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Team identifies highly mutagenic compounds
Credit: Heather Luis
Researchers say they have discovered compounds that are hundreds of times more mutagenic than known carcinogens.
These compounds are produced by certain types of chemical reactions, such as those found in vehicle exhaust or the reactions that take place when meat is grilled over a flame.
The discovery of these compounds raises additional concerns about the health impacts of heavily polluted urban air and dietary exposure to carcinogens, according to the researchers.
Their findings were published in Environmental Science and Technology.
“Some of the compounds that we’ve discovered are far more mutagenic than we previously understood and may exist in the environment as a result of heavy air pollution from vehicles or some types of food preparation,” said Staci Simonich, PhD, of Oregon State University College of Agricultural Sciences.
“We don’t know at this point what levels may be present and will explore that in continued research.”
The parent compounds involved in this research are polycyclic aromatic hydrocarbons (PAHs), which are formed naturally as the result of almost any type of combustion.
Many PAHs, such as benzo[a]pyrene, have been shown to induce leukemias, lymphomas, and other cancers. PAHs are now believed to be more of a health concern than we thought in the past and are the subject of extensive research around the world.
PAHs can become even more of a problem when they chemically interact with nitrogen to become nitrated (NPAHs), according to scientists.
The newly discovered compounds are NPAHs that were unknown to this point. The researchers found the direct mutagenicity of the NPAHs with 1 nitrogen group can be 6 to 432 times more than the parent compound. NPAHs based on 2 nitrogen groups can be 272 to 467 times more mutagenic.
And the team said the mutagenic assays they used may actually have understated the increase in toxicity. It could be even higher. 
Credit: Heather Luis
Researchers say they have discovered compounds that are hundreds of times more mutagenic than known carcinogens.
These compounds are produced by certain types of chemical reactions, such as those found in vehicle exhaust or the reactions that take place when meat is grilled over a flame.
The discovery of these compounds raises additional concerns about the health impacts of heavily polluted urban air and dietary exposure to carcinogens, according to the researchers.
Their findings were published in Environmental Science and Technology.
“Some of the compounds that we’ve discovered are far more mutagenic than we previously understood and may exist in the environment as a result of heavy air pollution from vehicles or some types of food preparation,” said Staci Simonich, PhD, of Oregon State University College of Agricultural Sciences.
“We don’t know at this point what levels may be present and will explore that in continued research.”
The parent compounds involved in this research are polycyclic aromatic hydrocarbons (PAHs), which are formed naturally as the result of almost any type of combustion.
Many PAHs, such as benzo[a]pyrene, have been shown to induce leukemias, lymphomas, and other cancers. PAHs are now believed to be more of a health concern than we thought in the past and are the subject of extensive research around the world.
PAHs can become even more of a problem when they chemically interact with nitrogen to become nitrated (NPAHs), according to scientists.
The newly discovered compounds are NPAHs that were unknown to this point. The researchers found the direct mutagenicity of the NPAHs with 1 nitrogen group can be 6 to 432 times more than the parent compound. NPAHs based on 2 nitrogen groups can be 272 to 467 times more mutagenic.
And the team said the mutagenic assays they used may actually have understated the increase in toxicity. It could be even higher.
Credit: Heather Luis
Researchers say they have discovered compounds that are hundreds of times more mutagenic than known carcinogens.
These compounds are produced by certain types of chemical reactions, such as those found in vehicle exhaust or the reactions that take place when meat is grilled over a flame.
The discovery of these compounds raises additional concerns about the health impacts of heavily polluted urban air and dietary exposure to carcinogens, according to the researchers.
Their findings were published in Environmental Science and Technology.
“Some of the compounds that we’ve discovered are far more mutagenic than we previously understood and may exist in the environment as a result of heavy air pollution from vehicles or some types of food preparation,” said Staci Simonich, PhD, of Oregon State University College of Agricultural Sciences.
“We don’t know at this point what levels may be present and will explore that in continued research.”
The parent compounds involved in this research are polycyclic aromatic hydrocarbons (PAHs), which are formed naturally as the result of almost any type of combustion.
Many PAHs, such as benzo[a]pyrene, have been shown to induce leukemias, lymphomas, and other cancers. PAHs are now believed to be more of a health concern than we thought in the past and are the subject of extensive research around the world.
PAHs can become even more of a problem when they chemically interact with nitrogen to become nitrated (NPAHs), according to scientists.
The newly discovered compounds are NPAHs that were unknown to this point. The researchers found the direct mutagenicity of the NPAHs with 1 nitrogen group can be 6 to 432 times more than the parent compound. NPAHs based on 2 nitrogen groups can be 272 to 467 times more mutagenic.
And the team said the mutagenic assays they used may actually have understated the increase in toxicity. It could be even higher.
Chemo patients may have higher VTE risk than trials suggest
Credit: Andre E.X. Brown
A large-scale analysis assessing the real-world risk of venous thromboembolism (VTE) among chemotherapy patients showed a greater occurrence of VTE than that identified in clinical trials.
The data also revealed a progressively increased risk during the year following treatment initiation.
The study, published in The Oncologist, showed that outpatients receiving chemotherapy were at high risk of both VTE and major bleeding complications.
The risks were particularly high for patients with pancreas, stomach, and lung cancer.
Gary H. Lyman, MD, of the Duke University School of Medicine in Durham, North Carolina, and his colleagues conducted this research, analyzing data from the United States IMPACT healthcare claims database.
Their sample included 27,479 patients with solid tumor malignancies who had undergone chemotherapy. The researchers retrospectively evaluated the patients’ VTE risk, as well as their risk of bleeding and the economic burden borne by the patient as a result of the disease.
The team used 3 definitions of VTE. Definition A included patients who had 1 or more VTE claim. Definition B included patients with 2 or more VTE claims 30 days or more apart, 1 inpatient claim, or 1 outpatient claim in which they received an anticoagulant within 90 days.
Definition C excluded from definition B any VTE events within 90 days of any major or invasive surgery. Codes relating to esophageal, renal, and uterine cancer were excluded.
VTE risk
The risk of VTE increased over time, with a greater percentage of patients developing the complication at 12 months after initiation of chemotherapy than at 3.5 months. This held true across the 3 definitions of VTE considered.
According to definition A, the overall VTE incidence was 7.3% (4.6%-11.6%) at 3.5 months and 13.5% (9.8%-21.3%) at a year.
Rates of VTE were similar according to definitions B and C. At 3.5 months, the rates were 3.4%-9.6% and 3.2%-8.7%, respectively. At 12 months, they were 7.1%-17.7% and 6.7%-16.6%, respectively.
According to definition A, VTE was most frequently observed in cancers of the pancreas (11.6%), lung (8.5%), and stomach (8.3%).
Major bleeding
Patients with VTE had a higher risk of major bleeding events in the year following chemotherapy initiation.
Individuals receiving outpatient chemotherapy who developed VTE according to definition A at 3.5 months had a higher risk for major bleeding complications within 3.5 months than patients who were not receiving outpatient chemotherapy—11.0% and 3.8%, respectively.
The incidence of major bleeding within 12 months after the index date was 19.8% in patients with VTE (according to definition A) and 9.6% in patients without VTE.
Healthcare costs
While the baseline healthcare costs of patients who would develop VTE were comparable to those of patients who would not, the costs soared for VTE patients over the year following chemotherapy initiation.
On average, in the first 12 months after the index date, patients with VTE had $110,719 worth of healthcare costs, compared with $76,804 for patients without VTE. This difference was primarily accounted for by VTE-related inpatient, outpatient, and emergency room expenses.
Claims data vs trial data
The researchers noted that the incidence of VTE reported in this study is inconsistent with data previously reported in randomized clinical trials, which may be due to the selection of lower-risk patients for participation in these studies.
“Importantly, this observational study suggests that the observed rates of symptomatic VTE in real-world practice are considerably greater than reported in patients eligible for randomized clinical trials,” Dr Lyman said.
“Clinical oncologists need to be aware of the increased risk of this serious complication of cancer and cancer treatment, and, when the risk is sufficiently great, and the balance of benefits and harms acceptable, oncologists should consider prophylactic anticoagulation.”
Dr Lyman and his colleagues hypothesized that there is a definable, high-risk cohort of patients who would benefit from thromboprophylaxis.
And the scope of this risk warrants consideration for the use of treatments such as low- and ultra-low-molecular-weight heparins, which recent studies have found to be safe and effective thromboprophylaxis for chemotherapy patients.
Credit: Andre E.X. Brown
A large-scale analysis assessing the real-world risk of venous thromboembolism (VTE) among chemotherapy patients showed a greater occurrence of VTE than that identified in clinical trials.
The data also revealed a progressively increased risk during the year following treatment initiation.
The study, published in The Oncologist, showed that outpatients receiving chemotherapy were at high risk of both VTE and major bleeding complications.
The risks were particularly high for patients with pancreas, stomach, and lung cancer.
Gary H. Lyman, MD, of the Duke University School of Medicine in Durham, North Carolina, and his colleagues conducted this research, analyzing data from the United States IMPACT healthcare claims database.
Their sample included 27,479 patients with solid tumor malignancies who had undergone chemotherapy. The researchers retrospectively evaluated the patients’ VTE risk, as well as their risk of bleeding and the economic burden borne by the patient as a result of the disease.
The team used 3 definitions of VTE. Definition A included patients who had 1 or more VTE claim. Definition B included patients with 2 or more VTE claims 30 days or more apart, 1 inpatient claim, or 1 outpatient claim in which they received an anticoagulant within 90 days.
Definition C excluded from definition B any VTE events within 90 days of any major or invasive surgery. Codes relating to esophageal, renal, and uterine cancer were excluded.
VTE risk
The risk of VTE increased over time, with a greater percentage of patients developing the complication at 12 months after initiation of chemotherapy than at 3.5 months. This held true across the 3 definitions of VTE considered.
According to definition A, the overall VTE incidence was 7.3% (4.6%-11.6%) at 3.5 months and 13.5% (9.8%-21.3%) at a year.
Rates of VTE were similar according to definitions B and C. At 3.5 months, the rates were 3.4%-9.6% and 3.2%-8.7%, respectively. At 12 months, they were 7.1%-17.7% and 6.7%-16.6%, respectively.
According to definition A, VTE was most frequently observed in cancers of the pancreas (11.6%), lung (8.5%), and stomach (8.3%).
Major bleeding
Patients with VTE had a higher risk of major bleeding events in the year following chemotherapy initiation.
Individuals receiving outpatient chemotherapy who developed VTE according to definition A at 3.5 months had a higher risk for major bleeding complications within 3.5 months than patients who were not receiving outpatient chemotherapy—11.0% and 3.8%, respectively.
The incidence of major bleeding within 12 months after the index date was 19.8% in patients with VTE (according to definition A) and 9.6% in patients without VTE.
Healthcare costs
While the baseline healthcare costs of patients who would develop VTE were comparable to those of patients who would not, the costs soared for VTE patients over the year following chemotherapy initiation.
On average, in the first 12 months after the index date, patients with VTE had $110,719 worth of healthcare costs, compared with $76,804 for patients without VTE. This difference was primarily accounted for by VTE-related inpatient, outpatient, and emergency room expenses.
Claims data vs trial data
The researchers noted that the incidence of VTE reported in this study is inconsistent with data previously reported in randomized clinical trials, which may be due to the selection of lower-risk patients for participation in these studies.
“Importantly, this observational study suggests that the observed rates of symptomatic VTE in real-world practice are considerably greater than reported in patients eligible for randomized clinical trials,” Dr Lyman said.
“Clinical oncologists need to be aware of the increased risk of this serious complication of cancer and cancer treatment, and, when the risk is sufficiently great, and the balance of benefits and harms acceptable, oncologists should consider prophylactic anticoagulation.”
Dr Lyman and his colleagues hypothesized that there is a definable, high-risk cohort of patients who would benefit from thromboprophylaxis.
And the scope of this risk warrants consideration for the use of treatments such as low- and ultra-low-molecular-weight heparins, which recent studies have found to be safe and effective thromboprophylaxis for chemotherapy patients.
Credit: Andre E.X. Brown
A large-scale analysis assessing the real-world risk of venous thromboembolism (VTE) among chemotherapy patients showed a greater occurrence of VTE than that identified in clinical trials.
The data also revealed a progressively increased risk during the year following treatment initiation.
The study, published in The Oncologist, showed that outpatients receiving chemotherapy were at high risk of both VTE and major bleeding complications.
The risks were particularly high for patients with pancreas, stomach, and lung cancer.
Gary H. Lyman, MD, of the Duke University School of Medicine in Durham, North Carolina, and his colleagues conducted this research, analyzing data from the United States IMPACT healthcare claims database.
Their sample included 27,479 patients with solid tumor malignancies who had undergone chemotherapy. The researchers retrospectively evaluated the patients’ VTE risk, as well as their risk of bleeding and the economic burden borne by the patient as a result of the disease.
The team used 3 definitions of VTE. Definition A included patients who had 1 or more VTE claim. Definition B included patients with 2 or more VTE claims 30 days or more apart, 1 inpatient claim, or 1 outpatient claim in which they received an anticoagulant within 90 days.
Definition C excluded from definition B any VTE events within 90 days of any major or invasive surgery. Codes relating to esophageal, renal, and uterine cancer were excluded.
VTE risk
The risk of VTE increased over time, with a greater percentage of patients developing the complication at 12 months after initiation of chemotherapy than at 3.5 months. This held true across the 3 definitions of VTE considered.
According to definition A, the overall VTE incidence was 7.3% (4.6%-11.6%) at 3.5 months and 13.5% (9.8%-21.3%) at a year.
