Heidi Splete

A post hoc analysis of pregnancies among women participating in clinical trials of tildrakizumab showed no new safety signals and no reports of birth defects.

“Although contraception in female patients of childbearing age was mandatory before initiation of and during tildrakizumab therapy, some pregnancies occurred during the tildrakizumab clinical development program as protocol violations,” wrote Kathleen Haycraft, MD, of Riverside Dermatology & Spa, Hannibal, Mo., and colleagues.

Tildrakizumab (Ilumya), an interleukin-23 antagonist, was approved in 2018 by the Food and Drug Administration for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Effects on birth outcomes or on neonates exposed during pregnancy have not been studied, the researchers said.

“Tildrakizumab plasma half-life after subcutaneous administration is approximately 25 days; therefore, tildrakizumab administered even in the first trimester may cross the placental barrier,” they noted.

In a research letter published in the British Journal of Dermatology, the investigators reviewed data from nine phase 1, 2, and 3 clinical trials and identified 528 women of childbearing age who received tildrakizumab. Fourteen pregnancies were reported among these women: six from a contraceptive failure, and eight for lack of contraception use. (One of the phase 1 trials was in patients with Crohn’s disease, which included one of the pregnancies; the rest were in patients with psoriasis.)

The 14 pregnancy outcomes included 2 spontaneous abortions (14.3%), 4 elective abortions (28.6%), and 8 live births (57.1%), which included 1 premature birth, with “no identifiable congenital anomalies,” the authors wrote. The longest duration of exposure to tildrakizumab in a pregnant woman was 1,196 days; this pregnancy resulted in a premature live birth at 36 weeks with no anomalies. The spontaneous abortion rate was similar to the rate in the general population, which is 12%-15%, the authors noted.

While the study “adds to the existing evidence on the outcomes of biologic treatment of psoriasis,” the findings were limited by several factors including the small number of pregnancies, short duration of exposure to tildrakizumab, variations in dosing, and lack of controls, the researchers noted. “Additional data from a larger population following tildrakizumab exposure are required to fully evaluate the safety and tolerability of tildrakizumab treatment during pregnancy,” they said. In the meantime, they advised women of childbearing age with psoriasis to continue to avoid pregnancy and follow practice guidelines for contraceptive use while taking the biologic therapy.

The studies were supported by Merck Sharp & Dohme, a Merck & Co. subsidiary; analyses were supported by Sun Pharmaceutical Industries. Lead author Dr. Haycraft disclosed relationships with companies including Sun, Celgene, Lilly, Novartis, Ortho-Derm, and Pfizer. Other authors disclosed relationships with Novartis, Celgene, Ortho Dermatologics, Janssen, and Merck; two authors are Sun employees.

dermnews@mdedge.com

SOURCE: Haycraft K et al. Br J Dermatol. 2020 Jan 29. doi: 10.1111/bjd.18897.

A post hoc analysis of pregnancies among women participating in clinical trials of tildrakizumab showed no new safety signals and no reports of birth defects.

“Although contraception in female patients of childbearing age was mandatory before initiation of and during tildrakizumab therapy, some pregnancies occurred during the tildrakizumab clinical development program as protocol violations,” wrote Kathleen Haycraft, MD, of Riverside Dermatology & Spa, Hannibal, Mo., and colleagues.

Tildrakizumab (Ilumya), an interleukin-23 antagonist, was approved in 2018 by the Food and Drug Administration for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Effects on birth outcomes or on neonates exposed during pregnancy have not been studied, the researchers said.

“Tildrakizumab plasma half-life after subcutaneous administration is approximately 25 days; therefore, tildrakizumab administered even in the first trimester may cross the placental barrier,” they noted.

In a research letter published in the British Journal of Dermatology, the investigators reviewed data from nine phase 1, 2, and 3 clinical trials and identified 528 women of childbearing age who received tildrakizumab. Fourteen pregnancies were reported among these women: six from a contraceptive failure, and eight for lack of contraception use. (One of the phase 1 trials was in patients with Crohn’s disease, which included one of the pregnancies; the rest were in patients with psoriasis.)

The 14 pregnancy outcomes included 2 spontaneous abortions (14.3%), 4 elective abortions (28.6%), and 8 live births (57.1%), which included 1 premature birth, with “no identifiable congenital anomalies,” the authors wrote. The longest duration of exposure to tildrakizumab in a pregnant woman was 1,196 days; this pregnancy resulted in a premature live birth at 36 weeks with no anomalies. The spontaneous abortion rate was similar to the rate in the general population, which is 12%-15%, the authors noted.

While the study “adds to the existing evidence on the outcomes of biologic treatment of psoriasis,” the findings were limited by several factors including the small number of pregnancies, short duration of exposure to tildrakizumab, variations in dosing, and lack of controls, the researchers noted. “Additional data from a larger population following tildrakizumab exposure are required to fully evaluate the safety and tolerability of tildrakizumab treatment during pregnancy,” they said. In the meantime, they advised women of childbearing age with psoriasis to continue to avoid pregnancy and follow practice guidelines for contraceptive use while taking the biologic therapy.

The studies were supported by Merck Sharp & Dohme, a Merck & Co. subsidiary; analyses were supported by Sun Pharmaceutical Industries. Lead author Dr. Haycraft disclosed relationships with companies including Sun, Celgene, Lilly, Novartis, Ortho-Derm, and Pfizer. Other authors disclosed relationships with Novartis, Celgene, Ortho Dermatologics, Janssen, and Merck; two authors are Sun employees.

dermnews@mdedge.com

SOURCE: Haycraft K et al. Br J Dermatol. 2020 Jan 29. doi: 10.1111/bjd.18897.

A post hoc analysis of pregnancies among women participating in clinical trials of tildrakizumab showed no new safety signals and no reports of birth defects.

“Although contraception in female patients of childbearing age was mandatory before initiation of and during tildrakizumab therapy, some pregnancies occurred during the tildrakizumab clinical development program as protocol violations,” wrote Kathleen Haycraft, MD, of Riverside Dermatology & Spa, Hannibal, Mo., and colleagues.

Tildrakizumab (Ilumya), an interleukin-23 antagonist, was approved in 2018 by the Food and Drug Administration for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Effects on birth outcomes or on neonates exposed during pregnancy have not been studied, the researchers said.

“Tildrakizumab plasma half-life after subcutaneous administration is approximately 25 days; therefore, tildrakizumab administered even in the first trimester may cross the placental barrier,” they noted.

In a research letter published in the British Journal of Dermatology, the investigators reviewed data from nine phase 1, 2, and 3 clinical trials and identified 528 women of childbearing age who received tildrakizumab. Fourteen pregnancies were reported among these women: six from a contraceptive failure, and eight for lack of contraception use. (One of the phase 1 trials was in patients with Crohn’s disease, which included one of the pregnancies; the rest were in patients with psoriasis.)

The 14 pregnancy outcomes included 2 spontaneous abortions (14.3%), 4 elective abortions (28.6%), and 8 live births (57.1%), which included 1 premature birth, with “no identifiable congenital anomalies,” the authors wrote. The longest duration of exposure to tildrakizumab in a pregnant woman was 1,196 days; this pregnancy resulted in a premature live birth at 36 weeks with no anomalies. The spontaneous abortion rate was similar to the rate in the general population, which is 12%-15%, the authors noted.

While the study “adds to the existing evidence on the outcomes of biologic treatment of psoriasis,” the findings were limited by several factors including the small number of pregnancies, short duration of exposure to tildrakizumab, variations in dosing, and lack of controls, the researchers noted. “Additional data from a larger population following tildrakizumab exposure are required to fully evaluate the safety and tolerability of tildrakizumab treatment during pregnancy,” they said. In the meantime, they advised women of childbearing age with psoriasis to continue to avoid pregnancy and follow practice guidelines for contraceptive use while taking the biologic therapy.

The studies were supported by Merck Sharp & Dohme, a Merck & Co. subsidiary; analyses were supported by Sun Pharmaceutical Industries. Lead author Dr. Haycraft disclosed relationships with companies including Sun, Celgene, Lilly, Novartis, Ortho-Derm, and Pfizer. Other authors disclosed relationships with Novartis, Celgene, Ortho Dermatologics, Janssen, and Merck; two authors are Sun employees.

dermnews@mdedge.com

SOURCE: Haycraft K et al. Br J Dermatol. 2020 Jan 29. doi: 10.1111/bjd.18897.

Combining the measures of the Clinical Disease Activity Index and the Disease Activity Score in 28 joints provides an opportunity adjust treatment for patients with RA, based on data from a cross-sectional study of 1,585 adults.

Suze777/Thinkstock

Although the Clinical Disease Activity Index (CDAI) is considered more stringent, comparisons with the Disease Activity Score in 28 joints with erythrocyte sedimentation rate (DAS28-ESR) outside of clinical trials are limited, wrote Satoshi Takanashi, MD, of Keio University School of Medicine in Tokyo, and colleagues.

In a study published in Annals of the Rheumatic Diseases, the researchers reviewed data from 1,585 consecutive RA patients seen at Keio University Hospital in Tokyo. The average age of the patients was 64 years, 84% were women, and the average duration of disease was 12 years.

Overall, more patients met the CDAI remission criteria but not the DAS28-ESR criteria, with the exception of patients treated with an interleukin-6 inhibitor.

Of the patients in remission based on CDAI, the proportion who were not in DAS28-ESR remission was 19.4% for those treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), 18.2% for tumor necrosis factor inhibitors, 4.2% for IL-6 inhibitors, 27.6% for CTLA4-Ig fusion protein, and 33.3% for Janus kinase inhibitors.

Of the patients in DAS28-ESR remission, those not also in CDAI remission totaled 11.7% with csDMARDs, 15.4% with tumor necrosis factor inhibitors, 29.5% with IL-6 inhibitors, 16.0% with CTLA4-Ig, and 14.3% with Janus kinase inhibitors.

