Blood test shows potential as an early biomarker of methotrexate inefficacy

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A newly developed gene expression classifier may be able to identify rheumatoid arthritis patients who are unlikely to benefit from methotrexate, according to an analysis of blood samples from patients who had just begun the drug.

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“This study highlights the potential of early treatment biomarker monitoring in RA and raises important questions regarding acceptable levels of performance for complementary diagnostic testing,” wrote lead author Darren Plant, PhD, of the University of Manchester (England), and his coauthors. The study was published in Arthritis & Rheumatology.

The study analyzed 85 participants in the Rheumatoid Arthritis Medication Study, a U.K.-based longitudinal observational study of RA patients taking methotrexate for the first time, and classified them as either good responders (n = 42) or nonresponders (n = 43) after 6 months on the drug, based on European League Against Rheumatism response criteria. Dr. Plant and his colleagues then performed gene expression profiling on whole-blood samples from those participants, collected before treatment and after 4 weeks on methotrexate.

Ultimately, pathway analysis indicated an overrepresentation of type 1 interferon signaling pathway genes in nonresponsive patients at both pretreatment (P = 2.8 x 10-25) and 4 weeks (P = 4.9 x 10-28). As such, the coauthors “developed a gene expression classifier that could potentially provide an early response biomarker of methotrexate inefficacy” at 6 months based on the gene expression ratio between 4 weeks and pretreatment, which yielded an area under the receiver operating characteristic curve (ROC AUC) of 0.78. This was proven stable in cross validation and superior to models including clinical covariates (ROC AUC = 0.65).



The authors did not replicate the results in an independent cohort, but the authors noted that the “utility of a gene expression classifier of methotrexate nonresponse now requires validation, not only in independent samples but also using independent technology.”

The study was also potentially limited by the fact that the patients at baseline were atypical in having a long disease duration at a median of 6-9 years but relatively low disease activity, based on a mean 28-joint Disease Activity Score (DAS28) of 4.8 in good responders and 4.0 in nonresponders. The authors also acknowledged both the objective and subjective nature of the DAS28 and its components in approximating disease activity. The authors also did not include a negative predictive value in their analysis, which would have been useful in considering the value of the test.

The study was jointly funded by Pfizer, the Medical Research Council, and Arthritis Research UK. No conflicts of interest were reported.

SOURCE: Plant D et al. Arthritis Rheumatol. 2019 Jan 7. doi: 10.1002/art.40810.

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A newly developed gene expression classifier may be able to identify rheumatoid arthritis patients who are unlikely to benefit from methotrexate, according to an analysis of blood samples from patients who had just begun the drug.

copyright Martynasfoto/Thinkstock

“This study highlights the potential of early treatment biomarker monitoring in RA and raises important questions regarding acceptable levels of performance for complementary diagnostic testing,” wrote lead author Darren Plant, PhD, of the University of Manchester (England), and his coauthors. The study was published in Arthritis & Rheumatology.

The study analyzed 85 participants in the Rheumatoid Arthritis Medication Study, a U.K.-based longitudinal observational study of RA patients taking methotrexate for the first time, and classified them as either good responders (n = 42) or nonresponders (n = 43) after 6 months on the drug, based on European League Against Rheumatism response criteria. Dr. Plant and his colleagues then performed gene expression profiling on whole-blood samples from those participants, collected before treatment and after 4 weeks on methotrexate.

Ultimately, pathway analysis indicated an overrepresentation of type 1 interferon signaling pathway genes in nonresponsive patients at both pretreatment (P = 2.8 x 10-25) and 4 weeks (P = 4.9 x 10-28). As such, the coauthors “developed a gene expression classifier that could potentially provide an early response biomarker of methotrexate inefficacy” at 6 months based on the gene expression ratio between 4 weeks and pretreatment, which yielded an area under the receiver operating characteristic curve (ROC AUC) of 0.78. This was proven stable in cross validation and superior to models including clinical covariates (ROC AUC = 0.65).



The authors did not replicate the results in an independent cohort, but the authors noted that the “utility of a gene expression classifier of methotrexate nonresponse now requires validation, not only in independent samples but also using independent technology.”

The study was also potentially limited by the fact that the patients at baseline were atypical in having a long disease duration at a median of 6-9 years but relatively low disease activity, based on a mean 28-joint Disease Activity Score (DAS28) of 4.8 in good responders and 4.0 in nonresponders. The authors also acknowledged both the objective and subjective nature of the DAS28 and its components in approximating disease activity. The authors also did not include a negative predictive value in their analysis, which would have been useful in considering the value of the test.

The study was jointly funded by Pfizer, the Medical Research Council, and Arthritis Research UK. No conflicts of interest were reported.

SOURCE: Plant D et al. Arthritis Rheumatol. 2019 Jan 7. doi: 10.1002/art.40810.

 

A newly developed gene expression classifier may be able to identify rheumatoid arthritis patients who are unlikely to benefit from methotrexate, according to an analysis of blood samples from patients who had just begun the drug.

copyright Martynasfoto/Thinkstock

“This study highlights the potential of early treatment biomarker monitoring in RA and raises important questions regarding acceptable levels of performance for complementary diagnostic testing,” wrote lead author Darren Plant, PhD, of the University of Manchester (England), and his coauthors. The study was published in Arthritis & Rheumatology.

The study analyzed 85 participants in the Rheumatoid Arthritis Medication Study, a U.K.-based longitudinal observational study of RA patients taking methotrexate for the first time, and classified them as either good responders (n = 42) or nonresponders (n = 43) after 6 months on the drug, based on European League Against Rheumatism response criteria. Dr. Plant and his colleagues then performed gene expression profiling on whole-blood samples from those participants, collected before treatment and after 4 weeks on methotrexate.

Ultimately, pathway analysis indicated an overrepresentation of type 1 interferon signaling pathway genes in nonresponsive patients at both pretreatment (P = 2.8 x 10-25) and 4 weeks (P = 4.9 x 10-28). As such, the coauthors “developed a gene expression classifier that could potentially provide an early response biomarker of methotrexate inefficacy” at 6 months based on the gene expression ratio between 4 weeks and pretreatment, which yielded an area under the receiver operating characteristic curve (ROC AUC) of 0.78. This was proven stable in cross validation and superior to models including clinical covariates (ROC AUC = 0.65).



The authors did not replicate the results in an independent cohort, but the authors noted that the “utility of a gene expression classifier of methotrexate nonresponse now requires validation, not only in independent samples but also using independent technology.”

The study was also potentially limited by the fact that the patients at baseline were atypical in having a long disease duration at a median of 6-9 years but relatively low disease activity, based on a mean 28-joint Disease Activity Score (DAS28) of 4.8 in good responders and 4.0 in nonresponders. The authors also acknowledged both the objective and subjective nature of the DAS28 and its components in approximating disease activity. The authors also did not include a negative predictive value in their analysis, which would have been useful in considering the value of the test.

The study was jointly funded by Pfizer, the Medical Research Council, and Arthritis Research UK. No conflicts of interest were reported.

SOURCE: Plant D et al. Arthritis Rheumatol. 2019 Jan 7. doi: 10.1002/art.40810.

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Key clinical point: Whole-blood gene expression profiling in RA patients may help to predict early nonresponse to methotrexate.

Major finding: A blood test that uses a gene expression ratio between 4 weeks and pretreatment yielded a ROC AUC of 0.78 for predicting methotrexate inefficacy at 6 months.

Study details: An analysis of blood samples from 85 participants in a U.K.-based longitudinal observational study of RA patients starting methotrexate for the first time.

Disclosures: The study was jointly funded by Pfizer, the Medical Research Council, and Arthritis Research UK. No conflicts of interest were reported.

Source: Plant D et al. Arthritis Rheumatol. 2019 Jan 7. doi: 10.1002/art.40810.

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Ducray Densiage Redensifying Hair Care to Launch in March

Ducray Laboratoires Dermatologiques introduces the Densiage Redensifying hair care line for patients with thin and brittle hair. This line consists of 4 products: the Densiage Redensifying Shampoo to noticeably improve hair quality; the Densiage Redensifying Conditioner to provide detangling benefits and leave hair softer; the Densiage Redensifying Serum to promote development of thicker denser hair with more volume; and the Densiage Dietary Supplement for Aging Hair to provide nutrients to maintain hair density and protect against signs of aging. The line will be available in March 2019. For more information, visit www.ducray.com.

Revance Announces Phase 3 Results for Neuromodulator DaxibotulinumtoxinA

Revance Therapeutics, Inc, works to submit a Biologics License Application with the US Food and Drug Administration in the first half of 2019 for its injectable neuromodulator  axibotulinumtoxinA (RT002) following results from a phase 3 open-label, longterm safety study on treating moderate to severe glabellar (frown) lines. Participants received up to 3 treatments of RT002 and were followed for more than 1.5 years. Overall, the safety findings were consistent with the known safety profiles for currently available neuromodulators in aesthetics. Measuring duration of effect, the median time to return to baseline glabellar line severity was 28 weeks. The median time to loss of none or mild wrinkle severity was 24 weeks. The results demonstrate that RT002, utilizing proprietary stabilizing excipient peptide technology in its formulation, produces long duration and high response rates and is well tolerated over successive treatments. For more information, visit www.revance.com.

SNA-120 Demonstrates Potential for Psoriasis in Phase 2b Trial

Sienna Biopharmaceuticals announces results of a phase 2b study of the tropomyosin receptor kinase A (TrkA) inhibitor SNA-120 (pegcantratinib) for mild to moderate psoriasis, with itch as the primary end point. SNA-120 blocks nerve growth factor signaling, which plays an important role in the pathogenesis of psoriasis and itch. Participants (N=208) achieved 58% improvement in itch from baseline; efficacy results indicated 75% reduction in psoriasis area and severity index score from baseline in 27% of participants versus 13% with vehicle, and 29% of participants achieved 2-grade improvement in investigator global assessment versus 13% with vehicle. These results demonstrate the potential of SNA-120 as a topical nonsteroidal treatment of psoriasis. Phase 3 studies for psoriasis will begin in the second half of 2019. For more information, visit www.siennabio.com.

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Ducray Densiage Redensifying Hair Care to Launch in March

Ducray Laboratoires Dermatologiques introduces the Densiage Redensifying hair care line for patients with thin and brittle hair. This line consists of 4 products: the Densiage Redensifying Shampoo to noticeably improve hair quality; the Densiage Redensifying Conditioner to provide detangling benefits and leave hair softer; the Densiage Redensifying Serum to promote development of thicker denser hair with more volume; and the Densiage Dietary Supplement for Aging Hair to provide nutrients to maintain hair density and protect against signs of aging. The line will be available in March 2019. For more information, visit www.ducray.com.

Revance Announces Phase 3 Results for Neuromodulator DaxibotulinumtoxinA

Revance Therapeutics, Inc, works to submit a Biologics License Application with the US Food and Drug Administration in the first half of 2019 for its injectable neuromodulator  axibotulinumtoxinA (RT002) following results from a phase 3 open-label, longterm safety study on treating moderate to severe glabellar (frown) lines. Participants received up to 3 treatments of RT002 and were followed for more than 1.5 years. Overall, the safety findings were consistent with the known safety profiles for currently available neuromodulators in aesthetics. Measuring duration of effect, the median time to return to baseline glabellar line severity was 28 weeks. The median time to loss of none or mild wrinkle severity was 24 weeks. The results demonstrate that RT002, utilizing proprietary stabilizing excipient peptide technology in its formulation, produces long duration and high response rates and is well tolerated over successive treatments. For more information, visit www.revance.com.

