User login
Vaccine granted orphan designation for MDS
The US Food and Drug Administration (FDA) has granted orphan drug designation to DSP-7888, an investigational cancer peptide vaccine, for the treatment of myelodysplastic syndromes (MDS).
DSP-7888 contains peptides to induce Wilms’ tumor gene 1 (WT1)-specific cytotoxic T lymphocytes and helper T cells, which attack WT1-expressing cancerous cells found in various hematologic and solid tumor malignancies.
DSP-7888 is being developed by Boston Biomedical, Inc.
The first clinical data for DSP-7888, from a phase 1/2 study in patients with MDS who progressed on or after first-line azacitidine treatment, were presented at the 2016 ASH Annual Meeting.
Results were reported in 12 patients—7 with higher-risk MDS and 5 with lower-risk disease.
DSP-7888 was given at doses of 3.5 mg/body (n=6) or 10.5 mg/body (n=6) by intradermal injections every 2 to 4 weeks.
There were no dose-limiting toxicities. The most common adverse event was injection site reactions. Six patients had grade 3 injection site reactions.
There were 5 serious adverse events—3 injection site reactions, 1 case of pyrexia, and 1 case of myocarditis.
Eight patients had stable disease, 2 with hematological improvements.
Cytotoxic T lymphocyte induction was observed in 6 patients, and delayed type hypersensitivity response was observed in 10 patients.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved. 
The US Food and Drug Administration (FDA) has granted orphan drug designation to DSP-7888, an investigational cancer peptide vaccine, for the treatment of myelodysplastic syndromes (MDS).
DSP-7888 contains peptides to induce Wilms’ tumor gene 1 (WT1)-specific cytotoxic T lymphocytes and helper T cells, which attack WT1-expressing cancerous cells found in various hematologic and solid tumor malignancies.
DSP-7888 is being developed by Boston Biomedical, Inc.
The first clinical data for DSP-7888, from a phase 1/2 study in patients with MDS who progressed on or after first-line azacitidine treatment, were presented at the 2016 ASH Annual Meeting.
Results were reported in 12 patients—7 with higher-risk MDS and 5 with lower-risk disease.
DSP-7888 was given at doses of 3.5 mg/body (n=6) or 10.5 mg/body (n=6) by intradermal injections every 2 to 4 weeks.
There were no dose-limiting toxicities. The most common adverse event was injection site reactions. Six patients had grade 3 injection site reactions.
There were 5 serious adverse events—3 injection site reactions, 1 case of pyrexia, and 1 case of myocarditis.
Eight patients had stable disease, 2 with hematological improvements.
Cytotoxic T lymphocyte induction was observed in 6 patients, and delayed type hypersensitivity response was observed in 10 patients.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.
The US Food and Drug Administration (FDA) has granted orphan drug designation to DSP-7888, an investigational cancer peptide vaccine, for the treatment of myelodysplastic syndromes (MDS).
DSP-7888 contains peptides to induce Wilms’ tumor gene 1 (WT1)-specific cytotoxic T lymphocytes and helper T cells, which attack WT1-expressing cancerous cells found in various hematologic and solid tumor malignancies.
DSP-7888 is being developed by Boston Biomedical, Inc.
The first clinical data for DSP-7888, from a phase 1/2 study in patients with MDS who progressed on or after first-line azacitidine treatment, were presented at the 2016 ASH Annual Meeting.
Results were reported in 12 patients—7 with higher-risk MDS and 5 with lower-risk disease.
DSP-7888 was given at doses of 3.5 mg/body (n=6) or 10.5 mg/body (n=6) by intradermal injections every 2 to 4 weeks.
There were no dose-limiting toxicities. The most common adverse event was injection site reactions. Six patients had grade 3 injection site reactions.
There were 5 serious adverse events—3 injection site reactions, 1 case of pyrexia, and 1 case of myocarditis.
Eight patients had stable disease, 2 with hematological improvements.
Cytotoxic T lymphocyte induction was observed in 6 patients, and delayed type hypersensitivity response was observed in 10 patients.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.
One-year cost of preeclampsia tops $2 billion
The cost of medical care for preeclampsia is estimated to be $2.18 billion for the first year surrounding delivery, split almost evenly between care for mothers and infants, according to a new report.
Preeclampsia is increasing at a more rapid rate than diabetes, ischemic heart failure, Alzheimer’s disease, obesity, and chronic kidney disease – disorders for which substantially more funding has been allocated for research and treatment, said Warren Stevens, PhD, of Precision Health Economics, Los Angeles, and his associates. Precision Health Economics provides consulting and other research services to pharmaceutical, device, government, and nongovernmental groups.
Compared with a healthy pregnancy, preeclampsia increased the probability that a mother would have at least one adverse outcome from 4.6% to 10.1%, and it increased the probability that an infant would have at least one adverse outcome from 7.9% to 14.2%. For mothers, preeclampsia was estimated to raise costs by $6,583 per birth, which translates to an increase of $1.03 billion for U.S. mothers during a single year (2012). For infants, the disorder raised costs by $1.15 billion during that year.
Infant costs varied according to the gestational age at delivery, ranging from $1,311 per birth at 36 weeks’ gestation to $150,000 per birth at 26 weeks’ gestation, Dr. Stevens and his associates reported (Am J Obstet Gynecol. 2017 Jul 11. doi: 10.1016/j.ajog.2017.04.032).
This study could not take into account longer-term adverse outcomes associated with preeclampsia. Women with a history of the disorder are at double the risk of developing ischemic heart disease or cerebrovascular disease compared with women without such a history, and at three times the risk of developing hypertension. Infants are at increased risk of developing stroke, metabolic syndrome, and chronic heart disease, the investigators noted.
The study was supported by rEVO Biologics. Five of the study authors are employees of rEVO Biologics and one author is a steering committee member for a clinical trial supported by the company; another study author is a consultant at Precision Health Economics.
Quantifying the total cost of a health problem helps to show the public, payers, and health care administrators the magnitude of the problem on a population level. By underscoring the economic burden of preeclampsia, Stevens et al. provided important information about the high costs of this condition.
However, we need to go beyond health burden and cost-of-illness studies when considering the value of interventions to prevent and better manage preeclampsia and its adverse outcomes. Cost of the intervention and the cost savings associated with preventing one case of the condition are important parameters that can be used to calculate the potential savings of interventions. In fact, if the lifetimes costs of caring for children with adverse outcomes of preeclampsia are included, the potential cost savings from effective interventions may be even greater.
Rui Li, PhD, and William M. Callaghan, MD, are in the division of reproductive health at the Centers for Disease Control and Prevention, Atlanta. Eleni Tsigas is with the Preeclampsia Foundation in Melbourne, Fla. They reported having no relevant financial disclosures. These remarks are adapted from an editorial (Am J Obstet Gynecol. 2017 Jul 11. doi: 10.1016/j.ajog.2017.06.011).
Quantifying the total cost of a health problem helps to show the public, payers, and health care administrators the magnitude of the problem on a population level. By underscoring the economic burden of preeclampsia, Stevens et al. provided important information about the high costs of this condition.
However, we need to go beyond health burden and cost-of-illness studies when considering the value of interventions to prevent and better manage preeclampsia and its adverse outcomes. Cost of the intervention and the cost savings associated with preventing one case of the condition are important parameters that can be used to calculate the potential savings of interventions. In fact, if the lifetimes costs of caring for children with adverse outcomes of preeclampsia are included, the potential cost savings from effective interventions may be even greater.
Rui Li, PhD, and William M. Callaghan, MD, are in the division of reproductive health at the Centers for Disease Control and Prevention, Atlanta. Eleni Tsigas is with the Preeclampsia Foundation in Melbourne, Fla. They reported having no relevant financial disclosures. These remarks are adapted from an editorial (Am J Obstet Gynecol. 2017 Jul 11. doi: 10.1016/j.ajog.2017.06.011).
Quantifying the total cost of a health problem helps to show the public, payers, and health care administrators the magnitude of the problem on a population level. By underscoring the economic burden of preeclampsia, Stevens et al. provided important information about the high costs of this condition.
However, we need to go beyond health burden and cost-of-illness studies when considering the value of interventions to prevent and better manage preeclampsia and its adverse outcomes. Cost of the intervention and the cost savings associated with preventing one case of the condition are important parameters that can be used to calculate the potential savings of interventions. In fact, if the lifetimes costs of caring for children with adverse outcomes of preeclampsia are included, the potential cost savings from effective interventions may be even greater.
Rui Li, PhD, and William M. Callaghan, MD, are in the division of reproductive health at the Centers for Disease Control and Prevention, Atlanta. Eleni Tsigas is with the Preeclampsia Foundation in Melbourne, Fla. They reported having no relevant financial disclosures. These remarks are adapted from an editorial (Am J Obstet Gynecol. 2017 Jul 11. doi: 10.1016/j.ajog.2017.06.011).
The cost of medical care for preeclampsia is estimated to be $2.18 billion for the first year surrounding delivery, split almost evenly between care for mothers and infants, according to a new report.
Preeclampsia is increasing at a more rapid rate than diabetes, ischemic heart failure, Alzheimer’s disease, obesity, and chronic kidney disease – disorders for which substantially more funding has been allocated for research and treatment, said Warren Stevens, PhD, of Precision Health Economics, Los Angeles, and his associates. Precision Health Economics provides consulting and other research services to pharmaceutical, device, government, and nongovernmental groups.
Compared with a healthy pregnancy, preeclampsia increased the probability that a mother would have at least one adverse outcome from 4.6% to 10.1%, and it increased the probability that an infant would have at least one adverse outcome from 7.9% to 14.2%. For mothers, preeclampsia was estimated to raise costs by $6,583 per birth, which translates to an increase of $1.03 billion for U.S. mothers during a single year (2012). For infants, the disorder raised costs by $1.15 billion during that year.
Infant costs varied according to the gestational age at delivery, ranging from $1,311 per birth at 36 weeks’ gestation to $150,000 per birth at 26 weeks’ gestation, Dr. Stevens and his associates reported (Am J Obstet Gynecol. 2017 Jul 11. doi: 10.1016/j.ajog.2017.04.032).
This study could not take into account longer-term adverse outcomes associated with preeclampsia. Women with a history of the disorder are at double the risk of developing ischemic heart disease or cerebrovascular disease compared with women without such a history, and at three times the risk of developing hypertension. Infants are at increased risk of developing stroke, metabolic syndrome, and chronic heart disease, the investigators noted.
The study was supported by rEVO Biologics. Five of the study authors are employees of rEVO Biologics and one author is a steering committee member for a clinical trial supported by the company; another study author is a consultant at Precision Health Economics.
The cost of medical care for preeclampsia is estimated to be $2.18 billion for the first year surrounding delivery, split almost evenly between care for mothers and infants, according to a new report.
Preeclampsia is increasing at a more rapid rate than diabetes, ischemic heart failure, Alzheimer’s disease, obesity, and chronic kidney disease – disorders for which substantially more funding has been allocated for research and treatment, said Warren Stevens, PhD, of Precision Health Economics, Los Angeles, and his associates. Precision Health Economics provides consulting and other research services to pharmaceutical, device, government, and nongovernmental groups.
Compared with a healthy pregnancy, preeclampsia increased the probability that a mother would have at least one adverse outcome from 4.6% to 10.1%, and it increased the probability that an infant would have at least one adverse outcome from 7.9% to 14.2%. For mothers, preeclampsia was estimated to raise costs by $6,583 per birth, which translates to an increase of $1.03 billion for U.S. mothers during a single year (2012). For infants, the disorder raised costs by $1.15 billion during that year.
Infant costs varied according to the gestational age at delivery, ranging from $1,311 per birth at 36 weeks’ gestation to $150,000 per birth at 26 weeks’ gestation, Dr. Stevens and his associates reported (Am J Obstet Gynecol. 2017 Jul 11. doi: 10.1016/j.ajog.2017.04.032).
