A real-time, computer-aided detection system using artificial intelligence significantly improved adenoma detection during high-definition colonoscopy in a multicenter, randomized clinical trial.

The adenoma detection rate was 55% in the intervention group and 40% in the control group, Alessandro Repici, MD, PhD, and his associates wrote in Gastroenterology. Improved detection of smaller adenomas explained the difference. After age, sex, and indication for colonoscopy were controlled for, computer-aided detection (CADe) increased the probability of adenoma detection by 30% (risk ratio, 1.30; 95% confidence interval, 1.14-1.45).

The CADe system did not increase the likelihood of resecting non-neoplastic lesions (26% versus 29% in the control group), said Dr. Repici, of Humanitas Research Hospital in Milano, Italy. “The per-protocol analysis produced similar results,” he and his associates wrote. “The substantial improvement for adenoma detection rate and mean number of adenomas per colonoscopy, without increasing the removal of nonneoplastic lesions, is likely to improve the quality of colonoscopy without affecting its efficiency.”

Screening colonoscopies miss about 25% of adenomas, increasing patients’ risk for colorectal cancer. Although real-time CADe systems can identify colorectal neoplasias, comprehensive studies of the effect of CADe systems on adenoma detection and other colonoscopy quality measures are lacking.

The study included 685 adults from three centers in Italy who underwent screening colonoscopies for colorectal cancer, postpolypectomy surveillance, or workup based on a positive fecal immunochemical test or signs and symptoms of colorectal cancer. Patients were randomly assigned on a one-to-one basis to receive high-definition colonoscopies with or without the CADe system, which consists of an artificial intelligence–based medical device (GI Genius, Medtronic) that processes colonoscopy images in real time and superimposes a green box over suspected lesions. Six experienced endoscopists performed the colonoscopies; the minimum withdrawal time was 6 minutes, and histopathology was the reference standard.

The average number of adenomas detected per colonoscopy was 1.1 (standard deviation, 0.5) in the CADe group and 0.7 (SD, 1.2) in the control group, for an incidence rate ratio of 1.46 (95% CI, 1.15-1.86). The CADe system also significantly improved the detection of adenomas measuring 5 mm or less (34% vs. 27% in the control group; RR, 1.26; 95% CI, 1.01-1.52) and adenomas measuring 6-9 mm (11% vs. 6%, respectively; RR, 1.78; 95% CI, 1.09-2.86). Detection of larger adenomas did not significantly differ between groups. These findings did not vary based on adenoma morphology (polypoid or nonpolypoid) or location (proximal or distal colon), the researchers said.

Detection of multiple adenomas also was higher in the intervention group than in the control group (23% vs. 15%, respectively; RR, 1.50; 95% CI, 1.19-1.95). There were no significant differences in the detection of sessile serrated lesions (7% and 5%) and nonneoplastic lesions (20% and 17%). Average withdrawal times did not significantly differ between groups (417 seconds for CADe and 435 seconds for the control group).

The CADe system is a convolutional neural network that was trained and validated using a series of more than 2,600 histologically confirmed polyps from 840 participants in a prior clinical trial (Gastroenterology 2019;156:2198-207.e1). The system takes an average of 1.5 microseconds to output processed images.

“The addition of real-time CADe to colonoscopy resulted in a 30% and 46% relative increase in adenoma detection rate and the average number of adenomas detected per colonoscopy, demonstrating its efficacy in improving the detection of colorectal neoplasia at screening and diagnostic colonoscopy,” the investigators wrote. “[The s]afety of CADe was demonstrated by the lack of increase of both useless resections and withdrawal time, as well as by the exclusion of any underskilling in the study period.”

Medtronic loaned the equipment for the study. Dr. Repici and the senior author disclosed consulting fees from Medtronic.

SOURCE: Repici A et al. Gastroenterology. 2020 May 3. doi: 10.1053/j.gastro.2020.04.062.

A real-time, computer-aided detection system using artificial intelligence significantly improved adenoma detection during high-definition colonoscopy in a multicenter, randomized clinical trial.

The adenoma detection rate was 55% in the intervention group and 40% in the control group, Alessandro Repici, MD, PhD, and his associates wrote in Gastroenterology. Improved detection of smaller adenomas explained the difference. After age, sex, and indication for colonoscopy were controlled for, computer-aided detection (CADe) increased the probability of adenoma detection by 30% (risk ratio, 1.30; 95% confidence interval, 1.14-1.45).

The CADe system did not increase the likelihood of resecting non-neoplastic lesions (26% versus 29% in the control group), said Dr. Repici, of Humanitas Research Hospital in Milano, Italy. “The per-protocol analysis produced similar results,” he and his associates wrote. “The substantial improvement for adenoma detection rate and mean number of adenomas per colonoscopy, without increasing the removal of nonneoplastic lesions, is likely to improve the quality of colonoscopy without affecting its efficiency.”

Screening colonoscopies miss about 25% of adenomas, increasing patients’ risk for colorectal cancer. Although real-time CADe systems can identify colorectal neoplasias, comprehensive studies of the effect of CADe systems on adenoma detection and other colonoscopy quality measures are lacking.

The study included 685 adults from three centers in Italy who underwent screening colonoscopies for colorectal cancer, postpolypectomy surveillance, or workup based on a positive fecal immunochemical test or signs and symptoms of colorectal cancer. Patients were randomly assigned on a one-to-one basis to receive high-definition colonoscopies with or without the CADe system, which consists of an artificial intelligence–based medical device (GI Genius, Medtronic) that processes colonoscopy images in real time and superimposes a green box over suspected lesions. Six experienced endoscopists performed the colonoscopies; the minimum withdrawal time was 6 minutes, and histopathology was the reference standard.

The average number of adenomas detected per colonoscopy was 1.1 (standard deviation, 0.5) in the CADe group and 0.7 (SD, 1.2) in the control group, for an incidence rate ratio of 1.46 (95% CI, 1.15-1.86). The CADe system also significantly improved the detection of adenomas measuring 5 mm or less (34% vs. 27% in the control group; RR, 1.26; 95% CI, 1.01-1.52) and adenomas measuring 6-9 mm (11% vs. 6%, respectively; RR, 1.78; 95% CI, 1.09-2.86). Detection of larger adenomas did not significantly differ between groups. These findings did not vary based on adenoma morphology (polypoid or nonpolypoid) or location (proximal or distal colon), the researchers said.

Detection of multiple adenomas also was higher in the intervention group than in the control group (23% vs. 15%, respectively; RR, 1.50; 95% CI, 1.19-1.95). There were no significant differences in the detection of sessile serrated lesions (7% and 5%) and nonneoplastic lesions (20% and 17%). Average withdrawal times did not significantly differ between groups (417 seconds for CADe and 435 seconds for the control group).

The CADe system is a convolutional neural network that was trained and validated using a series of more than 2,600 histologically confirmed polyps from 840 participants in a prior clinical trial (Gastroenterology 2019;156:2198-207.e1). The system takes an average of 1.5 microseconds to output processed images.

“The addition of real-time CADe to colonoscopy resulted in a 30% and 46% relative increase in adenoma detection rate and the average number of adenomas detected per colonoscopy, demonstrating its efficacy in improving the detection of colorectal neoplasia at screening and diagnostic colonoscopy,” the investigators wrote. “[The s]afety of CADe was demonstrated by the lack of increase of both useless resections and withdrawal time, as well as by the exclusion of any underskilling in the study period.”

Medtronic loaned the equipment for the study. Dr. Repici and the senior author disclosed consulting fees from Medtronic.

SOURCE: Repici A et al. Gastroenterology. 2020 May 3. doi: 10.1053/j.gastro.2020.04.062.

A real-time, computer-aided detection system using artificial intelligence significantly improved adenoma detection during high-definition colonoscopy in a multicenter, randomized clinical trial.

The adenoma detection rate was 55% in the intervention group and 40% in the control group, Alessandro Repici, MD, PhD, and his associates wrote in Gastroenterology. Improved detection of smaller adenomas explained the difference. After age, sex, and indication for colonoscopy were controlled for, computer-aided detection (CADe) increased the probability of adenoma detection by 30% (risk ratio, 1.30; 95% confidence interval, 1.14-1.45).

The CADe system did not increase the likelihood of resecting non-neoplastic lesions (26% versus 29% in the control group), said Dr. Repici, of Humanitas Research Hospital in Milano, Italy. “The per-protocol analysis produced similar results,” he and his associates wrote. “The substantial improvement for adenoma detection rate and mean number of adenomas per colonoscopy, without increasing the removal of nonneoplastic lesions, is likely to improve the quality of colonoscopy without affecting its efficiency.”

Screening colonoscopies miss about 25% of adenomas, increasing patients’ risk for colorectal cancer. Although real-time CADe systems can identify colorectal neoplasias, comprehensive studies of the effect of CADe systems on adenoma detection and other colonoscopy quality measures are lacking.

The study included 685 adults from three centers in Italy who underwent screening colonoscopies for colorectal cancer, postpolypectomy surveillance, or workup based on a positive fecal immunochemical test or signs and symptoms of colorectal cancer. Patients were randomly assigned on a one-to-one basis to receive high-definition colonoscopies with or without the CADe system, which consists of an artificial intelligence–based medical device (GI Genius, Medtronic) that processes colonoscopy images in real time and superimposes a green box over suspected lesions. Six experienced endoscopists performed the colonoscopies; the minimum withdrawal time was 6 minutes, and histopathology was the reference standard.

The average number of adenomas detected per colonoscopy was 1.1 (standard deviation, 0.5) in the CADe group and 0.7 (SD, 1.2) in the control group, for an incidence rate ratio of 1.46 (95% CI, 1.15-1.86). The CADe system also significantly improved the detection of adenomas measuring 5 mm or less (34% vs. 27% in the control group; RR, 1.26; 95% CI, 1.01-1.52) and adenomas measuring 6-9 mm (11% vs. 6%, respectively; RR, 1.78; 95% CI, 1.09-2.86). Detection of larger adenomas did not significantly differ between groups. These findings did not vary based on adenoma morphology (polypoid or nonpolypoid) or location (proximal or distal colon), the researchers said.

Detection of multiple adenomas also was higher in the intervention group than in the control group (23% vs. 15%, respectively; RR, 1.50; 95% CI, 1.19-1.95). There were no significant differences in the detection of sessile serrated lesions (7% and 5%) and nonneoplastic lesions (20% and 17%). Average withdrawal times did not significantly differ between groups (417 seconds for CADe and 435 seconds for the control group).

The CADe system is a convolutional neural network that was trained and validated using a series of more than 2,600 histologically confirmed polyps from 840 participants in a prior clinical trial (Gastroenterology 2019;156:2198-207.e1). The system takes an average of 1.5 microseconds to output processed images.

“The addition of real-time CADe to colonoscopy resulted in a 30% and 46% relative increase in adenoma detection rate and the average number of adenomas detected per colonoscopy, demonstrating its efficacy in improving the detection of colorectal neoplasia at screening and diagnostic colonoscopy,” the investigators wrote. “[The s]afety of CADe was demonstrated by the lack of increase of both useless resections and withdrawal time, as well as by the exclusion of any underskilling in the study period.”

Medtronic loaned the equipment for the study. Dr. Repici and the senior author disclosed consulting fees from Medtronic.

SOURCE: Repici A et al. Gastroenterology. 2020 May 3. doi: 10.1053/j.gastro.2020.04.062.

High-definition chromoendoscopy significantly outperformed high-definition white-light endoscopy for detecting dysplastic lesions in patients with inflammatory bowel disease, according to the findings of a single-center prospective randomized trial.

In the intention-to-diagnose analysis, rates of dysplasia detection were 11% for high-definition chromoendoscopy and 5% for high-definition white-light endoscopy (P = .032). The per-protocol analysis produced a similar result (12% vs. 5%, respectively; P = .027). High-definition chromoendoscopy also detected significantly more dysplastic lesions per 10 minutes of colonoscope withdrawal time in the per-protocol analysis, although the difference did not reach statistical significance in the intention-to-diagnose analysis.

Overall, the findings “support the use of chromoendoscopy for surveillance of patients with inflammatory bowel diseases,” Bjarki Alexandersson, a PhD student at Karolinska University Hospital in Solna, Stockholm, and his associates wrote in Clinical Gastroenterology and Hepatology. Patients with inflammatory bowel disease are at increased risk for colorectal cancer. Most guidelines support chromoendoscopy for the surveillance of these patients, as do the results of two recent meta-analyses in which chromoendoscopy detected significantly more dysplasias among patients with inflammatory bowel disease than did white light endoscopy. However, in subgroup analyses of these studies, the difference only emerged when comparing chromoendoscopy with standard (not high-definition) white-light endoscopy. “Thus, the evidence in support of chromoendoscopy using high-definition endoscopes is weak,” the researchers wrote.

For the study, they prospectively enrolled 305 patients with ulcerative colitis or Crohn’s disease who were referred for surveillance colonoscopy at an academic hospital in Sweden from March 2011 through April 2016. Participants were randomly assigned to receive either high-definition chromoendoscopy with indigo carmine (152 patients) or high-definition white-light endoscopy (153 patients).

In the intention-to-diagnose analysis, dysplasias were detected in 17 (11%) patients evaluated by high-definition chromoendoscopy, compared with 7 (5%) patients evaluated by high-definition white-light endoscopy (P = .032). After excluding 20 patients for inadequate bowel preparation, 18 patients for protocol violations, and 4 patients for incomplete colonoscopies, the per-protocol population consisted of 263 patients. Dysplasias were detected in 12% of patients evaluated by high-definition chromoendoscopy and in 5% of those evaluated by high-definition white-light endoscopy (P = .027).

All patients also had 32 samples collected by random biopsy, which used to be standard for detecting dysplasia in inflammatory bowel disease but has become more controversial in the era of video endoscopy, the researchers noted. In all, random biopsy evaluation identified dysplasias in nine patients, including six in the high-definition chromoendoscopy group and three in the high-definition white-light endoscopy group. Random biopsies were low-yield, identifying dysplasias in 0.092% of all specimens and 3% of colonoscopies. However, 20% of patients with dysplasias were identified only through random biopsy. This finding resembles that of another recent randomized trial in which 13% of patients with inflammatory bowel disease had dysplasias detected only through random biopsy (Gut. 2018;67:616-24), the researchers noted.

They also evaluated the number of macroscopic dysplastic lesions identified for every 10 minutes of colonoscope withdrawal time. These numbers were not significantly different in the intention-to-diagnose analysis (0.066 lesions in the high-definition chromoendoscopy group vs. 0.027 lesions in the high-definition white-light endoscopy group; P = .056). However, the per-protocol analysis revealed a significant difference (0.073 vs. 0.029 dysplastic lesions, respectively; P = .031).

“Based on our findings, we recommend the use of high-definition chromoendoscopy in inflammatory bowel disease surveillance,” the researchers concluded. They acknowledged several limitations: the study included patients from only one center, most dyplastic lesions were small and, thus, had an unclear natural history, and the endoscopists included both experts and nonexperts.

The Stockholm City Council provided funding. The researchers reported having no conflicts of interest.

SOURCE: Alexandersson B et al. Clin Gastroenterol Hepatol. 2020 Apr 27. doi: 10.1016/j.cgh.2020.04.049.

High-definition chromoendoscopy significantly outperformed high-definition white-light endoscopy for detecting dysplastic lesions in patients with inflammatory bowel disease, according to the findings of a single-center prospective randomized trial.

In the intention-to-diagnose analysis, rates of dysplasia detection were 11% for high-definition chromoendoscopy and 5% for high-definition white-light endoscopy (P = .032). The per-protocol analysis produced a similar result (12% vs. 5%, respectively; P = .027). High-definition chromoendoscopy also detected significantly more dysplastic lesions per 10 minutes of colonoscope withdrawal time in the per-protocol analysis, although the difference did not reach statistical significance in the intention-to-diagnose analysis.

Overall, the findings “support the use of chromoendoscopy for surveillance of patients with inflammatory bowel diseases,” Bjarki Alexandersson, a PhD student at Karolinska University Hospital in Solna, Stockholm, and his associates wrote in Clinical Gastroenterology and Hepatology. Patients with inflammatory bowel disease are at increased risk for colorectal cancer. Most guidelines support chromoendoscopy for the surveillance of these patients, as do the results of two recent meta-analyses in which chromoendoscopy detected significantly more dysplasias among patients with inflammatory bowel disease than did white light endoscopy. However, in subgroup analyses of these studies, the difference only emerged when comparing chromoendoscopy with standard (not high-definition) white-light endoscopy. “Thus, the evidence in support of chromoendoscopy using high-definition endoscopes is weak,” the researchers wrote.

For the study, they prospectively enrolled 305 patients with ulcerative colitis or Crohn’s disease who were referred for surveillance colonoscopy at an academic hospital in Sweden from March 2011 through April 2016. Participants were randomly assigned to receive either high-definition chromoendoscopy with indigo carmine (152 patients) or high-definition white-light endoscopy (153 patients).

In the intention-to-diagnose analysis, dysplasias were detected in 17 (11%) patients evaluated by high-definition chromoendoscopy, compared with 7 (5%) patients evaluated by high-definition white-light endoscopy (P = .032). After excluding 20 patients for inadequate bowel preparation, 18 patients for protocol violations, and 4 patients for incomplete colonoscopies, the per-protocol population consisted of 263 patients. Dysplasias were detected in 12% of patients evaluated by high-definition chromoendoscopy and in 5% of those evaluated by high-definition white-light endoscopy (P = .027).

All patients also had 32 samples collected by random biopsy, which used to be standard for detecting dysplasia in inflammatory bowel disease but has become more controversial in the era of video endoscopy, the researchers noted. In all, random biopsy evaluation identified dysplasias in nine patients, including six in the high-definition chromoendoscopy group and three in the high-definition white-light endoscopy group. Random biopsies were low-yield, identifying dysplasias in 0.092% of all specimens and 3% of colonoscopies. However, 20% of patients with dysplasias were identified only through random biopsy. This finding resembles that of another recent randomized trial in which 13% of patients with inflammatory bowel disease had dysplasias detected only through random biopsy (Gut. 2018;67:616-24), the researchers noted.

