- Email: [email protected]
The Association between Alzheimer's Disease Severity as measured by RMBPC and Caregiver-reported Outcomes
2013 AAGP Annual Meeting Poster Number: NR 09
Prevention of Depression Using Escitalopram in Patients Undergoing Treatment for Head and Neck Cancer William Burke, MD1; Kendra Schmid, PhD1; William Lydiatt, MD1,2 1 2
University of Nebraska Medical Center, Omaha, NE Nebraska Methodist Cancer Center, Omaha, NE
Introduction: Major depressive disorder develops in up to half of patients undergoing treatment for head and neck cancer resulting in significant morbidity. Preventing depression during the course of cancer treatment may, thus, be of great benefit. To determine whether prophylactic use of the antidepressant escitalopram would decrease the incidence of depression in subjects receiving primary therapy for head and neck cancer. Methods: A randomized, double-blind, placebo-controlled trial of escitalopram versus placebo was conducted in a group of non-depressed subjects diagnosed with head and neck cancer who were about to enter cancer treatment. Subjects were stratified by gender, site, stage (early versus advanced), and by primary modality of treatment (radiation versus surgery). The primary outcome measure was the number of participants who developed moderate or greater depression (scores on the Quick Inventory of Depressive Symptomology-Self Rated > 11). Results: 148 patients were randomized. Significantly fewer subjects receiving escitalopram developed depression (24.6% placebo vs. 10% escitalopram, stratified log-rank test p ¼ 0.04). A Cox proportional hazard regression model compared the two treatment groups after controlling for age, baseline smoking status, and stratification variables. The hazard ratio of 0.37 (95% CI: 0.14, 0.96) demonstrated an advantage of escitalopram (p ¼ 0.04). Patients undergoing radiotherapy as the initial modality were significantly more likely to develop depression than those receiving surgery (radiotherapy, compared to surgery group, HR 3.6 [95% CI: 1.38, 9.40, p ¼ 0.009]). Subjects in the escitalopram group who completed the study and were not depressed rated their overall quality of life as significantly better for 3 consecutive months following cessation of drug. Conclusions: In non-depressed subjects undergoing treatment for head and neck cancer, prophylactic escitalopram reduced the risk of developing depression by more than 50%. In non-depressed subjects who completed the trial, quality of life was also significantly better for 3 consecutive months following cessation of the drug in the escitalopram group. These findings have important implications for management of head and neck patients.
Poster Number: NR 10
The Association between Alzheimer’s Disease Severity as measured by RMBPC and Caregiver-reported Outcomes Michael Durkin, MSc1; Shaloo Gupta, MS3; Deborah Freedman, MBA3; Jonathan Chapnick, BA3; Sonali Shah, PharmD2 1
Janssen Scientific Affairs, LLC, Titusville, NJ Pfizer, New York, NY 3 Kantar Health, Princeton, NJ 2
Introduction: The objective was to describe the self-reported attributes and outcomes for caregivers of patients with Alzheimer’s disease (AD) and quantify the association of patient severity with caregiving hours per week reported by caregiver. Methods: From a 2009 survey of 1079 AD caregivers, responses from unpaid primary caregivers of community-dwelling AD patients were selected. Patient severity was calculated from responses to the Revised Memory and Behavioral Problem Checklist (RMBPC) as a continuous (0-4) variable. Caregiver attributes and outcomes were described for three cohorts based on RMBPC; Mild (RMBPC < 1.25), Moderate (1.25 RMBPC < 2.25), and Severe (RMBPC 2.25) and compared using chi-square tests for categorical variables and ANOVA for continuous variables. A generalized linear regression model with a negative binomial distribution was constructed for ‘caregiving hours per week’ with RMBPC, age, gender, marital status, relation to