Joining Gastroenterology as an editorial fellow is an invaluable experience for the future scientific career. When I joined the fellowship, my main objectives were to learn important aspects about scientific publishing, while improving my editorial and writing skills. Importantly, participating in the fellowship would allow me to determine fields in gastroenterology and hepatology that need more intensive research, evaluate and review manuscripts submitted to a high-impact journal, learn which aspects are important for manuscripts to be considered for publication, and learn how to prepare concise summaries to share with readers. As an editorial fellow, I would not only work with experts on manuscript review and editing, but also be mentored by experts in the field to prepare for a career in scientific publishing.

The application process is easy and straightforward. A curriculum vitae, motivation letter, and conflict of interest form are needed to be considered for the position. Furthermore, a letter of recommendation has to be provided from senior faculty. For the latter, it is beneficial to have worked with someone who is currently active in scientific publishing.

After joining the editorial board, fellows are assigned to associate editors based on their previous experience. Fellows are expected to peer-review manuscripts and discuss their reviews with the associate editors during a brief call or by email, where it is also determined whether additional feedback from the board of editors is needed to move manuscripts forward. If so, fellows are given the opportunity to present manuscripts they reviewed to the editorial board and prepare the decision letter with comments to the authors and editors. This experience teaches which qualities manuscripts need to fulfill to be considered for publication, and how to communicate decisions to authors. During the meetings with the editorial board, fellows are also encouraged to provide feedback for additional manuscripts discussed.

Additionally, fellows have the chance to work on the “Covering the Cover” section of the journal under close mentorship of the responsible editors. Here, they learn to draft short synopses of submitted manuscripts that should be highlighted in the respective sections to give readers a brief overview of important pieces of research with potential clinical applicability. This experience teaches how to write concisely and rephrase the main message of manuscripts without overstating findings and conclusions. Additionally, fellows are invited to write commentaries on recent articles published in other journals and highlight these to Gastroenterology’s readership. This experience teaches how to critically comment on published literature and point out its strengths and limitations. Overall, these learning experiences improve not only editorial and writing skills, but also knowledge in the respective areas of research.

Finally, fellows have the opportunity to write a commentary about a topic of their choice. This experience allows fellows to deepen their expertise in an area of research on an emerging topic they would like to highlight to their readers. Since this type of article is peer reviewed, reviewers’ comments help identify weaknesses of the initially submitted manuscript and increase the awareness about factors that need to be addressed to finally provide a high-quality article that is of value to Gastroenterology’s readership.

Concluding, being an editorial fellow for Gastroenterology is an extremely valuable experience. From an editorial aspect, fellows learn to review, summarize, and comment on submitted manuscripts, as well as which factors need to be addressed by manuscripts to be considered for publication to a high-impact journal. Additionally, fellows network with leaders in the field and expand their knowledge on topics they had not worked on previously. Overall, the fellowship helps improve editorial and writing skills, while staying current in the literature, a skill set that can be applied broadly in the future medical and scientific career.

Dr. Kefalakes is a clinical fellow and research group leader in the department of gastroenterology, hepatology, and endocrinology at Hannover (Germany) Medical School. She has nothing to declare.

Joining Gastroenterology as an editorial fellow is an invaluable experience for the future scientific career. When I joined the fellowship, my main objectives were to learn important aspects about scientific publishing, while improving my editorial and writing skills. Importantly, participating in the fellowship would allow me to determine fields in gastroenterology and hepatology that need more intensive research, evaluate and review manuscripts submitted to a high-impact journal, learn which aspects are important for manuscripts to be considered for publication, and learn how to prepare concise summaries to share with readers. As an editorial fellow, I would not only work with experts on manuscript review and editing, but also be mentored by experts in the field to prepare for a career in scientific publishing.

The application process is easy and straightforward. A curriculum vitae, motivation letter, and conflict of interest form are needed to be considered for the position. Furthermore, a letter of recommendation has to be provided from senior faculty. For the latter, it is beneficial to have worked with someone who is currently active in scientific publishing.

After joining the editorial board, fellows are assigned to associate editors based on their previous experience. Fellows are expected to peer-review manuscripts and discuss their reviews with the associate editors during a brief call or by email, where it is also determined whether additional feedback from the board of editors is needed to move manuscripts forward. If so, fellows are given the opportunity to present manuscripts they reviewed to the editorial board and prepare the decision letter with comments to the authors and editors. This experience teaches which qualities manuscripts need to fulfill to be considered for publication, and how to communicate decisions to authors. During the meetings with the editorial board, fellows are also encouraged to provide feedback for additional manuscripts discussed.

Additionally, fellows have the chance to work on the “Covering the Cover” section of the journal under close mentorship of the responsible editors. Here, they learn to draft short synopses of submitted manuscripts that should be highlighted in the respective sections to give readers a brief overview of important pieces of research with potential clinical applicability. This experience teaches how to write concisely and rephrase the main message of manuscripts without overstating findings and conclusions. Additionally, fellows are invited to write commentaries on recent articles published in other journals and highlight these to Gastroenterology’s readership. This experience teaches how to critically comment on published literature and point out its strengths and limitations. Overall, these learning experiences improve not only editorial and writing skills, but also knowledge in the respective areas of research.

Finally, fellows have the opportunity to write a commentary about a topic of their choice. This experience allows fellows to deepen their expertise in an area of research on an emerging topic they would like to highlight to their readers. Since this type of article is peer reviewed, reviewers’ comments help identify weaknesses of the initially submitted manuscript and increase the awareness about factors that need to be addressed to finally provide a high-quality article that is of value to Gastroenterology’s readership.

Concluding, being an editorial fellow for Gastroenterology is an extremely valuable experience. From an editorial aspect, fellows learn to review, summarize, and comment on submitted manuscripts, as well as which factors need to be addressed by manuscripts to be considered for publication to a high-impact journal. Additionally, fellows network with leaders in the field and expand their knowledge on topics they had not worked on previously. Overall, the fellowship helps improve editorial and writing skills, while staying current in the literature, a skill set that can be applied broadly in the future medical and scientific career.

Dr. Kefalakes is a clinical fellow and research group leader in the department of gastroenterology, hepatology, and endocrinology at Hannover (Germany) Medical School. She has nothing to declare.

Joining Gastroenterology as an editorial fellow is an invaluable experience for the future scientific career. When I joined the fellowship, my main objectives were to learn important aspects about scientific publishing, while improving my editorial and writing skills. Importantly, participating in the fellowship would allow me to determine fields in gastroenterology and hepatology that need more intensive research, evaluate and review manuscripts submitted to a high-impact journal, learn which aspects are important for manuscripts to be considered for publication, and learn how to prepare concise summaries to share with readers. As an editorial fellow, I would not only work with experts on manuscript review and editing, but also be mentored by experts in the field to prepare for a career in scientific publishing.

The application process is easy and straightforward. A curriculum vitae, motivation letter, and conflict of interest form are needed to be considered for the position. Furthermore, a letter of recommendation has to be provided from senior faculty. For the latter, it is beneficial to have worked with someone who is currently active in scientific publishing.

After joining the editorial board, fellows are assigned to associate editors based on their previous experience. Fellows are expected to peer-review manuscripts and discuss their reviews with the associate editors during a brief call or by email, where it is also determined whether additional feedback from the board of editors is needed to move manuscripts forward. If so, fellows are given the opportunity to present manuscripts they reviewed to the editorial board and prepare the decision letter with comments to the authors and editors. This experience teaches which qualities manuscripts need to fulfill to be considered for publication, and how to communicate decisions to authors. During the meetings with the editorial board, fellows are also encouraged to provide feedback for additional manuscripts discussed.

Additionally, fellows have the chance to work on the “Covering the Cover” section of the journal under close mentorship of the responsible editors. Here, they learn to draft short synopses of submitted manuscripts that should be highlighted in the respective sections to give readers a brief overview of important pieces of research with potential clinical applicability. This experience teaches how to write concisely and rephrase the main message of manuscripts without overstating findings and conclusions. Additionally, fellows are invited to write commentaries on recent articles published in other journals and highlight these to Gastroenterology’s readership. This experience teaches how to critically comment on published literature and point out its strengths and limitations. Overall, these learning experiences improve not only editorial and writing skills, but also knowledge in the respective areas of research.

Finally, fellows have the opportunity to write a commentary about a topic of their choice. This experience allows fellows to deepen their expertise in an area of research on an emerging topic they would like to highlight to their readers. Since this type of article is peer reviewed, reviewers’ comments help identify weaknesses of the initially submitted manuscript and increase the awareness about factors that need to be addressed to finally provide a high-quality article that is of value to Gastroenterology’s readership.

Concluding, being an editorial fellow for Gastroenterology is an extremely valuable experience. From an editorial aspect, fellows learn to review, summarize, and comment on submitted manuscripts, as well as which factors need to be addressed by manuscripts to be considered for publication to a high-impact journal. Additionally, fellows network with leaders in the field and expand their knowledge on topics they had not worked on previously. Overall, the fellowship helps improve editorial and writing skills, while staying current in the literature, a skill set that can be applied broadly in the future medical and scientific career.

Dr. Kefalakes is a clinical fellow and research group leader in the department of gastroenterology, hepatology, and endocrinology at Hannover (Germany) Medical School. She has nothing to declare.

Herpes zoster does not appear to increase dementia risk – on the contrary, the viral infection may offer some protection, a large population-based study suggests.

“We were surprised by these results [and] the reasons for the decreased risk are unclear,” study author Sigrun Alba Johannesdottir Schmidt, MD, PhD, with Aarhus (Denmark) University Hospital, said in a news release.

The study was published online in Neurology.
 

Conflicting findings

Herpes zoster (HZ) is an acute, cutaneous viral infection caused by the reactivation of varicella-zoster virus (VZV). Previous population-based studies have reported both decreased and increased risks of dementia after having HZ.

It’s thought that HZ may contribute to the development of dementia through neuroinflammation, cerebral vasculopathy, or direct neural damage, but epidemiologic evidence is limited.

To investigate further, Dr. Schmidt and colleagues used Danish medical registries to identify 247,305 people who had visited a hospital for HZ or were prescribed antiviral medication for HZ over a 20-year period and matched them to 1,235,890 people who did not have HZ. For both cohorts, the median age was 64 years, and 61% were women.

