Willingness to Participate in Alzheimer Disease Research and Attitudes Towards Proxy-Informed Consent: Results From the Health and Retirement Study

Ayalon, Liat

doi:10.1097/jgp.0b013e31818cd3d3

Cited by 19 publications

(21 citation statements)

References 25 publications

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“…Written informed consent included a description of the study design, benefit and possible side effects of the trial. We took into consideration that even individuals with mild cognitive impairment might have impaired capacity to consent to research (Warner and Nomani, 2008; Ayalon, 2009) and obtained informed consent from all patients and all surrogates/caregivers or the authorized legal representatives. Caregivers also gave consent to participate as informants.…”

Section: Methodsmentioning

confidence: 99%

Impact of a stepwise protocol for treating pain on pain intensity in nursing home patients with dementia: A cluster randomized trial

Sandvik

Selbæk

Seifert

et al. 2014

European Journal of Pain

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BackgroundPain is frequent and distressing in people with dementia, but no randomized controlled trials have evaluated the effect of analgesic treatment on pain intensity as a key outcome.MethodsThree hundred fifty-two people with dementia and significant agitation from 60 nursing home units were included in this study. These units, representing 18 nursing homes in western Norway, were randomized to a stepwise protocol of treating pain (SPTP) or usual care. The SPTP group received acetaminophen, morphine, buprenorphine transdermal patch and pregabalin for 8 weeks, with a 4-week washout period. Medications were governed by the SPTP and each participant's existing prescriptions. We obtained pain intensity scores from 327 patients (intervention n = 164, control n = 163) at five time points assessed by the primary outcome measure, Mobilization-Observation-Behaviour-Intensity-Dementia-2 (MOBID-2) Pain Scale. The secondary outcome was activities of daily living (ADL). We used a linear intercept mixed model in a two-way repeated measures configuration to assess change over time and between groups.ResultsThe SPTP conferred significant benefit in MOBID-2 scores compared with the control group [average treatment effect (ATE) −1.388; p < 0.001] at week 8, and MOBID-2 scores worsened during the washout period (ATE = −0.701; p = 0.022). Examining different analgesic treatments, benefit was conferred to patients receiving acetaminophen compared with the controls at week 2 (ATE = −0.663; p = 0.010), continuing to increase until week 8 (ATE = −1.297; p < 0.001). Although there were no overall improvements in ADL, an increase was seen in the group receiving acetaminophen (ATE = +1.0; p = 0.022).ConclusionPain medication significantly improved pain in the intervention group, with indications that acetaminophen also improved ADL function.What's already known about this topic?Many people with dementia experience pain regularly, but are not able to communicate this to their carers or physicians due to the limited self-report capacity inherent in the symptomatology of dementia.Few studies have investigated the direct effect of pain treatment on pain intensity in patients suffering from dementia, with previous studies using proxy measures of behavioural symptoms.What does this study add?A stepwise protocol to treat pain in nursing home residents with moderate to severe dementia significantly reduced pain intensity.Pain treatment by acetaminophen improved activities of daily living.There is an urgent need for a standardized approach to assessment and treatment of pain for nursing home residents with dementia.

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Section: Methodsmentioning

confidence: 99%

Impact of a stepwise protocol for treating pain on pain intensity in nursing home patients with dementia: A cluster randomized trial

Sandvik

Selbæk

Seifert

et al. 2014

European Journal of Pain

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“…The findings on risk tolerance in the AD literature are mixed, often varying depending on the probability and magnitude of benefit. For example, Oremus and colleagues [34] found that most caregivers were unwilling to accept moderate side effects such as headache or nausea, while other studies showed that many older adults would accept a chance of severe side effects such as death or brain inflammation [35,36]. As there are many aspects of risk tolerance that should be addressed, including the nature of the side effects and the risk-benefit ratio, further investigation into this issue in the context of dementia clinical trials is warranted.…”

Section: Discussionmentioning

confidence: 99%

When Patient Engagement and Research Ethics Collide: Lessons from a Dementia Forum

Robillard

Feng

2017

JAD

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Abstract. The importance of patient engagement in research has been gaining recognition since the turn of the 21st century. However, little is known about the perspectives of people with dementia on the process of discovery. To fill this gap and to inform priorities in patient engagement in the context of dementia research, the Clinic for Alzheimer Disease and Related Disorders at the University of British Columbia hosted an interactive session for members of the patient community and of the general public to share their views on various ethical aspects of the research process. Results from the session indicate that several current research ethics policies and norms in dementia research are not in line with participants' preferences. Here we discuss the importance of bridging the gap between researchers and patients and call for reforms in current standards of dementia research.

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“… §§§ Kim et al 2009 and Ayalon 2009 rely on the same data but report slightly different numbers due to methodology. We use the numbers reported by Kim et al…”

Section: Tablementioning

confidence: 99%

Using Data to Improve Surrogate Consent for Clinical Research with Incapacitated Adults

Abdoler

Wendler

2012

Journal of Empirical Research on Human Research Ethics

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Current practice relies on surrogates to enroll incapacitated adults in research. Yet, it is unclear to what extent this practice protects adults who have lost the ability to consent for themselves. To address this question, we conducted two literature searches to identify articles which report empirical data on three issues central to protecting adults who have lost the ability to consent: (1) adults’ willingness to participate in research should they lose the ability to consent; (2) adults’ willingness to allow a surrogate to make research decisions for them; and (3) the extent to which surrogates’ enrollment decisions are consistent with their charges’ preferences and values. These searches identified 21 articles, representing 20 distinct datasets. The data indicate that many adults are willing to participate in research should they lose the ability to consent, and many are willing to allow their family members to make research decisions for them if they become incapacitated. The data also raise concern that surrogates may be making research enrollment decisions that, in some cases, are inconsistent with their charges’ preferences and values. These findings suggest that modifications to current practice should be considered to better protect adults who have lost the ability to consent. One option would be to require, in addition to surrogate permission and subject assent, sufficient evidence that enrollment is consistent with the individual’s preferences and values.

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Willingness to Participate in Alzheimer Disease Research and Attitudes Towards Proxy-Informed Consent: Results From the Health and Retirement Study

Cited by 19 publications

References 25 publications

Impact of a stepwise protocol for treating pain on pain intensity in nursing home patients with dementia: A cluster randomized trial

Impact of a stepwise protocol for treating pain on pain intensity in nursing home patients with dementia: A cluster randomized trial

When Patient Engagement and Research Ethics Collide: Lessons from a Dementia Forum

Using Data to Improve Surrogate Consent for Clinical Research with Incapacitated Adults

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