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Maternal antidepressants unrelated to autism in offspring
Maternal use of antidepressants during pregnancy is unrelated to autism spectrum disorder in the offspring, according to two separate, population-level cohort studies that used sophisticated statistical techniques to account for numerous confounding factors.
Both studies were reported online April 18 in JAMA.
Some previous studies have reported a possible link between in utero exposure to antidepressants, particularly SSRIs, and autism. But they had limited ability to control for key confounders, notably the mother’s underlying depression.
Overall, 1.1% of these children were diagnosed as having autism spectrum disorder. This prevalence is consistent with current population estimates, indicating that few if any cases of the disorder were missed, said Dr. Brown of Women’s College Research Institute in Toronto and the division of epidemiology, University of Toronto, and her associates.
In initial, unadjusted analyses of the data, the risk of autism was higher in exposed than in nonexposed children. However, that association disappeared once the data were adjusted to account for numerous potential confounders.
Further analysis comparing the exposed children with their unexposed siblings also found that after adjusting for confounding factors, prenatal exposure to antidepressants did not affect the risk of developing autism. In addition, this lack of association also was found in the subgroup of children whose mothers took antidepressants shortly before but not during pregnancy.
Taken together, these findings “suggest that confounding by indication for the medication may explain previously observed associations between in utero serotonergic antidepressant exposure and autism spectrum disorder,” Dr. Brown and her associates said (JAMA. 2017 Apr 18. doi: 10.1001.jama.2017.3415). In the other study, Ayesha C. Sujan and her associates analyzed data in several nationwide Swedish registries to examine whether first trimester exposure to any antidepressants raised the risk of a range of neurodevelopmental problems, including autism. This study involved 1,580,629 offspring, including 22,544 (1.4%) whose mothers took antidepressants during the first trimester.
As with Dr. Brown’s study, the initial unadjusted analysis showed an association between antidepressant exposure and autism, but that association disappeared once the data were adjusted to account for confounding factors. In the final data analysis, first trimester exposure was associated with preterm birth (odds ratio, 1.34) but not with small-for-gestational-age size (OR, 1.01), autism spectrum disorder (hazard ratio, 0.83), or attention deficit/hyperactivity disorder (HR, 0.99), said Ms. Sujan of the department of psychological and brain sciences, Indiana University, Bloomington, and her associates.
“These results are consistent with the hypothesis that genetic factors, familial environmental factors, or both, account for the population-wide associations between first-trimester antidepressant exposure and these outcomes,” they noted (JAMA. 2017 Apr 18. doi: 10.1001/jama.2017.3413).
These two studies add to the growing literature suggesting that any association between prenatal antidepressant exposure and autism spectrum disorder may not be causal.
Both reports should reassure both parents and clinicians.
And regardless of whether any such association reflects antidepressant effects, the mother’s underlying mental health, or other factors, efforts should focus on promoting optimal child health in ways that harness the child’s inherent developmental plasticity.
Tim F. Oberlander, MD, is in the division of developmental pediatrics at the University of British Columbia and at the British Columbia Children’s Hospital Research Institute, both in Vancouver. Lonnie Zwaigenbaum, MD, is in the department of pediatrics at the University of Alberta, Edmonton. They reported having no relevant financial disclosures. These remarks were excerpted from an editorial accompanying the two reports (JAMA. 2017;317[15]:1533-4).
These two studies add to the growing literature suggesting that any association between prenatal antidepressant exposure and autism spectrum disorder may not be causal.
Both reports should reassure both parents and clinicians.
And regardless of whether any such association reflects antidepressant effects, the mother’s underlying mental health, or other factors, efforts should focus on promoting optimal child health in ways that harness the child’s inherent developmental plasticity.
Tim F. Oberlander, MD, is in the division of developmental pediatrics at the University of British Columbia and at the British Columbia Children’s Hospital Research Institute, both in Vancouver. Lonnie Zwaigenbaum, MD, is in the department of pediatrics at the University of Alberta, Edmonton. They reported having no relevant financial disclosures. These remarks were excerpted from an editorial accompanying the two reports (JAMA. 2017;317[15]:1533-4).
These two studies add to the growing literature suggesting that any association between prenatal antidepressant exposure and autism spectrum disorder may not be causal.
Both reports should reassure both parents and clinicians.
And regardless of whether any such association reflects antidepressant effects, the mother’s underlying mental health, or other factors, efforts should focus on promoting optimal child health in ways that harness the child’s inherent developmental plasticity.
Tim F. Oberlander, MD, is in the division of developmental pediatrics at the University of British Columbia and at the British Columbia Children’s Hospital Research Institute, both in Vancouver. Lonnie Zwaigenbaum, MD, is in the department of pediatrics at the University of Alberta, Edmonton. They reported having no relevant financial disclosures. These remarks were excerpted from an editorial accompanying the two reports (JAMA. 2017;317[15]:1533-4).
Maternal use of antidepressants during pregnancy is unrelated to autism spectrum disorder in the offspring, according to two separate, population-level cohort studies that used sophisticated statistical techniques to account for numerous confounding factors.
Both studies were reported online April 18 in JAMA.
Some previous studies have reported a possible link between in utero exposure to antidepressants, particularly SSRIs, and autism. But they had limited ability to control for key confounders, notably the mother’s underlying depression.
Overall, 1.1% of these children were diagnosed as having autism spectrum disorder. This prevalence is consistent with current population estimates, indicating that few if any cases of the disorder were missed, said Dr. Brown of Women’s College Research Institute in Toronto and the division of epidemiology, University of Toronto, and her associates.
In initial, unadjusted analyses of the data, the risk of autism was higher in exposed than in nonexposed children. However, that association disappeared once the data were adjusted to account for numerous potential confounders.
Further analysis comparing the exposed children with their unexposed siblings also found that after adjusting for confounding factors, prenatal exposure to antidepressants did not affect the risk of developing autism. In addition, this lack of association also was found in the subgroup of children whose mothers took antidepressants shortly before but not during pregnancy.
Taken together, these findings “suggest that confounding by indication for the medication may explain previously observed associations between in utero serotonergic antidepressant exposure and autism spectrum disorder,” Dr. Brown and her associates said (JAMA. 2017 Apr 18. doi: 10.1001.jama.2017.3415). In the other study, Ayesha C. Sujan and her associates analyzed data in several nationwide Swedish registries to examine whether first trimester exposure to any antidepressants raised the risk of a range of neurodevelopmental problems, including autism. This study involved 1,580,629 offspring, including 22,544 (1.4%) whose mothers took antidepressants during the first trimester.
As with Dr. Brown’s study, the initial unadjusted analysis showed an association between antidepressant exposure and autism, but that association disappeared once the data were adjusted to account for confounding factors. In the final data analysis, first trimester exposure was associated with preterm birth (odds ratio, 1.34) but not with small-for-gestational-age size (OR, 1.01), autism spectrum disorder (hazard ratio, 0.83), or attention deficit/hyperactivity disorder (HR, 0.99), said Ms. Sujan of the department of psychological and brain sciences, Indiana University, Bloomington, and her associates.
“These results are consistent with the hypothesis that genetic factors, familial environmental factors, or both, account for the population-wide associations between first-trimester antidepressant exposure and these outcomes,” they noted (JAMA. 2017 Apr 18. doi: 10.1001/jama.2017.3413).
Maternal use of antidepressants during pregnancy is unrelated to autism spectrum disorder in the offspring, according to two separate, population-level cohort studies that used sophisticated statistical techniques to account for numerous confounding factors.
Both studies were reported online April 18 in JAMA.
Some previous studies have reported a possible link between in utero exposure to antidepressants, particularly SSRIs, and autism. But they had limited ability to control for key confounders, notably the mother’s underlying depression.
Overall, 1.1% of these children were diagnosed as having autism spectrum disorder. This prevalence is consistent with current population estimates, indicating that few if any cases of the disorder were missed, said Dr. Brown of Women’s College Research Institute in Toronto and the division of epidemiology, University of Toronto, and her associates.
In initial, unadjusted analyses of the data, the risk of autism was higher in exposed than in nonexposed children. However, that association disappeared once the data were adjusted to account for numerous potential confounders.
Further analysis comparing the exposed children with their unexposed siblings also found that after adjusting for confounding factors, prenatal exposure to antidepressants did not affect the risk of developing autism. In addition, this lack of association also was found in the subgroup of children whose mothers took antidepressants shortly before but not during pregnancy.
Taken together, these findings “suggest that confounding by indication for the medication may explain previously observed associations between in utero serotonergic antidepressant exposure and autism spectrum disorder,” Dr. Brown and her associates said (JAMA. 2017 Apr 18. doi: 10.1001.jama.2017.3415). In the other study, Ayesha C. Sujan and her associates analyzed data in several nationwide Swedish registries to examine whether first trimester exposure to any antidepressants raised the risk of a range of neurodevelopmental problems, including autism. This study involved 1,580,629 offspring, including 22,544 (1.4%) whose mothers took antidepressants during the first trimester.
As with Dr. Brown’s study, the initial unadjusted analysis showed an association between antidepressant exposure and autism, but that association disappeared once the data were adjusted to account for confounding factors. In the final data analysis, first trimester exposure was associated with preterm birth (odds ratio, 1.34) but not with small-for-gestational-age size (OR, 1.01), autism spectrum disorder (hazard ratio, 0.83), or attention deficit/hyperactivity disorder (HR, 0.99), said Ms. Sujan of the department of psychological and brain sciences, Indiana University, Bloomington, and her associates.
“These results are consistent with the hypothesis that genetic factors, familial environmental factors, or both, account for the population-wide associations between first-trimester antidepressant exposure and these outcomes,” they noted (JAMA. 2017 Apr 18. doi: 10.1001/jama.2017.3413).
FROM JAMA
Key clinical point: Maternal use of antidepressants during pregnancy is unrelated to autism spectrum disorder in offspring.
Major finding: Prenatal exposure to antidepressants was not associated with small-for-gestational-age size (OR, 1.01), autism spectrum disorder (HR, 0.83), or attention deficit/hyperactivity disorder (HR, 0.99).
Data source: Two separate retrospective cohort studies involving 35,906 births in Canada and 1,580,629 in Sweden.
Disclosures: Dr. Brown’s study was supported by the Institute for Clinical Evaluative Sciences and the Ontario Ministry of Health and Long-Term Care. Dr. Brown and her associates reported having no relevant financial disclosures. Dr. Sujan’s study was supported by the U.S. National Institute of Mental Health, the National Institute on Drug Abuse, the National Science Foundation, and others. Dr. Sujan reported having no relevant financial disclosures; her associates reported ties to numerous industry sources.
New diagnostic tool identifies severe ADAMTS13 deficiency
Researchers have developed and validated a new diagnostic tool – the PLASMIC score – that rapidly predicts severe ADAMTS13 deficiency in patients who present with thrombotic microangiopathy, effectively distinguishing those who have thrombotic thrombocytopenic purpura (TTP) from those with other disorders, according to a report published in Lancet Haematology.
