NEW ORLEANS – A novel electromagnetic navigation bronchoscopy system can improve targeting of peripheral lung lesions, according to an industry-sponsored, prospective study.

The system, which incorporates fluoroscopic navigation, increased the percentage of cases in which the target overlapped with the lesion, from 60% to 83%. The percentage of cases without any target overlap decreased from 32% to 5%.

“Tomosynthesis-based fluoroscopic navigation … improves the three-dimensional convergence between the virtual target and the actual target,” said Krish Bhadra, MD, of CHI Memorial Medical Group in Chattanooga, Tenn.

Dr. Bhadra presented results with this system at the annual meeting of the American College of Chest Physicians.

He and his colleagues conducted a study of Medtronic’s superDimension navigation system (version 7.2), which provides real-time imaging with three-dimensional fluoroscopy. The system has a “local registration” feature, which uses fluoroscopy and an algorithm to update the virtual target location during the procedure. This allows the user to reposition the catheter based on the location of the lesion.

The researchers tested the system in 50 patients from two centers (NCT03585959). Patients’ lesions had to be larger than 10 mm, not visible endobronchially, and not reachable by convex endobronchial ultrasound. Lesions within 10 mm of the diaphragm were excluded.

The median lesion size was 17.0 mm, 61.2% were smaller than 20 mm, 65.3% were in the upper lobe, and 53.1% had a bronchus sign present. The median distance from lesion to pleura was 5.9 mm.

Dr. Bhadra said the system performed as designed in all cases, and the protocol-defined technical success rate was 95.9% (47/49). Local registration was attempted in 49 patients and was successful in 47 patients (95.9%). In the unsuccessful cases, local registration was not completed based on the system design because the correction distance was greater than 3.0 cm.

The study’s primary endpoint was three-dimensional overlap of the virtual target and the actual lesion, as confirmed by cone-beam computed tomography. Success was defined as greater than 0% overlap after location correction. Target overlap was achieved in 59.6% (28/47) of cases before local registration and 83.0% (39/47) of cases after.

There were six cases in which local registration was successful, but these subjects weren’t evaluable because of failed procedure recording. When those subjects were excluded, target overlap was achieved in 95.1% (39/41) of cases after local registration.

The median percent overlap between the virtual target and the actual lesion was 11.4% before local registration and 32.8% after. The percentage of cases without any target overlap decreased from 31.7% (13/41) before local registration to 4.9% (2/41) after.

Focusing on the two cases without target overlap, Dr. Bhadra noted that he was able to get a biopsy that proved a malignancy in one of those patients. In the other patient, Dr. Bhadra was able to identify features of organizing pneumonia.

“Even though we did not have overlap, we must have been close enough that we were able to get malignant tissue in one [patient] and features of organizing pneumonia in a patient who’s got no history of organizing pneumonia,” Dr. Bhadra said.

He and his colleagues did not evaluate diagnostic yield in this study, but they did assess complications up to 7 days after the procedure.

The team reported one case of pneumothorax, but the patient didn’t require a chest tube. Additionally, there were two cases of bronchopulmonary hemorrhage, but the patients didn’t require any interventions.

This study was sponsored by Medtronic. Dr. Bhadra disclosed relationships with Medtronic, Boston Scientific, BodyVision, Auris Surgical Robotics, Intuitive Surgical, Veracyte, Biodesix, Merit Medical Endotek, and Johnson & Johnson.

jensmith@mdedge.com

SOURCE: Bhadra K et al. CHEST 2019. doi: 10.1016/j.chest.2019.08.314.

NEW ORLEANS – A novel electromagnetic navigation bronchoscopy system can improve targeting of peripheral lung lesions, according to an industry-sponsored, prospective study.

The system, which incorporates fluoroscopic navigation, increased the percentage of cases in which the target overlapped with the lesion, from 60% to 83%. The percentage of cases without any target overlap decreased from 32% to 5%.

“Tomosynthesis-based fluoroscopic navigation … improves the three-dimensional convergence between the virtual target and the actual target,” said Krish Bhadra, MD, of CHI Memorial Medical Group in Chattanooga, Tenn.

Dr. Bhadra presented results with this system at the annual meeting of the American College of Chest Physicians.

He and his colleagues conducted a study of Medtronic’s superDimension navigation system (version 7.2), which provides real-time imaging with three-dimensional fluoroscopy. The system has a “local registration” feature, which uses fluoroscopy and an algorithm to update the virtual target location during the procedure. This allows the user to reposition the catheter based on the location of the lesion.

The researchers tested the system in 50 patients from two centers (NCT03585959). Patients’ lesions had to be larger than 10 mm, not visible endobronchially, and not reachable by convex endobronchial ultrasound. Lesions within 10 mm of the diaphragm were excluded.

The median lesion size was 17.0 mm, 61.2% were smaller than 20 mm, 65.3% were in the upper lobe, and 53.1% had a bronchus sign present. The median distance from lesion to pleura was 5.9 mm.

Dr. Bhadra said the system performed as designed in all cases, and the protocol-defined technical success rate was 95.9% (47/49). Local registration was attempted in 49 patients and was successful in 47 patients (95.9%). In the unsuccessful cases, local registration was not completed based on the system design because the correction distance was greater than 3.0 cm.

The study’s primary endpoint was three-dimensional overlap of the virtual target and the actual lesion, as confirmed by cone-beam computed tomography. Success was defined as greater than 0% overlap after location correction. Target overlap was achieved in 59.6% (28/47) of cases before local registration and 83.0% (39/47) of cases after.

There were six cases in which local registration was successful, but these subjects weren’t evaluable because of failed procedure recording. When those subjects were excluded, target overlap was achieved in 95.1% (39/41) of cases after local registration.

The median percent overlap between the virtual target and the actual lesion was 11.4% before local registration and 32.8% after. The percentage of cases without any target overlap decreased from 31.7% (13/41) before local registration to 4.9% (2/41) after.

Focusing on the two cases without target overlap, Dr. Bhadra noted that he was able to get a biopsy that proved a malignancy in one of those patients. In the other patient, Dr. Bhadra was able to identify features of organizing pneumonia.

“Even though we did not have overlap, we must have been close enough that we were able to get malignant tissue in one [patient] and features of organizing pneumonia in a patient who’s got no history of organizing pneumonia,” Dr. Bhadra said.

He and his colleagues did not evaluate diagnostic yield in this study, but they did assess complications up to 7 days after the procedure.

The team reported one case of pneumothorax, but the patient didn’t require a chest tube. Additionally, there were two cases of bronchopulmonary hemorrhage, but the patients didn’t require any interventions.

This study was sponsored by Medtronic. Dr. Bhadra disclosed relationships with Medtronic, Boston Scientific, BodyVision, Auris Surgical Robotics, Intuitive Surgical, Veracyte, Biodesix, Merit Medical Endotek, and Johnson & Johnson.

jensmith@mdedge.com

SOURCE: Bhadra K et al. CHEST 2019. doi: 10.1016/j.chest.2019.08.314.

NEW ORLEANS – A novel electromagnetic navigation bronchoscopy system can improve targeting of peripheral lung lesions, according to an industry-sponsored, prospective study.

The system, which incorporates fluoroscopic navigation, increased the percentage of cases in which the target overlapped with the lesion, from 60% to 83%. The percentage of cases without any target overlap decreased from 32% to 5%.

“Tomosynthesis-based fluoroscopic navigation … improves the three-dimensional convergence between the virtual target and the actual target,” said Krish Bhadra, MD, of CHI Memorial Medical Group in Chattanooga, Tenn.

Dr. Bhadra presented results with this system at the annual meeting of the American College of Chest Physicians.

He and his colleagues conducted a study of Medtronic’s superDimension navigation system (version 7.2), which provides real-time imaging with three-dimensional fluoroscopy. The system has a “local registration” feature, which uses fluoroscopy and an algorithm to update the virtual target location during the procedure. This allows the user to reposition the catheter based on the location of the lesion.

The researchers tested the system in 50 patients from two centers (NCT03585959). Patients’ lesions had to be larger than 10 mm, not visible endobronchially, and not reachable by convex endobronchial ultrasound. Lesions within 10 mm of the diaphragm were excluded.

The median lesion size was 17.0 mm, 61.2% were smaller than 20 mm, 65.3% were in the upper lobe, and 53.1% had a bronchus sign present. The median distance from lesion to pleura was 5.9 mm.

Dr. Bhadra said the system performed as designed in all cases, and the protocol-defined technical success rate was 95.9% (47/49). Local registration was attempted in 49 patients and was successful in 47 patients (95.9%). In the unsuccessful cases, local registration was not completed based on the system design because the correction distance was greater than 3.0 cm.

The study’s primary endpoint was three-dimensional overlap of the virtual target and the actual lesion, as confirmed by cone-beam computed tomography. Success was defined as greater than 0% overlap after location correction. Target overlap was achieved in 59.6% (28/47) of cases before local registration and 83.0% (39/47) of cases after.

There were six cases in which local registration was successful, but these subjects weren’t evaluable because of failed procedure recording. When those subjects were excluded, target overlap was achieved in 95.1% (39/41) of cases after local registration.

The median percent overlap between the virtual target and the actual lesion was 11.4% before local registration and 32.8% after. The percentage of cases without any target overlap decreased from 31.7% (13/41) before local registration to 4.9% (2/41) after.

