Study Overview

Objective. To compare the incidence of hepatic decompensation in patients who are co-infected with HIV and hepatitis C (HCV) and who underwent antiretroviral treatment and patients who are HCV-monoinfected.

Design. Retrospective cohort study.

Participants and setting. This study used the Veterans Aging Cohort Study Virtual Cohort (VACS-VC), which includes electronic medical record data from patients who are HIV-infected and are receiving care at Veterans Affairs (VA) medical facilities in the United States. Inclusion criteria for patients who were co-infected were: detectable HCV RNA, recently initiated antiretroviral therapy (ART), defined as use of ≥ 3 antiretroviral drugs from 2 classes or ≥ 3 nucleoside analogues within the VA system, HIV RNA level > 500 copies/mL within 180 days before starting ART, and were seen in the VACS-VC for at least 12 months after initiating ART. Inclusion criteria for patients who were monoinfected with HCV were detectable HCV RNA, no HIV diagnosis or antiretroviral prescriptions, and seen in the VACS-VC for at least 12 months prior to inclusion into the study. Exclusion criteria were hepatic decompensation, hepatocellular carcinoma, and liver transplant during the 12-month baseline period or receipt of interferon-based HCV therapy.

Main outcome measure. The primary outcome was incident hepatic decompensation, defined as diagnosis of ascites, spontaneous bacterial peritonitis, or esophageal variceal hemorrhage at hospital discharge or 2 such outpatient diagnoses.

Main results. A total of 10,359 patients met inclusion criteria and were enrolled between 1997 and 2010. Of these, 4280 were patients co-infected with HIV and HCV and treated with antiretroviral agents and 6079 were patients who were HCV-monoinfected. Age, race/ethnicity, and history of diabetes, alcohol dependence or abuse, and injection or non-injection drug were similar between the 2 groups. The majority of participants were men. HCV genotype 1 was most prevalent in both groups. There were more patients who had HCV RNA levels ≥ 400,000 IU/mL and/or ≥ 1x10⁶ copies/mL in the co-infected group versus the monoinfected group.

Hepatic decompensation occurred more frequently among those who were co-infected and receiving ART (271 [6.3%]) than among those who were monoinfected (305 [5.0%], P = 0.004). The incidence rate was 9.5 events per 1000 person-years (95% CI, 7.6–11.9) among patients co-infected with HIV and HCV and treated with ART and 5.7 events per 1000 person-years (95% CI, 4.4–7.4) among patients who were monoinfected. Variceal hemorrhage was less common among patients who were co-infected as compared to those who were monoinfected (71 [26.2%] vs. 168 [55.1%], P < 0.001). The proportion of patients with ascites (226 [83.4%] in the co-infected group vs. 236 [77.4%] in the monoinfected, P = 0.070) and spontaneous bacterial peritonitis (48 [17.7%] in the co-infected group vs. 68 [22.3%] in the monoinfected, P = 0.171) were similar. After adjustment for age, race/ethnicity, diabetes, BMI, history of alcohol abuse, injection or non-injection drug use, and VA center patient volume, patients who were co-infected and receiving ART had a higher rate of hepatic decompensation than monoinfected patients (hazard ratio, 1.83 [95% CI, 1.54–2.18]).

In subgroup analysis, rates of decompensation remained higher even among co-infected patients who maintained HIV RNA levels < 1000 copies/mL (hazard ratio 1.65 [95% CI 1.20–2.27])

Conclusion. Patients who were co-infected with HIV and HCV and treated with ART had higher rates of hepatic decompensation compared with patients monoinfected with HCV. Good control of HIV viral loads in co-infected patients may not be sufficient to improve health outcomes.

Commentary

Currently, it is estimated that there are 3.5 to 5.5 million people in the United States infected with HCV, accounting for about 1.5% of the population. Approximately 20% to 40% of those infected will develop chronic infection and 10% to 25% of these patients will progress to experience severe liver disease [1]. Yet of the 3.5 million people who are thought be chronically infected with HCV, only 50% are diagnosed and are aware of the infection and a mere 16% are treated for HCV [2].

Estimates suggest that about 10% of those with HCV are also infected with HIV. In the era prior to ART for HIV infections, patients with HIV and HCV most commonly died of HIV-related causes. In the post-ART era, patients are surviving longer and are now experiencing HCV-related comorbidities [3].

This study compares the incidence of hepatic decompensation in patients with HIV and HCV co-infection who are undergoing treatment with ART and those with HCV monoinfection. The results show that patients who were co-infected and treated with ART had higher incidence of hepatic decompensation as compared with those who were monoinfected. This study’s strengths are the large enrollment numbers (> 10,000 patients) and the long follow-up periods (6.8 and 9.9 years for the co-infected and monoinfected cohorts, respectively). As the authors indicate, the weakness of this study is the exclusion of the diagnosis of hepatic encephalopathy and jaundice from their definition of hepatic decompensation. Their reasoning for doing so is that these frequently occur due to unrelated causes, such as narcotic overdose and biliary obstruction. It is possible that this resulted in  an underestimation of hepatic decompensation. Finally, 98.8% of the enrolled patients were male. The study results cannot be generalized to women.

Since 2011, the availability of direct-acting antivirals for the treatment of HCV has rapidly increased. These new agents have improved treatment outcomes with better sustained virological response, shorter treatment duration, and better adverse event rates [4]. Telaprevir and boceprevir were first-generation protease inhibitors, and  these were followed by simeprevir in 2013. Sofosbuvir also became available in 2013 as the first polymerase inhibitor. These agents were and continue to be evaluated for use in HIV/HCV co-infected patients both in treatment-naive and previously treated patients with good outcomes. A fifth agent, faldaprevir, another protease inhibitor, is expected to become available this year and others are in clinical trials [5]. Sustained virologic response rates of 67% to 88% depending on genotype with regimens using sofosbuvir in co-infected patients for example, have been achieved, which are similar to rates in monoinfected patients [6].

Applications for Clinical Practice

The authors found that management of HIV viral loads to less than 1000 copies/mL reduced the risk for hepatic decompensation. However, the difference in incidence rates between those whose HIV load was < 1000 copies/mL and those whose viral load was ≥ 1000 copies/mL was small (9.4 [95% CI, 5.4–16.2] vs. 9.6 [95% CI, 7.5–12.2]). The findings suggest that control of HIV viral loads in co-infected patients is not sufficient to reduce the rate of liver complications. The authors propose that earlier consideration be given to treatment of HCV infection in co-infected patients to improve health outcomes. The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America have published guidelines for the diagnosis and management of HCV [7]. The difference in hepatic decompensation rates between mono- and co-infected patients should become less relevant as use of direct-acting antivirals expands.

—Mayu O. Frank, MS, ANP-BC and Allison Squires, PhD, RN, New York University College of Nursing

Study Overview

Objective. To compare the incidence of hepatic decompensation in patients who are co-infected with HIV and hepatitis C (HCV) and who underwent antiretroviral treatment and patients who are HCV-monoinfected.

Design. Retrospective cohort study.

Participants and setting. This study used the Veterans Aging Cohort Study Virtual Cohort (VACS-VC), which includes electronic medical record data from patients who are HIV-infected and are receiving care at Veterans Affairs (VA) medical facilities in the United States. Inclusion criteria for patients who were co-infected were: detectable HCV RNA, recently initiated antiretroviral therapy (ART), defined as use of ≥ 3 antiretroviral drugs from 2 classes or ≥ 3 nucleoside analogues within the VA system, HIV RNA level > 500 copies/mL within 180 days before starting ART, and were seen in the VACS-VC for at least 12 months after initiating ART. Inclusion criteria for patients who were monoinfected with HCV were detectable HCV RNA, no HIV diagnosis or antiretroviral prescriptions, and seen in the VACS-VC for at least 12 months prior to inclusion into the study. Exclusion criteria were hepatic decompensation, hepatocellular carcinoma, and liver transplant during the 12-month baseline period or receipt of interferon-based HCV therapy.

Main outcome measure. The primary outcome was incident hepatic decompensation, defined as diagnosis of ascites, spontaneous bacterial peritonitis, or esophageal variceal hemorrhage at hospital discharge or 2 such outpatient diagnoses.

Main results. A total of 10,359 patients met inclusion criteria and were enrolled between 1997 and 2010. Of these, 4280 were patients co-infected with HIV and HCV and treated with antiretroviral agents and 6079 were patients who were HCV-monoinfected. Age, race/ethnicity, and history of diabetes, alcohol dependence or abuse, and injection or non-injection drug were similar between the 2 groups. The majority of participants were men. HCV genotype 1 was most prevalent in both groups. There were more patients who had HCV RNA levels ≥ 400,000 IU/mL and/or ≥ 1x10⁶ copies/mL in the co-infected group versus the monoinfected group.

Hepatic decompensation occurred more frequently among those who were co-infected and receiving ART (271 [6.3%]) than among those who were monoinfected (305 [5.0%], P = 0.004). The incidence rate was 9.5 events per 1000 person-years (95% CI, 7.6–11.9) among patients co-infected with HIV and HCV and treated with ART and 5.7 events per 1000 person-years (95% CI, 4.4–7.4) among patients who were monoinfected. Variceal hemorrhage was less common among patients who were co-infected as compared to those who were monoinfected (71 [26.2%] vs. 168 [55.1%], P < 0.001). The proportion of patients with ascites (226 [83.4%] in the co-infected group vs. 236 [77.4%] in the monoinfected, P = 0.070) and spontaneous bacterial peritonitis (48 [17.7%] in the co-infected group vs. 68 [22.3%] in the monoinfected, P = 0.171) were similar. After adjustment for age, race/ethnicity, diabetes, BMI, history of alcohol abuse, injection or non-injection drug use, and VA center patient volume, patients who were co-infected and receiving ART had a higher rate of hepatic decompensation than monoinfected patients (hazard ratio, 1.83 [95% CI, 1.54–2.18]).

In subgroup analysis, rates of decompensation remained higher even among co-infected patients who maintained HIV RNA levels < 1000 copies/mL (hazard ratio 1.65 [95% CI 1.20–2.27])

Conclusion. Patients who were co-infected with HIV and HCV and treated with ART had higher rates of hepatic decompensation compared with patients monoinfected with HCV. Good control of HIV viral loads in co-infected patients may not be sufficient to improve health outcomes.

Commentary

Currently, it is estimated that there are 3.5 to 5.5 million people in the United States infected with HCV, accounting for about 1.5% of the population. Approximately 20% to 40% of those infected will develop chronic infection and 10% to 25% of these patients will progress to experience severe liver disease [1]. Yet of the 3.5 million people who are thought be chronically infected with HCV, only 50% are diagnosed and are aware of the infection and a mere 16% are treated for HCV [2].

Estimates suggest that about 10% of those with HCV are also infected with HIV. In the era prior to ART for HIV infections, patients with HIV and HCV most commonly died of HIV-related causes. In the post-ART era, patients are surviving longer and are now experiencing HCV-related comorbidities [3].

This study compares the incidence of hepatic decompensation in patients with HIV and HCV co-infection who are undergoing treatment with ART and those with HCV monoinfection. The results show that patients who were co-infected and treated with ART had higher incidence of hepatic decompensation as compared with those who were monoinfected. This study’s strengths are the large enrollment numbers (> 10,000 patients) and the long follow-up periods (6.8 and 9.9 years for the co-infected and monoinfected cohorts, respectively). As the authors indicate, the weakness of this study is the exclusion of the diagnosis of hepatic encephalopathy and jaundice from their definition of hepatic decompensation. Their reasoning for doing so is that these frequently occur due to unrelated causes, such as narcotic overdose and biliary obstruction. It is possible that this resulted in  an underestimation of hepatic decompensation. Finally, 98.8% of the enrolled patients were male. The study results cannot be generalized to women.

Since 2011, the availability of direct-acting antivirals for the treatment of HCV has rapidly increased. These new agents have improved treatment outcomes with better sustained virological response, shorter treatment duration, and better adverse event rates [4]. Telaprevir and boceprevir were first-generation protease inhibitors, and  these were followed by simeprevir in 2013. Sofosbuvir also became available in 2013 as the first polymerase inhibitor. These agents were and continue to be evaluated for use in HIV/HCV co-infected patients both in treatment-naive and previously treated patients with good outcomes. A fifth agent, faldaprevir, another protease inhibitor, is expected to become available this year and others are in clinical trials [5]. Sustained virologic response rates of 67% to 88% depending on genotype with regimens using sofosbuvir in co-infected patients for example, have been achieved, which are similar to rates in monoinfected patients [6].

Applications for Clinical Practice

The authors found that management of HIV viral loads to less than 1000 copies/mL reduced the risk for hepatic decompensation. However, the difference in incidence rates between those whose HIV load was < 1000 copies/mL and those whose viral load was ≥ 1000 copies/mL was small (9.4 [95% CI, 5.4–16.2] vs. 9.6 [95% CI, 7.5–12.2]). The findings suggest that control of HIV viral loads in co-infected patients is not sufficient to reduce the rate of liver complications. The authors propose that earlier consideration be given to treatment of HCV infection in co-infected patients to improve health outcomes. The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America have published guidelines for the diagnosis and management of HCV [7]. The difference in hepatic decompensation rates between mono- and co-infected patients should become less relevant as use of direct-acting antivirals expands.

—Mayu O. Frank, MS, ANP-BC and Allison Squires, PhD, RN, New York University College of Nursing

Study Overview

Objective. To compare the incidence of hepatic decompensation in patients who are co-infected with HIV and hepatitis C (HCV) and who underwent antiretroviral treatment and patients who are HCV-monoinfected.

Design. Retrospective cohort study.

Participants and setting. This study used the Veterans Aging Cohort Study Virtual Cohort (VACS-VC), which includes electronic medical record data from patients who are HIV-infected and are receiving care at Veterans Affairs (VA) medical facilities in the United States. Inclusion criteria for patients who were co-infected were: detectable HCV RNA, recently initiated antiretroviral therapy (ART), defined as use of ≥ 3 antiretroviral drugs from 2 classes or ≥ 3 nucleoside analogues within the VA system, HIV RNA level > 500 copies/mL within 180 days before starting ART, and were seen in the VACS-VC for at least 12 months after initiating ART. Inclusion criteria for patients who were monoinfected with HCV were detectable HCV RNA, no HIV diagnosis or antiretroviral prescriptions, and seen in the VACS-VC for at least 12 months prior to inclusion into the study. Exclusion criteria were hepatic decompensation, hepatocellular carcinoma, and liver transplant during the 12-month baseline period or receipt of interferon-based HCV therapy.