patient, living situation, employment and income as covariates. Results: Of the 849 caregivers meeting study criteria, 18.8% were caring for persons categorized as Mild (n¼160), 52.4% as Moderate (n¼445) and 26.4% as Severe (n¼244). Significant differences (p<0.05) were observed among the severity groups in attributes such as age, relation to AD patient, diagnosed depression and diagnosed anxiety and in caregiver outcomes such as Zarit Caregiver Burden Scale, Desire to Institutionalize Scale, SF-12 Mental and Physical Composite Summary Scores, work days per month missed due to caregiving and caregiving hours per week (Mild¼43.6 hours, Moderate¼ 47.9 hours, Severe¼ 55.1 hours). A positive relationship between RMBPC and caregiving hours was seen in the multivariate analysis, with a 1 point
Am J Geriatr Psychiatry 21:3, Supplement 1
S133
2013 AAGP Annual Meeting change in RMBPC associated with a 10% change in hours (p¼0.005). Two factors associated with less time caregiving were household income greater than $50,000 (p¼0.013) and living apart from the AD patient (p<0.001). Conclusions: In this survey of unpaid caregivers of AD patients living in the community, differences in caregiver characteristics and outcomes were quantified among those caring for Mild, Moderate and Severe AD patients. The findings of this study suggest that higher patient severity is associated with increased burden on caregivers in terms of caregiving time, lost work time and quality of life. Caregiver Attributes and Outcomes by Patient Severity Severity by RMBPC Score Total (N¼849) Mild (N¼160) Moderate (N¼445) Severe (N¼244) P Value Caregiver Attributes Age (Mean SD) Gender (Female) Relationship to Alzheimer’s Disease Patient Spouse/significant other Daughter/Son/In-Law Grandchild Other Caregiver Employment Full-Time, Part-Time, or Self Employed Not Employed Diagnosed with Anxiety Diagnosed with Depression Caregiver Outcomes Zarit Caregiver Burden Scale (Mean SD) Desire To Institutionalize Scale (Mean SD) SF-12v2: Mental Component Summary (Mean SD) SF-12v2: Physical Component Summary (Mean SD) Work Days Missed Due to Caregiving (Mean SD) Hours per Week Providing Care (Mean SD)
51.09 13.43 69.61%
53.07 14.69 65.00%
51.86 13.20 70.79%
48.39 12.63 70.49%
<.001 0.370 0.007
15.55% 61.96% 15.43% 7.07%
20.63% 61.25% 12.50% 5.63%
16.85% 62.70% 13.03% 7.42%
9.84% 61.07% 21.72% 7.38%
55.12% 44.88% 28.15% 31.21%
56.25% 43.75% 10.00% 11.25%
54.16% 45.84% 29.44% 30.34%
56.15% 43.85% 37.70% 45.90%
<.001 <.001
37.67 15.52
44.86 16.56
<.001
0.838
37.45 16.90 25.53 14.26 2.50 2.03
1.28 1.52
2.56 2.01
3.18 2.02
<.001
42.43 11.87
48.41 10.67
42.58 11.53
38.25 11.55
<.001
47.81 11.25
49.76 9.66
47.95 11.22
46.29 12.07
0.009
5.95 15.13
1.39 3.09
5.48 12.49
9.75 21.76
<.001
49.12 37.36
43.64 34.55
47.86 37.63
55.06 38.00
0.013
Poster Number: NR 11
The Association between Patient Dependence and Caregiver Burden in Alzheimer’s Disease
Michael Durkin, MSc1; Sonali Shah, PharmD2; Shaloo Gupta, MS3; Deborah Freedman, MBA3; Jonathan Chapnick, BA3 1
Janssen Scientific Affairs, LLC, Titusville, NJ Pfizer, New York, NY 3 Kantar Health, Princeton, NJ 2
Introduction: The objective was to examine how self-reported burden for caregivers of patients with Alzheimer’s disease (AD) self-reported burden differs by quartile of Dependence Scale (DS) and quantify the association between DS score and Zarit Burden Interview (ZBI) score. Methods: Responses from unpaid primary caregivers of community-dwelling AD patients were analyzed from a 2009 survey of 1079 AD caregivers. Patient dependence was evaluated from responses to the 15 item DS. Caregiver outcomes were stratified into four cohorts based on DS quartiles; Q1 (DS¼0-6), Q2 (DS¼7-8), Q3 (DS¼9-10) and Q4 (DS¼11-15) and compared using chi-square tests for categorical outcomes and ANOVA for continuous variables. Outcomes examined included caregiver burden as measured by the ZBI and health-related quality of life as measured by the SF-12 and SF-6D. A least squares linear regression