“The fact that many patients fulfilled the CDAI but not DAS28-ESR remission could be explained by several reasons including residual synovitis in joints that are not included in the main 28 joints, which could lead to an increase in acute phase reactants and elevate only DAS28-ESR, extra-articular involvement or other comorbidities that could elevate the C-reactive protein irrelevant to arthritis,” the researchers noted. The prevalence of complications was higher in patients in CDAI remission and DAS28-ESR nonremission independent of rheumatoid or nonrheumatoid comorbid conditions, they added.

The findings were limited by several factors, including the cross-sectional study design that did not evaluate longitudinal radiological and functional progression, the researchers wrote.

“However, patients in both CDAI and DAS28-ESR remission were apparently in better condition than those who met either criteria; therefore, in the management of rheumatoid arthritis, assessing patients with two composite measures can yield important opportunities to consider what causes the discrepancy between the measures and adjust treatment appropriately,” they concluded.

The authors did not report having a specific grant for this research. Two of the paper’s three authors disclosed relationships with multiple companies that market drugs for RA.

SOURCE: Takanashi S et al. Ann Rheum Dis. 2020 Jan 29. doi: 10.1136/annrheumdis-2019-216607.

Combining the measures of the Clinical Disease Activity Index and the Disease Activity Score in 28 joints provides an opportunity adjust treatment for patients with RA, based on data from a cross-sectional study of 1,585 adults.

Suze777/Thinkstock

Although the Clinical Disease Activity Index (CDAI) is considered more stringent, comparisons with the Disease Activity Score in 28 joints with erythrocyte sedimentation rate (DAS28-ESR) outside of clinical trials are limited, wrote Satoshi Takanashi, MD, of Keio University School of Medicine in Tokyo, and colleagues.

In a study published in Annals of the Rheumatic Diseases, the researchers reviewed data from 1,585 consecutive RA patients seen at Keio University Hospital in Tokyo. The average age of the patients was 64 years, 84% were women, and the average duration of disease was 12 years.

Overall, more patients met the CDAI remission criteria but not the DAS28-ESR criteria, with the exception of patients treated with an interleukin-6 inhibitor.

Of the patients in remission based on CDAI, the proportion who were not in DAS28-ESR remission was 19.4% for those treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), 18.2% for tumor necrosis factor inhibitors, 4.2% for IL-6 inhibitors, 27.6% for CTLA4-Ig fusion protein, and 33.3% for Janus kinase inhibitors.

Of the patients in DAS28-ESR remission, those not also in CDAI remission totaled 11.7% with csDMARDs, 15.4% with tumor necrosis factor inhibitors, 29.5% with IL-6 inhibitors, 16.0% with CTLA4-Ig, and 14.3% with Janus kinase inhibitors.

“The fact that many patients fulfilled the CDAI but not DAS28-ESR remission could be explained by several reasons including residual synovitis in joints that are not included in the main 28 joints, which could lead to an increase in acute phase reactants and elevate only DAS28-ESR, extra-articular involvement or other comorbidities that could elevate the C-reactive protein irrelevant to arthritis,” the researchers noted. The prevalence of complications was higher in patients in CDAI remission and DAS28-ESR nonremission independent of rheumatoid or nonrheumatoid comorbid conditions, they added.

The findings were limited by several factors, including the cross-sectional study design that did not evaluate longitudinal radiological and functional progression, the researchers wrote.

“However, patients in both CDAI and DAS28-ESR remission were apparently in better condition than those who met either criteria; therefore, in the management of rheumatoid arthritis, assessing patients with two composite measures can yield important opportunities to consider what causes the discrepancy between the measures and adjust treatment appropriately,” they concluded.

The authors did not report having a specific grant for this research. Two of the paper’s three authors disclosed relationships with multiple companies that market drugs for RA.

SOURCE: Takanashi S et al. Ann Rheum Dis. 2020 Jan 29. doi: 10.1136/annrheumdis-2019-216607.

Combining the measures of the Clinical Disease Activity Index and the Disease Activity Score in 28 joints provides an opportunity adjust treatment for patients with RA, based on data from a cross-sectional study of 1,585 adults.

Suze777/Thinkstock

Although the Clinical Disease Activity Index (CDAI) is considered more stringent, comparisons with the Disease Activity Score in 28 joints with erythrocyte sedimentation rate (DAS28-ESR) outside of clinical trials are limited, wrote Satoshi Takanashi, MD, of Keio University School of Medicine in Tokyo, and colleagues.

In a study published in Annals of the Rheumatic Diseases, the researchers reviewed data from 1,585 consecutive RA patients seen at Keio University Hospital in Tokyo. The average age of the patients was 64 years, 84% were women, and the average duration of disease was 12 years.

Overall, more patients met the CDAI remission criteria but not the DAS28-ESR criteria, with the exception of patients treated with an interleukin-6 inhibitor.

Of the patients in remission based on CDAI, the proportion who were not in DAS28-ESR remission was 19.4% for those treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), 18.2% for tumor necrosis factor inhibitors, 4.2% for IL-6 inhibitors, 27.6% for CTLA4-Ig fusion protein, and 33.3% for Janus kinase inhibitors.

Of the patients in DAS28-ESR remission, those not also in CDAI remission totaled 11.7% with csDMARDs, 15.4% with tumor necrosis factor inhibitors, 29.5% with IL-6 inhibitors, 16.0% with CTLA4-Ig, and 14.3% with Janus kinase inhibitors.

“The fact that many patients fulfilled the CDAI but not DAS28-ESR remission could be explained by several reasons including residual synovitis in joints that are not included in the main 28 joints, which could lead to an increase in acute phase reactants and elevate only DAS28-ESR, extra-articular involvement or other comorbidities that could elevate the C-reactive protein irrelevant to arthritis,” the researchers noted. The prevalence of complications was higher in patients in CDAI remission and DAS28-ESR nonremission independent of rheumatoid or nonrheumatoid comorbid conditions, they added.

The findings were limited by several factors, including the cross-sectional study design that did not evaluate longitudinal radiological and functional progression, the researchers wrote.

“However, patients in both CDAI and DAS28-ESR remission were apparently in better condition than those who met either criteria; therefore, in the management of rheumatoid arthritis, assessing patients with two composite measures can yield important opportunities to consider what causes the discrepancy between the measures and adjust treatment appropriately,” they concluded.

The authors did not report having a specific grant for this research. Two of the paper’s three authors disclosed relationships with multiple companies that market drugs for RA.

SOURCE: Takanashi S et al. Ann Rheum Dis. 2020 Jan 29. doi: 10.1136/annrheumdis-2019-216607.

Endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) had the highest diagnostic yield of lung lesions, compared with other bronchoscopic approaches, according to a multisite study of current and former smokers with suspected lung cancer.

Bronchoscopy has long played a role in the identification of lung lesions, but the yield varies according to many factors associated with the lesion and the type of bronchoscopy, and recent studies suggest that the yield may be lower than previously thought, wrote Gerard A. Silvestri, MD, of Medical University of South Carolina, Charleston, and colleagues.

In a study published in Chest, the researchers sought to assess the yield of bronchoscopy based on procedure and characteristics, as well as the physician-calculated pretest probability of cancer.

They conducted a secondary analysis of 687 patients from the AEGIS trial, a prospective 28-site study of current and former smokers who underwent bronchoscopy for suspected lung cancer. Patients under 21, those without a history of smoking, and those with a concurrent cancer or history of lung cancer were excluded. The average age of the participants was 63 years, and two-thirds were male. Of these, 474 had diagnostic bronchoscopies and 213 had nondiagnostic bronchoscopies.

The overall diagnostic yield was 69%. However, the diagnostic yield significantly higher (80%) with the use of EBUS-TBNA, compared with 55% for standard bronchoscopy with biopsy +/– fluoroscopy, 57% for electromagnetic navigation, and 74% for combination procedures.

Patients with diagnostic bronchoscopies were significantly more likely than were those who had nondiagnostic bronchoscopies to have lesions greater than 3 cm (67% vs. 45%), to have central locations (75% vs. 50%), and to have lymphadenopathy (57% vs. 55%).

In addition, yields were significantly higher (77%) for patients whose preprocedure physician-assessed probability of cancer was at least 60%, compared with yields in those whose preprocedure physician-assessed probability of cancer was less than 10% or 10%-60% (44% and 42%, respectively).

The study findings were limited by several factors including the high prevalence of cancer in the study population, a 1-year follow-up that may have missed slow-growing cancers, and lack of data on the presence or absence of a bronchus sign, the researchers noted. However, the results were strengthened by the large size, mixture of sites, and use of multiple technologies and presentations, they said.

The study is the largest to assess diagnostic yields and various bronchoscopy techniques and supports EBUS-TBNA as the most reliable, but patient selection and improved procedural training can help improve diagnostic yields, the researchers emphasized.

“While the overall yield of bronchoscopy is reasonable, EBUS-TBNA is the only technique that reliably provides a diagnosis in those suspected of having lung cancer, likely because the biopsy is targeting a central lymph node and there is direct visualization of the needle passing into the target,” they said. However,“better bronchoscopic technology is needed and there are devices in the development pipeline that promise improved diagnostic yield, though these products will require evaluation through prospective comparative effectiveness trials prior to widespread adoption,” they noted. Clinicians should be prepared to pursue alternatives to bronchoscopy if a diagnosis is unlikely, they concluded.

Dr. Silvestri disclosed research grant awards to his university from Olympus America, Auris robotics, Veracyte, and Veran Medical, as well as consulting fees from Olympus and Auris robotics.

SOURCE: Silvestri GA et al. CHEST. 2020 Jan 21. doi: 10.1016/j.chest.2019.12.024.

Endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) had the highest diagnostic yield of lung lesions, compared with other bronchoscopic approaches, according to a multisite study of current and former smokers with suspected lung cancer.

Bronchoscopy has long played a role in the identification of lung lesions, but the yield varies according to many factors associated with the lesion and the type of bronchoscopy, and recent studies suggest that the yield may be lower than previously thought, wrote Gerard A. Silvestri, MD, of Medical University of South Carolina, Charleston, and colleagues.