Main outcome measure. The primary outcome was incident hepatic decompensation, defined as diagnosis of ascites, spontaneous bacterial peritonitis, or esophageal variceal hemorrhage at hospital discharge or 2 such outpatient diagnoses.

Main results. A total of 10,359 patients met inclusion criteria and were enrolled between 1997 and 2010. Of these, 4280 were patients co-infected with HIV and HCV and treated with antiretroviral agents and 6079 were patients who were HCV-monoinfected. Age, race/ethnicity, and history of diabetes, alcohol dependence or abuse, and injection or non-injection drug were similar between the 2 groups. The majority of participants were men. HCV genotype 1 was most prevalent in both groups. There were more patients who had HCV RNA levels ≥ 400,000 IU/mL and/or ≥ 1x10⁶ copies/mL in the co-infected group versus the monoinfected group.

Hepatic decompensation occurred more frequently among those who were co-infected and receiving ART (271 [6.3%]) than among those who were monoinfected (305 [5.0%], P = 0.004). The incidence rate was 9.5 events per 1000 person-years (95% CI, 7.6–11.9) among patients co-infected with HIV and HCV and treated with ART and 5.7 events per 1000 person-years (95% CI, 4.4–7.4) among patients who were monoinfected. Variceal hemorrhage was less common among patients who were co-infected as compared to those who were monoinfected (71 [26.2%] vs. 168 [55.1%], P < 0.001). The proportion of patients with ascites (226 [83.4%] in the co-infected group vs. 236 [77.4%] in the monoinfected, P = 0.070) and spontaneous bacterial peritonitis (48 [17.7%] in the co-infected group vs. 68 [22.3%] in the monoinfected, P = 0.171) were similar. After adjustment for age, race/ethnicity, diabetes, BMI, history of alcohol abuse, injection or non-injection drug use, and VA center patient volume, patients who were co-infected and receiving ART had a higher rate of hepatic decompensation than monoinfected patients (hazard ratio, 1.83 [95% CI, 1.54–2.18]).

In subgroup analysis, rates of decompensation remained higher even among co-infected patients who maintained HIV RNA levels < 1000 copies/mL (hazard ratio 1.65 [95% CI 1.20–2.27])

Conclusion. Patients who were co-infected with HIV and HCV and treated with ART had higher rates of hepatic decompensation compared with patients monoinfected with HCV. Good control of HIV viral loads in co-infected patients may not be sufficient to improve health outcomes.

Commentary

Currently, it is estimated that there are 3.5 to 5.5 million people in the United States infected with HCV, accounting for about 1.5% of the population. Approximately 20% to 40% of those infected will develop chronic infection and 10% to 25% of these patients will progress to experience severe liver disease [1]. Yet of the 3.5 million people who are thought be chronically infected with HCV, only 50% are diagnosed and are aware of the infection and a mere 16% are treated for HCV [2].

Estimates suggest that about 10% of those with HCV are also infected with HIV. In the era prior to ART for HIV infections, patients with HIV and HCV most commonly died of HIV-related causes. In the post-ART era, patients are surviving longer and are now experiencing HCV-related comorbidities [3].

This study compares the incidence of hepatic decompensation in patients with HIV and HCV co-infection who are undergoing treatment with ART and those with HCV monoinfection. The results show that patients who were co-infected and treated with ART had higher incidence of hepatic decompensation as compared with those who were monoinfected. This study’s strengths are the large enrollment numbers (> 10,000 patients) and the long follow-up periods (6.8 and 9.9 years for the co-infected and monoinfected cohorts, respectively). As the authors indicate, the weakness of this study is the exclusion of the diagnosis of hepatic encephalopathy and jaundice from their definition of hepatic decompensation. Their reasoning for doing so is that these frequently occur due to unrelated causes, such as narcotic overdose and biliary obstruction. It is possible that this resulted in  an underestimation of hepatic decompensation. Finally, 98.8% of the enrolled patients were male. The study results cannot be generalized to women.

Since 2011, the availability of direct-acting antivirals for the treatment of HCV has rapidly increased. These new agents have improved treatment outcomes with better sustained virological response, shorter treatment duration, and better adverse event rates [4]. Telaprevir and boceprevir were first-generation protease inhibitors, and  these were followed by simeprevir in 2013. Sofosbuvir also became available in 2013 as the first polymerase inhibitor. These agents were and continue to be evaluated for use in HIV/HCV co-infected patients both in treatment-naive and previously treated patients with good outcomes. A fifth agent, faldaprevir, another protease inhibitor, is expected to become available this year and others are in clinical trials [5]. Sustained virologic response rates of 67% to 88% depending on genotype with regimens using sofosbuvir in co-infected patients for example, have been achieved, which are similar to rates in monoinfected patients [6].

Applications for Clinical Practice

The authors found that management of HIV viral loads to less than 1000 copies/mL reduced the risk for hepatic decompensation. However, the difference in incidence rates between those whose HIV load was < 1000 copies/mL and those whose viral load was ≥ 1000 copies/mL was small (9.4 [95% CI, 5.4–16.2] vs. 9.6 [95% CI, 7.5–12.2]). The findings suggest that control of HIV viral loads in co-infected patients is not sufficient to reduce the rate of liver complications. The authors propose that earlier consideration be given to treatment of HCV infection in co-infected patients to improve health outcomes. The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America have published guidelines for the diagnosis and management of HCV [7]. The difference in hepatic decompensation rates between mono- and co-infected patients should become less relevant as use of direct-acting antivirals expands.

—Mayu O. Frank, MS, ANP-BC and Allison Squires, PhD, RN, New York University College of Nursing

Study Overview

Objective. To evaluate the usefulness of the Frailty Index (FI) as a prognostic indicator of adverse outcomes in geriatric trauma patients.

Design. Prospective cohort study.

Setting and participants. Geriatric (aged 65 and over) trauma patients admitted to inpatient units at a Level 1 trauma center in Arizona were enrolled. Patients were excluded if they were intubated/nonresponsive with no family members present or transferred from another institution (eg, skilled nursing facility). The following categories of data were collected: (a) patient demographics, (b) type and mechanism of injury, (c) vital signs (eg, Glasgow coma scale score, systolic blood pressure, heart rate, body temperature), (d) need for operative intervention, (e) in-hospital complications, (f) hospital and intensive care unit  (ICU) lengths of stay, and (g) discharge disposition.

Patients or, in the case of nonresponsive patients, their closest relative, responded to the 50-item Frailty Index questionnaire, which includes questions regarding age, comorbid conditions, medications, activities of daily living (ADLs), social activities, mood, and nutrition. FI score ranges from 0 (non-frail) to 1 (frail), with an FI of 0.25 or more indicative of frailty based on established guidelines. Patients were categorized as frail or non-frail according to their FI scores and were followed during the course of their hospitalization.

Main outcome measure. The primary outcome measure was in-hospital complications. In-hospital complications included myocardial infarction, cardiopulmonary arrest, pneumonia, pulmonary embolism, sepsis, urinary tract infection, deep venous thrombosis, disseminated intravascular coagulation, renal insufficiency, and reoperation. The secondary outcome measure was adverse discharge disposition, which was defined as death during the course of hospitalization or discharge to a skilled nursing facility.

Main results. The sample consisted of 250 patients with a mean age of 77.9 years. Among these, 44.0% were considered frail. Patients with frailty were more likely to have a higher Injury Severity Score (P = 0.04) and a higher mean FI (P = 0.01) than those without frailty. There were no statistically significant differences with respect to age (P = 0.21), mechanism of injury (P = 0.09), systolic blood pressure (P = 0.30), or Glasgow Coma Scale score (P = 0.91) between the groups.

Patients with frailty were more likely to develop in-hospital complications (37.3% vs 21.4%, P = 0.001) than those without frailty. Among these complications, pneumonia and urinary tract infection were the most common. There were no differences in the rate of re-operation (P = 0.54) between the 2 groups. An FI of 0.25 or higher was associated with the development of in-hospital complications (P = 0.001) even after adjust-ing for age, systolic blood pressure, heart rate, and Injury Severity Score.

Frail patients had longer hospital length of stay (P = 0.01) and ICU length of stay (P = 0.01), and were more likely to have adverse discharge disposition (37.3% vs. 12.9%, P = 0.001). All patients who died during the course of hospitalization (n = 5) were considered frail. Frailty was also found to be a predictor of adverse discharge disposition (P = 0.001) after adjustment for age, male sex, Injury Severity Score, and mechanism of injury.

Conclusion. The FI is effective in identifying geriatric trauma patients who are vulnerable to poor health outcomes.

Commentary

The diagnosis and treatment of elderly patients is complicated by the presence of multiple geriatric syndromes, including frailty [1]. Frailty is defined as increased vulnerability to negative health outcomes, marked by physical and functional decline, that eventually leads to disability, dependency, and mortality [2]. Factors such as age, malnutrition, and disease give way to dysregulations of bodily systems that eventually lead to reductions in mobility, strength, and cognition in frail older adults [3]. In turn, frail patients, who lack the physiological reserves to withstand illness and adapt to stressors, experience high incidences of hospitalizations, mortality, and reduced quality of life. Unsurprisingly, mortality rates among geriatric trauma patients are higher than those found in ordinary adult trauma patients [4]. It is, therefore, essential to identify patients with frailty at the outset of hospitalization in order to improve health outcomes and reduce mortality rates in this population. Yet, there is a dearth of assessment tools to predict outcomes in frail trauma patients [5].

This study has several strengths. Outcome measures are plainly stated. The inclusion criteria was broad enough to include most geriatric trauma patients, but the authors eliminated a number of confounders by excluding patients admitted from institutional settings, who may have been more susceptible to negative health outcomes at baseline than noninstitutionalized adults. Recruitment strategies were acceptable and reflect ethical standards. Groups were defined based on an accepted and previously validated FI cutoff. Lack of blinding did not threaten the study’s design given that most outcomes were beyond the control of study participants. Multivariate regression adjusted for a number of potential confounders including age, length of hospitalization, and injury severity. The Injury Severity Score, the Abbreviated Injury Scale score, and the Glasgow Coma Scale score are validated instruments that are widely used and enable standardized assessments of cognition and degree of injury.

The study methodology also possesses a number of weaknesses. The authors followed patients from admission to discharge; however, they did not re-evaluate patients following their release from the inpatient setting. It is, therefore, not clear whether the FI is predictive of quality of life, functional status, or hospital readmissions upon discharge into the community. The cohort was largely male (69.2%) and predominately Caucasian. Participants were recruited from only one medical center. All of these limit the study’s generalizability. In addition, the authors do not clarify how they came to define the criteria for in-hospital complications or adverse discharge disposition. For example, the study does not consider skin breakdown, a common concern among older patients who are hospitalized, as an in-hospital complication. In addition, the authors did not adjust for the number of diagnoses at baseline or the presence of chronic comorbid conditions, which are also associated with negative health outcomes.

Applications for Clinical Practice

Although lengthy, with over 50 variables in 5 categories, the FI has the potential to help health care providers improve risk stratification, assess patient acuity, and formulate treatment plans to improve the health of frail elderly patients. The FI will enable hospitals to direct appropriate resources, including staff, to the most vulnerable subsets of patients in order to improve outcomes and reduce costs. Moreover, awareness of frailty enables greater discussion between patients and families of trauma patients about the risks and benefits of complex intervention, increases referrals to palliative care, and improves quality of life in this population [6].

—Tina Sadarangani, MSN, APRN, and Allison Squires, PhD, RN, New York University College of Nursing

Study Overview

Objective. To evaluate the usefulness of the Frailty Index (FI) as a prognostic indicator of adverse outcomes in geriatric trauma patients.

Design. Prospective cohort study.

Setting and participants. Geriatric (aged 65 and over) trauma patients admitted to inpatient units at a Level 1 trauma center in Arizona were enrolled. Patients were excluded if they were intubated/nonresponsive with no family members present or transferred from another institution (eg, skilled nursing facility). The following categories of data were collected: (a) patient demographics, (b) type and mechanism of injury, (c) vital signs (eg, Glasgow coma scale score, systolic blood pressure, heart rate, body temperature), (d) need for operative intervention, (e) in-hospital complications, (f) hospital and intensive care unit  (ICU) lengths of stay, and (g) discharge disposition.

Patients or, in the case of nonresponsive patients, their closest relative, responded to the 50-item Frailty Index questionnaire, which includes questions regarding age, comorbid conditions, medications, activities of daily living (ADLs), social activities, mood, and nutrition. FI score ranges from 0 (non-frail) to 1 (frail), with an FI of 0.25 or more indicative of frailty based on established guidelines. Patients were categorized as frail or non-frail according to their FI scores and were followed during the course of their hospitalization.

Main outcome measure. The primary outcome measure was in-hospital complications. In-hospital complications included myocardial infarction, cardiopulmonary arrest, pneumonia, pulmonary embolism, sepsis, urinary tract infection, deep venous thrombosis, disseminated intravascular coagulation, renal insufficiency, and reoperation. The secondary outcome measure was adverse discharge disposition, which was defined as death during the course of hospitalization or discharge to a skilled nursing facility.

Main results. The sample consisted of 250 patients with a mean age of 77.9 years. Among these, 44.0% were considered frail. Patients with frailty were more likely to have a higher Injury Severity Score (P = 0.04) and a higher mean FI (P = 0.01) than those without frailty. There were no statistically significant differences with respect to age (P = 0.21), mechanism of injury (P = 0.09), systolic blood pressure (P = 0.30), or Glasgow Coma Scale score (P = 0.91) between the groups.

Patients with frailty were more likely to develop in-hospital complications (37.3% vs 21.4%, P = 0.001) than those without frailty. Among these complications, pneumonia and urinary tract infection were the most common. There were no differences in the rate of re-operation (P = 0.54) between the 2 groups. An FI of 0.25 or higher was associated with the development of in-hospital complications (P = 0.001) even after adjust-ing for age, systolic blood pressure, heart rate, and Injury Severity Score.

