From Baylor Scott & White Health.

Abstract

• Objective: To assess the impact of a community health worker–led diabetes education program (DEP) on hospital utilization trends and to evaluate the return on investment.
• Methods: A retrospective, pre-post study design was used to examine differences in inpatient and emergency department (ED) utilization and costs for DEP patients in the year prior to and following enrollment. Patients with diabetes who received care at the same clinics but who were not enrolled in DEP served as a control group. Analysis of covariance was used to test for differences in utilization outcomes between DEP patients and controls, controlling for age, sex, and ethnicity.
• Results: DEP patients had a significant reduction in mean inpatient encounters (0.08 vs. 0.18), LOS per inpatient encounter (0.28 vs. 0.67), and inpatient cost per patient ($406 vs. $902) following DEP enrollment. Patients in the control group also experienced a significant reduction in inpatient LOS and costs. Neither group experienced a significant difference in ED utilization or costs. Return on investment for DEP was –66%, as the annual cost savings generated per patient from reduced utilization ($137.19) were less than the annual DEP costs (investment) per patient ($402.80).
• Conclusion: CHW-led diabetes education programs like DEP may provide additional benefits than can be gained from access to primary care alone in terms of avoidance of costly hospitalizations for diabetes-related complications. Although the DEP did not generate an overall cost savings for the health care system in the short term, additional savings may be generated in the long term through reductions of diabetes-related complications.

Diabetes poses a significant burden on the population of the United States in terms of morbidity, mortality, and costs of care. Currently, 29.1 million people in the United States have diabetes [1], and it is expected that 1 in 3 people could have diabetes by the year 2050 [2]. The economic impact of diabetes is also significant; as of 2012, 1 in 5 health care dollars went towards diabetes care [3], and the total cost of diabetes was estimated to be $245 billion [1]. This rapid increase in the incidence of diabetes and associated costs emphasizes the need for cost-effective strategies to prevent and manage diabetes within the U.S. population.

One strategy that has shown success in improving diabetes care and outcomes is the use of community health workers (CHWs) to deliver disease education and management programs. A CHW is a front-line public health worker who is often a trusted member of the community and has the capacity to influence patient understanding, enhance patient compliance, and promote more equitable practices in patient care management [4–6]. Several studies have shown that CHW-led interventions in diabetes management can help patients achieve control over their disease and improved health indicators such as HbA1c, blood pressure, lipid levels, and weight [7–17]. In addition, a few studies have shown that CHW-led interventions for patients with diabetes can help these patients avoid costly health care utilization in the form of emergency department (ED) visits and hospitalizations. Fedder et al found that diabetes patients on Medicaid who worked closely with CHWs experienced a decrease in ED visits (38%), hospitalizations (30%), and hospital admissions from ED (53%) [11]. This CHW intervention was associated with improved patient quality of life and a cost-savings of $2245 per patient per year for a total savings of $262,080 for 117 patients. More recently, a 2010 randomized controlled trial showed that African-American patients with diabetes who worked with a nurse case manager and a CHW were 23% less likely to make ED visits than those who just had a nurse case manager [18].

Despite the documented successes of CHW programs, the CHW model has not been widely adopted within integrated health care systems. A major barrier to adoption of CHW programs has been the lack of sustained funding for CHW services [17,19]. Historically, many CHW programs were supported by grants, as most payers were unwilling to fund these initiatives [4,17,19.] In 2008, the Centers for Medicare and Medicaid Services provided a mechanism to support CHW activities by approving a Medicaid state plan amendment authorizing payment for CHWs who worked under Medicaid-approved providers, such as physicians and nurses [19]. However, the lack of data available regarding the costs, cost-effectiveness, and potential costs savings of CHW programs continues to serve as a barrier to adoption [13,20].

Baylor Scott & White Health North (BSWH), formerly Baylor Health Care System in Dallas, Texas, created the CHW-led Diabetes Equity Project, a 5-year program supported with funding from Merck Foundation’s Alliance to Reduce Disparities in Diabetes, with the goal of reducing observed disparities in diabetes care and outcomes in the medically underserved, predominantly Hispanic communities surrounding BSWH hospitals [16,21,22]. The program featured specially trained, bilingual CHWs who served as members of primary care teams in 5 community clinics and delivered a culturally relevant diabetes self-management and education curriculum (DSME) targeting barriers to diabetes management commonly experienced by Hispanics. The objective of this study was to assess the impact of a CHW-led diabetes educucation program (DEP) on hospital utilization trends and to evaluate the return on investment of the program.

Methods

Setting

BSWH is one of the largest nonprofit health care systems in the United States and includes 46 hospitals, > 800 patient care sites, > 6000 affiliated physicians, 35,000 employees, and an accountable care organization. This study was conducted in 5 community clinics located in the Dallas metroplex surrounding BSWH North hospitals. The community clinics serve low-income, uninsured, and chronically ill patients. The study was approved by the Baylor Research Institute institutional review board.

DEP Intervention

The DEP program consisted of 2 initial 60-minute educational sessions and quarterly clinical assessments scheduled for 30 to 60 minutes for a maximum of 6 patient-contact hours over 12 consecutive months. The DSME curriculum for DEP was adapted from CoDE, a pilot program implemented in a Dallas clinic serving a largely uninsured Mexican American population [23]. Patients who participated in CoDE for 12 months experienced a significant reduction in HbA1c [23,24]. During the 2 educational sessions, the CHWs educated DEP participants about diabetes and the importance of blood glucose control, medication adherence, diet, and exercise. In addition to the educational sessions, CHWs performed quarterly clinical assessments of HbA1c, blood pressure, weight, and foot condition (visual and monofilament assessment). They also assessed self-management behaviors and facilitated goal setting at each visit. The CHWs documented patient visits in the electronic health record and contacted the patient’s primary care provider immediately if the patient was symptomatic or had critical blood glucose or blood pressure measurements as defined by program protocol.

Participants

Study participants were recruited from the clinics or referred by Baylor care coordinators following hospital visits related to uncontrolled diabetes from September 2009 to July 2013. Participants had to be 18 years or older with a diagnosis of type 2 diabetes and be uninsured or underinsured. Although the program targeted Hispanic patients, all patients who met the inclusion criteria were eligible to participate. To control for internal threats to validity such as history and maturation biases, we created a control group consisting of clinic patients who had a diagnosis of diabetes and met the DEP inclusion criteria but who did not enroll in DEP.

Assessment

We used a retrospective pre-post study design to assess the impact of the DEP on hospital utilization trends and the program’s return on investment (ROI). The primary outcomes were number of hospital encounters, length of stay (LOS) per encounter, and direct cost per patient. The pre-enrollment period was defined as the year priod to the day of the initial DEP visit (the date of enrollment for DEP patients) or the initial clinic visit (the date of “enrollment” for control patients). All study participants were included in the analysis regardless of their number of inpatient or ED encounters. If a participant did not have a documented encounter during the analysis time period, encounters, LOS, and medical costs were set to zero. Patients with at least 2 HbA1c measurements taken during the first year post enrollment were included in the analysis.

Data Sources

Inpatient and emergency department (ED) utilization data were obtained from the Dallas Fort-Worth Hospital Council (DFWHC) database. The DFWHC captures administrative data from over 80 participating hospital systems and 9 million unique patients in North Texas. The DFWHC applied a matching algorithm using first and last name and date of birth to match study participants with encounter and length of stay detail for all hospitalizations across all DFWHC member hospitals. We obtained direct medical costs for patients treated at BSWH facilities from the BSWH Trendstar administrative database. Direct medical cost was not available for encounters at non-BSWH facilities so cost was estimated for these patients based on BSWH costs using a prediction model that accounted for LOS, primary ICD-9 diagnosis, patient age, sex, and race. The model explained approximately 66% of the variation in direct costs (R² = 0.6581).

Statistical Analysis

All analyses were performed in SAS V9.3 using an α level of 0.05. A 2-tailed independent samples t test was used to test the mean differences in utilization outcomes one year prior to and post program enrollment. An analysis of covariance (ANCOVA) was used to assess whether the mean change in utilization outcomes was greater for DEP patients than the control group, , after controlling for age, sex, and ethnicity. The gamma distribution with a log link function was used to model direct cost and the negative binomial distribution was used to model hospital encounters and LOS.

The ROI calculation included 2 components: DEP investment cost and risk-adjusted direct medical cost savings 1 year post program enrollment. DEP investment cost included the average yearly costs per community health worker, the fixed one-time start-up costs distributed across the length of the program (4 years), and the salaries of the 5 community health workers employed for the duration of the program. These costs were divided by the number of patients who enrolled in the DEP to calculate the per patient cost (investment). Direct medical cost savings were calculated as the mean reduction in hospitalization and ED costs per patient adjusted for age, sex, and ethnicity.

To account for DEP participants without encounter data, we estimated average cost savings in a 4-step process using a propensity score adjustment approach. We stratified encounters based on admission type (inpatient vs. ED) and combined the average cost savings calculated for both admission types to calculate mean total medical cost savings.

In the first step, direct cost was modeled on DEP participants with an encounter to obtain parameter estimates for pre- and post- program enrollment, age, sex, and ethnicity. The model was based on the log-link function with the gamma distribution. In the second step, we ran a propensity score logistic regression model to estimate the probability of any encounter being identified in the DFWHC database, adjusted for age, sex, ethnicity, and DEP clinic. In the third step, we generated 10,000 bootstrap samples, with replacement, to estimate the DEP population’s median expected change in cost. In the bootstrap sample, the parameter estimates from step 1 were used to predict the cost pre- and post- program enrollment for each patient. The expected change in cost per participant was then calculated, while adjusting for the propensity to have an encounter, estimated in step 2. The formula for calculating change in cost was Expected change in cost = [pre probability*pre cost – post probability*post cost].

In the final step, we retained the median cost savings from each bootstrap sample. Inpatient and ED cost savings were combined to produce a total cost savings across the patient population. The ROI formula was Financial gain (utilization cost savings – DEP investment)/DEP investment.

Results

Participant Demographics

Of the 1140 study participants, 878 were DEP patients and 262 were controls (Table 1). The majority of DEP patients were Hispanic females older than 40 years while the majority of the the control group was non-Hispanic males older than 40. Table 2 and Table 3 display the top 5 primary ICD-9 diagnoses by intervention group and pre/post enrollment status. Type 2 diabetes was the top diagnosis among DEP participants and controls with a pre-enrollment encounter. 

Inpatient Encounters

Fourteen percent of the DEP participants and 37% of control group patients matched to an inpatient record during the pre-enrollment time period. The number of mean inpatient encounters for DEP participants decreased from 0.18 to 0.08 (P < 0.001) in the post period 

Emergency Department Encounters

Eight percent of the DEP participants and 30% of controls matched to an ED record for the year prior to program enrollment. Neither DEP patients nor patients in the control group had a significant reduction in mean ED encounters (P = 0.88 and 0.74, respectively) or costs (P = 0.76 and 0.12, respectively) post enrollment.

The cost savings per DEP patient are shown in Table 5. The annual cost for a CHW to educate 1 DEP patient was $403. The combined inpatient and ED cost savings for DEP patients post-program enrollment was $137 per patient. ROI for the DEP was –66%, indicating that DEP investment costs were greater than the savings achieved through the reduction of inpatient and ED costs for DEP patients.

Discussion

In our examination of the impact of the DEP on inpatient and ED utilization, we found that DEP patients experienced a significant decrease in inpatient visits, LOS, and direct costs in the year following DEP enrollment. In comparison, a control group of patients who were treated at the same clinics as DEP patients also experienced significant decreases in inpatient LOS and direct costs. No significant differences in ED visits, LOS, or direct costs were observed for either DEP patients or control patients in the post period.

The reduction in inpatient visits and LOS for DEP patients in the year following DEP enrollment indicates that the DEP helped patients achieve improved health and avoid costly hospitalizations. The control group did experience greater reductions in inpatient utilization, LOS, and direct costs. However, because this was not designed as a controlled trial, we utilized a nonequivalent control group and inherent differences between the DEP and control patients and utilization patterns made it difficult to draw unbiased comparisons between the groups. For instance, the number of inpatient encounters, LOS, and costs were 2 to 3 times higher in the pre-period for the control group. The mean number of inpatient encounters for DEP patients prior to DEP participation was 0.18, and the smaller change observed in utilization for DEP patients is likely due to a floor effect.

Despite the observed reductions for both DEP patients and the control group in inpatient utilization, neither group had significant reductions in ED visits or costs per patient in the post- period. The majority of ED use in the pre-period may have been due to diabetes-related complications that are difficult to prevent even with improved diabetes care or for emergencies not related to diabetes, as we included all ED admissions regardless of admitting diagnosis. In addition, similar to observed trends in inpatient utilization, ED use in the pre-period was relatively low for DEP patients (0.16), and the lack of observed changes in ED utilization for DEP patients was also likely due to a floor effect.

