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Sharon Worcester is an award-winning medical journalist for MDedge News. She has been with the company since 1996, first as the Southeast Bureau Chief (1996-2009) when the company was known as International Medical News Group, then as a freelance writer (2010-2015) before returning as a reporter in 2015. She previously worked as a daily newspaper reporter covering health and local government. Sharon currently reports primarily on oncology and hematology. She has a BA from Eckerd College and an MA in Mass Communication/Print Journalism from the University of Florida. Connect with her via LinkedIn and follow her on twitter @SW_MedReporter.
Poor glucose control linked with longer hospital stay, higher costs
BOSTON – Poor glucose control was associated with longer length of stay and higher costs among hospitalized adults in a large community health system.
Of 9,995 patients who were admitted to any of five Scripps Health hospitals in San Diego County between 2012 and 2013 and who underwent point-of-care blood glucose monitoring regardless of diabetes diagnosis, 1,236 (12%) had blood glucose values greater than 400 mg/dL (poor glucose control), and 8,759 (88%) had blood glucose values between 70 and 199 mg/dL (good glucose control). After controlling for age and gender, those with poor glucose control had a significantly longer mean length of stay than did those with good control (mean of 8.5 vs. 5.74 days), Laura Talavera of Scripps Whittier Diabetes Institute, San Diego, reported at the annual scientific sessions of the American Diabetes Association.
A unit-specific analysis showed that mean length of stay also was significantly longer among those with poor glucose control in critical care units, Ms. Talavera said.
Additionally, those with poor control who had the longest lengths of stay had no diabetes diagnosis code; additional research is needed to determine whether those were patients with diabetes that was not coded or if they were in fact patients without diabetes, she said.
Not surprisingly, given the strong correlation between length of stay and hospital costs, those with poor glucose control also had significantly higher total variable costs, compared with those with good control (mean of $16,382 vs. $13,896).
Patients included in the study were aged 18-104 years (mean of 66 years), and 52% were men. The hospitals had an ethnically diverse patient mix, which varied by location, yet the findings were similar at each hospital, Ms. Talavera said, adding that each hospital had a clinical team including an advanced-practice nurse and a diabetes educator, and standard glucose management protocols were in place.
“We certainly did have other patients that might have been in the 200-300 [mg/dL] range, which we recognize is also poor control, but we really wanted to focus in on those in the most severe hyperglycemic range,” she said, noting that those at the other end of the spectrum of poor control – patients with hypoglycemia – were not included in this analysis as the number of patients with hypoglycemia and severe hypoglycemia was fairly low, and the investigators “wanted to focus in on what was a particular challenge for us.”
The findings have implications for the care of many hospitalized patients; a recent public health report from the University of California, Los Angeles, noted that one of every three hospital admissions in California involves a diagnosis of diabetes mellitus. As hospitals comprise the largest proportion of total health care expenditures (43%) related to diabetes care, the current findings – particularly the finding that 12% of subjects had at least one blood glucose value greater than 400 mg/dL – suggest that putting systems of care in place to rapidly identify and improve glucose control might lead to shorter lengths of stay and lower cost, she concluded.
Ms. Talavera reported having no conflicts of interest to disclose.
BOSTON – Poor glucose control was associated with longer length of stay and higher costs among hospitalized adults in a large community health system.
Of 9,995 patients who were admitted to any of five Scripps Health hospitals in San Diego County between 2012 and 2013 and who underwent point-of-care blood glucose monitoring regardless of diabetes diagnosis, 1,236 (12%) had blood glucose values greater than 400 mg/dL (poor glucose control), and 8,759 (88%) had blood glucose values between 70 and 199 mg/dL (good glucose control). After controlling for age and gender, those with poor glucose control had a significantly longer mean length of stay than did those with good control (mean of 8.5 vs. 5.74 days), Laura Talavera of Scripps Whittier Diabetes Institute, San Diego, reported at the annual scientific sessions of the American Diabetes Association.
A unit-specific analysis showed that mean length of stay also was significantly longer among those with poor glucose control in critical care units, Ms. Talavera said.
Additionally, those with poor control who had the longest lengths of stay had no diabetes diagnosis code; additional research is needed to determine whether those were patients with diabetes that was not coded or if they were in fact patients without diabetes, she said.
Not surprisingly, given the strong correlation between length of stay and hospital costs, those with poor glucose control also had significantly higher total variable costs, compared with those with good control (mean of $16,382 vs. $13,896).
Patients included in the study were aged 18-104 years (mean of 66 years), and 52% were men. The hospitals had an ethnically diverse patient mix, which varied by location, yet the findings were similar at each hospital, Ms. Talavera said, adding that each hospital had a clinical team including an advanced-practice nurse and a diabetes educator, and standard glucose management protocols were in place.
“We certainly did have other patients that might have been in the 200-300 [mg/dL] range, which we recognize is also poor control, but we really wanted to focus in on those in the most severe hyperglycemic range,” she said, noting that those at the other end of the spectrum of poor control – patients with hypoglycemia – were not included in this analysis as the number of patients with hypoglycemia and severe hypoglycemia was fairly low, and the investigators “wanted to focus in on what was a particular challenge for us.”
The findings have implications for the care of many hospitalized patients; a recent public health report from the University of California, Los Angeles, noted that one of every three hospital admissions in California involves a diagnosis of diabetes mellitus. As hospitals comprise the largest proportion of total health care expenditures (43%) related to diabetes care, the current findings – particularly the finding that 12% of subjects had at least one blood glucose value greater than 400 mg/dL – suggest that putting systems of care in place to rapidly identify and improve glucose control might lead to shorter lengths of stay and lower cost, she concluded.
Ms. Talavera reported having no conflicts of interest to disclose.
BOSTON – Poor glucose control was associated with longer length of stay and higher costs among hospitalized adults in a large community health system.
Of 9,995 patients who were admitted to any of five Scripps Health hospitals in San Diego County between 2012 and 2013 and who underwent point-of-care blood glucose monitoring regardless of diabetes diagnosis, 1,236 (12%) had blood glucose values greater than 400 mg/dL (poor glucose control), and 8,759 (88%) had blood glucose values between 70 and 199 mg/dL (good glucose control). After controlling for age and gender, those with poor glucose control had a significantly longer mean length of stay than did those with good control (mean of 8.5 vs. 5.74 days), Laura Talavera of Scripps Whittier Diabetes Institute, San Diego, reported at the annual scientific sessions of the American Diabetes Association.
A unit-specific analysis showed that mean length of stay also was significantly longer among those with poor glucose control in critical care units, Ms. Talavera said.
Additionally, those with poor control who had the longest lengths of stay had no diabetes diagnosis code; additional research is needed to determine whether those were patients with diabetes that was not coded or if they were in fact patients without diabetes, she said.
Not surprisingly, given the strong correlation between length of stay and hospital costs, those with poor glucose control also had significantly higher total variable costs, compared with those with good control (mean of $16,382 vs. $13,896).
Patients included in the study were aged 18-104 years (mean of 66 years), and 52% were men. The hospitals had an ethnically diverse patient mix, which varied by location, yet the findings were similar at each hospital, Ms. Talavera said, adding that each hospital had a clinical team including an advanced-practice nurse and a diabetes educator, and standard glucose management protocols were in place.
“We certainly did have other patients that might have been in the 200-300 [mg/dL] range, which we recognize is also poor control, but we really wanted to focus in on those in the most severe hyperglycemic range,” she said, noting that those at the other end of the spectrum of poor control – patients with hypoglycemia – were not included in this analysis as the number of patients with hypoglycemia and severe hypoglycemia was fairly low, and the investigators “wanted to focus in on what was a particular challenge for us.”
The findings have implications for the care of many hospitalized patients; a recent public health report from the University of California, Los Angeles, noted that one of every three hospital admissions in California involves a diagnosis of diabetes mellitus. As hospitals comprise the largest proportion of total health care expenditures (43%) related to diabetes care, the current findings – particularly the finding that 12% of subjects had at least one blood glucose value greater than 400 mg/dL – suggest that putting systems of care in place to rapidly identify and improve glucose control might lead to shorter lengths of stay and lower cost, she concluded.
Ms. Talavera reported having no conflicts of interest to disclose.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: Poor glucose control was associated with longer length of stay and higher costs among hospitalized adults in a large community health system.
Major finding: Patients with poor glucose control had a significantly longer mean length of stay than did those with good control (mean of 8.5 vs. 5.74 days).
Data source: A retrospective review of 9,995 hospitalized adults.
Disclosures: Ms. Talavera reported having no conflicts of interest to disclose.
FDA approves Rexulti for schizophrenia, depression in schizophrenia
The Food and Drug Administration has approved brexpiprazole (Rexulti) tablets for schizophrenia in adults and as an add-on therapy for adults who are treated with antidepressants for major depressive disorder.
The effectiveness of brexpiprazole for treating schizophrenia was evaluated in more than 1,300 patients in two 6-week clinical trials, and the drug was shown to reduce the occurrence of symptoms, compared with placebo. Effectiveness of brexpiprazole as add-on therapy in the setting of major depressive disorder was evaluated in 1,046 patients in two 6-week trials, and the subjects, whose depression was inadequately treated with antidepressants alone, reported fewer symptoms of depression with brexpiprazole, compared with placebo.
“Schizophrenia and major depressive disorder can be disabling and can greatly disrupt day-to-day activities. Medications affect everyone differently, so it is important to have a variety of treatment options available for patients with mental illness,” Dr. Mitchell Mathis, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said in a July 13 statement announcing the July 10 approval.
Brexpiprazole, like other drugs used to treat schizophrenia, will carry a boxed warning alerting health care professionals about an increased risk of death with off-label use for treating behavioral problems in older persons with dementia-related psychosis. Also in the boxed warning is an alert of an increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.
The drug is manufactured by Otsuka under the trade name Rexulti.
The Food and Drug Administration has approved brexpiprazole (Rexulti) tablets for schizophrenia in adults and as an add-on therapy for adults who are treated with antidepressants for major depressive disorder.
The effectiveness of brexpiprazole for treating schizophrenia was evaluated in more than 1,300 patients in two 6-week clinical trials, and the drug was shown to reduce the occurrence of symptoms, compared with placebo. Effectiveness of brexpiprazole as add-on therapy in the setting of major depressive disorder was evaluated in 1,046 patients in two 6-week trials, and the subjects, whose depression was inadequately treated with antidepressants alone, reported fewer symptoms of depression with brexpiprazole, compared with placebo.
“Schizophrenia and major depressive disorder can be disabling and can greatly disrupt day-to-day activities. Medications affect everyone differently, so it is important to have a variety of treatment options available for patients with mental illness,” Dr. Mitchell Mathis, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said in a July 13 statement announcing the July 10 approval.
Brexpiprazole, like other drugs used to treat schizophrenia, will carry a boxed warning alerting health care professionals about an increased risk of death with off-label use for treating behavioral problems in older persons with dementia-related psychosis. Also in the boxed warning is an alert of an increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.
The drug is manufactured by Otsuka under the trade name Rexulti.
The Food and Drug Administration has approved brexpiprazole (Rexulti) tablets for schizophrenia in adults and as an add-on therapy for adults who are treated with antidepressants for major depressive disorder.
The effectiveness of brexpiprazole for treating schizophrenia was evaluated in more than 1,300 patients in two 6-week clinical trials, and the drug was shown to reduce the occurrence of symptoms, compared with placebo. Effectiveness of brexpiprazole as add-on therapy in the setting of major depressive disorder was evaluated in 1,046 patients in two 6-week trials, and the subjects, whose depression was inadequately treated with antidepressants alone, reported fewer symptoms of depression with brexpiprazole, compared with placebo.
“Schizophrenia and major depressive disorder can be disabling and can greatly disrupt day-to-day activities. Medications affect everyone differently, so it is important to have a variety of treatment options available for patients with mental illness,” Dr. Mitchell Mathis, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said in a July 13 statement announcing the July 10 approval.
Brexpiprazole, like other drugs used to treat schizophrenia, will carry a boxed warning alerting health care professionals about an increased risk of death with off-label use for treating behavioral problems in older persons with dementia-related psychosis. Also in the boxed warning is an alert of an increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.
The drug is manufactured by Otsuka under the trade name Rexulti.