SNA-120 Demonstrates Potential for Psoriasis in Phase 2b Trial

Sienna Biopharmaceuticals announces results of a phase 2b study of the tropomyosin receptor kinase A (TrkA) inhibitor SNA-120 (pegcantratinib) for mild to moderate psoriasis, with itch as the primary end point. SNA-120 blocks nerve growth factor signaling, which plays an important role in the pathogenesis of psoriasis and itch. Participants (N=208) achieved 58% improvement in itch from baseline; efficacy results indicated 75% reduction in psoriasis area and severity index score from baseline in 27% of participants versus 13% with vehicle, and 29% of participants achieved 2-grade improvement in investigator global assessment versus 13% with vehicle. These results demonstrate the potential of SNA-120 as a topical nonsteroidal treatment of psoriasis. Phase 3 studies for psoriasis will begin in the second half of 2019. For more information, visit www.siennabio.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].

Ducray Densiage Redensifying Hair Care to Launch in March

Ducray Laboratoires Dermatologiques introduces the Densiage Redensifying hair care line for patients with thin and brittle hair. This line consists of 4 products: the Densiage Redensifying Shampoo to noticeably improve hair quality; the Densiage Redensifying Conditioner to provide detangling benefits and leave hair softer; the Densiage Redensifying Serum to promote development of thicker denser hair with more volume; and the Densiage Dietary Supplement for Aging Hair to provide nutrients to maintain hair density and protect against signs of aging. The line will be available in March 2019. For more information, visit www.ducray.com.

Revance Announces Phase 3 Results for Neuromodulator DaxibotulinumtoxinA

Revance Therapeutics, Inc, works to submit a Biologics License Application with the US Food and Drug Administration in the first half of 2019 for its injectable neuromodulator  axibotulinumtoxinA (RT002) following results from a phase 3 open-label, longterm safety study on treating moderate to severe glabellar (frown) lines. Participants received up to 3 treatments of RT002 and were followed for more than 1.5 years. Overall, the safety findings were consistent with the known safety profiles for currently available neuromodulators in aesthetics. Measuring duration of effect, the median time to return to baseline glabellar line severity was 28 weeks. The median time to loss of none or mild wrinkle severity was 24 weeks. The results demonstrate that RT002, utilizing proprietary stabilizing excipient peptide technology in its formulation, produces long duration and high response rates and is well tolerated over successive treatments. For more information, visit www.revance.com.

SNA-120 Demonstrates Potential for Psoriasis in Phase 2b Trial

Sienna Biopharmaceuticals announces results of a phase 2b study of the tropomyosin receptor kinase A (TrkA) inhibitor SNA-120 (pegcantratinib) for mild to moderate psoriasis, with itch as the primary end point. SNA-120 blocks nerve growth factor signaling, which plays an important role in the pathogenesis of psoriasis and itch. Participants (N=208) achieved 58% improvement in itch from baseline; efficacy results indicated 75% reduction in psoriasis area and severity index score from baseline in 27% of participants versus 13% with vehicle, and 29% of participants achieved 2-grade improvement in investigator global assessment versus 13% with vehicle. These results demonstrate the potential of SNA-120 as a topical nonsteroidal treatment of psoriasis. Phase 3 studies for psoriasis will begin in the second half of 2019. For more information, visit www.siennabio.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].

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Population-level rate of SUDEP may have decreased

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The population-level rate of sudden unexpected death in epilepsy (SUDEP) may have decreased over time, according to data described at the annual meeting of the American Epilepsy Society. Whether this decrease resulted from an improved understanding of SUDEP risk or a focus on risk-reduction strategies is unknown, said Daniel Friedman, MD, associate professor of neurology at the New York University Langone Health.

Dr. Daniel Friedman

In addition, the rates of SUDEP in various populations differ according to their socioeconomic status. Differences in access to care are a potential, but unconfirmed, explanation for this association, said Dr. Friedman. Another possible explanation is that confounders such as mental health disorders, substance abuse, and insufficient social support affect individuals’ ability to manage their disorder.

Dr. Friedman and colleagues initially examined SUDEP rates over time in a cohort of patients who received vagus nerve stimulator (VNS) implantation for drug-resistant epilepsy. They analyzed data for 40,443 patients who underwent surgery during 1988-2012. The age-adjusted SUDEP rate per 1,000 person-years of follow-up decreased significantly from 2.47 in years 1-2 to 1.68 in years 3-10. “There was no control group, so we couldn’t necessarily attribute the SUDEP rate reduction to the intervention,” said Dr. Friedman. A study by Tomson et al of patients with epilepsy who received VNS implantation had similar findings.

The literature about the mechanisms of SUDEP and reduction of SUDEP risk has increased in recent years. Neurologists have advocated for greater disclosure to patients of SUDEP risk, as well as better risk counseling. Dr. Friedman and his colleagues decided to investigate whether these factors have affected the risk of SUDEP during the past decade.

They retrospectively examined data for people whose deaths had been investigated at medical examiner’s offices in New York City, San Diego County, and Maryland. They focused on decedents for whom epilepsy or seizure was listed as a cause or contributor to death or as a comorbid condition on the death certificate. They reviewed all available reports, including investigator notes, autopsy reports, and medical records. Next, Dr. Friedman and his colleagues calculated the annual SUDEP rate as a proportion of the general population, estimated using annual Census and American Community Survey data. They used the Mann-Kendall test to analyze the trends in SUDEP rate during 2009-2015.

Of 1,466 deaths in people with epilepsy during this period, 1,124 were classified as definite SUDEP, probable SUDEP, or near SUDEP. Approximately 63% of SUDEP cases were male, and 45% were African-American. The mean age at death was 38 years.

Dr. Friedman’s group found a significant decrease in the overall incidence of SUDEP in the total population during 2009-2015. When they examined the three regions separately, they found decreases in SUDEP incidence in New York City and Maryland, but not in San Diego County. They found no difference in SUDEP rates by season or by day of the week.

In a subsequent analysis, Dr. Friedman and his colleagues adjudicated all deaths related to seizure and epilepsy in the three regions during 2009-2010 and 2014-2015 and identified all cases of definite and probable SUDEP. The estimated rate of SUDEP decreased by about 36% from the first period to the second period. SUDEP rates as a proportion of the total population in those regions also declined.

The investigators also examined differences in estimated SUDEP rates in the United States according to median household income. In New York, the zip codes with the highest SUDEP rates tended to have the lowest median household incomes. The zip codes in the lowest quartile of family household income had a SUDEP rate more than twice as high as that in the zip codes in the highest income quartile. This association held true for the period from 2009-2010 and for 2014-2015.

Dr. Friedman and colleagues received funding from Finding a Cure for Epilepsy and Seizures, which is affiliated with the NYU Comprehensive Epilepsy Center and NYU Langone Health.
 

SOURCE: Cihan E et al. AES 2018, Abstract 2.419.

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The population-level rate of sudden unexpected death in epilepsy (SUDEP) may have decreased over time, according to data described at the annual meeting of the American Epilepsy Society. Whether this decrease resulted from an improved understanding of SUDEP risk or a focus on risk-reduction strategies is unknown, said Daniel Friedman, MD, associate professor of neurology at the New York University Langone Health.

Dr. Daniel Friedman

In addition, the rates of SUDEP in various populations differ according to their socioeconomic status. Differences in access to care are a potential, but unconfirmed, explanation for this association, said Dr. Friedman. Another possible explanation is that confounders such as mental health disorders, substance abuse, and insufficient social support affect individuals’ ability to manage their disorder.

Dr. Friedman and colleagues initially examined SUDEP rates over time in a cohort of patients who received vagus nerve stimulator (VNS) implantation for drug-resistant epilepsy. They analyzed data for 40,443 patients who underwent surgery during 1988-2012. The age-adjusted SUDEP rate per 1,000 person-years of follow-up decreased significantly from 2.47 in years 1-2 to 1.68 in years 3-10. “There was no control group, so we couldn’t necessarily attribute the SUDEP rate reduction to the intervention,” said Dr. Friedman. A study by Tomson et al of patients with epilepsy who received VNS implantation had similar findings.

The literature about the mechanisms of SUDEP and reduction of SUDEP risk has increased in recent years. Neurologists have advocated for greater disclosure to patients of SUDEP risk, as well as better risk counseling. Dr. Friedman and his colleagues decided to investigate whether these factors have affected the risk of SUDEP during the past decade.

They retrospectively examined data for people whose deaths had been investigated at medical examiner’s offices in New York City, San Diego County, and Maryland. They focused on decedents for whom epilepsy or seizure was listed as a cause or contributor to death or as a comorbid condition on the death certificate. They reviewed all available reports, including investigator notes, autopsy reports, and medical records. Next, Dr. Friedman and his colleagues calculated the annual SUDEP rate as a proportion of the general population, estimated using annual Census and American Community Survey data. They used the Mann-Kendall test to analyze the trends in SUDEP rate during 2009-2015.

Of 1,466 deaths in people with epilepsy during this period, 1,124 were classified as definite SUDEP, probable SUDEP, or near SUDEP. Approximately 63% of SUDEP cases were male, and 45% were African-American. The mean age at death was 38 years.

Dr. Friedman’s group found a significant decrease in the overall incidence of SUDEP in the total population during 2009-2015. When they examined the three regions separately, they found decreases in SUDEP incidence in New York City and Maryland, but not in San Diego County. They found no difference in SUDEP rates by season or by day of the week.

In a subsequent analysis, Dr. Friedman and his colleagues adjudicated all deaths related to seizure and epilepsy in the three regions during 2009-2010 and 2014-2015 and identified all cases of definite and probable SUDEP. The estimated rate of SUDEP decreased by about 36% from the first period to the second period. SUDEP rates as a proportion of the total population in those regions also declined.

The investigators also examined differences in estimated SUDEP rates in the United States according to median household income. In New York, the zip codes with the highest SUDEP rates tended to have the lowest median household incomes. The zip codes in the lowest quartile of family household income had a SUDEP rate more than twice as high as that in the zip codes in the highest income quartile. This association held true for the period from 2009-2010 and for 2014-2015.

Dr. Friedman and colleagues received funding from Finding a Cure for Epilepsy and Seizures, which is affiliated with the NYU Comprehensive Epilepsy Center and NYU Langone Health.
 

SOURCE: Cihan E et al. AES 2018, Abstract 2.419.

The population-level rate of sudden unexpected death in epilepsy (SUDEP) may have decreased over time, according to data described at the annual meeting of the American Epilepsy Society. Whether this decrease resulted from an improved understanding of SUDEP risk or a focus on risk-reduction strategies is unknown, said Daniel Friedman, MD, associate professor of neurology at the New York University Langone Health.