Frail patients had longer hospital length of stay (P = 0.01) and ICU length of stay (P = 0.01), and were more likely to have adverse discharge disposition (37.3% vs. 12.9%, P = 0.001). All patients who died during the course of hospitalization (n = 5) were considered frail. Frailty was also found to be a predictor of adverse discharge disposition (P = 0.001) after adjustment for age, male sex, Injury Severity Score, and mechanism of injury.

Conclusion. The FI is effective in identifying geriatric trauma patients who are vulnerable to poor health outcomes.

Commentary

The diagnosis and treatment of elderly patients is complicated by the presence of multiple geriatric syndromes, including frailty [1]. Frailty is defined as increased vulnerability to negative health outcomes, marked by physical and functional decline, that eventually leads to disability, dependency, and mortality [2]. Factors such as age, malnutrition, and disease give way to dysregulations of bodily systems that eventually lead to reductions in mobility, strength, and cognition in frail older adults [3]. In turn, frail patients, who lack the physiological reserves to withstand illness and adapt to stressors, experience high incidences of hospitalizations, mortality, and reduced quality of life. Unsurprisingly, mortality rates among geriatric trauma patients are higher than those found in ordinary adult trauma patients [4]. It is, therefore, essential to identify patients with frailty at the outset of hospitalization in order to improve health outcomes and reduce mortality rates in this population. Yet, there is a dearth of assessment tools to predict outcomes in frail trauma patients [5].

This study has several strengths. Outcome measures are plainly stated. The inclusion criteria was broad enough to include most geriatric trauma patients, but the authors eliminated a number of confounders by excluding patients admitted from institutional settings, who may have been more susceptible to negative health outcomes at baseline than noninstitutionalized adults. Recruitment strategies were acceptable and reflect ethical standards. Groups were defined based on an accepted and previously validated FI cutoff. Lack of blinding did not threaten the study’s design given that most outcomes were beyond the control of study participants. Multivariate regression adjusted for a number of potential confounders including age, length of hospitalization, and injury severity. The Injury Severity Score, the Abbreviated Injury Scale score, and the Glasgow Coma Scale score are validated instruments that are widely used and enable standardized assessments of cognition and degree of injury.

The study methodology also possesses a number of weaknesses. The authors followed patients from admission to discharge; however, they did not re-evaluate patients following their release from the inpatient setting. It is, therefore, not clear whether the FI is predictive of quality of life, functional status, or hospital readmissions upon discharge into the community. The cohort was largely male (69.2%) and predominately Caucasian. Participants were recruited from only one medical center. All of these limit the study’s generalizability. In addition, the authors do not clarify how they came to define the criteria for in-hospital complications or adverse discharge disposition. For example, the study does not consider skin breakdown, a common concern among older patients who are hospitalized, as an in-hospital complication. In addition, the authors did not adjust for the number of diagnoses at baseline or the presence of chronic comorbid conditions, which are also associated with negative health outcomes.

Applications for Clinical Practice

Although lengthy, with over 50 variables in 5 categories, the FI has the potential to help health care providers improve risk stratification, assess patient acuity, and formulate treatment plans to improve the health of frail elderly patients. The FI will enable hospitals to direct appropriate resources, including staff, to the most vulnerable subsets of patients in order to improve outcomes and reduce costs. Moreover, awareness of frailty enables greater discussion between patients and families of trauma patients about the risks and benefits of complex intervention, increases referrals to palliative care, and improves quality of life in this population [6].

—Tina Sadarangani, MSN, APRN, and Allison Squires, PhD, RN, New York University College of Nursing

Study Overview

Objective. To evaluate the usefulness of the Frailty Index (FI) as a prognostic indicator of adverse outcomes in geriatric trauma patients.

Design. Prospective cohort study.

Setting and participants. Geriatric (aged 65 and over) trauma patients admitted to inpatient units at a Level 1 trauma center in Arizona were enrolled. Patients were excluded if they were intubated/nonresponsive with no family members present or transferred from another institution (eg, skilled nursing facility). The following categories of data were collected: (a) patient demographics, (b) type and mechanism of injury, (c) vital signs (eg, Glasgow coma scale score, systolic blood pressure, heart rate, body temperature), (d) need for operative intervention, (e) in-hospital complications, (f) hospital and intensive care unit  (ICU) lengths of stay, and (g) discharge disposition.

Patients or, in the case of nonresponsive patients, their closest relative, responded to the 50-item Frailty Index questionnaire, which includes questions regarding age, comorbid conditions, medications, activities of daily living (ADLs), social activities, mood, and nutrition. FI score ranges from 0 (non-frail) to 1 (frail), with an FI of 0.25 or more indicative of frailty based on established guidelines. Patients were categorized as frail or non-frail according to their FI scores and were followed during the course of their hospitalization.

Main outcome measure. The primary outcome measure was in-hospital complications. In-hospital complications included myocardial infarction, cardiopulmonary arrest, pneumonia, pulmonary embolism, sepsis, urinary tract infection, deep venous thrombosis, disseminated intravascular coagulation, renal insufficiency, and reoperation. The secondary outcome measure was adverse discharge disposition, which was defined as death during the course of hospitalization or discharge to a skilled nursing facility.

Main results. The sample consisted of 250 patients with a mean age of 77.9 years. Among these, 44.0% were considered frail. Patients with frailty were more likely to have a higher Injury Severity Score (P = 0.04) and a higher mean FI (P = 0.01) than those without frailty. There were no statistically significant differences with respect to age (P = 0.21), mechanism of injury (P = 0.09), systolic blood pressure (P = 0.30), or Glasgow Coma Scale score (P = 0.91) between the groups.

Patients with frailty were more likely to develop in-hospital complications (37.3% vs 21.4%, P = 0.001) than those without frailty. Among these complications, pneumonia and urinary tract infection were the most common. There were no differences in the rate of re-operation (P = 0.54) between the 2 groups. An FI of 0.25 or higher was associated with the development of in-hospital complications (P = 0.001) even after adjust-ing for age, systolic blood pressure, heart rate, and Injury Severity Score.

Frail patients had longer hospital length of stay (P = 0.01) and ICU length of stay (P = 0.01), and were more likely to have adverse discharge disposition (37.3% vs. 12.9%, P = 0.001). All patients who died during the course of hospitalization (n = 5) were considered frail. Frailty was also found to be a predictor of adverse discharge disposition (P = 0.001) after adjustment for age, male sex, Injury Severity Score, and mechanism of injury.

Conclusion. The FI is effective in identifying geriatric trauma patients who are vulnerable to poor health outcomes.

Commentary

The diagnosis and treatment of elderly patients is complicated by the presence of multiple geriatric syndromes, including frailty [1]. Frailty is defined as increased vulnerability to negative health outcomes, marked by physical and functional decline, that eventually leads to disability, dependency, and mortality [2]. Factors such as age, malnutrition, and disease give way to dysregulations of bodily systems that eventually lead to reductions in mobility, strength, and cognition in frail older adults [3]. In turn, frail patients, who lack the physiological reserves to withstand illness and adapt to stressors, experience high incidences of hospitalizations, mortality, and reduced quality of life. Unsurprisingly, mortality rates among geriatric trauma patients are higher than those found in ordinary adult trauma patients [4]. It is, therefore, essential to identify patients with frailty at the outset of hospitalization in order to improve health outcomes and reduce mortality rates in this population. Yet, there is a dearth of assessment tools to predict outcomes in frail trauma patients [5].

This study has several strengths. Outcome measures are plainly stated. The inclusion criteria was broad enough to include most geriatric trauma patients, but the authors eliminated a number of confounders by excluding patients admitted from institutional settings, who may have been more susceptible to negative health outcomes at baseline than noninstitutionalized adults. Recruitment strategies were acceptable and reflect ethical standards. Groups were defined based on an accepted and previously validated FI cutoff. Lack of blinding did not threaten the study’s design given that most outcomes were beyond the control of study participants. Multivariate regression adjusted for a number of potential confounders including age, length of hospitalization, and injury severity. The Injury Severity Score, the Abbreviated Injury Scale score, and the Glasgow Coma Scale score are validated instruments that are widely used and enable standardized assessments of cognition and degree of injury.

The study methodology also possesses a number of weaknesses. The authors followed patients from admission to discharge; however, they did not re-evaluate patients following their release from the inpatient setting. It is, therefore, not clear whether the FI is predictive of quality of life, functional status, or hospital readmissions upon discharge into the community. The cohort was largely male (69.2%) and predominately Caucasian. Participants were recruited from only one medical center. All of these limit the study’s generalizability. In addition, the authors do not clarify how they came to define the criteria for in-hospital complications or adverse discharge disposition. For example, the study does not consider skin breakdown, a common concern among older patients who are hospitalized, as an in-hospital complication. In addition, the authors did not adjust for the number of diagnoses at baseline or the presence of chronic comorbid conditions, which are also associated with negative health outcomes.

Applications for Clinical Practice

Although lengthy, with over 50 variables in 5 categories, the FI has the potential to help health care providers improve risk stratification, assess patient acuity, and formulate treatment plans to improve the health of frail elderly patients. The FI will enable hospitals to direct appropriate resources, including staff, to the most vulnerable subsets of patients in order to improve outcomes and reduce costs. Moreover, awareness of frailty enables greater discussion between patients and families of trauma patients about the risks and benefits of complex intervention, increases referrals to palliative care, and improves quality of life in this population [6].

—Tina Sadarangani, MSN, APRN, and Allison Squires, PhD, RN, New York University College of Nursing

Patients started on less costly generic statin drugs have significantly better adherence than those started on brand name statins, as well as improved cardiovascular outcomes, according to results from a study that looked at records from more than 90,000 Medicare patients aged 65 and older (mean age 75.6, 61% female) over a 2-year period.

The study, led by Joshua J. Gagne, Pharm.D., Sc.D., of Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, and published online Sept. 15 in Annals of Internal Medicine (doi:10.7326/M13-2942), found that the average portion of days covered under prescribed statin therapy was 77% for patients started on generic lovastatin, pravastatin, or simvastatin, and 71% for patients started on name brands of these medications (P < .001). Researchers pinpointed cost as the likeliest reason for the differences in adherence; mean copay in the study was $10 for generics and $48 for brand-name drugs.

©PhotoDisk

Dr. Gagne and colleagues also reported that patients on generics saw an 8% reduction in cardiovascular events (as measured by a composite outcome of hospitalization for an acute coronary syndrome, stroke, or all-cause mortality), compared with those on brand-name medications (hazard ratio, 0.92; 95% confidence interval, 0.86-0.99).

Dr. Gagne and colleagues called the difference in cardiovascular outcomes “commensurate with the expected effect” based on differences in adherence, while noting that theirs was the first study to demonstrate differences in health outcomes related to the dispensing of generic or brand-name statins. Most patients in the study (n = 83,731) were started on generics. Generic drug recipients were more likely to be women (62% vs. 54%), and brand-name statin recipients were more likely to be white (66% vs. 48%).

“In the setting of tiered copayments in typical pharmacy benefit designs, initiating a generic versus a brand-name statin seems to be associated with lower out-of-pocket costs, improved adherence to therapy, and improved clinical outcomes,” the researchers concluded (Ann. Int. Med. 2014;161:400-7. [doi:10.7326/M13-2942]).

Dr. Gagne and colleagues noted among the limitations of their study its nonrandomized design, the use of only three statins, and the fact that they could not determine who decided whether patients initiated a generic or brand-name drug, noting that many states require pharmacists to dispense generics unless a prescriber or patient requests otherwise. The results may not apply to patients with types of insurance other than Medicare, they noted.

Teva pharmaceuticals, a manufacturer of generic medications, sponsored the study; Dr. Gagne and a coauthor, Niteesh K. Choudhry, M.D., Ph.D., disclosed grant support from Teva, while three coauthors disclosed being employees of CVS Caremark, a major pharmacy benefits administrator.

Patients started on less costly generic statin drugs have significantly better adherence than those started on brand name statins, as well as improved cardiovascular outcomes, according to results from a study that looked at records from more than 90,000 Medicare patients aged 65 and older (mean age 75.6, 61% female) over a 2-year period.

The study, led by Joshua J. Gagne, Pharm.D., Sc.D., of Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, and published online Sept. 15 in Annals of Internal Medicine (doi:10.7326/M13-2942), found that the average portion of days covered under prescribed statin therapy was 77% for patients started on generic lovastatin, pravastatin, or simvastatin, and 71% for patients started on name brands of these medications (P < .001). Researchers pinpointed cost as the likeliest reason for the differences in adherence; mean copay in the study was $10 for generics and $48 for brand-name drugs.

©PhotoDisk

Dr. Gagne and colleagues also reported that patients on generics saw an 8% reduction in cardiovascular events (as measured by a composite outcome of hospitalization for an acute coronary syndrome, stroke, or all-cause mortality), compared with those on brand-name medications (hazard ratio, 0.92; 95% confidence interval, 0.86-0.99).

Dr. Gagne and colleagues called the difference in cardiovascular outcomes “commensurate with the expected effect” based on differences in adherence, while noting that theirs was the first study to demonstrate differences in health outcomes related to the dispensing of generic or brand-name statins. Most patients in the study (n = 83,731) were started on generics. Generic drug recipients were more likely to be women (62% vs. 54%), and brand-name statin recipients were more likely to be white (66% vs. 48%).

“In the setting of tiered copayments in typical pharmacy benefit designs, initiating a generic versus a brand-name statin seems to be associated with lower out-of-pocket costs, improved adherence to therapy, and improved clinical outcomes,” the researchers concluded (Ann. Int. Med. 2014;161:400-7. [doi:10.7326/M13-2942]).

Dr. Gagne and colleagues noted among the limitations of their study its nonrandomized design, the use of only three statins, and the fact that they could not determine who decided whether patients initiated a generic or brand-name drug, noting that many states require pharmacists to dispense generics unless a prescriber or patient requests otherwise. The results may not apply to patients with types of insurance other than Medicare, they noted.

Teva pharmaceuticals, a manufacturer of generic medications, sponsored the study; Dr. Gagne and a coauthor, Niteesh K. Choudhry, M.D., Ph.D., disclosed grant support from Teva, while three coauthors disclosed being employees of CVS Caremark, a major pharmacy benefits administrator.

Patients started on less costly generic statin drugs have significantly better adherence than those started on brand name statins, as well as improved cardiovascular outcomes, according to results from a study that looked at records from more than 90,000 Medicare patients aged 65 and older (mean age 75.6, 61% female) over a 2-year period.

