Regular Research Article
“Thinking About It for Somebody Else”: Alzheimer's Disease Research and Proxy Decision Makers' Translation of Ethical Principles Into Practice

https://doi.org/10.1016/j.jagp.2012.11.014Get rights and content

Objectives

Ethical guidelines suggest that, when enrolling patients with dementia in research, alterative decision makers (proxies) should base their decision on a “substituted judgment” of how the patient would have decided. If unable to make a substituted judgment, proxies are asked to decide on the basis of the patient's best interests. This mixed-methods study is the first to examine explicitly whether and to what degree proxies differentiate between these two approaches and what considerations influence their mode of decision making.

Design

Interview study regarding enrollment of relative in hypothetical clinical trial of an investigational drug for Alzheimer disease. Participants were randomized to respond to questions about one of four hypothetical clinical trials that differed by levels of described risk and potential benefit.

Participants

Proxy decision makers (N = 40).

Measurements

Open-ended and rating-scaled items.

Results

Half of the proxies agreed with both of two rating-scaled items asking about different approaches to decision making—that is, agreeing that they would decide on the basis of how their relative would have decided and agreeing that they would decide on the basis of what they believed was in their relative's best interests. Narrative responses elaborated on themes within the following three major domains: Substituted judgment, best interests, and weighing substituted judgment and best interests. Substituted judgment was framed as honoring the patient's wishes and values. Best interests was described as a perceived duty to maintain quality of life and avoid burdens or risks. Weighing the two standards emerged as a challenging yet important, way of honoring wishes while maintaining quality of life. An unexpected theme was the attempt by alternative decision makers to discern their loved one's current versus premorbid research preferences.

Conclusions

Tensions exist between abstract ethical principles regarding decision-making “standards” and their translation into research decisions.

Section snippets

Participants

Proxy decision makers (adult children/stepchildren/grandchildren, spouses, siblings) for AD patients were eligible to participate in the larger study of proxy consent whose goal was to examine the influences on proxy decision making for AD research and the perspectives of proxies on AD research risks and benefits. Participants were recruited through community programs and events for dementia caregivers and families, as well as through online postings. Under the California law,12 participants

Participant Characteristics

Table 1 provides demographic characteristics of the 40 participating proxies. AD patients' characteristics are shown in Table 2. Most of the AD patients (n = 37, 97.5%) had not previously participated in AD-related research.

Endorsement of Decision-Making Standards

A majority of proxies (n = 27, 67.5%; Figure 1) agreed or strongly agreed that they would base their decision on what their loved one would choose, were he or she able to make the decision—that is, “substituted judgment.” But a majority (n = 31, 77.5%) also agreed or

Discussion

Using scaled questionnaire items and open-ended items, this study examined how proxy decision makers for people with AD described and framed their use of best interests and substituted judgment in the research context. Contrary to our hypothesis that proxies would more strongly endorse the use of best interests than substituted judgment, this “either/or” hypothesis appeared too simplistic to capture the complex situation confronting alternative decision makers, as described later. We did,

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