnosis of PsA was revised to "no PsA" after MSUS. The addition of MSUS changed the sensitivity and specificity of early PsA screening strategy from 88.2% and 54.4% to 70.6% and 90.4%, respectively. The positive predictive value increased to 56.5% from 25.4% after MSUS. Thus, the use of a quick MSUS using HHUD may lead to more accurate referral to rheumatologists. The challenge is seamless integration of MSUS into busy dermatology practices.

The goal of PsA treatment is to achieve a state of remission or low disease activity. Criteria for minimal disease activity (MDA) have been established. Achieving MDA leads to better health-related quality of life (HRQOL), as well as less joint damage. In a prospective cohort study that included 240 patients with newly diagnosed disease-modifying antirheumatic drug-naive PsA, Snoeck Henkemans and colleagues demonstrate that failure to achieve MDA in the first year after the diagnosis of PsA was associated with worse HRQOL and health status, functional impairment, fatigue, pain, and higher anxiety and depression. Compared with patients who achieved sustained MDA in the first year after diagnosis, those who did not achieve MDA had higher scores for pain, fatigue, and functional ability and higher anxiety and depression during follow-up, which persisted despite treatment intensification. Thus, implementation of treat-to-target strategies with the aim of achieving sustained MDA within 1 year of diagnosis is likely to have better long-term benefits in this lifelong disease.

Another study emphasized the need for early treatment to improve long-term outcomes. In a post hoc analysis of two phase 3 trials including 1554 patients with PsA who received 300-mg or 150-mg secukinumab with or without a loading dose, Mease and colleagues showed that high baseline radiographic damage reduced the likelihood of achieving MDA.

Overall, these studies indicate that early diagnosis and treatment prior to developing joint damage with the aim to achieve sustained MDA within a year will lead to better long-term outcome for patients with PsA.

Appropriate assessment of MSK symptoms and signs by dermatologists may lead to more appropriate referral to rheumatologists. MSUS is being increasingly explored for early identification of PsA. A handheld, chip-based ultrasound device (HHUD) is a novel promising instrument that can be easily implemented in clinical practice. In a prospective study including 140 patients with psoriasis who presented to dermatologists with arthralgia. Grobelski and colleagues screened for PsA using medical history, CE, and the German Psoriasis Arthritis Diagnostic PsA screening questionnaire (GEPARD) paired with MSUS examination of up to three painful joints by trained dermatologists. Nineteen patients (13.6%) were diagnosed with PsA by rheumatologists. Interestingly, in 45 of the 46 patients the preliminary diagnosis of PsA was revised to "no PsA" after MSUS. The addition of MSUS changed the sensitivity and specificity of early PsA screening strategy from 88.2% and 54.4% to 70.6% and 90.4%, respectively. The positive predictive value increased to 56.5% from 25.4% after MSUS. Thus, the use of a quick MSUS using HHUD may lead to more accurate referral to rheumatologists. The challenge is seamless integration of MSUS into busy dermatology practices.

The goal of PsA treatment is to achieve a state of remission or low disease activity. Criteria for minimal disease activity (MDA) have been established. Achieving MDA leads to better health-related quality of life (HRQOL), as well as less joint damage. In a prospective cohort study that included 240 patients with newly diagnosed disease-modifying antirheumatic drug-naive PsA, Snoeck Henkemans and colleagues demonstrate that failure to achieve MDA in the first year after the diagnosis of PsA was associated with worse HRQOL and health status, functional impairment, fatigue, pain, and higher anxiety and depression. Compared with patients who achieved sustained MDA in the first year after diagnosis, those who did not achieve MDA had higher scores for pain, fatigue, and functional ability and higher anxiety and depression during follow-up, which persisted despite treatment intensification. Thus, implementation of treat-to-target strategies with the aim of achieving sustained MDA within 1 year of diagnosis is likely to have better long-term benefits in this lifelong disease.

Another study emphasized the need for early treatment to improve long-term outcomes. In a post hoc analysis of two phase 3 trials including 1554 patients with PsA who received 300-mg or 150-mg secukinumab with or without a loading dose, Mease and colleagues showed that high baseline radiographic damage reduced the likelihood of achieving MDA.

Overall, these studies indicate that early diagnosis and treatment prior to developing joint damage with the aim to achieve sustained MDA within a year will lead to better long-term outcome for patients with PsA.

Appropriate assessment of MSK symptoms and signs by dermatologists may lead to more appropriate referral to rheumatologists. MSUS is being increasingly explored for early identification of PsA. A handheld, chip-based ultrasound device (HHUD) is a novel promising instrument that can be easily implemented in clinical practice. In a prospective study including 140 patients with psoriasis who presented to dermatologists with arthralgia. Grobelski and colleagues screened for PsA using medical history, CE, and the German Psoriasis Arthritis Diagnostic PsA screening questionnaire (GEPARD) paired with MSUS examination of up to three painful joints by trained dermatologists. Nineteen patients (13.6%) were diagnosed with PsA by rheumatologists. Interestingly, in 45 of the 46 patients the preliminary diagnosis of PsA was revised to "no PsA" after MSUS. The addition of MSUS changed the sensitivity and specificity of early PsA screening strategy from 88.2% and 54.4% to 70.6% and 90.4%, respectively. The positive predictive value increased to 56.5% from 25.4% after MSUS. Thus, the use of a quick MSUS using HHUD may lead to more accurate referral to rheumatologists. The challenge is seamless integration of MSUS into busy dermatology practices.