This study could not take into account longer-term adverse outcomes associated with preeclampsia. Women with a history of the disorder are at double the risk of developing ischemic heart disease or cerebrovascular disease compared with women without such a history, and at three times the risk of developing hypertension. Infants are at increased risk of developing stroke, metabolic syndrome, and chronic heart disease, the investigators noted.
The study was supported by rEVO Biologics. Five of the study authors are employees of rEVO Biologics and one author is a steering committee member for a clinical trial supported by the company; another study author is a consultant at Precision Health Economics.
FROM THE AMERICAN JOURNAL OF OBSTETRICS & GYNECOLOGY
Key clinical point:
Major finding: Compared with healthy pregnancy, preeclampsia increased the probability that a mother would have at least one adverse outcome from 4.6% to 10.1%, and it increased the probability that an infant would have at least one adverse outcome from 7.9% to 14.2%.
Data source: A retrospective cohort study using secondary analysis of numerous data sets and extrapolating from approximately 2 million births in 2012 (1,918,498 births without preeclampsia and 69,193 with preeclampsia).
Disclosures: The study was supported by rEVO Biologics. Five of the study authors are employees of Precision Health Economics and one author is a consultant there; another author is on the steering committee for a clinical trial supported by rEVO Biologics.
Bariatric Surgery for CKD
Q) I know that diabetes can be controlled with bariatric surgery. Is there any proof that it also helps with kidney disease?
With obesity reaching epidemic proportions in the United States, the number of patients undergoing bariatric surgery has increased in recent years. The procedure has been identified as the most effective intervention for the morbidly obese (BMI > 35).1, 2
Obesity is an independent risk factor for the development and progression of chronic kidney disease (CKD).3 It causes changes in the kidney, including hyperfiltration, proteinuria, albuminuria, and reduced glomerular filtration rate (GFR); however, the underlying mechanisms are still poorly understood.4 Research has demonstrated bariatric surgery’s positive effect on morbidly obese patients with CKD, as well as its benefit for patients with diabetes and hypertension—the two major causes of CKD.1,2
Several studies have found that weight loss resulting from bariatric surgery improves proteinuria, albuminuria, and GFR.2,3,5-9 Findings related to serum creatinine (SCr) have been somewhat conflicting. In severely obese patients, the surgery was associated with a reduction in SCr. This association persisted in those with and without baseline CKD, hypertension, and/or diabetes.5 However, other studies found that the procedure lowered SCr in patients with mild renal impairment (SCr 1.3-1.6 mg/dL) but increased levels in those with moderate renal impairment (SCr > 1.6 mg/dL).10 Because the effects of bariatric surgery on kidney function appear to differ based on CKD stage, further research is needed.
Overall, we can conclude that bariatric surgery has merit as an option to prevent and/or slow progression of early-stage CKD in severely obese patients. Larger, long-term studies are needed to analyze the duration of these effects on kidney outcomes, including the development of end-stage kidney disease. And additional research is needed to determine the risks and benefits associated with bariatric surgery in this population. —ZK-K
Zorica Kauric-Klein, APRN-BC, PhD
Assistant Clinical Professor, College of Nursing, Wayne State University, Detroit
1. Schauer PR, Bhatt DL, Kirwan JP, et al; STAMPEDE Investigators. Bariatric surgery versus intensive medical therapy for diabetes—5-year outcomes. N Engl J Med. 2017;376(7):641-651.
2. Ricci C, Gaeta M, Rausa E, et al. Early impact of bariatric surgery on type II diabetes, hypertension, and hyperlipidemia: a systematic review, meta-analysis and meta-regression on 6,587 patients. Obes Surg. 2014;24(4):522-528.
3. Bolignano D, Zoccali C. Effects of weight loss on renal function in obese CKD patients: a systematic review. Nephrol Dial Transplant. 2013;28(suppl 4):82-98.
4. Hall ME, do Carmo JM, da Silva AA, et al. Obesity, hypertension, and chronic kidney disease. Int J Nephrol Renovasc Dis. 2014;7:75-88.
5. Chang AR, Chen Y, Still C, et al. Bariatric surgery is associated with improvement in kidney outcomes. Kidney Int. 2016;90(1):164-171.
6. Ruiz-Tovar J, Giner L, Sarro-Sobrin F, et al. Laparoscopic sleeve gastrectomy prevents the deterioration of renal function in morbidly obese patients over 40 years. Obes Surg. 2015;25(5):796-799.
7. Neff KJ, Baud G, Raverdy V, et al. Renal function and remission of hypertension after bariatric surgery: a 5-year prospective cohort study. Obes Surg. 2017;27(3):613-619.
8. Nehus EJ, Khoury JC, Inge TH, et al. Kidney outcomes three years after bariatric surgery in severely obese adolescents. Kidney Int. 2017;91(2):451-458.
9. Carlsson LMS, Romeo S, Jacobson P, et al. The incidence of albuminuria after bariatric surgery and usual care in Swedish obese subjects (SOS): a prospective controlled intervention trial. Int J Obes (Lond). 2015;39(1):169-175.
10. Schuster DP, Teodorescu M, Mikami D, et al. Effect of bariatric surgery on normal and abnormal renal function. Surg Obes Relat Dis. 2011;7(4):459-464.
Clinician Reviews in partnership with
Renal Consult is edited by Jane S. Davis, CRNP, DNP, a member of the Clinician Reviews editorial board, who is a nurse practitioner in the Division of Nephrology at the University of Alabama at Birmingham and is the communications chairperson for the National Kidney Foundation’s Council of Advanced Practitioners (NKF-CAP); and Kim Zuber, PA-C, MSPS, DFAAPA, a semi-retired PA who works with the American Academy of Nephrology PAs and is a past chair of the NKF-CAP. This month’s responses were authored by Zorica Kauric-Klein, APRN-BC, PhD, who is an Assistant Clinical Professor in the College of Nursing at Wayne State University in Detroit, and Rebecca Clawson, MAT, PA-C, who is an Instructor in the PA Program at LSU Health Shreveport in Louisiana.
Clinician Reviews in partnership with
Renal Consult is edited by Jane S. Davis, CRNP, DNP, a member of the Clinician Reviews editorial board, who is a nurse practitioner in the Division of Nephrology at the University of Alabama at Birmingham and is the communications chairperson for the National Kidney Foundation’s Council of Advanced Practitioners (NKF-CAP); and Kim Zuber, PA-C, MSPS, DFAAPA, a semi-retired PA who works with the American Academy of Nephrology PAs and is a past chair of the NKF-CAP. This month’s responses were authored by Zorica Kauric-Klein, APRN-BC, PhD, who is an Assistant Clinical Professor in the College of Nursing at Wayne State University in Detroit, and Rebecca Clawson, MAT, PA-C, who is an Instructor in the PA Program at LSU Health Shreveport in Louisiana.
Clinician Reviews in partnership with
Renal Consult is edited by Jane S. Davis, CRNP, DNP, a member of the Clinician Reviews editorial board, who is a nurse practitioner in the Division of Nephrology at the University of Alabama at Birmingham and is the communications chairperson for the National Kidney Foundation’s Council of Advanced Practitioners (NKF-CAP); and Kim Zuber, PA-C, MSPS, DFAAPA, a semi-retired PA who works with the American Academy of Nephrology PAs and is a past chair of the NKF-CAP. This month’s responses were authored by Zorica Kauric-Klein, APRN-BC, PhD, who is an Assistant Clinical Professor in the College of Nursing at Wayne State University in Detroit, and Rebecca Clawson, MAT, PA-C, who is an Instructor in the PA Program at LSU Health Shreveport in Louisiana.
Q) I know that diabetes can be controlled with bariatric surgery. Is there any proof that it also helps with kidney disease?
With obesity reaching epidemic proportions in the United States, the number of patients undergoing bariatric surgery has increased in recent years. The procedure has been identified as the most effective intervention for the morbidly obese (BMI > 35).1, 2
Obesity is an independent risk factor for the development and progression of chronic kidney disease (CKD).3 It causes changes in the kidney, including hyperfiltration, proteinuria, albuminuria, and reduced glomerular filtration rate (GFR); however, the underlying mechanisms are still poorly understood.4 Research has demonstrated bariatric surgery’s positive effect on morbidly obese patients with CKD, as well as its benefit for patients with diabetes and hypertension—the two major causes of CKD.1,2
Several studies have found that weight loss resulting from bariatric surgery improves proteinuria, albuminuria, and GFR.2,3,5-9 Findings related to serum creatinine (SCr) have been somewhat conflicting. In severely obese patients, the surgery was associated with a reduction in SCr. This association persisted in those with and without baseline CKD, hypertension, and/or diabetes.5 However, other studies found that the procedure lowered SCr in patients with mild renal impairment (SCr 1.3-1.6 mg/dL) but increased levels in those with moderate renal impairment (SCr > 1.6 mg/dL).10 Because the effects of bariatric surgery on kidney function appear to differ based on CKD stage, further research is needed.
Overall, we can conclude that bariatric surgery has merit as an option to prevent and/or slow progression of early-stage CKD in severely obese patients. Larger, long-term studies are needed to analyze the duration of these effects on kidney outcomes, including the development of end-stage kidney disease. And additional research is needed to determine the risks and benefits associated with bariatric surgery in this population. —ZK-K
Zorica Kauric-Klein, APRN-BC, PhD
Assistant Clinical Professor, College of Nursing, Wayne State University, Detroit
Q) I know that diabetes can be controlled with bariatric surgery. Is there any proof that it also helps with kidney disease?
With obesity reaching epidemic proportions in the United States, the number of patients undergoing bariatric surgery has increased in recent years. The procedure has been identified as the most effective intervention for the morbidly obese (BMI > 35).1, 2
Obesity is an independent risk factor for the development and progression of chronic kidney disease (CKD).3 It causes changes in the kidney, including hyperfiltration, proteinuria, albuminuria, and reduced glomerular filtration rate (GFR); however, the underlying mechanisms are still poorly understood.4 Research has demonstrated bariatric surgery’s positive effect on morbidly obese patients with CKD, as well as its benefit for patients with diabetes and hypertension—the two major causes of CKD.1,2
Several studies have found that weight loss resulting from bariatric surgery improves proteinuria, albuminuria, and GFR.2,3,5-9 Findings related to serum creatinine (SCr) have been somewhat conflicting. In severely obese patients, the surgery was associated with a reduction in SCr. This association persisted in those with and without baseline CKD, hypertension, and/or diabetes.5 However, other studies found that the procedure lowered SCr in patients with mild renal impairment (SCr 1.3-1.6 mg/dL) but increased levels in those with moderate renal impairment (SCr > 1.6 mg/dL).10 Because the effects of bariatric surgery on kidney function appear to differ based on CKD stage, further research is needed.
Overall, we can conclude that bariatric surgery has merit as an option to prevent and/or slow progression of early-stage CKD in severely obese patients. Larger, long-term studies are needed to analyze the duration of these effects on kidney outcomes, including the development of end-stage kidney disease. And additional research is needed to determine the risks and benefits associated with bariatric surgery in this population. —ZK-K
Zorica Kauric-Klein, APRN-BC, PhD
Assistant Clinical Professor, College of Nursing, Wayne State University, Detroit
1. Schauer PR, Bhatt DL, Kirwan JP, et al; STAMPEDE Investigators. Bariatric surgery versus intensive medical therapy for diabetes—5-year outcomes. N Engl J Med. 2017;376(7):641-651.
2. Ricci C, Gaeta M, Rausa E, et al. Early impact of bariatric surgery on type II diabetes, hypertension, and hyperlipidemia: a systematic review, meta-analysis and meta-regression on 6,587 patients. Obes Surg. 2014;24(4):522-528.
