Thrombophilia is a prothrombotic state, either acquired or inherited, leading to a thrombotic predisposition.¹ The most common heritable thrombophilias include factor V Leiden (FVL) and prothrombin G20210A. The most common acquired thrombophilia is the presence of phospholipid antibodies.¹ Thrombotic risk varies with thrombophilia type. For example, deficiencies of antithrombin, protein C and protein S, and the presence of phospholipid antibodies, confer higher risk than FVL and prothrombin G20210A.^2-5 Other thrombophilias (eg, methylenetetrahydrofolate reductase mutation, increased factor VIII activity) are relatively uncommon and/or their impact on thrombosis risk appears to be either minimal or unknown.^1-6 There is little clinical evidence that testing for thrombophilia impacts subsequent thrombosis prevention.^5,7,8 Multiple clinical guidelines and medical societies recommend against the routine and indiscriminate use of thrombophilia testing.^8-13 In general, thrombophilia testing should be considered only if the result would lead to changes in anticoagulant initiation, intensity, and/or duration, or might inform interventions to prevent thrombosis in asymptomatic family members.^8-13 However, thrombophilia testing rarely changes the acute management of a thrombotic event and may have harmful effects on patients and their family members because positive results may unnecessarily increase anxiety and negative results may provide false reassurance.^6,14-18 The cost-effectiveness of thrombophilia testing is unknown. Economic models have sought to quantify cost-effectiveness, but conclusions from these studies are limited.⁷

The utility of thrombophilia testing in emergency department (ED) and inpatient settings is further limited because patients are often treated and discharged before thrombophilia test results are available. Additionally, in these settings, multiple factors increase the risk of false-positive or false-negative results (eg, acute thrombosis, acute illness, pregnancy, and anticoagulant therapy).^19,20 The purpose of this study was to systematically assess thrombophilia testing patterns in the ED and hospitalized patients at an academic medical center and to quantify the proportion of tests associated with minimal clinical utility. We hypothesize that the majority of thrombophilia tests completed in the inpatient setting are associated with minimal clinical utility.

Setting and Patients

This study was conducted at University of Utah Health Care (UUHC) University Hospital, a 488-bed academic medical center with a level I trauma center, primary stroke center, and 50-bed ED. Laboratory services for UUHC, including thrombophilia testing, are provided by a national reference laboratory, Associated Regional and University Pathologists Laboratories. This study included patients ≥18 years of age who received thrombophilia testing (Supplementary Table 1) during an ED visit or inpatient admission at University Hospital between July 1, 2014 and December 31, 2014. There were no exclusion criteria. An institutional electronic data repository was used to identify patients matching inclusion criteria. All study activities were reviewed and approved by the UUHC Institutional Review Board with a waiver of informed consent.

Outcomes

An electronic database query was used to identify patients, collect patient demographic information, and collect test characteristics. Each patient’s electronic medical record was manually reviewed to collect all other outcomes. Indication for thrombophilia testing was identified by manual review of provider notes. Thrombophilia tests occurring in situations associated with minimal clinical utility were defined as tests meeting at least one of the following criteria: patient discharged before test results were available for review; test type not recommended by published guidelines or by UUHC Thrombosis Service physicians for thrombophilia testing (Supplementary Table 2); test performed in situations associated with decreased accuracy; test was a duplicate test as a result of different thrombophilia panels containing identical tests; and test followed a provoked venous thromboembolism (VTE). Testing in situations associated with decreased accuracy are summarized in Supplementary Table 3 and included at least one of the following at the time of the test: anticoagulant therapy, acute thrombosis, pregnant or <8 weeks postpartum, and receiving estrogen-containing medications. Only test types known to be affected by the respective situation were included. Testing following a provoked VTE was defined as testing prompted by an acute thrombosis and performed within 3 months following major surgery (defined administratively as any surgery performed in an operating room), during pregnancy, <8 weeks postpartum, or while on estrogen-containing medications. Thrombophilia testing during anticoagulant therapy was defined as testing within 4 half-lives of anticoagulant administration based on medication administration records. Anticoagulant therapy changes were identified by comparing prior-to-admission and discharge medication lists.

Data Analysis

Patient and laboratory characteristics were summarized using descriptive statistics, including mean and standard deviation (SD) for continuous variables and proportions for categorical variables. Data analysis was performed using Excel (Version 2013, Microsoft Corporation. Redmond, Washington).

During the 6-month study period, 163 patients received at least 1 thrombophilia test during an ED visit or inpatient admission. Patient characteristics are summarized in Table 1. Tested patients were most commonly inpatients (96%) and female (71%). A total of 1451 thrombophilia tests were performed with a mean (± SD) of 8.9 ± 6.0 tests per patient. Testing characteristics are summarized in Table 2. Of the 39 different test types performed, the most commonly ordered were cardiolipin IgG and IgM antibodies (9% each), lupus anticoagulant (9%), and β₂-glycoprotein 1 IgG and IgM antibodies (8% each). When combined with testing for phosphatidyl antibodies, antiphospholipid tests accounted for 70% of all tests. Overall, 134 (9%) test results were positive. The mean time for results to become available was 2.2 ± 2.5 days. The frequency of test types with corresponding positivity rates and mean time for results to become available are summarized in Supplementary Table 4.

The indications for thrombophilia testing are summarized in Table 3. Ischemic stroke was the most common indication for testing (50% of tests; 35% of patients), followed by VTE (21% of tests; 21% of patients), and pregnancy-related conditions (eg, preeclampsia, intrauterine fetal demise; 15% of tests; 25% of patients). Overall, 911 tests (63%) occurred in situations associated with minimal clinical utility, with 126 patients (77%) receiving at least one of these tests (Table 4).

In this retrospective analysis, 1451 thrombophilia tests were performed in 163 patients over 6 months. Tested patients were relatively young, which is likely explained by the number of patients tested for pregnancy-related conditions and the fact that a stroke or VTE in younger patients more frequently prompted providers to suspect thrombophilia. Nearly three-fourths of patients were female, which is likely due to testing for pregnancy-related conditions and possibly diagnostic suspicion bias given the comparative predilection of antiphospholipid syndrome for women. The patient characteristics in our study are consistent with other studies evaluating thrombophilia testing.^21,22

Thrombophilia testing was most frequently prompted by stroke, VTE, and pregnancy-related conditions. Only 26% of patients had acute thrombosis identified during the admission, primarily because of the high proportion of tests for cryptogenic strokes and pregnancy-related conditions. Thrombophilia testing is recommended in patients who have had a stroke when the stroke is considered to be cryptogenic after a standard stroke evaluation.²³ Thrombophilia testing in pregnancy-related conditions is controversial but is often considered in situations such as stillbirths with severe placental pathology and/or significant growth restriction, or in mothers with a personal or family history of thrombosis.²⁴ The proportion of testing for pregnancy-related conditions may be greater than at other institutions because UUHC Maternal Fetal Medicine is a referral center for women with conditions associated with hypercoagulability. Anticoagulant therapy was initiated in 21% of patients, but specifically in response to thrombophilia testing in only 2 instances; in most cases, anticoagulant therapy was initiated regardless of thrombophilia test results.

The results of this study confirm our hypothesis because the majority of thrombophilia tests occurred in situations associated with minimal clinical utility. Testing in these situations was not isolated to specific patients or medical services because 77% of tested patients received at least 1 test associated with minimal clinical utility. Our study took a conservative approach in defining scenarios associated with minimal clinical utility because other situations can also affect testing accuracy (eg, hepatic disease, nephrotic syndrome) but were not included in our analysis of this outcome.

The results of this study highlight opportunities to improve thrombophilia testing practices at our institution and may be generalizable to institutions with similar testing patterns. Because multiple medical services order thrombophilia tests, strategies to improve testing practices are still being determined. The results of this study can serve as a baseline for comparison after strategies are implemented. The most common situation associated with minimal clinical utility was the use of test types not generally recommended by guidelines or UUHC Thrombosis Service physicians for thrombophilia testing (eg, β₂-glycoprotein 1 IgA antibodies, phosphatidyl antibodies). We intend to require a hematology or thrombosis specialty consult prior to ordering these tests. This intervention alone could potentially decrease unnecessary testing by a third. Another consideration is to require a specialty consult prior to any inpatient thrombophilia testing. This strategy has been found to decrease inappropriate testing at other institutions.²¹ We also intend to streamline available thrombophilia testing panels because a poorly designed panel could lead to ordering of multiple tests associated with minimal clinical utility. At least 12 different thrombophilia panels are currently available in our computerized physician order entry system (see Supplementary Table 5). We hypothesize that current panel designs contribute to providers inadvertently ordering unintended or duplicate tests and that reducing the number of available panels and clearly delineating what tests are contained in each panel is likely to reduce unnecessary testing. Other strategies being considered include using electronic clinical decision support tools, implementing strict ordering criteria for all inpatient testing, and establishing a thrombosis stewardship program.

Our study was unique in at least 2 ways. First, previous studies describing thrombophilia testing have described testing patterns for patients with specific indications (eg, VTE), whereas our study described all thrombophilia tests regardless of indication. This allows for testing pattern comparisons across indications and medical services, increasing the generalizability of our results. Second, this study quantifies tests occurring in situations associated with a practical definition of minimal clinical utility.

Our study has several limitations: (1) Many variables were reliant on provider notes and other documentation, which allows for potential misclassification of variables. (2) It was not always possible to determine the ultimate utility of each test in clinical management decisions, and our study did not investigate the impact of thrombophilia testing on duration of anticoagulant therapy. Additionally, select situations could benefit from testing regardless if anticoagulant therapy is altered (eg, informing contraceptive choices). (3) Testing performed following a provoked acute thrombosis was defined as testing within 3 months following administratively defined major surgery. This definition could have included some minor procedures that do not substantially increase VTE risk, resulting in underestimated clinical utility. (4) The UUHC University Hospital serves as a referral hospital for a large geographical area, and investigators did not have access to outpatient records for a large proportion of discharged patients. As a result, frequency of repeat testing could not be assessed, possibly resulting in overestimated clinical utility. (5) In categorizing indications for testing, testing for CVST was subcategorized under testing for ischemic stroke based on presenting symptoms rather than on underlying pathophysiology. The rationale for this categorization is that patients with CVST were often tested based on presenting symptoms. Additionally, tests for CVST were ordered by the neurology service, which also ordered tests for all other ischemic stroke indications. (6) The purpose of our study was to investigate the subset of the hospital’s patient population that received thrombophilia testing, and patients were identified by tests received and not by diagnosis codes. As a result, we are unable to provide the proportion of total patients treated at the hospital for specific conditions who were tested (eg, the proportion of stroke patients that received thrombophilia testing). (7) Current practice guidelines do not recommend testing for phosphatidyl antibodies, even when traditional antiphospholipid testing is negative.^25-27 Although expert panels continue to explore associations between phosphatidyl antibodies and pregnancy morbidity and thrombotic events, the low level of evidence is insufficient to guide clinical management.²⁸ Therefore, we categorized all phosphatidyl testing as associated with minimal clinical utility.

In a large academic medical center, the majority of tests occurred in situations associated with minimal clinical utility. Strategies to improve thrombophilia testing practices are needed in order to minimize potentially inappropriate testing, provide more cost-effective care, and promote value-driven outcomes.

Disclosure

S.W. received financial support for this submitted work via a Bristol-Myers-Squibb grant. G.F. received financial support from Portola Pharmaceuticals for consulting and lectures that were not related to this submitted work.

Thrombophilia is a prothrombotic state, either acquired or inherited, leading to a thrombotic predisposition.¹ The most common heritable thrombophilias include factor V Leiden (FVL) and prothrombin G20210A. The most common acquired thrombophilia is the presence of phospholipid antibodies.¹ Thrombotic risk varies with thrombophilia type. For example, deficiencies of antithrombin, protein C and protein S, and the presence of phospholipid antibodies, confer higher risk than FVL and prothrombin G20210A.^2-5 Other thrombophilias (eg, methylenetetrahydrofolate reductase mutation, increased factor VIII activity) are relatively uncommon and/or their impact on thrombosis risk appears to be either minimal or unknown.^1-6 There is little clinical evidence that testing for thrombophilia impacts subsequent thrombosis prevention.^5,7,8 Multiple clinical guidelines and medical societies recommend against the routine and indiscriminate use of thrombophilia testing.^8-13 In general, thrombophilia testing should be considered only if the result would lead to changes in anticoagulant initiation, intensity, and/or duration, or might inform interventions to prevent thrombosis in asymptomatic family members.^8-13 However, thrombophilia testing rarely changes the acute management of a thrombotic event and may have harmful effects on patients and their family members because positive results may unnecessarily increase anxiety and negative results may provide false reassurance.^6,14-18 The cost-effectiveness of thrombophilia testing is unknown. Economic models have sought to quantify cost-effectiveness, but conclusions from these studies are limited.⁷

The utility of thrombophilia testing in emergency department (ED) and inpatient settings is further limited because patients are often treated and discharged before thrombophilia test results are available. Additionally, in these settings, multiple factors increase the risk of false-positive or false-negative results (eg, acute thrombosis, acute illness, pregnancy, and anticoagulant therapy).^19,20 The purpose of this study was to systematically assess thrombophilia testing patterns in the ED and hospitalized patients at an academic medical center and to quantify the proportion of tests associated with minimal clinical utility. We hypothesize that the majority of thrombophilia tests completed in the inpatient setting are associated with minimal clinical utility.

