According to the American Cancer Society, about 22,530 women will receive a new diagnosis of ovarian cancer this year. In this video series, Drs. Mark Einstein, Jenna Marcus, and Stuart Lichtman discuss new therapeutics, surgical innovations, and treatment options for primary and advanced/recurrent ovarian cancer.

Click here to visit the site.

This video roundtable was produced by the Custom Programs division. The faculty received modest honoraria from Custom Programs for participating in this roundtable.

The faculty was solely responsible for the content presented.

Disclosures

Dr. Einstein discloses that he has participated in educational speaking activties for Altum Pharma, Cynvec, Papivax, PDS Biotechnologies, and Photocure. He also was the overall or local primary investigator for clinical trials for AstraZeneca, Becton-Dickinson, Inovio, Johnson & Johnson, Pfizer, and PDS Biotechnologies.

Dr. Marcus has no conflicts to disclose.

Dr. Lichtman has no conflicts to disclose.

According to the American Cancer Society, about 22,530 women will receive a new diagnosis of ovarian cancer this year. In this video series, Drs. Mark Einstein, Jenna Marcus, and Stuart Lichtman discuss new therapeutics, surgical innovations, and treatment options for primary and advanced/recurrent ovarian cancer.

Click here to visit the site.

This video roundtable was produced by the Custom Programs division. The faculty received modest honoraria from Custom Programs for participating in this roundtable.

The faculty was solely responsible for the content presented.

Disclosures

Dr. Einstein discloses that he has participated in educational speaking activties for Altum Pharma, Cynvec, Papivax, PDS Biotechnologies, and Photocure. He also was the overall or local primary investigator for clinical trials for AstraZeneca, Becton-Dickinson, Inovio, Johnson & Johnson, Pfizer, and PDS Biotechnologies.

Dr. Marcus has no conflicts to disclose.

Dr. Lichtman has no conflicts to disclose.

According to the American Cancer Society, about 22,530 women will receive a new diagnosis of ovarian cancer this year. In this video series, Drs. Mark Einstein, Jenna Marcus, and Stuart Lichtman discuss new therapeutics, surgical innovations, and treatment options for primary and advanced/recurrent ovarian cancer.

Click here to visit the site.

This video roundtable was produced by the Custom Programs division. The faculty received modest honoraria from Custom Programs for participating in this roundtable.

The faculty was solely responsible for the content presented.

Disclosures

Dr. Einstein discloses that he has participated in educational speaking activties for Altum Pharma, Cynvec, Papivax, PDS Biotechnologies, and Photocure. He also was the overall or local primary investigator for clinical trials for AstraZeneca, Becton-Dickinson, Inovio, Johnson & Johnson, Pfizer, and PDS Biotechnologies.

Dr. Marcus has no conflicts to disclose.

Dr. Lichtman has no conflicts to disclose.

This week in cardiology news, revised atrial fibrillation guidelines revamp anticoagulation, the SPRINT MIND results showing that tight BP control staves off mild cognitive impairment are published, the FDA discovers that nitrosamine-contaminated ARBs have been on the market for years, and subclinical hypothyroidism boosts the immediate risk of heart failure.

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This week in cardiology news, revised atrial fibrillation guidelines revamp anticoagulation, the SPRINT MIND results showing that tight BP control staves off mild cognitive impairment are published, the FDA discovers that nitrosamine-contaminated ARBs have been on the market for years, and subclinical hypothyroidism boosts the immediate risk of heart failure.

Amazon Alexa
Apple Podcasts
Google Podcasts
TuneIn






 

This week in cardiology news, revised atrial fibrillation guidelines revamp anticoagulation, the SPRINT MIND results showing that tight BP control staves off mild cognitive impairment are published, the FDA discovers that nitrosamine-contaminated ARBs have been on the market for years, and subclinical hypothyroidism boosts the immediate risk of heart failure.

Amazon Alexa
Apple Podcasts
Google Podcasts
TuneIn






 

SAN DIEGO – Minimal residual disease (MRD) response at the end of induction correlates with outcomes in previously untreated follicular lymphoma patients who receive obinutuzumab- or rituximab-based immunochemotherapy, according to updated results from the phase 3 GALLIUM study.

After 57 months of follow-up, and regardless of treatment arm, 564 MRD-evaluable patients who were MRD negative at the end of induction had significantly greater probability of progression-free survival (PFS) than did 70 patients who were MRD positive at the end of induction (about 80% vs. 50%; hazard ratio, 0.38), Christiane Pott, MD, reported at the annual meeting of the American Society of Hematology.

GALLIUM participants were adults with follicular lymphoma requiring treatment. They were randomized to receive standard chemotherapy in combination with 6-8 cycles of either intravenous obinutuzumab at a dose of 1,000 mg on days 1, 8, and 15 of cycle 1 and on day 1 of the remaining cycles or intravenous rituximab at a dose of 375mg/m² on day 1 of each cycle. Responders in each group received their assigned antibody as maintenance every 2 months for up to 2 years, said Dr. Pott, of University Hospital of Schleswig‐Holstein, Kiel, Germany.

Of 324 MRD-evaluable patients in the obinutuzumab arm who continued on maintenance treatment, 300 (92.6%) were MRD-negative at the end of induction, compared with 264 of 310 (85.2%) in the rituximab arm.

The majority of the MRD-negative patients remained negative during maintenance, including 67% of patients receiving obinutuzumab and 63.2% of patient receiving rituximab, she said. There was no difference seen in the relapse rate between groups – 6.3% vs. 6.1%, respectively.

The rate of disease progression or death was 11.4% in the obinutuzumab arm and 15.5% in the rituximab arm.

Additionally, 24 patients in the obinutuzumab arm and 46 in the rituximab arm were MRD positive at the end of induction but were eligible for maintenance therapy based on clinical response; of these, 22 (92%) and 36 (78%), respectively, achieved MRD negativity during maintenance, with 18 and 27 patients in the arms, respectively, achieving MRD negativity within the first 4 months of maintenance therapy, she said.

Of the 12 patients who never achieved an MRD response, 8 progressed or died within 7 months after the end of induction, 1 progressed after 15 months, 1 progressed after 26 months, and 2 remained MRD positive during maintenance up to month 8 and month 12, respectively, but had no documented tumor progression until day 1,348 and day 1,709.

“MRD status reflects the depth of response to treatment and provides insight regarding prognosis after first-line therapy in patients with follicular lymphoma,” Dr. Pott said in an interview, adding that “the findings of the current analysis demonstrate the prognostic value of MRD response assessments in previously untreated follicular lymphoma patients receiving immunochemotherapy.”

Further, the finding that a majority of patients who were MRD positive at the end of induction achieved MRD negativity during the first 4 months of maintenance is likely indicative of the efficacy of continued treatment, and it also suggests that response kinetics can be slower than in patients with an early MRD response at midinduction, she said.

“Also, responses that are beyond the sensitivity of the MRD assay may be less deep,” she added, noting that patients who failed to achieve MRD negativity at the end of induction or during early maintenance had a high chance of experiencing early progression or death.

The findings have implications for individualized treatment based on patient response, as well as for future clinical trial design, she said.

For example, MRD status could allow for earlier identification of patients with poor prognosis who aren’t likely to benefit from maintenance therapy. In clinical trials, it could be used to assess the efficiency of new treatments and to stratify patients based on the likelihood of response, allowing for the evaluation of different treatments in those groups, she explained.

“That would be a very important step in the direction of tailored therapies,” she said, adding that patients with follicular lymphoma tend to have very long PFS, and earlier outcomes parameters or tools beyond clinical parameters for assessing treatment efficiency are needed.

“I hope that future trials will address MRD-based treatment stratification as the adverse prognosis we detect by residual disease might be overcome by an MRD-based switch of patients to more effective and efficient treatments, including novel drugs,” she said.

The GALLIUM study is supported by F. Hoffmann–La Roche. Dr. Pott reported having no financial disclosures.

sworcester@mdedge.com

SOURCE: Pott C et al. ASH 2018, Abstract 396.

SAN DIEGO – Minimal residual disease (MRD) response at the end of induction correlates with outcomes in previously untreated follicular lymphoma patients who receive obinutuzumab- or rituximab-based immunochemotherapy, according to updated results from the phase 3 GALLIUM study.

After 57 months of follow-up, and regardless of treatment arm, 564 MRD-evaluable patients who were MRD negative at the end of induction had significantly greater probability of progression-free survival (PFS) than did 70 patients who were MRD positive at the end of induction (about 80% vs. 50%; hazard ratio, 0.38), Christiane Pott, MD, reported at the annual meeting of the American Society of Hematology.

GALLIUM participants were adults with follicular lymphoma requiring treatment. They were randomized to receive standard chemotherapy in combination with 6-8 cycles of either intravenous obinutuzumab at a dose of 1,000 mg on days 1, 8, and 15 of cycle 1 and on day 1 of the remaining cycles or intravenous rituximab at a dose of 375mg/m² on day 1 of each cycle. Responders in each group received their assigned antibody as maintenance every 2 months for up to 2 years, said Dr. Pott, of University Hospital of Schleswig‐Holstein, Kiel, Germany.

Of 324 MRD-evaluable patients in the obinutuzumab arm who continued on maintenance treatment, 300 (92.6%) were MRD-negative at the end of induction, compared with 264 of 310 (85.2%) in the rituximab arm.

The majority of the MRD-negative patients remained negative during maintenance, including 67% of patients receiving obinutuzumab and 63.2% of patient receiving rituximab, she said. There was no difference seen in the relapse rate between groups – 6.3% vs. 6.1%, respectively.

The rate of disease progression or death was 11.4% in the obinutuzumab arm and 15.5% in the rituximab arm.

Additionally, 24 patients in the obinutuzumab arm and 46 in the rituximab arm were MRD positive at the end of induction but were eligible for maintenance therapy based on clinical response; of these, 22 (92%) and 36 (78%), respectively, achieved MRD negativity during maintenance, with 18 and 27 patients in the arms, respectively, achieving MRD negativity within the first 4 months of maintenance therapy, she said.

Of the 12 patients who never achieved an MRD response, 8 progressed or died within 7 months after the end of induction, 1 progressed after 15 months, 1 progressed after 26 months, and 2 remained MRD positive during maintenance up to month 8 and month 12, respectively, but had no documented tumor progression until day 1,348 and day 1,709.