Dementia was diagnosed in 9.7% of zoster patients and 10.3% of matched control persons during up to 21 years of follow-up.

Contrary to the researchers’ expectation, HZ was associated with a small (7%) decreased relative risk of all-cause dementia during follow-up (hazard ratio, 0.93; 95% confidence interval, 0.90-0.95).

There was no increased long-term risk of dementia in subgroup analyses, except possibly among those with HZ that involved the central nervous system (HR, 1.94; 95% CI, 0.78-4.80), which has been shown before.

However, the population attributable fraction of dementia caused by this rare complication is low (< 1%), suggesting that universal vaccination against VZV in the elderly has limited potential to reduce dementia risk, the investigators noted.

Nonetheless, Dr. Schmidt said shingles vaccination should be encouraged in older people because it can prevent complications from the disease.

The research team admitted that the slightly decreased long-term risk of dementia, including Alzheimer’s disease, was “unexpected.” The reasons for this decreased risk are unclear, they say, and could be explained by missed diagnoses of shingles in people with undiagnosed dementia.

They were not able to examine whether antiviral treatment modifies the association between HZ and dementia and said that this topic merits further research.

The study was supported by the Edel and Wilhelm Daubenmerkls Charitable Foundation. The authors disclosed no relevant financial relationships.

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

Herpes zoster does not appear to increase dementia risk – on the contrary, the viral infection may offer some protection, a large population-based study suggests.

“We were surprised by these results [and] the reasons for the decreased risk are unclear,” study author Sigrun Alba Johannesdottir Schmidt, MD, PhD, with Aarhus (Denmark) University Hospital, said in a news release.

The study was published online in Neurology.
 

Conflicting findings

Herpes zoster (HZ) is an acute, cutaneous viral infection caused by the reactivation of varicella-zoster virus (VZV). Previous population-based studies have reported both decreased and increased risks of dementia after having HZ.

It’s thought that HZ may contribute to the development of dementia through neuroinflammation, cerebral vasculopathy, or direct neural damage, but epidemiologic evidence is limited.

To investigate further, Dr. Schmidt and colleagues used Danish medical registries to identify 247,305 people who had visited a hospital for HZ or were prescribed antiviral medication for HZ over a 20-year period and matched them to 1,235,890 people who did not have HZ. For both cohorts, the median age was 64 years, and 61% were women.

Dementia was diagnosed in 9.7% of zoster patients and 10.3% of matched control persons during up to 21 years of follow-up.

Contrary to the researchers’ expectation, HZ was associated with a small (7%) decreased relative risk of all-cause dementia during follow-up (hazard ratio, 0.93; 95% confidence interval, 0.90-0.95).

There was no increased long-term risk of dementia in subgroup analyses, except possibly among those with HZ that involved the central nervous system (HR, 1.94; 95% CI, 0.78-4.80), which has been shown before.

However, the population attributable fraction of dementia caused by this rare complication is low (< 1%), suggesting that universal vaccination against VZV in the elderly has limited potential to reduce dementia risk, the investigators noted.

Nonetheless, Dr. Schmidt said shingles vaccination should be encouraged in older people because it can prevent complications from the disease.

The research team admitted that the slightly decreased long-term risk of dementia, including Alzheimer’s disease, was “unexpected.” The reasons for this decreased risk are unclear, they say, and could be explained by missed diagnoses of shingles in people with undiagnosed dementia.

They were not able to examine whether antiviral treatment modifies the association between HZ and dementia and said that this topic merits further research.

The study was supported by the Edel and Wilhelm Daubenmerkls Charitable Foundation. The authors disclosed no relevant financial relationships.

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

Herpes zoster does not appear to increase dementia risk – on the contrary, the viral infection may offer some protection, a large population-based study suggests.

“We were surprised by these results [and] the reasons for the decreased risk are unclear,” study author Sigrun Alba Johannesdottir Schmidt, MD, PhD, with Aarhus (Denmark) University Hospital, said in a news release.

The study was published online in Neurology.
 

Conflicting findings

Herpes zoster (HZ) is an acute, cutaneous viral infection caused by the reactivation of varicella-zoster virus (VZV). Previous population-based studies have reported both decreased and increased risks of dementia after having HZ.

It’s thought that HZ may contribute to the development of dementia through neuroinflammation, cerebral vasculopathy, or direct neural damage, but epidemiologic evidence is limited.

To investigate further, Dr. Schmidt and colleagues used Danish medical registries to identify 247,305 people who had visited a hospital for HZ or were prescribed antiviral medication for HZ over a 20-year period and matched them to 1,235,890 people who did not have HZ. For both cohorts, the median age was 64 years, and 61% were women.

Dementia was diagnosed in 9.7% of zoster patients and 10.3% of matched control persons during up to 21 years of follow-up.

Contrary to the researchers’ expectation, HZ was associated with a small (7%) decreased relative risk of all-cause dementia during follow-up (hazard ratio, 0.93; 95% confidence interval, 0.90-0.95).

There was no increased long-term risk of dementia in subgroup analyses, except possibly among those with HZ that involved the central nervous system (HR, 1.94; 95% CI, 0.78-4.80), which has been shown before.

However, the population attributable fraction of dementia caused by this rare complication is low (< 1%), suggesting that universal vaccination against VZV in the elderly has limited potential to reduce dementia risk, the investigators noted.

Nonetheless, Dr. Schmidt said shingles vaccination should be encouraged in older people because it can prevent complications from the disease.

The research team admitted that the slightly decreased long-term risk of dementia, including Alzheimer’s disease, was “unexpected.” The reasons for this decreased risk are unclear, they say, and could be explained by missed diagnoses of shingles in people with undiagnosed dementia.

They were not able to examine whether antiviral treatment modifies the association between HZ and dementia and said that this topic merits further research.

The study was supported by the Edel and Wilhelm Daubenmerkls Charitable Foundation. The authors disclosed no relevant financial relationships.

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

The combination of neoadjuvant chemotherapy with immunotherapy led to significant improvements in survival for patients with resectable stage IIIA-B non–small cell lung cancer (NSCLC), according to researchers reporting earlier this month in Chicago at the annual meeting of the American Society of Clinical Oncology.

Advanced stage IIIA NSCLC is incurable in most patients with lung cancer, and with existing treatments only 30% of patients will live up to 5 years. In this study, neoadjuvant chemotherapy with nivolumab significantly increased the pathological complete response rate in 36.2% of patients, compared with 6.8% who received chemo alone, said study author Mariano Provencio-Pulla, MD, PhD, Instituto Investigacion Sanitaria Puerta de Hierro-Segovia de Arana, Spain. The major pathologic response (MPR) – which accounts for residual viable tumor of less than or equal to 10 – was better in the treatment group as compared with patients who received chemotherapy alone (52% vs 14%). The objective response rate (ORR) – or, the percentage of patients who had a partial or complete response to treatment – was 74% in the treatment group, compared with 48% among patients who received chemotherapy.

“In our opinion this should be the standard of care for patients,” Dr. Provencio-Pulla said during his presentation.

The ASCO treatment guidelines for stage III NSCLC, specify that some patients can receive immunotherapy for up to a year, but for resectable stage III disease, this therapy is still under investigation.

In this study, called NADIM II (NCT03838159), investigators enrolled 87 patients with resectable clinical stage IIIA disease between February 2019 and November 2021. NADIM II is an open-label, randomized, two-arm, phase 2, multicenter clinical trial. Patients had ECOG scores of 0-1 and no known EGFR/ALK alterations. Patients received either nivolumab 360 mg with paclitaxel 200 mg/m² and carboplatin AUC5 for three cycles every 21 days as treatment before or after surgery. Patients who received a resection that left no microscopic tumor in the primary tumor bed, received adjuvant nivolumab between weeks 3 and 8 after surgery for 6 months.

At 91%, almost all patients who received the immunotherapy and chemotherapy treatment underwent surgery, compared with 69% of patients in the chemotherapy treatment group. In the treatment group, patients with pathological complete response (pCR) had higher PD-L1 tumor proportion score (TPS) scores (median 70%).

The primary endpoint was pathological complete response of 0% viable tumor cells in resected lung and lymph nodes. The major pathological response was no more than 10% viable tumor remaining. The secondary endpoints included overall response rate, toxicity profile, and potential predictive biomarkers.

The addition of neoadjuvant nivolumab to chemotherapy significantly improved pCR (odds ratio, 7.88). The safety profile was “tolerable” with a moderate increase in grade 3-4 toxicity; plus no surgery was delayed because of problems with the treatment, Dr. Provencio-Pulla said.

This study was funded by Fundación GECP. Dr. Provencio-Pulla has received funding from Bristol-Myers Squibb, the maker of Opdivo (nivolumab).

The combination of neoadjuvant chemotherapy with immunotherapy led to significant improvements in survival for patients with resectable stage IIIA-B non–small cell lung cancer (NSCLC), according to researchers reporting earlier this month in Chicago at the annual meeting of the American Society of Clinical Oncology.

Advanced stage IIIA NSCLC is incurable in most patients with lung cancer, and with existing treatments only 30% of patients will live up to 5 years. In this study, neoadjuvant chemotherapy with nivolumab significantly increased the pathological complete response rate in 36.2% of patients, compared with 6.8% who received chemo alone, said study author Mariano Provencio-Pulla, MD, PhD, Instituto Investigacion Sanitaria Puerta de Hierro-Segovia de Arana, Spain. The major pathologic response (MPR) – which accounts for residual viable tumor of less than or equal to 10 – was better in the treatment group as compared with patients who received chemotherapy alone (52% vs 14%). The objective response rate (ORR) – or, the percentage of patients who had a partial or complete response to treatment – was 74% in the treatment group, compared with 48% among patients who received chemotherapy.

“In our opinion this should be the standard of care for patients,” Dr. Provencio-Pulla said during his presentation.

The ASCO treatment guidelines for stage III NSCLC, specify that some patients can receive immunotherapy for up to a year, but for resectable stage III disease, this therapy is still under investigation.

In this study, called NADIM II (NCT03838159), investigators enrolled 87 patients with resectable clinical stage IIIA disease between February 2019 and November 2021. NADIM II is an open-label, randomized, two-arm, phase 2, multicenter clinical trial. Patients had ECOG scores of 0-1 and no known EGFR/ALK alterations. Patients received either nivolumab 360 mg with paclitaxel 200 mg/m² and carboplatin AUC5 for three cycles every 21 days as treatment before or after surgery. Patients who received a resection that left no microscopic tumor in the primary tumor bed, received adjuvant nivolumab between weeks 3 and 8 after surgery for 6 months.