Rates of VTE were similar according to definitions B and C. At 3.5 months, the rates were 3.4%-9.6% and 3.2%-8.7%, respectively. At 12 months, they were 7.1%-17.7% and 6.7%-16.6%, respectively.
According to definition A, VTE was most frequently observed in cancers of the pancreas (11.6%), lung (8.5%), and stomach (8.3%).
Major bleeding
Patients with VTE had a higher risk of major bleeding events in the year following chemotherapy initiation.
Individuals receiving outpatient chemotherapy who developed VTE according to definition A at 3.5 months had a higher risk for major bleeding complications within 3.5 months than patients who were not receiving outpatient chemotherapy—11.0% and 3.8%, respectively.
The incidence of major bleeding within 12 months after the index date was 19.8% in patients with VTE (according to definition A) and 9.6% in patients without VTE.
Healthcare costs
While the baseline healthcare costs of patients who would develop VTE were comparable to those of patients who would not, the costs soared for VTE patients over the year following chemotherapy initiation.
On average, in the first 12 months after the index date, patients with VTE had $110,719 worth of healthcare costs, compared with $76,804 for patients without VTE. This difference was primarily accounted for by VTE-related inpatient, outpatient, and emergency room expenses.
Claims data vs trial data
The researchers noted that the incidence of VTE reported in this study is inconsistent with data previously reported in randomized clinical trials, which may be due to the selection of lower-risk patients for participation in these studies.
“Importantly, this observational study suggests that the observed rates of symptomatic VTE in real-world practice are considerably greater than reported in patients eligible for randomized clinical trials,” Dr Lyman said.
“Clinical oncologists need to be aware of the increased risk of this serious complication of cancer and cancer treatment, and, when the risk is sufficiently great, and the balance of benefits and harms acceptable, oncologists should consider prophylactic anticoagulation.”
Dr Lyman and his colleagues hypothesized that there is a definable, high-risk cohort of patients who would benefit from thromboprophylaxis.
And the scope of this risk warrants consideration for the use of treatments such as low- and ultra-low-molecular-weight heparins, which recent studies have found to be safe and effective thromboprophylaxis for chemotherapy patients.
Patients' Point of View on Informed Consent: A Prospective Study in Carpal Tunnel Surgery
US health spending growth slowed in 2012
Credit: Petr Kratochvil
In 2012, overall US health expenditures grew slower than the economy as a whole, according to a report by the Centers for Medicare & Medicaid Services (CMS).
US health spending grew at an annual rate of 3.7% in 2012, to reach $2.8 trillion, or $8915 per person. The rate of growth was 3.9%, and reached $2.7 trillion, in 2011.
Health spending as a share of gross domestic product also fell slightly, from 17.3% in 2011 to 17.2% in 2012.
According to the report, this low growth was driven by slower growth in expenditures on prescription drugs, nursing homes, private health insurance, and Medicare.
On the other hand, growth accelerated for hospital expenditures, physician and clinical services, home healthcare, Medicaid, and out-of-pocket spending.
An article summarizing these findings appears in the January issue of Health Affairs. The full report is available on the CMS National Health Expenditures website.
Areas of slow growth
Medicare spending growth increased by 4.8% in 2012, to reach $572.5 billion, but this was a slight slowdown compared to the 5.0% growth seen in 2011. Medicare expenditures represented 20% of national health spending in 2012.
Retail prescription drug spending also slowed in 2012, growing 0.4%, compared to 2.5% in 2011. This was the result of numerous drugs losing their patent protection, which lead to increased sales of lower-cost generics.
Private health insurance spending increased 3.2% in 2012, compared to 3.4% growth in 2011. The net cost ratio for private health insurance—the difference between premiums and benefits as a share of premiums—was 12.0% in 2012 and 12.4% in 2011.
Spending for freestanding nursing care facilities and continuing-care retirement communities increased by 1.6% in 2012, down from 4.3% growth in 2011, due to a one-time Medicare rate adjustment for skilled nursing facilities.
Accelerated spending
Total Medicaid spending grew 3.3% in 2012, to reach $421.2 billion, an increase over the 2.4% growth seen in 2011. Federal Medicaid expenditures decreased 4.2% in 2012, while state and local Medicaid expenditures grew 15.0%—a result of the expiration of enhanced federal aid to states in the middle of 2011.
Hospital spending increased 4.9% in 2012, up from the 3.5% growth seen in 2011. The accelerated growth in 2012 was influenced by a growth in prices, as well as increased use and intensity of services. Growth in spending from Medicare, Medicaid, and private health insurance hospital spending all accelerated in 2012 compared to 2011.
Spending on home healthcare increased 5.1% in 2012, up from 4.1% growth in 2011. Medicare and Medicaid spending accounted for about 81% of total home healthcare spending in 2012. Medicare spending grew at a faster rate in 2012, but Medicaid spending slowed.
Physician and clinical services spending grew 4.6% in 2012, compared to 4.1% growth in 2011.
Although the growth in prices slowed slightly in 2012, non-price factors such as the use and intensity of services increased faster in 2012.
Out-of-pocket spending increased 3.8% in 2012, to $328.2 billion, up from 3.5% growth in 2011. According to CMS, this reflects higher cost-sharing and increased enrollment in consumer-directed health plans.
Credit: Petr Kratochvil
In 2012, overall US health expenditures grew slower than the economy as a whole, according to a report by the Centers for Medicare & Medicaid Services (CMS).
US health spending grew at an annual rate of 3.7% in 2012, to reach $2.8 trillion, or $8915 per person. The rate of growth was 3.9%, and reached $2.7 trillion, in 2011.
Health spending as a share of gross domestic product also fell slightly, from 17.3% in 2011 to 17.2% in 2012.
According to the report, this low growth was driven by slower growth in expenditures on prescription drugs, nursing homes, private health insurance, and Medicare.
On the other hand, growth accelerated for hospital expenditures, physician and clinical services, home healthcare, Medicaid, and out-of-pocket spending.
An article summarizing these findings appears in the January issue of Health Affairs. The full report is available on the CMS National Health Expenditures website.
Areas of slow growth
Medicare spending growth increased by 4.8% in 2012, to reach $572.5 billion, but this was a slight slowdown compared to the 5.0% growth seen in 2011. Medicare expenditures represented 20% of national health spending in 2012.
Retail prescription drug spending also slowed in 2012, growing 0.4%, compared to 2.5% in 2011. This was the result of numerous drugs losing their patent protection, which lead to increased sales of lower-cost generics.
Private health insurance spending increased 3.2% in 2012, compared to 3.4% growth in 2011. The net cost ratio for private health insurance—the difference between premiums and benefits as a share of premiums—was 12.0% in 2012 and 12.4% in 2011.
Spending for freestanding nursing care facilities and continuing-care retirement communities increased by 1.6% in 2012, down from 4.3% growth in 2011, due to a one-time Medicare rate adjustment for skilled nursing facilities.
Accelerated spending
Total Medicaid spending grew 3.3% in 2012, to reach $421.2 billion, an increase over the 2.4% growth seen in 2011. Federal Medicaid expenditures decreased 4.2% in 2012, while state and local Medicaid expenditures grew 15.0%—a result of the expiration of enhanced federal aid to states in the middle of 2011.
Hospital spending increased 4.9% in 2012, up from the 3.5% growth seen in 2011. The accelerated growth in 2012 was influenced by a growth in prices, as well as increased use and intensity of services. Growth in spending from Medicare, Medicaid, and private health insurance hospital spending all accelerated in 2012 compared to 2011.
Spending on home healthcare increased 5.1% in 2012, up from 4.1% growth in 2011. Medicare and Medicaid spending accounted for about 81% of total home healthcare spending in 2012. Medicare spending grew at a faster rate in 2012, but Medicaid spending slowed.
Physician and clinical services spending grew 4.6% in 2012, compared to 4.1% growth in 2011.
Although the growth in prices slowed slightly in 2012, non-price factors such as the use and intensity of services increased faster in 2012.
Out-of-pocket spending increased 3.8% in 2012, to $328.2 billion, up from 3.5% growth in 2011. According to CMS, this reflects higher cost-sharing and increased enrollment in consumer-directed health plans.
Credit: Petr Kratochvil
In 2012, overall US health expenditures grew slower than the economy as a whole, according to a report by the Centers for Medicare & Medicaid Services (CMS).
US health spending grew at an annual rate of 3.7% in 2012, to reach $2.8 trillion, or $8915 per person. The rate of growth was 3.9%, and reached $2.7 trillion, in 2011.
Health spending as a share of gross domestic product also fell slightly, from 17.3% in 2011 to 17.2% in 2012.
According to the report, this low growth was driven by slower growth in expenditures on prescription drugs, nursing homes, private health insurance, and Medicare.
On the other hand, growth accelerated for hospital expenditures, physician and clinical services, home healthcare, Medicaid, and out-of-pocket spending.
An article summarizing these findings appears in the January issue of Health Affairs. The full report is available on the CMS National Health Expenditures website.
Areas of slow growth
Medicare spending growth increased by 4.8% in 2012, to reach $572.5 billion, but this was a slight slowdown compared to the 5.0% growth seen in 2011. Medicare expenditures represented 20% of national health spending in 2012.
Retail prescription drug spending also slowed in 2012, growing 0.4%, compared to 2.5% in 2011. This was the result of numerous drugs losing their patent protection, which lead to increased sales of lower-cost generics.
Private health insurance spending increased 3.2% in 2012, compared to 3.4% growth in 2011. The net cost ratio for private health insurance—the difference between premiums and benefits as a share of premiums—was 12.0% in 2012 and 12.4% in 2011.
Spending for freestanding nursing care facilities and continuing-care retirement communities increased by 1.6% in 2012, down from 4.3% growth in 2011, due to a one-time Medicare rate adjustment for skilled nursing facilities.
Accelerated spending
Total Medicaid spending grew 3.3% in 2012, to reach $421.2 billion, an increase over the 2.4% growth seen in 2011. Federal Medicaid expenditures decreased 4.2% in 2012, while state and local Medicaid expenditures grew 15.0%—a result of the expiration of enhanced federal aid to states in the middle of 2011.
Hospital spending increased 4.9% in 2012, up from the 3.5% growth seen in 2011. The accelerated growth in 2012 was influenced by a growth in prices, as well as increased use and intensity of services. Growth in spending from Medicare, Medicaid, and private health insurance hospital spending all accelerated in 2012 compared to 2011.
Spending on home healthcare increased 5.1% in 2012, up from 4.1% growth in 2011. Medicare and Medicaid spending accounted for about 81% of total home healthcare spending in 2012. Medicare spending grew at a faster rate in 2012, but Medicaid spending slowed.
Physician and clinical services spending grew 4.6% in 2012, compared to 4.1% growth in 2011.
Although the growth in prices slowed slightly in 2012, non-price factors such as the use and intensity of services increased faster in 2012.
Out-of-pocket spending increased 3.8% in 2012, to $328.2 billion, up from 3.5% growth in 2011. According to CMS, this reflects higher cost-sharing and increased enrollment in consumer-directed health plans.
Internists may be ill-equipped to care for childhood cancer survivors
Credit: CDC
A survey of general internists suggests a few obstacles may prevent these physicians from providing optimal care for childhood cancer survivors.
Most of the internists surveyed were unfamiliar with surveillance guidelines, felt “somewhat uncomfortable” caring for childhood cancer survivors, and would prefer to follow patients in collaboration with a cancer center.
Nevertheless, about half of the survey respondents had recently cared for at least 1 childhood cancer survivor.
And a majority of these physicians said they never received a summary of their patients’ cancer treatment.
Eugene Suh, MD, of Loyola University Medical Center in Maywood, Illinois, and his colleagues reported these findings in Annals of Internal Medicine.
The researchers surveyed 1110 general internists, gauging their care preferences, comfort levels with caring for childhood cancer survivors, and knowledge of surveillance guidelines.
Only 36.9% of respondents said they were “somewhat comfortable” or “comfortable” caring for survivors of Hodgkin lymphoma. Twenty-seven percent felt the same about survivors of acute lymphoblastic leukemia. And 25% felt that way about osteosarcoma survivors.
In all, 51.1% of respondents had cared for at least 1 childhood cancer survivor in the 5 years preceding the survey. But 72% of these physicians had never received treatment summaries for these patients.
Eighty-four percent of respondents said they would prefer to treat childhood cancer survivors in collaboration with a physician based at a cancer center or a long-term follow-up clinic. And 10.5% said they would refer survivors to a cancer center-based physician, long-term follow-up clinic, or another primary care physician.
Only 12% of respondents said they felt at least “somewhat familiar” with surveillance guidelines. And the internists’ responses to a vignette case supported this answer.
The survey included questions about surveillance for a hypothetical 16-year-old Hodgkin lymphoma survivor who had received mantle radiation and anthracycline chemotherapy.
Ninety-one percent of respondents failed to recommend appropriate breast cancer surveillance for this patient, 85% did not recommend appropriate cardiac surveillance, and 24% failed to recommend appropriate thyroid surveillance.
Dr Suh and his colleagues said these results suggest a need for improved education among general internists but also the need for better collaboration between oncologists and primary care physicians.
A related editorial includes suggestions for educational initiatives.
Credit: CDC
A survey of general internists suggests a few obstacles may prevent these physicians from providing optimal care for childhood cancer survivors.
Most of the internists surveyed were unfamiliar with surveillance guidelines, felt “somewhat uncomfortable” caring for childhood cancer survivors, and would prefer to follow patients in collaboration with a cancer center.
Nevertheless, about half of the survey respondents had recently cared for at least 1 childhood cancer survivor.
And a majority of these physicians said they never received a summary of their patients’ cancer treatment.