Dr. Daniel Friedman

In addition, the rates of SUDEP in various populations differ according to their socioeconomic status. Differences in access to care are a potential, but unconfirmed, explanation for this association, said Dr. Friedman. Another possible explanation is that confounders such as mental health disorders, substance abuse, and insufficient social support affect individuals’ ability to manage their disorder.

Dr. Friedman and colleagues initially examined SUDEP rates over time in a cohort of patients who received vagus nerve stimulator (VNS) implantation for drug-resistant epilepsy. They analyzed data for 40,443 patients who underwent surgery during 1988-2012. The age-adjusted SUDEP rate per 1,000 person-years of follow-up decreased significantly from 2.47 in years 1-2 to 1.68 in years 3-10. “There was no control group, so we couldn’t necessarily attribute the SUDEP rate reduction to the intervention,” said Dr. Friedman. A study by Tomson et al of patients with epilepsy who received VNS implantation had similar findings.

The literature about the mechanisms of SUDEP and reduction of SUDEP risk has increased in recent years. Neurologists have advocated for greater disclosure to patients of SUDEP risk, as well as better risk counseling. Dr. Friedman and his colleagues decided to investigate whether these factors have affected the risk of SUDEP during the past decade.

They retrospectively examined data for people whose deaths had been investigated at medical examiner’s offices in New York City, San Diego County, and Maryland. They focused on decedents for whom epilepsy or seizure was listed as a cause or contributor to death or as a comorbid condition on the death certificate. They reviewed all available reports, including investigator notes, autopsy reports, and medical records. Next, Dr. Friedman and his colleagues calculated the annual SUDEP rate as a proportion of the general population, estimated using annual Census and American Community Survey data. They used the Mann-Kendall test to analyze the trends in SUDEP rate during 2009-2015.

Of 1,466 deaths in people with epilepsy during this period, 1,124 were classified as definite SUDEP, probable SUDEP, or near SUDEP. Approximately 63% of SUDEP cases were male, and 45% were African-American. The mean age at death was 38 years.

Dr. Friedman’s group found a significant decrease in the overall incidence of SUDEP in the total population during 2009-2015. When they examined the three regions separately, they found decreases in SUDEP incidence in New York City and Maryland, but not in San Diego County. They found no difference in SUDEP rates by season or by day of the week.

In a subsequent analysis, Dr. Friedman and his colleagues adjudicated all deaths related to seizure and epilepsy in the three regions during 2009-2010 and 2014-2015 and identified all cases of definite and probable SUDEP. The estimated rate of SUDEP decreased by about 36% from the first period to the second period. SUDEP rates as a proportion of the total population in those regions also declined.

The investigators also examined differences in estimated SUDEP rates in the United States according to median household income. In New York, the zip codes with the highest SUDEP rates tended to have the lowest median household incomes. The zip codes in the lowest quartile of family household income had a SUDEP rate more than twice as high as that in the zip codes in the highest income quartile. This association held true for the period from 2009-2010 and for 2014-2015.

Dr. Friedman and colleagues received funding from Finding a Cure for Epilepsy and Seizures, which is affiliated with the NYU Comprehensive Epilepsy Center and NYU Langone Health.
 

SOURCE: Cihan E et al. AES 2018, Abstract 2.419.

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Key clinical point: Data indicate a decline over time in the incidence of SUDEP.

Major finding: The incidence of SUDEP declined by 36% from 2009-2010 to 2014-2015.

Study details: A retrospective analysis of medical examiner data on 1,466 deaths in people with epilepsy.

Disclosures: Finding a Cure for Epilepsy and Seizures provided funding for the study.

Source: Cihan E et al. AES 2018, Abstract 2.419.

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Adding veliparib to doublet therapy for NSCLC gives slight boost in PFS

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Adding the poly (ADP-ribose) polymerase (PARP) inhibitor veliparib to platinum doublet chemotherapy modestly improved progression-free survival in a randomized, placebo-controlled, phase 2 trial of 128 patients with extensive-stage non–small cell lung cancer.

Improved progression-free survival (PFS) “did not translate into reduction in overall mortality for patients treated with veliparib. However, the improvement in the point estimate of PFS was quite modest at 6.1 months, compared with 5.5 months [in the placebo control arm],” wrote Taofeek K. Owonikoko, MD, PhD, of Emory University, Atlanta, together with his coinvestigators in the Journal of Clinical Oncology.

Preclinical studies suggest that veliparib helps potentiate standard chemotherapy of non–small cell lung cancer (NSCLC), but clinical trials have yielded mixed results for PARP inhibition in this cancer. Patients in this study had untreated, extensive-stage NSCLC and an Eastern Cooperative Oncology Group performance status of 0 or 1. They received four 3-week cycles of cisplatin-etoposide (75 mg/m2 intravenously on day 1 and 100 mg/m2 on days 1-3) plus either veliparib (100 mg orally twice per day on days 1-7) or placebo.

Grade 3 or higher lymphopenia and neutropenia were more common in the veliparib arm but did not reduce treatment delivery. After a median follow-up time of 18.5 months, overall response rate was 72% in the veliparib arm versus 66% in the control arm (P =.57). Median overall survival times were 10.3 months and 8.9 months, respectively (hazard ratio, 0.83; P = .17).

The unstratified HR for PFS favored the veliparib-doublet arm but did not reach statistical significance (0.75; P = .06). After stratifying patients by sex and serum lactate dehydrogenase levels, the HR for PFS favored veliparib-doublet chemotherapy (0.63; P = .01). However, veliparib showed a much stronger effect in the subgroup of men with abnormal lactate dehydrogenase levels (adjusted HR, 0.34; P less than .001), which violated the “proportional hazards within strata assumption” on which this model was based, rendering the overall stratified HR uninterpretable, the researchers wrote.

They added that, before pursuing a larger definitive clinical trial, they await results from the ongoing phase 2 M14-361 study, in which patients with extensive-stage NSCLC are receiving platinum doublet therapy with carboplatin-etoposide plus either veliparib or placebo.

Funders included the Eastern Cooperative Oncology Group–American College of Radiology Imaging Network Cancer Research Group and the National Cancer Institute. Dr. Owonikoko reported ties to Novartis, Astellas Pharma, Celgene, and several other pharmaceutical companies.

SOURCE: Owonikoko TK et al. J Clin Oncol. 2018 Dec 5. doi: 10.1200/JCO.18.00264.

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Adding the poly (ADP-ribose) polymerase (PARP) inhibitor veliparib to platinum doublet chemotherapy modestly improved progression-free survival in a randomized, placebo-controlled, phase 2 trial of 128 patients with extensive-stage non–small cell lung cancer.

Improved progression-free survival (PFS) “did not translate into reduction in overall mortality for patients treated with veliparib. However, the improvement in the point estimate of PFS was quite modest at 6.1 months, compared with 5.5 months [in the placebo control arm],” wrote Taofeek K. Owonikoko, MD, PhD, of Emory University, Atlanta, together with his coinvestigators in the Journal of Clinical Oncology.

Preclinical studies suggest that veliparib helps potentiate standard chemotherapy of non–small cell lung cancer (NSCLC), but clinical trials have yielded mixed results for PARP inhibition in this cancer. Patients in this study had untreated, extensive-stage NSCLC and an Eastern Cooperative Oncology Group performance status of 0 or 1. They received four 3-week cycles of cisplatin-etoposide (75 mg/m2 intravenously on day 1 and 100 mg/m2 on days 1-3) plus either veliparib (100 mg orally twice per day on days 1-7) or placebo.

Grade 3 or higher lymphopenia and neutropenia were more common in the veliparib arm but did not reduce treatment delivery. After a median follow-up time of 18.5 months, overall response rate was 72% in the veliparib arm versus 66% in the control arm (P =.57). Median overall survival times were 10.3 months and 8.9 months, respectively (hazard ratio, 0.83; P = .17).

The unstratified HR for PFS favored the veliparib-doublet arm but did not reach statistical significance (0.75; P = .06). After stratifying patients by sex and serum lactate dehydrogenase levels, the HR for PFS favored veliparib-doublet chemotherapy (0.63; P = .01). However, veliparib showed a much stronger effect in the subgroup of men with abnormal lactate dehydrogenase levels (adjusted HR, 0.34; P less than .001), which violated the “proportional hazards within strata assumption” on which this model was based, rendering the overall stratified HR uninterpretable, the researchers wrote.

They added that, before pursuing a larger definitive clinical trial, they await results from the ongoing phase 2 M14-361 study, in which patients with extensive-stage NSCLC are receiving platinum doublet therapy with carboplatin-etoposide plus either veliparib or placebo.

Funders included the Eastern Cooperative Oncology Group–American College of Radiology Imaging Network Cancer Research Group and the National Cancer Institute. Dr. Owonikoko reported ties to Novartis, Astellas Pharma, Celgene, and several other pharmaceutical companies.

SOURCE: Owonikoko TK et al. J Clin Oncol. 2018 Dec 5. doi: 10.1200/JCO.18.00264.

Adding the poly (ADP-ribose) polymerase (PARP) inhibitor veliparib to platinum doublet chemotherapy modestly improved progression-free survival in a randomized, placebo-controlled, phase 2 trial of 128 patients with extensive-stage non–small cell lung cancer.

Improved progression-free survival (PFS) “did not translate into reduction in overall mortality for patients treated with veliparib. However, the improvement in the point estimate of PFS was quite modest at 6.1 months, compared with 5.5 months [in the placebo control arm],” wrote Taofeek K. Owonikoko, MD, PhD, of Emory University, Atlanta, together with his coinvestigators in the Journal of Clinical Oncology.

Preclinical studies suggest that veliparib helps potentiate standard chemotherapy of non–small cell lung cancer (NSCLC), but clinical trials have yielded mixed results for PARP inhibition in this cancer. Patients in this study had untreated, extensive-stage NSCLC and an Eastern Cooperative Oncology Group performance status of 0 or 1. They received four 3-week cycles of cisplatin-etoposide (75 mg/m2 intravenously on day 1 and 100 mg/m2 on days 1-3) plus either veliparib (100 mg orally twice per day on days 1-7) or placebo.

Grade 3 or higher lymphopenia and neutropenia were more common in the veliparib arm but did not reduce treatment delivery. After a median follow-up time of 18.5 months, overall response rate was 72% in the veliparib arm versus 66% in the control arm (P =.57). Median overall survival times were 10.3 months and 8.9 months, respectively (hazard ratio, 0.83; P = .17).

The unstratified HR for PFS favored the veliparib-doublet arm but did not reach statistical significance (0.75; P = .06). After stratifying patients by sex and serum lactate dehydrogenase levels, the HR for PFS favored veliparib-doublet chemotherapy (0.63; P = .01). However, veliparib showed a much stronger effect in the subgroup of men with abnormal lactate dehydrogenase levels (adjusted HR, 0.34; P less than .001), which violated the “proportional hazards within strata assumption” on which this model was based, rendering the overall stratified HR uninterpretable, the researchers wrote.

They added that, before pursuing a larger definitive clinical trial, they await results from the ongoing phase 2 M14-361 study, in which patients with extensive-stage NSCLC are receiving platinum doublet therapy with carboplatin-etoposide plus either veliparib or placebo.