The study, led by Joshua J. Gagne, Pharm.D., Sc.D., of Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, and published online Sept. 15 in Annals of Internal Medicine (doi:10.7326/M13-2942), found that the average portion of days covered under prescribed statin therapy was 77% for patients started on generic lovastatin, pravastatin, or simvastatin, and 71% for patients started on name brands of these medications (P < .001). Researchers pinpointed cost as the likeliest reason for the differences in adherence; mean copay in the study was $10 for generics and $48 for brand-name drugs.

©PhotoDisk

Dr. Gagne and colleagues also reported that patients on generics saw an 8% reduction in cardiovascular events (as measured by a composite outcome of hospitalization for an acute coronary syndrome, stroke, or all-cause mortality), compared with those on brand-name medications (hazard ratio, 0.92; 95% confidence interval, 0.86-0.99).

Dr. Gagne and colleagues called the difference in cardiovascular outcomes “commensurate with the expected effect” based on differences in adherence, while noting that theirs was the first study to demonstrate differences in health outcomes related to the dispensing of generic or brand-name statins. Most patients in the study (n = 83,731) were started on generics. Generic drug recipients were more likely to be women (62% vs. 54%), and brand-name statin recipients were more likely to be white (66% vs. 48%).

“In the setting of tiered copayments in typical pharmacy benefit designs, initiating a generic versus a brand-name statin seems to be associated with lower out-of-pocket costs, improved adherence to therapy, and improved clinical outcomes,” the researchers concluded (Ann. Int. Med. 2014;161:400-7. [doi:10.7326/M13-2942]).

Dr. Gagne and colleagues noted among the limitations of their study its nonrandomized design, the use of only three statins, and the fact that they could not determine who decided whether patients initiated a generic or brand-name drug, noting that many states require pharmacists to dispense generics unless a prescriber or patient requests otherwise. The results may not apply to patients with types of insurance other than Medicare, they noted.

Teva pharmaceuticals, a manufacturer of generic medications, sponsored the study; Dr. Gagne and a coauthor, Niteesh K. Choudhry, M.D., Ph.D., disclosed grant support from Teva, while three coauthors disclosed being employees of CVS Caremark, a major pharmacy benefits administrator.

Over the last 20 years, litigation rates, malpractice coverage costs, and the number of cesarean deliveries have increased significantly. In fact, many ObGyns have dropped their obstetric practices because of the increased cost of malpractice insurance, say researchers from Johns Hopkins and Brown, and three states (New York, Florida, and Virginia) now have birth injury funds to help deflect the burden of malpractice insurance and litigation costs.¹

What is the existing state-level relationship between malpractice rates and the mode of delivery, including cesarean delivery (CD) and vaginal delivery (VD), as well as operative vaginal delivery (OVD)? And how do the state-run injury funds affect this relationship, asked Clark T. Johnson, MD, MPH, and Erika F. Werner, MD.

To answer their question, the investigators collected 8 years of data on mode of delivery (from the Centers for Disease Control and Prevention National Vital Statistics System) and malpractice rates for ObGyns in each US state (from the 2011 Medical Liability Monitor Rate Survey). The researchers used linear regression modeling to analyze their 2003−2010 data.¹

They found that states with higher malpractice rates had higher CD delivery rates and lower VD rates than states with lower malpractice rates, and that higher malpractice rates also correlated with lower rates of OVD, including the use of forceps and vacuum extraction. Overall, the change in malpractice rates between 2003 and 2010 did not correlate with the rates of OVD.¹

Those states with the highest average annual malpractice insurance rate (> $120,000) to cover claims with a cap of $1 million/$3 million in 2010, were Florida, New York, and Connecticut. Illinois, Pennsylvania, New Jersey, and Maryland had an average annual rate of $100,000 to $120,000.

Those states with the lowest average annual malpractice insurance rate (0$ to $40,000) were North Dakota, South Dakota, Nebraska, Minnesota, Iowa, and Wisconsin.

In the 1980s, medical malpractice insurance rates soared and insurance companies were faced with eliminating coverage to obstetricians. In 1987, the Virginia General Assembly developed the Virginia Birth-Related Neurological Injury Compensation Program. This no-fault system ensures lifetime care to eligible participants, and has successfully stabilized the malpractice environment in the state.² Birth-related neurologic injury funds were also created in Florida in 1988³ and in New York in 2011.⁴

The three states with birth injury funds showed a decrease in malpractice rates, a slower rate of CD-rate increase, and an OVD-rate decrease. However, the researchers note that while developing a state birth injury fund is seen as a trend that might reduce malpractice rates, there were not enough data to demonstrate significance.¹

Over the last 20 years, litigation rates, malpractice coverage costs, and the number of cesarean deliveries have increased significantly. In fact, many ObGyns have dropped their obstetric practices because of the increased cost of malpractice insurance, say researchers from Johns Hopkins and Brown, and three states (New York, Florida, and Virginia) now have birth injury funds to help deflect the burden of malpractice insurance and litigation costs.¹

What is the existing state-level relationship between malpractice rates and the mode of delivery, including cesarean delivery (CD) and vaginal delivery (VD), as well as operative vaginal delivery (OVD)? And how do the state-run injury funds affect this relationship, asked Clark T. Johnson, MD, MPH, and Erika F. Werner, MD.

To answer their question, the investigators collected 8 years of data on mode of delivery (from the Centers for Disease Control and Prevention National Vital Statistics System) and malpractice rates for ObGyns in each US state (from the 2011 Medical Liability Monitor Rate Survey). The researchers used linear regression modeling to analyze their 2003−2010 data.¹

They found that states with higher malpractice rates had higher CD delivery rates and lower VD rates than states with lower malpractice rates, and that higher malpractice rates also correlated with lower rates of OVD, including the use of forceps and vacuum extraction. Overall, the change in malpractice rates between 2003 and 2010 did not correlate with the rates of OVD.¹

Those states with the highest average annual malpractice insurance rate (> $120,000) to cover claims with a cap of $1 million/$3 million in 2010, were Florida, New York, and Connecticut. Illinois, Pennsylvania, New Jersey, and Maryland had an average annual rate of $100,000 to $120,000.

Those states with the lowest average annual malpractice insurance rate (0$ to $40,000) were North Dakota, South Dakota, Nebraska, Minnesota, Iowa, and Wisconsin.

In the 1980s, medical malpractice insurance rates soared and insurance companies were faced with eliminating coverage to obstetricians. In 1987, the Virginia General Assembly developed the Virginia Birth-Related Neurological Injury Compensation Program. This no-fault system ensures lifetime care to eligible participants, and has successfully stabilized the malpractice environment in the state.² Birth-related neurologic injury funds were also created in Florida in 1988³ and in New York in 2011.⁴

The three states with birth injury funds showed a decrease in malpractice rates, a slower rate of CD-rate increase, and an OVD-rate decrease. However, the researchers note that while developing a state birth injury fund is seen as a trend that might reduce malpractice rates, there were not enough data to demonstrate significance.¹

Over the last 20 years, litigation rates, malpractice coverage costs, and the number of cesarean deliveries have increased significantly. In fact, many ObGyns have dropped their obstetric practices because of the increased cost of malpractice insurance, say researchers from Johns Hopkins and Brown, and three states (New York, Florida, and Virginia) now have birth injury funds to help deflect the burden of malpractice insurance and litigation costs.¹

What is the existing state-level relationship between malpractice rates and the mode of delivery, including cesarean delivery (CD) and vaginal delivery (VD), as well as operative vaginal delivery (OVD)? And how do the state-run injury funds affect this relationship, asked Clark T. Johnson, MD, MPH, and Erika F. Werner, MD.

To answer their question, the investigators collected 8 years of data on mode of delivery (from the Centers for Disease Control and Prevention National Vital Statistics System) and malpractice rates for ObGyns in each US state (from the 2011 Medical Liability Monitor Rate Survey). The researchers used linear regression modeling to analyze their 2003−2010 data.¹

They found that states with higher malpractice rates had higher CD delivery rates and lower VD rates than states with lower malpractice rates, and that higher malpractice rates also correlated with lower rates of OVD, including the use of forceps and vacuum extraction. Overall, the change in malpractice rates between 2003 and 2010 did not correlate with the rates of OVD.¹

Those states with the highest average annual malpractice insurance rate (> $120,000) to cover claims with a cap of $1 million/$3 million in 2010, were Florida, New York, and Connecticut. Illinois, Pennsylvania, New Jersey, and Maryland had an average annual rate of $100,000 to $120,000.

Those states with the lowest average annual malpractice insurance rate (0$ to $40,000) were North Dakota, South Dakota, Nebraska, Minnesota, Iowa, and Wisconsin.

In the 1980s, medical malpractice insurance rates soared and insurance companies were faced with eliminating coverage to obstetricians. In 1987, the Virginia General Assembly developed the Virginia Birth-Related Neurological Injury Compensation Program. This no-fault system ensures lifetime care to eligible participants, and has successfully stabilized the malpractice environment in the state.² Birth-related neurologic injury funds were also created in Florida in 1988³ and in New York in 2011.⁴

The three states with birth injury funds showed a decrease in malpractice rates, a slower rate of CD-rate increase, and an OVD-rate decrease. However, the researchers note that while developing a state birth injury fund is seen as a trend that might reduce malpractice rates, there were not enough data to demonstrate significance.¹

The VA Learning Opportunity Residency (VALOR) program is a prelicensure experience with a nurse preceptor for rising senior students enrolled in a bachelor of science in nursing program. Students must have a minimum 3.0 grade-point average to apply. The program provides 800 hours of paid learning experiences in diverse didactic and hands-on clinical situations. The first 400 hours of the program (10 weeks) occur over the summer, and the second 400 hours take place during the fall and spring semesters of the student’s last year of school.¹ During the last 400 hours, students are placed in the areas they are interested in working as new graduate nurses.

The aim of the Salem VALOR program is to develop the next generation of VAMC nurses by recruiting new graduate nurses. The Salem VAMC structures the VALOR program to meet the needs of both the students and the facility. According to Glenda Fuller, the student programs manager for the VA, national VALOR retention rates from 2007 to 2011 have averaged 38%. However, more applicants apply for new graduate nurse positions than are available. Included in the VHA Directive 2011-039, facilities that hire a nurse with ≤ 1 year of experience must enroll them in a yearlong transition-to-practice program.² Therefore, facilities may limit the number of new graduate nurse positions.

On entry into the VALOR program, participants write a journal entry regarding their fears and concerns about becoming a new graduate nurse. In addition, each student turns in a written reflection about their experiences each week and participates in daily group discussions with the program coordinator. The last day of the summer portion of the program, students again write about their fears and concerns about becoming a new graduate nurse. After reviewing the VALOR journals, conducting focus groups, and taking notes during the daily meetings, the authors describe the following VALOR experience from the summer of 2013 at the Salem VAMC.

Preparing New Graduates

Hospitals are under pressure to provide high-quality nursing care despite hiring new graduate nurses who are unfamiliar and inexperienced in caring for patients’ complex health care needs. New graduate nurses currently make up more than 10% of hospital nursing staff, and that number is expected to grow as baby boomers retire.³ Boswell and colleagues suggest that those new graduate nurses are unprepared for the registered nurse role.⁴ Identifying strategies to facilitate the transition from student to the new graduate nurse role will likely decrease attrition rates and increase the effectiveness and the quality of patient care. Nursing programs, such as the VALOR, can ease the transition from the classroom to the working environment.⁵

This result is evident when observing how VALOR students enhance their nursing skills after the 10-week summer program. VALOR participant Andrea King published her summer experience at the Salem VAMC in The Torch, the Virginia Nursing Students’ Association newsletter.⁶ “I had so much practice and eventually confidence in my nursing skills,” she wrote, “that I had the autonomy and independence to feel like I was working as an actual nurse.”⁶

The VALOR Experience

During the summer months, senior nursing students have the opportunity to go on rounds with the chaplain, work with nurse practitioners, attend outings with mental health patients, participate in home health visits, interact with patients in groups, and rotate to different hospital units. Students attend FranklinCovey classes (which specialize in employee performance improvement), participate in an evidence-based practice (EBP) project (which helps them to learn about teamwork), and collaborate with interdisciplinary health care professionals. At the end of the summer, students present their team EBP project to the nurse executive committee. Presentation experience assists students in acquiring public speaking skills. Students are nervous about presenting to a room full of executives. However, they learn to depend on one another and to strengthen weaknesses and build on strengths.

When high-performing students come together as one cohort, this dynamic poses challenges for the VALOR participants. One student described her vulnerability in relation to her VALOR peers as “the hardest hit to my self-confidence has been working with such intelligent and accomplished cohorts.” Another student found that even though she was at the top of her class, working with the other VALORs “challenged her self-confidence” because all the program participants were high-performing students. She found it pushed her to perform better. One person reflected, “I feel the VALOR experience has really given all of us the opportunity to unleash our full potential. I have no doubt that these students will become future health care leaders.”

Building Skills

Learning new skills and interacting with physicians are stressful experiences for new graduate nurses.⁷ A study by Casey and colleagues suggests that new graduate nurses feel inadequate and lack self-confidence.⁸ VALOR participants share these concerns. The initial journal entries revealed fears of making a mistake, harming patients, fitting in to the work culture, working with doctors, feeling anxious about patient interactions, and performing clinical skills competently.

Initially, students focused on needing extensive practice with nursing skills as evidenced by one student’s comments, “I’m honestly concerned about some of the procedures; I’ve only put in 3 IVs during nursing school, I am not confident walking in to a room and performing a procedure on my own. I would be overwhelmed.” When considering RN-to-MD communication, one student commented, “I’m nervous, doctors can be very hard on new nurses, I’ve witnessed this over and over.”

During the first weeks, the participants discussed the fear of being “on their own” without the benefit of their instructor once they graduate. One person noted this feeling as “The seed of fear grows as graduation approaches.” This lack of self-confidence and feeling scared is a consistent issue with all the VALOR students the first day of the program.

During the program, VALOR students developed nursing skills and became certified in advanced cardiac life support (ACLS). One student suggested that the ACLS class was a great team builder and instilled confidence among the VALOR participants. Another student shared, “We all agreed that attaining this certification was a culmination of our overall VA experience.” A student who was working in an acute care area applied the newly learned ACLS skills the following week when a patient coded. The student’s journal reflected how preparation makes a difference and described his experience and knowing how to react as “powerful.”