Eugene Suh, MD, of Loyola University Medical Center in Maywood, Illinois, and his colleagues reported these findings in Annals of Internal Medicine.
The researchers surveyed 1110 general internists, gauging their care preferences, comfort levels with caring for childhood cancer survivors, and knowledge of surveillance guidelines.
Only 36.9% of respondents said they were “somewhat comfortable” or “comfortable” caring for survivors of Hodgkin lymphoma. Twenty-seven percent felt the same about survivors of acute lymphoblastic leukemia. And 25% felt that way about osteosarcoma survivors.
In all, 51.1% of respondents had cared for at least 1 childhood cancer survivor in the 5 years preceding the survey. But 72% of these physicians had never received treatment summaries for these patients.
Eighty-four percent of respondents said they would prefer to treat childhood cancer survivors in collaboration with a physician based at a cancer center or a long-term follow-up clinic. And 10.5% said they would refer survivors to a cancer center-based physician, long-term follow-up clinic, or another primary care physician.
Only 12% of respondents said they felt at least “somewhat familiar” with surveillance guidelines. And the internists’ responses to a vignette case supported this answer.
The survey included questions about surveillance for a hypothetical 16-year-old Hodgkin lymphoma survivor who had received mantle radiation and anthracycline chemotherapy.
Ninety-one percent of respondents failed to recommend appropriate breast cancer surveillance for this patient, 85% did not recommend appropriate cardiac surveillance, and 24% failed to recommend appropriate thyroid surveillance.
Dr Suh and his colleagues said these results suggest a need for improved education among general internists but also the need for better collaboration between oncologists and primary care physicians.
A related editorial includes suggestions for educational initiatives.
Credit: CDC
A survey of general internists suggests a few obstacles may prevent these physicians from providing optimal care for childhood cancer survivors.
Most of the internists surveyed were unfamiliar with surveillance guidelines, felt “somewhat uncomfortable” caring for childhood cancer survivors, and would prefer to follow patients in collaboration with a cancer center.
Nevertheless, about half of the survey respondents had recently cared for at least 1 childhood cancer survivor.
And a majority of these physicians said they never received a summary of their patients’ cancer treatment.
Eugene Suh, MD, of Loyola University Medical Center in Maywood, Illinois, and his colleagues reported these findings in Annals of Internal Medicine.
The researchers surveyed 1110 general internists, gauging their care preferences, comfort levels with caring for childhood cancer survivors, and knowledge of surveillance guidelines.
Only 36.9% of respondents said they were “somewhat comfortable” or “comfortable” caring for survivors of Hodgkin lymphoma. Twenty-seven percent felt the same about survivors of acute lymphoblastic leukemia. And 25% felt that way about osteosarcoma survivors.
In all, 51.1% of respondents had cared for at least 1 childhood cancer survivor in the 5 years preceding the survey. But 72% of these physicians had never received treatment summaries for these patients.
Eighty-four percent of respondents said they would prefer to treat childhood cancer survivors in collaboration with a physician based at a cancer center or a long-term follow-up clinic. And 10.5% said they would refer survivors to a cancer center-based physician, long-term follow-up clinic, or another primary care physician.
Only 12% of respondents said they felt at least “somewhat familiar” with surveillance guidelines. And the internists’ responses to a vignette case supported this answer.
The survey included questions about surveillance for a hypothetical 16-year-old Hodgkin lymphoma survivor who had received mantle radiation and anthracycline chemotherapy.
Ninety-one percent of respondents failed to recommend appropriate breast cancer surveillance for this patient, 85% did not recommend appropriate cardiac surveillance, and 24% failed to recommend appropriate thyroid surveillance.
Dr Suh and his colleagues said these results suggest a need for improved education among general internists but also the need for better collaboration between oncologists and primary care physicians.
A related editorial includes suggestions for educational initiatives.
Out-of-pocket costs hinder adherence to imatinib
Credit: CDC
When their share of prescription costs becomes too high, many patients with chronic myeloid leukemia (CML) will skip doses of imatinib or stop taking the drug entirely, new research suggests.
In a study of about 1500 patients, the median co-payment for an imatinib prescription was about $30 per fill, but the range was $0 to $4792.
Patients with higher co-payments were 70% more likely than their peers to stop taking imatinib and 42% more likely to skip doses of the drug.
Stacie B. Dusetzina, PhD, of the University of North Carolina at Chapel Hill, and her colleagues conducted this research and described the results in the Journal of Clinical Oncology.
Co-payment requirements vary
The researchers analyzed health plan claims from privately insured adults (ages 18 to 64) from 2002 to 2011. The data included 1541 CML patients beginning treatment with imatinib.
For the whole study period, the mean co-payment was $108 for a 30-day supply of imatinib. Patients in the lowest 25th percentile paid a mean of $17, and patients in the upper 75th percentile paid a mean of $53.
As expected, monthly co-payments increased over time. They averaged $55 in 2002 and $145 in 2011, with 6.4% of patients paying more than $500 a month.
Dr Dusetzina noted that the data only included patients on employer-based insurance plans, and most individuals had low out-of-pocket costs.
“We studied people who are part of large employer groups, so their insurance is probably more generous than someone who is buying insurance on a private market that does not have a lot of negotiating power,” she said.
Costs correlate with adherence
In the first 180 days of treatment, 30% of patients with higher co-payments were non-adherent to imatinib treatment, compared to 21% of patients with lower co-payments. Non-adherence was defined as having less than 80% of days with imatinib available.
Seventeen percent of patients with higher co-payments discontinued taking imatinib, compared to 10% of patients with lower co-payments. Discontinuation was defined as having a gap of more than 60 days after the exhaustion of imatinib therapy.
These data did not include patients who could not begin taking imatinib due to costs. Therefore, Dr Dusetzina said this study likely underestimates the effects of drug costs on treatment adherence.
“If you went to the pharmacy to obtain your prescription, and they said it was $5000, and you walked away because you couldn’t afford to pay, you’re not in the data,” she said. “We could only study individuals who filled at least one prescription.”
Dr Dusetzina also said these findings have implications beyond imatinib and CML. Many new treatments for rare conditions can cost insurers and patients more than $100,000 year.
“Our results are particularly relevant for specialty pharmaceutical products—those that cost over $10,000 a month,” she said.
“However, the lessons learned likely relate to any pharmaceutical product that has high out-of-pocket costs. It is important that we identify strategies to make effective but expensive medications more affordable to patients.”
Credit: CDC
When their share of prescription costs becomes too high, many patients with chronic myeloid leukemia (CML) will skip doses of imatinib or stop taking the drug entirely, new research suggests.
In a study of about 1500 patients, the median co-payment for an imatinib prescription was about $30 per fill, but the range was $0 to $4792.
Patients with higher co-payments were 70% more likely than their peers to stop taking imatinib and 42% more likely to skip doses of the drug.
Stacie B. Dusetzina, PhD, of the University of North Carolina at Chapel Hill, and her colleagues conducted this research and described the results in the Journal of Clinical Oncology.
Co-payment requirements vary
The researchers analyzed health plan claims from privately insured adults (ages 18 to 64) from 2002 to 2011. The data included 1541 CML patients beginning treatment with imatinib.
For the whole study period, the mean co-payment was $108 for a 30-day supply of imatinib. Patients in the lowest 25th percentile paid a mean of $17, and patients in the upper 75th percentile paid a mean of $53.
As expected, monthly co-payments increased over time. They averaged $55 in 2002 and $145 in 2011, with 6.4% of patients paying more than $500 a month.
Dr Dusetzina noted that the data only included patients on employer-based insurance plans, and most individuals had low out-of-pocket costs.
“We studied people who are part of large employer groups, so their insurance is probably more generous than someone who is buying insurance on a private market that does not have a lot of negotiating power,” she said.
Costs correlate with adherence
In the first 180 days of treatment, 30% of patients with higher co-payments were non-adherent to imatinib treatment, compared to 21% of patients with lower co-payments. Non-adherence was defined as having less than 80% of days with imatinib available.
Seventeen percent of patients with higher co-payments discontinued taking imatinib, compared to 10% of patients with lower co-payments. Discontinuation was defined as having a gap of more than 60 days after the exhaustion of imatinib therapy.
These data did not include patients who could not begin taking imatinib due to costs. Therefore, Dr Dusetzina said this study likely underestimates the effects of drug costs on treatment adherence.
“If you went to the pharmacy to obtain your prescription, and they said it was $5000, and you walked away because you couldn’t afford to pay, you’re not in the data,” she said. “We could only study individuals who filled at least one prescription.”
Dr Dusetzina also said these findings have implications beyond imatinib and CML. Many new treatments for rare conditions can cost insurers and patients more than $100,000 year.
“Our results are particularly relevant for specialty pharmaceutical products—those that cost over $10,000 a month,” she said.
“However, the lessons learned likely relate to any pharmaceutical product that has high out-of-pocket costs. It is important that we identify strategies to make effective but expensive medications more affordable to patients.”
Credit: CDC
When their share of prescription costs becomes too high, many patients with chronic myeloid leukemia (CML) will skip doses of imatinib or stop taking the drug entirely, new research suggests.
In a study of about 1500 patients, the median co-payment for an imatinib prescription was about $30 per fill, but the range was $0 to $4792.
Patients with higher co-payments were 70% more likely than their peers to stop taking imatinib and 42% more likely to skip doses of the drug.
Stacie B. Dusetzina, PhD, of the University of North Carolina at Chapel Hill, and her colleagues conducted this research and described the results in the Journal of Clinical Oncology.
Co-payment requirements vary
The researchers analyzed health plan claims from privately insured adults (ages 18 to 64) from 2002 to 2011. The data included 1541 CML patients beginning treatment with imatinib.
For the whole study period, the mean co-payment was $108 for a 30-day supply of imatinib. Patients in the lowest 25th percentile paid a mean of $17, and patients in the upper 75th percentile paid a mean of $53.
As expected, monthly co-payments increased over time. They averaged $55 in 2002 and $145 in 2011, with 6.4% of patients paying more than $500 a month.
Dr Dusetzina noted that the data only included patients on employer-based insurance plans, and most individuals had low out-of-pocket costs.
“We studied people who are part of large employer groups, so their insurance is probably more generous than someone who is buying insurance on a private market that does not have a lot of negotiating power,” she said.
Costs correlate with adherence
In the first 180 days of treatment, 30% of patients with higher co-payments were non-adherent to imatinib treatment, compared to 21% of patients with lower co-payments. Non-adherence was defined as having less than 80% of days with imatinib available.
Seventeen percent of patients with higher co-payments discontinued taking imatinib, compared to 10% of patients with lower co-payments. Discontinuation was defined as having a gap of more than 60 days after the exhaustion of imatinib therapy.
These data did not include patients who could not begin taking imatinib due to costs. Therefore, Dr Dusetzina said this study likely underestimates the effects of drug costs on treatment adherence.
“If you went to the pharmacy to obtain your prescription, and they said it was $5000, and you walked away because you couldn’t afford to pay, you’re not in the data,” she said. “We could only study individuals who filled at least one prescription.”
Dr Dusetzina also said these findings have implications beyond imatinib and CML. Many new treatments for rare conditions can cost insurers and patients more than $100,000 year.
“Our results are particularly relevant for specialty pharmaceutical products—those that cost over $10,000 a month,” she said.
“However, the lessons learned likely relate to any pharmaceutical product that has high out-of-pocket costs. It is important that we identify strategies to make effective but expensive medications more affordable to patients.”
Promoting gender equity at scientific meetings
Credit: Darren Baker
Women are underrepresented among speakers at scientific meetings, but a new study has revealed a way to address this deficit.
An analysis of 460 scientific sessions showed that including at least 1 woman on a convening committee can increase the proportion of female speakers by as much as 86%.
And it significantly reduced the likelihood that a session would have an all-male list of speakers.
Arturo Casadevall, MD, PhD, of the Albert Einstein College of Medicine in the Bronx, New York, and Jo Handelsman, PhD, of Yale University in New Haven, Connecticut, recounted these discoveries in mBio.
The pair had analyzed data from 2 large meetings sponsored by the American Society for Microbiology—the General Meeting (GM) and the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
The data included 1845 speakers at 460 sessions from the annual meetings in 2011, 2012, and 2013.
The researchers classified sessions according to whether they had been convened by 2 men, a man and a woman, or 2 women, then tallied the gender representation among speakers for each symposium.
Despite differences in the operating procedures for the 2 meetings, the results for the GMs and ICAAC meetings closely paralleled one another. For both, there was a positive correlation between the participation of women as session conveners and participation by female scientists in those sessions.
At the 3 GMs, 104 sessions were convened by all-male teams, and 112 sessions had at least 1 female convener.
Sessions convened by 2 men had an average of 25% female speakers. And sessions including at least 1 female convener had an average of 43% female speakers, for a 72% increase in women speakers.
On average, 30% of GM sessions had all-male speakers if the conveners were both males. But 8.9% of the convener teams containing at least 1 woman had an all-male list of speakers (P=0.0002).
At the 3 ICAAC meetings, 145 sessions were convened by male-only teams, and 99 had at least 1 female convener.
Including at least 1 woman in the convening team increased the proportion of female speakers by 74%. Including a women also significantly reduced the number of sessions with all-male speakers (P=0.0042).
Dr Casadeveall cautioned that this study revealed correlations, not proof of causation. And further research is needed to explain why the presence of a woman on a convening committee is correlated with increased numbers of female speakers.
But the data suggest that involving women as conveners could have a significant effect on the gender distribution of the speakers and promote gender equity.