Sepsis’ Readmission Costs Dwarf Heart Attack, Heart Failure Costs
Sepsis-related hospital readmission costs in California adults were more than double those for congestive heart failure (CHF) and more than triple those for acute myocardial infarction (AMI) between 2009 and 2011, a retrospective cohort analysis showed.
The all-cause, 30-day readmission rates among 240,198 sepsis patients, 193,153 CHF patients, and 105,684 AMI patients were 20.4%, 23.6%, and 17.7%, respectively, and the estimated annual costs of those readmissions were $500 million, $229 million, and $142 million, respectively, Dr. Dong W. Chang of Harbor-UCLA Medical Center, Torrance, Calif. and colleagues reported online in Critical Care Medicine (June 30, 2015 [doi:10.1097/CCM.0000000000001159]).
Patient-level factors associated with greater likelihood of 30-day readmission after sepsis included younger age (odds ratio, 1.34 for youngest vs. oldest age categories), black race (odds ratio, 1.29 vs. white race), Native American race (odds ratio, 2.39 vs. white race), and lower income (odds ratio, 1.13 for lowest vs. highest income quartiles). Male gender, residence in metropolitan areas, and greater burden of medical comorbidities were also associated with readmission after sepsis.
Hospital-level factors associated with greater likelihood of readmission included health care delivery to the highest vs. lowest quintile of minorities (odds ratio, 1.28), for-profit status (odds ratio, 1.34), and university vs. nonuniversity hospital setting (odds ratio, 1.35), the investigators found.
The findings, derived from the Healthcare Cost and Utilization Project State Inpatient Database maintained by the Agency for Healthcare Research and Quality, show that sepsis is a leading contributor to excess health care costs related to hospital readmissions.
A better understanding of the causative events leading to sepsis readmissions is needed, the investigators noted, and if studies and policies seeking to reduce hospital readmissions are to be effective, they will need to focus on the problem of sepsis-related readmissions – on a level that is at least comparable to CHF and AMI.
Dr. Chang received research support from the National Institutes of Health.
Sepsis-related hospital readmission costs in California adults were more than double those for congestive heart failure (CHF) and more than triple those for acute myocardial infarction (AMI) between 2009 and 2011, a retrospective cohort analysis showed.
The all-cause, 30-day readmission rates among 240,198 sepsis patients, 193,153 CHF patients, and 105,684 AMI patients were 20.4%, 23.6%, and 17.7%, respectively, and the estimated annual costs of those readmissions were $500 million, $229 million, and $142 million, respectively, Dr. Dong W. Chang of Harbor-UCLA Medical Center, Torrance, Calif. and colleagues reported online in Critical Care Medicine (June 30, 2015 [doi:10.1097/CCM.0000000000001159]).
Patient-level factors associated with greater likelihood of 30-day readmission after sepsis included younger age (odds ratio, 1.34 for youngest vs. oldest age categories), black race (odds ratio, 1.29 vs. white race), Native American race (odds ratio, 2.39 vs. white race), and lower income (odds ratio, 1.13 for lowest vs. highest income quartiles). Male gender, residence in metropolitan areas, and greater burden of medical comorbidities were also associated with readmission after sepsis.
Hospital-level factors associated with greater likelihood of readmission included health care delivery to the highest vs. lowest quintile of minorities (odds ratio, 1.28), for-profit status (odds ratio, 1.34), and university vs. nonuniversity hospital setting (odds ratio, 1.35), the investigators found.
The findings, derived from the Healthcare Cost and Utilization Project State Inpatient Database maintained by the Agency for Healthcare Research and Quality, show that sepsis is a leading contributor to excess health care costs related to hospital readmissions.
A better understanding of the causative events leading to sepsis readmissions is needed, the investigators noted, and if studies and policies seeking to reduce hospital readmissions are to be effective, they will need to focus on the problem of sepsis-related readmissions – on a level that is at least comparable to CHF and AMI.
Dr. Chang received research support from the National Institutes of Health.
Sepsis-related hospital readmission costs in California adults were more than double those for congestive heart failure (CHF) and more than triple those for acute myocardial infarction (AMI) between 2009 and 2011, a retrospective cohort analysis showed.
The all-cause, 30-day readmission rates among 240,198 sepsis patients, 193,153 CHF patients, and 105,684 AMI patients were 20.4%, 23.6%, and 17.7%, respectively, and the estimated annual costs of those readmissions were $500 million, $229 million, and $142 million, respectively, Dr. Dong W. Chang of Harbor-UCLA Medical Center, Torrance, Calif. and colleagues reported online in Critical Care Medicine (June 30, 2015 [doi:10.1097/CCM.0000000000001159]).
Patient-level factors associated with greater likelihood of 30-day readmission after sepsis included younger age (odds ratio, 1.34 for youngest vs. oldest age categories), black race (odds ratio, 1.29 vs. white race), Native American race (odds ratio, 2.39 vs. white race), and lower income (odds ratio, 1.13 for lowest vs. highest income quartiles). Male gender, residence in metropolitan areas, and greater burden of medical comorbidities were also associated with readmission after sepsis.
Hospital-level factors associated with greater likelihood of readmission included health care delivery to the highest vs. lowest quintile of minorities (odds ratio, 1.28), for-profit status (odds ratio, 1.34), and university vs. nonuniversity hospital setting (odds ratio, 1.35), the investigators found.
The findings, derived from the Healthcare Cost and Utilization Project State Inpatient Database maintained by the Agency for Healthcare Research and Quality, show that sepsis is a leading contributor to excess health care costs related to hospital readmissions.
A better understanding of the causative events leading to sepsis readmissions is needed, the investigators noted, and if studies and policies seeking to reduce hospital readmissions are to be effective, they will need to focus on the problem of sepsis-related readmissions – on a level that is at least comparable to CHF and AMI.
Dr. Chang received research support from the National Institutes of Health.
FROM CRITICAL CARE MEDICINE
Sepsis’ readmission costs dwarf heart attack, heart failure costs
Sepsis-related hospital readmission costs in California adults were more than double those for congestive heart failure (CHF) and more than triple those for acute myocardial infarction (AMI) between 2009 and 2011, a retrospective cohort analysis showed.
The all-cause, 30-day readmission rates among 240,198 sepsis patients, 193,153 CHF patients, and 105,684 AMI patients were 20.4%, 23.6%, and 17.7%, respectively, and the estimated annual costs of those readmissions were $500 million, $229 million, and $142 million, respectively, Dr. Dong W. Chang of Harbor-UCLA Medical Center, Torrance, Calif. and colleagues reported online in Critical Care Medicine (June 30, 2015 [doi:10.1097/CCM.0000000000001159]).
Patient-level factors associated with greater likelihood of 30-day readmission after sepsis included younger age (odds ratio, 1.34 for youngest vs. oldest age categories), black race (odds ratio, 1.29 vs. white race), Native American race (odds ratio, 2.39 vs. white race), and lower income (odds ratio, 1.13 for lowest vs. highest income quartiles). Male gender, residence in metropolitan areas, and greater burden of medical comorbidities were also associated with readmission after sepsis.
Hospital-level factors associated with greater likelihood of readmission included health care delivery to the highest vs. lowest quintile of minorities (odds ratio, 1.28), for-profit status (odds ratio, 1.34), and university vs. nonuniversity hospital setting (odds ratio, 1.35), the investigators found.
The findings, derived from the Healthcare Cost and Utilization Project State Inpatient Database maintained by the Agency for Healthcare Research and Quality, show that sepsis is a leading contributor to excess health care costs related to hospital readmissions.
A better understanding of the causative events leading to sepsis readmissions is needed, the investigators noted, and if studies and policies seeking to reduce hospital readmissions are to be effective, they will need to focus on the problem of sepsis-related readmissions – on a level that is at least comparable to CHF and AMI.
Dr. Chang received research support from the National Institutes of Health.
Sepsis-related hospital readmission costs in California adults were more than double those for congestive heart failure (CHF) and more than triple those for acute myocardial infarction (AMI) between 2009 and 2011, a retrospective cohort analysis showed.
The all-cause, 30-day readmission rates among 240,198 sepsis patients, 193,153 CHF patients, and 105,684 AMI patients were 20.4%, 23.6%, and 17.7%, respectively, and the estimated annual costs of those readmissions were $500 million, $229 million, and $142 million, respectively, Dr. Dong W. Chang of Harbor-UCLA Medical Center, Torrance, Calif. and colleagues reported online in Critical Care Medicine (June 30, 2015 [doi:10.1097/CCM.0000000000001159]).
Patient-level factors associated with greater likelihood of 30-day readmission after sepsis included younger age (odds ratio, 1.34 for youngest vs. oldest age categories), black race (odds ratio, 1.29 vs. white race), Native American race (odds ratio, 2.39 vs. white race), and lower income (odds ratio, 1.13 for lowest vs. highest income quartiles). Male gender, residence in metropolitan areas, and greater burden of medical comorbidities were also associated with readmission after sepsis.
Hospital-level factors associated with greater likelihood of readmission included health care delivery to the highest vs. lowest quintile of minorities (odds ratio, 1.28), for-profit status (odds ratio, 1.34), and university vs. nonuniversity hospital setting (odds ratio, 1.35), the investigators found.
The findings, derived from the Healthcare Cost and Utilization Project State Inpatient Database maintained by the Agency for Healthcare Research and Quality, show that sepsis is a leading contributor to excess health care costs related to hospital readmissions.
A better understanding of the causative events leading to sepsis readmissions is needed, the investigators noted, and if studies and policies seeking to reduce hospital readmissions are to be effective, they will need to focus on the problem of sepsis-related readmissions – on a level that is at least comparable to CHF and AMI.
Dr. Chang received research support from the National Institutes of Health.
Sepsis-related hospital readmission costs in California adults were more than double those for congestive heart failure (CHF) and more than triple those for acute myocardial infarction (AMI) between 2009 and 2011, a retrospective cohort analysis showed.
The all-cause, 30-day readmission rates among 240,198 sepsis patients, 193,153 CHF patients, and 105,684 AMI patients were 20.4%, 23.6%, and 17.7%, respectively, and the estimated annual costs of those readmissions were $500 million, $229 million, and $142 million, respectively, Dr. Dong W. Chang of Harbor-UCLA Medical Center, Torrance, Calif. and colleagues reported online in Critical Care Medicine (June 30, 2015 [doi:10.1097/CCM.0000000000001159]).
Patient-level factors associated with greater likelihood of 30-day readmission after sepsis included younger age (odds ratio, 1.34 for youngest vs. oldest age categories), black race (odds ratio, 1.29 vs. white race), Native American race (odds ratio, 2.39 vs. white race), and lower income (odds ratio, 1.13 for lowest vs. highest income quartiles). Male gender, residence in metropolitan areas, and greater burden of medical comorbidities were also associated with readmission after sepsis.
Hospital-level factors associated with greater likelihood of readmission included health care delivery to the highest vs. lowest quintile of minorities (odds ratio, 1.28), for-profit status (odds ratio, 1.34), and university vs. nonuniversity hospital setting (odds ratio, 1.35), the investigators found.
The findings, derived from the Healthcare Cost and Utilization Project State Inpatient Database maintained by the Agency for Healthcare Research and Quality, show that sepsis is a leading contributor to excess health care costs related to hospital readmissions.
A better understanding of the causative events leading to sepsis readmissions is needed, the investigators noted, and if studies and policies seeking to reduce hospital readmissions are to be effective, they will need to focus on the problem of sepsis-related readmissions – on a level that is at least comparable to CHF and AMI.
Dr. Chang received research support from the National Institutes of Health.
FROM CRITICAL CARE MEDICINE
Key clinical point: Sepsis-related hospital readmission costs in California adults were more than double those for congestive heart failure and more than triple those for acute myocardial infarction between 2009 and 2011.
Major finding: The estimated annual costs of sepsis, CHF, and AMI readmissions were $500 million, $229 million, and $142 million, respectively.
Data source: A retrospective cohort study of more than 539,000 hospitalizations.
Disclosures: Dr. Chang received research support from the National Institutes of Health.
Diabetes educators enhance care, improve outcomes in the primary care settings
BOSTON – Using certified diabetes educators to intensify the therapeutic management of people with diabetes was feasible in the primary care setting and effective for improving hemoglobin A1c in a cluster-randomized controlled trial.