At 91%, almost all patients who received the immunotherapy and chemotherapy treatment underwent surgery, compared with 69% of patients in the chemotherapy treatment group. In the treatment group, patients with pathological complete response (pCR) had higher PD-L1 tumor proportion score (TPS) scores (median 70%).

The primary endpoint was pathological complete response of 0% viable tumor cells in resected lung and lymph nodes. The major pathological response was no more than 10% viable tumor remaining. The secondary endpoints included overall response rate, toxicity profile, and potential predictive biomarkers.

The addition of neoadjuvant nivolumab to chemotherapy significantly improved pCR (odds ratio, 7.88). The safety profile was “tolerable” with a moderate increase in grade 3-4 toxicity; plus no surgery was delayed because of problems with the treatment, Dr. Provencio-Pulla said.

This study was funded by Fundación GECP. Dr. Provencio-Pulla has received funding from Bristol-Myers Squibb, the maker of Opdivo (nivolumab).

The combination of neoadjuvant chemotherapy with immunotherapy led to significant improvements in survival for patients with resectable stage IIIA-B non–small cell lung cancer (NSCLC), according to researchers reporting earlier this month in Chicago at the annual meeting of the American Society of Clinical Oncology.

Advanced stage IIIA NSCLC is incurable in most patients with lung cancer, and with existing treatments only 30% of patients will live up to 5 years. In this study, neoadjuvant chemotherapy with nivolumab significantly increased the pathological complete response rate in 36.2% of patients, compared with 6.8% who received chemo alone, said study author Mariano Provencio-Pulla, MD, PhD, Instituto Investigacion Sanitaria Puerta de Hierro-Segovia de Arana, Spain. The major pathologic response (MPR) – which accounts for residual viable tumor of less than or equal to 10 – was better in the treatment group as compared with patients who received chemotherapy alone (52% vs 14%). The objective response rate (ORR) – or, the percentage of patients who had a partial or complete response to treatment – was 74% in the treatment group, compared with 48% among patients who received chemotherapy.

“In our opinion this should be the standard of care for patients,” Dr. Provencio-Pulla said during his presentation.

The ASCO treatment guidelines for stage III NSCLC, specify that some patients can receive immunotherapy for up to a year, but for resectable stage III disease, this therapy is still under investigation.

In this study, called NADIM II (NCT03838159), investigators enrolled 87 patients with resectable clinical stage IIIA disease between February 2019 and November 2021. NADIM II is an open-label, randomized, two-arm, phase 2, multicenter clinical trial. Patients had ECOG scores of 0-1 and no known EGFR/ALK alterations. Patients received either nivolumab 360 mg with paclitaxel 200 mg/m² and carboplatin AUC5 for three cycles every 21 days as treatment before or after surgery. Patients who received a resection that left no microscopic tumor in the primary tumor bed, received adjuvant nivolumab between weeks 3 and 8 after surgery for 6 months.

At 91%, almost all patients who received the immunotherapy and chemotherapy treatment underwent surgery, compared with 69% of patients in the chemotherapy treatment group. In the treatment group, patients with pathological complete response (pCR) had higher PD-L1 tumor proportion score (TPS) scores (median 70%).

The primary endpoint was pathological complete response of 0% viable tumor cells in resected lung and lymph nodes. The major pathological response was no more than 10% viable tumor remaining. The secondary endpoints included overall response rate, toxicity profile, and potential predictive biomarkers.

The addition of neoadjuvant nivolumab to chemotherapy significantly improved pCR (odds ratio, 7.88). The safety profile was “tolerable” with a moderate increase in grade 3-4 toxicity; plus no surgery was delayed because of problems with the treatment, Dr. Provencio-Pulla said.

This study was funded by Fundación GECP. Dr. Provencio-Pulla has received funding from Bristol-Myers Squibb, the maker of Opdivo (nivolumab).

An artificial intelligence (AI)–based computer-aided polyp detection (CADe) system missed fewer adenomas, polyps, and sessile serrated lesions and identified more adenomas per colonoscopy than a high-definition white light (HDWL) colonoscopy, according to findings from a randomized study.

While adenoma detection by colonoscopy is associated with a reduced risk of interval colon cancer, detection rates of adenomas vary among physicians. AI approaches, such as machine learning and deep learning, may improve adenoma detection rates during colonoscopy and thus potentially improve outcomes for patients, suggested study authors led by Jeremy R. Glissen Brown, MD, of the Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, who reported their trial findings in Clinical Gastroenterology and Hepatology.

The investigators explained that, although AI approaches may offer benefits in adenoma detection, there have been no prospective data for U.S. populations on the efficacy of an AI-based CADe system for improving adenoma detection rates (ADRs) and reducing adenoma miss rates (AMRs). To overcome this research gap, the investigators performed a prospective, multicenter, single-blind randomized tandem colonoscopy study which assessed a deep learning–based CADe system in 232 patients.

Individuals who presented to the four included U.S. medical centers for either colorectal cancer screening or surveillance were randomly assigned to the CADe system colonoscopy first (n = 116) or HDWL colonoscopy first (n = 116). This was immediately followed by the other procedure, in tandem fashion, performed by the same endoscopist. AMR was the primary outcome of interest, while secondary outcomes were adenomas per colonoscopy (APC) and the miss rate of sessile serrated lesions (SSL).

The researchers excluded 9 patients, which resulted in a total patient population of 223 patients. Approximately 45.3% of the cohort was female, 67.7% were White, and 21% were Black. Most patients (60%) were indicated for primary colorectal cancer screening.

Compared with the HDWL-first group, the AMR was significantly lower in the CADe-first group (31.25% vs. 20.12%, respectively; P = .0247). The researchers commented that, although the CADe system resulted in a statistically significantly lower AMR, the rate still reflects missed adenomas.

Additionally, the CADe-first group had a lower SSL miss rate, compared with the HDWL-first group (7.14% vs. 42.11%, respectively; P = .0482). The researchers noted that their study is one of the first research studies to show that a computer-assisted polyp detection system can reduce the SSL miss rate. The first-pass APC was also significantly higher in the CADe-first group (1.19 vs. 0.90; P = .0323). No statistically significant difference was observed between the groups in regard to the first-pass ADR (50.44% for the CADe-first group vs. 43.64 % for the HDWL-first group; P = .3091).

A multivariate logistic regression analysis identified three significant factors predictive of missed polyps: use of HDWL first vs. the computer-assisted detection system first (odds ratio, 1.8830; P = .0214), age 65 years or younger (OR, 1.7390; P = .0451), and right colon vs. other location (OR, 1.7865; P = .0436).

According to the researchers, the study was not powered to identify differences in ADR, thereby limiting the interpretation of this analysis. In addition, the investigators noted that the tandem colonoscopy study design is limited in its generalizability to real-world clinical settings. Also, given that endoscopists were not blinded to group assignments while performing each withdrawal, the researchers commented that “it is possible that endoscopist performance was influenced by being observed or that endoscopists who participated for the length of the study became over-reliant on” the CADe system during withdrawal, resulting in an underestimate or overestimation of the system’s performance.

The authors concluded that their findings suggest that an AI-based CADe system with colonoscopy “has the potential to decrease interprovider variability in colonoscopy quality by reducing AMR, even in experienced providers.”

This was an investigator-initiated study, with research software and study funding provided by Wision AI. The investigators reported relationships with Wision AI, as well as Olympus, Fujifilm, and Medtronic.

An artificial intelligence (AI)–based computer-aided polyp detection (CADe) system missed fewer adenomas, polyps, and sessile serrated lesions and identified more adenomas per colonoscopy than a high-definition white light (HDWL) colonoscopy, according to findings from a randomized study.

While adenoma detection by colonoscopy is associated with a reduced risk of interval colon cancer, detection rates of adenomas vary among physicians. AI approaches, such as machine learning and deep learning, may improve adenoma detection rates during colonoscopy and thus potentially improve outcomes for patients, suggested study authors led by Jeremy R. Glissen Brown, MD, of the Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, who reported their trial findings in Clinical Gastroenterology and Hepatology.

The investigators explained that, although AI approaches may offer benefits in adenoma detection, there have been no prospective data for U.S. populations on the efficacy of an AI-based CADe system for improving adenoma detection rates (ADRs) and reducing adenoma miss rates (AMRs). To overcome this research gap, the investigators performed a prospective, multicenter, single-blind randomized tandem colonoscopy study which assessed a deep learning–based CADe system in 232 patients.

Individuals who presented to the four included U.S. medical centers for either colorectal cancer screening or surveillance were randomly assigned to the CADe system colonoscopy first (n = 116) or HDWL colonoscopy first (n = 116). This was immediately followed by the other procedure, in tandem fashion, performed by the same endoscopist. AMR was the primary outcome of interest, while secondary outcomes were adenomas per colonoscopy (APC) and the miss rate of sessile serrated lesions (SSL).

The researchers excluded 9 patients, which resulted in a total patient population of 223 patients. Approximately 45.3% of the cohort was female, 67.7% were White, and 21% were Black. Most patients (60%) were indicated for primary colorectal cancer screening.

Compared with the HDWL-first group, the AMR was significantly lower in the CADe-first group (31.25% vs. 20.12%, respectively; P = .0247). The researchers commented that, although the CADe system resulted in a statistically significantly lower AMR, the rate still reflects missed adenomas.

Additionally, the CADe-first group had a lower SSL miss rate, compared with the HDWL-first group (7.14% vs. 42.11%, respectively; P = .0482). The researchers noted that their study is one of the first research studies to show that a computer-assisted polyp detection system can reduce the SSL miss rate. The first-pass APC was also significantly higher in the CADe-first group (1.19 vs. 0.90; P = .0323). No statistically significant difference was observed between the groups in regard to the first-pass ADR (50.44% for the CADe-first group vs. 43.64 % for the HDWL-first group; P = .3091).

A multivariate logistic regression analysis identified three significant factors predictive of missed polyps: use of HDWL first vs. the computer-assisted detection system first (odds ratio, 1.8830; P = .0214), age 65 years or younger (OR, 1.7390; P = .0451), and right colon vs. other location (OR, 1.7865; P = .0436).

