By David Miller, MD, Clinical Vice President at Bracket
Cognitive and Functional outcomes are generally the co-primary endpoints in most symptomatic and disease-modifying clinical trials of Alzheimer’s disease. But Quality of Life (QOL) is an important component in understanding the disease, and measuring it can be difficult.
There are a handful of measures currently used in clinical trials to evaluate QOL. However, like other clinical outcomes in Alzheimer’s disease, there are unique challenges to understand QOL and difficulties to measure its change.
One important consideration is that as the dementia progresses, insight worsens. Therefore, determining when a reported change is real and when it it’s colored by diminished insight can prove challenging. Often, caregivers are asked to serve as a proxy for the patient. However, this raises the question of when in the illness course the patient’s insight is better (earlier in the course) and when the caregiver’s becomes more reliable.
A recent article in Alzheimer’s & Dementia examined some of the issues relative to these challenges. In this study, the researchers examined a cohort of patients and caregivers and analyzed both patient and caregiver reports of QOL to try and better understand the differences. There were several important results in this study, including this;
Older patient age was associated with overestimation of QOL by caregivers, whereas neuropsychiatric inventory score and caregiver burden were associated with underestimation.
At Bracket, we’ve focused on making sure the QOL outcome measures are implemented in a valid and reliable way. Clear and concise training for investigators and raters on how QOL information should be collected is essential. Distinguishing between patient and proxy versions is important, as is effectively outlining how the sponsor company wants caregivers to provide the information. For example, distinguishing for a caregiver between their own estimate of a patient’s health OR their estimate of how the caregiver thinks a patient would answer on their own, if they could. Generally, the way QOL is handled is specified in the protocol – whether subject and/or proxy – and is not left up to the rater to decide which way to administer it.
These nuances are important, and are incorporated into Bracket’s customized training programs. Through effective training and remediation efforts, hopefully researchers are better prepared for handling these issues when they arise with their patients in a clinical trial.
FULL CITATION: Assessing Alzheimer’s disease patients’ quality of life: Discrepancies between patient and caregiver perspectives
JOURNAL: Alzheimer’s & Dementia. Volume 12, Issue 4, Pages 427–437
AUTHORS: Sandrine Andrieu, Nicola Coley, Yves Rolland, Christelle Cantet, Catherine Arnaud, Sophie Guyonnet, Fati Nourhashemi, Alain Grand, Bruno Vellas the PLASA group