Among 175 subjects enrolled from 15 participating centers, intensified evidence-based diabetes medication management protocols delivered by the certified diabetes educators (CDEs) were associated with significantly decreased HbA1c (from 8.8% to 7.8%) at 1 year, while usual care in 65 patients was associated with a slight increase in HbA1c, from 8.2% to 8.3%, Janice C. Zgibor, Ph.D. of the University of Pittsburgh reported at the annual scientific sessions of the American Diabetes Association.
Among those with an HbA1c of 8% or greater at baseline, participation in the diabetes education group was associated with a greater likelihood of beginning a new medication during the course of the study, although the number of patients in the control group who received a new medication also increased over time, she said.
Participants in the study had a mean age of 61 years and were from a group of nonacademic primary care practices that researchers recruited and randomized to provide the intensified diabetes management protocols provided by CDEs or to provide usual care to their diabetic patients. All study participants had type 2 diabetes diagnosed at least 1 year earlier and had HbA1c, blood pressure, and low-density lipoprotein cholesterol values above goal at last assessment.
The experimental treatment protocols were patient centered and took into consideration the patient’s lifestyle, psychosocial factors, risk for hypoglycemia or other adverse events, disease duration, comorbidities, and support systems that included financial resources. Education and support were delivered by a CDE during visits in the practice setting or by phone or e-mail. Usual care involved one monthly support group meeting held in the primary care practice or a nearby location and conducted by the CDE.
CDEs ordered medication changes and lab work as needed via the electronic health record, pending physician approval.
All protocols were evidence based and adhered to ADA standards of care and other guidelines and were updated as evidence changed, Dr. Zgibor noted.
The intervention group subjects continued to see significant HbA1c improvement over 12 months, even after adjusting for differences in baseline HbA1c between the groups. The greatest improvement in the intervention group was seen at 3 months. The control group experienced a slight improvement at that time, but HbA1c in that group eventually started to increase.
“The absolute risk reduction was 30%. That means that an additional patient would improve due to treatment with the protocols, one wouldn’t change at all, and one would change on their own,” she said, adding that the findings suggest that it is feasible for diabetes educators to implement treatment protocols to intensify treatment.
The findings are timely, because while improvement has been seen over time in the proportion of persons with diabetes over the age of 20 years who meet goals for HbA1c, blood pressure, and cholesterol, only 18% reach the goals for all three, she said, adding that many approaches, including physician prompts, patient reminders, and incentives for both providers and patients have been tried and have contributed to improvement. The Institute of Medicine has called for redesigned strategies and noted them as a health care system priority topic.
Another IOM priority topic is to compare the effectiveness of using allied health providers for chronic conditions, and the findings from several studies have demonstrated that these providers can be integrated into primary care to improve diabetes outcomes, she said.
The current study bolsters those findings.
“This approach was well accepted by our physicians and their staff. There were significant improvements in HbA1c and they were sustained, treatment intensification was greatest in the intervention group after the first visit with the CDE, and over time the control group also experienced some treatment intensification. CDEs can be incorporated into the work flow of primary care. However, funding for dissemination and sustainability is problematic,” she said.
She noted, however, that the ADA and American Association of Diabetes Educators (AADE) recognition of self-management education provides a mechanism for reimbursement, but providers need to buy into the model.
Potential solutions for sustainability could include training office nurses to implement treatment intensification or alert providers to the need for treatment intensification, pooling resources (practices could share a CDE), and connection of CDEs to electronic health records to trigger alerts to providers to intensify treatment, she said.
Another University of Pittsburgh study presented at the ADA annual scientific sessions also demonstrated feasibility of a primary care approach to providing diabetes education, and reaffirmed the benefits of diabetes education in all patients with diabetes.
In that study, the feasibility of quality improvement approaches being used in other aspects of primary care, such as population management, electronic communication, and practice redesign, was evaluated in the context of diabetes education, according to Linda Siminerio, Ph.D., of the University of Pittsburgh.
Three CDEs were introduced to practices in their respective urban, suburban, and rural communities, and they proactively identified patients who might benefit from diabetes education, such as those at high risk for complications or with newly diagnosed diabetes, and those with frequent emergency department visits or hospitalizations. They arranged for referral and diabetes education visits and worked with primary care physicians on treatment plans.
Of 141 patients with type 2 diabetes who met with a CDE for diabetes education during the course of the study, those with pre-education HbA1c levels at or below 7% maintained those levels at 6 months and at 12 months. Those with pre-education HbA1c between 7% and 9% experienced significant reductions in HbA1c at 6 months, and the levels were maintained at 12 months.
Those at highest risk – with pre-education HbA1c greater than 9% – also experienced significant reductions in HbA1c at 6 months, with maintenance of the improvements at 12 months.
Overall the population also experienced significant improvements in triglycerides and total cholesterol levels, but systolic blood pressure and weight did not change significantly.
“These findings demonstrate the feasibility and potential effectiveness of this novel education practice–based approach to improving glycemia in type 2 diabetes patients and lowering triglycerides (which could be indicative of a positive impact from lifestyle changes that were supported by the diabetes educator), reaffirming the benefit of education in all patients, particularly those at highest risk,” said Dr. Siminerio, who also is chair of the National Diabetes Education Program.
This model, known as Glucose to Goal program, reflected a team approach with the provider and educator both contributing to possible initiation of supportive therapy, she said, noting that the approach was somewhat similar to that used in Dr. Zgibor’s study, except protocols weren’t used.
“That’s because we didn’t have them available, but we hope to have them soon. We will be partnering on this and deploying this model across our whole health system,” she said.
Dr. Siminerio noted a number of “anecdotal undocumented successes,” including patient reports of better communication and support, educator reports of an increase in patient access and volume of patients reached, and primary care physician support for the program and reports of quality improvement and reduced workload.
This approach holds promise to support diabetes care that is cost effective and scalable, she said, noting that it “integrates team care while leveraging existing infrastructure.”
Additional research is needed to assess long-term effectiveness, she said, noting that developing effective diabetes education programs is imperative, as diabetes self-management and time spent with diabetes educators has repeatedly been shown to improve clinical, psychological and behavioral outcomes, yet diabetes education is underutilized.
“Nationally, only 6.8% of individuals with newly diagnosed type 2 diabetes participate in diabetes self-management education within 12 months of diagnosis, and, only 4% of Medicare participants are reported to have received DSME [diabetes self-management education] and/or medical nutrition therapy,” she said.
Of note, the ADA and AADE, along with the Academy of Nutrition and Dietetics, released a joint position statement on DSME during the ADA annual scientific sessions.
The statement, jointly published online in Diabetes Care, The Diabetes Educator, and the Journal of the Academy of Nutrition and Dietetics, highlighted four critical times for assessing the need for DSME and support referral: at diagnosis, on an annual basis, when new complicating factors influence self-management and transitions in care occur. The statement provides guidance on the type of information and support patients might need at theses “critical junctures,” and outlines the appropriate content, roles, and action steps for both the referring provider and the diabetes educators (Diabetes Care 2015 June 5 [doi:10.2337/dc15-0730]).
A major gap in diabetes education is in the area of referrals; there aren’t many providers routinely referring patients to diabetes educators, because either they don’t know how to refer, can’t find an educator, or aren’t aware of the value of diabetes education, according to a press release on the statement.
“Yet those referrals are critical,” Dr. Siminerio said in the release.
“Referrals influence patient behavior a great deal. When providers refer patients to diabetes education, we see an 83% participation rate, but without those referrals participation is abysmally low. If patients believe their physicians think diabetes education is important, they take it a lot more seriously. Patients trust their providers,” she said.
The Remedy Study was funded by the ADA. Dr. Zgibor reported having no other disclosures. Dr. Siminerio reported receiving research support from Becton, Dickinson and Co.
BOSTON – Using certified diabetes educators to intensify the therapeutic management of people with diabetes was feasible in the primary care setting and effective for improving hemoglobin A1c in a cluster-randomized controlled trial.
Among 175 subjects enrolled from 15 participating centers, intensified evidence-based diabetes medication management protocols delivered by the certified diabetes educators (CDEs) were associated with significantly decreased HbA1c (from 8.8% to 7.8%) at 1 year, while usual care in 65 patients was associated with a slight increase in HbA1c, from 8.2% to 8.3%, Janice C. Zgibor, Ph.D. of the University of Pittsburgh reported at the annual scientific sessions of the American Diabetes Association.
Among those with an HbA1c of 8% or greater at baseline, participation in the diabetes education group was associated with a greater likelihood of beginning a new medication during the course of the study, although the number of patients in the control group who received a new medication also increased over time, she said.
Participants in the study had a mean age of 61 years and were from a group of nonacademic primary care practices that researchers recruited and randomized to provide the intensified diabetes management protocols provided by CDEs or to provide usual care to their diabetic patients. All study participants had type 2 diabetes diagnosed at least 1 year earlier and had HbA1c, blood pressure, and low-density lipoprotein cholesterol values above goal at last assessment.
The experimental treatment protocols were patient centered and took into consideration the patient’s lifestyle, psychosocial factors, risk for hypoglycemia or other adverse events, disease duration, comorbidities, and support systems that included financial resources. Education and support were delivered by a CDE during visits in the practice setting or by phone or e-mail. Usual care involved one monthly support group meeting held in the primary care practice or a nearby location and conducted by the CDE.
CDEs ordered medication changes and lab work as needed via the electronic health record, pending physician approval.
All protocols were evidence based and adhered to ADA standards of care and other guidelines and were updated as evidence changed, Dr. Zgibor noted.
The intervention group subjects continued to see significant HbA1c improvement over 12 months, even after adjusting for differences in baseline HbA1c between the groups. The greatest improvement in the intervention group was seen at 3 months. The control group experienced a slight improvement at that time, but HbA1c in that group eventually started to increase.
“The absolute risk reduction was 30%. That means that an additional patient would improve due to treatment with the protocols, one wouldn’t change at all, and one would change on their own,” she said, adding that the findings suggest that it is feasible for diabetes educators to implement treatment protocols to intensify treatment.
The findings are timely, because while improvement has been seen over time in the proportion of persons with diabetes over the age of 20 years who meet goals for HbA1c, blood pressure, and cholesterol, only 18% reach the goals for all three, she said, adding that many approaches, including physician prompts, patient reminders, and incentives for both providers and patients have been tried and have contributed to improvement. The Institute of Medicine has called for redesigned strategies and noted them as a health care system priority topic.
Another IOM priority topic is to compare the effectiveness of using allied health providers for chronic conditions, and the findings from several studies have demonstrated that these providers can be integrated into primary care to improve diabetes outcomes, she said.
The current study bolsters those findings.
“This approach was well accepted by our physicians and their staff. There were significant improvements in HbA1c and they were sustained, treatment intensification was greatest in the intervention group after the first visit with the CDE, and over time the control group also experienced some treatment intensification. CDEs can be incorporated into the work flow of primary care. However, funding for dissemination and sustainability is problematic,” she said.
She noted, however, that the ADA and American Association of Diabetes Educators (AADE) recognition of self-management education provides a mechanism for reimbursement, but providers need to buy into the model.
Potential solutions for sustainability could include training office nurses to implement treatment intensification or alert providers to the need for treatment intensification, pooling resources (practices could share a CDE), and connection of CDEs to electronic health records to trigger alerts to providers to intensify treatment, she said.
Another University of Pittsburgh study presented at the ADA annual scientific sessions also demonstrated feasibility of a primary care approach to providing diabetes education, and reaffirmed the benefits of diabetes education in all patients with diabetes.
In that study, the feasibility of quality improvement approaches being used in other aspects of primary care, such as population management, electronic communication, and practice redesign, was evaluated in the context of diabetes education, according to Linda Siminerio, Ph.D., of the University of Pittsburgh.
Three CDEs were introduced to practices in their respective urban, suburban, and rural communities, and they proactively identified patients who might benefit from diabetes education, such as those at high risk for complications or with newly diagnosed diabetes, and those with frequent emergency department visits or hospitalizations. They arranged for referral and diabetes education visits and worked with primary care physicians on treatment plans.
Of 141 patients with type 2 diabetes who met with a CDE for diabetes education during the course of the study, those with pre-education HbA1c levels at or below 7% maintained those levels at 6 months and at 12 months. Those with pre-education HbA1c between 7% and 9% experienced significant reductions in HbA1c at 6 months, and the levels were maintained at 12 months.