According to the researchers, the study was not powered to identify differences in ADR, thereby limiting the interpretation of this analysis. In addition, the investigators noted that the tandem colonoscopy study design is limited in its generalizability to real-world clinical settings. Also, given that endoscopists were not blinded to group assignments while performing each withdrawal, the researchers commented that “it is possible that endoscopist performance was influenced by being observed or that endoscopists who participated for the length of the study became over-reliant on” the CADe system during withdrawal, resulting in an underestimate or overestimation of the system’s performance.

The authors concluded that their findings suggest that an AI-based CADe system with colonoscopy “has the potential to decrease interprovider variability in colonoscopy quality by reducing AMR, even in experienced providers.”

This was an investigator-initiated study, with research software and study funding provided by Wision AI. The investigators reported relationships with Wision AI, as well as Olympus, Fujifilm, and Medtronic.

An artificial intelligence (AI)–based computer-aided polyp detection (CADe) system missed fewer adenomas, polyps, and sessile serrated lesions and identified more adenomas per colonoscopy than a high-definition white light (HDWL) colonoscopy, according to findings from a randomized study.

While adenoma detection by colonoscopy is associated with a reduced risk of interval colon cancer, detection rates of adenomas vary among physicians. AI approaches, such as machine learning and deep learning, may improve adenoma detection rates during colonoscopy and thus potentially improve outcomes for patients, suggested study authors led by Jeremy R. Glissen Brown, MD, of the Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, who reported their trial findings in Clinical Gastroenterology and Hepatology.

The investigators explained that, although AI approaches may offer benefits in adenoma detection, there have been no prospective data for U.S. populations on the efficacy of an AI-based CADe system for improving adenoma detection rates (ADRs) and reducing adenoma miss rates (AMRs). To overcome this research gap, the investigators performed a prospective, multicenter, single-blind randomized tandem colonoscopy study which assessed a deep learning–based CADe system in 232 patients.

Individuals who presented to the four included U.S. medical centers for either colorectal cancer screening or surveillance were randomly assigned to the CADe system colonoscopy first (n = 116) or HDWL colonoscopy first (n = 116). This was immediately followed by the other procedure, in tandem fashion, performed by the same endoscopist. AMR was the primary outcome of interest, while secondary outcomes were adenomas per colonoscopy (APC) and the miss rate of sessile serrated lesions (SSL).

The researchers excluded 9 patients, which resulted in a total patient population of 223 patients. Approximately 45.3% of the cohort was female, 67.7% were White, and 21% were Black. Most patients (60%) were indicated for primary colorectal cancer screening.

Compared with the HDWL-first group, the AMR was significantly lower in the CADe-first group (31.25% vs. 20.12%, respectively; P = .0247). The researchers commented that, although the CADe system resulted in a statistically significantly lower AMR, the rate still reflects missed adenomas.

Additionally, the CADe-first group had a lower SSL miss rate, compared with the HDWL-first group (7.14% vs. 42.11%, respectively; P = .0482). The researchers noted that their study is one of the first research studies to show that a computer-assisted polyp detection system can reduce the SSL miss rate. The first-pass APC was also significantly higher in the CADe-first group (1.19 vs. 0.90; P = .0323). No statistically significant difference was observed between the groups in regard to the first-pass ADR (50.44% for the CADe-first group vs. 43.64 % for the HDWL-first group; P = .3091).

A multivariate logistic regression analysis identified three significant factors predictive of missed polyps: use of HDWL first vs. the computer-assisted detection system first (odds ratio, 1.8830; P = .0214), age 65 years or younger (OR, 1.7390; P = .0451), and right colon vs. other location (OR, 1.7865; P = .0436).

According to the researchers, the study was not powered to identify differences in ADR, thereby limiting the interpretation of this analysis. In addition, the investigators noted that the tandem colonoscopy study design is limited in its generalizability to real-world clinical settings. Also, given that endoscopists were not blinded to group assignments while performing each withdrawal, the researchers commented that “it is possible that endoscopist performance was influenced by being observed or that endoscopists who participated for the length of the study became over-reliant on” the CADe system during withdrawal, resulting in an underestimate or overestimation of the system’s performance.

The authors concluded that their findings suggest that an AI-based CADe system with colonoscopy “has the potential to decrease interprovider variability in colonoscopy quality by reducing AMR, even in experienced providers.”

This was an investigator-initiated study, with research software and study funding provided by Wision AI. The investigators reported relationships with Wision AI, as well as Olympus, Fujifilm, and Medtronic.

Patients successfully resuscitated after an out-of-hospital cardiac arrest who did not have ST-segment elevation on their electrocardiogram did not benefit from emergency coronary angiography in a new randomized clinical trial.

In the EMERGE trial, a strategy of emergency coronary angiography was not found to be better than a strategy of delayed coronary angiography with respect to the 180-day survival rate with no or minimal neurologic sequelae.

The authors note that, although the study was underpowered, the results are consistent with previously published studies and do not support routine emergency coronary angiography in survivors of out-of-hospital cardiac arrest without ST elevation.

But senior author, Christian Spaulding, MD, PhD, European Hospital Georges Pompidou, Paris, believes some such patients may still benefit from emergency angiography.

“Most patients who have been resuscitated after out of hospital cardiac arrest will have neurological damage, which will be the primary cause of death,” Dr. Spaulding told this news organization. “It will not make any difference to these patients if they have a coronary lesion treated. So, going forward, I think we need to look for patients who are likely not to have a high degree of neurological damage and who could still benefit from early angiography.”

The EMERGE study was published online  in JAMA Cardiology.

In patients who have suffered an out-of-hospital cardiac arrest with no obvious noncardiac cause such as trauma, it is believed that the cardiac arrest is caused by coronary occlusions, and emergency angiography may be able to improve survival in these patients, Dr. Spaulding explained.

In about one-third of such patients, the ECG before hospitalization shows ST elevation, and in this group, there is a high probability (around 70%-80%) that there is going to be a coronary occlusion, so these patients are usually taken directly to emergency angiography.

But, in the other two-thirds of patients, there is no ST elevation on the ECG, and in these patients the chances of finding a coronary occlusion are lower (around 25%-35%).

The EMERGE trial was conducted in this latter group without ST elevation.

For the study, which was conducted in 22 French centers, 279 such patients (mean age, 64 years) were randomized to either emergency or delayed (48-96 hours) coronary angiography. The mean time delay between randomization and coronary angiography was 0.6 hours in the emergency group and 55.1 hours in the delayed group.

The primary outcome was the 180-day survival rate with minimal neurological damage, defined as Cerebral Performance Category of 2 or less. This occurred in 34.1% of the emergency angiography group and 30.7% of the delayed angiography group (hazard ratio, 0.87; 95% confidence interval, 0.65-1.15; P = .32).

There was also no difference in the overall survival rate at 180 days (36.2% vs. 33.3%; HR, 0.86; P = .31) and in secondary outcomes between the two groups.

Dr. Spaulding noted that three other randomized trials in a similar patient population have all shown similar results, with no difference in survival found between patients who have emergency coronary angiography as soon as they are admitted to hospital and those in whom angiography was not performed until a couple of days later.

However, several registry studies in a total of more than 6,000 patients have suggested a benefit of immediate angiography in these patients. “So, there is some disconnect here,” he said.

Dr. Spaulding believes the reason for this disconnect may be that the registry studies may have included patients with less neurological damage so more likely to survive and to benefit from having coronary lesions treated promptly.

“Paramedics sometimes make a judgment on which patients may have minimal neurological damage, and this may affect the choice of hospital a patient is taken to, and then the emergency department doctor may again assess whether a patient should go for immediate angiography or not. So, patients in these registry studies who received emergency angiography were likely already preselected to some extent,” he suggested.

In contrast, the randomized trials have accepted all patients, so there were probably more with neurological damage. “In our trial, almost 70% of patients were in asystole. These are the ones who [are] the most likely to have neurological damage,” he pointed out.

“Because there was such a striking difference in the registry studies, I think there is a group of patients [who] will benefit from immediate emergency coronary angiography, but we have to work out how to select these patients,” he commented.

Dr. Spaulding noted that a recent registry study published in JACC: Cardiovascular Interventions used a score known as MIRACLE2, (which takes into account various factors including age of patient and type of rhythm on ECG) and the degree of cardiogenic shock on arrival at hospital as measured by the SCAI shock score to define a potential cohort of patients at low risk for neurologic injury who benefit most from immediate coronary angiography.

“In my practice at present, I would advise the emergency team that a young patient who had had resuscitation started quickly, had been defibrillated early, and got to hospital quickly should go for an immediate coronary angiogram. It can’t do any harm, and there may be a benefit in such patients,” Dr. Spaulding added.The EMERGE study was supported in part by Assistance Publique–Hôpitaux de Paris and the French Ministry of Health, through the national Programme Hospitalier de Recherche Clinique. Dr. Spaulding reports no relevant financial relationships.

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

Patients successfully resuscitated after an out-of-hospital cardiac arrest who did not have ST-segment elevation on their electrocardiogram did not benefit from emergency coronary angiography in a new randomized clinical trial.

In the EMERGE trial, a strategy of emergency coronary angiography was not found to be better than a strategy of delayed coronary angiography with respect to the 180-day survival rate with no or minimal neurologic sequelae.

The authors note that, although the study was underpowered, the results are consistent with previously published studies and do not support routine emergency coronary angiography in survivors of out-of-hospital cardiac arrest without ST elevation.

But senior author, Christian Spaulding, MD, PhD, European Hospital Georges Pompidou, Paris, believes some such patients may still benefit from emergency angiography.

“Most patients who have been resuscitated after out of hospital cardiac arrest will have neurological damage, which will be the primary cause of death,” Dr. Spaulding told this news organization. “It will not make any difference to these patients if they have a coronary lesion treated. So, going forward, I think we need to look for patients who are likely not to have a high degree of neurological damage and who could still benefit from early angiography.”

The EMERGE study was published online  in JAMA Cardiology.

In patients who have suffered an out-of-hospital cardiac arrest with no obvious noncardiac cause such as trauma, it is believed that the cardiac arrest is caused by coronary occlusions, and emergency angiography may be able to improve survival in these patients, Dr. Spaulding explained.

In about one-third of such patients, the ECG before hospitalization shows ST elevation, and in this group, there is a high probability (around 70%-80%) that there is going to be a coronary occlusion, so these patients are usually taken directly to emergency angiography.