Focusing on the two cases without target overlap, Dr. Bhadra noted that he was able to get a biopsy that proved a malignancy in one of those patients. In the other patient, Dr. Bhadra was able to identify features of organizing pneumonia.

“Even though we did not have overlap, we must have been close enough that we were able to get malignant tissue in one [patient] and features of organizing pneumonia in a patient who’s got no history of organizing pneumonia,” Dr. Bhadra said.

He and his colleagues did not evaluate diagnostic yield in this study, but they did assess complications up to 7 days after the procedure.

The team reported one case of pneumothorax, but the patient didn’t require a chest tube. Additionally, there were two cases of bronchopulmonary hemorrhage, but the patients didn’t require any interventions.

This study was sponsored by Medtronic. Dr. Bhadra disclosed relationships with Medtronic, Boston Scientific, BodyVision, Auris Surgical Robotics, Intuitive Surgical, Veracyte, Biodesix, Merit Medical Endotek, and Johnson & Johnson.

jensmith@mdedge.com

SOURCE: Bhadra K et al. CHEST 2019. doi: 10.1016/j.chest.2019.08.314.

Treating Clostridioides difficile infection with fecal microbiota transplantation is associated with a lower risk of bloodstream infection and recurrence than treatment with antibiotics, new research has found.

A paper published in Annals of Internal Medicine presents outcomes of a prospective cohort study in 290 inpatients with recurrent C. difficile infection, 109 of whom were treated with fecal microbiota transplantation (FMT); the remainder were treated with antibiotics including metronidazole, vancomycin, and fidaxomicin.

While the FMT group had a higher mean number of previous C. difficile infections than the antibiotics group (2.82 vs. 1.23, respectively), a sustained cure was achieved in 97% of the FMT group, compared with 38% in the antibiotics group.

Blood cultures were done if patients developed a temperature above 30° C or showed symptoms that might be attributable to sepsis. Bloodstream infections were diagnosed in 5% (5 patients) of those treated with FMT, and 22% (40 patients) in the antibiotics group.

The patients in the FMT group with bloodstream infections all had bacterial infections – one of which was polymicrobial – and there were no cases of fungal bloodstream infections. In the antibiotics group, 28 patients (15%) had bacterial bloodstream infections – 11 of which were polymicrobial – and 12 (7%) had fungal bloodstream infections.

Bloodstream infections were particularly evident among the 11 patients whose C. difficile infection was treated with fidaxomicin, 4 of whom developed a bloodstream infection.

Overall, 27% of patients died during the 90-day follow-up, with 7% dying because of bloodstream infections, all of whom were in the antibiotic-treated cohort. Three patients in the FMT group died because of overwhelming C. difficile infection, compared with 12 in the antibiotic cohort.

Nearly three-quarters of deaths occurred within 30 days of the end of treatment; 5 of these deaths were in the FMT group, and 53 were in the antibiotics group.

“These findings suggest that the longer 90-day [overall survival] of patients in the FMT group is attributable to cure of [C. difficile infection] leading to an improvement in clinical condition,” wrote Gianluca Ianiro, MD, from the Catholic University of the Sacred Heart in Rome, and coauthors.

The 90-day overall survival rate was 92% in the FMT group and 61% in the antibiotic group. Patients treated with FMT also showed significantly shorter mean duration of hospital stay at 13.3 days, compared with 29.7 days in patients treated with antibiotics.

The authors noted the results should be interpreted with caution because of baseline differences between the two groups that were not entirely accounted for by using propensity matching. However, even in the propensity-matched cohort of 57 patients from each group, there was still a significantly higher overall survival at 90 days among patients treated with FMT.

One author declared grants from the pharmaceutical sector outside the submitted work. No funding or other conflicts of interest were reported.

SOURCE: Ianiro G et al. Ann Intern Med. 2019 Nov 4. doi: 10.7326/M18-3635.

Treating Clostridioides difficile infection with fecal microbiota transplantation is associated with a lower risk of bloodstream infection and recurrence than treatment with antibiotics, new research has found.

A paper published in Annals of Internal Medicine presents outcomes of a prospective cohort study in 290 inpatients with recurrent C. difficile infection, 109 of whom were treated with fecal microbiota transplantation (FMT); the remainder were treated with antibiotics including metronidazole, vancomycin, and fidaxomicin.

While the FMT group had a higher mean number of previous C. difficile infections than the antibiotics group (2.82 vs. 1.23, respectively), a sustained cure was achieved in 97% of the FMT group, compared with 38% in the antibiotics group.

Blood cultures were done if patients developed a temperature above 30° C or showed symptoms that might be attributable to sepsis. Bloodstream infections were diagnosed in 5% (5 patients) of those treated with FMT, and 22% (40 patients) in the antibiotics group.

The patients in the FMT group with bloodstream infections all had bacterial infections – one of which was polymicrobial – and there were no cases of fungal bloodstream infections. In the antibiotics group, 28 patients (15%) had bacterial bloodstream infections – 11 of which were polymicrobial – and 12 (7%) had fungal bloodstream infections.

Bloodstream infections were particularly evident among the 11 patients whose C. difficile infection was treated with fidaxomicin, 4 of whom developed a bloodstream infection.

Overall, 27% of patients died during the 90-day follow-up, with 7% dying because of bloodstream infections, all of whom were in the antibiotic-treated cohort. Three patients in the FMT group died because of overwhelming C. difficile infection, compared with 12 in the antibiotic cohort.

Nearly three-quarters of deaths occurred within 30 days of the end of treatment; 5 of these deaths were in the FMT group, and 53 were in the antibiotics group.

“These findings suggest that the longer 90-day [overall survival] of patients in the FMT group is attributable to cure of [C. difficile infection] leading to an improvement in clinical condition,” wrote Gianluca Ianiro, MD, from the Catholic University of the Sacred Heart in Rome, and coauthors.

The 90-day overall survival rate was 92% in the FMT group and 61% in the antibiotic group. Patients treated with FMT also showed significantly shorter mean duration of hospital stay at 13.3 days, compared with 29.7 days in patients treated with antibiotics.

The authors noted the results should be interpreted with caution because of baseline differences between the two groups that were not entirely accounted for by using propensity matching. However, even in the propensity-matched cohort of 57 patients from each group, there was still a significantly higher overall survival at 90 days among patients treated with FMT.

One author declared grants from the pharmaceutical sector outside the submitted work. No funding or other conflicts of interest were reported.

SOURCE: Ianiro G et al. Ann Intern Med. 2019 Nov 4. doi: 10.7326/M18-3635.

Treating Clostridioides difficile infection with fecal microbiota transplantation is associated with a lower risk of bloodstream infection and recurrence than treatment with antibiotics, new research has found.

A paper published in Annals of Internal Medicine presents outcomes of a prospective cohort study in 290 inpatients with recurrent C. difficile infection, 109 of whom were treated with fecal microbiota transplantation (FMT); the remainder were treated with antibiotics including metronidazole, vancomycin, and fidaxomicin.

While the FMT group had a higher mean number of previous C. difficile infections than the antibiotics group (2.82 vs. 1.23, respectively), a sustained cure was achieved in 97% of the FMT group, compared with 38% in the antibiotics group.

Blood cultures were done if patients developed a temperature above 30° C or showed symptoms that might be attributable to sepsis. Bloodstream infections were diagnosed in 5% (5 patients) of those treated with FMT, and 22% (40 patients) in the antibiotics group.

The patients in the FMT group with bloodstream infections all had bacterial infections – one of which was polymicrobial – and there were no cases of fungal bloodstream infections. In the antibiotics group, 28 patients (15%) had bacterial bloodstream infections – 11 of which were polymicrobial – and 12 (7%) had fungal bloodstream infections.

Bloodstream infections were particularly evident among the 11 patients whose C. difficile infection was treated with fidaxomicin, 4 of whom developed a bloodstream infection.

Overall, 27% of patients died during the 90-day follow-up, with 7% dying because of bloodstream infections, all of whom were in the antibiotic-treated cohort. Three patients in the FMT group died because of overwhelming C. difficile infection, compared with 12 in the antibiotic cohort.

Nearly three-quarters of deaths occurred within 30 days of the end of treatment; 5 of these deaths were in the FMT group, and 53 were in the antibiotics group.

“These findings suggest that the longer 90-day [overall survival] of patients in the FMT group is attributable to cure of [C. difficile infection] leading to an improvement in clinical condition,” wrote Gianluca Ianiro, MD, from the Catholic University of the Sacred Heart in Rome, and coauthors.

The 90-day overall survival rate was 92% in the FMT group and 61% in the antibiotic group. Patients treated with FMT also showed significantly shorter mean duration of hospital stay at 13.3 days, compared with 29.7 days in patients treated with antibiotics.

The authors noted the results should be interpreted with caution because of baseline differences between the two groups that were not entirely accounted for by using propensity matching. However, even in the propensity-matched cohort of 57 patients from each group, there was still a significantly higher overall survival at 90 days among patients treated with FMT.

One author declared grants from the pharmaceutical sector outside the submitted work. No funding or other conflicts of interest were reported.

SOURCE: Ianiro G et al. Ann Intern Med. 2019 Nov 4. doi: 10.7326/M18-3635.

BARCELONA – Disturbed HDL cholesterol metabolism is one of the earliest features that may predispose individuals to the development of type 2 diabetes, according to data from a genetics and metabolomics study conducted in the United Kingdom.