Those at highest risk – with pre-education HbA1c greater than 9% – also experienced significant reductions in HbA1c at 6 months, with maintenance of the improvements at 12 months.
Overall the population also experienced significant improvements in triglycerides and total cholesterol levels, but systolic blood pressure and weight did not change significantly.
“These findings demonstrate the feasibility and potential effectiveness of this novel education practice–based approach to improving glycemia in type 2 diabetes patients and lowering triglycerides (which could be indicative of a positive impact from lifestyle changes that were supported by the diabetes educator), reaffirming the benefit of education in all patients, particularly those at highest risk,” said Dr. Siminerio, who also is chair of the National Diabetes Education Program.
This model, known as Glucose to Goal program, reflected a team approach with the provider and educator both contributing to possible initiation of supportive therapy, she said, noting that the approach was somewhat similar to that used in Dr. Zgibor’s study, except protocols weren’t used.
“That’s because we didn’t have them available, but we hope to have them soon. We will be partnering on this and deploying this model across our whole health system,” she said.
Dr. Siminerio noted a number of “anecdotal undocumented successes,” including patient reports of better communication and support, educator reports of an increase in patient access and volume of patients reached, and primary care physician support for the program and reports of quality improvement and reduced workload.
This approach holds promise to support diabetes care that is cost effective and scalable, she said, noting that it “integrates team care while leveraging existing infrastructure.”
Additional research is needed to assess long-term effectiveness, she said, noting that developing effective diabetes education programs is imperative, as diabetes self-management and time spent with diabetes educators has repeatedly been shown to improve clinical, psychological and behavioral outcomes, yet diabetes education is underutilized.
“Nationally, only 6.8% of individuals with newly diagnosed type 2 diabetes participate in diabetes self-management education within 12 months of diagnosis, and, only 4% of Medicare participants are reported to have received DSME [diabetes self-management education] and/or medical nutrition therapy,” she said.
Of note, the ADA and AADE, along with the Academy of Nutrition and Dietetics, released a joint position statement on DSME during the ADA annual scientific sessions.
The statement, jointly published online in Diabetes Care, The Diabetes Educator, and the Journal of the Academy of Nutrition and Dietetics, highlighted four critical times for assessing the need for DSME and support referral: at diagnosis, on an annual basis, when new complicating factors influence self-management and transitions in care occur. The statement provides guidance on the type of information and support patients might need at theses “critical junctures,” and outlines the appropriate content, roles, and action steps for both the referring provider and the diabetes educators (Diabetes Care 2015 June 5 [doi:10.2337/dc15-0730]).
A major gap in diabetes education is in the area of referrals; there aren’t many providers routinely referring patients to diabetes educators, because either they don’t know how to refer, can’t find an educator, or aren’t aware of the value of diabetes education, according to a press release on the statement.
“Yet those referrals are critical,” Dr. Siminerio said in the release.
“Referrals influence patient behavior a great deal. When providers refer patients to diabetes education, we see an 83% participation rate, but without those referrals participation is abysmally low. If patients believe their physicians think diabetes education is important, they take it a lot more seriously. Patients trust their providers,” she said.
The Remedy Study was funded by the ADA. Dr. Zgibor reported having no other disclosures. Dr. Siminerio reported receiving research support from Becton, Dickinson and Co.
BOSTON – Using certified diabetes educators to intensify the therapeutic management of people with diabetes was feasible in the primary care setting and effective for improving hemoglobin A1c in a cluster-randomized controlled trial.
Among 175 subjects enrolled from 15 participating centers, intensified evidence-based diabetes medication management protocols delivered by the certified diabetes educators (CDEs) were associated with significantly decreased HbA1c (from 8.8% to 7.8%) at 1 year, while usual care in 65 patients was associated with a slight increase in HbA1c, from 8.2% to 8.3%, Janice C. Zgibor, Ph.D. of the University of Pittsburgh reported at the annual scientific sessions of the American Diabetes Association.
Among those with an HbA1c of 8% or greater at baseline, participation in the diabetes education group was associated with a greater likelihood of beginning a new medication during the course of the study, although the number of patients in the control group who received a new medication also increased over time, she said.
Participants in the study had a mean age of 61 years and were from a group of nonacademic primary care practices that researchers recruited and randomized to provide the intensified diabetes management protocols provided by CDEs or to provide usual care to their diabetic patients. All study participants had type 2 diabetes diagnosed at least 1 year earlier and had HbA1c, blood pressure, and low-density lipoprotein cholesterol values above goal at last assessment.
The experimental treatment protocols were patient centered and took into consideration the patient’s lifestyle, psychosocial factors, risk for hypoglycemia or other adverse events, disease duration, comorbidities, and support systems that included financial resources. Education and support were delivered by a CDE during visits in the practice setting or by phone or e-mail. Usual care involved one monthly support group meeting held in the primary care practice or a nearby location and conducted by the CDE.
CDEs ordered medication changes and lab work as needed via the electronic health record, pending physician approval.
All protocols were evidence based and adhered to ADA standards of care and other guidelines and were updated as evidence changed, Dr. Zgibor noted.
The intervention group subjects continued to see significant HbA1c improvement over 12 months, even after adjusting for differences in baseline HbA1c between the groups. The greatest improvement in the intervention group was seen at 3 months. The control group experienced a slight improvement at that time, but HbA1c in that group eventually started to increase.
“The absolute risk reduction was 30%. That means that an additional patient would improve due to treatment with the protocols, one wouldn’t change at all, and one would change on their own,” she said, adding that the findings suggest that it is feasible for diabetes educators to implement treatment protocols to intensify treatment.
The findings are timely, because while improvement has been seen over time in the proportion of persons with diabetes over the age of 20 years who meet goals for HbA1c, blood pressure, and cholesterol, only 18% reach the goals for all three, she said, adding that many approaches, including physician prompts, patient reminders, and incentives for both providers and patients have been tried and have contributed to improvement. The Institute of Medicine has called for redesigned strategies and noted them as a health care system priority topic.
Another IOM priority topic is to compare the effectiveness of using allied health providers for chronic conditions, and the findings from several studies have demonstrated that these providers can be integrated into primary care to improve diabetes outcomes, she said.
The current study bolsters those findings.
“This approach was well accepted by our physicians and their staff. There were significant improvements in HbA1c and they were sustained, treatment intensification was greatest in the intervention group after the first visit with the CDE, and over time the control group also experienced some treatment intensification. CDEs can be incorporated into the work flow of primary care. However, funding for dissemination and sustainability is problematic,” she said.
She noted, however, that the ADA and American Association of Diabetes Educators (AADE) recognition of self-management education provides a mechanism for reimbursement, but providers need to buy into the model.
Potential solutions for sustainability could include training office nurses to implement treatment intensification or alert providers to the need for treatment intensification, pooling resources (practices could share a CDE), and connection of CDEs to electronic health records to trigger alerts to providers to intensify treatment, she said.
Another University of Pittsburgh study presented at the ADA annual scientific sessions also demonstrated feasibility of a primary care approach to providing diabetes education, and reaffirmed the benefits of diabetes education in all patients with diabetes.
In that study, the feasibility of quality improvement approaches being used in other aspects of primary care, such as population management, electronic communication, and practice redesign, was evaluated in the context of diabetes education, according to Linda Siminerio, Ph.D., of the University of Pittsburgh.
Three CDEs were introduced to practices in their respective urban, suburban, and rural communities, and they proactively identified patients who might benefit from diabetes education, such as those at high risk for complications or with newly diagnosed diabetes, and those with frequent emergency department visits or hospitalizations. They arranged for referral and diabetes education visits and worked with primary care physicians on treatment plans.
Of 141 patients with type 2 diabetes who met with a CDE for diabetes education during the course of the study, those with pre-education HbA1c levels at or below 7% maintained those levels at 6 months and at 12 months. Those with pre-education HbA1c between 7% and 9% experienced significant reductions in HbA1c at 6 months, and the levels were maintained at 12 months.
Those at highest risk – with pre-education HbA1c greater than 9% – also experienced significant reductions in HbA1c at 6 months, with maintenance of the improvements at 12 months.
Overall the population also experienced significant improvements in triglycerides and total cholesterol levels, but systolic blood pressure and weight did not change significantly.
“These findings demonstrate the feasibility and potential effectiveness of this novel education practice–based approach to improving glycemia in type 2 diabetes patients and lowering triglycerides (which could be indicative of a positive impact from lifestyle changes that were supported by the diabetes educator), reaffirming the benefit of education in all patients, particularly those at highest risk,” said Dr. Siminerio, who also is chair of the National Diabetes Education Program.
This model, known as Glucose to Goal program, reflected a team approach with the provider and educator both contributing to possible initiation of supportive therapy, she said, noting that the approach was somewhat similar to that used in Dr. Zgibor’s study, except protocols weren’t used.
“That’s because we didn’t have them available, but we hope to have them soon. We will be partnering on this and deploying this model across our whole health system,” she said.
Dr. Siminerio noted a number of “anecdotal undocumented successes,” including patient reports of better communication and support, educator reports of an increase in patient access and volume of patients reached, and primary care physician support for the program and reports of quality improvement and reduced workload.
This approach holds promise to support diabetes care that is cost effective and scalable, she said, noting that it “integrates team care while leveraging existing infrastructure.”
Additional research is needed to assess long-term effectiveness, she said, noting that developing effective diabetes education programs is imperative, as diabetes self-management and time spent with diabetes educators has repeatedly been shown to improve clinical, psychological and behavioral outcomes, yet diabetes education is underutilized.
“Nationally, only 6.8% of individuals with newly diagnosed type 2 diabetes participate in diabetes self-management education within 12 months of diagnosis, and, only 4% of Medicare participants are reported to have received DSME [diabetes self-management education] and/or medical nutrition therapy,” she said.
Of note, the ADA and AADE, along with the Academy of Nutrition and Dietetics, released a joint position statement on DSME during the ADA annual scientific sessions.
The statement, jointly published online in Diabetes Care, The Diabetes Educator, and the Journal of the Academy of Nutrition and Dietetics, highlighted four critical times for assessing the need for DSME and support referral: at diagnosis, on an annual basis, when new complicating factors influence self-management and transitions in care occur. The statement provides guidance on the type of information and support patients might need at theses “critical junctures,” and outlines the appropriate content, roles, and action steps for both the referring provider and the diabetes educators (Diabetes Care 2015 June 5 [doi:10.2337/dc15-0730]).
A major gap in diabetes education is in the area of referrals; there aren’t many providers routinely referring patients to diabetes educators, because either they don’t know how to refer, can’t find an educator, or aren’t aware of the value of diabetes education, according to a press release on the statement.
“Yet those referrals are critical,” Dr. Siminerio said in the release.
“Referrals influence patient behavior a great deal. When providers refer patients to diabetes education, we see an 83% participation rate, but without those referrals participation is abysmally low. If patients believe their physicians think diabetes education is important, they take it a lot more seriously. Patients trust their providers,” she said.
The Remedy Study was funded by the ADA. Dr. Zgibor reported having no other disclosures. Dr. Siminerio reported receiving research support from Becton, Dickinson and Co.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: Integrating Diabetes Education into primary care using certified diabetes educators is feasible and effective for improving outcomes.
Disclosures: The Remedy Study was funded by the ADA. Dr. Zgibor reported having no other disclosures. Dr. Siminerio reported receiving research support from Becton, Dickinson and Co.
Risk of major bleeding is decreased when AF patients do not receive bridging anticoagulation
TORONTO – Forgoing bridging anticoagulation in patients with atrial fibrillation (AF) is noninferior to perioperative bridging with low-molecular-weight heparin for the prevention of arterial thromboembolism and decreases the risk of major bleeding.
Those results emerged from trial data presented at the International Society on Thrombosis and Haemostasis congress and published simultaneously in the New England Journal of Medicine. Study investigator Dr. Thomas Ortel, chief of the division of hematology at Duke University Medical Center, Durham, N.C., discussed results of the BRIDGE (Effectiveness of Bridging Anticoagulation for Surgery) trial, which evaluated the safety and efficacy of bridging anticoagulant therapy.