The DEP generated a negative ROI (–66%) in the short term as the annual cost savings generated per patient from reduced utilization ($137) were less than the annual DEP costs (investment) per patient ($403). This finding is not surprising, as it is difficult to achieve cost savings for interventions designed to increase access to health care in underserved populations.[15] Although Fedder et al. observed an average savings of $2245 per patient per year in Medicaid reimbursements for a CHW-led outreach program for patients on Medicaid with diabetes, patients who participated in this program had much higher inpatient encounters (0.95 vs. 0.18) and ED utilization (1.49 vs. 0.16) at baseline compared to DEP patients. DEP patients may not have been as sick as these patients or have been more reluctant to seek medical care due to their lack of insurance. In addition, Fedder et al did not factor in the costs of the CHW program in the cost savings calculation. However, these costs were likely to be much lower than the costs of the DEP, as the program relied on volunteer CHWs instead of paid CHWs who were also certified medical assistants.

Several studies have evaluated the cost-effectiveness of CHW-led diabetes management programs rather than the ROI as these types of programs are often associated with improved health outcomes but also increased health care costs as the result of expanding health care access and services to underserved populations [15,25–29]. Most of these evaluations modeled the long-term cost-effectiveness, as the majority of cost savings from diabetes management programs are likely to accrue in the long run as a result of the prevention of diabetes-related complications such as amputations, blindness, kidney failure, coronary heart disease, and stroke [15,25]. Although these CHW-led interventions for diabetes differed in scope, the incremental cost effectiveness ratios for these interventions were less than the common willingness-to-pay threshold of $50,000 per quality-adjusted life year (QALY). These studies may have underestimated the societal benefits of these programs as they did not incorporate non-medical cost savings such as those that may be attributed to gains in productivity [26].

A recent cost-effectiveness analysis of the DEP and the 4 other programs that were part of the Alliance to Reduce Disparities in Diabetes found that these programs spent an average of $975 per patient in the first year and additional $520 per patient in subsequent years to improve care for diabetes patients [15]. Based on improvements in health indicators such as HbA1c, systolic blood pressure, and total cholesterol observed for participants in Alliance programs, the incremental cost-effectiveness ratio of these programs was $23,161 per QALY given the optimistic assumption that the observed improvements in health indicators were all attributable to the interventions. DEP patients achieved a 1% average reduction in mean HbA1c and this improvement was sustained over the course of the program. The UK Prospective Diabetes Study Group found that every 1% reduction in HbA1C reduces a patient’s risk of developing eye, kidney, and nerve disease by 40% and the risk of heart attack by 14% [30]. Thus, if DEP patients sustain improvements gained as a result of program participation, they may avoid serious and expensive medical complications in the future.

Ultimately, the goal of the DEP was to provide patients with improved access to diabetes care and to help them achieve improved glucose control. Improving access to chronic disease care is costly. However, employment of CHWs is a less costly alternative to employing additional clinicians, and CHWs may be more effective in assisting patients with chronic disease management particularly those from underserved and vulnerable populations. Although we did not generate a positive ROI for the DEP in this short-term analysis, the program is likely cost-effective when the low cost of the program is compared with the improvements in health outcomes we have observed.

This study had several limitations. There were observed differences in gender and ethnicity between the intervention and control groups and it is likely that risk-adjustment (including propensity scoring) did not fully accountfor underlying differences between the populations. The observed reductions in inpatient utilization and costs in the intervention group may have been due to other factors besides the DEP as the control group also achieved reductions in inpatient LOS and costs. The control group did contain a few outliers in terms of high pre-period medical costs which were retained in the analysis and these outliers may have caused reductions in costs for this group to be overstated. The observed outcomes may also be biased due to intervention contamination. Patients in the control group attended the same clinics as DEP patients and were treated by the same primary care physicians. The primary care physicians likely applied the knowledge gained from working with DEP patients and the CHWs, including how to identify and help patients address the specific barriers to diabetes self-management faced by clinic patients, to the treatment of patients who were not enrolled in the DEP. The fact that health care utilization and costs were much higher for patients in the control group in the pre-period indicates that these patients had greater severity of illness and additional comorbidities, and the observed reductions in utilization and costs for these patients may have been the result of obtaining access to a regular source of primary care through the clinics. However, the observed decrease in inpatient encounters from .18 to .08 in the post period for DEP patients as well as the observed decreases in inpatient LOS and direct costs indicate that the DEP may provide additional benefits compared to access to primary care alone in terms of avoidance costly hospitalizations for diabetes-related complications.

Conclusion

From the health care system perspective, CHW-led diabetes education programs like the DEP may provide additional benefits than can be gained from access to primary care alone in terms of avoidance of costly hospitalizations for diabetes-related complications. Although the costs of the DEP were greater than the savings it generated through reduced inpatient utilization and costs in the short term, additional savings to the health care system or society may be generated in the long term through reductions of diabetes-related complications in patients who were able to achieve improved glycemic control through program participation. More importantly, the improvements in glycemic control achieved by DEP patients can lead to both short and long term gains in overall health and quality of life.

Corresponding author: Ashley Collinsworth, ScD, MPH, Scott & White Health, Center for Clinical Effectiveness, Dallas, TX 75206, [email protected].

Funding/support: This program/initiative was supported by a grant from the Merck Company Foundation through its Merck Alliance to Reduce Disparities in Diabetes program.

From Baylor Scott & White Health.

Abstract

• Objective: To assess the impact of a community health worker–led diabetes education program (DEP) on hospital utilization trends and to evaluate the return on investment.
• Methods: A retrospective, pre-post study design was used to examine differences in inpatient and emergency department (ED) utilization and costs for DEP patients in the year prior to and following enrollment. Patients with diabetes who received care at the same clinics but who were not enrolled in DEP served as a control group. Analysis of covariance was used to test for differences in utilization outcomes between DEP patients and controls, controlling for age, sex, and ethnicity.
• Results: DEP patients had a significant reduction in mean inpatient encounters (0.08 vs. 0.18), LOS per inpatient encounter (0.28 vs. 0.67), and inpatient cost per patient ($406 vs. $902) following DEP enrollment. Patients in the control group also experienced a significant reduction in inpatient LOS and costs. Neither group experienced a significant difference in ED utilization or costs. Return on investment for DEP was –66%, as the annual cost savings generated per patient from reduced utilization ($137.19) were less than the annual DEP costs (investment) per patient ($402.80).
• Conclusion: CHW-led diabetes education programs like DEP may provide additional benefits than can be gained from access to primary care alone in terms of avoidance of costly hospitalizations for diabetes-related complications. Although the DEP did not generate an overall cost savings for the health care system in the short term, additional savings may be generated in the long term through reductions of diabetes-related complications.

Diabetes poses a significant burden on the population of the United States in terms of morbidity, mortality, and costs of care. Currently, 29.1 million people in the United States have diabetes [1], and it is expected that 1 in 3 people could have diabetes by the year 2050 [2]. The economic impact of diabetes is also significant; as of 2012, 1 in 5 health care dollars went towards diabetes care [3], and the total cost of diabetes was estimated to be $245 billion [1]. This rapid increase in the incidence of diabetes and associated costs emphasizes the need for cost-effective strategies to prevent and manage diabetes within the U.S. population.

One strategy that has shown success in improving diabetes care and outcomes is the use of community health workers (CHWs) to deliver disease education and management programs. A CHW is a front-line public health worker who is often a trusted member of the community and has the capacity to influence patient understanding, enhance patient compliance, and promote more equitable practices in patient care management [4–6]. Several studies have shown that CHW-led interventions in diabetes management can help patients achieve control over their disease and improved health indicators such as HbA1c, blood pressure, lipid levels, and weight [7–17]. In addition, a few studies have shown that CHW-led interventions for patients with diabetes can help these patients avoid costly health care utilization in the form of emergency department (ED) visits and hospitalizations. Fedder et al found that diabetes patients on Medicaid who worked closely with CHWs experienced a decrease in ED visits (38%), hospitalizations (30%), and hospital admissions from ED (53%) [11]. This CHW intervention was associated with improved patient quality of life and a cost-savings of $2245 per patient per year for a total savings of $262,080 for 117 patients. More recently, a 2010 randomized controlled trial showed that African-American patients with diabetes who worked with a nurse case manager and a CHW were 23% less likely to make ED visits than those who just had a nurse case manager [18].

Despite the documented successes of CHW programs, the CHW model has not been widely adopted within integrated health care systems. A major barrier to adoption of CHW programs has been the lack of sustained funding for CHW services [17,19]. Historically, many CHW programs were supported by grants, as most payers were unwilling to fund these initiatives [4,17,19.] In 2008, the Centers for Medicare and Medicaid Services provided a mechanism to support CHW activities by approving a Medicaid state plan amendment authorizing payment for CHWs who worked under Medicaid-approved providers, such as physicians and nurses [19]. However, the lack of data available regarding the costs, cost-effectiveness, and potential costs savings of CHW programs continues to serve as a barrier to adoption [13,20].

Baylor Scott & White Health North (BSWH), formerly Baylor Health Care System in Dallas, Texas, created the CHW-led Diabetes Equity Project, a 5-year program supported with funding from Merck Foundation’s Alliance to Reduce Disparities in Diabetes, with the goal of reducing observed disparities in diabetes care and outcomes in the medically underserved, predominantly Hispanic communities surrounding BSWH hospitals [16,21,22]. The program featured specially trained, bilingual CHWs who served as members of primary care teams in 5 community clinics and delivered a culturally relevant diabetes self-management and education curriculum (DSME) targeting barriers to diabetes management commonly experienced by Hispanics. The objective of this study was to assess the impact of a CHW-led diabetes educucation program (DEP) on hospital utilization trends and to evaluate the return on investment of the program.

Methods

Setting

BSWH is one of the largest nonprofit health care systems in the United States and includes 46 hospitals, > 800 patient care sites, > 6000 affiliated physicians, 35,000 employees, and an accountable care organization. This study was conducted in 5 community clinics located in the Dallas metroplex surrounding BSWH North hospitals. The community clinics serve low-income, uninsured, and chronically ill patients. The study was approved by the Baylor Research Institute institutional review board.

DEP Intervention

The DEP program consisted of 2 initial 60-minute educational sessions and quarterly clinical assessments scheduled for 30 to 60 minutes for a maximum of 6 patient-contact hours over 12 consecutive months. The DSME curriculum for DEP was adapted from CoDE, a pilot program implemented in a Dallas clinic serving a largely uninsured Mexican American population [23]. Patients who participated in CoDE for 12 months experienced a significant reduction in HbA1c [23,24]. During the 2 educational sessions, the CHWs educated DEP participants about diabetes and the importance of blood glucose control, medication adherence, diet, and exercise. In addition to the educational sessions, CHWs performed quarterly clinical assessments of HbA1c, blood pressure, weight, and foot condition (visual and monofilament assessment). They also assessed self-management behaviors and facilitated goal setting at each visit. The CHWs documented patient visits in the electronic health record and contacted the patient’s primary care provider immediately if the patient was symptomatic or had critical blood glucose or blood pressure measurements as defined by program protocol.

Participants

Study participants were recruited from the clinics or referred by Baylor care coordinators following hospital visits related to uncontrolled diabetes from September 2009 to July 2013. Participants had to be 18 years or older with a diagnosis of type 2 diabetes and be uninsured or underinsured. Although the program targeted Hispanic patients, all patients who met the inclusion criteria were eligible to participate. To control for internal threats to validity such as history and maturation biases, we created a control group consisting of clinic patients who had a diagnosis of diabetes and met the DEP inclusion criteria but who did not enroll in DEP.

Assessment

We used a retrospective pre-post study design to assess the impact of the DEP on hospital utilization trends and the program’s return on investment (ROI). The primary outcomes were number of hospital encounters, length of stay (LOS) per encounter, and direct cost per patient. The pre-enrollment period was defined as the year priod to the day of the initial DEP visit (the date of enrollment for DEP patients) or the initial clinic visit (the date of “enrollment” for control patients). All study participants were included in the analysis regardless of their number of inpatient or ED encounters. If a participant did not have a documented encounter during the analysis time period, encounters, LOS, and medical costs were set to zero. Patients with at least 2 HbA1c measurements taken during the first year post enrollment were included in the analysis.

Data Sources

Inpatient and emergency department (ED) utilization data were obtained from the Dallas Fort-Worth Hospital Council (DFWHC) database. The DFWHC captures administrative data from over 80 participating hospital systems and 9 million unique patients in North Texas. The DFWHC applied a matching algorithm using first and last name and date of birth to match study participants with encounter and length of stay detail for all hospitalizations across all DFWHC member hospitals. We obtained direct medical costs for patients treated at BSWH facilities from the BSWH Trendstar administrative database. Direct medical cost was not available for encounters at non-BSWH facilities so cost was estimated for these patients based on BSWH costs using a prediction model that accounted for LOS, primary ICD-9 diagnosis, patient age, sex, and race. The model explained approximately 66% of the variation in direct costs (R² = 0.6581).

Statistical Analysis

All analyses were performed in SAS V9.3 using an α level of 0.05. A 2-tailed independent samples t test was used to test the mean differences in utilization outcomes one year prior to and post program enrollment. An analysis of covariance (ANCOVA) was used to assess whether the mean change in utilization outcomes was greater for DEP patients than the control group, , after controlling for age, sex, and ethnicity. The gamma distribution with a log link function was used to model direct cost and the negative binomial distribution was used to model hospital encounters and LOS.

The ROI calculation included 2 components: DEP investment cost and risk-adjusted direct medical cost savings 1 year post program enrollment. DEP investment cost included the average yearly costs per community health worker, the fixed one-time start-up costs distributed across the length of the program (4 years), and the salaries of the 5 community health workers employed for the duration of the program. These costs were divided by the number of patients who enrolled in the DEP to calculate the per patient cost (investment). Direct medical cost savings were calculated as the mean reduction in hospitalization and ED costs per patient adjusted for age, sex, and ethnicity.