Sara Freeman/MDedge News

Changes in HDL cholesterol metabolism were seen in children as young as 8 years, decades before the clinical onset of disease, Joshua Bell, PhD, a research fellow at the University of Bristol (England), reported at the annual meeting of the European Association for the Study of Diabetes.

“We know that type 2 diabetes certainly doesn’t develop overnight,” Dr. Bell said. Indeed, data exist showing that there are changes in glucose metabolism several years before a formal diagnosis may be made in adults. “What we don’t know is what the very earliest features of diabetes look like,” he added.

“The main assumption is that type 2 diabetes is a metabolic disease, and so disease features are visible in systemic metabolism,” explained Dr. Bell. What was not clear, however, was that if any metabolic features – seen mainly in observational studies and in adults – were caused by the disease itself or perhaps were independent causes of type 2 diabetes.To investigate, Dr. Bell and associates performed a study linking genetic liability with metabolomic data collected at four time points from 4,761 offspring from participants in the Avon Longitudinal Study of Parents and Children cohort, which is also known as the Children of the 90s cohort. More than 200 metabolic traits were considered, and a genetic risk score comprising more than 162 single nucleotide polymorphisms previously linked to adult type 2 diabetes was used.

The metabolomic traits considered included lipoprotein subclass-specific cholesterol and triglyceride content, amino and fatty acids, and inflammatory glycoprotein acetyls, which had been measured in childhood at the age of 8 years, in adolescence at 16 years, in young adulthood at 18 years, and in adulthood at 25 years.

Early metabolic features of type 2 diabetes liability were grouped together and one feature that stood out was the sizes of lipid particles. In particular, it was the size of HDL cholesterol particle subtypes in children at the age of 8 years. Before other types of changes in lipid particles were being seen, there were reductions in the lipid content of HDL cholesterol particle subtypes, notably those that were very large.

By age 16 years, strong associations remained with lower lipids in HDL cholesterol particle subtypes and type 2 diabetes liability, which became stronger with preglycemic traits, such as citrate, and with glycoprotein acetyls. By age 18 years, elevations were seen in branched amino acids, and by age 25, association had strengthened for the lipid content of very low–density lipoprotein cholesterol.

“Linking genetic liability to adult disease with traits measured much earlier in life can tell you something about how the disease activity unfolds over a lifetime,” Dr. Bell said, adding that the feature that was “most consistently tracked” could be evaluated and could help reveal whether or not an individual might go on to develop type 2 diabetes.

In a press release issued by the EASD, Dr. Bell observed: “It’s remarkable that we can see signs of adult diabetes in the blood from such a young age. Knowing what early features of type 2 diabetes look like, could help us to intervene much earlier to halt progression to full-blown diabetes and its complications.”

The study was funded by Diabetes U.K., Cancer Research U.K., the Elizabeth Blackwell Institute for Health Research, the Wellcome Trust, the Medical Research Council, and the University of Bristol. Dr. Bell said he had no conflicts of interest to declare.

SOURCE: Bell J et al. bioRxiv. 2019 Sep 17. doi: 10.1101/767756.
 

BARCELONA – Disturbed HDL cholesterol metabolism is one of the earliest features that may predispose individuals to the development of type 2 diabetes, according to data from a genetics and metabolomics study conducted in the United Kingdom.

Sara Freeman/MDedge News

Changes in HDL cholesterol metabolism were seen in children as young as 8 years, decades before the clinical onset of disease, Joshua Bell, PhD, a research fellow at the University of Bristol (England), reported at the annual meeting of the European Association for the Study of Diabetes.

“We know that type 2 diabetes certainly doesn’t develop overnight,” Dr. Bell said. Indeed, data exist showing that there are changes in glucose metabolism several years before a formal diagnosis may be made in adults. “What we don’t know is what the very earliest features of diabetes look like,” he added.

“The main assumption is that type 2 diabetes is a metabolic disease, and so disease features are visible in systemic metabolism,” explained Dr. Bell. What was not clear, however, was that if any metabolic features – seen mainly in observational studies and in adults – were caused by the disease itself or perhaps were independent causes of type 2 diabetes.To investigate, Dr. Bell and associates performed a study linking genetic liability with metabolomic data collected at four time points from 4,761 offspring from participants in the Avon Longitudinal Study of Parents and Children cohort, which is also known as the Children of the 90s cohort. More than 200 metabolic traits were considered, and a genetic risk score comprising more than 162 single nucleotide polymorphisms previously linked to adult type 2 diabetes was used.

The metabolomic traits considered included lipoprotein subclass-specific cholesterol and triglyceride content, amino and fatty acids, and inflammatory glycoprotein acetyls, which had been measured in childhood at the age of 8 years, in adolescence at 16 years, in young adulthood at 18 years, and in adulthood at 25 years.

Early metabolic features of type 2 diabetes liability were grouped together and one feature that stood out was the sizes of lipid particles. In particular, it was the size of HDL cholesterol particle subtypes in children at the age of 8 years. Before other types of changes in lipid particles were being seen, there were reductions in the lipid content of HDL cholesterol particle subtypes, notably those that were very large.

By age 16 years, strong associations remained with lower lipids in HDL cholesterol particle subtypes and type 2 diabetes liability, which became stronger with preglycemic traits, such as citrate, and with glycoprotein acetyls. By age 18 years, elevations were seen in branched amino acids, and by age 25, association had strengthened for the lipid content of very low–density lipoprotein cholesterol.

“Linking genetic liability to adult disease with traits measured much earlier in life can tell you something about how the disease activity unfolds over a lifetime,” Dr. Bell said, adding that the feature that was “most consistently tracked” could be evaluated and could help reveal whether or not an individual might go on to develop type 2 diabetes.

In a press release issued by the EASD, Dr. Bell observed: “It’s remarkable that we can see signs of adult diabetes in the blood from such a young age. Knowing what early features of type 2 diabetes look like, could help us to intervene much earlier to halt progression to full-blown diabetes and its complications.”

The study was funded by Diabetes U.K., Cancer Research U.K., the Elizabeth Blackwell Institute for Health Research, the Wellcome Trust, the Medical Research Council, and the University of Bristol. Dr. Bell said he had no conflicts of interest to declare.

SOURCE: Bell J et al. bioRxiv. 2019 Sep 17. doi: 10.1101/767756.
 

BARCELONA – Disturbed HDL cholesterol metabolism is one of the earliest features that may predispose individuals to the development of type 2 diabetes, according to data from a genetics and metabolomics study conducted in the United Kingdom.

Sara Freeman/MDedge News

Changes in HDL cholesterol metabolism were seen in children as young as 8 years, decades before the clinical onset of disease, Joshua Bell, PhD, a research fellow at the University of Bristol (England), reported at the annual meeting of the European Association for the Study of Diabetes.

“We know that type 2 diabetes certainly doesn’t develop overnight,” Dr. Bell said. Indeed, data exist showing that there are changes in glucose metabolism several years before a formal diagnosis may be made in adults. “What we don’t know is what the very earliest features of diabetes look like,” he added.

“The main assumption is that type 2 diabetes is a metabolic disease, and so disease features are visible in systemic metabolism,” explained Dr. Bell. What was not clear, however, was that if any metabolic features – seen mainly in observational studies and in adults – were caused by the disease itself or perhaps were independent causes of type 2 diabetes.To investigate, Dr. Bell and associates performed a study linking genetic liability with metabolomic data collected at four time points from 4,761 offspring from participants in the Avon Longitudinal Study of Parents and Children cohort, which is also known as the Children of the 90s cohort. More than 200 metabolic traits were considered, and a genetic risk score comprising more than 162 single nucleotide polymorphisms previously linked to adult type 2 diabetes was used.

The metabolomic traits considered included lipoprotein subclass-specific cholesterol and triglyceride content, amino and fatty acids, and inflammatory glycoprotein acetyls, which had been measured in childhood at the age of 8 years, in adolescence at 16 years, in young adulthood at 18 years, and in adulthood at 25 years.

Early metabolic features of type 2 diabetes liability were grouped together and one feature that stood out was the sizes of lipid particles. In particular, it was the size of HDL cholesterol particle subtypes in children at the age of 8 years. Before other types of changes in lipid particles were being seen, there were reductions in the lipid content of HDL cholesterol particle subtypes, notably those that were very large.

By age 16 years, strong associations remained with lower lipids in HDL cholesterol particle subtypes and type 2 diabetes liability, which became stronger with preglycemic traits, such as citrate, and with glycoprotein acetyls. By age 18 years, elevations were seen in branched amino acids, and by age 25, association had strengthened for the lipid content of very low–density lipoprotein cholesterol.

“Linking genetic liability to adult disease with traits measured much earlier in life can tell you something about how the disease activity unfolds over a lifetime,” Dr. Bell said, adding that the feature that was “most consistently tracked” could be evaluated and could help reveal whether or not an individual might go on to develop type 2 diabetes.

In a press release issued by the EASD, Dr. Bell observed: “It’s remarkable that we can see signs of adult diabetes in the blood from such a young age. Knowing what early features of type 2 diabetes look like, could help us to intervene much earlier to halt progression to full-blown diabetes and its complications.”

The study was funded by Diabetes U.K., Cancer Research U.K., the Elizabeth Blackwell Institute for Health Research, the Wellcome Trust, the Medical Research Council, and the University of Bristol. Dr. Bell said he had no conflicts of interest to declare.

