- Email: [email protected]
A New Measure of Healthcare Resource Utilization in Heart Failure: Development and Content Validity Evaluation
S116 Journal of Cardiac Failure Vol. 21 No. 8S August 2015 Table 1. Adjusted Clinical Outcomes
No HF n56540 (67%) Rate Stroke or Non-CNS Embolism All Cause Mortality Cardiovascular Mortality All-cause Hospitalization
HF n 5 3203 (33%)
HFpEF n 5 2013 (67%)
HFrEF n 5 985 (33%)
Rate* HR+ (95% CI) P Value Rate* HR+ (95% CI) P Value Rate* HR+ (95% CI) P Value
0.88
1.28
1.11 (0.83-1.48)
0.47
1.36
1.15 (0.83-1.59)
0.40
1.12
1.06 (0.67-1.67)
0.82
3.52 1.08 28.15
10.19 4.99 48.97
1.69 (1.49-1.92) 2.12 (1.70-2.63) 1.31 (1.23-1.39)
!0.0001 !0.0001 !0.0001
9.16 3.80 49.33
1.51 (1.31-1.74) 1.93 (1.53-2.45 1.29(1.20-1.39)
!0.0001 !0.0001 !0.0001
12.25 7.45 50.45
2.06(1.74-2.44) 4.09 (3.19-5.23) 1.38 (1.25-1.51)
!0.0001 !0.0001 !0.0001
*rate per 100 patient years. + compared with no HF group and adjusted for prespecified covariates.
patients with HF compared with those without HF is not well described. Methods: We analyzed data from ORBIT-AF, a national registry that enrolled 10,135 AF patients seen in 176 U.S. community practices. Cox multivariable proportional hazards modeling was used to determine associations between HF diagnosis as well as left ventricular ejection fraction (LVEF) and a range of outcomes, including stroke or non-CNS embolism, survival and hospitalization. Wilcoxon rank sum test was used to compare Atrial Fibrillation Effect on Quality-of-life questionnaire (AFEQT) scores between patients without HF and those with HF and reduced as well as preserved EF. Results: Overall, 33% (n53203) of ORBIT-AF patients had HF; of these 33% had reduced LVEF (EF ! 40%). AF patients with HF were older (median age 76 vs. 74), more likely to have diabetes, COPD, and kidney disease, and had higher CHA2DS2-VASc score (median 5 vs. 3) than those without HF (all p!0.0001). Oral anticoagulation was prescribed more commonly in patients with HF (81% vs. 74%) while rhythm control was used more commonly in patients without HF (34% vs. 26%). Compared with patients without HF, those with HF had similar rate of stroke or non-CNS embolism but higher rates of all-cause mortality and all-cause hospitalizations, and lower AFEQT overall score (76.9 v. 83.3, p!0.0001). Worse outcomes associated with HF were notable among both those preserved as well as reduced EF (Table 1). Conclusions: Among AF patients, HF was associated with increased risk of death and hospitalization and worse quality of life, but similar stroke or non-CNS embolism rates. These findings highlight the risk of concomitant HF among those with AF and the need to develop therapeutic strategies targeting functional status and survival for patients with HF and AF.