To account for DEP participants without encounter data, we estimated average cost savings in a 4-step process using a propensity score adjustment approach. We stratified encounters based on admission type (inpatient vs. ED) and combined the average cost savings calculated for both admission types to calculate mean total medical cost savings.

In the first step, direct cost was modeled on DEP participants with an encounter to obtain parameter estimates for pre- and post- program enrollment, age, sex, and ethnicity. The model was based on the log-link function with the gamma distribution. In the second step, we ran a propensity score logistic regression model to estimate the probability of any encounter being identified in the DFWHC database, adjusted for age, sex, ethnicity, and DEP clinic. In the third step, we generated 10,000 bootstrap samples, with replacement, to estimate the DEP population’s median expected change in cost. In the bootstrap sample, the parameter estimates from step 1 were used to predict the cost pre- and post- program enrollment for each patient. The expected change in cost per participant was then calculated, while adjusting for the propensity to have an encounter, estimated in step 2. The formula for calculating change in cost was Expected change in cost = [pre probability*pre cost – post probability*post cost].

In the final step, we retained the median cost savings from each bootstrap sample. Inpatient and ED cost savings were combined to produce a total cost savings across the patient population. The ROI formula was Financial gain (utilization cost savings – DEP investment)/DEP investment.

Results

Participant Demographics

Of the 1140 study participants, 878 were DEP patients and 262 were controls (Table 1). The majority of DEP patients were Hispanic females older than 40 years while the majority of the the control group was non-Hispanic males older than 40. Table 2 and Table 3 display the top 5 primary ICD-9 diagnoses by intervention group and pre/post enrollment status. Type 2 diabetes was the top diagnosis among DEP participants and controls with a pre-enrollment encounter. 

Inpatient Encounters

Fourteen percent of the DEP participants and 37% of control group patients matched to an inpatient record during the pre-enrollment time period. The number of mean inpatient encounters for DEP participants decreased from 0.18 to 0.08 (P < 0.001) in the post period 

Emergency Department Encounters

Eight percent of the DEP participants and 30% of controls matched to an ED record for the year prior to program enrollment. Neither DEP patients nor patients in the control group had a significant reduction in mean ED encounters (P = 0.88 and 0.74, respectively) or costs (P = 0.76 and 0.12, respectively) post enrollment.

The cost savings per DEP patient are shown in Table 5. The annual cost for a CHW to educate 1 DEP patient was $403. The combined inpatient and ED cost savings for DEP patients post-program enrollment was $137 per patient. ROI for the DEP was –66%, indicating that DEP investment costs were greater than the savings achieved through the reduction of inpatient and ED costs for DEP patients.

Discussion

In our examination of the impact of the DEP on inpatient and ED utilization, we found that DEP patients experienced a significant decrease in inpatient visits, LOS, and direct costs in the year following DEP enrollment. In comparison, a control group of patients who were treated at the same clinics as DEP patients also experienced significant decreases in inpatient LOS and direct costs. No significant differences in ED visits, LOS, or direct costs were observed for either DEP patients or control patients in the post period.

The reduction in inpatient visits and LOS for DEP patients in the year following DEP enrollment indicates that the DEP helped patients achieve improved health and avoid costly hospitalizations. The control group did experience greater reductions in inpatient utilization, LOS, and direct costs. However, because this was not designed as a controlled trial, we utilized a nonequivalent control group and inherent differences between the DEP and control patients and utilization patterns made it difficult to draw unbiased comparisons between the groups. For instance, the number of inpatient encounters, LOS, and costs were 2 to 3 times higher in the pre-period for the control group. The mean number of inpatient encounters for DEP patients prior to DEP participation was 0.18, and the smaller change observed in utilization for DEP patients is likely due to a floor effect.

Despite the observed reductions for both DEP patients and the control group in inpatient utilization, neither group had significant reductions in ED visits or costs per patient in the post- period. The majority of ED use in the pre-period may have been due to diabetes-related complications that are difficult to prevent even with improved diabetes care or for emergencies not related to diabetes, as we included all ED admissions regardless of admitting diagnosis. In addition, similar to observed trends in inpatient utilization, ED use in the pre-period was relatively low for DEP patients (0.16), and the lack of observed changes in ED utilization for DEP patients was also likely due to a floor effect.

The DEP generated a negative ROI (–66%) in the short term as the annual cost savings generated per patient from reduced utilization ($137) were less than the annual DEP costs (investment) per patient ($403). This finding is not surprising, as it is difficult to achieve cost savings for interventions designed to increase access to health care in underserved populations.[15] Although Fedder et al. observed an average savings of $2245 per patient per year in Medicaid reimbursements for a CHW-led outreach program for patients on Medicaid with diabetes, patients who participated in this program had much higher inpatient encounters (0.95 vs. 0.18) and ED utilization (1.49 vs. 0.16) at baseline compared to DEP patients. DEP patients may not have been as sick as these patients or have been more reluctant to seek medical care due to their lack of insurance. In addition, Fedder et al did not factor in the costs of the CHW program in the cost savings calculation. However, these costs were likely to be much lower than the costs of the DEP, as the program relied on volunteer CHWs instead of paid CHWs who were also certified medical assistants.

Several studies have evaluated the cost-effectiveness of CHW-led diabetes management programs rather than the ROI as these types of programs are often associated with improved health outcomes but also increased health care costs as the result of expanding health care access and services to underserved populations [15,25–29]. Most of these evaluations modeled the long-term cost-effectiveness, as the majority of cost savings from diabetes management programs are likely to accrue in the long run as a result of the prevention of diabetes-related complications such as amputations, blindness, kidney failure, coronary heart disease, and stroke [15,25]. Although these CHW-led interventions for diabetes differed in scope, the incremental cost effectiveness ratios for these interventions were less than the common willingness-to-pay threshold of $50,000 per quality-adjusted life year (QALY). These studies may have underestimated the societal benefits of these programs as they did not incorporate non-medical cost savings such as those that may be attributed to gains in productivity [26].

A recent cost-effectiveness analysis of the DEP and the 4 other programs that were part of the Alliance to Reduce Disparities in Diabetes found that these programs spent an average of $975 per patient in the first year and additional $520 per patient in subsequent years to improve care for diabetes patients [15]. Based on improvements in health indicators such as HbA1c, systolic blood pressure, and total cholesterol observed for participants in Alliance programs, the incremental cost-effectiveness ratio of these programs was $23,161 per QALY given the optimistic assumption that the observed improvements in health indicators were all attributable to the interventions. DEP patients achieved a 1% average reduction in mean HbA1c and this improvement was sustained over the course of the program. The UK Prospective Diabetes Study Group found that every 1% reduction in HbA1C reduces a patient’s risk of developing eye, kidney, and nerve disease by 40% and the risk of heart attack by 14% [30]. Thus, if DEP patients sustain improvements gained as a result of program participation, they may avoid serious and expensive medical complications in the future.

Ultimately, the goal of the DEP was to provide patients with improved access to diabetes care and to help them achieve improved glucose control. Improving access to chronic disease care is costly. However, employment of CHWs is a less costly alternative to employing additional clinicians, and CHWs may be more effective in assisting patients with chronic disease management particularly those from underserved and vulnerable populations. Although we did not generate a positive ROI for the DEP in this short-term analysis, the program is likely cost-effective when the low cost of the program is compared with the improvements in health outcomes we have observed.

This study had several limitations. There were observed differences in gender and ethnicity between the intervention and control groups and it is likely that risk-adjustment (including propensity scoring) did not fully accountfor underlying differences between the populations. The observed reductions in inpatient utilization and costs in the intervention group may have been due to other factors besides the DEP as the control group also achieved reductions in inpatient LOS and costs. The control group did contain a few outliers in terms of high pre-period medical costs which were retained in the analysis and these outliers may have caused reductions in costs for this group to be overstated. The observed outcomes may also be biased due to intervention contamination. Patients in the control group attended the same clinics as DEP patients and were treated by the same primary care physicians. The primary care physicians likely applied the knowledge gained from working with DEP patients and the CHWs, including how to identify and help patients address the specific barriers to diabetes self-management faced by clinic patients, to the treatment of patients who were not enrolled in the DEP. The fact that health care utilization and costs were much higher for patients in the control group in the pre-period indicates that these patients had greater severity of illness and additional comorbidities, and the observed reductions in utilization and costs for these patients may have been the result of obtaining access to a regular source of primary care through the clinics. However, the observed decrease in inpatient encounters from .18 to .08 in the post period for DEP patients as well as the observed decreases in inpatient LOS and direct costs indicate that the DEP may provide additional benefits compared to access to primary care alone in terms of avoidance costly hospitalizations for diabetes-related complications.

Conclusion

From the health care system perspective, CHW-led diabetes education programs like the DEP may provide additional benefits than can be gained from access to primary care alone in terms of avoidance of costly hospitalizations for diabetes-related complications. Although the costs of the DEP were greater than the savings it generated through reduced inpatient utilization and costs in the short term, additional savings to the health care system or society may be generated in the long term through reductions of diabetes-related complications in patients who were able to achieve improved glycemic control through program participation. More importantly, the improvements in glycemic control achieved by DEP patients can lead to both short and long term gains in overall health and quality of life.

Corresponding author: Ashley Collinsworth, ScD, MPH, Scott & White Health, Center for Clinical Effectiveness, Dallas, TX 75206, [email protected].

Funding/support: This program/initiative was supported by a grant from the Merck Company Foundation through its Merck Alliance to Reduce Disparities in Diabetes program.

From Baylor Scott & White Health.

Abstract

• Objective: To assess the impact of a community health worker–led diabetes education program (DEP) on hospital utilization trends and to evaluate the return on investment.
• Methods: A retrospective, pre-post study design was used to examine differences in inpatient and emergency department (ED) utilization and costs for DEP patients in the year prior to and following enrollment. Patients with diabetes who received care at the same clinics but who were not enrolled in DEP served as a control group. Analysis of covariance was used to test for differences in utilization outcomes between DEP patients and controls, controlling for age, sex, and ethnicity.
• Results: DEP patients had a significant reduction in mean inpatient encounters (0.08 vs. 0.18), LOS per inpatient encounter (0.28 vs. 0.67), and inpatient cost per patient ($406 vs. $902) following DEP enrollment. Patients in the control group also experienced a significant reduction in inpatient LOS and costs. Neither group experienced a significant difference in ED utilization or costs. Return on investment for DEP was –66%, as the annual cost savings generated per patient from reduced utilization ($137.19) were less than the annual DEP costs (investment) per patient ($402.80).
• Conclusion: CHW-led diabetes education programs like DEP may provide additional benefits than can be gained from access to primary care alone in terms of avoidance of costly hospitalizations for diabetes-related complications. Although the DEP did not generate an overall cost savings for the health care system in the short term, additional savings may be generated in the long term through reductions of diabetes-related complications.

Diabetes poses a significant burden on the population of the United States in terms of morbidity, mortality, and costs of care. Currently, 29.1 million people in the United States have diabetes [1], and it is expected that 1 in 3 people could have diabetes by the year 2050 [2]. The economic impact of diabetes is also significant; as of 2012, 1 in 5 health care dollars went towards diabetes care [3], and the total cost of diabetes was estimated to be $245 billion [1]. This rapid increase in the incidence of diabetes and associated costs emphasizes the need for cost-effective strategies to prevent and manage diabetes within the U.S. population.

One strategy that has shown success in improving diabetes care and outcomes is the use of community health workers (CHWs) to deliver disease education and management programs. A CHW is a front-line public health worker who is often a trusted member of the community and has the capacity to influence patient understanding, enhance patient compliance, and promote more equitable practices in patient care management [4–6]. Several studies have shown that CHW-led interventions in diabetes management can help patients achieve control over their disease and improved health indicators such as HbA1c, blood pressure, lipid levels, and weight [7–17]. In addition, a few studies have shown that CHW-led interventions for patients with diabetes can help these patients avoid costly health care utilization in the form of emergency department (ED) visits and hospitalizations. Fedder et al found that diabetes patients on Medicaid who worked closely with CHWs experienced a decrease in ED visits (38%), hospitalizations (30%), and hospital admissions from ED (53%) [11]. This CHW intervention was associated with improved patient quality of life and a cost-savings of $2245 per patient per year for a total savings of $262,080 for 117 patients. More recently, a 2010 randomized controlled trial showed that African-American patients with diabetes who worked with a nurse case manager and a CHW were 23% less likely to make ED visits than those who just had a nurse case manager [18].

Despite the documented successes of CHW programs, the CHW model has not been widely adopted within integrated health care systems. A major barrier to adoption of CHW programs has been the lack of sustained funding for CHW services [17,19]. Historically, many CHW programs were supported by grants, as most payers were unwilling to fund these initiatives [4,17,19.] In 2008, the Centers for Medicare and Medicaid Services provided a mechanism to support CHW activities by approving a Medicaid state plan amendment authorizing payment for CHWs who worked under Medicaid-approved providers, such as physicians and nurses [19]. However, the lack of data available regarding the costs, cost-effectiveness, and potential costs savings of CHW programs continues to serve as a barrier to adoption [13,20].