Many disorders or clinical events can present as a thrombotic microangiopathy, including hemolytic uremic syndrome, disseminated intravascular coagulation, and malignant hypertension; this abnormality can even be an adverse effect of hematopoietic stem cell transplantation or solid-organ transplantation. Rapidly differentiating TTP from such disorders facilitates urgent treatment with plasma exchange or plasma transfusion. But testing for elevated ADAMTS13 levels to make this distinction currently requires long turnaround times and is unavailable in some locations, said Pavan K. Bendapudi, MD, of the division of hematology, Massachusetts General Hospital, Boston, and his associates.
The PLASMIC score “is designed specifically to aid practitioners who might have little experience managing thrombotic microangiopathy, and it can distinguish TTP from a broad range of thrombotic microangiopathy subtypes, including those that seem most similar to TTP,” they wrote.
The researchers developed a 7-point scoring system to predict the likelihood of elevated ADAMTS13 levels by analyzing 29 clinical and laboratory variables that would aid in diagnosis, using a cohort of 214 consecutive patients enrolled in a multicenter research registry in 2004-2012. They narrowed their initial finding of 11 key variables down to 5 key variables that best predicted severe ADAMTSD13 deficiency: platelet count lower than 29x109 per liter, creatinine less than 1.8 mg/dL, international normalized ratio (INR) less than 1.3, mean corpuscular volume (MCV) less than 86.5/L, and a combined hemolysis variable based on reticulocyte count, the presence of haptoglobin, and bilirubin level.
Two additional variables – cancer diagnosed during the preceding year and the absence of stem cell or organ transplantation – were absent in all patients who had severe ADAMTS13 deficiency in this derivation cohort and were included in the PLASMIC score because of their high negative predictive value. Thus, the diagnostic score was named for its seven components: platelet count, combined hemolysis variable, absence of active cancer; absence of stem cell or solid-organ transplant, MCV, INR, and creatinine. Each component was assigned 1 point on the 7-point scale.
None of the 84 patients in this derivation cohort with a PLASMIC score of 0-4 had severe ADAMTS13 deficiency, while 81% of those with a score of 6 or 7 did have a severe ADAMTS13 deficiency. Patients who were eventually diagnosed as having TTP had a median score of 7. In contrast, patients with thrombotic microangiopathy traced to rheumatologic disorders had a median score of 5, those with drug-associated thrombotic microangiopathy had a median score of 4, and those with disseminated intravascular coagulation had a median score of 4. The PLASMIC score also appeared to discriminate among TTP, typical hemolytic uremia syndrome, and atypical hemolytic uremia syndrome, which have “strikingly similar clinical presentations,” Dr. Bendapudi and his associates said.
Unlike TTP, the disorders with lower PLASMIC scores tended to carry a much poorer prognosis. In this cohort, patients with higher PLASMIC scores had significantly better survival time (median survival not yet reached), compared with those who had a score of 5 (median survival, 1,670 days) and those with a score of 1-4 (median survival, 287 days).
The investigators then validated their findings in two independent cohorts: 154 people with thrombotic microangiopathy from the same patient registry but from more recent years (2012-2015), and 152 patients from an Alabama registry. In the first validation cohort, none of the 89 patients assigned a score of 0-4 had severe ADAMTS13 deficiency, while 62% of those given a score of 6 or 7 had a severe deficiency. In the second validation cohort, only two patients (4%) with scores of 0-4 had a severe ADAMTS13 deficiency, while 82% of those with a score of 6 or 7 had a severe deficiency.
Based on these findings, a PLASMIC score of 0-4 denotes low risk for ADAMTS13 deficiency, a score of 5 denotes intermediate risk, and a score of 6 or 7 denotes high risk and thus probable TTP, Dr. Bendapudi and his associates said (Lancet Haematol. 2017;4:e157-64).
The PLASMIC score was superior to both a two-component prediction tool currently used in France and to a clinical consensus score, “further demonstrating the real-world utility of our prediction tool,” the researchers wrote.
The PLASMIC score offers a clear improvement in the prediction of severe ADAMTS13 deficiency when added to clinical expertise, so it is an important step forward in the early management of TTP.
Use of this score should allow earlier treatment of patients with TTP, who would greatly benefit from plasma exchange or plasma administration. It also can be useful in less serious and less uncertain situations in which emergency plasma therapy is discussed.
Mattieu Jamme, MD, and Eric Rondeau, MD, are in the Service des Urgences Nephrologiques et Transpantation Renale at Hospital Tenon, Paris. They reported having no relevant financial disclosures. Dr. Jamme and Dr. Rondeau made these remarks in an editorial comment accompanying Dr. Bendapudi’s report (Lancet Haematol. 2017. doi: 10.1016/S2352-3026(17)30024-8).
The PLASMIC score offers a clear improvement in the prediction of severe ADAMTS13 deficiency when added to clinical expertise, so it is an important step forward in the early management of TTP.
Use of this score should allow earlier treatment of patients with TTP, who would greatly benefit from plasma exchange or plasma administration. It also can be useful in less serious and less uncertain situations in which emergency plasma therapy is discussed.
Mattieu Jamme, MD, and Eric Rondeau, MD, are in the Service des Urgences Nephrologiques et Transpantation Renale at Hospital Tenon, Paris. They reported having no relevant financial disclosures. Dr. Jamme and Dr. Rondeau made these remarks in an editorial comment accompanying Dr. Bendapudi’s report (Lancet Haematol. 2017. doi: 10.1016/S2352-3026(17)30024-8).
The PLASMIC score offers a clear improvement in the prediction of severe ADAMTS13 deficiency when added to clinical expertise, so it is an important step forward in the early management of TTP.
Use of this score should allow earlier treatment of patients with TTP, who would greatly benefit from plasma exchange or plasma administration. It also can be useful in less serious and less uncertain situations in which emergency plasma therapy is discussed.
Mattieu Jamme, MD, and Eric Rondeau, MD, are in the Service des Urgences Nephrologiques et Transpantation Renale at Hospital Tenon, Paris. They reported having no relevant financial disclosures. Dr. Jamme and Dr. Rondeau made these remarks in an editorial comment accompanying Dr. Bendapudi’s report (Lancet Haematol. 2017. doi: 10.1016/S2352-3026(17)30024-8).
Researchers have developed and validated a new diagnostic tool – the PLASMIC score – that rapidly predicts severe ADAMTS13 deficiency in patients who present with thrombotic microangiopathy, effectively distinguishing those who have thrombotic thrombocytopenic purpura (TTP) from those with other disorders, according to a report published in Lancet Haematology.
Many disorders or clinical events can present as a thrombotic microangiopathy, including hemolytic uremic syndrome, disseminated intravascular coagulation, and malignant hypertension; this abnormality can even be an adverse effect of hematopoietic stem cell transplantation or solid-organ transplantation. Rapidly differentiating TTP from such disorders facilitates urgent treatment with plasma exchange or plasma transfusion. But testing for elevated ADAMTS13 levels to make this distinction currently requires long turnaround times and is unavailable in some locations, said Pavan K. Bendapudi, MD, of the division of hematology, Massachusetts General Hospital, Boston, and his associates.
The PLASMIC score “is designed specifically to aid practitioners who might have little experience managing thrombotic microangiopathy, and it can distinguish TTP from a broad range of thrombotic microangiopathy subtypes, including those that seem most similar to TTP,” they wrote.
The researchers developed a 7-point scoring system to predict the likelihood of elevated ADAMTS13 levels by analyzing 29 clinical and laboratory variables that would aid in diagnosis, using a cohort of 214 consecutive patients enrolled in a multicenter research registry in 2004-2012. They narrowed their initial finding of 11 key variables down to 5 key variables that best predicted severe ADAMTSD13 deficiency: platelet count lower than 29x109 per liter, creatinine less than 1.8 mg/dL, international normalized ratio (INR) less than 1.3, mean corpuscular volume (MCV) less than 86.5/L, and a combined hemolysis variable based on reticulocyte count, the presence of haptoglobin, and bilirubin level.
Two additional variables – cancer diagnosed during the preceding year and the absence of stem cell or organ transplantation – were absent in all patients who had severe ADAMTS13 deficiency in this derivation cohort and were included in the PLASMIC score because of their high negative predictive value. Thus, the diagnostic score was named for its seven components: platelet count, combined hemolysis variable, absence of active cancer; absence of stem cell or solid-organ transplant, MCV, INR, and creatinine. Each component was assigned 1 point on the 7-point scale.
None of the 84 patients in this derivation cohort with a PLASMIC score of 0-4 had severe ADAMTS13 deficiency, while 81% of those with a score of 6 or 7 did have a severe ADAMTS13 deficiency. Patients who were eventually diagnosed as having TTP had a median score of 7. In contrast, patients with thrombotic microangiopathy traced to rheumatologic disorders had a median score of 5, those with drug-associated thrombotic microangiopathy had a median score of 4, and those with disseminated intravascular coagulation had a median score of 4. The PLASMIC score also appeared to discriminate among TTP, typical hemolytic uremia syndrome, and atypical hemolytic uremia syndrome, which have “strikingly similar clinical presentations,” Dr. Bendapudi and his associates said.
Unlike TTP, the disorders with lower PLASMIC scores tended to carry a much poorer prognosis. In this cohort, patients with higher PLASMIC scores had significantly better survival time (median survival not yet reached), compared with those who had a score of 5 (median survival, 1,670 days) and those with a score of 1-4 (median survival, 287 days).
The investigators then validated their findings in two independent cohorts: 154 people with thrombotic microangiopathy from the same patient registry but from more recent years (2012-2015), and 152 patients from an Alabama registry. In the first validation cohort, none of the 89 patients assigned a score of 0-4 had severe ADAMTS13 deficiency, while 62% of those given a score of 6 or 7 had a severe deficiency. In the second validation cohort, only two patients (4%) with scores of 0-4 had a severe ADAMTS13 deficiency, while 82% of those with a score of 6 or 7 had a severe deficiency.
Based on these findings, a PLASMIC score of 0-4 denotes low risk for ADAMTS13 deficiency, a score of 5 denotes intermediate risk, and a score of 6 or 7 denotes high risk and thus probable TTP, Dr. Bendapudi and his associates said (Lancet Haematol. 2017;4:e157-64).
The PLASMIC score was superior to both a two-component prediction tool currently used in France and to a clinical consensus score, “further demonstrating the real-world utility of our prediction tool,” the researchers wrote.
Researchers have developed and validated a new diagnostic tool – the PLASMIC score – that rapidly predicts severe ADAMTS13 deficiency in patients who present with thrombotic microangiopathy, effectively distinguishing those who have thrombotic thrombocytopenic purpura (TTP) from those with other disorders, according to a report published in Lancet Haematology.
Many disorders or clinical events can present as a thrombotic microangiopathy, including hemolytic uremic syndrome, disseminated intravascular coagulation, and malignant hypertension; this abnormality can even be an adverse effect of hematopoietic stem cell transplantation or solid-organ transplantation. Rapidly differentiating TTP from such disorders facilitates urgent treatment with plasma exchange or plasma transfusion. But testing for elevated ADAMTS13 levels to make this distinction currently requires long turnaround times and is unavailable in some locations, said Pavan K. Bendapudi, MD, of the division of hematology, Massachusetts General Hospital, Boston, and his associates.
The PLASMIC score “is designed specifically to aid practitioners who might have little experience managing thrombotic microangiopathy, and it can distinguish TTP from a broad range of thrombotic microangiopathy subtypes, including those that seem most similar to TTP,” they wrote.