“MRD status reflects the depth of response to treatment and provides insight regarding prognosis after first-line therapy in patients with follicular lymphoma,” Dr. Pott said in an interview, adding that “the findings of the current analysis demonstrate the prognostic value of MRD response assessments in previously untreated follicular lymphoma patients receiving immunochemotherapy.”

Further, the finding that a majority of patients who were MRD positive at the end of induction achieved MRD negativity during the first 4 months of maintenance is likely indicative of the efficacy of continued treatment, and it also suggests that response kinetics can be slower than in patients with an early MRD response at midinduction, she said.

“Also, responses that are beyond the sensitivity of the MRD assay may be less deep,” she added, noting that patients who failed to achieve MRD negativity at the end of induction or during early maintenance had a high chance of experiencing early progression or death.

The findings have implications for individualized treatment based on patient response, as well as for future clinical trial design, she said.

For example, MRD status could allow for earlier identification of patients with poor prognosis who aren’t likely to benefit from maintenance therapy. In clinical trials, it could be used to assess the efficiency of new treatments and to stratify patients based on the likelihood of response, allowing for the evaluation of different treatments in those groups, she explained.

“That would be a very important step in the direction of tailored therapies,” she said, adding that patients with follicular lymphoma tend to have very long PFS, and earlier outcomes parameters or tools beyond clinical parameters for assessing treatment efficiency are needed.

“I hope that future trials will address MRD-based treatment stratification as the adverse prognosis we detect by residual disease might be overcome by an MRD-based switch of patients to more effective and efficient treatments, including novel drugs,” she said.

The GALLIUM study is supported by F. Hoffmann–La Roche. Dr. Pott reported having no financial disclosures.

sworcester@mdedge.com

SOURCE: Pott C et al. ASH 2018, Abstract 396.

SAN DIEGO – Minimal residual disease (MRD) response at the end of induction correlates with outcomes in previously untreated follicular lymphoma patients who receive obinutuzumab- or rituximab-based immunochemotherapy, according to updated results from the phase 3 GALLIUM study.

After 57 months of follow-up, and regardless of treatment arm, 564 MRD-evaluable patients who were MRD negative at the end of induction had significantly greater probability of progression-free survival (PFS) than did 70 patients who were MRD positive at the end of induction (about 80% vs. 50%; hazard ratio, 0.38), Christiane Pott, MD, reported at the annual meeting of the American Society of Hematology.

GALLIUM participants were adults with follicular lymphoma requiring treatment. They were randomized to receive standard chemotherapy in combination with 6-8 cycles of either intravenous obinutuzumab at a dose of 1,000 mg on days 1, 8, and 15 of cycle 1 and on day 1 of the remaining cycles or intravenous rituximab at a dose of 375mg/m² on day 1 of each cycle. Responders in each group received their assigned antibody as maintenance every 2 months for up to 2 years, said Dr. Pott, of University Hospital of Schleswig‐Holstein, Kiel, Germany.

Of 324 MRD-evaluable patients in the obinutuzumab arm who continued on maintenance treatment, 300 (92.6%) were MRD-negative at the end of induction, compared with 264 of 310 (85.2%) in the rituximab arm.

The majority of the MRD-negative patients remained negative during maintenance, including 67% of patients receiving obinutuzumab and 63.2% of patient receiving rituximab, she said. There was no difference seen in the relapse rate between groups – 6.3% vs. 6.1%, respectively.

The rate of disease progression or death was 11.4% in the obinutuzumab arm and 15.5% in the rituximab arm.

Additionally, 24 patients in the obinutuzumab arm and 46 in the rituximab arm were MRD positive at the end of induction but were eligible for maintenance therapy based on clinical response; of these, 22 (92%) and 36 (78%), respectively, achieved MRD negativity during maintenance, with 18 and 27 patients in the arms, respectively, achieving MRD negativity within the first 4 months of maintenance therapy, she said.

Of the 12 patients who never achieved an MRD response, 8 progressed or died within 7 months after the end of induction, 1 progressed after 15 months, 1 progressed after 26 months, and 2 remained MRD positive during maintenance up to month 8 and month 12, respectively, but had no documented tumor progression until day 1,348 and day 1,709.

“MRD status reflects the depth of response to treatment and provides insight regarding prognosis after first-line therapy in patients with follicular lymphoma,” Dr. Pott said in an interview, adding that “the findings of the current analysis demonstrate the prognostic value of MRD response assessments in previously untreated follicular lymphoma patients receiving immunochemotherapy.”

Further, the finding that a majority of patients who were MRD positive at the end of induction achieved MRD negativity during the first 4 months of maintenance is likely indicative of the efficacy of continued treatment, and it also suggests that response kinetics can be slower than in patients with an early MRD response at midinduction, she said.

“Also, responses that are beyond the sensitivity of the MRD assay may be less deep,” she added, noting that patients who failed to achieve MRD negativity at the end of induction or during early maintenance had a high chance of experiencing early progression or death.

The findings have implications for individualized treatment based on patient response, as well as for future clinical trial design, she said.

For example, MRD status could allow for earlier identification of patients with poor prognosis who aren’t likely to benefit from maintenance therapy. In clinical trials, it could be used to assess the efficiency of new treatments and to stratify patients based on the likelihood of response, allowing for the evaluation of different treatments in those groups, she explained.

“That would be a very important step in the direction of tailored therapies,” she said, adding that patients with follicular lymphoma tend to have very long PFS, and earlier outcomes parameters or tools beyond clinical parameters for assessing treatment efficiency are needed.

“I hope that future trials will address MRD-based treatment stratification as the adverse prognosis we detect by residual disease might be overcome by an MRD-based switch of patients to more effective and efficient treatments, including novel drugs,” she said.

The GALLIUM study is supported by F. Hoffmann–La Roche. Dr. Pott reported having no financial disclosures.

sworcester@mdedge.com

SOURCE: Pott C et al. ASH 2018, Abstract 396.

In cases of lower gastrointestinal bleeding (LGIB), albumin and hemoglobin levels are the best independent predictors of severe bleeding, according to investigators.

These findings came from a sobering look at LGIB risk-prediction models. While some models could predict specific outcomes with reasonable accuracy, none of the models demonstrated broad predictive power, reported Natalie Tapaskar, MD, of the department of medicine at the University of Chicago, and her colleagues.

LGIB requires intensive resource utilization and proves fatal in 5%-15% of patients, which means timely and appropriate interventions are essential, especially for those with severe bleeding.

“There are limited data on accurately predicting the risk of adverse outcomes for hospitalized patients with LGIB,” the investigators wrote in Gastrointestinal Endoscopy, “especially in comparison to patients with upper gastrointestinal bleeding (UGIB), where tools such as the Glasgow-Blatchford Bleeding Score have been validated to accurately predict important clinical outcomes.”

To assess existing risk models for LGIB, the investigators performed a prospective observational study involving 170 patients with LGIB who underwent colonoscopy during April 2016–September 2017 at the University of Chicago Medical Center. Data were collected through comprehensive medical record review.

The primary outcome was severe bleeding. This was defined by acute bleeding during the first 24 hours of admission that required a transfusion of 2 or more units of packed red blood cells, and/or caused a 20% or greater decrease in hematocrit; and/or recurrent bleeding 24 hours after clinical stability, involving rectal bleeding with an additional drop in hematocrit of 20% or more, and/or readmission for LGIB within 1 week of discharge. Secondary outcomes included blood transfusion requirements, in-hospital recurrent bleeding, length of stay, ICU admission, intervention (surgery, interventional radiology, endoscopy), and the comparative predictive ability of seven clinical risk stratification models: AIMS65, Charlson Comorbidity Index, Glasgow-Blatchford, NOBLADS, Oakland, Sengupta, and Strate. Area under the receiver operating characteristic curve (AUC) was used to compare model predictive power. Risk of adverse outcomes was calculated by univariable and multivariable logistic regression.

Results showed that median patient age was 70 years. Most of the patients (80%) were African American and slightly more than half were female (58%). These demographic factors were not predictive of severe bleeding, which occurred in about half of the cases (52%). Upon admission, patients with severe bleeding were more likely to have chronic renal failure (30% vs. 17%; P = .05), lower albumin (3.6 g/dL vs. 3.95 g/dL; P less than .0001), lower hemoglobin (8.6 g/dL vs. 11.1 g/dL; P = .0001), lower systolic blood pressure (118 mm Hg vs. 132 mm Hg; P = .01), and higher creatinine (1.3 mg/dL vs. 1 mg/dL; P = .04). After adjustment for confounding variables, the strongest independent predictors of severe bleeding were low albumin (odds ratio, 2.56 per 1-g/dL decrease; P = .02) and low hemoglobin (OR, 1.28 per 1-g/dL decrease; P = .0015).

*This story was updated on Jan. 31, 2019.
 

SOURCE: Tapaskar N et al. Gastrointest Endosc. 2018 Dec 18. doi: 10.1016/j.gie.2018.12.011.

In cases of lower gastrointestinal bleeding (LGIB), albumin and hemoglobin levels are the best independent predictors of severe bleeding, according to investigators.

These findings came from a sobering look at LGIB risk-prediction models. While some models could predict specific outcomes with reasonable accuracy, none of the models demonstrated broad predictive power, reported Natalie Tapaskar, MD, of the department of medicine at the University of Chicago, and her colleagues.

LGIB requires intensive resource utilization and proves fatal in 5%-15% of patients, which means timely and appropriate interventions are essential, especially for those with severe bleeding.

“There are limited data on accurately predicting the risk of adverse outcomes for hospitalized patients with LGIB,” the investigators wrote in Gastrointestinal Endoscopy, “especially in comparison to patients with upper gastrointestinal bleeding (UGIB), where tools such as the Glasgow-Blatchford Bleeding Score have been validated to accurately predict important clinical outcomes.”

To assess existing risk models for LGIB, the investigators performed a prospective observational study involving 170 patients with LGIB who underwent colonoscopy during April 2016–September 2017 at the University of Chicago Medical Center. Data were collected through comprehensive medical record review.