Baylor Scott & White Health North (BSWH), formerly Baylor Health Care System in Dallas, Texas, created the CHW-led Diabetes Equity Project, a 5-year program supported with funding from Merck Foundation’s Alliance to Reduce Disparities in Diabetes, with the goal of reducing observed disparities in diabetes care and outcomes in the medically underserved, predominantly Hispanic communities surrounding BSWH hospitals [16,21,22]. The program featured specially trained, bilingual CHWs who served as members of primary care teams in 5 community clinics and delivered a culturally relevant diabetes self-management and education curriculum (DSME) targeting barriers to diabetes management commonly experienced by Hispanics. The objective of this study was to assess the impact of a CHW-led diabetes educucation program (DEP) on hospital utilization trends and to evaluate the return on investment of the program.

Methods

Setting

BSWH is one of the largest nonprofit health care systems in the United States and includes 46 hospitals, > 800 patient care sites, > 6000 affiliated physicians, 35,000 employees, and an accountable care organization. This study was conducted in 5 community clinics located in the Dallas metroplex surrounding BSWH North hospitals. The community clinics serve low-income, uninsured, and chronically ill patients. The study was approved by the Baylor Research Institute institutional review board.

DEP Intervention

The DEP program consisted of 2 initial 60-minute educational sessions and quarterly clinical assessments scheduled for 30 to 60 minutes for a maximum of 6 patient-contact hours over 12 consecutive months. The DSME curriculum for DEP was adapted from CoDE, a pilot program implemented in a Dallas clinic serving a largely uninsured Mexican American population [23]. Patients who participated in CoDE for 12 months experienced a significant reduction in HbA1c [23,24]. During the 2 educational sessions, the CHWs educated DEP participants about diabetes and the importance of blood glucose control, medication adherence, diet, and exercise. In addition to the educational sessions, CHWs performed quarterly clinical assessments of HbA1c, blood pressure, weight, and foot condition (visual and monofilament assessment). They also assessed self-management behaviors and facilitated goal setting at each visit. The CHWs documented patient visits in the electronic health record and contacted the patient’s primary care provider immediately if the patient was symptomatic or had critical blood glucose or blood pressure measurements as defined by program protocol.

Participants

Study participants were recruited from the clinics or referred by Baylor care coordinators following hospital visits related to uncontrolled diabetes from September 2009 to July 2013. Participants had to be 18 years or older with a diagnosis of type 2 diabetes and be uninsured or underinsured. Although the program targeted Hispanic patients, all patients who met the inclusion criteria were eligible to participate. To control for internal threats to validity such as history and maturation biases, we created a control group consisting of clinic patients who had a diagnosis of diabetes and met the DEP inclusion criteria but who did not enroll in DEP.

Assessment

We used a retrospective pre-post study design to assess the impact of the DEP on hospital utilization trends and the program’s return on investment (ROI). The primary outcomes were number of hospital encounters, length of stay (LOS) per encounter, and direct cost per patient. The pre-enrollment period was defined as the year priod to the day of the initial DEP visit (the date of enrollment for DEP patients) or the initial clinic visit (the date of “enrollment” for control patients). All study participants were included in the analysis regardless of their number of inpatient or ED encounters. If a participant did not have a documented encounter during the analysis time period, encounters, LOS, and medical costs were set to zero. Patients with at least 2 HbA1c measurements taken during the first year post enrollment were included in the analysis.

Data Sources

Inpatient and emergency department (ED) utilization data were obtained from the Dallas Fort-Worth Hospital Council (DFWHC) database. The DFWHC captures administrative data from over 80 participating hospital systems and 9 million unique patients in North Texas. The DFWHC applied a matching algorithm using first and last name and date of birth to match study participants with encounter and length of stay detail for all hospitalizations across all DFWHC member hospitals. We obtained direct medical costs for patients treated at BSWH facilities from the BSWH Trendstar administrative database. Direct medical cost was not available for encounters at non-BSWH facilities so cost was estimated for these patients based on BSWH costs using a prediction model that accounted for LOS, primary ICD-9 diagnosis, patient age, sex, and race. The model explained approximately 66% of the variation in direct costs (R² = 0.6581).

Statistical Analysis

All analyses were performed in SAS V9.3 using an α level of 0.05. A 2-tailed independent samples t test was used to test the mean differences in utilization outcomes one year prior to and post program enrollment. An analysis of covariance (ANCOVA) was used to assess whether the mean change in utilization outcomes was greater for DEP patients than the control group, , after controlling for age, sex, and ethnicity. The gamma distribution with a log link function was used to model direct cost and the negative binomial distribution was used to model hospital encounters and LOS.

The ROI calculation included 2 components: DEP investment cost and risk-adjusted direct medical cost savings 1 year post program enrollment. DEP investment cost included the average yearly costs per community health worker, the fixed one-time start-up costs distributed across the length of the program (4 years), and the salaries of the 5 community health workers employed for the duration of the program. These costs were divided by the number of patients who enrolled in the DEP to calculate the per patient cost (investment). Direct medical cost savings were calculated as the mean reduction in hospitalization and ED costs per patient adjusted for age, sex, and ethnicity.

To account for DEP participants without encounter data, we estimated average cost savings in a 4-step process using a propensity score adjustment approach. We stratified encounters based on admission type (inpatient vs. ED) and combined the average cost savings calculated for both admission types to calculate mean total medical cost savings.

In the first step, direct cost was modeled on DEP participants with an encounter to obtain parameter estimates for pre- and post- program enrollment, age, sex, and ethnicity. The model was based on the log-link function with the gamma distribution. In the second step, we ran a propensity score logistic regression model to estimate the probability of any encounter being identified in the DFWHC database, adjusted for age, sex, ethnicity, and DEP clinic. In the third step, we generated 10,000 bootstrap samples, with replacement, to estimate the DEP population’s median expected change in cost. In the bootstrap sample, the parameter estimates from step 1 were used to predict the cost pre- and post- program enrollment for each patient. The expected change in cost per participant was then calculated, while adjusting for the propensity to have an encounter, estimated in step 2. The formula for calculating change in cost was Expected change in cost = [pre probability*pre cost – post probability*post cost].

In the final step, we retained the median cost savings from each bootstrap sample. Inpatient and ED cost savings were combined to produce a total cost savings across the patient population. The ROI formula was Financial gain (utilization cost savings – DEP investment)/DEP investment.

Results

Participant Demographics

Of the 1140 study participants, 878 were DEP patients and 262 were controls (Table 1). The majority of DEP patients were Hispanic females older than 40 years while the majority of the the control group was non-Hispanic males older than 40. Table 2 and Table 3 display the top 5 primary ICD-9 diagnoses by intervention group and pre/post enrollment status. Type 2 diabetes was the top diagnosis among DEP participants and controls with a pre-enrollment encounter. 

Inpatient Encounters

Fourteen percent of the DEP participants and 37% of control group patients matched to an inpatient record during the pre-enrollment time period. The number of mean inpatient encounters for DEP participants decreased from 0.18 to 0.08 (P < 0.001) in the post period 

Emergency Department Encounters

Eight percent of the DEP participants and 30% of controls matched to an ED record for the year prior to program enrollment. Neither DEP patients nor patients in the control group had a significant reduction in mean ED encounters (P = 0.88 and 0.74, respectively) or costs (P = 0.76 and 0.12, respectively) post enrollment.

The cost savings per DEP patient are shown in Table 5. The annual cost for a CHW to educate 1 DEP patient was $403. The combined inpatient and ED cost savings for DEP patients post-program enrollment was $137 per patient. ROI for the DEP was –66%, indicating that DEP investment costs were greater than the savings achieved through the reduction of inpatient and ED costs for DEP patients.

Discussion

In our examination of the impact of the DEP on inpatient and ED utilization, we found that DEP patients experienced a significant decrease in inpatient visits, LOS, and direct costs in the year following DEP enrollment. In comparison, a control group of patients who were treated at the same clinics as DEP patients also experienced significant decreases in inpatient LOS and direct costs. No significant differences in ED visits, LOS, or direct costs were observed for either DEP patients or control patients in the post period.

The reduction in inpatient visits and LOS for DEP patients in the year following DEP enrollment indicates that the DEP helped patients achieve improved health and avoid costly hospitalizations. The control group did experience greater reductions in inpatient utilization, LOS, and direct costs. However, because this was not designed as a controlled trial, we utilized a nonequivalent control group and inherent differences between the DEP and control patients and utilization patterns made it difficult to draw unbiased comparisons between the groups. For instance, the number of inpatient encounters, LOS, and costs were 2 to 3 times higher in the pre-period for the control group. The mean number of inpatient encounters for DEP patients prior to DEP participation was 0.18, and the smaller change observed in utilization for DEP patients is likely due to a floor effect.

Despite the observed reductions for both DEP patients and the control group in inpatient utilization, neither group had significant reductions in ED visits or costs per patient in the post- period. The majority of ED use in the pre-period may have been due to diabetes-related complications that are difficult to prevent even with improved diabetes care or for emergencies not related to diabetes, as we included all ED admissions regardless of admitting diagnosis. In addition, similar to observed trends in inpatient utilization, ED use in the pre-period was relatively low for DEP patients (0.16), and the lack of observed changes in ED utilization for DEP patients was also likely due to a floor effect.

The DEP generated a negative ROI (–66%) in the short term as the annual cost savings generated per patient from reduced utilization ($137) were less than the annual DEP costs (investment) per patient ($403). This finding is not surprising, as it is difficult to achieve cost savings for interventions designed to increase access to health care in underserved populations.[15] Although Fedder et al. observed an average savings of $2245 per patient per year in Medicaid reimbursements for a CHW-led outreach program for patients on Medicaid with diabetes, patients who participated in this program had much higher inpatient encounters (0.95 vs. 0.18) and ED utilization (1.49 vs. 0.16) at baseline compared to DEP patients. DEP patients may not have been as sick as these patients or have been more reluctant to seek medical care due to their lack of insurance. In addition, Fedder et al did not factor in the costs of the CHW program in the cost savings calculation. However, these costs were likely to be much lower than the costs of the DEP, as the program relied on volunteer CHWs instead of paid CHWs who were also certified medical assistants.

Several studies have evaluated the cost-effectiveness of CHW-led diabetes management programs rather than the ROI as these types of programs are often associated with improved health outcomes but also increased health care costs as the result of expanding health care access and services to underserved populations [15,25–29]. Most of these evaluations modeled the long-term cost-effectiveness, as the majority of cost savings from diabetes management programs are likely to accrue in the long run as a result of the prevention of diabetes-related complications such as amputations, blindness, kidney failure, coronary heart disease, and stroke [15,25]. Although these CHW-led interventions for diabetes differed in scope, the incremental cost effectiveness ratios for these interventions were less than the common willingness-to-pay threshold of $50,000 per quality-adjusted life year (QALY). These studies may have underestimated the societal benefits of these programs as they did not incorporate non-medical cost savings such as those that may be attributed to gains in productivity [26].

A recent cost-effectiveness analysis of the DEP and the 4 other programs that were part of the Alliance to Reduce Disparities in Diabetes found that these programs spent an average of $975 per patient in the first year and additional $520 per patient in subsequent years to improve care for diabetes patients [15]. Based on improvements in health indicators such as HbA1c, systolic blood pressure, and total cholesterol observed for participants in Alliance programs, the incremental cost-effectiveness ratio of these programs was $23,161 per QALY given the optimistic assumption that the observed improvements in health indicators were all attributable to the interventions. DEP patients achieved a 1% average reduction in mean HbA1c and this improvement was sustained over the course of the program. The UK Prospective Diabetes Study Group found that every 1% reduction in HbA1C reduces a patient’s risk of developing eye, kidney, and nerve disease by 40% and the risk of heart attack by 14% [30]. Thus, if DEP patients sustain improvements gained as a result of program participation, they may avoid serious and expensive medical complications in the future.

Ultimately, the goal of the DEP was to provide patients with improved access to diabetes care and to help them achieve improved glucose control. Improving access to chronic disease care is costly. However, employment of CHWs is a less costly alternative to employing additional clinicians, and CHWs may be more effective in assisting patients with chronic disease management particularly those from underserved and vulnerable populations. Although we did not generate a positive ROI for the DEP in this short-term analysis, the program is likely cost-effective when the low cost of the program is compared with the improvements in health outcomes we have observed.

This study had several limitations. There were observed differences in gender and ethnicity between the intervention and control groups and it is likely that risk-adjustment (including propensity scoring) did not fully accountfor underlying differences between the populations. The observed reductions in inpatient utilization and costs in the intervention group may have been due to other factors besides the DEP as the control group also achieved reductions in inpatient LOS and costs. The control group did contain a few outliers in terms of high pre-period medical costs which were retained in the analysis and these outliers may have caused reductions in costs for this group to be overstated. The observed outcomes may also be biased due to intervention contamination. Patients in the control group attended the same clinics as DEP patients and were treated by the same primary care physicians. The primary care physicians likely applied the knowledge gained from working with DEP patients and the CHWs, including how to identify and help patients address the specific barriers to diabetes self-management faced by clinic patients, to the treatment of patients who were not enrolled in the DEP. The fact that health care utilization and costs were much higher for patients in the control group in the pre-period indicates that these patients had greater severity of illness and additional comorbidities, and the observed reductions in utilization and costs for these patients may have been the result of obtaining access to a regular source of primary care through the clinics. However, the observed decrease in inpatient encounters from .18 to .08 in the post period for DEP patients as well as the observed decreases in inpatient LOS and direct costs indicate that the DEP may provide additional benefits compared to access to primary care alone in terms of avoidance costly hospitalizations for diabetes-related complications.