Setting and Patients

This study was conducted at University of Utah Health Care (UUHC) University Hospital, a 488-bed academic medical center with a level I trauma center, primary stroke center, and 50-bed ED. Laboratory services for UUHC, including thrombophilia testing, are provided by a national reference laboratory, Associated Regional and University Pathologists Laboratories. This study included patients ≥18 years of age who received thrombophilia testing (Supplementary Table 1) during an ED visit or inpatient admission at University Hospital between July 1, 2014 and December 31, 2014. There were no exclusion criteria. An institutional electronic data repository was used to identify patients matching inclusion criteria. All study activities were reviewed and approved by the UUHC Institutional Review Board with a waiver of informed consent.

Outcomes

An electronic database query was used to identify patients, collect patient demographic information, and collect test characteristics. Each patient’s electronic medical record was manually reviewed to collect all other outcomes. Indication for thrombophilia testing was identified by manual review of provider notes. Thrombophilia tests occurring in situations associated with minimal clinical utility were defined as tests meeting at least one of the following criteria: patient discharged before test results were available for review; test type not recommended by published guidelines or by UUHC Thrombosis Service physicians for thrombophilia testing (Supplementary Table 2); test performed in situations associated with decreased accuracy; test was a duplicate test as a result of different thrombophilia panels containing identical tests; and test followed a provoked venous thromboembolism (VTE). Testing in situations associated with decreased accuracy are summarized in Supplementary Table 3 and included at least one of the following at the time of the test: anticoagulant therapy, acute thrombosis, pregnant or <8 weeks postpartum, and receiving estrogen-containing medications. Only test types known to be affected by the respective situation were included. Testing following a provoked VTE was defined as testing prompted by an acute thrombosis and performed within 3 months following major surgery (defined administratively as any surgery performed in an operating room), during pregnancy, <8 weeks postpartum, or while on estrogen-containing medications. Thrombophilia testing during anticoagulant therapy was defined as testing within 4 half-lives of anticoagulant administration based on medication administration records. Anticoagulant therapy changes were identified by comparing prior-to-admission and discharge medication lists.

Data Analysis

Patient and laboratory characteristics were summarized using descriptive statistics, including mean and standard deviation (SD) for continuous variables and proportions for categorical variables. Data analysis was performed using Excel (Version 2013, Microsoft Corporation. Redmond, Washington).

During the 6-month study period, 163 patients received at least 1 thrombophilia test during an ED visit or inpatient admission. Patient characteristics are summarized in Table 1. Tested patients were most commonly inpatients (96%) and female (71%). A total of 1451 thrombophilia tests were performed with a mean (± SD) of 8.9 ± 6.0 tests per patient. Testing characteristics are summarized in Table 2. Of the 39 different test types performed, the most commonly ordered were cardiolipin IgG and IgM antibodies (9% each), lupus anticoagulant (9%), and β₂-glycoprotein 1 IgG and IgM antibodies (8% each). When combined with testing for phosphatidyl antibodies, antiphospholipid tests accounted for 70% of all tests. Overall, 134 (9%) test results were positive. The mean time for results to become available was 2.2 ± 2.5 days. The frequency of test types with corresponding positivity rates and mean time for results to become available are summarized in Supplementary Table 4.

The indications for thrombophilia testing are summarized in Table 3. Ischemic stroke was the most common indication for testing (50% of tests; 35% of patients), followed by VTE (21% of tests; 21% of patients), and pregnancy-related conditions (eg, preeclampsia, intrauterine fetal demise; 15% of tests; 25% of patients). Overall, 911 tests (63%) occurred in situations associated with minimal clinical utility, with 126 patients (77%) receiving at least one of these tests (Table 4).

In this retrospective analysis, 1451 thrombophilia tests were performed in 163 patients over 6 months. Tested patients were relatively young, which is likely explained by the number of patients tested for pregnancy-related conditions and the fact that a stroke or VTE in younger patients more frequently prompted providers to suspect thrombophilia. Nearly three-fourths of patients were female, which is likely due to testing for pregnancy-related conditions and possibly diagnostic suspicion bias given the comparative predilection of antiphospholipid syndrome for women. The patient characteristics in our study are consistent with other studies evaluating thrombophilia testing.^21,22

Thrombophilia testing was most frequently prompted by stroke, VTE, and pregnancy-related conditions. Only 26% of patients had acute thrombosis identified during the admission, primarily because of the high proportion of tests for cryptogenic strokes and pregnancy-related conditions. Thrombophilia testing is recommended in patients who have had a stroke when the stroke is considered to be cryptogenic after a standard stroke evaluation.²³ Thrombophilia testing in pregnancy-related conditions is controversial but is often considered in situations such as stillbirths with severe placental pathology and/or significant growth restriction, or in mothers with a personal or family history of thrombosis.²⁴ The proportion of testing for pregnancy-related conditions may be greater than at other institutions because UUHC Maternal Fetal Medicine is a referral center for women with conditions associated with hypercoagulability. Anticoagulant therapy was initiated in 21% of patients, but specifically in response to thrombophilia testing in only 2 instances; in most cases, anticoagulant therapy was initiated regardless of thrombophilia test results.

The results of this study confirm our hypothesis because the majority of thrombophilia tests occurred in situations associated with minimal clinical utility. Testing in these situations was not isolated to specific patients or medical services because 77% of tested patients received at least 1 test associated with minimal clinical utility. Our study took a conservative approach in defining scenarios associated with minimal clinical utility because other situations can also affect testing accuracy (eg, hepatic disease, nephrotic syndrome) but were not included in our analysis of this outcome.

The results of this study highlight opportunities to improve thrombophilia testing practices at our institution and may be generalizable to institutions with similar testing patterns. Because multiple medical services order thrombophilia tests, strategies to improve testing practices are still being determined. The results of this study can serve as a baseline for comparison after strategies are implemented. The most common situation associated with minimal clinical utility was the use of test types not generally recommended by guidelines or UUHC Thrombosis Service physicians for thrombophilia testing (eg, β₂-glycoprotein 1 IgA antibodies, phosphatidyl antibodies). We intend to require a hematology or thrombosis specialty consult prior to ordering these tests. This intervention alone could potentially decrease unnecessary testing by a third. Another consideration is to require a specialty consult prior to any inpatient thrombophilia testing. This strategy has been found to decrease inappropriate testing at other institutions.²¹ We also intend to streamline available thrombophilia testing panels because a poorly designed panel could lead to ordering of multiple tests associated with minimal clinical utility. At least 12 different thrombophilia panels are currently available in our computerized physician order entry system (see Supplementary Table 5). We hypothesize that current panel designs contribute to providers inadvertently ordering unintended or duplicate tests and that reducing the number of available panels and clearly delineating what tests are contained in each panel is likely to reduce unnecessary testing. Other strategies being considered include using electronic clinical decision support tools, implementing strict ordering criteria for all inpatient testing, and establishing a thrombosis stewardship program.

Our study was unique in at least 2 ways. First, previous studies describing thrombophilia testing have described testing patterns for patients with specific indications (eg, VTE), whereas our study described all thrombophilia tests regardless of indication. This allows for testing pattern comparisons across indications and medical services, increasing the generalizability of our results. Second, this study quantifies tests occurring in situations associated with a practical definition of minimal clinical utility.

Our study has several limitations: (1) Many variables were reliant on provider notes and other documentation, which allows for potential misclassification of variables. (2) It was not always possible to determine the ultimate utility of each test in clinical management decisions, and our study did not investigate the impact of thrombophilia testing on duration of anticoagulant therapy. Additionally, select situations could benefit from testing regardless if anticoagulant therapy is altered (eg, informing contraceptive choices). (3) Testing performed following a provoked acute thrombosis was defined as testing within 3 months following administratively defined major surgery. This definition could have included some minor procedures that do not substantially increase VTE risk, resulting in underestimated clinical utility. (4) The UUHC University Hospital serves as a referral hospital for a large geographical area, and investigators did not have access to outpatient records for a large proportion of discharged patients. As a result, frequency of repeat testing could not be assessed, possibly resulting in overestimated clinical utility. (5) In categorizing indications for testing, testing for CVST was subcategorized under testing for ischemic stroke based on presenting symptoms rather than on underlying pathophysiology. The rationale for this categorization is that patients with CVST were often tested based on presenting symptoms. Additionally, tests for CVST were ordered by the neurology service, which also ordered tests for all other ischemic stroke indications. (6) The purpose of our study was to investigate the subset of the hospital’s patient population that received thrombophilia testing, and patients were identified by tests received and not by diagnosis codes. As a result, we are unable to provide the proportion of total patients treated at the hospital for specific conditions who were tested (eg, the proportion of stroke patients that received thrombophilia testing). (7) Current practice guidelines do not recommend testing for phosphatidyl antibodies, even when traditional antiphospholipid testing is negative.^25-27 Although expert panels continue to explore associations between phosphatidyl antibodies and pregnancy morbidity and thrombotic events, the low level of evidence is insufficient to guide clinical management.²⁸ Therefore, we categorized all phosphatidyl testing as associated with minimal clinical utility.

In a large academic medical center, the majority of tests occurred in situations associated with minimal clinical utility. Strategies to improve thrombophilia testing practices are needed in order to minimize potentially inappropriate testing, provide more cost-effective care, and promote value-driven outcomes.

Disclosure

S.W. received financial support for this submitted work via a Bristol-Myers-Squibb grant. G.F. received financial support from Portola Pharmaceuticals for consulting and lectures that were not related to this submitted work.

Thrombophilia is a prothrombotic state, either acquired or inherited, leading to a thrombotic predisposition.¹ The most common heritable thrombophilias include factor V Leiden (FVL) and prothrombin G20210A. The most common acquired thrombophilia is the presence of phospholipid antibodies.¹ Thrombotic risk varies with thrombophilia type. For example, deficiencies of antithrombin, protein C and protein S, and the presence of phospholipid antibodies, confer higher risk than FVL and prothrombin G20210A.^2-5 Other thrombophilias (eg, methylenetetrahydrofolate reductase mutation, increased factor VIII activity) are relatively uncommon and/or their impact on thrombosis risk appears to be either minimal or unknown.^1-6 There is little clinical evidence that testing for thrombophilia impacts subsequent thrombosis prevention.^5,7,8 Multiple clinical guidelines and medical societies recommend against the routine and indiscriminate use of thrombophilia testing.^8-13 In general, thrombophilia testing should be considered only if the result would lead to changes in anticoagulant initiation, intensity, and/or duration, or might inform interventions to prevent thrombosis in asymptomatic family members.^8-13 However, thrombophilia testing rarely changes the acute management of a thrombotic event and may have harmful effects on patients and their family members because positive results may unnecessarily increase anxiety and negative results may provide false reassurance.^6,14-18 The cost-effectiveness of thrombophilia testing is unknown. Economic models have sought to quantify cost-effectiveness, but conclusions from these studies are limited.⁷

The utility of thrombophilia testing in emergency department (ED) and inpatient settings is further limited because patients are often treated and discharged before thrombophilia test results are available. Additionally, in these settings, multiple factors increase the risk of false-positive or false-negative results (eg, acute thrombosis, acute illness, pregnancy, and anticoagulant therapy).^19,20 The purpose of this study was to systematically assess thrombophilia testing patterns in the ED and hospitalized patients at an academic medical center and to quantify the proportion of tests associated with minimal clinical utility. We hypothesize that the majority of thrombophilia tests completed in the inpatient setting are associated with minimal clinical utility.

Setting and Patients

This study was conducted at University of Utah Health Care (UUHC) University Hospital, a 488-bed academic medical center with a level I trauma center, primary stroke center, and 50-bed ED. Laboratory services for UUHC, including thrombophilia testing, are provided by a national reference laboratory, Associated Regional and University Pathologists Laboratories. This study included patients ≥18 years of age who received thrombophilia testing (Supplementary Table 1) during an ED visit or inpatient admission at University Hospital between July 1, 2014 and December 31, 2014. There were no exclusion criteria. An institutional electronic data repository was used to identify patients matching inclusion criteria. All study activities were reviewed and approved by the UUHC Institutional Review Board with a waiver of informed consent.

Outcomes

An electronic database query was used to identify patients, collect patient demographic information, and collect test characteristics. Each patient’s electronic medical record was manually reviewed to collect all other outcomes. Indication for thrombophilia testing was identified by manual review of provider notes. Thrombophilia tests occurring in situations associated with minimal clinical utility were defined as tests meeting at least one of the following criteria: patient discharged before test results were available for review; test type not recommended by published guidelines or by UUHC Thrombosis Service physicians for thrombophilia testing (Supplementary Table 2); test performed in situations associated with decreased accuracy; test was a duplicate test as a result of different thrombophilia panels containing identical tests; and test followed a provoked venous thromboembolism (VTE). Testing in situations associated with decreased accuracy are summarized in Supplementary Table 3 and included at least one of the following at the time of the test: anticoagulant therapy, acute thrombosis, pregnant or <8 weeks postpartum, and receiving estrogen-containing medications. Only test types known to be affected by the respective situation were included. Testing following a provoked VTE was defined as testing prompted by an acute thrombosis and performed within 3 months following major surgery (defined administratively as any surgery performed in an operating room), during pregnancy, <8 weeks postpartum, or while on estrogen-containing medications. Thrombophilia testing during anticoagulant therapy was defined as testing within 4 half-lives of anticoagulant administration based on medication administration records. Anticoagulant therapy changes were identified by comparing prior-to-admission and discharge medication lists.