The primary outcome was severe bleeding. This was defined by acute bleeding during the first 24 hours of admission that required a transfusion of 2 or more units of packed red blood cells, and/or caused a 20% or greater decrease in hematocrit; and/or recurrent bleeding 24 hours after clinical stability, involving rectal bleeding with an additional drop in hematocrit of 20% or more, and/or readmission for LGIB within 1 week of discharge. Secondary outcomes included blood transfusion requirements, in-hospital recurrent bleeding, length of stay, ICU admission, intervention (surgery, interventional radiology, endoscopy), and the comparative predictive ability of seven clinical risk stratification models: AIMS65, Charlson Comorbidity Index, Glasgow-Blatchford, NOBLADS, Oakland, Sengupta, and Strate. Area under the receiver operating characteristic curve (AUC) was used to compare model predictive power. Risk of adverse outcomes was calculated by univariable and multivariable logistic regression.

Results showed that median patient age was 70 years. Most of the patients (80%) were African American and slightly more than half were female (58%). These demographic factors were not predictive of severe bleeding, which occurred in about half of the cases (52%). Upon admission, patients with severe bleeding were more likely to have chronic renal failure (30% vs. 17%; P = .05), lower albumin (3.6 g/dL vs. 3.95 g/dL; P less than .0001), lower hemoglobin (8.6 g/dL vs. 11.1 g/dL; P = .0001), lower systolic blood pressure (118 mm Hg vs. 132 mm Hg; P = .01), and higher creatinine (1.3 mg/dL vs. 1 mg/dL; P = .04). After adjustment for confounding variables, the strongest independent predictors of severe bleeding were low albumin (odds ratio, 2.56 per 1-g/dL decrease; P = .02) and low hemoglobin (OR, 1.28 per 1-g/dL decrease; P = .0015).

*This story was updated on Jan. 31, 2019.
 

SOURCE: Tapaskar N et al. Gastrointest Endosc. 2018 Dec 18. doi: 10.1016/j.gie.2018.12.011.

In cases of lower gastrointestinal bleeding (LGIB), albumin and hemoglobin levels are the best independent predictors of severe bleeding, according to investigators.

These findings came from a sobering look at LGIB risk-prediction models. While some models could predict specific outcomes with reasonable accuracy, none of the models demonstrated broad predictive power, reported Natalie Tapaskar, MD, of the department of medicine at the University of Chicago, and her colleagues.

LGIB requires intensive resource utilization and proves fatal in 5%-15% of patients, which means timely and appropriate interventions are essential, especially for those with severe bleeding.

“There are limited data on accurately predicting the risk of adverse outcomes for hospitalized patients with LGIB,” the investigators wrote in Gastrointestinal Endoscopy, “especially in comparison to patients with upper gastrointestinal bleeding (UGIB), where tools such as the Glasgow-Blatchford Bleeding Score have been validated to accurately predict important clinical outcomes.”

To assess existing risk models for LGIB, the investigators performed a prospective observational study involving 170 patients with LGIB who underwent colonoscopy during April 2016–September 2017 at the University of Chicago Medical Center. Data were collected through comprehensive medical record review.

The primary outcome was severe bleeding. This was defined by acute bleeding during the first 24 hours of admission that required a transfusion of 2 or more units of packed red blood cells, and/or caused a 20% or greater decrease in hematocrit; and/or recurrent bleeding 24 hours after clinical stability, involving rectal bleeding with an additional drop in hematocrit of 20% or more, and/or readmission for LGIB within 1 week of discharge. Secondary outcomes included blood transfusion requirements, in-hospital recurrent bleeding, length of stay, ICU admission, intervention (surgery, interventional radiology, endoscopy), and the comparative predictive ability of seven clinical risk stratification models: AIMS65, Charlson Comorbidity Index, Glasgow-Blatchford, NOBLADS, Oakland, Sengupta, and Strate. Area under the receiver operating characteristic curve (AUC) was used to compare model predictive power. Risk of adverse outcomes was calculated by univariable and multivariable logistic regression.

Results showed that median patient age was 70 years. Most of the patients (80%) were African American and slightly more than half were female (58%). These demographic factors were not predictive of severe bleeding, which occurred in about half of the cases (52%). Upon admission, patients with severe bleeding were more likely to have chronic renal failure (30% vs. 17%; P = .05), lower albumin (3.6 g/dL vs. 3.95 g/dL; P less than .0001), lower hemoglobin (8.6 g/dL vs. 11.1 g/dL; P = .0001), lower systolic blood pressure (118 mm Hg vs. 132 mm Hg; P = .01), and higher creatinine (1.3 mg/dL vs. 1 mg/dL; P = .04). After adjustment for confounding variables, the strongest independent predictors of severe bleeding were low albumin (odds ratio, 2.56 per 1-g/dL decrease; P = .02) and low hemoglobin (OR, 1.28 per 1-g/dL decrease; P = .0015).

*This story was updated on Jan. 31, 2019.
 

SOURCE: Tapaskar N et al. Gastrointest Endosc. 2018 Dec 18. doi: 10.1016/j.gie.2018.12.011.

Thymectomy may continue to benefit patients with myasthenia gravis 5 years after the procedure, according to an extension study published in Lancet Neurology. Patients with generalized nonthymomatous myasthenia gravis who underwent thymectomy had better long-term clinical outcomes and required less prednisone, compared with patients who received prednisone alone.

Douglas Levere/University at Buffalo

The study evaluated the clinical status, medication requirements, and adverse events of patients with myasthenia gravis who completed a randomized controlled trial of thymectomy plus prednisone versus prednisone alone and agreed to participate in a rater-blinded 2-year extension.

“Thymectomy within the first few years of the disease course in addition to prednisone therapy confers benefits that persist for 5 years ... in patients with generalized nonthymomatous myasthenia gravis,” said lead study author Gil I. Wolfe, MD, chair of the department of neurology at the University at Buffalo in New York, and his research colleagues. “Results from the extension study provide further support for the use of thymectomy in management of myasthenia gravis and should encourage serious consideration of this treatment option in discussions between clinicians and their patients,” they wrote. “Our results should lead to revision of clinical guidelines in favor of thymectomy and could potentially reverse downward trends in the use of thymectomy in overall management of myasthenia gravis.”

The main 3-year results of the Thymectomy Trial in Nonthymomatous Myasthenia Gravis Patients Receiving Prednisone (MGTX) were reported in 2016; the international trial found that thymectomy plus prednisone was superior to prednisone alone at 3 years (N Engl J Med. 2016 Aug 11;375[6]:511-22). The extension study aimed to assess the durability of the treatment response.

MGTX enrolled patients aged 18-65 years who had generalized nonthymomatous myasthenia gravis of less than 5 years’ duration and Myasthenia Gravis Foundation of America Clinical Classification Class II-IV disease. Of 111 patients who completed MGTX, 68 entered the extension study, and 50 completed the 60-month assessment (24 patients in the prednisone alone group and 26 patients in the prednisone plus thymectomy group).

At 5 years, patients in the thymectomy plus prednisone group had significantly lower time-weighted average Quantitative Myasthenia Gravis (QMG) scores (5.47 vs. 9.34) and mean alternate-day prednisone doses (24 mg vs. 48 mg), compared with patients who received prednisone alone. Twelve of 35 patients in the thymectomy group and 14 of 33 patients in the prednisone group had at least one adverse event by month 60. No treatment-related deaths occurred in the extension phase.

At 5 years, significantly more patients who underwent thymectomy had minimal manifestation status (i.e., no functional limitations from the disease other than some muscle weakness) – 88% versus 58%. The corresponding figures at 3 years were 67% and 47%.

In addition, 3-year and 5-year data indicate that the need for hospitalization is reduced after surgery, compared with medical therapy alone, Dr. Wolfe said.

Two patients in each treatment arm had an increase of 2 points or more in the QMG score, indicating clinical worsening.

“Our current findings reinforce the benefit of thymectomy seen in [MGTX], dispelling doubts about the procedure’s benefits and how long those benefits last,” said Dr. Wolfe. “We do hope that the new findings help reverse the apparent reluctance to do thymectomy and that the proportion of patients with myasthenia gravis who undergo thymectomy will increase.”

The authors noted that the small sample size of the extension study may limit its generalizability.

The study received funding from the National Institutes of Health. Dr. Wolfe reported grants from the NIH, the Muscular Dystrophy Association, the Myasthenia Gravis Foundation of America, CSL-Behring, and ArgenX, as well as personal fees from Grifols, Shire, and Alexion Pharmaceuticals. Coauthors reported working with and receiving funds from agencies, foundations, and pharmaceutical companies.

jremaly@mdedge.com

SOURCE: Wolfe GI et al. Lancet Neurol. 2019 Jan 25. doi: 10.1016/S1474-4422(18)30392-2.

Thymectomy may continue to benefit patients with myasthenia gravis 5 years after the procedure, according to an extension study published in Lancet Neurology. Patients with generalized nonthymomatous myasthenia gravis who underwent thymectomy had better long-term clinical outcomes and required less prednisone, compared with patients who received prednisone alone.

Douglas Levere/University at Buffalo

The study evaluated the clinical status, medication requirements, and adverse events of patients with myasthenia gravis who completed a randomized controlled trial of thymectomy plus prednisone versus prednisone alone and agreed to participate in a rater-blinded 2-year extension.

“Thymectomy within the first few years of the disease course in addition to prednisone therapy confers benefits that persist for 5 years ... in patients with generalized nonthymomatous myasthenia gravis,” said lead study author Gil I. Wolfe, MD, chair of the department of neurology at the University at Buffalo in New York, and his research colleagues. “Results from the extension study provide further support for the use of thymectomy in management of myasthenia gravis and should encourage serious consideration of this treatment option in discussions between clinicians and their patients,” they wrote. “Our results should lead to revision of clinical guidelines in favor of thymectomy and could potentially reverse downward trends in the use of thymectomy in overall management of myasthenia gravis.”

The main 3-year results of the Thymectomy Trial in Nonthymomatous Myasthenia Gravis Patients Receiving Prednisone (MGTX) were reported in 2016; the international trial found that thymectomy plus prednisone was superior to prednisone alone at 3 years (N Engl J Med. 2016 Aug 11;375[6]:511-22). The extension study aimed to assess the durability of the treatment response.

MGTX enrolled patients aged 18-65 years who had generalized nonthymomatous myasthenia gravis of less than 5 years’ duration and Myasthenia Gravis Foundation of America Clinical Classification Class II-IV disease. Of 111 patients who completed MGTX, 68 entered the extension study, and 50 completed the 60-month assessment (24 patients in the prednisone alone group and 26 patients in the prednisone plus thymectomy group).