Funders included the Eastern Cooperative Oncology Group–American College of Radiology Imaging Network Cancer Research Group and the National Cancer Institute. Dr. Owonikoko reported ties to Novartis, Astellas Pharma, Celgene, and several other pharmaceutical companies.

SOURCE: Owonikoko TK et al. J Clin Oncol. 2018 Dec 5. doi: 10.1200/JCO.18.00264.

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FROM THE JOURNAL OF CLINICAL ONCOLOGY

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Key clinical point: Adding veliparib to platinum-based doublet chemotherapy modestly improved progression-free survival in patients with extensive-stage non–small cell lung cancer.

Major finding: After a median follow-up of 18.5 months, median progression-free survival was 6.1 months for veliparib plus cisplatin-etoposide versus 5.5 months for placebo plus cisplatin-etoposide (unstratified hazard ratio, 0.75; P = .06).

Data source: A phase 2, randomized, placebo-controlled trial of 128 adults with untreated, extensive-stage non–small cell lung cancer (ECOG-ACRIN 2511).

Disclosures: Funders included the Eastern Cooperative Oncology Group–American College of Radiology Imaging Network Cancer Research Group and the National Cancer Institute. Dr. Owonikoko reported ties to Novartis, Astellas Pharma, Celgene, and several other pharmaceutical companies.

Source: Owonikoko TK et al. J Clin Oncol. 2018 Dec 5. doi: 10.1200/JCO.18.00264.

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Flu season showing signs of decline

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The 2018-2019 flu season may have peaked as measures of influenza-like illness (ILI) activity dropped in the first week of the new year, according to the U.S. Centers for Disease Control and Prevention.

The proportion of outpatients visits for ILI dropped to 3.5% for the week ending Jan. 5, 2019, after reaching 4.0% the previous week. Outpatient ILI visits first topped the national baseline of 2.2% during the week ending Dec. 8, 2018, and have remained above that value for 5 consecutive weeks, the CDC’s influenza division said on Jan. 11.



Flu activity reported by the states reflects the national drop: 10 states came in at level 10 on the CDC’s 1-10 scale of activity for the week ending Jan. 5 – down from 12 the week before – and a total of 15 were in the high range from 8 to 10, compared with 19 the previous week, the CDC said. Two states, Mississippi and Texas, dropped from level 10 to level 7, which the CDC categorizes as moderate activity.

A total of 73 ILI-related deaths were reported during the week ending Dec. 29 (the latest with data available; reporting less than 68% complete), which already exceeds the 71 deaths reported for the week ending Dec. 22 (reporting 85% complete). Flu deaths totaled 437 through the first 13 weeks of the 2018-2019 season, compared with the 1,659 that occurred during weeks 1-13 of the very severe 2017-2018 season, CDC data show.



For the week ending Jan. 5, the CDC received reports of three flu-related pediatric deaths, all of which occurred the previous week. For the season so far, there have been 16 pediatric deaths, compared with 20 at this point in the 2017-2018 season.

Estimates released during the flu season for the first time show that between 6 and 7 million Americans have been infected since Oct. 1, 2018, and that 69,000-84,000 people have been hospitalized with the flu through Jan. 5, 2019. These cumulative totals have previously been available only at the end of the season, the CDC noted.

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The 2018-2019 flu season may have peaked as measures of influenza-like illness (ILI) activity dropped in the first week of the new year, according to the U.S. Centers for Disease Control and Prevention.

The proportion of outpatients visits for ILI dropped to 3.5% for the week ending Jan. 5, 2019, after reaching 4.0% the previous week. Outpatient ILI visits first topped the national baseline of 2.2% during the week ending Dec. 8, 2018, and have remained above that value for 5 consecutive weeks, the CDC’s influenza division said on Jan. 11.



Flu activity reported by the states reflects the national drop: 10 states came in at level 10 on the CDC’s 1-10 scale of activity for the week ending Jan. 5 – down from 12 the week before – and a total of 15 were in the high range from 8 to 10, compared with 19 the previous week, the CDC said. Two states, Mississippi and Texas, dropped from level 10 to level 7, which the CDC categorizes as moderate activity.

A total of 73 ILI-related deaths were reported during the week ending Dec. 29 (the latest with data available; reporting less than 68% complete), which already exceeds the 71 deaths reported for the week ending Dec. 22 (reporting 85% complete). Flu deaths totaled 437 through the first 13 weeks of the 2018-2019 season, compared with the 1,659 that occurred during weeks 1-13 of the very severe 2017-2018 season, CDC data show.



For the week ending Jan. 5, the CDC received reports of three flu-related pediatric deaths, all of which occurred the previous week. For the season so far, there have been 16 pediatric deaths, compared with 20 at this point in the 2017-2018 season.

Estimates released during the flu season for the first time show that between 6 and 7 million Americans have been infected since Oct. 1, 2018, and that 69,000-84,000 people have been hospitalized with the flu through Jan. 5, 2019. These cumulative totals have previously been available only at the end of the season, the CDC noted.

 

The 2018-2019 flu season may have peaked as measures of influenza-like illness (ILI) activity dropped in the first week of the new year, according to the U.S. Centers for Disease Control and Prevention.

The proportion of outpatients visits for ILI dropped to 3.5% for the week ending Jan. 5, 2019, after reaching 4.0% the previous week. Outpatient ILI visits first topped the national baseline of 2.2% during the week ending Dec. 8, 2018, and have remained above that value for 5 consecutive weeks, the CDC’s influenza division said on Jan. 11.



Flu activity reported by the states reflects the national drop: 10 states came in at level 10 on the CDC’s 1-10 scale of activity for the week ending Jan. 5 – down from 12 the week before – and a total of 15 were in the high range from 8 to 10, compared with 19 the previous week, the CDC said. Two states, Mississippi and Texas, dropped from level 10 to level 7, which the CDC categorizes as moderate activity.

A total of 73 ILI-related deaths were reported during the week ending Dec. 29 (the latest with data available; reporting less than 68% complete), which already exceeds the 71 deaths reported for the week ending Dec. 22 (reporting 85% complete). Flu deaths totaled 437 through the first 13 weeks of the 2018-2019 season, compared with the 1,659 that occurred during weeks 1-13 of the very severe 2017-2018 season, CDC data show.



For the week ending Jan. 5, the CDC received reports of three flu-related pediatric deaths, all of which occurred the previous week. For the season so far, there have been 16 pediatric deaths, compared with 20 at this point in the 2017-2018 season.

Estimates released during the flu season for the first time show that between 6 and 7 million Americans have been infected since Oct. 1, 2018, and that 69,000-84,000 people have been hospitalized with the flu through Jan. 5, 2019. These cumulative totals have previously been available only at the end of the season, the CDC noted.

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Beware of the Ides of August

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I suspect, like me, you have never put much stock in astrology. It just doesn’t feel like a good fit with our science-based training. But recent evidence suggests that maybe we should be paying more attention to the whether our patient is a Taurus or a Leo when we are hunting for a diagnosis.

patchareeporn_s/Getty Images

Three researchers from Harvard’s Schools of Medicine and Public Health have followed several hundred thousand children born between 2007 and 2009 until 2016 (“Attention deficit–hyperactivity disorder and month of school enrollment,” N Engl J Med. 2018;379:2122-30). Their data revealed that, in states with a Sept. 1 school entry cutoff, children born in August had rates of diagnosis and treatment of ADHD that were 34% higher than those born in other months.

Their findings could mean that astrology deserves a lot more credibility than we have been giving it. More likely it suggests that those of us committed to the health and education of children deserve a booby prize for objectivity. In a New York Times Op-Ed piece, the study’s investigators point out that their data show that the relative immaturity of the youngest children in a class too often is interpreted as a symptom of ADHD (“The Link Between August Birthdays and ADHD,” 2018 Nov 28. Jena AB et al.).

For many of us who practiced pediatrics before the ADHD phenomenon erupted, this new study substantiates our suspicion that the condition is currently being both overdiagnosed and overtreated. The data leave unanswered the question of whom or what is to blame for starting the epidemic. However, the study does suggest that physicians and educators deserve some culpability by failing to maintain their objectivity when interpreting childhood behavior.

I clearly can recall the first time I spoke to a group of teachers about the articles I had been reading that suggested a beneficial effect of treating “hyperactive” children with stimulant medication. The teachers uniformly were incredulous and repulsed by the counterintuitive notion of medicating children whom they saw as difficult, but not out of the broad range of age and developmental maturity they could expect to see in their classrooms.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff
A mere 5 years later I began to see children in the office whose teachers were urging me to consider prescribing stimulant medication. Exactly what had happened over that interval is unclear. But I suspect that, through the educational grapevine, teachers were hearing about children with major problems with hyperactivity and inattention who had responded dramatically to a stimulant. My guess is that those dramatic responders were in that group of unfortunate children who enter into the world with an as yet poorly defined structural and/or biochemical constitution that I would call “true” ADHD.

The next part of the narrative is where the story gets sad. Deceived by those success stories we – doctors, parents, and educators – began to narrow our view of normal behavior because we now had a medication to “correct” a certain constellation of problem behaviors. Pharmaceutical companies joined us with their best efforts to meet the demand we were creating.

Forgotten was the fact that children mature at different rates and that normal but less mature children can exhibit many of the behaviors we now place under the ADHD umbrella and be considered as candidates for medication. Until recently, other causes of hyperactivity such as sleep deprivation were ignored. Hopefully, this new study will rekindle an interest in how parents, pediatricians, and educators evaluate and manage those children who arrive in school several months behind their peers in emotional and behavioral development.
 

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 [email protected].

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I suspect, like me, you have never put much stock in astrology. It just doesn’t feel like a good fit with our science-based training. But recent evidence suggests that maybe we should be paying more attention to the whether our patient is a Taurus or a Leo when we are hunting for a diagnosis.

patchareeporn_s/Getty Images

Three researchers from Harvard’s Schools of Medicine and Public Health have followed several hundred thousand children born between 2007 and 2009 until 2016 (“Attention deficit–hyperactivity disorder and month of school enrollment,” N Engl J Med. 2018;379:2122-30). Their data revealed that, in states with a Sept. 1 school entry cutoff, children born in August had rates of diagnosis and treatment of ADHD that were 34% higher than those born in other months.

Their findings could mean that astrology deserves a lot more credibility than we have been giving it. More likely it suggests that those of us committed to the health and education of children deserve a booby prize for objectivity. In a New York Times Op-Ed piece, the study’s investigators point out that their data show that the relative immaturity of the youngest children in a class too often is interpreted as a symptom of ADHD (“The Link Between August Birthdays and ADHD,” 2018 Nov 28. Jena AB et al.).

For many of us who practiced pediatrics before the ADHD phenomenon erupted, this new study substantiates our suspicion that the condition is currently being both overdiagnosed and overtreated. The data leave unanswered the question of whom or what is to blame for starting the epidemic. However, the study does suggest that physicians and educators deserve some culpability by failing to maintain their objectivity when interpreting childhood behavior.