Bridging anticoagulation is frequently used in patients taking chronic oral anticoagulant therapy who need their anticoagulation transiently held for an operation or invasive procedure. The need for bridging anticoagulation never has been shown definitively, however, Dr. Ortel said in an interview.
“This is the first prospective, randomized, placebo-controlled, double-blind clinical trial to investigate the role of bridging anticoagulant therapy in patients with AF on chronic anticoagulation with warfarin who need the anticoagulant therapy held for an elective operation or invasive procedure,” he said.
Dr. Ortel and his coauthors evaluated 1,884 patients in the trial, which compared bridging and no bridging in patients with nonvalvular/valvular AF or atrial flutter who required warfarin interruption for elective surgery. The median age was 72.7 years, and 73% of patients were male. A total of 336 patients had a history of stroke or transient ischemic attack.
After stopping warfarin 5 days before the procedure, study participants received dalteparin 100 IU/kg (934 patients) or matching placebo (950 patients) for 3 days before and 5-9 days after the procedure. Dalteparin/placebo was resumed 12-24 hours after minor surgery and 48-72 hours after major surgery.
Warfarin was resumed 24 hours or less after the procedure. Follow-up lasted 30 ± 7 days after the procedure. Primary outcomes were arterial thromboembolism and major bleeding. Secondary outcomes were minor bleeding, death, myocardial infarction, and venous thromboembolism.
Protocol adherence occurred in 81% of patients before the procedure, and in 94.5% of patients post procedure.
The incidence of arterial thromboembolism was 0.4% in the no-bridging group, compared with 0.3% in the bridging group (95% confidence interval, –0.6 to 0.8; P = .01 for noninferiority). The incidence of major bleeding was 1.3% in the no-bridging group and 3.2% in the bridging group (relative risk, 0.41; 95% CI, 0.20-0.78; P = .005 for superiority).
“Current practice guidelines provide weak and inconsistent recommendations concerning the need for bridging anticoagulation,” Dr. Ortel said. “This study provides the highest level of evidence to support a strong recommendation concerning the role of bridging in this patient population.”
It is estimated that approximately one in six warfarin-treated patients with AF will need anticoagulation transiently held for an elective operation or invasive procedure each year, making this a common clinical scenario for providers, Dr. Ortel said. Knowing the findings from the BRIDGE trial will help guide clinicians in making decisions when this situation arises in their patients, he concluded.
“With the introduction of the direct oral anticoagulants, we will now need to develop periprocedural approaches to manage patients on a variety of different agents,” he said. “Warfarin continues to be extensively used in many of these patients, however, and the BRIDGE trial will contribute to improved management for these individuals.”
In response to an audience member’s question about which patients should receive bridging anticoagulation, Dr. Ortel said that “right now, our data would suggest that for AF patients, we don’t need to bridge.”
“I can’t say that, necessarily, for prosthetic heart valves or for venous thromboembolism. I think some of the recommendations that you’ve seen in the guidelines where people try to stratify this by how recently they had thromboembolism or by what type of heart valve they have – those might be the higher-risk patients to consider. But that’s all based on existing guidelines and no prospective data, so I feel comfortable telling you who you don’t need to bridge in, but I’m not going to tell you who you should,” he added.
The BRIDGE Trial was sponsored by the National Heart, Lung, and Blood Institute. Dr. Ortel disclosed grant/research support from Eisai Co. Ltd and Pfizer Inc.
TORONTO – Forgoing bridging anticoagulation in patients with atrial fibrillation (AF) is noninferior to perioperative bridging with low-molecular-weight heparin for the prevention of arterial thromboembolism and decreases the risk of major bleeding.
Those results emerged from trial data presented at the International Society on Thrombosis and Haemostasis congress and published simultaneously in the New England Journal of Medicine. Study investigator Dr. Thomas Ortel, chief of the division of hematology at Duke University Medical Center, Durham, N.C., discussed results of the BRIDGE (Effectiveness of Bridging Anticoagulation for Surgery) trial, which evaluated the safety and efficacy of bridging anticoagulant therapy.
Bridging anticoagulation is frequently used in patients taking chronic oral anticoagulant therapy who need their anticoagulation transiently held for an operation or invasive procedure. The need for bridging anticoagulation never has been shown definitively, however, Dr. Ortel said in an interview.
“This is the first prospective, randomized, placebo-controlled, double-blind clinical trial to investigate the role of bridging anticoagulant therapy in patients with AF on chronic anticoagulation with warfarin who need the anticoagulant therapy held for an elective operation or invasive procedure,” he said.
Dr. Ortel and his coauthors evaluated 1,884 patients in the trial, which compared bridging and no bridging in patients with nonvalvular/valvular AF or atrial flutter who required warfarin interruption for elective surgery. The median age was 72.7 years, and 73% of patients were male. A total of 336 patients had a history of stroke or transient ischemic attack.
After stopping warfarin 5 days before the procedure, study participants received dalteparin 100 IU/kg (934 patients) or matching placebo (950 patients) for 3 days before and 5-9 days after the procedure. Dalteparin/placebo was resumed 12-24 hours after minor surgery and 48-72 hours after major surgery.
Warfarin was resumed 24 hours or less after the procedure. Follow-up lasted 30 ± 7 days after the procedure. Primary outcomes were arterial thromboembolism and major bleeding. Secondary outcomes were minor bleeding, death, myocardial infarction, and venous thromboembolism.
Protocol adherence occurred in 81% of patients before the procedure, and in 94.5% of patients post procedure.
The incidence of arterial thromboembolism was 0.4% in the no-bridging group, compared with 0.3% in the bridging group (95% confidence interval, –0.6 to 0.8; P = .01 for noninferiority). The incidence of major bleeding was 1.3% in the no-bridging group and 3.2% in the bridging group (relative risk, 0.41; 95% CI, 0.20-0.78; P = .005 for superiority).
“Current practice guidelines provide weak and inconsistent recommendations concerning the need for bridging anticoagulation,” Dr. Ortel said. “This study provides the highest level of evidence to support a strong recommendation concerning the role of bridging in this patient population.”
It is estimated that approximately one in six warfarin-treated patients with AF will need anticoagulation transiently held for an elective operation or invasive procedure each year, making this a common clinical scenario for providers, Dr. Ortel said. Knowing the findings from the BRIDGE trial will help guide clinicians in making decisions when this situation arises in their patients, he concluded.
“With the introduction of the direct oral anticoagulants, we will now need to develop periprocedural approaches to manage patients on a variety of different agents,” he said. “Warfarin continues to be extensively used in many of these patients, however, and the BRIDGE trial will contribute to improved management for these individuals.”
In response to an audience member’s question about which patients should receive bridging anticoagulation, Dr. Ortel said that “right now, our data would suggest that for AF patients, we don’t need to bridge.”
“I can’t say that, necessarily, for prosthetic heart valves or for venous thromboembolism. I think some of the recommendations that you’ve seen in the guidelines where people try to stratify this by how recently they had thromboembolism or by what type of heart valve they have – those might be the higher-risk patients to consider. But that’s all based on existing guidelines and no prospective data, so I feel comfortable telling you who you don’t need to bridge in, but I’m not going to tell you who you should,” he added.
The BRIDGE Trial was sponsored by the National Heart, Lung, and Blood Institute. Dr. Ortel disclosed grant/research support from Eisai Co. Ltd and Pfizer Inc.
TORONTO – Forgoing bridging anticoagulation in patients with atrial fibrillation (AF) is noninferior to perioperative bridging with low-molecular-weight heparin for the prevention of arterial thromboembolism and decreases the risk of major bleeding.
Those results emerged from trial data presented at the International Society on Thrombosis and Haemostasis congress and published simultaneously in the New England Journal of Medicine. Study investigator Dr. Thomas Ortel, chief of the division of hematology at Duke University Medical Center, Durham, N.C., discussed results of the BRIDGE (Effectiveness of Bridging Anticoagulation for Surgery) trial, which evaluated the safety and efficacy of bridging anticoagulant therapy.
Bridging anticoagulation is frequently used in patients taking chronic oral anticoagulant therapy who need their anticoagulation transiently held for an operation or invasive procedure. The need for bridging anticoagulation never has been shown definitively, however, Dr. Ortel said in an interview.
“This is the first prospective, randomized, placebo-controlled, double-blind clinical trial to investigate the role of bridging anticoagulant therapy in patients with AF on chronic anticoagulation with warfarin who need the anticoagulant therapy held for an elective operation or invasive procedure,” he said.
Dr. Ortel and his coauthors evaluated 1,884 patients in the trial, which compared bridging and no bridging in patients with nonvalvular/valvular AF or atrial flutter who required warfarin interruption for elective surgery. The median age was 72.7 years, and 73% of patients were male. A total of 336 patients had a history of stroke or transient ischemic attack.
After stopping warfarin 5 days before the procedure, study participants received dalteparin 100 IU/kg (934 patients) or matching placebo (950 patients) for 3 days before and 5-9 days after the procedure. Dalteparin/placebo was resumed 12-24 hours after minor surgery and 48-72 hours after major surgery.
Warfarin was resumed 24 hours or less after the procedure. Follow-up lasted 30 ± 7 days after the procedure. Primary outcomes were arterial thromboembolism and major bleeding. Secondary outcomes were minor bleeding, death, myocardial infarction, and venous thromboembolism.
Protocol adherence occurred in 81% of patients before the procedure, and in 94.5% of patients post procedure.
The incidence of arterial thromboembolism was 0.4% in the no-bridging group, compared with 0.3% in the bridging group (95% confidence interval, –0.6 to 0.8; P = .01 for noninferiority). The incidence of major bleeding was 1.3% in the no-bridging group and 3.2% in the bridging group (relative risk, 0.41; 95% CI, 0.20-0.78; P = .005 for superiority).
“Current practice guidelines provide weak and inconsistent recommendations concerning the need for bridging anticoagulation,” Dr. Ortel said. “This study provides the highest level of evidence to support a strong recommendation concerning the role of bridging in this patient population.”
It is estimated that approximately one in six warfarin-treated patients with AF will need anticoagulation transiently held for an elective operation or invasive procedure each year, making this a common clinical scenario for providers, Dr. Ortel said. Knowing the findings from the BRIDGE trial will help guide clinicians in making decisions when this situation arises in their patients, he concluded.
“With the introduction of the direct oral anticoagulants, we will now need to develop periprocedural approaches to manage patients on a variety of different agents,” he said. “Warfarin continues to be extensively used in many of these patients, however, and the BRIDGE trial will contribute to improved management for these individuals.”
In response to an audience member’s question about which patients should receive bridging anticoagulation, Dr. Ortel said that “right now, our data would suggest that for AF patients, we don’t need to bridge.”
“I can’t say that, necessarily, for prosthetic heart valves or for venous thromboembolism. I think some of the recommendations that you’ve seen in the guidelines where people try to stratify this by how recently they had thromboembolism or by what type of heart valve they have – those might be the higher-risk patients to consider. But that’s all based on existing guidelines and no prospective data, so I feel comfortable telling you who you don’t need to bridge in, but I’m not going to tell you who you should,” he added.
The BRIDGE Trial was sponsored by the National Heart, Lung, and Blood Institute. Dr. Ortel disclosed grant/research support from Eisai Co. Ltd and Pfizer Inc.
FROM 2015 ISTH CONGRESS
Key clinical point: Forgoing bridging anticoagulation in patients with atrial fibrillation is noninferior to perioperative bridging for preventing arterial thromboembolism and decreasing the risk of major bleeding.
Major finding: The incidence of arterial thromboembolism was 0.4% vs. 0.3% in the no-bridging and bridging groups, respectively. The incidence of major bleeding was 1.3% in the no-bridging group and 3.2% in the bridging group.
Data source: A prospective, randomized, placebo-controlled, double-blind trial of 1,884 patients with nonvalvular/valvular AF or atrial flutter who required warfarin interruption for elective surgery.
Disclosures: The BRIDGE Trial was sponsored by the National Heart, Lung, and Blood Institute. Dr. Ortel disclosed grant/research support from Eisai Co. Ltd and Pfizer Inc.
High VTE recurrence risk persists for at least 3 years
TORONTO – The risk of recurrence following an initial episode of venous thromboembolism is highest in the first 3 months, but remains high for up to 3 years, according to findings from a population-based study involving 2,989 adults.