At 5 years, patients in the thymectomy plus prednisone group had significantly lower time-weighted average Quantitative Myasthenia Gravis (QMG) scores (5.47 vs. 9.34) and mean alternate-day prednisone doses (24 mg vs. 48 mg), compared with patients who received prednisone alone. Twelve of 35 patients in the thymectomy group and 14 of 33 patients in the prednisone group had at least one adverse event by month 60. No treatment-related deaths occurred in the extension phase.

At 5 years, significantly more patients who underwent thymectomy had minimal manifestation status (i.e., no functional limitations from the disease other than some muscle weakness) – 88% versus 58%. The corresponding figures at 3 years were 67% and 47%.

In addition, 3-year and 5-year data indicate that the need for hospitalization is reduced after surgery, compared with medical therapy alone, Dr. Wolfe said.

Two patients in each treatment arm had an increase of 2 points or more in the QMG score, indicating clinical worsening.

“Our current findings reinforce the benefit of thymectomy seen in [MGTX], dispelling doubts about the procedure’s benefits and how long those benefits last,” said Dr. Wolfe. “We do hope that the new findings help reverse the apparent reluctance to do thymectomy and that the proportion of patients with myasthenia gravis who undergo thymectomy will increase.”

The authors noted that the small sample size of the extension study may limit its generalizability.

The study received funding from the National Institutes of Health. Dr. Wolfe reported grants from the NIH, the Muscular Dystrophy Association, the Myasthenia Gravis Foundation of America, CSL-Behring, and ArgenX, as well as personal fees from Grifols, Shire, and Alexion Pharmaceuticals. Coauthors reported working with and receiving funds from agencies, foundations, and pharmaceutical companies.

jremaly@mdedge.com

SOURCE: Wolfe GI et al. Lancet Neurol. 2019 Jan 25. doi: 10.1016/S1474-4422(18)30392-2.

Thymectomy may continue to benefit patients with myasthenia gravis 5 years after the procedure, according to an extension study published in Lancet Neurology. Patients with generalized nonthymomatous myasthenia gravis who underwent thymectomy had better long-term clinical outcomes and required less prednisone, compared with patients who received prednisone alone.

Douglas Levere/University at Buffalo

The study evaluated the clinical status, medication requirements, and adverse events of patients with myasthenia gravis who completed a randomized controlled trial of thymectomy plus prednisone versus prednisone alone and agreed to participate in a rater-blinded 2-year extension.

“Thymectomy within the first few years of the disease course in addition to prednisone therapy confers benefits that persist for 5 years ... in patients with generalized nonthymomatous myasthenia gravis,” said lead study author Gil I. Wolfe, MD, chair of the department of neurology at the University at Buffalo in New York, and his research colleagues. “Results from the extension study provide further support for the use of thymectomy in management of myasthenia gravis and should encourage serious consideration of this treatment option in discussions between clinicians and their patients,” they wrote. “Our results should lead to revision of clinical guidelines in favor of thymectomy and could potentially reverse downward trends in the use of thymectomy in overall management of myasthenia gravis.”

The main 3-year results of the Thymectomy Trial in Nonthymomatous Myasthenia Gravis Patients Receiving Prednisone (MGTX) were reported in 2016; the international trial found that thymectomy plus prednisone was superior to prednisone alone at 3 years (N Engl J Med. 2016 Aug 11;375[6]:511-22). The extension study aimed to assess the durability of the treatment response.

MGTX enrolled patients aged 18-65 years who had generalized nonthymomatous myasthenia gravis of less than 5 years’ duration and Myasthenia Gravis Foundation of America Clinical Classification Class II-IV disease. Of 111 patients who completed MGTX, 68 entered the extension study, and 50 completed the 60-month assessment (24 patients in the prednisone alone group and 26 patients in the prednisone plus thymectomy group).

At 5 years, patients in the thymectomy plus prednisone group had significantly lower time-weighted average Quantitative Myasthenia Gravis (QMG) scores (5.47 vs. 9.34) and mean alternate-day prednisone doses (24 mg vs. 48 mg), compared with patients who received prednisone alone. Twelve of 35 patients in the thymectomy group and 14 of 33 patients in the prednisone group had at least one adverse event by month 60. No treatment-related deaths occurred in the extension phase.

At 5 years, significantly more patients who underwent thymectomy had minimal manifestation status (i.e., no functional limitations from the disease other than some muscle weakness) – 88% versus 58%. The corresponding figures at 3 years were 67% and 47%.

In addition, 3-year and 5-year data indicate that the need for hospitalization is reduced after surgery, compared with medical therapy alone, Dr. Wolfe said.

Two patients in each treatment arm had an increase of 2 points or more in the QMG score, indicating clinical worsening.

“Our current findings reinforce the benefit of thymectomy seen in [MGTX], dispelling doubts about the procedure’s benefits and how long those benefits last,” said Dr. Wolfe. “We do hope that the new findings help reverse the apparent reluctance to do thymectomy and that the proportion of patients with myasthenia gravis who undergo thymectomy will increase.”

The authors noted that the small sample size of the extension study may limit its generalizability.

The study received funding from the National Institutes of Health. Dr. Wolfe reported grants from the NIH, the Muscular Dystrophy Association, the Myasthenia Gravis Foundation of America, CSL-Behring, and ArgenX, as well as personal fees from Grifols, Shire, and Alexion Pharmaceuticals. Coauthors reported working with and receiving funds from agencies, foundations, and pharmaceutical companies.

jremaly@mdedge.com

SOURCE: Wolfe GI et al. Lancet Neurol. 2019 Jan 25. doi: 10.1016/S1474-4422(18)30392-2.

TRANSforming Gynecology is a column about the ways in which ob.gyns. can become leaders in addressing the needs of the transgender/gender-nonconforming population. We hope to provide readers with some basic tools to help open the door to this marginalized population. We will lay the groundwork with an article on terminology and the importance of language before moving onto more focused discussions of topics that intersect with medical care of gender-nonconforming individuals. Transgender individuals experience among the worst health care outcomes of any demographic, and we hope that this column can be a starting point for providers to continue affirming the needs of marginalized populations in their everyday practice.

Josve05a/Getty Images

We live in a society in which most people’s gender identities are congruent with the sex they were assigned at birth based on physical characteristics. Transgender and gender-nonconforming people – often referred to as trans people, broadly – feel that their gender identity does not match their sex assigned at birth. This gender nonconformity, or the extent to which someone’s gender identity or expression differs from the cultural norm assigned to people with certain sexual organs, is in fact a matter of diversity, not pathology.

To truly provide sensitive care to trans patients, medical providers must first gain familiarity with the terminology used when discussing gender diversity. Gender identity, for starters, refers to an individual’s own personal and internal experience of themselves as a man, woman, some of both, or neither gender.¹ It is only possible to learn a person’s gender identity through direct communication because gender identity is not always signaled by a certain gender expression. Gender expression is an external display usually through clothing, attitudes, or body language, that may or may not fit into socially recognized masculine or feminine categories.¹ A separate aspect of the human experience is sexuality, such as gay, straight, bisexual, lesbian, etc. Sexuality should not be confused with sexual practices, which can sometimes deviate from a person’s sexuality. Gender identity is distinct from sexuality and sexual practices because people of any gender identity can hold any sexuality and engage in any sexual practices. Tied up in all of these categories is sex assigned at birth, which is a process by which health care providers categorize babies into two buckets based on the appearance of the external genitalia at the time of birth. It bears mentioning that the assignment of sex based on the appearance of external genitalia at the time of birth is a biologically inconsistent method that can lead to the exclusion of and nonconsensual mutilation of intersex people, who are individuals born with ambiguous genitalia and/or discrepancies between sex chromosome genotype and phenotype (stay tuned for more on people who are intersex in a future article).

A simplified way of remembering the distinctions between these concepts is that gender identity is who you go to bed as; gender expression is what you were wearing before you went to bed; sexuality is whom you tell others/yourself you go to bed with; sexual practice is whom you actually go to bed with; and sex assigned at birth is what you have between your legs when you are born (generally in a bed).

It is pivotal that medical providers understand that a person’s sex assigned at birth, gender identity, gender expression, sexuality, sexual practice, and romantic attraction can vary widely along a spectrum in each distinct category.² For example, the current social norm dictates that someone born with a penis and assigned male at birth (AMAB) will feel that he is male, dress in a masculine fashion, and be both sexually and romantically attracted to someone born with a vagina who was assigned female at birth (AFAB), feels that she is female, dresses femininely, and likewise is sexually and romantically attracted to him. One possible alternative reality is a person who was born with a vagina that was therefore AFAB that experiences a masculine gender identity while engaging in a feminine gender expression in order to conform to social norms. In addition, they may be sexually attracted to people whom they perceive to be feminine while engaging in sexual activity with people who were AMAB. Informed medical care for trans persons starts with the basic understanding that an individual’s gender identity may not necessarily align with their gender expression, sex assigned at birth, sexual attraction, or romantic attraction.

As obstetrician-gynecologists, we are tasked by the American College of Obstetricians and Gynecologists to provide nondiscriminatory care to all patients, regardless of gender identity.³ We must be careful not to assume that all of our patients are cisgender women who use “she/hers/her” pronouns. By simply asking patients what names or pronouns they would like us to use before initiating care, we become more sensitive to variations in gender identity. Many providers may feel uncertain about how to initiate or respond to this line of questioning. One way that health care practices can begin to respectfully access information around gender identity is to create intake forms that include more than two options for gender or to alter their office visit note templates to include a section that prompts the provider to include a discussion surrounding gender identity. By offering these opportunities for inclusion, we become more welcoming of gender minorities like transgender men seeking cervical cancer screening.

There are a number of reasons that trans persons have limited access to the health care system, but the greatest barrier reported by transgender patients is the paucity of knowledgeable providers.⁴Learning the common terminology used by the trans population is a logical first step for physicians seeking to provide more affirming care to an already marginalized patient population. Familiarity with this terminology normalizes the idea of gender diversity and subsequently reduces the risk of providers making assumptions about patients that contributes to suboptimal care.

Dr. Joyner is an assistant professor at Emory University, Atlanta, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joey Bahng is a PGY-1 resident physician in Emory University’s gynecology & obstetrics residency program. Dr. Bahng identifies as nonbinary and uses they/them/their as their personal pronouns. Dr. Joyner and Dr. Bahng reported no financial disclosures.