The researchers developed a 7-point scoring system to predict the likelihood of elevated ADAMTS13 levels by analyzing 29 clinical and laboratory variables that would aid in diagnosis, using a cohort of 214 consecutive patients enrolled in a multicenter research registry in 2004-2012. They narrowed their initial finding of 11 key variables down to 5 key variables that best predicted severe ADAMTSD13 deficiency: platelet count lower than 29x109 per liter, creatinine less than 1.8 mg/dL, international normalized ratio (INR) less than 1.3, mean corpuscular volume (MCV) less than 86.5/L, and a combined hemolysis variable based on reticulocyte count, the presence of haptoglobin, and bilirubin level.
Two additional variables – cancer diagnosed during the preceding year and the absence of stem cell or organ transplantation – were absent in all patients who had severe ADAMTS13 deficiency in this derivation cohort and were included in the PLASMIC score because of their high negative predictive value. Thus, the diagnostic score was named for its seven components: platelet count, combined hemolysis variable, absence of active cancer; absence of stem cell or solid-organ transplant, MCV, INR, and creatinine. Each component was assigned 1 point on the 7-point scale.
None of the 84 patients in this derivation cohort with a PLASMIC score of 0-4 had severe ADAMTS13 deficiency, while 81% of those with a score of 6 or 7 did have a severe ADAMTS13 deficiency. Patients who were eventually diagnosed as having TTP had a median score of 7. In contrast, patients with thrombotic microangiopathy traced to rheumatologic disorders had a median score of 5, those with drug-associated thrombotic microangiopathy had a median score of 4, and those with disseminated intravascular coagulation had a median score of 4. The PLASMIC score also appeared to discriminate among TTP, typical hemolytic uremia syndrome, and atypical hemolytic uremia syndrome, which have “strikingly similar clinical presentations,” Dr. Bendapudi and his associates said.
Unlike TTP, the disorders with lower PLASMIC scores tended to carry a much poorer prognosis. In this cohort, patients with higher PLASMIC scores had significantly better survival time (median survival not yet reached), compared with those who had a score of 5 (median survival, 1,670 days) and those with a score of 1-4 (median survival, 287 days).
The investigators then validated their findings in two independent cohorts: 154 people with thrombotic microangiopathy from the same patient registry but from more recent years (2012-2015), and 152 patients from an Alabama registry. In the first validation cohort, none of the 89 patients assigned a score of 0-4 had severe ADAMTS13 deficiency, while 62% of those given a score of 6 or 7 had a severe deficiency. In the second validation cohort, only two patients (4%) with scores of 0-4 had a severe ADAMTS13 deficiency, while 82% of those with a score of 6 or 7 had a severe deficiency.
Based on these findings, a PLASMIC score of 0-4 denotes low risk for ADAMTS13 deficiency, a score of 5 denotes intermediate risk, and a score of 6 or 7 denotes high risk and thus probable TTP, Dr. Bendapudi and his associates said (Lancet Haematol. 2017;4:e157-64).
The PLASMIC score was superior to both a two-component prediction tool currently used in France and to a clinical consensus score, “further demonstrating the real-world utility of our prediction tool,” the researchers wrote.
FROM LANCET HAEMATOLOGY
Key clinical point: A new diagnostic tool – the PLASMIC score – predicts severe ADAMTS13 deficiency, effectively distinguishing thrombotic thrombocytopenic purpura from other causes of thrombotic microangiopathy.
Major finding: None of the 84 patients with a PLASMIC score of 0-4 out of a possible 7 proved to have severe ADAMTS13 deficiency, while 81% of those with a score of 6 or 7 did prove to have a severe ADAMTS13 deficiency.
Data source: A series of retrospective cohort studies analyzing data in patient registries to develop (215 patients) and then validate (306 patients) a new diagnostic tool.
Disclosures: This work was supported by the Luick Family Fund of Massachusetts General Hospital, the American Society of Hematology, and the National Heart, Lung, and Blood Institute. Dr. Bendapudi and his associates reported having no relevant financial disclosures.
Hospital floors are an overlooked reservoir for pathogens
Floors in hospital patients’ rooms are frequently contaminated with pathogens such as Clostridium difficile, methicillin-resistant Staphylococcus aureus, and vancomycin-resistant Enterococci, which are easily transmitted to the hands of patients, care providers, and visitors, according to a report published in the American Journal of Infection Control.
Disinfection usually focuses on surfaces that are frequently touched by patients’ or health care workers’ hands, such as bed rails and call buttons. Floor disinfection has received limited attention.
However, floors are frequently touched by objects that are then handled, such as shoes and socks, said Abhishek Deshpande, MD, PhD, of the Cleveland Clinic, and his associates.
To examine the extent of floor contamination and the potential for transfer of pathogens to hands, the investigators surveyed five Cleveland-area hospitals. 
They collected samples from 1-square-foot areas of floors adjacent to beds and in bathrooms in C. difficile isolation rooms, and in 2-3 randomly selected nonisolation rooms on the same wards. At least 30 rooms at each hospital were cultured for C. difficile, MRSA, and VRE, either during a patient stay or after the rooms had been cleaned at patient discharge.
In addition, the researchers performed a point-prevalence survey of the number and type of high-touch objects contacting floors in 10-25 randomly selected occupied patient rooms at each hospital. After they handled these objects, their hands also were cultured.
Floor contamination was common with all of the pathogens, particularly with C. difficile. The frequency of contamination was similar across the five hospitals, in both bedroom and bathroom sites, and even in the 50 rooms that had been cleaned at the last patient discharge.
C. difficile spores were recovered from the floors of 47%-55% of rooms, MRSA was recovered from the floors of 8%-32% of rooms, and VRE were recovered from the floors of 13%-30% of rooms.
In addition, 41 of 100 occupied rooms had 1-4 “high-touch” objects in direct contact with the floors, including personal items such as clothing, canes, or cellphone chargers; medical supplies or devices such as pulse oximeters, call buttons, heating pads, urinals, blood pressure cuffs, and wash basins; and linens such as bed sheets, pillows, and towels.
Of the 31 cultures taken from both bare and gloved hands that handled these items, MRSA was recovered from 18%, VRE were recovered from 6%, and C. difficile was recovered from 3%.
“These results suggest that floors in hospital rooms could be an underappreciated source for dissemination of pathogens,” Dr. Deshpande and his associates noted (Am J Infect Control. 2017 Mar 1;45[3]:336-8).
“It would be reasonable to educate health care personnel and patients that they should avoid placing high-touch objects on the floor when possible,” they added.
Moreover, the efficacy of current floor-cleaning and disinfection techniques should be reexamined, particularly with regard to eliminating C. difficile spores.
Other modes of transmission from floors also should be assessed, such as contamination of wheelchairs and wheeled equipment. And transmission of other pathogens, such as gram-negative organisms and viruses, should be examined, the investigators said.
The Agency for Healthcare Research and Quality and the U.S. Department of Veterans Affairs funded the study. Dr. Deshpande reported receiving research grants from 3M, Clorox, and Steris, and one of his associates reported receiving research grants from Clorox, Ecolab, GOJO, Merck, Pfizer, and Steris.
Floors in hospital patients’ rooms are frequently contaminated with pathogens such as Clostridium difficile, methicillin-resistant Staphylococcus aureus, and vancomycin-resistant Enterococci, which are easily transmitted to the hands of patients, care providers, and visitors, according to a report published in the American Journal of Infection Control.
Disinfection usually focuses on surfaces that are frequently touched by patients’ or health care workers’ hands, such as bed rails and call buttons. Floor disinfection has received limited attention.
However, floors are frequently touched by objects that are then handled, such as shoes and socks, said Abhishek Deshpande, MD, PhD, of the Cleveland Clinic, and his associates.
To examine the extent of floor contamination and the potential for transfer of pathogens to hands, the investigators surveyed five Cleveland-area hospitals.
They collected samples from 1-square-foot areas of floors adjacent to beds and in bathrooms in C. difficile isolation rooms, and in 2-3 randomly selected nonisolation rooms on the same wards. At least 30 rooms at each hospital were cultured for C. difficile, MRSA, and VRE, either during a patient stay or after the rooms had been cleaned at patient discharge.
In addition, the researchers performed a point-prevalence survey of the number and type of high-touch objects contacting floors in 10-25 randomly selected occupied patient rooms at each hospital. After they handled these objects, their hands also were cultured.
Floor contamination was common with all of the pathogens, particularly with C. difficile. The frequency of contamination was similar across the five hospitals, in both bedroom and bathroom sites, and even in the 50 rooms that had been cleaned at the last patient discharge.
C. difficile spores were recovered from the floors of 47%-55% of rooms, MRSA was recovered from the floors of 8%-32% of rooms, and VRE were recovered from the floors of 13%-30% of rooms.
In addition, 41 of 100 occupied rooms had 1-4 “high-touch” objects in direct contact with the floors, including personal items such as clothing, canes, or cellphone chargers; medical supplies or devices such as pulse oximeters, call buttons, heating pads, urinals, blood pressure cuffs, and wash basins; and linens such as bed sheets, pillows, and towels.
Of the 31 cultures taken from both bare and gloved hands that handled these items, MRSA was recovered from 18%, VRE were recovered from 6%, and C. difficile was recovered from 3%.
“These results suggest that floors in hospital rooms could be an underappreciated source for dissemination of pathogens,” Dr. Deshpande and his associates noted (Am J Infect Control. 2017 Mar 1;45[3]:336-8).
“It would be reasonable to educate health care personnel and patients that they should avoid placing high-touch objects on the floor when possible,” they added.
Moreover, the efficacy of current floor-cleaning and disinfection techniques should be reexamined, particularly with regard to eliminating C. difficile spores.
Other modes of transmission from floors also should be assessed, such as contamination of wheelchairs and wheeled equipment. And transmission of other pathogens, such as gram-negative organisms and viruses, should be examined, the investigators said.
The Agency for Healthcare Research and Quality and the U.S. Department of Veterans Affairs funded the study. Dr. Deshpande reported receiving research grants from 3M, Clorox, and Steris, and one of his associates reported receiving research grants from Clorox, Ecolab, GOJO, Merck, Pfizer, and Steris.
Floors in hospital patients’ rooms are frequently contaminated with pathogens such as Clostridium difficile, methicillin-resistant Staphylococcus aureus, and vancomycin-resistant Enterococci, which are easily transmitted to the hands of patients, care providers, and visitors, according to a report published in the American Journal of Infection Control.
Disinfection usually focuses on surfaces that are frequently touched by patients’ or health care workers’ hands, such as bed rails and call buttons. Floor disinfection has received limited attention.
However, floors are frequently touched by objects that are then handled, such as shoes and socks, said Abhishek Deshpande, MD, PhD, of the Cleveland Clinic, and his associates.
To examine the extent of floor contamination and the potential for transfer of pathogens to hands, the investigators surveyed five Cleveland-area hospitals.
They collected samples from 1-square-foot areas of floors adjacent to beds and in bathrooms in C. difficile isolation rooms, and in 2-3 randomly selected nonisolation rooms on the same wards. At least 30 rooms at each hospital were cultured for C. difficile, MRSA, and VRE, either during a patient stay or after the rooms had been cleaned at patient discharge.