But, in the other two-thirds of patients, there is no ST elevation on the ECG, and in these patients the chances of finding a coronary occlusion are lower (around 25%-35%).

The EMERGE trial was conducted in this latter group without ST elevation.

For the study, which was conducted in 22 French centers, 279 such patients (mean age, 64 years) were randomized to either emergency or delayed (48-96 hours) coronary angiography. The mean time delay between randomization and coronary angiography was 0.6 hours in the emergency group and 55.1 hours in the delayed group.

The primary outcome was the 180-day survival rate with minimal neurological damage, defined as Cerebral Performance Category of 2 or less. This occurred in 34.1% of the emergency angiography group and 30.7% of the delayed angiography group (hazard ratio, 0.87; 95% confidence interval, 0.65-1.15; P = .32).

There was also no difference in the overall survival rate at 180 days (36.2% vs. 33.3%; HR, 0.86; P = .31) and in secondary outcomes between the two groups.

Dr. Spaulding noted that three other randomized trials in a similar patient population have all shown similar results, with no difference in survival found between patients who have emergency coronary angiography as soon as they are admitted to hospital and those in whom angiography was not performed until a couple of days later.

However, several registry studies in a total of more than 6,000 patients have suggested a benefit of immediate angiography in these patients. “So, there is some disconnect here,” he said.

Dr. Spaulding believes the reason for this disconnect may be that the registry studies may have included patients with less neurological damage so more likely to survive and to benefit from having coronary lesions treated promptly.

“Paramedics sometimes make a judgment on which patients may have minimal neurological damage, and this may affect the choice of hospital a patient is taken to, and then the emergency department doctor may again assess whether a patient should go for immediate angiography or not. So, patients in these registry studies who received emergency angiography were likely already preselected to some extent,” he suggested.

In contrast, the randomized trials have accepted all patients, so there were probably more with neurological damage. “In our trial, almost 70% of patients were in asystole. These are the ones who [are] the most likely to have neurological damage,” he pointed out.

“Because there was such a striking difference in the registry studies, I think there is a group of patients [who] will benefit from immediate emergency coronary angiography, but we have to work out how to select these patients,” he commented.

Dr. Spaulding noted that a recent registry study published in JACC: Cardiovascular Interventions used a score known as MIRACLE2, (which takes into account various factors including age of patient and type of rhythm on ECG) and the degree of cardiogenic shock on arrival at hospital as measured by the SCAI shock score to define a potential cohort of patients at low risk for neurologic injury who benefit most from immediate coronary angiography.

“In my practice at present, I would advise the emergency team that a young patient who had had resuscitation started quickly, had been defibrillated early, and got to hospital quickly should go for an immediate coronary angiogram. It can’t do any harm, and there may be a benefit in such patients,” Dr. Spaulding added.The EMERGE study was supported in part by Assistance Publique–Hôpitaux de Paris and the French Ministry of Health, through the national Programme Hospitalier de Recherche Clinique. Dr. Spaulding reports no relevant financial relationships.

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

Patients successfully resuscitated after an out-of-hospital cardiac arrest who did not have ST-segment elevation on their electrocardiogram did not benefit from emergency coronary angiography in a new randomized clinical trial.

In the EMERGE trial, a strategy of emergency coronary angiography was not found to be better than a strategy of delayed coronary angiography with respect to the 180-day survival rate with no or minimal neurologic sequelae.

The authors note that, although the study was underpowered, the results are consistent with previously published studies and do not support routine emergency coronary angiography in survivors of out-of-hospital cardiac arrest without ST elevation.

But senior author, Christian Spaulding, MD, PhD, European Hospital Georges Pompidou, Paris, believes some such patients may still benefit from emergency angiography.

“Most patients who have been resuscitated after out of hospital cardiac arrest will have neurological damage, which will be the primary cause of death,” Dr. Spaulding told this news organization. “It will not make any difference to these patients if they have a coronary lesion treated. So, going forward, I think we need to look for patients who are likely not to have a high degree of neurological damage and who could still benefit from early angiography.”

The EMERGE study was published online  in JAMA Cardiology.

In patients who have suffered an out-of-hospital cardiac arrest with no obvious noncardiac cause such as trauma, it is believed that the cardiac arrest is caused by coronary occlusions, and emergency angiography may be able to improve survival in these patients, Dr. Spaulding explained.

In about one-third of such patients, the ECG before hospitalization shows ST elevation, and in this group, there is a high probability (around 70%-80%) that there is going to be a coronary occlusion, so these patients are usually taken directly to emergency angiography.

But, in the other two-thirds of patients, there is no ST elevation on the ECG, and in these patients the chances of finding a coronary occlusion are lower (around 25%-35%).

The EMERGE trial was conducted in this latter group without ST elevation.

For the study, which was conducted in 22 French centers, 279 such patients (mean age, 64 years) were randomized to either emergency or delayed (48-96 hours) coronary angiography. The mean time delay between randomization and coronary angiography was 0.6 hours in the emergency group and 55.1 hours in the delayed group.

The primary outcome was the 180-day survival rate with minimal neurological damage, defined as Cerebral Performance Category of 2 or less. This occurred in 34.1% of the emergency angiography group and 30.7% of the delayed angiography group (hazard ratio, 0.87; 95% confidence interval, 0.65-1.15; P = .32).

There was also no difference in the overall survival rate at 180 days (36.2% vs. 33.3%; HR, 0.86; P = .31) and in secondary outcomes between the two groups.

Dr. Spaulding noted that three other randomized trials in a similar patient population have all shown similar results, with no difference in survival found between patients who have emergency coronary angiography as soon as they are admitted to hospital and those in whom angiography was not performed until a couple of days later.

However, several registry studies in a total of more than 6,000 patients have suggested a benefit of immediate angiography in these patients. “So, there is some disconnect here,” he said.

Dr. Spaulding believes the reason for this disconnect may be that the registry studies may have included patients with less neurological damage so more likely to survive and to benefit from having coronary lesions treated promptly.

“Paramedics sometimes make a judgment on which patients may have minimal neurological damage, and this may affect the choice of hospital a patient is taken to, and then the emergency department doctor may again assess whether a patient should go for immediate angiography or not. So, patients in these registry studies who received emergency angiography were likely already preselected to some extent,” he suggested.

In contrast, the randomized trials have accepted all patients, so there were probably more with neurological damage. “In our trial, almost 70% of patients were in asystole. These are the ones who [are] the most likely to have neurological damage,” he pointed out.

“Because there was such a striking difference in the registry studies, I think there is a group of patients [who] will benefit from immediate emergency coronary angiography, but we have to work out how to select these patients,” he commented.

Dr. Spaulding noted that a recent registry study published in JACC: Cardiovascular Interventions used a score known as MIRACLE2, (which takes into account various factors including age of patient and type of rhythm on ECG) and the degree of cardiogenic shock on arrival at hospital as measured by the SCAI shock score to define a potential cohort of patients at low risk for neurologic injury who benefit most from immediate coronary angiography.

“In my practice at present, I would advise the emergency team that a young patient who had had resuscitation started quickly, had been defibrillated early, and got to hospital quickly should go for an immediate coronary angiogram. It can’t do any harm, and there may be a benefit in such patients,” Dr. Spaulding added.The EMERGE study was supported in part by Assistance Publique–Hôpitaux de Paris and the French Ministry of Health, through the national Programme Hospitalier de Recherche Clinique. Dr. Spaulding reports no relevant financial relationships.

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

For patients with severe COVID-19 who had an underlying hematologic malignancy or solid cancer, outcomes were significantly better following treatment with plasma from convalescent and vaccinated patients, new research shows.

The study demonstrated that “plasma from convalescent or vaccinated individuals shortens the time to improvement in hematological and solid cancer patients with severe COVID-19” and “prolongs overall survival,” said study coauthor Maike Janssen, MD, of the department of internal medicine at Heidelberg (Germany) University Hospital.

Dr. Janssen presented the study findings at the annual congress of the European Hematology Association held in Vienna.

Although people with COVID-19 do not appear to benefit from treatment with convalescent plasma, some data indicate that certain patients who cannot mount a strong immune response to SARS-CoV-2 infection may benefit.

In this recent multicenter study, 134 patients with confirmed COVID-19 whose oxygen saturation was 94% or lower were randomly assigned to undergo treatment with convalescent or vaccinated SARS-CoV-2 plasma (n = 68) or to receive standard of care (n = 66). Patients fell into four clinical groups: those with a hematologic malignancy or who had undergone active cancer therapy for any cancer within the past 24 months; those with chronic immunosuppression; those between the ages of 50 and 75 with lymphopenia and/or elevated D-dimer levels; and those older than 75 years.

The convalescent or vaccinated SARS-CoV-2 plasma was administered in two bags (238-337 mL plasma each) from different donors on days 1 and 2. Only plasma from donors with high levels of neutralizing activity (titers above 1:80) were included. The primary endpoint was time to improvement by 2 points on a 7-point scale or discharge from the hospital. The secondary endpoint was improvement in overall survival.

The authors found that overall, patients in the plasma group demonstrated a shorter time to improvement – median of 12.5 days, vs. 18 days – but the difference was not significant (P = .29).

However, for the subgroup of 56 patients with hematologic/solid cancers, the time to improvement was significantly shorter: 13 days vs. 31 days (hazard ratio [HR], 2.5; P = .003).

Similarly, plasma therapy did not improve overall survival in the study population overall – there were 12 deaths in the plasma group over 80 days, vs. 15 in the control group (P = .80). Patients in the hematologic/solid cancer subgroup who received plasma therapy did demonstrate significantly better overall survival (HR, 0.28; P = .042).

No similar significant differences in time to improvement or overall survival were observed in the other three groups. “We found that plasma did not improve outcomes in immune-competent patients with other risk factors and/or older age,” Dr. Janssen said.

Although study enrollment ended when the Omicron variant began surging, Dr. Janssen noted that plasma from Omicron patients may also be of benefit to those with hematologic cancers.

“We have treated some patients in individual cases using plasma from Omicron patients who were already vaccinated or with breakthrough infections, and we did see benefits in those cases,” she noted.

The study was funded by the Federal Ministry of Education and Research, Germany. Dr. Janssen has disclosed no relevant financial relationships.