Data Analysis

Patient and laboratory characteristics were summarized using descriptive statistics, including mean and standard deviation (SD) for continuous variables and proportions for categorical variables. Data analysis was performed using Excel (Version 2013, Microsoft Corporation. Redmond, Washington).

During the 6-month study period, 163 patients received at least 1 thrombophilia test during an ED visit or inpatient admission. Patient characteristics are summarized in Table 1. Tested patients were most commonly inpatients (96%) and female (71%). A total of 1451 thrombophilia tests were performed with a mean (± SD) of 8.9 ± 6.0 tests per patient. Testing characteristics are summarized in Table 2. Of the 39 different test types performed, the most commonly ordered were cardiolipin IgG and IgM antibodies (9% each), lupus anticoagulant (9%), and β₂-glycoprotein 1 IgG and IgM antibodies (8% each). When combined with testing for phosphatidyl antibodies, antiphospholipid tests accounted for 70% of all tests. Overall, 134 (9%) test results were positive. The mean time for results to become available was 2.2 ± 2.5 days. The frequency of test types with corresponding positivity rates and mean time for results to become available are summarized in Supplementary Table 4.

The indications for thrombophilia testing are summarized in Table 3. Ischemic stroke was the most common indication for testing (50% of tests; 35% of patients), followed by VTE (21% of tests; 21% of patients), and pregnancy-related conditions (eg, preeclampsia, intrauterine fetal demise; 15% of tests; 25% of patients). Overall, 911 tests (63%) occurred in situations associated with minimal clinical utility, with 126 patients (77%) receiving at least one of these tests (Table 4).

In this retrospective analysis, 1451 thrombophilia tests were performed in 163 patients over 6 months. Tested patients were relatively young, which is likely explained by the number of patients tested for pregnancy-related conditions and the fact that a stroke or VTE in younger patients more frequently prompted providers to suspect thrombophilia. Nearly three-fourths of patients were female, which is likely due to testing for pregnancy-related conditions and possibly diagnostic suspicion bias given the comparative predilection of antiphospholipid syndrome for women. The patient characteristics in our study are consistent with other studies evaluating thrombophilia testing.^21,22

Thrombophilia testing was most frequently prompted by stroke, VTE, and pregnancy-related conditions. Only 26% of patients had acute thrombosis identified during the admission, primarily because of the high proportion of tests for cryptogenic strokes and pregnancy-related conditions. Thrombophilia testing is recommended in patients who have had a stroke when the stroke is considered to be cryptogenic after a standard stroke evaluation.²³ Thrombophilia testing in pregnancy-related conditions is controversial but is often considered in situations such as stillbirths with severe placental pathology and/or significant growth restriction, or in mothers with a personal or family history of thrombosis.²⁴ The proportion of testing for pregnancy-related conditions may be greater than at other institutions because UUHC Maternal Fetal Medicine is a referral center for women with conditions associated with hypercoagulability. Anticoagulant therapy was initiated in 21% of patients, but specifically in response to thrombophilia testing in only 2 instances; in most cases, anticoagulant therapy was initiated regardless of thrombophilia test results.

The results of this study confirm our hypothesis because the majority of thrombophilia tests occurred in situations associated with minimal clinical utility. Testing in these situations was not isolated to specific patients or medical services because 77% of tested patients received at least 1 test associated with minimal clinical utility. Our study took a conservative approach in defining scenarios associated with minimal clinical utility because other situations can also affect testing accuracy (eg, hepatic disease, nephrotic syndrome) but were not included in our analysis of this outcome.

The results of this study highlight opportunities to improve thrombophilia testing practices at our institution and may be generalizable to institutions with similar testing patterns. Because multiple medical services order thrombophilia tests, strategies to improve testing practices are still being determined. The results of this study can serve as a baseline for comparison after strategies are implemented. The most common situation associated with minimal clinical utility was the use of test types not generally recommended by guidelines or UUHC Thrombosis Service physicians for thrombophilia testing (eg, β₂-glycoprotein 1 IgA antibodies, phosphatidyl antibodies). We intend to require a hematology or thrombosis specialty consult prior to ordering these tests. This intervention alone could potentially decrease unnecessary testing by a third. Another consideration is to require a specialty consult prior to any inpatient thrombophilia testing. This strategy has been found to decrease inappropriate testing at other institutions.²¹ We also intend to streamline available thrombophilia testing panels because a poorly designed panel could lead to ordering of multiple tests associated with minimal clinical utility. At least 12 different thrombophilia panels are currently available in our computerized physician order entry system (see Supplementary Table 5). We hypothesize that current panel designs contribute to providers inadvertently ordering unintended or duplicate tests and that reducing the number of available panels and clearly delineating what tests are contained in each panel is likely to reduce unnecessary testing. Other strategies being considered include using electronic clinical decision support tools, implementing strict ordering criteria for all inpatient testing, and establishing a thrombosis stewardship program.

Our study was unique in at least 2 ways. First, previous studies describing thrombophilia testing have described testing patterns for patients with specific indications (eg, VTE), whereas our study described all thrombophilia tests regardless of indication. This allows for testing pattern comparisons across indications and medical services, increasing the generalizability of our results. Second, this study quantifies tests occurring in situations associated with a practical definition of minimal clinical utility.

Our study has several limitations: (1) Many variables were reliant on provider notes and other documentation, which allows for potential misclassification of variables. (2) It was not always possible to determine the ultimate utility of each test in clinical management decisions, and our study did not investigate the impact of thrombophilia testing on duration of anticoagulant therapy. Additionally, select situations could benefit from testing regardless if anticoagulant therapy is altered (eg, informing contraceptive choices). (3) Testing performed following a provoked acute thrombosis was defined as testing within 3 months following administratively defined major surgery. This definition could have included some minor procedures that do not substantially increase VTE risk, resulting in underestimated clinical utility. (4) The UUHC University Hospital serves as a referral hospital for a large geographical area, and investigators did not have access to outpatient records for a large proportion of discharged patients. As a result, frequency of repeat testing could not be assessed, possibly resulting in overestimated clinical utility. (5) In categorizing indications for testing, testing for CVST was subcategorized under testing for ischemic stroke based on presenting symptoms rather than on underlying pathophysiology. The rationale for this categorization is that patients with CVST were often tested based on presenting symptoms. Additionally, tests for CVST were ordered by the neurology service, which also ordered tests for all other ischemic stroke indications. (6) The purpose of our study was to investigate the subset of the hospital’s patient population that received thrombophilia testing, and patients were identified by tests received and not by diagnosis codes. As a result, we are unable to provide the proportion of total patients treated at the hospital for specific conditions who were tested (eg, the proportion of stroke patients that received thrombophilia testing). (7) Current practice guidelines do not recommend testing for phosphatidyl antibodies, even when traditional antiphospholipid testing is negative.^25-27 Although expert panels continue to explore associations between phosphatidyl antibodies and pregnancy morbidity and thrombotic events, the low level of evidence is insufficient to guide clinical management.²⁸ Therefore, we categorized all phosphatidyl testing as associated with minimal clinical utility.

In a large academic medical center, the majority of tests occurred in situations associated with minimal clinical utility. Strategies to improve thrombophilia testing practices are needed in order to minimize potentially inappropriate testing, provide more cost-effective care, and promote value-driven outcomes.

Disclosure

S.W. received financial support for this submitted work via a Bristol-Myers-Squibb grant. G.F. received financial support from Portola Pharmaceuticals for consulting and lectures that were not related to this submitted work.

Discussions about cardiopulmonary resuscitation (CPR) can be difficult due to their association with end of life. The Patient Self Determination Act (H.R.4449 — 101st Congress [1989-1990]) and institutional standards mandate collaboration between care providers and patients regarding goals of care in emergency situations such as cardiopulmonary arrest. The default option is to provide CPR, which may involve chest compressions, intubation, and/or defibrillation. Yet numerous studies show that a significant number of patients have no code preference documented in their medical chart, and even fewer report a conversation with their care provider about their wishes regarding CPR.^1-3 CPR is an invasive and potentially painful procedure with a higher chance of failure than success⁴, and yet many patients report that their provider did not discuss with them the risks and benefits of resuscitation.^5,6 Further highlighting the importance of individual discussions about CPR preferences is the reality that factors such as age and disease burden further skew the likelihood of survival after cardiopulmonary arrest.⁷

Complicating the lack of appropriate provider and patient discussion of the risks and benefits of resuscitation are significant misunderstandings about CPR in the lay population. Patients routinely overestimate the likelihood of survival following CPR.^8,9 This may be partially due to the portrayal of CPR in the lay media as highly efficacious.¹⁰ Other factors known to prevent effective provider-and-patient discussions about CPR preferences are providers’ discomfort with the subject¹¹ and perceived time constraints.¹²

Informational videos have been developed to assist patients with decision making about CPR and have been shown to impact patients’ choices in the setting of life-limiting diseases such as advanced cancer,^13-14 serious illness with a prognosis of less than 1 year,¹⁵ and dementia.¹⁶ While discussion of code status is vitally important in end-of-life planning for seriously ill individuals, delayed discussion of CPR preferences is associated with a significant increase in the number of invasive procedures performed at the end of life, increased length of stay in the hospital, and increased medical cost.¹⁷ Despite clear evidence that earlier discussion of resuscitation options are valuable, no studies have examined the impact of a video about code status options in the general patient population.

Here we present our findings of a randomized trial in patients hospitalized on the general medicine wards who were 65 years of age or older, regardless of illness severity or diagnosis. The video tool was a supplement for, rather than a replacement of, standard provider and patient communication about code preferences, and we compared patients who watched the video against controls who had standard discussions with their providers. Our video detailed the process of chest compressions and intubation during CPR and explained the differences between the code statuses: full code, do not resuscitate (DNR), and do not resuscitate/do not intubate (DNR/DNI). We found a significant difference between the 2 groups, with significantly more individuals in the video group choosing DNR/DNI. These findings suggest that video support tools may be a useful supplement to traditional provider discussions about code preferences in the general patient population.

We enrolled patients from the general medicine wards at the Minneapolis VA Hospital from September 28, 2015 to October 23, 2015. Eligibility criteria included age 65 years or older, ability to provide informed consent, and ability to communicate in English. Study recruitment and data collection were performed by a study coordinator who was a house staff physician and had no role in the care of the participants. The medical charts of all general medicine patients were reviewed to determine if they met the age criteria. The physician of record for potential participants was contacted to assess if the patient was able to provide informed consent and communicate in English. Eligible patients were approached and informed consent was obtained from those who chose to participate in the study. After obtaining informed consent, patients were randomized using a random number generator to the intervention or usual-care arm of the study.

Those who were assigned to the intervention arm watched a 6-minute long video explaining the code-preference choices of full code, DNR, or DNR/DNI. Full code was described as possibly including CPR, intubation, and/or defibrillation depending on the clinical situation. Do not resuscitate was described as meaning no CPR or defibrillation but possible intubation in the case of respiratory failure. Do not resuscitate/do not intubate was explained as meaning no CPR, no defibrillation, and no intubation but rather permitting “natural death” to occur. The video showed a mock code with chest compressions, defibrillation, and intubation on a mannequin as well as palliative care specialists who discussed potential complications and survival rates of inhospital resuscitation.

The video was created at the University of Minnesota with the departments of palliative care and internal medicine (www.mmcgmeservices.org/codestat.html). After viewing the video, participants in the intervention arm filled out a questionnaire designed to assess their knowledge and beliefs about CPR and trust in their medical care providers. They were asked to circle their code preference. The participants’ medical teams were made aware of the code preferences and were counseled to discuss code preferences further if it was different from their previously documented code preference.

Participants in the control arm were assigned to usual care. At the institution where this study occurred, a discussion about code preferences between the patient and their medical team is considered the standard of care. After informed consent was obtained, participants filled out the same questionnaire as the participants in the intervention arm. They were asked to circle their code status preference. If they chose to ask questions about resuscitation, these were answered, but the study coordinator did not volunteer information about resuscitation or intervene in the medical care of the participants in any way.

Study Participants

A total of 273 potentially eligible patients were approached to participate and 119 (44%) enrolled. (Figure 1). Of the 154 patients that were deemed eligible after initial screening, 42 patients were unable to give consent due to the severity of their illness or because of their mental status. Another 112 patients declined participation in the study, citing reasons such as disinterest in the consent paperwork, desire to spend time with visitors, and unease with the subject matter. Patients who declined participation did not differ significantly by age, sex, or race from those enrolled in the study.

Among the 119 participants, 60 were randomized to the control arm, and 59 were randomized to the intervention arm. Participants in the 2 arms did not differ significantly in age, sex, or race (P > 0.05), although all 4 women in the study were randomized to the intervention arm. Eighty-seven percent of the study population identified as white with the remainder including black, Asian, Pacific Islander, Native American, or declining to answer. The mean age was 75.8 years in the control arm vs. 75.2 years in the intervention arm.