They also evaluated the number of macroscopic dysplastic lesions identified for every 10 minutes of colonoscope withdrawal time. These numbers were not significantly different in the intention-to-diagnose analysis (0.066 lesions in the high-definition chromoendoscopy group vs. 0.027 lesions in the high-definition white-light endoscopy group; P = .056). However, the per-protocol analysis revealed a significant difference (0.073 vs. 0.029 dysplastic lesions, respectively; P = .031).

“Based on our findings, we recommend the use of high-definition chromoendoscopy in inflammatory bowel disease surveillance,” the researchers concluded. They acknowledged several limitations: the study included patients from only one center, most dyplastic lesions were small and, thus, had an unclear natural history, and the endoscopists included both experts and nonexperts.

The Stockholm City Council provided funding. The researchers reported having no conflicts of interest.

SOURCE: Alexandersson B et al. Clin Gastroenterol Hepatol. 2020 Apr 27. doi: 10.1016/j.cgh.2020.04.049.

High-definition chromoendoscopy significantly outperformed high-definition white-light endoscopy for detecting dysplastic lesions in patients with inflammatory bowel disease, according to the findings of a single-center prospective randomized trial.

In the intention-to-diagnose analysis, rates of dysplasia detection were 11% for high-definition chromoendoscopy and 5% for high-definition white-light endoscopy (P = .032). The per-protocol analysis produced a similar result (12% vs. 5%, respectively; P = .027). High-definition chromoendoscopy also detected significantly more dysplastic lesions per 10 minutes of colonoscope withdrawal time in the per-protocol analysis, although the difference did not reach statistical significance in the intention-to-diagnose analysis.

Overall, the findings “support the use of chromoendoscopy for surveillance of patients with inflammatory bowel diseases,” Bjarki Alexandersson, a PhD student at Karolinska University Hospital in Solna, Stockholm, and his associates wrote in Clinical Gastroenterology and Hepatology. Patients with inflammatory bowel disease are at increased risk for colorectal cancer. Most guidelines support chromoendoscopy for the surveillance of these patients, as do the results of two recent meta-analyses in which chromoendoscopy detected significantly more dysplasias among patients with inflammatory bowel disease than did white light endoscopy. However, in subgroup analyses of these studies, the difference only emerged when comparing chromoendoscopy with standard (not high-definition) white-light endoscopy. “Thus, the evidence in support of chromoendoscopy using high-definition endoscopes is weak,” the researchers wrote.

For the study, they prospectively enrolled 305 patients with ulcerative colitis or Crohn’s disease who were referred for surveillance colonoscopy at an academic hospital in Sweden from March 2011 through April 2016. Participants were randomly assigned to receive either high-definition chromoendoscopy with indigo carmine (152 patients) or high-definition white-light endoscopy (153 patients).

In the intention-to-diagnose analysis, dysplasias were detected in 17 (11%) patients evaluated by high-definition chromoendoscopy, compared with 7 (5%) patients evaluated by high-definition white-light endoscopy (P = .032). After excluding 20 patients for inadequate bowel preparation, 18 patients for protocol violations, and 4 patients for incomplete colonoscopies, the per-protocol population consisted of 263 patients. Dysplasias were detected in 12% of patients evaluated by high-definition chromoendoscopy and in 5% of those evaluated by high-definition white-light endoscopy (P = .027).

All patients also had 32 samples collected by random biopsy, which used to be standard for detecting dysplasia in inflammatory bowel disease but has become more controversial in the era of video endoscopy, the researchers noted. In all, random biopsy evaluation identified dysplasias in nine patients, including six in the high-definition chromoendoscopy group and three in the high-definition white-light endoscopy group. Random biopsies were low-yield, identifying dysplasias in 0.092% of all specimens and 3% of colonoscopies. However, 20% of patients with dysplasias were identified only through random biopsy. This finding resembles that of another recent randomized trial in which 13% of patients with inflammatory bowel disease had dysplasias detected only through random biopsy (Gut. 2018;67:616-24), the researchers noted.

They also evaluated the number of macroscopic dysplastic lesions identified for every 10 minutes of colonoscope withdrawal time. These numbers were not significantly different in the intention-to-diagnose analysis (0.066 lesions in the high-definition chromoendoscopy group vs. 0.027 lesions in the high-definition white-light endoscopy group; P = .056). However, the per-protocol analysis revealed a significant difference (0.073 vs. 0.029 dysplastic lesions, respectively; P = .031).

“Based on our findings, we recommend the use of high-definition chromoendoscopy in inflammatory bowel disease surveillance,” the researchers concluded. They acknowledged several limitations: the study included patients from only one center, most dyplastic lesions were small and, thus, had an unclear natural history, and the endoscopists included both experts and nonexperts.

The Stockholm City Council provided funding. The researchers reported having no conflicts of interest.

SOURCE: Alexandersson B et al. Clin Gastroenterol Hepatol. 2020 Apr 27. doi: 10.1016/j.cgh.2020.04.049.

Patients with early onset cancers have an increased prevalence of germline pathogenic variants, suggesting that genetic testing would be worthwhile in this population, according to a presentation at the AACR virtual meeting II.

Investigators analyzed blood samples from 1,201 patients who were aged 18-39 years when diagnosed with a solid tumor malignancy.

In this group, there were 877 patients with early onset cancers, defined as cancers for which 39 years of age is greater than 1 standard deviation below the mean age of diagnosis for the cancer type.

The remaining 324 patients had young adult cancers, defined as cancers for which 39 years of age is less than 1 standard deviation below the mean age of diagnosis.

The most common early onset cancers were breast, colorectal, kidney, pancreas, and ovarian cancer.

The most common young adult cancers were sarcoma, brain cancer, and testicular cancer, as expected, said investigator Zsofia K. Stadler, MD, of Memorial Sloan Kettering Cancer Center in New York.

Dr. Stadler and colleagues performed next-generation sequencing of the patient samples using a panel of up to 88 genes previously implicated in cancer predisposition. This revealed a significantly higher prevalence of germline mutations in patients with early onset cancers than in those with young adult cancers – 21% and 13%, respectively (P = .002).

In patients with only high- and moderate-risk cancer susceptibility genes, the prevalence was 15% in the early onset group and 10% in the young adult group (P = .01). “Among the early onset cancer group, pancreas, breast, and kidney cancer patients harbored the highest rates of germline mutations,” Dr. Stadler said, noting that the spectrum of mutated genes differed in early onset and young adult cancer patients.

“In early onset patients, the most commonly mutated genes were BRCA1 and BRCA2 [4.9%], Lynch syndrome genes [2.2%], ATM [1.6%], and CHECK2 [1.7%],” Dr. Stadler said. “On the other hand, in young adults, TP53 mutations [2.2%], and SDHA and SDHB mutations dominated [1.9%], with the majority of mutations occurring in sarcoma patients.”

These findings suggest the prevalence of inherited cancer susceptibility syndromes in young adults with cancer is not uniform.

“We found a very high prevalence of germline mutations in young patients with cancer types that typically present at later ages,” Dr. Stadler said, referring to the early onset patients.

Conversely, the young adult cancer patients had a prevalence and spectrum of mutations more similar to what is seen in pediatric cancer populations, she noted.

The findings are surprising, according to AACR past president Elaine R. Mardis, PhD, of The Ohio State University in Columbus.

Dr. Mardis said the results show that, in young adults with early onset cancers, “the germline prevalence of these mutations is significantly higher than we had previously thought.”

“Although representing only about 4% of all cancers, young adults with cancer ... face unique challenges,” Dr. Stadler said. “Identifying whether a young patient’s cancer occurred in the setting of an inherited cancer predisposition syndrome is especially important in this patient population.”

Such knowledge “can significantly impact the risk of second primary cancers and the need for increased surveillance measures or even risk-reducing surgeries,” Dr. Stadler explained. She added that it can also have implications for identifying at-risk family members, such as younger siblings or children who should pursue genetic testing and appropriate prevention measures.

“Our results suggest that, among patients with early onset cancer, the increased prevalence of germline mutations supports a role for genetic testing, irrespective of tumor type,” Dr. Stadler said.

This study was partially funded by the Precision, Interception and Prevention Program, the Robert and Katie Niehaus Center for Inherited Cancer Genomics, the Marie-Josee and Henry R. Kravis Center for Molecular Oncology, and a National Cancer Institute Cancer Center Core Grant. Dr. Stadler reported that an immediate family member serves as a consultant in ophthalmology for Allergan, Adverum Biotechnologies, Alimera Sciences, BioMarin, Fortress Biotech, Genentech/Roche, Novartis, Optos, Regeneron, Regenxbio, and Spark Therapeutics. Dr. Mardis disclosed relationships with Qiagen NV, Pact Pharma LLC, Moderna Inc., and Interpreta LLC.

sworcester@mdedge.com

SOURCE: Stadler Z et al. AACR 2020, Abstract 1122.

Patients with early onset cancers have an increased prevalence of germline pathogenic variants, suggesting that genetic testing would be worthwhile in this population, according to a presentation at the AACR virtual meeting II.

Investigators analyzed blood samples from 1,201 patients who were aged 18-39 years when diagnosed with a solid tumor malignancy.

In this group, there were 877 patients with early onset cancers, defined as cancers for which 39 years of age is greater than 1 standard deviation below the mean age of diagnosis for the cancer type.

The remaining 324 patients had young adult cancers, defined as cancers for which 39 years of age is less than 1 standard deviation below the mean age of diagnosis.

The most common early onset cancers were breast, colorectal, kidney, pancreas, and ovarian cancer.

The most common young adult cancers were sarcoma, brain cancer, and testicular cancer, as expected, said investigator Zsofia K. Stadler, MD, of Memorial Sloan Kettering Cancer Center in New York.

Dr. Stadler and colleagues performed next-generation sequencing of the patient samples using a panel of up to 88 genes previously implicated in cancer predisposition. This revealed a significantly higher prevalence of germline mutations in patients with early onset cancers than in those with young adult cancers – 21% and 13%, respectively (P = .002).

In patients with only high- and moderate-risk cancer susceptibility genes, the prevalence was 15% in the early onset group and 10% in the young adult group (P = .01). “Among the early onset cancer group, pancreas, breast, and kidney cancer patients harbored the highest rates of germline mutations,” Dr. Stadler said, noting that the spectrum of mutated genes differed in early onset and young adult cancer patients.

“In early onset patients, the most commonly mutated genes were BRCA1 and BRCA2 [4.9%], Lynch syndrome genes [2.2%], ATM [1.6%], and CHECK2 [1.7%],” Dr. Stadler said. “On the other hand, in young adults, TP53 mutations [2.2%], and SDHA and SDHB mutations dominated [1.9%], with the majority of mutations occurring in sarcoma patients.”

These findings suggest the prevalence of inherited cancer susceptibility syndromes in young adults with cancer is not uniform.

“We found a very high prevalence of germline mutations in young patients with cancer types that typically present at later ages,” Dr. Stadler said, referring to the early onset patients.

Conversely, the young adult cancer patients had a prevalence and spectrum of mutations more similar to what is seen in pediatric cancer populations, she noted.

The findings are surprising, according to AACR past president Elaine R. Mardis, PhD, of The Ohio State University in Columbus.

Dr. Mardis said the results show that, in young adults with early onset cancers, “the germline prevalence of these mutations is significantly higher than we had previously thought.”

“Although representing only about 4% of all cancers, young adults with cancer ... face unique challenges,” Dr. Stadler said. “Identifying whether a young patient’s cancer occurred in the setting of an inherited cancer predisposition syndrome is especially important in this patient population.”

Such knowledge “can significantly impact the risk of second primary cancers and the need for increased surveillance measures or even risk-reducing surgeries,” Dr. Stadler explained. She added that it can also have implications for identifying at-risk family members, such as younger siblings or children who should pursue genetic testing and appropriate prevention measures.

“Our results suggest that, among patients with early onset cancer, the increased prevalence of germline mutations supports a role for genetic testing, irrespective of tumor type,” Dr. Stadler said.

This study was partially funded by the Precision, Interception and Prevention Program, the Robert and Katie Niehaus Center for Inherited Cancer Genomics, the Marie-Josee and Henry R. Kravis Center for Molecular Oncology, and a National Cancer Institute Cancer Center Core Grant. Dr. Stadler reported that an immediate family member serves as a consultant in ophthalmology for Allergan, Adverum Biotechnologies, Alimera Sciences, BioMarin, Fortress Biotech, Genentech/Roche, Novartis, Optos, Regeneron, Regenxbio, and Spark Therapeutics. Dr. Mardis disclosed relationships with Qiagen NV, Pact Pharma LLC, Moderna Inc., and Interpreta LLC.

sworcester@mdedge.com

SOURCE: Stadler Z et al. AACR 2020, Abstract 1122.

Patients with early onset cancers have an increased prevalence of germline pathogenic variants, suggesting that genetic testing would be worthwhile in this population, according to a presentation at the AACR virtual meeting II.

Investigators analyzed blood samples from 1,201 patients who were aged 18-39 years when diagnosed with a solid tumor malignancy.

In this group, there were 877 patients with early onset cancers, defined as cancers for which 39 years of age is greater than 1 standard deviation below the mean age of diagnosis for the cancer type.

The remaining 324 patients had young adult cancers, defined as cancers for which 39 years of age is less than 1 standard deviation below the mean age of diagnosis.

The most common early onset cancers were breast, colorectal, kidney, pancreas, and ovarian cancer.

The most common young adult cancers were sarcoma, brain cancer, and testicular cancer, as expected, said investigator Zsofia K. Stadler, MD, of Memorial Sloan Kettering Cancer Center in New York.

Dr. Stadler and colleagues performed next-generation sequencing of the patient samples using a panel of up to 88 genes previously implicated in cancer predisposition. This revealed a significantly higher prevalence of germline mutations in patients with early onset cancers than in those with young adult cancers – 21% and 13%, respectively (P = .002).

In patients with only high- and moderate-risk cancer susceptibility genes, the prevalence was 15% in the early onset group and 10% in the young adult group (P = .01). “Among the early onset cancer group, pancreas, breast, and kidney cancer patients harbored the highest rates of germline mutations,” Dr. Stadler said, noting that the spectrum of mutated genes differed in early onset and young adult cancer patients.

“In early onset patients, the most commonly mutated genes were BRCA1 and BRCA2 [4.9%], Lynch syndrome genes [2.2%], ATM [1.6%], and CHECK2 [1.7%],” Dr. Stadler said. “On the other hand, in young adults, TP53 mutations [2.2%], and SDHA and SDHB mutations dominated [1.9%], with the majority of mutations occurring in sarcoma patients.”

These findings suggest the prevalence of inherited cancer susceptibility syndromes in young adults with cancer is not uniform.

“We found a very high prevalence of germline mutations in young patients with cancer types that typically present at later ages,” Dr. Stadler said, referring to the early onset patients.

Conversely, the young adult cancer patients had a prevalence and spectrum of mutations more similar to what is seen in pediatric cancer populations, she noted.

The findings are surprising, according to AACR past president Elaine R. Mardis, PhD, of The Ohio State University in Columbus.

Dr. Mardis said the results show that, in young adults with early onset cancers, “the germline prevalence of these mutations is significantly higher than we had previously thought.”

“Although representing only about 4% of all cancers, young adults with cancer ... face unique challenges,” Dr. Stadler said. “Identifying whether a young patient’s cancer occurred in the setting of an inherited cancer predisposition syndrome is especially important in this patient population.”

Such knowledge “can significantly impact the risk of second primary cancers and the need for increased surveillance measures or even risk-reducing surgeries,” Dr. Stadler explained. She added that it can also have implications for identifying at-risk family members, such as younger siblings or children who should pursue genetic testing and appropriate prevention measures.

“Our results suggest that, among patients with early onset cancer, the increased prevalence of germline mutations supports a role for genetic testing, irrespective of tumor type,” Dr. Stadler said.

This study was partially funded by the Precision, Interception and Prevention Program, the Robert and Katie Niehaus Center for Inherited Cancer Genomics, the Marie-Josee and Henry R. Kravis Center for Molecular Oncology, and a National Cancer Institute Cancer Center Core Grant. Dr. Stadler reported that an immediate family member serves as a consultant in ophthalmology for Allergan, Adverum Biotechnologies, Alimera Sciences, BioMarin, Fortress Biotech, Genentech/Roche, Novartis, Optos, Regeneron, Regenxbio, and Spark Therapeutics. Dr. Mardis disclosed relationships with Qiagen NV, Pact Pharma LLC, Moderna Inc., and Interpreta LLC.

sworcester@mdedge.com

SOURCE: Stadler Z et al. AACR 2020, Abstract 1122.

Swapping out intravenous fentanyl in favor of IV acetaminophen in patients with ST-elevation MI (STEMI) provides comparable pain relief but with desirably higher blood levels of ticagrelor both immediately after primary percutaneous intervention and 1 hour post procedure.

Bruce Jancin/Frontline Medical News

That’s according to results of the Dutch ON-TIME 3 trial, presented by Anne H. Tavenier, MD, at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“Our trial results have implications for the prehospital treatment of STEMI patients,” said Dr. Tavenier, a cardiologist at the Isala Clinic in Zwolle, the Netherlands.

The explanation for the success of this novel STEMI pain management strategy? The synthetic opioid fentanyl impairs gastrointestinal absorption of oral P2Y12 receptor antagonists such as ticagrelor. Opiates do so as well, whereas acetaminophen does not, she explained.

The potent platelet inhibition provided by oral P2Y12 inhibitors is crucial to successful primary PCI for STEMI. But these platelet inhibitory effects are inherently slowed in STEMI patients owing to hemodynamic changes and delayed GI absorption. And even though both American College of Cardiology/American Heart Association and European Society of Cardiology guidelines recommend the use of opioids for pain control in STEMI patients, the fact is that these medications further delay the absorption of oral P2Y12 inhibitors. And this delay is further exacerbated by the nausea and vomiting which are common side effects of IV fentanyl, she continued.