Conclusion

From the health care system perspective, CHW-led diabetes education programs like the DEP may provide additional benefits than can be gained from access to primary care alone in terms of avoidance of costly hospitalizations for diabetes-related complications. Although the costs of the DEP were greater than the savings it generated through reduced inpatient utilization and costs in the short term, additional savings to the health care system or society may be generated in the long term through reductions of diabetes-related complications in patients who were able to achieve improved glycemic control through program participation. More importantly, the improvements in glycemic control achieved by DEP patients can lead to both short and long term gains in overall health and quality of life.

Corresponding author: Ashley Collinsworth, ScD, MPH, Scott & White Health, Center for Clinical Effectiveness, Dallas, TX 75206, [email protected].

Funding/support: This program/initiative was supported by a grant from the Merck Company Foundation through its Merck Alliance to Reduce Disparities in Diabetes program.

ORLANDO – Most adolescents expressed interest in and support for access to over-the-counter oral contraceptives, a survey found.

Data from a separate cross-sectional study showed that adolescents are skilled at self-screening for contraindications to combined OCs, demonstrating preliminary support for the safety of over-the-counter access.

Fuse/ThinkStockPhotos.com

Of 348 girls aged 14-17 years who completed the survey in the first study, 73% reported supporting over-the-counter (OTC) OC access for teens, and 61% reported being likely to use OCs if they were available OTC. Significant associations were found between support for OTC access and having used birth control and having had sex. An association was also found between the likelihood of OTC use and having used birth control, having had sex, and being white, Ruth Manski of the Jane Fonda Center for Adolescent Reproductive Health, Atlanta, reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Those who had never been tested for sexually transmitted infections were more likely to support OTC access (91% vs. 76%).

Support for, and the likelihood of, using OTC OCs were not influenced by age, geographic region, rural/urban location, health insurance status, or pregnancy history. Race played a factor in that white participants were more likely than nonwhite participants to be interested in OTC access. The study also showed that participants understood an average of 7.1 of 8 key product-labeling concepts, and that most would be willing to pay up to $20 per month for OTC OCs, with the largest percentage (42%) willing to pay between $11 and $20. About a third said they would pay $21 or more.

Survey respondents were girls recruited via Facebook advertisements in 2014. Nearly a third (32%) were aged 17 years, 31% were aged 16 years, 24% were aged 15, and 13% were aged 14. Most (79%) were white, Ms. Manski said, adding that the respondents represented 44 states, 53% lived in a suburban area, 41% had private health insurance, and 33% had public health insurance.

About 90% reported having used contraception, and 44% reported having had sex. Of those who had sex, 60% reported having had unprotected sex, 58% used OCs, and 12% reported having been pregnant.

“So results from this study show that participants are supportive of over-the-counter access and that they’re interested in obtaining oral contraceptives over the counter. The findings also suggest that teenagers understand how to use oral contraceptives based on independent label review, which offers some evidence in response to concerns raised in other studies about teenagers’ ability to understand how to use over-the-counter products,” Ms. Manski said.

The findings suggest that while cost is a concern for teens and could impact their contraceptive choices, making OCs available OTC without age restrictions may help increase adolescents’ contraceptive access and use, she said, noting that this is important given the unique barriers that adolescents face with respect to accessing contraception.

The high levels of interest, and the perception of benefit, highlight the potential of this strategy to increase contraceptive access and reduce unintended pregnancy, she added.

Although some respondents expressed concerns about safety and the potential impact on sexual behavior, the evidence with respect to currently available OTC emergency contraception demonstrates that easier access does not increase sexual risk taking, and that teens can safely use OTC emergency contraception, she said.

However, the behavioral effects of OTC OC availability are not known and should be evaluated in actual use studies, Ms. Manski added.

Concerns about the safety of OTC OC access were specifically addressed in the second study, which sought to determine whether adolescents are capable of self-screening for contraindications to OC use.

Prior studies have shown that adults are able to self-screen adequately, but little is known about adolescents’ ability to do so, Dr. Rebekah L. Williams of Riley Hospital for Children, Indianapolis, said at the meeting.

Findings in the first 61 teens aged 14-21 years enrolled in the study showed that the teens were actually more likely than their providers to report potential contraindications.

The teens completed screening questionnaires prior to their office visit, and the provider completed the medical history questionnaire after the visit.

Perfectly concordant responses between providers and patients were seen for six potential contraindications: diabetes (which was present in two cases) and heavy smoking, breastfeeding, wheelchair use, surgery within 4 weeks, and current HIV medication use (which were not present in any cases). Discordant responses were seen for the remaining potential contraindications, including breast cancer, liver disease, medication interactions, smoking, migraine, hypertension, gallbladder disease, thromboembolism/heart disease, having a first-degree relative with thromboembolism, weight over 200 pounds, and having been told/having the perception that OCs should not be used.

Potential contraindications reported only by the participant were breast cancer, liver disease, medication interaction, any smoking, hypertension, personal history of thromboembolism or heart disease, and having a first-degree relative with thromboembolism.

Participants were adolescents with a mean age of 17 years from a primary care medicine clinic in a Midwest urban setting. Of the 61 subjects, 62% were black, 62% reported having ever used contraceptives, 44% were currently using contraceptives, and 62% said they would be interested in OTC OC access. Among the 38 who reported having penile/vaginal sex, 87% had ever used OCs, and 60% were currently using them.

“In summary, adolescent women are interested in over-the-counter access to combined oral contraceptive pills, they’re skilled at self-screening, and they’re mostly more likely than providers to report potential contraindications. So these data really provide some preliminary support for the over-the-counter provision of oral contraceptive pills to adolescents,” Dr. Williams said, noting that additional research is needed to assess adolescents’ ability to use combined oral contraceptive pills correctly.

In addition, larger studies in groups with a higher prevalence of contraindications are needed, as are studies with recruitment from nonclinical settings and more diverse populations, she said.

Ms. Manski and Dr. Williams both reported having no relevant financial disclosures.

[email protected]

ORLANDO – Most adolescents expressed interest in and support for access to over-the-counter oral contraceptives, a survey found.

Data from a separate cross-sectional study showed that adolescents are skilled at self-screening for contraindications to combined OCs, demonstrating preliminary support for the safety of over-the-counter access.

Fuse/ThinkStockPhotos.com

Of 348 girls aged 14-17 years who completed the survey in the first study, 73% reported supporting over-the-counter (OTC) OC access for teens, and 61% reported being likely to use OCs if they were available OTC. Significant associations were found between support for OTC access and having used birth control and having had sex. An association was also found between the likelihood of OTC use and having used birth control, having had sex, and being white, Ruth Manski of the Jane Fonda Center for Adolescent Reproductive Health, Atlanta, reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Those who had never been tested for sexually transmitted infections were more likely to support OTC access (91% vs. 76%).

Support for, and the likelihood of, using OTC OCs were not influenced by age, geographic region, rural/urban location, health insurance status, or pregnancy history. Race played a factor in that white participants were more likely than nonwhite participants to be interested in OTC access. The study also showed that participants understood an average of 7.1 of 8 key product-labeling concepts, and that most would be willing to pay up to $20 per month for OTC OCs, with the largest percentage (42%) willing to pay between $11 and $20. About a third said they would pay $21 or more.

Survey respondents were girls recruited via Facebook advertisements in 2014. Nearly a third (32%) were aged 17 years, 31% were aged 16 years, 24% were aged 15, and 13% were aged 14. Most (79%) were white, Ms. Manski said, adding that the respondents represented 44 states, 53% lived in a suburban area, 41% had private health insurance, and 33% had public health insurance.

About 90% reported having used contraception, and 44% reported having had sex. Of those who had sex, 60% reported having had unprotected sex, 58% used OCs, and 12% reported having been pregnant.

“So results from this study show that participants are supportive of over-the-counter access and that they’re interested in obtaining oral contraceptives over the counter. The findings also suggest that teenagers understand how to use oral contraceptives based on independent label review, which offers some evidence in response to concerns raised in other studies about teenagers’ ability to understand how to use over-the-counter products,” Ms. Manski said.

The findings suggest that while cost is a concern for teens and could impact their contraceptive choices, making OCs available OTC without age restrictions may help increase adolescents’ contraceptive access and use, she said, noting that this is important given the unique barriers that adolescents face with respect to accessing contraception.

The high levels of interest, and the perception of benefit, highlight the potential of this strategy to increase contraceptive access and reduce unintended pregnancy, she added.

Although some respondents expressed concerns about safety and the potential impact on sexual behavior, the evidence with respect to currently available OTC emergency contraception demonstrates that easier access does not increase sexual risk taking, and that teens can safely use OTC emergency contraception, she said.

However, the behavioral effects of OTC OC availability are not known and should be evaluated in actual use studies, Ms. Manski added.

Concerns about the safety of OTC OC access were specifically addressed in the second study, which sought to determine whether adolescents are capable of self-screening for contraindications to OC use.

Prior studies have shown that adults are able to self-screen adequately, but little is known about adolescents’ ability to do so, Dr. Rebekah L. Williams of Riley Hospital for Children, Indianapolis, said at the meeting.

Findings in the first 61 teens aged 14-21 years enrolled in the study showed that the teens were actually more likely than their providers to report potential contraindications.

The teens completed screening questionnaires prior to their office visit, and the provider completed the medical history questionnaire after the visit.

Perfectly concordant responses between providers and patients were seen for six potential contraindications: diabetes (which was present in two cases) and heavy smoking, breastfeeding, wheelchair use, surgery within 4 weeks, and current HIV medication use (which were not present in any cases). Discordant responses were seen for the remaining potential contraindications, including breast cancer, liver disease, medication interactions, smoking, migraine, hypertension, gallbladder disease, thromboembolism/heart disease, having a first-degree relative with thromboembolism, weight over 200 pounds, and having been told/having the perception that OCs should not be used.

Potential contraindications reported only by the participant were breast cancer, liver disease, medication interaction, any smoking, hypertension, personal history of thromboembolism or heart disease, and having a first-degree relative with thromboembolism.

Participants were adolescents with a mean age of 17 years from a primary care medicine clinic in a Midwest urban setting. Of the 61 subjects, 62% were black, 62% reported having ever used contraceptives, 44% were currently using contraceptives, and 62% said they would be interested in OTC OC access. Among the 38 who reported having penile/vaginal sex, 87% had ever used OCs, and 60% were currently using them.

“In summary, adolescent women are interested in over-the-counter access to combined oral contraceptive pills, they’re skilled at self-screening, and they’re mostly more likely than providers to report potential contraindications. So these data really provide some preliminary support for the over-the-counter provision of oral contraceptive pills to adolescents,” Dr. Williams said, noting that additional research is needed to assess adolescents’ ability to use combined oral contraceptive pills correctly.

In addition, larger studies in groups with a higher prevalence of contraindications are needed, as are studies with recruitment from nonclinical settings and more diverse populations, she said.

Ms. Manski and Dr. Williams both reported having no relevant financial disclosures.

[email protected]

ORLANDO – Most adolescents expressed interest in and support for access to over-the-counter oral contraceptives, a survey found.

Data from a separate cross-sectional study showed that adolescents are skilled at self-screening for contraindications to combined OCs, demonstrating preliminary support for the safety of over-the-counter access.

Fuse/ThinkStockPhotos.com

Of 348 girls aged 14-17 years who completed the survey in the first study, 73% reported supporting over-the-counter (OTC) OC access for teens, and 61% reported being likely to use OCs if they were available OTC. Significant associations were found between support for OTC access and having used birth control and having had sex. An association was also found between the likelihood of OTC use and having used birth control, having had sex, and being white, Ruth Manski of the Jane Fonda Center for Adolescent Reproductive Health, Atlanta, reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Those who had never been tested for sexually transmitted infections were more likely to support OTC access (91% vs. 76%).

Support for, and the likelihood of, using OTC OCs were not influenced by age, geographic region, rural/urban location, health insurance status, or pregnancy history. Race played a factor in that white participants were more likely than nonwhite participants to be interested in OTC access. The study also showed that participants understood an average of 7.1 of 8 key product-labeling concepts, and that most would be willing to pay up to $20 per month for OTC OCs, with the largest percentage (42%) willing to pay between $11 and $20. About a third said they would pay $21 or more.

Survey respondents were girls recruited via Facebook advertisements in 2014. Nearly a third (32%) were aged 17 years, 31% were aged 16 years, 24% were aged 15, and 13% were aged 14. Most (79%) were white, Ms. Manski said, adding that the respondents represented 44 states, 53% lived in a suburban area, 41% had private health insurance, and 33% had public health insurance.

About 90% reported having used contraception, and 44% reported having had sex. Of those who had sex, 60% reported having had unprotected sex, 58% used OCs, and 12% reported having been pregnant.

“So results from this study show that participants are supportive of over-the-counter access and that they’re interested in obtaining oral contraceptives over the counter. The findings also suggest that teenagers understand how to use oral contraceptives based on independent label review, which offers some evidence in response to concerns raised in other studies about teenagers’ ability to understand how to use over-the-counter products,” Ms. Manski said.