I clearly can recall the first time I spoke to a group of teachers about the articles I had been reading that suggested a beneficial effect of treating “hyperactive” children with stimulant medication. The teachers uniformly were incredulous and repulsed by the counterintuitive notion of medicating children whom they saw as difficult, but not out of the broad range of age and developmental maturity they could expect to see in their classrooms.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff
A mere 5 years later I began to see children in the office whose teachers were urging me to consider prescribing stimulant medication. Exactly what had happened over that interval is unclear. But I suspect that, through the educational grapevine, teachers were hearing about children with major problems with hyperactivity and inattention who had responded dramatically to a stimulant. My guess is that those dramatic responders were in that group of unfortunate children who enter into the world with an as yet poorly defined structural and/or biochemical constitution that I would call “true” ADHD.

The next part of the narrative is where the story gets sad. Deceived by those success stories we – doctors, parents, and educators – began to narrow our view of normal behavior because we now had a medication to “correct” a certain constellation of problem behaviors. Pharmaceutical companies joined us with their best efforts to meet the demand we were creating.

Forgotten was the fact that children mature at different rates and that normal but less mature children can exhibit many of the behaviors we now place under the ADHD umbrella and be considered as candidates for medication. Until recently, other causes of hyperactivity such as sleep deprivation were ignored. Hopefully, this new study will rekindle an interest in how parents, pediatricians, and educators evaluate and manage those children who arrive in school several months behind their peers in emotional and behavioral development.
 

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 [email protected].

I suspect, like me, you have never put much stock in astrology. It just doesn’t feel like a good fit with our science-based training. But recent evidence suggests that maybe we should be paying more attention to the whether our patient is a Taurus or a Leo when we are hunting for a diagnosis.

patchareeporn_s/Getty Images

Three researchers from Harvard’s Schools of Medicine and Public Health have followed several hundred thousand children born between 2007 and 2009 until 2016 (“Attention deficit–hyperactivity disorder and month of school enrollment,” N Engl J Med. 2018;379:2122-30). Their data revealed that, in states with a Sept. 1 school entry cutoff, children born in August had rates of diagnosis and treatment of ADHD that were 34% higher than those born in other months.

Their findings could mean that astrology deserves a lot more credibility than we have been giving it. More likely it suggests that those of us committed to the health and education of children deserve a booby prize for objectivity. In a New York Times Op-Ed piece, the study’s investigators point out that their data show that the relative immaturity of the youngest children in a class too often is interpreted as a symptom of ADHD (“The Link Between August Birthdays and ADHD,” 2018 Nov 28. Jena AB et al.).

For many of us who practiced pediatrics before the ADHD phenomenon erupted, this new study substantiates our suspicion that the condition is currently being both overdiagnosed and overtreated. The data leave unanswered the question of whom or what is to blame for starting the epidemic. However, the study does suggest that physicians and educators deserve some culpability by failing to maintain their objectivity when interpreting childhood behavior.

I clearly can recall the first time I spoke to a group of teachers about the articles I had been reading that suggested a beneficial effect of treating “hyperactive” children with stimulant medication. The teachers uniformly were incredulous and repulsed by the counterintuitive notion of medicating children whom they saw as difficult, but not out of the broad range of age and developmental maturity they could expect to see in their classrooms.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff
A mere 5 years later I began to see children in the office whose teachers were urging me to consider prescribing stimulant medication. Exactly what had happened over that interval is unclear. But I suspect that, through the educational grapevine, teachers were hearing about children with major problems with hyperactivity and inattention who had responded dramatically to a stimulant. My guess is that those dramatic responders were in that group of unfortunate children who enter into the world with an as yet poorly defined structural and/or biochemical constitution that I would call “true” ADHD.

The next part of the narrative is where the story gets sad. Deceived by those success stories we – doctors, parents, and educators – began to narrow our view of normal behavior because we now had a medication to “correct” a certain constellation of problem behaviors. Pharmaceutical companies joined us with their best efforts to meet the demand we were creating.

Forgotten was the fact that children mature at different rates and that normal but less mature children can exhibit many of the behaviors we now place under the ADHD umbrella and be considered as candidates for medication. Until recently, other causes of hyperactivity such as sleep deprivation were ignored. Hopefully, this new study will rekindle an interest in how parents, pediatricians, and educators evaluate and manage those children who arrive in school several months behind their peers in emotional and behavioral development.
 

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 [email protected].

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Fri, 01/11/2019 - 12:00

For more information about upcoming events and award deadlines, please visit http://agau.gastro.org and http://www.gastro.org/research-funding.

UPCOMING EVENTS

Feb. 16, 2019
AGA Regional Practice Skills Workshop – Ohio
The workshop provides fellows with insights on life in private practice, life in academia, and other career opportunities. Attendees will also gain practical knowledge on key topics such as contract negotiations, billing/coding, health care policy, and other topics that can help to enhance their career. Work/life balance and financial management as an early career professional are also addressed.
Columbus, OH

Feb. 20-21, 2019
Two-Day, In-Depth Coding Seminar by McVey Associates, Inc.

Become a certified GI coder with a two-day, in-depth training course provided by McVey Associates, Inc.
Hartford, CT

Feb. 21, 2019
Coding and Reimbursement Solutions by McVey Associates, Inc.
Improve the efficiency and performance of your practice by staying current on the latest reimbursement, coding, and compliance changes.
Richmond, VA

March 8-9, 2019
2019 Women’s Leadership Conference

The conference is specifically designed for women looking to advance their careers, further professional goals, enhance personal growth, and effectively network.
Bethesda, MD

March 8-10, 2019
FORWARD Program

AGA’s Fostering Opportunities Resulting in Workforce and Research Diversity (FORWARD) Program is a new initiative funded by NIH, supporting the career entry and development for underrepresented minority physician scientists in gastroenterology. The program provides concrete leadership and skill development that includes scientific manuscript and grant writing, research development, executive coaching, and more.
Bethesda, MD

March 8-10, 2019
Future Leaders Program

The Future Leaders Program provides a pathway within the organization to network, connect with mentors, develop leadership skills and learn about AGA’s governance and operations while advancing your career and supporting the profession.
Bethesda, MD

March 23–24, 2019
2019 Gut Microbiota for Health World Summit
The 2019 program will present the latest evidence on the interaction between diet, nutrition and the gut microbiome. Learn how diet and nutrition are being used in concert with traditional therapies to manage GI disorders.
Miami, FL

March 30, 2019
AGA Regional Practice Skills Workshop – Massachusetts

The workshop provides fellows with insights on life in private practice, life in academia and other career opportunities. Attendees will also gain practical knowledge on key topics such as contract negotiations, billing/coding, health care policy and other topics that can help to enhance their career. Work/life balance and financial management as an early career professional are also addressed.
Boston, MA

April 10-12, 2019
2019 AGA Tech Summit

By bringing together and fostering collaboration among innovators, entrepreneurs, clinicians, MedTech companies,regulatory agency representatives and venture capitalists, the Tech Summit helps ensure a pipeline of GI innovation that ultimately will improve delivery of care and patient outcomes.
San Francisco, CA

May 18-21, 2019
Digestive Disease Week (DDW)®

DDW® is the world’s leading educational forum for academicians, clinicians, researchers, students and trainees working in gastroenterology, hepatology, GI endoscopy, gastrointestinal surgery and related fields. Whether you work in patient care, research, education or administration, the DDW program offers something for you. DDW is co-sponsored by AGA, AASLD, ASGE and SSAT.
San Diego, CA

AWARDS APPLICATION DEADLINES

AGA Fellow Abstract Award
This travel award provides nine $500 and one $1,000 prize to recipients who are MD, PhD, or equivalent fellows presenting posters/oral sessions at Digestive Disease Week® (DDW).
Application Deadline: Feb. 15, 2019

AGA Moti L. & Kamla Rustgi International Travel Awards
This travel award provides two $750 prizes to recipients who are young basic, translational, or clinical investigators residing outside North America to support travel and related expenses to attend Digestive Disease Week® (DDW).
Application Deadline: Feb. 15, 2019

AGA Student Abstract Award
This travel award provides nine $500 and one $1,000 prize to recipients who are high school, undergraduate, graduate, or medical students, or residents (residents up to year three postgraduate) presenting posters/oral sessions at Digestive Disease Week® (DDW).
Application Deadline: Feb. 15, 2019

AGA-Gastric Cancer Foundation Ben Feinstein Memorial Research Scholar Award in Gastric Cancer
This award provides $100,000 per year for three years (total $300,000) to early career faculty (i.e., investigator, instructor, research associate, or equivalent) working toward an independent career in gastric cancer research. Research involving precancerous lesions will be considered if relevance to gastric cancer is explicitly outlined.
Application Deadline: Dec. 16, 2019

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For more information about upcoming events and award deadlines, please visit http://agau.gastro.org and http://www.gastro.org/research-funding.

UPCOMING EVENTS

Feb. 16, 2019
AGA Regional Practice Skills Workshop – Ohio
The workshop provides fellows with insights on life in private practice, life in academia, and other career opportunities. Attendees will also gain practical knowledge on key topics such as contract negotiations, billing/coding, health care policy, and other topics that can help to enhance their career. Work/life balance and financial management as an early career professional are also addressed.
Columbus, OH

Feb. 20-21, 2019
Two-Day, In-Depth Coding Seminar by McVey Associates, Inc.

Become a certified GI coder with a two-day, in-depth training course provided by McVey Associates, Inc.
Hartford, CT

Feb. 21, 2019
Coding and Reimbursement Solutions by McVey Associates, Inc.
Improve the efficiency and performance of your practice by staying current on the latest reimbursement, coding, and compliance changes.
Richmond, VA

March 8-9, 2019
2019 Women’s Leadership Conference

The conference is specifically designed for women looking to advance their careers, further professional goals, enhance personal growth, and effectively network.
Bethesda, MD

March 8-10, 2019
FORWARD Program

AGA’s Fostering Opportunities Resulting in Workforce and Research Diversity (FORWARD) Program is a new initiative funded by NIH, supporting the career entry and development for underrepresented minority physician scientists in gastroenterology. The program provides concrete leadership and skill development that includes scientific manuscript and grant writing, research development, executive coaching, and more.
Bethesda, MD

March 8-10, 2019
Future Leaders Program

The Future Leaders Program provides a pathway within the organization to network, connect with mentors, develop leadership skills and learn about AGA’s governance and operations while advancing your career and supporting the profession.
Bethesda, MD

March 23–24, 2019
2019 Gut Microbiota for Health World Summit
The 2019 program will present the latest evidence on the interaction between diet, nutrition and the gut microbiome. Learn how diet and nutrition are being used in concert with traditional therapies to manage GI disorders.
Miami, FL

March 30, 2019
AGA Regional Practice Skills Workshop – Massachusetts

The workshop provides fellows with insights on life in private practice, life in academia and other career opportunities. Attendees will also gain practical knowledge on key topics such as contract negotiations, billing/coding, health care policy and other topics that can help to enhance their career. Work/life balance and financial management as an early career professional are also addressed.
Boston, MA

April 10-12, 2019
2019 AGA Tech Summit

By bringing together and fostering collaboration among innovators, entrepreneurs, clinicians, MedTech companies,regulatory agency representatives and venture capitalists, the Tech Summit helps ensure a pipeline of GI innovation that ultimately will improve delivery of care and patient outcomes.
San Francisco, CA