The impetus for the ON-TIME 3 trial was straightforward, the cardiologist said: “For years, STEMI patients have been treated with morphine or morphinelike drugs like fentanyl because of pain or sympathetic stress. To date, trials investigating alternative analgesics to opioids have been scarce.”

ON-TIME 3 was a multicenter, open-label, phase 4 clinical trial in which 195 STEMI patients with a self-reported pain score of at least 4 on a 0-10 scale received crushed ticagrelor in the ambulance along with either 1,000 mg of IV acetaminophen or fentanyl at 1-2 mcg/kg.

Ticagrelor blood levels were significantly higher in the IV acetaminophen group when measured just prior to primary PCI (151 ng/mL versus 60 ng/mL in the IV fentanyl group; immediately after PCI (326 versus 115 ng/mL), and 1 hour post PCI (488 versus 372 ng/mL).

However, there was no significant between-group difference in levels of platelet reactivity units measured immediately after primary PCI, Dr. Tavenier added.

Discussant Christoph K. Naber, MD, PhD, confessed that prior to ON-TIME 3 he was unaware that administering opioids to STEMI patients results in delayed absorption of oral P2Y12 inhibitors. Upon delving into the literature, however, he found that this is indeed a well-documented problem.

“The open question I have about this very elegant trial is whether the increased P2Y12 levels will translate into a measurable difference in clinical outcomes,” said Dr. Naber, an interventional cardiologist at the Wilhemshaven (Germany) Clinic.

The answer to that question would require a larger, longer-term trial. And he’s disinclined to wait around for that to happen.

“I think when we look at the risk balance, the risk of switching from an opioid to acetaminophen, if it works for the patient, is rather low. So this might be something to introduce in my practice,” the cardiologist said.

Dr. Tavenier and Dr. Naber reported having no financial conflicts of interest.

bjancin@mdedge.com

SOURCE: Tavenier AH. EuroPCR 2020.

Swapping out intravenous fentanyl in favor of IV acetaminophen in patients with ST-elevation MI (STEMI) provides comparable pain relief but with desirably higher blood levels of ticagrelor both immediately after primary percutaneous intervention and 1 hour post procedure.

Bruce Jancin/Frontline Medical News

That’s according to results of the Dutch ON-TIME 3 trial, presented by Anne H. Tavenier, MD, at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“Our trial results have implications for the prehospital treatment of STEMI patients,” said Dr. Tavenier, a cardiologist at the Isala Clinic in Zwolle, the Netherlands.

The explanation for the success of this novel STEMI pain management strategy? The synthetic opioid fentanyl impairs gastrointestinal absorption of oral P2Y12 receptor antagonists such as ticagrelor. Opiates do so as well, whereas acetaminophen does not, she explained.

The potent platelet inhibition provided by oral P2Y12 inhibitors is crucial to successful primary PCI for STEMI. But these platelet inhibitory effects are inherently slowed in STEMI patients owing to hemodynamic changes and delayed GI absorption. And even though both American College of Cardiology/American Heart Association and European Society of Cardiology guidelines recommend the use of opioids for pain control in STEMI patients, the fact is that these medications further delay the absorption of oral P2Y12 inhibitors. And this delay is further exacerbated by the nausea and vomiting which are common side effects of IV fentanyl, she continued.

The impetus for the ON-TIME 3 trial was straightforward, the cardiologist said: “For years, STEMI patients have been treated with morphine or morphinelike drugs like fentanyl because of pain or sympathetic stress. To date, trials investigating alternative analgesics to opioids have been scarce.”

ON-TIME 3 was a multicenter, open-label, phase 4 clinical trial in which 195 STEMI patients with a self-reported pain score of at least 4 on a 0-10 scale received crushed ticagrelor in the ambulance along with either 1,000 mg of IV acetaminophen or fentanyl at 1-2 mcg/kg.

Ticagrelor blood levels were significantly higher in the IV acetaminophen group when measured just prior to primary PCI (151 ng/mL versus 60 ng/mL in the IV fentanyl group; immediately after PCI (326 versus 115 ng/mL), and 1 hour post PCI (488 versus 372 ng/mL).

However, there was no significant between-group difference in levels of platelet reactivity units measured immediately after primary PCI, Dr. Tavenier added.

Discussant Christoph K. Naber, MD, PhD, confessed that prior to ON-TIME 3 he was unaware that administering opioids to STEMI patients results in delayed absorption of oral P2Y12 inhibitors. Upon delving into the literature, however, he found that this is indeed a well-documented problem.

“The open question I have about this very elegant trial is whether the increased P2Y12 levels will translate into a measurable difference in clinical outcomes,” said Dr. Naber, an interventional cardiologist at the Wilhemshaven (Germany) Clinic.

The answer to that question would require a larger, longer-term trial. And he’s disinclined to wait around for that to happen.

“I think when we look at the risk balance, the risk of switching from an opioid to acetaminophen, if it works for the patient, is rather low. So this might be something to introduce in my practice,” the cardiologist said.

Dr. Tavenier and Dr. Naber reported having no financial conflicts of interest.

bjancin@mdedge.com

SOURCE: Tavenier AH. EuroPCR 2020.

Swapping out intravenous fentanyl in favor of IV acetaminophen in patients with ST-elevation MI (STEMI) provides comparable pain relief but with desirably higher blood levels of ticagrelor both immediately after primary percutaneous intervention and 1 hour post procedure.

Bruce Jancin/Frontline Medical News

That’s according to results of the Dutch ON-TIME 3 trial, presented by Anne H. Tavenier, MD, at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“Our trial results have implications for the prehospital treatment of STEMI patients,” said Dr. Tavenier, a cardiologist at the Isala Clinic in Zwolle, the Netherlands.

The explanation for the success of this novel STEMI pain management strategy? The synthetic opioid fentanyl impairs gastrointestinal absorption of oral P2Y12 receptor antagonists such as ticagrelor. Opiates do so as well, whereas acetaminophen does not, she explained.

The potent platelet inhibition provided by oral P2Y12 inhibitors is crucial to successful primary PCI for STEMI. But these platelet inhibitory effects are inherently slowed in STEMI patients owing to hemodynamic changes and delayed GI absorption. And even though both American College of Cardiology/American Heart Association and European Society of Cardiology guidelines recommend the use of opioids for pain control in STEMI patients, the fact is that these medications further delay the absorption of oral P2Y12 inhibitors. And this delay is further exacerbated by the nausea and vomiting which are common side effects of IV fentanyl, she continued.

The impetus for the ON-TIME 3 trial was straightforward, the cardiologist said: “For years, STEMI patients have been treated with morphine or morphinelike drugs like fentanyl because of pain or sympathetic stress. To date, trials investigating alternative analgesics to opioids have been scarce.”

ON-TIME 3 was a multicenter, open-label, phase 4 clinical trial in which 195 STEMI patients with a self-reported pain score of at least 4 on a 0-10 scale received crushed ticagrelor in the ambulance along with either 1,000 mg of IV acetaminophen or fentanyl at 1-2 mcg/kg.

Ticagrelor blood levels were significantly higher in the IV acetaminophen group when measured just prior to primary PCI (151 ng/mL versus 60 ng/mL in the IV fentanyl group; immediately after PCI (326 versus 115 ng/mL), and 1 hour post PCI (488 versus 372 ng/mL).

However, there was no significant between-group difference in levels of platelet reactivity units measured immediately after primary PCI, Dr. Tavenier added.

Discussant Christoph K. Naber, MD, PhD, confessed that prior to ON-TIME 3 he was unaware that administering opioids to STEMI patients results in delayed absorption of oral P2Y12 inhibitors. Upon delving into the literature, however, he found that this is indeed a well-documented problem.

“The open question I have about this very elegant trial is whether the increased P2Y12 levels will translate into a measurable difference in clinical outcomes,” said Dr. Naber, an interventional cardiologist at the Wilhemshaven (Germany) Clinic.

The answer to that question would require a larger, longer-term trial. And he’s disinclined to wait around for that to happen.

“I think when we look at the risk balance, the risk of switching from an opioid to acetaminophen, if it works for the patient, is rather low. So this might be something to introduce in my practice,” the cardiologist said.

Dr. Tavenier and Dr. Naber reported having no financial conflicts of interest.

bjancin@mdedge.com

SOURCE: Tavenier AH. EuroPCR 2020.

Measuring success with a treat-to-target strategy in psoriatic arthritis patients proved to be more comprehensive with the Psoriatic Arthritis Disease Activity Score (PASDAS) than it was with the Disease Activity Score in 28 joints (DAS28), according to findings from a prospective cohort study.

Fewer patients had a low disease activity score according to DAS28, and a higher percentage of patients deemed adequately treated according to DAS28 were found to have residual disease activity, compared with the number of patients so categorized according to PASDAS, researcher Michelle Mulder reported in her presentation of the study at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

“PASDAS implementation in a tightly monitored PsA [psoriatic arthritis] cohort suggests relevant residual disease burden, even though DAS28 was measured at every visit previously,” said Ms. Mulder, an MD/PhD student at Sint Maartenskliniek in Nijmegen, The Netherlands.

The presentation was convincing to Philip Helliwell, MD, PhD, who is a professor of clinical rheumatology at Leeds (England) University, and was also one of the developers of PASDAS. “We know it can be used in clinical practice with a certain amount of organization and clinical staff to help you,” he said during another presentation at GRAPPA.

Treat to target is a widely accepted therapeutic strategy. It’s particularly common in rheumatoid arthritis, but increasing evidence suggests that it improves patient outcomes in psoriatic arthritis. DAS28 is frequently used in treat-to-target approaches in rheumatoid arthritis, and often gets applied to psoriatic arthritis since rheumatologists are already comfortable with it, according to Ms. Mulder. “However, DAS28 has shown some limitations when used in psoriatic arthritis. For example, its joint count is limited to only 28 joints, and it does not take all PsA domains into account,” she said.

DAS28 was previously used at Sint Maartenskliniek in combination with psoriatic arthritis–specific assessment recommendations, but the institution opted in 2019 to switch to PASDAS, which was developed by GRAPPA and the European League Against Rheumatism. “To better adhere to international PsA guidelines, we chose to implement PASDAS in our cohort with the assumption that it might improve patient care,” Ms. Mulder said.

With DAS28, clinicians measured the C-reactive protein (CRP) and Patient Global Visual Analog Scale (VAS) domains and were advised to examine 28 joints for tender and swollen joint count domains. Under the PASDAS guidance, clinicians examined 68 joints for tenderness, 66 joints for swelling, CRP, Patient Global VAS, Physician Global VAS, Leeds Enthesitis Index, dactylitis, and the 12-item Short Form Physical Composite Scale. They also examined the skin, nails, and axial disease.

To examine the effects of the switch from DAS28 to PASDAS, the researchers compared outcomes in 855 patients before and after the change during March to December 2019. The mean age of patients was 55 years, and 46% were female. The mean disease duration was 10 years, and the mean PASDAS score was 3.1. A total of 96% of participants were negative for anti-cyclic citrullinated peptide. Overall, 30% had arthritis, 9% had axial disease, 3% had dactylitis, 21% had enthesitis, 51% had skin disease, and 42% had nail disease.

About three-quarters (77.4%) of patients reached the threshold of low disease activity (LDA) according to the DAS28 measure, while 53.1% did so using the PASDAS. High disease activity occurred in 7.8% of patients according to DAS28, compared with 2.7% as measured by PASDAS. Patients who reached only the DAS28 LDA target but not the PASDAS target, compared with patients who reached the LDA target in both measures, had significantly worse counts for swelling in 66 joints (0.7 vs. 0.2; P < .001) and tenderness in 68 joints (2.1 vs. 0.7; P < .001), as well as worse scores for enthesitis (0.5 vs. 0.1; P < .001), dactylitis (4% vs. 1%; P = .005), patient global VAS (44.0 vs. 14.4; P < .001), Health Assessment Questionnaire (0.8 vs. 0.4; P < .001) and Patient Acceptable Symptom State (unacceptable score in 17% vs. 3%; P < .001).

Ms. Mulder acknowledged that PASDAS imposes a significant burden on clinicians, and noted that Sint Maartenskliniek created patient infrastructure to handle the load. “It’s very important that you set up your clinic in a specific way. When the patient comes in, we draw blood immediately and we ask them to fill in the questionnaires, and then they go to a specialized nurse who measures all the different components of the PASDAS. It took a lot of time to train the specialized nurses and to implement the PASDAS score in our electronic health records. After we did those things, it was quite easy because we have this whole setup. It takes time and it is difficult, but it is definitely possible to do it,” Ms. Mulder said during a live Q&A following her prerecorded presentation.

The study received no funding. Ms. Mulder had no relevant financial disclosures. Dr. Helliwell has financial ties to AbbVie, Amgen, Celgen, Galapagos, Janssen, Novartis, Pfizer, and UCB.

SOURCE: Mulder M et al. GRAPPA 2020 Virtual Annual Meeting.

Measuring success with a treat-to-target strategy in psoriatic arthritis patients proved to be more comprehensive with the Psoriatic Arthritis Disease Activity Score (PASDAS) than it was with the Disease Activity Score in 28 joints (DAS28), according to findings from a prospective cohort study.

Fewer patients had a low disease activity score according to DAS28, and a higher percentage of patients deemed adequately treated according to DAS28 were found to have residual disease activity, compared with the number of patients so categorized according to PASDAS, researcher Michelle Mulder reported in her presentation of the study at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

“PASDAS implementation in a tightly monitored PsA [psoriatic arthritis] cohort suggests relevant residual disease burden, even though DAS28 was measured at every visit previously,” said Ms. Mulder, an MD/PhD student at Sint Maartenskliniek in Nijmegen, The Netherlands.

The presentation was convincing to Philip Helliwell, MD, PhD, who is a professor of clinical rheumatology at Leeds (England) University, and was also one of the developers of PASDAS. “We know it can be used in clinical practice with a certain amount of organization and clinical staff to help you,” he said during another presentation at GRAPPA.

Treat to target is a widely accepted therapeutic strategy. It’s particularly common in rheumatoid arthritis, but increasing evidence suggests that it improves patient outcomes in psoriatic arthritis. DAS28 is frequently used in treat-to-target approaches in rheumatoid arthritis, and often gets applied to psoriatic arthritis since rheumatologists are already comfortable with it, according to Ms. Mulder. “However, DAS28 has shown some limitations when used in psoriatic arthritis. For example, its joint count is limited to only 28 joints, and it does not take all PsA domains into account,” she said.

DAS28 was previously used at Sint Maartenskliniek in combination with psoriatic arthritis–specific assessment recommendations, but the institution opted in 2019 to switch to PASDAS, which was developed by GRAPPA and the European League Against Rheumatism. “To better adhere to international PsA guidelines, we chose to implement PASDAS in our cohort with the assumption that it might improve patient care,” Ms. Mulder said.

With DAS28, clinicians measured the C-reactive protein (CRP) and Patient Global Visual Analog Scale (VAS) domains and were advised to examine 28 joints for tender and swollen joint count domains. Under the PASDAS guidance, clinicians examined 68 joints for tenderness, 66 joints for swelling, CRP, Patient Global VAS, Physician Global VAS, Leeds Enthesitis Index, dactylitis, and the 12-item Short Form Physical Composite Scale. They also examined the skin, nails, and axial disease.

To examine the effects of the switch from DAS28 to PASDAS, the researchers compared outcomes in 855 patients before and after the change during March to December 2019. The mean age of patients was 55 years, and 46% were female. The mean disease duration was 10 years, and the mean PASDAS score was 3.1. A total of 96% of participants were negative for anti-cyclic citrullinated peptide. Overall, 30% had arthritis, 9% had axial disease, 3% had dactylitis, 21% had enthesitis, 51% had skin disease, and 42% had nail disease.

About three-quarters (77.4%) of patients reached the threshold of low disease activity (LDA) according to the DAS28 measure, while 53.1% did so using the PASDAS. High disease activity occurred in 7.8% of patients according to DAS28, compared with 2.7% as measured by PASDAS. Patients who reached only the DAS28 LDA target but not the PASDAS target, compared with patients who reached the LDA target in both measures, had significantly worse counts for swelling in 66 joints (0.7 vs. 0.2; P < .001) and tenderness in 68 joints (2.1 vs. 0.7; P < .001), as well as worse scores for enthesitis (0.5 vs. 0.1; P < .001), dactylitis (4% vs. 1%; P = .005), patient global VAS (44.0 vs. 14.4; P < .001), Health Assessment Questionnaire (0.8 vs. 0.4; P < .001) and Patient Acceptable Symptom State (unacceptable score in 17% vs. 3%; P < .001).

Ms. Mulder acknowledged that PASDAS imposes a significant burden on clinicians, and noted that Sint Maartenskliniek created patient infrastructure to handle the load. “It’s very important that you set up your clinic in a specific way. When the patient comes in, we draw blood immediately and we ask them to fill in the questionnaires, and then they go to a specialized nurse who measures all the different components of the PASDAS. It took a lot of time to train the specialized nurses and to implement the PASDAS score in our electronic health records. After we did those things, it was quite easy because we have this whole setup. It takes time and it is difficult, but it is definitely possible to do it,” Ms. Mulder said during a live Q&A following her prerecorded presentation.

The study received no funding. Ms. Mulder had no relevant financial disclosures. Dr. Helliwell has financial ties to AbbVie, Amgen, Celgen, Galapagos, Janssen, Novartis, Pfizer, and UCB.

SOURCE: Mulder M et al. GRAPPA 2020 Virtual Annual Meeting.

Measuring success with a treat-to-target strategy in psoriatic arthritis patients proved to be more comprehensive with the Psoriatic Arthritis Disease Activity Score (PASDAS) than it was with the Disease Activity Score in 28 joints (DAS28), according to findings from a prospective cohort study.

Fewer patients had a low disease activity score according to DAS28, and a higher percentage of patients deemed adequately treated according to DAS28 were found to have residual disease activity, compared with the number of patients so categorized according to PASDAS, researcher Michelle Mulder reported in her presentation of the study at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

“PASDAS implementation in a tightly monitored PsA [psoriatic arthritis] cohort suggests relevant residual disease burden, even though DAS28 was measured at every visit previously,” said Ms. Mulder, an MD/PhD student at Sint Maartenskliniek in Nijmegen, The Netherlands.