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

For patients with severe COVID-19 who had an underlying hematologic malignancy or solid cancer, outcomes were significantly better following treatment with plasma from convalescent and vaccinated patients, new research shows.

The study demonstrated that “plasma from convalescent or vaccinated individuals shortens the time to improvement in hematological and solid cancer patients with severe COVID-19” and “prolongs overall survival,” said study coauthor Maike Janssen, MD, of the department of internal medicine at Heidelberg (Germany) University Hospital.

Dr. Janssen presented the study findings at the annual congress of the European Hematology Association held in Vienna.

Although people with COVID-19 do not appear to benefit from treatment with convalescent plasma, some data indicate that certain patients who cannot mount a strong immune response to SARS-CoV-2 infection may benefit.

In this recent multicenter study, 134 patients with confirmed COVID-19 whose oxygen saturation was 94% or lower were randomly assigned to undergo treatment with convalescent or vaccinated SARS-CoV-2 plasma (n = 68) or to receive standard of care (n = 66). Patients fell into four clinical groups: those with a hematologic malignancy or who had undergone active cancer therapy for any cancer within the past 24 months; those with chronic immunosuppression; those between the ages of 50 and 75 with lymphopenia and/or elevated D-dimer levels; and those older than 75 years.

The convalescent or vaccinated SARS-CoV-2 plasma was administered in two bags (238-337 mL plasma each) from different donors on days 1 and 2. Only plasma from donors with high levels of neutralizing activity (titers above 1:80) were included. The primary endpoint was time to improvement by 2 points on a 7-point scale or discharge from the hospital. The secondary endpoint was improvement in overall survival.

The authors found that overall, patients in the plasma group demonstrated a shorter time to improvement – median of 12.5 days, vs. 18 days – but the difference was not significant (P = .29).

However, for the subgroup of 56 patients with hematologic/solid cancers, the time to improvement was significantly shorter: 13 days vs. 31 days (hazard ratio [HR], 2.5; P = .003).

Similarly, plasma therapy did not improve overall survival in the study population overall – there were 12 deaths in the plasma group over 80 days, vs. 15 in the control group (P = .80). Patients in the hematologic/solid cancer subgroup who received plasma therapy did demonstrate significantly better overall survival (HR, 0.28; P = .042).

No similar significant differences in time to improvement or overall survival were observed in the other three groups. “We found that plasma did not improve outcomes in immune-competent patients with other risk factors and/or older age,” Dr. Janssen said.

Although study enrollment ended when the Omicron variant began surging, Dr. Janssen noted that plasma from Omicron patients may also be of benefit to those with hematologic cancers.

“We have treated some patients in individual cases using plasma from Omicron patients who were already vaccinated or with breakthrough infections, and we did see benefits in those cases,” she noted.

The study was funded by the Federal Ministry of Education and Research, Germany. Dr. Janssen has disclosed no relevant financial relationships.

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

For patients with severe COVID-19 who had an underlying hematologic malignancy or solid cancer, outcomes were significantly better following treatment with plasma from convalescent and vaccinated patients, new research shows.

The study demonstrated that “plasma from convalescent or vaccinated individuals shortens the time to improvement in hematological and solid cancer patients with severe COVID-19” and “prolongs overall survival,” said study coauthor Maike Janssen, MD, of the department of internal medicine at Heidelberg (Germany) University Hospital.

Dr. Janssen presented the study findings at the annual congress of the European Hematology Association held in Vienna.

Although people with COVID-19 do not appear to benefit from treatment with convalescent plasma, some data indicate that certain patients who cannot mount a strong immune response to SARS-CoV-2 infection may benefit.

In this recent multicenter study, 134 patients with confirmed COVID-19 whose oxygen saturation was 94% or lower were randomly assigned to undergo treatment with convalescent or vaccinated SARS-CoV-2 plasma (n = 68) or to receive standard of care (n = 66). Patients fell into four clinical groups: those with a hematologic malignancy or who had undergone active cancer therapy for any cancer within the past 24 months; those with chronic immunosuppression; those between the ages of 50 and 75 with lymphopenia and/or elevated D-dimer levels; and those older than 75 years.

The convalescent or vaccinated SARS-CoV-2 plasma was administered in two bags (238-337 mL plasma each) from different donors on days 1 and 2. Only plasma from donors with high levels of neutralizing activity (titers above 1:80) were included. The primary endpoint was time to improvement by 2 points on a 7-point scale or discharge from the hospital. The secondary endpoint was improvement in overall survival.

The authors found that overall, patients in the plasma group demonstrated a shorter time to improvement – median of 12.5 days, vs. 18 days – but the difference was not significant (P = .29).

However, for the subgroup of 56 patients with hematologic/solid cancers, the time to improvement was significantly shorter: 13 days vs. 31 days (hazard ratio [HR], 2.5; P = .003).

Similarly, plasma therapy did not improve overall survival in the study population overall – there were 12 deaths in the plasma group over 80 days, vs. 15 in the control group (P = .80). Patients in the hematologic/solid cancer subgroup who received plasma therapy did demonstrate significantly better overall survival (HR, 0.28; P = .042).

No similar significant differences in time to improvement or overall survival were observed in the other three groups. “We found that plasma did not improve outcomes in immune-competent patients with other risk factors and/or older age,” Dr. Janssen said.

Although study enrollment ended when the Omicron variant began surging, Dr. Janssen noted that plasma from Omicron patients may also be of benefit to those with hematologic cancers.

“We have treated some patients in individual cases using plasma from Omicron patients who were already vaccinated or with breakthrough infections, and we did see benefits in those cases,” she noted.

The study was funded by the Federal Ministry of Education and Research, Germany. Dr. Janssen has disclosed no relevant financial relationships.

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

On the top left of my desktop is an electronic sticky note entitled, “Apply in Future.” This was where the AGA editorial fellowship was listed when I first started GI fellowship. My interest in the behind-the-scenes of scientific publishing developed early. I wanted to learn not only about the decision-making by the editorial board but also other aspects that impact the process from submission to publication. While waiting for my opportunity to apply, I became a reviewer for several journals and then an associate editor of ACG Case Reports Journal, which gave me some insight.

I applied to the editorial fellowship as a second-year fellow, to start as a third-year fellow. I figured this would give me several chances to apply again if I was not selected! I started off by talking to my program director to ensure that I would have enough time, given other responsibilities. The application consisted of a cover letter, where I expressed why I was interested, particularly focusing on my passion for research and my experience with scientific publishing, a letter of recommendation, and a CV. I was ecstatic when I was selected for the AGA editorial fellowship for Clinical Gastroenterology and Hepatology (CGH), whose editorial board’s mission best aligned with my interests.

Dr. Jonathan Buscaglia was the editorial fellows’ mentor for CGH – he met with us and provided an outline of the year. For the first 6 months, I was a reviewer for submitted manuscripts within my topic of interest – pancreaticobiliary diseases and advanced endoscopy and technology. Dr. Buscaglia gave me feedback on my reviews to improve my critical assessment of study designs and interpreted results. After 6 months as a reviewer, I took on the role of an associate editor. I selected reviewers, evaluated the reviews, and made the decision to accept or reject a manuscript. I presented my assigned manuscript at the weekly board of editors meeting, which was one of the biggest learning experiences. Leading researchers from all over the world gathered at a virtual table and discussed whether each study would have clinical impact on the medical community. Each editor contributed a unique perspective that facilitated a robust and thoughtful discussion of each manuscript brought to the table. I was in awe each week.

What I have learned so far during my year as an AGA editorial fellow with CGH has shaped my approach to personal research and will continue to do so as I develop my research career. It has greatly improved my assessment of the literature and I hope to continue to be involved in the critical review process, especially as a reviewer in my early career, and eventually, a part of an editorial board for a journal that truly impacts clinical medicine, such as Clinical Gastroenterology and Hepatology.
 

Dr. Trieu is a gastroenterology and hepatology fellow at Loyola University Medical Center, Maywood, Ill. She has no conflicts of interest to disclose.

On the top left of my desktop is an electronic sticky note entitled, “Apply in Future.” This was where the AGA editorial fellowship was listed when I first started GI fellowship. My interest in the behind-the-scenes of scientific publishing developed early. I wanted to learn not only about the decision-making by the editorial board but also other aspects that impact the process from submission to publication. While waiting for my opportunity to apply, I became a reviewer for several journals and then an associate editor of ACG Case Reports Journal, which gave me some insight.

I applied to the editorial fellowship as a second-year fellow, to start as a third-year fellow. I figured this would give me several chances to apply again if I was not selected! I started off by talking to my program director to ensure that I would have enough time, given other responsibilities. The application consisted of a cover letter, where I expressed why I was interested, particularly focusing on my passion for research and my experience with scientific publishing, a letter of recommendation, and a CV. I was ecstatic when I was selected for the AGA editorial fellowship for Clinical Gastroenterology and Hepatology (CGH), whose editorial board’s mission best aligned with my interests.

Dr. Jonathan Buscaglia was the editorial fellows’ mentor for CGH – he met with us and provided an outline of the year. For the first 6 months, I was a reviewer for submitted manuscripts within my topic of interest – pancreaticobiliary diseases and advanced endoscopy and technology. Dr. Buscaglia gave me feedback on my reviews to improve my critical assessment of study designs and interpreted results. After 6 months as a reviewer, I took on the role of an associate editor. I selected reviewers, evaluated the reviews, and made the decision to accept or reject a manuscript. I presented my assigned manuscript at the weekly board of editors meeting, which was one of the biggest learning experiences. Leading researchers from all over the world gathered at a virtual table and discussed whether each study would have clinical impact on the medical community. Each editor contributed a unique perspective that facilitated a robust and thoughtful discussion of each manuscript brought to the table. I was in awe each week.

What I have learned so far during my year as an AGA editorial fellow with CGH has shaped my approach to personal research and will continue to do so as I develop my research career. It has greatly improved my assessment of the literature and I hope to continue to be involved in the critical review process, especially as a reviewer in my early career, and eventually, a part of an editorial board for a journal that truly impacts clinical medicine, such as Clinical Gastroenterology and Hepatology.
 

Dr. Trieu is a gastroenterology and hepatology fellow at Loyola University Medical Center, Maywood, Ill. She has no conflicts of interest to disclose.

