Casarett, David

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Now showing 1 - 3 of 3
  • Publication
    Open Label Extension Studies and the Ethical Design of Clinical Trials
    (2001-08-01) Cassarett, David; Karlawish, Jason; Sankar, Pamela; Hirschman, Karen; Asch, David A.
  • Publication
    Older Adults’ Attitudes Toward Enrollment of Noncompetent Subjects Participating in Alzheimer’s Research
    (2009-02-01) Karlawish, Jason; Rubright, Jonathan; Casarett, David; Cary, Mark; Ten Have, Thomas; Sankar, Pamela
    OBJECTIVE: Research that seeks to enroll noncompetent patients with Alzheimer’s disease without presenting any potential benefit to participants is the source of substantial ethical controversy. The authors used hypothetical Alzheimer’s disease studies that included either a blood draw or a blood draw and lumbar puncture to explore older persons’ attitudes on this question. METHOD: Face-to-face interviews were conducted with 538 persons age 65 and older. Questions explored participants’ understanding of research concepts, their views on enrolling persons with Alzheimer’s disease in research, and their preferences regarding having a proxy decision maker, granting advance consent, and granting their proxy leeway to override the participant’s decision. Additional questions assessed altruism, trust, value for research, and perceptions of Alzheimer’s disease. RESULTS: The majority (83%) were willing to grant advance consent to a blood draw study, and nearly half (48%) to a blood draw plus lumbar puncture study. Most (96%) were willing to identify a proxy for research decision making, and most were willing to grant their proxy leeway over their advance consent: 81% for the blood draw study and 70% for the blood draw plus lumbar puncture study. Combining the preferences for advance consent and leeway, the proportion who would permit being enrolled in the blood draw and lumbar puncture studies, respectively, were 92% and 75%. Multivariate models showed that willingness to be enrolled in research was most strongly associated with a favorable attitude toward biomedical research. CONCLUSIONS: Older adults generally support enrolling noncompetent persons with Alzheimer’s disease into research that does not present a benefit to subjects. Willingness to grant their proxy leeway over advance consent and a favorable attitude about biomedical research substantially explain this willingness.
  • Publication
    Why would caregivers not want to treat their relative's Alzheimer's disease?
    (2003-10-01) Karlawish, Jason; Casarett, David; Tenhave, Thomas; Asch, David A.; James, Bryan D.; Clark, Christine M.
    Objectives: To determine family caregivers' willingness to use Alzheimer's disease (AD)-slowing medicines and to examine the relationships between this willingness, dementia severity, and caregiver characteristics. Design: Cross-sectional survey. Setting: In-home interviews of patients from the Memory Disorders Clinic of the University of Pennsylvania's Alzheimer's Disease Center. Participants: One hundred two caregivers of patients with mild to severe AD who were registered at an Alzheimer's disease center. Measurements: Subjects participated in an in-home interview to assess their willingness to use a risk-free AD-slowing medicine and a medicine with 3% annual risk of gastrointestinal bleeding. Results: Half of the patients had severe dementia (n=52). Seventeen (17%) of the caregivers did not want their relative to take a risk-free medicine that could slow AD. Half (n=52) did not want their relative to take an AD-slowing medicine that had a 3% annual risk of gastrointestinal bleeding. Caregivers who were more likely to forgo risk-free treatment of AD were older (odds ratio (OR)=1.7, P=.04), were depressed (OR=3.66, P=.03), had relatives living in a nursing home (OR=3.6, P=.02), had relatives with more-severe dementia according to the Mini-Mental State Examination (MMSE) (OR=2.29, P=.03) or Dementia Severity Rating Scale (DSRS) (OR=2.55, P=.002), and rated their relatives' quality of life (QOL) poorly on a single-item global rating (OR=0.25, P=.001) and the 13-item quality-of-life (QOL)-AD scale (OR=0.38, P=.002). Caregivers who were more likely to forgo a risky treatment were nonwhite (OR=6.53, P=.005), had financial burden (OR=2.93, P=.02), and rated their relative's QOL poorly on a single-item global rating (OR=0.61, P=.01) and the QOL-AD (OR=0.56, P=.01). Conclusion: These results suggest that caregivers are generally willing to slow the progression of their relative's dementia even into the severe stage of the disease, especially if it can be done without risk to the patient. Clinical trials and practice guidelines should recognize that a caregiver's assessment of patient QOL and the factors that influence it affect a caregiver's willingness to use AD-slowing treatments.