Primary diagnoses in the study group ranged widely from relatively minor skin infections to acute pancreatitis. The control arm and the intervention arm did not differ significantly in the incidence of heart failure, pulmonary disease, renal dialysis, cirrhosis, stroke, or active cancer (P > 0.05). Patients were considered as having a stroke if they had suffered a stroke during their hospital admission or if they had long-term sequelae of prior stroke. Patients were considered as having active cancer if they were currently undergoing treatment or had metastases. Participants were considered as having multiple morbidities if they possessed 2 or more of the listed conditions. Between the control arm and the intervention arm, there was no significant difference in the number of participants with multiple morbidities (27% in the control group and 24% in the video group).

Code Status Preference

There was a significant difference in the code status preferences of the intervention arm and the control arm (P < 0.00001; Figure 2). In the control arm, 71% of participants chose full code, 12% chose DNR, and 17% chose DNR/DNI. In the intervention arm, only 37% chose full code, 7% chose DNR, and 56% chose DNR/DNI.

Secondary outcomes

Participants in the control and intervention arms were asked about their trust in their medical team (Question 1, Figure 3). There was no significant difference, but a trend towards less trust in the intervention group (P = 0.083) was seen with 93% of the control arm and 76% of the intervention arm agreeing with the statement “My doctors and healthcare team want what is best for me.”

Question 2, “If I choose to avoid resuscitation efforts, I will not receive care,” was designed to assess participants’ knowledge and perception about the care they would receive if they chose DNR/DNI as their code status. No significant difference was seen between the control and the interventions arms, with 28% of the control group agreeing with the statement, compared to 22% of the video group.

For question 3, participants were asked to respond to the statement “I would like to live as long as possible, even if I never leave the hospital.” No significant differences were seen between the control and the intervention arms, with 22% of both groups agreeing with the statement.

When we examined participant responses by the code status chosen, a significantly higher percentage of participants who chose full code agreed with the statement in question 3 (P = 0.0133). Of participants who chose full code, 27% agreed with the statement, compared to 18% of participants who chose DNR and 12% of participants who chose DNR/DNI. There was no significant difference (P > 0.05) between participant code status choice and either Question 1 or 2.

This study examined the effect of watching a video about CPR and intubation on the code status preferences of hospitalized patients. Participants who viewed a video about CPR and intubation were more likely to choose to forgo these treatments. Participants who chose CPR and intubation were more likely to agree that they would want to live as long as possible even if that time were spent in a medical setting.

To our knowledge, this is the first study to examine the role of a video decision support tool about code choices in the general hospital population, regardless of prognosis. Previous work has trialed the use of video support tools in hospitalized patients with a prognosis of less than 1 year,¹⁵ patients admitted to the ICU,¹⁸ and outpatients with cancer¹⁸ and those with dementia.¹⁶ Unlike previous studies, our study included a variety of illness severity.

Discussions about resuscitation are important for all adults admitted to the hospital because of the unpredictable nature of illness and the importance of providing high-quality care at the end of life.  A recent study indicates that in-hospital cardiopulmonary arrest occurs in almost 1 per 1000 hospital days.¹⁹ These discussions are particularly salient for patients 65 years and older because of the higher incidence of death in this group. Inpatient admission is often a result of a change in health status, making it an important time for patients to reassess their resuscitation preferences based on their physical state and known comorbidities.

Video tools supplement the traditional code status discussion in several key ways. They provide a visual simulation of the procedures that occur during a typical resuscitation. These tools can help patients understand what CPR and intubation entail and transmit information that might be missed in verbal discussions. Visual media is now a common way for patients to obtain medical information^20-22 and may be particularly helpful to patients who have low health literacy.²³Video tools also help ensure that patients receive all the facts about resuscitation irrespective of how busy their provider may be or how comfortable the provider is with the topic. Lastly, video tools can reinforce information that is shared in the initial code status discussion. Given the significant differences in code status preference between our control and video arms, it is clear that the video tool has a significant impact on patient choices.

While we feel that our study clearly indicates the utility of video tools in code status discussion in hospitalized patients, there are some limitations. The current study enrolled participants who were predominantly white and male. All participants were recruited from the Minneapolis Veterans Affairs Health Care System, Minnesota. The relatively homogenous study population may impact the study’s generalizability. Another potential limitation of our study was the large number of eligible participants who declined to participate (41%), with many citing that they did not want to sign the consent paperwork. Additionally, the study coordinator was not blinded to the randomization of the participants, which could result in ascertainment bias. Also of concern was a trend, albeit nonsignificant, towards less trust in the healthcare team in the video group. Because the study was not designed to assess trust in the healthcare team both before and after the intervention, it is unclear if this difference was a result of the video.

Another area of potential concern is that visual images can be edited to sway viewers’ opinions based on the way content is presented. In our video, we included input from palliative care and internal medicine specialists. Cardiopulmonary resuscitation and intubation were performed on a CPR mannequin. The risks and benefits of CPR and intubation were discussed, as were the implications of choosing DNR or DNR/DNI code statuses.

The questionnaire that we used to assess participants’ knowledge and beliefs about resuscitation showed no differences between the control and the intervention arms of the study. We were surprised that a significant number of participants in the intervention group agreed with the statement, “If I choose to avoid resuscitation efforts, I will not receive care.” Our video specifically addressed the common belief that choosing DNR/DNI or DNR code statuses means that a patient will not continue to receive medical care. It is possible that participants were confused by the way the question was worded or that they understood the question to apply only to care received after a cardiopulmonary arrest had occurred.

This study and several others^14-16 show that the use of video tools impacts participants’ code status preferences. There is clinical and humanistic importance in helping patients make informed decisions regarding whether or not they would want CPR and/or intubation if their heart were to stop or if they were to stop breathing. The data suggest that video tools are an efficient way to improve patient care and should be made widely available.

Disclosures: The authors report no conflicts of interest.

Discussions about cardiopulmonary resuscitation (CPR) can be difficult due to their association with end of life. The Patient Self Determination Act (H.R.4449 — 101st Congress [1989-1990]) and institutional standards mandate collaboration between care providers and patients regarding goals of care in emergency situations such as cardiopulmonary arrest. The default option is to provide CPR, which may involve chest compressions, intubation, and/or defibrillation. Yet numerous studies show that a significant number of patients have no code preference documented in their medical chart, and even fewer report a conversation with their care provider about their wishes regarding CPR.^1-3 CPR is an invasive and potentially painful procedure with a higher chance of failure than success⁴, and yet many patients report that their provider did not discuss with them the risks and benefits of resuscitation.^5,6 Further highlighting the importance of individual discussions about CPR preferences is the reality that factors such as age and disease burden further skew the likelihood of survival after cardiopulmonary arrest.⁷

Complicating the lack of appropriate provider and patient discussion of the risks and benefits of resuscitation are significant misunderstandings about CPR in the lay population. Patients routinely overestimate the likelihood of survival following CPR.^8,9 This may be partially due to the portrayal of CPR in the lay media as highly efficacious.¹⁰ Other factors known to prevent effective provider-and-patient discussions about CPR preferences are providers’ discomfort with the subject¹¹ and perceived time constraints.¹²

Informational videos have been developed to assist patients with decision making about CPR and have been shown to impact patients’ choices in the setting of life-limiting diseases such as advanced cancer,^13-14 serious illness with a prognosis of less than 1 year,¹⁵ and dementia.¹⁶ While discussion of code status is vitally important in end-of-life planning for seriously ill individuals, delayed discussion of CPR preferences is associated with a significant increase in the number of invasive procedures performed at the end of life, increased length of stay in the hospital, and increased medical cost.¹⁷ Despite clear evidence that earlier discussion of resuscitation options are valuable, no studies have examined the impact of a video about code status options in the general patient population.

Here we present our findings of a randomized trial in patients hospitalized on the general medicine wards who were 65 years of age or older, regardless of illness severity or diagnosis. The video tool was a supplement for, rather than a replacement of, standard provider and patient communication about code preferences, and we compared patients who watched the video against controls who had standard discussions with their providers. Our video detailed the process of chest compressions and intubation during CPR and explained the differences between the code statuses: full code, do not resuscitate (DNR), and do not resuscitate/do not intubate (DNR/DNI). We found a significant difference between the 2 groups, with significantly more individuals in the video group choosing DNR/DNI. These findings suggest that video support tools may be a useful supplement to traditional provider discussions about code preferences in the general patient population.

We enrolled patients from the general medicine wards at the Minneapolis VA Hospital from September 28, 2015 to October 23, 2015. Eligibility criteria included age 65 years or older, ability to provide informed consent, and ability to communicate in English. Study recruitment and data collection were performed by a study coordinator who was a house staff physician and had no role in the care of the participants. The medical charts of all general medicine patients were reviewed to determine if they met the age criteria. The physician of record for potential participants was contacted to assess if the patient was able to provide informed consent and communicate in English. Eligible patients were approached and informed consent was obtained from those who chose to participate in the study. After obtaining informed consent, patients were randomized using a random number generator to the intervention or usual-care arm of the study.

Those who were assigned to the intervention arm watched a 6-minute long video explaining the code-preference choices of full code, DNR, or DNR/DNI. Full code was described as possibly including CPR, intubation, and/or defibrillation depending on the clinical situation. Do not resuscitate was described as meaning no CPR or defibrillation but possible intubation in the case of respiratory failure. Do not resuscitate/do not intubate was explained as meaning no CPR, no defibrillation, and no intubation but rather permitting “natural death” to occur. The video showed a mock code with chest compressions, defibrillation, and intubation on a mannequin as well as palliative care specialists who discussed potential complications and survival rates of inhospital resuscitation.

The video was created at the University of Minnesota with the departments of palliative care and internal medicine (www.mmcgmeservices.org/codestat.html). After viewing the video, participants in the intervention arm filled out a questionnaire designed to assess their knowledge and beliefs about CPR and trust in their medical care providers. They were asked to circle their code preference. The participants’ medical teams were made aware of the code preferences and were counseled to discuss code preferences further if it was different from their previously documented code preference.

Participants in the control arm were assigned to usual care. At the institution where this study occurred, a discussion about code preferences between the patient and their medical team is considered the standard of care. After informed consent was obtained, participants filled out the same questionnaire as the participants in the intervention arm. They were asked to circle their code status preference. If they chose to ask questions about resuscitation, these were answered, but the study coordinator did not volunteer information about resuscitation or intervene in the medical care of the participants in any way.

Study Participants

A total of 273 potentially eligible patients were approached to participate and 119 (44%) enrolled. (Figure 1). Of the 154 patients that were deemed eligible after initial screening, 42 patients were unable to give consent due to the severity of their illness or because of their mental status. Another 112 patients declined participation in the study, citing reasons such as disinterest in the consent paperwork, desire to spend time with visitors, and unease with the subject matter. Patients who declined participation did not differ significantly by age, sex, or race from those enrolled in the study.

Among the 119 participants, 60 were randomized to the control arm, and 59 were randomized to the intervention arm. Participants in the 2 arms did not differ significantly in age, sex, or race (P > 0.05), although all 4 women in the study were randomized to the intervention arm. Eighty-seven percent of the study population identified as white with the remainder including black, Asian, Pacific Islander, Native American, or declining to answer. The mean age was 75.8 years in the control arm vs. 75.2 years in the intervention arm.

Primary diagnoses in the study group ranged widely from relatively minor skin infections to acute pancreatitis. The control arm and the intervention arm did not differ significantly in the incidence of heart failure, pulmonary disease, renal dialysis, cirrhosis, stroke, or active cancer (P > 0.05). Patients were considered as having a stroke if they had suffered a stroke during their hospital admission or if they had long-term sequelae of prior stroke. Patients were considered as having active cancer if they were currently undergoing treatment or had metastases. Participants were considered as having multiple morbidities if they possessed 2 or more of the listed conditions. Between the control arm and the intervention arm, there was no significant difference in the number of participants with multiple morbidities (27% in the control group and 24% in the video group).

Code Status Preference

There was a significant difference in the code status preferences of the intervention arm and the control arm (P < 0.00001; Figure 2). In the control arm, 71% of participants chose full code, 12% chose DNR, and 17% chose DNR/DNI. In the intervention arm, only 37% chose full code, 7% chose DNR, and 56% chose DNR/DNI.

Secondary outcomes

Participants in the control and intervention arms were asked about their trust in their medical team (Question 1, Figure 3). There was no significant difference, but a trend towards less trust in the intervention group (P = 0.083) was seen with 93% of the control arm and 76% of the intervention arm agreeing with the statement “My doctors and healthcare team want what is best for me.”

Question 2, “If I choose to avoid resuscitation efforts, I will not receive care,” was designed to assess participants’ knowledge and perception about the care they would receive if they chose DNR/DNI as their code status. No significant difference was seen between the control and the interventions arms, with 28% of the control group agreeing with the statement, compared to 22% of the video group.

For question 3, participants were asked to respond to the statement “I would like to live as long as possible, even if I never leave the hospital.” No significant differences were seen between the control and the intervention arms, with 22% of both groups agreeing with the statement.

When we examined participant responses by the code status chosen, a significantly higher percentage of participants who chose full code agreed with the statement in question 3 (P = 0.0133). Of participants who chose full code, 27% agreed with the statement, compared to 18% of participants who chose DNR and 12% of participants who chose DNR/DNI. There was no significant difference (P > 0.05) between participant code status choice and either Question 1 or 2.