3. Bolignano D, Zoccali C. Effects of weight loss on renal function in obese CKD patients: a systematic review. Nephrol Dial Transplant. 2013;28(suppl 4):82-98.
4. Hall ME, do Carmo JM, da Silva AA, et al. Obesity, hypertension, and chronic kidney disease. Int J Nephrol Renovasc Dis. 2014;7:75-88.
5. Chang AR, Chen Y, Still C, et al. Bariatric surgery is associated with improvement in kidney outcomes. Kidney Int. 2016;90(1):164-171.
6. Ruiz-Tovar J, Giner L, Sarro-Sobrin F, et al. Laparoscopic sleeve gastrectomy prevents the deterioration of renal function in morbidly obese patients over 40 years. Obes Surg. 2015;25(5):796-799.
7. Neff KJ, Baud G, Raverdy V, et al. Renal function and remission of hypertension after bariatric surgery: a 5-year prospective cohort study. Obes Surg. 2017;27(3):613-619.
8. Nehus EJ, Khoury JC, Inge TH, et al. Kidney outcomes three years after bariatric surgery in severely obese adolescents. Kidney Int. 2017;91(2):451-458.
9. Carlsson LMS, Romeo S, Jacobson P, et al. The incidence of albuminuria after bariatric surgery and usual care in Swedish obese subjects (SOS): a prospective controlled intervention trial. Int J Obes (Lond). 2015;39(1):169-175.
10. Schuster DP, Teodorescu M, Mikami D, et al. Effect of bariatric surgery on normal and abnormal renal function. Surg Obes Relat Dis. 2011;7(4):459-464.
1. Schauer PR, Bhatt DL, Kirwan JP, et al; STAMPEDE Investigators. Bariatric surgery versus intensive medical therapy for diabetes—5-year outcomes. N Engl J Med. 2017;376(7):641-651.
2. Ricci C, Gaeta M, Rausa E, et al. Early impact of bariatric surgery on type II diabetes, hypertension, and hyperlipidemia: a systematic review, meta-analysis and meta-regression on 6,587 patients. Obes Surg. 2014;24(4):522-528.
3. Bolignano D, Zoccali C. Effects of weight loss on renal function in obese CKD patients: a systematic review. Nephrol Dial Transplant. 2013;28(suppl 4):82-98.
4. Hall ME, do Carmo JM, da Silva AA, et al. Obesity, hypertension, and chronic kidney disease. Int J Nephrol Renovasc Dis. 2014;7:75-88.
5. Chang AR, Chen Y, Still C, et al. Bariatric surgery is associated with improvement in kidney outcomes. Kidney Int. 2016;90(1):164-171.
6. Ruiz-Tovar J, Giner L, Sarro-Sobrin F, et al. Laparoscopic sleeve gastrectomy prevents the deterioration of renal function in morbidly obese patients over 40 years. Obes Surg. 2015;25(5):796-799.
7. Neff KJ, Baud G, Raverdy V, et al. Renal function and remission of hypertension after bariatric surgery: a 5-year prospective cohort study. Obes Surg. 2017;27(3):613-619.
8. Nehus EJ, Khoury JC, Inge TH, et al. Kidney outcomes three years after bariatric surgery in severely obese adolescents. Kidney Int. 2017;91(2):451-458.
9. Carlsson LMS, Romeo S, Jacobson P, et al. The incidence of albuminuria after bariatric surgery and usual care in Swedish obese subjects (SOS): a prospective controlled intervention trial. Int J Obes (Lond). 2015;39(1):169-175.
10. Schuster DP, Teodorescu M, Mikami D, et al. Effect of bariatric surgery on normal and abnormal renal function. Surg Obes Relat Dis. 2011;7(4):459-464.
OMV meningococcal vaccine also protected against gonorrhea
A group B meningococcal outer-membrane-vesicle (OMV) vaccine used during a meningitis outbreak in New Zealand also protected against gonorrhea, according to a report published online July 10 in the Lancet.
Even though Neisseria meningitidis and Neisseria gonorrhoeae cause distinctly different diseases, the bacteria are closely related and are genetically and antigenically very similar. Most of the virulence factors present in one pathogen have an equivalent in the other, “providing at least one biologically plausible mechanism for cross-protection,” said Helen Petousis-Harris, PhD, of the department of general practice and primary health care, University of Auckland (New Zealand), and her associates. 
Approximately 1 million people – 81% of the New Zealand population younger than 20 years – received almost 3 million doses of the OMV meningococcal B vaccine (MeNZB) in a 2-year mass immunization program during the outbreak, allowing the investigators to compare the rate of gonorrhea between vaccinated and unvaccinated people. They performed a retrospective case-control study involving 14,730 participants, using information from a national health care database, a national immunization registry, and 11 sexual health clinics covering diverse geographic regions. This included 1,241 cases of gonorrhea (cases), 12,487 cases of chlamydia (controls), and 1,002 cases of gonorrhea plus chlamydia coinfection (categorized as controls or cases in separate analyses).
“The adjusted estimate for vaccine effectiveness of the MeNZB against confirmed cases of gonorrhea” was 31% (95% confidence interval, 21-39; P less than .0001), a finding that remained robust across several sensitivity analyses, Dr. Petousis-Harris and her associates said (Lancet. 2017 July 10. doi: 10.1016/S0140-6736(17)31449-6).
“To our knowledge, ours is the first study to show an association between a vaccine and a reduction in the risk of gonorrhea,” they noted. “The potential ability of an OMV group B meningococcal vaccine to provide even modest protection against gonorrhea would have substantial public health benefits in view of the prevalence of gonorrhea. Modeling suggests that a vaccine with 30% efficacy could decrease the prevalence of gonorrhea by more than 30% within 15 years, if immunity is maintained.”
These findings also are important in view of the organism’s increasing resistance to existing antibiotics. Moreover, if further study confirms that the MeNZB vaccine offers some degree of cross-protection against gonorrhea, these data can inform the development of a gonorrhea vaccine, the investigators added.
This study was funded by GlaxoSmithKline Vaccines and Auckland UniServices. Dr. Petousis-Harris reported serving as a consultant for GSK, Merck, and Pfizer, and one of her associates reported ties to Novartis Vaccines, GSK, Protein Sciences, and Merck.
Over decades of research, all of the attempts to create a vaccine against gonorrhea have failed, largely because of the variable nature of Neisseria gonorrhoeae antigens and the failure of the bacteria to induce a protective immune response, so the findings of Dr. Petousis-Harris and her associates are “a step in the right direction” and should reinvigorate interest and investment in this endeavor.
Although MeNZB is no longer available, another meningococcal vaccine (4CMenB, Bexsero) contains the same outer-membrane-vesicle antigen and three of the same recombinant proteins. As the authors pointed out, immunizing adolescents with this vaccine could reduce the rate of gonorrhea substantially, even if it has only moderate efficacy and duration of effect. In particular, reducing the pool of asymptomatic carriers would decrease both transmission and the severe sequelae that develop when the infection goes undetected.
Kate L. Seib, PhD, is a microbiologist at the Institute for Glycomics at Griffith University in Southport, Australia. She reported support by a career development fellowship from the Australian National Health and Medical Research Council. Dr. Seib made these remarks in an accompanying editorial comment (Lancet. 2017 July 10. doi: 10.1016/S0140-6736(17)31605-7).
Over decades of research, all of the attempts to create a vaccine against gonorrhea have failed, largely because of the variable nature of Neisseria gonorrhoeae antigens and the failure of the bacteria to induce a protective immune response, so the findings of Dr. Petousis-Harris and her associates are “a step in the right direction” and should reinvigorate interest and investment in this endeavor.
Although MeNZB is no longer available, another meningococcal vaccine (4CMenB, Bexsero) contains the same outer-membrane-vesicle antigen and three of the same recombinant proteins. As the authors pointed out, immunizing adolescents with this vaccine could reduce the rate of gonorrhea substantially, even if it has only moderate efficacy and duration of effect. In particular, reducing the pool of asymptomatic carriers would decrease both transmission and the severe sequelae that develop when the infection goes undetected.
Kate L. Seib, PhD, is a microbiologist at the Institute for Glycomics at Griffith University in Southport, Australia. She reported support by a career development fellowship from the Australian National Health and Medical Research Council. Dr. Seib made these remarks in an accompanying editorial comment (Lancet. 2017 July 10. doi: 10.1016/S0140-6736(17)31605-7).
Over decades of research, all of the attempts to create a vaccine against gonorrhea have failed, largely because of the variable nature of Neisseria gonorrhoeae antigens and the failure of the bacteria to induce a protective immune response, so the findings of Dr. Petousis-Harris and her associates are “a step in the right direction” and should reinvigorate interest and investment in this endeavor.
Although MeNZB is no longer available, another meningococcal vaccine (4CMenB, Bexsero) contains the same outer-membrane-vesicle antigen and three of the same recombinant proteins. As the authors pointed out, immunizing adolescents with this vaccine could reduce the rate of gonorrhea substantially, even if it has only moderate efficacy and duration of effect. In particular, reducing the pool of asymptomatic carriers would decrease both transmission and the severe sequelae that develop when the infection goes undetected.
Kate L. Seib, PhD, is a microbiologist at the Institute for Glycomics at Griffith University in Southport, Australia. She reported support by a career development fellowship from the Australian National Health and Medical Research Council. Dr. Seib made these remarks in an accompanying editorial comment (Lancet. 2017 July 10. doi: 10.1016/S0140-6736(17)31605-7).
A group B meningococcal outer-membrane-vesicle (OMV) vaccine used during a meningitis outbreak in New Zealand also protected against gonorrhea, according to a report published online July 10 in the Lancet.
Even though Neisseria meningitidis and Neisseria gonorrhoeae cause distinctly different diseases, the bacteria are closely related and are genetically and antigenically very similar. Most of the virulence factors present in one pathogen have an equivalent in the other, “providing at least one biologically plausible mechanism for cross-protection,” said Helen Petousis-Harris, PhD, of the department of general practice and primary health care, University of Auckland (New Zealand), and her associates.
Approximately 1 million people – 81% of the New Zealand population younger than 20 years – received almost 3 million doses of the OMV meningococcal B vaccine (MeNZB) in a 2-year mass immunization program during the outbreak, allowing the investigators to compare the rate of gonorrhea between vaccinated and unvaccinated people. They performed a retrospective case-control study involving 14,730 participants, using information from a national health care database, a national immunization registry, and 11 sexual health clinics covering diverse geographic regions. This included 1,241 cases of gonorrhea (cases), 12,487 cases of chlamydia (controls), and 1,002 cases of gonorrhea plus chlamydia coinfection (categorized as controls or cases in separate analyses).
“The adjusted estimate for vaccine effectiveness of the MeNZB against confirmed cases of gonorrhea” was 31% (95% confidence interval, 21-39; P less than .0001), a finding that remained robust across several sensitivity analyses, Dr. Petousis-Harris and her associates said (Lancet. 2017 July 10. doi: 10.1016/S0140-6736(17)31449-6).
“To our knowledge, ours is the first study to show an association between a vaccine and a reduction in the risk of gonorrhea,” they noted. “The potential ability of an OMV group B meningococcal vaccine to provide even modest protection against gonorrhea would have substantial public health benefits in view of the prevalence of gonorrhea. Modeling suggests that a vaccine with 30% efficacy could decrease the prevalence of gonorrhea by more than 30% within 15 years, if immunity is maintained.”
These findings also are important in view of the organism’s increasing resistance to existing antibiotics. Moreover, if further study confirms that the MeNZB vaccine offers some degree of cross-protection against gonorrhea, these data can inform the development of a gonorrhea vaccine, the investigators added.
This study was funded by GlaxoSmithKline Vaccines and Auckland UniServices. Dr. Petousis-Harris reported serving as a consultant for GSK, Merck, and Pfizer, and one of her associates reported ties to Novartis Vaccines, GSK, Protein Sciences, and Merck.
