Assessing capacity to consent for research in cognitively impaired older patients

Abstract

BackgroundThe number of clinical trials including older patients, and particularly patients with cognitive impairment, is increasing. While statutory provisions exist to make sure that the capacity to consent is assessed systematically for each patient, many gray areas remain with regard to how this assessment is made or should be made in the routine practice of clinical research.ObjectivesThe aim of this review was to draw up an inventory of assessment tools evaluating older patients’ capacity to consent specifically applicable to clinical research, which could be used in routine practice.MethodsTwo authors independently searched PubMed, Cochrane, and Google Scholar data-bases between November 2015 and January 2016. The search was actualized in April 2017. We used keywords (MeSH terms and text words) referring to informed consent, capacity to consent, consent for research, research ethics, cognitive impairment, vulnerable older patients, and assessment tools. Existing reviews were also considered.ResultsAmong the numerous existing tools for assessing capacity to consent, 14 seemed potentially suited for clinical research and six were evaluated in older patients. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) was the most frequently cited.ConclusionThe MacCAT-CR is currently the most used and the best validated questionnaire. However, it appears difficult to use and time-consuming. A more recent tool, the University of California Brief Assessment of Capacity to Consent (UBACC), seems interesting for routine practice because of its simplicity, relevance, and applicability in older patients.

Geriatricians’ Standpoint Regarding the Informed Consent Process among Patients with Alzheimer's Disease: The Lebanese Context

“…Testing of the DMC is used to determine the extent of an individual's independence 13 . Therefore, making judgments based on only one parameter would be erroneous 13 .…”

“…Testing of the DMC is used to determine the extent of an individual's independence 13 . Therefore, making judgments based on only one parameter would be erroneous 13 . However, ndings showed that the Geriatrician relied only on one method while testing the DMC, either a tool or clinical experience.…”

“…Moreover, UBACC is potentially useful for screening purposes, and not to come up with nal judgments 15 . Similarly, the sole use of clinical expertise to make a judgment of the patients' DMC was shown to be imprecise 13 .…”

“…The UBACC is a potentially useful instrument for screening to identify those who are in need of more comprehensive decisional capacity assessment, and not to come up with nal judgments 15 . Moreover, many clinicians or researchers use solely their clinical experience to judge patients' DMC, however, this approach is imprecise 13 .…”

Consenso informato al trattamento medico: valutazione della capacità decisionale del paziente anziano

“…The patient needs to be able to express a treatment choice, and this decision needs to be stable enough for the treat- The use of structured approaches to assess these abilities can be very helpful for termined cutoff separating capacity and incapacity and appears difficult to use and time-consuming [11] . istics [4] .…”