In addition, the researchers performed a point-prevalence survey of the number and type of high-touch objects contacting floors in 10-25 randomly selected occupied patient rooms at each hospital. After they handled these objects, their hands also were cultured.
Floor contamination was common with all of the pathogens, particularly with C. difficile. The frequency of contamination was similar across the five hospitals, in both bedroom and bathroom sites, and even in the 50 rooms that had been cleaned at the last patient discharge.
C. difficile spores were recovered from the floors of 47%-55% of rooms, MRSA was recovered from the floors of 8%-32% of rooms, and VRE were recovered from the floors of 13%-30% of rooms.
In addition, 41 of 100 occupied rooms had 1-4 “high-touch” objects in direct contact with the floors, including personal items such as clothing, canes, or cellphone chargers; medical supplies or devices such as pulse oximeters, call buttons, heating pads, urinals, blood pressure cuffs, and wash basins; and linens such as bed sheets, pillows, and towels.
Of the 31 cultures taken from both bare and gloved hands that handled these items, MRSA was recovered from 18%, VRE were recovered from 6%, and C. difficile was recovered from 3%.
“These results suggest that floors in hospital rooms could be an underappreciated source for dissemination of pathogens,” Dr. Deshpande and his associates noted (Am J Infect Control. 2017 Mar 1;45[3]:336-8).
“It would be reasonable to educate health care personnel and patients that they should avoid placing high-touch objects on the floor when possible,” they added.
Moreover, the efficacy of current floor-cleaning and disinfection techniques should be reexamined, particularly with regard to eliminating C. difficile spores.
Other modes of transmission from floors also should be assessed, such as contamination of wheelchairs and wheeled equipment. And transmission of other pathogens, such as gram-negative organisms and viruses, should be examined, the investigators said.
The Agency for Healthcare Research and Quality and the U.S. Department of Veterans Affairs funded the study. Dr. Deshpande reported receiving research grants from 3M, Clorox, and Steris, and one of his associates reported receiving research grants from Clorox, Ecolab, GOJO, Merck, Pfizer, and Steris.
FROM THE AMERICAN JOURNAL OF INFECTION CONTROL
Key clinical point: Floors in hospital patients’ rooms are frequently contaminated with pathogens that are easily transmitted to the hands of patients, care providers, and visitors.
Major finding: C. difficile spores were recovered from the floors of 47%-55% of rooms, MRSA was recovered from the floors of 8%-32% of rooms, and VRE were recovered from the floors of 13%-30% of rooms.
Data source: A survey of five Cleveland-area hospitals in which 318 samples were collected from floors in patient rooms and bathrooms.
Disclosures: The Agency for Healthcare Research and Quality and the U.S. Department of Veterans Affairs funded the study. Dr. Deshpande reported receiving research grants from 3M, Clorox, and Steris, and one of his associates reported receiving research grants from Clorox, Ecolab, Gojo, Merck, Pfizer, and Steris.
ACC/AHA vs. USPSTF statin guidelines
The American College of Cardiology/American Heart Association guidelines for preventive statin therapy would cover an estimated 9.3 million more U.S. adults than would the U.S. Preventive Services Task Force guidelines, according to a report published online April 18 in JAMA.
Most of this difference can be attributed to younger adults and those with diabetes, for whom the ACC/AHA guidelines recommend statin therapy but the USPSTF guidelines do not, said Neha J. Pagidipati, MD, of the Duke Clinical Research Institute, Durham, N.C., and her associates.
They compared the proportion of patients who would be eligible for primary prevention statin therapy according to these two sets of guidelines by applying the eligibility criteria to a sample of 3,416 participants in the nationally representative 2009-2014 National Health and Nutrition Examination Survey (NHANES). These participants were 40-75 years of age, were free of cardiovascular disease, and had triglyceride levels of 400 mg/dL or less. A total of 747 (21.5%) were taking lipid-lowering medication at the time of the survey.
If the USPSTF guidelines (JAMA. 2016 Nov 15;316[19]:1997-2007)were fully implemented in this cohort, 15.8% more of the participants would be taking statin therapy. In contrast, if the ACC/AHA guidelines (Circulation. 2014 Jun 24;129[25 Suppl 2]:S1-4) were fully implemented in this cohort, 24.3% more would be taking statins.
A total of 8.9% of the cohort would be recommended for statin therapy under the ACC/AHA guidelines but not the USPSTF guidelines. Most of this discrepancy could be attributed to the youngest adults and to those with diabetes. The ACC/AHA guidelines were much more likely to recommend statins to patients aged 40-59 years. Such patients have a relatively low 10-year risk of cardiovascular events (7.0%) but a much higher longer-term risk of 34.6% at 30 years, the investigators said.
“Given that half of all [cardiovascular] events in men and one-third in women occur before age 65 years, reliance on 10-year risk alone may miss many younger individuals who could potentially benefit from long-term statin therapy,” they noted (JAMA 2017 Apr 18. doi: 10.1001/jama.2017.3416).
Further analysis broke down which adults the ACC/AHA guidelines covered, in contrast to the USPSTF guidelines: younger male smokers, younger men with dyslipidemia, younger men with high LDL-cholesterol levels, younger women with obesity, and older men who didn’t have high LDL-cholesterol levels.
Extrapolating these findings to the general U.S. population, “there could be an estimated 17.1 million vs 26.4 million U.S. adults with a new recommendation for statin therapy, based on the USPSTF recommendations vs the ACC/AHA guideline recommendations, respectively – an estimated difference of 9.3 million individuals,” Dr. Pagidipati and her associates wrote.
“Alternative approaches to augmenting risk-based cholesterol guidelines, including those that explicitly incorporate potential benefit of therapy, should be considered,” they added.
This study was supported by the Duke Clinical Research Institute. Dr. Pagidipati reported having no relevant financial disclosures; her associates reported ties to numerous industry sources.
The American College of Cardiology/American Heart Association guidelines for preventive statin therapy would cover an estimated 9.3 million more U.S. adults than would the U.S. Preventive Services Task Force guidelines, according to a report published online April 18 in JAMA.
Most of this difference can be attributed to younger adults and those with diabetes, for whom the ACC/AHA guidelines recommend statin therapy but the USPSTF guidelines do not, said Neha J. Pagidipati, MD, of the Duke Clinical Research Institute, Durham, N.C., and her associates.
They compared the proportion of patients who would be eligible for primary prevention statin therapy according to these two sets of guidelines by applying the eligibility criteria to a sample of 3,416 participants in the nationally representative 2009-2014 National Health and Nutrition Examination Survey (NHANES). These participants were 40-75 years of age, were free of cardiovascular disease, and had triglyceride levels of 400 mg/dL or less. A total of 747 (21.5%) were taking lipid-lowering medication at the time of the survey.
If the USPSTF guidelines (JAMA. 2016 Nov 15;316[19]:1997-2007)were fully implemented in this cohort, 15.8% more of the participants would be taking statin therapy. In contrast, if the ACC/AHA guidelines (Circulation. 2014 Jun 24;129[25 Suppl 2]:S1-4) were fully implemented in this cohort, 24.3% more would be taking statins.
A total of 8.9% of the cohort would be recommended for statin therapy under the ACC/AHA guidelines but not the USPSTF guidelines. Most of this discrepancy could be attributed to the youngest adults and to those with diabetes. The ACC/AHA guidelines were much more likely to recommend statins to patients aged 40-59 years. Such patients have a relatively low 10-year risk of cardiovascular events (7.0%) but a much higher longer-term risk of 34.6% at 30 years, the investigators said.
“Given that half of all [cardiovascular] events in men and one-third in women occur before age 65 years, reliance on 10-year risk alone may miss many younger individuals who could potentially benefit from long-term statin therapy,” they noted (JAMA 2017 Apr 18. doi: 10.1001/jama.2017.3416).
Further analysis broke down which adults the ACC/AHA guidelines covered, in contrast to the USPSTF guidelines: younger male smokers, younger men with dyslipidemia, younger men with high LDL-cholesterol levels, younger women with obesity, and older men who didn’t have high LDL-cholesterol levels.
Extrapolating these findings to the general U.S. population, “there could be an estimated 17.1 million vs 26.4 million U.S. adults with a new recommendation for statin therapy, based on the USPSTF recommendations vs the ACC/AHA guideline recommendations, respectively – an estimated difference of 9.3 million individuals,” Dr. Pagidipati and her associates wrote.
“Alternative approaches to augmenting risk-based cholesterol guidelines, including those that explicitly incorporate potential benefit of therapy, should be considered,” they added.
This study was supported by the Duke Clinical Research Institute. Dr. Pagidipati reported having no relevant financial disclosures; her associates reported ties to numerous industry sources.
The American College of Cardiology/American Heart Association guidelines for preventive statin therapy would cover an estimated 9.3 million more U.S. adults than would the U.S. Preventive Services Task Force guidelines, according to a report published online April 18 in JAMA.
Most of this difference can be attributed to younger adults and those with diabetes, for whom the ACC/AHA guidelines recommend statin therapy but the USPSTF guidelines do not, said Neha J. Pagidipati, MD, of the Duke Clinical Research Institute, Durham, N.C., and her associates.
They compared the proportion of patients who would be eligible for primary prevention statin therapy according to these two sets of guidelines by applying the eligibility criteria to a sample of 3,416 participants in the nationally representative 2009-2014 National Health and Nutrition Examination Survey (NHANES). These participants were 40-75 years of age, were free of cardiovascular disease, and had triglyceride levels of 400 mg/dL or less. A total of 747 (21.5%) were taking lipid-lowering medication at the time of the survey.
If the USPSTF guidelines (JAMA. 2016 Nov 15;316[19]:1997-2007)were fully implemented in this cohort, 15.8% more of the participants would be taking statin therapy. In contrast, if the ACC/AHA guidelines (Circulation. 2014 Jun 24;129[25 Suppl 2]:S1-4) were fully implemented in this cohort, 24.3% more would be taking statins.
A total of 8.9% of the cohort would be recommended for statin therapy under the ACC/AHA guidelines but not the USPSTF guidelines. Most of this discrepancy could be attributed to the youngest adults and to those with diabetes. The ACC/AHA guidelines were much more likely to recommend statins to patients aged 40-59 years. Such patients have a relatively low 10-year risk of cardiovascular events (7.0%) but a much higher longer-term risk of 34.6% at 30 years, the investigators said.
“Given that half of all [cardiovascular] events in men and one-third in women occur before age 65 years, reliance on 10-year risk alone may miss many younger individuals who could potentially benefit from long-term statin therapy,” they noted (JAMA 2017 Apr 18. doi: 10.1001/jama.2017.3416).
Further analysis broke down which adults the ACC/AHA guidelines covered, in contrast to the USPSTF guidelines: younger male smokers, younger men with dyslipidemia, younger men with high LDL-cholesterol levels, younger women with obesity, and older men who didn’t have high LDL-cholesterol levels.
Extrapolating these findings to the general U.S. population, “there could be an estimated 17.1 million vs 26.4 million U.S. adults with a new recommendation for statin therapy, based on the USPSTF recommendations vs the ACC/AHA guideline recommendations, respectively – an estimated difference of 9.3 million individuals,” Dr. Pagidipati and her associates wrote.
“Alternative approaches to augmenting risk-based cholesterol guidelines, including those that explicitly incorporate potential benefit of therapy, should be considered,” they added.