The presentation was convincing to Philip Helliwell, MD, PhD, who is a professor of clinical rheumatology at Leeds (England) University, and was also one of the developers of PASDAS. “We know it can be used in clinical practice with a certain amount of organization and clinical staff to help you,” he said during another presentation at GRAPPA.

Treat to target is a widely accepted therapeutic strategy. It’s particularly common in rheumatoid arthritis, but increasing evidence suggests that it improves patient outcomes in psoriatic arthritis. DAS28 is frequently used in treat-to-target approaches in rheumatoid arthritis, and often gets applied to psoriatic arthritis since rheumatologists are already comfortable with it, according to Ms. Mulder. “However, DAS28 has shown some limitations when used in psoriatic arthritis. For example, its joint count is limited to only 28 joints, and it does not take all PsA domains into account,” she said.

DAS28 was previously used at Sint Maartenskliniek in combination with psoriatic arthritis–specific assessment recommendations, but the institution opted in 2019 to switch to PASDAS, which was developed by GRAPPA and the European League Against Rheumatism. “To better adhere to international PsA guidelines, we chose to implement PASDAS in our cohort with the assumption that it might improve patient care,” Ms. Mulder said.

With DAS28, clinicians measured the C-reactive protein (CRP) and Patient Global Visual Analog Scale (VAS) domains and were advised to examine 28 joints for tender and swollen joint count domains. Under the PASDAS guidance, clinicians examined 68 joints for tenderness, 66 joints for swelling, CRP, Patient Global VAS, Physician Global VAS, Leeds Enthesitis Index, dactylitis, and the 12-item Short Form Physical Composite Scale. They also examined the skin, nails, and axial disease.

To examine the effects of the switch from DAS28 to PASDAS, the researchers compared outcomes in 855 patients before and after the change during March to December 2019. The mean age of patients was 55 years, and 46% were female. The mean disease duration was 10 years, and the mean PASDAS score was 3.1. A total of 96% of participants were negative for anti-cyclic citrullinated peptide. Overall, 30% had arthritis, 9% had axial disease, 3% had dactylitis, 21% had enthesitis, 51% had skin disease, and 42% had nail disease.

About three-quarters (77.4%) of patients reached the threshold of low disease activity (LDA) according to the DAS28 measure, while 53.1% did so using the PASDAS. High disease activity occurred in 7.8% of patients according to DAS28, compared with 2.7% as measured by PASDAS. Patients who reached only the DAS28 LDA target but not the PASDAS target, compared with patients who reached the LDA target in both measures, had significantly worse counts for swelling in 66 joints (0.7 vs. 0.2; P < .001) and tenderness in 68 joints (2.1 vs. 0.7; P < .001), as well as worse scores for enthesitis (0.5 vs. 0.1; P < .001), dactylitis (4% vs. 1%; P = .005), patient global VAS (44.0 vs. 14.4; P < .001), Health Assessment Questionnaire (0.8 vs. 0.4; P < .001) and Patient Acceptable Symptom State (unacceptable score in 17% vs. 3%; P < .001).

Ms. Mulder acknowledged that PASDAS imposes a significant burden on clinicians, and noted that Sint Maartenskliniek created patient infrastructure to handle the load. “It’s very important that you set up your clinic in a specific way. When the patient comes in, we draw blood immediately and we ask them to fill in the questionnaires, and then they go to a specialized nurse who measures all the different components of the PASDAS. It took a lot of time to train the specialized nurses and to implement the PASDAS score in our electronic health records. After we did those things, it was quite easy because we have this whole setup. It takes time and it is difficult, but it is definitely possible to do it,” Ms. Mulder said during a live Q&A following her prerecorded presentation.

The study received no funding. Ms. Mulder had no relevant financial disclosures. Dr. Helliwell has financial ties to AbbVie, Amgen, Celgen, Galapagos, Janssen, Novartis, Pfizer, and UCB.

SOURCE: Mulder M et al. GRAPPA 2020 Virtual Annual Meeting.

Clinicians and researchers have focused on the acute phase of COVID-19 infection, but it’s increasingly clear that some recovered patients discharged from acute care need continued monitoring for long-lasting effects, a study has found.

In a research letter published online July 9 in JAMA, Angelo Carfi, MD, and colleagues from the Gemelli Against COVID-19 Post–Acute Care Study Group in Rome, report that 87.4% of 143 previously hospitalized patients had at least one persistent symptom 2 months or longer after initial onset and at more than a month after discharge.

Postdischarge assessments of patients who met criteria for SARS-CoV-2 negativity, including a reverse transcriptase–polymerase chain reaction test, were conducted from April 21 to May 29. Among the results:

• Only 12.6% of the 143 patients were completely free of any COVID-19 symptom
• About 32% of patients had one or two symptoms and 55% had three or more
• None had fever or other signs and symptoms of acute illness
• About 53% of patients still had fatigue, 43.4% had dyspnea, 27.3% had joint pain, and had 21.7% chest pain
• About 44% reported worsened quality of life on the EuroQol visual analog scale.

The sample cohort, assessed in a COVID-19 patient service recently established at the Fondazione Policlinico Universitario Agostino Gemelli had a mean age of 56.5 years and 37% were women. The mean length of hospital stay was 13.5 days. During their hospitalization, 72.7% of patients showed evidence of interstitial pneumonia. Noninvasive ventilation was given to 14.7% of patients and 4.9% received invasive ventilation.

The reality of lingering symptoms has led Dr. Carfi’s clinic to schedule a final “wrap-up visit” for patients after full assessment. “On that occasion the doctor prescribes anything necessary to correct the anomalies found during the full evaluation,” Dr. Carfi, a geriatrician at the Gemelli clinic, said in an interview. “These usually include vitamin supplementation and, in selected cases, a new drug prescription such as a blood thinner if necessary.”

Patients can also enroll in a training program in which breathing status is monitored.

In North America, doctors are also addressing the reality that the road to recovery can be a long and upward one, with persistent symptoms worse than those seen with acute influenza infection. “We see patients who were first diagnosed in March or April and still have symptoms in July,” said Zijian Chen, MD, an endocrinologist and medical director of Mount Sinai Health System’s Center for Post-COVID Care in New York.

“Persistent symptoms are much worse for COVID patients than flu patients. Even flu patients who spent time in the intensive care unit recover fully, and we can optimize their breathing before discharge,” Dr. Chen said in an interview.

As in the Italian study, Dr. Chen sees patients with COVID-19 who have ongoing shortness of breath, some requiring supplemental oxygen, or with persistent chest pain on exertion, blood clotting problems, poor concentration, gastrointestinal distress, and reduced muscle strength and impaired grasping power. He doesn’t rule out permanent lung damage in some. “Even asymptomatic individuals already show lung scarring on imaging,” he said.

The Mount Sinai program provides specialized interdisciplinary management that may include CT scans, endoscopy, and drugs such as respiratory medications or anticoagulants. It also offers training to combat the fatigue and deconditioning caused by the infection, symptoms that are not medically treatable but impact quality of life.

“These patients do get better, but I expect they may still have symptoms requiring monitoring after a year,” Dr. Chen said.

The study received no specific funding. Dr. Carfi and colleagues have disclosed no relevant financial relationships. Dr. Chen has disclosed no relevant financial relationships.

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

Clinicians and researchers have focused on the acute phase of COVID-19 infection, but it’s increasingly clear that some recovered patients discharged from acute care need continued monitoring for long-lasting effects, a study has found.

In a research letter published online July 9 in JAMA, Angelo Carfi, MD, and colleagues from the Gemelli Against COVID-19 Post–Acute Care Study Group in Rome, report that 87.4% of 143 previously hospitalized patients had at least one persistent symptom 2 months or longer after initial onset and at more than a month after discharge.

Postdischarge assessments of patients who met criteria for SARS-CoV-2 negativity, including a reverse transcriptase–polymerase chain reaction test, were conducted from April 21 to May 29. Among the results:

• Only 12.6% of the 143 patients were completely free of any COVID-19 symptom
• About 32% of patients had one or two symptoms and 55% had three or more
• None had fever or other signs and symptoms of acute illness
• About 53% of patients still had fatigue, 43.4% had dyspnea, 27.3% had joint pain, and had 21.7% chest pain
• About 44% reported worsened quality of life on the EuroQol visual analog scale.

The sample cohort, assessed in a COVID-19 patient service recently established at the Fondazione Policlinico Universitario Agostino Gemelli had a mean age of 56.5 years and 37% were women. The mean length of hospital stay was 13.5 days. During their hospitalization, 72.7% of patients showed evidence of interstitial pneumonia. Noninvasive ventilation was given to 14.7% of patients and 4.9% received invasive ventilation.

The reality of lingering symptoms has led Dr. Carfi’s clinic to schedule a final “wrap-up visit” for patients after full assessment. “On that occasion the doctor prescribes anything necessary to correct the anomalies found during the full evaluation,” Dr. Carfi, a geriatrician at the Gemelli clinic, said in an interview. “These usually include vitamin supplementation and, in selected cases, a new drug prescription such as a blood thinner if necessary.”

Patients can also enroll in a training program in which breathing status is monitored.

In North America, doctors are also addressing the reality that the road to recovery can be a long and upward one, with persistent symptoms worse than those seen with acute influenza infection. “We see patients who were first diagnosed in March or April and still have symptoms in July,” said Zijian Chen, MD, an endocrinologist and medical director of Mount Sinai Health System’s Center for Post-COVID Care in New York.

“Persistent symptoms are much worse for COVID patients than flu patients. Even flu patients who spent time in the intensive care unit recover fully, and we can optimize their breathing before discharge,” Dr. Chen said in an interview.

As in the Italian study, Dr. Chen sees patients with COVID-19 who have ongoing shortness of breath, some requiring supplemental oxygen, or with persistent chest pain on exertion, blood clotting problems, poor concentration, gastrointestinal distress, and reduced muscle strength and impaired grasping power. He doesn’t rule out permanent lung damage in some. “Even asymptomatic individuals already show lung scarring on imaging,” he said.

The Mount Sinai program provides specialized interdisciplinary management that may include CT scans, endoscopy, and drugs such as respiratory medications or anticoagulants. It also offers training to combat the fatigue and deconditioning caused by the infection, symptoms that are not medically treatable but impact quality of life.

“These patients do get better, but I expect they may still have symptoms requiring monitoring after a year,” Dr. Chen said.

The study received no specific funding. Dr. Carfi and colleagues have disclosed no relevant financial relationships. Dr. Chen has disclosed no relevant financial relationships.

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

Clinicians and researchers have focused on the acute phase of COVID-19 infection, but it’s increasingly clear that some recovered patients discharged from acute care need continued monitoring for long-lasting effects, a study has found.

In a research letter published online July 9 in JAMA, Angelo Carfi, MD, and colleagues from the Gemelli Against COVID-19 Post–Acute Care Study Group in Rome, report that 87.4% of 143 previously hospitalized patients had at least one persistent symptom 2 months or longer after initial onset and at more than a month after discharge.

Postdischarge assessments of patients who met criteria for SARS-CoV-2 negativity, including a reverse transcriptase–polymerase chain reaction test, were conducted from April 21 to May 29. Among the results:

• Only 12.6% of the 143 patients were completely free of any COVID-19 symptom
• About 32% of patients had one or two symptoms and 55% had three or more
• None had fever or other signs and symptoms of acute illness
• About 53% of patients still had fatigue, 43.4% had dyspnea, 27.3% had joint pain, and had 21.7% chest pain
• About 44% reported worsened quality of life on the EuroQol visual analog scale.

The sample cohort, assessed in a COVID-19 patient service recently established at the Fondazione Policlinico Universitario Agostino Gemelli had a mean age of 56.5 years and 37% were women. The mean length of hospital stay was 13.5 days. During their hospitalization, 72.7% of patients showed evidence of interstitial pneumonia. Noninvasive ventilation was given to 14.7% of patients and 4.9% received invasive ventilation.

The reality of lingering symptoms has led Dr. Carfi’s clinic to schedule a final “wrap-up visit” for patients after full assessment. “On that occasion the doctor prescribes anything necessary to correct the anomalies found during the full evaluation,” Dr. Carfi, a geriatrician at the Gemelli clinic, said in an interview. “These usually include vitamin supplementation and, in selected cases, a new drug prescription such as a blood thinner if necessary.”

Patients can also enroll in a training program in which breathing status is monitored.

In North America, doctors are also addressing the reality that the road to recovery can be a long and upward one, with persistent symptoms worse than those seen with acute influenza infection. “We see patients who were first diagnosed in March or April and still have symptoms in July,” said Zijian Chen, MD, an endocrinologist and medical director of Mount Sinai Health System’s Center for Post-COVID Care in New York.

“Persistent symptoms are much worse for COVID patients than flu patients. Even flu patients who spent time in the intensive care unit recover fully, and we can optimize their breathing before discharge,” Dr. Chen said in an interview.

As in the Italian study, Dr. Chen sees patients with COVID-19 who have ongoing shortness of breath, some requiring supplemental oxygen, or with persistent chest pain on exertion, blood clotting problems, poor concentration, gastrointestinal distress, and reduced muscle strength and impaired grasping power. He doesn’t rule out permanent lung damage in some. “Even asymptomatic individuals already show lung scarring on imaging,” he said.

The Mount Sinai program provides specialized interdisciplinary management that may include CT scans, endoscopy, and drugs such as respiratory medications or anticoagulants. It also offers training to combat the fatigue and deconditioning caused by the infection, symptoms that are not medically treatable but impact quality of life.

“These patients do get better, but I expect they may still have symptoms requiring monitoring after a year,” Dr. Chen said.

The study received no specific funding. Dr. Carfi and colleagues have disclosed no relevant financial relationships. Dr. Chen has disclosed no relevant financial relationships.

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

All patients with microscopic colitis who had biopsies of both the ascending and descending colon had positive slide review for at least one of the two sites, according to the findings of a single-center retrospective study.

“Microscopic colitis can be detected with 100% sensitivity by analyzing biopsy specimens from the ascending and descending colon. We propose a Western protocol (taking two biopsy specimens each from the ascending colon and the descending colon) in the evaluation of patients for microscopic colitis,” wrote Boris Virine, MD, of London (Ont.) Health Sciences Centre, Western University, together with his associates in Clinical Gastroenterology and Hepatology.

That is half the minimum number of samples recommended by current guidelines, the researchers noted. “The American Society for Gastrointestinal Endoscopy recommends two or more biopsy specimens from the right, transverse, left, and sigmoid colons; however, these recommendations were based on expert opinion rather than scientific evidence, and these guidelines have not been validated,” they wrote.

Microscopic colitis includes lymphocytic and collagenous subtypes, neither of which is grossly apparent on colonoscopy. “Endoscopists therefore often collect multiple random colonic biopsies, potentially oversampling, increasing times of colonoscopy and slide review,” Dr. Virine and his associates wrote.

To better pinpoint optimal biopsy sites and specimen numbers, they studied 101 patients consecutively diagnosed with biopsy-confirmed microscopic colitis at London Health Sciences Centre from 2017 through 2018. Patients with other colonic diseases were excluded from the study. Dr. Virine assessed all individual biopsy fragments, and another pathologist performed a second review of complex cases.

A total of 52 patients had biopsy-confirmed collagenous colitis – that is, normal crypt architecture, increased mononuclear inflammatory cells in the lamina propria, and a thickened subepithelial collagen band. Forty-two patients had lymphocytic colitis, defined as normal crypt architecture, increased mononuclear inflammatory cells in the lamina propria, and increased intraepithelial lymphocytosis. Seven patients had both disease subtypes.

For each patient, an average of nine (standard deviation, 4.9) biopsies had been collected. The most commonly sampled site was the ascending colon (biopsied in 47% of patients in whom at least one sample was labeled by site), followed by the descending colon (40%), rectum (21%), transverse colon (20%), sigmoid colon (15%), cecum (8%), and splenic and hepatic flexures (2% each). Diagnostic sensitivity was highest for the ascending colon (97%), transverse colon (96%), and sigmoid colon (91%) and lowest for the splenic flexure (75%), hepatic flexure (78%), and rectum (82%). The diagnostic sensitivity of the descending colon was 85%. However, all 39 patients with biopsies of both the ascending and descending colon had at least one biopsy that was positive for microscopic colitis (sensitivity, 100%).

“Based on the results of our study, collecting biopsy specimens from both the ascending and descending colons has the same overall sensitivity as following the guidelines,” the researchers concluded. “Because no single site in the colon was diffusely positive for microscopic colitis in 100% of cases, the possibility remains that collecting biopsy specimens from two sites could offer comparable sensitivity with biopsy specimens from each segment of the colon.”

No funding sources were reported. Dr. Virine and the senior author reported having no conflicts of interest. One coauthor disclosed ties to AbbVie, Allergan, Ferring, Janssen, Lupin Pendopharm, Pfizer, Shire, and Takeda.

SOURCE: Virine B et al. Clin Gastroenterol Hepatol. 2020 Feb 25. doi: 10.1016/j.cgh.2020.02.036.

All patients with microscopic colitis who had biopsies of both the ascending and descending colon had positive slide review for at least one of the two sites, according to the findings of a single-center retrospective study.

“Microscopic colitis can be detected with 100% sensitivity by analyzing biopsy specimens from the ascending and descending colon. We propose a Western protocol (taking two biopsy specimens each from the ascending colon and the descending colon) in the evaluation of patients for microscopic colitis,” wrote Boris Virine, MD, of London (Ont.) Health Sciences Centre, Western University, together with his associates in Clinical Gastroenterology and Hepatology.

That is half the minimum number of samples recommended by current guidelines, the researchers noted. “The American Society for Gastrointestinal Endoscopy recommends two or more biopsy specimens from the right, transverse, left, and sigmoid colons; however, these recommendations were based on expert opinion rather than scientific evidence, and these guidelines have not been validated,” they wrote.