“Meeting program committees could carefully consider the gender composition of those assigned to pull together scientific sessions,” Dr Casadevall said, “and make efforts to involve women scientists as conveners for sessions and symposia.”
Credit: Darren Baker
Women are underrepresented among speakers at scientific meetings, but a new study has revealed a way to address this deficit.
An analysis of 460 scientific sessions showed that including at least 1 woman on a convening committee can increase the proportion of female speakers by as much as 86%.
And it significantly reduced the likelihood that a session would have an all-male list of speakers.
Arturo Casadevall, MD, PhD, of the Albert Einstein College of Medicine in the Bronx, New York, and Jo Handelsman, PhD, of Yale University in New Haven, Connecticut, recounted these discoveries in mBio.
The pair had analyzed data from 2 large meetings sponsored by the American Society for Microbiology—the General Meeting (GM) and the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
The data included 1845 speakers at 460 sessions from the annual meetings in 2011, 2012, and 2013.
The researchers classified sessions according to whether they had been convened by 2 men, a man and a woman, or 2 women, then tallied the gender representation among speakers for each symposium.
Despite differences in the operating procedures for the 2 meetings, the results for the GMs and ICAAC meetings closely paralleled one another. For both, there was a positive correlation between the participation of women as session conveners and participation by female scientists in those sessions.
At the 3 GMs, 104 sessions were convened by all-male teams, and 112 sessions had at least 1 female convener.
Sessions convened by 2 men had an average of 25% female speakers. And sessions including at least 1 female convener had an average of 43% female speakers, for a 72% increase in women speakers.
On average, 30% of GM sessions had all-male speakers if the conveners were both males. But 8.9% of the convener teams containing at least 1 woman had an all-male list of speakers (P=0.0002).
At the 3 ICAAC meetings, 145 sessions were convened by male-only teams, and 99 had at least 1 female convener.
Including at least 1 woman in the convening team increased the proportion of female speakers by 74%. Including a women also significantly reduced the number of sessions with all-male speakers (P=0.0042).
Dr Casadeveall cautioned that this study revealed correlations, not proof of causation. And further research is needed to explain why the presence of a woman on a convening committee is correlated with increased numbers of female speakers.
But the data suggest that involving women as conveners could have a significant effect on the gender distribution of the speakers and promote gender equity.
“Meeting program committees could carefully consider the gender composition of those assigned to pull together scientific sessions,” Dr Casadevall said, “and make efforts to involve women scientists as conveners for sessions and symposia.”
Credit: Darren Baker
Women are underrepresented among speakers at scientific meetings, but a new study has revealed a way to address this deficit.
An analysis of 460 scientific sessions showed that including at least 1 woman on a convening committee can increase the proportion of female speakers by as much as 86%.
And it significantly reduced the likelihood that a session would have an all-male list of speakers.
Arturo Casadevall, MD, PhD, of the Albert Einstein College of Medicine in the Bronx, New York, and Jo Handelsman, PhD, of Yale University in New Haven, Connecticut, recounted these discoveries in mBio.
The pair had analyzed data from 2 large meetings sponsored by the American Society for Microbiology—the General Meeting (GM) and the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
The data included 1845 speakers at 460 sessions from the annual meetings in 2011, 2012, and 2013.
The researchers classified sessions according to whether they had been convened by 2 men, a man and a woman, or 2 women, then tallied the gender representation among speakers for each symposium.
Despite differences in the operating procedures for the 2 meetings, the results for the GMs and ICAAC meetings closely paralleled one another. For both, there was a positive correlation between the participation of women as session conveners and participation by female scientists in those sessions.
At the 3 GMs, 104 sessions were convened by all-male teams, and 112 sessions had at least 1 female convener.
Sessions convened by 2 men had an average of 25% female speakers. And sessions including at least 1 female convener had an average of 43% female speakers, for a 72% increase in women speakers.
On average, 30% of GM sessions had all-male speakers if the conveners were both males. But 8.9% of the convener teams containing at least 1 woman had an all-male list of speakers (P=0.0002).
At the 3 ICAAC meetings, 145 sessions were convened by male-only teams, and 99 had at least 1 female convener.
Including at least 1 woman in the convening team increased the proportion of female speakers by 74%. Including a women also significantly reduced the number of sessions with all-male speakers (P=0.0042).
Dr Casadeveall cautioned that this study revealed correlations, not proof of causation. And further research is needed to explain why the presence of a woman on a convening committee is correlated with increased numbers of female speakers.
But the data suggest that involving women as conveners could have a significant effect on the gender distribution of the speakers and promote gender equity.
“Meeting program committees could carefully consider the gender composition of those assigned to pull together scientific sessions,” Dr Casadevall said, “and make efforts to involve women scientists as conveners for sessions and symposia.”
Gene panel identifies residual neuroblastoma metastases
BRUSSELS – In advanced-stage neuroblastoma patients with residual metastases in their bone marrow following two cycles of anti-GD2 immunotherapy, another cycle of this treatment is futile and only causes adverse events, based on a review of 343 stage IV patients treated at one U.S. center.
"Bone marrow minimal residual disease [MRD] measured after two cycles of immunotherapy was the strongest predictor of outcome, irrespective of disease status at the start of immunotherapy," Dr. Nai-Kong V. Cheung said at the Markers in Cancer meeting. "If a patient is positive for MRD after two cycles, don’t continue the treatment."
In the series of 343 patients aged 18 months or older with metastatic, stage IV neuroblastoma that he reviewed, all patients with detectable MRD after two cycles of immunotherapy with GD2 antibody eventually relapsed or died within the next 5 years. In contrast, roughly half of the patients who lacked MRD after the first two cycles of anti-GD2 therapy remained progression free and alive during up to 20 years of follow-up.
The full course of anti-GD2 treatment takes 2 years, has the potential to cause adverse effects, and is painful and expensive. "Why continue and subject patients to a treatment that won’t be beneficial?" Dr. Cheung asked during an interview. "We can use [MRD] as a marker to take patients off of a protocol that will not be useful to them and try a different treatment."
Immunotherapy with anti-GD2 is part of standard treatment for patients with advanced neuroblastoma.
Dr. Cheung, a pediatric oncologist and head of the neuroblastoma program at Memorial Sloan-Kettering Cancer Center in New York, and his associates used a four-marker genetic analysis to find evidence of residual, metastatic neuroblastoma cells in patients’ bone marrow. The four markers they used were:
• GD2 synthase, the gene for an enzyme that helps produce a ganglioside-abundant in neuroblastoma cells;
• PHOX2B, the gene for a transcription factor that promotes nerve cell growth and maturation;
• CCND1, the gene for cyclin D1 protein, an oncogene; and
• ISL 1, the gene for islet 1, a transcription factor involved in cell growth.
The database included 169 patients treated during first remission, 69 treated during second or later remission, and 105 with primary refractory disease. The researchers used the four-test genetic panel to screen for MRD in bone marrow specimens taken from these patients after the first two rounds of anti-GD2 treatment with or without granulocyte-macrophage colony-stimulating factor in a series of four treatment protocols. A patient was considered positive for MRD if at least one of the genetic markers was positive for the presence of neuroblastoma cells in the bone marrow.
In a multivariate analysis, patients negative for MRD had about a fourfold increased rate of progression-free survival and about a threefold increased rate of overall survival, compared with patients positive for MRD; both differences were statistically significant.
Dr. Cheung said that the four-gene panel his group used was developed through a project begun 15 years ago to look for the most discriminating gene signatures of metastatic neuroblastoma cells against the background of normal bone marrow cells, the metastatic destination for at least 90% of advanced neuroblastoma tumors. A similar approach could identify genetic tests for treatment response of other metastatic tumor types, he said.
The meeting was sponsored by the American Society of Clinical Oncology, the European Organisation for Research and Treatment of Cancer, and the National Cancer Institute. Dr. Cheung said that he is a coinventor on patents held by Memorial Sloan-Kettering Cancer Center.
On Twitter @mitchelzoler
BRUSSELS – In advanced-stage neuroblastoma patients with residual metastases in their bone marrow following two cycles of anti-GD2 immunotherapy, another cycle of this treatment is futile and only causes adverse events, based on a review of 343 stage IV patients treated at one U.S. center.
"Bone marrow minimal residual disease [MRD] measured after two cycles of immunotherapy was the strongest predictor of outcome, irrespective of disease status at the start of immunotherapy," Dr. Nai-Kong V. Cheung said at the Markers in Cancer meeting. "If a patient is positive for MRD after two cycles, don’t continue the treatment."
In the series of 343 patients aged 18 months or older with metastatic, stage IV neuroblastoma that he reviewed, all patients with detectable MRD after two cycles of immunotherapy with GD2 antibody eventually relapsed or died within the next 5 years. In contrast, roughly half of the patients who lacked MRD after the first two cycles of anti-GD2 therapy remained progression free and alive during up to 20 years of follow-up.
The full course of anti-GD2 treatment takes 2 years, has the potential to cause adverse effects, and is painful and expensive. "Why continue and subject patients to a treatment that won’t be beneficial?" Dr. Cheung asked during an interview. "We can use [MRD] as a marker to take patients off of a protocol that will not be useful to them and try a different treatment."
Immunotherapy with anti-GD2 is part of standard treatment for patients with advanced neuroblastoma.
Dr. Cheung, a pediatric oncologist and head of the neuroblastoma program at Memorial Sloan-Kettering Cancer Center in New York, and his associates used a four-marker genetic analysis to find evidence of residual, metastatic neuroblastoma cells in patients’ bone marrow. The four markers they used were:
• GD2 synthase, the gene for an enzyme that helps produce a ganglioside-abundant in neuroblastoma cells;
• PHOX2B, the gene for a transcription factor that promotes nerve cell growth and maturation;
• CCND1, the gene for cyclin D1 protein, an oncogene; and
• ISL 1, the gene for islet 1, a transcription factor involved in cell growth.
The database included 169 patients treated during first remission, 69 treated during second or later remission, and 105 with primary refractory disease. The researchers used the four-test genetic panel to screen for MRD in bone marrow specimens taken from these patients after the first two rounds of anti-GD2 treatment with or without granulocyte-macrophage colony-stimulating factor in a series of four treatment protocols. A patient was considered positive for MRD if at least one of the genetic markers was positive for the presence of neuroblastoma cells in the bone marrow.
In a multivariate analysis, patients negative for MRD had about a fourfold increased rate of progression-free survival and about a threefold increased rate of overall survival, compared with patients positive for MRD; both differences were statistically significant.
Dr. Cheung said that the four-gene panel his group used was developed through a project begun 15 years ago to look for the most discriminating gene signatures of metastatic neuroblastoma cells against the background of normal bone marrow cells, the metastatic destination for at least 90% of advanced neuroblastoma tumors. A similar approach could identify genetic tests for treatment response of other metastatic tumor types, he said.
The meeting was sponsored by the American Society of Clinical Oncology, the European Organisation for Research and Treatment of Cancer, and the National Cancer Institute. Dr. Cheung said that he is a coinventor on patents held by Memorial Sloan-Kettering Cancer Center.
On Twitter @mitchelzoler
BRUSSELS – In advanced-stage neuroblastoma patients with residual metastases in their bone marrow following two cycles of anti-GD2 immunotherapy, another cycle of this treatment is futile and only causes adverse events, based on a review of 343 stage IV patients treated at one U.S. center.
"Bone marrow minimal residual disease [MRD] measured after two cycles of immunotherapy was the strongest predictor of outcome, irrespective of disease status at the start of immunotherapy," Dr. Nai-Kong V. Cheung said at the Markers in Cancer meeting. "If a patient is positive for MRD after two cycles, don’t continue the treatment."
In the series of 343 patients aged 18 months or older with metastatic, stage IV neuroblastoma that he reviewed, all patients with detectable MRD after two cycles of immunotherapy with GD2 antibody eventually relapsed or died within the next 5 years. In contrast, roughly half of the patients who lacked MRD after the first two cycles of anti-GD2 therapy remained progression free and alive during up to 20 years of follow-up.
The full course of anti-GD2 treatment takes 2 years, has the potential to cause adverse effects, and is painful and expensive. "Why continue and subject patients to a treatment that won’t be beneficial?" Dr. Cheung asked during an interview. "We can use [MRD] as a marker to take patients off of a protocol that will not be useful to them and try a different treatment."
Immunotherapy with anti-GD2 is part of standard treatment for patients with advanced neuroblastoma.
Dr. Cheung, a pediatric oncologist and head of the neuroblastoma program at Memorial Sloan-Kettering Cancer Center in New York, and his associates used a four-marker genetic analysis to find evidence of residual, metastatic neuroblastoma cells in patients’ bone marrow. The four markers they used were:
• GD2 synthase, the gene for an enzyme that helps produce a ganglioside-abundant in neuroblastoma cells;
• PHOX2B, the gene for a transcription factor that promotes nerve cell growth and maturation;
• CCND1, the gene for cyclin D1 protein, an oncogene; and
• ISL 1, the gene for islet 1, a transcription factor involved in cell growth.
The database included 169 patients treated during first remission, 69 treated during second or later remission, and 105 with primary refractory disease. The researchers used the four-test genetic panel to screen for MRD in bone marrow specimens taken from these patients after the first two rounds of anti-GD2 treatment with or without granulocyte-macrophage colony-stimulating factor in a series of four treatment protocols. A patient was considered positive for MRD if at least one of the genetic markers was positive for the presence of neuroblastoma cells in the bone marrow.
In a multivariate analysis, patients negative for MRD had about a fourfold increased rate of progression-free survival and about a threefold increased rate of overall survival, compared with patients positive for MRD; both differences were statistically significant.