The goal of PsA treatment is to achieve a state of remission or low disease activity. Criteria for minimal disease activity (MDA) have been established. Achieving MDA leads to better health-related quality of life (HRQOL), as well as less joint damage. In a prospective cohort study that included 240 patients with newly diagnosed disease-modifying antirheumatic drug-naive PsA, Snoeck Henkemans and colleagues demonstrate that failure to achieve MDA in the first year after the diagnosis of PsA was associated with worse HRQOL and health status, functional impairment, fatigue, pain, and higher anxiety and depression. Compared with patients who achieved sustained MDA in the first year after diagnosis, those who did not achieve MDA had higher scores for pain, fatigue, and functional ability and higher anxiety and depression during follow-up, which persisted despite treatment intensification. Thus, implementation of treat-to-target strategies with the aim of achieving sustained MDA within 1 year of diagnosis is likely to have better long-term benefits in this lifelong disease.

Another study emphasized the need for early treatment to improve long-term outcomes. In a post hoc analysis of two phase 3 trials including 1554 patients with PsA who received 300-mg or 150-mg secukinumab with or without a loading dose, Mease and colleagues showed that high baseline radiographic damage reduced the likelihood of achieving MDA.

Overall, these studies indicate that early diagnosis and treatment prior to developing joint damage with the aim to achieve sustained MDA within a year will lead to better long-term outcome for patients with PsA.

SAN DIEGO – Evidence of melanoma in the ancient past is rare, but according to James W. Patterson, MD, signs of melanoma with cutaneous lesions and diffuse bony metastases have been discovered in Peruvian Inca mummies.

“Radiocarbon dating indicated that these mummies were 2,400 years old,” Dr. Patterson, professor emeritus of pathology and dermatology at the University of Virginia, Charlottesville, said at the annual Cutaneous Malignancy Update.

In 1820, William Norris, a general practitioner from Stourbridge, England, published the first English language report of melanoma in the Edinburgh Medical and Surgical Journal. “The report was titled ‘A case of fungoid disease,’ so it appears that melanoma was often regarded as a fungal infection back then,” Dr. Patterson said. In the report, Dr. Norris described the tumor in a 59-year-old man as “nearly half the size of a hen’s egg, of a deep brown color, of a firm and fleshy feel, [and] ulcerated on its surface.” Dr. Norris authored a later work titled “Eight cases of melanosis, with pathological and therapeutical remarks on that disease.”

In 1840, a full 2 decades following the first published report from Dr. Norris, the British surgeon Samuel Cooper published a book titled “First Lines of Theory and Practice of Surgery,” in which he described patients with advanced stage melanoma as untreatable and postulated that the only chance for survival was early removal of the tumor.

Dr. Patterson reported having no relevant disclosures.

SAN DIEGO – Evidence of melanoma in the ancient past is rare, but according to James W. Patterson, MD, signs of melanoma with cutaneous lesions and diffuse bony metastases have been discovered in Peruvian Inca mummies.

“Radiocarbon dating indicated that these mummies were 2,400 years old,” Dr. Patterson, professor emeritus of pathology and dermatology at the University of Virginia, Charlottesville, said at the annual Cutaneous Malignancy Update.

In 1820, William Norris, a general practitioner from Stourbridge, England, published the first English language report of melanoma in the Edinburgh Medical and Surgical Journal. “The report was titled ‘A case of fungoid disease,’ so it appears that melanoma was often regarded as a fungal infection back then,” Dr. Patterson said. In the report, Dr. Norris described the tumor in a 59-year-old man as “nearly half the size of a hen’s egg, of a deep brown color, of a firm and fleshy feel, [and] ulcerated on its surface.” Dr. Norris authored a later work titled “Eight cases of melanosis, with pathological and therapeutical remarks on that disease.”

In 1840, a full 2 decades following the first published report from Dr. Norris, the British surgeon Samuel Cooper published a book titled “First Lines of Theory and Practice of Surgery,” in which he described patients with advanced stage melanoma as untreatable and postulated that the only chance for survival was early removal of the tumor.

Dr. Patterson reported having no relevant disclosures.

SAN DIEGO – Evidence of melanoma in the ancient past is rare, but according to James W. Patterson, MD, signs of melanoma with cutaneous lesions and diffuse bony metastases have been discovered in Peruvian Inca mummies.

“Radiocarbon dating indicated that these mummies were 2,400 years old,” Dr. Patterson, professor emeritus of pathology and dermatology at the University of Virginia, Charlottesville, said at the annual Cutaneous Malignancy Update.

In 1820, William Norris, a general practitioner from Stourbridge, England, published the first English language report of melanoma in the Edinburgh Medical and Surgical Journal. “The report was titled ‘A case of fungoid disease,’ so it appears that melanoma was often regarded as a fungal infection back then,” Dr. Patterson said. In the report, Dr. Norris described the tumor in a 59-year-old man as “nearly half the size of a hen’s egg, of a deep brown color, of a firm and fleshy feel, [and] ulcerated on its surface.” Dr. Norris authored a later work titled “Eight cases of melanosis, with pathological and therapeutical remarks on that disease.”

In 1840, a full 2 decades following the first published report from Dr. Norris, the British surgeon Samuel Cooper published a book titled “First Lines of Theory and Practice of Surgery,” in which he described patients with advanced stage melanoma as untreatable and postulated that the only chance for survival was early removal of the tumor.

Dr. Patterson reported having no relevant disclosures.

THE CASE

A 14-year-old boy sought care at our clinic for persistent chest pain after being hit in the chest with a teammate’s shoulder during a basketball game 3 weeks earlier. He had aching midsternal chest pain that worsened with direct pressure and when he sneezed, twisted, or bent forward. There was no bruising or swelling.