Microscopic colitis includes lymphocytic and collagenous subtypes, neither of which is grossly apparent on colonoscopy. “Endoscopists therefore often collect multiple random colonic biopsies, potentially oversampling, increasing times of colonoscopy and slide review,” Dr. Virine and his associates wrote.

To better pinpoint optimal biopsy sites and specimen numbers, they studied 101 patients consecutively diagnosed with biopsy-confirmed microscopic colitis at London Health Sciences Centre from 2017 through 2018. Patients with other colonic diseases were excluded from the study. Dr. Virine assessed all individual biopsy fragments, and another pathologist performed a second review of complex cases.

A total of 52 patients had biopsy-confirmed collagenous colitis – that is, normal crypt architecture, increased mononuclear inflammatory cells in the lamina propria, and a thickened subepithelial collagen band. Forty-two patients had lymphocytic colitis, defined as normal crypt architecture, increased mononuclear inflammatory cells in the lamina propria, and increased intraepithelial lymphocytosis. Seven patients had both disease subtypes.

For each patient, an average of nine (standard deviation, 4.9) biopsies had been collected. The most commonly sampled site was the ascending colon (biopsied in 47% of patients in whom at least one sample was labeled by site), followed by the descending colon (40%), rectum (21%), transverse colon (20%), sigmoid colon (15%), cecum (8%), and splenic and hepatic flexures (2% each). Diagnostic sensitivity was highest for the ascending colon (97%), transverse colon (96%), and sigmoid colon (91%) and lowest for the splenic flexure (75%), hepatic flexure (78%), and rectum (82%). The diagnostic sensitivity of the descending colon was 85%. However, all 39 patients with biopsies of both the ascending and descending colon had at least one biopsy that was positive for microscopic colitis (sensitivity, 100%).

“Based on the results of our study, collecting biopsy specimens from both the ascending and descending colons has the same overall sensitivity as following the guidelines,” the researchers concluded. “Because no single site in the colon was diffusely positive for microscopic colitis in 100% of cases, the possibility remains that collecting biopsy specimens from two sites could offer comparable sensitivity with biopsy specimens from each segment of the colon.”

No funding sources were reported. Dr. Virine and the senior author reported having no conflicts of interest. One coauthor disclosed ties to AbbVie, Allergan, Ferring, Janssen, Lupin Pendopharm, Pfizer, Shire, and Takeda.

SOURCE: Virine B et al. Clin Gastroenterol Hepatol. 2020 Feb 25. doi: 10.1016/j.cgh.2020.02.036.

All patients with microscopic colitis who had biopsies of both the ascending and descending colon had positive slide review for at least one of the two sites, according to the findings of a single-center retrospective study.

“Microscopic colitis can be detected with 100% sensitivity by analyzing biopsy specimens from the ascending and descending colon. We propose a Western protocol (taking two biopsy specimens each from the ascending colon and the descending colon) in the evaluation of patients for microscopic colitis,” wrote Boris Virine, MD, of London (Ont.) Health Sciences Centre, Western University, together with his associates in Clinical Gastroenterology and Hepatology.

That is half the minimum number of samples recommended by current guidelines, the researchers noted. “The American Society for Gastrointestinal Endoscopy recommends two or more biopsy specimens from the right, transverse, left, and sigmoid colons; however, these recommendations were based on expert opinion rather than scientific evidence, and these guidelines have not been validated,” they wrote.

Microscopic colitis includes lymphocytic and collagenous subtypes, neither of which is grossly apparent on colonoscopy. “Endoscopists therefore often collect multiple random colonic biopsies, potentially oversampling, increasing times of colonoscopy and slide review,” Dr. Virine and his associates wrote.

To better pinpoint optimal biopsy sites and specimen numbers, they studied 101 patients consecutively diagnosed with biopsy-confirmed microscopic colitis at London Health Sciences Centre from 2017 through 2018. Patients with other colonic diseases were excluded from the study. Dr. Virine assessed all individual biopsy fragments, and another pathologist performed a second review of complex cases.

A total of 52 patients had biopsy-confirmed collagenous colitis – that is, normal crypt architecture, increased mononuclear inflammatory cells in the lamina propria, and a thickened subepithelial collagen band. Forty-two patients had lymphocytic colitis, defined as normal crypt architecture, increased mononuclear inflammatory cells in the lamina propria, and increased intraepithelial lymphocytosis. Seven patients had both disease subtypes.

For each patient, an average of nine (standard deviation, 4.9) biopsies had been collected. The most commonly sampled site was the ascending colon (biopsied in 47% of patients in whom at least one sample was labeled by site), followed by the descending colon (40%), rectum (21%), transverse colon (20%), sigmoid colon (15%), cecum (8%), and splenic and hepatic flexures (2% each). Diagnostic sensitivity was highest for the ascending colon (97%), transverse colon (96%), and sigmoid colon (91%) and lowest for the splenic flexure (75%), hepatic flexure (78%), and rectum (82%). The diagnostic sensitivity of the descending colon was 85%. However, all 39 patients with biopsies of both the ascending and descending colon had at least one biopsy that was positive for microscopic colitis (sensitivity, 100%).

“Based on the results of our study, collecting biopsy specimens from both the ascending and descending colons has the same overall sensitivity as following the guidelines,” the researchers concluded. “Because no single site in the colon was diffusely positive for microscopic colitis in 100% of cases, the possibility remains that collecting biopsy specimens from two sites could offer comparable sensitivity with biopsy specimens from each segment of the colon.”

No funding sources were reported. Dr. Virine and the senior author reported having no conflicts of interest. One coauthor disclosed ties to AbbVie, Allergan, Ferring, Janssen, Lupin Pendopharm, Pfizer, Shire, and Takeda.

SOURCE: Virine B et al. Clin Gastroenterol Hepatol. 2020 Feb 25. doi: 10.1016/j.cgh.2020.02.036.

Concentrations of neurofilament light (NfL) chain in blood can detect concussion, its severity and help predict recovery in patients with mild traumatic brain injury (TBI), new research indicates.

“Blood NfL may be used to aid in the diagnosis of patients with concussion or mild TBI [and] to identify individuals at increased risk of developing persistent postconcussive symptoms following TBI,” said lead author Pashtun Shahim, MD, PhD, National Institutes of Health Clinical Center, Bethesda, Md.

“This study is the first to do a detailed assessment of serum NfL chain and advanced brain imaging in multiple cohorts, brain injury severities, and time points after injury. The cohorts included professional athletes and nonathletes, and over time up to 5 years after TBI,” Dr. Shahim added.

The study was published online July 8 in Neurology.
 

Rapid indicator of neuronal damage

The researchers studied two cohorts of patients with head injuries. In the first, they determined serum and CSF NfL chain levels in professional Swedish ice hockey players (median age, 27 years), including 45 with acute concussion, 31 with repetitive concussions and persistent post-concussive symptoms (PCS), 28 who contributed samples during preseason with no recent concussion, and 14 healthy nonathletes.

CSF and serum NfL concentrations were closely correlated (r = 0.71; P < .0001). Serum NfL distinguished players with persistent PCS due to repetitive concussions from preseason concussion-free players, with an area under the receiver operating characteristic curve of 0.97. Higher CSF and serum NfL levels were associated with a higher number of concussions and severity of PCS after 1 year.

The second cohort involved 230 clinic-based adults (mean age, 43 years), including 162 with TBI and 68 healthy controls. In this cohort, patients with TBI had increased serum NfL concentrations compared with controls for up to 5 years, and these concentrations were able to distinguish between mild, moderate, and severe TBI. Serum NfL also correlated with measures of functional outcome, MRI brain atrophy, and diffusion tensor imaging estimates of traumatic axonal injury.

“Our findings suggest that NfL concentrations in serum offer rapid and accessible means of assessing and predicting neuronal damage in patients with TBI,” the investigators wrote.

What’s needed going forward, said Dr. Shahim, is “validation in larger cohorts for determining what levels of NfL in blood may be associated with a specific type of TBI, and what the levels are in healthy individuals of different ages.”

Not ready for prime time

In an accompanying editorial, Christopher Filley, MD, University of Colorado at Denver, Aurora, noted that NfL “may prove useful in identifying TBI patients at risk for prolonged symptoms and in enabling more focused treatment for these individuals.”

“These reports are richly laden with acute and longitudinal data that not only support the use of NfL as a convenient diagnostic test for TBI, but plausibly correlate with the neuropathology of TBI that is thought to play a major role in immediate and lasting cognitive disability,” he wrote.

Although the origin of TBI-induced cognitive decline is not entirely explained by traumatic axonal injury, “NfL appears to have much promise as a blood test that relates directly to the ubiquitous white matter damage of TBI, revealing a great deal about not only whether a TBI occurred, but also the extent of injury sustained, and how this injury may affect patient outcome for years thereafter,” Dr. Filley wrote.

However, he cautioned more research is needed before the blood test can be routinely applied to TBI diagnosis in clinical practice. “Among the hurdles still ahead are the standardization of measurement techniques across analytical platforms, and the determination of precise cutoffs between normal and abnormal values in different ages groups and at varying levels of TBI severity,” Dr. Filley noted.

The research was supported by the National Institutes of Health, the Department of Defense, the Center for Neuroscience and Regenerative Medicine at the Uniformed Services University, and the Swedish Research Council. Dr. Shahim and Dr. Filley have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Concentrations of neurofilament light (NfL) chain in blood can detect concussion, its severity and help predict recovery in patients with mild traumatic brain injury (TBI), new research indicates.

“Blood NfL may be used to aid in the diagnosis of patients with concussion or mild TBI [and] to identify individuals at increased risk of developing persistent postconcussive symptoms following TBI,” said lead author Pashtun Shahim, MD, PhD, National Institutes of Health Clinical Center, Bethesda, Md.

“This study is the first to do a detailed assessment of serum NfL chain and advanced brain imaging in multiple cohorts, brain injury severities, and time points after injury. The cohorts included professional athletes and nonathletes, and over time up to 5 years after TBI,” Dr. Shahim added.

The study was published online July 8 in Neurology.
 

Rapid indicator of neuronal damage

The researchers studied two cohorts of patients with head injuries. In the first, they determined serum and CSF NfL chain levels in professional Swedish ice hockey players (median age, 27 years), including 45 with acute concussion, 31 with repetitive concussions and persistent post-concussive symptoms (PCS), 28 who contributed samples during preseason with no recent concussion, and 14 healthy nonathletes.

CSF and serum NfL concentrations were closely correlated (r = 0.71; P < .0001). Serum NfL distinguished players with persistent PCS due to repetitive concussions from preseason concussion-free players, with an area under the receiver operating characteristic curve of 0.97. Higher CSF and serum NfL levels were associated with a higher number of concussions and severity of PCS after 1 year.

The second cohort involved 230 clinic-based adults (mean age, 43 years), including 162 with TBI and 68 healthy controls. In this cohort, patients with TBI had increased serum NfL concentrations compared with controls for up to 5 years, and these concentrations were able to distinguish between mild, moderate, and severe TBI. Serum NfL also correlated with measures of functional outcome, MRI brain atrophy, and diffusion tensor imaging estimates of traumatic axonal injury.

“Our findings suggest that NfL concentrations in serum offer rapid and accessible means of assessing and predicting neuronal damage in patients with TBI,” the investigators wrote.

What’s needed going forward, said Dr. Shahim, is “validation in larger cohorts for determining what levels of NfL in blood may be associated with a specific type of TBI, and what the levels are in healthy individuals of different ages.”

Not ready for prime time

In an accompanying editorial, Christopher Filley, MD, University of Colorado at Denver, Aurora, noted that NfL “may prove useful in identifying TBI patients at risk for prolonged symptoms and in enabling more focused treatment for these individuals.”

“These reports are richly laden with acute and longitudinal data that not only support the use of NfL as a convenient diagnostic test for TBI, but plausibly correlate with the neuropathology of TBI that is thought to play a major role in immediate and lasting cognitive disability,” he wrote.

Although the origin of TBI-induced cognitive decline is not entirely explained by traumatic axonal injury, “NfL appears to have much promise as a blood test that relates directly to the ubiquitous white matter damage of TBI, revealing a great deal about not only whether a TBI occurred, but also the extent of injury sustained, and how this injury may affect patient outcome for years thereafter,” Dr. Filley wrote.

However, he cautioned more research is needed before the blood test can be routinely applied to TBI diagnosis in clinical practice. “Among the hurdles still ahead are the standardization of measurement techniques across analytical platforms, and the determination of precise cutoffs between normal and abnormal values in different ages groups and at varying levels of TBI severity,” Dr. Filley noted.

The research was supported by the National Institutes of Health, the Department of Defense, the Center for Neuroscience and Regenerative Medicine at the Uniformed Services University, and the Swedish Research Council. Dr. Shahim and Dr. Filley have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Concentrations of neurofilament light (NfL) chain in blood can detect concussion, its severity and help predict recovery in patients with mild traumatic brain injury (TBI), new research indicates.

“Blood NfL may be used to aid in the diagnosis of patients with concussion or mild TBI [and] to identify individuals at increased risk of developing persistent postconcussive symptoms following TBI,” said lead author Pashtun Shahim, MD, PhD, National Institutes of Health Clinical Center, Bethesda, Md.

“This study is the first to do a detailed assessment of serum NfL chain and advanced brain imaging in multiple cohorts, brain injury severities, and time points after injury. The cohorts included professional athletes and nonathletes, and over time up to 5 years after TBI,” Dr. Shahim added.

The study was published online July 8 in Neurology.
 

Rapid indicator of neuronal damage

The researchers studied two cohorts of patients with head injuries. In the first, they determined serum and CSF NfL chain levels in professional Swedish ice hockey players (median age, 27 years), including 45 with acute concussion, 31 with repetitive concussions and persistent post-concussive symptoms (PCS), 28 who contributed samples during preseason with no recent concussion, and 14 healthy nonathletes.

CSF and serum NfL concentrations were closely correlated (r = 0.71; P < .0001). Serum NfL distinguished players with persistent PCS due to repetitive concussions from preseason concussion-free players, with an area under the receiver operating characteristic curve of 0.97. Higher CSF and serum NfL levels were associated with a higher number of concussions and severity of PCS after 1 year.

The second cohort involved 230 clinic-based adults (mean age, 43 years), including 162 with TBI and 68 healthy controls. In this cohort, patients with TBI had increased serum NfL concentrations compared with controls for up to 5 years, and these concentrations were able to distinguish between mild, moderate, and severe TBI. Serum NfL also correlated with measures of functional outcome, MRI brain atrophy, and diffusion tensor imaging estimates of traumatic axonal injury.

“Our findings suggest that NfL concentrations in serum offer rapid and accessible means of assessing and predicting neuronal damage in patients with TBI,” the investigators wrote.

What’s needed going forward, said Dr. Shahim, is “validation in larger cohorts for determining what levels of NfL in blood may be associated with a specific type of TBI, and what the levels are in healthy individuals of different ages.”

Not ready for prime time

In an accompanying editorial, Christopher Filley, MD, University of Colorado at Denver, Aurora, noted that NfL “may prove useful in identifying TBI patients at risk for prolonged symptoms and in enabling more focused treatment for these individuals.”

“These reports are richly laden with acute and longitudinal data that not only support the use of NfL as a convenient diagnostic test for TBI, but plausibly correlate with the neuropathology of TBI that is thought to play a major role in immediate and lasting cognitive disability,” he wrote.

Although the origin of TBI-induced cognitive decline is not entirely explained by traumatic axonal injury, “NfL appears to have much promise as a blood test that relates directly to the ubiquitous white matter damage of TBI, revealing a great deal about not only whether a TBI occurred, but also the extent of injury sustained, and how this injury may affect patient outcome for years thereafter,” Dr. Filley wrote.

However, he cautioned more research is needed before the blood test can be routinely applied to TBI diagnosis in clinical practice. “Among the hurdles still ahead are the standardization of measurement techniques across analytical platforms, and the determination of precise cutoffs between normal and abnormal values in different ages groups and at varying levels of TBI severity,” Dr. Filley noted.

The research was supported by the National Institutes of Health, the Department of Defense, the Center for Neuroscience and Regenerative Medicine at the Uniformed Services University, and the Swedish Research Council. Dr. Shahim and Dr. Filley have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Ten patients smiled and waved out on the computer monitor, as Jacob Mirsky, MD, greeted each one, asked them to introduce themselves, and inquired as to how each was doing with their stress reduction tactics.

The attendees of the online session had been patients at in-person group visits at the Massachusetts General Hospital Revere HealthCare Center. But those in-person group sessions, known as shared medical appointments (SMAs), were shut down when COVID-19 arrived.

“Our group patients have been missing the sessions,” said Dr. Mirsky, a general internist who codirects the center’s group visit program. The online sessions, called virtual SMAs (V-SMAs), work well with COVID-19 social distancing.

In the group sessions, Dr. Mirsky reads a standardized message that addresses privacy concerns during the session. For the next 60-90 minutes, “we ask them to talk about what has gone well for them and what they are struggling with,” he said. “Then I answer their questions using materials in a PowerPoint to address key points, such as reducing salt for high blood pressure or interpreting blood sugar levels for diabetes.

“I try to end group sessions with one area of focus,” Dr. Mirsky said. “In the stress reduction group, this could be meditation. In the diabetes group, it could be a discussion on weight loss.” Then the program’s health coach goes over some key concepts on behavior change and invites participants to contact her after the session.

“The nice thing is that these virtual sessions are fully reimbursable by all of our insurers in Massachusetts,” Dr. Mirsky said. Through evaluation and management (E/M) codes, each patient in a group visit is paid the same as a patient in an individual visit with the same level of complexity.

Dr. Mirsky writes a note in the chart about each patient who was in the group session. “This includes information about the specific patient, such as the history and physical, and information about the group meeting,” he said. In the next few months, the center plans to put its other group sessions online – on blood pressure, obesity, diabetes, and insomnia.

Attracting doctors who hadn’t done groups before

The COVID-19 crisis has given group visits a second wind. Some doctors who never used SMAs before are now trying out this new mode of patient engagement, said Marianne Sumego, MD, director of the Cleveland Clinic’s SMA program, which began 21 years ago.