This study examined the effect of watching a video about CPR and intubation on the code status preferences of hospitalized patients. Participants who viewed a video about CPR and intubation were more likely to choose to forgo these treatments. Participants who chose CPR and intubation were more likely to agree that they would want to live as long as possible even if that time were spent in a medical setting.

To our knowledge, this is the first study to examine the role of a video decision support tool about code choices in the general hospital population, regardless of prognosis. Previous work has trialed the use of video support tools in hospitalized patients with a prognosis of less than 1 year,¹⁵ patients admitted to the ICU,¹⁸ and outpatients with cancer¹⁸ and those with dementia.¹⁶ Unlike previous studies, our study included a variety of illness severity.

Discussions about resuscitation are important for all adults admitted to the hospital because of the unpredictable nature of illness and the importance of providing high-quality care at the end of life.  A recent study indicates that in-hospital cardiopulmonary arrest occurs in almost 1 per 1000 hospital days.¹⁹ These discussions are particularly salient for patients 65 years and older because of the higher incidence of death in this group. Inpatient admission is often a result of a change in health status, making it an important time for patients to reassess their resuscitation preferences based on their physical state and known comorbidities.

Video tools supplement the traditional code status discussion in several key ways. They provide a visual simulation of the procedures that occur during a typical resuscitation. These tools can help patients understand what CPR and intubation entail and transmit information that might be missed in verbal discussions. Visual media is now a common way for patients to obtain medical information^20-22 and may be particularly helpful to patients who have low health literacy.²³Video tools also help ensure that patients receive all the facts about resuscitation irrespective of how busy their provider may be or how comfortable the provider is with the topic. Lastly, video tools can reinforce information that is shared in the initial code status discussion. Given the significant differences in code status preference between our control and video arms, it is clear that the video tool has a significant impact on patient choices.

While we feel that our study clearly indicates the utility of video tools in code status discussion in hospitalized patients, there are some limitations. The current study enrolled participants who were predominantly white and male. All participants were recruited from the Minneapolis Veterans Affairs Health Care System, Minnesota. The relatively homogenous study population may impact the study’s generalizability. Another potential limitation of our study was the large number of eligible participants who declined to participate (41%), with many citing that they did not want to sign the consent paperwork. Additionally, the study coordinator was not blinded to the randomization of the participants, which could result in ascertainment bias. Also of concern was a trend, albeit nonsignificant, towards less trust in the healthcare team in the video group. Because the study was not designed to assess trust in the healthcare team both before and after the intervention, it is unclear if this difference was a result of the video.

Another area of potential concern is that visual images can be edited to sway viewers’ opinions based on the way content is presented. In our video, we included input from palliative care and internal medicine specialists. Cardiopulmonary resuscitation and intubation were performed on a CPR mannequin. The risks and benefits of CPR and intubation were discussed, as were the implications of choosing DNR or DNR/DNI code statuses.

The questionnaire that we used to assess participants’ knowledge and beliefs about resuscitation showed no differences between the control and the intervention arms of the study. We were surprised that a significant number of participants in the intervention group agreed with the statement, “If I choose to avoid resuscitation efforts, I will not receive care.” Our video specifically addressed the common belief that choosing DNR/DNI or DNR code statuses means that a patient will not continue to receive medical care. It is possible that participants were confused by the way the question was worded or that they understood the question to apply only to care received after a cardiopulmonary arrest had occurred.

This study and several others^14-16 show that the use of video tools impacts participants’ code status preferences. There is clinical and humanistic importance in helping patients make informed decisions regarding whether or not they would want CPR and/or intubation if their heart were to stop or if they were to stop breathing. The data suggest that video tools are an efficient way to improve patient care and should be made widely available.

Disclosures: The authors report no conflicts of interest.

Discussions about cardiopulmonary resuscitation (CPR) can be difficult due to their association with end of life. The Patient Self Determination Act (H.R.4449 — 101st Congress [1989-1990]) and institutional standards mandate collaboration between care providers and patients regarding goals of care in emergency situations such as cardiopulmonary arrest. The default option is to provide CPR, which may involve chest compressions, intubation, and/or defibrillation. Yet numerous studies show that a significant number of patients have no code preference documented in their medical chart, and even fewer report a conversation with their care provider about their wishes regarding CPR.^1-3 CPR is an invasive and potentially painful procedure with a higher chance of failure than success⁴, and yet many patients report that their provider did not discuss with them the risks and benefits of resuscitation.^5,6 Further highlighting the importance of individual discussions about CPR preferences is the reality that factors such as age and disease burden further skew the likelihood of survival after cardiopulmonary arrest.⁷

Complicating the lack of appropriate provider and patient discussion of the risks and benefits of resuscitation are significant misunderstandings about CPR in the lay population. Patients routinely overestimate the likelihood of survival following CPR.^8,9 This may be partially due to the portrayal of CPR in the lay media as highly efficacious.¹⁰ Other factors known to prevent effective provider-and-patient discussions about CPR preferences are providers’ discomfort with the subject¹¹ and perceived time constraints.¹²

Informational videos have been developed to assist patients with decision making about CPR and have been shown to impact patients’ choices in the setting of life-limiting diseases such as advanced cancer,^13-14 serious illness with a prognosis of less than 1 year,¹⁵ and dementia.¹⁶ While discussion of code status is vitally important in end-of-life planning for seriously ill individuals, delayed discussion of CPR preferences is associated with a significant increase in the number of invasive procedures performed at the end of life, increased length of stay in the hospital, and increased medical cost.¹⁷ Despite clear evidence that earlier discussion of resuscitation options are valuable, no studies have examined the impact of a video about code status options in the general patient population.

Here we present our findings of a randomized trial in patients hospitalized on the general medicine wards who were 65 years of age or older, regardless of illness severity or diagnosis. The video tool was a supplement for, rather than a replacement of, standard provider and patient communication about code preferences, and we compared patients who watched the video against controls who had standard discussions with their providers. Our video detailed the process of chest compressions and intubation during CPR and explained the differences between the code statuses: full code, do not resuscitate (DNR), and do not resuscitate/do not intubate (DNR/DNI). We found a significant difference between the 2 groups, with significantly more individuals in the video group choosing DNR/DNI. These findings suggest that video support tools may be a useful supplement to traditional provider discussions about code preferences in the general patient population.

We enrolled patients from the general medicine wards at the Minneapolis VA Hospital from September 28, 2015 to October 23, 2015. Eligibility criteria included age 65 years or older, ability to provide informed consent, and ability to communicate in English. Study recruitment and data collection were performed by a study coordinator who was a house staff physician and had no role in the care of the participants. The medical charts of all general medicine patients were reviewed to determine if they met the age criteria. The physician of record for potential participants was contacted to assess if the patient was able to provide informed consent and communicate in English. Eligible patients were approached and informed consent was obtained from those who chose to participate in the study. After obtaining informed consent, patients were randomized using a random number generator to the intervention or usual-care arm of the study.

Those who were assigned to the intervention arm watched a 6-minute long video explaining the code-preference choices of full code, DNR, or DNR/DNI. Full code was described as possibly including CPR, intubation, and/or defibrillation depending on the clinical situation. Do not resuscitate was described as meaning no CPR or defibrillation but possible intubation in the case of respiratory failure. Do not resuscitate/do not intubate was explained as meaning no CPR, no defibrillation, and no intubation but rather permitting “natural death” to occur. The video showed a mock code with chest compressions, defibrillation, and intubation on a mannequin as well as palliative care specialists who discussed potential complications and survival rates of inhospital resuscitation.

The video was created at the University of Minnesota with the departments of palliative care and internal medicine (www.mmcgmeservices.org/codestat.html). After viewing the video, participants in the intervention arm filled out a questionnaire designed to assess their knowledge and beliefs about CPR and trust in their medical care providers. They were asked to circle their code preference. The participants’ medical teams were made aware of the code preferences and were counseled to discuss code preferences further if it was different from their previously documented code preference.

Participants in the control arm were assigned to usual care. At the institution where this study occurred, a discussion about code preferences between the patient and their medical team is considered the standard of care. After informed consent was obtained, participants filled out the same questionnaire as the participants in the intervention arm. They were asked to circle their code status preference. If they chose to ask questions about resuscitation, these were answered, but the study coordinator did not volunteer information about resuscitation or intervene in the medical care of the participants in any way.

Study Participants

A total of 273 potentially eligible patients were approached to participate and 119 (44%) enrolled. (Figure 1). Of the 154 patients that were deemed eligible after initial screening, 42 patients were unable to give consent due to the severity of their illness or because of their mental status. Another 112 patients declined participation in the study, citing reasons such as disinterest in the consent paperwork, desire to spend time with visitors, and unease with the subject matter. Patients who declined participation did not differ significantly by age, sex, or race from those enrolled in the study.

Among the 119 participants, 60 were randomized to the control arm, and 59 were randomized to the intervention arm. Participants in the 2 arms did not differ significantly in age, sex, or race (P > 0.05), although all 4 women in the study were randomized to the intervention arm. Eighty-seven percent of the study population identified as white with the remainder including black, Asian, Pacific Islander, Native American, or declining to answer. The mean age was 75.8 years in the control arm vs. 75.2 years in the intervention arm.

Primary diagnoses in the study group ranged widely from relatively minor skin infections to acute pancreatitis. The control arm and the intervention arm did not differ significantly in the incidence of heart failure, pulmonary disease, renal dialysis, cirrhosis, stroke, or active cancer (P > 0.05). Patients were considered as having a stroke if they had suffered a stroke during their hospital admission or if they had long-term sequelae of prior stroke. Patients were considered as having active cancer if they were currently undergoing treatment or had metastases. Participants were considered as having multiple morbidities if they possessed 2 or more of the listed conditions. Between the control arm and the intervention arm, there was no significant difference in the number of participants with multiple morbidities (27% in the control group and 24% in the video group).

Code Status Preference

There was a significant difference in the code status preferences of the intervention arm and the control arm (P < 0.00001; Figure 2). In the control arm, 71% of participants chose full code, 12% chose DNR, and 17% chose DNR/DNI. In the intervention arm, only 37% chose full code, 7% chose DNR, and 56% chose DNR/DNI.

Secondary outcomes

Participants in the control and intervention arms were asked about their trust in their medical team (Question 1, Figure 3). There was no significant difference, but a trend towards less trust in the intervention group (P = 0.083) was seen with 93% of the control arm and 76% of the intervention arm agreeing with the statement “My doctors and healthcare team want what is best for me.”

Question 2, “If I choose to avoid resuscitation efforts, I will not receive care,” was designed to assess participants’ knowledge and perception about the care they would receive if they chose DNR/DNI as their code status. No significant difference was seen between the control and the interventions arms, with 28% of the control group agreeing with the statement, compared to 22% of the video group.

For question 3, participants were asked to respond to the statement “I would like to live as long as possible, even if I never leave the hospital.” No significant differences were seen between the control and the intervention arms, with 22% of both groups agreeing with the statement.

When we examined participant responses by the code status chosen, a significantly higher percentage of participants who chose full code agreed with the statement in question 3 (P = 0.0133). Of participants who chose full code, 27% agreed with the statement, compared to 18% of participants who chose DNR and 12% of participants who chose DNR/DNI. There was no significant difference (P > 0.05) between participant code status choice and either Question 1 or 2.

This study examined the effect of watching a video about CPR and intubation on the code status preferences of hospitalized patients. Participants who viewed a video about CPR and intubation were more likely to choose to forgo these treatments. Participants who chose CPR and intubation were more likely to agree that they would want to live as long as possible even if that time were spent in a medical setting.

To our knowledge, this is the first study to examine the role of a video decision support tool about code choices in the general hospital population, regardless of prognosis. Previous work has trialed the use of video support tools in hospitalized patients with a prognosis of less than 1 year,¹⁵ patients admitted to the ICU,¹⁸ and outpatients with cancer¹⁸ and those with dementia.¹⁶ Unlike previous studies, our study included a variety of illness severity.

Discussions about resuscitation are important for all adults admitted to the hospital because of the unpredictable nature of illness and the importance of providing high-quality care at the end of life.  A recent study indicates that in-hospital cardiopulmonary arrest occurs in almost 1 per 1000 hospital days.¹⁹ These discussions are particularly salient for patients 65 years and older because of the higher incidence of death in this group. Inpatient admission is often a result of a change in health status, making it an important time for patients to reassess their resuscitation preferences based on their physical state and known comorbidities.

Video tools supplement the traditional code status discussion in several key ways. They provide a visual simulation of the procedures that occur during a typical resuscitation. These tools can help patients understand what CPR and intubation entail and transmit information that might be missed in verbal discussions. Visual media is now a common way for patients to obtain medical information^20-22 and may be particularly helpful to patients who have low health literacy.²³Video tools also help ensure that patients receive all the facts about resuscitation irrespective of how busy their provider may be or how comfortable the provider is with the topic. Lastly, video tools can reinforce information that is shared in the initial code status discussion. Given the significant differences in code status preference between our control and video arms, it is clear that the video tool has a significant impact on patient choices.