SOURCE: Bell J et al. bioRxiv. 2019 Sep 17. doi: 10.1101/767756.
 

Treatment with trifluridine/tipiracil was safe and showed efficacy in patients with metastatic gastric cancer or gastroesophageal junction cancer regardless of their gastrectomy status, results of a preplanned analysis from the phase 3 randomized TAGS trial showed.

Trifluridine/tipiracil (FTD/TPI) was associated with significantly better overall survival (OS) and progression-free survival (PFS) than placebo in patients who had undergone gastrectomy, reported David H. Ilson, MD, PhD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues.

“The benefits of FTD/TPI were especially noteworthy in the subpopulation of patients who had undergone gastrectomy, who tended to be more heavily pretreated and were less tolerant of therapy. The overall safety profile of the drug, including the incidence of severe AEs [adverse events] was similar among patients who had or had not undergone gastrectomy. No new safety concerns were reported in patients who had undergone gastrectomy,” they wrote in JAMA Oncology.

FTD/TPI is an oral drug combining the thymidine analogue trifluridine and tipiracil, an inhibitor of trifluridine degradation. The drug was approved by the FDA in 2015 under the trade name Lonsurf for the treatment of refractory metastatic colorectal cancer, and in 2019 for patients with metastatic gastric cancer or gastroesophageal junction cancer (mGC/GEJC) that had been treated with at least two lines of chemotherapy.

In a phase 2 study conducted in Japan with 29 patients with metastatic gastric cancer that had progressed after chemotherapy with fluoropyrimidine, platinum, taxanes, or irinotecan, FTD/TPI was associated with a median overall survival of 8.7 months and an investigator-assessed disease control rate of 65.5%,

As previously reported, in the randomized, controlled TAGS (TAS-102 Gastric Study), median overall survival, the primary endpoint, was 5.7 months for patients assigned to receive trifluridine/tipiracil, compared with 3.6 months for patients randomized to placebo.

The current study is a preplanned subgroup analysis from the TAGS trial. Of 507 randomized patients, 221 had undergone gastrectomy, and of this group 147 were randomized to FTD/TPI and 74 to placebo. The remaining 286 patients had not undergone gastrectomy, and of this group 190 were randomized to FTD/TPI and 96 to placebo.

Among patients who had undergone gastrectomy, the hazard ratio for OS of patients treated with FTD/TPI vs. placebo was 0.57 (95% confidence interval, 0.41-0.79), and the HR for PFS was 0.48 (95% CI, 0.35-0.65).

In the no-gastrectomy subgroup, the overall survival HR for patients who received FTD/TPI vs. placebo was 0.80 (95% CI , 0.60-1.06), and the HR for PFS was 0.65 (95% CI, 0.49-0.85).

Grade 3 or greater adverse events with FTD/TPI occurred in 84.1% of gastrectomy patients and 76.3% of no-gastrectomy patients. Grade 3 or greater neutropenia occurred in 44.1% and 26.3%, respectively; grade 3 or greater anemia in 21.4% vs. 17.4%; and grade 3 or greater leukopenia was observed in 14.5% vs. 5.3%.

Dose modifications because of adverse events were required for 64.8% of patients who had undergone gastrectomy, and in 53.2% of those who had not.

Treatment discontinuations because of AEs occurred in 10.3% and 14.7%, respectively.

The study was funded by Taiho Oncology and Taiho Pharmaceutical Company. Dr. Islon reported grants and advisory role support from Taiho and others. Multiple coauthors had similar disclosures.

SOURCE: Ilson DH et al. JAMA Oncol. 2019 Oct 10. doi: 10.1001/jamaoncol.2019.3531.

Treatment with trifluridine/tipiracil was safe and showed efficacy in patients with metastatic gastric cancer or gastroesophageal junction cancer regardless of their gastrectomy status, results of a preplanned analysis from the phase 3 randomized TAGS trial showed.

Trifluridine/tipiracil (FTD/TPI) was associated with significantly better overall survival (OS) and progression-free survival (PFS) than placebo in patients who had undergone gastrectomy, reported David H. Ilson, MD, PhD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues.

“The benefits of FTD/TPI were especially noteworthy in the subpopulation of patients who had undergone gastrectomy, who tended to be more heavily pretreated and were less tolerant of therapy. The overall safety profile of the drug, including the incidence of severe AEs [adverse events] was similar among patients who had or had not undergone gastrectomy. No new safety concerns were reported in patients who had undergone gastrectomy,” they wrote in JAMA Oncology.

FTD/TPI is an oral drug combining the thymidine analogue trifluridine and tipiracil, an inhibitor of trifluridine degradation. The drug was approved by the FDA in 2015 under the trade name Lonsurf for the treatment of refractory metastatic colorectal cancer, and in 2019 for patients with metastatic gastric cancer or gastroesophageal junction cancer (mGC/GEJC) that had been treated with at least two lines of chemotherapy.

In a phase 2 study conducted in Japan with 29 patients with metastatic gastric cancer that had progressed after chemotherapy with fluoropyrimidine, platinum, taxanes, or irinotecan, FTD/TPI was associated with a median overall survival of 8.7 months and an investigator-assessed disease control rate of 65.5%,

As previously reported, in the randomized, controlled TAGS (TAS-102 Gastric Study), median overall survival, the primary endpoint, was 5.7 months for patients assigned to receive trifluridine/tipiracil, compared with 3.6 months for patients randomized to placebo.

The current study is a preplanned subgroup analysis from the TAGS trial. Of 507 randomized patients, 221 had undergone gastrectomy, and of this group 147 were randomized to FTD/TPI and 74 to placebo. The remaining 286 patients had not undergone gastrectomy, and of this group 190 were randomized to FTD/TPI and 96 to placebo.

Among patients who had undergone gastrectomy, the hazard ratio for OS of patients treated with FTD/TPI vs. placebo was 0.57 (95% confidence interval, 0.41-0.79), and the HR for PFS was 0.48 (95% CI, 0.35-0.65).

In the no-gastrectomy subgroup, the overall survival HR for patients who received FTD/TPI vs. placebo was 0.80 (95% CI , 0.60-1.06), and the HR for PFS was 0.65 (95% CI, 0.49-0.85).

Grade 3 or greater adverse events with FTD/TPI occurred in 84.1% of gastrectomy patients and 76.3% of no-gastrectomy patients. Grade 3 or greater neutropenia occurred in 44.1% and 26.3%, respectively; grade 3 or greater anemia in 21.4% vs. 17.4%; and grade 3 or greater leukopenia was observed in 14.5% vs. 5.3%.

Dose modifications because of adverse events were required for 64.8% of patients who had undergone gastrectomy, and in 53.2% of those who had not.

Treatment discontinuations because of AEs occurred in 10.3% and 14.7%, respectively.

The study was funded by Taiho Oncology and Taiho Pharmaceutical Company. Dr. Islon reported grants and advisory role support from Taiho and others. Multiple coauthors had similar disclosures.

SOURCE: Ilson DH et al. JAMA Oncol. 2019 Oct 10. doi: 10.1001/jamaoncol.2019.3531.

Treatment with trifluridine/tipiracil was safe and showed efficacy in patients with metastatic gastric cancer or gastroesophageal junction cancer regardless of their gastrectomy status, results of a preplanned analysis from the phase 3 randomized TAGS trial showed.

Trifluridine/tipiracil (FTD/TPI) was associated with significantly better overall survival (OS) and progression-free survival (PFS) than placebo in patients who had undergone gastrectomy, reported David H. Ilson, MD, PhD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues.

“The benefits of FTD/TPI were especially noteworthy in the subpopulation of patients who had undergone gastrectomy, who tended to be more heavily pretreated and were less tolerant of therapy. The overall safety profile of the drug, including the incidence of severe AEs [adverse events] was similar among patients who had or had not undergone gastrectomy. No new safety concerns were reported in patients who had undergone gastrectomy,” they wrote in JAMA Oncology.

FTD/TPI is an oral drug combining the thymidine analogue trifluridine and tipiracil, an inhibitor of trifluridine degradation. The drug was approved by the FDA in 2015 under the trade name Lonsurf for the treatment of refractory metastatic colorectal cancer, and in 2019 for patients with metastatic gastric cancer or gastroesophageal junction cancer (mGC/GEJC) that had been treated with at least two lines of chemotherapy.

In a phase 2 study conducted in Japan with 29 patients with metastatic gastric cancer that had progressed after chemotherapy with fluoropyrimidine, platinum, taxanes, or irinotecan, FTD/TPI was associated with a median overall survival of 8.7 months and an investigator-assessed disease control rate of 65.5%,

As previously reported, in the randomized, controlled TAGS (TAS-102 Gastric Study), median overall survival, the primary endpoint, was 5.7 months for patients assigned to receive trifluridine/tipiracil, compared with 3.6 months for patients randomized to placebo.

The current study is a preplanned subgroup analysis from the TAGS trial. Of 507 randomized patients, 221 had undergone gastrectomy, and of this group 147 were randomized to FTD/TPI and 74 to placebo. The remaining 286 patients had not undergone gastrectomy, and of this group 190 were randomized to FTD/TPI and 96 to placebo.