In this era of COVID-19, group visits have either switched to V-SMAs or halted. However, the COVID-19 crisis has given group visits a second wind. Some doctors who never used SMAs before are now trying out this new mode of patient engagement,

Many of the 100 doctors using SMAs at the Cleveland Clinic have switched over to V-SMAs for now, and the new mode is also attracting colleagues who are new to SMAs, she said.

“When doctors started using telemedicine, virtual group visits started making sense to them,” Dr. Sumego said. “This is a time of a great deal of experimentation in practice design.”

Indeed, V-SMAs have eliminated some problems that had discouraged doctors from trying SMAs, said Amy Wheeler, MD, a general internist who founded the Revere SMA program and codirects it with Dr. Mirsky.

V-SMAs eliminate the need for a large space to hold sessions and reduce the number of staff needed to run sessions, Dr. Wheeler said. “Virtual group visits can actually be easier to use than in-person group visits.”

Dr. Sumego believes small practices in particular will take up V-SMAs because they are easier to run than regular SMAs. “Necessity drives change,” she said. “Across the country everyone is looking at the virtual group model.”

Group visits can help your bottom line

Medicare and many private payers cover group visits. In most cases, they tend to pay the same rate as for an individual office visit. As with telehealth, Medicare and many other payers are temporarily reimbursing for virtual visits at the same rate as for real visits.

Not all payers have a stated policy about covering SMAs, and physicians have to ask. The Centers for Medicare & Medicaid Services, for example, has not published any coding rules on SMAs. But in response to a query by the American Academy of Family Physicians, CMS said it would allow use of CPT codes for E/M services for individual patients.

Blue Cross Blue Shield of North Carolina is one of the few payers with a clearly stated policy on its website. Like Medicare, the insurer accepts E/M codes, and it requires that patients’ attendance must be voluntary; they must be established patients; and the visit must be specific to a disease or condition, although several conditions are allowed.

Dr. Mirsky said his group uses the same E/M level – 99213 – for all of his SMA patients. “Since a regular primary care visit is usually billed at a level 3 or 4, depending on how many topics are covered, we chose level 3 for groups, because the group session deals with just one topic.”

One challenge for billing for SMAs is that most health insurers require patients to provide a copay for each visit, which can discourage patients in groups that meet frequently, says Wayne Dysinger, MD, founder of Lifestyle Medical Solutions, a two-physician primary care practice in Riverside, Calif.

But Dr. Dysinger, who has been using SMAs for 5 years, usually doesn’t have to worry about copays because much of his work is capitated and doesn’t require a copay.

Also, some of Dr. Dysinger’s SMA patients are in direct primary care, in which the patients pay an $18 monthly membership fee. Other practices may charge a flat out-of-pocket fee.
 

How group visits operate

SMAs are based on the observation that patients with the same condition generally ask their doctor the same questions, and rather than repeat the answers each time, why not provide them to a group?

Dr. Wheeler said trying to be more efficient with her time was the primary reason she became interested in SMAs a dozen years ago. “I was trying to squeeze the advice patients needed into a normal patient visit, and it wasn’t working. When I tried to tell them everything they needed to know, I’d run behind for the rest of my day’s visits.”

She found she was continually repeating the same conversation with patients, but these talks weren’t detailed enough to be effective. “When my weight loss patients came back for the next appointment, they had not made the recommended changes in lifestyle. I started to realize how complicated weight loss was.” So Dr. Wheeler founded the SMA program at the Revere Center.

Doctors enjoy the patient interaction

Some doctors who use SMAs talk about how connected they feel with their patients. “For me, the group sessions are the most gratifying part of the week,” Dr. Dysinger says. “I like to see the patients interacting with me and with each other, and watch their health behavior change over time.”

“These groups have a great deal of energy,” he said. “They have a kind of vulnerability that is very raw, very human. People make commitments to meet goals. Will they meet them or not?”

Dr. Dysinger’s enthusiasm has been echoed by other doctors. In a study of older patients, physicians who used SMAs were more satisfied with care than physicians who relied on standard one-to-one interactions. In another study, the researchers surmised that, in SMAs, doctors learn from their patients how they can better meet their needs.

Dr. Dysinger thinks SMAs are widely applicable in primary care. He estimates that 80%-85% of appointments at a primary care practice involve chronic diseases, and this type of patient is a good fit for group visits. SMAs typically treat patients with diabetes, asthma, arthritis, and obesity.

Dr. Sumego said SMAs are used for specialty care at Cleveland Clinic, such as to help patients before and after bariatric surgery. SMAs have also been used to treat patients with ulcerative colitis, multiple sclerosis, cancer, HIV, menopause, insomnia, and stress, according to one report.

Dr. Dysinger, who runs a small practice, organizes his group sessions somewhat differently. He doesn’t organize his groups around conditions like diabetes, but instead his groups focus on four “pillars” of lifestyle medicine: nourishment, movement, resilience (involving sleep and stress), and connectedness.
 

Why patients like group visits

Feeling part of a whole is a major draw for many patients. “Patients seem to like committing to something bigger than just themselves,” Dr. Wheeler said. “They enjoy the sense of community that groups have, the joy of supporting one another.”

“It’s feeling that you’re not alone,” Dr. Mirsky said. “When a patient struggling with diabetes hears how hard it is for another patient, it validates their experience and gives them someone to connect with. There is a positive peer pressure.”

Many programs, including Dr. Wheeler’s and Dr. Mirsky’s in Boston, allow patients to drop in and out of sessions, rather than attending one course all the way through. But even under this format, Dr. Wheeler said that patients often tend to stick together. “At the end of a session, one patient asks another: ‘Which session do you want to go to next?’ ” she said.

Patients also learn from each other in SMAs. Patients exchange experiences and share advice they may not have had the chance to get during an individual visit.

The group dynamic can make it easier for some patients to reveal sensitive information, said Dr. Dysinger. “In these groups, people feel free to talk about their bowel movements, or about having to deal with the influence of a parent on their lives,” Dr. Dysinger said. “The sessions can have the feel of an [Alcoholics Anonymous] meeting, but they’re firmly grounded in medicine.”

Potential downsides of virtual group visits

SMAs and VSMAs may not work for every practice. Some small practices may not have enough patients to organize a group visit around a particular condition – even a common one like diabetes. In a presentation before the Society of General Internal Medicine, a physician from the Medical University of South Carolina, Charleston, warned that it may be difficult for a practice to fill diabetes group visits every year.

Additionally, some patients don’t want to talk about personal matters in a group. “They may not want to reveal certain things about themselves,” Dr. Mirsky said. “So I tell the group that if there is anything that anyone wants to talk about in private, I’m available.”

Another drawback of SMAs is that more experienced patients may have to slog through information they already know, which is a particular problem when patients can drop in and out of sessions. Dr. Mirsky noted that “what often ends up happening is that the experienced participant helps the newcomer.”

Finally, confidentially is a big concern in a group session. “In a one-on-one visit, you can go into details about the patient’s health, and even bring up an entry in the chart,” Dr. Wheeler said. “But in a group visit, you can’t raise any personal details about a patient unless the patient brings it up first.”

SMA patients sign confidentiality agreements in which they agree not to talk about other patients outside the session. Ensuring confidentiality becomes more complicated in virtual group visits, because someone located in the room near a participant could overhear the conversation. For this reason, patients in V-SMAs are advised to use headphones or, at a minimum, close the door to the room they are in.

To address privacy concerns, Zoom encrypts its data, but some privacy breeches have been reported, and a U.S. senator has been looking into Zoom’s privacy vulnerabilities.

Transferring groups to virtual groups

It took the COVID-19 crisis for most doctors to take up virtual SMAs. Dr. Sumego said that the Cleveland Clinic started virtual SMAs more than a year ago, but most other groups operating SMAs were apparently not providing them virtually before COVID-19 started.

Dr. Dysinger said he tried virtual SMAs in 2017 but dropped them because the technology – using Zoom – was challenging at the time, and his staff and most patients were resistant. “Only three to five people were attending the virtual sessions, and the meetings took place in the evening, which was hard on the staff.”

“When COVID-19 first appeared, our initial response was to try to keep the in-person group and add social distancing to it, but that wasn’t workable, so very quickly we shifted to Zoom meetings,” Dr. Dysinger said. “We had experience with Zoom already, and the Zoom technology had improved and was easier to use. COVID-19 forced it all forward.”

Are V-SMAs effective? While there have been many studies showing the effectiveness of in-person SMAs, there have been very few on V-SMAs. One 2018 study of obesity patients found that those attending in-person SMAs lost somewhat more weight than those in V-SMAs.

As with telemedicine, some patients have trouble with the technology of V-SMAs. Dr. Dysinger said 5%-10% of his SMA patients don’t make the switch over to V-SMAs – mainly because of problems in adapting to the technology – but the rest are happy. “We’re averaging 10 people per meeting, and as many as 20.”

Getting comfortable with group visits

Dealing with group visits takes a very different mindset than what doctors normally have, Dr. Wheeler said. “It took me 6-8 months to feel comfortable enough with group sessions to do them myself,” she recalled. “This was a very different way to practice, compared to the one-on-one care I was trained to give patients. Others may find the transition easier, though.

“Doctors are used to being in control of the patient visit, but the exchange in a group visit is more fluid,” Dr. Wheeler said. “Patients offer their own opinions, and this sends the discussion off on a tangent that is often quite useful. As doctors, we have to learn when to let these tangents continue, and know when the discussion might have to be brought back to the theme at hand. Often it’s better not to intercede.”

Do doctors need training to conduct SMAs? Patients in group visits reported worse communication with physicians than those in individual visits, according to a 2014 study. The authors surmised that the doctors needed to learn how to talk to groups and suggested that they get some training.

The potential staying power of V-SMAs post COVID?

Once the COVID-19 crisis is over, Medicare is scheduled to no longer provide the same level of reimbursement for virtual sessions as for real sessions. Dr. Mirsky anticipates a great deal of resistance to this change from thousands of physicians and patients who have become comfortable with telehealth, including virtual SMAs.

Dr. Dysinger thinks V-SMAs will continue. “When COVID-19 clears and we can go back to in-person groups, we expect to keep some virtual groups. People have already come to accept and value virtual groups.”

Dr. Wheeler sees virtual groups playing an essential role post COVID-19, when practices have to get back up to speed. “Virtual group visits could make it easier to deal with a large backlog of patients who couldn’t be seen up until now,” she said. “And virtual groups will be the only way to see patients who are still reluctant to meet in a group.”

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

Ten patients smiled and waved out on the computer monitor, as Jacob Mirsky, MD, greeted each one, asked them to introduce themselves, and inquired as to how each was doing with their stress reduction tactics.

The attendees of the online session had been patients at in-person group visits at the Massachusetts General Hospital Revere HealthCare Center. But those in-person group sessions, known as shared medical appointments (SMAs), were shut down when COVID-19 arrived.

“Our group patients have been missing the sessions,” said Dr. Mirsky, a general internist who codirects the center’s group visit program. The online sessions, called virtual SMAs (V-SMAs), work well with COVID-19 social distancing.

In the group sessions, Dr. Mirsky reads a standardized message that addresses privacy concerns during the session. For the next 60-90 minutes, “we ask them to talk about what has gone well for them and what they are struggling with,” he said. “Then I answer their questions using materials in a PowerPoint to address key points, such as reducing salt for high blood pressure or interpreting blood sugar levels for diabetes.

“I try to end group sessions with one area of focus,” Dr. Mirsky said. “In the stress reduction group, this could be meditation. In the diabetes group, it could be a discussion on weight loss.” Then the program’s health coach goes over some key concepts on behavior change and invites participants to contact her after the session.

“The nice thing is that these virtual sessions are fully reimbursable by all of our insurers in Massachusetts,” Dr. Mirsky said. Through evaluation and management (E/M) codes, each patient in a group visit is paid the same as a patient in an individual visit with the same level of complexity.

Dr. Mirsky writes a note in the chart about each patient who was in the group session. “This includes information about the specific patient, such as the history and physical, and information about the group meeting,” he said. In the next few months, the center plans to put its other group sessions online – on blood pressure, obesity, diabetes, and insomnia.

Attracting doctors who hadn’t done groups before

The COVID-19 crisis has given group visits a second wind. Some doctors who never used SMAs before are now trying out this new mode of patient engagement, said Marianne Sumego, MD, director of the Cleveland Clinic’s SMA program, which began 21 years ago.

In this era of COVID-19, group visits have either switched to V-SMAs or halted. However, the COVID-19 crisis has given group visits a second wind. Some doctors who never used SMAs before are now trying out this new mode of patient engagement,

Many of the 100 doctors using SMAs at the Cleveland Clinic have switched over to V-SMAs for now, and the new mode is also attracting colleagues who are new to SMAs, she said.

“When doctors started using telemedicine, virtual group visits started making sense to them,” Dr. Sumego said. “This is a time of a great deal of experimentation in practice design.”

Indeed, V-SMAs have eliminated some problems that had discouraged doctors from trying SMAs, said Amy Wheeler, MD, a general internist who founded the Revere SMA program and codirects it with Dr. Mirsky.

V-SMAs eliminate the need for a large space to hold sessions and reduce the number of staff needed to run sessions, Dr. Wheeler said. “Virtual group visits can actually be easier to use than in-person group visits.”

Dr. Sumego believes small practices in particular will take up V-SMAs because they are easier to run than regular SMAs. “Necessity drives change,” she said. “Across the country everyone is looking at the virtual group model.”

Group visits can help your bottom line

Medicare and many private payers cover group visits. In most cases, they tend to pay the same rate as for an individual office visit. As with telehealth, Medicare and many other payers are temporarily reimbursing for virtual visits at the same rate as for real visits.

Not all payers have a stated policy about covering SMAs, and physicians have to ask. The Centers for Medicare & Medicaid Services, for example, has not published any coding rules on SMAs. But in response to a query by the American Academy of Family Physicians, CMS said it would allow use of CPT codes for E/M services for individual patients.

Blue Cross Blue Shield of North Carolina is one of the few payers with a clearly stated policy on its website. Like Medicare, the insurer accepts E/M codes, and it requires that patients’ attendance must be voluntary; they must be established patients; and the visit must be specific to a disease or condition, although several conditions are allowed.

Dr. Mirsky said his group uses the same E/M level – 99213 – for all of his SMA patients. “Since a regular primary care visit is usually billed at a level 3 or 4, depending on how many topics are covered, we chose level 3 for groups, because the group session deals with just one topic.”

One challenge for billing for SMAs is that most health insurers require patients to provide a copay for each visit, which can discourage patients in groups that meet frequently, says Wayne Dysinger, MD, founder of Lifestyle Medical Solutions, a two-physician primary care practice in Riverside, Calif.

But Dr. Dysinger, who has been using SMAs for 5 years, usually doesn’t have to worry about copays because much of his work is capitated and doesn’t require a copay.

Also, some of Dr. Dysinger’s SMA patients are in direct primary care, in which the patients pay an $18 monthly membership fee. Other practices may charge a flat out-of-pocket fee.
 

How group visits operate

SMAs are based on the observation that patients with the same condition generally ask their doctor the same questions, and rather than repeat the answers each time, why not provide them to a group?

Dr. Wheeler said trying to be more efficient with her time was the primary reason she became interested in SMAs a dozen years ago. “I was trying to squeeze the advice patients needed into a normal patient visit, and it wasn’t working. When I tried to tell them everything they needed to know, I’d run behind for the rest of my day’s visits.”

She found she was continually repeating the same conversation with patients, but these talks weren’t detailed enough to be effective. “When my weight loss patients came back for the next appointment, they had not made the recommended changes in lifestyle. I started to realize how complicated weight loss was.” So Dr. Wheeler founded the SMA program at the Revere Center.

Doctors enjoy the patient interaction

Some doctors who use SMAs talk about how connected they feel with their patients. “For me, the group sessions are the most gratifying part of the week,” Dr. Dysinger says. “I like to see the patients interacting with me and with each other, and watch their health behavior change over time.”

“These groups have a great deal of energy,” he said. “They have a kind of vulnerability that is very raw, very human. People make commitments to meet goals. Will they meet them or not?”

Dr. Dysinger’s enthusiasm has been echoed by other doctors. In a study of older patients, physicians who used SMAs were more satisfied with care than physicians who relied on standard one-to-one interactions. In another study, the researchers surmised that, in SMAs, doctors learn from their patients how they can better meet their needs.

Dr. Dysinger thinks SMAs are widely applicable in primary care. He estimates that 80%-85% of appointments at a primary care practice involve chronic diseases, and this type of patient is a good fit for group visits. SMAs typically treat patients with diabetes, asthma, arthritis, and obesity.

Dr. Sumego said SMAs are used for specialty care at Cleveland Clinic, such as to help patients before and after bariatric surgery. SMAs have also been used to treat patients with ulcerative colitis, multiple sclerosis, cancer, HIV, menopause, insomnia, and stress, according to one report.

Dr. Dysinger, who runs a small practice, organizes his group sessions somewhat differently. He doesn’t organize his groups around conditions like diabetes, but instead his groups focus on four “pillars” of lifestyle medicine: nourishment, movement, resilience (involving sleep and stress), and connectedness.
 

Why patients like group visits

Feeling part of a whole is a major draw for many patients. “Patients seem to like committing to something bigger than just themselves,” Dr. Wheeler said. “They enjoy the sense of community that groups have, the joy of supporting one another.”

“It’s feeling that you’re not alone,” Dr. Mirsky said. “When a patient struggling with diabetes hears how hard it is for another patient, it validates their experience and gives them someone to connect with. There is a positive peer pressure.”

Many programs, including Dr. Wheeler’s and Dr. Mirsky’s in Boston, allow patients to drop in and out of sessions, rather than attending one course all the way through. But even under this format, Dr. Wheeler said that patients often tend to stick together. “At the end of a session, one patient asks another: ‘Which session do you want to go to next?’ ” she said.

Patients also learn from each other in SMAs. Patients exchange experiences and share advice they may not have had the chance to get during an individual visit.