Over a mean of 23 months (median, 30 months), there were 329 VTE recurrences in the study subjects. Cumulative incidence rates were 5.1% at 3 months, and 14.5% at 3 years. The corresponding rates were 8.7% and 24.8% among those with active cancer, 5.2% and 13.0% among those with provoked VTE, and 3.8% and 13.1% among those with unprovoked VTE, Dr. Wei Huang reported at the International Society on Thrombosis and Haemostasis congress.
Independent predictors of recurrence within 3 years after the index event were active cancer with chemotherapy (hazard ratio, 2.59), active cancer without chemotherapy (HR, 1.59), hypercoagulable state (HR, 2.53) superficial thrombophlebitis (HR, 1.62), varicose vein stripping (HR, 1.75), and inferior vena cava (IVC) filter placement (HR, 2.04), said Dr. Huang of the University of Massachusetts, Worcester.
Individuals included in the study were all residents of the Worcester Metropolitan Statistical Area (WMSA) who had a validated diagnosis of acute first-time deep vein thrombosis and/or pulmonary embolism in a hospital or ambulatory care center that provided short-term care for WMSA residents between 1999 and 2009. Medical records and national and local death registry data were reviewed to examine outcomes up to 3 years after the index event.
Subjects were adults with a mean age of 64 years; 44% were men, and 94% where white. Pulmonary embolism with or without deep vein thrombosis occurred in 42%, and 17% of cases were associated with cancer, 43% involved provoked VTE, and 40% involved unprovoked VTE.
Provoked VTE was defined as VTE occurring within 3 months of a prior surgery, pregnancy, trauma, fracture, or hospitalization in patients without presence of active cancer.
Though limited by the lack of information about variations in physician practices across regions, and by the high proportion of white resident in the WMSA, which both raise questions about whether the findings are generalizable to the U.S. population, the identification of these predictors could allow for improved estimation of risk for individual patients, and may aid in the design of new interventional studies, Dr. Huang concluded.
This study was supported by the National Institutes of Health.
TORONTO – The risk of recurrence following an initial episode of venous thromboembolism is highest in the first 3 months, but remains high for up to 3 years, according to findings from a population-based study involving 2,989 adults.
Over a mean of 23 months (median, 30 months), there were 329 VTE recurrences in the study subjects. Cumulative incidence rates were 5.1% at 3 months, and 14.5% at 3 years. The corresponding rates were 8.7% and 24.8% among those with active cancer, 5.2% and 13.0% among those with provoked VTE, and 3.8% and 13.1% among those with unprovoked VTE, Dr. Wei Huang reported at the International Society on Thrombosis and Haemostasis congress.
Independent predictors of recurrence within 3 years after the index event were active cancer with chemotherapy (hazard ratio, 2.59), active cancer without chemotherapy (HR, 1.59), hypercoagulable state (HR, 2.53) superficial thrombophlebitis (HR, 1.62), varicose vein stripping (HR, 1.75), and inferior vena cava (IVC) filter placement (HR, 2.04), said Dr. Huang of the University of Massachusetts, Worcester.
Individuals included in the study were all residents of the Worcester Metropolitan Statistical Area (WMSA) who had a validated diagnosis of acute first-time deep vein thrombosis and/or pulmonary embolism in a hospital or ambulatory care center that provided short-term care for WMSA residents between 1999 and 2009. Medical records and national and local death registry data were reviewed to examine outcomes up to 3 years after the index event.
Subjects were adults with a mean age of 64 years; 44% were men, and 94% where white. Pulmonary embolism with or without deep vein thrombosis occurred in 42%, and 17% of cases were associated with cancer, 43% involved provoked VTE, and 40% involved unprovoked VTE.
Provoked VTE was defined as VTE occurring within 3 months of a prior surgery, pregnancy, trauma, fracture, or hospitalization in patients without presence of active cancer.
Though limited by the lack of information about variations in physician practices across regions, and by the high proportion of white resident in the WMSA, which both raise questions about whether the findings are generalizable to the U.S. population, the identification of these predictors could allow for improved estimation of risk for individual patients, and may aid in the design of new interventional studies, Dr. Huang concluded.
This study was supported by the National Institutes of Health.
TORONTO – The risk of recurrence following an initial episode of venous thromboembolism is highest in the first 3 months, but remains high for up to 3 years, according to findings from a population-based study involving 2,989 adults.
Over a mean of 23 months (median, 30 months), there were 329 VTE recurrences in the study subjects. Cumulative incidence rates were 5.1% at 3 months, and 14.5% at 3 years. The corresponding rates were 8.7% and 24.8% among those with active cancer, 5.2% and 13.0% among those with provoked VTE, and 3.8% and 13.1% among those with unprovoked VTE, Dr. Wei Huang reported at the International Society on Thrombosis and Haemostasis congress.
Independent predictors of recurrence within 3 years after the index event were active cancer with chemotherapy (hazard ratio, 2.59), active cancer without chemotherapy (HR, 1.59), hypercoagulable state (HR, 2.53) superficial thrombophlebitis (HR, 1.62), varicose vein stripping (HR, 1.75), and inferior vena cava (IVC) filter placement (HR, 2.04), said Dr. Huang of the University of Massachusetts, Worcester.
Individuals included in the study were all residents of the Worcester Metropolitan Statistical Area (WMSA) who had a validated diagnosis of acute first-time deep vein thrombosis and/or pulmonary embolism in a hospital or ambulatory care center that provided short-term care for WMSA residents between 1999 and 2009. Medical records and national and local death registry data were reviewed to examine outcomes up to 3 years after the index event.
Subjects were adults with a mean age of 64 years; 44% were men, and 94% where white. Pulmonary embolism with or without deep vein thrombosis occurred in 42%, and 17% of cases were associated with cancer, 43% involved provoked VTE, and 40% involved unprovoked VTE.
Provoked VTE was defined as VTE occurring within 3 months of a prior surgery, pregnancy, trauma, fracture, or hospitalization in patients without presence of active cancer.
Though limited by the lack of information about variations in physician practices across regions, and by the high proportion of white resident in the WMSA, which both raise questions about whether the findings are generalizable to the U.S. population, the identification of these predictors could allow for improved estimation of risk for individual patients, and may aid in the design of new interventional studies, Dr. Huang concluded.
This study was supported by the National Institutes of Health.
AT THE 2015 ISTH CONGRESS
Key clinical point: The risk of recurrence following an initial episode of venous thromboembolism is highest in the first 3 months, but remains high for up to 3 years, according to findings from a population-based study involving 2,989 adults.
Major finding: Active cancer with chemotherapy was the strongest predictor of VTE recurrence (hazard ratio, 2.59).
Data source: Population-based surveillance of 2,989 adults patients.
Disclosures: The National Institutes of Health supported the study.
ADA: Intensive lifestyle interventions save costs in highest-risk adults
BOSTON – Intensive behavioral counseling as recommended by the U.S. Preventive Services Task Force for obese and overweight adults at risk for cardiovascular disease would increase quality-adjusted life years in a cost-effective manner in the U.S. population, according to a lifetime disease progression model.
For each person receiving the intervention, the model showed an average increase in quality-adjusted life years (QALY) of 0.019 at a cost of $197 over 25 years. The incremental cost-effectiveness ratio was $10,500 per QALY, Ping Zhang, Ph.D., of the Centers for Disease Control and Prevention, Atlanta, reported at the annual scientific sessions of the American Diabetes Association.
“Given a conventional willingness to pay at $50,000 per QALY, we would say it’s pretty cost-effective,” Dr. Zhang said, noting that in this model representing 101 million U.S. adults, 23,000 cases of cardiovascular disease and 671,000 cases of diabetes would be prevented at a total intervention cost of $58 billion.
Given that “huge amount,” he and his colleagues stratified individuals based on body mass index and cardiovascular disease risk factors to determine who would benefit most from intervention. They found the intervention to be cost saving or above cost saving in obese individuals with impaired fasting glucose (with the greatest benefits in those with at least two additional risk factors), and to be cost-effective or above cost-effective in obese individuals without impaired fasting glucose and in overweight individuals with impaired fasting glucose, he said.
For those who are overweight but who do not have impaired fasting glucose, the cost of intervention was above $50,000 and thus not considered cost-effective.
The USPSTF recommendations, made in August 2014 based on health benefits of such counseling as demonstrated in randomized clinical trials, call for intensive behavioral counseling interventions to promote a healthful diet and physical activity in overweight and obese adults with at least one cardiovascular disease risk factor, such as hypertension, dyslipidemia, impaired fasting glucose, or metabolic syndrome.
To examine the long-term health implications and cost-effectiveness of the recommendations, Dr. Zhang and his colleagues estimated baseline risk factor levels and population characteristics based on 2005-2012 National Health and Nutrition Examination Survey (NHANES) data, and based assumptions about the effectiveness of the interventions on USPSTF data showing a 54% reduction in risk of diabetes, a 2.06 mm Hg reduction in systolic blood pressure, a 5.43 mg/dL reduction in total cholesterol, and 1.0 kg/m2 reduction in body mass index after a median of 16 sessions in 12 months.
Costs of counseling were assumed to be $576 per person based on reported estimates, and future QALYs and costs were discounted at 3% per year.
Dr. Zhang recommended prioritizing interventions. If resources are limited, invest first in those with the highest risk: obese adults with impaired fasting glucose and hypertension, followed by those who are obese and have impaired fasting glucose, he advised.
Dr. Zhang reported having no disclosures.
BOSTON – Intensive behavioral counseling as recommended by the U.S. Preventive Services Task Force for obese and overweight adults at risk for cardiovascular disease would increase quality-adjusted life years in a cost-effective manner in the U.S. population, according to a lifetime disease progression model.
For each person receiving the intervention, the model showed an average increase in quality-adjusted life years (QALY) of 0.019 at a cost of $197 over 25 years. The incremental cost-effectiveness ratio was $10,500 per QALY, Ping Zhang, Ph.D., of the Centers for Disease Control and Prevention, Atlanta, reported at the annual scientific sessions of the American Diabetes Association.
“Given a conventional willingness to pay at $50,000 per QALY, we would say it’s pretty cost-effective,” Dr. Zhang said, noting that in this model representing 101 million U.S. adults, 23,000 cases of cardiovascular disease and 671,000 cases of diabetes would be prevented at a total intervention cost of $58 billion.
Given that “huge amount,” he and his colleagues stratified individuals based on body mass index and cardiovascular disease risk factors to determine who would benefit most from intervention. They found the intervention to be cost saving or above cost saving in obese individuals with impaired fasting glucose (with the greatest benefits in those with at least two additional risk factors), and to be cost-effective or above cost-effective in obese individuals without impaired fasting glucose and in overweight individuals with impaired fasting glucose, he said.
For those who are overweight but who do not have impaired fasting glucose, the cost of intervention was above $50,000 and thus not considered cost-effective.
The USPSTF recommendations, made in August 2014 based on health benefits of such counseling as demonstrated in randomized clinical trials, call for intensive behavioral counseling interventions to promote a healthful diet and physical activity in overweight and obese adults with at least one cardiovascular disease risk factor, such as hypertension, dyslipidemia, impaired fasting glucose, or metabolic syndrome.
To examine the long-term health implications and cost-effectiveness of the recommendations, Dr. Zhang and his colleagues estimated baseline risk factor levels and population characteristics based on 2005-2012 National Health and Nutrition Examination Survey (NHANES) data, and based assumptions about the effectiveness of the interventions on USPSTF data showing a 54% reduction in risk of diabetes, a 2.06 mm Hg reduction in systolic blood pressure, a 5.43 mg/dL reduction in total cholesterol, and 1.0 kg/m2 reduction in body mass index after a median of 16 sessions in 12 months.
Costs of counseling were assumed to be $576 per person based on reported estimates, and future QALYs and costs were discounted at 3% per year.
Dr. Zhang recommended prioritizing interventions. If resources are limited, invest first in those with the highest risk: obese adults with impaired fasting glucose and hypertension, followed by those who are obese and have impaired fasting glucose, he advised.
Dr. Zhang reported having no disclosures.
BOSTON – Intensive behavioral counseling as recommended by the U.S. Preventive Services Task Force for obese and overweight adults at risk for cardiovascular disease would increase quality-adjusted life years in a cost-effective manner in the U.S. population, according to a lifetime disease progression model.