Among patients who had undergone gastrectomy, the hazard ratio for OS of patients treated with FTD/TPI vs. placebo was 0.57 (95% confidence interval, 0.41-0.79), and the HR for PFS was 0.48 (95% CI, 0.35-0.65).

In the no-gastrectomy subgroup, the overall survival HR for patients who received FTD/TPI vs. placebo was 0.80 (95% CI , 0.60-1.06), and the HR for PFS was 0.65 (95% CI, 0.49-0.85).

Grade 3 or greater adverse events with FTD/TPI occurred in 84.1% of gastrectomy patients and 76.3% of no-gastrectomy patients. Grade 3 or greater neutropenia occurred in 44.1% and 26.3%, respectively; grade 3 or greater anemia in 21.4% vs. 17.4%; and grade 3 or greater leukopenia was observed in 14.5% vs. 5.3%.

Dose modifications because of adverse events were required for 64.8% of patients who had undergone gastrectomy, and in 53.2% of those who had not.

Treatment discontinuations because of AEs occurred in 10.3% and 14.7%, respectively.

The study was funded by Taiho Oncology and Taiho Pharmaceutical Company. Dr. Islon reported grants and advisory role support from Taiho and others. Multiple coauthors had similar disclosures.

SOURCE: Ilson DH et al. JAMA Oncol. 2019 Oct 10. doi: 10.1001/jamaoncol.2019.3531.

CHICAGO – Many patients with thyroid cancer can be sent home after lateral neck dissections with few or no opioids, in the experience of an institution that made a sea change in opioid prescribing practices.

Kari Oakes/MDedge News

Between 2012 to mid-2019, Oregon Health & Science University (OHSU), Portland, saw 243 patients who received lateral neck dissections for thyroid cancer and were opioid naive. Before a shift in prescribing practices in early 2017, 5.3% of patients were discharged without opioids after lateral neck dissections for thyroid cancer, whereas after the shift, 41.7% of patients went home on an opioid-free regimen, James Y. Lim, MD, an endocrine surgeon and assistant professor at the university, said during a poster presentation at the annual meeting of the American Thyroid Association.

The initiative, led by Maisie L. Shindo, MD, was started at the OHSU Thyroid and Parathyroid Center in late 2016 in an effort to reduce the number of opioid prescriptions in postoperative patients, Dr. Lim explained in an interview after his presentation. Dr. Shindo, coauthor of the study, directs the thyroid and parathyroid surgery department at the university.

“Before the initiative, standard postoperative pain control consisted of opioids. However, it was common for patients to mention that they did not need them at all,” said Dr. Lim. “Our prescribing practices today reflect the ability to maintain patient comfort without having to resort to opioids. We are able to keep more than 90% of our patients comfortable with a multimodal approach to pain,” he said.

Dr. Lim and colleagues used a retrospective record review to tally how many opioids were initially prescribed at discharge after lateral neck dissections for thyroid cancer, along with the number and quantity of refills for opioids after discharge. Opioid doses were converted to morphine milligram equivalents (MME), and dosing patterns were compared for the periods before and after Feb. 1, 2017, when operating surgeons changed opioid prescribing patterns. These two subgroups were termed group 1 and group 2, respectively.

In all, 143 of the total 243 patients included in the study were women, and the mean age at the time of surgery was 47 years. Patients in group 1 had 170 surgeries, and those in group 2 had 103 surgeries.

Group 1 patients received a mean 295.4 MME after surgery, and group 2 patients received a mean 85.89 MME, though there was wide variation in discharge prescribing within each group. The absolute difference between the pre- and postinitiative groups was 209.51 MME (95% confidence interval, 157.8-261.2), for an effect size of 1.08. The MME figures for each group reflected both discharge medication and any refills or rescue prescriptions that were required.

“Decreasing the volume of opioids prescribed at discharge will decrease waste and reduce potential for addiction,” the authors noted.

As far as is known, “this is the first study that seeks to identify the extent of opioid needs after an extensive neck dissection for thyroid cancer operation,” said Dr. Lim, who added that he has been surprised at how well patients do after surgery. He said he and other surgeons had expected patients to have more pain from lateral neck dissections than they seem to experience.

“There have been studies, including from our own institution, that reported the relatively small need for opioids after a central neck procedure, such as a total thyroidectomy,” Dr. Lim said. “Our study showed that those requirements remain low even with more extensive lateral neck dissections. In the last 8 months of the study, more than 70% of patients with lateral neck dissections did not require opioids on discharge.”

Dr. Lim said that he and the rest of the care team advise patients to ramp up nonpharmacologic options, including ibuprofen, acetaminophen, ice packs, and throat lozenges – all of which can make a big difference in postoperative comfort.

Paying attention to how patients fare during an inpatient stay or even same-day procedures can help physicians estimate postdischarge needs, said Dr. Lim: “For our lateral neck dissections, patients usually stay overnight, and we can get a pretty good estimate of how their pain is being managed off opioids. For same-day procedures, it requires evaluating the patient before discharge and reassessing the pain needs at that time.”

Helping patients and their families understand the postoperative course and what level of discomfort they can expect has helped in the effort to minimize opioid use, Dr. Lim said. Overall, patients, family, and staff have received the changes “very well,” he added.

Practices that are considering a move toward opioid-free or opioid-sparing regimens after surgery should know that “it does require buy-in from all members of the medical team as well as the patients,” Dr. Lim emphasized.

“It starts at the initial surgical consultation, with surgeons educating patients on what to expect in terms of postoperative discomfort and pain. Patients are informed that they will have some discomfort and mild pain that is generally controlled with nonopioid, over-the-counter medications and cold therapy to the surgical site,” he explained.

“It requires education of the nurses and residents to encourage moving away from using opioids as a first-line therapy,” but it’s worth the hard work to get to a point where patients are going home with few, or no, opioids, said Dr. Lim. “Ultimately, patients are happier and are often relieved that their pain can be controlled without opioids,” he said.

Dr. Shindo is the senior author of a related study examining opioid reduction in neck dissection for a variety of head and neck cancers. In that study, she and her coauthors found that opioid requirements vary by cancer type. In an upcoming manuscript, the researchers are aiming to characterize typical opioid requirements for commonly performed procedures, to provide surgeons with evidence-based baselines for appropriate, but not excessive, opioid prescribing.

Dr. Lim reported no outside sources of funding. He, Dr. Shindo, and a third author reported that they had no conflicts of interest.

koakes@mdedge.com

SOURCE: Lim J et al. ATA 2019, Poster 401.

CHICAGO – Many patients with thyroid cancer can be sent home after lateral neck dissections with few or no opioids, in the experience of an institution that made a sea change in opioid prescribing practices.

Kari Oakes/MDedge News

Between 2012 to mid-2019, Oregon Health & Science University (OHSU), Portland, saw 243 patients who received lateral neck dissections for thyroid cancer and were opioid naive. Before a shift in prescribing practices in early 2017, 5.3% of patients were discharged without opioids after lateral neck dissections for thyroid cancer, whereas after the shift, 41.7% of patients went home on an opioid-free regimen, James Y. Lim, MD, an endocrine surgeon and assistant professor at the university, said during a poster presentation at the annual meeting of the American Thyroid Association.

The initiative, led by Maisie L. Shindo, MD, was started at the OHSU Thyroid and Parathyroid Center in late 2016 in an effort to reduce the number of opioid prescriptions in postoperative patients, Dr. Lim explained in an interview after his presentation. Dr. Shindo, coauthor of the study, directs the thyroid and parathyroid surgery department at the university.

“Before the initiative, standard postoperative pain control consisted of opioids. However, it was common for patients to mention that they did not need them at all,” said Dr. Lim. “Our prescribing practices today reflect the ability to maintain patient comfort without having to resort to opioids. We are able to keep more than 90% of our patients comfortable with a multimodal approach to pain,” he said.

Dr. Lim and colleagues used a retrospective record review to tally how many opioids were initially prescribed at discharge after lateral neck dissections for thyroid cancer, along with the number and quantity of refills for opioids after discharge. Opioid doses were converted to morphine milligram equivalents (MME), and dosing patterns were compared for the periods before and after Feb. 1, 2017, when operating surgeons changed opioid prescribing patterns. These two subgroups were termed group 1 and group 2, respectively.

In all, 143 of the total 243 patients included in the study were women, and the mean age at the time of surgery was 47 years. Patients in group 1 had 170 surgeries, and those in group 2 had 103 surgeries.

Group 1 patients received a mean 295.4 MME after surgery, and group 2 patients received a mean 85.89 MME, though there was wide variation in discharge prescribing within each group. The absolute difference between the pre- and postinitiative groups was 209.51 MME (95% confidence interval, 157.8-261.2), for an effect size of 1.08. The MME figures for each group reflected both discharge medication and any refills or rescue prescriptions that were required.

“Decreasing the volume of opioids prescribed at discharge will decrease waste and reduce potential for addiction,” the authors noted.

As far as is known, “this is the first study that seeks to identify the extent of opioid needs after an extensive neck dissection for thyroid cancer operation,” said Dr. Lim, who added that he has been surprised at how well patients do after surgery. He said he and other surgeons had expected patients to have more pain from lateral neck dissections than they seem to experience.

“There have been studies, including from our own institution, that reported the relatively small need for opioids after a central neck procedure, such as a total thyroidectomy,” Dr. Lim said. “Our study showed that those requirements remain low even with more extensive lateral neck dissections. In the last 8 months of the study, more than 70% of patients with lateral neck dissections did not require opioids on discharge.”