The Reality of Nursing

The VALOR program helps connect the academic environment with the realities of the workplace. Wilson found bridging the theory-practice gap between school and workplace improves learning opportunities for students.⁹ Wilson also suggests that having peers to identify with helps to bridge the theory-practice gap.⁹ Journal entries reflected “the perfect hospital” of textbooks was different from working every day and “almost being a nurse.” During the VALOR program, students immerse themselves in the realistic nursing environment of staff shortages, equipment unavailability, disgruntled patients, and peer-to-peer communication that is not always civil. The 40-hour workweek provides a realistic hands-on view of nursing and introduces students to socializing as a nurse and the nursing work culture.

After the 2013 summer portion of the program, students were able to differentiate between the realities of the world of health care and the academic view of the health care environment. As students progressed over the summer, a noticeable transformation took place. The student who wrote about needing more skills practice on day 1 found that she was comfortable with injections, hanging IVs, and providing patient care at the end of week 3. Students grew more comfortable collaborating with doctors and other interdisciplinary professionals. They also became competent with basic nursing skills and had a realistic view of the nursing world.

In addition, students became aware of the emotional aspects of nursing. One student discussed making a difference in a veteran’s life after participating in a substance abuse group. “While I was on my way home I started thinking about those vets and their stories, and I started getting emotional. I just felt bad that after doing the great deed of fighting for our country that they became victims of substance abuse,” the student explained. “That afternoon, as I departed the vets, I left hopeful and realized I could make a difference in the life of a veteran.” Another student perceived that doctors were discussing a veteran’s terminal lung cancer “nonchalantly” and reflected, “though I do recognize that a certain degree of disconnection must take place, a certain measure of empathy must remain at all times to effect positive outcomes in the patient’s health.”

VALOR students noted that the program gave them exposure to different areas of nursing. This experience assisted them in deciding on an area of nursing interest. One student who always wanted to be an emergency department nurse found that after that rotation, she was not “cut out to be an emergency department nurse.” Some students came into the program thinking they knew precisely what they wanted to do following graduation, but found a new interest.

Daily Debriefings

Through daily debriefing discussions, students learn about best practices, patient advocacy, nursing leadership, and communication skills. Some have said that it has helped them “get through the day” knowing they had an outlet to review their experiences with VALOR peers. Discussions focus on both the positive and negative aspects of their day.

Students found that group discussions bonded them as a team and allowed them to share their feelings openly. One student found, “What really impacted me was just the amount of learning I received from my VALOR friends.” The group discussions and projects allow students who may typically work in isolation to come together as a team, providing a safe outlet for reflection and self-expression. Meeting daily with peers to share personal experiences increases team cohesion. Research suggests that students learn from their peers.^10,11 Working closely with these students, the benefit of peer-to-peer learning was obvious. Students support and teach one another in a nonthreatening environment, which enhances their learning process.

End of the Summer Journey

For the students’ final journal entry, they are asked to identify their greatest fear from week 1 and describe how that has changed by week 10. Journal entries indicated that the students were no longer afraid of being a new nurse, and doctors were “not so scary anymore.” Students already know that nursing is not “going to be peachy,” but participating in the VALOR program allayed their worst fears. One student wrote, “When I had the experiences of doctors, dieticians, and physical therapists asking me questions about my patient and taking what I said seriously, it really boosted my confidence.”

Students seemed less nervous taking on the new graduate nurse role, because they practiced skills and experienced the real life of a nurse. The student who was worried about starting IVs stated, “It is second nature now.” The student who was worried about talking to doctors is now paging and communicating with them in teams. “I feel that I’m more likely to converse with other members of the health care team because of this experience,” one student reported. Another student experienced being afraid of practicing clinical skills because of her lack of experience. “I had put in only 3 IVs previously. I had never seen a cardiac catheterization,” she related.  “I had never run an electrocardiography (EKG), and I had never had an opportunity to see many of the things I have seen. I was afraid of taking a full patient load, and I was apprehensive about simple things such as hanging IV medications. I was unsure of myself, and desperately needed practice. I lacked confidence, and needed to gain experience. Now, looking back, those things seem silly.”

Coming out of this program, one student suggested, “I have found that my expectations were blown away.” The 2013 cohort walked away from the summer portion of the program with ACLS training, EKG classes, interdisciplinary team experiences, FranklinCovey personal development seminars, and most of all, hands-on experience that provided these future nurses with confidence in their abilities. Participants felt that after this summer they would be “a step ahead” of their peers when they returned to school in the fall. One student related, after returning to school, “My professor asked me to help teach an EKG class since I was ACLS certified.”

Conclusion

The goal of sharing the VALOR program and students’ experiences at the Salem VAMC is to highlight how students grow clinically and professionally. The program is not a single-person endeavor. The chief nurse executive, managers, interdisciplinary health care professionals, and nursing preceptors support the program. Gaining stakeholder buy-in for the program results in positive experiences for both students and veterans.

Taking top-performing students and grouping them as a cohort creates a learning experience for students and benefits the facility. Students develop essential nursing skills, which assist their transition to the new graduate nurse role. In the words of one student, “As this experience comes to a close, I find myself increasingly apprehensive of finishing. The VALOR position has been like a dream come true for me. I have developed as a person and a future nurse.” As the new generation of nurses, the VALORs provide the institution with fresh eyes and new ideas on how to improve the system and to care for our nation’s veterans.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

The VA Learning Opportunity Residency (VALOR) program is a prelicensure experience with a nurse preceptor for rising senior students enrolled in a bachelor of science in nursing program. Students must have a minimum 3.0 grade-point average to apply. The program provides 800 hours of paid learning experiences in diverse didactic and hands-on clinical situations. The first 400 hours of the program (10 weeks) occur over the summer, and the second 400 hours take place during the fall and spring semesters of the student’s last year of school.¹ During the last 400 hours, students are placed in the areas they are interested in working as new graduate nurses.

The aim of the Salem VALOR program is to develop the next generation of VAMC nurses by recruiting new graduate nurses. The Salem VAMC structures the VALOR program to meet the needs of both the students and the facility. According to Glenda Fuller, the student programs manager for the VA, national VALOR retention rates from 2007 to 2011 have averaged 38%. However, more applicants apply for new graduate nurse positions than are available. Included in the VHA Directive 2011-039, facilities that hire a nurse with ≤ 1 year of experience must enroll them in a yearlong transition-to-practice program.² Therefore, facilities may limit the number of new graduate nurse positions.

On entry into the VALOR program, participants write a journal entry regarding their fears and concerns about becoming a new graduate nurse. In addition, each student turns in a written reflection about their experiences each week and participates in daily group discussions with the program coordinator. The last day of the summer portion of the program, students again write about their fears and concerns about becoming a new graduate nurse. After reviewing the VALOR journals, conducting focus groups, and taking notes during the daily meetings, the authors describe the following VALOR experience from the summer of 2013 at the Salem VAMC.

Preparing New Graduates

Hospitals are under pressure to provide high-quality nursing care despite hiring new graduate nurses who are unfamiliar and inexperienced in caring for patients’ complex health care needs. New graduate nurses currently make up more than 10% of hospital nursing staff, and that number is expected to grow as baby boomers retire.³ Boswell and colleagues suggest that those new graduate nurses are unprepared for the registered nurse role.⁴ Identifying strategies to facilitate the transition from student to the new graduate nurse role will likely decrease attrition rates and increase the effectiveness and the quality of patient care. Nursing programs, such as the VALOR, can ease the transition from the classroom to the working environment.⁵

This result is evident when observing how VALOR students enhance their nursing skills after the 10-week summer program. VALOR participant Andrea King published her summer experience at the Salem VAMC in The Torch, the Virginia Nursing Students’ Association newsletter.⁶ “I had so much practice and eventually confidence in my nursing skills,” she wrote, “that I had the autonomy and independence to feel like I was working as an actual nurse.”⁶

The VALOR Experience

During the summer months, senior nursing students have the opportunity to go on rounds with the chaplain, work with nurse practitioners, attend outings with mental health patients, participate in home health visits, interact with patients in groups, and rotate to different hospital units. Students attend FranklinCovey classes (which specialize in employee performance improvement), participate in an evidence-based practice (EBP) project (which helps them to learn about teamwork), and collaborate with interdisciplinary health care professionals. At the end of the summer, students present their team EBP project to the nurse executive committee. Presentation experience assists students in acquiring public speaking skills. Students are nervous about presenting to a room full of executives. However, they learn to depend on one another and to strengthen weaknesses and build on strengths.

When high-performing students come together as one cohort, this dynamic poses challenges for the VALOR participants. One student described her vulnerability in relation to her VALOR peers as “the hardest hit to my self-confidence has been working with such intelligent and accomplished cohorts.” Another student found that even though she was at the top of her class, working with the other VALORs “challenged her self-confidence” because all the program participants were high-performing students. She found it pushed her to perform better. One person reflected, “I feel the VALOR experience has really given all of us the opportunity to unleash our full potential. I have no doubt that these students will become future health care leaders.”

Building Skills

Learning new skills and interacting with physicians are stressful experiences for new graduate nurses.⁷ A study by Casey and colleagues suggests that new graduate nurses feel inadequate and lack self-confidence.⁸ VALOR participants share these concerns. The initial journal entries revealed fears of making a mistake, harming patients, fitting in to the work culture, working with doctors, feeling anxious about patient interactions, and performing clinical skills competently.

Initially, students focused on needing extensive practice with nursing skills as evidenced by one student’s comments, “I’m honestly concerned about some of the procedures; I’ve only put in 3 IVs during nursing school, I am not confident walking in to a room and performing a procedure on my own. I would be overwhelmed.” When considering RN-to-MD communication, one student commented, “I’m nervous, doctors can be very hard on new nurses, I’ve witnessed this over and over.”

During the first weeks, the participants discussed the fear of being “on their own” without the benefit of their instructor once they graduate. One person noted this feeling as “The seed of fear grows as graduation approaches.” This lack of self-confidence and feeling scared is a consistent issue with all the VALOR students the first day of the program.

During the program, VALOR students developed nursing skills and became certified in advanced cardiac life support (ACLS). One student suggested that the ACLS class was a great team builder and instilled confidence among the VALOR participants. Another student shared, “We all agreed that attaining this certification was a culmination of our overall VA experience.” A student who was working in an acute care area applied the newly learned ACLS skills the following week when a patient coded. The student’s journal reflected how preparation makes a difference and described his experience and knowing how to react as “powerful.”

The Reality of Nursing

The VALOR program helps connect the academic environment with the realities of the workplace. Wilson found bridging the theory-practice gap between school and workplace improves learning opportunities for students.⁹ Wilson also suggests that having peers to identify with helps to bridge the theory-practice gap.⁹ Journal entries reflected “the perfect hospital” of textbooks was different from working every day and “almost being a nurse.” During the VALOR program, students immerse themselves in the realistic nursing environment of staff shortages, equipment unavailability, disgruntled patients, and peer-to-peer communication that is not always civil. The 40-hour workweek provides a realistic hands-on view of nursing and introduces students to socializing as a nurse and the nursing work culture.

After the 2013 summer portion of the program, students were able to differentiate between the realities of the world of health care and the academic view of the health care environment. As students progressed over the summer, a noticeable transformation took place. The student who wrote about needing more skills practice on day 1 found that she was comfortable with injections, hanging IVs, and providing patient care at the end of week 3. Students grew more comfortable collaborating with doctors and other interdisciplinary professionals. They also became competent with basic nursing skills and had a realistic view of the nursing world.

In addition, students became aware of the emotional aspects of nursing. One student discussed making a difference in a veteran’s life after participating in a substance abuse group. “While I was on my way home I started thinking about those vets and their stories, and I started getting emotional. I just felt bad that after doing the great deed of fighting for our country that they became victims of substance abuse,” the student explained. “That afternoon, as I departed the vets, I left hopeful and realized I could make a difference in the life of a veteran.” Another student perceived that doctors were discussing a veteran’s terminal lung cancer “nonchalantly” and reflected, “though I do recognize that a certain degree of disconnection must take place, a certain measure of empathy must remain at all times to effect positive outcomes in the patient’s health.”

VALOR students noted that the program gave them exposure to different areas of nursing. This experience assisted them in deciding on an area of nursing interest. One student who always wanted to be an emergency department nurse found that after that rotation, she was not “cut out to be an emergency department nurse.” Some students came into the program thinking they knew precisely what they wanted to do following graduation, but found a new interest.

Daily Debriefings

Through daily debriefing discussions, students learn about best practices, patient advocacy, nursing leadership, and communication skills. Some have said that it has helped them “get through the day” knowing they had an outlet to review their experiences with VALOR peers. Discussions focus on both the positive and negative aspects of their day.

Students found that group discussions bonded them as a team and allowed them to share their feelings openly. One student found, “What really impacted me was just the amount of learning I received from my VALOR friends.” The group discussions and projects allow students who may typically work in isolation to come together as a team, providing a safe outlet for reflection and self-expression. Meeting daily with peers to share personal experiences increases team cohesion. Research suggests that students learn from their peers.^10,11 Working closely with these students, the benefit of peer-to-peer learning was obvious. Students support and teach one another in a nonthreatening environment, which enhances their learning process.

End of the Summer Journey

For the students’ final journal entry, they are asked to identify their greatest fear from week 1 and describe how that has changed by week 10. Journal entries indicated that the students were no longer afraid of being a new nurse, and doctors were “not so scary anymore.” Students already know that nursing is not “going to be peachy,” but participating in the VALOR program allayed their worst fears. One student wrote, “When I had the experiences of doctors, dieticians, and physical therapists asking me questions about my patient and taking what I said seriously, it really boosted my confidence.”

Students seemed less nervous taking on the new graduate nurse role, because they practiced skills and experienced the real life of a nurse. The student who was worried about starting IVs stated, “It is second nature now.” The student who was worried about talking to doctors is now paging and communicating with them in teams. “I feel that I’m more likely to converse with other members of the health care team because of this experience,” one student reported. Another student experienced being afraid of practicing clinical skills because of her lack of experience. “I had put in only 3 IVs previously. I had never seen a cardiac catheterization,” she related.  “I had never run an electrocardiography (EKG), and I had never had an opportunity to see many of the things I have seen. I was afraid of taking a full patient load, and I was apprehensive about simple things such as hanging IV medications. I was unsure of myself, and desperately needed practice. I lacked confidence, and needed to gain experience. Now, looking back, those things seem silly.”