1. Lancet. 2016 Jul 23;388(10042):390-400.

2. www.genderbread.org/resource/genderbread-person-v4-0.

3. Obstet Gynecol. 2011 Dec;118(6):1454-8.

4. Curr Opin Endocrinol Diabetes Obes. 2016 Apr 1;23(2):168-71.

TRANSforming Gynecology is a column about the ways in which ob.gyns. can become leaders in addressing the needs of the transgender/gender-nonconforming population. We hope to provide readers with some basic tools to help open the door to this marginalized population. We will lay the groundwork with an article on terminology and the importance of language before moving onto more focused discussions of topics that intersect with medical care of gender-nonconforming individuals. Transgender individuals experience among the worst health care outcomes of any demographic, and we hope that this column can be a starting point for providers to continue affirming the needs of marginalized populations in their everyday practice.

Josve05a/Getty Images

We live in a society in which most people’s gender identities are congruent with the sex they were assigned at birth based on physical characteristics. Transgender and gender-nonconforming people – often referred to as trans people, broadly – feel that their gender identity does not match their sex assigned at birth. This gender nonconformity, or the extent to which someone’s gender identity or expression differs from the cultural norm assigned to people with certain sexual organs, is in fact a matter of diversity, not pathology.

To truly provide sensitive care to trans patients, medical providers must first gain familiarity with the terminology used when discussing gender diversity. Gender identity, for starters, refers to an individual’s own personal and internal experience of themselves as a man, woman, some of both, or neither gender.¹ It is only possible to learn a person’s gender identity through direct communication because gender identity is not always signaled by a certain gender expression. Gender expression is an external display usually through clothing, attitudes, or body language, that may or may not fit into socially recognized masculine or feminine categories.¹ A separate aspect of the human experience is sexuality, such as gay, straight, bisexual, lesbian, etc. Sexuality should not be confused with sexual practices, which can sometimes deviate from a person’s sexuality. Gender identity is distinct from sexuality and sexual practices because people of any gender identity can hold any sexuality and engage in any sexual practices. Tied up in all of these categories is sex assigned at birth, which is a process by which health care providers categorize babies into two buckets based on the appearance of the external genitalia at the time of birth. It bears mentioning that the assignment of sex based on the appearance of external genitalia at the time of birth is a biologically inconsistent method that can lead to the exclusion of and nonconsensual mutilation of intersex people, who are individuals born with ambiguous genitalia and/or discrepancies between sex chromosome genotype and phenotype (stay tuned for more on people who are intersex in a future article).

A simplified way of remembering the distinctions between these concepts is that gender identity is who you go to bed as; gender expression is what you were wearing before you went to bed; sexuality is whom you tell others/yourself you go to bed with; sexual practice is whom you actually go to bed with; and sex assigned at birth is what you have between your legs when you are born (generally in a bed).

It is pivotal that medical providers understand that a person’s sex assigned at birth, gender identity, gender expression, sexuality, sexual practice, and romantic attraction can vary widely along a spectrum in each distinct category.² For example, the current social norm dictates that someone born with a penis and assigned male at birth (AMAB) will feel that he is male, dress in a masculine fashion, and be both sexually and romantically attracted to someone born with a vagina who was assigned female at birth (AFAB), feels that she is female, dresses femininely, and likewise is sexually and romantically attracted to him. One possible alternative reality is a person who was born with a vagina that was therefore AFAB that experiences a masculine gender identity while engaging in a feminine gender expression in order to conform to social norms. In addition, they may be sexually attracted to people whom they perceive to be feminine while engaging in sexual activity with people who were AMAB. Informed medical care for trans persons starts with the basic understanding that an individual’s gender identity may not necessarily align with their gender expression, sex assigned at birth, sexual attraction, or romantic attraction.

As obstetrician-gynecologists, we are tasked by the American College of Obstetricians and Gynecologists to provide nondiscriminatory care to all patients, regardless of gender identity.³ We must be careful not to assume that all of our patients are cisgender women who use “she/hers/her” pronouns. By simply asking patients what names or pronouns they would like us to use before initiating care, we become more sensitive to variations in gender identity. Many providers may feel uncertain about how to initiate or respond to this line of questioning. One way that health care practices can begin to respectfully access information around gender identity is to create intake forms that include more than two options for gender or to alter their office visit note templates to include a section that prompts the provider to include a discussion surrounding gender identity. By offering these opportunities for inclusion, we become more welcoming of gender minorities like transgender men seeking cervical cancer screening.

There are a number of reasons that trans persons have limited access to the health care system, but the greatest barrier reported by transgender patients is the paucity of knowledgeable providers.⁴Learning the common terminology used by the trans population is a logical first step for physicians seeking to provide more affirming care to an already marginalized patient population. Familiarity with this terminology normalizes the idea of gender diversity and subsequently reduces the risk of providers making assumptions about patients that contributes to suboptimal care.

Dr. Joyner is an assistant professor at Emory University, Atlanta, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joey Bahng is a PGY-1 resident physician in Emory University’s gynecology & obstetrics residency program. Dr. Bahng identifies as nonbinary and uses they/them/their as their personal pronouns. Dr. Joyner and Dr. Bahng reported no financial disclosures.

1. Lancet. 2016 Jul 23;388(10042):390-400.

2. www.genderbread.org/resource/genderbread-person-v4-0.

3. Obstet Gynecol. 2011 Dec;118(6):1454-8.

4. Curr Opin Endocrinol Diabetes Obes. 2016 Apr 1;23(2):168-71.

TRANSforming Gynecology is a column about the ways in which ob.gyns. can become leaders in addressing the needs of the transgender/gender-nonconforming population. We hope to provide readers with some basic tools to help open the door to this marginalized population. We will lay the groundwork with an article on terminology and the importance of language before moving onto more focused discussions of topics that intersect with medical care of gender-nonconforming individuals. Transgender individuals experience among the worst health care outcomes of any demographic, and we hope that this column can be a starting point for providers to continue affirming the needs of marginalized populations in their everyday practice.

Josve05a/Getty Images

We live in a society in which most people’s gender identities are congruent with the sex they were assigned at birth based on physical characteristics. Transgender and gender-nonconforming people – often referred to as trans people, broadly – feel that their gender identity does not match their sex assigned at birth. This gender nonconformity, or the extent to which someone’s gender identity or expression differs from the cultural norm assigned to people with certain sexual organs, is in fact a matter of diversity, not pathology.

To truly provide sensitive care to trans patients, medical providers must first gain familiarity with the terminology used when discussing gender diversity. Gender identity, for starters, refers to an individual’s own personal and internal experience of themselves as a man, woman, some of both, or neither gender.¹ It is only possible to learn a person’s gender identity through direct communication because gender identity is not always signaled by a certain gender expression. Gender expression is an external display usually through clothing, attitudes, or body language, that may or may not fit into socially recognized masculine or feminine categories.¹ A separate aspect of the human experience is sexuality, such as gay, straight, bisexual, lesbian, etc. Sexuality should not be confused with sexual practices, which can sometimes deviate from a person’s sexuality. Gender identity is distinct from sexuality and sexual practices because people of any gender identity can hold any sexuality and engage in any sexual practices. Tied up in all of these categories is sex assigned at birth, which is a process by which health care providers categorize babies into two buckets based on the appearance of the external genitalia at the time of birth. It bears mentioning that the assignment of sex based on the appearance of external genitalia at the time of birth is a biologically inconsistent method that can lead to the exclusion of and nonconsensual mutilation of intersex people, who are individuals born with ambiguous genitalia and/or discrepancies between sex chromosome genotype and phenotype (stay tuned for more on people who are intersex in a future article).

A simplified way of remembering the distinctions between these concepts is that gender identity is who you go to bed as; gender expression is what you were wearing before you went to bed; sexuality is whom you tell others/yourself you go to bed with; sexual practice is whom you actually go to bed with; and sex assigned at birth is what you have between your legs when you are born (generally in a bed).

It is pivotal that medical providers understand that a person’s sex assigned at birth, gender identity, gender expression, sexuality, sexual practice, and romantic attraction can vary widely along a spectrum in each distinct category.² For example, the current social norm dictates that someone born with a penis and assigned male at birth (AMAB) will feel that he is male, dress in a masculine fashion, and be both sexually and romantically attracted to someone born with a vagina who was assigned female at birth (AFAB), feels that she is female, dresses femininely, and likewise is sexually and romantically attracted to him. One possible alternative reality is a person who was born with a vagina that was therefore AFAB that experiences a masculine gender identity while engaging in a feminine gender expression in order to conform to social norms. In addition, they may be sexually attracted to people whom they perceive to be feminine while engaging in sexual activity with people who were AMAB. Informed medical care for trans persons starts with the basic understanding that an individual’s gender identity may not necessarily align with their gender expression, sex assigned at birth, sexual attraction, or romantic attraction.

As obstetrician-gynecologists, we are tasked by the American College of Obstetricians and Gynecologists to provide nondiscriminatory care to all patients, regardless of gender identity.³ We must be careful not to assume that all of our patients are cisgender women who use “she/hers/her” pronouns. By simply asking patients what names or pronouns they would like us to use before initiating care, we become more sensitive to variations in gender identity. Many providers may feel uncertain about how to initiate or respond to this line of questioning. One way that health care practices can begin to respectfully access information around gender identity is to create intake forms that include more than two options for gender or to alter their office visit note templates to include a section that prompts the provider to include a discussion surrounding gender identity. By offering these opportunities for inclusion, we become more welcoming of gender minorities like transgender men seeking cervical cancer screening.

There are a number of reasons that trans persons have limited access to the health care system, but the greatest barrier reported by transgender patients is the paucity of knowledgeable providers.⁴Learning the common terminology used by the trans population is a logical first step for physicians seeking to provide more affirming care to an already marginalized patient population. Familiarity with this terminology normalizes the idea of gender diversity and subsequently reduces the risk of providers making assumptions about patients that contributes to suboptimal care.

Dr. Joyner is an assistant professor at Emory University, Atlanta, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joey Bahng is a PGY-1 resident physician in Emory University’s gynecology & obstetrics residency program. Dr. Bahng identifies as nonbinary and uses they/them/their as their personal pronouns. Dr. Joyner and Dr. Bahng reported no financial disclosures.

1. Lancet. 2016 Jul 23;388(10042):390-400.

2. www.genderbread.org/resource/genderbread-person-v4-0.