Dr. Lim said that he and the rest of the care team advise patients to ramp up nonpharmacologic options, including ibuprofen, acetaminophen, ice packs, and throat lozenges – all of which can make a big difference in postoperative comfort.

Paying attention to how patients fare during an inpatient stay or even same-day procedures can help physicians estimate postdischarge needs, said Dr. Lim: “For our lateral neck dissections, patients usually stay overnight, and we can get a pretty good estimate of how their pain is being managed off opioids. For same-day procedures, it requires evaluating the patient before discharge and reassessing the pain needs at that time.”

Helping patients and their families understand the postoperative course and what level of discomfort they can expect has helped in the effort to minimize opioid use, Dr. Lim said. Overall, patients, family, and staff have received the changes “very well,” he added.

Practices that are considering a move toward opioid-free or opioid-sparing regimens after surgery should know that “it does require buy-in from all members of the medical team as well as the patients,” Dr. Lim emphasized.

“It starts at the initial surgical consultation, with surgeons educating patients on what to expect in terms of postoperative discomfort and pain. Patients are informed that they will have some discomfort and mild pain that is generally controlled with nonopioid, over-the-counter medications and cold therapy to the surgical site,” he explained.

“It requires education of the nurses and residents to encourage moving away from using opioids as a first-line therapy,” but it’s worth the hard work to get to a point where patients are going home with few, or no, opioids, said Dr. Lim. “Ultimately, patients are happier and are often relieved that their pain can be controlled without opioids,” he said.

Dr. Shindo is the senior author of a related study examining opioid reduction in neck dissection for a variety of head and neck cancers. In that study, she and her coauthors found that opioid requirements vary by cancer type. In an upcoming manuscript, the researchers are aiming to characterize typical opioid requirements for commonly performed procedures, to provide surgeons with evidence-based baselines for appropriate, but not excessive, opioid prescribing.

Dr. Lim reported no outside sources of funding. He, Dr. Shindo, and a third author reported that they had no conflicts of interest.

koakes@mdedge.com

SOURCE: Lim J et al. ATA 2019, Poster 401.

CHICAGO – Many patients with thyroid cancer can be sent home after lateral neck dissections with few or no opioids, in the experience of an institution that made a sea change in opioid prescribing practices.

Kari Oakes/MDedge News

Between 2012 to mid-2019, Oregon Health & Science University (OHSU), Portland, saw 243 patients who received lateral neck dissections for thyroid cancer and were opioid naive. Before a shift in prescribing practices in early 2017, 5.3% of patients were discharged without opioids after lateral neck dissections for thyroid cancer, whereas after the shift, 41.7% of patients went home on an opioid-free regimen, James Y. Lim, MD, an endocrine surgeon and assistant professor at the university, said during a poster presentation at the annual meeting of the American Thyroid Association.

The initiative, led by Maisie L. Shindo, MD, was started at the OHSU Thyroid and Parathyroid Center in late 2016 in an effort to reduce the number of opioid prescriptions in postoperative patients, Dr. Lim explained in an interview after his presentation. Dr. Shindo, coauthor of the study, directs the thyroid and parathyroid surgery department at the university.

“Before the initiative, standard postoperative pain control consisted of opioids. However, it was common for patients to mention that they did not need them at all,” said Dr. Lim. “Our prescribing practices today reflect the ability to maintain patient comfort without having to resort to opioids. We are able to keep more than 90% of our patients comfortable with a multimodal approach to pain,” he said.

Dr. Lim and colleagues used a retrospective record review to tally how many opioids were initially prescribed at discharge after lateral neck dissections for thyroid cancer, along with the number and quantity of refills for opioids after discharge. Opioid doses were converted to morphine milligram equivalents (MME), and dosing patterns were compared for the periods before and after Feb. 1, 2017, when operating surgeons changed opioid prescribing patterns. These two subgroups were termed group 1 and group 2, respectively.

In all, 143 of the total 243 patients included in the study were women, and the mean age at the time of surgery was 47 years. Patients in group 1 had 170 surgeries, and those in group 2 had 103 surgeries.

Group 1 patients received a mean 295.4 MME after surgery, and group 2 patients received a mean 85.89 MME, though there was wide variation in discharge prescribing within each group. The absolute difference between the pre- and postinitiative groups was 209.51 MME (95% confidence interval, 157.8-261.2), for an effect size of 1.08. The MME figures for each group reflected both discharge medication and any refills or rescue prescriptions that were required.

“Decreasing the volume of opioids prescribed at discharge will decrease waste and reduce potential for addiction,” the authors noted.

As far as is known, “this is the first study that seeks to identify the extent of opioid needs after an extensive neck dissection for thyroid cancer operation,” said Dr. Lim, who added that he has been surprised at how well patients do after surgery. He said he and other surgeons had expected patients to have more pain from lateral neck dissections than they seem to experience.

“There have been studies, including from our own institution, that reported the relatively small need for opioids after a central neck procedure, such as a total thyroidectomy,” Dr. Lim said. “Our study showed that those requirements remain low even with more extensive lateral neck dissections. In the last 8 months of the study, more than 70% of patients with lateral neck dissections did not require opioids on discharge.”

Dr. Lim said that he and the rest of the care team advise patients to ramp up nonpharmacologic options, including ibuprofen, acetaminophen, ice packs, and throat lozenges – all of which can make a big difference in postoperative comfort.

Paying attention to how patients fare during an inpatient stay or even same-day procedures can help physicians estimate postdischarge needs, said Dr. Lim: “For our lateral neck dissections, patients usually stay overnight, and we can get a pretty good estimate of how their pain is being managed off opioids. For same-day procedures, it requires evaluating the patient before discharge and reassessing the pain needs at that time.”

Helping patients and their families understand the postoperative course and what level of discomfort they can expect has helped in the effort to minimize opioid use, Dr. Lim said. Overall, patients, family, and staff have received the changes “very well,” he added.

Practices that are considering a move toward opioid-free or opioid-sparing regimens after surgery should know that “it does require buy-in from all members of the medical team as well as the patients,” Dr. Lim emphasized.

“It starts at the initial surgical consultation, with surgeons educating patients on what to expect in terms of postoperative discomfort and pain. Patients are informed that they will have some discomfort and mild pain that is generally controlled with nonopioid, over-the-counter medications and cold therapy to the surgical site,” he explained.

“It requires education of the nurses and residents to encourage moving away from using opioids as a first-line therapy,” but it’s worth the hard work to get to a point where patients are going home with few, or no, opioids, said Dr. Lim. “Ultimately, patients are happier and are often relieved that their pain can be controlled without opioids,” he said.

Dr. Shindo is the senior author of a related study examining opioid reduction in neck dissection for a variety of head and neck cancers. In that study, she and her coauthors found that opioid requirements vary by cancer type. In an upcoming manuscript, the researchers are aiming to characterize typical opioid requirements for commonly performed procedures, to provide surgeons with evidence-based baselines for appropriate, but not excessive, opioid prescribing.

Dr. Lim reported no outside sources of funding. He, Dr. Shindo, and a third author reported that they had no conflicts of interest.

koakes@mdedge.com

SOURCE: Lim J et al. ATA 2019, Poster 401.

In their article, “Feasibility—and safety—of reducing the traditional 14 prenatal visits to 8 or 10” (July 2019), Erin Clark, MD, Yvonne Butler-Tobah, MD, and Lauren D. Demosthenes, MD, argued as to why a “one-size-fits all” approach to prenatal care should be redesigned for low-risk expectant mothers. They highlighted 3 institutions that developed a reduced-visit prenatal care model incorporating remote monitoring and mobile health app technology. Women who used the reduced visit option were overall satisfied with the technology employed and with their health care experience.

OBG Management polled readers with this question: “Do you agree that the number of prenatal care visits for low-risk women should be reduced?” 

In their article, “Feasibility—and safety—of reducing the traditional 14 prenatal visits to 8 or 10” (July 2019), Erin Clark, MD, Yvonne Butler-Tobah, MD, and Lauren D. Demosthenes, MD, argued as to why a “one-size-fits all” approach to prenatal care should be redesigned for low-risk expectant mothers. They highlighted 3 institutions that developed a reduced-visit prenatal care model incorporating remote monitoring and mobile health app technology. Women who used the reduced visit option were overall satisfied with the technology employed and with their health care experience.

OBG Management polled readers with this question: “Do you agree that the number of prenatal care visits for low-risk women should be reduced?” 

In their article, “Feasibility—and safety—of reducing the traditional 14 prenatal visits to 8 or 10” (July 2019), Erin Clark, MD, Yvonne Butler-Tobah, MD, and Lauren D. Demosthenes, MD, argued as to why a “one-size-fits all” approach to prenatal care should be redesigned for low-risk expectant mothers. They highlighted 3 institutions that developed a reduced-visit prenatal care model incorporating remote monitoring and mobile health app technology. Women who used the reduced visit option were overall satisfied with the technology employed and with their health care experience.

OBG Management polled readers with this question: “Do you agree that the number of prenatal care visits for low-risk women should be reduced?” 