277 A New Measure of Healthcare Resource Utilization in Heart Failure: Development and Content Validity Evaluation Miyeon Jung, Marita Titler, Penny Riley, Barry Bleske, Susan J. Pressler; University of Michigan, Ann Arbor, MI Introduction: Heart failure (HF) is a leading cause of healthcare costs. Measures to evaluate healthcare resource utilization and costs using a societal perspective are needed for future studies to fully examine the influence of HF on society, but few measures are available. Aims: To describe development and initial evaluation of content validity of a new measure of healthcare resource utilization in HF, the Modified Resource Utilization Questionnaire for Heart Failure (mRUQ-HF). Methods: The mRUQ-HF was developed by modifying the existing Resource Utilization Questionnaire that was designed to measure utilization for Type 1 diabetes (mRUG-T1DM; Smaldone, Tsimicalis, & Stone, 2011). All items of the questionnaire were revised to be consistent with costs of HF care. The final mRUG-HF is a14-item self-report questionnaire of comprehensive lists of choice related to healthcare utilization. Five items were designed to measure direct and non-direct healthcare costs and 9 items were designed to measure loss of time and productivity attributable to HF. Content validity was evaluated by five experts in HF and health economics research. Experts evaluated each item for clarity and consistency with constructs of healthcare resource utilization using 4-point rating scales (1 5 not, 2 5 somewhat, 3 5 quite, and 4 5 highly). The content validity index (CVI) was calculated at item and scale levels based on agreement across experts. Results: The CVI for clarity of the individual items ranged from 0.80 to 1.00. Nine items were rated as highly clear by all 5 experts (CVI 5 1.00). Five items were rated as highly clear by 4 experts and somewhat clear by 1 expert (CVI 5 0.80). The CVI for consistency of individual items with constructs of healthcare resource utilization was rated as highly consistent by all 5 experts (CVI 5 1.00). The CVI for the overall scale was measured by calculating universal agreement and average agreement (Polit & Beck,2006). For clarity of the mRUG-HF, universal agreement CVI was calculated by the proportion of items rated as ‘quite’ or ‘highly’ by ALL experts, and it was 0.64 (9 items out of 14). Average agreement CVI was calculated by the proportion of items rated as ‘quite’ or ‘highly’ across the ratings, and it was 0.92 (55 out of 60 ratings). Scale-level CVI, universal and average agreement for consistency of the mRUG-HF were 1.0 for both. Recommended minimum scale-level CVIs for universal agreement and average proportion are 0.80 and 0.90, respectively. Based on the CVI values, overall content validity of the mRUG-HF was acceptable. Conclusions: Initial content validity of the mRUQ-HF was supported. The new questionnaire is available for validation with HF patients in future studies.
279 Vascular Reactivity Analysis in Patients with Continuous Flow Left Ventricular Assist Devices (CF-LVADs) - the Role of Endothelial Function in Continuous Flow Physiology Cesar Uribe, Keith A. Youker, Barry H. Trachtenberg, Guha Ashrith, Jerry D. Estep, Guillermo Torre-Amione, Brian A. Bruckner, John P. Cooke, Arvind Bhimaraj; The Methodist Hospital, Houston, TX Background: Endothelial dysfunction associated with heart failure should improve after a CF-LVAD placement due to correction of the heart failure environment. Yet, a loss of pulsatility could counteract such improvement as endothelial cells need a pulse pressure for normal function. Mixed results of endothelial dysfunction in CF-LVAD when compared to pulsatile VAD have been reported utilizing both brachial reactivity and EndoPATÒ machines. Both these tests rely on physical pulse volume and might be impacted by the mere loss of pulsatility. Hence, we set out to analyze endothelial function utilizing thermal digital monitoring (VENDYS) in patients with CF-LVADs. Methods: We recruited stable patients during their routine visits and performed the VENDYS test in a soothing environment. Aortic valve opening was determined with a portable echo (GE V-scan) and graded as per previously described classification. Rest of the data was collected from the patient charts. Patients were classified into three groups based on parameters of vascular reactivity index (VRI) described in normal population: poor (!1) intermediate (1 - 2) and good VRI (2 - 3) with higher VRI correlated with better endothelial function, hence better outcomes. Pearsons correlation and T-test were performed, P-values ! 0.05 were considered significant. Results: 40 patients had Heartmate II and 2 had Heartware devices. Table 1 describes the characteristics of the 3 cohorts of endothelial function. Overall 81% had aortic valve opening consistently at the time of endothelial function assessment. Only 19% had a poor VRI, while majority had an intermediate VRI. Older patients had worse endothelial function while rest of the baseline characteristics including aortic valve opening and flow were not different between the groups. Correlation between VRI and VAD flow (r5 -0.2766 P value5 0.08) and high Doppler blood pressure (r5 -0.2656 P value50.09) showed no significance. However, 50% of the patients with a poor VRI had adverse events while only 23% of those with good endothelial function did (Table 1). The 2 patients with poor VRI who had a GI bleed had 5 episodes while the 3 patients with good VRI had 4 episodes. Conclusion: In a cohort of CF-LVAD patients where the majority had their aortic valve open, endothelial function, as reflected by DTM was poor in only a few. It is not clear if endothelial dysfunction contributes to any of adverse events for CF-LVAD patients but there seem to be a higher recurrence of GI bleeding in patients who had a poor endothelial function. Table 1.