Dr. Cheung said that the four-gene panel his group used was developed through a project begun 15 years ago to look for the most discriminating gene signatures of metastatic neuroblastoma cells against the background of normal bone marrow cells, the metastatic destination for at least 90% of advanced neuroblastoma tumors. A similar approach could identify genetic tests for treatment response of other metastatic tumor types, he said.
The meeting was sponsored by the American Society of Clinical Oncology, the European Organisation for Research and Treatment of Cancer, and the National Cancer Institute. Dr. Cheung said that he is a coinventor on patents held by Memorial Sloan-Kettering Cancer Center.
On Twitter @mitchelzoler
AT THE MARKERS IN CANCER MEETING
Major finding: In a multivariate analysis, patients negative for minimal residual disease had about a fourfold increased rate of progression-free survival and about a threefold increased rate of overall survival, compared with patients positive for MRD; both differences were statistically significant.
Data source: A review of 343 patients with stage IV neuroblastoma treated with immunotherapy at one U.S. center.
Disclosures: Dr. Cheung said that he is a coinventor on patents held by Memorial Sloan-Kettering Cancer Center.
NICE recommends pixantrone for NHL
Credit: Bill Branson
Counter to its previous recommendations, the UK’s National Institute for Health and Care Excellence (NICE) is now supporting the use of pixantrone for certain patients with non-Hodgkin lymphoma (NHL).
In prior draft guidance documents, NICE said it could not recommend the antineoplastic agent for patients with relapsed or refractory NHL, due to concerns about efficacy and cost.
But now, in its final draft guidance, the agency has said pixantrone should be funded by the National Health Service to treat certain patients with B-cell NHL.
NICE is recommending pixantrone for patients with relapsed or refractory disease who have already received rituximab and are receiving their third- or fourth-line treatment.
The NICE guidance also says pixantrone can only be funded if the manufacturer, Cell Therapeutics, provides the drug at a discounted rate, as agreed between the manufacturer and the Department of Health.
“We are pleased that the manufacturer was able to provide a patient access scheme,” said Carole Longson, NICE Health Technology Evaluation Centre Director. “Pixantrone will be a useful addition to the treatment options available.”
Consultees now have until January 23, 2014, to appeal the draft recommendation. If no appeals are lodged, the final guidance should be published in February.
Clinical effectiveness
NICE’s current recommendations are based on the opinion of an independent appraisal committee. The committee considered data from the EXTEND PIX301 clinical trial. The committee said there are a number of uncertainties associated with this trial.
However, the group also said there was limited evidence suggesting that pixantrone works better than other available treatments for patients who had previously received rituximab and patients receiving third- or fourth-line treatment.
The EXTEND PIX301 trial enrolled 140 patients with aggressive B-cell lymphoma. Half of the patients were randomized to receive pixantrone and the other half to their physicians’ choice of treatment.
At the end of treatment, confirmed and unconfirmed response rates for the intent-to-treat population were significantly higher in the pixantrone arm than the comparator arm—20% and 5.7%, respectively (P=0.021). The same was true after 18 months of follow-up—24.3% and 7.1%, respectively (P=0.009).
The median progression-free survival was significantly longer in the pixantrone arm than the comparator arm—5.3 months and 2.6 months, respectively (P=0.005). But there was no significant difference in median overall survival—10.2 months and 7.6 months, respectively (P=0.251).
Cell Therapeutics also submitted results observed in 4 subgroups of patients with aggressive disease and in patients who had previously received rituximab. For detailed data from the trial, see pages 3 through 13 of the final draft guidance.
Cost-effectiveness
The appraisal committee said the manufacturer’s patient access scheme (the details of which are commercial-in-confidence) improved the cost-effectiveness of pixantrone.
The treatment would be cost-effective for patients who had previously received rituximab and patients receiving their third- or fourth-line treatment. The drug’s incremental cost-effectiveness ratio was estimated to be under £22,000 per quality adjusted life year gained for both groups.
According to the manufacturer, pixantrone costs £553.50 per 20 mL vial, excluding tax. The estimated cost of a course of treatment is £19,926.
The costs were calculated over 4 cycles using an average of 3 vials per dose and were based on the median length of treatment in the EXTEND PIX301 trial. Costs may vary in different settings because of negotiated discounts.
Marketing authorization
Pixantrone has conditional marketing authorization in the European Union as monotherapy for adults with relapsed or refractory NHL who have received at least 2 previous lines of treatment. However, the European Medicine’s Agency has noted that it is unclear whether pixantrone is effective as fifth-line or greater treatment in refractory patients.
The drug’s marketing authorization is linked to results of the phase 3 PIX306 trial, which is investigating pixantrone plus rituximab versus gemcitabine plus rituximab in patients with relapsed or refractory B-cell NHL who have previously received a rituximab-containing regimen.
Credit: Bill Branson
Counter to its previous recommendations, the UK’s National Institute for Health and Care Excellence (NICE) is now supporting the use of pixantrone for certain patients with non-Hodgkin lymphoma (NHL).
In prior draft guidance documents, NICE said it could not recommend the antineoplastic agent for patients with relapsed or refractory NHL, due to concerns about efficacy and cost.
But now, in its final draft guidance, the agency has said pixantrone should be funded by the National Health Service to treat certain patients with B-cell NHL.
NICE is recommending pixantrone for patients with relapsed or refractory disease who have already received rituximab and are receiving their third- or fourth-line treatment.
The NICE guidance also says pixantrone can only be funded if the manufacturer, Cell Therapeutics, provides the drug at a discounted rate, as agreed between the manufacturer and the Department of Health.
“We are pleased that the manufacturer was able to provide a patient access scheme,” said Carole Longson, NICE Health Technology Evaluation Centre Director. “Pixantrone will be a useful addition to the treatment options available.”
Consultees now have until January 23, 2014, to appeal the draft recommendation. If no appeals are lodged, the final guidance should be published in February.
Clinical effectiveness
NICE’s current recommendations are based on the opinion of an independent appraisal committee. The committee considered data from the EXTEND PIX301 clinical trial. The committee said there are a number of uncertainties associated with this trial.
However, the group also said there was limited evidence suggesting that pixantrone works better than other available treatments for patients who had previously received rituximab and patients receiving third- or fourth-line treatment.
The EXTEND PIX301 trial enrolled 140 patients with aggressive B-cell lymphoma. Half of the patients were randomized to receive pixantrone and the other half to their physicians’ choice of treatment.
At the end of treatment, confirmed and unconfirmed response rates for the intent-to-treat population were significantly higher in the pixantrone arm than the comparator arm—20% and 5.7%, respectively (P=0.021). The same was true after 18 months of follow-up—24.3% and 7.1%, respectively (P=0.009).
The median progression-free survival was significantly longer in the pixantrone arm than the comparator arm—5.3 months and 2.6 months, respectively (P=0.005). But there was no significant difference in median overall survival—10.2 months and 7.6 months, respectively (P=0.251).
Cell Therapeutics also submitted results observed in 4 subgroups of patients with aggressive disease and in patients who had previously received rituximab. For detailed data from the trial, see pages 3 through 13 of the final draft guidance.
Cost-effectiveness
The appraisal committee said the manufacturer’s patient access scheme (the details of which are commercial-in-confidence) improved the cost-effectiveness of pixantrone.
The treatment would be cost-effective for patients who had previously received rituximab and patients receiving their third- or fourth-line treatment. The drug’s incremental cost-effectiveness ratio was estimated to be under £22,000 per quality adjusted life year gained for both groups.
According to the manufacturer, pixantrone costs £553.50 per 20 mL vial, excluding tax. The estimated cost of a course of treatment is £19,926.
The costs were calculated over 4 cycles using an average of 3 vials per dose and were based on the median length of treatment in the EXTEND PIX301 trial. Costs may vary in different settings because of negotiated discounts.
Marketing authorization
Pixantrone has conditional marketing authorization in the European Union as monotherapy for adults with relapsed or refractory NHL who have received at least 2 previous lines of treatment. However, the European Medicine’s Agency has noted that it is unclear whether pixantrone is effective as fifth-line or greater treatment in refractory patients.
The drug’s marketing authorization is linked to results of the phase 3 PIX306 trial, which is investigating pixantrone plus rituximab versus gemcitabine plus rituximab in patients with relapsed or refractory B-cell NHL who have previously received a rituximab-containing regimen.
Credit: Bill Branson
Counter to its previous recommendations, the UK’s National Institute for Health and Care Excellence (NICE) is now supporting the use of pixantrone for certain patients with non-Hodgkin lymphoma (NHL).
In prior draft guidance documents, NICE said it could not recommend the antineoplastic agent for patients with relapsed or refractory NHL, due to concerns about efficacy and cost.
But now, in its final draft guidance, the agency has said pixantrone should be funded by the National Health Service to treat certain patients with B-cell NHL.
NICE is recommending pixantrone for patients with relapsed or refractory disease who have already received rituximab and are receiving their third- or fourth-line treatment.
The NICE guidance also says pixantrone can only be funded if the manufacturer, Cell Therapeutics, provides the drug at a discounted rate, as agreed between the manufacturer and the Department of Health.
“We are pleased that the manufacturer was able to provide a patient access scheme,” said Carole Longson, NICE Health Technology Evaluation Centre Director. “Pixantrone will be a useful addition to the treatment options available.”
Consultees now have until January 23, 2014, to appeal the draft recommendation. If no appeals are lodged, the final guidance should be published in February.
Clinical effectiveness
NICE’s current recommendations are based on the opinion of an independent appraisal committee. The committee considered data from the EXTEND PIX301 clinical trial. The committee said there are a number of uncertainties associated with this trial.
However, the group also said there was limited evidence suggesting that pixantrone works better than other available treatments for patients who had previously received rituximab and patients receiving third- or fourth-line treatment.
The EXTEND PIX301 trial enrolled 140 patients with aggressive B-cell lymphoma. Half of the patients were randomized to receive pixantrone and the other half to their physicians’ choice of treatment.
At the end of treatment, confirmed and unconfirmed response rates for the intent-to-treat population were significantly higher in the pixantrone arm than the comparator arm—20% and 5.7%, respectively (P=0.021). The same was true after 18 months of follow-up—24.3% and 7.1%, respectively (P=0.009).
The median progression-free survival was significantly longer in the pixantrone arm than the comparator arm—5.3 months and 2.6 months, respectively (P=0.005). But there was no significant difference in median overall survival—10.2 months and 7.6 months, respectively (P=0.251).
Cell Therapeutics also submitted results observed in 4 subgroups of patients with aggressive disease and in patients who had previously received rituximab. For detailed data from the trial, see pages 3 through 13 of the final draft guidance.
Cost-effectiveness
The appraisal committee said the manufacturer’s patient access scheme (the details of which are commercial-in-confidence) improved the cost-effectiveness of pixantrone.
The treatment would be cost-effective for patients who had previously received rituximab and patients receiving their third- or fourth-line treatment. The drug’s incremental cost-effectiveness ratio was estimated to be under £22,000 per quality adjusted life year gained for both groups.
According to the manufacturer, pixantrone costs £553.50 per 20 mL vial, excluding tax. The estimated cost of a course of treatment is £19,926.
The costs were calculated over 4 cycles using an average of 3 vials per dose and were based on the median length of treatment in the EXTEND PIX301 trial. Costs may vary in different settings because of negotiated discounts.
Marketing authorization
Pixantrone has conditional marketing authorization in the European Union as monotherapy for adults with relapsed or refractory NHL who have received at least 2 previous lines of treatment. However, the European Medicine’s Agency has noted that it is unclear whether pixantrone is effective as fifth-line or greater treatment in refractory patients.
The drug’s marketing authorization is linked to results of the phase 3 PIX306 trial, which is investigating pixantrone plus rituximab versus gemcitabine plus rituximab in patients with relapsed or refractory B-cell NHL who have previously received a rituximab-containing regimen.
Suicide on Medical Units
Suicide is the tenth leading cause of death in the United States,[1] resulting in the deaths of over 34,000 people each year.[2] In 2007, 165,997 individuals were hospitalized for self‐inflicted injuries, and 395,320 people were treated for self‐harm in emergency departments.[2] In 2003, the American Psychiatric Association reported that approximately 1500 suicides take place within hospital facilities in the United States each year.[3]
Although a number of studies have examined inpatient suicides that occurred on psychiatric units,[4, 5, 6, 7, 8] fewer have focused on suicides occurring on medical units. A Joint Commission review of inpatient suicide on medical/surgical units[9] found that 14.25% of all inpatient suicides occurred while the patient was on a medical unit, and now recommends that all hospitals identify individuals at risk for suicide, develop interventions for suicidal patients, and educate staff about the risk factors of suicide. Bostwick and Rackley[10] reviewed studies of suicide on medical/surgical units and found that few of the patients had histories of mental illness or suicidal ideation and recommend close attention to agitated patients, aggressively treating depression and pain, modifying the environment where possible, and observation of patients thought to be at risk. Wint and Alil[5] also report a high level of depression in patients who commit suicide in general hospitals and suggest that improved recognition of depression in general hospital patients will reduce suicide.
GOALS FOR THIS STUDY
Few studies have examined suicide on acute medical and surgical and intensive care units (ICUs), and there are no large studies conducted in the United States. The goal of this study was to describe suicide attempts and completions in the medical setting using Root Cause Analysis (RCA) reports of these events in the Veterans Health Administration (VHA).
METHODS
Study Design and Theoretical Model
This is an observational review of all RCA reports of suicide attempts or completions on the medical‐surgical wards and ICUs in the VHA system between December 1, 1999 (when the RCA system started) and December 31, 2012. The Committee for the Protection of Human Subjects, Dartmouth College considered this project exempt.