S134
Am J Geriatr Psychiatry 21:3, Supplement 1
Prevention of Depression Using Escitalopram in Patients Undergoing Treatment for Head and Neck Cancer William Burke, MD1; Kendra Schmid, PhD1; William Lydiatt, MD1,2 1 2
University of Nebraska Medical Center, Omaha, NE Nebraska Methodist Cancer Center, Omaha, NE
Introduction: Major depressive disorder develops in up to half of patients undergoing treatment for head and neck cancer resulting in significant morbidity. Preventing depression during the course of cancer treatment may, thus, be of great benefit. To determine whether prophylactic use of the antidepressant escitalopram would decrease the incidence of depression in subjects receiving primary therapy for head and neck cancer. Methods: A randomized, double-blind, placebo-controlled trial of escitalopram versus placebo was conducted in a group of non-depressed subjects diagnosed with head and neck cancer who were about to enter cancer treatment. Subjects were stratified by gender, site, stage (early versus advanced), and by primary modality of treatment (radiation versus surgery). The primary outcome measure was the number of participants who developed moderate or greater depression (scores on the Quick Inventory of Depressive Symptomology-Self Rated > 11). Results: 148 patients were randomized. Significantly fewer subjects receiving escitalopram developed depression (24.6% placebo vs. 10% escitalopram, stratified log-rank test p ¼ 0.04). A Cox proportional hazard regression model compared the two treatment groups after controlling for age, baseline smoking status, and stratification variables. The hazard ratio of 0.37 (95% CI: 0.14, 0.96) demonstrated an advantage of escitalopram (p ¼ 0.04). Patients undergoing radiotherapy as the initial modality were significantly more likely to develop depression than those receiving surgery (radiotherapy, compared to surgery group, HR 3.6 [95% CI: 1.38, 9.40, p ¼ 0.009]). Subjects in the escitalopram group who completed the study and were not depressed rated their overall quality of life as significantly better for 3 consecutive months following cessation of drug. Conclusions: In non-depressed subjects undergoing treatment for head and neck cancer, prophylactic escitalopram reduced the risk of developing depression by more than 50%. In non-depressed subjects who completed the trial, quality of life was also significantly better for 3 consecutive months following cessation of the drug in the escitalopram group. These findings have important implications for management of head and neck patients.
Poster Number: NR 10
The Association between Alzheimer’s Disease Severity as measured by RMBPC and Caregiver-reported Outcomes Michael Durkin, MSc1; Shaloo Gupta, MS3; Deborah Freedman, MBA3; Jonathan Chapnick, BA3; Sonali Shah, PharmD2 1
Janssen Scientific Affairs, LLC, Titusville, NJ Pfizer, New York, NY 3 Kantar Health, Princeton, NJ 2
Introduction: The objective was to describe the self-reported attributes and outcomes for caregivers of patients with Alzheimer’s disease (AD) and quantify the association of patient severity with caregiving hours per week reported by caregiver. Methods: From a 2009 survey of 1079 AD caregivers, responses from unpaid primary caregivers of community-dwelling AD patients were selected. Patient severity was calculated from responses to the Revised Memory and Behavioral Problem Checklist (RMBPC) as a continuous (0-4) variable. Caregiver attributes and outcomes were described for three cohorts based on RMBPC; Mild (RMBPC < 1.25), Moderate (1.25 RMBPC < 2.25), and Severe (RMBPC 2.25) and compared using chi-square tests for categorical variables and ANOVA for continuous variables. A generalized linear regression model with a negative binomial distribution was constructed for ‘caregiving hours per week’ with RMBPC, age, gender, marital status, relation to patient, living situation, employment and income as covariates. Results: Of the 849 caregivers meeting study criteria, 