In a study published in Chest, the researchers sought to assess the yield of bronchoscopy based on procedure and characteristics, as well as the physician-calculated pretest probability of cancer.

They conducted a secondary analysis of 687 patients from the AEGIS trial, a prospective 28-site study of current and former smokers who underwent bronchoscopy for suspected lung cancer. Patients under 21, those without a history of smoking, and those with a concurrent cancer or history of lung cancer were excluded. The average age of the participants was 63 years, and two-thirds were male. Of these, 474 had diagnostic bronchoscopies and 213 had nondiagnostic bronchoscopies.

The overall diagnostic yield was 69%. However, the diagnostic yield significantly higher (80%) with the use of EBUS-TBNA, compared with 55% for standard bronchoscopy with biopsy +/– fluoroscopy, 57% for electromagnetic navigation, and 74% for combination procedures.

Patients with diagnostic bronchoscopies were significantly more likely than were those who had nondiagnostic bronchoscopies to have lesions greater than 3 cm (67% vs. 45%), to have central locations (75% vs. 50%), and to have lymphadenopathy (57% vs. 55%).

In addition, yields were significantly higher (77%) for patients whose preprocedure physician-assessed probability of cancer was at least 60%, compared with yields in those whose preprocedure physician-assessed probability of cancer was less than 10% or 10%-60% (44% and 42%, respectively).

The study findings were limited by several factors including the high prevalence of cancer in the study population, a 1-year follow-up that may have missed slow-growing cancers, and lack of data on the presence or absence of a bronchus sign, the researchers noted. However, the results were strengthened by the large size, mixture of sites, and use of multiple technologies and presentations, they said.

The study is the largest to assess diagnostic yields and various bronchoscopy techniques and supports EBUS-TBNA as the most reliable, but patient selection and improved procedural training can help improve diagnostic yields, the researchers emphasized.

“While the overall yield of bronchoscopy is reasonable, EBUS-TBNA is the only technique that reliably provides a diagnosis in those suspected of having lung cancer, likely because the biopsy is targeting a central lymph node and there is direct visualization of the needle passing into the target,” they said. However,“better bronchoscopic technology is needed and there are devices in the development pipeline that promise improved diagnostic yield, though these products will require evaluation through prospective comparative effectiveness trials prior to widespread adoption,” they noted. Clinicians should be prepared to pursue alternatives to bronchoscopy if a diagnosis is unlikely, they concluded.

Dr. Silvestri disclosed research grant awards to his university from Olympus America, Auris robotics, Veracyte, and Veran Medical, as well as consulting fees from Olympus and Auris robotics.

SOURCE: Silvestri GA et al. CHEST. 2020 Jan 21. doi: 10.1016/j.chest.2019.12.024.

Endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) had the highest diagnostic yield of lung lesions, compared with other bronchoscopic approaches, according to a multisite study of current and former smokers with suspected lung cancer.

Bronchoscopy has long played a role in the identification of lung lesions, but the yield varies according to many factors associated with the lesion and the type of bronchoscopy, and recent studies suggest that the yield may be lower than previously thought, wrote Gerard A. Silvestri, MD, of Medical University of South Carolina, Charleston, and colleagues.

In a study published in Chest, the researchers sought to assess the yield of bronchoscopy based on procedure and characteristics, as well as the physician-calculated pretest probability of cancer.

They conducted a secondary analysis of 687 patients from the AEGIS trial, a prospective 28-site study of current and former smokers who underwent bronchoscopy for suspected lung cancer. Patients under 21, those without a history of smoking, and those with a concurrent cancer or history of lung cancer were excluded. The average age of the participants was 63 years, and two-thirds were male. Of these, 474 had diagnostic bronchoscopies and 213 had nondiagnostic bronchoscopies.

The overall diagnostic yield was 69%. However, the diagnostic yield significantly higher (80%) with the use of EBUS-TBNA, compared with 55% for standard bronchoscopy with biopsy +/– fluoroscopy, 57% for electromagnetic navigation, and 74% for combination procedures.

Patients with diagnostic bronchoscopies were significantly more likely than were those who had nondiagnostic bronchoscopies to have lesions greater than 3 cm (67% vs. 45%), to have central locations (75% vs. 50%), and to have lymphadenopathy (57% vs. 55%).

In addition, yields were significantly higher (77%) for patients whose preprocedure physician-assessed probability of cancer was at least 60%, compared with yields in those whose preprocedure physician-assessed probability of cancer was less than 10% or 10%-60% (44% and 42%, respectively).

The study findings were limited by several factors including the high prevalence of cancer in the study population, a 1-year follow-up that may have missed slow-growing cancers, and lack of data on the presence or absence of a bronchus sign, the researchers noted. However, the results were strengthened by the large size, mixture of sites, and use of multiple technologies and presentations, they said.

The study is the largest to assess diagnostic yields and various bronchoscopy techniques and supports EBUS-TBNA as the most reliable, but patient selection and improved procedural training can help improve diagnostic yields, the researchers emphasized.

“While the overall yield of bronchoscopy is reasonable, EBUS-TBNA is the only technique that reliably provides a diagnosis in those suspected of having lung cancer, likely because the biopsy is targeting a central lymph node and there is direct visualization of the needle passing into the target,” they said. However,“better bronchoscopic technology is needed and there are devices in the development pipeline that promise improved diagnostic yield, though these products will require evaluation through prospective comparative effectiveness trials prior to widespread adoption,” they noted. Clinicians should be prepared to pursue alternatives to bronchoscopy if a diagnosis is unlikely, they concluded.

Dr. Silvestri disclosed research grant awards to his university from Olympus America, Auris robotics, Veracyte, and Veran Medical, as well as consulting fees from Olympus and Auris robotics.

SOURCE: Silvestri GA et al. CHEST. 2020 Jan 21. doi: 10.1016/j.chest.2019.12.024.

Incidence of colorectal cancer spiked among adults in the United States between the ages of 49 and 50 years, the age when many have routine screening colonoscopies, based on data from a cross-sectional study of 165,160 patients.

“We would expect to see some degree of CRC incidence increase from 49 to 50 years of age owing to screening uptake and diagnosis of preexisting CRCs that may have been clinically undetected,” wrote Wesal H. Abualkhair, MD, of Tulane University, New Orleans, and colleagues.

In a study published in JAMA Network Open, the researchers reviewed data from the Surveillance, Epidemiology, and End Results (SEER) registries from 2000 to 2015 on colorectal cancer incidence in 1-year intervals for adults aged 30-60 years, focusing on the year between ages 49 and 50.

Overall, the incidence of colorectal cancer increased by 46.1% from 49 to 50 years of age, and 93% of these cases were invasive.

The increase in cancer rates occurred across geographical regions, sex, and race, and likely reflects the impact of screening rather than advancing age, the researchers said.

They also found a significant increase in 5-year relative survival (6.9% absolute increase, 10% relative increase) for the transition between 49 and 50 years of age; no other age transitions showed a significant change.

The findings were limited by several factors, including the lack of specific outcomes data and inability to determine the number of years that the cancers existed before diagnosis, the researchers said. However, the results were strengthened by the large study population and detailed yearly assessment.

“Our analysis of the transition from 49 to 50 years provides new, registry-based data regarding risk among individuals younger than 50 years, which can add to preexisting modeling studies to help inform decision-making on the age at which to initiate screening,” the researchers said.

The study did not receive outside funding. Lead author Dr. Abualkhair had no financial conflicts to disclose.

SOURCE: Abualkhair WH et al. JAMA Network Open. 2020 Jan 31. doi: 10.1001/jamanetworkopen.2019.20407.

Incidence of colorectal cancer spiked among adults in the United States between the ages of 49 and 50 years, the age when many have routine screening colonoscopies, based on data from a cross-sectional study of 165,160 patients.

“We would expect to see some degree of CRC incidence increase from 49 to 50 years of age owing to screening uptake and diagnosis of preexisting CRCs that may have been clinically undetected,” wrote Wesal H. Abualkhair, MD, of Tulane University, New Orleans, and colleagues.

In a study published in JAMA Network Open, the researchers reviewed data from the Surveillance, Epidemiology, and End Results (SEER) registries from 2000 to 2015 on colorectal cancer incidence in 1-year intervals for adults aged 30-60 years, focusing on the year between ages 49 and 50.

Overall, the incidence of colorectal cancer increased by 46.1% from 49 to 50 years of age, and 93% of these cases were invasive.

The increase in cancer rates occurred across geographical regions, sex, and race, and likely reflects the impact of screening rather than advancing age, the researchers said.

They also found a significant increase in 5-year relative survival (6.9% absolute increase, 10% relative increase) for the transition between 49 and 50 years of age; no other age transitions showed a significant change.

The findings were limited by several factors, including the lack of specific outcomes data and inability to determine the number of years that the cancers existed before diagnosis, the researchers said. However, the results were strengthened by the large study population and detailed yearly assessment.

“Our analysis of the transition from 49 to 50 years provides new, registry-based data regarding risk among individuals younger than 50 years, which can add to preexisting modeling studies to help inform decision-making on the age at which to initiate screening,” the researchers said.

The study did not receive outside funding. Lead author Dr. Abualkhair had no financial conflicts to disclose.

SOURCE: Abualkhair WH et al. JAMA Network Open. 2020 Jan 31. doi: 10.1001/jamanetworkopen.2019.20407.

Incidence of colorectal cancer spiked among adults in the United States between the ages of 49 and 50 years, the age when many have routine screening colonoscopies, based on data from a cross-sectional study of 165,160 patients.

“We would expect to see some degree of CRC incidence increase from 49 to 50 years of age owing to screening uptake and diagnosis of preexisting CRCs that may have been clinically undetected,” wrote Wesal H. Abualkhair, MD, of Tulane University, New Orleans, and colleagues.

In a study published in JAMA Network Open, the researchers reviewed data from the Surveillance, Epidemiology, and End Results (SEER) registries from 2000 to 2015 on colorectal cancer incidence in 1-year intervals for adults aged 30-60 years, focusing on the year between ages 49 and 50.