3. Obstet Gynecol. 2011 Dec;118(6):1454-8.

4. Curr Opin Endocrinol Diabetes Obes. 2016 Apr 1;23(2):168-71.

Integrating comprehensive and collaborative hepatitis C virus (HCV) care within a Veterans Affairs residential treatment program can substantially increase diagnosis and treatment of HCV-infected veterans with substance use disorder (SUD), according to the results of an evaluation study for the period from December 2014 to April 2018.

s-c-s/Thinkstock

A total of 97.5% (582/597) of patient admissions to the program were screened for HCV infection, and 12.7% (74/582) of the cases were confirmed to be HCV positive. All of the positive cases were sent to an infectious disease (ID) clinic for further evaluation and, if appropriate, to begin HCV pharmacotherapy, according to the report, published in the Journal of Substance Abuse Treatment.

Of the HCV-positive cases, 78.4% (58/74) received pharmacotherapy, with a sustained virologic response rate of 82.8% (48/58), wrote Mary Jane Burton, MD, of the G.V. (Sonny) Montgomery VA Medical Center, Jackson, Miss., and her colleagues.

As part of the program, all veterans admitted to the SUD residential program were offered screening for HCV. Veterans with negative screening results received education about how to remain HCV negative via handouts and veterans who screened positive received brief supportive counseling and were referred to the ID clinic via a consult. Veterans confirmed to have chronic HCV infection receive education and evaluation in the HCV clinic while they attend the residential SUD program. Treatment for HCV is instituted as early as feasible and prescribing is in accordance with VA guidelines (Department of Veterans Affairs, 2018), with the goal of initiating pharmacotherapy treatment for HCV while the veteran is still in the residential program, according to the researchers.

Following discharge from the program, veterans on HCV treatment are scheduled for follow-up every 2 weeks in the HCV treatment clinic for the remainder of their pharmacotherapy, the researchers added.

Patient-level barriers to HCV treatment among the SUD population include reduced health literacy, low health care utilization, comorbid mental health conditions, and poor social support, according to the literature. Because multidisciplinary approaches to HCV treatment that mitigate these barriers have been shown to increase treatment uptake among these patients, the VA program was initiated, the researchers stated. Dr. Burton and her colleagues reported that 18.9% (14/74) of the HCV-positive cases were newly diagnosed and would have likely gone undetected without this program (J Substance Abuse Treatment. 2019;98:9-14).

“We have demonstrated that integrating a comprehensive HCV screening, education, referral, and treatment program within residential SUD treatment is feasible and effective in diagnosing previously unrecognized HCV infections, transitioning veterans into HCV care, and promoting treatment initiation,” the researchers concluded.

The Department of Veterans Affairs and the VA Center for Innovation supported the study. Dr. Burton reported research support from Merck Sharpe & Dohme.

mlesney@mdedge.com

Integrating comprehensive and collaborative hepatitis C virus (HCV) care within a Veterans Affairs residential treatment program can substantially increase diagnosis and treatment of HCV-infected veterans with substance use disorder (SUD), according to the results of an evaluation study for the period from December 2014 to April 2018.

s-c-s/Thinkstock

A total of 97.5% (582/597) of patient admissions to the program were screened for HCV infection, and 12.7% (74/582) of the cases were confirmed to be HCV positive. All of the positive cases were sent to an infectious disease (ID) clinic for further evaluation and, if appropriate, to begin HCV pharmacotherapy, according to the report, published in the Journal of Substance Abuse Treatment.

Of the HCV-positive cases, 78.4% (58/74) received pharmacotherapy, with a sustained virologic response rate of 82.8% (48/58), wrote Mary Jane Burton, MD, of the G.V. (Sonny) Montgomery VA Medical Center, Jackson, Miss., and her colleagues.

As part of the program, all veterans admitted to the SUD residential program were offered screening for HCV. Veterans with negative screening results received education about how to remain HCV negative via handouts and veterans who screened positive received brief supportive counseling and were referred to the ID clinic via a consult. Veterans confirmed to have chronic HCV infection receive education and evaluation in the HCV clinic while they attend the residential SUD program. Treatment for HCV is instituted as early as feasible and prescribing is in accordance with VA guidelines (Department of Veterans Affairs, 2018), with the goal of initiating pharmacotherapy treatment for HCV while the veteran is still in the residential program, according to the researchers.

Following discharge from the program, veterans on HCV treatment are scheduled for follow-up every 2 weeks in the HCV treatment clinic for the remainder of their pharmacotherapy, the researchers added.

Patient-level barriers to HCV treatment among the SUD population include reduced health literacy, low health care utilization, comorbid mental health conditions, and poor social support, according to the literature. Because multidisciplinary approaches to HCV treatment that mitigate these barriers have been shown to increase treatment uptake among these patients, the VA program was initiated, the researchers stated. Dr. Burton and her colleagues reported that 18.9% (14/74) of the HCV-positive cases were newly diagnosed and would have likely gone undetected without this program (J Substance Abuse Treatment. 2019;98:9-14).

“We have demonstrated that integrating a comprehensive HCV screening, education, referral, and treatment program within residential SUD treatment is feasible and effective in diagnosing previously unrecognized HCV infections, transitioning veterans into HCV care, and promoting treatment initiation,” the researchers concluded.

The Department of Veterans Affairs and the VA Center for Innovation supported the study. Dr. Burton reported research support from Merck Sharpe & Dohme.

mlesney@mdedge.com

Integrating comprehensive and collaborative hepatitis C virus (HCV) care within a Veterans Affairs residential treatment program can substantially increase diagnosis and treatment of HCV-infected veterans with substance use disorder (SUD), according to the results of an evaluation study for the period from December 2014 to April 2018.

s-c-s/Thinkstock

A total of 97.5% (582/597) of patient admissions to the program were screened for HCV infection, and 12.7% (74/582) of the cases were confirmed to be HCV positive. All of the positive cases were sent to an infectious disease (ID) clinic for further evaluation and, if appropriate, to begin HCV pharmacotherapy, according to the report, published in the Journal of Substance Abuse Treatment.

Of the HCV-positive cases, 78.4% (58/74) received pharmacotherapy, with a sustained virologic response rate of 82.8% (48/58), wrote Mary Jane Burton, MD, of the G.V. (Sonny) Montgomery VA Medical Center, Jackson, Miss., and her colleagues.

As part of the program, all veterans admitted to the SUD residential program were offered screening for HCV. Veterans with negative screening results received education about how to remain HCV negative via handouts and veterans who screened positive received brief supportive counseling and were referred to the ID clinic via a consult. Veterans confirmed to have chronic HCV infection receive education and evaluation in the HCV clinic while they attend the residential SUD program. Treatment for HCV is instituted as early as feasible and prescribing is in accordance with VA guidelines (Department of Veterans Affairs, 2018), with the goal of initiating pharmacotherapy treatment for HCV while the veteran is still in the residential program, according to the researchers.

Following discharge from the program, veterans on HCV treatment are scheduled for follow-up every 2 weeks in the HCV treatment clinic for the remainder of their pharmacotherapy, the researchers added.

Patient-level barriers to HCV treatment among the SUD population include reduced health literacy, low health care utilization, comorbid mental health conditions, and poor social support, according to the literature. Because multidisciplinary approaches to HCV treatment that mitigate these barriers have been shown to increase treatment uptake among these patients, the VA program was initiated, the researchers stated. Dr. Burton and her colleagues reported that 18.9% (14/74) of the HCV-positive cases were newly diagnosed and would have likely gone undetected without this program (J Substance Abuse Treatment. 2019;98:9-14).

“We have demonstrated that integrating a comprehensive HCV screening, education, referral, and treatment program within residential SUD treatment is feasible and effective in diagnosing previously unrecognized HCV infections, transitioning veterans into HCV care, and promoting treatment initiation,” the researchers concluded.

The Department of Veterans Affairs and the VA Center for Innovation supported the study. Dr. Burton reported research support from Merck Sharpe & Dohme.

mlesney@mdedge.com

No significant difference in rate of death was found in patients who underwent either bilateral or single internal thoracic artery grafting during coronary artery bypass grafting (CABG) surgery, according to a randomized trial of patients who were scheduled to undergo CABG.

“At 10 years, in intention-to-treat analyses, there were no significant between-group differences in all-cause mortality,” wrote lead author David P. Taggart, MD, PhD, of the University of Oxford (England), and his coauthors, adding that “the results of this trial are not consistent with data from previous, nonrandomized studies.” The study was published in the New England Journal of Medicine.

In the multicenter, unblinded Arterial Revascularization Trial (ART), 3,102 patients with multivessel coronary artery disease were divided into two groups: the bilateral-graft group (1,548 patients) and the single-graft group (1,554). They were assigned to receive bilateral internal thoracic artery grafts or a standard single left internal thoracic artery graft during CABG, respectively. However, 13.9% of the patients in the bilateral-graft group received only a single internal thoracic artery graft, while 21.8% of those in the single-graft group also received a radial artery graft.


At 10-year follow-up, 644 patients (20.8%) had died; 315 deaths (20.3%) occurred in the bilateral-graft group and 329 (21.2%) occurred in the single-graft group. A total of 385 patients (24.9%) suffered MI, stroke, or death in the bilateral-graft group, compared with 425 (27.3%) in the single-graft group (hazard ratio, 0.90; 95% confidence interval, 0.79-1.03).

The coauthors noted several reasons that the results of their trial may not have matched previous data, including conflicting evidence about vein graft failure’s clinical effect on survival and the aforementioned patients who were assigned to a specific group but received alternate grafting. In addition, they acknowledged that ART was an unblinded trial and “biases may be introduced in the treatment of patients, depending on their randomization assignment.”

The study was supported by grants from the British Heart Foundation, the U.K. Medical Research Council, and the National Institute of Health Research Efficacy and Mechanistic Evaluation Program. No relevant conflicts of interest were reported.

SOURCE: Taggart DP et al. N Engl J Med. 2019 Jan 31. doi: 10.1056/NEJMoa1808783.

No significant difference in rate of death was found in patients who underwent either bilateral or single internal thoracic artery grafting during coronary artery bypass grafting (CABG) surgery, according to a randomized trial of patients who were scheduled to undergo CABG.

“At 10 years, in intention-to-treat analyses, there were no significant between-group differences in all-cause mortality,” wrote lead author David P. Taggart, MD, PhD, of the University of Oxford (England), and his coauthors, adding that “the results of this trial are not consistent with data from previous, nonrandomized studies.” The study was published in the New England Journal of Medicine.