This study was supported by the Duke Clinical Research Institute. Dr. Pagidipati reported having no relevant financial disclosures; her associates reported ties to numerous industry sources.
FROM JAMA
Key clinical point: The ACC/AHA guidelines for preventive statin therapy would cover an estimated 9 million more U.S. adults than the USPSTF guidelines.
Major finding: 8.9% of the 3,416 NHANES participants would be recommended for statin therapy under the ACC/AHA guidelines but not the USPSTF guidelines.
Data source: An analysis of the difference in eligibility for preventive statin therapy between two sets of guidelines using data for 3,416 participants in the nationally representative NHANES survey in 2009-2014.
Disclosures: This study was supported by the Duke Clinical Research Institute. Dr. Pagidipati reported having no relevant financial disclosures; her associates reported ties to numerous industry sources.
Ultrasound, cystoscopy combo tops CT for asymptomatic microscopic hematuria
Combining renal ultrasound and bladder cystoscopy is the most cost-effective approach for the initial evaluation of asymptomatic microscopic hematuria, even among patients at risk for genitourinary malignancy, according to a report published online April 17 in JAMA Internal Medicine.
“The superiority of this approach over the use of CT plus cystoscopy is driven primarily by higher costs of CT and the associated complications, albeit rare,” said Joshua A. Halpern, MD, of the department of urology, CornellUniversity, New York, and his associates. “Given the low prevalence of upper-tract malignant abnormalities in patients with asymptomatic microscopic hematuria, the small advantage in the sensitivity of CT imaging does not compensate for the significant additional costs.”
Every year, hundreds of thousands of patients undergo urinalysis for a variety of indications, and an estimated 40% are found to have microscopic hematuria in the absence of any urinary symptoms. This finding requires further evaluation because of one particular possible cause: a genitourinary malignancy. An estimated 11% of people with asymptomatic microscopic hematuria are found to have malignant abnormalities, the investigators said.
They assessed the cost-effectiveness of four common follow-up evaluations by creating a decision-analysis model to simulate the rates of cancer detection in adults with no history of cancer and with negative urine cultures that ruled out UTI as the cause of the hematuria.
The model was based on data from real-world experience in the medical literature and incorporated information on cancer incidence, diagnostic test accuracy, and complications.
The four approaches they examined were CT plus cystoscopy, which is considered the preferred method of diagnostic work-up by the American Urological Association; renal ultrasound plus cystoscopy, which many clinicians in the United States and other countries use instead; cystoscopy alone; and CT alone.
Compared with no follow-up evaluation, CT alone detected the fewest cancers (221 per 10,000 patients) at the highest cost ($9,300,000 per 10,000 patients). Cystoscopy alone detected 222 cancers per 10,000 at a cost of $10,287 per 10,000. Ultrasound plus cystoscopy detected 23 additional cancers per 10,000 patients at a relatively low cost of $53,810 per 10,000. Replacing ultrasound with CT detected just one additional cancer but cost an additional $6,480,484 per 10,000 patients.
The findings were similar in several sensitivity analyses, as well as in a subgroup analysis involving only higher-risk patients – men, smokers, and patients aged 50 years and older, the investigators noted (JAMA Intern Med. 2017 Apr 17. doi: 10.1001/jamaintenmed.2017.0739).
Dr. Halpern and his associates also applied their results to nationwide 2012 statistics for 485,222 patient visits to urologists to assess microscopic hematuria. If all urologists complied with AUA guidelines and used CT instead of ultrasound plus cystoscopy to assess these patients, they would have detected only 60 additional cancers, at an additional cost of $389,914,648.
Given these findings, renal ultrasound plus bladder cystoscopy should be considered the first-line assessment for these patients, Dr. Halpern and his associates said. Rewriting practice guidelines accordingly “will substantially reduce national expenditures associated with asymptomatic microscopic hematuria evaluation by up to $390 million.”
Moreover, recommending ultrasound rather than CT might have the unintended but beneficial consequence of improving compliance with further evaluation, because many primary care physicians are reluctant to refer these patients for radiocontrast CT studies, the researchers noted.
No sponsor was cited for this study. Dr. Halpern and his associates reported having no relevant financial disclosures.
The substantial differences between ultrasound and CT in cost per cancer detected, combined with the harm from CT-related contrast reactions and radiation exposure, strongly support renal ultrasound plus cystoscopy as the preferred first-line approach to assessing asymptomatic microscopic hematuria.
According to Halpern et al., this approach would cost approximately $54,000 per cancer detected. Replacing ultrasound with CT would detect just 1 additional cancer per 10,000 assessments, at an incremental cost of $6.5 million.
Leslee L. Subak, MD, and Deborah Grady, MD, are in the departments of obstetrics, gynecology, and reproductive sciences; urology; and epidemiology and biostatistics at the University of California, San Francisco. Dr. Subak reported receiving funding from Astellas to research urinary incontinence. Dr. Subak and Dr. Grady made these remarks in an invited commentary accompanying Dr. Halpern’s report (JAMA Intern Med. 2017 Apr 17. doi: 10.1001/jamainternmed.2017.0758).
The substantial differences between ultrasound and CT in cost per cancer detected, combined with the harm from CT-related contrast reactions and radiation exposure, strongly support renal ultrasound plus cystoscopy as the preferred first-line approach to assessing asymptomatic microscopic hematuria.
According to Halpern et al., this approach would cost approximately $54,000 per cancer detected. Replacing ultrasound with CT would detect just 1 additional cancer per 10,000 assessments, at an incremental cost of $6.5 million.
Leslee L. Subak, MD, and Deborah Grady, MD, are in the departments of obstetrics, gynecology, and reproductive sciences; urology; and epidemiology and biostatistics at the University of California, San Francisco. Dr. Subak reported receiving funding from Astellas to research urinary incontinence. Dr. Subak and Dr. Grady made these remarks in an invited commentary accompanying Dr. Halpern’s report (JAMA Intern Med. 2017 Apr 17. doi: 10.1001/jamainternmed.2017.0758).
The substantial differences between ultrasound and CT in cost per cancer detected, combined with the harm from CT-related contrast reactions and radiation exposure, strongly support renal ultrasound plus cystoscopy as the preferred first-line approach to assessing asymptomatic microscopic hematuria.
According to Halpern et al., this approach would cost approximately $54,000 per cancer detected. Replacing ultrasound with CT would detect just 1 additional cancer per 10,000 assessments, at an incremental cost of $6.5 million.
Leslee L. Subak, MD, and Deborah Grady, MD, are in the departments of obstetrics, gynecology, and reproductive sciences; urology; and epidemiology and biostatistics at the University of California, San Francisco. Dr. Subak reported receiving funding from Astellas to research urinary incontinence. Dr. Subak and Dr. Grady made these remarks in an invited commentary accompanying Dr. Halpern’s report (JAMA Intern Med. 2017 Apr 17. doi: 10.1001/jamainternmed.2017.0758).
Combining renal ultrasound and bladder cystoscopy is the most cost-effective approach for the initial evaluation of asymptomatic microscopic hematuria, even among patients at risk for genitourinary malignancy, according to a report published online April 17 in JAMA Internal Medicine.
“The superiority of this approach over the use of CT plus cystoscopy is driven primarily by higher costs of CT and the associated complications, albeit rare,” said Joshua A. Halpern, MD, of the department of urology, CornellUniversity, New York, and his associates. “Given the low prevalence of upper-tract malignant abnormalities in patients with asymptomatic microscopic hematuria, the small advantage in the sensitivity of CT imaging does not compensate for the significant additional costs.”
Every year, hundreds of thousands of patients undergo urinalysis for a variety of indications, and an estimated 40% are found to have microscopic hematuria in the absence of any urinary symptoms. This finding requires further evaluation because of one particular possible cause: a genitourinary malignancy. An estimated 11% of people with asymptomatic microscopic hematuria are found to have malignant abnormalities, the investigators said.
They assessed the cost-effectiveness of four common follow-up evaluations by creating a decision-analysis model to simulate the rates of cancer detection in adults with no history of cancer and with negative urine cultures that ruled out UTI as the cause of the hematuria.
The model was based on data from real-world experience in the medical literature and incorporated information on cancer incidence, diagnostic test accuracy, and complications.
The four approaches they examined were CT plus cystoscopy, which is considered the preferred method of diagnostic work-up by the American Urological Association; renal ultrasound plus cystoscopy, which many clinicians in the United States and other countries use instead; cystoscopy alone; and CT alone.
Compared with no follow-up evaluation, CT alone detected the fewest cancers (221 per 10,000 patients) at the highest cost ($9,300,000 per 10,000 patients). Cystoscopy alone detected 222 cancers per 10,000 at a cost of $10,287 per 10,000. Ultrasound plus cystoscopy detected 23 additional cancers per 10,000 patients at a relatively low cost of $53,810 per 10,000. Replacing ultrasound with CT detected just one additional cancer but cost an additional $6,480,484 per 10,000 patients.
The findings were similar in several sensitivity analyses, as well as in a subgroup analysis involving only higher-risk patients – men, smokers, and patients aged 50 years and older, the investigators noted (JAMA Intern Med. 2017 Apr 17. doi: 10.1001/jamaintenmed.2017.0739).
Dr. Halpern and his associates also applied their results to nationwide 2012 statistics for 485,222 patient visits to urologists to assess microscopic hematuria. If all urologists complied with AUA guidelines and used CT instead of ultrasound plus cystoscopy to assess these patients, they would have detected only 60 additional cancers, at an additional cost of $389,914,648.
Given these findings, renal ultrasound plus bladder cystoscopy should be considered the first-line assessment for these patients, Dr. Halpern and his associates said. Rewriting practice guidelines accordingly “will substantially reduce national expenditures associated with asymptomatic microscopic hematuria evaluation by up to $390 million.”
Moreover, recommending ultrasound rather than CT might have the unintended but beneficial consequence of improving compliance with further evaluation, because many primary care physicians are reluctant to refer these patients for radiocontrast CT studies, the researchers noted.
No sponsor was cited for this study. Dr. Halpern and his associates reported having no relevant financial disclosures.
Combining renal ultrasound and bladder cystoscopy is the most cost-effective approach for the initial evaluation of asymptomatic microscopic hematuria, even among patients at risk for genitourinary malignancy, according to a report published online April 17 in JAMA Internal Medicine.
“The superiority of this approach over the use of CT plus cystoscopy is driven primarily by higher costs of CT and the associated complications, albeit rare,” said Joshua A. Halpern, MD, of the department of urology, CornellUniversity, New York, and his associates. “Given the low prevalence of upper-tract malignant abnormalities in patients with asymptomatic microscopic hematuria, the small advantage in the sensitivity of CT imaging does not compensate for the significant additional costs.”
Every year, hundreds of thousands of patients undergo urinalysis for a variety of indications, and an estimated 40% are found to have microscopic hematuria in the absence of any urinary symptoms. This finding requires further evaluation because of one particular possible cause: a genitourinary malignancy. An estimated 11% of people with asymptomatic microscopic hematuria are found to have malignant abnormalities, the investigators said.
They assessed the cost-effectiveness of four common follow-up evaluations by creating a decision-analysis model to simulate the rates of cancer detection in adults with no history of cancer and with negative urine cultures that ruled out UTI as the cause of the hematuria.