Overall, the incidence of colorectal cancer increased by 46.1% from 49 to 50 years of age, and 93% of these cases were invasive.

The increase in cancer rates occurred across geographical regions, sex, and race, and likely reflects the impact of screening rather than advancing age, the researchers said.

They also found a significant increase in 5-year relative survival (6.9% absolute increase, 10% relative increase) for the transition between 49 and 50 years of age; no other age transitions showed a significant change.

The findings were limited by several factors, including the lack of specific outcomes data and inability to determine the number of years that the cancers existed before diagnosis, the researchers said. However, the results were strengthened by the large study population and detailed yearly assessment.

“Our analysis of the transition from 49 to 50 years provides new, registry-based data regarding risk among individuals younger than 50 years, which can add to preexisting modeling studies to help inform decision-making on the age at which to initiate screening,” the researchers said.

The study did not receive outside funding. Lead author Dr. Abualkhair had no financial conflicts to disclose.

SOURCE: Abualkhair WH et al. JAMA Network Open. 2020 Jan 31. doi: 10.1001/jamanetworkopen.2019.20407.

Assessing appendicitis in children with initial ultrasound followed by computed tomography in the absence of appendix visualization and presence of secondary signs was the most cost-effective approach, according to data from a modeling study of 10 strategies.

Ultrasound is safer and less expensive than computed tomography and avoids radiation exposure; however, cost-effectiveness models of various approaches to imaging have not been well studied, wrote Rebecca Jennings, MD, of Seattle Children’s Hospital, Washington, and colleagues.

In a study published in Pediatrics, the researchers simulated a hypothetical patient population using a Markov cohort model and compared 10 different strategies including CT only, MRI only, and ultrasound followed by CT or MRI after ultrasounds that are negative or fail to visualize the appendix.

Overall, the most cost-effective strategy for moderate-risk patients was the use of ultrasound followed by CT or MRI if the ultrasound failed to visualize the appendix and secondary signs of inflammation were present in the right lower quadrant. The cost of this strategy was $4,815, with effectiveness of 0.99694 quality-adjusted life-years. “The most cost-effective strategy is highly dependent on a patient’s risk stratification,” the researchers noted. Based on their model, imaging was not cost effective for patients with a prevalence less than 16% or greater than 95%. However, those with appendicitis risk between 16% and 95% and no secondary signs of inflammation can forgo further imaging, even without visualization of the appendix for maximum cost-effectiveness, the researchers said.

The study was limited by several factors, including the inability to account for all potential costs related to imaging and outcomes, lack of accounting for the use of sedation when assessing costs, and inability to separate imaging costs from total hospital costs, the researchers noted. However, the results suggest that tailored imaging approaches based on patient risk are the most cost-effective strategies to assess appendicitis, they said.

“The diagnosis and exclusion of appendicitis continues to be one of the primary concerns of providers who care for children with abdominal pain,” wrote Rebecca M. Rentea, MD, and Charles L. Snyder, MD, of Children’s Mercy Hospital Kansas City, Mo., in an accompanying editorial (Pediatrics. 2020 Feb;145:e20193349).

“The best diagnostic and imaging approach to appendicitis has been a topic of interest for some time, and improvements such as appendicitis scoring systems, decreased use of ionized radiation, and adoption of clinical algorithms have been incremental but steady,” they said. Despite the potential of missed appendicitis, the use of an algorithm based on an initial ultrasound and previous possibility of appendicitis described in the study was the most cost effective, they said. In addition, “the ability to visualize the appendix did not alter the most cost-effective approach in those with a moderate risk of appendicitis (most patients),” they concluded.

The study was supported by the University of Washington and Seattle Children’s Hospital Quality Improvement Scholars Program. The researchers had no financial conflicts to disclose.

Dr. Rentea and Dr. Snyder had no financial conflicts to disclose.

SOURCE: Jennings R et al. Pediatrics. 2020. doi: 10.1542/peds.2019-1352.

Assessing appendicitis in children with initial ultrasound followed by computed tomography in the absence of appendix visualization and presence of secondary signs was the most cost-effective approach, according to data from a modeling study of 10 strategies.

Ultrasound is safer and less expensive than computed tomography and avoids radiation exposure; however, cost-effectiveness models of various approaches to imaging have not been well studied, wrote Rebecca Jennings, MD, of Seattle Children’s Hospital, Washington, and colleagues.

In a study published in Pediatrics, the researchers simulated a hypothetical patient population using a Markov cohort model and compared 10 different strategies including CT only, MRI only, and ultrasound followed by CT or MRI after ultrasounds that are negative or fail to visualize the appendix.

Overall, the most cost-effective strategy for moderate-risk patients was the use of ultrasound followed by CT or MRI if the ultrasound failed to visualize the appendix and secondary signs of inflammation were present in the right lower quadrant. The cost of this strategy was $4,815, with effectiveness of 0.99694 quality-adjusted life-years. “The most cost-effective strategy is highly dependent on a patient’s risk stratification,” the researchers noted. Based on their model, imaging was not cost effective for patients with a prevalence less than 16% or greater than 95%. However, those with appendicitis risk between 16% and 95% and no secondary signs of inflammation can forgo further imaging, even without visualization of the appendix for maximum cost-effectiveness, the researchers said.

The study was limited by several factors, including the inability to account for all potential costs related to imaging and outcomes, lack of accounting for the use of sedation when assessing costs, and inability to separate imaging costs from total hospital costs, the researchers noted. However, the results suggest that tailored imaging approaches based on patient risk are the most cost-effective strategies to assess appendicitis, they said.

“The diagnosis and exclusion of appendicitis continues to be one of the primary concerns of providers who care for children with abdominal pain,” wrote Rebecca M. Rentea, MD, and Charles L. Snyder, MD, of Children’s Mercy Hospital Kansas City, Mo., in an accompanying editorial (Pediatrics. 2020 Feb;145:e20193349).

“The best diagnostic and imaging approach to appendicitis has been a topic of interest for some time, and improvements such as appendicitis scoring systems, decreased use of ionized radiation, and adoption of clinical algorithms have been incremental but steady,” they said. Despite the potential of missed appendicitis, the use of an algorithm based on an initial ultrasound and previous possibility of appendicitis described in the study was the most cost effective, they said. In addition, “the ability to visualize the appendix did not alter the most cost-effective approach in those with a moderate risk of appendicitis (most patients),” they concluded.

The study was supported by the University of Washington and Seattle Children’s Hospital Quality Improvement Scholars Program. The researchers had no financial conflicts to disclose.

Dr. Rentea and Dr. Snyder had no financial conflicts to disclose.

SOURCE: Jennings R et al. Pediatrics. 2020. doi: 10.1542/peds.2019-1352.

Assessing appendicitis in children with initial ultrasound followed by computed tomography in the absence of appendix visualization and presence of secondary signs was the most cost-effective approach, according to data from a modeling study of 10 strategies.

Ultrasound is safer and less expensive than computed tomography and avoids radiation exposure; however, cost-effectiveness models of various approaches to imaging have not been well studied, wrote Rebecca Jennings, MD, of Seattle Children’s Hospital, Washington, and colleagues.

In a study published in Pediatrics, the researchers simulated a hypothetical patient population using a Markov cohort model and compared 10 different strategies including CT only, MRI only, and ultrasound followed by CT or MRI after ultrasounds that are negative or fail to visualize the appendix.

Overall, the most cost-effective strategy for moderate-risk patients was the use of ultrasound followed by CT or MRI if the ultrasound failed to visualize the appendix and secondary signs of inflammation were present in the right lower quadrant. The cost of this strategy was $4,815, with effectiveness of 0.99694 quality-adjusted life-years. “The most cost-effective strategy is highly dependent on a patient’s risk stratification,” the researchers noted. Based on their model, imaging was not cost effective for patients with a prevalence less than 16% or greater than 95%. However, those with appendicitis risk between 16% and 95% and no secondary signs of inflammation can forgo further imaging, even without visualization of the appendix for maximum cost-effectiveness, the researchers said.

The study was limited by several factors, including the inability to account for all potential costs related to imaging and outcomes, lack of accounting for the use of sedation when assessing costs, and inability to separate imaging costs from total hospital costs, the researchers noted. However, the results suggest that tailored imaging approaches based on patient risk are the most cost-effective strategies to assess appendicitis, they said.

“The diagnosis and exclusion of appendicitis continues to be one of the primary concerns of providers who care for children with abdominal pain,” wrote Rebecca M. Rentea, MD, and Charles L. Snyder, MD, of Children’s Mercy Hospital Kansas City, Mo., in an accompanying editorial (Pediatrics. 2020 Feb;145:e20193349).

“The best diagnostic and imaging approach to appendicitis has been a topic of interest for some time, and improvements such as appendicitis scoring systems, decreased use of ionized radiation, and adoption of clinical algorithms have been incremental but steady,” they said. Despite the potential of missed appendicitis, the use of an algorithm based on an initial ultrasound and previous possibility of appendicitis described in the study was the most cost effective, they said. In addition, “the ability to visualize the appendix did not alter the most cost-effective approach in those with a moderate risk of appendicitis (most patients),” they concluded.

The study was supported by the University of Washington and Seattle Children’s Hospital Quality Improvement Scholars Program. The researchers had no financial conflicts to disclose.

Dr. Rentea and Dr. Snyder had no financial conflicts to disclose.

SOURCE: Jennings R et al. Pediatrics. 2020. doi: 10.1542/peds.2019-1352.

Most patients with epidermolysis bullosa who use topical products choose antimicrobials, according to data from a survey of 202 children and adults.

Management of epidermolysis bullosa (EB) involves a combination of skin protection and infection management, but patient home care practices have not been well studied, wrote Leila Shayegan of Columbia University, New York, and colleagues.