In the multicenter, unblinded Arterial Revascularization Trial (ART), 3,102 patients with multivessel coronary artery disease were divided into two groups: the bilateral-graft group (1,548 patients) and the single-graft group (1,554). They were assigned to receive bilateral internal thoracic artery grafts or a standard single left internal thoracic artery graft during CABG, respectively. However, 13.9% of the patients in the bilateral-graft group received only a single internal thoracic artery graft, while 21.8% of those in the single-graft group also received a radial artery graft.


At 10-year follow-up, 644 patients (20.8%) had died; 315 deaths (20.3%) occurred in the bilateral-graft group and 329 (21.2%) occurred in the single-graft group. A total of 385 patients (24.9%) suffered MI, stroke, or death in the bilateral-graft group, compared with 425 (27.3%) in the single-graft group (hazard ratio, 0.90; 95% confidence interval, 0.79-1.03).

The coauthors noted several reasons that the results of their trial may not have matched previous data, including conflicting evidence about vein graft failure’s clinical effect on survival and the aforementioned patients who were assigned to a specific group but received alternate grafting. In addition, they acknowledged that ART was an unblinded trial and “biases may be introduced in the treatment of patients, depending on their randomization assignment.”

The study was supported by grants from the British Heart Foundation, the U.K. Medical Research Council, and the National Institute of Health Research Efficacy and Mechanistic Evaluation Program. No relevant conflicts of interest were reported.

SOURCE: Taggart DP et al. N Engl J Med. 2019 Jan 31. doi: 10.1056/NEJMoa1808783.

No significant difference in rate of death was found in patients who underwent either bilateral or single internal thoracic artery grafting during coronary artery bypass grafting (CABG) surgery, according to a randomized trial of patients who were scheduled to undergo CABG.

“At 10 years, in intention-to-treat analyses, there were no significant between-group differences in all-cause mortality,” wrote lead author David P. Taggart, MD, PhD, of the University of Oxford (England), and his coauthors, adding that “the results of this trial are not consistent with data from previous, nonrandomized studies.” The study was published in the New England Journal of Medicine.

In the multicenter, unblinded Arterial Revascularization Trial (ART), 3,102 patients with multivessel coronary artery disease were divided into two groups: the bilateral-graft group (1,548 patients) and the single-graft group (1,554). They were assigned to receive bilateral internal thoracic artery grafts or a standard single left internal thoracic artery graft during CABG, respectively. However, 13.9% of the patients in the bilateral-graft group received only a single internal thoracic artery graft, while 21.8% of those in the single-graft group also received a radial artery graft.


At 10-year follow-up, 644 patients (20.8%) had died; 315 deaths (20.3%) occurred in the bilateral-graft group and 329 (21.2%) occurred in the single-graft group. A total of 385 patients (24.9%) suffered MI, stroke, or death in the bilateral-graft group, compared with 425 (27.3%) in the single-graft group (hazard ratio, 0.90; 95% confidence interval, 0.79-1.03).

The coauthors noted several reasons that the results of their trial may not have matched previous data, including conflicting evidence about vein graft failure’s clinical effect on survival and the aforementioned patients who were assigned to a specific group but received alternate grafting. In addition, they acknowledged that ART was an unblinded trial and “biases may be introduced in the treatment of patients, depending on their randomization assignment.”

The study was supported by grants from the British Heart Foundation, the U.K. Medical Research Council, and the National Institute of Health Research Efficacy and Mechanistic Evaluation Program. No relevant conflicts of interest were reported.

SOURCE: Taggart DP et al. N Engl J Med. 2019 Jan 31. doi: 10.1056/NEJMoa1808783.

If you live in Spokane, Wash., 99213 and 99214 are important numbers. Interchanging the last two digits can send your mail into the Twilight Zone. Otherwise those five digit sequences have little significance to most Americans ... unless of course you are a physician. You have been told multiple times by practice administrators and business consultants that the failure to attach the proper sequence to your bill for services can threaten the sustainability of your practice’s bottom line or put you at risk for a costly fine.

utah778/Thinkstock

Numerical codes for office visits were not handed down on stone tablets. There was a time when a physician simply charged for something he called an “office visit” and about half that for a “short” office visit that took less time and probably nothing for a “quick recheck.” He chose the fees based on what he felt was reasonable. I remember reading of one physician who pegged his charges at a dollar per penny of the cost of a regular postage stamp. For a variety of obvious and some unfortunate reasons, these loosely structured fee structures have disappeared.

Now a physician is asked to justify his or her charges by documenting what transpired during the office visit. The patient always has been the best witness, and at least has some sense of how much work the physician has had to do to arrive at diagnosis and suggest a treatment plan. Because the patient usually was paying the bill and had a personal stake in the value of the services provided, this system seemed to make sense.

However, now some large corporate entity or government agency probably is paying the bill and would like some idea of what it is being billed for. Justifying the service provided now falls on the physician. When the billing codes were first introduced and before the payers became more curious, it was easy. I simply applied 99213 to all my office visits and once or twice a day I would code out a visit that seemed more complex as a 99214. I wasn’t keeping track of how many minutes I spent in each visit, how many questions I asked, or how many body parts I examined. Except for patients with injured extremities, everyone was pretty much getting the same exam. My coding was based on my perception of value and effort. If it took more time than usual to remove a bit of cerumen or reassure an unusually concerned parent I chalked that up as my misfortune, not a reason to code the visit as a 99214. If I felt I needed more money, I assumed that my best option was to see more patients. Neither the patients nor the payers seemed to be complaining.

But obviously somewhere someone felt that there were too many providers gaming the system and there needed to be a better way to assign value to what a physician was doing in his or her examining room. Not surprisingly, the current coding system is flawed. I don’t have a workable alternative. However, I always have felt that if the folks who were paying the bills would come visit my office (unannounced if they wish) and spend a morning watching me see patients, they could more accurately assign a value to my work. I’m not sure how many of you would be comfortable with that degree of transparency. But for me it would be worth it if it freed me from the burden of coding to justify my effort.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

If you live in Spokane, Wash., 99213 and 99214 are important numbers. Interchanging the last two digits can send your mail into the Twilight Zone. Otherwise those five digit sequences have little significance to most Americans ... unless of course you are a physician. You have been told multiple times by practice administrators and business consultants that the failure to attach the proper sequence to your bill for services can threaten the sustainability of your practice’s bottom line or put you at risk for a costly fine.

utah778/Thinkstock

Numerical codes for office visits were not handed down on stone tablets. There was a time when a physician simply charged for something he called an “office visit” and about half that for a “short” office visit that took less time and probably nothing for a “quick recheck.” He chose the fees based on what he felt was reasonable. I remember reading of one physician who pegged his charges at a dollar per penny of the cost of a regular postage stamp. For a variety of obvious and some unfortunate reasons, these loosely structured fee structures have disappeared.

Now a physician is asked to justify his or her charges by documenting what transpired during the office visit. The patient always has been the best witness, and at least has some sense of how much work the physician has had to do to arrive at diagnosis and suggest a treatment plan. Because the patient usually was paying the bill and had a personal stake in the value of the services provided, this system seemed to make sense.

However, now some large corporate entity or government agency probably is paying the bill and would like some idea of what it is being billed for. Justifying the service provided now falls on the physician. When the billing codes were first introduced and before the payers became more curious, it was easy. I simply applied 99213 to all my office visits and once or twice a day I would code out a visit that seemed more complex as a 99214. I wasn’t keeping track of how many minutes I spent in each visit, how many questions I asked, or how many body parts I examined. Except for patients with injured extremities, everyone was pretty much getting the same exam. My coding was based on my perception of value and effort. If it took more time than usual to remove a bit of cerumen or reassure an unusually concerned parent I chalked that up as my misfortune, not a reason to code the visit as a 99214. If I felt I needed more money, I assumed that my best option was to see more patients. Neither the patients nor the payers seemed to be complaining.

But obviously somewhere someone felt that there were too many providers gaming the system and there needed to be a better way to assign value to what a physician was doing in his or her examining room. Not surprisingly, the current coding system is flawed. I don’t have a workable alternative. However, I always have felt that if the folks who were paying the bills would come visit my office (unannounced if they wish) and spend a morning watching me see patients, they could more accurately assign a value to my work. I’m not sure how many of you would be comfortable with that degree of transparency. But for me it would be worth it if it freed me from the burden of coding to justify my effort.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

If you live in Spokane, Wash., 99213 and 99214 are important numbers. Interchanging the last two digits can send your mail into the Twilight Zone. Otherwise those five digit sequences have little significance to most Americans ... unless of course you are a physician. You have been told multiple times by practice administrators and business consultants that the failure to attach the proper sequence to your bill for services can threaten the sustainability of your practice’s bottom line or put you at risk for a costly fine.

utah778/Thinkstock

Numerical codes for office visits were not handed down on stone tablets. There was a time when a physician simply charged for something he called an “office visit” and about half that for a “short” office visit that took less time and probably nothing for a “quick recheck.” He chose the fees based on what he felt was reasonable. I remember reading of one physician who pegged his charges at a dollar per penny of the cost of a regular postage stamp. For a variety of obvious and some unfortunate reasons, these loosely structured fee structures have disappeared.

Now a physician is asked to justify his or her charges by documenting what transpired during the office visit. The patient always has been the best witness, and at least has some sense of how much work the physician has had to do to arrive at diagnosis and suggest a treatment plan. Because the patient usually was paying the bill and had a personal stake in the value of the services provided, this system seemed to make sense.

However, now some large corporate entity or government agency probably is paying the bill and would like some idea of what it is being billed for. Justifying the service provided now falls on the physician. When the billing codes were first introduced and before the payers became more curious, it was easy. I simply applied 99213 to all my office visits and once or twice a day I would code out a visit that seemed more complex as a 99214. I wasn’t keeping track of how many minutes I spent in each visit, how many questions I asked, or how many body parts I examined. Except for patients with injured extremities, everyone was pretty much getting the same exam. My coding was based on my perception of value and effort. If it took more time than usual to remove a bit of cerumen or reassure an unusually concerned parent I chalked that up as my misfortune, not a reason to code the visit as a 99214. If I felt I needed more money, I assumed that my best option was to see more patients. Neither the patients nor the payers seemed to be complaining.