While we feel that our study clearly indicates the utility of video tools in code status discussion in hospitalized patients, there are some limitations. The current study enrolled participants who were predominantly white and male. All participants were recruited from the Minneapolis Veterans Affairs Health Care System, Minnesota. The relatively homogenous study population may impact the study’s generalizability. Another potential limitation of our study was the large number of eligible participants who declined to participate (41%), with many citing that they did not want to sign the consent paperwork. Additionally, the study coordinator was not blinded to the randomization of the participants, which could result in ascertainment bias. Also of concern was a trend, albeit nonsignificant, towards less trust in the healthcare team in the video group. Because the study was not designed to assess trust in the healthcare team both before and after the intervention, it is unclear if this difference was a result of the video.

Another area of potential concern is that visual images can be edited to sway viewers’ opinions based on the way content is presented. In our video, we included input from palliative care and internal medicine specialists. Cardiopulmonary resuscitation and intubation were performed on a CPR mannequin. The risks and benefits of CPR and intubation were discussed, as were the implications of choosing DNR or DNR/DNI code statuses.

The questionnaire that we used to assess participants’ knowledge and beliefs about resuscitation showed no differences between the control and the intervention arms of the study. We were surprised that a significant number of participants in the intervention group agreed with the statement, “If I choose to avoid resuscitation efforts, I will not receive care.” Our video specifically addressed the common belief that choosing DNR/DNI or DNR code statuses means that a patient will not continue to receive medical care. It is possible that participants were confused by the way the question was worded or that they understood the question to apply only to care received after a cardiopulmonary arrest had occurred.

This study and several others^14-16 show that the use of video tools impacts participants’ code status preferences. There is clinical and humanistic importance in helping patients make informed decisions regarding whether or not they would want CPR and/or intubation if their heart were to stop or if they were to stop breathing. The data suggest that video tools are an efficient way to improve patient care and should be made widely available.

Disclosures: The authors report no conflicts of interest.

BACKGROUND: There is increasing recognition that patients have critical insights into care experiences, including about breakdowns in care. Harnessing patient perspectives for hospital improvement requires an in-depth understanding of the types of breakdowns patients identify and the impact of these events.

Also in JHM

Excess readmission vs. excess penalties: Maximum readmission penalties as a function of socioeconomics and geography

AUTHORS: Chris M. Caracciolo, MPH, Devin M. Parker, MS, Emily Marshall, MS, Jeremiah R. Brown, PhD, MS

Impact of a safety huddle-based intervention on monitor alarm rates in low-acuity pediatric intensive care unit patientsAUTHORS: Maya Dewan, MD, MPH, Heather Wolfe, MD, MSHP, Richard Lin, MD, Eileen Ware, RN, Michelle Weiss, RN, Lihai Song, MS, Matthew MacMurchy, BA, Daniela Davis, MD, MSCE, Christopher P. Bonafide MD MSCE

Perspectives of clinicians at skilled nursing facilities on 30-day hospital readmissions: A qualitative studyAUTHORS: Bennett W. Clark, MD, Katelyn Baron, MSIOP, Kathleen Tynan-McKiernan, RN, MSN, Meredith Campbell Britton, LMSW, Karl E. Minges, PhD, Sarwat I. Chaudhry, MD

Use of postacute facility care in children hospitalized with acute respiratory illnessAUTHORS: Jay G. Berry, MD, MPH, Karen M. Wilson, MD, MPH, FAAP, Helene Dumas, PT, MS, Edwin Simpser, MD, Jane O’Brien, MD, Kathleen Whitford, PNP, Rachna May, MD, Vineeta Mittal, MD, Nancy Murphy, MD, David Steinhorn, MD, Rishi Agrawal, MD, MPH, Kris Rehm, MD, Michelle Marks, DO, FAAP, SFHM, Christine Traul, MD, Michael Dribbon, PhD, Christopher J. Haines, DO, MBA, FAAP, FACEP, Matt Hall, PhD

A contemporary assessment of mechanical complication rates and trainee perceptions of central venous catheter insertionAUTHORS: Lauren Heidemann, MD, Niket Nathani, MD, Rommel Sagana, MD, Vineet Chopra, MD, MSc, Michael Heung, MD, MS

For more articles and subscription information, visit www.journalofhospitalmedicine.com.

BACKGROUND: There is increasing recognition that patients have critical insights into care experiences, including about breakdowns in care. Harnessing patient perspectives for hospital improvement requires an in-depth understanding of the types of breakdowns patients identify and the impact of these events.

Also in JHM

Excess readmission vs. excess penalties: Maximum readmission penalties as a function of socioeconomics and geography

AUTHORS: Chris M. Caracciolo, MPH, Devin M. Parker, MS, Emily Marshall, MS, Jeremiah R. Brown, PhD, MS

Impact of a safety huddle-based intervention on monitor alarm rates in low-acuity pediatric intensive care unit patientsAUTHORS: Maya Dewan, MD, MPH, Heather Wolfe, MD, MSHP, Richard Lin, MD, Eileen Ware, RN, Michelle Weiss, RN, Lihai Song, MS, Matthew MacMurchy, BA, Daniela Davis, MD, MSCE, Christopher P. Bonafide MD MSCE

Perspectives of clinicians at skilled nursing facilities on 30-day hospital readmissions: A qualitative studyAUTHORS: Bennett W. Clark, MD, Katelyn Baron, MSIOP, Kathleen Tynan-McKiernan, RN, MSN, Meredith Campbell Britton, LMSW, Karl E. Minges, PhD, Sarwat I. Chaudhry, MD

Use of postacute facility care in children hospitalized with acute respiratory illnessAUTHORS: Jay G. Berry, MD, MPH, Karen M. Wilson, MD, MPH, FAAP, Helene Dumas, PT, MS, Edwin Simpser, MD, Jane O’Brien, MD, Kathleen Whitford, PNP, Rachna May, MD, Vineeta Mittal, MD, Nancy Murphy, MD, David Steinhorn, MD, Rishi Agrawal, MD, MPH, Kris Rehm, MD, Michelle Marks, DO, FAAP, SFHM, Christine Traul, MD, Michael Dribbon, PhD, Christopher J. Haines, DO, MBA, FAAP, FACEP, Matt Hall, PhD

A contemporary assessment of mechanical complication rates and trainee perceptions of central venous catheter insertionAUTHORS: Lauren Heidemann, MD, Niket Nathani, MD, Rommel Sagana, MD, Vineet Chopra, MD, MSc, Michael Heung, MD, MS

For more articles and subscription information, visit www.journalofhospitalmedicine.com.

BACKGROUND: There is increasing recognition that patients have critical insights into care experiences, including about breakdowns in care. Harnessing patient perspectives for hospital improvement requires an in-depth understanding of the types of breakdowns patients identify and the impact of these events.

Also in JHM

Excess readmission vs. excess penalties: Maximum readmission penalties as a function of socioeconomics and geography

AUTHORS: Chris M. Caracciolo, MPH, Devin M. Parker, MS, Emily Marshall, MS, Jeremiah R. Brown, PhD, MS

Impact of a safety huddle-based intervention on monitor alarm rates in low-acuity pediatric intensive care unit patientsAUTHORS: Maya Dewan, MD, MPH, Heather Wolfe, MD, MSHP, Richard Lin, MD, Eileen Ware, RN, Michelle Weiss, RN, Lihai Song, MS, Matthew MacMurchy, BA, Daniela Davis, MD, MSCE, Christopher P. Bonafide MD MSCE

Perspectives of clinicians at skilled nursing facilities on 30-day hospital readmissions: A qualitative studyAUTHORS: Bennett W. Clark, MD, Katelyn Baron, MSIOP, Kathleen Tynan-McKiernan, RN, MSN, Meredith Campbell Britton, LMSW, Karl E. Minges, PhD, Sarwat I. Chaudhry, MD

Use of postacute facility care in children hospitalized with acute respiratory illnessAUTHORS: Jay G. Berry, MD, MPH, Karen M. Wilson, MD, MPH, FAAP, Helene Dumas, PT, MS, Edwin Simpser, MD, Jane O’Brien, MD, Kathleen Whitford, PNP, Rachna May, MD, Vineeta Mittal, MD, Nancy Murphy, MD, David Steinhorn, MD, Rishi Agrawal, MD, MPH, Kris Rehm, MD, Michelle Marks, DO, FAAP, SFHM, Christine Traul, MD, Michael Dribbon, PhD, Christopher J. Haines, DO, MBA, FAAP, FACEP, Matt Hall, PhD

A contemporary assessment of mechanical complication rates and trainee perceptions of central venous catheter insertionAUTHORS: Lauren Heidemann, MD, Niket Nathani, MD, Rommel Sagana, MD, Vineet Chopra, MD, MSc, Michael Heung, MD, MS

For more articles and subscription information, visit www.journalofhospitalmedicine.com.

“A good understanding of the diverse veteran populations is imperative if the VA is to genuinely resolve the inequities for those at high risk and with the most need,” says the introduction to the first-ever National Veteran Health Equity Report. The report, which contains demographic information on veterans who received VHA care in Fiscal Year (FY) 2013, is designed to provide that comparative information on minorities, women, and other veteran groups. For example:

• Although women represented only about 7% of patients in FY2013, their numbers in VHA have more than doubled since 2000—140% growth, far outstripping the 63% growth among men over the same period;
• In FY2013, 46% of veterans were aged ≥ 65 years;
• More than one-third of veterans lived in rural areas;
• Almost one-half of VHA patients had a service-connected disability. All racial/ethnic minority patient groups, compared with whites, were more likely to have a service-connected disability;

• A higher proportion of women had a service-connected disability, and women are twice as likely to be diagnosed with depression;
• Overall, 33% of VHA patients had ≥ 1 mental health diagnoses. Women and blacks/African Americans were “over-represented” among patients diagnosed with serious mental illness;

• Veterans with serious mental illness also had higher diagnosis rates for musculoskeletal disorders (60% vs 43%) and gastrointestinal conditions (48% vs 30%). In fact, among the top 20 diagnosed conditions, rates for the SMI group exceeded that for the veterans with no mental health diagnosis for 17 conditions by a margin of > 10% for 7. The largest disparities were in tobacco use disorder, psychosocial factors, spine disorders, and housing insufficiency; and
• The only condition in which the diagnosed rate in a racial/ethnic group exceeded that for whites by a margin of 10% was PTSD, diagnosed in 21% of American Indian/Alaska Natives, versus 11% of whites.

Although the report targeted  6 million veterans accessing VA care in FY13, the estimated number of living veterans is about 22 million. It is a “starting place,” the developers promise. Next iterations will continue to evolve to meet the unique needs of diverse veterans.

“A good understanding of the diverse veteran populations is imperative if the VA is to genuinely resolve the inequities for those at high risk and with the most need,” says the introduction to the first-ever National Veteran Health Equity Report. The report, which contains demographic information on veterans who received VHA care in Fiscal Year (FY) 2013, is designed to provide that comparative information on minorities, women, and other veteran groups. For example:

• Although women represented only about 7% of patients in FY2013, their numbers in VHA have more than doubled since 2000—140% growth, far outstripping the 63% growth among men over the same period;
• In FY2013, 46% of veterans were aged ≥ 65 years;
• More than one-third of veterans lived in rural areas;
• Almost one-half of VHA patients had a service-connected disability. All racial/ethnic minority patient groups, compared with whites, were more likely to have a service-connected disability;

• A higher proportion of women had a service-connected disability, and women are twice as likely to be diagnosed with depression;
• Overall, 33% of VHA patients had ≥ 1 mental health diagnoses. Women and blacks/African Americans were “over-represented” among patients diagnosed with serious mental illness;

• Veterans with serious mental illness also had higher diagnosis rates for musculoskeletal disorders (60% vs 43%) and gastrointestinal conditions (48% vs 30%). In fact, among the top 20 diagnosed conditions, rates for the SMI group exceeded that for the veterans with no mental health diagnosis for 17 conditions by a margin of > 10% for 7. The largest disparities were in tobacco use disorder, psychosocial factors, spine disorders, and housing insufficiency; and
• The only condition in which the diagnosed rate in a racial/ethnic group exceeded that for whites by a margin of 10% was PTSD, diagnosed in 21% of American Indian/Alaska Natives, versus 11% of whites.

Although the report targeted  6 million veterans accessing VA care in FY13, the estimated number of living veterans is about 22 million. It is a “starting place,” the developers promise. Next iterations will continue to evolve to meet the unique needs of diverse veterans.

“A good understanding of the diverse veteran populations is imperative if the VA is to genuinely resolve the inequities for those at high risk and with the most need,” says the introduction to the first-ever National Veteran Health Equity Report. The report, which contains demographic information on veterans who received VHA care in Fiscal Year (FY) 2013, is designed to provide that comparative information on minorities, women, and other veteran groups. For example:

• Although women represented only about 7% of patients in FY2013, their numbers in VHA have more than doubled since 2000—140% growth, far outstripping the 63% growth among men over the same period;
• In FY2013, 46% of veterans were aged ≥ 65 years;
• More than one-third of veterans lived in rural areas;
• Almost one-half of VHA patients had a service-connected disability. All racial/ethnic minority patient groups, compared with whites, were more likely to have a service-connected disability;

• A higher proportion of women had a service-connected disability, and women are twice as likely to be diagnosed with depression;
• Overall, 33% of VHA patients had ≥ 1 mental health diagnoses. Women and blacks/African Americans were “over-represented” among patients diagnosed with serious mental illness;

• Veterans with serious mental illness also had higher diagnosis rates for musculoskeletal disorders (60% vs 43%) and gastrointestinal conditions (48% vs 30%). In fact, among the top 20 diagnosed conditions, rates for the SMI group exceeded that for the veterans with no mental health diagnosis for 17 conditions by a margin of > 10% for 7. The largest disparities were in tobacco use disorder, psychosocial factors, spine disorders, and housing insufficiency; and
• The only condition in which the diagnosed rate in a racial/ethnic group exceeded that for whites by a margin of 10% was PTSD, diagnosed in 21% of American Indian/Alaska Natives, versus 11% of whites.

