Caregiver-specific outcomes in antidementia clinical drug trials

A systematic review and meta-analysis

Jennifer Hagerty Lingler, Lynn Margaret Martire, Richard Schulz

Research output: Contribution to journalReview article

65 Citations (Scopus)

Abstract

OBJECTIVES: To describe the range of caregiver-specific outcomes and approaches to their study within antidementia drug trials and to quantify the effect of cholinesterase inhibitors on burden and active time use of caregivers of persons with Alzheimer's disease (AD). DESIGN: Systematic review of English-language publications and unpublished reports of antidementia clinical drug trials that included caregiver-specific outcomes. Study characteristics and methodological quality were summarized. Random effects meta-analyses were conducted for the outcomes of caregiver burden and active time use. SETTING: Community. PARTICIPANTS: Informal caregivers of participants in clinical trials of antidementia drugs. MEASUREMENTS: Burden, time use, psychological well-being, healthcare costs, and ease of use of or satisfaction with intervention. RESULTS: Seventeen studies involving 4,744 subjects were identified. Four trials (n = 1,594) met criteria for inclusion in the burden analysis, and six trials (n = 2,286) met criteria for inclusion in the time-use analysis. Most investigations involved drugs now approved by the Food and Drug Administration for the treatment of AD; donepezil was the most frequently studied intervention in the set of studies. Methodological quality varied across trials. The weighted average effect sizes were Cohen's d = 0.18 (95% confidence interval (CI) = 0.04-0.32) and d= 0.15 (95% CI = 0.07-0.24) for the outcomes of caregiver burden and time use, respectively. CONCLUSION: Cholinesterase inhibitors have a small beneficial effect on burden and active time use among caregivers of persons with AD. Recommendations to enhance the quality and interpretability of AD clinical trials that involve caregiver-specific outcomes are presented.

Original languageEnglish (US)
Pages (from-to)983-990
Number of pages8
JournalJournal of the American Geriatrics Society
Volume53
Issue number6
DOIs
StatePublished - Jun 1 2005

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Caregivers
Meta-Analysis
Clinical Trials
Pharmaceutical Preparations
Alzheimer Disease
Cholinesterase Inhibitors
Confidence Intervals
United States Food and Drug Administration
Health Care Costs
Publications
Language
Psychology

All Science Journal Classification (ASJC) codes

  • Geriatrics and Gerontology

Cite this

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abstract = "OBJECTIVES: To describe the range of caregiver-specific outcomes and approaches to their study within antidementia drug trials and to quantify the effect of cholinesterase inhibitors on burden and active time use of caregivers of persons with Alzheimer's disease (AD). DESIGN: Systematic review of English-language publications and unpublished reports of antidementia clinical drug trials that included caregiver-specific outcomes. Study characteristics and methodological quality were summarized. Random effects meta-analyses were conducted for the outcomes of caregiver burden and active time use. SETTING: Community. PARTICIPANTS: Informal caregivers of participants in clinical trials of antidementia drugs. MEASUREMENTS: Burden, time use, psychological well-being, healthcare costs, and ease of use of or satisfaction with intervention. RESULTS: Seventeen studies involving 4,744 subjects were identified. Four trials (n = 1,594) met criteria for inclusion in the burden analysis, and six trials (n = 2,286) met criteria for inclusion in the time-use analysis. Most investigations involved drugs now approved by the Food and Drug Administration for the treatment of AD; donepezil was the most frequently studied intervention in the set of studies. Methodological quality varied across trials. The weighted average effect sizes were Cohen's d = 0.18 (95{\%} confidence interval (CI) = 0.04-0.32) and d= 0.15 (95{\%} CI = 0.07-0.24) for the outcomes of caregiver burden and time use, respectively. CONCLUSION: Cholinesterase inhibitors have a small beneficial effect on burden and active time use among caregivers of persons with AD. Recommendations to enhance the quality and interpretability of AD clinical trials that involve caregiver-specific outcomes are presented.",
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Caregiver-specific outcomes in antidementia clinical drug trials : A systematic review and meta-analysis. / Lingler, Jennifer Hagerty; Martire, Lynn Margaret; Schulz, Richard.

In: Journal of the American Geriatrics Society, Vol. 53, No. 6, 01.06.2005, p. 983-990.

Research output: Contribution to journalReview article

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