May 18-21, 2019
Digestive Disease Week (DDW)®

DDW® is the world’s leading educational forum for academicians, clinicians, researchers, students and trainees working in gastroenterology, hepatology, GI endoscopy, gastrointestinal surgery and related fields. Whether you work in patient care, research, education or administration, the DDW program offers something for you. DDW is co-sponsored by AGA, AASLD, ASGE and SSAT.
San Diego, CA

AWARDS APPLICATION DEADLINES

AGA Fellow Abstract Award
This travel award provides nine $500 and one $1,000 prize to recipients who are MD, PhD, or equivalent fellows presenting posters/oral sessions at Digestive Disease Week® (DDW).
Application Deadline: Feb. 15, 2019

AGA Moti L. & Kamla Rustgi International Travel Awards
This travel award provides two $750 prizes to recipients who are young basic, translational, or clinical investigators residing outside North America to support travel and related expenses to attend Digestive Disease Week® (DDW).
Application Deadline: Feb. 15, 2019

AGA Student Abstract Award
This travel award provides nine $500 and one $1,000 prize to recipients who are high school, undergraduate, graduate, or medical students, or residents (residents up to year three postgraduate) presenting posters/oral sessions at Digestive Disease Week® (DDW).
Application Deadline: Feb. 15, 2019

AGA-Gastric Cancer Foundation Ben Feinstein Memorial Research Scholar Award in Gastric Cancer
This award provides $100,000 per year for three years (total $300,000) to early career faculty (i.e., investigator, instructor, research associate, or equivalent) working toward an independent career in gastric cancer research. Research involving precancerous lesions will be considered if relevance to gastric cancer is explicitly outlined.
Application Deadline: Dec. 16, 2019

For more information about upcoming events and award deadlines, please visit http://agau.gastro.org and http://www.gastro.org/research-funding.

UPCOMING EVENTS

Feb. 16, 2019
AGA Regional Practice Skills Workshop – Ohio
The workshop provides fellows with insights on life in private practice, life in academia, and other career opportunities. Attendees will also gain practical knowledge on key topics such as contract negotiations, billing/coding, health care policy, and other topics that can help to enhance their career. Work/life balance and financial management as an early career professional are also addressed.
Columbus, OH

Feb. 20-21, 2019
Two-Day, In-Depth Coding Seminar by McVey Associates, Inc.

Become a certified GI coder with a two-day, in-depth training course provided by McVey Associates, Inc.
Hartford, CT

Feb. 21, 2019
Coding and Reimbursement Solutions by McVey Associates, Inc.
Improve the efficiency and performance of your practice by staying current on the latest reimbursement, coding, and compliance changes.
Richmond, VA

March 8-9, 2019
2019 Women’s Leadership Conference

The conference is specifically designed for women looking to advance their careers, further professional goals, enhance personal growth, and effectively network.
Bethesda, MD

March 8-10, 2019
FORWARD Program

AGA’s Fostering Opportunities Resulting in Workforce and Research Diversity (FORWARD) Program is a new initiative funded by NIH, supporting the career entry and development for underrepresented minority physician scientists in gastroenterology. The program provides concrete leadership and skill development that includes scientific manuscript and grant writing, research development, executive coaching, and more.
Bethesda, MD

March 8-10, 2019
Future Leaders Program

The Future Leaders Program provides a pathway within the organization to network, connect with mentors, develop leadership skills and learn about AGA’s governance and operations while advancing your career and supporting the profession.
Bethesda, MD

March 23–24, 2019
2019 Gut Microbiota for Health World Summit
The 2019 program will present the latest evidence on the interaction between diet, nutrition and the gut microbiome. Learn how diet and nutrition are being used in concert with traditional therapies to manage GI disorders.
Miami, FL

March 30, 2019
AGA Regional Practice Skills Workshop – Massachusetts

The workshop provides fellows with insights on life in private practice, life in academia and other career opportunities. Attendees will also gain practical knowledge on key topics such as contract negotiations, billing/coding, health care policy and other topics that can help to enhance their career. Work/life balance and financial management as an early career professional are also addressed.
Boston, MA

April 10-12, 2019
2019 AGA Tech Summit

By bringing together and fostering collaboration among innovators, entrepreneurs, clinicians, MedTech companies,regulatory agency representatives and venture capitalists, the Tech Summit helps ensure a pipeline of GI innovation that ultimately will improve delivery of care and patient outcomes.
San Francisco, CA

May 18-21, 2019
Digestive Disease Week (DDW)®

DDW® is the world’s leading educational forum for academicians, clinicians, researchers, students and trainees working in gastroenterology, hepatology, GI endoscopy, gastrointestinal surgery and related fields. Whether you work in patient care, research, education or administration, the DDW program offers something for you. DDW is co-sponsored by AGA, AASLD, ASGE and SSAT.
San Diego, CA

AWARDS APPLICATION DEADLINES

AGA Fellow Abstract Award
This travel award provides nine $500 and one $1,000 prize to recipients who are MD, PhD, or equivalent fellows presenting posters/oral sessions at Digestive Disease Week® (DDW).
Application Deadline: Feb. 15, 2019

AGA Moti L. & Kamla Rustgi International Travel Awards
This travel award provides two $750 prizes to recipients who are young basic, translational, or clinical investigators residing outside North America to support travel and related expenses to attend Digestive Disease Week® (DDW).
Application Deadline: Feb. 15, 2019

AGA Student Abstract Award
This travel award provides nine $500 and one $1,000 prize to recipients who are high school, undergraduate, graduate, or medical students, or residents (residents up to year three postgraduate) presenting posters/oral sessions at Digestive Disease Week® (DDW).
Application Deadline: Feb. 15, 2019

AGA-Gastric Cancer Foundation Ben Feinstein Memorial Research Scholar Award in Gastric Cancer
This award provides $100,000 per year for three years (total $300,000) to early career faculty (i.e., investigator, instructor, research associate, or equivalent) working toward an independent career in gastric cancer research. Research involving precancerous lesions will be considered if relevance to gastric cancer is explicitly outlined.
Application Deadline: Dec. 16, 2019

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February 2019 - ICYMI

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Gastroenterology

How to approach a patient with refractory or recurrent benign esophageal stricture. Siersema PD. 2019 Jan;156(1):7-10. doi.org/10.1053/j.gastro.2018.11.040

How to approach a patient with ampullary lesion. Kandler J; Neuhaus H. 2018 Dec;155(6):1670-6. doi.org/10.1053/j.gastro.2018.11.010

How to promote the academic success of junior faculty physicians in gastroenterology. Shaheen NJ; Sandler RS. 2018 Nov;155(5):1293-7. doi.org/10.1053/j.gastro.2018.10.006

Clin Gastro Hepatol

Screening and surveillance of varices in patients with cirrhosis. Jakab SS; Garcia-Tsao G. 2019 Jan;17(1):26-9. doi.org/10.1016/j.cgh.2018.03.012

Common gastrostomy feeding tube complications and troubleshooting. Sealock RJ; Munot K. 2018 Dec;16(12):1864-9. doi.org/10.1016/j.cgh.2018.07.037

Endobariatrics: A primer. Storm AC; Abu Dayyeh BK; Topazian M. 2018 Nov;16(11):1701-4. doi.org/10.1016/j.cgh.2018.03.009

 

AGA Perspectives

My experiences during AGA’s Advocacy Day: Facilitating change
Published on 12/05/2018 by Yamini Natarajan, MD.

Lessons learned from the AGA Future Leaders Program
Published on 12/05/2018 by Jennifer Weiss, MD, MS, AGAF.

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Gastroenterology

How to approach a patient with refractory or recurrent benign esophageal stricture. Siersema PD. 2019 Jan;156(1):7-10. doi.org/10.1053/j.gastro.2018.11.040

How to approach a patient with ampullary lesion. Kandler J; Neuhaus H. 2018 Dec;155(6):1670-6. doi.org/10.1053/j.gastro.2018.11.010

How to promote the academic success of junior faculty physicians in gastroenterology. Shaheen NJ; Sandler RS. 2018 Nov;155(5):1293-7. doi.org/10.1053/j.gastro.2018.10.006

Clin Gastro Hepatol

Screening and surveillance of varices in patients with cirrhosis. Jakab SS; Garcia-Tsao G. 2019 Jan;17(1):26-9. doi.org/10.1016/j.cgh.2018.03.012

Common gastrostomy feeding tube complications and troubleshooting. Sealock RJ; Munot K. 2018 Dec;16(12):1864-9. doi.org/10.1016/j.cgh.2018.07.037

Endobariatrics: A primer. Storm AC; Abu Dayyeh BK; Topazian M. 2018 Nov;16(11):1701-4. doi.org/10.1016/j.cgh.2018.03.009

 

AGA Perspectives

My experiences during AGA’s Advocacy Day: Facilitating change
Published on 12/05/2018 by Yamini Natarajan, MD.

Lessons learned from the AGA Future Leaders Program
Published on 12/05/2018 by Jennifer Weiss, MD, MS, AGAF.

 

Gastroenterology

How to approach a patient with refractory or recurrent benign esophageal stricture. Siersema PD. 2019 Jan;156(1):7-10. doi.org/10.1053/j.gastro.2018.11.040

How to approach a patient with ampullary lesion. Kandler J; Neuhaus H. 2018 Dec;155(6):1670-6. doi.org/10.1053/j.gastro.2018.11.010

How to promote the academic success of junior faculty physicians in gastroenterology. Shaheen NJ; Sandler RS. 2018 Nov;155(5):1293-7. doi.org/10.1053/j.gastro.2018.10.006

Clin Gastro Hepatol

Screening and surveillance of varices in patients with cirrhosis. Jakab SS; Garcia-Tsao G. 2019 Jan;17(1):26-9. doi.org/10.1016/j.cgh.2018.03.012

Common gastrostomy feeding tube complications and troubleshooting. Sealock RJ; Munot K. 2018 Dec;16(12):1864-9. doi.org/10.1016/j.cgh.2018.07.037

Endobariatrics: A primer. Storm AC; Abu Dayyeh BK; Topazian M. 2018 Nov;16(11):1701-4. doi.org/10.1016/j.cgh.2018.03.009

 

AGA Perspectives

My experiences during AGA’s Advocacy Day: Facilitating change
Published on 12/05/2018 by Yamini Natarajan, MD.

Lessons learned from the AGA Future Leaders Program
Published on 12/05/2018 by Jennifer Weiss, MD, MS, AGAF.

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STUDY: Oncologists alter treatment based on financial incentives

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Oncologists frequently alter their treatment recommendations based on reimbursement incentives, an analysis suggests.

Lead author Aaron P. Mitchell, MD, of Memorial Sloan Kettering Cancer Center, New York, and his colleagues conducted a systematic review of 18 studies that examined the association between reimbursement incentives and oncology care delivery. Researchers obtained study data through PubMed/MEDLINE, Web of Science, Proquest Health Management, Econlit, and Business Source Premier. There were no date restrictions on the data.

The majority of studies (15 of 18) showed an association between reimbursement and care delivery consistent with physician responsiveness to financial incentives. Specifically, the review suggests that self-referral arrangements may increase radiotherapy use and that profitability of systemic anticancer agents may affect physicians’ choice of cancer medication, according to the analysis published in JAMA Oncology.