On examination, the patient demonstrated normal perfusion and normal work of breathing. He had focal tenderness with palpation at the manubrium with no noticeable step-off, and mild tenderness at the adjacent costochondral junctions and over his pectoral muscles. His sternal pain along the proximal sternum was reproducible with a weighted wall push-up. Although the patient maintained full range of motion in his upper extremities, he did have sternal pain with flexion, abduction, and external rotation of the bilateral upper extremities against resistance. Anteroposterior (AP) and lateral chest radiographs were unremarkable.

THE DIAGNOSIS

The unremarkable chest radiographs prompted further investigation with a diagnostic ultrasound, which revealed a small cortical defect with overlying anechoic fluid collection in the area of focal tenderness. T2-weighted magnetic resonance imaging (MRI) of the chest was performed; it revealed a transverse, nondisplaced fracture of the superior body of the sternum with surrounding bone marrow edema (FIGURE).

DISCUSSION

Fractures of the sternum comprise < 1% of traumatic fractures and have a low mortality rate (0.7%).^1,2 The rarity of these fractures is attributed to the ribs’ elastic recoil, which protects the chest wall from anterior ­forces.^1,3 These fractures are even more unusual in children due to the increased elasticity of their chest walls.^4-6 Thus, it takes a significant amount of force for a child’s sternum to fracture.

While isolated sternum fractures can occur, two-thirds of sternum fractures are nonisolated and are associated with injuries to surrounding structures (including the heart, lungs, and vasculature) or fractures of the ribs and spine.^2,3 Most often, these injuries are caused by significant blunt trauma to the anterior chest, rapid deceleration, or flexion-­compression injury.^2,3 They are typically transverse and localized, with 70% of fractures occurring in the mid-body and 17.6% at the manubriosternal joint.^1,3,6

Athletes with a sternal fracture typically present as our patient did, with a history of blunt force trauma to the chest and with pain and tenderness over the anterior midline of the chest that increases with respiration or movement.¹ A physical examination that includes chest palpation and auscultation of the heart and lungs must be performed to rule out damage to intrathoracic structures and assess the patient’s cardiac and pulmonary stability. An electrocardiogram should be performed to confirm that there are no cardiovascular complications.^3,4

Initial imaging should include AP and lateral chest radiographs because any displacement will occur in the sagittal plane.^1,2,4-6 If the radiograph shows no clear pathology, follow up with computed tomography, ultrasound, MRI, or technetium bone scans to gain additional information.¹ Diagnosis of sternal fractures is especially difficult in children due to the presence of ossification centers for bone growth, which may be misinterpreted as a sternal fracture in the absence of a proper understanding of sternal development.^5,6 On ultrasound, sternal fractures appear as a sharp step-off in the cortex, whereas in the absence of fracture, there is no cortical step-off and the cartilaginous plate between ossification centers appears in line with the cortex.⁷

Continue to: A self-limiting injury that requires proper pain control

 

 

A self-limiting injury that requires proper pain control

Isolated sternal fractures are typically self-limiting with a good prognosis.² These injuries are managed supportively with rest, ice, and analgesics¹; proper pain control is crucial to prevent respiratory compromise.⁸

Complete recovery for most patients occurs in 10 to 12 weeks.⁹ Recovery periods longer than 12 weeks are associated with nonisolated sternal fractures that are complicated by soft-tissue injury, injuries to the chest wall (such as sternoclavicular joint dislocation, usually from a fall on the shoulder), or fracture nonunion.^1,2,5

Although sternum fractures are rare in pediatric patients, twothirds of these fractures are associated with injuries to surrounding structures.

Anterior sternoclavicular joint dislocations and stable posterior dislocations are managed with closed reduction and immobilization in a figure-of-eight brace.¹ Operative management is reserved for patients with displaced fractures, sternal deformity, chest wall instability, respiratory insufficiency, uncontrolled pain, or fracture nonunion.^1,3,8

A return-to-play protocol can begin once the patient is asymptomatic.¹ The timeframe for a full return to play can vary from 6 weeks to 6 months, depending on the severity of the fracture.¹ This process is guided by how quickly the symptoms resolve and by radiographic stability.⁹

Our patient was followed every 3 to 4 weeks and started physical therapy 6 weeks after his injury occurred. He was held from play for 10 weeks and gradually returned to play; he returned to full-contact activity after tolerating a practice without pain.

THE TAKEAWAY

Children typically have greater chest wall elasticity, and thus, it is unusual for them to sustain a sternal fracture. Diagnosis in children is complicated by the presence of ossification centers for bone growth on imaging. In this case, the fracture was first noticed on ultrasound and confirmed with MRI. Since these fractures can be associated with damage to surrounding structures, additional injuries should be considered when evaluating a patient with a sternum fracture.

CORRESPONDENCE
Catherine Romaine, East Carolina University, Brody School of Medicine, 600 Moye Boulevard, Greenville, NC 27834; romainec19@students.ecu.edu

THE CASE

A 14-year-old boy sought care at our clinic for persistent chest pain after being hit in the chest with a teammate’s shoulder during a basketball game 3 weeks earlier. He had aching midsternal chest pain that worsened with direct pressure and when he sneezed, twisted, or bent forward. There was no bruising or swelling.