For each person receiving the intervention, the model showed an average increase in quality-adjusted life years (QALY) of 0.019 at a cost of $197 over 25 years. The incremental cost-effectiveness ratio was $10,500 per QALY, Ping Zhang, Ph.D., of the Centers for Disease Control and Prevention, Atlanta, reported at the annual scientific sessions of the American Diabetes Association.
“Given a conventional willingness to pay at $50,000 per QALY, we would say it’s pretty cost-effective,” Dr. Zhang said, noting that in this model representing 101 million U.S. adults, 23,000 cases of cardiovascular disease and 671,000 cases of diabetes would be prevented at a total intervention cost of $58 billion.
Given that “huge amount,” he and his colleagues stratified individuals based on body mass index and cardiovascular disease risk factors to determine who would benefit most from intervention. They found the intervention to be cost saving or above cost saving in obese individuals with impaired fasting glucose (with the greatest benefits in those with at least two additional risk factors), and to be cost-effective or above cost-effective in obese individuals without impaired fasting glucose and in overweight individuals with impaired fasting glucose, he said.
For those who are overweight but who do not have impaired fasting glucose, the cost of intervention was above $50,000 and thus not considered cost-effective.
The USPSTF recommendations, made in August 2014 based on health benefits of such counseling as demonstrated in randomized clinical trials, call for intensive behavioral counseling interventions to promote a healthful diet and physical activity in overweight and obese adults with at least one cardiovascular disease risk factor, such as hypertension, dyslipidemia, impaired fasting glucose, or metabolic syndrome.
To examine the long-term health implications and cost-effectiveness of the recommendations, Dr. Zhang and his colleagues estimated baseline risk factor levels and population characteristics based on 2005-2012 National Health and Nutrition Examination Survey (NHANES) data, and based assumptions about the effectiveness of the interventions on USPSTF data showing a 54% reduction in risk of diabetes, a 2.06 mm Hg reduction in systolic blood pressure, a 5.43 mg/dL reduction in total cholesterol, and 1.0 kg/m2 reduction in body mass index after a median of 16 sessions in 12 months.
Costs of counseling were assumed to be $576 per person based on reported estimates, and future QALYs and costs were discounted at 3% per year.
Dr. Zhang recommended prioritizing interventions. If resources are limited, invest first in those with the highest risk: obese adults with impaired fasting glucose and hypertension, followed by those who are obese and have impaired fasting glucose, he advised.
Dr. Zhang reported having no disclosures.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: Intensive behavioral counseling as recommended by the USPSTF for obese and overweight adults at risk for cardiovascular disease would increase quality-adjusted life years in a cost-effective manner in the U.S. population.
Major finding: The average increase in QALY was 0.019 at a cost of $197 over 25 years, for an incremental cost-effectiveness ratio of $10,500 per QALY.
Data source: A lifetime disease progression model study applied to a population of 101 million U.S. adults.
Disclosures: Dr. Zhang reported having no disclosures.
Cochrane review finds midurethral slings safe, effective
Midurethral sling operations for stress urinary incontinence (SUI) are safe, and – regardless of the routes traversed – are highly effective in the short and mid term, according to a new Cochrane systematic review.
Evidence showing long-term effectiveness is also accruing, but too few of the existing trials have reported outcomes beyond 5 years, Dr. Abigail A. Ford of Bradford (England) Royal Infirmary and her colleagues from the Cochrane Incontinence Group reported.
The findings, based on a review of 81 trials involving a total of 12,113 women, were published July 1 (Cochrane Database Syst. Rev. 2015 [doi:10.1002/14651858.CD006375.pub3]).
Moderate-quality evidence indicates that the transobturator route and retropubic route provide similar rates of subjective and objective cure at up to 1 year (relative risk, 0.98 for both). Low-quality evidence suggests the subjective cure rates are similar with these two approaches at between 1 and 5 years (RR, 0.97), and moderate-quality evidence suggests the subjective cure rates are similar beyond 5 years with the two approaches (RR, 0.95), the investigators said.
Overall, about 80% of women undergoing surgery using either approach experience significant improvement in symptoms at up to 5 years after the surgery; that drops to about 70% after 5 years, based on the few studies that followed patients that long.
Although the overall adverse event rate was low, morbidity rates were higher with the retropubic route. For example, the rate of bladder perforation was 0.6% with the transobturator route vs. 4.5% with the retropubic route. Major vascular/visceral injury, mean operating time, operative blood loss, and hospital length of stay were all lower with the transobturator route. Further, voiding dysfunction was less common with the transobturator route (RR, 0.53).
Groin pain was more common in women in the transobturator vs. retropubic groups (6.4% vs. 1.3%), but suprapubic pain was less common (0.8% vs. 2.9%); both types of pain were of short duration.
The Cochrane investigators also found moderate-quality evidence for the following.
The overall rate of vaginal tape erosion, exposure, or extrusion was low (24 per 1,000 and 21 per 1,000 procedures for the transobturator and retropubic routes, respectively (RR, 1.13).
A retropubic bottom-to-top route was more effective than a top-to-bottom route for subjective cure (RR, 1.10).
Subjective cure rates in the short and mid term were similar when transobturator tape was passed using a medial-to-lateral or lateral-to-medial approach (RR, 1.00 and 1.06, respectively).
Voiding dysfunction was more common with the medial-to-lateral approach (RR, 1.74), but vaginal perforation was less frequent in the medial-to-lateral route (RR, 0.25).
It was unclear, due to very low-quality evidence, whether the lower rates of vaginal epithelial perforation affected vaginal tape erosion, the investigators noted.
The investigators reviewed the literature from 1947 up to June 2014, including only randomized and quasi-randomized controlled trials involving women with stress urinary incontinence, urodynamic stress incontinence, or mixed urinary incontinence, which contribute to up to 80% of cases of urinary incontinence.
They noted that concerns regarding mesh erosion are ongoing, but that the latest white paper and safety communications on meshes released by the Food and Drug Administration in 2011 “relates to ongoing concern with mesh used to treat pelvic organ prolapse and not the small strip of mesh/tape/sling used to treat SUI. In fact, the FDA states that the safety and effectiveness of midurethral slings is well established in clinical trials with 1-year follow-up.”
Overall, the current review highlights the positive impact that midurethral sling operations have on quality of life in women with stress urinary incontinence, but additional reporting of long-term outcomes is needed, the investigators wrote.
“We need to know more about what happens to women in the long term,” Dr. Joseph Ogah, one of the Cochrane investigators and a consultant gynecologist at the University Hospitals of Morecambe Bay NHS Foundation Trust in Cumbria, England, said in a statement. “This review found 35 trials carried out more than 5 years ago: If all the women in these trials were followed up, we would know much more about how long the operations last and, crucially, whether they had developed late but important side effects. Rather than starting any new trials in this area we need to obtain long-term follow-up from the existing trials.”
The review was supported by the National Institute for Health Research in the United Kingdom. Some of the review authors reported industry sponsorship to attend scientific conferences.
Midurethral sling operations for stress urinary incontinence (SUI) are safe, and – regardless of the routes traversed – are highly effective in the short and mid term, according to a new Cochrane systematic review.
Evidence showing long-term effectiveness is also accruing, but too few of the existing trials have reported outcomes beyond 5 years, Dr. Abigail A. Ford of Bradford (England) Royal Infirmary and her colleagues from the Cochrane Incontinence Group reported.
The findings, based on a review of 81 trials involving a total of 12,113 women, were published July 1 (Cochrane Database Syst. Rev. 2015 [doi:10.1002/14651858.CD006375.pub3]).
Moderate-quality evidence indicates that the transobturator route and retropubic route provide similar rates of subjective and objective cure at up to 1 year (relative risk, 0.98 for both). Low-quality evidence suggests the subjective cure rates are similar with these two approaches at between 1 and 5 years (RR, 0.97), and moderate-quality evidence suggests the subjective cure rates are similar beyond 5 years with the two approaches (RR, 0.95), the investigators said.
Overall, about 80% of women undergoing surgery using either approach experience significant improvement in symptoms at up to 5 years after the surgery; that drops to about 70% after 5 years, based on the few studies that followed patients that long.
Although the overall adverse event rate was low, morbidity rates were higher with the retropubic route. For example, the rate of bladder perforation was 0.6% with the transobturator route vs. 4.5% with the retropubic route. Major vascular/visceral injury, mean operating time, operative blood loss, and hospital length of stay were all lower with the transobturator route. Further, voiding dysfunction was less common with the transobturator route (RR, 0.53).
Groin pain was more common in women in the transobturator vs. retropubic groups (6.4% vs. 1.3%), but suprapubic pain was less common (0.8% vs. 2.9%); both types of pain were of short duration.
The Cochrane investigators also found moderate-quality evidence for the following.
The overall rate of vaginal tape erosion, exposure, or extrusion was low (24 per 1,000 and 21 per 1,000 procedures for the transobturator and retropubic routes, respectively (RR, 1.13).
A retropubic bottom-to-top route was more effective than a top-to-bottom route for subjective cure (RR, 1.10).
Subjective cure rates in the short and mid term were similar when transobturator tape was passed using a medial-to-lateral or lateral-to-medial approach (RR, 1.00 and 1.06, respectively).
Voiding dysfunction was more common with the medial-to-lateral approach (RR, 1.74), but vaginal perforation was less frequent in the medial-to-lateral route (RR, 0.25).
It was unclear, due to very low-quality evidence, whether the lower rates of vaginal epithelial perforation affected vaginal tape erosion, the investigators noted.
The investigators reviewed the literature from 1947 up to June 2014, including only randomized and quasi-randomized controlled trials involving women with stress urinary incontinence, urodynamic stress incontinence, or mixed urinary incontinence, which contribute to up to 80% of cases of urinary incontinence.
They noted that concerns regarding mesh erosion are ongoing, but that the latest white paper and safety communications on meshes released by the Food and Drug Administration in 2011 “relates to ongoing concern with mesh used to treat pelvic organ prolapse and not the small strip of mesh/tape/sling used to treat SUI. In fact, the FDA states that the safety and effectiveness of midurethral slings is well established in clinical trials with 1-year follow-up.”
Overall, the current review highlights the positive impact that midurethral sling operations have on quality of life in women with stress urinary incontinence, but additional reporting of long-term outcomes is needed, the investigators wrote.
“We need to know more about what happens to women in the long term,” Dr. Joseph Ogah, one of the Cochrane investigators and a consultant gynecologist at the University Hospitals of Morecambe Bay NHS Foundation Trust in Cumbria, England, said in a statement. “This review found 35 trials carried out more than 5 years ago: If all the women in these trials were followed up, we would know much more about how long the operations last and, crucially, whether they had developed late but important side effects. Rather than starting any new trials in this area we need to obtain long-term follow-up from the existing trials.”
The review was supported by the National Institute for Health Research in the United Kingdom. Some of the review authors reported industry sponsorship to attend scientific conferences.
Midurethral sling operations for stress urinary incontinence (SUI) are safe, and – regardless of the routes traversed – are highly effective in the short and mid term, according to a new Cochrane systematic review.
Evidence showing long-term effectiveness is also accruing, but too few of the existing trials have reported outcomes beyond 5 years, Dr. Abigail A. Ford of Bradford (England) Royal Infirmary and her colleagues from the Cochrane Incontinence Group reported.
The findings, based on a review of 81 trials involving a total of 12,113 women, were published July 1 (Cochrane Database Syst. Rev. 2015 [doi:10.1002/14651858.CD006375.pub3]).
Moderate-quality evidence indicates that the transobturator route and retropubic route provide similar rates of subjective and objective cure at up to 1 year (relative risk, 0.98 for both). Low-quality evidence suggests the subjective cure rates are similar with these two approaches at between 1 and 5 years (RR, 0.97), and moderate-quality evidence suggests the subjective cure rates are similar beyond 5 years with the two approaches (RR, 0.95), the investigators said.
Overall, about 80% of women undergoing surgery using either approach experience significant improvement in symptoms at up to 5 years after the surgery; that drops to about 70% after 5 years, based on the few studies that followed patients that long.
