Assessment of Cognitive Impairment in Older Research Participants
Journal Title: Biomedical Journal of Scientific & Technical Research (BJSTR) - Year 2017, Vol 1, Issue 3
Abstract
In any clinical trial or observational study, a certain level of cognitive function is required in order to ensure participant safety and ability to comply with the study protocol. Participants should adequately understand what is involved in their participation, as well as any potential risks or benefits of participation. The costs of using a specific screening method, however, need to be weighed against the information obtained. This prevents the inefficient use of available resources, such as avoiding assessments that require an extremely long administration time and unnecessarily increase participant burden. Due to the inherent challenges in obtaining a valid assessment of cognitive function in a time efficient manner, all potential assessment measures should be evaluated with a “best fit” approach. Keeping this “best fit” approach in mind, we reviewed and evaluated a number of screening tests for assessing cognitive impairment based on recommendations provided by experts in the field. Based on our review, we provide recommendations about existing methods for screening cognitive function in older research participants. Using the “best fit” approach, we would recommend the Mini-Mental State Examination (MMSE) to screen for cognitive impairment in older research participants. Other measures, such as the Cognitive Abilities Screening Instrument (CASI) and Modified Mini-Mental State (3MS), are indeed promising, but the MMSE can be administered in a time efficient manner and has the highest amount of supporting literature.In any clinical trial or observational study, a certain level of cognitive function is required in order to ensure participant safety and ability to comply with the study protocol. Participants should adequately understand what is involved in their participation, as well as any potential risks or benefits of participation. Although studies involving simple surveys or questionnaires may not require as careful screening as potentially higher risk studies(e.g., pharmacological interventions), [1] it is always necessary to ensure the participant fully understands the potential risks involved before agreeing to participate in the study. Age has been found to be significantly associated with cognitive decline [2,3] thus cognitive function and understanding of study risks and procedures should be carefully assessed in studies involving adults who are 60 years and older [4]. Careful assessment of cognitive function in older research participants, as well as screening for mild cognitive impairment, could help to prevent incidents such as an accidental overdose resulting from a previously forgotten dose being taken. Ensuring that the participant is capable of adhering to study protocols can prevent inappropriate requirements from being placed on the participant. Additionally, screening for cognitive impairment benefits the scientific community at large; ensuring that participants fully understand what they are agreeing to is vital for ethically sound science.
Authors and Affiliations
Robbie Ingram, Robert Fieo, Stephen D Anton
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