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Reliability and Validity Testing of the MD Anderson Symptom Inventory-Heart Failure (MDASI-HF): A Pilot Study of an Evaluative Instrument for Symptom Identification in Heart Failure Patients with Cancer
S116 Journal of Cardiac Failure Vol. 12 No. 6 Suppl. 2006 380
382
Reliability and Validity Testing of the MD Anderson Symptom Inventory-Heart Failure (MDASI-HF): A Pilot Study of an Evaluative Instrument for Symptom Identification in Heart Failure Patients with Cancer Anecita P. Fadol1, Jeanette G. Kernicki2, Daniel J. Lenihan1, Tito Mendoza3, Charles S. Cleeland3; 1Cardiology, The University of Texas MD Anderson Cancer Center, Houston, TX; 2College of Nursing, Texas Woman’s University, Houston, TX; 3 Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX
Beta-Blocker Uptitration in Nurse-Based Heart Failure Clinics e How Well Does It Work? Results from the Danish Heart Failure Clinics Network Finn Gustafsson1, Lars Videbaek2, Hans Ulriksen3, Berit B. Andersen4, Morten Schou5, Per Hildebrandt5; 1Department of Cardiology, Rigshospitalet, Copenhagen, Denmark; 2Department of Cardiology, Odense University Hospital, Odense, Denmark; 3Department of Medicine, Skive Sygehus, Skive, Denmark; 4Department of Medicine, Esbjerg Hospital, Esbjerg, Denmark; 5Department of Cardiology, Frederiksberg University Hospital, Frederiksberg, Denmark
Objective: Symptom assessment can be difficult in patients with heart failure and it is known that progression of symptoms is a harbinger of disease progression. Currently, assessment tools for symptom progression in heart failure are not typically utilized in clinical practice. In patients with both heart failure and cancer who have common symptoms signifying progression, this can be especially challenging. A need exists for a symptom assessment instrument for this patient population that can discern between symptoms that result from these two conditions. Thus, a pilot study to evaluate the reliability and validity of an instrument for symptom assessment of cancer patients with heart failure, the MD Anderson Symptom Inventory- Heart Failure (MDASI-HF) was performed. Materials and Methods: Thirty two patients diagnosed with cancer and heart failure provided ratings for the pilot study on the 24 symptom severity questions and six interference items measuring symptom burden. Results: Criterion validity showed moderate correlation scores with the Eastern Cooperative Oncology Group (ECOG) performance status with r 5 .73, .66, and .75 for the mean core items, heart failure items, and interference items respectively; and the New York Heart Association (NYHA) functional classification with r 5 .72(core items), .71 (heart failure items), and .78 (interference items). All correlations were statistically significant. Construct validity was determined using factor analysis, which yielded a six factor solution accounting for 80% of the common variance. Internal consistency reliability showed a Cronbach’s coefficient alpha of .936 for the severity items, and .906 for the interference items. Conclusion: Preliminary results suggest that the MDASI-HF appears to be a valid tool in examining symptom prevalence and burden in heart failure patients with cancer. Further study is needed to establish validity and reliability of the instrument in discerning symptom burden in patients with both conditions.
Background: In recent years nurse-based clinics dedicated to the care of heart failure (HF) patients have emerged. One major argument for initiating such clinics was to promote the time-consuming task of initiation and uptitration of beta-blocking drugs. In Denmark, most heart failure clinics share a heart failure-dedicated electronic patient file system (Hjerterplus), which also serves as a clinical database. Using data from this database, the aim of the present study was to determine 1) the rate of success in betablocker (BB) uptitration after three months and 2) to identify potential predictors of non-treatment and uptitration failure. Methods and patients: 2448 consecutive outpatients followed in 14 specialized nurse based HF clinics from April 2002 to November 2005. BB treatment (yes/no) and doses were recorded three months after the initial clinic visit. Mean age (SD) was 68,3 (11,7) years and 28 % were women. Left ventricular systolic dysfunction (LVEF ! 0.45) was present in 96 %. Results: At referral 18 % were treated with BB. After three months 79 % were treated with BB and 90 % received an angiotensin converting enzyme inhibitor or -receptor blocker. Mean BB dose (relative to target dose) was 50 (4) %. More men (81 %) than women (74 %) received a BB at three months (P ! 0.001), and BB doses in women were lower (mean dose relative to target 42 % vs. 52 % in men, P ! 0.001). Furthermore BB treatment and doses at three months depended on age (mean age on BB vs. no BB: 67,7 vs. 72,1 years, P ! 0.01). The effect of gender on BB treatment and dose was independent of the effect of age (multivariable analysis). Diabetes, atrial fibrillation, baseline heart rate, baseline blood pressure and LVEF did not predict BB treatment or dose at three months. Conclusion: This large registry of consecutive HF outpatients shows that nurse-based HF clinics are effective in initiating BB treatment, but doses are not optimal. Women and elderly are less likely to receive optimal treatment with BB. Efforts should be made to ensure that BB treatment is initiated also in elderly and women, and strategies to ensure continued drug uptitration appear to be necessary.