The VHA provides comprehensive healthcare services to over 6 million veterans across the United States through 152 VHA medical centers. Over the study period there were approximately 7,289,770 admissions to medical‐surgical wards and ICUs in the VHA (average number of admissions per year between 2000 and 2012=560,771.5, standard deviation=25,535.7).
The VHA National Center for Patient Safety RCA Program
Patient safety including the investigation of adverse events is coordinated by the National Center for Patient Safety (NCPS). The NCPS has instituted a systematic and structured RCA program to individually and collectively analyze adverse events.[11, 12]
RCA is a method for examining the underlying causes of an adverse event such as a hospital related death, surgical error, or suicide. The focus of an RCA is on the systemic and organizational factors that may have contributed to an adverse event.[11, 12] The RCA process within the VHA is conducted by multidisciplinary teams organized by the hospital's patient safety manager. In general, an RCA describes what happened, how it happened, and what should be done to avoid the same event happening again.[11]
Because of the focus on the system, the information contained in the RCA reports does not include detailed demographic data about the patients involved in the events. RCA reports that are submitted to NCPS include narrative descriptions of the event, all contributing factors, a final understanding of the event, and a specific action plan for addressing underlying causes of the event.
Analysis of RCA Reports
Our goal was to identify suicide attempts and completed suicides that occurred on acute care medical‐surgical wards or ICUs. The search was completed through use of event codes for suicide or suicide attempts entered in the RCA and through the use of natural language processing software to identify the terms related to suicide or suicide attempts anywhere in the RCA text (PolyAnalyst; Megaputer, Bloomington, IN).
Data Processing
Each RCA report was coded for the location of the event, method of self‐harm, and root causes; where possible, we also coded medical diagnosis, reason for admission, history of suicidal behavior, age, and gender. The coding system was developed in a previous study of RCA reports of suicide.[13]
RESULTS
Our search resulted in 525 RCA reports of inpatient suicide attempts and completions. These were obtained from the 14,851 total RCA reports in the RCA dataset. Of the 525, we identified 50 cases that occurred while the patient was on the acute medical‐surgical unit (43 cases) or ICU (7 cases). Other cases occurred on mental health units, emergency department, or other areas of the hospital. Five cases were completed suicides, and 45 were suicide attempts. Based on the number of admissions per year reported above, the approximate rate of completed inpatient suicides on medical‐surgical and ICUs is 0.6 per million admissions. (For comparison, the rate of completed suicide on psychiatric units in the VA has been estimated to be 8.7 per million admissions.[14] Table 1 displays the admitting diagnosis and demographic data for those RCA reports that contained this information. The most common admitting diagnoses were alcohol detoxification and chest pain or rule out myocardial infarction (MI); note that 12 reports did not contain an admitting diagnosis. Table 2 displays the methods and root causes for the 50 cases; there were 118 root causes generated. The most common methods were cutting, overdose, and hanging; and the most common root causes were poor communication, need for staff training in suicide assessment, and need to improve suicide risk assessment.
| Medical‐Surgical | ICU | |||
|---|---|---|---|---|
| Attempts | Completions | Attempts | Completions | |
| ||||
| Admitting diagnosis, N=50 | ||||
| Alcohol detox | 3 | 2 | 2 | 0 |
| Chest pain or rule out MI | 5 | 0 | 0 | 0 |
| Delirium | 1 | 0 | 0 | 0 |
| Peripheral infection/cellulitis | 2 | 1 | 0 | 0 |
| Spine surgery or spine issue | 2 | 0 | 0 | 0 |
| Lung CA | 1 | 1 | 0 | 0 |
| Cystopy (bladder surgery) | 2 | 0 | 0 | 0 |
| Head and neck CA | 1 | 0 | 1 | 0 |
| Other | 4 | 0 | 0 | 0 |
| Respiratory (COPD) | 2 | 0 | 1 | 0 |
| Suicide attempt by overdose | 2 | 0 | 0 | 0 |
| Lung infection | 1 | 0 | 1 | 0 |
| CVA | 0 | 1 | 0 | 0 |
| Unknown | 12 | 0 | 2 | 0 |
| Demographics N =50 | ||||
| % male | 91.40% | 100% | 80% | NA |
| Average age, y | 56 | 53 | 47 | NA |
| History of suicidal thoughts or behaviors | 16 | 2 | 3 | 0 |
| Medical‐Surgical | ICU | |||
|---|---|---|---|---|
| Attempts | Completions | Attempts | Completions | |
| ||||
| Methods | ||||
| Cutting with a sharp object | 29% | 0% | 43% | None |
| Overdose | 26% | 20% | 0% | None |
| Hanging | 18% | 40% | 29% | None |
| Strangulation | 8% | 0% | 0% | None |
| Jumping | 5% | 0% | 14% | None |
| Asphyxiation | 8% | 0% | 0% | None |
| Removed lines or equipment | 5% | 0% | 14% | None |
| Gun shot | 0% | 40% | 0% | None |
| Column total | 100% | 100% | 100% | None |
| Root causes | ||||
| Poor communication between providers or services | 22% | 9% | 7% | None |
| Need for staff training in suicide assessment | 14% | 0% | 20% | None |
| Need to improve process of suicide assessment | 13% | 9% | 13% | None |
| Need for improvement of risk documentation | 9% | 0% | 7% | None |
| Physical environment is a risk factor | 7% | 0% | 20% | None |
| Contraband search needs improvement | 7% | 18% | 0% | None |
| Problems with treatment for suicidal patients | 7% | 27% | 7% | None |
| Not following existing policies | 5% | 0% | 0% | None |
| Medical assess or treatment delayed or incomplete | 5% | 0% | 0% | None |
| Easy access to medication for overdose | 4% | 9% | 0% | None |
| Stressed by medical/mental health/pain problems | 5% | 18% | 20% | None |
| Other root causes | 1% | 0% | 7% | None |
| No root cause | 1% | 9% | 0% | None |
| Column totals | 100% | 100% | 100% | None |
DISCUSSION
This study examined the specific systemic factors involved in suicide attempts and completions in medical‐surgical and intensive care units in a large, national hospital sample. Overall, the number of completed suicides over the 13‐year period was small (5 in total). The most common reason for admission was alcohol detoxification. Many patients going through alcohol detoxification experience agitation, which is a risk factor for suicide among medical patients.[10] This hypothesis is further supported by the fact that 2 of the 5 completed suicides were admitted for alcohol detoxification. Interestingly, only 2 of the patients who attempted suicide in the hospital were also admitted for medical conditions related to a prior suicide attempt. It is likely the case that patients admitted for a suicide attempt are closely watched throughout the admission and so may have fewer opportunities to repeat the suicide attempt.
The most common method of suicide attempts was cutting with a sharp object. However, cutting did not result in death, whereas overdose, hanging, and gunshot did. As a precaution, especially with patients with a known history of suicidal ideation, removing sharp objects such as razor blades and knives as well as extra medications is a reasonable first step. It may also be possible to create safer bathroom environments, at least in some medical rooms for potentially suicidal patients, which have break‐away shower curtains, sealed grab‐bars, and a general reduction of anchor points for hanging (see
As with other studies of RCAs,[15, 16] we found that problems communicating risk was the most common identified root cause for suicide attempts and completions. Problems communicating risk most often involved knowledge of suicide risk or specific suicide mitigation plans that were not shared by the treatment team or communicated during handoffs. Most frequently, this communication problem involved team members assessing a patient to be at high risk for suicide, but that information was not provided to other care team members. This root cause also included situations in which the treatment plan for suicide prevention was inadequately disseminated to the entire treatment team. It is critical that good systems are in place so that staff members have the time to communicate critical information about patients. In addition, the system should be standardized so that the same information is communicated each time there is a handoff. The lack of clear steps to mitigate suicide risk when a patient was identified at high risk was also a commonly cited root cause. The most extreme examples involved completed suicides occurring with a patient receiving 1‐on‐1 staffing. This 1‐on‐1 staffing did not include specific guidance for the sitters such as the need to remove personal items that could be used for self‐harm. We also saw that staff on medical units needed to learn more about risk factors for suicide and how to conduct a suicide assessment with their patients. Another root cause was the stress caused by the medical and psychiatric conditions of the patients. It is notable that no completed suicides occurred in ICUs, suggesting that closer observation and/or a higher level of medical incapacitation can reduce the risk of completed suicides.
To address these root causes, staff should be educated about risk factors for suicide, and standardized high‐risk for suicide order sets and checklists should be used to ensure staff execute the desired care processes and communicate them to all staff. In addition, specific training in suicide prevention should be provided to staff involved in 1‐on‐1 observation for high‐risk patients. Again, this may be aided by a checklist to help staff remember the protocol for what may be a low‐frequency event. A high risk suicide care process may include:
- Conducting contraband searches for items that could be used for self‐harm, modifying the environment of a small percentage of toilet rooms on medical floors to reduce anchor points for hanging. A high risk patient could then be moved to these rooms.
- Regular psychiatric input into the treatment plan.
- Discharge planning that includes attention to the potential for depression and suicidal ideation upon discharge.
Limitations
This study has several limitations. First, our data only contained suicide attempts and completions that were reported through our patient safety system in the VHA, and only completed suicides require an RCA, thus there are likely some events that were not included. Second, the RCA reports focus on the systemic vulnerabilities in medical‐surgical units and ICUs that may have contributed to the adverse event rather than the specific characteristics of the patients involved, so we do not have complete demographic information about these individual patients. Third, our sample was mostly male, so the results may not generalize well to units with a higher percentage of female patients.
These limitations notwithstanding, we know of no other study to present data on suicide attempts and completions in medical‐surgical and ICUs in a large national medical system.
Disclosures: This material is the result of work supported with resources and the use of facilities at the Department of Veterans Affairs National Center for Patient Safety at Ann Arbor, Michigan, and the Veterans Affairs Medical Centers, White River Junction, Vermont. The Research and Development Committee, White River Junction VA Medical Center approved this project, and the Committee for the Protection of Human Subjects, Dartmouth College considered this project exempt. The views expressed in this article do not necessarily represent the views of the Department of Veterans Affairs or the United States government. The authors report no conflicts of interest.
- Centers for Disease Control and Prevention. National Center for Injury and Prevention Control. WISQARS (Web‐based Injury Statistics Query and Reporting System). Available at: http://www.cdc.gov/injury/wisqars/index.html. Accessed September 27, 2012.
- Centers for Disease Control and Prevention. Suicide: facts at a glance. Available at: http://www.cdc.gov/ViolencePrevention/pdf/Suicide_DataSheet‐a.pdf. Accessed September 27, 2012.
- American Psychiatric Association. Practice guideline for the assessment and treatment of patients with suicidal behaviors. Am J Psychiatry. 2003;160:1–60.
- , . Inpatient suicide: preventing a common sentinel event. Gen Hosp Psychiatry. 2009;31:103–109.
- , . Suicidality in the general hospitalized patient. Hosp Physician. 2006;42(1):13–18.
- , , . Suicide inside: a systematic review of inpatient suicides. J Nervous and Ment Dis. 2010;198(5):315–328.
- , , . Environmental risk factors in hospital suicide. Suicide Life Threat Behav. 2004;34(4):448–453.
- , , . Clinical correlates of inpatient suicide. J Clin Psychiatry. 2003;64(1):14–19.
- A follow‐up report on preventing suicide: focus on medical/surgical units and the emergency department. Sentinel Event Alert. 2010;(46):1–4.
- , . Completed suicide in medical/surgical patients: who is at risk? Curr Psychiatry Rep. 2007;9(3):242–246.
- , , , , , , et al. Developing and deploying a patient safety program in a large health care system: you can't fix what you don't know about. Jt Comm J Qual Improv. 2001;27:522–532.
- , . Developing a culture of safety in the Veterans Health Administration. Eff Clin Pract. 2007;3:270–276.
- , , , , . Actions and Implementation Strategies to Reduce Suicidal Events in the VHA. Jt Comm J on Qual and Safe. 2006:32(3):130–141.
- , , , et al. An examination of the effectiveness of a mental health environment of care checklist in reducing suicide on inpatient mental health units. Arch GenPsychiatry. 2012:69(6):588–592.
- , , , , . Helping elderly patients to avoid suicide: a review of case reports from a national Veterans Affairs database. J Nerv Ment Dis. 2013;201(1):12–16.
- , , , , . Suicide attempts and completions in the emergency department in Veterans Affairs hospitals. Emerg Med J. 2012;29(5):399–403.
Suicide is the tenth leading cause of death in the United States,[1] resulting in the deaths of over 34,000 people each year.[2] In 2007, 165,997 individuals were hospitalized for self‐inflicted injuries, and 395,320 people were treated for self‐harm in emergency departments.[2] In 2003, the American Psychiatric Association reported that approximately 1500 suicides take place within hospital facilities in the United States each year.[3]
Although a number of studies have examined inpatient suicides that occurred on psychiatric units,[4, 5, 6, 7, 8] fewer have focused on suicides occurring on medical units. A Joint Commission review of inpatient suicide on medical/surgical units[9] found that 14.25% of all inpatient suicides occurred while the patient was on a medical unit, and now recommends that all hospitals identify individuals at risk for suicide, develop interventions for suicidal patients, and educate staff about the risk factors of suicide. Bostwick and Rackley[10] reviewed studies of suicide on medical/surgical units and found that few of the patients had histories of mental illness or suicidal ideation and recommend close attention to agitated patients, aggressively treating depression and pain, modifying the environment where possible, and observation of patients thought to be at risk. Wint and Alil[5] also report a high level of depression in patients who commit suicide in general hospitals and suggest that improved recognition of depression in general hospital patients will reduce suicide.