Coming out of this program, one student suggested, “I have found that my expectations were blown away.” The 2013 cohort walked away from the summer portion of the program with ACLS training, EKG classes, interdisciplinary team experiences, FranklinCovey personal development seminars, and most of all, hands-on experience that provided these future nurses with confidence in their abilities. Participants felt that after this summer they would be “a step ahead” of their peers when they returned to school in the fall. One student related, after returning to school, “My professor asked me to help teach an EKG class since I was ACLS certified.”

Conclusion

The goal of sharing the VALOR program and students’ experiences at the Salem VAMC is to highlight how students grow clinically and professionally. The program is not a single-person endeavor. The chief nurse executive, managers, interdisciplinary health care professionals, and nursing preceptors support the program. Gaining stakeholder buy-in for the program results in positive experiences for both students and veterans.

Taking top-performing students and grouping them as a cohort creates a learning experience for students and benefits the facility. Students develop essential nursing skills, which assist their transition to the new graduate nurse role. In the words of one student, “As this experience comes to a close, I find myself increasingly apprehensive of finishing. The VALOR position has been like a dream come true for me. I have developed as a person and a future nurse.” As the new generation of nurses, the VALORs provide the institution with fresh eyes and new ideas on how to improve the system and to care for our nation’s veterans.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

The VA Learning Opportunity Residency (VALOR) program is a prelicensure experience with a nurse preceptor for rising senior students enrolled in a bachelor of science in nursing program. Students must have a minimum 3.0 grade-point average to apply. The program provides 800 hours of paid learning experiences in diverse didactic and hands-on clinical situations. The first 400 hours of the program (10 weeks) occur over the summer, and the second 400 hours take place during the fall and spring semesters of the student’s last year of school.¹ During the last 400 hours, students are placed in the areas they are interested in working as new graduate nurses.

The aim of the Salem VALOR program is to develop the next generation of VAMC nurses by recruiting new graduate nurses. The Salem VAMC structures the VALOR program to meet the needs of both the students and the facility. According to Glenda Fuller, the student programs manager for the VA, national VALOR retention rates from 2007 to 2011 have averaged 38%. However, more applicants apply for new graduate nurse positions than are available. Included in the VHA Directive 2011-039, facilities that hire a nurse with ≤ 1 year of experience must enroll them in a yearlong transition-to-practice program.² Therefore, facilities may limit the number of new graduate nurse positions.

On entry into the VALOR program, participants write a journal entry regarding their fears and concerns about becoming a new graduate nurse. In addition, each student turns in a written reflection about their experiences each week and participates in daily group discussions with the program coordinator. The last day of the summer portion of the program, students again write about their fears and concerns about becoming a new graduate nurse. After reviewing the VALOR journals, conducting focus groups, and taking notes during the daily meetings, the authors describe the following VALOR experience from the summer of 2013 at the Salem VAMC.

Preparing New Graduates

Hospitals are under pressure to provide high-quality nursing care despite hiring new graduate nurses who are unfamiliar and inexperienced in caring for patients’ complex health care needs. New graduate nurses currently make up more than 10% of hospital nursing staff, and that number is expected to grow as baby boomers retire.³ Boswell and colleagues suggest that those new graduate nurses are unprepared for the registered nurse role.⁴ Identifying strategies to facilitate the transition from student to the new graduate nurse role will likely decrease attrition rates and increase the effectiveness and the quality of patient care. Nursing programs, such as the VALOR, can ease the transition from the classroom to the working environment.⁵

This result is evident when observing how VALOR students enhance their nursing skills after the 10-week summer program. VALOR participant Andrea King published her summer experience at the Salem VAMC in The Torch, the Virginia Nursing Students’ Association newsletter.⁶ “I had so much practice and eventually confidence in my nursing skills,” she wrote, “that I had the autonomy and independence to feel like I was working as an actual nurse.”⁶

The VALOR Experience

During the summer months, senior nursing students have the opportunity to go on rounds with the chaplain, work with nurse practitioners, attend outings with mental health patients, participate in home health visits, interact with patients in groups, and rotate to different hospital units. Students attend FranklinCovey classes (which specialize in employee performance improvement), participate in an evidence-based practice (EBP) project (which helps them to learn about teamwork), and collaborate with interdisciplinary health care professionals. At the end of the summer, students present their team EBP project to the nurse executive committee. Presentation experience assists students in acquiring public speaking skills. Students are nervous about presenting to a room full of executives. However, they learn to depend on one another and to strengthen weaknesses and build on strengths.

When high-performing students come together as one cohort, this dynamic poses challenges for the VALOR participants. One student described her vulnerability in relation to her VALOR peers as “the hardest hit to my self-confidence has been working with such intelligent and accomplished cohorts.” Another student found that even though she was at the top of her class, working with the other VALORs “challenged her self-confidence” because all the program participants were high-performing students. She found it pushed her to perform better. One person reflected, “I feel the VALOR experience has really given all of us the opportunity to unleash our full potential. I have no doubt that these students will become future health care leaders.”

Building Skills

Learning new skills and interacting with physicians are stressful experiences for new graduate nurses.⁷ A study by Casey and colleagues suggests that new graduate nurses feel inadequate and lack self-confidence.⁸ VALOR participants share these concerns. The initial journal entries revealed fears of making a mistake, harming patients, fitting in to the work culture, working with doctors, feeling anxious about patient interactions, and performing clinical skills competently.

Initially, students focused on needing extensive practice with nursing skills as evidenced by one student’s comments, “I’m honestly concerned about some of the procedures; I’ve only put in 3 IVs during nursing school, I am not confident walking in to a room and performing a procedure on my own. I would be overwhelmed.” When considering RN-to-MD communication, one student commented, “I’m nervous, doctors can be very hard on new nurses, I’ve witnessed this over and over.”

During the first weeks, the participants discussed the fear of being “on their own” without the benefit of their instructor once they graduate. One person noted this feeling as “The seed of fear grows as graduation approaches.” This lack of self-confidence and feeling scared is a consistent issue with all the VALOR students the first day of the program.

During the program, VALOR students developed nursing skills and became certified in advanced cardiac life support (ACLS). One student suggested that the ACLS class was a great team builder and instilled confidence among the VALOR participants. Another student shared, “We all agreed that attaining this certification was a culmination of our overall VA experience.” A student who was working in an acute care area applied the newly learned ACLS skills the following week when a patient coded. The student’s journal reflected how preparation makes a difference and described his experience and knowing how to react as “powerful.”

The Reality of Nursing

The VALOR program helps connect the academic environment with the realities of the workplace. Wilson found bridging the theory-practice gap between school and workplace improves learning opportunities for students.⁹ Wilson also suggests that having peers to identify with helps to bridge the theory-practice gap.⁹ Journal entries reflected “the perfect hospital” of textbooks was different from working every day and “almost being a nurse.” During the VALOR program, students immerse themselves in the realistic nursing environment of staff shortages, equipment unavailability, disgruntled patients, and peer-to-peer communication that is not always civil. The 40-hour workweek provides a realistic hands-on view of nursing and introduces students to socializing as a nurse and the nursing work culture.

After the 2013 summer portion of the program, students were able to differentiate between the realities of the world of health care and the academic view of the health care environment. As students progressed over the summer, a noticeable transformation took place. The student who wrote about needing more skills practice on day 1 found that she was comfortable with injections, hanging IVs, and providing patient care at the end of week 3. Students grew more comfortable collaborating with doctors and other interdisciplinary professionals. They also became competent with basic nursing skills and had a realistic view of the nursing world.

In addition, students became aware of the emotional aspects of nursing. One student discussed making a difference in a veteran’s life after participating in a substance abuse group. “While I was on my way home I started thinking about those vets and their stories, and I started getting emotional. I just felt bad that after doing the great deed of fighting for our country that they became victims of substance abuse,” the student explained. “That afternoon, as I departed the vets, I left hopeful and realized I could make a difference in the life of a veteran.” Another student perceived that doctors were discussing a veteran’s terminal lung cancer “nonchalantly” and reflected, “though I do recognize that a certain degree of disconnection must take place, a certain measure of empathy must remain at all times to effect positive outcomes in the patient’s health.”

VALOR students noted that the program gave them exposure to different areas of nursing. This experience assisted them in deciding on an area of nursing interest. One student who always wanted to be an emergency department nurse found that after that rotation, she was not “cut out to be an emergency department nurse.” Some students came into the program thinking they knew precisely what they wanted to do following graduation, but found a new interest.

Daily Debriefings

Through daily debriefing discussions, students learn about best practices, patient advocacy, nursing leadership, and communication skills. Some have said that it has helped them “get through the day” knowing they had an outlet to review their experiences with VALOR peers. Discussions focus on both the positive and negative aspects of their day.

Students found that group discussions bonded them as a team and allowed them to share their feelings openly. One student found, “What really impacted me was just the amount of learning I received from my VALOR friends.” The group discussions and projects allow students who may typically work in isolation to come together as a team, providing a safe outlet for reflection and self-expression. Meeting daily with peers to share personal experiences increases team cohesion. Research suggests that students learn from their peers.^10,11 Working closely with these students, the benefit of peer-to-peer learning was obvious. Students support and teach one another in a nonthreatening environment, which enhances their learning process.

End of the Summer Journey

For the students’ final journal entry, they are asked to identify their greatest fear from week 1 and describe how that has changed by week 10. Journal entries indicated that the students were no longer afraid of being a new nurse, and doctors were “not so scary anymore.” Students already know that nursing is not “going to be peachy,” but participating in the VALOR program allayed their worst fears. One student wrote, “When I had the experiences of doctors, dieticians, and physical therapists asking me questions about my patient and taking what I said seriously, it really boosted my confidence.”

Students seemed less nervous taking on the new graduate nurse role, because they practiced skills and experienced the real life of a nurse. The student who was worried about starting IVs stated, “It is second nature now.” The student who was worried about talking to doctors is now paging and communicating with them in teams. “I feel that I’m more likely to converse with other members of the health care team because of this experience,” one student reported. Another student experienced being afraid of practicing clinical skills because of her lack of experience. “I had put in only 3 IVs previously. I had never seen a cardiac catheterization,” she related.  “I had never run an electrocardiography (EKG), and I had never had an opportunity to see many of the things I have seen. I was afraid of taking a full patient load, and I was apprehensive about simple things such as hanging IV medications. I was unsure of myself, and desperately needed practice. I lacked confidence, and needed to gain experience. Now, looking back, those things seem silly.”

Coming out of this program, one student suggested, “I have found that my expectations were blown away.” The 2013 cohort walked away from the summer portion of the program with ACLS training, EKG classes, interdisciplinary team experiences, FranklinCovey personal development seminars, and most of all, hands-on experience that provided these future nurses with confidence in their abilities. Participants felt that after this summer they would be “a step ahead” of their peers when they returned to school in the fall. One student related, after returning to school, “My professor asked me to help teach an EKG class since I was ACLS certified.”

Conclusion

The goal of sharing the VALOR program and students’ experiences at the Salem VAMC is to highlight how students grow clinically and professionally. The program is not a single-person endeavor. The chief nurse executive, managers, interdisciplinary health care professionals, and nursing preceptors support the program. Gaining stakeholder buy-in for the program results in positive experiences for both students and veterans.

Taking top-performing students and grouping them as a cohort creates a learning experience for students and benefits the facility. Students develop essential nursing skills, which assist their transition to the new graduate nurse role. In the words of one student, “As this experience comes to a close, I find myself increasingly apprehensive of finishing. The VALOR position has been like a dream come true for me. I have developed as a person and a future nurse.” As the new generation of nurses, the VALORs provide the institution with fresh eyes and new ideas on how to improve the system and to care for our nation’s veterans.

Author disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Team performing surgery

Credit: Piotr Bodzek

HOUSTON—A family of hemostatic products can decrease the need for blood transfusions, reduce hospital stays, and cut the cost of care for certain surgical patients, a retrospective study suggests.

Researchers compared the SURGICEL family of topical, absorbable hemostats—which are based on oxidized regenerated cellulose—to other adjunctive hemostats—flowables, gelatin, and thrombin—in patients undergoing a range of surgical procedures.

The team presented their findings in a poster at the Society for the Advancement of Blood Management Annual Meeting. The study was sponsored by Ethicon, makers of the SURGICEL products.

The goal of this research was to compare the healthcare resource utilization, costs, and outcomes associated with SURGICEL products—SURGICEL® ORIGINAL, SURGICEL® NU-KNIT®, SURGICEL® FIBRILLAR™, and SURGICEL® SNOW™—to those associated with other adjunctive hemostats.

The researchers analyzed data from adult patients (18 years and older) from the Premier Research Database who were discharged from the hospital between January 1, 2011, and December 31, 2012.

Patients had undergone cholecystectomy (n=3045), cardiovascular surgery (n=11,359), hysterectomy (n=4674), or carotid endarterectomy (5445).

The researchers found that fewer units of hemostat were used per discharge among patients who received SURGICEL products than among those who received other hemostats, regardless of the type of surgery.

Hemostat use was 18% lower for cholecystectomy patients (P<0.0001), 28% lower for cardiovascular patients (P<0.0001), 16% lower for hysterectomy patients (P<0.05), and 41% for carotid endarterectomy patients (P<0.0001).

SURGICEL products were also associated with a reduction in blood transfusions for some patients. Transfusions were reduced by 5% among hysterectomy patients (not significant), 18% in cholecystectomy patients (P<0.05), and 32% for carotid endarterectomy patients (P<0.0001).

The mean length of hospital stay and the mean length of stay in the intensive care unit (ICU) were both lower for certain patients who received SURGICEL products.

Hospital stays were 12% lower in cholecystectomy patients (P<0.05) and 8% lower in carotid endarterectomy patients (P<0.0001). And ICU stays were 3% lower in cholecystectomy patients (not significant) and 8% lower in carotid endarterectomy patients (P<0.05).

ICU costs were not significantly lower for patients who received SURGICEL products. However, the costs of hemostats and all-cause costs were lower with SURGICEL products than with other hemostats.

The cost of hemostats was 59% lower for in cholecystectomy patients (P<0.0001), 33% lower in cardiovascular patients (P<0.0001), 57% lower in hysterectomy patients (P<0.0001), and 49% lower in carotid endarterectomy patients (P<0.0001).