Of the 18 studies, 4 found that physicians respond to reimbursement incentives by preferentially using more-profitable treatments over less-profitable treatments, while 1 found evidence that reimbursement may be associated with doctors’ surgical approach to breast cancer. Particularly, oncologists were more likely to use breast-conserving therapy plus adjuvant radiotherapy rather than mastectomy alone when either reimbursement for breast-conserving therapy was higher or payment for mastectomy was lower. However, the same study did not find a statistically significant increase in breast-conserving therapy without adjuvant radiotherapy in association with the same reimbursement differences.

Another analysis in the data set determined preference for administering treatment in a more-profitable hospital outpatient setting, compared with an office setting. Meanwhile, five studies found that physicians are more likely to use radiotherapy when they or their practices profited through self-referral for radiotherapy or when practicing in freestanding facilities. (Urology practices are able to bill for radiotherapy services when using the in-office referral exception to the Stark Law.) Two of the four studies found that self-referral for radiotherapy was associated with increased use of intensity-modulated radiotherapy, while one study found that self-referral was associated with both receipt of any active therapy (radiotherapy, surgery, cryotherapy, or androgen deprivation therapy) and with receipt of radiotherapy specifically.

In relation to cancer drugs, one study found that physicians decreased their use of medications that showed the greatest declines in profitability. Another study found that after changes in compensation for drug administration resulting from the Medicare Modernization Act of 2003, patients dying of cancer were less likely to receive systemic therapy within the last 30 days of life. Another study found that physicians used less irinotecan after the drug’s patent protection expired and a lower-cost, less-profitable generic alternative became available. In addition, there was a significant increase in office-based cystoscopic procedures following an increase in reimbursement for procedures performed in the office setting and the absence of a coincident change in procedures performed in the hospital or ambulatory surgery settings, where reimbursement did not change, one of the studies found.

The authors concluded that some oncologists may, in certain circumstances, alter treatment recommendations based on personal revenue considerations. Changing such practices could lower health care spending and prevent potentially inappropriate treatment.

Dr. Walter Stadler

The findings from the systematic review are not surprising, said Walter Stadler, MD, a professor at the University of Chicago and chief of the hematology/oncology section.

“Financial incentives are always going to influence physicians and you cannot fully prevent that,” he said in an interview. “We all like to believe, we are all completely altruistic, but physicians respond to the same financial pressures that anybody else responds to. We’re not unique in that way.”

Particularly, when two treatment modalities are equally efficacious, it makes sense that financial incentives may impact the doctor’s choice.

“There are always outliers, but physicians as a community are not necessarily going to do something that is directly harmful for patients based only on financial incentives,” he said. “But if there are two medically equivalent choices, than financial incentives will play a role.”

Dr. Wheeler has received research grant funding from Pfizer unrelated to this work. No other disclosures were reported.

SOURCE: Mitchell AP et al. JAMA Oncol. 2019 Jan 3. doi: 10.1001/jamaoncol.2018.6196.

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Oncologists frequently alter their treatment recommendations based on reimbursement incentives, an analysis suggests.

Lead author Aaron P. Mitchell, MD, of Memorial Sloan Kettering Cancer Center, New York, and his colleagues conducted a systematic review of 18 studies that examined the association between reimbursement incentives and oncology care delivery. Researchers obtained study data through PubMed/MEDLINE, Web of Science, Proquest Health Management, Econlit, and Business Source Premier. There were no date restrictions on the data.

The majority of studies (15 of 18) showed an association between reimbursement and care delivery consistent with physician responsiveness to financial incentives. Specifically, the review suggests that self-referral arrangements may increase radiotherapy use and that profitability of systemic anticancer agents may affect physicians’ choice of cancer medication, according to the analysis published in JAMA Oncology.

Of the 18 studies, 4 found that physicians respond to reimbursement incentives by preferentially using more-profitable treatments over less-profitable treatments, while 1 found evidence that reimbursement may be associated with doctors’ surgical approach to breast cancer. Particularly, oncologists were more likely to use breast-conserving therapy plus adjuvant radiotherapy rather than mastectomy alone when either reimbursement for breast-conserving therapy was higher or payment for mastectomy was lower. However, the same study did not find a statistically significant increase in breast-conserving therapy without adjuvant radiotherapy in association with the same reimbursement differences.

Another analysis in the data set determined preference for administering treatment in a more-profitable hospital outpatient setting, compared with an office setting. Meanwhile, five studies found that physicians are more likely to use radiotherapy when they or their practices profited through self-referral for radiotherapy or when practicing in freestanding facilities. (Urology practices are able to bill for radiotherapy services when using the in-office referral exception to the Stark Law.) Two of the four studies found that self-referral for radiotherapy was associated with increased use of intensity-modulated radiotherapy, while one study found that self-referral was associated with both receipt of any active therapy (radiotherapy, surgery, cryotherapy, or androgen deprivation therapy) and with receipt of radiotherapy specifically.

In relation to cancer drugs, one study found that physicians decreased their use of medications that showed the greatest declines in profitability. Another study found that after changes in compensation for drug administration resulting from the Medicare Modernization Act of 2003, patients dying of cancer were less likely to receive systemic therapy within the last 30 days of life. Another study found that physicians used less irinotecan after the drug’s patent protection expired and a lower-cost, less-profitable generic alternative became available. In addition, there was a significant increase in office-based cystoscopic procedures following an increase in reimbursement for procedures performed in the office setting and the absence of a coincident change in procedures performed in the hospital or ambulatory surgery settings, where reimbursement did not change, one of the studies found.

The authors concluded that some oncologists may, in certain circumstances, alter treatment recommendations based on personal revenue considerations. Changing such practices could lower health care spending and prevent potentially inappropriate treatment.

Dr. Walter Stadler

The findings from the systematic review are not surprising, said Walter Stadler, MD, a professor at the University of Chicago and chief of the hematology/oncology section.

“Financial incentives are always going to influence physicians and you cannot fully prevent that,” he said in an interview. “We all like to believe, we are all completely altruistic, but physicians respond to the same financial pressures that anybody else responds to. We’re not unique in that way.”

Particularly, when two treatment modalities are equally efficacious, it makes sense that financial incentives may impact the doctor’s choice.

“There are always outliers, but physicians as a community are not necessarily going to do something that is directly harmful for patients based only on financial incentives,” he said. “But if there are two medically equivalent choices, than financial incentives will play a role.”

Dr. Wheeler has received research grant funding from Pfizer unrelated to this work. No other disclosures were reported.

SOURCE: Mitchell AP et al. JAMA Oncol. 2019 Jan 3. doi: 10.1001/jamaoncol.2018.6196.

Oncologists frequently alter their treatment recommendations based on reimbursement incentives, an analysis suggests.

Lead author Aaron P. Mitchell, MD, of Memorial Sloan Kettering Cancer Center, New York, and his colleagues conducted a systematic review of 18 studies that examined the association between reimbursement incentives and oncology care delivery. Researchers obtained study data through PubMed/MEDLINE, Web of Science, Proquest Health Management, Econlit, and Business Source Premier. There were no date restrictions on the data.

The majority of studies (15 of 18) showed an association between reimbursement and care delivery consistent with physician responsiveness to financial incentives. Specifically, the review suggests that self-referral arrangements may increase radiotherapy use and that profitability of systemic anticancer agents may affect physicians’ choice of cancer medication, according to the analysis published in JAMA Oncology.

Of the 18 studies, 4 found that physicians respond to reimbursement incentives by preferentially using more-profitable treatments over less-profitable treatments, while 1 found evidence that reimbursement may be associated with doctors’ surgical approach to breast cancer. Particularly, oncologists were more likely to use breast-conserving therapy plus adjuvant radiotherapy rather than mastectomy alone when either reimbursement for breast-conserving therapy was higher or payment for mastectomy was lower. However, the same study did not find a statistically significant increase in breast-conserving therapy without adjuvant radiotherapy in association with the same reimbursement differences.

Another analysis in the data set determined preference for administering treatment in a more-profitable hospital outpatient setting, compared with an office setting. Meanwhile, five studies found that physicians are more likely to use radiotherapy when they or their practices profited through self-referral for radiotherapy or when practicing in freestanding facilities. (Urology practices are able to bill for radiotherapy services when using the in-office referral exception to the Stark Law.) Two of the four studies found that self-referral for radiotherapy was associated with increased use of intensity-modulated radiotherapy, while one study found that self-referral was associated with both receipt of any active therapy (radiotherapy, surgery, cryotherapy, or androgen deprivation therapy) and with receipt of radiotherapy specifically.

In relation to cancer drugs, one study found that physicians decreased their use of medications that showed the greatest declines in profitability. Another study found that after changes in compensation for drug administration resulting from the Medicare Modernization Act of 2003, patients dying of cancer were less likely to receive systemic therapy within the last 30 days of life. Another study found that physicians used less irinotecan after the drug’s patent protection expired and a lower-cost, less-profitable generic alternative became available. In addition, there was a significant increase in office-based cystoscopic procedures following an increase in reimbursement for procedures performed in the office setting and the absence of a coincident change in procedures performed in the hospital or ambulatory surgery settings, where reimbursement did not change, one of the studies found.

The authors concluded that some oncologists may, in certain circumstances, alter treatment recommendations based on personal revenue considerations. Changing such practices could lower health care spending and prevent potentially inappropriate treatment.

Dr. Walter Stadler

The findings from the systematic review are not surprising, said Walter Stadler, MD, a professor at the University of Chicago and chief of the hematology/oncology section.

“Financial incentives are always going to influence physicians and you cannot fully prevent that,” he said in an interview. “We all like to believe, we are all completely altruistic, but physicians respond to the same financial pressures that anybody else responds to. We’re not unique in that way.”

Particularly, when two treatment modalities are equally efficacious, it makes sense that financial incentives may impact the doctor’s choice.

“There are always outliers, but physicians as a community are not necessarily going to do something that is directly harmful for patients based only on financial incentives,” he said. “But if there are two medically equivalent choices, than financial incentives will play a role.”

Dr. Wheeler has received research grant funding from Pfizer unrelated to this work. No other disclosures were reported.

SOURCE: Mitchell AP et al. JAMA Oncol. 2019 Jan 3. doi: 10.1001/jamaoncol.2018.6196.

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FROM JAMA ONCOLOGY

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Key clinical point: Oncologists alter treatment based on reimbursement incentives, a review of studies found.

Major finding: Of 18 studies reviewed, 15 show an association between reimbursement incentives and treatment decisions by physicians.

Study details: A review of 18 studies found by a search through PubMed/MEDLINE, Web of Science, Proquest Health Management, Econlit, and Business Source Premier.

Disclosures: Dr. Wheeler has received research grant funding from Pfizer unrelated to this work. No other disclosures were reported.

Source: Mitchell AP et al. JAMA Oncol. 2019 Jan 3. doi: 10.1001/jamaoncol.2018.6196.

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Children who are coughing: Is it flu or bacterial pneumonia?

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Fri, 01/18/2019 - 18:14

We are in the middle of flu season, and many of our patients are coughing. Is it the flu or might the child have a secondary bacterial pneumonia? Let’s start with the history for a tip off. The course of flu and respiratory viral infections in general involves a typical pattern of timing for fever and cough.