A group B meningococcal outer-membrane-vesicle (OMV) vaccine used during a meningitis outbreak in New Zealand also protected against gonorrhea, according to a report published online July 10 in the Lancet.
Even though Neisseria meningitidis and Neisseria gonorrhoeae cause distinctly different diseases, the bacteria are closely related and are genetically and antigenically very similar. Most of the virulence factors present in one pathogen have an equivalent in the other, “providing at least one biologically plausible mechanism for cross-protection,” said Helen Petousis-Harris, PhD, of the department of general practice and primary health care, University of Auckland (New Zealand), and her associates.
Approximately 1 million people – 81% of the New Zealand population younger than 20 years – received almost 3 million doses of the OMV meningococcal B vaccine (MeNZB) in a 2-year mass immunization program during the outbreak, allowing the investigators to compare the rate of gonorrhea between vaccinated and unvaccinated people. They performed a retrospective case-control study involving 14,730 participants, using information from a national health care database, a national immunization registry, and 11 sexual health clinics covering diverse geographic regions. This included 1,241 cases of gonorrhea (cases), 12,487 cases of chlamydia (controls), and 1,002 cases of gonorrhea plus chlamydia coinfection (categorized as controls or cases in separate analyses).
“The adjusted estimate for vaccine effectiveness of the MeNZB against confirmed cases of gonorrhea” was 31% (95% confidence interval, 21-39; P less than .0001), a finding that remained robust across several sensitivity analyses, Dr. Petousis-Harris and her associates said (Lancet. 2017 July 10. doi: 10.1016/S0140-6736(17)31449-6).
“To our knowledge, ours is the first study to show an association between a vaccine and a reduction in the risk of gonorrhea,” they noted. “The potential ability of an OMV group B meningococcal vaccine to provide even modest protection against gonorrhea would have substantial public health benefits in view of the prevalence of gonorrhea. Modeling suggests that a vaccine with 30% efficacy could decrease the prevalence of gonorrhea by more than 30% within 15 years, if immunity is maintained.”
These findings also are important in view of the organism’s increasing resistance to existing antibiotics. Moreover, if further study confirms that the MeNZB vaccine offers some degree of cross-protection against gonorrhea, these data can inform the development of a gonorrhea vaccine, the investigators added.
This study was funded by GlaxoSmithKline Vaccines and Auckland UniServices. Dr. Petousis-Harris reported serving as a consultant for GSK, Merck, and Pfizer, and one of her associates reported ties to Novartis Vaccines, GSK, Protein Sciences, and Merck.
FROM THE LANCET
Key clinical point:
Major finding: The adjusted estimate for the effectiveness of the MeNZB vaccine against cases of gonorrhea was 31%.
Data source: A retrospective case-control study involving 14,730 patients at 11 sexual health clinics across New Zealand.
Disclosures: This study was funded by GlaxoSmithKline Vaccines and Auckland UniServices. Dr. Petousis-Harris reported serving as a consultant for GSK, Merck, and Pfizer, and one of her associates reported ties to Novartis Vaccines, GSK, Protein Sciences, and Merck.
ABS offers a new path to board certification
The American Board of Surgery announced a revised and reformulated path for surgeons to board certification that will replace the current Maintenance of Certification process now in place.
The new program will offer surgeons greater flexibility and more practice-relevant options to achieve lifelong learning in their field and continuous board certification. The ABS based the program on feedback from diplomates (ABS-certified surgeons) including the findings from a 2016 survey sent to 5,000 diplomates.
Effective immediately, diplomates will be asked to report their professional standing, CME activities, and practice assessment participation every 5 years, rather than every 3 years. All diplomates will have their current reporting cycle extended by 2 years. The self-assessment CME requirement has been has been reduced by half. For 2018, more options for recertification will be offered with a greater focus on ongoing, high-value, and practice-relevant learning. The current 10-year interval recertification examination will continue to be offered for those who choose it. Input from diplomates will be sought in the coming months to provide input on the new program.
Find the full statement at http://www.absurgery.org/default.jsp?news_mocchange0717.
The American Board of Surgery announced a revised and reformulated path for surgeons to board certification that will replace the current Maintenance of Certification process now in place.
The new program will offer surgeons greater flexibility and more practice-relevant options to achieve lifelong learning in their field and continuous board certification. The ABS based the program on feedback from diplomates (ABS-certified surgeons) including the findings from a 2016 survey sent to 5,000 diplomates.
Effective immediately, diplomates will be asked to report their professional standing, CME activities, and practice assessment participation every 5 years, rather than every 3 years. All diplomates will have their current reporting cycle extended by 2 years. The self-assessment CME requirement has been has been reduced by half. For 2018, more options for recertification will be offered with a greater focus on ongoing, high-value, and practice-relevant learning. The current 10-year interval recertification examination will continue to be offered for those who choose it. Input from diplomates will be sought in the coming months to provide input on the new program.
Find the full statement at http://www.absurgery.org/default.jsp?news_mocchange0717.
The American Board of Surgery announced a revised and reformulated path for surgeons to board certification that will replace the current Maintenance of Certification process now in place.
The new program will offer surgeons greater flexibility and more practice-relevant options to achieve lifelong learning in their field and continuous board certification. The ABS based the program on feedback from diplomates (ABS-certified surgeons) including the findings from a 2016 survey sent to 5,000 diplomates.
Effective immediately, diplomates will be asked to report their professional standing, CME activities, and practice assessment participation every 5 years, rather than every 3 years. All diplomates will have their current reporting cycle extended by 2 years. The self-assessment CME requirement has been has been reduced by half. For 2018, more options for recertification will be offered with a greater focus on ongoing, high-value, and practice-relevant learning. The current 10-year interval recertification examination will continue to be offered for those who choose it. Input from diplomates will be sought in the coming months to provide input on the new program.
Find the full statement at http://www.absurgery.org/default.jsp?news_mocchange0717.
Algorithm for identifying IPF has low PPV
ICD-9 codes were poor at picking out idiopathic pulmonary fibrosis patients from administrative databases for epidemiologic studies, but a new tool could improve diagnostic accuracy, according to Kaiser Permanente and University of California, San Francisco (UCSF), investigators.
“In the age of large administrative databases and electronic medical records, there is rich opportunity to conduct population-based studies” of disease behavior, outcomes, health care use, and other matters, but researchers first need to be able to accurately identify patients with idiopathic pulmonary fibrosis (IPF) in large data sets, said investigators led by Brett Ley, MD, an assistant professor of medicine at UCSF.
The research community has traditionally relied on claims for specific IPF diagnostic codes – ICD-9 code 516.3 or ICD-9-CM code 516.31 – to identify patients, but the approach had never been validated. To see how well it works, the investigators applied it to the nearly 5.4 million adults in the Kaiser Permanente Northern California system during 2000-2014. After patients with interstitial lung disease-associated codes entered on or after the day of the last IPF code were excluded, the algorithm identified 2,608 patients as having IPF (Ann Am Thorac Soc. 2017 Jun;14[6]:880-7).
Next, the investigators randomly selected 150 of those patients and examined their medical records, procedure codes, CTs, and other patient-level data to see how many of them really had IPF. The results weren’t good. The positive predictive value of the IPF code-based algorithm was only 42.2%, with a sensitivity 55.6%.
The widely used code-based IPF algorithm does “not generate accurate estimates of IPF incidence and prevalence. ... Over half of the patients identified as having IPF ... did not have IPF on case review. Alarmingly, whereas half of the misclassified cases had an alternative [interstitial lung disease] diagnosis, the other half had no clinical or radiologic evidence of ILD [interstitial lung disease] at all.” The algorithm also “likely misses a substantial proportion of patients who do have IPF,” Dr. Ley and his colleagues said.
“We can only speculate about the reasons. ... It seems likely to be due to a combination of misdiagnosis at the clinical level and miscoding at the administrative level,” they said.
To try to improve the situation, the team tweaked the algorithm to include only patients 50 years or older who had at least two 516.3 or 516.31 claims 1 month or more apart and a chest CT procedure code beforehand. They again excluded ILD-associated claims on or after the day of the last IPF code.
Although the sensitivity of the modified algorithm was lower than the original, it had a more robust positive predictive value of 70.4% in the derivation cohort and 61.8% in the validation cohort, both derived from the 150 patients used to validate the original algorithm.
“By making a few simple, empirically derived changes to the IPF algorithm,” it’s possible to “more reliably identif[y] patients” with IPF. “We believe the modified IPF algorithm will be useful for population-based studies of IPF ... that require high diagnostic certainty,” the investigators concluded.
The traditional algorithm found an incidence of 6.8 cases per 100,000 person-years, which was on the low end of previous reports, perhaps because of the relative health and youth of the 5.4 million patient pool. As in past studies, IPF incidence increased with older age and was highest in white patients and men.
“Whether the more specific codes provided by the ICD-10 system will allow for improved case classification of IPF requires further study,” the investigators noted.
The work was funded by the National Institutes of Health. Dr. Ley reported speaker’s fees from Genentech, and one of the authors was an employee of the company. The senior author Harold Collard, MD, an associate professor in UCSF’s Division of Pulmonary and Critical Care Medicine, reported personal fees from Takeda, ImmuneWorks, Parexel, Pharma Capital Partners, and others.
This study glaringly displays potential problems with using ICD codes for research purposes and calls into question results from a handful of studies that yielded epidemiological estimates for idiopathic pulmonary fibrosis. We are reminded that practitioner-generated diagnostic codes of IPF recorded in the medical record are subject to inaccuracies, which can be illuminated by the “gold standard” – multidisciplinary adjudication.
Moving forward, particularly as longitudinal, nationwide IPF registries come online, patient-level case validation should be employed. As we move into the era of ICD-10, the study should serve as a call to improve IPF case ascertainment accuracy for any investigators choosing to use large data analytic strategies. Doing so will mute the background noise and allow us to better hear the signals of this complex disease.
Evans R. Fernandez Perez, MD, is a pulmonologist at National Jewish Health, Denver. He made his comments in an editorial, and reported speaker’s fees from Boehringer Ingelheim and Genentech (Ann Am Thorac Soc. 2017 Jun;14[6]:829-30).
This study glaringly displays potential problems with using ICD codes for research purposes and calls into question results from a handful of studies that yielded epidemiological estimates for idiopathic pulmonary fibrosis. We are reminded that practitioner-generated diagnostic codes of IPF recorded in the medical record are subject to inaccuracies, which can be illuminated by the “gold standard” – multidisciplinary adjudication.
Moving forward, particularly as longitudinal, nationwide IPF registries come online, patient-level case validation should be employed. As we move into the era of ICD-10, the study should serve as a call to improve IPF case ascertainment accuracy for any investigators choosing to use large data analytic strategies. Doing so will mute the background noise and allow us to better hear the signals of this complex disease.
Evans R. Fernandez Perez, MD, is a pulmonologist at National Jewish Health, Denver. He made his comments in an editorial, and reported speaker’s fees from Boehringer Ingelheim and Genentech (Ann Am Thorac Soc. 2017 Jun;14[6]:829-30).
This study glaringly displays potential problems with using ICD codes for research purposes and calls into question results from a handful of studies that yielded epidemiological estimates for idiopathic pulmonary fibrosis. We are reminded that practitioner-generated diagnostic codes of IPF recorded in the medical record are subject to inaccuracies, which can be illuminated by the “gold standard” – multidisciplinary adjudication.
Moving forward, particularly as longitudinal, nationwide IPF registries come online, patient-level case validation should be employed. As we move into the era of ICD-10, the study should serve as a call to improve IPF case ascertainment accuracy for any investigators choosing to use large data analytic strategies. Doing so will mute the background noise and allow us to better hear the signals of this complex disease.
Evans R. Fernandez Perez, MD, is a pulmonologist at National Jewish Health, Denver. He made his comments in an editorial, and reported speaker’s fees from Boehringer Ingelheim and Genentech (Ann Am Thorac Soc. 2017 Jun;14[6]:829-30).