383
381 Changes in B-Type Natriuretic Peptide Levels Do Not Detect Differences in Volume Removed by Ultrafiltration or Diuretics in Patients with Heart Failure Maya E. Guglin1, Erika D. Feller2, Maria Rosa Costanzo3, Allen S. Anderson4, Paul A. Sobotka5; 1Department of Medicine, Wayne State University, Detroit, MI; 2 Deoartment of Medicine, University of Maryland, Baltimore, MD; 3Midwest Heart Foundation, Naperville, IL; 4Department of Medicine, University of Chicago, Chicago, IL; 5CHF Solutions, Brooklyn Park, MN Background: The Ultrafiltration versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure (UNLOAD) trial showed that among 200 heart failure (HF) patients (pts) with volume overload (63 6 15 yrs, 69% male, 71% LVEF ! / 5 40%), compared to the intravenous (IV)diuretic group, the ultrafiltration (UF) group had greater weight (5.0 6 3.1vs 3.1 6 3.5 Kg; p 5 0.001) and net fluid loss (4.6 vs 3.3 L; p 5 0.001) at 48 h after randomization and fewer re-hospitalizations for HF in 90 days (0.22 6 0.54 vs 0.46 6 0.76; p 5 0.022). The study permits evaluation of the relationship between changes in B-type natriuretic peptide (BNP) levels and changes in volume in HF pts. Methods: BNP levels were measured using the TriageÒ BNP Test (Biosite Inc. San Diego, CA) at trial entry, 48 h after randomization, at 30 and 90 days. Differences in BNP levels between groups were evaluated with Wilcoxon’s rank sum test. Change over time in BNP levels within groups was tested using Wilcoxon’s matched pairs signed ranks test. Correlations between changes in BNP levels and fluid loss were calculated using Spearman’s rho. P-values (2-tailed) ! 0.05 were considered statistically significant. Results: Baseline BNP levels (pg/ml) were similar in the UF and IV diuretics groups (1239 6 1092 vs 1148 6 1075; p 5 0.840). Changes in BNP levels were similar between groups at 48 h (p 5 0.576), 30 (p 5 0.463) and 90 days (p 5 0.684). At 48 h there was no significant correlation between changes in weight and in BNP levels in either UF (r 5 0.061; p 5 0.743) or IV diuretics group (r 5 0.057; p 5 0.753). Changes in BNP levels at 48 h did not predict re-hospitalization in either UF (HR 5 0.9997, CI 0.9988-1.0006; p 5 0.541) or IV diuretics group (HR 5 1.0005, CI 0.999-1.0012; p 5 0.122). Changes in BNP and in serum creatinine levels were not correlated in either UF (r 5 0.117; p 5 0.516) or IV diuretic group (r 5 0.057; p 5 0.738). Conclusions: The similar changes in BNP levels in the two groups, despite greater weight and fluid loss with UF than with IV diuretics, suggest that measures of this biomarker cannot detect the significant differences in volume removed by the two therapies. Changes in BNP levels also lack the sensitivity to predict re-hospitalizations for HF.