Although the overall adverse event rate was low, morbidity rates were higher with the retropubic route. For example, the rate of bladder perforation was 0.6% with the transobturator route vs. 4.5% with the retropubic route. Major vascular/visceral injury, mean operating time, operative blood loss, and hospital length of stay were all lower with the transobturator route. Further, voiding dysfunction was less common with the transobturator route (RR, 0.53).
Groin pain was more common in women in the transobturator vs. retropubic groups (6.4% vs. 1.3%), but suprapubic pain was less common (0.8% vs. 2.9%); both types of pain were of short duration.
The Cochrane investigators also found moderate-quality evidence for the following.
The overall rate of vaginal tape erosion, exposure, or extrusion was low (24 per 1,000 and 21 per 1,000 procedures for the transobturator and retropubic routes, respectively (RR, 1.13).
A retropubic bottom-to-top route was more effective than a top-to-bottom route for subjective cure (RR, 1.10).
Subjective cure rates in the short and mid term were similar when transobturator tape was passed using a medial-to-lateral or lateral-to-medial approach (RR, 1.00 and 1.06, respectively).
Voiding dysfunction was more common with the medial-to-lateral approach (RR, 1.74), but vaginal perforation was less frequent in the medial-to-lateral route (RR, 0.25).
It was unclear, due to very low-quality evidence, whether the lower rates of vaginal epithelial perforation affected vaginal tape erosion, the investigators noted.
The investigators reviewed the literature from 1947 up to June 2014, including only randomized and quasi-randomized controlled trials involving women with stress urinary incontinence, urodynamic stress incontinence, or mixed urinary incontinence, which contribute to up to 80% of cases of urinary incontinence.
They noted that concerns regarding mesh erosion are ongoing, but that the latest white paper and safety communications on meshes released by the Food and Drug Administration in 2011 “relates to ongoing concern with mesh used to treat pelvic organ prolapse and not the small strip of mesh/tape/sling used to treat SUI. In fact, the FDA states that the safety and effectiveness of midurethral slings is well established in clinical trials with 1-year follow-up.”
Overall, the current review highlights the positive impact that midurethral sling operations have on quality of life in women with stress urinary incontinence, but additional reporting of long-term outcomes is needed, the investigators wrote.
“We need to know more about what happens to women in the long term,” Dr. Joseph Ogah, one of the Cochrane investigators and a consultant gynecologist at the University Hospitals of Morecambe Bay NHS Foundation Trust in Cumbria, England, said in a statement. “This review found 35 trials carried out more than 5 years ago: If all the women in these trials were followed up, we would know much more about how long the operations last and, crucially, whether they had developed late but important side effects. Rather than starting any new trials in this area we need to obtain long-term follow-up from the existing trials.”
The review was supported by the National Institute for Health Research in the United Kingdom. Some of the review authors reported industry sponsorship to attend scientific conferences.
FROM THE COCHRANE DATABASE OF SYSTEMATIC REVIEWS
Key clinical point: Midurethral sling operations for stress urinary incontinence are safe and effective in the short and mid term.
Major finding: About 80% of women continue to experience significant improvement at up to 5 years.
Data source: A systematic review of the literature, including 81 studies involving 12,113 women.
Disclosures: The review was supported by the National Institute for Health Research in the United Kingdom. Some of the review authors reported industry sponsorship to attend scientific conferences.
Cuba eliminates mother-to-child transmission of HIV, syphilis
Cuba has become the first country to receive official validation from the World Health Organization that it has eliminated mother-to-child transmission of HIV and syphilis – an achievement that officials credit to a long-standing tradition of universal health care coverage and access in the island nation.
“This historic achievement was made possible by a health system that provides equitable, integrated health services based on primary health care that include difficult and complex interventions like those required for prevention of mother-to-child transmission of HIV and syphilis,” Dr. Carissa F. Etienne, director of the Pan American Health Organization (PAHO), WHO’s Regional Office of the Americas, said during a press briefing.
Cuba’s success demonstrates that universal access and universal health coverage are feasible and are, indeed, the key to success, even against challenges as daunting as HIV, she added.
Several other countries are also poised to request validation of the elimination of vertical HIV and syphilis transmission – defined as fewer than two cases of HIV in every 100 babies born to women with HIV and fewer than one case of syphilis for every 2,000 live births, according to Dr. Etienne.
Even some larger countries – including the United States and Canada – may have also achieved elimination of vertical transmission of HIV and syphilis, but they have not requested validation yet, she said.
The validation process is rigorous and requires a visit by an international panel of experts convened by PAHO/WHO; in Cuba, the panel spent several days visiting health centers, laboratories, and government offices, and also interviewed health officials and other key players, paying particular attention to human rights issues.
Validation requires that impact indicators (such as achieving fewer than 50 cases of new pediatric infections caused by mother-to-child transmissions per 100,000 live births and an HIV transmission rate of less than 5% in breastfeeding populations and less than 2% in non–breastfeeding populations) be met for at least a year. Additionally, process indicators, (95% of pregnant women receiving an antenatal visit, knowing their HIV status and/or being tested for syphilis, and receiving appropriate treatment) must be met for at least 2 years.
Cuba, which has been part of a regional initiative led by PAHO and WHO to eliminate vertical transmission of HIV and syphilis, achieved its goal by ensuring early access to prenatal care, HIV and syphilis testing for pregnant women and their partners, treatment for those who test positive and their babies, substitution of breastfeeding among those affected, and prevention of HIV and syphilis before and during pregnancy through promotion of condoms use and other measures.
Cuba, and any country that receives validation of elimination must maintain ongoing programs to ensure continued success.
Every year, an estimated 1.4 million women living with HIV become pregnant. If untreated, they have a 15%-45% chance of transmitting the virus to their children during pregnancy, labor, delivery, or breast-feeding. That risk drops to just over 1% if antiretroviral medicines are given to both mothers and children throughout the stages when infection can occur, according to PAHO/WHO, which noted in a press release that the number of children born annually with HIV has almost halved since 2009 – down from 400,000 to 240,000 in 2013.
However, stepped-up efforts will be needed to reach the global target of less than 40,000 new child infections per year.
“To achieve that, we need a final push to ensure that all pregnant women have access to sexual and reproductive health services that include HIV and syphilis testing and antiretroviral and penicillin treatment,” Dr. Etienne said. “Treatment is essential to save women’s lives, to clear maternal syphilis, and to reduce the chances that mothers will transmit these infections to their babies.”
Cuba has become the first country to receive official validation from the World Health Organization that it has eliminated mother-to-child transmission of HIV and syphilis – an achievement that officials credit to a long-standing tradition of universal health care coverage and access in the island nation.
“This historic achievement was made possible by a health system that provides equitable, integrated health services based on primary health care that include difficult and complex interventions like those required for prevention of mother-to-child transmission of HIV and syphilis,” Dr. Carissa F. Etienne, director of the Pan American Health Organization (PAHO), WHO’s Regional Office of the Americas, said during a press briefing.
Cuba’s success demonstrates that universal access and universal health coverage are feasible and are, indeed, the key to success, even against challenges as daunting as HIV, she added.
Several other countries are also poised to request validation of the elimination of vertical HIV and syphilis transmission – defined as fewer than two cases of HIV in every 100 babies born to women with HIV and fewer than one case of syphilis for every 2,000 live births, according to Dr. Etienne.
Even some larger countries – including the United States and Canada – may have also achieved elimination of vertical transmission of HIV and syphilis, but they have not requested validation yet, she said.
The validation process is rigorous and requires a visit by an international panel of experts convened by PAHO/WHO; in Cuba, the panel spent several days visiting health centers, laboratories, and government offices, and also interviewed health officials and other key players, paying particular attention to human rights issues.
Validation requires that impact indicators (such as achieving fewer than 50 cases of new pediatric infections caused by mother-to-child transmissions per 100,000 live births and an HIV transmission rate of less than 5% in breastfeeding populations and less than 2% in non–breastfeeding populations) be met for at least a year. Additionally, process indicators, (95% of pregnant women receiving an antenatal visit, knowing their HIV status and/or being tested for syphilis, and receiving appropriate treatment) must be met for at least 2 years.
Cuba, which has been part of a regional initiative led by PAHO and WHO to eliminate vertical transmission of HIV and syphilis, achieved its goal by ensuring early access to prenatal care, HIV and syphilis testing for pregnant women and their partners, treatment for those who test positive and their babies, substitution of breastfeeding among those affected, and prevention of HIV and syphilis before and during pregnancy through promotion of condoms use and other measures.
Cuba, and any country that receives validation of elimination must maintain ongoing programs to ensure continued success.
Every year, an estimated 1.4 million women living with HIV become pregnant. If untreated, they have a 15%-45% chance of transmitting the virus to their children during pregnancy, labor, delivery, or breast-feeding. That risk drops to just over 1% if antiretroviral medicines are given to both mothers and children throughout the stages when infection can occur, according to PAHO/WHO, which noted in a press release that the number of children born annually with HIV has almost halved since 2009 – down from 400,000 to 240,000 in 2013.
However, stepped-up efforts will be needed to reach the global target of less than 40,000 new child infections per year.
“To achieve that, we need a final push to ensure that all pregnant women have access to sexual and reproductive health services that include HIV and syphilis testing and antiretroviral and penicillin treatment,” Dr. Etienne said. “Treatment is essential to save women’s lives, to clear maternal syphilis, and to reduce the chances that mothers will transmit these infections to their babies.”
Cuba has become the first country to receive official validation from the World Health Organization that it has eliminated mother-to-child transmission of HIV and syphilis – an achievement that officials credit to a long-standing tradition of universal health care coverage and access in the island nation.
“This historic achievement was made possible by a health system that provides equitable, integrated health services based on primary health care that include difficult and complex interventions like those required for prevention of mother-to-child transmission of HIV and syphilis,” Dr. Carissa F. Etienne, director of the Pan American Health Organization (PAHO), WHO’s Regional Office of the Americas, said during a press briefing.
Cuba’s success demonstrates that universal access and universal health coverage are feasible and are, indeed, the key to success, even against challenges as daunting as HIV, she added.
Several other countries are also poised to request validation of the elimination of vertical HIV and syphilis transmission – defined as fewer than two cases of HIV in every 100 babies born to women with HIV and fewer than one case of syphilis for every 2,000 live births, according to Dr. Etienne.
Even some larger countries – including the United States and Canada – may have also achieved elimination of vertical transmission of HIV and syphilis, but they have not requested validation yet, she said.
The validation process is rigorous and requires a visit by an international panel of experts convened by PAHO/WHO; in Cuba, the panel spent several days visiting health centers, laboratories, and government offices, and also interviewed health officials and other key players, paying particular attention to human rights issues.
Validation requires that impact indicators (such as achieving fewer than 50 cases of new pediatric infections caused by mother-to-child transmissions per 100,000 live births and an HIV transmission rate of less than 5% in breastfeeding populations and less than 2% in non–breastfeeding populations) be met for at least a year. Additionally, process indicators, (95% of pregnant women receiving an antenatal visit, knowing their HIV status and/or being tested for syphilis, and receiving appropriate treatment) must be met for at least 2 years.
Cuba, which has been part of a regional initiative led by PAHO and WHO to eliminate vertical transmission of HIV and syphilis, achieved its goal by ensuring early access to prenatal care, HIV and syphilis testing for pregnant women and their partners, treatment for those who test positive and their babies, substitution of breastfeeding among those affected, and prevention of HIV and syphilis before and during pregnancy through promotion of condoms use and other measures.
Cuba, and any country that receives validation of elimination must maintain ongoing programs to ensure continued success.
Every year, an estimated 1.4 million women living with HIV become pregnant. If untreated, they have a 15%-45% chance of transmitting the virus to their children during pregnancy, labor, delivery, or breast-feeding. That risk drops to just over 1% if antiretroviral medicines are given to both mothers and children throughout the stages when infection can occur, according to PAHO/WHO, which noted in a press release that the number of children born annually with HIV has almost halved since 2009 – down from 400,000 to 240,000 in 2013.
However, stepped-up efforts will be needed to reach the global target of less than 40,000 new child infections per year.
“To achieve that, we need a final push to ensure that all pregnant women have access to sexual and reproductive health services that include HIV and syphilis testing and antiretroviral and penicillin treatment,” Dr. Etienne said. “Treatment is essential to save women’s lives, to clear maternal syphilis, and to reduce the chances that mothers will transmit these infections to their babies.”