On examination, the patient demonstrated normal perfusion and normal work of breathing. He had focal tenderness with palpation at the manubrium with no noticeable step-off, and mild tenderness at the adjacent costochondral junctions and over his pectoral muscles. His sternal pain along the proximal sternum was reproducible with a weighted wall push-up. Although the patient maintained full range of motion in his upper extremities, he did have sternal pain with flexion, abduction, and external rotation of the bilateral upper extremities against resistance. Anteroposterior (AP) and lateral chest radiographs were unremarkable.

THE DIAGNOSIS

The unremarkable chest radiographs prompted further investigation with a diagnostic ultrasound, which revealed a small cortical defect with overlying anechoic fluid collection in the area of focal tenderness. T2-weighted magnetic resonance imaging (MRI) of the chest was performed; it revealed a transverse, nondisplaced fracture of the superior body of the sternum with surrounding bone marrow edema (FIGURE).

DISCUSSION

Fractures of the sternum comprise < 1% of traumatic fractures and have a low mortality rate (0.7%).^1,2 The rarity of these fractures is attributed to the ribs’ elastic recoil, which protects the chest wall from anterior ­forces.^1,3 These fractures are even more unusual in children due to the increased elasticity of their chest walls.^4-6 Thus, it takes a significant amount of force for a child’s sternum to fracture.

While isolated sternum fractures can occur, two-thirds of sternum fractures are nonisolated and are associated with injuries to surrounding structures (including the heart, lungs, and vasculature) or fractures of the ribs and spine.^2,3 Most often, these injuries are caused by significant blunt trauma to the anterior chest, rapid deceleration, or flexion-­compression injury.^2,3 They are typically transverse and localized, with 70% of fractures occurring in the mid-body and 17.6% at the manubriosternal joint.^1,3,6

Athletes with a sternal fracture typically present as our patient did, with a history of blunt force trauma to the chest and with pain and tenderness over the anterior midline of the chest that increases with respiration or movement.¹ A physical examination that includes chest palpation and auscultation of the heart and lungs must be performed to rule out damage to intrathoracic structures and assess the patient’s cardiac and pulmonary stability. An electrocardiogram should be performed to confirm that there are no cardiovascular complications.^3,4

Initial imaging should include AP and lateral chest radiographs because any displacement will occur in the sagittal plane.^1,2,4-6 If the radiograph shows no clear pathology, follow up with computed tomography, ultrasound, MRI, or technetium bone scans to gain additional information.¹ Diagnosis of sternal fractures is especially difficult in children due to the presence of ossification centers for bone growth, which may be misinterpreted as a sternal fracture in the absence of a proper understanding of sternal development.^5,6 On ultrasound, sternal fractures appear as a sharp step-off in the cortex, whereas in the absence of fracture, there is no cortical step-off and the cartilaginous plate between ossification centers appears in line with the cortex.⁷

Continue to: A self-limiting injury that requires proper pain control

 

 

A self-limiting injury that requires proper pain control

Isolated sternal fractures are typically self-limiting with a good prognosis.² These injuries are managed supportively with rest, ice, and analgesics¹; proper pain control is crucial to prevent respiratory compromise.⁸

Complete recovery for most patients occurs in 10 to 12 weeks.⁹ Recovery periods longer than 12 weeks are associated with nonisolated sternal fractures that are complicated by soft-tissue injury, injuries to the chest wall (such as sternoclavicular joint dislocation, usually from a fall on the shoulder), or fracture nonunion.^1,2,5

Although sternum fractures are rare in pediatric patients, twothirds of these fractures are associated with injuries to surrounding structures.

Anterior sternoclavicular joint dislocations and stable posterior dislocations are managed with closed reduction and immobilization in a figure-of-eight brace.¹ Operative management is reserved for patients with displaced fractures, sternal deformity, chest wall instability, respiratory insufficiency, uncontrolled pain, or fracture nonunion.^1,3,8

A return-to-play protocol can begin once the patient is asymptomatic.¹ The timeframe for a full return to play can vary from 6 weeks to 6 months, depending on the severity of the fracture.¹ This process is guided by how quickly the symptoms resolve and by radiographic stability.⁹

Our patient was followed every 3 to 4 weeks and started physical therapy 6 weeks after his injury occurred. He was held from play for 10 weeks and gradually returned to play; he returned to full-contact activity after tolerating a practice without pain.

THE TAKEAWAY

Children typically have greater chest wall elasticity, and thus, it is unusual for them to sustain a sternal fracture. Diagnosis in children is complicated by the presence of ossification centers for bone growth on imaging. In this case, the fracture was first noticed on ultrasound and confirmed with MRI. Since these fractures can be associated with damage to surrounding structures, additional injuries should be considered when evaluating a patient with a sternum fracture.

CORRESPONDENCE
Catherine Romaine, East Carolina University, Brody School of Medicine, 600 Moye Boulevard, Greenville, NC 27834; romainec19@students.ecu.edu

THE CASE

A 14-year-old boy sought care at our clinic for persistent chest pain after being hit in the chest with a teammate’s shoulder during a basketball game 3 weeks earlier. He had aching midsternal chest pain that worsened with direct pressure and when he sneezed, twisted, or bent forward. There was no bruising or swelling.

On examination, the patient demonstrated normal perfusion and normal work of breathing. He had focal tenderness with palpation at the manubrium with no noticeable step-off, and mild tenderness at the adjacent costochondral junctions and over his pectoral muscles. His sternal pain along the proximal sternum was reproducible with a weighted wall push-up. Although the patient maintained full range of motion in his upper extremities, he did have sternal pain with flexion, abduction, and external rotation of the bilateral upper extremities against resistance. Anteroposterior (AP) and lateral chest radiographs were unremarkable.