Total
!1
N 42 (100%) 8 (19%) VENDYS score 1.7160.78 0.4560.35 Age 57612.8 60.367.5 Male 34 (81%) 5 (62.5%) Caucasian 17(40%) 2 (25%) DT 31 (74%) 6 (75%) AV opened 34 (81%) 7 (87%) Days under 5856567 2446276 support BUN 275.476282.4 25.25616.47 Hgb 11.0662.22 9.7761.47 Flow 5.4961.34 6.461.47 Patients with 17(100%) 4 (23%) events GIB 10 (58%) 2 Infections 4 (23%) 1 Arrhythmia 1 (6%) 0 ADHF 3 (18%) 0 Death 3 (14%) 1
1 to 2
2 to 3
p value
21 (50%) 1.6960.28 59.6610.1 19 (90%) 9 (43%) 17 (81%) 17 (81%) 6726586
13 (31%) 2.560.35 50.2616.7 10 (77%) 6 (46%) 8 (61%) 10 (77%) 4976582
0.073 0.2082 0.6009 0.45 0.835 0.17
24.867.23 20.667.54 11.5662.45 11.0462.01 5.2161.51 5.3760.51 10 (59%) 3 (18%)
0.41 0.15 0.098 0.3
5 3 1 3 2
0.99 0.36 0.59 0.19 0.46
3 0 0 0 0
VENDYS score: Endothelial function based thermal vascular reactivity. DT: Destination Therapy. AV: Aortic valve. GIB: Gastrointestinal bleeding. ADHF: Acute decompensated heart failure.
No HF n56540 (67%) Rate Stroke or Non-CNS Embolism All Cause Mortality Cardiovascular Mortality All-cause Hospitalization
HF n 5 3203 (33%)
HFpEF n 5 2013 (67%)
HFrEF n 5 985 (33%)
Rate* HR+ (95% CI) P Value Rate* HR+ (95% CI) P Value Rate* HR+ (95% CI) P Value
0.88
1.28
1.11 (0.83-1.48)
0.47
1.36
1.15 (0.83-1.59)
0.40
1.12
1.06 (0.67-1.67)
0.82
3.52 1.08 28.15
10.19 4.99 48.97
1.69 (1.49-1.92) 2.12 (1.70-2.63) 1.31 (1.23-1.39)
!0.0001 !0.0001 !0.0001
9.16 3.80 49.33
1.51 (1.31-1.74) 1.93 (1.53-2.45 1.29(1.20-1.39)
!0.0001 !0.0001 !0.0001
12.25 7.45 50.45
2.06(1.74-2.44) 4.09 (3.19-5.23) 1.38 (1.25-1.51)
!0.0001 !0.0001 !0.0001
*rate per 100 patient years. + compared with no HF group and adjusted for prespecified covariates.
