The CMAI scale attempts to quantify qualitative data which was used to select participants. Results were therefore subjected to observer bias and individual interpretation. This may have been avoided in a randomized and case-controlled study.
Were there many refusals, withdrawals, dropouts, or deaths?
Participation bias
Research ethics concerns.
Was the informed consent obtained?
Were the participants reasonably able to take part?
Was the study potentially/actually harmful to participants/others?
List any ethical issues that are of concern to you as a reader and potential user of the research (e.g., truthfulness, confidentiality, coercion).
Informed consent was acquired from families and proxies, however, it was not obtained from the test subjects.
Setting.
What was the environment in which the data were collected?
Other: Long-term care facility for persons with dementia.
Experiment (if applicable).
What was the special treatment or intervention?
Throughout the sixteen week study, the subject’s CMAI was completed every other day in order to determine agitation levels and a baseline was established after two weeks of behavioural monitoring. Then, two drops of undiluted lavender oil (relaxant) was applied to a fabric sachet every three hours, three times per day, and pinned near the subject’s clavicle. Lavender was replaced with thyme oil (stimulant) for two weeks and was followed by a placebo (unscented grapeseed oil) lasting another two weeks. A second cycle of thyme and lavender was done, and the study concluded after two weeks of post-treatment agitation monitoring.
Did the participants in the study know whether they received the intervention or a placebo?
What methods, if any, were used to “blind” the participants, staff, and data collectors from knowledge about the study that might influence the results?
The residents were most likely unaware as to the effects of the different oils used at different stages of treatment, due to cognitive impairment. It was unclear if the nursing staff were aware of the expected outcomes and whether the same staff were consistently used to monitor and measure agitation levels.
Was there any contamination or mixing of treatments across the study groups?
Were there any other factors related to the intervention/treatment that might have influenced the outcomes?
Performance bias occurred due to the nursing staff’s role in the study. Also, it was unclear whether the subjects were cognizant to the different treatments they were receiving. Thus, the study would have benefited from a double-blind method of testing.
Data collection.
What was the data collection method/tool used?
Were methods used to insure that data were reliably collected (e.g., differences between rater, differences between times of measurement)?
Yes • No • Not reported
If yes, what were they?
Not applicable.
Were methods used to ensure the validity of the collected data (e.g.,...