18.8% were caring for persons categorized as Mild (n¼160), 52.4% as Moderate (n¼445) and 26.4% as Severe (n¼244). Significant differences (p<0.05) were observed among the severity groups in attributes such as age, relation to AD patient, diagnosed depression and diagnosed anxiety and in caregiver outcomes such as Zarit Caregiver Burden Scale, Desire to Institutionalize Scale, SF-12 Mental and Physical Composite Summary Scores, work days per month missed due to caregiving and caregiving hours per week (Mild¼43.6 hours, Moderate¼ 47.9 hours, Severe¼ 55.1 hours). A positive relationship between RMBPC and caregiving hours was seen in the multivariate analysis, with a 1 point
Am J Geriatr Psychiatry 21:3, Supplement 1
S133
2013 AAGP Annual Meeting change in RMBPC associated with a 10% change in hours (p¼0.005). Two factors associated with less time caregiving were household income greater than $50,000 (p¼0.013) and living apart from the AD patient (p<0.001). Conclusions: In this survey of unpaid caregivers of AD patients living in the community, differences in caregiver characteristics and outcomes were quantified among those caring for Mild, Moderate and Severe AD patients. The findings of this study suggest that higher patient severity is associated with increased burden on caregivers in terms of caregiving time, lost work time and quality of life. Caregiver Attributes and Outcomes by Patient Severity Severity by RMBPC Score Total (N¼849) Mild (N¼160) Moderate (N¼445) Severe (N¼244) P Value Caregiver Attributes Age (Mean SD) Gender (Female) Relationship to Alzheimer’s Disease Patient Spouse/significant other Daughter/Son/In-Law Grandchild Other Caregiver Employment Full-Time, Part-Time, or Self Employed Not Employed Diagnosed with Anxiety Diagnosed with Depression Caregiver Outcomes Zarit Caregiver Burden Scale (Mean SD) Desire To Institutionalize Scale (Mean SD) SF-12v2: Mental Component Summary (Mean SD) SF-12v2: Physical Component Summary (Mean SD) Work Days Missed Due to Caregiving (Mean SD) Hours per Week Providing Care (Mean SD)
51.09 13.43 69.61%
53.07 14.69 65.00%
51.86 13.20 70.79%
48.39 12.63 70.49%
<.001 0.370 0.007
15.55% 61.96% 15.43% 7.07%
20.63% 61.25% 12.50% 5.63%
16.85% 62.70% 13.03% 7.42%
9.84% 61.07% 21.72% 7.38%
55.12% 44.88% 28.15% 31.21%
56.25% 43.75% 10.00% 11.25%
54.16% 45.84% 29.44% 30.34%
56.15% 43.85% 37.70% 45.90%
<.001 <.001
37.67 15.52
44.86 16.56
<.001
0.838
37.45 16.90 25.53 14.26 2.50 2.03
1.28 1.52
2.56 2.01
3.18 2.02
<.001
42.43 11.87
48.41 10.67
42.58 11.53
38.25 11.55
<.001
47.81 11.25
49.76 9.66
47.95 11.22
46.29 12.07
0.009
5.95 15.13
1.39 3.09
5.48 12.49
9.75 21.76
<.001
49.12 37.36
43.64 34.55
47.86 37.63
55.06 38.00
0.013
Poster Number: NR 11
The Association between Patient Dependence and Caregiver Burden in Alzheimer’s Disease
Michael Durkin, MSc1; Sonali Shah, PharmD2; Shaloo Gupta, MS3; Deborah Freedman, MBA3; Jonathan Chapnick, BA3 1
Janssen Scientific Affairs, LLC, Titusville, NJ Pfizer, New York, NY 3 Kantar Health, Princeton, NJ 2
Introduction: The objective was to examine how self-reported burden for caregivers of patients with Alzheimer’s disease (AD) self-reported burden differs by quartile of Dependence Scale (DS) and quantify the association between DS score and Zarit Burden Interview (ZBI) score. Methods: Responses from unpaid primary caregivers of community-dwelling AD patients were analyzed from a 2009 survey of 1079 AD caregivers. Patient dependence was evaluated from responses to the 15 item DS. Caregiver outcomes were stratified into four cohorts based on DS quartiles; Q1 (DS¼0-6), Q2 (DS¼7-8), Q3 (DS¼9-10) and Q4 (DS¼11-15) and compared using chi-square tests for categorical outcomes and ANOVA for continuous variables. Outcomes examined included caregiver burden as measured by the ZBI and health-related quality of life as measured by the SF-12 and SF-6D. A least squares linear regression
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Am J Geriatr Psychiatry 21:3, Supplement 1