ICD-9 codes were poor at picking out idiopathic pulmonary fibrosis patients from administrative databases for epidemiologic studies, but a new tool could improve diagnostic accuracy, according to Kaiser Permanente and University of California, San Francisco (UCSF), investigators.
“In the age of large administrative databases and electronic medical records, there is rich opportunity to conduct population-based studies” of disease behavior, outcomes, health care use, and other matters, but researchers first need to be able to accurately identify patients with idiopathic pulmonary fibrosis (IPF) in large data sets, said investigators led by Brett Ley, MD, an assistant professor of medicine at UCSF.
The research community has traditionally relied on claims for specific IPF diagnostic codes – ICD-9 code 516.3 or ICD-9-CM code 516.31 – to identify patients, but the approach had never been validated. To see how well it works, the investigators applied it to the nearly 5.4 million adults in the Kaiser Permanente Northern California system during 2000-2014. After patients with interstitial lung disease-associated codes entered on or after the day of the last IPF code were excluded, the algorithm identified 2,608 patients as having IPF (Ann Am Thorac Soc. 2017 Jun;14[6]:880-7).
Next, the investigators randomly selected 150 of those patients and examined their medical records, procedure codes, CTs, and other patient-level data to see how many of them really had IPF. The results weren’t good. The positive predictive value of the IPF code-based algorithm was only 42.2%, with a sensitivity 55.6%.
The widely used code-based IPF algorithm does “not generate accurate estimates of IPF incidence and prevalence. ... Over half of the patients identified as having IPF ... did not have IPF on case review. Alarmingly, whereas half of the misclassified cases had an alternative [interstitial lung disease] diagnosis, the other half had no clinical or radiologic evidence of ILD [interstitial lung disease] at all.” The algorithm also “likely misses a substantial proportion of patients who do have IPF,” Dr. Ley and his colleagues said.
“We can only speculate about the reasons. ... It seems likely to be due to a combination of misdiagnosis at the clinical level and miscoding at the administrative level,” they said.
To try to improve the situation, the team tweaked the algorithm to include only patients 50 years or older who had at least two 516.3 or 516.31 claims 1 month or more apart and a chest CT procedure code beforehand. They again excluded ILD-associated claims on or after the day of the last IPF code.
Although the sensitivity of the modified algorithm was lower than the original, it had a more robust positive predictive value of 70.4% in the derivation cohort and 61.8% in the validation cohort, both derived from the 150 patients used to validate the original algorithm.
“By making a few simple, empirically derived changes to the IPF algorithm,” it’s possible to “more reliably identif[y] patients” with IPF. “We believe the modified IPF algorithm will be useful for population-based studies of IPF ... that require high diagnostic certainty,” the investigators concluded.
The traditional algorithm found an incidence of 6.8 cases per 100,000 person-years, which was on the low end of previous reports, perhaps because of the relative health and youth of the 5.4 million patient pool. As in past studies, IPF incidence increased with older age and was highest in white patients and men.
“Whether the more specific codes provided by the ICD-10 system will allow for improved case classification of IPF requires further study,” the investigators noted.
The work was funded by the National Institutes of Health. Dr. Ley reported speaker’s fees from Genentech, and one of the authors was an employee of the company. The senior author Harold Collard, MD, an associate professor in UCSF’s Division of Pulmonary and Critical Care Medicine, reported personal fees from Takeda, ImmuneWorks, Parexel, Pharma Capital Partners, and others.
ICD-9 codes were poor at picking out idiopathic pulmonary fibrosis patients from administrative databases for epidemiologic studies, but a new tool could improve diagnostic accuracy, according to Kaiser Permanente and University of California, San Francisco (UCSF), investigators.
“In the age of large administrative databases and electronic medical records, there is rich opportunity to conduct population-based studies” of disease behavior, outcomes, health care use, and other matters, but researchers first need to be able to accurately identify patients with idiopathic pulmonary fibrosis (IPF) in large data sets, said investigators led by Brett Ley, MD, an assistant professor of medicine at UCSF.
The research community has traditionally relied on claims for specific IPF diagnostic codes – ICD-9 code 516.3 or ICD-9-CM code 516.31 – to identify patients, but the approach had never been validated. To see how well it works, the investigators applied it to the nearly 5.4 million adults in the Kaiser Permanente Northern California system during 2000-2014. After patients with interstitial lung disease-associated codes entered on or after the day of the last IPF code were excluded, the algorithm identified 2,608 patients as having IPF (Ann Am Thorac Soc. 2017 Jun;14[6]:880-7).
Next, the investigators randomly selected 150 of those patients and examined their medical records, procedure codes, CTs, and other patient-level data to see how many of them really had IPF. The results weren’t good. The positive predictive value of the IPF code-based algorithm was only 42.2%, with a sensitivity 55.6%.
The widely used code-based IPF algorithm does “not generate accurate estimates of IPF incidence and prevalence. ... Over half of the patients identified as having IPF ... did not have IPF on case review. Alarmingly, whereas half of the misclassified cases had an alternative [interstitial lung disease] diagnosis, the other half had no clinical or radiologic evidence of ILD [interstitial lung disease] at all.” The algorithm also “likely misses a substantial proportion of patients who do have IPF,” Dr. Ley and his colleagues said.
“We can only speculate about the reasons. ... It seems likely to be due to a combination of misdiagnosis at the clinical level and miscoding at the administrative level,” they said.
To try to improve the situation, the team tweaked the algorithm to include only patients 50 years or older who had at least two 516.3 or 516.31 claims 1 month or more apart and a chest CT procedure code beforehand. They again excluded ILD-associated claims on or after the day of the last IPF code.
Although the sensitivity of the modified algorithm was lower than the original, it had a more robust positive predictive value of 70.4% in the derivation cohort and 61.8% in the validation cohort, both derived from the 150 patients used to validate the original algorithm.
“By making a few simple, empirically derived changes to the IPF algorithm,” it’s possible to “more reliably identif[y] patients” with IPF. “We believe the modified IPF algorithm will be useful for population-based studies of IPF ... that require high diagnostic certainty,” the investigators concluded.
The traditional algorithm found an incidence of 6.8 cases per 100,000 person-years, which was on the low end of previous reports, perhaps because of the relative health and youth of the 5.4 million patient pool. As in past studies, IPF incidence increased with older age and was highest in white patients and men.
“Whether the more specific codes provided by the ICD-10 system will allow for improved case classification of IPF requires further study,” the investigators noted.
The work was funded by the National Institutes of Health. Dr. Ley reported speaker’s fees from Genentech, and one of the authors was an employee of the company. The senior author Harold Collard, MD, an associate professor in UCSF’s Division of Pulmonary and Critical Care Medicine, reported personal fees from Takeda, ImmuneWorks, Parexel, Pharma Capital Partners, and others.
FROM THE ANNALS OF THE AMERICAN THORACIC SOCIETY
Key clinical point:
Major finding: The positive predictive value of the traditional IPF code-based algorithm was only 42.2%, with a sensitivity of 55.6%.
Data source: A study including almost 5.4 million patients at Kaiser Permanente Northern California.
Disclosures: The work was funded by the National Institutes of Health. One of the investigators was a Genentech employee. Others reported speaker’s and personal fees from Genentech and other companies.
Allopurinol and ventricular arrhythmias: Is there a link?
MADRID – Newly begun allopurinol treatment of elderly patients was linked with a significantly reduced incidence of ventricular arrhythmias in a review of more than 28,000 Medicare beneficiaries.
The antiarrhythmic effect appeared to strengthen with more prolonged allopurinol treatment, reaching a 28% reduction in ventricular arrhythmia incidence among patients on allopurinol for more than 2 years, compared with patients who never received the uric acid reducer, Jasvinder A. Singh, MD, reported in a poster at the European Congress of Rheumatology.
He and his associates used data collected from more than 3 million U.S. Medicare beneficiaries during 2006-2012 from a random Medicare 5% sample. This group included 28,755 patients who began a prescription for allopurinol after not having filled a prescription for the drug during the prior 365 days. The patients averaged 77 years of age.
The outcome of interest was a new onset ventricular arrhythmia, defined as an arrhythmia episode in a patient with no prior record of arrhythmia during the previous 365 days. Arrhythmia occurred in 2,538 of the patients on new allopurinol treatment (9%).
In a multivariate analysis that compared new allopurinol users with patients without allopurinol exposure and controlled for several demographic and clinical features, allopurinol use was linked with a statistically significant 18% reduced rate of incident ventricular arrhythmias in those who recieved it, compared with similar patients who did not receive allopurinol, Dr. Singh and his associates reported.
An additional analysis looked at the relative risk reduction associated with various lengths of allopurinol use. Compared with patients not on allopurinol, those taking it for more than 2 years had a significant 28% reduced rate of arrhythmias; those on it for 6 months to 2 years had a significant 24% reduction in incident arrhythmias; and those on it for 1-180 days had no significant change in their arrhythmia incidence.
Other individual factors that significantly correlated with increased ventricular arrhythmias included older age, male sex, African American race, presence of comorbidities, and treatment with a beta-blockers. Like allopurinol, treatment with a statin linked with a significantly reduced arrhythmia incidence.
In a second, related report at the meeting, Dr. Singh and his associates used a very similar data set to see if a link existed between new-onset allopurinol treatment and a reduced incidence of peripheral artery disease. This analysis showed that allopurinol use linked with a statistically significant 12% reduction in new onset peripheral artery disease. They again found that the clinical impact of allopurinol treatment grew larger as the duration of allopurinol treatment increased.
Dr. Singh has financial ties to Allergan, Bioiberica, Crealta, Iroko, Merz, Regeneron, Savient, and Takeda.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
MADRID – Newly begun allopurinol treatment of elderly patients was linked with a significantly reduced incidence of ventricular arrhythmias in a review of more than 28,000 Medicare beneficiaries.
The antiarrhythmic effect appeared to strengthen with more prolonged allopurinol treatment, reaching a 28% reduction in ventricular arrhythmia incidence among patients on allopurinol for more than 2 years, compared with patients who never received the uric acid reducer, Jasvinder A. Singh, MD, reported in a poster at the European Congress of Rheumatology.
He and his associates used data collected from more than 3 million U.S. Medicare beneficiaries during 2006-2012 from a random Medicare 5% sample. This group included 28,755 patients who began a prescription for allopurinol after not having filled a prescription for the drug during the prior 365 days. The patients averaged 77 years of age.
The outcome of interest was a new onset ventricular arrhythmia, defined as an arrhythmia episode in a patient with no prior record of arrhythmia during the previous 365 days. Arrhythmia occurred in 2,538 of the patients on new allopurinol treatment (9%).
In a multivariate analysis that compared new allopurinol users with patients without allopurinol exposure and controlled for several demographic and clinical features, allopurinol use was linked with a statistically significant 18% reduced rate of incident ventricular arrhythmias in those who recieved it, compared with similar patients who did not receive allopurinol, Dr. Singh and his associates reported.
An additional analysis looked at the relative risk reduction associated with various lengths of allopurinol use. Compared with patients not on allopurinol, those taking it for more than 2 years had a significant 28% reduced rate of arrhythmias; those on it for 6 months to 2 years had a significant 24% reduction in incident arrhythmias; and those on it for 1-180 days had no significant change in their arrhythmia incidence.
Other individual factors that significantly correlated with increased ventricular arrhythmias included older age, male sex, African American race, presence of comorbidities, and treatment with a beta-blockers. Like allopurinol, treatment with a statin linked with a significantly reduced arrhythmia incidence.
In a second, related report at the meeting, Dr. Singh and his associates used a very similar data set to see if a link existed between new-onset allopurinol treatment and a reduced incidence of peripheral artery disease. This analysis showed that allopurinol use linked with a statistically significant 12% reduction in new onset peripheral artery disease. They again found that the clinical impact of allopurinol treatment grew larger as the duration of allopurinol treatment increased.