The model was based on data from real-world experience in the medical literature and incorporated information on cancer incidence, diagnostic test accuracy, and complications.
The four approaches they examined were CT plus cystoscopy, which is considered the preferred method of diagnostic work-up by the American Urological Association; renal ultrasound plus cystoscopy, which many clinicians in the United States and other countries use instead; cystoscopy alone; and CT alone.
Compared with no follow-up evaluation, CT alone detected the fewest cancers (221 per 10,000 patients) at the highest cost ($9,300,000 per 10,000 patients). Cystoscopy alone detected 222 cancers per 10,000 at a cost of $10,287 per 10,000. Ultrasound plus cystoscopy detected 23 additional cancers per 10,000 patients at a relatively low cost of $53,810 per 10,000. Replacing ultrasound with CT detected just one additional cancer but cost an additional $6,480,484 per 10,000 patients.
The findings were similar in several sensitivity analyses, as well as in a subgroup analysis involving only higher-risk patients – men, smokers, and patients aged 50 years and older, the investigators noted (JAMA Intern Med. 2017 Apr 17. doi: 10.1001/jamaintenmed.2017.0739).
Dr. Halpern and his associates also applied their results to nationwide 2012 statistics for 485,222 patient visits to urologists to assess microscopic hematuria. If all urologists complied with AUA guidelines and used CT instead of ultrasound plus cystoscopy to assess these patients, they would have detected only 60 additional cancers, at an additional cost of $389,914,648.
Given these findings, renal ultrasound plus bladder cystoscopy should be considered the first-line assessment for these patients, Dr. Halpern and his associates said. Rewriting practice guidelines accordingly “will substantially reduce national expenditures associated with asymptomatic microscopic hematuria evaluation by up to $390 million.”
Moreover, recommending ultrasound rather than CT might have the unintended but beneficial consequence of improving compliance with further evaluation, because many primary care physicians are reluctant to refer these patients for radiocontrast CT studies, the researchers noted.
No sponsor was cited for this study. Dr. Halpern and his associates reported having no relevant financial disclosures.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Combining renal ultrasound and bladder cystoscopy is the most cost-effective approach for the initial evaluation of asymptomatic microscopic hematuria.
Major finding: If all urologists complied with AUA guidelines and used CT instead of ultrasound plus cystoscopy to assess the 485,222 patients who were seen for asymptomatic microscopic hematuria in 2012, they would have detected only 60 additional cancers, at an additional cost of $389,914,648.
Data source: Decision-analysis modeling of four common approaches to assessing asymptomatic microscopic hematuria.
Disclosures: No sponsor was cited for this study. Dr. Halpern and his associates reported having no relevant financial disclosures.
Study shows no adverse events with long-term denosumab in postmenopausal women
Extended follow-up of postmenopausal women taking denosumab for high-risk osteoporosis in the FREEDOM trial showed no increasing rates of either common adverse events or specific adverse events identified in the original study.
“This analysis provides reassuring information regarding safety and tolerability of both short-term and longer-term treatment with denosumab,” said Nelson B. Watts, MD, of Mercy Health, Cincinnati, and his associates.
The average age of the women was 72.3 years, and about 23% had vertebral fractures at baseline. The specific, infrequent adverse events that occurred more commonly in the denosumab group than the placebo group in the original trial were malignancy, eczema/dermatitis, pancreatitis, endocarditis, delayed fracture healing, infections, opportunistic infections, and cellulitis or erysipelas. The more common adverse events associated with the active treatment, and currently listed in the prescribing information for denosumab, were back pain, pain in the extremities, musculoskeletal pain, hypercholesterolemia, and cystitis, the investigators reported (J Bone Mineral Res. 2017 Apr 3. doi: 10.1002/jbmr.3119).
“We found no evidence for a relationship between treatment with denosumab and increasing rates of either low-frequency adverse events or common adverse events in patients who were assigned to placebo in the [original] trial and received 3 years of denosumab in the extension study, and no indication of increased incidence of low-frequency adverse events and common adverse events in patients receiving denosumab in years 4-6, compared with years 1-3,” Dr. Watts and his associates wrote.
This study was funded by Amgen, maker of denosumab (Prolia). Dr. Watts reported ties to Amgen, Shire, AbbVie, Merck, Radius, Sanofi, and Osteodynamics; his associates reported ties to numerous industry sources.
Extended follow-up of postmenopausal women taking denosumab for high-risk osteoporosis in the FREEDOM trial showed no increasing rates of either common adverse events or specific adverse events identified in the original study.
“This analysis provides reassuring information regarding safety and tolerability of both short-term and longer-term treatment with denosumab,” said Nelson B. Watts, MD, of Mercy Health, Cincinnati, and his associates.
The average age of the women was 72.3 years, and about 23% had vertebral fractures at baseline. The specific, infrequent adverse events that occurred more commonly in the denosumab group than the placebo group in the original trial were malignancy, eczema/dermatitis, pancreatitis, endocarditis, delayed fracture healing, infections, opportunistic infections, and cellulitis or erysipelas. The more common adverse events associated with the active treatment, and currently listed in the prescribing information for denosumab, were back pain, pain in the extremities, musculoskeletal pain, hypercholesterolemia, and cystitis, the investigators reported (J Bone Mineral Res. 2017 Apr 3. doi: 10.1002/jbmr.3119).
“We found no evidence for a relationship between treatment with denosumab and increasing rates of either low-frequency adverse events or common adverse events in patients who were assigned to placebo in the [original] trial and received 3 years of denosumab in the extension study, and no indication of increased incidence of low-frequency adverse events and common adverse events in patients receiving denosumab in years 4-6, compared with years 1-3,” Dr. Watts and his associates wrote.
This study was funded by Amgen, maker of denosumab (Prolia). Dr. Watts reported ties to Amgen, Shire, AbbVie, Merck, Radius, Sanofi, and Osteodynamics; his associates reported ties to numerous industry sources.
Extended follow-up of postmenopausal women taking denosumab for high-risk osteoporosis in the FREEDOM trial showed no increasing rates of either common adverse events or specific adverse events identified in the original study.
“This analysis provides reassuring information regarding safety and tolerability of both short-term and longer-term treatment with denosumab,” said Nelson B. Watts, MD, of Mercy Health, Cincinnati, and his associates.
The average age of the women was 72.3 years, and about 23% had vertebral fractures at baseline. The specific, infrequent adverse events that occurred more commonly in the denosumab group than the placebo group in the original trial were malignancy, eczema/dermatitis, pancreatitis, endocarditis, delayed fracture healing, infections, opportunistic infections, and cellulitis or erysipelas. The more common adverse events associated with the active treatment, and currently listed in the prescribing information for denosumab, were back pain, pain in the extremities, musculoskeletal pain, hypercholesterolemia, and cystitis, the investigators reported (J Bone Mineral Res. 2017 Apr 3. doi: 10.1002/jbmr.3119).
“We found no evidence for a relationship between treatment with denosumab and increasing rates of either low-frequency adverse events or common adverse events in patients who were assigned to placebo in the [original] trial and received 3 years of denosumab in the extension study, and no indication of increased incidence of low-frequency adverse events and common adverse events in patients receiving denosumab in years 4-6, compared with years 1-3,” Dr. Watts and his associates wrote.
This study was funded by Amgen, maker of denosumab (Prolia). Dr. Watts reported ties to Amgen, Shire, AbbVie, Merck, Radius, Sanofi, and Osteodynamics; his associates reported ties to numerous industry sources.
FROM THE JOURNAL OF BONE AND MINERAL RESEARCH
Key clinical point: Denosumab, taken long term, is not linked with any adverse events.
Major finding: Extended follow-up of postmenopausal women taking denosumab for high-risk osteoporosis showed no increasing rates of either common adverse events or of specific adverse events identified in the original trial.
Data source: Extended (6-year) follow-up of 4,550 women in the international phase III randomized, double-blind FREEDOM trial.
Disclosures: This study was funded by Amgen, maker of denosumab. Dr. Watts reported ties to Amgen, Shire, AbbVie, Merck, Radius, Sanofi, and Osteodynamics; his associates reported ties to numerous industry sources.
Both diabetes types increase markedly among youths
The annual incidence of both types 1 and 2 diabetes markedly increased among youths between 2002 and 2012, especially among those in minority racial and ethnic groups, according to a report published online April 13 in the New England Journal of Medicine.
Researchers analyzed trends in diabetes incidence in the observational Search for Diabetes in Youth study, which conducts annual population-based case ascertainment of the disease in people aged 0-20 years. SEARCH is funded by the Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases.
In this analysis of SEARCH data, there were 11,245 youths with type 1 diabetes in 54,239,600 person-years of surveillance and 2,846 with type 2 diabetes in 28,029,000 person-years of surveillance.
“We estimated that approximately 15,900 cases of type 1 diabetes were diagnosed annually in the U.S. in the 2002-2003 period, and this number increased to 17,900 annually in the 2011-2012 period. Overall, the adjusted annual relative increase in the incidence of type 1 diabetes was 1.8%,” noted Elizabeth J. Mayer-Davis, PhD, of the departments of nutrition and medicine, University of North Carolina, Chapel Hill, and her associates (N Engl J Med. 2017 April 13. doi: 101056/NEJMoa1610187).
Similarly, they estimated that approximately 3,800 cases of type 2 diabetes were diagnosed in the first year of the study, increasing to 5,300 in the final year. The annual relative increase in type 2 diabetes was 4.8%.
The rate of increase varied across the five major ethnic groups studied: non-Hispanic whites, non-Hispanic blacks, Hispanics, Asians or Pacific Islanders, and Native Americans. Type 1 diabetes incidence rose rapidly among Hispanic youths, and type 2 diabetes rose rapidly in all racial and ethnic groups other than whites, with the greatest rate of increase among Native Americans.
These increases suggest “a growing disease burden that will not be shared equally” because of differences among ethnic groups in barriers to care, methods of treatment, and clinical outcomes. “These findings highlight the critical need to identify approaches to reduce disparities among racial and ethnic groups,” Dr. Mayer-Davis and her associates noted.
The National Institute of Diabetes and Digestive and Kidney Diseases and the Centers for Disease Control and Prevention funded the study. Dr. Mayer-Davis reported having no relevant disclosures. One of her associates reported serving as a consultant to Denka-Seiken and MedTest DX.
This study by Mayer-Davis et al. provides the most current data available on the incidence of diabetes in this age group.
The consequence of this increase in diabetes among youths is that the overall disease burden on public health is actually increasing, despite improvements in mortality and CVD rates among older diabetes patients.
According to the 2015 Global Burden of Disease report, the number of years lived with disability has increased by 32.5% and the number of years of life lost has increased by 25.4%.
What do the marked increase in the incidence of diabetes and more people at risk imply about therapy? Data from two large studies over the past several decades support that intensive glycemic control improved outcomes in persons with type 1 or type 2 diabetes mellitus. But what is missing, despite a growing understanding about the pathogenesis of each condition, is knowledge about how best to lower the number of new cases and how best to treat problems once they arise in persons with diabetes.
It is clear that we are far from controlling the negative effects of diabetes on health worldwide. As the prevalence increases, we clearly need new approaches to reduce the burden of this disease on public health.