In a study published in Pediatric Dermatology, the researchers surveyed 202 patients who were enrolled in the Epidermolysis Bullosa Clinical Characterization and Outcomes Database during 2017. The patients ranged in age from 1 month to 62 years with an average age of 11 years; 52% were female. The patients represented a range of EB subtypes, including 130 patients with dystrophic EB, 51 patients with EB simplex, 21 with junctional EB, and 3 patients each with Kindler syndrome and unspecified subtypes.

Overall, most of the patients reported cleaning their skin either every day (37%) or every other day (32%). Of the 188 patients who reported using topical products on their wounds, 131 (70%) said they used at least one antimicrobial product, while 125 patients (66%) reported using at least one emollient; 32 (17%) used emollients only, and 21(11%) reported no use of topical products.

The most popular topical antibiotics were mupirocin (31%) and bacitracin (31%). In addition, 14% of respondents used silver-containing products, and 16% used medical-grade honey. Roughly half (51%) of patients who reported use of at least one antimicrobial product used two or more different antimicrobial products.

A total of 38% of patients used only water for cleansing. Of the 131 patients who reported using additives in their cleansing water, 57% added salt, 54% added bleach, 27% added vinegar, and 26% reported “other” additive use, which could include Epsom salt, baking soda, oatmeal, or essential oils, the researchers said. The concentrations of these additives ranged from barely effective 0.002% sodium hypochlorite and 0.002% acetic acid solutions to potentially cytotoxic solutions of 0.09% sodium hypochlorite and 0.156% acetic acid.

“Although the survey was not designed to correlate skin care practices with wound culture results and resistance patterns, widespread use of topical antimicrobials described among EB patients highlights the need for increased emphasis on antibiotic stewardship,” the researchers noted. They added that health care providers should educate patients and families not only about mindful use of antibiotics, but also appropriate concentrations of cleansing additives.

“Optimizing EB patient home skin care routines, along with future longitudinal studies on the impact of EB skin care interventions on microbial resistance patterns, wound healing and [squamous cell carcinoma] risk are necessary to improve outcomes for patients with EB,” they emphasized.

The Epidermolysis Bullosa Clinical Characterization and Outcomes Database used in the study is funded by the Epidermolysis Bullosa Research Partnership and the Epidermolysis Bullosa Medical Research Foundation. Ms. Shayegan had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple companies including Abeona Therapeutics, Castle Creek Pharmaceuticals, Fibrocell Science, ProQR, and Scioderm.

SOURCE: Shayegan L et al. Pediatr Dermatol. 2020. doi: 10.1111/pde.14102.

Most patients with epidermolysis bullosa who use topical products choose antimicrobials, according to data from a survey of 202 children and adults.

Management of epidermolysis bullosa (EB) involves a combination of skin protection and infection management, but patient home care practices have not been well studied, wrote Leila Shayegan of Columbia University, New York, and colleagues.

In a study published in Pediatric Dermatology, the researchers surveyed 202 patients who were enrolled in the Epidermolysis Bullosa Clinical Characterization and Outcomes Database during 2017. The patients ranged in age from 1 month to 62 years with an average age of 11 years; 52% were female. The patients represented a range of EB subtypes, including 130 patients with dystrophic EB, 51 patients with EB simplex, 21 with junctional EB, and 3 patients each with Kindler syndrome and unspecified subtypes.

Overall, most of the patients reported cleaning their skin either every day (37%) or every other day (32%). Of the 188 patients who reported using topical products on their wounds, 131 (70%) said they used at least one antimicrobial product, while 125 patients (66%) reported using at least one emollient; 32 (17%) used emollients only, and 21(11%) reported no use of topical products.

The most popular topical antibiotics were mupirocin (31%) and bacitracin (31%). In addition, 14% of respondents used silver-containing products, and 16% used medical-grade honey. Roughly half (51%) of patients who reported use of at least one antimicrobial product used two or more different antimicrobial products.

A total of 38% of patients used only water for cleansing. Of the 131 patients who reported using additives in their cleansing water, 57% added salt, 54% added bleach, 27% added vinegar, and 26% reported “other” additive use, which could include Epsom salt, baking soda, oatmeal, or essential oils, the researchers said. The concentrations of these additives ranged from barely effective 0.002% sodium hypochlorite and 0.002% acetic acid solutions to potentially cytotoxic solutions of 0.09% sodium hypochlorite and 0.156% acetic acid.

“Although the survey was not designed to correlate skin care practices with wound culture results and resistance patterns, widespread use of topical antimicrobials described among EB patients highlights the need for increased emphasis on antibiotic stewardship,” the researchers noted. They added that health care providers should educate patients and families not only about mindful use of antibiotics, but also appropriate concentrations of cleansing additives.

“Optimizing EB patient home skin care routines, along with future longitudinal studies on the impact of EB skin care interventions on microbial resistance patterns, wound healing and [squamous cell carcinoma] risk are necessary to improve outcomes for patients with EB,” they emphasized.

The Epidermolysis Bullosa Clinical Characterization and Outcomes Database used in the study is funded by the Epidermolysis Bullosa Research Partnership and the Epidermolysis Bullosa Medical Research Foundation. Ms. Shayegan had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple companies including Abeona Therapeutics, Castle Creek Pharmaceuticals, Fibrocell Science, ProQR, and Scioderm.

SOURCE: Shayegan L et al. Pediatr Dermatol. 2020. doi: 10.1111/pde.14102.

Most patients with epidermolysis bullosa who use topical products choose antimicrobials, according to data from a survey of 202 children and adults.

Management of epidermolysis bullosa (EB) involves a combination of skin protection and infection management, but patient home care practices have not been well studied, wrote Leila Shayegan of Columbia University, New York, and colleagues.

In a study published in Pediatric Dermatology, the researchers surveyed 202 patients who were enrolled in the Epidermolysis Bullosa Clinical Characterization and Outcomes Database during 2017. The patients ranged in age from 1 month to 62 years with an average age of 11 years; 52% were female. The patients represented a range of EB subtypes, including 130 patients with dystrophic EB, 51 patients with EB simplex, 21 with junctional EB, and 3 patients each with Kindler syndrome and unspecified subtypes.

Overall, most of the patients reported cleaning their skin either every day (37%) or every other day (32%). Of the 188 patients who reported using topical products on their wounds, 131 (70%) said they used at least one antimicrobial product, while 125 patients (66%) reported using at least one emollient; 32 (17%) used emollients only, and 21(11%) reported no use of topical products.

The most popular topical antibiotics were mupirocin (31%) and bacitracin (31%). In addition, 14% of respondents used silver-containing products, and 16% used medical-grade honey. Roughly half (51%) of patients who reported use of at least one antimicrobial product used two or more different antimicrobial products.

A total of 38% of patients used only water for cleansing. Of the 131 patients who reported using additives in their cleansing water, 57% added salt, 54% added bleach, 27% added vinegar, and 26% reported “other” additive use, which could include Epsom salt, baking soda, oatmeal, or essential oils, the researchers said. The concentrations of these additives ranged from barely effective 0.002% sodium hypochlorite and 0.002% acetic acid solutions to potentially cytotoxic solutions of 0.09% sodium hypochlorite and 0.156% acetic acid.

“Although the survey was not designed to correlate skin care practices with wound culture results and resistance patterns, widespread use of topical antimicrobials described among EB patients highlights the need for increased emphasis on antibiotic stewardship,” the researchers noted. They added that health care providers should educate patients and families not only about mindful use of antibiotics, but also appropriate concentrations of cleansing additives.

“Optimizing EB patient home skin care routines, along with future longitudinal studies on the impact of EB skin care interventions on microbial resistance patterns, wound healing and [squamous cell carcinoma] risk are necessary to improve outcomes for patients with EB,” they emphasized.

The Epidermolysis Bullosa Clinical Characterization and Outcomes Database used in the study is funded by the Epidermolysis Bullosa Research Partnership and the Epidermolysis Bullosa Medical Research Foundation. Ms. Shayegan had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple companies including Abeona Therapeutics, Castle Creek Pharmaceuticals, Fibrocell Science, ProQR, and Scioderm.

SOURCE: Shayegan L et al. Pediatr Dermatol. 2020. doi: 10.1111/pde.14102.

Women with osteoporosis who received a single infusion of zoledronate after discontinuing denosumab (Prolia) maintained bone mineral density at both the lumbar spine and the total hip, based on data from 120 individuals.

Although denosumab is often prescribed for postmenopausal osteoporosis, its effects disappear when treatment ends, wrote Judith Everts-Graber, MD, of OsteoRheuma Bern (Switzerland), and colleagues. In addition, recent reports of increased fractures in osteoporotic women after denosumab discontinuation highlight the need for subsequent therapy, but no protocol has been established.

In a study published in the Journal of Bone and Mineral Research, the investigators reviewed data from women aged older than 48 years with postmenopausal osteoporosis who were treated with denosumab between Aug. 1, 2010, and March 31, 2019. The women received four or more injections of 60 mg denosumab administered at 6-month intervals, followed by a single infusion of 5 mg zoledronate 6 months after the final denosumab injection. Patients were evaluated using dual-energy x-ray absorptiometry and vertebral fracture assessment every 2 years after starting denosumab; the average duration of treatment was 3 years.

At an average of 2.5 years after discontinuing denosumab, women who received zoledronate retained 66% of bone mineral density (BMD) gains at the lumbar spine, 49% at the total hip, and 57% at the femoral neck. In addition, three patients developed symptomatic single vertebral fractures and four patients developed peripheral fractures between 1 and 3 years after their last denosumab injections, but none of these patients sustained multiple fractures.

All bone loss occurred within 18 months of denosumab discontinuation, and no significant differences appeared between patients with gains in BMD greater than or less than 9%.

The study findings were limited by several factors, including the retrospective design and the lack of a control group, the researchers noted. However, they collected data from 11 of 28 patients who did not follow the treatment recommendations and did not receive zoledronate after discontinuing denosumab. “As expected, BMD of the lumbar spine and total hip decreased to baseline,” they wrote. In addition, 2 of the 11 patients experienced multiple vertebral fractures.