THE DIAGNOSIS

The unremarkable chest radiographs prompted further investigation with a diagnostic ultrasound, which revealed a small cortical defect with overlying anechoic fluid collection in the area of focal tenderness. T2-weighted magnetic resonance imaging (MRI) of the chest was performed; it revealed a transverse, nondisplaced fracture of the superior body of the sternum with surrounding bone marrow edema (FIGURE).

DISCUSSION

Fractures of the sternum comprise < 1% of traumatic fractures and have a low mortality rate (0.7%).^1,2 The rarity of these fractures is attributed to the ribs’ elastic recoil, which protects the chest wall from anterior ­forces.^1,3 These fractures are even more unusual in children due to the increased elasticity of their chest walls.^4-6 Thus, it takes a significant amount of force for a child’s sternum to fracture.

While isolated sternum fractures can occur, two-thirds of sternum fractures are nonisolated and are associated with injuries to surrounding structures (including the heart, lungs, and vasculature) or fractures of the ribs and spine.^2,3 Most often, these injuries are caused by significant blunt trauma to the anterior chest, rapid deceleration, or flexion-­compression injury.^2,3 They are typically transverse and localized, with 70% of fractures occurring in the mid-body and 17.6% at the manubriosternal joint.^1,3,6

Athletes with a sternal fracture typically present as our patient did, with a history of blunt force trauma to the chest and with pain and tenderness over the anterior midline of the chest that increases with respiration or movement.¹ A physical examination that includes chest palpation and auscultation of the heart and lungs must be performed to rule out damage to intrathoracic structures and assess the patient’s cardiac and pulmonary stability. An electrocardiogram should be performed to confirm that there are no cardiovascular complications.^3,4

Initial imaging should include AP and lateral chest radiographs because any displacement will occur in the sagittal plane.^1,2,4-6 If the radiograph shows no clear pathology, follow up with computed tomography, ultrasound, MRI, or technetium bone scans to gain additional information.¹ Diagnosis of sternal fractures is especially difficult in children due to the presence of ossification centers for bone growth, which may be misinterpreted as a sternal fracture in the absence of a proper understanding of sternal development.^5,6 On ultrasound, sternal fractures appear as a sharp step-off in the cortex, whereas in the absence of fracture, there is no cortical step-off and the cartilaginous plate between ossification centers appears in line with the cortex.⁷

Continue to: A self-limiting injury that requires proper pain control

 

 

A self-limiting injury that requires proper pain control

Isolated sternal fractures are typically self-limiting with a good prognosis.² These injuries are managed supportively with rest, ice, and analgesics¹; proper pain control is crucial to prevent respiratory compromise.⁸

Complete recovery for most patients occurs in 10 to 12 weeks.⁹ Recovery periods longer than 12 weeks are associated with nonisolated sternal fractures that are complicated by soft-tissue injury, injuries to the chest wall (such as sternoclavicular joint dislocation, usually from a fall on the shoulder), or fracture nonunion.^1,2,5

Although sternum fractures are rare in pediatric patients, twothirds of these fractures are associated with injuries to surrounding structures.

Anterior sternoclavicular joint dislocations and stable posterior dislocations are managed with closed reduction and immobilization in a figure-of-eight brace.¹ Operative management is reserved for patients with displaced fractures, sternal deformity, chest wall instability, respiratory insufficiency, uncontrolled pain, or fracture nonunion.^1,3,8

A return-to-play protocol can begin once the patient is asymptomatic.¹ The timeframe for a full return to play can vary from 6 weeks to 6 months, depending on the severity of the fracture.¹ This process is guided by how quickly the symptoms resolve and by radiographic stability.⁹

Our patient was followed every 3 to 4 weeks and started physical therapy 6 weeks after his injury occurred. He was held from play for 10 weeks and gradually returned to play; he returned to full-contact activity after tolerating a practice without pain.

THE TAKEAWAY

Children typically have greater chest wall elasticity, and thus, it is unusual for them to sustain a sternal fracture. Diagnosis in children is complicated by the presence of ossification centers for bone growth on imaging. In this case, the fracture was first noticed on ultrasound and confirmed with MRI. Since these fractures can be associated with damage to surrounding structures, additional injuries should be considered when evaluating a patient with a sternum fracture.

CORRESPONDENCE
Catherine Romaine, East Carolina University, Brody School of Medicine, 600 Moye Boulevard, Greenville, NC 27834; romainec19@students.ecu.edu

ILLUSTRATIVE CASE

A 52-year-old woman presents to the emergency department complaining of dysuria and a fever. Her work-up yields a diagnosis of sepsis secondary to pyelonephritis and bacteremia. She is admitted and started on broad-spectrum antimicrobial therapy. The patient’s symptoms improve significantly over the next 48 hours of treatment. When should antibiotic therapy be discontinued to reduce the patient’s risk for antibiotic-associated AEs and to optimize antimicrobial stewardship?