Julie R. Ingelfinger, M.D., and John A. Jarcho, M.D., are deputy editors of The New England Journal of Medicine. They reported having no relevant disclosures. Dr. Ingelfinger and Dr. Jarcho made these remarks in an editorial accompanying Dr. Mayer-Davis’s report (N Engl J Med. 2017 April 13. doi: 10.1056/NEJMe1616575).
This study by Mayer-Davis et al. provides the most current data available on the incidence of diabetes in this age group.
The consequence of this increase in diabetes among youths is that the overall disease burden on public health is actually increasing, despite improvements in mortality and CVD rates among older diabetes patients.
According to the 2015 Global Burden of Disease report, the number of years lived with disability has increased by 32.5% and the number of years of life lost has increased by 25.4%.
What do the marked increase in the incidence of diabetes and more people at risk imply about therapy? Data from two large studies over the past several decades support that intensive glycemic control improved outcomes in persons with type 1 or type 2 diabetes mellitus. But what is missing, despite a growing understanding about the pathogenesis of each condition, is knowledge about how best to lower the number of new cases and how best to treat problems once they arise in persons with diabetes.
It is clear that we are far from controlling the negative effects of diabetes on health worldwide. As the prevalence increases, we clearly need new approaches to reduce the burden of this disease on public health.
Julie R. Ingelfinger, M.D., and John A. Jarcho, M.D., are deputy editors of The New England Journal of Medicine. They reported having no relevant disclosures. Dr. Ingelfinger and Dr. Jarcho made these remarks in an editorial accompanying Dr. Mayer-Davis’s report (N Engl J Med. 2017 April 13. doi: 10.1056/NEJMe1616575).
This study by Mayer-Davis et al. provides the most current data available on the incidence of diabetes in this age group.
The consequence of this increase in diabetes among youths is that the overall disease burden on public health is actually increasing, despite improvements in mortality and CVD rates among older diabetes patients.
According to the 2015 Global Burden of Disease report, the number of years lived with disability has increased by 32.5% and the number of years of life lost has increased by 25.4%.
What do the marked increase in the incidence of diabetes and more people at risk imply about therapy? Data from two large studies over the past several decades support that intensive glycemic control improved outcomes in persons with type 1 or type 2 diabetes mellitus. But what is missing, despite a growing understanding about the pathogenesis of each condition, is knowledge about how best to lower the number of new cases and how best to treat problems once they arise in persons with diabetes.
It is clear that we are far from controlling the negative effects of diabetes on health worldwide. As the prevalence increases, we clearly need new approaches to reduce the burden of this disease on public health.
Julie R. Ingelfinger, M.D., and John A. Jarcho, M.D., are deputy editors of The New England Journal of Medicine. They reported having no relevant disclosures. Dr. Ingelfinger and Dr. Jarcho made these remarks in an editorial accompanying Dr. Mayer-Davis’s report (N Engl J Med. 2017 April 13. doi: 10.1056/NEJMe1616575).
The annual incidence of both types 1 and 2 diabetes markedly increased among youths between 2002 and 2012, especially among those in minority racial and ethnic groups, according to a report published online April 13 in the New England Journal of Medicine.
Researchers analyzed trends in diabetes incidence in the observational Search for Diabetes in Youth study, which conducts annual population-based case ascertainment of the disease in people aged 0-20 years. SEARCH is funded by the Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases.
In this analysis of SEARCH data, there were 11,245 youths with type 1 diabetes in 54,239,600 person-years of surveillance and 2,846 with type 2 diabetes in 28,029,000 person-years of surveillance.
“We estimated that approximately 15,900 cases of type 1 diabetes were diagnosed annually in the U.S. in the 2002-2003 period, and this number increased to 17,900 annually in the 2011-2012 period. Overall, the adjusted annual relative increase in the incidence of type 1 diabetes was 1.8%,” noted Elizabeth J. Mayer-Davis, PhD, of the departments of nutrition and medicine, University of North Carolina, Chapel Hill, and her associates (N Engl J Med. 2017 April 13. doi: 101056/NEJMoa1610187).
Similarly, they estimated that approximately 3,800 cases of type 2 diabetes were diagnosed in the first year of the study, increasing to 5,300 in the final year. The annual relative increase in type 2 diabetes was 4.8%.
The rate of increase varied across the five major ethnic groups studied: non-Hispanic whites, non-Hispanic blacks, Hispanics, Asians or Pacific Islanders, and Native Americans. Type 1 diabetes incidence rose rapidly among Hispanic youths, and type 2 diabetes rose rapidly in all racial and ethnic groups other than whites, with the greatest rate of increase among Native Americans.
These increases suggest “a growing disease burden that will not be shared equally” because of differences among ethnic groups in barriers to care, methods of treatment, and clinical outcomes. “These findings highlight the critical need to identify approaches to reduce disparities among racial and ethnic groups,” Dr. Mayer-Davis and her associates noted.
The National Institute of Diabetes and Digestive and Kidney Diseases and the Centers for Disease Control and Prevention funded the study. Dr. Mayer-Davis reported having no relevant disclosures. One of her associates reported serving as a consultant to Denka-Seiken and MedTest DX.
The annual incidence of both types 1 and 2 diabetes markedly increased among youths between 2002 and 2012, especially among those in minority racial and ethnic groups, according to a report published online April 13 in the New England Journal of Medicine.
Researchers analyzed trends in diabetes incidence in the observational Search for Diabetes in Youth study, which conducts annual population-based case ascertainment of the disease in people aged 0-20 years. SEARCH is funded by the Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases.
In this analysis of SEARCH data, there were 11,245 youths with type 1 diabetes in 54,239,600 person-years of surveillance and 2,846 with type 2 diabetes in 28,029,000 person-years of surveillance.
“We estimated that approximately 15,900 cases of type 1 diabetes were diagnosed annually in the U.S. in the 2002-2003 period, and this number increased to 17,900 annually in the 2011-2012 period. Overall, the adjusted annual relative increase in the incidence of type 1 diabetes was 1.8%,” noted Elizabeth J. Mayer-Davis, PhD, of the departments of nutrition and medicine, University of North Carolina, Chapel Hill, and her associates (N Engl J Med. 2017 April 13. doi: 101056/NEJMoa1610187).
Similarly, they estimated that approximately 3,800 cases of type 2 diabetes were diagnosed in the first year of the study, increasing to 5,300 in the final year. The annual relative increase in type 2 diabetes was 4.8%.
The rate of increase varied across the five major ethnic groups studied: non-Hispanic whites, non-Hispanic blacks, Hispanics, Asians or Pacific Islanders, and Native Americans. Type 1 diabetes incidence rose rapidly among Hispanic youths, and type 2 diabetes rose rapidly in all racial and ethnic groups other than whites, with the greatest rate of increase among Native Americans.
These increases suggest “a growing disease burden that will not be shared equally” because of differences among ethnic groups in barriers to care, methods of treatment, and clinical outcomes. “These findings highlight the critical need to identify approaches to reduce disparities among racial and ethnic groups,” Dr. Mayer-Davis and her associates noted.
The National Institute of Diabetes and Digestive and Kidney Diseases and the Centers for Disease Control and Prevention funded the study. Dr. Mayer-Davis reported having no relevant disclosures. One of her associates reported serving as a consultant to Denka-Seiken and MedTest DX.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Both types 1 and 2 diabetes increased markedly among youths between 2002 and 2012, especially among those in minority racial and ethnic groups.
Major finding: The incidence of type 1 diabetes increased an estimated 1.8% per year and that of type 2 diabetes increased 4.8% per year between 2002 and 2012.
Data source: An observational study assessing a nationally representative sample of youths aged 0-20 years in five states, including 11,245 with type 1 and 2,846 with type 2 diabetes.
Disclosures: The National Institute of Diabetes and Digestive and Kidney Diseases and the Centers for Disease Control and Prevention funded the study. Dr. Mayer-Davis reported having no relevant disclosures. One of her associates reported serving as a consultant to Denka-Seiken and MedTest DX.
CCP status doesn’t influence tocilizumab’s effectiveness in RA
Among adults with rheumatoid arthritis, serologic status regarding anti–cyclic citrullinated peptide (CCP) antibodies doesn’t appear to influence the effectiveness of tocilizumab therapy, according to a report published in Seminars in Arthritis and Rheumatism.
Compared with patients who have anti-CCP antibodies, those who don’t show differences in immune activation that may affect their response to various therapies. In particular, some experts have hypothesized that monoclonal antibodies such as tocilizumab that target the interleukin-6 receptor would be more effective in patients who are seronegative for anti-CCP antibodies than in those who are seropositive. Being able to predict patient response based on easily available biomarkers like CCP status would greatly assist treatment selection, said Laura C. Cappelli, MD, of the division of rheumatology at Johns Hopkins University, Baltimore, and her associates.
All but one of these eight measures of disease activity (the mHAQ) improved significantly with tocilizumab, regardless of patient anti-CCP status. In addition, the magnitude of change did not differ by anti-CCP status. These results persisted across several sensitivity analyses, Dr. Cappelli and her associates said (Semin Arthritis Rheum. 2017 Apr 1. doi: 10.1016/j.semarthrit.2017.03.024).
The findings indicate that CCP seronegativity does not improve the response to tocilizumab in this population derived from real-world patients at diverse clinical sites, the investigators noted.
This study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Cappelli and her associates reported having no relevant financial disclosures.
Among adults with rheumatoid arthritis, serologic status regarding anti–cyclic citrullinated peptide (CCP) antibodies doesn’t appear to influence the effectiveness of tocilizumab therapy, according to a report published in Seminars in Arthritis and Rheumatism.
Compared with patients who have anti-CCP antibodies, those who don’t show differences in immune activation that may affect their response to various therapies. In particular, some experts have hypothesized that monoclonal antibodies such as tocilizumab that target the interleukin-6 receptor would be more effective in patients who are seronegative for anti-CCP antibodies than in those who are seropositive. Being able to predict patient response based on easily available biomarkers like CCP status would greatly assist treatment selection, said Laura C. Cappelli, MD, of the division of rheumatology at Johns Hopkins University, Baltimore, and her associates.
All but one of these eight measures of disease activity (the mHAQ) improved significantly with tocilizumab, regardless of patient anti-CCP status. In addition, the magnitude of change did not differ by anti-CCP status. These results persisted across several sensitivity analyses, Dr. Cappelli and her associates said (Semin Arthritis Rheum. 2017 Apr 1. doi: 10.1016/j.semarthrit.2017.03.024).
The findings indicate that CCP seronegativity does not improve the response to tocilizumab in this population derived from real-world patients at diverse clinical sites, the investigators noted.
This study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Cappelli and her associates reported having no relevant financial disclosures.
Among adults with rheumatoid arthritis, serologic status regarding anti–cyclic citrullinated peptide (CCP) antibodies doesn’t appear to influence the effectiveness of tocilizumab therapy, according to a report published in Seminars in Arthritis and Rheumatism.
Compared with patients who have anti-CCP antibodies, those who don’t show differences in immune activation that may affect their response to various therapies. In particular, some experts have hypothesized that monoclonal antibodies such as tocilizumab that target the interleukin-6 receptor would be more effective in patients who are seronegative for anti-CCP antibodies than in those who are seropositive. Being able to predict patient response based on easily available biomarkers like CCP status would greatly assist treatment selection, said Laura C. Cappelli, MD, of the division of rheumatology at Johns Hopkins University, Baltimore, and her associates.