The all-cause costs per discharge were 1% lower for hysterectomy patients (P<0.05), 6% lower for carotid endarterectomy patients (P<0.0001), and 14% lower for cholecystectomy patients (P<0.0001).

Cost savings ranged from $71 to $155 per procedure.

“This study adds to the growing body of evidence that suggests the SURGICEL family of topical, absorbable hemostats has the potential to reduce burdens associated with bleeding and bleeding-related complications, which translates into cost and resource-use savings for healthcare providers,” said study investigator Jerome Riebman, MD, director of medical affairs at Ethicon.

Dr Riebman and his colleagues did note that this study was subject to limitations. For example, not all of the factors influencing the physicians’ choice of treatment were available in the dataset.

Furthermore, it’s not clear whether the hospitals studied are representative of all US hospitals. And coding errors or omitted procedure/product codes could have led to patient misclassification and potential bias in the results.

Team performing surgery

Credit: Piotr Bodzek

HOUSTON—A family of hemostatic products can decrease the need for blood transfusions, reduce hospital stays, and cut the cost of care for certain surgical patients, a retrospective study suggests.

Researchers compared the SURGICEL family of topical, absorbable hemostats—which are based on oxidized regenerated cellulose—to other adjunctive hemostats—flowables, gelatin, and thrombin—in patients undergoing a range of surgical procedures.

The team presented their findings in a poster at the Society for the Advancement of Blood Management Annual Meeting. The study was sponsored by Ethicon, makers of the SURGICEL products.

The goal of this research was to compare the healthcare resource utilization, costs, and outcomes associated with SURGICEL products—SURGICEL® ORIGINAL, SURGICEL® NU-KNIT®, SURGICEL® FIBRILLAR™, and SURGICEL® SNOW™—to those associated with other adjunctive hemostats.

The researchers analyzed data from adult patients (18 years and older) from the Premier Research Database who were discharged from the hospital between January 1, 2011, and December 31, 2012.

Patients had undergone cholecystectomy (n=3045), cardiovascular surgery (n=11,359), hysterectomy (n=4674), or carotid endarterectomy (5445).

The researchers found that fewer units of hemostat were used per discharge among patients who received SURGICEL products than among those who received other hemostats, regardless of the type of surgery.

Hemostat use was 18% lower for cholecystectomy patients (P<0.0001), 28% lower for cardiovascular patients (P<0.0001), 16% lower for hysterectomy patients (P<0.05), and 41% for carotid endarterectomy patients (P<0.0001).

SURGICEL products were also associated with a reduction in blood transfusions for some patients. Transfusions were reduced by 5% among hysterectomy patients (not significant), 18% in cholecystectomy patients (P<0.05), and 32% for carotid endarterectomy patients (P<0.0001).

The mean length of hospital stay and the mean length of stay in the intensive care unit (ICU) were both lower for certain patients who received SURGICEL products.

Hospital stays were 12% lower in cholecystectomy patients (P<0.05) and 8% lower in carotid endarterectomy patients (P<0.0001). And ICU stays were 3% lower in cholecystectomy patients (not significant) and 8% lower in carotid endarterectomy patients (P<0.05).

ICU costs were not significantly lower for patients who received SURGICEL products. However, the costs of hemostats and all-cause costs were lower with SURGICEL products than with other hemostats.

The cost of hemostats was 59% lower for in cholecystectomy patients (P<0.0001), 33% lower in cardiovascular patients (P<0.0001), 57% lower in hysterectomy patients (P<0.0001), and 49% lower in carotid endarterectomy patients (P<0.0001).

The all-cause costs per discharge were 1% lower for hysterectomy patients (P<0.05), 6% lower for carotid endarterectomy patients (P<0.0001), and 14% lower for cholecystectomy patients (P<0.0001).

Cost savings ranged from $71 to $155 per procedure.

“This study adds to the growing body of evidence that suggests the SURGICEL family of topical, absorbable hemostats has the potential to reduce burdens associated with bleeding and bleeding-related complications, which translates into cost and resource-use savings for healthcare providers,” said study investigator Jerome Riebman, MD, director of medical affairs at Ethicon.

Dr Riebman and his colleagues did note that this study was subject to limitations. For example, not all of the factors influencing the physicians’ choice of treatment were available in the dataset.

Furthermore, it’s not clear whether the hospitals studied are representative of all US hospitals. And coding errors or omitted procedure/product codes could have led to patient misclassification and potential bias in the results.

Team performing surgery

Credit: Piotr Bodzek

HOUSTON—A family of hemostatic products can decrease the need for blood transfusions, reduce hospital stays, and cut the cost of care for certain surgical patients, a retrospective study suggests.

Researchers compared the SURGICEL family of topical, absorbable hemostats—which are based on oxidized regenerated cellulose—to other adjunctive hemostats—flowables, gelatin, and thrombin—in patients undergoing a range of surgical procedures.

The team presented their findings in a poster at the Society for the Advancement of Blood Management Annual Meeting. The study was sponsored by Ethicon, makers of the SURGICEL products.

The goal of this research was to compare the healthcare resource utilization, costs, and outcomes associated with SURGICEL products—SURGICEL® ORIGINAL, SURGICEL® NU-KNIT®, SURGICEL® FIBRILLAR™, and SURGICEL® SNOW™—to those associated with other adjunctive hemostats.

The researchers analyzed data from adult patients (18 years and older) from the Premier Research Database who were discharged from the hospital between January 1, 2011, and December 31, 2012.

Patients had undergone cholecystectomy (n=3045), cardiovascular surgery (n=11,359), hysterectomy (n=4674), or carotid endarterectomy (5445).

The researchers found that fewer units of hemostat were used per discharge among patients who received SURGICEL products than among those who received other hemostats, regardless of the type of surgery.

Hemostat use was 18% lower for cholecystectomy patients (P<0.0001), 28% lower for cardiovascular patients (P<0.0001), 16% lower for hysterectomy patients (P<0.05), and 41% for carotid endarterectomy patients (P<0.0001).

SURGICEL products were also associated with a reduction in blood transfusions for some patients. Transfusions were reduced by 5% among hysterectomy patients (not significant), 18% in cholecystectomy patients (P<0.05), and 32% for carotid endarterectomy patients (P<0.0001).

The mean length of hospital stay and the mean length of stay in the intensive care unit (ICU) were both lower for certain patients who received SURGICEL products.

Hospital stays were 12% lower in cholecystectomy patients (P<0.05) and 8% lower in carotid endarterectomy patients (P<0.0001). And ICU stays were 3% lower in cholecystectomy patients (not significant) and 8% lower in carotid endarterectomy patients (P<0.05).

ICU costs were not significantly lower for patients who received SURGICEL products. However, the costs of hemostats and all-cause costs were lower with SURGICEL products than with other hemostats.

The cost of hemostats was 59% lower for in cholecystectomy patients (P<0.0001), 33% lower in cardiovascular patients (P<0.0001), 57% lower in hysterectomy patients (P<0.0001), and 49% lower in carotid endarterectomy patients (P<0.0001).

The all-cause costs per discharge were 1% lower for hysterectomy patients (P<0.05), 6% lower for carotid endarterectomy patients (P<0.0001), and 14% lower for cholecystectomy patients (P<0.0001).

Cost savings ranged from $71 to $155 per procedure.

“This study adds to the growing body of evidence that suggests the SURGICEL family of topical, absorbable hemostats has the potential to reduce burdens associated with bleeding and bleeding-related complications, which translates into cost and resource-use savings for healthcare providers,” said study investigator Jerome Riebman, MD, director of medical affairs at Ethicon.

Dr Riebman and his colleagues did note that this study was subject to limitations. For example, not all of the factors influencing the physicians’ choice of treatment were available in the dataset.

Furthermore, it’s not clear whether the hospitals studied are representative of all US hospitals. And coding errors or omitted procedure/product codes could have led to patient misclassification and potential bias in the results.

Lab mice

Credit: Aaron Logan

A compound that has demonstrated efficacy in older adults with acute myeloid leukemia (AML) may be a viable option for childhood acute lymphoblastic

leukemia (ALL) as well.

The drug, CPX-351, is a fixed-ratio combination of cytarabine and daunorubicin inside a lipid vesicle.

It previously showed promise in a phase 2 trial of AML patients ages 60 to 75 years. Now, preclinical results suggest CPX-351 can work against aggressive

pediatric ALL too.

The research appears in Pediatric Blood & Cancer. It was supported by the National Cancer Institute.

“Cytarabine and anthracyclines such as daunorubicin are commonly used to treat ALL in pediatric patients, and while these drug are very effective in front-line, multidrug, combination chemotherapy regimens, there remains room for improvement, especially in pediatric patients who relapse within 36 months of diagnosis,” said study author Richard Lock, PhD, of Children’s Cancer Institute in Sydney, Australia.

“We are very encouraged by these preclinical results, indicating that the proprietary CPX-351 formulation of cytarabine and daunorubicin may be an important tool to maximize efficacy outcomes in relapsed ALL, and we believe these data substantiate the need for additional, clinical study in pediatric patients.”

Dr Lock and his colleagues studied CPX-351 in mice inoculated with leukemia cells from 5 children who had died from ALL. Three of the children, 2 with B-precursor ALL and 1 with T-cell ALL, had relapsed disease at the time of biopsy.

The researchers inoculated up to 18 mice for each of the 5 leukemia types and then randomized the mice to treatment or control.

The maximum-tolerated dose of CPX-351 was 5 units/kg (corresponding to 5 mg/kg cytarabine and 2.2 mg/kg daunorubicin). This dose provided clinically relevant plasma drug exposure and correlated to the pharmacokinetic properties observed in patients with AML.

The researchers found that all 5 models of ALL were “highly responsive” to CPX-351. In the 4 models of B-precursor ALL, the median group response was a complete response. In the mice inoculated with T-cell ALL, the median group response was a partial response.

Among treated mice, event-free survival ranged from 32.8 days to 41.9 days. And among controls, event-free survival ranged from 2.4 days to 10.8 days.

Dr Lock and his colleagues believe these results suggest CPX-351 may be a promising treatment for ALL and support its testing in pediatric leukemia patients.

CPX-351 is currently under investigation in a phase 3 trial in older patients with high-risk (secondary) AML.

Lab mice

Credit: Aaron Logan

A compound that has demonstrated efficacy in older adults with acute myeloid leukemia (AML) may be a viable option for childhood acute lymphoblastic

leukemia (ALL) as well.

The drug, CPX-351, is a fixed-ratio combination of cytarabine and daunorubicin inside a lipid vesicle.

It previously showed promise in a phase 2 trial of AML patients ages 60 to 75 years. Now, preclinical results suggest CPX-351 can work against aggressive

pediatric ALL too.

The research appears in Pediatric Blood & Cancer. It was supported by the National Cancer Institute.

“Cytarabine and anthracyclines such as daunorubicin are commonly used to treat ALL in pediatric patients, and while these drug are very effective in front-line, multidrug, combination chemotherapy regimens, there remains room for improvement, especially in pediatric patients who relapse within 36 months of diagnosis,” said study author Richard Lock, PhD, of Children’s Cancer Institute in Sydney, Australia.

“We are very encouraged by these preclinical results, indicating that the proprietary CPX-351 formulation of cytarabine and daunorubicin may be an important tool to maximize efficacy outcomes in relapsed ALL, and we believe these data substantiate the need for additional, clinical study in pediatric patients.”

Dr Lock and his colleagues studied CPX-351 in mice inoculated with leukemia cells from 5 children who had died from ALL. Three of the children, 2 with B-precursor ALL and 1 with T-cell ALL, had relapsed disease at the time of biopsy.

The researchers inoculated up to 18 mice for each of the 5 leukemia types and then randomized the mice to treatment or control.

The maximum-tolerated dose of CPX-351 was 5 units/kg (corresponding to 5 mg/kg cytarabine and 2.2 mg/kg daunorubicin). This dose provided clinically relevant plasma drug exposure and correlated to the pharmacokinetic properties observed in patients with AML.

The researchers found that all 5 models of ALL were “highly responsive” to CPX-351. In the 4 models of B-precursor ALL, the median group response was a complete response. In the mice inoculated with T-cell ALL, the median group response was a partial response.

Among treated mice, event-free survival ranged from 32.8 days to 41.9 days. And among controls, event-free survival ranged from 2.4 days to 10.8 days.

Dr Lock and his colleagues believe these results suggest CPX-351 may be a promising treatment for ALL and support its testing in pediatric leukemia patients.

CPX-351 is currently under investigation in a phase 3 trial in older patients with high-risk (secondary) AML.

Lab mice

Credit: Aaron Logan

A compound that has demonstrated efficacy in older adults with acute myeloid leukemia (AML) may be a viable option for childhood acute lymphoblastic

leukemia (ALL) as well.

The drug, CPX-351, is a fixed-ratio combination of cytarabine and daunorubicin inside a lipid vesicle.

It previously showed promise in a phase 2 trial of AML patients ages 60 to 75 years. Now, preclinical results suggest CPX-351 can work against aggressive

pediatric ALL too.

The research appears in Pediatric Blood & Cancer. It was supported by the National Cancer Institute.

“Cytarabine and anthracyclines such as daunorubicin are commonly used to treat ALL in pediatric patients, and while these drug are very effective in front-line, multidrug, combination chemotherapy regimens, there remains room for improvement, especially in pediatric patients who relapse within 36 months of diagnosis,” said study author Richard Lock, PhD, of Children’s Cancer Institute in Sydney, Australia.

“We are very encouraged by these preclinical results, indicating that the proprietary CPX-351 formulation of cytarabine and daunorubicin may be an important tool to maximize efficacy outcomes in relapsed ALL, and we believe these data substantiate the need for additional, clinical study in pediatric patients.”

Dr Lock and his colleagues studied CPX-351 in mice inoculated with leukemia cells from 5 children who had died from ALL. Three of the children, 2 with B-precursor ALL and 1 with T-cell ALL, had relapsed disease at the time of biopsy.

The researchers inoculated up to 18 mice for each of the 5 leukemia types and then randomized the mice to treatment or control.

The maximum-tolerated dose of CPX-351 was 5 units/kg (corresponding to 5 mg/kg cytarabine and 2.2 mg/kg daunorubicin). This dose provided clinically relevant plasma drug exposure and correlated to the pharmacokinetic properties observed in patients with AML.