Antimicrobial resistance is a growing public health risk associated with considerable morbidity and mortality, extended hospitalization, and increased medical expenditures.^2-4 Antibiotic stewardship is vital in curbing antimicrobial resistance. The predictive biomarker PCT has emerged as both a diagnostic and prognostic agent for numerous infectious diseases. It has recently received much attention as an adjunct to clinical judgment for discontinuation of antibiotic therapy in hospitalized patients with lower respiratory tract infections and/or sepsis.^5-11 Indeed, use of PCT guidance in these patients has resulted in decreased AEs, as well as an enhanced survival benefit.^5-15

The utility of PCT-guided early discontinuation of antibiotics had yet to be studied in an expanded population of hospitalized patients with sepsis—especially with regard to AEs associated with multidrug-resistant organisms (MDROs) and Clostridioides difficile (formerly Clostridium difficile). The Surviving Sepsis Campaign’s 2021 international guidelines support the use of PCT in conjunction with clinical evaluation for shortening the duration of antibiotic therapy (“weak recommendation, low quality of evidence”).¹⁶ They also suggest daily reassessment for de-­escalation of antibiotic use (“weak recommendation, very low quality of evidence”) as a possible way to decrease MDROs and AEs but state that more and better trials are needed.¹⁵

STUDY SUMMARY

PCT-guided intervention reduced infection-associated AEs

This pragmatic, real-world, multicenter, randomized clinical trial evaluated the use of PCT-guided early discontinuation of antibiotic therapy in patients with sepsis, in hopes of decreasing infection-associated AEs related to prolonged antibiotic exposure.¹ The trial took place in 7 hospitals in Athens, Greece, with 266 patients randomized to the PCT-guided intervention or the standard of care (SOC)—the 2016 international guidelines for the management of sepsis and septic shock from the Surviving Sepsis campaign.¹⁷ Study participants had sepsis, as defined by a sequential organ failure assessment (SOFA) score ≥ 2, and infections that included pneumonia, pyelonephritis, or bacteremia.¹⁶ Pregnancy, lactation, HIV infection with a low CD4 count, neutropenia, cystic fibrosis, and viral, parasitic, or tuberculosis infections were exclusion criteria. Of note, all patients were managed on general medical wards and not in intensive care units.

This trial demonstrated the benefit of PCT-guided antimicrobial therapy in reducing infection-associated AEs, length of antibiotic treatment, and 28-day mortality for patients with sepsis.

Serum PCT samples were collected at baseline and then at Day 5 of therapy. ­Discontinuation of antibiotic therapy in the PCT trial arm occurred once PCT levels were ≤ 0.5 mcg/L or were reduced by at least 80%. If PCT levels did not meet one of these criteria, the lab test would be repeated daily and antibiotic therapy would continue until the rule was met. Neither patients nor investigators were blinded to the treatment assignments, but investigators in the SOC arm were kept unaware of Day 5 PCT results. In the PCT arm, 71% of participants met Day 5 criteria for stopping antibiotics, and a retrospective analysis indicated that a near-identical 70% in the SOC arm also would have met the same criteria.

The assessment of stool colonization with either C difficile or MDROs was done by stool cultures at baseline and on Days 7, 28, and 180.

The primary outcome of infection-­associated AEs, which was evaluated at 180 days, was defined as new cases of C difficile or MDRO infection, or death associated with baseline infection with either C difficile or an MDRO. Of the 133 participants allocated to each trial arm, 8 patients in the intervention group and 2 in the SOC group withdrew consent prior to treatment in the intervention group, with the remaining 125 and 131 participants, respectively, completing the interventions and not lost to follow-up.

Continue to: In an intention-to-treat analysis...

In an intention-to-treat analysis, 9 participants (7.2%; 95% CI, 3.8%-13.1%) in the PCT group compared with 20 participants (15.3%; 95% CI, 10.1%-22.4%) in the SOC group experienced the primary outcome of an antibiotic-associated AE at 180 days, resulting in a hazard ratio (HR) of 0.45 (95% CI, 0.2-0.98).

Secondary outcomes also favored the PCT arm regarding 28-day mortality (19 vs 37 patients; HR = 0.51; 95% CI, 0.29-0.89), median length of antibiotic treatment (5 days in the PCT group and 10 days in the SOC group; P < .001), and median hospitalization cost (24% greater in the SOC group; P = .05). Results for 180-day mortality were 30.4% in the PCT arm and 38.2% in the SOC arm (HR = 0.71; 95% CI, 0.42-1.19), thereby not achieving statistical significance.

WHAT'S NEW

An effective tool in reducing AEs in patients with sepsis

In this multicenter trial, PCT proved successful as a clinical decision tool for discontinuing antibiotic therapy and decreasing infection-associated AEs in patients with sepsis.

Caveats

A promising approach but its superiority is uncertain

The confidence interval for the AE hazard ratio was very wide, but significant, suggesting greater uncertainty and less precision in the chance of obtaining improved outcomes with PCT-guided intervention. However, these data also clarify that outcomes should (at least) not be worse with PCT-directed therapy.

CHALLENGES TO IMPLEMENTATION

Assay limitations and potential resistance to a new decision tool

The primary challenge to implementation is likely the availability of the PCT assay and the immediacy of turnaround time to enable physicians to make daily decisions regarding antibiotic therapy de-escalation. Additionally, as with any new knowledge, local culture and physician buy-in may limit implementation of this ever-more-valuable patient care tool.

ILLUSTRATIVE CASE

A 52-year-old woman presents to the emergency department complaining of dysuria and a fever. Her work-up yields a diagnosis of sepsis secondary to pyelonephritis and bacteremia. She is admitted and started on broad-spectrum antimicrobial therapy. The patient’s symptoms improve significantly over the next 48 hours of treatment. When should antibiotic therapy be discontinued to reduce the patient’s risk for antibiotic-associated AEs and to optimize antimicrobial stewardship?