Preliminary Results of a Simple Bedside Method To Distinguish Systolic from Diastolic LV Failure e A Radial Pulse-Wave Analysis Report Vijayasree Kudithipudi, Vincent L. Sorrell; Cardiology, University of Arizona, Tucson, AZ Background: Heart failure poses an increasingly significant medical and economic burden. Management options and additional diagnostic testing is contingent upon determining the LV systolic and diastolic function. A rapid, non invasive tool to accurately distinguish systolic from diastolic dysfunction would be valued. We tested the ability of an FDA-approved radial tonometry device (Sphygmocor; AtCor Medical Corp; Sydney, Australia) for this novel purpose. Methods: 73 randomly selected patients evaluated with echocardiography underwent simultaneous radial artery tonometry. Conventional 2D and Doppler echocardiography was performed to determine systolic and diastolic function. Group I patients had a normal LVEF $ 55% (62 6 0.8)[Group IA 5 normal diastolic function; IB 5 abnormal diastolic function]. Group II patients had an impaired LVEF ! 55% (34 6 2) [see Table]. The central aortic waveform was derived from the radial pulse analysis using nearly real-time, off-line automated software and allowed the determination of the Central Aortic BP (CABP), Augmentation Index (AI), Ejection Duration (ED) and Viability Index (VI). AI 5 ratio of augmentation pressure to the pulse pressure; VI 5 ratio of diastolic area with systolic area per minute; ED 5 the time from the opening to the closure of the aortic valve. Results: The study population was 63 6 13 years old; 58% were female; 53% were evaluated specifically for heart failure symptoms. Other than the VI, which was consistently higher in Group II (p 5 0.003), there were no significant differences between any of the clinical or pulse-derived findings (see Figure). Conclusion: In this preliminary investigation, it appears that this radial pulse technique may provide clinicians with a rapid bedside tool to categorize patients into systolic or diastolic heart failure categories. A prospective investigation to further clarify this relationship is warranted. Table showing LVEF groups and their respective indices expressed as mean ± SEM Group IA (n 5 21) VI AI ED LVEF CABP * 5 p ! 0.05.
151 24 303 62 36
6 6 6 6 6
8 3 7 0.9 3
Group IB (n 5 25) 151 21 284 61 42
6 6 6 6 6
5 2 6 0.8 3
Group II (n 5 27) 172 22 291 34 26
6 6 6 6 6
8* 3 7 2* 3
p for group I vs II 0.003 NS NS 0.004 NS
382
Reliability and Validity Testing of the MD Anderson Symptom Inventory-Heart Failure (MDASI-HF): A Pilot Study of an Evaluative Instrument for Symptom Identification in Heart Failure Patients with Cancer Anecita P. Fadol1, Jeanette G. Kernicki2, Daniel J. Lenihan1, Tito Mendoza3, Charles S. Cleeland3; 1Cardiology, The University of Texas MD Anderson Cancer Center, Houston, TX; 2College of Nursing, Texas Woman’s University, Houston, TX; 3 Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX
Beta-Blocker Uptitration in Nurse-Based Heart Failure Clinics e How Well Does It Work? Results from the Danish Heart Failure Clinics Network Finn Gustafsson1, Lars Videbaek2, Hans Ulriksen3, Berit B. Andersen4, Morten Schou5, Per Hildebrandt5; 1Department of Cardiology, Rigshospitalet, Copenhagen, Denmark; 2Department of Cardiology, Odense University Hospital, Odense, Denmark; 3Department of Medicine, Skive Sygehus, Skive, Denmark; 4Department of Medicine, Esbjerg Hospital, Esbjerg, Denmark; 5Department of Cardiology, Frederiksberg University Hospital, Frederiksberg, Denmark
Objective: Symptom assessment can be difficult in patients with heart failure and it is known that progression of symptoms is a harbinger of disease progression. Currently, assessment tools for symptom progression in heart failure are not typically utilized in clinical practice. In patients with both heart failure and cancer who have common symptoms signifying progression, this can be especially challenging. A need exists for a symptom assessment instrument for this patient population that can discern between symptoms that result from these two conditions. Thus, a pilot study to evaluate the reliability and validity of an instrument for symptom assessment of cancer patients with heart failure, the MD Anderson Symptom Inventory- Heart Failure (MDASI-HF) was performed. Materials and Methods: Thirty two patients diagnosed with cancer and heart failure provided ratings for the pilot study on the 24 symptom severity questions and six interference items measuring symptom burden. Results: Criterion validity showed moderate correlation scores with the Eastern Cooperative Oncology Group (ECOG) performance status with r 5 .73, .66, and .75 for the mean core items, heart failure items, and interference items respectively; and the New York Heart Association (NYHA) functional classification with r 5 .72(core items), .71 (heart failure items), and .78 (interference items). All correlations were statistically significant. Construct validity was determined using factor analysis, which yielded a six factor solution accounting for 80% of the common variance. Internal consistency reliability showed a Cronbach’s coefficient alpha of .936 for the severity items, and .906 for the interference items. Conclusion: Preliminary results suggest that the MDASI-HF appears to be a valid tool in examining symptom prevalence and burden in heart failure patients with cancer. Further study is needed to establish validity and reliability of the instrument in discerning symptom burden in patients with both conditions.