Dr. Singh has financial ties to Allergan, Bioiberica, Crealta, Iroko, Merz, Regeneron, Savient, and Takeda.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
MADRID – Newly begun allopurinol treatment of elderly patients was linked with a significantly reduced incidence of ventricular arrhythmias in a review of more than 28,000 Medicare beneficiaries.
The antiarrhythmic effect appeared to strengthen with more prolonged allopurinol treatment, reaching a 28% reduction in ventricular arrhythmia incidence among patients on allopurinol for more than 2 years, compared with patients who never received the uric acid reducer, Jasvinder A. Singh, MD, reported in a poster at the European Congress of Rheumatology.
He and his associates used data collected from more than 3 million U.S. Medicare beneficiaries during 2006-2012 from a random Medicare 5% sample. This group included 28,755 patients who began a prescription for allopurinol after not having filled a prescription for the drug during the prior 365 days. The patients averaged 77 years of age.
The outcome of interest was a new onset ventricular arrhythmia, defined as an arrhythmia episode in a patient with no prior record of arrhythmia during the previous 365 days. Arrhythmia occurred in 2,538 of the patients on new allopurinol treatment (9%).
In a multivariate analysis that compared new allopurinol users with patients without allopurinol exposure and controlled for several demographic and clinical features, allopurinol use was linked with a statistically significant 18% reduced rate of incident ventricular arrhythmias in those who recieved it, compared with similar patients who did not receive allopurinol, Dr. Singh and his associates reported.
An additional analysis looked at the relative risk reduction associated with various lengths of allopurinol use. Compared with patients not on allopurinol, those taking it for more than 2 years had a significant 28% reduced rate of arrhythmias; those on it for 6 months to 2 years had a significant 24% reduction in incident arrhythmias; and those on it for 1-180 days had no significant change in their arrhythmia incidence.
Other individual factors that significantly correlated with increased ventricular arrhythmias included older age, male sex, African American race, presence of comorbidities, and treatment with a beta-blockers. Like allopurinol, treatment with a statin linked with a significantly reduced arrhythmia incidence.
In a second, related report at the meeting, Dr. Singh and his associates used a very similar data set to see if a link existed between new-onset allopurinol treatment and a reduced incidence of peripheral artery disease. This analysis showed that allopurinol use linked with a statistically significant 12% reduction in new onset peripheral artery disease. They again found that the clinical impact of allopurinol treatment grew larger as the duration of allopurinol treatment increased.
Dr. Singh has financial ties to Allergan, Bioiberica, Crealta, Iroko, Merz, Regeneron, Savient, and Takeda.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT THE EULAR 2017 CONGRESS
Key clinical point:
Major finding: Patients on allopurinol for more than 2 years had a 28% reduced rate of ventricular arrhythmias, compared with those not on allopurinol treatment.
Data source: A 5% random sample of Medicare beneficiaries during 2006-2012.
Disclosures: Dr. Singh has been a consultant to Allergan, Bioiberica, Crealta, Iroko, Merz, Regeneron, Savient, and Takeda and has received research support from Savient and Takeda.
Optimal age for cardiovascular disease screening remains elusive
SAN FRANCISCO – In the United States, deaths from cardiovascular disease fell by about 50% in men and women between 1980 and 2000, and fell an additional 31% between 2000 and 2010, according to Robert Baron, MD.
That’s the good news, driven largely by the introduction of statin therapy and by risk-factor modifications. The not-so-great news? The optimal screening age for CVD risk remains elusive.
“We’ve been arguing about this for at least 30 years,” he said at the UCSF Annual Advances in Internal Medicine.
The 2013 American College of Cardiology/American Heart Association Guideline on the Assessment of Cardiovascular Risk recommends screening at age 21 years to identify those with an LDL cholesterol level greater than 190 mg/dL, while a more recent draft recommendation statement from the United States Preventive Services Task Force (USPSTF) recommends screening at age 35 in men and 45 in women for most cases, or at age 20 in people deemed to be at increased risk. Both sets of guidelines recommend the use of statins in patients with atherosclerotic cardiovascular disease, and LDL of 190 mg/dL or greater, and/or diabetes.
“In essence, the USPSTF guidelines are saying definitely use statins for primary prevention in high-risk people; they’re just creating a little more gray area as to what exactly constitutes high risk,” said Dr. Baron, an internist who is associate dean at UCSF Medical Center, San Francisco. “The question is, how do you draw the line? I would argue that depends on the patient preference.”
In a recently published analysis, researchers set out to determine how the USPSTF guidelines compare with the ACC/AHA guidelines in terms of the proportion of U.S. adults potentially treated (JAMA. 2017 Apr 18; 317[15]:1563-7). After using estimates based on data from 3,416 participants in the 2009-2014 National Health and Nutrition Examination Survey, the researchers found that USPSTF recommendations would be associated with statin initiation in 16% of U.S. adults aged 40-75 years without prior CVD, compared with 24% according to the ACC/AHA guidelines.
Among those adults for whom therapy would no longer be recommended under the USPSTF recommendations, 55% are aged 40-59 years with a mean 30-year cardiovascular risk exceeding 30%, and 28% have diabetes. According to Dr. Baron, the comparison “reinforces the primary prevention message. It gives the patient a bit more flexibility.”
After starting patients on a statin, the best available evidence recommends monitoring adherence but not treating to a specific LDL goal, he said. Statins should not be used in patients older than age 75 unless they have existing ASCVD. The addition of other lipid-modifying drugs is generally not recommended, but it may be needed in patients who demonstrate intolerance to statins. Patients should also avoid using NSAIDS, which raise CVD risk, and instead use medications that lower it, such as aspirin, he said.
Dr. Baron reported having no relevant financial disclosures.
SAN FRANCISCO – In the United States, deaths from cardiovascular disease fell by about 50% in men and women between 1980 and 2000, and fell an additional 31% between 2000 and 2010, according to Robert Baron, MD.
That’s the good news, driven largely by the introduction of statin therapy and by risk-factor modifications. The not-so-great news? The optimal screening age for CVD risk remains elusive.
“We’ve been arguing about this for at least 30 years,” he said at the UCSF Annual Advances in Internal Medicine.
The 2013 American College of Cardiology/American Heart Association Guideline on the Assessment of Cardiovascular Risk recommends screening at age 21 years to identify those with an LDL cholesterol level greater than 190 mg/dL, while a more recent draft recommendation statement from the United States Preventive Services Task Force (USPSTF) recommends screening at age 35 in men and 45 in women for most cases, or at age 20 in people deemed to be at increased risk. Both sets of guidelines recommend the use of statins in patients with atherosclerotic cardiovascular disease, and LDL of 190 mg/dL or greater, and/or diabetes.
“In essence, the USPSTF guidelines are saying definitely use statins for primary prevention in high-risk people; they’re just creating a little more gray area as to what exactly constitutes high risk,” said Dr. Baron, an internist who is associate dean at UCSF Medical Center, San Francisco. “The question is, how do you draw the line? I would argue that depends on the patient preference.”
In a recently published analysis, researchers set out to determine how the USPSTF guidelines compare with the ACC/AHA guidelines in terms of the proportion of U.S. adults potentially treated (JAMA. 2017 Apr 18; 317[15]:1563-7). After using estimates based on data from 3,416 participants in the 2009-2014 National Health and Nutrition Examination Survey, the researchers found that USPSTF recommendations would be associated with statin initiation in 16% of U.S. adults aged 40-75 years without prior CVD, compared with 24% according to the ACC/AHA guidelines.
Among those adults for whom therapy would no longer be recommended under the USPSTF recommendations, 55% are aged 40-59 years with a mean 30-year cardiovascular risk exceeding 30%, and 28% have diabetes. According to Dr. Baron, the comparison “reinforces the primary prevention message. It gives the patient a bit more flexibility.”
After starting patients on a statin, the best available evidence recommends monitoring adherence but not treating to a specific LDL goal, he said. Statins should not be used in patients older than age 75 unless they have existing ASCVD. The addition of other lipid-modifying drugs is generally not recommended, but it may be needed in patients who demonstrate intolerance to statins. Patients should also avoid using NSAIDS, which raise CVD risk, and instead use medications that lower it, such as aspirin, he said.
Dr. Baron reported having no relevant financial disclosures.
SAN FRANCISCO – In the United States, deaths from cardiovascular disease fell by about 50% in men and women between 1980 and 2000, and fell an additional 31% between 2000 and 2010, according to Robert Baron, MD.
That’s the good news, driven largely by the introduction of statin therapy and by risk-factor modifications. The not-so-great news? The optimal screening age for CVD risk remains elusive.
“We’ve been arguing about this for at least 30 years,” he said at the UCSF Annual Advances in Internal Medicine.
The 2013 American College of Cardiology/American Heart Association Guideline on the Assessment of Cardiovascular Risk recommends screening at age 21 years to identify those with an LDL cholesterol level greater than 190 mg/dL, while a more recent draft recommendation statement from the United States Preventive Services Task Force (USPSTF) recommends screening at age 35 in men and 45 in women for most cases, or at age 20 in people deemed to be at increased risk. Both sets of guidelines recommend the use of statins in patients with atherosclerotic cardiovascular disease, and LDL of 190 mg/dL or greater, and/or diabetes.
“In essence, the USPSTF guidelines are saying definitely use statins for primary prevention in high-risk people; they’re just creating a little more gray area as to what exactly constitutes high risk,” said Dr. Baron, an internist who is associate dean at UCSF Medical Center, San Francisco. “The question is, how do you draw the line? I would argue that depends on the patient preference.”
In a recently published analysis, researchers set out to determine how the USPSTF guidelines compare with the ACC/AHA guidelines in terms of the proportion of U.S. adults potentially treated (JAMA. 2017 Apr 18; 317[15]:1563-7). After using estimates based on data from 3,416 participants in the 2009-2014 National Health and Nutrition Examination Survey, the researchers found that USPSTF recommendations would be associated with statin initiation in 16% of U.S. adults aged 40-75 years without prior CVD, compared with 24% according to the ACC/AHA guidelines.
Among those adults for whom therapy would no longer be recommended under the USPSTF recommendations, 55% are aged 40-59 years with a mean 30-year cardiovascular risk exceeding 30%, and 28% have diabetes. According to Dr. Baron, the comparison “reinforces the primary prevention message. It gives the patient a bit more flexibility.”
After starting patients on a statin, the best available evidence recommends monitoring adherence but not treating to a specific LDL goal, he said. Statins should not be used in patients older than age 75 unless they have existing ASCVD. The addition of other lipid-modifying drugs is generally not recommended, but it may be needed in patients who demonstrate intolerance to statins. Patients should also avoid using NSAIDS, which raise CVD risk, and instead use medications that lower it, such as aspirin, he said.
Dr. Baron reported having no relevant financial disclosures.
EXPERT ANALYSIS FROM THE ANNUAL ADVANCES IN INTERNAL MEDICINE
Higher ADHD risk seen in children with migraine
BOSTON – Children aged 5-12 years with signs of migraine headache were as much as seven times as likely as other children to also appear to have attention-deficit/hyperactivity disorder (ADHD), but those with tension-type headaches didn’t face a higher risk of ADHD, a Brazilian study showed.
It’s not clear why the apparent link between migraines and ADHD exists. However, lead study author Marco Antônio Arruda, MD, PhD, a pediatric neurologist in São Paulo (Brazil) University, said in an interview that other research has linked migraine to mental health problems.
The study, presented at the annual meeting of the American Academy of Neurology and published online in the Journal of Attention Disorders (2017. doi: 10.1177/1087054717710767), was launched to better understand the connection between migraine and ADHD, which are thought to each affect as many as 1 in 10 children.