The findings suggest that while cost is a concern for teens and could impact their contraceptive choices, making OCs available OTC without age restrictions may help increase adolescents’ contraceptive access and use, she said, noting that this is important given the unique barriers that adolescents face with respect to accessing contraception.

The high levels of interest, and the perception of benefit, highlight the potential of this strategy to increase contraceptive access and reduce unintended pregnancy, she added.

Although some respondents expressed concerns about safety and the potential impact on sexual behavior, the evidence with respect to currently available OTC emergency contraception demonstrates that easier access does not increase sexual risk taking, and that teens can safely use OTC emergency contraception, she said.

However, the behavioral effects of OTC OC availability are not known and should be evaluated in actual use studies, Ms. Manski added.

Concerns about the safety of OTC OC access were specifically addressed in the second study, which sought to determine whether adolescents are capable of self-screening for contraindications to OC use.

Prior studies have shown that adults are able to self-screen adequately, but little is known about adolescents’ ability to do so, Dr. Rebekah L. Williams of Riley Hospital for Children, Indianapolis, said at the meeting.

Findings in the first 61 teens aged 14-21 years enrolled in the study showed that the teens were actually more likely than their providers to report potential contraindications.

The teens completed screening questionnaires prior to their office visit, and the provider completed the medical history questionnaire after the visit.

Perfectly concordant responses between providers and patients were seen for six potential contraindications: diabetes (which was present in two cases) and heavy smoking, breastfeeding, wheelchair use, surgery within 4 weeks, and current HIV medication use (which were not present in any cases). Discordant responses were seen for the remaining potential contraindications, including breast cancer, liver disease, medication interactions, smoking, migraine, hypertension, gallbladder disease, thromboembolism/heart disease, having a first-degree relative with thromboembolism, weight over 200 pounds, and having been told/having the perception that OCs should not be used.

Potential contraindications reported only by the participant were breast cancer, liver disease, medication interaction, any smoking, hypertension, personal history of thromboembolism or heart disease, and having a first-degree relative with thromboembolism.

Participants were adolescents with a mean age of 17 years from a primary care medicine clinic in a Midwest urban setting. Of the 61 subjects, 62% were black, 62% reported having ever used contraceptives, 44% were currently using contraceptives, and 62% said they would be interested in OTC OC access. Among the 38 who reported having penile/vaginal sex, 87% had ever used OCs, and 60% were currently using them.

“In summary, adolescent women are interested in over-the-counter access to combined oral contraceptive pills, they’re skilled at self-screening, and they’re mostly more likely than providers to report potential contraindications. So these data really provide some preliminary support for the over-the-counter provision of oral contraceptive pills to adolescents,” Dr. Williams said, noting that additional research is needed to assess adolescents’ ability to use combined oral contraceptive pills correctly.

In addition, larger studies in groups with a higher prevalence of contraindications are needed, as are studies with recruitment from nonclinical settings and more diverse populations, she said.

Ms. Manski and Dr. Williams both reported having no relevant financial disclosures.

[email protected]

Photomicrograph of liver

tissue with active HCV

Photo: Sutter Health

VIENNA, AUSTRIA—A 5-year retrospective study has shown that the cancer rate in patients with hepatitis C virus (HCV) is about double that for people without HCV, even when liver cancer is excluded.

And when liver cancer is included, the rate increases to 2.5 times higher in people with HCV.

Researchers presented these findings at the International Liver Congress 2015 as abstract 0058.

The team reviewed patient records from 2008 to 2012 at Kaiser Permanente Southern California, recording all cancer diagnoses in patients 18 years or older with or without HCV.

During the 5-year time period, there were 145,210 patient years in the HCV cohort and 13,948,826 patient years in the non-HCV cohort.

The mean age at cancer diagnosis was 61.8 in the HCV cohort and 63.5 in the non-HCV cohort.

Researchers recorded 2213 cancer diagnoses in the HCV cohort (1524/100,000). This number decreased to 1654 when they excluded liver cancer (1139/100,000).

In the non-HCV cohort, they recorded 84,419 cancer diagnoses (605/100,000), which decreased to 83,795 when liver cancer was excluded (601/100,000).

Cancer types known to be associated with HCV include non-Hodgkin lymphoma (NHL), renal and prostate cancers, and liver cancer.

NHL occurred 3.63 times more frequently in patients with HCV than in those without HCV, and myeloma occurred 2.93 times more frequently.

Renal cancer occurred 3.27 times and prostate cancer 1.98 times more frequently in patients with HCV than in those without.

“The results suggest that cancer rates are increased in the cohort of hepatitis C patients versus the non-hepatitis C patients, both including and excluding liver cancers,” said senior study author Lisa Nyberg, MD, MPH, of Kaiser Permanente.

“These findings certainly point to the suggestion that hepatitis C may be associated with an increased risk of cancer.”

However, she added that the findings “must be interpreted with caution, as the study also showed that confounding factors such as alcohol abuse, tobacco, obesity, and diabetes modified the results.”

Photomicrograph of liver

tissue with active HCV

Photo: Sutter Health

VIENNA, AUSTRIA—A 5-year retrospective study has shown that the cancer rate in patients with hepatitis C virus (HCV) is about double that for people without HCV, even when liver cancer is excluded.

And when liver cancer is included, the rate increases to 2.5 times higher in people with HCV.

Researchers presented these findings at the International Liver Congress 2015 as abstract 0058.

The team reviewed patient records from 2008 to 2012 at Kaiser Permanente Southern California, recording all cancer diagnoses in patients 18 years or older with or without HCV.

During the 5-year time period, there were 145,210 patient years in the HCV cohort and 13,948,826 patient years in the non-HCV cohort.

The mean age at cancer diagnosis was 61.8 in the HCV cohort and 63.5 in the non-HCV cohort.

Researchers recorded 2213 cancer diagnoses in the HCV cohort (1524/100,000). This number decreased to 1654 when they excluded liver cancer (1139/100,000).

In the non-HCV cohort, they recorded 84,419 cancer diagnoses (605/100,000), which decreased to 83,795 when liver cancer was excluded (601/100,000).

Cancer types known to be associated with HCV include non-Hodgkin lymphoma (NHL), renal and prostate cancers, and liver cancer.

NHL occurred 3.63 times more frequently in patients with HCV than in those without HCV, and myeloma occurred 2.93 times more frequently.

Renal cancer occurred 3.27 times and prostate cancer 1.98 times more frequently in patients with HCV than in those without.

“The results suggest that cancer rates are increased in the cohort of hepatitis C patients versus the non-hepatitis C patients, both including and excluding liver cancers,” said senior study author Lisa Nyberg, MD, MPH, of Kaiser Permanente.

“These findings certainly point to the suggestion that hepatitis C may be associated with an increased risk of cancer.”

However, she added that the findings “must be interpreted with caution, as the study also showed that confounding factors such as alcohol abuse, tobacco, obesity, and diabetes modified the results.”

Photomicrograph of liver

tissue with active HCV

Photo: Sutter Health

VIENNA, AUSTRIA—A 5-year retrospective study has shown that the cancer rate in patients with hepatitis C virus (HCV) is about double that for people without HCV, even when liver cancer is excluded.

And when liver cancer is included, the rate increases to 2.5 times higher in people with HCV.

Researchers presented these findings at the International Liver Congress 2015 as abstract 0058.

The team reviewed patient records from 2008 to 2012 at Kaiser Permanente Southern California, recording all cancer diagnoses in patients 18 years or older with or without HCV.

During the 5-year time period, there were 145,210 patient years in the HCV cohort and 13,948,826 patient years in the non-HCV cohort.

The mean age at cancer diagnosis was 61.8 in the HCV cohort and 63.5 in the non-HCV cohort.

Researchers recorded 2213 cancer diagnoses in the HCV cohort (1524/100,000). This number decreased to 1654 when they excluded liver cancer (1139/100,000).

In the non-HCV cohort, they recorded 84,419 cancer diagnoses (605/100,000), which decreased to 83,795 when liver cancer was excluded (601/100,000).

Cancer types known to be associated with HCV include non-Hodgkin lymphoma (NHL), renal and prostate cancers, and liver cancer.

NHL occurred 3.63 times more frequently in patients with HCV than in those without HCV, and myeloma occurred 2.93 times more frequently.

Renal cancer occurred 3.27 times and prostate cancer 1.98 times more frequently in patients with HCV than in those without.

“The results suggest that cancer rates are increased in the cohort of hepatitis C patients versus the non-hepatitis C patients, both including and excluding liver cancers,” said senior study author Lisa Nyberg, MD, MPH, of Kaiser Permanente.

“These findings certainly point to the suggestion that hepatitis C may be associated with an increased risk of cancer.”

However, she added that the findings “must be interpreted with caution, as the study also showed that confounding factors such as alcohol abuse, tobacco, obesity, and diabetes modified the results.”

SAN DIEGO– A fuller picture of the benefits of vorapaxar for secondary cardiovascular prevention emerged from three separate secondary analyses of the pivotal Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2°P TIMI-50) trial presented at the annual meeting of the American College of Cardiology.

These new reports provided evidence that vorapaxar (Zontivity), a first-in-class, once-daily thrombin inhibitor with rapid onset and a half-life in excess of 7 days, reduces acute limb ischemia and the need for peripheral revascularization in patients with peripheral arterial disease (PAD), and also that the antiplatelet agent is particularly beneficial in patients with a history of coronary artery bypass graft surgery.

That being said, the three secondary analyses were post hoc and as such are inherently exploratory and hypothesis-generating rather than definitive, the investigators noted.

The Food and Drug Administration approved vorapaxar in May 2014 for the reduction of thrombotic cardiovascular events in patients with a history of MI or in patients with PAD in the absence of a previous stroke or TIA. Marketing approval was based chiefly on the results of the landmark 26,449-patient, double-blind, prospective, multinational TIMI 50 trial. In an analysis of the 20,170 randomized patients without a prior stroke or TIA, vorapaxar at 2.5 mg once daily, when added to standard therapy with aspirin and/or clopidogrel, reduced the 3-year rate of a composite outcome – comprised of cardiovascular death, MI, or stroke – by 20% compared with placebo, with a number-needed-to-treat of 63 (J. Am. Heart Assoc. 2015 [doi: 10.1161/JAHA.114.001505]).

At ACC 15, Dr. Ethan C. Kosova presented a subanalysis involving the 2,942 TIMI 50 participants who had undergone CABG surgery prior to the study. The rationale for taking a closer look at this group is that rates of venous graft occlusion and recurrent ischemic events remain high after CABG surgery, so the efficacy and safety of vorapaxar in this population are of particular interest.

Underscoring the high-risk nature of this population, at baseline the patients with a history of CABG were significantly older and had higher rates of hypertension, dyslipidemia, diabetes, PAD, heart failure, and chronic kidney disease than participants without prior CABG who had no history of stroke or TIA, observed Dr. Kosova of Brigham and Women’s Hospital, Boston.

The 3-year composite event rate of cardiovascular death, MI, or stroke occurred in 11.9% of the 1,471 patients with prior CABG who were randomized to vorapaxar compared with 15.6% of those on placebo. That translates into a 29% relative risk reduction and a number-needed-to-treat of 27, an even stronger result than in the general study population.

Moreover, the clinically relevant composite outcome consisting of cardiovascular death or MI occurred in 10.9% of those on vorapaxar compared with 14.3% of controls, for a 29% relative risk reduction and a number-needed-to-treat of 29, he continued.

The 3-year all-cause mortality was 5.8% in patients with prior CABG who received vorapaxar compared to 8% in those on placebo.

Vorapaxar, which inhibits protease-activated receptor-1 on platelets and vascular endothelium, increased the rate of GUSTO moderate-to-severe bleeding: 6.8% compared with 3.7% in controls.

“Putting together the efficacy and safety data to derive the net clinical outcome – the combined endpoint of all-cause mortality, MI, cerebrovascular accident, and GUSTO severe bleeding – the result was a 28% improvement with vorapaxar compared with placebo,” Dr. Kosova said.

In a separate presentation focused on the 3,787 patients who gained entry into the TIMI 50 trial on the basis of symptomatic PAD, Dr. Antonio Gutierrez reported that acute limb ischemia occurred in 109 of them during the trial. Fifty-four percent of these events were due to acute surgical graft thrombosis, 27% to in situ thrombosis of a native vessel, and lesser numbers were due to thromboembolissm or stent thrombosis.

The 3-year acute limb ischemia rate in patients with baseline PAD was 3.9% with placebo compared to 2.3% with vorapaxar, for a 42% relative risk reduction, according to Dr. Gutierrez of Brigham and Women’s Hospital.

Dr. Ian Gilchrist, also from Brigham and Women’s Hospital, reported that in TIMI 50 participants with a history of PAD, vorapaxar resulted in a 16% reduction in the need for peripheral revascularization procedures for claudication, with rates of 9.4% for vorapaxar and 11.6% for placebo. There was also a statistically significant 41% reduction in the rate of surgical peripheral revascularization procedures, with rates of 4.5% for vorapaxar and 7.7% for placebo.

The TIMI 50 trial was funded by Merck. Drs. Kosova, Gutierrez, and Gilchrist reported having no financial conflicts of interest.