Antimicrobial resistance is a growing public health risk associated with considerable morbidity and mortality, extended hospitalization, and increased medical expenditures.^2-4 Antibiotic stewardship is vital in curbing antimicrobial resistance. The predictive biomarker PCT has emerged as both a diagnostic and prognostic agent for numerous infectious diseases. It has recently received much attention as an adjunct to clinical judgment for discontinuation of antibiotic therapy in hospitalized patients with lower respiratory tract infections and/or sepsis.^5-11 Indeed, use of PCT guidance in these patients has resulted in decreased AEs, as well as an enhanced survival benefit.^5-15

The utility of PCT-guided early discontinuation of antibiotics had yet to be studied in an expanded population of hospitalized patients with sepsis—especially with regard to AEs associated with multidrug-resistant organisms (MDROs) and Clostridioides difficile (formerly Clostridium difficile). The Surviving Sepsis Campaign’s 2021 international guidelines support the use of PCT in conjunction with clinical evaluation for shortening the duration of antibiotic therapy (“weak recommendation, low quality of evidence”).¹⁶ They also suggest daily reassessment for de-­escalation of antibiotic use (“weak recommendation, very low quality of evidence”) as a possible way to decrease MDROs and AEs but state that more and better trials are needed.¹⁵

STUDY SUMMARY

PCT-guided intervention reduced infection-associated AEs

This pragmatic, real-world, multicenter, randomized clinical trial evaluated the use of PCT-guided early discontinuation of antibiotic therapy in patients with sepsis, in hopes of decreasing infection-associated AEs related to prolonged antibiotic exposure.¹ The trial took place in 7 hospitals in Athens, Greece, with 266 patients randomized to the PCT-guided intervention or the standard of care (SOC)—the 2016 international guidelines for the management of sepsis and septic shock from the Surviving Sepsis campaign.¹⁷ Study participants had sepsis, as defined by a sequential organ failure assessment (SOFA) score ≥ 2, and infections that included pneumonia, pyelonephritis, or bacteremia.¹⁶ Pregnancy, lactation, HIV infection with a low CD4 count, neutropenia, cystic fibrosis, and viral, parasitic, or tuberculosis infections were exclusion criteria. Of note, all patients were managed on general medical wards and not in intensive care units.

This trial demonstrated the benefit of PCT-guided antimicrobial therapy in reducing infection-associated AEs, length of antibiotic treatment, and 28-day mortality for patients with sepsis.

Serum PCT samples were collected at baseline and then at Day 5 of therapy. ­Discontinuation of antibiotic therapy in the PCT trial arm occurred once PCT levels were ≤ 0.5 mcg/L or were reduced by at least 80%. If PCT levels did not meet one of these criteria, the lab test would be repeated daily and antibiotic therapy would continue until the rule was met. Neither patients nor investigators were blinded to the treatment assignments, but investigators in the SOC arm were kept unaware of Day 5 PCT results. In the PCT arm, 71% of participants met Day 5 criteria for stopping antibiotics, and a retrospective analysis indicated that a near-identical 70% in the SOC arm also would have met the same criteria.

The assessment of stool colonization with either C difficile or MDROs was done by stool cultures at baseline and on Days 7, 28, and 180.

The primary outcome of infection-­associated AEs, which was evaluated at 180 days, was defined as new cases of C difficile or MDRO infection, or death associated with baseline infection with either C difficile or an MDRO. Of the 133 participants allocated to each trial arm, 8 patients in the intervention group and 2 in the SOC group withdrew consent prior to treatment in the intervention group, with the remaining 125 and 131 participants, respectively, completing the interventions and not lost to follow-up.

Continue to: In an intention-to-treat analysis...

In an intention-to-treat analysis, 9 participants (7.2%; 95% CI, 3.8%-13.1%) in the PCT group compared with 20 participants (15.3%; 95% CI, 10.1%-22.4%) in the SOC group experienced the primary outcome of an antibiotic-associated AE at 180 days, resulting in a hazard ratio (HR) of 0.45 (95% CI, 0.2-0.98).

Secondary outcomes also favored the PCT arm regarding 28-day mortality (19 vs 37 patients; HR = 0.51; 95% CI, 0.29-0.89), median length of antibiotic treatment (5 days in the PCT group and 10 days in the SOC group; P < .001), and median hospitalization cost (24% greater in the SOC group; P = .05). Results for 180-day mortality were 30.4% in the PCT arm and 38.2% in the SOC arm (HR = 0.71; 95% CI, 0.42-1.19), thereby not achieving statistical significance.

WHAT'S NEW

An effective tool in reducing AEs in patients with sepsis

In this multicenter trial, PCT proved successful as a clinical decision tool for discontinuing antibiotic therapy and decreasing infection-associated AEs in patients with sepsis.

Caveats

A promising approach but its superiority is uncertain

The confidence interval for the AE hazard ratio was very wide, but significant, suggesting greater uncertainty and less precision in the chance of obtaining improved outcomes with PCT-guided intervention. However, these data also clarify that outcomes should (at least) not be worse with PCT-directed therapy.

CHALLENGES TO IMPLEMENTATION

Assay limitations and potential resistance to a new decision tool

The primary challenge to implementation is likely the availability of the PCT assay and the immediacy of turnaround time to enable physicians to make daily decisions regarding antibiotic therapy de-escalation. Additionally, as with any new knowledge, local culture and physician buy-in may limit implementation of this ever-more-valuable patient care tool.

ILLUSTRATIVE CASE

A 52-year-old woman presents to the emergency department complaining of dysuria and a fever. Her work-up yields a diagnosis of sepsis secondary to pyelonephritis and bacteremia. She is admitted and started on broad-spectrum antimicrobial therapy. The patient’s symptoms improve significantly over the next 48 hours of treatment. When should antibiotic therapy be discontinued to reduce the patient’s risk for antibiotic-associated AEs and to optimize antimicrobial stewardship?