The study analyzes data from mothers and teachers of 5,671 children aged 5-12 years who answered questions as part of a Brazil-wide epidemiologic study called the Attention Brazil Project. Just over half of the participants were boys, and about half were from the Brazilian middle class.
Based on answers from mothers and teachers, the researchers estimated that 9% of the children had episodic migraine and 0.6% had chronic migraine. The level of episodic tension-type headache was estimated at 12.8%, with a lower rate in the two poorest vs. the two richest quintiles (8.6% vs. 14.4%, respectively; relative risk, 0.6; 95% confidence interval, 0.5-0.8).
The researchers estimated that 5.3% of the children overall showed signs of ADHD (7.5% in boys vs. 3.1% in girls; RR, 2.4; 95% CI, 1.9-3.1).
There was no sign that children with tension-type headaches had a significantly higher risk of ADHD than other children. However, compared with controls, those with various types of migraine headaches did have a higher risk of ADHD. Nearly 11% of those with migraine overall showed signs of ADHD, compared with 2.6% of the control group (RR, 4.1; 95% CI, 2.7-6.2). The numbers for episodic migraine were nearly identical to those for migraine overall: 10.2% vs. 2.6% (RR, 3.8; 95% CI, 2.5-5.9).
Just over 19% of kids in a third migraine group – those with chronic migraine, defined as headaches appearing more than 14 days per month for the last 3 months – showed signs of ADHD, compared with just 2.6% of the control group (RR = 7.3; 95% CI, 3.5-15.5).
“A number of risk factors to the association were identified, including male gender, prenatal exposure to tobacco, high headache frequency, and below average school performance,” Dr. Arruda said. “However, we did not find a significant influence of age, race, city density, national region where a child lives, income class, and prenatal exposure to alcohol in the comorbidity of ADHD and migraine in this sample. These results help us to identify risk groups allowing early interventions.”
Regarding an explanation for the links between migraines and ADHD, Dr. Arruda pointed to genetic and epigenetic factors that affect brain neurotransmitters and said he believes that stress and other stimuli could be influencing dopamine and noradrenergic processes.
Dr. Arruda said his next step is to examine whether stimulant drugs – the class used to treat ADHD – may help reduce headaches too.
“My clinical experience strongly indicates that psychostimulants have a highly positive effect on migraine prophylaxis, although headache occurs in the very beginning of the treatment,” Dr. Arruda said. “So, we are looking for financial support to conduct a randomized, double-blind, placebo control study to check this hypothesis.”
The study received no specific funding, and Dr. Arruda reported no relevant financial disclosures.
BOSTON – Children aged 5-12 years with signs of migraine headache were as much as seven times as likely as other children to also appear to have attention-deficit/hyperactivity disorder (ADHD), but those with tension-type headaches didn’t face a higher risk of ADHD, a Brazilian study showed.
It’s not clear why the apparent link between migraines and ADHD exists. However, lead study author Marco Antônio Arruda, MD, PhD, a pediatric neurologist in São Paulo (Brazil) University, said in an interview that other research has linked migraine to mental health problems.
The study, presented at the annual meeting of the American Academy of Neurology and published online in the Journal of Attention Disorders (2017. doi: 10.1177/1087054717710767), was launched to better understand the connection between migraine and ADHD, which are thought to each affect as many as 1 in 10 children.
The study analyzes data from mothers and teachers of 5,671 children aged 5-12 years who answered questions as part of a Brazil-wide epidemiologic study called the Attention Brazil Project. Just over half of the participants were boys, and about half were from the Brazilian middle class.
Based on answers from mothers and teachers, the researchers estimated that 9% of the children had episodic migraine and 0.6% had chronic migraine. The level of episodic tension-type headache was estimated at 12.8%, with a lower rate in the two poorest vs. the two richest quintiles (8.6% vs. 14.4%, respectively; relative risk, 0.6; 95% confidence interval, 0.5-0.8).
The researchers estimated that 5.3% of the children overall showed signs of ADHD (7.5% in boys vs. 3.1% in girls; RR, 2.4; 95% CI, 1.9-3.1).
There was no sign that children with tension-type headaches had a significantly higher risk of ADHD than other children. However, compared with controls, those with various types of migraine headaches did have a higher risk of ADHD. Nearly 11% of those with migraine overall showed signs of ADHD, compared with 2.6% of the control group (RR, 4.1; 95% CI, 2.7-6.2). The numbers for episodic migraine were nearly identical to those for migraine overall: 10.2% vs. 2.6% (RR, 3.8; 95% CI, 2.5-5.9).
Just over 19% of kids in a third migraine group – those with chronic migraine, defined as headaches appearing more than 14 days per month for the last 3 months – showed signs of ADHD, compared with just 2.6% of the control group (RR = 7.3; 95% CI, 3.5-15.5).
“A number of risk factors to the association were identified, including male gender, prenatal exposure to tobacco, high headache frequency, and below average school performance,” Dr. Arruda said. “However, we did not find a significant influence of age, race, city density, national region where a child lives, income class, and prenatal exposure to alcohol in the comorbidity of ADHD and migraine in this sample. These results help us to identify risk groups allowing early interventions.”
Regarding an explanation for the links between migraines and ADHD, Dr. Arruda pointed to genetic and epigenetic factors that affect brain neurotransmitters and said he believes that stress and other stimuli could be influencing dopamine and noradrenergic processes.
Dr. Arruda said his next step is to examine whether stimulant drugs – the class used to treat ADHD – may help reduce headaches too.
“My clinical experience strongly indicates that psychostimulants have a highly positive effect on migraine prophylaxis, although headache occurs in the very beginning of the treatment,” Dr. Arruda said. “So, we are looking for financial support to conduct a randomized, double-blind, placebo control study to check this hypothesis.”
The study received no specific funding, and Dr. Arruda reported no relevant financial disclosures.
BOSTON – Children aged 5-12 years with signs of migraine headache were as much as seven times as likely as other children to also appear to have attention-deficit/hyperactivity disorder (ADHD), but those with tension-type headaches didn’t face a higher risk of ADHD, a Brazilian study showed.
It’s not clear why the apparent link between migraines and ADHD exists. However, lead study author Marco Antônio Arruda, MD, PhD, a pediatric neurologist in São Paulo (Brazil) University, said in an interview that other research has linked migraine to mental health problems.
The study, presented at the annual meeting of the American Academy of Neurology and published online in the Journal of Attention Disorders (2017. doi: 10.1177/1087054717710767), was launched to better understand the connection between migraine and ADHD, which are thought to each affect as many as 1 in 10 children.
The study analyzes data from mothers and teachers of 5,671 children aged 5-12 years who answered questions as part of a Brazil-wide epidemiologic study called the Attention Brazil Project. Just over half of the participants were boys, and about half were from the Brazilian middle class.
Based on answers from mothers and teachers, the researchers estimated that 9% of the children had episodic migraine and 0.6% had chronic migraine. The level of episodic tension-type headache was estimated at 12.8%, with a lower rate in the two poorest vs. the two richest quintiles (8.6% vs. 14.4%, respectively; relative risk, 0.6; 95% confidence interval, 0.5-0.8).
The researchers estimated that 5.3% of the children overall showed signs of ADHD (7.5% in boys vs. 3.1% in girls; RR, 2.4; 95% CI, 1.9-3.1).
There was no sign that children with tension-type headaches had a significantly higher risk of ADHD than other children. However, compared with controls, those with various types of migraine headaches did have a higher risk of ADHD. Nearly 11% of those with migraine overall showed signs of ADHD, compared with 2.6% of the control group (RR, 4.1; 95% CI, 2.7-6.2). The numbers for episodic migraine were nearly identical to those for migraine overall: 10.2% vs. 2.6% (RR, 3.8; 95% CI, 2.5-5.9).
Just over 19% of kids in a third migraine group – those with chronic migraine, defined as headaches appearing more than 14 days per month for the last 3 months – showed signs of ADHD, compared with just 2.6% of the control group (RR = 7.3; 95% CI, 3.5-15.5).
“A number of risk factors to the association were identified, including male gender, prenatal exposure to tobacco, high headache frequency, and below average school performance,” Dr. Arruda said. “However, we did not find a significant influence of age, race, city density, national region where a child lives, income class, and prenatal exposure to alcohol in the comorbidity of ADHD and migraine in this sample. These results help us to identify risk groups allowing early interventions.”
Regarding an explanation for the links between migraines and ADHD, Dr. Arruda pointed to genetic and epigenetic factors that affect brain neurotransmitters and said he believes that stress and other stimuli could be influencing dopamine and noradrenergic processes.
Dr. Arruda said his next step is to examine whether stimulant drugs – the class used to treat ADHD – may help reduce headaches too.
“My clinical experience strongly indicates that psychostimulants have a highly positive effect on migraine prophylaxis, although headache occurs in the very beginning of the treatment,” Dr. Arruda said. “So, we are looking for financial support to conduct a randomized, double-blind, placebo control study to check this hypothesis.”
The study received no specific funding, and Dr. Arruda reported no relevant financial disclosures.
AT AAN 2017
Key clinical point: , but there’s no excess risk in children with tension-type headaches.
Major finding: Of children with chronic migraine, 19.4% (0.6% of the total) showed signs of ADHD, vs. 2.6% of the control group (RR, 7.3; 95% CI, 3.5-15.5).
Data source: Surveys of mothers and teachers of 5,671 Brazilian children aged 5-12 years.
Disclosures: The study received no specific funding, and Dr. Arruda reported no relevant financial disclosures.
How to get through the tough talks about alopecia areata
CHICAGO – If you can’t set the temptation to hurry aside and take the time to listen, things may not go well, said Neil Prose, MD.
With the caveat that Janus kinase inhibitors show promise, Dr. Prose said that “most children who are destined to lose their hair will probably do so despite all of our best efforts.” Figuring out how to engage children and parents and frame a positive conversation about alopecia can present a real challenge, especially in the context of a busy practice, said Dr. Prose, professor of dermatology and medical director of Patterson Place Pediatric Dermatology at Duke University, Durham, N.C.
“These are very culturally-specific suggestions, but see which ones work for you,” said Dr. Prose, speaking to an international audience at the World Congress of Pediatric Dermatology.
Dr. Prose depicted two opposing images. In one, he said, the patient and you are sitting on opposite sides of the table, with the prospect of hair loss looming between them. By contrast, “imagine what it would take to be on the same side of the table, looking at the problem together,” he said.
There are many barriers that stand in the way of getting you and the patient on the same side of the issue of dealing with severe alopecia areata. The high emotional content of the discussion can be big factor, not just for the patient and family members, but also for you.
“We are often dealing with patient disappointment and, frankly, with our own sense of personal failure” when there isn’t always a good set of options, said Dr. Prose. Other specific aspects of severe pediatric alopecia areata that make the conversation difficult include the high degree of uncertainty that any particular treatment will succeed and a knowledge of how to give patients and family members hope without raising expectations unrealistically.
Coming back to the important first steps of not rushing the visit and being sure to listen, Dr. Prose said that, for him, the process begins before he enters the room, when he takes a moment to clear his mind. “It starts for me just before I open the door to the examining room. As human beings, we are infinitely distractible. It’s very hard for us to simply pay attention.”
Yet, this is vitally important, he said, because families need to be heard. Citing the oft-quoted statistic that, on average, a physician interrupts a patient in the first 17 seconds of the office visit, Dr. Prose said, “Many of us are ‘explainaholics,’ ’’ spending precious visit time talking about what the physician thinks is important.
Still, it’s important to validate parents’ concerns and to alleviate guilt. “Patients’ families sometimes feel guilty because they are so upset and worried – and it’s not cancer,” said Dr. Prose. Potential impacts on quality of life are still huge, and all parents want the best for their children, he pointed out.
One way he likes to begin a follow-up visit is simply to ask, “So, how’s everyone doing?” This opens the door to allow the child and the family to talk about what’s important to them. These may be symptom-related, but social issues also may be what’s looming largest.