[email protected]

SAN DIEGO– A fuller picture of the benefits of vorapaxar for secondary cardiovascular prevention emerged from three separate secondary analyses of the pivotal Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2°P TIMI-50) trial presented at the annual meeting of the American College of Cardiology.

These new reports provided evidence that vorapaxar (Zontivity), a first-in-class, once-daily thrombin inhibitor with rapid onset and a half-life in excess of 7 days, reduces acute limb ischemia and the need for peripheral revascularization in patients with peripheral arterial disease (PAD), and also that the antiplatelet agent is particularly beneficial in patients with a history of coronary artery bypass graft surgery.

That being said, the three secondary analyses were post hoc and as such are inherently exploratory and hypothesis-generating rather than definitive, the investigators noted.

The Food and Drug Administration approved vorapaxar in May 2014 for the reduction of thrombotic cardiovascular events in patients with a history of MI or in patients with PAD in the absence of a previous stroke or TIA. Marketing approval was based chiefly on the results of the landmark 26,449-patient, double-blind, prospective, multinational TIMI 50 trial. In an analysis of the 20,170 randomized patients without a prior stroke or TIA, vorapaxar at 2.5 mg once daily, when added to standard therapy with aspirin and/or clopidogrel, reduced the 3-year rate of a composite outcome – comprised of cardiovascular death, MI, or stroke – by 20% compared with placebo, with a number-needed-to-treat of 63 (J. Am. Heart Assoc. 2015 [doi: 10.1161/JAHA.114.001505]).

At ACC 15, Dr. Ethan C. Kosova presented a subanalysis involving the 2,942 TIMI 50 participants who had undergone CABG surgery prior to the study. The rationale for taking a closer look at this group is that rates of venous graft occlusion and recurrent ischemic events remain high after CABG surgery, so the efficacy and safety of vorapaxar in this population are of particular interest.

Underscoring the high-risk nature of this population, at baseline the patients with a history of CABG were significantly older and had higher rates of hypertension, dyslipidemia, diabetes, PAD, heart failure, and chronic kidney disease than participants without prior CABG who had no history of stroke or TIA, observed Dr. Kosova of Brigham and Women’s Hospital, Boston.

The 3-year composite event rate of cardiovascular death, MI, or stroke occurred in 11.9% of the 1,471 patients with prior CABG who were randomized to vorapaxar compared with 15.6% of those on placebo. That translates into a 29% relative risk reduction and a number-needed-to-treat of 27, an even stronger result than in the general study population.

Moreover, the clinically relevant composite outcome consisting of cardiovascular death or MI occurred in 10.9% of those on vorapaxar compared with 14.3% of controls, for a 29% relative risk reduction and a number-needed-to-treat of 29, he continued.

The 3-year all-cause mortality was 5.8% in patients with prior CABG who received vorapaxar compared to 8% in those on placebo.

Vorapaxar, which inhibits protease-activated receptor-1 on platelets and vascular endothelium, increased the rate of GUSTO moderate-to-severe bleeding: 6.8% compared with 3.7% in controls.

“Putting together the efficacy and safety data to derive the net clinical outcome – the combined endpoint of all-cause mortality, MI, cerebrovascular accident, and GUSTO severe bleeding – the result was a 28% improvement with vorapaxar compared with placebo,” Dr. Kosova said.

In a separate presentation focused on the 3,787 patients who gained entry into the TIMI 50 trial on the basis of symptomatic PAD, Dr. Antonio Gutierrez reported that acute limb ischemia occurred in 109 of them during the trial. Fifty-four percent of these events were due to acute surgical graft thrombosis, 27% to in situ thrombosis of a native vessel, and lesser numbers were due to thromboembolissm or stent thrombosis.

The 3-year acute limb ischemia rate in patients with baseline PAD was 3.9% with placebo compared to 2.3% with vorapaxar, for a 42% relative risk reduction, according to Dr. Gutierrez of Brigham and Women’s Hospital.

Dr. Ian Gilchrist, also from Brigham and Women’s Hospital, reported that in TIMI 50 participants with a history of PAD, vorapaxar resulted in a 16% reduction in the need for peripheral revascularization procedures for claudication, with rates of 9.4% for vorapaxar and 11.6% for placebo. There was also a statistically significant 41% reduction in the rate of surgical peripheral revascularization procedures, with rates of 4.5% for vorapaxar and 7.7% for placebo.

The TIMI 50 trial was funded by Merck. Drs. Kosova, Gutierrez, and Gilchrist reported having no financial conflicts of interest.

[email protected]

SAN DIEGO– A fuller picture of the benefits of vorapaxar for secondary cardiovascular prevention emerged from three separate secondary analyses of the pivotal Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2°P TIMI-50) trial presented at the annual meeting of the American College of Cardiology.

These new reports provided evidence that vorapaxar (Zontivity), a first-in-class, once-daily thrombin inhibitor with rapid onset and a half-life in excess of 7 days, reduces acute limb ischemia and the need for peripheral revascularization in patients with peripheral arterial disease (PAD), and also that the antiplatelet agent is particularly beneficial in patients with a history of coronary artery bypass graft surgery.

That being said, the three secondary analyses were post hoc and as such are inherently exploratory and hypothesis-generating rather than definitive, the investigators noted.

The Food and Drug Administration approved vorapaxar in May 2014 for the reduction of thrombotic cardiovascular events in patients with a history of MI or in patients with PAD in the absence of a previous stroke or TIA. Marketing approval was based chiefly on the results of the landmark 26,449-patient, double-blind, prospective, multinational TIMI 50 trial. In an analysis of the 20,170 randomized patients without a prior stroke or TIA, vorapaxar at 2.5 mg once daily, when added to standard therapy with aspirin and/or clopidogrel, reduced the 3-year rate of a composite outcome – comprised of cardiovascular death, MI, or stroke – by 20% compared with placebo, with a number-needed-to-treat of 63 (J. Am. Heart Assoc. 2015 [doi: 10.1161/JAHA.114.001505]).

At ACC 15, Dr. Ethan C. Kosova presented a subanalysis involving the 2,942 TIMI 50 participants who had undergone CABG surgery prior to the study. The rationale for taking a closer look at this group is that rates of venous graft occlusion and recurrent ischemic events remain high after CABG surgery, so the efficacy and safety of vorapaxar in this population are of particular interest.

Underscoring the high-risk nature of this population, at baseline the patients with a history of CABG were significantly older and had higher rates of hypertension, dyslipidemia, diabetes, PAD, heart failure, and chronic kidney disease than participants without prior CABG who had no history of stroke or TIA, observed Dr. Kosova of Brigham and Women’s Hospital, Boston.

The 3-year composite event rate of cardiovascular death, MI, or stroke occurred in 11.9% of the 1,471 patients with prior CABG who were randomized to vorapaxar compared with 15.6% of those on placebo. That translates into a 29% relative risk reduction and a number-needed-to-treat of 27, an even stronger result than in the general study population.

Moreover, the clinically relevant composite outcome consisting of cardiovascular death or MI occurred in 10.9% of those on vorapaxar compared with 14.3% of controls, for a 29% relative risk reduction and a number-needed-to-treat of 29, he continued.

The 3-year all-cause mortality was 5.8% in patients with prior CABG who received vorapaxar compared to 8% in those on placebo.

Vorapaxar, which inhibits protease-activated receptor-1 on platelets and vascular endothelium, increased the rate of GUSTO moderate-to-severe bleeding: 6.8% compared with 3.7% in controls.

“Putting together the efficacy and safety data to derive the net clinical outcome – the combined endpoint of all-cause mortality, MI, cerebrovascular accident, and GUSTO severe bleeding – the result was a 28% improvement with vorapaxar compared with placebo,” Dr. Kosova said.

In a separate presentation focused on the 3,787 patients who gained entry into the TIMI 50 trial on the basis of symptomatic PAD, Dr. Antonio Gutierrez reported that acute limb ischemia occurred in 109 of them during the trial. Fifty-four percent of these events were due to acute surgical graft thrombosis, 27% to in situ thrombosis of a native vessel, and lesser numbers were due to thromboembolissm or stent thrombosis.

The 3-year acute limb ischemia rate in patients with baseline PAD was 3.9% with placebo compared to 2.3% with vorapaxar, for a 42% relative risk reduction, according to Dr. Gutierrez of Brigham and Women’s Hospital.

Dr. Ian Gilchrist, also from Brigham and Women’s Hospital, reported that in TIMI 50 participants with a history of PAD, vorapaxar resulted in a 16% reduction in the need for peripheral revascularization procedures for claudication, with rates of 9.4% for vorapaxar and 11.6% for placebo. There was also a statistically significant 41% reduction in the rate of surgical peripheral revascularization procedures, with rates of 4.5% for vorapaxar and 7.7% for placebo.

The TIMI 50 trial was funded by Merck. Drs. Kosova, Gutierrez, and Gilchrist reported having no financial conflicts of interest.

[email protected]

Team performing surgery

Photo by Piotr Bodzek

The US Food and Drug Administration (FDA) has approved the first spray-dried fibrin sealant to help control bleeding during surgery.

The agency approved Raplixa (formerly known as Fibrocaps) for use in adults to control bleeding from small blood vessels when standard surgical techniques are ineffective or impractical.

The standard techniques include suture, ligature, or cautery.

Raplixa contains fibrinogen and thrombin, proteins found in human plasma. When the surgical team applies Raplixa to the bleeding site, the sealant dissolves in the blood, and the fibrinogen and thrombin proteins react, resulting in the formation of blood clots.

The protein components are individually purified using a manufacturing process that includes virus inactivation and removal steps to help reduce the risk for the transmission of blood-borne viruses. The fibrin sealant components are then spray-dried, blended, and packaged in a vial.

Raplixa can be applied directly from the original product vial or by spraying it with a delivery device. Raplixa is used in conjunction with an absorbable gelatin sponge.

“The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial,” said Karen Midthun, MD, of the FDA’s Center for Biologics Evaluation and Research.

“This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature.”

Raplixa was approved for use in the European Union in March, based on the recommendation of the European Medicines Agency’s Committee for Medicinal Products for Human Use.

Phase 3 trial

The FDA approved Raplixa based on data from the FINISH-3 trial, a  randomized, single-blind, controlled, phase 3 study of 719 patients undergoing spinal surgery (n=183), hepatic resection (n=180), vascular surgery (n=175), or soft tissue dissection (n=181) in 4 countries over 11 months.

As reported in the Journal of the American College of Surgeons, adults with mild or moderate surgical bleeding were randomized to recieve Raplixa or the gelatin sponge. Researchers recorded the time to hemostasis over 5 minutes within each surgical indication.

Four hundred and eighty patients were treated with Raplixa, and 239 were treated with the gelatin sponge. Surgeons used the spray device in 53% of Raplixa procedures.

Raplixa used in conjunction with the gelatin sponge significantly reduced time to hemostasis compared to the gelatin sponge alone (P<0.001 for each of the 4 sugical indications).

Raplixa also significantly reduced median time to hemostasis for each indication (P<0.0001).

Adverse events were similar between the treatment arms. The most commonly reported adverse reactions were surgical pain, nausea, constipation, fever, and decreased blood pressure.

Two percent of Raplixa-treated patients developed non-neutralizing anti-thrombin antibodies, as did 3% of patients treated with the gelatin sponge.

Raplixa is manufactured by ProFibrix BV, a wholly owned subsidiary of The Medicines Company, based in Parsippany, New Jersey.

Team performing surgery

Photo by Piotr Bodzek

The US Food and Drug Administration (FDA) has approved the first spray-dried fibrin sealant to help control bleeding during surgery.

The agency approved Raplixa (formerly known as Fibrocaps) for use in adults to control bleeding from small blood vessels when standard surgical techniques are ineffective or impractical.

The standard techniques include suture, ligature, or cautery.

Raplixa contains fibrinogen and thrombin, proteins found in human plasma. When the surgical team applies Raplixa to the bleeding site, the sealant dissolves in the blood, and the fibrinogen and thrombin proteins react, resulting in the formation of blood clots.

The protein components are individually purified using a manufacturing process that includes virus inactivation and removal steps to help reduce the risk for the transmission of blood-borne viruses. The fibrin sealant components are then spray-dried, blended, and packaged in a vial.

Raplixa can be applied directly from the original product vial or by spraying it with a delivery device. Raplixa is used in conjunction with an absorbable gelatin sponge.

“The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial,” said Karen Midthun, MD, of the FDA’s Center for Biologics Evaluation and Research.

“This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature.”

Raplixa was approved for use in the European Union in March, based on the recommendation of the European Medicines Agency’s Committee for Medicinal Products for Human Use.

Phase 3 trial

The FDA approved Raplixa based on data from the FINISH-3 trial, a  randomized, single-blind, controlled, phase 3 study of 719 patients undergoing spinal surgery (n=183), hepatic resection (n=180), vascular surgery (n=175), or soft tissue dissection (n=181) in 4 countries over 11 months.

As reported in the Journal of the American College of Surgeons, adults with mild or moderate surgical bleeding were randomized to recieve Raplixa or the gelatin sponge. Researchers recorded the time to hemostasis over 5 minutes within each surgical indication.

Four hundred and eighty patients were treated with Raplixa, and 239 were treated with the gelatin sponge. Surgeons used the spray device in 53% of Raplixa procedures.