The group dynamic can make it easier for some patients to reveal sensitive information, said Dr. Dysinger. “In these groups, people feel free to talk about their bowel movements, or about having to deal with the influence of a parent on their lives,” Dr. Dysinger said. “The sessions can have the feel of an [Alcoholics Anonymous] meeting, but they’re firmly grounded in medicine.”

Potential downsides of virtual group visits

SMAs and VSMAs may not work for every practice. Some small practices may not have enough patients to organize a group visit around a particular condition – even a common one like diabetes. In a presentation before the Society of General Internal Medicine, a physician from the Medical University of South Carolina, Charleston, warned that it may be difficult for a practice to fill diabetes group visits every year.

Additionally, some patients don’t want to talk about personal matters in a group. “They may not want to reveal certain things about themselves,” Dr. Mirsky said. “So I tell the group that if there is anything that anyone wants to talk about in private, I’m available.”

Another drawback of SMAs is that more experienced patients may have to slog through information they already know, which is a particular problem when patients can drop in and out of sessions. Dr. Mirsky noted that “what often ends up happening is that the experienced participant helps the newcomer.”

Finally, confidentially is a big concern in a group session. “In a one-on-one visit, you can go into details about the patient’s health, and even bring up an entry in the chart,” Dr. Wheeler said. “But in a group visit, you can’t raise any personal details about a patient unless the patient brings it up first.”

SMA patients sign confidentiality agreements in which they agree not to talk about other patients outside the session. Ensuring confidentiality becomes more complicated in virtual group visits, because someone located in the room near a participant could overhear the conversation. For this reason, patients in V-SMAs are advised to use headphones or, at a minimum, close the door to the room they are in.

To address privacy concerns, Zoom encrypts its data, but some privacy breeches have been reported, and a U.S. senator has been looking into Zoom’s privacy vulnerabilities.

Transferring groups to virtual groups

It took the COVID-19 crisis for most doctors to take up virtual SMAs. Dr. Sumego said that the Cleveland Clinic started virtual SMAs more than a year ago, but most other groups operating SMAs were apparently not providing them virtually before COVID-19 started.

Dr. Dysinger said he tried virtual SMAs in 2017 but dropped them because the technology – using Zoom – was challenging at the time, and his staff and most patients were resistant. “Only three to five people were attending the virtual sessions, and the meetings took place in the evening, which was hard on the staff.”

“When COVID-19 first appeared, our initial response was to try to keep the in-person group and add social distancing to it, but that wasn’t workable, so very quickly we shifted to Zoom meetings,” Dr. Dysinger said. “We had experience with Zoom already, and the Zoom technology had improved and was easier to use. COVID-19 forced it all forward.”

Are V-SMAs effective? While there have been many studies showing the effectiveness of in-person SMAs, there have been very few on V-SMAs. One 2018 study of obesity patients found that those attending in-person SMAs lost somewhat more weight than those in V-SMAs.

As with telemedicine, some patients have trouble with the technology of V-SMAs. Dr. Dysinger said 5%-10% of his SMA patients don’t make the switch over to V-SMAs – mainly because of problems in adapting to the technology – but the rest are happy. “We’re averaging 10 people per meeting, and as many as 20.”

Getting comfortable with group visits

Dealing with group visits takes a very different mindset than what doctors normally have, Dr. Wheeler said. “It took me 6-8 months to feel comfortable enough with group sessions to do them myself,” she recalled. “This was a very different way to practice, compared to the one-on-one care I was trained to give patients. Others may find the transition easier, though.

“Doctors are used to being in control of the patient visit, but the exchange in a group visit is more fluid,” Dr. Wheeler said. “Patients offer their own opinions, and this sends the discussion off on a tangent that is often quite useful. As doctors, we have to learn when to let these tangents continue, and know when the discussion might have to be brought back to the theme at hand. Often it’s better not to intercede.”

Do doctors need training to conduct SMAs? Patients in group visits reported worse communication with physicians than those in individual visits, according to a 2014 study. The authors surmised that the doctors needed to learn how to talk to groups and suggested that they get some training.

The potential staying power of V-SMAs post COVID?

Once the COVID-19 crisis is over, Medicare is scheduled to no longer provide the same level of reimbursement for virtual sessions as for real sessions. Dr. Mirsky anticipates a great deal of resistance to this change from thousands of physicians and patients who have become comfortable with telehealth, including virtual SMAs.

Dr. Dysinger thinks V-SMAs will continue. “When COVID-19 clears and we can go back to in-person groups, we expect to keep some virtual groups. People have already come to accept and value virtual groups.”

Dr. Wheeler sees virtual groups playing an essential role post COVID-19, when practices have to get back up to speed. “Virtual group visits could make it easier to deal with a large backlog of patients who couldn’t be seen up until now,” she said. “And virtual groups will be the only way to see patients who are still reluctant to meet in a group.”

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

Ten patients smiled and waved out on the computer monitor, as Jacob Mirsky, MD, greeted each one, asked them to introduce themselves, and inquired as to how each was doing with their stress reduction tactics.

The attendees of the online session had been patients at in-person group visits at the Massachusetts General Hospital Revere HealthCare Center. But those in-person group sessions, known as shared medical appointments (SMAs), were shut down when COVID-19 arrived.

“Our group patients have been missing the sessions,” said Dr. Mirsky, a general internist who codirects the center’s group visit program. The online sessions, called virtual SMAs (V-SMAs), work well with COVID-19 social distancing.

In the group sessions, Dr. Mirsky reads a standardized message that addresses privacy concerns during the session. For the next 60-90 minutes, “we ask them to talk about what has gone well for them and what they are struggling with,” he said. “Then I answer their questions using materials in a PowerPoint to address key points, such as reducing salt for high blood pressure or interpreting blood sugar levels for diabetes.

“I try to end group sessions with one area of focus,” Dr. Mirsky said. “In the stress reduction group, this could be meditation. In the diabetes group, it could be a discussion on weight loss.” Then the program’s health coach goes over some key concepts on behavior change and invites participants to contact her after the session.

“The nice thing is that these virtual sessions are fully reimbursable by all of our insurers in Massachusetts,” Dr. Mirsky said. Through evaluation and management (E/M) codes, each patient in a group visit is paid the same as a patient in an individual visit with the same level of complexity.

Dr. Mirsky writes a note in the chart about each patient who was in the group session. “This includes information about the specific patient, such as the history and physical, and information about the group meeting,” he said. In the next few months, the center plans to put its other group sessions online – on blood pressure, obesity, diabetes, and insomnia.

Attracting doctors who hadn’t done groups before

The COVID-19 crisis has given group visits a second wind. Some doctors who never used SMAs before are now trying out this new mode of patient engagement, said Marianne Sumego, MD, director of the Cleveland Clinic’s SMA program, which began 21 years ago.

In this era of COVID-19, group visits have either switched to V-SMAs or halted. However, the COVID-19 crisis has given group visits a second wind. Some doctors who never used SMAs before are now trying out this new mode of patient engagement,

Many of the 100 doctors using SMAs at the Cleveland Clinic have switched over to V-SMAs for now, and the new mode is also attracting colleagues who are new to SMAs, she said.

“When doctors started using telemedicine, virtual group visits started making sense to them,” Dr. Sumego said. “This is a time of a great deal of experimentation in practice design.”

Indeed, V-SMAs have eliminated some problems that had discouraged doctors from trying SMAs, said Amy Wheeler, MD, a general internist who founded the Revere SMA program and codirects it with Dr. Mirsky.

V-SMAs eliminate the need for a large space to hold sessions and reduce the number of staff needed to run sessions, Dr. Wheeler said. “Virtual group visits can actually be easier to use than in-person group visits.”

Dr. Sumego believes small practices in particular will take up V-SMAs because they are easier to run than regular SMAs. “Necessity drives change,” she said. “Across the country everyone is looking at the virtual group model.”

Group visits can help your bottom line

Medicare and many private payers cover group visits. In most cases, they tend to pay the same rate as for an individual office visit. As with telehealth, Medicare and many other payers are temporarily reimbursing for virtual visits at the same rate as for real visits.

Not all payers have a stated policy about covering SMAs, and physicians have to ask. The Centers for Medicare & Medicaid Services, for example, has not published any coding rules on SMAs. But in response to a query by the American Academy of Family Physicians, CMS said it would allow use of CPT codes for E/M services for individual patients.

Blue Cross Blue Shield of North Carolina is one of the few payers with a clearly stated policy on its website. Like Medicare, the insurer accepts E/M codes, and it requires that patients’ attendance must be voluntary; they must be established patients; and the visit must be specific to a disease or condition, although several conditions are allowed.

Dr. Mirsky said his group uses the same E/M level – 99213 – for all of his SMA patients. “Since a regular primary care visit is usually billed at a level 3 or 4, depending on how many topics are covered, we chose level 3 for groups, because the group session deals with just one topic.”

One challenge for billing for SMAs is that most health insurers require patients to provide a copay for each visit, which can discourage patients in groups that meet frequently, says Wayne Dysinger, MD, founder of Lifestyle Medical Solutions, a two-physician primary care practice in Riverside, Calif.

But Dr. Dysinger, who has been using SMAs for 5 years, usually doesn’t have to worry about copays because much of his work is capitated and doesn’t require a copay.

Also, some of Dr. Dysinger’s SMA patients are in direct primary care, in which the patients pay an $18 monthly membership fee. Other practices may charge a flat out-of-pocket fee.
 

How group visits operate

SMAs are based on the observation that patients with the same condition generally ask their doctor the same questions, and rather than repeat the answers each time, why not provide them to a group?

Dr. Wheeler said trying to be more efficient with her time was the primary reason she became interested in SMAs a dozen years ago. “I was trying to squeeze the advice patients needed into a normal patient visit, and it wasn’t working. When I tried to tell them everything they needed to know, I’d run behind for the rest of my day’s visits.”

She found she was continually repeating the same conversation with patients, but these talks weren’t detailed enough to be effective. “When my weight loss patients came back for the next appointment, they had not made the recommended changes in lifestyle. I started to realize how complicated weight loss was.” So Dr. Wheeler founded the SMA program at the Revere Center.

Doctors enjoy the patient interaction

Some doctors who use SMAs talk about how connected they feel with their patients. “For me, the group sessions are the most gratifying part of the week,” Dr. Dysinger says. “I like to see the patients interacting with me and with each other, and watch their health behavior change over time.”

“These groups have a great deal of energy,” he said. “They have a kind of vulnerability that is very raw, very human. People make commitments to meet goals. Will they meet them or not?”

Dr. Dysinger’s enthusiasm has been echoed by other doctors. In a study of older patients, physicians who used SMAs were more satisfied with care than physicians who relied on standard one-to-one interactions. In another study, the researchers surmised that, in SMAs, doctors learn from their patients how they can better meet their needs.

Dr. Dysinger thinks SMAs are widely applicable in primary care. He estimates that 80%-85% of appointments at a primary care practice involve chronic diseases, and this type of patient is a good fit for group visits. SMAs typically treat patients with diabetes, asthma, arthritis, and obesity.

Dr. Sumego said SMAs are used for specialty care at Cleveland Clinic, such as to help patients before and after bariatric surgery. SMAs have also been used to treat patients with ulcerative colitis, multiple sclerosis, cancer, HIV, menopause, insomnia, and stress, according to one report.

Dr. Dysinger, who runs a small practice, organizes his group sessions somewhat differently. He doesn’t organize his groups around conditions like diabetes, but instead his groups focus on four “pillars” of lifestyle medicine: nourishment, movement, resilience (involving sleep and stress), and connectedness.
 

Why patients like group visits

Feeling part of a whole is a major draw for many patients. “Patients seem to like committing to something bigger than just themselves,” Dr. Wheeler said. “They enjoy the sense of community that groups have, the joy of supporting one another.”

“It’s feeling that you’re not alone,” Dr. Mirsky said. “When a patient struggling with diabetes hears how hard it is for another patient, it validates their experience and gives them someone to connect with. There is a positive peer pressure.”

Many programs, including Dr. Wheeler’s and Dr. Mirsky’s in Boston, allow patients to drop in and out of sessions, rather than attending one course all the way through. But even under this format, Dr. Wheeler said that patients often tend to stick together. “At the end of a session, one patient asks another: ‘Which session do you want to go to next?’ ” she said.

Patients also learn from each other in SMAs. Patients exchange experiences and share advice they may not have had the chance to get during an individual visit.

The group dynamic can make it easier for some patients to reveal sensitive information, said Dr. Dysinger. “In these groups, people feel free to talk about their bowel movements, or about having to deal with the influence of a parent on their lives,” Dr. Dysinger said. “The sessions can have the feel of an [Alcoholics Anonymous] meeting, but they’re firmly grounded in medicine.”

Potential downsides of virtual group visits

SMAs and VSMAs may not work for every practice. Some small practices may not have enough patients to organize a group visit around a particular condition – even a common one like diabetes. In a presentation before the Society of General Internal Medicine, a physician from the Medical University of South Carolina, Charleston, warned that it may be difficult for a practice to fill diabetes group visits every year.

Additionally, some patients don’t want to talk about personal matters in a group. “They may not want to reveal certain things about themselves,” Dr. Mirsky said. “So I tell the group that if there is anything that anyone wants to talk about in private, I’m available.”

Another drawback of SMAs is that more experienced patients may have to slog through information they already know, which is a particular problem when patients can drop in and out of sessions. Dr. Mirsky noted that “what often ends up happening is that the experienced participant helps the newcomer.”

Finally, confidentially is a big concern in a group session. “In a one-on-one visit, you can go into details about the patient’s health, and even bring up an entry in the chart,” Dr. Wheeler said. “But in a group visit, you can’t raise any personal details about a patient unless the patient brings it up first.”

SMA patients sign confidentiality agreements in which they agree not to talk about other patients outside the session. Ensuring confidentiality becomes more complicated in virtual group visits, because someone located in the room near a participant could overhear the conversation. For this reason, patients in V-SMAs are advised to use headphones or, at a minimum, close the door to the room they are in.

To address privacy concerns, Zoom encrypts its data, but some privacy breeches have been reported, and a U.S. senator has been looking into Zoom’s privacy vulnerabilities.

Transferring groups to virtual groups

It took the COVID-19 crisis for most doctors to take up virtual SMAs. Dr. Sumego said that the Cleveland Clinic started virtual SMAs more than a year ago, but most other groups operating SMAs were apparently not providing them virtually before COVID-19 started.

Dr. Dysinger said he tried virtual SMAs in 2017 but dropped them because the technology – using Zoom – was challenging at the time, and his staff and most patients were resistant. “Only three to five people were attending the virtual sessions, and the meetings took place in the evening, which was hard on the staff.”

“When COVID-19 first appeared, our initial response was to try to keep the in-person group and add social distancing to it, but that wasn’t workable, so very quickly we shifted to Zoom meetings,” Dr. Dysinger said. “We had experience with Zoom already, and the Zoom technology had improved and was easier to use. COVID-19 forced it all forward.”

Are V-SMAs effective? While there have been many studies showing the effectiveness of in-person SMAs, there have been very few on V-SMAs. One 2018 study of obesity patients found that those attending in-person SMAs lost somewhat more weight than those in V-SMAs.

As with telemedicine, some patients have trouble with the technology of V-SMAs. Dr. Dysinger said 5%-10% of his SMA patients don’t make the switch over to V-SMAs – mainly because of problems in adapting to the technology – but the rest are happy. “We’re averaging 10 people per meeting, and as many as 20.”

Getting comfortable with group visits

Dealing with group visits takes a very different mindset than what doctors normally have, Dr. Wheeler said. “It took me 6-8 months to feel comfortable enough with group sessions to do them myself,” she recalled. “This was a very different way to practice, compared to the one-on-one care I was trained to give patients. Others may find the transition easier, though.

“Doctors are used to being in control of the patient visit, but the exchange in a group visit is more fluid,” Dr. Wheeler said. “Patients offer their own opinions, and this sends the discussion off on a tangent that is often quite useful. As doctors, we have to learn when to let these tangents continue, and know when the discussion might have to be brought back to the theme at hand. Often it’s better not to intercede.”

Do doctors need training to conduct SMAs? Patients in group visits reported worse communication with physicians than those in individual visits, according to a 2014 study. The authors surmised that the doctors needed to learn how to talk to groups and suggested that they get some training.

The potential staying power of V-SMAs post COVID?

Once the COVID-19 crisis is over, Medicare is scheduled to no longer provide the same level of reimbursement for virtual sessions as for real sessions. Dr. Mirsky anticipates a great deal of resistance to this change from thousands of physicians and patients who have become comfortable with telehealth, including virtual SMAs.

Dr. Dysinger thinks V-SMAs will continue. “When COVID-19 clears and we can go back to in-person groups, we expect to keep some virtual groups. People have already come to accept and value virtual groups.”

Dr. Wheeler sees virtual groups playing an essential role post COVID-19, when practices have to get back up to speed. “Virtual group visits could make it easier to deal with a large backlog of patients who couldn’t be seen up until now,” she said. “And virtual groups will be the only way to see patients who are still reluctant to meet in a group.”

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

An intervention designed to prevent serious fall injuries among older adults was less effective than researchers expected but did identify important ways for clinicians to help, including screening all older patients for fall risk and deprescribing certain medications when possible.

The study was conducted by Shalender Bhasin, MD, MBBS, from Brigham and Women’s Hospital and Harvard Medical School in Boston and colleagues on behalf of the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial investigators and was published online July 8 in The New England Journal of Medicine.

Patients are often unaware of their increased risk until they have fallen for the first time, and they often underestimate how many of their risk factors can be improved, Dr. Bhasin said in an interview.

“Fall injuries are a very important cause of injury-related deaths among older adults, and these are preventable. Yet they are so difficult; for 30 years the rates of fall injuries have not declined,” he said.

Using a pragmatic, cluster-randomized trial, the researchers studied the clinical effectiveness of a “patient-centered intervention that combined elements of practice redesign (reconfiguration of workflow to improve quality of care) and an evidence-based, multifactorial, individually tailored intervention implemented by specially trained nurses in primary care settings,” the authors explained.