Background: In recent years nurse-based clinics dedicated to the care of heart failure (HF) patients have emerged. One major argument for initiating such clinics was to promote the time-consuming task of initiation and uptitration of beta-blocking drugs. In Denmark, most heart failure clinics share a heart failure-dedicated electronic patient file system (Hjerterplus), which also serves as a clinical database. Using data from this database, the aim of the present study was to determine 1) the rate of success in betablocker (BB) uptitration after three months and 2) to identify potential predictors of non-treatment and uptitration failure. Methods and patients: 2448 consecutive outpatients followed in 14 specialized nurse based HF clinics from April 2002 to November 2005. BB treatment (yes/no) and doses were recorded three months after the initial clinic visit. Mean age (SD) was 68,3 (11,7) years and 28 % were women. Left ventricular systolic dysfunction (LVEF ! 0.45) was present in 96 %. Results: At referral 18 % were treated with BB. After three months 79 % were treated with BB and 90 % received an angiotensin converting enzyme inhibitor or -receptor blocker. Mean BB dose (relative to target dose) was 50 (4) %. More men (81 %) than women (74 %) received a BB at three months (P ! 0.001), and BB doses in women were lower (mean dose relative to target 42 % vs. 52 % in men, P ! 0.001). Furthermore BB treatment and doses at three months depended on age (mean age on BB vs. no BB: 67,7 vs. 72,1 years, P ! 0.01). The effect of gender on BB treatment and dose was independent of the effect of age (multivariable analysis). Diabetes, atrial fibrillation, baseline heart rate, baseline blood pressure and LVEF did not predict BB treatment or dose at three months. Conclusion: This large registry of consecutive HF outpatients shows that nurse-based HF clinics are effective in initiating BB treatment, but doses are not optimal. Women and elderly are less likely to receive optimal treatment with BB. Efforts should be made to ensure that BB treatment is initiated also in elderly and women, and strategies to ensure continued drug uptitration appear to be necessary.
383
381 Changes in B-Type Natriuretic Peptide Levels Do Not Detect Differences in Volume Removed by Ultrafiltration or Diuretics in Patients with Heart Failure Maya E. Guglin1, Erika D. Feller2, Maria Rosa Costanzo3, Allen S. Anderson4, Paul A. Sobotka5; 1Department of Medicine, Wayne State University, Detroit, MI; 2 Deoartment of Medicine, University of Maryland, Baltimore, MD; 3Midwest Heart Foundation, Naperville, IL; 4Department of Medicine, University of Chicago, Chicago, IL; 5CHF Solutions, Brooklyn Park, MN Background: The Ultrafiltration versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure (UNLOAD) trial showed that among 200 heart failure (HF) patients (pts) with volume overload (63 6 15 yrs, 69% male, 71% LVEF ! / 5 40%), compared to the intravenous (IV)diuretic group, the ultrafiltration (UF) group had greater weight (5.0 6 3.1vs 3.1 6 3.5 Kg; p 5 0.001) and net fluid loss (4.6 vs 3.3 L; p 5 0.001) at 48 h after randomization and fewer re-hospitalizations for HF in 90 days (0.22 6 0.54 vs 0.46 6 0.76; p 5 0.022). The study permits evaluation of the relationship between changes in B-type natriuretic peptide (BNP) levels and changes in volume in HF pts. Methods: BNP levels were measured using the TriageÒ BNP Test (Biosite Inc. San Diego, CA) at trial entry, 48 h after randomization, at 30 and 90 days. Differences in BNP levels between groups were evaluated with Wilcoxon’s rank sum test. Change over time in BNP levels within groups was tested using Wilcoxon’s matched pairs signed ranks test. Correlations between changes in BNP levels and fluid loss were calculated using Spearman’s rho. P-values (2-tailed) ! 