Raplixa used in conjunction with the gelatin sponge significantly reduced time to hemostasis compared to the gelatin sponge alone (P<0.001 for each of the 4 sugical indications).

Raplixa also significantly reduced median time to hemostasis for each indication (P<0.0001).

Adverse events were similar between the treatment arms. The most commonly reported adverse reactions were surgical pain, nausea, constipation, fever, and decreased blood pressure.

Two percent of Raplixa-treated patients developed non-neutralizing anti-thrombin antibodies, as did 3% of patients treated with the gelatin sponge.

Raplixa is manufactured by ProFibrix BV, a wholly owned subsidiary of The Medicines Company, based in Parsippany, New Jersey.

Team performing surgery

Photo by Piotr Bodzek

The US Food and Drug Administration (FDA) has approved the first spray-dried fibrin sealant to help control bleeding during surgery.

The agency approved Raplixa (formerly known as Fibrocaps) for use in adults to control bleeding from small blood vessels when standard surgical techniques are ineffective or impractical.

The standard techniques include suture, ligature, or cautery.

Raplixa contains fibrinogen and thrombin, proteins found in human plasma. When the surgical team applies Raplixa to the bleeding site, the sealant dissolves in the blood, and the fibrinogen and thrombin proteins react, resulting in the formation of blood clots.

The protein components are individually purified using a manufacturing process that includes virus inactivation and removal steps to help reduce the risk for the transmission of blood-borne viruses. The fibrin sealant components are then spray-dried, blended, and packaged in a vial.

Raplixa can be applied directly from the original product vial or by spraying it with a delivery device. Raplixa is used in conjunction with an absorbable gelatin sponge.

“The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial,” said Karen Midthun, MD, of the FDA’s Center for Biologics Evaluation and Research.

“This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature.”

Raplixa was approved for use in the European Union in March, based on the recommendation of the European Medicines Agency’s Committee for Medicinal Products for Human Use.

Phase 3 trial

The FDA approved Raplixa based on data from the FINISH-3 trial, a  randomized, single-blind, controlled, phase 3 study of 719 patients undergoing spinal surgery (n=183), hepatic resection (n=180), vascular surgery (n=175), or soft tissue dissection (n=181) in 4 countries over 11 months.

As reported in the Journal of the American College of Surgeons, adults with mild or moderate surgical bleeding were randomized to recieve Raplixa or the gelatin sponge. Researchers recorded the time to hemostasis over 5 minutes within each surgical indication.

Four hundred and eighty patients were treated with Raplixa, and 239 were treated with the gelatin sponge. Surgeons used the spray device in 53% of Raplixa procedures.

Raplixa used in conjunction with the gelatin sponge significantly reduced time to hemostasis compared to the gelatin sponge alone (P<0.001 for each of the 4 sugical indications).

Raplixa also significantly reduced median time to hemostasis for each indication (P<0.0001).

Adverse events were similar between the treatment arms. The most commonly reported adverse reactions were surgical pain, nausea, constipation, fever, and decreased blood pressure.

Two percent of Raplixa-treated patients developed non-neutralizing anti-thrombin antibodies, as did 3% of patients treated with the gelatin sponge.

Raplixa is manufactured by ProFibrix BV, a wholly owned subsidiary of The Medicines Company, based in Parsippany, New Jersey.

Photographs from Hospital Medicine 2015, which took place March 29-April 1 at the Gaylord National Hotel and Conference Center in National Harbor, Md.

Photos by Manuel Noguera

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Photographs from Hospital Medicine 2015, which took place March 29-April 1 at the Gaylord National Hotel and Conference Center in National Harbor, Md.

Photos by Manuel Noguera

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Photographs from Hospital Medicine 2015, which took place March 29-April 1 at the Gaylord National Hotel and Conference Center in National Harbor, Md.

Photos by Manuel Noguera

[gallery ids="9197,9196,9195,9194,9193,9192,9191,9190,9189,9188,9187,9186,9185,9184,9183,9182,9181,9180,9179,9178,9177,9176,9175,9171"]

Excerpts from our interview with Team Hospitalist member David Weidig, MD, director of hospital medicine for Aurora Medical Group in West Allis, Wis., about best practices for multi-site hospital medicine.

[audio mp3="http://www.the-hospitalist.org/wp-content/uploads/2015/05/David-Weidig_HM15_FINAL_050215.mp3"][/audio]

Excerpts from our interview with Team Hospitalist member David Weidig, MD, director of hospital medicine for Aurora Medical Group in West Allis, Wis., about best practices for multi-site hospital medicine.

[audio mp3="http://www.the-hospitalist.org/wp-content/uploads/2015/05/David-Weidig_HM15_FINAL_050215.mp3"][/audio]

Excerpts from our interview with Team Hospitalist member David Weidig, MD, director of hospital medicine for Aurora Medical Group in West Allis, Wis., about best practices for multi-site hospital medicine.

[audio mp3="http://www.the-hospitalist.org/wp-content/uploads/2015/05/David-Weidig_HM15_FINAL_050215.mp3"][/audio]

SHM founder Win Whitcomb, MD, MHM, chief medical officer of Remedy Partners of Darien, Conn., talks about the annual practice management pre-course in an ever-changing healthcare landscape.

SHM founder Win Whitcomb, MD, MHM, chief medical officer of Remedy Partners of Darien, Conn., talks about the annual practice management pre-course in an ever-changing healthcare landscape.

SHM founder Win Whitcomb, MD, MHM, chief medical officer of Remedy Partners of Darien, Conn., talks about the annual practice management pre-course in an ever-changing healthcare landscape.

In the United States, the cosmetic use of botulinum toxin type A (BTX-A) has continued to grow over the last 15 years, according to multispecialty data recently released by the American Society for Aesthetic Plastic Surgery. During these years, many of our patients, if not ourselves, have undergone treatment faithfully every 3 to 6 months to combat the signs of aging. Subsequently, with the monitoring of adverse events (AEs), the US Food and Drug Administration has issued a black box warning that covers serious side effects—respiratory compromise and death—associated with treatment, yet most of what is listed in the black box warning pertains to medical use rather than cosmetic use. However, with the ever-growing indications for BTX-A, we must be cognizant of the fact that our patients may be receiving concomitant treatment with BTX-A for medical conditions (eg, migraines, hyperhidrosis, achalasia, dysphonia, dystonia, strabismus) by other specialists. Thus, there is a need to understand the potential side effects associated with BTX-A treatments and long-term consequences.

In a January 21 article published online in Pharmacology Yiannakopoulou looked at national monitoring programs through the US Food and Drug Administration and the Danish Medicines Agency. Many of the AEs reported were related to medical use of BTX-A, including anaphylaxis, death, generalized weakness, and dysphagia. Serious AEs related to the cosmetic use of BTX-A included thyroid eye disease, sarcoidal granuloma, pseudoaneurysm of the frontal branch of the superior temporal artery, and severe respiratory failure. Additionally, a patient receiving BTX-A for palmar and axillary hyperhidrosis developed botulinumlike generalized weakness. Upon review of epidemiological studies, the incidence and types of AEs were covered. The vast majority of these events were related to the medical use of BTX-A, which could stem from the lack of long-term studies on cosmetic patients and the lack of reporting of many AEs. The author summarized that minimizing potential AEs relies on proper injection technique, proper storage of the medication, proper dosing, and thorough knowledge of the anatomy.

What’s the issue?

Botulinum toxin type A remains one of the most gratifying treatments for both physicians and patients alike. However, with the potential for abuse, as in the case of the recent fake Botox Cosmetic that has shown up on the market in the United States), we must remain vigilant for AEs. Furthermore, we must continue to emphasize to patients that it is a medical treatment and deserves all the attention and respect we give to other medical interventions. However, as the Yiannakopoulou review has shown, proper injection techniques have a low rate of AEs in the cosmetic use of BTX-A. Have you seen an increase in the number of cosmetic BTX-A patients receiving concomitant treatments with BTX-A for medical conditions? If so, how do you manage them?

We want to know your views! Tell us what you think.

In the United States, the cosmetic use of botulinum toxin type A (BTX-A) has continued to grow over the last 15 years, according to multispecialty data recently released by the American Society for Aesthetic Plastic Surgery. During these years, many of our patients, if not ourselves, have undergone treatment faithfully every 3 to 6 months to combat the signs of aging. Subsequently, with the monitoring of adverse events (AEs), the US Food and Drug Administration has issued a black box warning that covers serious side effects—respiratory compromise and death—associated with treatment, yet most of what is listed in the black box warning pertains to medical use rather than cosmetic use. However, with the ever-growing indications for BTX-A, we must be cognizant of the fact that our patients may be receiving concomitant treatment with BTX-A for medical conditions (eg, migraines, hyperhidrosis, achalasia, dysphonia, dystonia, strabismus) by other specialists. Thus, there is a need to understand the potential side effects associated with BTX-A treatments and long-term consequences.

In a January 21 article published online in Pharmacology Yiannakopoulou looked at national monitoring programs through the US Food and Drug Administration and the Danish Medicines Agency. Many of the AEs reported were related to medical use of BTX-A, including anaphylaxis, death, generalized weakness, and dysphagia. Serious AEs related to the cosmetic use of BTX-A included thyroid eye disease, sarcoidal granuloma, pseudoaneurysm of the frontal branch of the superior temporal artery, and severe respiratory failure. Additionally, a patient receiving BTX-A for palmar and axillary hyperhidrosis developed botulinumlike generalized weakness. Upon review of epidemiological studies, the incidence and types of AEs were covered. The vast majority of these events were related to the medical use of BTX-A, which could stem from the lack of long-term studies on cosmetic patients and the lack of reporting of many AEs. The author summarized that minimizing potential AEs relies on proper injection technique, proper storage of the medication, proper dosing, and thorough knowledge of the anatomy.

What’s the issue?

Botulinum toxin type A remains one of the most gratifying treatments for both physicians and patients alike. However, with the potential for abuse, as in the case of the recent fake Botox Cosmetic that has shown up on the market in the United States), we must remain vigilant for AEs. Furthermore, we must continue to emphasize to patients that it is a medical treatment and deserves all the attention and respect we give to other medical interventions. However, as the Yiannakopoulou review has shown, proper injection techniques have a low rate of AEs in the cosmetic use of BTX-A. Have you seen an increase in the number of cosmetic BTX-A patients receiving concomitant treatments with BTX-A for medical conditions? If so, how do you manage them?

We want to know your views! Tell us what you think.

In the United States, the cosmetic use of botulinum toxin type A (BTX-A) has continued to grow over the last 15 years, according to multispecialty data recently released by the American Society for Aesthetic Plastic Surgery. During these years, many of our patients, if not ourselves, have undergone treatment faithfully every 3 to 6 months to combat the signs of aging. Subsequently, with the monitoring of adverse events (AEs), the US Food and Drug Administration has issued a black box warning that covers serious side effects—respiratory compromise and death—associated with treatment, yet most of what is listed in the black box warning pertains to medical use rather than cosmetic use. However, with the ever-growing indications for BTX-A, we must be cognizant of the fact that our patients may be receiving concomitant treatment with BTX-A for medical conditions (eg, migraines, hyperhidrosis, achalasia, dysphonia, dystonia, strabismus) by other specialists. Thus, there is a need to understand the potential side effects associated with BTX-A treatments and long-term consequences.

In a January 21 article published online in Pharmacology Yiannakopoulou looked at national monitoring programs through the US Food and Drug Administration and the Danish Medicines Agency. Many of the AEs reported were related to medical use of BTX-A, including anaphylaxis, death, generalized weakness, and dysphagia. Serious AEs related to the cosmetic use of BTX-A included thyroid eye disease, sarcoidal granuloma, pseudoaneurysm of the frontal branch of the superior temporal artery, and severe respiratory failure. Additionally, a patient receiving BTX-A for palmar and axillary hyperhidrosis developed botulinumlike generalized weakness. Upon review of epidemiological studies, the incidence and types of AEs were covered. The vast majority of these events were related to the medical use of BTX-A, which could stem from the lack of long-term studies on cosmetic patients and the lack of reporting of many AEs. The author summarized that minimizing potential AEs relies on proper injection technique, proper storage of the medication, proper dosing, and thorough knowledge of the anatomy.

What’s the issue?

Botulinum toxin type A remains one of the most gratifying treatments for both physicians and patients alike. However, with the potential for abuse, as in the case of the recent fake Botox Cosmetic that has shown up on the market in the United States), we must remain vigilant for AEs. Furthermore, we must continue to emphasize to patients that it is a medical treatment and deserves all the attention and respect we give to other medical interventions. However, as the Yiannakopoulou review has shown, proper injection techniques have a low rate of AEs in the cosmetic use of BTX-A. Have you seen an increase in the number of cosmetic BTX-A patients receiving concomitant treatments with BTX-A for medical conditions? If so, how do you manage them?

We want to know your views! Tell us what you think.

New SHM President Robert Harrington Jr., MD, SFHM, talks about his views on hospital medicine, the society and the value of diversity and teamwork.

New SHM President Robert Harrington Jr., MD, SFHM, talks about his views on hospital medicine, the society and the value of diversity and teamwork.

New SHM President Robert Harrington Jr., MD, SFHM, talks about his views on hospital medicine, the society and the value of diversity and teamwork.