patients with HF compared with those without HF is not well described. Methods: We analyzed data from ORBIT-AF, a national registry that enrolled 10,135 AF patients seen in 176 U.S. community practices. Cox multivariable proportional hazards modeling was used to determine associations between HF diagnosis as well as left ventricular ejection fraction (LVEF) and a range of outcomes, including stroke or non-CNS embolism, survival and hospitalization. Wilcoxon rank sum test was used to compare Atrial Fibrillation Effect on Quality-of-life questionnaire (AFEQT) scores between patients without HF and those with HF and reduced as well as preserved EF. Results: Overall, 33% (n53203) of ORBIT-AF patients had HF; of these 33% had reduced LVEF (EF ! 40%). AF patients with HF were older (median age 76 vs. 74), more likely to have diabetes, COPD, and kidney disease, and had higher CHA2DS2-VASc score (median 5 vs. 3) than those without HF (all p!0.0001). Oral anticoagulation was prescribed more commonly in patients with HF (81% vs. 74%) while rhythm control was used more commonly in patients without HF (34% vs. 26%). Compared with patients without HF, those with HF had similar rate of stroke or non-CNS embolism but higher rates of all-cause mortality and all-cause hospitalizations, and lower AFEQT overall score (76.9 v. 83.3, p!0.0001). Worse outcomes associated with HF were notable among both those preserved as well as reduced EF (Table 1). Conclusions: Among AF patients, HF was associated with increased risk of death and hospitalization and worse quality of life, but similar stroke or non-CNS embolism rates. These findings highlight the risk of concomitant HF among those with AF and the need to develop therapeutic strategies targeting functional status and survival for patients with HF and AF.
277 A New Measure of Healthcare Resource Utilization in Heart Failure: Development and Content Validity Evaluation Miyeon Jung, Marita Titler, Penny Riley, Barry Bleske, Susan J. Pressler; University of Michigan, Ann Arbor, MI Introduction: Heart failure (HF) is a leading cause of healthcare costs. Measures to evaluate healthcare resource utilization and costs using a societal perspective are needed for future studies to fully examine the influence of HF on society, but few measures are available. Aims: To describe development and initial evaluation of content validity of a new measure of healthcare resource utilization in HF, the Modified Resource Utilization Questionnaire for Heart Failure (mRUQ-HF). Methods: The mRUQ-HF was developed by modifying the existing Resource Utilization Questionnaire that was designed to measure utilization for Type 1 diabetes (mRUG-T1DM; Smaldone, Tsimicalis, & Stone, 2011). All items of the questionnaire were revised to be consistent with costs of HF care. The final mRUG-HF is a14-item self-report questionnaire of comprehensive lists of choice related to healthcare utilization. Five items were designed to measure direct and non-direct healthcare costs and 9 items were designed to measure loss of time and productivity attributable to HF. Content validity was evaluated by five experts in HF and health economics research. Experts evaluated each item for clarity and consistency with constructs of healthcare resource utilization using 4-point rating scales (1 5 not, 2 5 somewhat, 3 5 quite, and 4 5 highly). The content validity index (CVI) was calculated at item and scale levels based on agreement across experts. Results: The CVI for clarity of the individual items ranged from 0.80 to 1.00. Nine items were rated as highly clear by all 5 experts (CVI 5 1.00). Five items were rated as highly clear by 4 experts and somewhat clear by 1 expert (CVI 5 0.80). The CVI for consistency of individual items with constructs of healthcare resource utilization was rated as highly consistent by all 5 experts (CVI 5 1.00). The CVI for the overall scale was measured by calculating universal agreement and average agreement (Polit & Beck,2006). For clarity of the mRUG-HF, universal agreement CVI was calculated by the proportion of items rated as ‘quite’ or ‘highly’ by ALL experts, and it was 0.64 (9 items out of 14). Average agreement CVI was calculated by the proportion of items rated as ‘quite’ or ‘highly’ across the ratings, and it was 0.92 (55 out of 60 ratings). Scale-level CVI, universal and average agreement for consistency of the mRUG-HF were 1.0 for both. Recommended minimum scale-level CVIs for universal agreement and average proportion are 0.80 and 0.90, respectively. Based on the CVI values, overall content validity of the mRUG-HF was acceptable. Conclusions: Initial content validity of the mRUQ-HF was supported. The new questionnaire is available for validation with HF patients in future studies.