A single 5-mg infusion of zoledronate “may be a promising step in identifying sequential long-term treatment strategies for osteoporosis,” the researchers concluded. “Nevertheless, each patient requires an individualized surveillance and treatment plan after denosumab discontinuation, including BMD assessment, evaluation of bone turnover markers and consideration of individual clinical risk factors, in particular prevalent fragility fractures.”

The study was funded by OsteoRheuma Bern. The researchers reported having no financial conflicts.

SOURCE: Everts-Graber J et al. J Bone Miner Res. 2020 Jan 28. doi: 10.1002/jbmr.3962.

Women with osteoporosis who received a single infusion of zoledronate after discontinuing denosumab (Prolia) maintained bone mineral density at both the lumbar spine and the total hip, based on data from 120 individuals.

Although denosumab is often prescribed for postmenopausal osteoporosis, its effects disappear when treatment ends, wrote Judith Everts-Graber, MD, of OsteoRheuma Bern (Switzerland), and colleagues. In addition, recent reports of increased fractures in osteoporotic women after denosumab discontinuation highlight the need for subsequent therapy, but no protocol has been established.

In a study published in the Journal of Bone and Mineral Research, the investigators reviewed data from women aged older than 48 years with postmenopausal osteoporosis who were treated with denosumab between Aug. 1, 2010, and March 31, 2019. The women received four or more injections of 60 mg denosumab administered at 6-month intervals, followed by a single infusion of 5 mg zoledronate 6 months after the final denosumab injection. Patients were evaluated using dual-energy x-ray absorptiometry and vertebral fracture assessment every 2 years after starting denosumab; the average duration of treatment was 3 years.

At an average of 2.5 years after discontinuing denosumab, women who received zoledronate retained 66% of bone mineral density (BMD) gains at the lumbar spine, 49% at the total hip, and 57% at the femoral neck. In addition, three patients developed symptomatic single vertebral fractures and four patients developed peripheral fractures between 1 and 3 years after their last denosumab injections, but none of these patients sustained multiple fractures.

All bone loss occurred within 18 months of denosumab discontinuation, and no significant differences appeared between patients with gains in BMD greater than or less than 9%.

The study findings were limited by several factors, including the retrospective design and the lack of a control group, the researchers noted. However, they collected data from 11 of 28 patients who did not follow the treatment recommendations and did not receive zoledronate after discontinuing denosumab. “As expected, BMD of the lumbar spine and total hip decreased to baseline,” they wrote. In addition, 2 of the 11 patients experienced multiple vertebral fractures.

A single 5-mg infusion of zoledronate “may be a promising step in identifying sequential long-term treatment strategies for osteoporosis,” the researchers concluded. “Nevertheless, each patient requires an individualized surveillance and treatment plan after denosumab discontinuation, including BMD assessment, evaluation of bone turnover markers and consideration of individual clinical risk factors, in particular prevalent fragility fractures.”

The study was funded by OsteoRheuma Bern. The researchers reported having no financial conflicts.

SOURCE: Everts-Graber J et al. J Bone Miner Res. 2020 Jan 28. doi: 10.1002/jbmr.3962.

Women with osteoporosis who received a single infusion of zoledronate after discontinuing denosumab (Prolia) maintained bone mineral density at both the lumbar spine and the total hip, based on data from 120 individuals.

Although denosumab is often prescribed for postmenopausal osteoporosis, its effects disappear when treatment ends, wrote Judith Everts-Graber, MD, of OsteoRheuma Bern (Switzerland), and colleagues. In addition, recent reports of increased fractures in osteoporotic women after denosumab discontinuation highlight the need for subsequent therapy, but no protocol has been established.

In a study published in the Journal of Bone and Mineral Research, the investigators reviewed data from women aged older than 48 years with postmenopausal osteoporosis who were treated with denosumab between Aug. 1, 2010, and March 31, 2019. The women received four or more injections of 60 mg denosumab administered at 6-month intervals, followed by a single infusion of 5 mg zoledronate 6 months after the final denosumab injection. Patients were evaluated using dual-energy x-ray absorptiometry and vertebral fracture assessment every 2 years after starting denosumab; the average duration of treatment was 3 years.

At an average of 2.5 years after discontinuing denosumab, women who received zoledronate retained 66% of bone mineral density (BMD) gains at the lumbar spine, 49% at the total hip, and 57% at the femoral neck. In addition, three patients developed symptomatic single vertebral fractures and four patients developed peripheral fractures between 1 and 3 years after their last denosumab injections, but none of these patients sustained multiple fractures.

All bone loss occurred within 18 months of denosumab discontinuation, and no significant differences appeared between patients with gains in BMD greater than or less than 9%.

The study findings were limited by several factors, including the retrospective design and the lack of a control group, the researchers noted. However, they collected data from 11 of 28 patients who did not follow the treatment recommendations and did not receive zoledronate after discontinuing denosumab. “As expected, BMD of the lumbar spine and total hip decreased to baseline,” they wrote. In addition, 2 of the 11 patients experienced multiple vertebral fractures.

A single 5-mg infusion of zoledronate “may be a promising step in identifying sequential long-term treatment strategies for osteoporosis,” the researchers concluded. “Nevertheless, each patient requires an individualized surveillance and treatment plan after denosumab discontinuation, including BMD assessment, evaluation of bone turnover markers and consideration of individual clinical risk factors, in particular prevalent fragility fractures.”

The study was funded by OsteoRheuma Bern. The researchers reported having no financial conflicts.

SOURCE: Everts-Graber J et al. J Bone Miner Res. 2020 Jan 28. doi: 10.1002/jbmr.3962.

Picosecond and Q-switched (QS) lasers are safe and effective for removing tattoos from the oral mucosa, according to results of two recent cases, researchers reported.

Mucocutaneous tattoos are relatively rare, and lasers have been used for their removal, but cases and results have not been well documented, wrote Hao Feng, MD, then of the Laser & Skin Surgery Center of New York, and the department of dermatology, New York University, and coauthors.

In a report published in Lasers in Surgery and Medicine, the clinicians noted significant improvement with no scarring or dyspigmentation at 1 month after the last treatment session in two patients, with mucosal tattoos that had not been previously treated.

In one case, a healthy 19-year-old woman with Fitzpatrick skin type II presented for removal of a 6‐month‐old, black tattoo on the mucosal surface of her lower lip. She received six treatment sessions at months 0, 1, 3, 5, 7, and 12 with a QS 694‐nm ruby laser at settings of 6-mm spot size, 20-nanosecond pulse duration, and 3.0-3.5 J/cm².

In a second case, a 30‐year‐old man with Fitzpatrick skin type IV presented for removal of a 10‐year‐old black tattoo on his left buccal mucosa. He received one treatment with 755-nm alexandrite picosecond lasers at settings of 2.5-mm spot size, 500-picosecond pulse duration, and 3.36 J/cm².

Both patients experienced local mild discomfort, erythema, and edema after treatment.

“Older tattoos respond better and quicker on the skin to laser treatments, and it is likely the reason why the buccal mucosa tattoo (10 years) resolved with a single treatment whereas the lower lip tattoo (6 months) required six treatments,” the authors noted.

Mucosal tattoos, they added, “tend to respond better, faster, and with less unwanted side effects than tattoos on the skin. This may relate to the fact that mucosal skin is thinner, non-keratinized, well‐vascularized, and contains less melanin content.”

As to which laser is the best choice for removing mucosal tattoos, the authors noted that it is unclear, but while they said they have been using picosecond lasers for tattoo removals, QS lasers “remain excellent treatment modalities,” they wrote.

“Given the excellent clinical response combined with lack of scarring and dyspigmentation in our highly satisfied patients, it is the authors’ opinion that laser treatment should be considered as the first‐line treatment in removing unwanted cosmetic mucosal tattoos. This can be accomplished with various wavelengths in the picosecond and nanosecond domains,” they concluded.

Dr. Feng, who is now director of laser surgery and cosmetic dermatology at the University of Connecticut Health Center, Farmington, disclosed serving as a consultant and medical monitor for Cytrellis Biosystems. Another author disclosed serving on the advisory boards for Cytrellis, Syneron Candela, and Cynosure; owning stocks or having stock options with Cytrellis; and investing in Syneron Candela, Cynosure, and Cytrellis. The remaining two authors had no disclosures.

SOURCE: Feng H et al. Lasers Surg Med. 2019 Dec 30. doi: 10.1002/lsm.23207.

Picosecond and Q-switched (QS) lasers are safe and effective for removing tattoos from the oral mucosa, according to results of two recent cases, researchers reported.

Mucocutaneous tattoos are relatively rare, and lasers have been used for their removal, but cases and results have not been well documented, wrote Hao Feng, MD, then of the Laser & Skin Surgery Center of New York, and the department of dermatology, New York University, and coauthors.

In a report published in Lasers in Surgery and Medicine, the clinicians noted significant improvement with no scarring or dyspigmentation at 1 month after the last treatment session in two patients, with mucosal tattoos that had not been previously treated.

In one case, a healthy 19-year-old woman with Fitzpatrick skin type II presented for removal of a 6‐month‐old, black tattoo on the mucosal surface of her lower lip. She received six treatment sessions at months 0, 1, 3, 5, 7, and 12 with a QS 694‐nm ruby laser at settings of 6-mm spot size, 20-nanosecond pulse duration, and 3.0-3.5 J/cm².

In a second case, a 30‐year‐old man with Fitzpatrick skin type IV presented for removal of a 10‐year‐old black tattoo on his left buccal mucosa. He received one treatment with 755-nm alexandrite picosecond lasers at settings of 2.5-mm spot size, 500-picosecond pulse duration, and 3.36 J/cm².

Both patients experienced local mild discomfort, erythema, and edema after treatment.

“Older tattoos respond better and quicker on the skin to laser treatments, and it is likely the reason why the buccal mucosa tattoo (10 years) resolved with a single treatment whereas the lower lip tattoo (6 months) required six treatments,” the authors noted.

Mucosal tattoos, they added, “tend to respond better, faster, and with less unwanted side effects than tattoos on the skin. This may relate to the fact that mucosal skin is thinner, non-keratinized, well‐vascularized, and contains less melanin content.”