Antimicrobial resistance is a growing public health risk associated with considerable morbidity and mortality, extended hospitalization, and increased medical expenditures.^2-4 Antibiotic stewardship is vital in curbing antimicrobial resistance. The predictive biomarker PCT has emerged as both a diagnostic and prognostic agent for numerous infectious diseases. It has recently received much attention as an adjunct to clinical judgment for discontinuation of antibiotic therapy in hospitalized patients with lower respiratory tract infections and/or sepsis.^5-11 Indeed, use of PCT guidance in these patients has resulted in decreased AEs, as well as an enhanced survival benefit.^5-15

The utility of PCT-guided early discontinuation of antibiotics had yet to be studied in an expanded population of hospitalized patients with sepsis—especially with regard to AEs associated with multidrug-resistant organisms (MDROs) and Clostridioides difficile (formerly Clostridium difficile). The Surviving Sepsis Campaign’s 2021 international guidelines support the use of PCT in conjunction with clinical evaluation for shortening the duration of antibiotic therapy (“weak recommendation, low quality of evidence”).¹⁶ They also suggest daily reassessment for de-­escalation of antibiotic use (“weak recommendation, very low quality of evidence”) as a possible way to decrease MDROs and AEs but state that more and better trials are needed.¹⁵

STUDY SUMMARY

PCT-guided intervention reduced infection-associated AEs

This pragmatic, real-world, multicenter, randomized clinical trial evaluated the use of PCT-guided early discontinuation of antibiotic therapy in patients with sepsis, in hopes of decreasing infection-associated AEs related to prolonged antibiotic exposure.¹ The trial took place in 7 hospitals in Athens, Greece, with 266 patients randomized to the PCT-guided intervention or the standard of care (SOC)—the 2016 international guidelines for the management of sepsis and septic shock from the Surviving Sepsis campaign.¹⁷ Study participants had sepsis, as defined by a sequential organ failure assessment (SOFA) score ≥ 2, and infections that included pneumonia, pyelonephritis, or bacteremia.¹⁶ Pregnancy, lactation, HIV infection with a low CD4 count, neutropenia, cystic fibrosis, and viral, parasitic, or tuberculosis infections were exclusion criteria. Of note, all patients were managed on general medical wards and not in intensive care units.

This trial demonstrated the benefit of PCT-guided antimicrobial therapy in reducing infection-associated AEs, length of antibiotic treatment, and 28-day mortality for patients with sepsis.

Serum PCT samples were collected at baseline and then at Day 5 of therapy. ­Discontinuation of antibiotic therapy in the PCT trial arm occurred once PCT levels were ≤ 0.5 mcg/L or were reduced by at least 80%. If PCT levels did not meet one of these criteria, the lab test would be repeated daily and antibiotic therapy would continue until the rule was met. Neither patients nor investigators were blinded to the treatment assignments, but investigators in the SOC arm were kept unaware of Day 5 PCT results. In the PCT arm, 71% of participants met Day 5 criteria for stopping antibiotics, and a retrospective analysis indicated that a near-identical 70% in the SOC arm also would have met the same criteria.

The assessment of stool colonization with either C difficile or MDROs was done by stool cultures at baseline and on Days 7, 28, and 180.

The primary outcome of infection-­associated AEs, which was evaluated at 180 days, was defined as new cases of C difficile or MDRO infection, or death associated with baseline infection with either C difficile or an MDRO. Of the 133 participants allocated to each trial arm, 8 patients in the intervention group and 2 in the SOC group withdrew consent prior to treatment in the intervention group, with the remaining 125 and 131 participants, respectively, completing the interventions and not lost to follow-up.

Continue to: In an intention-to-treat analysis...

In an intention-to-treat analysis, 9 participants (7.2%; 95% CI, 3.8%-13.1%) in the PCT group compared with 20 participants (15.3%; 95% CI, 10.1%-22.4%) in the SOC group experienced the primary outcome of an antibiotic-associated AE at 180 days, resulting in a hazard ratio (HR) of 0.45 (95% CI, 0.2-0.98).

Secondary outcomes also favored the PCT arm regarding 28-day mortality (19 vs 37 patients; HR = 0.51; 95% CI, 0.29-0.89), median length of antibiotic treatment (5 days in the PCT group and 10 days in the SOC group; P < .001), and median hospitalization cost (24% greater in the SOC group; P = .05). Results for 180-day mortality were 30.4% in the PCT arm and 38.2% in the SOC arm (HR = 0.71; 95% CI, 0.42-1.19), thereby not achieving statistical significance.

WHAT'S NEW

An effective tool in reducing AEs in patients with sepsis

In this multicenter trial, PCT proved successful as a clinical decision tool for discontinuing antibiotic therapy and decreasing infection-associated AEs in patients with sepsis.

Caveats

A promising approach but its superiority is uncertain

The confidence interval for the AE hazard ratio was very wide, but significant, suggesting greater uncertainty and less precision in the chance of obtaining improved outcomes with PCT-guided intervention. However, these data also clarify that outcomes should (at least) not be worse with PCT-directed therapy.

CHALLENGES TO IMPLEMENTATION

Assay limitations and potential resistance to a new decision tool

The primary challenge to implementation is likely the availability of the PCT assay and the immediacy of turnaround time to enable physicians to make daily decisions regarding antibiotic therapy de-escalation. Additionally, as with any new knowledge, local culture and physician buy-in may limit implementation of this ever-more-valuable patient care tool.