On the top left of my desktop is an electronic sticky note entitled, “Apply in Future.” This was where the AGA editorial fellowship was listed when I first started GI fellowship. My interest in the behind-the-scenes of scientific publishing developed early. I wanted to learn not only about the decision-making by the editorial board but also other aspects that impact the process from submission to publication. While waiting for my opportunity to apply, I became a reviewer for several journals and then an associate editor of ACG Case Reports Journal, which gave me some insight.

I applied to the editorial fellowship as a second-year fellow, to start as a third-year fellow. I figured this would give me several chances to apply again if I was not selected! I started off by talking to my program director to ensure that I would have enough time, given other responsibilities. The application consisted of a cover letter, where I expressed why I was interested, particularly focusing on my passion for research and my experience with scientific publishing, a letter of recommendation, and a CV. I was ecstatic when I was selected for the AGA editorial fellowship for Clinical Gastroenterology and Hepatology (CGH), whose editorial board’s mission best aligned with my interests.

Dr. Jonathan Buscaglia was the editorial fellows’ mentor for CGH – he met with us and provided an outline of the year. For the first 6 months, I was a reviewer for submitted manuscripts within my topic of interest – pancreaticobiliary diseases and advanced endoscopy and technology. Dr. Buscaglia gave me feedback on my reviews to improve my critical assessment of study designs and interpreted results. After 6 months as a reviewer, I took on the role of an associate editor. I selected reviewers, evaluated the reviews, and made the decision to accept or reject a manuscript. I presented my assigned manuscript at the weekly board of editors meeting, which was one of the biggest learning experiences. Leading researchers from all over the world gathered at a virtual table and discussed whether each study would have clinical impact on the medical community. Each editor contributed a unique perspective that facilitated a robust and thoughtful discussion of each manuscript brought to the table. I was in awe each week.

What I have learned so far during my year as an AGA editorial fellow with CGH has shaped my approach to personal research and will continue to do so as I develop my research career. It has greatly improved my assessment of the literature and I hope to continue to be involved in the critical review process, especially as a reviewer in my early career, and eventually, a part of an editorial board for a journal that truly impacts clinical medicine, such as Clinical Gastroenterology and Hepatology.
 

Dr. Trieu is a gastroenterology and hepatology fellow at Loyola University Medical Center, Maywood, Ill. She has no conflicts of interest to disclose.

Goal-directed glycemic management – which may include new technologies for glucose monitoring – for non–critically ill hospitalized patients who have diabetes or newly recognized hyperglycemia can improve outcomes, according to a new practice guideline from the Endocrine Society.  

Even though roughly 35% of hospitalized patients have diabetes or newly discovered hyperglycemia, there is “wide variability in glycemic management in clinical practice,” writing panel chair Mary Korytkowski, MD, from the University of Pittsburgh, said at the annual meeting of the Endocrine Society. “These patients get admitted to every patient service in the hospital, meaning that every clinical service will encounter this group of patients, and their glycemic management can have a major effect on their outcomes. Both short term and long term.”

This guideline provides strategies “to achieve previously recommended glycemic goals while also reducing the risk for hypoglycemia, and this includes inpatient use of insulin pump therapy or continuous glucose monitoring [CGM] devices, among others,” she said.

It also includes “recommendations for preoperative glycemic goals as well as when the use of correctional insulin – well known as sliding scale insulin – may be appropriate” and when it is not.

The document, which replaces a 2012 guideline, was published online in the Journal of Clinical Endocrinology & Metabolism.

A multidisciplinary panel developed the document over the last 3 years to answer 10 clinical practice questions related to management of non–critically ill hospitalized patients with diabetes or newly discovered hyperglycemia.
 

Use of CGM devices in hospital

The first recommendation is: “In adults with insulin-treated diabetes hospitalized for noncritical illness who are at high risk of hypoglycemia, we suggest the use of real-time [CGM] with confirmatory bedside point-of-care blood glucose monitoring for adjustments in insulin dosing rather than point-of-care blood glucose rather than testing alone in hospital settings where resources and training are available.” (Conditional recommendation. Low certainty of evidence).

“We were actually very careful in terms of looking at the data” for use of CGMs, Dr. Korytkowski said in an interview.

Although CGMs are approved by the Food and Drug Administration in the outpatient setting, and that’s becoming the standard of care there, they are not yet approved for in-hospital use.

However, the FDA granted an emergency allowance for use of CGMs in hospitals during the COVID-19 pandemic.

That was “when everyone was scrambling for what to do,” Dr. Korytkowski noted. “There was a shortage of personal protective equipment and a real interest in trying to limit the amount of exposure of healthcare personnel in some of these really critically ill patients for whom intravenous insulin therapy was used to control their glucose level.”

On March 1, the FDA granted Breakthrough Devices Designation for Dexcom CGM use in the hospital setting.

The new guideline suggests CGM be used to detect trends in glycemic management, with insulin dosing decisions made with point-of-care glucose measure (the standard of care).

To implement CGM for glycemic management in hospitals, Dr. Korytkowski said, would require “extensive staff and nursing education to have people with expertise available to provide support to nursing personnel who are both placing these devices, changing these devices, looking at trends, and then knowing when to remove them for certain procedures such as MRI or radiologic procedures.”

“We know that not all hospitals may be readily available to use these devices,” she said. “It is an area of active research. But the use of these devices during the pandemic, in both critical care and non–critical care setting has really provided us with a lot of information that was used to formulate this suggestion in the guideline.”

The document addresses the following areas: CGM, continuous subcutaneous insulin infusion pump therapy, inpatient diabetes education, prespecified preoperative glycemic targets, use of neutral protamine Hagedorn insulin for glucocorticoid or enteral nutrition-associated hyperglycemia, noninsulin therapies, preoperative carbohydrate-containing oral fluids, carbohydrate counting for prandial (mealtime) insulin dosing, and correctional and scheduled (basal or basal bolus) insulin therapies.

Nine key recommendations

Dr. Korytkowski identified nine key recommendations:

• CGM systems can help guide glycemic management with reduced risk for hypoglycemia.
• Patients experiencing glucocorticoid- or enteral nutrition–associated hyperglycemia require scheduled insulin therapy to address anticipated glucose excursions.
• Selected patients using insulin pump therapy prior to a hospital admission can continue to use these devices in the hospital if they have the mental and physical capacity to do so with knowledgeable hospital personnel.
• Diabetes self-management education provided to hospitalized patients can promote improved glycemic control following discharge with reductions in the risk for hospital readmission. “We know that is recommended for patients in the outpatient setting but often they do not get this,” she said. “We were able to observe that this can also impact long-term outcomes “
• Patients with diabetes scheduled for elective surgery may have improved postoperative outcomes when preoperative hemoglobin A1c is 8% or less and preoperative blood glucose is less than 180 mg/dL. “This recommendation answers the question: ‘Where should glycemic goals be for people who are undergoing surgery?’ ”
• Providing preoperative carbohydrate-containing beverages to patients with known diabetes is not recommended.
• Patients with newly recognized hyperglycemia or well-managed diabetes on noninsulin therapy may be treated with correctional insulin alone as initial therapy at hospital admission.
• Some noninsulin diabetes therapies can be used in combination with correction insulin for patients with type 2 diabetes who have mild hyperglycemia.
• Correctional insulin – “otherwise known as sliding-scale insulin” –  can be used as initial therapy for patients with newly recognized hyperglycemia or type 2 diabetes treated with noninsulin therapy prior to hospital admission.
• Scheduled insulin therapy is preferred for patients experiencing persistent blood glucose values greater than 180 mg/dL and is recommended for patients using insulin therapy prior to admission. 

The guideline writers’ hopes

“We hope that this guideline will resolve debates” about appropriate preoperative glycemic management and when sliding-scale insulin can be used and should not be used, said Dr. Korytkowski.

The authors also hope that “it will stimulate research funding for this very important aspect of diabetes care, and that hospitals will recognize the importance of having access to knowledgeable diabetes care and education specialists who can provide staff education regarding inpatient glycemic management, provide oversight for patients using insulin pump therapy or CGM devices, and empower hospital nurses to provide diabetes [self-management] education prior to patient discharge.”

Claire Pegg, the patient representative on the panel, hopes “that this guideline serves as the beginning of a conversation that will allow inpatient caregivers to provide individualized care to patients – some of whom may be self-sufficient with their glycemic management and others who need additional assistance.” 

Development of the guideline was funded by the Endocrine Society. Dr. Korytkowski has reported no relevant financial disclosures.

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

Goal-directed glycemic management – which may include new technologies for glucose monitoring – for non–critically ill hospitalized patients who have diabetes or newly recognized hyperglycemia can improve outcomes, according to a new practice guideline from the Endocrine Society.  

Even though roughly 35% of hospitalized patients have diabetes or newly discovered hyperglycemia, there is “wide variability in glycemic management in clinical practice,” writing panel chair Mary Korytkowski, MD, from the University of Pittsburgh, said at the annual meeting of the Endocrine Society. “These patients get admitted to every patient service in the hospital, meaning that every clinical service will encounter this group of patients, and their glycemic management can have a major effect on their outcomes. Both short term and long term.”

This guideline provides strategies “to achieve previously recommended glycemic goals while also reducing the risk for hypoglycemia, and this includes inpatient use of insulin pump therapy or continuous glucose monitoring [CGM] devices, among others,” she said.

It also includes “recommendations for preoperative glycemic goals as well as when the use of correctional insulin – well known as sliding scale insulin – may be appropriate” and when it is not.

The document, which replaces a 2012 guideline, was published online in the Journal of Clinical Endocrinology & Metabolism.

A multidisciplinary panel developed the document over the last 3 years to answer 10 clinical practice questions related to management of non–critically ill hospitalized patients with diabetes or newly discovered hyperglycemia.
 

Use of CGM devices in hospital

The first recommendation is: “In adults with insulin-treated diabetes hospitalized for noncritical illness who are at high risk of hypoglycemia, we suggest the use of real-time [CGM] with confirmatory bedside point-of-care blood glucose monitoring for adjustments in insulin dosing rather than point-of-care blood glucose rather than testing alone in hospital settings where resources and training are available.” (Conditional recommendation. Low certainty of evidence).

“We were actually very careful in terms of looking at the data” for use of CGMs, Dr. Korytkowski said in an interview.

Although CGMs are approved by the Food and Drug Administration in the outpatient setting, and that’s becoming the standard of care there, they are not yet approved for in-hospital use.