279 Vascular Reactivity Analysis in Patients with Continuous Flow Left Ventricular Assist Devices (CF-LVADs) - the Role of Endothelial Function in Continuous Flow Physiology Cesar Uribe, Keith A. Youker, Barry H. Trachtenberg, Guha Ashrith, Jerry D. Estep, Guillermo Torre-Amione, Brian A. Bruckner, John P. Cooke, Arvind Bhimaraj; The Methodist Hospital, Houston, TX Background: Endothelial dysfunction associated with heart failure should improve after a CF-LVAD placement due to correction of the heart failure environment. Yet, a loss of pulsatility could counteract such improvement as endothelial cells need a pulse pressure for normal function. Mixed results of endothelial dysfunction in CF-LVAD when compared to pulsatile VAD have been reported utilizing both brachial reactivity and EndoPATÒ machines. Both these tests rely on physical pulse volume and might be impacted by the mere loss of pulsatility. Hence, we set out to analyze endothelial function utilizing thermal digital monitoring (VENDYS) in patients with CF-LVADs. Methods: We recruited stable patients during their routine visits and performed the VENDYS test in a soothing environment. Aortic valve opening was determined with a portable echo (GE V-scan) and graded as per previously described classification. Rest of the data was collected from the patient charts. Patients were classified into three groups based on parameters of vascular reactivity index (VRI) described in normal population: poor (!1) intermediate (1 - 2) and good VRI (2 - 3) with higher VRI correlated with better endothelial function, hence better outcomes. Pearsons correlation and T-test were performed, P-values ! 0.05 were considered significant. Results: 40 patients had Heartmate II and 2 had Heartware devices. Table 1 describes the characteristics of the 3 cohorts of endothelial function. Overall 81% had aortic valve opening consistently at the time of endothelial function assessment. Only 19% had a poor VRI, while majority had an intermediate VRI. Older patients had worse endothelial function while rest of the baseline characteristics including aortic valve opening and flow were not different between the groups. Correlation between VRI and VAD flow (r5 -0.2766 P value5 0.08) and high Doppler blood pressure (r5 -0.2656 P value50.09) showed no significance. However, 50% of the patients with a poor VRI had adverse events while only 23% of those with good endothelial function did (Table 1). The 2 patients with poor VRI who had a GI bleed had 5 episodes while the 3 patients with good VRI had 4 episodes. Conclusion: In a cohort of CF-LVAD patients where the majority had their aortic valve open, endothelial function, as reflected by DTM was poor in only a few. It is not clear if endothelial dysfunction contributes to any of adverse events for CF-LVAD patients but there seem to be a higher recurrence of GI bleeding in patients who had a poor endothelial function. Table 1.
Total
!1
N 42 (100%) 8 (19%) VENDYS score 1.7160.78 0.4560.35 Age 57612.8 60.367.5 Male 34 (81%) 5 (62.5%) Caucasian 17(40%) 2 (25%) DT 31 (74%) 6 (75%) AV opened 34 (81%) 7 (87%) Days under 5856567 2446276 support BUN 275.476282.4 25.25616.47 Hgb 11.0662.22 9.7761.47 Flow 5.4961.34 6.461.47 Patients with 17(100%) 4 (23%) events GIB 10 (58%) 2 Infections 4 (23%) 1 Arrhythmia 1 (6%) 0 ADHF 3 (18%) 0 Death 3 (14%) 1
1 to 2
2 to 3
p value
21 (50%) 1.6960.28 59.6610.1 19 (90%) 9 (43%) 17 (81%) 17 (81%) 6726586
13 (31%) 2.560.35 50.2616.7 10 (77%) 6 (46%) 8 (61%) 10 (77%) 4976582
0.073 0.2082 0.6009 0.45 0.835 0.17
24.867.23 20.667.54 11.5662.45 11.0462.01 5.2161.51 5.3760.51 10 (59%) 3 (18%)
0.41 0.15 0.098 0.3
5 3 1 3 2
0.99 0.36 0.59 0.19 0.46
3 0 0 0 0
VENDYS score: Endothelial function based thermal vascular reactivity. DT: Destination Therapy. AV: Aortic valve. GIB: Gastrointestinal bleeding. ADHF: Acute decompensated heart failure.