GOALS FOR THIS STUDY
Few studies have examined suicide on acute medical and surgical and intensive care units (ICUs), and there are no large studies conducted in the United States. The goal of this study was to describe suicide attempts and completions in the medical setting using Root Cause Analysis (RCA) reports of these events in the Veterans Health Administration (VHA).
METHODS
Study Design and Theoretical Model
This is an observational review of all RCA reports of suicide attempts or completions on the medical‐surgical wards and ICUs in the VHA system between December 1, 1999 (when the RCA system started) and December 31, 2012. The Committee for the Protection of Human Subjects, Dartmouth College considered this project exempt.
The VHA provides comprehensive healthcare services to over 6 million veterans across the United States through 152 VHA medical centers. Over the study period there were approximately 7,289,770 admissions to medical‐surgical wards and ICUs in the VHA (average number of admissions per year between 2000 and 2012=560,771.5, standard deviation=25,535.7).
The VHA National Center for Patient Safety RCA Program
Patient safety including the investigation of adverse events is coordinated by the National Center for Patient Safety (NCPS). The NCPS has instituted a systematic and structured RCA program to individually and collectively analyze adverse events.[11, 12]
RCA is a method for examining the underlying causes of an adverse event such as a hospital related death, surgical error, or suicide. The focus of an RCA is on the systemic and organizational factors that may have contributed to an adverse event.[11, 12] The RCA process within the VHA is conducted by multidisciplinary teams organized by the hospital's patient safety manager. In general, an RCA describes what happened, how it happened, and what should be done to avoid the same event happening again.[11]
Because of the focus on the system, the information contained in the RCA reports does not include detailed demographic data about the patients involved in the events. RCA reports that are submitted to NCPS include narrative descriptions of the event, all contributing factors, a final understanding of the event, and a specific action plan for addressing underlying causes of the event.
Analysis of RCA Reports
Our goal was to identify suicide attempts and completed suicides that occurred on acute care medical‐surgical wards or ICUs. The search was completed through use of event codes for suicide or suicide attempts entered in the RCA and through the use of natural language processing software to identify the terms related to suicide or suicide attempts anywhere in the RCA text (PolyAnalyst; Megaputer, Bloomington, IN).
Data Processing
Each RCA report was coded for the location of the event, method of self‐harm, and root causes; where possible, we also coded medical diagnosis, reason for admission, history of suicidal behavior, age, and gender. The coding system was developed in a previous study of RCA reports of suicide.[13]
RESULTS
Our search resulted in 525 RCA reports of inpatient suicide attempts and completions. These were obtained from the 14,851 total RCA reports in the RCA dataset. Of the 525, we identified 50 cases that occurred while the patient was on the acute medical‐surgical unit (43 cases) or ICU (7 cases). Other cases occurred on mental health units, emergency department, or other areas of the hospital. Five cases were completed suicides, and 45 were suicide attempts. Based on the number of admissions per year reported above, the approximate rate of completed inpatient suicides on medical‐surgical and ICUs is 0.6 per million admissions. (For comparison, the rate of completed suicide on psychiatric units in the VA has been estimated to be 8.7 per million admissions.[14] Table 1 displays the admitting diagnosis and demographic data for those RCA reports that contained this information. The most common admitting diagnoses were alcohol detoxification and chest pain or rule out myocardial infarction (MI); note that 12 reports did not contain an admitting diagnosis. Table 2 displays the methods and root causes for the 50 cases; there were 118 root causes generated. The most common methods were cutting, overdose, and hanging; and the most common root causes were poor communication, need for staff training in suicide assessment, and need to improve suicide risk assessment.
| Medical‐Surgical | ICU | |||
|---|---|---|---|---|
| Attempts | Completions | Attempts | Completions | |
| ||||
| Admitting diagnosis, N=50 | ||||
| Alcohol detox | 3 | 2 | 2 | 0 |
| Chest pain or rule out MI | 5 | 0 | 0 | 0 |
| Delirium | 1 | 0 | 0 | 0 |
| Peripheral infection/cellulitis | 2 | 1 | 0 | 0 |
| Spine surgery or spine issue | 2 | 0 | 0 | 0 |
| Lung CA | 1 | 1 | 0 | 0 |
| Cystopy (bladder surgery) | 2 | 0 | 0 | 0 |
| Head and neck CA | 1 | 0 | 1 | 0 |
| Other | 4 | 0 | 0 | 0 |
| Respiratory (COPD) | 2 | 0 | 1 | 0 |
| Suicide attempt by overdose | 2 | 0 | 0 | 0 |
| Lung infection | 1 | 0 | 1 | 0 |
| CVA | 0 | 1 | 0 | 0 |
| Unknown | 12 | 0 | 2 | 0 |
| Demographics N =50 | ||||
| % male | 91.40% | 100% | 80% | NA |
| Average age, y | 56 | 53 | 47 | NA |
| History of suicidal thoughts or behaviors | 16 | 2 | 3 | 0 |
| Medical‐Surgical | ICU | |||
|---|---|---|---|---|
| Attempts | Completions | Attempts | Completions | |
| ||||
| Methods | ||||
| Cutting with a sharp object | 29% | 0% | 43% | None |
| Overdose | 26% | 20% | 0% | None |
| Hanging | 18% | 40% | 29% | None |
| Strangulation | 8% | 0% | 0% | None |
| Jumping | 5% | 0% | 14% | None |
| Asphyxiation | 8% | 0% | 0% | None |
| Removed lines or equipment | 5% | 0% | 14% | None |
| Gun shot | 0% | 40% | 0% | None |
| Column total | 100% | 100% | 100% | None |
| Root causes | ||||
| Poor communication between providers or services | 22% | 9% | 7% | None |
| Need for staff training in suicide assessment | 14% | 0% | 20% | None |
| Need to improve process of suicide assessment | 13% | 9% | 13% | None |
| Need for improvement of risk documentation | 9% | 0% | 7% | None |
| Physical environment is a risk factor | 7% | 0% | 20% | None |
| Contraband search needs improvement | 7% | 18% | 0% | None |
| Problems with treatment for suicidal patients | 7% | 27% | 7% | None |
| Not following existing policies | 5% | 0% | 0% | None |
| Medical assess or treatment delayed or incomplete | 5% | 0% | 0% | None |
| Easy access to medication for overdose | 4% | 9% | 0% | None |
| Stressed by medical/mental health/pain problems | 5% | 18% | 20% | None |
| Other root causes | 1% | 0% | 7% | None |
| No root cause | 1% | 9% | 0% | None |
| Column totals | 100% | 100% | 100% | None |
DISCUSSION
This study examined the specific systemic factors involved in suicide attempts and completions in medical‐surgical and intensive care units in a large, national hospital sample. Overall, the number of completed suicides over the 13‐year period was small (5 in total). The most common reason for admission was alcohol detoxification. Many patients going through alcohol detoxification experience agitation, which is a risk factor for suicide among medical patients.[10] This hypothesis is further supported by the fact that 2 of the 5 completed suicides were admitted for alcohol detoxification. Interestingly, only 2 of the patients who attempted suicide in the hospital were also admitted for medical conditions related to a prior suicide attempt. It is likely the case that patients admitted for a suicide attempt are closely watched throughout the admission and so may have fewer opportunities to repeat the suicide attempt.
The most common method of suicide attempts was cutting with a sharp object. However, cutting did not result in death, whereas overdose, hanging, and gunshot did. As a precaution, especially with patients with a known history of suicidal ideation, removing sharp objects such as razor blades and knives as well as extra medications is a reasonable first step. It may also be possible to create safer bathroom environments, at least in some medical rooms for potentially suicidal patients, which have break‐away shower curtains, sealed grab‐bars, and a general reduction of anchor points for hanging (see
As with other studies of RCAs,[15, 16] we found that problems communicating risk was the most common identified root cause for suicide attempts and completions. Problems communicating risk most often involved knowledge of suicide risk or specific suicide mitigation plans that were not shared by the treatment team or communicated during handoffs. Most frequently, this communication problem involved team members assessing a patient to be at high risk for suicide, but that information was not provided to other care team members. This root cause also included situations in which the treatment plan for suicide prevention was inadequately disseminated to the entire treatment team. It is critical that good systems are in place so that staff members have the time to communicate critical information about patients. In addition, the system should be standardized so that the same information is communicated each time there is a handoff. The lack of clear steps to mitigate suicide risk when a patient was identified at high risk was also a commonly cited root cause. The most extreme examples involved completed suicides occurring with a patient receiving 1‐on‐1 staffing. This 1‐on‐1 staffing did not include specific guidance for the sitters such as the need to remove personal items that could be used for self‐harm. We also saw that staff on medical units needed to learn more about risk factors for suicide and how to conduct a suicide assessment with their patients. Another root cause was the stress caused by the medical and psychiatric conditions of the patients. It is notable that no completed suicides occurred in ICUs, suggesting that closer observation and/or a higher level of medical incapacitation can reduce the risk of completed suicides.
To address these root causes, staff should be educated about risk factors for suicide, and standardized high‐risk for suicide order sets and checklists should be used to ensure staff execute the desired care processes and communicate them to all staff. In addition, specific training in suicide prevention should be provided to staff involved in 1‐on‐1 observation for high‐risk patients. Again, this may be aided by a checklist to help staff remember the protocol for what may be a low‐frequency event. A high risk suicide care process may include:
- Conducting contraband searches for items that could be used for self‐harm, modifying the environment of a small percentage of toilet rooms on medical floors to reduce anchor points for hanging. A high risk patient could then be moved to these rooms.
- Regular psychiatric input into the treatment plan.
- Discharge planning that includes attention to the potential for depression and suicidal ideation upon discharge.
Limitations
This study has several limitations. First, our data only contained suicide attempts and completions that were reported through our patient safety system in the VHA, and only completed suicides require an RCA, thus there are likely some events that were not included. Second, the RCA reports focus on the systemic vulnerabilities in medical‐surgical units and ICUs that may have contributed to the adverse event rather than the specific characteristics of the patients involved, so we do not have complete demographic information about these individual patients. Third, our sample was mostly male, so the results may not generalize well to units with a higher percentage of female patients.
These limitations notwithstanding, we know of no other study to present data on suicide attempts and completions in medical‐surgical and ICUs in a large national medical system.
Disclosures: This material is the result of work supported with resources and the use of facilities at the Department of Veterans Affairs National Center for Patient Safety at Ann Arbor, Michigan, and the Veterans Affairs Medical Centers, White River Junction, Vermont. The Research and Development Committee, White River Junction VA Medical Center approved this project, and the Committee for the Protection of Human Subjects, Dartmouth College considered this project exempt. The views expressed in this article do not necessarily represent the views of the Department of Veterans Affairs or the United States government. The authors report no conflicts of interest.
Suicide is the tenth leading cause of death in the United States,[1] resulting in the deaths of over 34,000 people each year.[2] In 2007, 165,997 individuals were hospitalized for self‐inflicted injuries, and 395,320 people were treated for self‐harm in emergency departments.[2] In 2003, the American Psychiatric Association reported that approximately 1500 suicides take place within hospital facilities in the United States each year.[3]
Although a number of studies have examined inpatient suicides that occurred on psychiatric units,[4, 5, 6, 7, 8] fewer have focused on suicides occurring on medical units. A Joint Commission review of inpatient suicide on medical/surgical units[9] found that 14.25% of all inpatient suicides occurred while the patient was on a medical unit, and now recommends that all hospitals identify individuals at risk for suicide, develop interventions for suicidal patients, and educate staff about the risk factors of suicide. Bostwick and Rackley[10] reviewed studies of suicide on medical/surgical units and found that few of the patients had histories of mental illness or suicidal ideation and recommend close attention to agitated patients, aggressively treating depression and pain, modifying the environment where possible, and observation of patients thought to be at risk. Wint and Alil[5] also report a high level of depression in patients who commit suicide in general hospitals and suggest that improved recognition of depression in general hospital patients will reduce suicide.
GOALS FOR THIS STUDY
Few studies have examined suicide on acute medical and surgical and intensive care units (ICUs), and there are no large studies conducted in the United States. The goal of this study was to describe suicide attempts and completions in the medical setting using Root Cause Analysis (RCA) reports of these events in the Veterans Health Administration (VHA).
METHODS
Study Design and Theoretical Model
This is an observational review of all RCA reports of suicide attempts or completions on the medical‐surgical wards and ICUs in the VHA system between December 1, 1999 (when the RCA system started) and December 31, 2012. The Committee for the Protection of Human Subjects, Dartmouth College considered this project exempt.
The VHA provides comprehensive healthcare services to over 6 million veterans across the United States through 152 VHA medical centers. Over the study period there were approximately 7,289,770 admissions to medical‐surgical wards and ICUs in the VHA (average number of admissions per year between 2000 and 2012=560,771.5, standard deviation=25,535.7).
The VHA National Center for Patient Safety RCA Program
Patient safety including the investigation of adverse events is coordinated by the National Center for Patient Safety (NCPS). The NCPS has instituted a systematic and structured RCA program to individually and collectively analyze adverse events.[11, 12]
RCA is a method for examining the underlying causes of an adverse event such as a hospital related death, surgical error, or suicide. The focus of an RCA is on the systemic and organizational factors that may have contributed to an adverse event.[11, 12] The RCA process within the VHA is conducted by multidisciplinary teams organized by the hospital's patient safety manager. In general, an RCA describes what happened, how it happened, and what should be done to avoid the same event happening again.[11]
Because of the focus on the system, the information contained in the RCA reports does not include detailed demographic data about the patients involved in the events. RCA reports that are submitted to NCPS include narrative descriptions of the event, all contributing factors, a final understanding of the event, and a specific action plan for addressing underlying causes of the event.