FDA REMOVES ALCOHOL BAN WITH ADDYI

Sprout Pharmaceuticals announced that the US Food and Drug Administration (FDA) has removed their contraindication on alcohol use with Addyi® (flibanserin). Addyi was approved in 2015 and is an oral nonhormonal pill for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Patients are advised to discontinue drinking alcohol at least 2 hours before taking Addyi at bedtime or skip the Addyi dose that evening.

The FDA also removed the requirement, under its Risk Evaluation and Mitigation Strategy (REMS) program, for health care practitioners or pharmacies to be certified to prescribe or dispense Addyi. Sprout says that to make all labeling elements consistent with the FDA’s findings the boxed warning will change and the medication guide will be updated and included under the REMS. 

The most commonly reported adverse events among patients taking Addyi are dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth. Addyi is contraindicated in patients taking moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors and in those with hepatic impairment.

FOR MORE INFORMATION AND THE FULL PRESCRIBING INFORMATION AND MEDICATION GUIDE, VISIT: www.addyi.com

FEZOLINETANT FOR VMS

FOR MORE INFORMATION, VISIT: http://www.clinicaltrials.gov, TRIAL IDENTIFIERS NCT04003155, NCT04003142, AND NCT04003389

SOLUTIONS FOR OUTCOME TRACKING

DrChrono and OutcomeMD announce a partnership to track and analyze patient outcome data and confounding factors. DrChrono is an electronic health record (EHR) system, and OutcomeMD is a software solution that uses literature-validated patient-reported outcome instruments to score and track a patient’s symptom severity and inform treatment decisions for users.

Via a HIPAA compliant process, patients answer a list of questions that are accessed through a web link on their mobile or desktop devices. OutcomeMD summarizes the symptoms into a score that displays to both the physician and patient. Patients’ answers and scores are pushed to the clinician’s DrChrono EHR medical note. As care progresses in the OutcomeMD platform, patients remotely track how their symptoms change, and notifications alert clinicians of patients who may need attention. The integration with DrChrono also allows patient data on confounding factors to be automatically pushed from the patient’s device into the clinician’s medical note. The partnership will enable physicians to visualize patients’ status, and all the factors involved in their care, on one screen, says DrChrono and OutcomeMD, strengthening documentation and saving time for both patients and clinicians. An integration demo video is available at https://youtu.be/jnh7YPII080.

FOR MORE INFORMATION, VISIT: www.outcomemd.com

Continue to: NEW MATERNITY GOWN...

 

 

NEW MATERNITY GOWN

ImageFIRST launched a new maternity gown for expecting mothers. The Comfort Care^® Maternity Gown is a lightweight, premium polyester/nylon fabric that front snaps to allow for skin-to-skin access and optional breastfeeding. The gown also includes shoulder snaps and a full cut for extra coverage and to accommodate a variety of body types, says ImageFIRST.

ImageFIRST is a national linen rental provider. It developed the Comfort Care^® Maternity Gown with input from labor and delivery departments to best meet the needs of expecting mothers. It also says that a portion of the proceeds from each gown rental will be donated to the National Pediatric Cancer Foundation. 

FOR MORE INFORMATION, VISIT: www.imagefirst.com

FDA REMOVES ALCOHOL BAN WITH ADDYI

Sprout Pharmaceuticals announced that the US Food and Drug Administration (FDA) has removed their contraindication on alcohol use with Addyi® (flibanserin). Addyi was approved in 2015 and is an oral nonhormonal pill for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Patients are advised to discontinue drinking alcohol at least 2 hours before taking Addyi at bedtime or skip the Addyi dose that evening.

The FDA also removed the requirement, under its Risk Evaluation and Mitigation Strategy (REMS) program, for health care practitioners or pharmacies to be certified to prescribe or dispense Addyi. Sprout says that to make all labeling elements consistent with the FDA’s findings the boxed warning will change and the medication guide will be updated and included under the REMS. 

The most commonly reported adverse events among patients taking Addyi are dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth. Addyi is contraindicated in patients taking moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors and in those with hepatic impairment.

FOR MORE INFORMATION AND THE FULL PRESCRIBING INFORMATION AND MEDICATION GUIDE, VISIT: www.addyi.com

FEZOLINETANT FOR VMS

FOR MORE INFORMATION, VISIT: http://www.clinicaltrials.gov, TRIAL IDENTIFIERS NCT04003155, NCT04003142, AND NCT04003389

SOLUTIONS FOR OUTCOME TRACKING

DrChrono and OutcomeMD announce a partnership to track and analyze patient outcome data and confounding factors. DrChrono is an electronic health record (EHR) system, and OutcomeMD is a software solution that uses literature-validated patient-reported outcome instruments to score and track a patient’s symptom severity and inform treatment decisions for users.

Via a HIPAA compliant process, patients answer a list of questions that are accessed through a web link on their mobile or desktop devices. OutcomeMD summarizes the symptoms into a score that displays to both the physician and patient. Patients’ answers and scores are pushed to the clinician’s DrChrono EHR medical note. As care progresses in the OutcomeMD platform, patients remotely track how their symptoms change, and notifications alert clinicians of patients who may need attention. The integration with DrChrono also allows patient data on confounding factors to be automatically pushed from the patient’s device into the clinician’s medical note. The partnership will enable physicians to visualize patients’ status, and all the factors involved in their care, on one screen, says DrChrono and OutcomeMD, strengthening documentation and saving time for both patients and clinicians. An integration demo video is available at https://youtu.be/jnh7YPII080.

FOR MORE INFORMATION, VISIT: www.outcomemd.com

Continue to: NEW MATERNITY GOWN...

 

 

NEW MATERNITY GOWN

ImageFIRST launched a new maternity gown for expecting mothers. The Comfort Care^® Maternity Gown is a lightweight, premium polyester/nylon fabric that front snaps to allow for skin-to-skin access and optional breastfeeding. The gown also includes shoulder snaps and a full cut for extra coverage and to accommodate a variety of body types, says ImageFIRST.

ImageFIRST is a national linen rental provider. It developed the Comfort Care^® Maternity Gown with input from labor and delivery departments to best meet the needs of expecting mothers. It also says that a portion of the proceeds from each gown rental will be donated to the National Pediatric Cancer Foundation. 

FOR MORE INFORMATION, VISIT: www.imagefirst.com

FDA REMOVES ALCOHOL BAN WITH ADDYI

Sprout Pharmaceuticals announced that the US Food and Drug Administration (FDA) has removed their contraindication on alcohol use with Addyi® (flibanserin). Addyi was approved in 2015 and is an oral nonhormonal pill for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Patients are advised to discontinue drinking alcohol at least 2 hours before taking Addyi at bedtime or skip the Addyi dose that evening.

The FDA also removed the requirement, under its Risk Evaluation and Mitigation Strategy (REMS) program, for health care practitioners or pharmacies to be certified to prescribe or dispense Addyi. Sprout says that to make all labeling elements consistent with the FDA’s findings the boxed warning will change and the medication guide will be updated and included under the REMS. 

The most commonly reported adverse events among patients taking Addyi are dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth. Addyi is contraindicated in patients taking moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors and in those with hepatic impairment.

FOR MORE INFORMATION AND THE FULL PRESCRIBING INFORMATION AND MEDICATION GUIDE, VISIT: www.addyi.com

FEZOLINETANT FOR VMS

FOR MORE INFORMATION, VISIT: http://www.clinicaltrials.gov, TRIAL IDENTIFIERS NCT04003155, NCT04003142, AND NCT04003389

SOLUTIONS FOR OUTCOME TRACKING

DrChrono and OutcomeMD announce a partnership to track and analyze patient outcome data and confounding factors. DrChrono is an electronic health record (EHR) system, and OutcomeMD is a software solution that uses literature-validated patient-reported outcome instruments to score and track a patient’s symptom severity and inform treatment decisions for users.

Via a HIPAA compliant process, patients answer a list of questions that are accessed through a web link on their mobile or desktop devices. OutcomeMD summarizes the symptoms into a score that displays to both the physician and patient. Patients’ answers and scores are pushed to the clinician’s DrChrono EHR medical note. As care progresses in the OutcomeMD platform, patients remotely track how their symptoms change, and notifications alert clinicians of patients who may need attention. The integration with DrChrono also allows patient data on confounding factors to be automatically pushed from the patient’s device into the clinician’s medical note. The partnership will enable physicians to visualize patients’ status, and all the factors involved in their care, on one screen, says DrChrono and OutcomeMD, strengthening documentation and saving time for both patients and clinicians. An integration demo video is available at https://youtu.be/jnh7YPII080.

FOR MORE INFORMATION, VISIT: www.outcomemd.com

Continue to: NEW MATERNITY GOWN...

 

 

NEW MATERNITY GOWN

ImageFIRST launched a new maternity gown for expecting mothers. The Comfort Care^® Maternity Gown is a lightweight, premium polyester/nylon fabric that front snaps to allow for skin-to-skin access and optional breastfeeding. The gown also includes shoulder snaps and a full cut for extra coverage and to accommodate a variety of body types, says ImageFIRST.

ImageFIRST is a national linen rental provider. It developed the Comfort Care^® Maternity Gown with input from labor and delivery departments to best meet the needs of expecting mothers. It also says that a portion of the proceeds from each gown rental will be donated to the National Pediatric Cancer Foundation. 

FOR MORE INFORMATION, VISIT: www.imagefirst.com

Stephen M. Hahn, MD, a radiation oncologist and researcher, may soon take the reins of the Food and Drug Administration.