However, the FDA granted an emergency allowance for use of CGMs in hospitals during the COVID-19 pandemic.

That was “when everyone was scrambling for what to do,” Dr. Korytkowski noted. “There was a shortage of personal protective equipment and a real interest in trying to limit the amount of exposure of healthcare personnel in some of these really critically ill patients for whom intravenous insulin therapy was used to control their glucose level.”

On March 1, the FDA granted Breakthrough Devices Designation for Dexcom CGM use in the hospital setting.

The new guideline suggests CGM be used to detect trends in glycemic management, with insulin dosing decisions made with point-of-care glucose measure (the standard of care).

To implement CGM for glycemic management in hospitals, Dr. Korytkowski said, would require “extensive staff and nursing education to have people with expertise available to provide support to nursing personnel who are both placing these devices, changing these devices, looking at trends, and then knowing when to remove them for certain procedures such as MRI or radiologic procedures.”

“We know that not all hospitals may be readily available to use these devices,” she said. “It is an area of active research. But the use of these devices during the pandemic, in both critical care and non–critical care setting has really provided us with a lot of information that was used to formulate this suggestion in the guideline.”

The document addresses the following areas: CGM, continuous subcutaneous insulin infusion pump therapy, inpatient diabetes education, prespecified preoperative glycemic targets, use of neutral protamine Hagedorn insulin for glucocorticoid or enteral nutrition-associated hyperglycemia, noninsulin therapies, preoperative carbohydrate-containing oral fluids, carbohydrate counting for prandial (mealtime) insulin dosing, and correctional and scheduled (basal or basal bolus) insulin therapies.

Nine key recommendations

Dr. Korytkowski identified nine key recommendations:

• CGM systems can help guide glycemic management with reduced risk for hypoglycemia.
• Patients experiencing glucocorticoid- or enteral nutrition–associated hyperglycemia require scheduled insulin therapy to address anticipated glucose excursions.
• Selected patients using insulin pump therapy prior to a hospital admission can continue to use these devices in the hospital if they have the mental and physical capacity to do so with knowledgeable hospital personnel.
• Diabetes self-management education provided to hospitalized patients can promote improved glycemic control following discharge with reductions in the risk for hospital readmission. “We know that is recommended for patients in the outpatient setting but often they do not get this,” she said. “We were able to observe that this can also impact long-term outcomes “
• Patients with diabetes scheduled for elective surgery may have improved postoperative outcomes when preoperative hemoglobin A1c is 8% or less and preoperative blood glucose is less than 180 mg/dL. “This recommendation answers the question: ‘Where should glycemic goals be for people who are undergoing surgery?’ ”
• Providing preoperative carbohydrate-containing beverages to patients with known diabetes is not recommended.
• Patients with newly recognized hyperglycemia or well-managed diabetes on noninsulin therapy may be treated with correctional insulin alone as initial therapy at hospital admission.
• Some noninsulin diabetes therapies can be used in combination with correction insulin for patients with type 2 diabetes who have mild hyperglycemia.
• Correctional insulin – “otherwise known as sliding-scale insulin” –  can be used as initial therapy for patients with newly recognized hyperglycemia or type 2 diabetes treated with noninsulin therapy prior to hospital admission.
• Scheduled insulin therapy is preferred for patients experiencing persistent blood glucose values greater than 180 mg/dL and is recommended for patients using insulin therapy prior to admission. 

The guideline writers’ hopes

“We hope that this guideline will resolve debates” about appropriate preoperative glycemic management and when sliding-scale insulin can be used and should not be used, said Dr. Korytkowski.

The authors also hope that “it will stimulate research funding for this very important aspect of diabetes care, and that hospitals will recognize the importance of having access to knowledgeable diabetes care and education specialists who can provide staff education regarding inpatient glycemic management, provide oversight for patients using insulin pump therapy or CGM devices, and empower hospital nurses to provide diabetes [self-management] education prior to patient discharge.”

Claire Pegg, the patient representative on the panel, hopes “that this guideline serves as the beginning of a conversation that will allow inpatient caregivers to provide individualized care to patients – some of whom may be self-sufficient with their glycemic management and others who need additional assistance.” 

Development of the guideline was funded by the Endocrine Society. Dr. Korytkowski has reported no relevant financial disclosures.

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

Goal-directed glycemic management – which may include new technologies for glucose monitoring – for non–critically ill hospitalized patients who have diabetes or newly recognized hyperglycemia can improve outcomes, according to a new practice guideline from the Endocrine Society.  

Even though roughly 35% of hospitalized patients have diabetes or newly discovered hyperglycemia, there is “wide variability in glycemic management in clinical practice,” writing panel chair Mary Korytkowski, MD, from the University of Pittsburgh, said at the annual meeting of the Endocrine Society. “These patients get admitted to every patient service in the hospital, meaning that every clinical service will encounter this group of patients, and their glycemic management can have a major effect on their outcomes. Both short term and long term.”

This guideline provides strategies “to achieve previously recommended glycemic goals while also reducing the risk for hypoglycemia, and this includes inpatient use of insulin pump therapy or continuous glucose monitoring [CGM] devices, among others,” she said.

It also includes “recommendations for preoperative glycemic goals as well as when the use of correctional insulin – well known as sliding scale insulin – may be appropriate” and when it is not.

The document, which replaces a 2012 guideline, was published online in the Journal of Clinical Endocrinology & Metabolism.

A multidisciplinary panel developed the document over the last 3 years to answer 10 clinical practice questions related to management of non–critically ill hospitalized patients with diabetes or newly discovered hyperglycemia.
 

Use of CGM devices in hospital

The first recommendation is: “In adults with insulin-treated diabetes hospitalized for noncritical illness who are at high risk of hypoglycemia, we suggest the use of real-time [CGM] with confirmatory bedside point-of-care blood glucose monitoring for adjustments in insulin dosing rather than point-of-care blood glucose rather than testing alone in hospital settings where resources and training are available.” (Conditional recommendation. Low certainty of evidence).

“We were actually very careful in terms of looking at the data” for use of CGMs, Dr. Korytkowski said in an interview.

Although CGMs are approved by the Food and Drug Administration in the outpatient setting, and that’s becoming the standard of care there, they are not yet approved for in-hospital use.

However, the FDA granted an emergency allowance for use of CGMs in hospitals during the COVID-19 pandemic.

That was “when everyone was scrambling for what to do,” Dr. Korytkowski noted. “There was a shortage of personal protective equipment and a real interest in trying to limit the amount of exposure of healthcare personnel in some of these really critically ill patients for whom intravenous insulin therapy was used to control their glucose level.”

On March 1, the FDA granted Breakthrough Devices Designation for Dexcom CGM use in the hospital setting.

The new guideline suggests CGM be used to detect trends in glycemic management, with insulin dosing decisions made with point-of-care glucose measure (the standard of care).

To implement CGM for glycemic management in hospitals, Dr. Korytkowski said, would require “extensive staff and nursing education to have people with expertise available to provide support to nursing personnel who are both placing these devices, changing these devices, looking at trends, and then knowing when to remove them for certain procedures such as MRI or radiologic procedures.”

“We know that not all hospitals may be readily available to use these devices,” she said. “It is an area of active research. But the use of these devices during the pandemic, in both critical care and non–critical care setting has really provided us with a lot of information that was used to formulate this suggestion in the guideline.”

The document addresses the following areas: CGM, continuous subcutaneous insulin infusion pump therapy, inpatient diabetes education, prespecified preoperative glycemic targets, use of neutral protamine Hagedorn insulin for glucocorticoid or enteral nutrition-associated hyperglycemia, noninsulin therapies, preoperative carbohydrate-containing oral fluids, carbohydrate counting for prandial (mealtime) insulin dosing, and correctional and scheduled (basal or basal bolus) insulin therapies.

Nine key recommendations

Dr. Korytkowski identified nine key recommendations:

• CGM systems can help guide glycemic management with reduced risk for hypoglycemia.
• Patients experiencing glucocorticoid- or enteral nutrition–associated hyperglycemia require scheduled insulin therapy to address anticipated glucose excursions.
• Selected patients using insulin pump therapy prior to a hospital admission can continue to use these devices in the hospital if they have the mental and physical capacity to do so with knowledgeable hospital personnel.
• Diabetes self-management education provided to hospitalized patients can promote improved glycemic control following discharge with reductions in the risk for hospital readmission. “We know that is recommended for patients in the outpatient setting but often they do not get this,” she said. “We were able to observe that this can also impact long-term outcomes “
• Patients with diabetes scheduled for elective surgery may have improved postoperative outcomes when preoperative hemoglobin A1c is 8% or less and preoperative blood glucose is less than 180 mg/dL. “This recommendation answers the question: ‘Where should glycemic goals be for people who are undergoing surgery?’ ”
• Providing preoperative carbohydrate-containing beverages to patients with known diabetes is not recommended.
• Patients with newly recognized hyperglycemia or well-managed diabetes on noninsulin therapy may be treated with correctional insulin alone as initial therapy at hospital admission.
• Some noninsulin diabetes therapies can be used in combination with correction insulin for patients with type 2 diabetes who have mild hyperglycemia.
• Correctional insulin – “otherwise known as sliding-scale insulin” –  can be used as initial therapy for patients with newly recognized hyperglycemia or type 2 diabetes treated with noninsulin therapy prior to hospital admission.
• Scheduled insulin therapy is preferred for patients experiencing persistent blood glucose values greater than 180 mg/dL and is recommended for patients using insulin therapy prior to admission. 

The guideline writers’ hopes

“We hope that this guideline will resolve debates” about appropriate preoperative glycemic management and when sliding-scale insulin can be used and should not be used, said Dr. Korytkowski.

The authors also hope that “it will stimulate research funding for this very important aspect of diabetes care, and that hospitals will recognize the importance of having access to knowledgeable diabetes care and education specialists who can provide staff education regarding inpatient glycemic management, provide oversight for patients using insulin pump therapy or CGM devices, and empower hospital nurses to provide diabetes [self-management] education prior to patient discharge.”

Claire Pegg, the patient representative on the panel, hopes “that this guideline serves as the beginning of a conversation that will allow inpatient caregivers to provide individualized care to patients – some of whom may be self-sufficient with their glycemic management and others who need additional assistance.” 

Development of the guideline was funded by the Endocrine Society. Dr. Korytkowski has reported no relevant financial disclosures.

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