As to which laser is the best choice for removing mucosal tattoos, the authors noted that it is unclear, but while they said they have been using picosecond lasers for tattoo removals, QS lasers “remain excellent treatment modalities,” they wrote.

“Given the excellent clinical response combined with lack of scarring and dyspigmentation in our highly satisfied patients, it is the authors’ opinion that laser treatment should be considered as the first‐line treatment in removing unwanted cosmetic mucosal tattoos. This can be accomplished with various wavelengths in the picosecond and nanosecond domains,” they concluded.

Dr. Feng, who is now director of laser surgery and cosmetic dermatology at the University of Connecticut Health Center, Farmington, disclosed serving as a consultant and medical monitor for Cytrellis Biosystems. Another author disclosed serving on the advisory boards for Cytrellis, Syneron Candela, and Cynosure; owning stocks or having stock options with Cytrellis; and investing in Syneron Candela, Cynosure, and Cytrellis. The remaining two authors had no disclosures.

SOURCE: Feng H et al. Lasers Surg Med. 2019 Dec 30. doi: 10.1002/lsm.23207.

Picosecond and Q-switched (QS) lasers are safe and effective for removing tattoos from the oral mucosa, according to results of two recent cases, researchers reported.

Mucocutaneous tattoos are relatively rare, and lasers have been used for their removal, but cases and results have not been well documented, wrote Hao Feng, MD, then of the Laser & Skin Surgery Center of New York, and the department of dermatology, New York University, and coauthors.

In a report published in Lasers in Surgery and Medicine, the clinicians noted significant improvement with no scarring or dyspigmentation at 1 month after the last treatment session in two patients, with mucosal tattoos that had not been previously treated.

In one case, a healthy 19-year-old woman with Fitzpatrick skin type II presented for removal of a 6‐month‐old, black tattoo on the mucosal surface of her lower lip. She received six treatment sessions at months 0, 1, 3, 5, 7, and 12 with a QS 694‐nm ruby laser at settings of 6-mm spot size, 20-nanosecond pulse duration, and 3.0-3.5 J/cm².

In a second case, a 30‐year‐old man with Fitzpatrick skin type IV presented for removal of a 10‐year‐old black tattoo on his left buccal mucosa. He received one treatment with 755-nm alexandrite picosecond lasers at settings of 2.5-mm spot size, 500-picosecond pulse duration, and 3.36 J/cm².

Both patients experienced local mild discomfort, erythema, and edema after treatment.

“Older tattoos respond better and quicker on the skin to laser treatments, and it is likely the reason why the buccal mucosa tattoo (10 years) resolved with a single treatment whereas the lower lip tattoo (6 months) required six treatments,” the authors noted.

Mucosal tattoos, they added, “tend to respond better, faster, and with less unwanted side effects than tattoos on the skin. This may relate to the fact that mucosal skin is thinner, non-keratinized, well‐vascularized, and contains less melanin content.”

As to which laser is the best choice for removing mucosal tattoos, the authors noted that it is unclear, but while they said they have been using picosecond lasers for tattoo removals, QS lasers “remain excellent treatment modalities,” they wrote.

“Given the excellent clinical response combined with lack of scarring and dyspigmentation in our highly satisfied patients, it is the authors’ opinion that laser treatment should be considered as the first‐line treatment in removing unwanted cosmetic mucosal tattoos. This can be accomplished with various wavelengths in the picosecond and nanosecond domains,” they concluded.

Dr. Feng, who is now director of laser surgery and cosmetic dermatology at the University of Connecticut Health Center, Farmington, disclosed serving as a consultant and medical monitor for Cytrellis Biosystems. Another author disclosed serving on the advisory boards for Cytrellis, Syneron Candela, and Cynosure; owning stocks or having stock options with Cytrellis; and investing in Syneron Candela, Cynosure, and Cytrellis. The remaining two authors had no disclosures.

SOURCE: Feng H et al. Lasers Surg Med. 2019 Dec 30. doi: 10.1002/lsm.23207.

Use of fractional flow reserve significantly improved 1-year mortality rates in adults with stable ischemic heart disease, according to a review of 17,989 patients.

Although fractional flow reserve (FFR) has demonstrated value in guiding coronary revascularization, its impact on outcomes in patients with stable ischemic heart disease has not been well studied in a large population, wrote Rushi V. Parikh, MD, of the University of California, Los Angeles, and colleagues.

In a study published in the Journal of the American College of Cardiology, the researchers analyzed data from the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program for adults who underwent coronary angiography between January 2009 and September 2017. The study included patients with angiographically intermediate disease, defined as 40%-69% diameter stenosis on visual inspection.

The rate of FFR use increased from 14.8% to 18.5% during the study period for all patients with intermediate lesions, and from 44% to 75% for those who had percutaneous coronary intervention, the researchers wrote.

Overall, based on hazard models, 1-year mortality was significantly lower in patients who underwent FFR, compared with those who had angiography only (2.8% vs. 5.9%; P less than 0.001). In addition, FFR use in revascularization was associated with a 43% reduced 1-year mortality risk, compared with angiography only.

The findings were limited by several factors, including the observational nature of the study, inability to distinguish between cardiovascular and noncardiovascular mortality, lack of data on the technical performance of the FFR, and a relatively short follow-up period, the researchers noted.

However, the results were strengthened by the large sample size, and support the use of FFR-guided revascularization in patients with angiographically intermediate stenosis, they wrote.

“Future registry-based studies accounting for all physiologic modalities are warranted to accurately quantify the landscape of coronary physiology-guided revascularization,” they added.

The study was supported in part by the Rocky Mountain Regional VA Medical Center in Aurora, Colo. Lead author Dr. Parikh had no financial conflicts to disclose.

SOURCE: Parikh RV et al. J Am Coll Cardiol. 2020 Feb 4;75:409-19.

Use of fractional flow reserve significantly improved 1-year mortality rates in adults with stable ischemic heart disease, according to a review of 17,989 patients.

Although fractional flow reserve (FFR) has demonstrated value in guiding coronary revascularization, its impact on outcomes in patients with stable ischemic heart disease has not been well studied in a large population, wrote Rushi V. Parikh, MD, of the University of California, Los Angeles, and colleagues.

In a study published in the Journal of the American College of Cardiology, the researchers analyzed data from the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program for adults who underwent coronary angiography between January 2009 and September 2017. The study included patients with angiographically intermediate disease, defined as 40%-69% diameter stenosis on visual inspection.

The rate of FFR use increased from 14.8% to 18.5% during the study period for all patients with intermediate lesions, and from 44% to 75% for those who had percutaneous coronary intervention, the researchers wrote.

Overall, based on hazard models, 1-year mortality was significantly lower in patients who underwent FFR, compared with those who had angiography only (2.8% vs. 5.9%; P less than 0.001). In addition, FFR use in revascularization was associated with a 43% reduced 1-year mortality risk, compared with angiography only.

The findings were limited by several factors, including the observational nature of the study, inability to distinguish between cardiovascular and noncardiovascular mortality, lack of data on the technical performance of the FFR, and a relatively short follow-up period, the researchers noted.

However, the results were strengthened by the large sample size, and support the use of FFR-guided revascularization in patients with angiographically intermediate stenosis, they wrote.

“Future registry-based studies accounting for all physiologic modalities are warranted to accurately quantify the landscape of coronary physiology-guided revascularization,” they added.

The study was supported in part by the Rocky Mountain Regional VA Medical Center in Aurora, Colo. Lead author Dr. Parikh had no financial conflicts to disclose.

SOURCE: Parikh RV et al. J Am Coll Cardiol. 2020 Feb 4;75:409-19.

Use of fractional flow reserve significantly improved 1-year mortality rates in adults with stable ischemic heart disease, according to a review of 17,989 patients.

Although fractional flow reserve (FFR) has demonstrated value in guiding coronary revascularization, its impact on outcomes in patients with stable ischemic heart disease has not been well studied in a large population, wrote Rushi V. Parikh, MD, of the University of California, Los Angeles, and colleagues.

In a study published in the Journal of the American College of Cardiology, the researchers analyzed data from the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program for adults who underwent coronary angiography between January 2009 and September 2017. The study included patients with angiographically intermediate disease, defined as 40%-69% diameter stenosis on visual inspection.

The rate of FFR use increased from 14.8% to 18.5% during the study period for all patients with intermediate lesions, and from 44% to 75% for those who had percutaneous coronary intervention, the researchers wrote.

Overall, based on hazard models, 1-year mortality was significantly lower in patients who underwent FFR, compared with those who had angiography only (2.8% vs. 5.9%; P less than 0.001). In addition, FFR use in revascularization was associated with a 43% reduced 1-year mortality risk, compared with angiography only.

The findings were limited by several factors, including the observational nature of the study, inability to distinguish between cardiovascular and noncardiovascular mortality, lack of data on the technical performance of the FFR, and a relatively short follow-up period, the researchers noted.

However, the results were strengthened by the large sample size, and support the use of FFR-guided revascularization in patients with angiographically intermediate stenosis, they wrote.

“Future registry-based studies accounting for all physiologic modalities are warranted to accurately quantify the landscape of coronary physiology-guided revascularization,” they added.

The study was supported in part by the Rocky Mountain Regional VA Medical Center in Aurora, Colo. Lead author Dr. Parikh had no financial conflicts to disclose.

SOURCE: Parikh RV et al. J Am Coll Cardiol. 2020 Feb 4;75:409-19.

Clinicians can improve communications with parents during neonatal end-of-life situations by adopting key behaviors such as sitting down to talk to parents and using the infant’s name, according to data from a simulation study.

“Empirical evidence regarding communication with parents during and after a child’s critical instability or death is scarce,” wrote Marie-Hélène Lizotte, MD, of Centre Hospitalier Universitaire Sainte-Justine, Montréal, and colleagues. Noting that realistic simulation has been shown to help clinicians improve their communication skills, the investigators recruited clinicians to participate in a simulated unsuccessful neonatal resuscitation to identify behaviors associated with optimal parent communication.