Although the report targeted  6 million veterans accessing VA care in FY13, the estimated number of living veterans is about 22 million. It is a “starting place,” the developers promise. Next iterations will continue to evolve to meet the unique needs of diverse veterans.

Stack of money

Reference pricing effectively encourages patients to spend significantly less on prescription drugs, according to research published in NEJM.

Under the reference pricing strategy, the insurer or employer establishes its maximum contribution toward the price of therapeutically similar drugs, and the patient must pay the remainder out of pocket.

The insurer/employer contribution is based on the price of the lowest-priced drug in the therapeutic class, called the reference drug.

“If the patient chooses a cheap or moderately priced option, the employer’s contribution will cover most of the cost,” said study author James C. Robinson, PhD, of the University of California at Berkeley.

“However, if the patient insists on a particularly high-priced option, he or she will need to make a meaningful payment from personal resources.”

It has been theorized that this policy would encourage patients to save money by selecting cheaper drugs. However, little is known about how the policy has actually influenced patient spending.

The new study showed that reference pricing was associated with significant changes in drug selection and spending for patients covered by employment-based insurance in the US.

Researchers analyzed changes in prescriptions and pricing for 1302 drugs in 78 therapeutic classes in the US, before and after an alliance of private employers began using reference pricing.

The trends were compared to a cohort without reference pricing. The study’s dataset included 1.1 million prescriptions reimbursed from 2010 to 2014.

Implementation of reference pricing was associated with a 7% increase in prescriptions filled for the low-price reference drug within its therapeutic class, a 14% decrease in average price paid, and a 5% increase in consumer cost-sharing.

In the first 18 months after implementation, employers’ spending dropped $1.34 million, and employees’ cost-sharing increased $120,000.

Based on these findings, Dr Robinson and his colleagues concluded that reference pricing may be one instrument for influencing patients’ drug choices and drug prices paid by employers and insurers. The team believes that, in the future, pharmaceutical companies charging “premium prices” may need to demonstrate that their drugs provide “premium performance.”

“There is huge and unjustified variation within and across geographic areas in the prices charged for almost every test and treatment, drug and device, office visit and hospitalization,” Dr Robinson said.

“It’s not a surprise when one considers that most patients are covered by health insurance and, hence, do not shop among competing providers on the basis of price. Some providers look at price-unconscious consumer demand and ask themselves, ‘Why don’t we raise our prices?’”

This research was funded by the US Agency for Healthcare Research and Quality and the Genentech Foundation.

Stack of money

Reference pricing effectively encourages patients to spend significantly less on prescription drugs, according to research published in NEJM.

Under the reference pricing strategy, the insurer or employer establishes its maximum contribution toward the price of therapeutically similar drugs, and the patient must pay the remainder out of pocket.

The insurer/employer contribution is based on the price of the lowest-priced drug in the therapeutic class, called the reference drug.

“If the patient chooses a cheap or moderately priced option, the employer’s contribution will cover most of the cost,” said study author James C. Robinson, PhD, of the University of California at Berkeley.

“However, if the patient insists on a particularly high-priced option, he or she will need to make a meaningful payment from personal resources.”

It has been theorized that this policy would encourage patients to save money by selecting cheaper drugs. However, little is known about how the policy has actually influenced patient spending.

The new study showed that reference pricing was associated with significant changes in drug selection and spending for patients covered by employment-based insurance in the US.

Researchers analyzed changes in prescriptions and pricing for 1302 drugs in 78 therapeutic classes in the US, before and after an alliance of private employers began using reference pricing.

The trends were compared to a cohort without reference pricing. The study’s dataset included 1.1 million prescriptions reimbursed from 2010 to 2014.

Implementation of reference pricing was associated with a 7% increase in prescriptions filled for the low-price reference drug within its therapeutic class, a 14% decrease in average price paid, and a 5% increase in consumer cost-sharing.

In the first 18 months after implementation, employers’ spending dropped $1.34 million, and employees’ cost-sharing increased $120,000.

Based on these findings, Dr Robinson and his colleagues concluded that reference pricing may be one instrument for influencing patients’ drug choices and drug prices paid by employers and insurers. The team believes that, in the future, pharmaceutical companies charging “premium prices” may need to demonstrate that their drugs provide “premium performance.”

“There is huge and unjustified variation within and across geographic areas in the prices charged for almost every test and treatment, drug and device, office visit and hospitalization,” Dr Robinson said.

“It’s not a surprise when one considers that most patients are covered by health insurance and, hence, do not shop among competing providers on the basis of price. Some providers look at price-unconscious consumer demand and ask themselves, ‘Why don’t we raise our prices?’”

This research was funded by the US Agency for Healthcare Research and Quality and the Genentech Foundation.

Stack of money

Reference pricing effectively encourages patients to spend significantly less on prescription drugs, according to research published in NEJM.

Under the reference pricing strategy, the insurer or employer establishes its maximum contribution toward the price of therapeutically similar drugs, and the patient must pay the remainder out of pocket.

The insurer/employer contribution is based on the price of the lowest-priced drug in the therapeutic class, called the reference drug.

“If the patient chooses a cheap or moderately priced option, the employer’s contribution will cover most of the cost,” said study author James C. Robinson, PhD, of the University of California at Berkeley.

“However, if the patient insists on a particularly high-priced option, he or she will need to make a meaningful payment from personal resources.”

It has been theorized that this policy would encourage patients to save money by selecting cheaper drugs. However, little is known about how the policy has actually influenced patient spending.

The new study showed that reference pricing was associated with significant changes in drug selection and spending for patients covered by employment-based insurance in the US.

Researchers analyzed changes in prescriptions and pricing for 1302 drugs in 78 therapeutic classes in the US, before and after an alliance of private employers began using reference pricing.

The trends were compared to a cohort without reference pricing. The study’s dataset included 1.1 million prescriptions reimbursed from 2010 to 2014.

Implementation of reference pricing was associated with a 7% increase in prescriptions filled for the low-price reference drug within its therapeutic class, a 14% decrease in average price paid, and a 5% increase in consumer cost-sharing.

In the first 18 months after implementation, employers’ spending dropped $1.34 million, and employees’ cost-sharing increased $120,000.

Based on these findings, Dr Robinson and his colleagues concluded that reference pricing may be one instrument for influencing patients’ drug choices and drug prices paid by employers and insurers. The team believes that, in the future, pharmaceutical companies charging “premium prices” may need to demonstrate that their drugs provide “premium performance.”

“There is huge and unjustified variation within and across geographic areas in the prices charged for almost every test and treatment, drug and device, office visit and hospitalization,” Dr Robinson said.

“It’s not a surprise when one considers that most patients are covered by health insurance and, hence, do not shop among competing providers on the basis of price. Some providers look at price-unconscious consumer demand and ask themselves, ‘Why don’t we raise our prices?’”

This research was funded by the US Agency for Healthcare Research and Quality and the Genentech Foundation.

Lab mouse

A 3-drug combination has demonstrated long-term efficacy against acute lymphoblastic leukemia (ALL) in mice, according to research published in Nature Communications.

Researchers found that when the production of nucleotides is stopped, a DNA replication stress response is activated, and this allows ALL cells to survive.

The team used these findings to devise a 3-drug regimen that blocks both of the nucleotide biosynthetic pathways and inhibits the replication stress response.

One of the drugs is triapine (3-AP), which inhibits ribonucleotide reductase (RNR) and enhances salvage nucleotide biosynthesis.

Another drug is DI-82, which inhibits the nucleoside salvage kinase deoxycytidine kinase (dCK).

And the third drug is VE-822, which inhibits the replication stress-sensing kinase ataxia telangiectasia and Rad3-related protein (ATR).

The researchers tested these 3 drugs in a mouse model of pre-B-ALL. Starting on day 7 after inoculation of pre-B-ALL, the mice received 3-AP and DI-82 twice a day and VE-822 once a day.

The team said mice in the control group succumbed to their disease within 17 days. However, all of the mice that received the 3-drug combination were still disease-free 442 days after they had stopped treatment (on day 42).

The researchers said the combination was well-tolerated, as mice maintained their body weight and enjoyed long-term survival without any detectable pathology.

The team also tested a dosing regimen in which all 3 drugs were given once a day.

Although this was less effective than the first regimen, 4 of 5 mice had no detectable disease 313 days after stopping treatment.

Two of the researchers involved in this study are co-founders and equity holders of Trethera Corp, a company developing a dCK inhibitor known as TRE-515.

The University of California (where most of the study authors work) has patented intellectual property for small-molecule dCK inhibitors, and it was licensed by Trethera.

Lab mouse

A 3-drug combination has demonstrated long-term efficacy against acute lymphoblastic leukemia (ALL) in mice, according to research published in Nature Communications.

Researchers found that when the production of nucleotides is stopped, a DNA replication stress response is activated, and this allows ALL cells to survive.

The team used these findings to devise a 3-drug regimen that blocks both of the nucleotide biosynthetic pathways and inhibits the replication stress response.

One of the drugs is triapine (3-AP), which inhibits ribonucleotide reductase (RNR) and enhances salvage nucleotide biosynthesis.

Another drug is DI-82, which inhibits the nucleoside salvage kinase deoxycytidine kinase (dCK).

And the third drug is VE-822, which inhibits the replication stress-sensing kinase ataxia telangiectasia and Rad3-related protein (ATR).

The researchers tested these 3 drugs in a mouse model of pre-B-ALL. Starting on day 7 after inoculation of pre-B-ALL, the mice received 3-AP and DI-82 twice a day and VE-822 once a day.

The team said mice in the control group succumbed to their disease within 17 days. However, all of the mice that received the 3-drug combination were still disease-free 442 days after they had stopped treatment (on day 42).

The researchers said the combination was well-tolerated, as mice maintained their body weight and enjoyed long-term survival without any detectable pathology.

The team also tested a dosing regimen in which all 3 drugs were given once a day.

Although this was less effective than the first regimen, 4 of 5 mice had no detectable disease 313 days after stopping treatment.

Two of the researchers involved in this study are co-founders and equity holders of Trethera Corp, a company developing a dCK inhibitor known as TRE-515.

The University of California (where most of the study authors work) has patented intellectual property for small-molecule dCK inhibitors, and it was licensed by Trethera.

Lab mouse

A 3-drug combination has demonstrated long-term efficacy against acute lymphoblastic leukemia (ALL) in mice, according to research published in Nature Communications.

Researchers found that when the production of nucleotides is stopped, a DNA replication stress response is activated, and this allows ALL cells to survive.

The team used these findings to devise a 3-drug regimen that blocks both of the nucleotide biosynthetic pathways and inhibits the replication stress response.

One of the drugs is triapine (3-AP), which inhibits ribonucleotide reductase (RNR) and enhances salvage nucleotide biosynthesis.

Another drug is DI-82, which inhibits the nucleoside salvage kinase deoxycytidine kinase (dCK).

And the third drug is VE-822, which inhibits the replication stress-sensing kinase ataxia telangiectasia and Rad3-related protein (ATR).

The researchers tested these 3 drugs in a mouse model of pre-B-ALL. Starting on day 7 after inoculation of pre-B-ALL, the mice received 3-AP and DI-82 twice a day and VE-822 once a day.

The team said mice in the control group succumbed to their disease within 17 days. However, all of the mice that received the 3-drug combination were still disease-free 442 days after they had stopped treatment (on day 42).

The researchers said the combination was well-tolerated, as mice maintained their body weight and enjoyed long-term survival without any detectable pathology.

The team also tested a dosing regimen in which all 3 drugs were given once a day.

Although this was less effective than the first regimen, 4 of 5 mice had no detectable disease 313 days after stopping treatment.

Two of the researchers involved in this study are co-founders and equity holders of Trethera Corp, a company developing a dCK inhibitor known as TRE-515.

The University of California (where most of the study authors work) has patented intellectual property for small-molecule dCK inhibitors, and it was licensed by Trethera.

Photo by Bill Branson

The US Food and Drug Administration (FDA) has granted orphan drug designation to SENS-401 to be used for the prevention of platinum-induced ototoxicity in pediatric patients.

Platinum-based chemotherapies, particularly cisplatin, can induce severe hearing loss in cancer patients, but there is no pharmaceutical agent approved to treat this side effect.

“Hearing loss in pediatric oncology patients is one of the most frequent side effects of cisplatin treatment and may disable them for the rest of their lives,” said Nawal Ouzren, CEO of Sensorion, the company developing SENS-401.

“Based on its unique profile and the data generated to date, we believe SENS-401 has the potential to be a safe and effective treatment for this serious medical condition where a significant unmet need exists. As such, we look forward to working with the FDA and EMA [European Medicines Agency] to set up an IND [investigational new drug application] and design a phase 2 clinical trial in order to evaluate SENS-401 in this indication.”