0.05 were considered statistically significant. Results: Baseline BNP levels (pg/ml) were similar in the UF and IV diuretics groups (1239 6 1092 vs 1148 6 1075; p 5 0.840). Changes in BNP levels were similar between groups at 48 h (p 5 0.576), 30 (p 5 0.463) and 90 days (p 5 0.684). At 48 h there was no significant correlation between changes in weight and in BNP levels in either UF (r 5 0.061; p 5 0.743) or IV diuretics group (r 5 0.057; p 5 0.753). Changes in BNP levels at 48 h did not predict re-hospitalization in either UF (HR 5 0.9997, CI 0.9988-1.0006; p 5 0.541) or IV diuretics group (HR 5 1.0005, CI 0.999-1.0012; p 5 0.122). Changes in BNP and in serum creatinine levels were not correlated in either UF (r 5 0.117; p 5 0.516) or IV diuretic group (r 5 0.057; p 5 0.738). Conclusions: The similar changes in BNP levels in the two groups, despite greater weight and fluid loss with UF than with IV diuretics, suggest that measures of this biomarker cannot detect the significant differences in volume removed by the two therapies. Changes in BNP levels also lack the sensitivity to predict re-hospitalizations for HF.
Preliminary Results of a Simple Bedside Method To Distinguish Systolic from Diastolic LV Failure e A Radial Pulse-Wave Analysis Report Vijayasree Kudithipudi, Vincent L. Sorrell; Cardiology, University of Arizona, Tucson, AZ Background: Heart failure poses an increasingly significant medical and economic burden. Management options and additional diagnostic testing is contingent upon determining the LV systolic and diastolic function. A rapid, non invasive tool to accurately distinguish systolic from diastolic dysfunction would be valued. We tested the ability of an FDA-approved radial tonometry device (Sphygmocor; AtCor Medical Corp; Sydney, Australia) for this novel purpose. Methods: 73 randomly selected patients evaluated with echocardiography underwent simultaneous radial artery tonometry. Conventional 2D and Doppler echocardiography was performed to determine systolic and diastolic function. Group I patients had a normal LVEF $ 55% (62 6 0.8)[Group IA 5 normal diastolic function; IB 5 abnormal diastolic function]. Group II patients had an impaired LVEF ! 55% (34 6 2) [see Table]. The central aortic waveform was derived from the radial pulse analysis using nearly real-time, off-line automated software and allowed the determination of the Central Aortic BP (CABP), Augmentation Index (AI), Ejection Duration (ED) and Viability Index (VI). AI 5 ratio of augmentation pressure to the pulse pressure; VI 5 ratio of diastolic area with systolic area per minute; ED 5 the time from the opening to the closure of the aortic valve. Results: The study population was 63 6 13 years old; 58% were female; 53% were evaluated specifically for heart failure symptoms. Other than the VI, which was consistently higher in Group II (p 5 0.003), there were no significant differences between any of the clinical or pulse-derived findings (see Figure). Conclusion: In this preliminary investigation, it appears that this radial pulse technique may provide clinicians with a rapid bedside tool to categorize patients into systolic or diastolic heart failure categories. A prospective investigation to further clarify this relationship is warranted. Table showing LVEF groups and their respective indices expressed as mean ± SEM Group IA (n 5 21) VI AI ED LVEF CABP * 5 p ! 0.05.
151 24 303 62 36
6 6 6 6 6
8 3 7 0.9 3
Group IB (n 5 25) 151 21 284 61 42
6 6 6 6 6
5 2 6 0.8 3
Group II (n 5 27) 172 22 291 34 26
6 6 6 6 6
8* 3 7 2* 3
p for group I vs II 0.003 NS NS 0.004 NS