President Trump indicated his intent to nominate Dr. Hahn as FDA Commissioner in a brief Nov.1 statement that outlined Dr. Hahn’s background. Dr. Hahn currently serves as chief medical executive at MD Anderson Cancer Center, Houston, where he heads the radiology oncology division.

Dr. Hahn specializes in treating lung cancer and sarcoma and has authored 220 peer-reviewed original research articles, according to his biography. He was previously chair of the department of radiology oncology at the University of Pennsylvania, Philadelphia, and also served as a senior investigator at the National Cancer Institute.

Dr. Hahn completed his residency in radiation oncology at NCI and his residency in internal medicine at the University of California, San Francisco.

Margaret Foti, PhD, chief executive officer for the American Association for Cancer Research called Dr. Hahn a renowned expert in radiation oncology and research, an experienced and highly effective administrator, and an innovative leader.

“I have seen firsthand Dr. Hahn’s extraordinary dedication and commitment to cancer patients, and the AACR is extremely confident that he will be an outstanding leader for the FDA,” Dr. Foti said in a statement. “Dr. Hahn, who is board certified in both radiation and medical oncology, is esteemed for the breadth and depth of his scientific knowledge and expertise, and he has consistently advocated for a drug review process at the FDA that is both science-directed and patient-focused.”

The American Society of Clinical Oncology also congratulated Dr. Hahn on the upcoming nomination, noting that he has a strong grasp of the drug development process and understands the realities of working in a complex clinical care environment.

“The role of FDA commissioner requires a strong commitment to advancing the agency’s mission to protect public health across the United States, and an understanding of how to help speed innovations to get new treatments to patients, while also ensuring the safety and efficacy of the medical products that millions of Americans rely on to manage, treat, and cure their cancer,” the society stated. “ASCO has a long and productive history of collaborating with FDA, including with current acting Commissioner Norman E. “Ned” Sharpless, MD, in support of the agency’s important role in reducing cancer incidence, advancing treatment options, and improving the lives of individuals with cancer. We look forward to continuing our close collaboration to make it possible for every American with cancer to have access to medical products that are safe and effective.”

Dr. Sharpless will return to his position as NCI director; he served as interim FDA commissioner from the April departure of then-FDA commissioner, Scott Gottlieb, MD.

“As one of the nation’s leading oncologists who has devoted his entire professional career to helping patients in the fight against cancer, Ned is returning home to NCI to continue this work and we look forward to working closely with him once again,” Francis S. Collins, MD, director of the National Institutes of Health, said in a statement. “I want to thank Dr. Doug Lowy, principal deputy director of NCI, for having stepped in, once again, to take the helm at NCI and lead the institute so skillfully while Ned was at FDA.”

At press time, neither Dr. Hahn nor MD Anderson Cancer Center had returned messages seeking comment about his nomination.

agallegos@mdedge.com

Stephen M. Hahn, MD, a radiation oncologist and researcher, may soon take the reins of the Food and Drug Administration.

President Trump indicated his intent to nominate Dr. Hahn as FDA Commissioner in a brief Nov.1 statement that outlined Dr. Hahn’s background. Dr. Hahn currently serves as chief medical executive at MD Anderson Cancer Center, Houston, where he heads the radiology oncology division.

Dr. Hahn specializes in treating lung cancer and sarcoma and has authored 220 peer-reviewed original research articles, according to his biography. He was previously chair of the department of radiology oncology at the University of Pennsylvania, Philadelphia, and also served as a senior investigator at the National Cancer Institute.

Dr. Hahn completed his residency in radiation oncology at NCI and his residency in internal medicine at the University of California, San Francisco.

Margaret Foti, PhD, chief executive officer for the American Association for Cancer Research called Dr. Hahn a renowned expert in radiation oncology and research, an experienced and highly effective administrator, and an innovative leader.

“I have seen firsthand Dr. Hahn’s extraordinary dedication and commitment to cancer patients, and the AACR is extremely confident that he will be an outstanding leader for the FDA,” Dr. Foti said in a statement. “Dr. Hahn, who is board certified in both radiation and medical oncology, is esteemed for the breadth and depth of his scientific knowledge and expertise, and he has consistently advocated for a drug review process at the FDA that is both science-directed and patient-focused.”

The American Society of Clinical Oncology also congratulated Dr. Hahn on the upcoming nomination, noting that he has a strong grasp of the drug development process and understands the realities of working in a complex clinical care environment.

“The role of FDA commissioner requires a strong commitment to advancing the agency’s mission to protect public health across the United States, and an understanding of how to help speed innovations to get new treatments to patients, while also ensuring the safety and efficacy of the medical products that millions of Americans rely on to manage, treat, and cure their cancer,” the society stated. “ASCO has a long and productive history of collaborating with FDA, including with current acting Commissioner Norman E. “Ned” Sharpless, MD, in support of the agency’s important role in reducing cancer incidence, advancing treatment options, and improving the lives of individuals with cancer. We look forward to continuing our close collaboration to make it possible for every American with cancer to have access to medical products that are safe and effective.”

Dr. Sharpless will return to his position as NCI director; he served as interim FDA commissioner from the April departure of then-FDA commissioner, Scott Gottlieb, MD.

“As one of the nation’s leading oncologists who has devoted his entire professional career to helping patients in the fight against cancer, Ned is returning home to NCI to continue this work and we look forward to working closely with him once again,” Francis S. Collins, MD, director of the National Institutes of Health, said in a statement. “I want to thank Dr. Doug Lowy, principal deputy director of NCI, for having stepped in, once again, to take the helm at NCI and lead the institute so skillfully while Ned was at FDA.”

At press time, neither Dr. Hahn nor MD Anderson Cancer Center had returned messages seeking comment about his nomination.

agallegos@mdedge.com

Stephen M. Hahn, MD, a radiation oncologist and researcher, may soon take the reins of the Food and Drug Administration.

President Trump indicated his intent to nominate Dr. Hahn as FDA Commissioner in a brief Nov.1 statement that outlined Dr. Hahn’s background. Dr. Hahn currently serves as chief medical executive at MD Anderson Cancer Center, Houston, where he heads the radiology oncology division.

Dr. Hahn specializes in treating lung cancer and sarcoma and has authored 220 peer-reviewed original research articles, according to his biography. He was previously chair of the department of radiology oncology at the University of Pennsylvania, Philadelphia, and also served as a senior investigator at the National Cancer Institute.

Dr. Hahn completed his residency in radiation oncology at NCI and his residency in internal medicine at the University of California, San Francisco.

Margaret Foti, PhD, chief executive officer for the American Association for Cancer Research called Dr. Hahn a renowned expert in radiation oncology and research, an experienced and highly effective administrator, and an innovative leader.

“I have seen firsthand Dr. Hahn’s extraordinary dedication and commitment to cancer patients, and the AACR is extremely confident that he will be an outstanding leader for the FDA,” Dr. Foti said in a statement. “Dr. Hahn, who is board certified in both radiation and medical oncology, is esteemed for the breadth and depth of his scientific knowledge and expertise, and he has consistently advocated for a drug review process at the FDA that is both science-directed and patient-focused.”

The American Society of Clinical Oncology also congratulated Dr. Hahn on the upcoming nomination, noting that he has a strong grasp of the drug development process and understands the realities of working in a complex clinical care environment.

“The role of FDA commissioner requires a strong commitment to advancing the agency’s mission to protect public health across the United States, and an understanding of how to help speed innovations to get new treatments to patients, while also ensuring the safety and efficacy of the medical products that millions of Americans rely on to manage, treat, and cure their cancer,” the society stated. “ASCO has a long and productive history of collaborating with FDA, including with current acting Commissioner Norman E. “Ned” Sharpless, MD, in support of the agency’s important role in reducing cancer incidence, advancing treatment options, and improving the lives of individuals with cancer. We look forward to continuing our close collaboration to make it possible for every American with cancer to have access to medical products that are safe and effective.”

Dr. Sharpless will return to his position as NCI director; he served as interim FDA commissioner from the April departure of then-FDA commissioner, Scott Gottlieb, MD.

“As one of the nation’s leading oncologists who has devoted his entire professional career to helping patients in the fight against cancer, Ned is returning home to NCI to continue this work and we look forward to working closely with him once again,” Francis S. Collins, MD, director of the National Institutes of Health, said in a statement. “I want to thank Dr. Doug Lowy, principal deputy director of NCI, for having stepped in, once again, to take the helm at NCI and lead the institute so skillfully while Ned was at FDA.”

At press time, neither Dr. Hahn nor MD Anderson Cancer Center had returned messages seeking comment about his nomination.

agallegos@mdedge.com

Background: Despite the rise in utilization of PICC lines, few studies have addressed complications experienced by patients following PICC placement, especially subsequent to discharge from the inpatient setting.

Dr. Cooke is a hospitalist at Beth Israel Deaconess Medical Center.

Background: Despite the rise in utilization of PICC lines, few studies have addressed complications experienced by patients following PICC placement, especially subsequent to discharge from the inpatient setting.

Dr. Cooke is a hospitalist at Beth Israel Deaconess Medical Center.

Background: Despite the rise in utilization of PICC lines, few studies have addressed complications experienced by patients following PICC placement, especially subsequent to discharge from the inpatient setting.

Dr. Cooke is a hospitalist at Beth Israel Deaconess Medical Center.