About SENS-401

SENS-401 (R-azasetron besylate) is a small molecule intended to protect and preserve inner ear tissue when lesions cause progressive or sequelar hearing impairments. The drug can be taken orally or via an injection.

SENS-401 is one of the two enantiomer forms of SENS-218 (azasetron), a racemic molecule belonging to the family of setrons marketed in Asia under the name Serotone. Pharmacological and pharmacokinetic tests have shown a superior profile for SENS-401 compared with the other enantiomer or the racemic form.

Healthy subjects demonstrated a “very good clinical tolerance” to SENS-401 in a phase 1 study, according to Sensorion. The company is planning to launch a phase 2 trial of the drug for platinum-induced ototoxicity in 2018.

About orphan designation

The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.

The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.

Photo by Bill Branson

The US Food and Drug Administration (FDA) has granted orphan drug designation to SENS-401 to be used for the prevention of platinum-induced ototoxicity in pediatric patients.

Platinum-based chemotherapies, particularly cisplatin, can induce severe hearing loss in cancer patients, but there is no pharmaceutical agent approved to treat this side effect.

“Hearing loss in pediatric oncology patients is one of the most frequent side effects of cisplatin treatment and may disable them for the rest of their lives,” said Nawal Ouzren, CEO of Sensorion, the company developing SENS-401.

“Based on its unique profile and the data generated to date, we believe SENS-401 has the potential to be a safe and effective treatment for this serious medical condition where a significant unmet need exists. As such, we look forward to working with the FDA and EMA [European Medicines Agency] to set up an IND [investigational new drug application] and design a phase 2 clinical trial in order to evaluate SENS-401 in this indication.”

About SENS-401

SENS-401 (R-azasetron besylate) is a small molecule intended to protect and preserve inner ear tissue when lesions cause progressive or sequelar hearing impairments. The drug can be taken orally or via an injection.

SENS-401 is one of the two enantiomer forms of SENS-218 (azasetron), a racemic molecule belonging to the family of setrons marketed in Asia under the name Serotone. Pharmacological and pharmacokinetic tests have shown a superior profile for SENS-401 compared with the other enantiomer or the racemic form.

Healthy subjects demonstrated a “very good clinical tolerance” to SENS-401 in a phase 1 study, according to Sensorion. The company is planning to launch a phase 2 trial of the drug for platinum-induced ototoxicity in 2018.

About orphan designation

The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.

The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.

Photo by Bill Branson

The US Food and Drug Administration (FDA) has granted orphan drug designation to SENS-401 to be used for the prevention of platinum-induced ototoxicity in pediatric patients.

Platinum-based chemotherapies, particularly cisplatin, can induce severe hearing loss in cancer patients, but there is no pharmaceutical agent approved to treat this side effect.

“Hearing loss in pediatric oncology patients is one of the most frequent side effects of cisplatin treatment and may disable them for the rest of their lives,” said Nawal Ouzren, CEO of Sensorion, the company developing SENS-401.

“Based on its unique profile and the data generated to date, we believe SENS-401 has the potential to be a safe and effective treatment for this serious medical condition where a significant unmet need exists. As such, we look forward to working with the FDA and EMA [European Medicines Agency] to set up an IND [investigational new drug application] and design a phase 2 clinical trial in order to evaluate SENS-401 in this indication.”

About SENS-401

SENS-401 (R-azasetron besylate) is a small molecule intended to protect and preserve inner ear tissue when lesions cause progressive or sequelar hearing impairments. The drug can be taken orally or via an injection.

SENS-401 is one of the two enantiomer forms of SENS-218 (azasetron), a racemic molecule belonging to the family of setrons marketed in Asia under the name Serotone. Pharmacological and pharmacokinetic tests have shown a superior profile for SENS-401 compared with the other enantiomer or the racemic form.

Healthy subjects demonstrated a “very good clinical tolerance” to SENS-401 in a phase 1 study, according to Sensorion. The company is planning to launch a phase 2 trial of the drug for platinum-induced ototoxicity in 2018.

About orphan designation

The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.

The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.

New studies raise doubts on the reliability of physical exam findings in suspected pediatric community-acquired pneumonia cases and on the value of blood cultures in hospitalized pediatric CAP cases.

In one study, 128 cases of suspected CAP in children aged 3 months to 18 years presenting to an ED from July 2013 to May 2016 underwent paired assessments within 20 minutes of each other. Only 3 of 19 exam findings used to diagnose CAP – wheezing, retractions, and respiratory rate – had acceptable levels of inter-rater reliability, with the lower end of the 95% confidential interval at a Fleiss’ kappa value of 0.4 or higher.

CDC/Amanda Mills

Both studies were funded by the National Institutes of Health. For the physician exam study, additional funding was provided by individual grants from the Gerber Foundation, the National Center for Research Resources and the National Center for Advancing Translational Sciences, the National Institute for Allergy and Infectious Diseases and the National Institutes of Health, and a Trustee Award from Cincinnati Children’s Hospital Medical Center. For the blood cultures study, individual researchers received funding from the National Institute of Allergy and Infectious Diseases and the Agency for Healthcare Research and Quality. For the physician exam study, no financial disclosures were reported. For the blood cultures study, Anne Blaschke, MD, PhD, reported receiving research funding from and other financial relationships with BioFire Diagnostics.

New studies raise doubts on the reliability of physical exam findings in suspected pediatric community-acquired pneumonia cases and on the value of blood cultures in hospitalized pediatric CAP cases.

In one study, 128 cases of suspected CAP in children aged 3 months to 18 years presenting to an ED from July 2013 to May 2016 underwent paired assessments within 20 minutes of each other. Only 3 of 19 exam findings used to diagnose CAP – wheezing, retractions, and respiratory rate – had acceptable levels of inter-rater reliability, with the lower end of the 95% confidential interval at a Fleiss’ kappa value of 0.4 or higher.

CDC/Amanda Mills

Both studies were funded by the National Institutes of Health. For the physician exam study, additional funding was provided by individual grants from the Gerber Foundation, the National Center for Research Resources and the National Center for Advancing Translational Sciences, the National Institute for Allergy and Infectious Diseases and the National Institutes of Health, and a Trustee Award from Cincinnati Children’s Hospital Medical Center. For the blood cultures study, individual researchers received funding from the National Institute of Allergy and Infectious Diseases and the Agency for Healthcare Research and Quality. For the physician exam study, no financial disclosures were reported. For the blood cultures study, Anne Blaschke, MD, PhD, reported receiving research funding from and other financial relationships with BioFire Diagnostics.

New studies raise doubts on the reliability of physical exam findings in suspected pediatric community-acquired pneumonia cases and on the value of blood cultures in hospitalized pediatric CAP cases.

In one study, 128 cases of suspected CAP in children aged 3 months to 18 years presenting to an ED from July 2013 to May 2016 underwent paired assessments within 20 minutes of each other. Only 3 of 19 exam findings used to diagnose CAP – wheezing, retractions, and respiratory rate – had acceptable levels of inter-rater reliability, with the lower end of the 95% confidential interval at a Fleiss’ kappa value of 0.4 or higher.

CDC/Amanda Mills

Both studies were funded by the National Institutes of Health. For the physician exam study, additional funding was provided by individual grants from the Gerber Foundation, the National Center for Research Resources and the National Center for Advancing Translational Sciences, the National Institute for Allergy and Infectious Diseases and the National Institutes of Health, and a Trustee Award from Cincinnati Children’s Hospital Medical Center. For the blood cultures study, individual researchers received funding from the National Institute of Allergy and Infectious Diseases and the Agency for Healthcare Research and Quality. For the physician exam study, no financial disclosures were reported. For the blood cultures study, Anne Blaschke, MD, PhD, reported receiving research funding from and other financial relationships with BioFire Diagnostics.

I provided an update on existing, new, and upcoming medical therapies for Crohn’s disease (CD) and ulcerative colitis (UC), with a focus on studies presented at Digestive Disease Week^® 2017.

In one study of over 13,000 inflammatory bowel disease (IBD) patients in Medicare/Medicaid databases, it was found that among those treated with corticosteroids in the previous year, patients started on a tumor necrosis factor (TNF) inhibitor within the next year had mortality rates that were at least 22% lower than those of patients treated with prolonged corticosteroids over the next 12 months (Gastroenterology. 2017;152[5 Suppl 1]:S65-5). Initial results of the CALM study were presented, comparing a treat-to-target (T2T) algorithmic medical escalation approach in moderate to severe CD to a more conventional approach. Medical therapy was primarily adalimumab based and was escalated based on “success criteria,” which included not only symptomatic remission but also normalization of serum C-reactive protein and fecal calprotectin. At week 48, the rate of endoscopic remission was significantly higher (45.9%) in the T2T group than in conventionally managed patients (30.3%, P = .01), thus demonstrating the superiority of a T2T approach (Gastroenterology 2017;152[5 Suppl 1]:S155).

Dr. Loftus is professor of medicine, Mayo Clinic College of Medicine, director of the Inflammatory Bowel Disease Interest Group, the division of gastroenterology and hepatology, Rochester, Minn. He made his comments during the AGA Institute Presidential Plenary at the Annual Digestive Disease Week.

I provided an update on existing, new, and upcoming medical therapies for Crohn’s disease (CD) and ulcerative colitis (UC), with a focus on studies presented at Digestive Disease Week^® 2017.

In one study of over 13,000 inflammatory bowel disease (IBD) patients in Medicare/Medicaid databases, it was found that among those treated with corticosteroids in the previous year, patients started on a tumor necrosis factor (TNF) inhibitor within the next year had mortality rates that were at least 22% lower than those of patients treated with prolonged corticosteroids over the next 12 months (Gastroenterology. 2017;152[5 Suppl 1]:S65-5). Initial results of the CALM study were presented, comparing a treat-to-target (T2T) algorithmic medical escalation approach in moderate to severe CD to a more conventional approach. Medical therapy was primarily adalimumab based and was escalated based on “success criteria,” which included not only symptomatic remission but also normalization of serum C-reactive protein and fecal calprotectin. At week 48, the rate of endoscopic remission was significantly higher (45.9%) in the T2T group than in conventionally managed patients (30.3%, P = .01), thus demonstrating the superiority of a T2T approach (Gastroenterology 2017;152[5 Suppl 1]:S155).

Dr. Loftus is professor of medicine, Mayo Clinic College of Medicine, director of the Inflammatory Bowel Disease Interest Group, the division of gastroenterology and hepatology, Rochester, Minn. He made his comments during the AGA Institute Presidential Plenary at the Annual Digestive Disease Week.

I provided an update on existing, new, and upcoming medical therapies for Crohn’s disease (CD) and ulcerative colitis (UC), with a focus on studies presented at Digestive Disease Week^® 2017.

In one study of over 13,000 inflammatory bowel disease (IBD) patients in Medicare/Medicaid databases, it was found that among those treated with corticosteroids in the previous year, patients started on a tumor necrosis factor (TNF) inhibitor within the next year had mortality rates that were at least 22% lower than those of patients treated with prolonged corticosteroids over the next 12 months (Gastroenterology. 2017;152[5 Suppl 1]:S65-5). Initial results of the CALM study were presented, comparing a treat-to-target (T2T) algorithmic medical escalation approach in moderate to severe CD to a more conventional approach. Medical therapy was primarily adalimumab based and was escalated based on “success criteria,” which included not only symptomatic remission but also normalization of serum C-reactive protein and fecal calprotectin. At week 48, the rate of endoscopic remission was significantly higher (45.9%) in the T2T group than in conventionally managed patients (30.3%, P = .01), thus demonstrating the superiority of a T2T approach (Gastroenterology 2017;152[5 Suppl 1]:S155).

Dr. Loftus is professor of medicine, Mayo Clinic College of Medicine, director of the Inflammatory Bowel Disease Interest Group, the division of gastroenterology and hepatology, Rochester, Minn. He made his comments during the AGA Institute Presidential Plenary at the Annual Digestive Disease Week.

PARK CITY, UTAH – Copper IUDs really do increase the risk of bacterial vaginosis (BV), according to a longitudinal study of 234 women in Harare, Zimbabwe.

This notion has “always been a little bit controversial; it’s commonly believed by some and refuted by others,” but the findings from the new research “are real and generalizable,” said Sharon Hillier, PhD, the study’s senior investigator and the director of reproductive infectious disease research at Magee-Womens Hospital of the University of Pittsburgh.

aotto@frontlinemedcom.com

PARK CITY, UTAH – Copper IUDs really do increase the risk of bacterial vaginosis (BV), according to a longitudinal study of 234 women in Harare, Zimbabwe.

This notion has “always been a little bit controversial; it’s commonly believed by some and refuted by others,” but the findings from the new research “are real and generalizable,” said Sharon Hillier, PhD, the study’s senior investigator and the director of reproductive infectious disease research at Magee-Womens Hospital of the University of Pittsburgh.

aotto@frontlinemedcom.com

PARK CITY, UTAH – Copper IUDs really do increase the risk of bacterial vaginosis (BV), according to a longitudinal study of 234 women in Harare, Zimbabwe.

This notion has “always been a little bit controversial; it’s commonly believed by some and refuted by others,” but the findings from the new research “are real and generalizable,” said Sharon Hillier, PhD, the study’s senior investigator and the director of reproductive infectious disease research at Magee-Womens Hospital of the University of Pittsburgh.

aotto@frontlinemedcom.com