In order to decipher how hair loss is affecting a particular child, Dr. Prose said he likes to say, “I need to understand how this is affecting you, so we can decide together where to go from here.” This gives the family control in setting the agenda and begins the process of bringing you to the same side of the table.
Specific prompts that can help you understand how alopecia is affecting a child can include asking about how things are going at school, what the child’s friends know about his or her alopecia, whether there is mocking or bullying occurring, and how the patient, family, and teachers are addressing the global picture.
Parents can be asked whether they are noticing changes in behavior, and it’s a good idea to check in on how parents are coping as well, said Dr. Prose.
To ensure that families feel they’re being heard, and to make sure you are understanding correctly, it’s useful to mirror what’s been said, beginning with a phrase like, “So, what you’re saying is …” Putting a name to the emotions that emerge during the visit also can be useful, using phrases like, “I can imagine that this has been disappointing,” or “It feels like everyone is very worried.”
But, said Dr. Prose, don’t forget about opportunities to praise patients and their families when they’ve come through a tough time well. This validation is important, he said.
When treatment isn’t working, a first place to start is to acknowledge that you, along with the family, wish that things were turning out differently. Then, said Dr. Prose, it can be really important to reappraise treatment goals. After taking the emotional temperature of the room, it may be appropriate to ask, “Is it time to talk about not doing any more treatments?” This question can be put within the framework that hair may or may not regrow spontaneously anyway and that new treatments are emerging that may help in future.
When giving advice or talking about difficult issues, it can be helpful to ask permission, said Dr. Prose. He likes to begin with, “Would it be okay if I ...?” Then, he said, the door can be opened to give advice about school issues, to ask about difficult treatment decisions, or even to share tips learned from other families’ coping methods.
Don’t forget, said Dr. Prose, to refer patients to high-quality information and online support resources, such as the National Alopecia Areata Foundation. The Internet is full of inaccurate and scary information, and patients and families need help with this navigation, he said.
The very last question Dr. Prose asks during a visit is “What other questions do you have?” The question is always framed exactly like this, he said, because it assumes there will be more questions, and it gives families permission to ask more. Although most of the time there aren’t any further questions, Dr. Prose said, “Do not ask the question with your hand on the doorknob!”
Dr. Prose had no relevant financial disclosures.
koakes@frontlinemedcom.com
On Twitter @karioakes
CHICAGO – If you can’t set the temptation to hurry aside and take the time to listen, things may not go well, said Neil Prose, MD.
With the caveat that Janus kinase inhibitors show promise, Dr. Prose said that “most children who are destined to lose their hair will probably do so despite all of our best efforts.” Figuring out how to engage children and parents and frame a positive conversation about alopecia can present a real challenge, especially in the context of a busy practice, said Dr. Prose, professor of dermatology and medical director of Patterson Place Pediatric Dermatology at Duke University, Durham, N.C.
“These are very culturally-specific suggestions, but see which ones work for you,” said Dr. Prose, speaking to an international audience at the World Congress of Pediatric Dermatology.
Dr. Prose depicted two opposing images. In one, he said, the patient and you are sitting on opposite sides of the table, with the prospect of hair loss looming between them. By contrast, “imagine what it would take to be on the same side of the table, looking at the problem together,” he said.
There are many barriers that stand in the way of getting you and the patient on the same side of the issue of dealing with severe alopecia areata. The high emotional content of the discussion can be big factor, not just for the patient and family members, but also for you.
“We are often dealing with patient disappointment and, frankly, with our own sense of personal failure” when there isn’t always a good set of options, said Dr. Prose. Other specific aspects of severe pediatric alopecia areata that make the conversation difficult include the high degree of uncertainty that any particular treatment will succeed and a knowledge of how to give patients and family members hope without raising expectations unrealistically.
Coming back to the important first steps of not rushing the visit and being sure to listen, Dr. Prose said that, for him, the process begins before he enters the room, when he takes a moment to clear his mind. “It starts for me just before I open the door to the examining room. As human beings, we are infinitely distractible. It’s very hard for us to simply pay attention.”
Yet, this is vitally important, he said, because families need to be heard. Citing the oft-quoted statistic that, on average, a physician interrupts a patient in the first 17 seconds of the office visit, Dr. Prose said, “Many of us are ‘explainaholics,’ ’’ spending precious visit time talking about what the physician thinks is important.
Still, it’s important to validate parents’ concerns and to alleviate guilt. “Patients’ families sometimes feel guilty because they are so upset and worried – and it’s not cancer,” said Dr. Prose. Potential impacts on quality of life are still huge, and all parents want the best for their children, he pointed out.
One way he likes to begin a follow-up visit is simply to ask, “So, how’s everyone doing?” This opens the door to allow the child and the family to talk about what’s important to them. These may be symptom-related, but social issues also may be what’s looming largest.
In order to decipher how hair loss is affecting a particular child, Dr. Prose said he likes to say, “I need to understand how this is affecting you, so we can decide together where to go from here.” This gives the family control in setting the agenda and begins the process of bringing you to the same side of the table.
Specific prompts that can help you understand how alopecia is affecting a child can include asking about how things are going at school, what the child’s friends know about his or her alopecia, whether there is mocking or bullying occurring, and how the patient, family, and teachers are addressing the global picture.
Parents can be asked whether they are noticing changes in behavior, and it’s a good idea to check in on how parents are coping as well, said Dr. Prose.
To ensure that families feel they’re being heard, and to make sure you are understanding correctly, it’s useful to mirror what’s been said, beginning with a phrase like, “So, what you’re saying is …” Putting a name to the emotions that emerge during the visit also can be useful, using phrases like, “I can imagine that this has been disappointing,” or “It feels like everyone is very worried.”
But, said Dr. Prose, don’t forget about opportunities to praise patients and their families when they’ve come through a tough time well. This validation is important, he said.
When treatment isn’t working, a first place to start is to acknowledge that you, along with the family, wish that things were turning out differently. Then, said Dr. Prose, it can be really important to reappraise treatment goals. After taking the emotional temperature of the room, it may be appropriate to ask, “Is it time to talk about not doing any more treatments?” This question can be put within the framework that hair may or may not regrow spontaneously anyway and that new treatments are emerging that may help in future.
When giving advice or talking about difficult issues, it can be helpful to ask permission, said Dr. Prose. He likes to begin with, “Would it be okay if I ...?” Then, he said, the door can be opened to give advice about school issues, to ask about difficult treatment decisions, or even to share tips learned from other families’ coping methods.
Don’t forget, said Dr. Prose, to refer patients to high-quality information and online support resources, such as the National Alopecia Areata Foundation. The Internet is full of inaccurate and scary information, and patients and families need help with this navigation, he said.
The very last question Dr. Prose asks during a visit is “What other questions do you have?” The question is always framed exactly like this, he said, because it assumes there will be more questions, and it gives families permission to ask more. Although most of the time there aren’t any further questions, Dr. Prose said, “Do not ask the question with your hand on the doorknob!”
Dr. Prose had no relevant financial disclosures.
koakes@frontlinemedcom.com
On Twitter @karioakes
CHICAGO – If you can’t set the temptation to hurry aside and take the time to listen, things may not go well, said Neil Prose, MD.
With the caveat that Janus kinase inhibitors show promise, Dr. Prose said that “most children who are destined to lose their hair will probably do so despite all of our best efforts.” Figuring out how to engage children and parents and frame a positive conversation about alopecia can present a real challenge, especially in the context of a busy practice, said Dr. Prose, professor of dermatology and medical director of Patterson Place Pediatric Dermatology at Duke University, Durham, N.C.
“These are very culturally-specific suggestions, but see which ones work for you,” said Dr. Prose, speaking to an international audience at the World Congress of Pediatric Dermatology.
Dr. Prose depicted two opposing images. In one, he said, the patient and you are sitting on opposite sides of the table, with the prospect of hair loss looming between them. By contrast, “imagine what it would take to be on the same side of the table, looking at the problem together,” he said.
There are many barriers that stand in the way of getting you and the patient on the same side of the issue of dealing with severe alopecia areata. The high emotional content of the discussion can be big factor, not just for the patient and family members, but also for you.
“We are often dealing with patient disappointment and, frankly, with our own sense of personal failure” when there isn’t always a good set of options, said Dr. Prose. Other specific aspects of severe pediatric alopecia areata that make the conversation difficult include the high degree of uncertainty that any particular treatment will succeed and a knowledge of how to give patients and family members hope without raising expectations unrealistically.
Coming back to the important first steps of not rushing the visit and being sure to listen, Dr. Prose said that, for him, the process begins before he enters the room, when he takes a moment to clear his mind. “It starts for me just before I open the door to the examining room. As human beings, we are infinitely distractible. It’s very hard for us to simply pay attention.”
Yet, this is vitally important, he said, because families need to be heard. Citing the oft-quoted statistic that, on average, a physician interrupts a patient in the first 17 seconds of the office visit, Dr. Prose said, “Many of us are ‘explainaholics,’ ’’ spending precious visit time talking about what the physician thinks is important.
Still, it’s important to validate parents’ concerns and to alleviate guilt. “Patients’ families sometimes feel guilty because they are so upset and worried – and it’s not cancer,” said Dr. Prose. Potential impacts on quality of life are still huge, and all parents want the best for their children, he pointed out.
One way he likes to begin a follow-up visit is simply to ask, “So, how’s everyone doing?” This opens the door to allow the child and the family to talk about what’s important to them. These may be symptom-related, but social issues also may be what’s looming largest.
In order to decipher how hair loss is affecting a particular child, Dr. Prose said he likes to say, “I need to understand how this is affecting you, so we can decide together where to go from here.” This gives the family control in setting the agenda and begins the process of bringing you to the same side of the table.
Specific prompts that can help you understand how alopecia is affecting a child can include asking about how things are going at school, what the child’s friends know about his or her alopecia, whether there is mocking or bullying occurring, and how the patient, family, and teachers are addressing the global picture.
Parents can be asked whether they are noticing changes in behavior, and it’s a good idea to check in on how parents are coping as well, said Dr. Prose.
To ensure that families feel they’re being heard, and to make sure you are understanding correctly, it’s useful to mirror what’s been said, beginning with a phrase like, “So, what you’re saying is …” Putting a name to the emotions that emerge during the visit also can be useful, using phrases like, “I can imagine that this has been disappointing,” or “It feels like everyone is very worried.”
But, said Dr. Prose, don’t forget about opportunities to praise patients and their families when they’ve come through a tough time well. This validation is important, he said.
When treatment isn’t working, a first place to start is to acknowledge that you, along with the family, wish that things were turning out differently. Then, said Dr. Prose, it can be really important to reappraise treatment goals. After taking the emotional temperature of the room, it may be appropriate to ask, “Is it time to talk about not doing any more treatments?” This question can be put within the framework that hair may or may not regrow spontaneously anyway and that new treatments are emerging that may help in future.
When giving advice or talking about difficult issues, it can be helpful to ask permission, said Dr. Prose. He likes to begin with, “Would it be okay if I ...?” Then, he said, the door can be opened to give advice about school issues, to ask about difficult treatment decisions, or even to share tips learned from other families’ coping methods.
Don’t forget, said Dr. Prose, to refer patients to high-quality information and online support resources, such as the National Alopecia Areata Foundation. The Internet is full of inaccurate and scary information, and patients and families need help with this navigation, he said.
The very last question Dr. Prose asks during a visit is “What other questions do you have?” The question is always framed exactly like this, he said, because it assumes there will be more questions, and it gives families permission to ask more. Although most of the time there aren’t any further questions, Dr. Prose said, “Do not ask the question with your hand on the doorknob!”
Dr. Prose had no relevant financial disclosures.
koakes@frontlinemedcom.com
On Twitter @karioakes
EXPERT ANALYSIS FROM WCPD 2017