Participants in the intervention group worked with trained nurses (fall care managers) to identify their risk factors and determine which risks they wanted to modify. Participants in the control group received their typical care and a pamphlet with information on falls and were encouraged to talk with their primary care physicians (who received the results on risk factor screening) about fall prevention. Those in the intervention group also received the pamphlet.

Fall care managers evaluated patients’ home environments and in some cases visited the patient’s home, Dr. Bhasin said.

The researchers enrolled community-dwelling adults aged 70 years or older who were at higher risk for fall injuries from 86 primary care practices across 10 U.S. health care systems. Half of the practices were randomly assigned to provide the intervention to their patients; the other half of the practices provided enhanced usual care.

The researchers defined patients with increased risk for fall injuries as those who had suffered a fall-related injury at least twice during the previous year or those whose difficulties with balance or walking made them fearful of falling. Serious fall injuries were defined as falls that cause a fracture (other than a thoracic or lumbar vertebral fracture), joint dislocation, a cut needing closure, or falls that resulted in hospital admission for a “head injury, sprain or strain, bruising or swelling, or other serious injury,” they explained.

Demographic and baseline characteristics were similar for both groups of patients (mean age, 80 years; 62.0% women); 38.9% had experienced a fall-related injury during the previous year, and 35.1% had suffered at least two falls during the previous year.

The researchers hypothesized that serious fall injuries would be 20% lower in the intervention group, compared with the control group, but that was not the case.

The findings showed no significant difference between the intervention group (4.9 events per 100 person-years of follow-up) and the control group (5.3 events per 100 person-years of follow-up) for the rate of first adjudicated serious fall injury (hazard ratio, 0.92; P = .25). Results were similar in a practice-level analysis and a sensitivity analysis adjusted for participant-level covariates.

However, there was a difference in rates of first participant-reported fall injury, which was a secondary endpoint, at 25.6 events per 100 person-years of follow-up among participants in the intervention group versus 28.6 events among those in the control group (HR, 0.90; P = .004).

There were no significant differences between the groups for rates of all adjudicated serious fall injuries and all patient-reported fall injuries. Bone fractures and injuries resulting in hospitalization were the most frequent types of adjudicated serious fall injuries.

Rates of serious adverse events resulting in hospitalization were similar for the intervention group and the control group (32.8 and 33.3 hospitalizations per 100 person-years of follow-up, respectively), as well as rates of death (3.3 deaths per 100 person-years of follow-up in both groups).
 

Simple steps can help

“The most important thing clinicians can do is a quick screen for fall injury risk,” Dr. Bhasin said in an interview. The screening tool he uses consists of three questions and can be completed in less than a minute. Clinicians should share that information with patients, he continued.

“Just recognizing that they are at risk for falls, patients are much more motivated to take action,” Dr. Bhasin added.

The top three risk factors identified among trial participants were trouble with strength, gait, or balance; osteoporosis or vitamin D deficiency; and impaired vision. “The use of certain medications, postural hypotension, problems with feet or footwear, and home safety hazards were less commonly identified, and the use of certain medications was the least commonly prioritized,” the authors wrote.

It is vital that clinicians help patients implement changes, Dr. Bhasin said. He noted that many patients encounter barriers that prevent them from taking action, including transportation or insurance problems and lack of access to exercise programs in the community.

Deprescribing medications such as sleep medications and benzodiazepines is also a key piece of the puzzle, he added. “They’re pretty huge risks, and yet it is so hard to get people off these medications.”

Future research will focus on how to improve the intervention’s effectiveness and also will test the strategy among those with cognitive impairments who have even higher risk for fall injuries, Dr. Bhasin said.
 

Falls remain common

A report published online July 9 in Morbidity and Mortality Weekly Report underscores the prevalence of fall-related injuries: In 2018, more than one quarter (27.5%) of adults 65 years or older said they had fallen at least once during the previous year (35.6 million falls), and 10.2% said they had experienced a fall-related injury (8.4 million fall-related injuries). The percentage of adults who reported a fall increased during 2012-2016, then decreased during 2016-2018.

Briana Moreland, MPH, from Synergy America and the Division of Injury Prevention at National Center for Injury Prevention and Control of the Centers for Disease Control and Prevention and colleagues wrote that older adults and health care providers can work together to reduce fall risk.

“CDC created the Stopping Elderly Accidents, Deaths and Injuries (STEADI) initiative, which offers tools and resources for health care providers to screen their older patients for fall risk, assess modifiable fall risk factors, and to intervene with evidence-based fall prevention interventions (https://www.cdc.gov/steadi). These include medication management, vision screening, home modifications, referral to physical therapists who can address problems with gait, strength, and balance, and referral to effective community-based fall prevention programs,” Ms. Moreland and colleagues explain.

Dr. Bhasin has received grants from the National Institute on Aging (NIA) and Patient-Centered Outcomes Research Institute (PCORI) during the conduct of the study. He has received grants, personal fees, and nonfinancial support from AbbVie; grants from Transition Therapeutics, Alivegen, and Metro International Biotechnology; and personal fees from OPKO outside the submitted work. A coauthor received grants from the NIA and PCORI during the conduct of the study and is co-owner of Lynx Health, and another Peduzzi received grants and other compensation from NIA-PCORI during the conduct of the study. Two other authors have disclosed no relevant financial relationships. The remaining authors report a variety of relevant financial relationships; a complete list is available on the journal’s website. The authors of the article in Morbidity and Mortality Weekly Report have disclosed no relevant financial relationships.

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

An intervention designed to prevent serious fall injuries among older adults was less effective than researchers expected but did identify important ways for clinicians to help, including screening all older patients for fall risk and deprescribing certain medications when possible.

The study was conducted by Shalender Bhasin, MD, MBBS, from Brigham and Women’s Hospital and Harvard Medical School in Boston and colleagues on behalf of the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial investigators and was published online July 8 in The New England Journal of Medicine.

Patients are often unaware of their increased risk until they have fallen for the first time, and they often underestimate how many of their risk factors can be improved, Dr. Bhasin said in an interview.

“Fall injuries are a very important cause of injury-related deaths among older adults, and these are preventable. Yet they are so difficult; for 30 years the rates of fall injuries have not declined,” he said.

Using a pragmatic, cluster-randomized trial, the researchers studied the clinical effectiveness of a “patient-centered intervention that combined elements of practice redesign (reconfiguration of workflow to improve quality of care) and an evidence-based, multifactorial, individually tailored intervention implemented by specially trained nurses in primary care settings,” the authors explained.

Participants in the intervention group worked with trained nurses (fall care managers) to identify their risk factors and determine which risks they wanted to modify. Participants in the control group received their typical care and a pamphlet with information on falls and were encouraged to talk with their primary care physicians (who received the results on risk factor screening) about fall prevention. Those in the intervention group also received the pamphlet.

Fall care managers evaluated patients’ home environments and in some cases visited the patient’s home, Dr. Bhasin said.

The researchers enrolled community-dwelling adults aged 70 years or older who were at higher risk for fall injuries from 86 primary care practices across 10 U.S. health care systems. Half of the practices were randomly assigned to provide the intervention to their patients; the other half of the practices provided enhanced usual care.

The researchers defined patients with increased risk for fall injuries as those who had suffered a fall-related injury at least twice during the previous year or those whose difficulties with balance or walking made them fearful of falling. Serious fall injuries were defined as falls that cause a fracture (other than a thoracic or lumbar vertebral fracture), joint dislocation, a cut needing closure, or falls that resulted in hospital admission for a “head injury, sprain or strain, bruising or swelling, or other serious injury,” they explained.

Demographic and baseline characteristics were similar for both groups of patients (mean age, 80 years; 62.0% women); 38.9% had experienced a fall-related injury during the previous year, and 35.1% had suffered at least two falls during the previous year.

The researchers hypothesized that serious fall injuries would be 20% lower in the intervention group, compared with the control group, but that was not the case.

The findings showed no significant difference between the intervention group (4.9 events per 100 person-years of follow-up) and the control group (5.3 events per 100 person-years of follow-up) for the rate of first adjudicated serious fall injury (hazard ratio, 0.92; P = .25). Results were similar in a practice-level analysis and a sensitivity analysis adjusted for participant-level covariates.

However, there was a difference in rates of first participant-reported fall injury, which was a secondary endpoint, at 25.6 events per 100 person-years of follow-up among participants in the intervention group versus 28.6 events among those in the control group (HR, 0.90; P = .004).

There were no significant differences between the groups for rates of all adjudicated serious fall injuries and all patient-reported fall injuries. Bone fractures and injuries resulting in hospitalization were the most frequent types of adjudicated serious fall injuries.

Rates of serious adverse events resulting in hospitalization were similar for the intervention group and the control group (32.8 and 33.3 hospitalizations per 100 person-years of follow-up, respectively), as well as rates of death (3.3 deaths per 100 person-years of follow-up in both groups).
 

Simple steps can help

“The most important thing clinicians can do is a quick screen for fall injury risk,” Dr. Bhasin said in an interview. The screening tool he uses consists of three questions and can be completed in less than a minute. Clinicians should share that information with patients, he continued.

“Just recognizing that they are at risk for falls, patients are much more motivated to take action,” Dr. Bhasin added.

The top three risk factors identified among trial participants were trouble with strength, gait, or balance; osteoporosis or vitamin D deficiency; and impaired vision. “The use of certain medications, postural hypotension, problems with feet or footwear, and home safety hazards were less commonly identified, and the use of certain medications was the least commonly prioritized,” the authors wrote.

It is vital that clinicians help patients implement changes, Dr. Bhasin said. He noted that many patients encounter barriers that prevent them from taking action, including transportation or insurance problems and lack of access to exercise programs in the community.

Deprescribing medications such as sleep medications and benzodiazepines is also a key piece of the puzzle, he added. “They’re pretty huge risks, and yet it is so hard to get people off these medications.”

Future research will focus on how to improve the intervention’s effectiveness and also will test the strategy among those with cognitive impairments who have even higher risk for fall injuries, Dr. Bhasin said.
 

Falls remain common

A report published online July 9 in Morbidity and Mortality Weekly Report underscores the prevalence of fall-related injuries: In 2018, more than one quarter (27.5%) of adults 65 years or older said they had fallen at least once during the previous year (35.6 million falls), and 10.2% said they had experienced a fall-related injury (8.4 million fall-related injuries). The percentage of adults who reported a fall increased during 2012-2016, then decreased during 2016-2018.

Briana Moreland, MPH, from Synergy America and the Division of Injury Prevention at National Center for Injury Prevention and Control of the Centers for Disease Control and Prevention and colleagues wrote that older adults and health care providers can work together to reduce fall risk.

“CDC created the Stopping Elderly Accidents, Deaths and Injuries (STEADI) initiative, which offers tools and resources for health care providers to screen their older patients for fall risk, assess modifiable fall risk factors, and to intervene with evidence-based fall prevention interventions (https://www.cdc.gov/steadi). These include medication management, vision screening, home modifications, referral to physical therapists who can address problems with gait, strength, and balance, and referral to effective community-based fall prevention programs,” Ms. Moreland and colleagues explain.

Dr. Bhasin has received grants from the National Institute on Aging (NIA) and Patient-Centered Outcomes Research Institute (PCORI) during the conduct of the study. He has received grants, personal fees, and nonfinancial support from AbbVie; grants from Transition Therapeutics, Alivegen, and Metro International Biotechnology; and personal fees from OPKO outside the submitted work. A coauthor received grants from the NIA and PCORI during the conduct of the study and is co-owner of Lynx Health, and another Peduzzi received grants and other compensation from NIA-PCORI during the conduct of the study. Two other authors have disclosed no relevant financial relationships. The remaining authors report a variety of relevant financial relationships; a complete list is available on the journal’s website. The authors of the article in Morbidity and Mortality Weekly Report have disclosed no relevant financial relationships.

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

An intervention designed to prevent serious fall injuries among older adults was less effective than researchers expected but did identify important ways for clinicians to help, including screening all older patients for fall risk and deprescribing certain medications when possible.

The study was conducted by Shalender Bhasin, MD, MBBS, from Brigham and Women’s Hospital and Harvard Medical School in Boston and colleagues on behalf of the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial investigators and was published online July 8 in The New England Journal of Medicine.

Patients are often unaware of their increased risk until they have fallen for the first time, and they often underestimate how many of their risk factors can be improved, Dr. Bhasin said in an interview.

“Fall injuries are a very important cause of injury-related deaths among older adults, and these are preventable. Yet they are so difficult; for 30 years the rates of fall injuries have not declined,” he said.

Using a pragmatic, cluster-randomized trial, the researchers studied the clinical effectiveness of a “patient-centered intervention that combined elements of practice redesign (reconfiguration of workflow to improve quality of care) and an evidence-based, multifactorial, individually tailored intervention implemented by specially trained nurses in primary care settings,” the authors explained.

Participants in the intervention group worked with trained nurses (fall care managers) to identify their risk factors and determine which risks they wanted to modify. Participants in the control group received their typical care and a pamphlet with information on falls and were encouraged to talk with their primary care physicians (who received the results on risk factor screening) about fall prevention. Those in the intervention group also received the pamphlet.

Fall care managers evaluated patients’ home environments and in some cases visited the patient’s home, Dr. Bhasin said.

The researchers enrolled community-dwelling adults aged 70 years or older who were at higher risk for fall injuries from 86 primary care practices across 10 U.S. health care systems. Half of the practices were randomly assigned to provide the intervention to their patients; the other half of the practices provided enhanced usual care.

The researchers defined patients with increased risk for fall injuries as those who had suffered a fall-related injury at least twice during the previous year or those whose difficulties with balance or walking made them fearful of falling. Serious fall injuries were defined as falls that cause a fracture (other than a thoracic or lumbar vertebral fracture), joint dislocation, a cut needing closure, or falls that resulted in hospital admission for a “head injury, sprain or strain, bruising or swelling, or other serious injury,” they explained.

Demographic and baseline characteristics were similar for both groups of patients (mean age, 80 years; 62.0% women); 38.9% had experienced a fall-related injury during the previous year, and 35.1% had suffered at least two falls during the previous year.

The researchers hypothesized that serious fall injuries would be 20% lower in the intervention group, compared with the control group, but that was not the case.

The findings showed no significant difference between the intervention group (4.9 events per 100 person-years of follow-up) and the control group (5.3 events per 100 person-years of follow-up) for the rate of first adjudicated serious fall injury (hazard ratio, 0.92; P = .25). Results were similar in a practice-level analysis and a sensitivity analysis adjusted for participant-level covariates.

However, there was a difference in rates of first participant-reported fall injury, which was a secondary endpoint, at 25.6 events per 100 person-years of follow-up among participants in the intervention group versus 28.6 events among those in the control group (HR, 0.90; P = .004).

There were no significant differences between the groups for rates of all adjudicated serious fall injuries and all patient-reported fall injuries. Bone fractures and injuries resulting in hospitalization were the most frequent types of adjudicated serious fall injuries.

Rates of serious adverse events resulting in hospitalization were similar for the intervention group and the control group (32.8 and 33.3 hospitalizations per 100 person-years of follow-up, respectively), as well as rates of death (3.3 deaths per 100 person-years of follow-up in both groups).
 

Simple steps can help

“The most important thing clinicians can do is a quick screen for fall injury risk,” Dr. Bhasin said in an interview. The screening tool he uses consists of three questions and can be completed in less than a minute. Clinicians should share that information with patients, he continued.

“Just recognizing that they are at risk for falls, patients are much more motivated to take action,” Dr. Bhasin added.

The top three risk factors identified among trial participants were trouble with strength, gait, or balance; osteoporosis or vitamin D deficiency; and impaired vision. “The use of certain medications, postural hypotension, problems with feet or footwear, and home safety hazards were less commonly identified, and the use of certain medications was the least commonly prioritized,” the authors wrote.

It is vital that clinicians help patients implement changes, Dr. Bhasin said. He noted that many patients encounter barriers that prevent them from taking action, including transportation or insurance problems and lack of access to exercise programs in the community.

Deprescribing medications such as sleep medications and benzodiazepines is also a key piece of the puzzle, he added. “They’re pretty huge risks, and yet it is so hard to get people off these medications.”

Future research will focus on how to improve the intervention’s effectiveness and also will test the strategy among those with cognitive impairments who have even higher risk for fall injuries, Dr. Bhasin said.
 

Falls remain common

A report published online July 9 in Morbidity and Mortality Weekly Report underscores the prevalence of fall-related injuries: In 2018, more than one quarter (27.5%) of adults 65 years or older said they had fallen at least once during the previous year (35.6 million falls), and 10.2% said they had experienced a fall-related injury (8.4 million fall-related injuries). The percentage of adults who reported a fall increased during 2012-2016, then decreased during 2016-2018.

Briana Moreland, MPH, from Synergy America and the Division of Injury Prevention at National Center for Injury Prevention and Control of the Centers for Disease Control and Prevention and colleagues wrote that older adults and health care providers can work together to reduce fall risk.

“CDC created the Stopping Elderly Accidents, Deaths and Injuries (STEADI) initiative, which offers tools and resources for health care providers to screen their older patients for fall risk, assess modifiable fall risk factors, and to intervene with evidence-based fall prevention interventions (https://www.cdc.gov/steadi). These include medication management, vision screening, home modifications, referral to physical therapists who can address problems with gait, strength, and balance, and referral to effective community-based fall prevention programs,” Ms. Moreland and colleagues explain.

Dr. Bhasin has received grants from the National Institute on Aging (NIA) and Patient-Centered Outcomes Research Institute (PCORI) during the conduct of the study. He has received grants, personal fees, and nonfinancial support from AbbVie; grants from Transition Therapeutics, Alivegen, and Metro International Biotechnology; and personal fees from OPKO outside the submitted work. A coauthor received grants from the NIA and PCORI during the conduct of the study and is co-owner of Lynx Health, and another Peduzzi received grants and other compensation from NIA-PCORI during the conduct of the study. Two other authors have disclosed no relevant financial relationships. The remaining authors report a variety of relevant financial relationships; a complete list is available on the journal’s website. The authors of the article in Morbidity and Mortality Weekly Report have disclosed no relevant financial relationships.

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