The researchers found that all 5 models of ALL were “highly responsive” to CPX-351. In the 4 models of B-precursor ALL, the median group response was a complete response. In the mice inoculated with T-cell ALL, the median group response was a partial response.

Among treated mice, event-free survival ranged from 32.8 days to 41.9 days. And among controls, event-free survival ranged from 2.4 days to 10.8 days.

Dr Lock and his colleagues believe these results suggest CPX-351 may be a promising treatment for ALL and support its testing in pediatric leukemia patients.

CPX-351 is currently under investigation in a phase 3 trial in older patients with high-risk (secondary) AML.

Preparing for radiation

Credit: Rhoda Baer

SAN FRANCISCO—Results of a large study suggest that consolidation radiation therapy (RT) can improve survival in patients with stage I and II Hodgkin lymphoma (HL), but the use of RT in these patients may be on the decline.

In this study of more than 40,000 patients, the 10-year survival rate was 84% among those who received RT and 76% among those who did not.

Despite this benefit, the use of RT declined during the period studied, from 56% in 1998 to 41% in 2011.

These data were presented at the American Society for Radiation Oncology’s 56th Annual Meeting (abstract 1042).

“Multiple prospective, randomized trials have shown a significant improvement in disease control with the addition of RT,” said lead study author Rahul R. Parikh, MD, of the Mount Sinai Health System in New York.

“However, previous trials were limited by low patient numbers and limited follow-up and, thus, were unable to demonstrate an overall survival benefit. This is the largest dataset in this patient population to demonstrate a survival benefit with the addition of RT.”

Dr Parikh and his colleagues studied 41,502 patients who were diagnosed with stage I and II HL from 1998 to 2011. They were included in the National Cancer Data Base, which consists of cases from 1500 sites and represents more than 75% of all cancers diagnosed in the US.

The average patient age was 37 years (range, 18 to 90). The median follow-up was 7.5 years. Ninety-six percent of patients (n=39,842) received multi-agent chemotherapy, and 49% (n=20,441) received a median RT dose of 30.6 Gy.

The 10-year overall survival of the entire group was 80.8%. Patients receiving RT had significantly better overall survival than those who did not (84.4% vs 76.4%; P<0.00001).

When adjusting for age, stage, comorbidity, transplant, chemotherapy use, and socioeconomic status, RT use was still associated with significantly improved overall survival (hazard ratio=0.51; P<0.00001).

The study also showed that omitting RT was related to higher rates of salvage transplant procedures, a surrogate for persistent/relapsed disease (P=0.04).

Nevertheless, RT use decreased at the study sites from 56% to 41% between 1998 and 2011.

In 88.4% of patients who did not receive RT, the physician-reported reason was that RT was not part of the planned initial treatment strategy.

The research also indicated that RT use was more likely among younger patients (40 years or younger), those in a higher socioeconomic status, those who had access to health insurance, and those who received treatment at comprehensive cancer centers (all P<0.0001).

“[W]e have highlighted ongoing disparities in Hodgkin’s disease treatment, and it is important that we recognize these findings as potential barriers to care,” Dr Parikh said.

“Given the survival benefit demonstrated in this study, radiotherapy should be included in the combined modality approach of multi-agent chemotherapy followed by consolidation RT in order to maintain high overall survival rates for this curable disease.”

Preparing for radiation

Credit: Rhoda Baer

SAN FRANCISCO—Results of a large study suggest that consolidation radiation therapy (RT) can improve survival in patients with stage I and II Hodgkin lymphoma (HL), but the use of RT in these patients may be on the decline.

In this study of more than 40,000 patients, the 10-year survival rate was 84% among those who received RT and 76% among those who did not.

Despite this benefit, the use of RT declined during the period studied, from 56% in 1998 to 41% in 2011.

These data were presented at the American Society for Radiation Oncology’s 56th Annual Meeting (abstract 1042).

“Multiple prospective, randomized trials have shown a significant improvement in disease control with the addition of RT,” said lead study author Rahul R. Parikh, MD, of the Mount Sinai Health System in New York.

“However, previous trials were limited by low patient numbers and limited follow-up and, thus, were unable to demonstrate an overall survival benefit. This is the largest dataset in this patient population to demonstrate a survival benefit with the addition of RT.”

Dr Parikh and his colleagues studied 41,502 patients who were diagnosed with stage I and II HL from 1998 to 2011. They were included in the National Cancer Data Base, which consists of cases from 1500 sites and represents more than 75% of all cancers diagnosed in the US.

The average patient age was 37 years (range, 18 to 90). The median follow-up was 7.5 years. Ninety-six percent of patients (n=39,842) received multi-agent chemotherapy, and 49% (n=20,441) received a median RT dose of 30.6 Gy.

The 10-year overall survival of the entire group was 80.8%. Patients receiving RT had significantly better overall survival than those who did not (84.4% vs 76.4%; P<0.00001).

When adjusting for age, stage, comorbidity, transplant, chemotherapy use, and socioeconomic status, RT use was still associated with significantly improved overall survival (hazard ratio=0.51; P<0.00001).

The study also showed that omitting RT was related to higher rates of salvage transplant procedures, a surrogate for persistent/relapsed disease (P=0.04).

Nevertheless, RT use decreased at the study sites from 56% to 41% between 1998 and 2011.

In 88.4% of patients who did not receive RT, the physician-reported reason was that RT was not part of the planned initial treatment strategy.

The research also indicated that RT use was more likely among younger patients (40 years or younger), those in a higher socioeconomic status, those who had access to health insurance, and those who received treatment at comprehensive cancer centers (all P<0.0001).

“[W]e have highlighted ongoing disparities in Hodgkin’s disease treatment, and it is important that we recognize these findings as potential barriers to care,” Dr Parikh said.

“Given the survival benefit demonstrated in this study, radiotherapy should be included in the combined modality approach of multi-agent chemotherapy followed by consolidation RT in order to maintain high overall survival rates for this curable disease.”

Preparing for radiation

Credit: Rhoda Baer

SAN FRANCISCO—Results of a large study suggest that consolidation radiation therapy (RT) can improve survival in patients with stage I and II Hodgkin lymphoma (HL), but the use of RT in these patients may be on the decline.

In this study of more than 40,000 patients, the 10-year survival rate was 84% among those who received RT and 76% among those who did not.

Despite this benefit, the use of RT declined during the period studied, from 56% in 1998 to 41% in 2011.

These data were presented at the American Society for Radiation Oncology’s 56th Annual Meeting (abstract 1042).

“Multiple prospective, randomized trials have shown a significant improvement in disease control with the addition of RT,” said lead study author Rahul R. Parikh, MD, of the Mount Sinai Health System in New York.

“However, previous trials were limited by low patient numbers and limited follow-up and, thus, were unable to demonstrate an overall survival benefit. This is the largest dataset in this patient population to demonstrate a survival benefit with the addition of RT.”

Dr Parikh and his colleagues studied 41,502 patients who were diagnosed with stage I and II HL from 1998 to 2011. They were included in the National Cancer Data Base, which consists of cases from 1500 sites and represents more than 75% of all cancers diagnosed in the US.

The average patient age was 37 years (range, 18 to 90). The median follow-up was 7.5 years. Ninety-six percent of patients (n=39,842) received multi-agent chemotherapy, and 49% (n=20,441) received a median RT dose of 30.6 Gy.

The 10-year overall survival of the entire group was 80.8%. Patients receiving RT had significantly better overall survival than those who did not (84.4% vs 76.4%; P<0.00001).

When adjusting for age, stage, comorbidity, transplant, chemotherapy use, and socioeconomic status, RT use was still associated with significantly improved overall survival (hazard ratio=0.51; P<0.00001).

The study also showed that omitting RT was related to higher rates of salvage transplant procedures, a surrogate for persistent/relapsed disease (P=0.04).

Nevertheless, RT use decreased at the study sites from 56% to 41% between 1998 and 2011.

In 88.4% of patients who did not receive RT, the physician-reported reason was that RT was not part of the planned initial treatment strategy.

The research also indicated that RT use was more likely among younger patients (40 years or younger), those in a higher socioeconomic status, those who had access to health insurance, and those who received treatment at comprehensive cancer centers (all P<0.0001).

“[W]e have highlighted ongoing disparities in Hodgkin’s disease treatment, and it is important that we recognize these findings as potential barriers to care,” Dr Parikh said.

“Given the survival benefit demonstrated in this study, radiotherapy should be included in the combined modality approach of multi-agent chemotherapy followed by consolidation RT in order to maintain high overall survival rates for this curable disease.”

Blood samples

Credit: Graham Colm

Individuals with type AB blood may be more likely than those with other blood types to develop memory loss in later years, according to a study published in Neurology.

Investigators found that people with AB blood were 82% more likely to develop cognitive impairment, which can lead to dementia.

Previous studies have shown that individuals with type O blood have a lower risk of heart disease and stroke, factors that can increase the risk of memory loss and dementia.

The new research was part of a larger study—the REasons for Geographic And Racial Differences in Stroke (REGARDS) Study—of more than 30,000 subjects who were followed for an average of 3.4 years.

“Our study looks at blood type and risk of cognitive impairment, but several studies have shown that factors such as high blood pressure, high cholesterol, and diabetes increase the risk of cognitive impairment and dementia,” said Mary Cushman, MD, of the University of Vermont College of Medicine in Burlington.

“Blood type is also related to other vascular conditions like stroke, so the findings highlight the connections between vascular issues and brain health. More research is needed to confirm these results.”

Dr Cushman and her colleagues had set out to assess the relationship between ABO group, factor VIII (FVIII), and incident cognitive impairment in a large, prospective cohort of black and white adults in the US.

The team used cognitive domain tests to assess cognitive impairment. They identified 495 subjects who had no cognitive impairment at baseline but became impaired during follow-up. The investigators then compared these cases with 587 control subjects.

It turned out that subjects with AB blood made up 6% of the group that developed cognitive impairment, which is higher than the 4% of AB individuals found in the general population.

Multivariate analysis—adjusted for age, race, region, and sex—suggested that subjects with AB blood and those with higher FVIII had an increased risk of cognitive impairment. The odds ratios were 1.82 and 1.24, respectively.

Subjects with AB blood had a higher average level of FVIII than subjects with other blood types. The mean level of FVIII was 142 IU/dL among AB subjects and 104 IU/dL among subjects with type O blood.

However, the investigators also found that FVIII mediated only 18% of the association between AB blood type and cognitive impairment.

Blood samples

Credit: Graham Colm

Individuals with type AB blood may be more likely than those with other blood types to develop memory loss in later years, according to a study published in Neurology.

Investigators found that people with AB blood were 82% more likely to develop cognitive impairment, which can lead to dementia.

Previous studies have shown that individuals with type O blood have a lower risk of heart disease and stroke, factors that can increase the risk of memory loss and dementia.

The new research was part of a larger study—the REasons for Geographic And Racial Differences in Stroke (REGARDS) Study—of more than 30,000 subjects who were followed for an average of 3.4 years.

“Our study looks at blood type and risk of cognitive impairment, but several studies have shown that factors such as high blood pressure, high cholesterol, and diabetes increase the risk of cognitive impairment and dementia,” said Mary Cushman, MD, of the University of Vermont College of Medicine in Burlington.

“Blood type is also related to other vascular conditions like stroke, so the findings highlight the connections between vascular issues and brain health. More research is needed to confirm these results.”

Dr Cushman and her colleagues had set out to assess the relationship between ABO group, factor VIII (FVIII), and incident cognitive impairment in a large, prospective cohort of black and white adults in the US.

The team used cognitive domain tests to assess cognitive impairment. They identified 495 subjects who had no cognitive impairment at baseline but became impaired during follow-up. The investigators then compared these cases with 587 control subjects.

It turned out that subjects with AB blood made up 6% of the group that developed cognitive impairment, which is higher than the 4% of AB individuals found in the general population.

Multivariate analysis—adjusted for age, race, region, and sex—suggested that subjects with AB blood and those with higher FVIII had an increased risk of cognitive impairment. The odds ratios were 1.82 and 1.24, respectively.

Subjects with AB blood had a higher average level of FVIII than subjects with other blood types. The mean level of FVIII was 142 IU/dL among AB subjects and 104 IU/dL among subjects with type O blood.

However, the investigators also found that FVIII mediated only 18% of the association between AB blood type and cognitive impairment.

Blood samples

Credit: Graham Colm

Individuals with type AB blood may be more likely than those with other blood types to develop memory loss in later years, according to a study published in Neurology.

Investigators found that people with AB blood were 82% more likely to develop cognitive impairment, which can lead to dementia.

Previous studies have shown that individuals with type O blood have a lower risk of heart disease and stroke, factors that can increase the risk of memory loss and dementia.

The new research was part of a larger study—the REasons for Geographic And Racial Differences in Stroke (REGARDS) Study—of more than 30,000 subjects who were followed for an average of 3.4 years.

“Our study looks at blood type and risk of cognitive impairment, but several studies have shown that factors such as high blood pressure, high cholesterol, and diabetes increase the risk of cognitive impairment and dementia,” said Mary Cushman, MD, of the University of Vermont College of Medicine in Burlington.

“Blood type is also related to other vascular conditions like stroke, so the findings highlight the connections between vascular issues and brain health. More research is needed to confirm these results.”

Dr Cushman and her colleagues had set out to assess the relationship between ABO group, factor VIII (FVIII), and incident cognitive impairment in a large, prospective cohort of black and white adults in the US.

The team used cognitive domain tests to assess cognitive impairment. They identified 495 subjects who had no cognitive impairment at baseline but became impaired during follow-up. The investigators then compared these cases with 587 control subjects.

It turned out that subjects with AB blood made up 6% of the group that developed cognitive impairment, which is higher than the 4% of AB individuals found in the general population.

Multivariate analysis—adjusted for age, race, region, and sex—suggested that subjects with AB blood and those with higher FVIII had an increased risk of cognitive impairment. The odds ratios were 1.82 and 1.24, respectively.

Subjects with AB blood had a higher average level of FVIII than subjects with other blood types. The mean level of FVIII was 142 IU/dL among AB subjects and 104 IU/dL among subjects with type O blood.

However, the investigators also found that FVIII mediated only 18% of the association between AB blood type and cognitive impairment.