Analysis of RCA Reports
Our goal was to identify suicide attempts and completed suicides that occurred on acute care medical‐surgical wards or ICUs. The search was completed through use of event codes for suicide or suicide attempts entered in the RCA and through the use of natural language processing software to identify the terms related to suicide or suicide attempts anywhere in the RCA text (PolyAnalyst; Megaputer, Bloomington, IN).
Data Processing
Each RCA report was coded for the location of the event, method of self‐harm, and root causes; where possible, we also coded medical diagnosis, reason for admission, history of suicidal behavior, age, and gender. The coding system was developed in a previous study of RCA reports of suicide.[13]
RESULTS
Our search resulted in 525 RCA reports of inpatient suicide attempts and completions. These were obtained from the 14,851 total RCA reports in the RCA dataset. Of the 525, we identified 50 cases that occurred while the patient was on the acute medical‐surgical unit (43 cases) or ICU (7 cases). Other cases occurred on mental health units, emergency department, or other areas of the hospital. Five cases were completed suicides, and 45 were suicide attempts. Based on the number of admissions per year reported above, the approximate rate of completed inpatient suicides on medical‐surgical and ICUs is 0.6 per million admissions. (For comparison, the rate of completed suicide on psychiatric units in the VA has been estimated to be 8.7 per million admissions.[14] Table 1 displays the admitting diagnosis and demographic data for those RCA reports that contained this information. The most common admitting diagnoses were alcohol detoxification and chest pain or rule out myocardial infarction (MI); note that 12 reports did not contain an admitting diagnosis. Table 2 displays the methods and root causes for the 50 cases; there were 118 root causes generated. The most common methods were cutting, overdose, and hanging; and the most common root causes were poor communication, need for staff training in suicide assessment, and need to improve suicide risk assessment.
| Medical‐Surgical | ICU | |||
|---|---|---|---|---|
| Attempts | Completions | Attempts | Completions | |
| ||||
| Admitting diagnosis, N=50 | ||||
| Alcohol detox | 3 | 2 | 2 | 0 |
| Chest pain or rule out MI | 5 | 0 | 0 | 0 |
| Delirium | 1 | 0 | 0 | 0 |
| Peripheral infection/cellulitis | 2 | 1 | 0 | 0 |
| Spine surgery or spine issue | 2 | 0 | 0 | 0 |
| Lung CA | 1 | 1 | 0 | 0 |
| Cystopy (bladder surgery) | 2 | 0 | 0 | 0 |
| Head and neck CA | 1 | 0 | 1 | 0 |
| Other | 4 | 0 | 0 | 0 |
| Respiratory (COPD) | 2 | 0 | 1 | 0 |
| Suicide attempt by overdose | 2 | 0 | 0 | 0 |
| Lung infection | 1 | 0 | 1 | 0 |
| CVA | 0 | 1 | 0 | 0 |
| Unknown | 12 | 0 | 2 | 0 |
| Demographics N =50 | ||||
| % male | 91.40% | 100% | 80% | NA |
| Average age, y | 56 | 53 | 47 | NA |
| History of suicidal thoughts or behaviors | 16 | 2 | 3 | 0 |
| Medical‐Surgical | ICU | |||
|---|---|---|---|---|
| Attempts | Completions | Attempts | Completions | |
| ||||
| Methods | ||||
| Cutting with a sharp object | 29% | 0% | 43% | None |
| Overdose | 26% | 20% | 0% | None |
| Hanging | 18% | 40% | 29% | None |
| Strangulation | 8% | 0% | 0% | None |
| Jumping | 5% | 0% | 14% | None |
| Asphyxiation | 8% | 0% | 0% | None |
| Removed lines or equipment | 5% | 0% | 14% | None |
| Gun shot | 0% | 40% | 0% | None |
| Column total | 100% | 100% | 100% | None |
| Root causes | ||||
| Poor communication between providers or services | 22% | 9% | 7% | None |
| Need for staff training in suicide assessment | 14% | 0% | 20% | None |
| Need to improve process of suicide assessment | 13% | 9% | 13% | None |
| Need for improvement of risk documentation | 9% | 0% | 7% | None |
| Physical environment is a risk factor | 7% | 0% | 20% | None |
| Contraband search needs improvement | 7% | 18% | 0% | None |
| Problems with treatment for suicidal patients | 7% | 27% | 7% | None |
| Not following existing policies | 5% | 0% | 0% | None |
| Medical assess or treatment delayed or incomplete | 5% | 0% | 0% | None |
| Easy access to medication for overdose | 4% | 9% | 0% | None |
| Stressed by medical/mental health/pain problems | 5% | 18% | 20% | None |
| Other root causes | 1% | 0% | 7% | None |
| No root cause | 1% | 9% | 0% | None |
| Column totals | 100% | 100% | 100% | None |
DISCUSSION
This study examined the specific systemic factors involved in suicide attempts and completions in medical‐surgical and intensive care units in a large, national hospital sample. Overall, the number of completed suicides over the 13‐year period was small (5 in total). The most common reason for admission was alcohol detoxification. Many patients going through alcohol detoxification experience agitation, which is a risk factor for suicide among medical patients.[10] This hypothesis is further supported by the fact that 2 of the 5 completed suicides were admitted for alcohol detoxification. Interestingly, only 2 of the patients who attempted suicide in the hospital were also admitted for medical conditions related to a prior suicide attempt. It is likely the case that patients admitted for a suicide attempt are closely watched throughout the admission and so may have fewer opportunities to repeat the suicide attempt.
The most common method of suicide attempts was cutting with a sharp object. However, cutting did not result in death, whereas overdose, hanging, and gunshot did. As a precaution, especially with patients with a known history of suicidal ideation, removing sharp objects such as razor blades and knives as well as extra medications is a reasonable first step. It may also be possible to create safer bathroom environments, at least in some medical rooms for potentially suicidal patients, which have break‐away shower curtains, sealed grab‐bars, and a general reduction of anchor points for hanging (see
As with other studies of RCAs,[15, 16] we found that problems communicating risk was the most common identified root cause for suicide attempts and completions. Problems communicating risk most often involved knowledge of suicide risk or specific suicide mitigation plans that were not shared by the treatment team or communicated during handoffs. Most frequently, this communication problem involved team members assessing a patient to be at high risk for suicide, but that information was not provided to other care team members. This root cause also included situations in which the treatment plan for suicide prevention was inadequately disseminated to the entire treatment team. It is critical that good systems are in place so that staff members have the time to communicate critical information about patients. In addition, the system should be standardized so that the same information is communicated each time there is a handoff. The lack of clear steps to mitigate suicide risk when a patient was identified at high risk was also a commonly cited root cause. The most extreme examples involved completed suicides occurring with a patient receiving 1‐on‐1 staffing. This 1‐on‐1 staffing did not include specific guidance for the sitters such as the need to remove personal items that could be used for self‐harm. We also saw that staff on medical units needed to learn more about risk factors for suicide and how to conduct a suicide assessment with their patients. Another root cause was the stress caused by the medical and psychiatric conditions of the patients. It is notable that no completed suicides occurred in ICUs, suggesting that closer observation and/or a higher level of medical incapacitation can reduce the risk of completed suicides.
To address these root causes, staff should be educated about risk factors for suicide, and standardized high‐risk for suicide order sets and checklists should be used to ensure staff execute the desired care processes and communicate them to all staff. In addition, specific training in suicide prevention should be provided to staff involved in 1‐on‐1 observation for high‐risk patients. Again, this may be aided by a checklist to help staff remember the protocol for what may be a low‐frequency event. A high risk suicide care process may include:
- Conducting contraband searches for items that could be used for self‐harm, modifying the environment of a small percentage of toilet rooms on medical floors to reduce anchor points for hanging. A high risk patient could then be moved to these rooms.
- Regular psychiatric input into the treatment plan.
- Discharge planning that includes attention to the potential for depression and suicidal ideation upon discharge.
Limitations
This study has several limitations. First, our data only contained suicide attempts and completions that were reported through our patient safety system in the VHA, and only completed suicides require an RCA, thus there are likely some events that were not included. Second, the RCA reports focus on the systemic vulnerabilities in medical‐surgical units and ICUs that may have contributed to the adverse event rather than the specific characteristics of the patients involved, so we do not have complete demographic information about these individual patients. Third, our sample was mostly male, so the results may not generalize well to units with a higher percentage of female patients.
These limitations notwithstanding, we know of no other study to present data on suicide attempts and completions in medical‐surgical and ICUs in a large national medical system.
Disclosures: This material is the result of work supported with resources and the use of facilities at the Department of Veterans Affairs National Center for Patient Safety at Ann Arbor, Michigan, and the Veterans Affairs Medical Centers, White River Junction, Vermont. The Research and Development Committee, White River Junction VA Medical Center approved this project, and the Committee for the Protection of Human Subjects, Dartmouth College considered this project exempt. The views expressed in this article do not necessarily represent the views of the Department of Veterans Affairs or the United States government. The authors report no conflicts of interest.
- Centers for Disease Control and Prevention. National Center for Injury and Prevention Control. WISQARS (Web‐based Injury Statistics Query and Reporting System). Available at: http://www.cdc.gov/injury/wisqars/index.html. Accessed September 27, 2012.
- Centers for Disease Control and Prevention. Suicide: facts at a glance. Available at: http://www.cdc.gov/ViolencePrevention/pdf/Suicide_DataSheet‐a.pdf. Accessed September 27, 2012.
- American Psychiatric Association. Practice guideline for the assessment and treatment of patients with suicidal behaviors. Am J Psychiatry. 2003;160:1–60.
- , . Inpatient suicide: preventing a common sentinel event. Gen Hosp Psychiatry. 2009;31:103–109.
- , . Suicidality in the general hospitalized patient. Hosp Physician. 2006;42(1):13–18.
- , , . Suicide inside: a systematic review of inpatient suicides. J Nervous and Ment Dis. 2010;198(5):315–328.
- , , . Environmental risk factors in hospital suicide. Suicide Life Threat Behav. 2004;34(4):448–453.
- , , . Clinical correlates of inpatient suicide. J Clin Psychiatry. 2003;64(1):14–19.
- A follow‐up report on preventing suicide: focus on medical/surgical units and the emergency department. Sentinel Event Alert. 2010;(46):1–4.
- , . Completed suicide in medical/surgical patients: who is at risk? Curr Psychiatry Rep. 2007;9(3):242–246.
- , , , , , , et al. Developing and deploying a patient safety program in a large health care system: you can't fix what you don't know about. Jt Comm J Qual Improv. 2001;27:522–532.
- , . Developing a culture of safety in the Veterans Health Administration. Eff Clin Pract. 2007;3:270–276.
- , , , , . Actions and Implementation Strategies to Reduce Suicidal Events in the VHA. Jt Comm J on Qual and Safe. 2006:32(3):130–141.
- , , , et al. An examination of the effectiveness of a mental health environment of care checklist in reducing suicide on inpatient mental health units. Arch GenPsychiatry. 2012:69(6):588–592.
- , , , , . Helping elderly patients to avoid suicide: a review of case reports from a national Veterans Affairs database. J Nerv Ment Dis. 2013;201(1):12–16.
- , , , , . Suicide attempts and completions in the emergency department in Veterans Affairs hospitals. Emerg Med J. 2012;29(5):399–403.
- Centers for Disease Control and Prevention. National Center for Injury and Prevention Control. WISQARS (Web‐based Injury Statistics Query and Reporting System). Available at: http://www.cdc.gov/injury/wisqars/index.html. Accessed September 27, 2012.
- Centers for Disease Control and Prevention. Suicide: facts at a glance. Available at: http://www.cdc.gov/ViolencePrevention/pdf/Suicide_DataSheet‐a.pdf. Accessed September 27, 2012.
- American Psychiatric Association. Practice guideline for the assessment and treatment of patients with suicidal behaviors. Am J Psychiatry. 2003;160:1–60.
- , . Inpatient suicide: preventing a common sentinel event. Gen Hosp Psychiatry. 2009;31:103–109.
- , . Suicidality in the general hospitalized patient. Hosp Physician. 2006;42(1):13–18.
- , , . Suicide inside: a systematic review of inpatient suicides. J Nervous and Ment Dis. 2010;198(5):315–328.
- , , . Environmental risk factors in hospital suicide. Suicide Life Threat Behav. 2004;34(4):448–453.
- , , . Clinical correlates of inpatient suicide. J Clin Psychiatry. 2003;64(1):14–19.
- A follow‐up report on preventing suicide: focus on medical/surgical units and the emergency department. Sentinel Event Alert. 2010;(46):1–4.
- , . Completed suicide in medical/surgical patients: who is at risk? Curr Psychiatry Rep. 2007;9(3):242–246.
- , , , , , , et al. Developing and deploying a patient safety program in a large health care system: you can't fix what you don't know about. Jt Comm J Qual Improv. 2001;27:522–532.
- , . Developing a culture of safety in the Veterans Health Administration. Eff Clin Pract. 2007;3:270–276.
- , , , , . Actions and Implementation Strategies to Reduce Suicidal Events in the VHA. Jt Comm J on Qual and Safe. 2006:32(3):130–141.
- , , , et al. An examination of the effectiveness of a mental health environment of care checklist in reducing suicide on inpatient mental health units. Arch GenPsychiatry. 2012:69(6):588–592.
- , , , , . Helping elderly patients to avoid suicide: a review of case reports from a national Veterans Affairs database. J Nerv Ment Dis. 2013;201(1):12–16.
- , , , , . Suicide attempts and completions in the emergency department in Veterans Affairs hospitals. Emerg Med J. 2012;29(5):399–403.