But obviously somewhere someone felt that there were too many providers gaming the system and there needed to be a better way to assign value to what a physician was doing in his or her examining room. Not surprisingly, the current coding system is flawed. I don’t have a workable alternative. However, I always have felt that if the folks who were paying the bills would come visit my office (unannounced if they wish) and spend a morning watching me see patients, they could more accurately assign a value to my work. I’m not sure how many of you would be comfortable with that degree of transparency. But for me it would be worth it if it freed me from the burden of coding to justify my effort.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

CORONADO, CALIF. – Mild obstructive sleep apnea (OSA) resolves in about one-third of children younger than age 3 years after an observation period of 3-12 months, results from a single-center study showed.

“OSA affects up to 6% of the pediatric population, and diagnosis of young children can be particularly challenging due to the heterogeneity of presenting symptoms,” Douglas C. von Allmen, MD, said at the Triological Society’s Combined Sections Meeting. “While school-age children may present with snoring, that’s less common in the younger population. Up to one-quarter of infants may have noisy breathing, which may mimic obstructive events throughout the first 3 years of life. Additionally, long-term clinical implications of mild sleep apnea in very young children is unclear.”

According to Dr. von Allmen, a fifth-year otolaryngology resident at the University of Cincinnati, management strategies of children with OSA can include a period of observation, particularly when there’s an absence of concerning findings on polysomnography (PSG), such as hypoventilation or significant hypoxia, or when the primary etiology of the OSA is unknown. “Additionally, few studies at this point have attempted to characterize the natural history of mild OSA in pediatric patients under 3 years of age,” he said.

In an effort to assess the effects of observation on the PSG outcomes of children under 3 years with mild OSA, Dr. Von Allmen and his colleagues performed a retrospective review of 26 children who had an overnight PSG with a follow-up PSG performed 3-12 months later. They excluded patients with neuromuscular disease, tracheostomy, or interstitial lung disease. All PSGs were performed at the Cincinnati Children’s Hospital Medical Center between 2012 and 2017 and were scored by a board-certified sleep physician. The researchers defined mild OSA as at least one, but fewer than five, events per hour. The mean age of the 26 patients was 7 months, 65% were male, 92% were white, and their median body mass index was in the 39th percentile. Comorbidities include laryngomalacia (40%), cardiac disease (40%), allergies (34%), asthma (23%), and Down syndrome (11%).

Between baseline and follow-up, the apnea-hypoapnea index (AHI) trended downward from 4.3 to 3.4 events per hour (P = .19), the obstructive AHI decreased significantly from 2.7 to 1.3 events per hour (P = .013), while the central apnea index also trended downward from 1.4 to 1.2 events per hour (P = .60). The oxyhemoglobin nadir and sleep efficiency did not change significantly, but there was a decrease in the arousal index (from 14.7 to 13 events per hour; P = .027) and in the percentage of REM sleep (from 33% to 30%; P = .008).

As for postobservation OSA severity outcomes, eight patients (31%) resolved spontaneously, one patient progressed from mild to moderate OSA, and the rest remained in their mild OSA state. Subanalysis revealed that OSA resolution rate was 36% in patients with laryngomalacia, compared with 27% in those with no laryngomalacia, a difference that did not reach statistical significance (P = .98).

Dr. von Allmen pointed out that the study cohort had comorbidities which may have contributed to the persistence of OSA. He also acknowledged certain limitations of the study, including its retrospective nature, the potential for selection bias, the small sample size, and the fact that it did not include a control sample of normal children. “The presence of laryngomalacia did not affect the resolution rate in our cohort, but we’ll need larger studies to better elucidate the factors that do affect persistent disease and to identify the optimal timing of intervention in children with mild OSA,” he said.

Dr. von Allmen reported having no financial disclosures. The study received a resident research award at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.

SOURCE: von Allmen DC et al. Triological CSM, Abstracts.

CORONADO, CALIF. – Mild obstructive sleep apnea (OSA) resolves in about one-third of children younger than age 3 years after an observation period of 3-12 months, results from a single-center study showed.

“OSA affects up to 6% of the pediatric population, and diagnosis of young children can be particularly challenging due to the heterogeneity of presenting symptoms,” Douglas C. von Allmen, MD, said at the Triological Society’s Combined Sections Meeting. “While school-age children may present with snoring, that’s less common in the younger population. Up to one-quarter of infants may have noisy breathing, which may mimic obstructive events throughout the first 3 years of life. Additionally, long-term clinical implications of mild sleep apnea in very young children is unclear.”

According to Dr. von Allmen, a fifth-year otolaryngology resident at the University of Cincinnati, management strategies of children with OSA can include a period of observation, particularly when there’s an absence of concerning findings on polysomnography (PSG), such as hypoventilation or significant hypoxia, or when the primary etiology of the OSA is unknown. “Additionally, few studies at this point have attempted to characterize the natural history of mild OSA in pediatric patients under 3 years of age,” he said.

In an effort to assess the effects of observation on the PSG outcomes of children under 3 years with mild OSA, Dr. Von Allmen and his colleagues performed a retrospective review of 26 children who had an overnight PSG with a follow-up PSG performed 3-12 months later. They excluded patients with neuromuscular disease, tracheostomy, or interstitial lung disease. All PSGs were performed at the Cincinnati Children’s Hospital Medical Center between 2012 and 2017 and were scored by a board-certified sleep physician. The researchers defined mild OSA as at least one, but fewer than five, events per hour. The mean age of the 26 patients was 7 months, 65% were male, 92% were white, and their median body mass index was in the 39th percentile. Comorbidities include laryngomalacia (40%), cardiac disease (40%), allergies (34%), asthma (23%), and Down syndrome (11%).

Between baseline and follow-up, the apnea-hypoapnea index (AHI) trended downward from 4.3 to 3.4 events per hour (P = .19), the obstructive AHI decreased significantly from 2.7 to 1.3 events per hour (P = .013), while the central apnea index also trended downward from 1.4 to 1.2 events per hour (P = .60). The oxyhemoglobin nadir and sleep efficiency did not change significantly, but there was a decrease in the arousal index (from 14.7 to 13 events per hour; P = .027) and in the percentage of REM sleep (from 33% to 30%; P = .008).

As for postobservation OSA severity outcomes, eight patients (31%) resolved spontaneously, one patient progressed from mild to moderate OSA, and the rest remained in their mild OSA state. Subanalysis revealed that OSA resolution rate was 36% in patients with laryngomalacia, compared with 27% in those with no laryngomalacia, a difference that did not reach statistical significance (P = .98).

Dr. von Allmen pointed out that the study cohort had comorbidities which may have contributed to the persistence of OSA. He also acknowledged certain limitations of the study, including its retrospective nature, the potential for selection bias, the small sample size, and the fact that it did not include a control sample of normal children. “The presence of laryngomalacia did not affect the resolution rate in our cohort, but we’ll need larger studies to better elucidate the factors that do affect persistent disease and to identify the optimal timing of intervention in children with mild OSA,” he said.

Dr. von Allmen reported having no financial disclosures. The study received a resident research award at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.

SOURCE: von Allmen DC et al. Triological CSM, Abstracts.

CORONADO, CALIF. – Mild obstructive sleep apnea (OSA) resolves in about one-third of children younger than age 3 years after an observation period of 3-12 months, results from a single-center study showed.

“OSA affects up to 6% of the pediatric population, and diagnosis of young children can be particularly challenging due to the heterogeneity of presenting symptoms,” Douglas C. von Allmen, MD, said at the Triological Society’s Combined Sections Meeting. “While school-age children may present with snoring, that’s less common in the younger population. Up to one-quarter of infants may have noisy breathing, which may mimic obstructive events throughout the first 3 years of life. Additionally, long-term clinical implications of mild sleep apnea in very young children is unclear.”

According to Dr. von Allmen, a fifth-year otolaryngology resident at the University of Cincinnati, management strategies of children with OSA can include a period of observation, particularly when there’s an absence of concerning findings on polysomnography (PSG), such as hypoventilation or significant hypoxia, or when the primary etiology of the OSA is unknown. “Additionally, few studies at this point have attempted to characterize the natural history of mild OSA in pediatric patients under 3 years of age,” he said.

In an effort to assess the effects of observation on the PSG outcomes of children under 3 years with mild OSA, Dr. Von Allmen and his colleagues performed a retrospective review of 26 children who had an overnight PSG with a follow-up PSG performed 3-12 months later. They excluded patients with neuromuscular disease, tracheostomy, or interstitial lung disease. All PSGs were performed at the Cincinnati Children’s Hospital Medical Center between 2012 and 2017 and were scored by a board-certified sleep physician. The researchers defined mild OSA as at least one, but fewer than five, events per hour. The mean age of the 26 patients was 7 months, 65% were male, 92% were white, and their median body mass index was in the 39th percentile. Comorbidities include laryngomalacia (40%), cardiac disease (40%), allergies (34%), asthma (23%), and Down syndrome (11%).

Between baseline and follow-up, the apnea-hypoapnea index (AHI) trended downward from 4.3 to 3.4 events per hour (P = .19), the obstructive AHI decreased significantly from 2.7 to 1.3 events per hour (P = .013), while the central apnea index also trended downward from 1.4 to 1.2 events per hour (P = .60). The oxyhemoglobin nadir and sleep efficiency did not change significantly, but there was a decrease in the arousal index (from 14.7 to 13 events per hour; P = .027) and in the percentage of REM sleep (from 33% to 30%; P = .008).

As for postobservation OSA severity outcomes, eight patients (31%) resolved spontaneously, one patient progressed from mild to moderate OSA, and the rest remained in their mild OSA state. Subanalysis revealed that OSA resolution rate was 36% in patients with laryngomalacia, compared with 27% in those with no laryngomalacia, a difference that did not reach statistical significance (P = .98).

Dr. von Allmen pointed out that the study cohort had comorbidities which may have contributed to the persistence of OSA. He also acknowledged certain limitations of the study, including its retrospective nature, the potential for selection bias, the small sample size, and the fact that it did not include a control sample of normal children. “The presence of laryngomalacia did not affect the resolution rate in our cohort, but we’ll need larger studies to better elucidate the factors that do affect persistent disease and to identify the optimal timing of intervention in children with mild OSA,” he said.

Dr. von Allmen reported having no financial disclosures. The study received a resident research award at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.

SOURCE: von Allmen DC et al. Triological CSM, Abstracts.