Behaviors associated with high scores for clinicians deemed “good communicators” included introducing themselves to parents, using the infant’s name (if known), sitting down to speak to parents, not leaving the infant alone on the bed after death, and allowing time for silence, the researchers reported in Pediatrics.

The investigators presented the video simulations to evaluators, including clinicians and bereaved parents. In the simulation, a term infant was born after an emergency cesarean delivery for fetal distress and died after an unsuccessful attempt at resuscitation. A manikin infant was programmed to remain pulseless, and two actors played the roles of the parents in the video.

Evaluators scored the videos for overall performance and for communication with the parent actors during and after the resuscitation.

Overall, parent evaluators and parent actors agreed with clinicians on what actions exemplified optimal communication in about 81% of evaluations. Discrepancies were mainly related to the language participants used related to death, as some parent evaluators said they had trouble understanding certain sentences or found them insensitive, such as “her heart never came back” and “allowing natural death.”

A total of 31 participants were recruited for the simulation, including 15 pediatric residents, 5 neonatal fellows, 3 neonatologists, 3 neonatal nurse practitioners, and 5 transport and resuscitation team providers. Videos of the simulations were examined by 21 evaluators, including bereaved parents, the parent actors, a neonatologist, a maternal-fetal medicine specialist, a psychologist, and a respiratory therapist. There were 651 evaluations.

The study findings were limited by several factors including the use of a single center, use of videos for evaluations, and the use of a single infant-resuscitation scenario, the researchers noted. The results were strengthened, however, by the large number of evaluations, and they support the core behaviors as “a skeleton on which to build additional skills with practice and training” with attention to cultural differences in their application, such as recognizing that infants are not named until after birth in some cultures, they said.

The existing literature on strategies for providing empathy and support to parents facing the death of a child is limited, but this simulation study provides a design model to help address this issue, Chris Feudtner, MD, of the Children’s Hospital of Philadelphia wrote in an accompanying editorial. “Overall, this study, in terms of design and methodologic rigor, is a great advance toward answering our key question: how to best support parents in such circumstances,” he said.

Dr. Feudtner said that he would divide the clinician behaviors into two groups. The first, “Calm kind politeness,” includes acknowledging the parents, introducing themselves, using the infant’s name, and remaining calm. The second set of behaviors, which he called “Skillful situational leadership,” includes preparing parents for the resuscitation activities and providing verbal milestones that prepared them for the fatal outcome.

“Picking up on a metaphor offered by the authors of the study, training and repetitive drills on these specific behaviors cannot be emphasized enough because they are not only the skeleton of excellent communication; they are likely also the muscles, the heart, and even the soul,” he concluded.

The study was supported by a grant from the Fonds de Recherche en Santé du Québec and the Medical Education Grant from Centre Hospitalier Universitaire Sainte-Justine. The researchers and Dr. Feudtner reported no financial conflicts.

SOURCE: Lizotte M-H et al. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-1925; Feudtner C. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-3116.
 

Clinicians can improve communications with parents during neonatal end-of-life situations by adopting key behaviors such as sitting down to talk to parents and using the infant’s name, according to data from a simulation study.

“Empirical evidence regarding communication with parents during and after a child’s critical instability or death is scarce,” wrote Marie-Hélène Lizotte, MD, of Centre Hospitalier Universitaire Sainte-Justine, Montréal, and colleagues. Noting that realistic simulation has been shown to help clinicians improve their communication skills, the investigators recruited clinicians to participate in a simulated unsuccessful neonatal resuscitation to identify behaviors associated with optimal parent communication.

Behaviors associated with high scores for clinicians deemed “good communicators” included introducing themselves to parents, using the infant’s name (if known), sitting down to speak to parents, not leaving the infant alone on the bed after death, and allowing time for silence, the researchers reported in Pediatrics.

The investigators presented the video simulations to evaluators, including clinicians and bereaved parents. In the simulation, a term infant was born after an emergency cesarean delivery for fetal distress and died after an unsuccessful attempt at resuscitation. A manikin infant was programmed to remain pulseless, and two actors played the roles of the parents in the video.

Evaluators scored the videos for overall performance and for communication with the parent actors during and after the resuscitation.

Overall, parent evaluators and parent actors agreed with clinicians on what actions exemplified optimal communication in about 81% of evaluations. Discrepancies were mainly related to the language participants used related to death, as some parent evaluators said they had trouble understanding certain sentences or found them insensitive, such as “her heart never came back” and “allowing natural death.”

A total of 31 participants were recruited for the simulation, including 15 pediatric residents, 5 neonatal fellows, 3 neonatologists, 3 neonatal nurse practitioners, and 5 transport and resuscitation team providers. Videos of the simulations were examined by 21 evaluators, including bereaved parents, the parent actors, a neonatologist, a maternal-fetal medicine specialist, a psychologist, and a respiratory therapist. There were 651 evaluations.

The study findings were limited by several factors including the use of a single center, use of videos for evaluations, and the use of a single infant-resuscitation scenario, the researchers noted. The results were strengthened, however, by the large number of evaluations, and they support the core behaviors as “a skeleton on which to build additional skills with practice and training” with attention to cultural differences in their application, such as recognizing that infants are not named until after birth in some cultures, they said.

The existing literature on strategies for providing empathy and support to parents facing the death of a child is limited, but this simulation study provides a design model to help address this issue, Chris Feudtner, MD, of the Children’s Hospital of Philadelphia wrote in an accompanying editorial. “Overall, this study, in terms of design and methodologic rigor, is a great advance toward answering our key question: how to best support parents in such circumstances,” he said.

Dr. Feudtner said that he would divide the clinician behaviors into two groups. The first, “Calm kind politeness,” includes acknowledging the parents, introducing themselves, using the infant’s name, and remaining calm. The second set of behaviors, which he called “Skillful situational leadership,” includes preparing parents for the resuscitation activities and providing verbal milestones that prepared them for the fatal outcome.

“Picking up on a metaphor offered by the authors of the study, training and repetitive drills on these specific behaviors cannot be emphasized enough because they are not only the skeleton of excellent communication; they are likely also the muscles, the heart, and even the soul,” he concluded.

The study was supported by a grant from the Fonds de Recherche en Santé du Québec and the Medical Education Grant from Centre Hospitalier Universitaire Sainte-Justine. The researchers and Dr. Feudtner reported no financial conflicts.

SOURCE: Lizotte M-H et al. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-1925; Feudtner C. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-3116.
 

Clinicians can improve communications with parents during neonatal end-of-life situations by adopting key behaviors such as sitting down to talk to parents and using the infant’s name, according to data from a simulation study.

“Empirical evidence regarding communication with parents during and after a child’s critical instability or death is scarce,” wrote Marie-Hélène Lizotte, MD, of Centre Hospitalier Universitaire Sainte-Justine, Montréal, and colleagues. Noting that realistic simulation has been shown to help clinicians improve their communication skills, the investigators recruited clinicians to participate in a simulated unsuccessful neonatal resuscitation to identify behaviors associated with optimal parent communication.

Behaviors associated with high scores for clinicians deemed “good communicators” included introducing themselves to parents, using the infant’s name (if known), sitting down to speak to parents, not leaving the infant alone on the bed after death, and allowing time for silence, the researchers reported in Pediatrics.

The investigators presented the video simulations to evaluators, including clinicians and bereaved parents. In the simulation, a term infant was born after an emergency cesarean delivery for fetal distress and died after an unsuccessful attempt at resuscitation. A manikin infant was programmed to remain pulseless, and two actors played the roles of the parents in the video.

Evaluators scored the videos for overall performance and for communication with the parent actors during and after the resuscitation.

Overall, parent evaluators and parent actors agreed with clinicians on what actions exemplified optimal communication in about 81% of evaluations. Discrepancies were mainly related to the language participants used related to death, as some parent evaluators said they had trouble understanding certain sentences or found them insensitive, such as “her heart never came back” and “allowing natural death.”

A total of 31 participants were recruited for the simulation, including 15 pediatric residents, 5 neonatal fellows, 3 neonatologists, 3 neonatal nurse practitioners, and 5 transport and resuscitation team providers. Videos of the simulations were examined by 21 evaluators, including bereaved parents, the parent actors, a neonatologist, a maternal-fetal medicine specialist, a psychologist, and a respiratory therapist. There were 651 evaluations.

The study findings were limited by several factors including the use of a single center, use of videos for evaluations, and the use of a single infant-resuscitation scenario, the researchers noted. The results were strengthened, however, by the large number of evaluations, and they support the core behaviors as “a skeleton on which to build additional skills with practice and training” with attention to cultural differences in their application, such as recognizing that infants are not named until after birth in some cultures, they said.

The existing literature on strategies for providing empathy and support to parents facing the death of a child is limited, but this simulation study provides a design model to help address this issue, Chris Feudtner, MD, of the Children’s Hospital of Philadelphia wrote in an accompanying editorial. “Overall, this study, in terms of design and methodologic rigor, is a great advance toward answering our key question: how to best support parents in such circumstances,” he said.

Dr. Feudtner said that he would divide the clinician behaviors into two groups. The first, “Calm kind politeness,” includes acknowledging the parents, introducing themselves, using the infant’s name, and remaining calm. The second set of behaviors, which he called “Skillful situational leadership,” includes preparing parents for the resuscitation activities and providing verbal milestones that prepared them for the fatal outcome.

“Picking up on a metaphor offered by the authors of the study, training and repetitive drills on these specific behaviors cannot be emphasized enough because they are not only the skeleton of excellent communication; they are likely also the muscles, the heart, and even the soul,” he concluded.

The study was supported by a grant from the Fonds de Recherche en Santé du Québec and the Medical Education Grant from Centre Hospitalier Universitaire Sainte-Justine. The researchers and Dr. Feudtner reported no financial conflicts.

SOURCE: Lizotte M-H et al. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-1925; Feudtner C. Pediatrics. 2020 Jan 27. doi: 10.1542/peds.2019-3116.