All but one of these eight measures of disease activity (the mHAQ) improved significantly with tocilizumab, regardless of patient anti-CCP status. In addition, the magnitude of change did not differ by anti-CCP status. These results persisted across several sensitivity analyses, Dr. Cappelli and her associates said (Semin Arthritis Rheum. 2017 Apr 1. doi: 10.1016/j.semarthrit.2017.03.024).
The findings indicate that CCP seronegativity does not improve the response to tocilizumab in this population derived from real-world patients at diverse clinical sites, the investigators noted.
This study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Cappelli and her associates reported having no relevant financial disclosures.
FROM SEMINARS IN ARTHRITIS AND RHEUMATISM
Key clinical point: In adults with RA, serologic status regarding anti–cyclic citrullinated peptide antibodies doesn’t appear to influence the effectiveness of tocilizumab therapy.
Major finding: Seven of eight measures of disease activity improved significantly with tocilizumab, regardless of the patients’ CCP status.
Data source: A secondary analysis of data from a patient registry regarding 316 adults who initiated tocilizumab in a 6-year period.
Disclosures: This study was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Cappelli and her associates reported having no relevant financial disclosures.
HCV treatment program achieves 97% SVR among homeless
A community-based primary care treatment program achieved a 97% sustained virologic response rate at 12 weeks among homeless adults with hepatitis C, according to a Research Letter to the Editor published online in JAMA Internal Medicine.
An estimated 44% of homeless adults have hepatitis C and face many barriers to effective treatment. Investigators described their experience with the Boston Health Care for the Homeless program during an 18-month period in which 64 such patients received oral direct-acting antivirals as part of integrated primary care services. Most were men, and the mean age was 55 years, said Joshua A. Barocas, MD, of the division of infectious diseases, Massachusetts General Hospital, Boston, and his associates.
Patients were selected for the therapy by clinicians – primary care physicians and nurse practitioners – based in part on their adherence to previous medical appointments. They received weekly phone calls from a care coordinator, and they were not required to maintain sobriety to remain eligible for Medicare or Medicaid coverage for the treatment.
Among the study participants, 62 of 64 (97%) achieved a sustained virologic response at 12 weeks. Only 13% reported missing more than three doses of oral antivirals. Viral testing showed genetic mutations conferring resistance to treatment in one of the two patients who did not achieve SVR, the investigators said (JAMA Intern Med. 2017 Apr 10. doi: 10.1001/jamainternmed.2017.0358).
“These findings demonstrate that with a dedicated program for treating HCV in homeless and marginally housed adults in a primary care setting, it is possible to achieve outcomes similar to those of clinical trials and other cohorts, despite significant additional barriers and competing priorities to health care faced by this population,” Dr. Barocas and his associates said.
The National Institute on Drug Abuse supported the study. Dr. Barocas and his associates reported having no relevant disclosures.
A community-based primary care treatment program achieved a 97% sustained virologic response rate at 12 weeks among homeless adults with hepatitis C, according to a Research Letter to the Editor published online in JAMA Internal Medicine.
An estimated 44% of homeless adults have hepatitis C and face many barriers to effective treatment. Investigators described their experience with the Boston Health Care for the Homeless program during an 18-month period in which 64 such patients received oral direct-acting antivirals as part of integrated primary care services. Most were men, and the mean age was 55 years, said Joshua A. Barocas, MD, of the division of infectious diseases, Massachusetts General Hospital, Boston, and his associates.
Patients were selected for the therapy by clinicians – primary care physicians and nurse practitioners – based in part on their adherence to previous medical appointments. They received weekly phone calls from a care coordinator, and they were not required to maintain sobriety to remain eligible for Medicare or Medicaid coverage for the treatment.
Among the study participants, 62 of 64 (97%) achieved a sustained virologic response at 12 weeks. Only 13% reported missing more than three doses of oral antivirals. Viral testing showed genetic mutations conferring resistance to treatment in one of the two patients who did not achieve SVR, the investigators said (JAMA Intern Med. 2017 Apr 10. doi: 10.1001/jamainternmed.2017.0358).
“These findings demonstrate that with a dedicated program for treating HCV in homeless and marginally housed adults in a primary care setting, it is possible to achieve outcomes similar to those of clinical trials and other cohorts, despite significant additional barriers and competing priorities to health care faced by this population,” Dr. Barocas and his associates said.
The National Institute on Drug Abuse supported the study. Dr. Barocas and his associates reported having no relevant disclosures.
A community-based primary care treatment program achieved a 97% sustained virologic response rate at 12 weeks among homeless adults with hepatitis C, according to a Research Letter to the Editor published online in JAMA Internal Medicine.
An estimated 44% of homeless adults have hepatitis C and face many barriers to effective treatment. Investigators described their experience with the Boston Health Care for the Homeless program during an 18-month period in which 64 such patients received oral direct-acting antivirals as part of integrated primary care services. Most were men, and the mean age was 55 years, said Joshua A. Barocas, MD, of the division of infectious diseases, Massachusetts General Hospital, Boston, and his associates.
Patients were selected for the therapy by clinicians – primary care physicians and nurse practitioners – based in part on their adherence to previous medical appointments. They received weekly phone calls from a care coordinator, and they were not required to maintain sobriety to remain eligible for Medicare or Medicaid coverage for the treatment.
Among the study participants, 62 of 64 (97%) achieved a sustained virologic response at 12 weeks. Only 13% reported missing more than three doses of oral antivirals. Viral testing showed genetic mutations conferring resistance to treatment in one of the two patients who did not achieve SVR, the investigators said (JAMA Intern Med. 2017 Apr 10. doi: 10.1001/jamainternmed.2017.0358).
“These findings demonstrate that with a dedicated program for treating HCV in homeless and marginally housed adults in a primary care setting, it is possible to achieve outcomes similar to those of clinical trials and other cohorts, despite significant additional barriers and competing priorities to health care faced by this population,” Dr. Barocas and his associates said.
The National Institute on Drug Abuse supported the study. Dr. Barocas and his associates reported having no relevant disclosures.
FROM JAMA INTERNAL MEDICINE
Key clinical point: A community-based primary-care treatment program achieved a 97% sustained virologic response rate at 12 weeks among homeless adults with hepatitis C.
Major finding: Among the study participants, 62 of 64 (97%) achieved a sustained virologic response at 12 weeks.
Data source: A retrospective cohort study of 64 homeless adults in Boston treated during an 18-month period.
Disclosures: The National Institute on Drug Abuse supported the study. Dr. Barocas and his associates reported having no relevant disclosures.
Physicians favor ACOG mammography recommendations
Primary care physicians tend to follow breast cancer screening recommendations from the American Congress of Obstetricians and Gynecologists, according to findings from a recent survey.
The American Congress of Obstetricians and Gynecologists (ACOG), the American Cancer Society (ACS), and the U.S. Preventive Services Task Force (USPSTF) offer conflicting guidelines on the optimal time to initiate and discontinue screening mammography, as well as the optimal screening interval. ACOG recommends annual screening for women aged 40 and older, while the ACS advises annual screening at age 45, and the USPSTF calls for biennial mammograms starting at age 50, though all three organizations stress individualized management.
There were 871 respondents, including family medicine/general practice physicians (44.2%), internists (29.7%), and gynecologists (26.1%). The average age of the respondents was 53 years, and more than half of them had been in practice for more than 20 years. A slight majority (55%) were men, and most (71%) were white.
A total of 26.0% of the respondents said they trusted ACOG screening guidelines the most, 23.8% said they trusted ACS guidelines, and 22.9% said they trusted USPSTF guidelines the most.
In total, 81% of physicians recommended screening to women aged 40-44 years, 88% recommended screening to women aged 45-49 years, and 67% recommended screening for women 75 years or older. Among physicians who recommended screening, most recommended annual exams.
These findings show that physicians differ sharply in their adherence to practice guidelines. The results also “provide an important benchmark as guidelines continue evolving, and underscore the need to delineate barriers and facilitators to implementing guidelines in clinical practice,” the researchers wrote.
Primary care physicians tend to follow breast cancer screening recommendations from the American Congress of Obstetricians and Gynecologists, according to findings from a recent survey.
The American Congress of Obstetricians and Gynecologists (ACOG), the American Cancer Society (ACS), and the U.S. Preventive Services Task Force (USPSTF) offer conflicting guidelines on the optimal time to initiate and discontinue screening mammography, as well as the optimal screening interval. ACOG recommends annual screening for women aged 40 and older, while the ACS advises annual screening at age 45, and the USPSTF calls for biennial mammograms starting at age 50, though all three organizations stress individualized management.
There were 871 respondents, including family medicine/general practice physicians (44.2%), internists (29.7%), and gynecologists (26.1%). The average age of the respondents was 53 years, and more than half of them had been in practice for more than 20 years. A slight majority (55%) were men, and most (71%) were white.
A total of 26.0% of the respondents said they trusted ACOG screening guidelines the most, 23.8% said they trusted ACS guidelines, and 22.9% said they trusted USPSTF guidelines the most.
In total, 81% of physicians recommended screening to women aged 40-44 years, 88% recommended screening to women aged 45-49 years, and 67% recommended screening for women 75 years or older. Among physicians who recommended screening, most recommended annual exams.
These findings show that physicians differ sharply in their adherence to practice guidelines. The results also “provide an important benchmark as guidelines continue evolving, and underscore the need to delineate barriers and facilitators to implementing guidelines in clinical practice,” the researchers wrote.
Primary care physicians tend to follow breast cancer screening recommendations from the American Congress of Obstetricians and Gynecologists, according to findings from a recent survey.
The American Congress of Obstetricians and Gynecologists (ACOG), the American Cancer Society (ACS), and the U.S. Preventive Services Task Force (USPSTF) offer conflicting guidelines on the optimal time to initiate and discontinue screening mammography, as well as the optimal screening interval. ACOG recommends annual screening for women aged 40 and older, while the ACS advises annual screening at age 45, and the USPSTF calls for biennial mammograms starting at age 50, though all three organizations stress individualized management.
There were 871 respondents, including family medicine/general practice physicians (44.2%), internists (29.7%), and gynecologists (26.1%). The average age of the respondents was 53 years, and more than half of them had been in practice for more than 20 years. A slight majority (55%) were men, and most (71%) were white.
A total of 26.0% of the respondents said they trusted ACOG screening guidelines the most, 23.8% said they trusted ACS guidelines, and 22.9% said they trusted USPSTF guidelines the most.
In total, 81% of physicians recommended screening to women aged 40-44 years, 88% recommended screening to women aged 45-49 years, and 67% recommended screening for women 75 years or older. Among physicians who recommended screening, most recommended annual exams.
These findings show that physicians differ sharply in their adherence to practice guidelines. The results also “provide an important benchmark as guidelines continue evolving, and underscore the need to delineate barriers and facilitators to implementing guidelines in clinical practice,” the researchers wrote.
FROM JAMA INTERNAL MEDICINE
Key clinical point:
Major finding: Across physicians groups, 81% of respondents recommended screening women aged 40-44 years.
Data source: An analysis of survey responses regarding breast cancer care from a nationally representative sample of 871 family/general medicine physicians, internists, and gynecologists.
Disclosures: The researchers reported having no conflicts of interest.