DavidWhalen/Thinkstock

A late-developing fever or fever that subsides then recurs should raise concern. A prolonged cough or cough that subsides then recurs also should raise concern. The respiratory rate and chest retractions are key physical findings that can aid in distinguishing children with bacterial pneumonia. Rales and decreased breath sounds in lung segments are best heard with deep breaths.

What diagnostic laboratory and imaging tests should be used

Fortunately, rapid tests to detect influenza are available, and many providers have added those to their laboratory evaluation. A complete blood count and differential may be helpful. If a pulse oximeter is available, checking oxygen saturation might be helpful. The American Academy of Pediatrics community pneumonia guideline states that routine chest radiographs are not necessary for the confirmation of suspected community-acquired pneumonia (CAP) in patients well enough to be treated in the outpatient setting (Clin Inf Dis. 2011 Oct;53[7]:e25–e76). Blood cultures should not be performed routinely in nontoxic, fully immunized children with CAP managed in the outpatient setting.

What antibiotic should be used

Antimicrobial therapy is not routinely required for preschool-aged children with cough, even cough caused by CAP, because viral pathogens are responsible for the great majority of clinical disease. If the diagnosis of CAP is made, the AAP endorses amoxicillin as first-line therapy for previously healthy, appropriately immunized infants and preschool children with mild to moderate CAP suspected to be of bacterial origin. For previously healthy, appropriately immunized school-aged children and adolescents with mild to moderate CAP, amoxicillin is recommended for treatment of Streptococcus pneumoniae, the most prominent invasive bacterial pathogen.

However, the treatment paradigm is complicated because Mycoplasma pneumoniae also should be considered in management decisions. Children with signs and symptoms suspicious for M. pneumoniae should be tested to help guide antibiotic selection. This may be a simple bedside cold agglutinin test. The highest incidence of Mycoplasma pneumonia is in 5- to 20-year-olds (51% in 5- to 9-year-olds, 74% in 9- to 15-year-olds, and 3%-18% in adults with pneumonia), but 9% of CAP occurs in patients younger than 5 years old. The clinical features of Mycoplasma pneumonia resemble influenza: The patient has gradual onset of headache, malaise, fever, sore throat, and cough. Mycoplasma pneumonia has a similar incidence of productive cough, rales, and diarrhea as pneumococcal CAP, but with more frequent upper respiratory symptoms and a normal leukocyte count. Mycoplasma bronchopneumonia occurs 30 times more frequently than Mycoplasma lobar pneumonia. The radiologic features of Mycoplasma is typical of a bronchopneumonia, usually involving a single lobe, subsegmental atelectasis, peribronchial thickening, and streaky interstitial densities. While Mycoplasma pneumonia is usually self-limited, the duration of illness is shortened by oral treatment with doxycycline, erythromycin, clarithromycin, or azithromycin.
 

 

 

What is the appropriate duration of antimicrobial therapy

Recommendations by the AAP for CAP note that treatment courses of 10 days have been best studied, although shorter courses may be just as effective, particularly for mild disease managed on an outpatient basis.

When should children be hospitalized

Dr. Michael E. Pichichero
Children and infants who have moderate to severe CAP should be hospitalized. These children are defined by several factors, including respiratory distress and hypoxemia (sustained saturation of peripheral oxygen [SpO2] less than 90%). Hospitalization also is recommended by the AAP for infants less than 6 months of age with suspected bacterial CAP and for children and infants for whom there is concern about careful observation at home or who are unable to comply with therapy or unable to be followed up.

Dr. Pichichero is a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital. He had no conflicts to declare. Email him at [email protected].

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We are in the middle of flu season, and many of our patients are coughing. Is it the flu or might the child have a secondary bacterial pneumonia? Let’s start with the history for a tip off. The course of flu and respiratory viral infections in general involves a typical pattern of timing for fever and cough.

DavidWhalen/Thinkstock

A late-developing fever or fever that subsides then recurs should raise concern. A prolonged cough or cough that subsides then recurs also should raise concern. The respiratory rate and chest retractions are key physical findings that can aid in distinguishing children with bacterial pneumonia. Rales and decreased breath sounds in lung segments are best heard with deep breaths.

What diagnostic laboratory and imaging tests should be used

Fortunately, rapid tests to detect influenza are available, and many providers have added those to their laboratory evaluation. A complete blood count and differential may be helpful. If a pulse oximeter is available, checking oxygen saturation might be helpful. The American Academy of Pediatrics community pneumonia guideline states that routine chest radiographs are not necessary for the confirmation of suspected community-acquired pneumonia (CAP) in patients well enough to be treated in the outpatient setting (Clin Inf Dis. 2011 Oct;53[7]:e25–e76). Blood cultures should not be performed routinely in nontoxic, fully immunized children with CAP managed in the outpatient setting.

What antibiotic should be used

Antimicrobial therapy is not routinely required for preschool-aged children with cough, even cough caused by CAP, because viral pathogens are responsible for the great majority of clinical disease. If the diagnosis of CAP is made, the AAP endorses amoxicillin as first-line therapy for previously healthy, appropriately immunized infants and preschool children with mild to moderate CAP suspected to be of bacterial origin. For previously healthy, appropriately immunized school-aged children and adolescents with mild to moderate CAP, amoxicillin is recommended for treatment of Streptococcus pneumoniae, the most prominent invasive bacterial pathogen.

However, the treatment paradigm is complicated because Mycoplasma pneumoniae also should be considered in management decisions. Children with signs and symptoms suspicious for M. pneumoniae should be tested to help guide antibiotic selection. This may be a simple bedside cold agglutinin test. The highest incidence of Mycoplasma pneumonia is in 5- to 20-year-olds (51% in 5- to 9-year-olds, 74% in 9- to 15-year-olds, and 3%-18% in adults with pneumonia), but 9% of CAP occurs in patients younger than 5 years old. The clinical features of Mycoplasma pneumonia resemble influenza: The patient has gradual onset of headache, malaise, fever, sore throat, and cough. Mycoplasma pneumonia has a similar incidence of productive cough, rales, and diarrhea as pneumococcal CAP, but with more frequent upper respiratory symptoms and a normal leukocyte count. Mycoplasma bronchopneumonia occurs 30 times more frequently than Mycoplasma lobar pneumonia. The radiologic features of Mycoplasma is typical of a bronchopneumonia, usually involving a single lobe, subsegmental atelectasis, peribronchial thickening, and streaky interstitial densities. While Mycoplasma pneumonia is usually self-limited, the duration of illness is shortened by oral treatment with doxycycline, erythromycin, clarithromycin, or azithromycin.
 

 

 

What is the appropriate duration of antimicrobial therapy

Recommendations by the AAP for CAP note that treatment courses of 10 days have been best studied, although shorter courses may be just as effective, particularly for mild disease managed on an outpatient basis.

When should children be hospitalized

Dr. Michael E. Pichichero
Children and infants who have moderate to severe CAP should be hospitalized. These children are defined by several factors, including respiratory distress and hypoxemia (sustained saturation of peripheral oxygen [SpO2] less than 90%). Hospitalization also is recommended by the AAP for infants less than 6 months of age with suspected bacterial CAP and for children and infants for whom there is concern about careful observation at home or who are unable to comply with therapy or unable to be followed up.

Dr. Pichichero is a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital. He had no conflicts to declare. Email him at [email protected].

We are in the middle of flu season, and many of our patients are coughing. Is it the flu or might the child have a secondary bacterial pneumonia? Let’s start with the history for a tip off. The course of flu and respiratory viral infections in general involves a typical pattern of timing for fever and cough.

DavidWhalen/Thinkstock

A late-developing fever or fever that subsides then recurs should raise concern. A prolonged cough or cough that subsides then recurs also should raise concern. The respiratory rate and chest retractions are key physical findings that can aid in distinguishing children with bacterial pneumonia. Rales and decreased breath sounds in lung segments are best heard with deep breaths.

What diagnostic laboratory and imaging tests should be used

Fortunately, rapid tests to detect influenza are available, and many providers have added those to their laboratory evaluation. A complete blood count and differential may be helpful. If a pulse oximeter is available, checking oxygen saturation might be helpful. The American Academy of Pediatrics community pneumonia guideline states that routine chest radiographs are not necessary for the confirmation of suspected community-acquired pneumonia (CAP) in patients well enough to be treated in the outpatient setting (Clin Inf Dis. 2011 Oct;53[7]:e25–e76). Blood cultures should not be performed routinely in nontoxic, fully immunized children with CAP managed in the outpatient setting.

What antibiotic should be used

Antimicrobial therapy is not routinely required for preschool-aged children with cough, even cough caused by CAP, because viral pathogens are responsible for the great majority of clinical disease. If the diagnosis of CAP is made, the AAP endorses amoxicillin as first-line therapy for previously healthy, appropriately immunized infants and preschool children with mild to moderate CAP suspected to be of bacterial origin. For previously healthy, appropriately immunized school-aged children and adolescents with mild to moderate CAP, amoxicillin is recommended for treatment of Streptococcus pneumoniae, the most prominent invasive bacterial pathogen.

However, the treatment paradigm is complicated because Mycoplasma pneumoniae also should be considered in management decisions. Children with signs and symptoms suspicious for M. pneumoniae should be tested to help guide antibiotic selection. This may be a simple bedside cold agglutinin test. The highest incidence of Mycoplasma pneumonia is in 5- to 20-year-olds (51% in 5- to 9-year-olds, 74% in 9- to 15-year-olds, and 3%-18% in adults with pneumonia), but 9% of CAP occurs in patients younger than 5 years old. The clinical features of Mycoplasma pneumonia resemble influenza: The patient has gradual onset of headache, malaise, fever, sore throat, and cough. Mycoplasma pneumonia has a similar incidence of productive cough, rales, and diarrhea as pneumococcal CAP, but with more frequent upper respiratory symptoms and a normal leukocyte count. Mycoplasma bronchopneumonia occurs 30 times more frequently than Mycoplasma lobar pneumonia. The radiologic features of Mycoplasma is typical of a bronchopneumonia, usually involving a single lobe, subsegmental atelectasis, peribronchial thickening, and streaky interstitial densities. While Mycoplasma pneumonia is usually self-limited, the duration of illness is shortened by oral treatment with doxycycline, erythromycin, clarithromycin, or azithromycin.
 

 

 

What is the appropriate duration of antimicrobial therapy

Recommendations by the AAP for CAP note that treatment courses of 10 days have been best studied, although shorter courses may be just as effective, particularly for mild disease managed on an outpatient basis.

When should children be hospitalized

Dr. Michael E. Pichichero
Children and infants who have moderate to severe CAP should be hospitalized. These children are defined by several factors, including respiratory distress and hypoxemia (sustained saturation of peripheral oxygen [SpO2] less than 90%). Hospitalization also is recommended by the AAP for infants less than 6 months of age with suspected bacterial CAP and for children and infants for whom there is concern about careful observation at home or who are unable to comply with therapy or unable to be followed up.

Dr. Pichichero is a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital. He had no conflicts to declare. Email him at [email protected].

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